DC Medical Malpractice & Patient Safety Blog

Last year, a group of doctors at New York’s Memorial Sloan-Kettering Cancer Center refused to prescribe Zaltrap, a new colon cancer drug, because it was twice as expensive as another drug and was not demonstrably more effective. The drug’s manufacturer cut the price in half.

A second drug protest last month, according to the New York Times, involved scores of cancer specialists from around the world in a united effort to persuade pharmaceutical companies to reduce prices on cancer drugs whose annual cost can be horrific.

Writing as a group in Blood, the journal of the American Society of Hematology, the doctors and researchers claimed that the prices of drugs used to treat myeloid leukemia, a cancer of the blood, are astronomical and unsustainable.

And immoral? How else would you describe a drug whose cost can exceed $100,000 … for a year?

The writers, said The Times, suggest that charging such exorbitant prices for a medicine necessary to save lives amounts to profiteering; that it’s gouging people who have no alternative.

So many medical professionals from so many countries (15) signifies that doctors, who can be remarkably ignorant of the cost to patients and insurers of some of their treatment, are starting to get it. As The Times reported, “[S]ome of the specialists even include researchers with close ties to the pharmaceutical industry.”

Many cancer drugs are expensive, but as chronic myeloid leukemia specialists, the journal writers were able to speak only to the medicines used in their field. One, called Gleevec, is a big moneymaker for its manufacturer, Novartis—sales in 2012 were $4.7 billion, making it the company’s best-selling drug. According to The Times, a newer Novartis leukemia drug, Tasigna, generated $1 billion.

The company, according to The Times, says few patients pay the full cost of Gleevec and that it’s priced so high because of the considerable expense in developing it, and because price reflects its value to patients.

So, if we’re interpreting the last point properly, the sicker you are, the more desperate you are, the more you should pay to get better?

When it came onto the U.S. market in 2001, Gleevec cost about $30,000 a year, the writers said. Since then, the price has tripled while newer, even more expensive drugs have also entered the market. As The Times noted, Gleevec’s cost recently came under the scrutiny of the Supreme Court in India, which ruled that it could not be patented. That was good news for manufacturers of generic versions, and patients who need them.

The intent of the Blood writers was to raise cost consciousness and initiate a dialog among manufacturers and members of the medical/insurance communities about controlling drug costs. Many of the 120-some writers work with pharmaceutical companies to develop and test new drugs. As we’ve noted many times, these financial relationships often are fraught with conflicts of interest. So it’s refreshing that this group, which supports a successful pharmaceutical industry, also believes that its prices are much higher than they need to be.

“If you are making $3 billion a year on Gleevec, could you get by with $2 billion?” Dr. Brian Druker, who was the primary academic involved in developing the drug, told The Times. “When do you cross the line from essential profits to profiteering?”

One co-author of the Blood article told The Times he knew several researchers who declined to become authors for fear of losing research money from the industry. The lead author agreed that was a risk. “I am sure I am going to be blackballed,” he said. “My research career will be hurt.”

But, he told The Times, it was time to speak out. “Pharmaceutical companies have lost their moral sense. [Prices] are getting to the point where it is becoming unsustainable.”

Representatives of Novartis said that the company provided Gleevec or Tasigna free to 5,000 uninsured or underinsured Americans each year, and that it has provided free drugs to more than 50,000 people in low-income countries.

But the writers said that despite these programs, most of the estimated 1.2 million to 1.5 million people in the world with chronic myeloid leukemia weren’t receiving the drugs. In some developing nations, cancer experts advocate risky bone marrow transplants because that one-time procedure is less expensive than continuing drug therapy.

The article also said the survival rate for U.S. patients appeared to be less than it should be, maybe because patients can’t afford the medicine. The drugs cost twice as much in the U.S. as in many other countries. And even if some patients have low out-of-pocket drug expenses, somebody in the health system has to pay, so the cost is just shifted, not necessarily reduced. And the writers say that some patient subsidy programs are difficult to use.

Raven Riedesel told The Times that she had been denied by various charities because her husband, a pipe fitter, makes too much money. But their insurance would require a $1,200 to $1,600 a month co-payment for Tasigna. She hadn’t yet approached Novartis itself.

“It would take everything that we had left over after buying necessities and paying our bills,” she told The Times. Now she’s in a clinical trial where she gets Tasigna free. It ends in November.

No one would ever describe “surgery” as a walk in the park, but if being operated on resolves a problem or makes it less bad, it can be worth the risk, trouble and discomfort. But what if you undergo surgery to resolve a problem you never had?

According to a preliminary paper presented earlier this month at the annual meeting of the American Association for Cancer Research, nearly 1 in 10 people having this surgery in fact have a benign disease; that is, they had surgery unnecessarily. About 2 in 100 of the patients with the benign condition died in the hospital after the lung surgery.

A couple of factors contribute to this troubling and wasteful medical “care.” One big one is a screening test that seems to indicate the presence of cancer, but in fact is a false positive. Last year we wrote about the abundance of this kind of misdiagnosis in lung cancer screenings.

The study was reported on MedPageToday. Although the average rate of benign lung disease is high, rates vary widely from state to state—Vermont registered the lowest (1.3%), and Hawaii had the highest (25%). And women were somewhat more likely to have the benign condition than men—9.8% to 8.5%.

The study was inspired by the National Lung Screening Test, which showed in 2010 that CT scans were superior to chest X-rays to reduce deaths from lung cancer, and which boosted the profile of the diagnostic scans.

But nearly 1 in 4 lung surgeries in that study resulted in a diagnosis of benign disease.

The new study relied on data from a single year for more than 25,000 patients who had surgery for known or suspected lung cancer. It examined the geographical variations for patterns that might inform a best-practice approach for successful screenings—those that find cancers without unacceptable rates of false-positives.

One reason there’s so much variation among the different states might be simply a matter of local standards of care. Patients in some places go into surgery much faster after a suspicious test than in other places. Speed, suggested the authors, might cause more errors.

Some places have higher incidents of certain disorders that might complicate things. One, for example, is histoplasmosis, a fungal infection found in humid areas. It can cause an imaging result that looks like it might be lung cancer.

Now, the researchers are studying data from several years to see if the rate of benign disease changes over a longer period of time. They’re also focusing on associations between benign disease rates and the prevalence of disease-causing fungi by region.

They’re trying to tease out the difference between the cultural practices of certain areas that would lead to higher rates of benign disease versus actual differences in the incidence of it from place to place.

Once you can tell the difference between a false-positive caused by hasty or misinformed medical practices from those caused by, say, an environmental organism, you can hone your screening recommendations to people who would benefit most.

Dr. Louis Weiner, who was not involved in the study, is affiliated with Lombardi Comprehensive Cancer Center at Georgetown University. His analysis? "This is information and information doesn't become powerful until you can convert it into knowledge."

If your doctor prescribes a screening test, ask:

• What are the possible benefits?


• What are the possible harms?


• How often do harms occur?


• Are there alternative tests?

For a long time, women were advised to get annual pap smears, especially if they had ever been diagnosed with HPV (human papillomavirus), a common sexually transmitted disease. Now, says the American Society for Colposcopy and Cervical Pathology, longer intervals are recommended—every five years for women 30 to 64, and those screenings should include both HPV and cervical cell anomalies (cytology).

The guidelines were published in the journal Obstetrics and Gynecology.

An accompanying editorial raised the same concerns of over-PSA testing: "In a move toward safety, the guidelines discourage intensive evaluation and treatment of women ages 21 to 24 years who have minimally abnormal cytology, a group at low risk of cancer but with a substantial risk of harm."

Sometimes, like prostate cancer, cervical lesions often regress on their own, without aggressive treatment.

The guideline, as described on MedPageToday.com, advised women who have tested negative for HPV and positive for atypical squamous cells of undetermined significant (ASCUS) to be screened for cytology and HPV at three-year intervals. ASCUS is the most common abnormal test result, but it isn’t usually associated with HPV and, as MedPageToday said, “carries low risk for invasive disease.”

For women with ASCUS who haven’t been tested for HPV, screening should be more frequent initially—once a year—but after a negative test it can be repeated at three-year intervals.

Women older than 65 with ASCUS, however, should be screened annually.

Positive results from a Pap test can fall into several different pathologies, some requiring more frequent follow-up than others. So, as always, individual diagnoses determine individual screening guidelines. But, in general, Pap tests needn’t be repeated as frequently as once thought.

Adopting that practice, however, is challenging because, as noted in another study reported on MedPageToday, “Most physicians wanted female patients to undergo cervical cancer screening more frequently than recommended under published guidelines, …”

That was the conclusion of a government survey of physicians published in JAMA Internal Medicine. As many as 8 in 10 doctors surveyed said they would recommend women with normal Pap tests and negative HPV tests be rescreened in three, instead of the now-recommended five, years.

In an accompanying editorial headlined “Swimming Upstream,” Dr. Michael LeFevre said that the study results show that "doing less" in medicine remains challenging for doctors even if scientific evidence indicates that approach is best for most patients.

"It is important to acknowledge that getting physicians to do less testing and patients to accept less testing in many clinical situations is like swimming upstream; it is hard,” said LeFevre. “The forces to do more rather than less, particularly for 'early detection' of asymptomatic disease, are powerful."

Our cultural belief that medicine does only good is the culprit here. But it seems to us that when you’re a doctor, you’re obliged to let science, not momentum, be your guide.

LeFevre believes that "some overuse of diagnostic testing in general and screening specifically" is the result of doctors worrying that if they don’t test they leave themselves open to charges of malpractice. And that lawsuits claiming excessive testing are not a compensating concern. This continuing refrain doesn’t get any truer by virtue of repetition.

He also explains that the fee-for-service payment model encourages overtesting because it means a bigger paycheck. Again, when the profit motive, not science, is your guide, the patient pays, figuratively and literally.

We agree with LeFevre’s conclusion that although screening tests will benefit some patients, "blind adherence to doing more whenever there is a possibility of good, no matter how remote that possibility is or how much harm is done in the process, should not be our approach."

If you have been screened for prostate or cervical cancer, or HPV, and your doctor advises rescreening more frequently than these guidelines, find out why. Know your test results, and what they mean.

The value of two regular common screening tests—for prostate and cervical cancers—were called into question earlier this month by yet more professional medical associations. Today we'll report on prostate cancer screening with the PSA test. Tomorrow: Pap tests for cervical cancer.

A statement issued by the clinical guidelines committee of American College of Physicians (ACP) said, “The potential harms of PSA testing outweigh the benefits for most men, such that testing should occur only after a careful discussion between physician and patient …”

Readers of this blog are familiar with the evolving awareness of potential harms from the prostate specific antigen (PSA) test. Although one life is saved for every 1,000 people screened over a 10-year period, more than 100 of those same 1,000 men will produce suspicious results when there is either no cancer or a cancer that is growing so slowly (or not at all) as to produce no threat.

For most men, a positive test means having a biopsy, whose risks include pain, fever, bleeding, infection and hospitalization. If cancer is detected, 9 in 10 men will have surgery and/or radiation even when the tumors are not life-threatening. Their side effects include impotence, urinary incontinence and blood clots.

"ACP recommends that clinicians should not screen for prostate cancer using the prostate-specific antigen test in patients who do not express a clear preference for screening," the panel said.

As explained on MedPageToday.com, the guideline statement is a melding of recent recommendations issued by other groups, including the American College of Preventive Medicine (ACPM), American Cancer Society (ACS), American Urological Association (AUA) and the U.S. Preventive Services Task Force (USPSTF).

The USPSTF doesn’t recommend routine PSA screening, but for men who choose to have the test, it advises that they being fully informed of the benefits and harms.

"Studies have shown,” said the ACP statement, “that up to one-third of men screened for prostate cancer were unaware that they were being tested, and many men who were aware that they were tested do not receive an adequate discussion of the benefits and harms of screening."

The ACP panel says doctors should address these issues with every patient:

• PSA testing is controversial.


• PSA tests can detect prostate cancer, but for most men, the harms outweigh the benefits.


• Relatively few prostate cancers prove to be aggressive and cause death; most are likely to be slow-growing and nonfatal.


• Most men who are not screened do not develop prostate cancer and die of other causes.


• Men who choose to be tested are much more likely to have prostate cancer diagnoses compared with men who decline to be screened.


• PSA tests do not distinguish between serious and nonserious cancers.


• At most, PSA testing prevents one prostate cancer death per 1,000 men screened after 11 years of follow-up.


• Screening can lead to many potential harms, some of them serious (including unnecessary biopsies and surgery).


• PSA testing can "open the door to more testing and treatment that a man may not actually want and that may actually harm him."


• Ongoing studies will provide more information about PSA testing, and recommendations might change.

Men at high risk—those with a family history of prostate cancer, smokers, the obese, African Americans, those older than 65—also should engage in the shared decision, said the ACP. The panel said there’s a lack of evidence that screening high-risk patients changes outcomes appreciably as compared with screening average-risk men.

Guidelines for how often women should get pap tests, which are used to detect cervical cancer, were updated this month as well. More on that in our next blog.

Talk about extremes. Last month we championed an exhaustive examination published in Time magazine of how health-care costs are unnecessarily inflated. But Time’s April 1 cover story, “How to Cure Cancer,” is more of an April Fool’s joke than a conscientious news story. It has been judged by Slate.com’s Seth Mnookin as possibly the worst magazine cover of the year.

And that might be a compliment.

The normally careful Time has indulged in the all-too-common media practice of medical news hype. As Slate says, “Time’s coverline is wrong, grandiose and cruel.”

The clarion cover title is followed by an asterisk directing readers to a smaller sub-headline that reads, “Yes, it’s now possible, thanks to new cancer dream teams that are delivering better results faster.”

It’s as if Time wants to reinforce its idiocy: That claim is demonstrably false.

As Mnookin points out, of course there have been advances in the diagnosis and treatment of cancer. But he estimates that 580,000 Americans will die this year from cancer, a number higher than fatalities from chronic lower respiratory diseases, strokes, accidents, Alzheimer’s disease and diabetes combined. Our success in treating tumors in late-stage cancers is, as he quotes the director of Yale’s Biology of Reproductive Tract Cancers Program, “abysmal.”

Time compounds its error by focusing on a foundation established by entertainment industry figures seeking to speed up cancer cures by funding collaborative research that will produce results in three years. As we noted in our April Patient Safety newsletter, superior, substantial results take time; they require an investment not only of money, but patience.

Granting so much magazine acreage to an organization that believes curing cancer is taking too long largely because the research community is fragmented and competitive is incomplete reporting and misleading. “There’s the potential for a real impact [on developing new cancer treatments] if there’s organizational momentum to pick up scientific strands, political strands, and epidemiological strands and weave them together,” Siddhartha Mukherjee told Slate. He’s a Columbia University hematologist and oncologist who wrote the Pulitzer Prize-winning book, “The Emperor of All Maladies: A Biography of Cancer.” “But to what extent were organizational barriers keeping us from having more successful solutions against various cancers?” he asked. “This is not just an organizational problem.”

Time’s is only the latest bully pulpit pronouncement that put the cancer-cure cart in front of the horse. As Mnookin points out, even the former director of the National Cancer Institute boasted in 2003 that the NCI would “eliminate suffering and death” from cancer by 2015.

The harm in such exaggeration is that people either stop taking even realistic claims seriously, or fail to pay attention at all. The harm is that funding for future cancer research could be compromised. The further harm is that outrageous claims are hurtful to people who are suffering from cancer, and their loved ones.

“It made me bristle,” Lisa Bonchek Adams told Slate. The 43-year-old mother of three has Stage IV breast cancer. “It means getting messages and calls from people pointing to that and saying, ‘See, you need to have hope—there’s going to be a cure.’ ”

It’s not true, “at least not for me,” she said. “Talking about a sudden cure—it’s magical thinking. My hope is not for a cure, it’s for treatment that can help people with side effects and ultimately treatment that may make this a manageable disease.”

But as Mnookin concludes, “that doesn’t make for a snappy coverline—although it does have the virtue of being true.”

The public lost the latest round of safety versus commerce when the federal government gave up its effort to require cigarette manufacturers to include prominent images on cigarette labels warning of the dangers of smoking.

As reported last week by the Washington Post, the FDA decided it couldn’t make a court-imposed deadline, and succumbed to the formidable opposition by the tobacco industry. (We recently wrote about the ongoing shiftiness of this industry.) Two years ago, the agency announced it would compel tobacco companies to include grisly images such as disease-riddled lungs, a smoker’s corpse and a man exhaling smoke through a tracheotomy hole in his throat on all cigarette packages.

The labels also were supposed to include the stop-smoking hotline telephone number, (800) QUIT-NOW.

The FDA, according to The Post, said it would “undertake research to support a new rulemaking consistent with the Tobacco Control Act.” That’s the 2009 law requiring the agency to find ways to reduce the estimated 440,000 annual deaths attributable to tobacco use. We also wrote recently about how states' budget cuts are compromising their ability to help smokers quit the lethal habit.

Big Tobacco, with its unlimited resources and zeal to keep people hooked on its deadly products, sued the FDA after it initiated the requirements in 2011. The industry said the required labels were too broad and violated its First Amendment rights. A federal judge issued a temporary injunction late that year, and in early 2012 ruled in favor of tobacco. He said that the proposed labels went too far, and were “neither designed to protect the consumer from confusion or deception, nor to increase consumer awareness of smoking risks.”

He said they were intended, according to The Post, “to evoke emotional responses that would provoke people to quit smoking or never start.”

In his ruling, he wrote that “an interest in informing or educating the public about the dangers of smoking might be compelling,” but that “an interest in simply advocating that the public not purchase a legal product is not.”

Last summer he was upheld by the U.S. Court of Appeals on the grounds the requirements breached the First Amendment. The government decided it couldn’t meet the deadline to appeal that ruling to the U.S. Supreme Court.

Several countries use horrifyingly graphic labels on cigarette packages. A World Health Organization survey, according to The Post, found that they were more effective as a deterrent to smoking than labels that issue warnings only in text.

Two treatments are proven to lengthen the lives of women with ovarian cancer, but only 1 in 3 patients gets them, according to a new study. It's no mystery why. The old rule for better health care -- experience, experience, experience -- is proven out again.

Ovarian cancer is a bone-scary diagnosis because of its dismal prognosis. But the understandable fright causes many women to make illogical moves when they reach out for care: First, they often look to a familiar face for treatment, such as the obstetrician who birthed their children (who usually is qualified on paper to take out ovaries, but lacks big-time experience with ovarian cancer). Second, they think they have to get surgery in a matter of days, not weeks, and that leads them to grab onto whatever surgeon can see them first.

These are mistakes that can shorten lives. The two treatments that are shown to lengthen life of ovarian cancer patients are:

* Debulking surgery.

* Chemotherapy delivered directly to the inside of the abdomen, called intraperitoneal (IP) chemo.

The best advice for women with a new diagnosis of ovarian cancer is to get to a "center of excellence" for cancer treatment, and to make sure the surgery is done by a gynecologic oncologist. That's a gynecologist with extra training in women's cancers of the reproductive organs.

Also, make sure the surgeon does ovarian debulking surgeries at least about once a month, or a dozen times a year. The operation often takes six or more hours, and it's necessary to have a surgeon with the skill, experience and meticulous patience to take out all visible signs of the cancer from inside the lower abdomen.

The seeds of cancer are scattered like Rice Krispies, and the best result is for those women who get all visible cancer removed by the surgeon, and then get the pelvis washed out with IP chemo.

Read more about this in a takeout in the New York Times by Denise Grady.

“The medical arena, like society at large, is permeated with self-interest,” says Dr. Michael Kirsch writing on MDWhistleblower, a website whose name pretty much tells you where he’s coming from.

Like us, he’s a big supporter of comparative effectiveness research, which means comparing different treatments for a given illness and compiling a body of knowledge from which doctors and patients can choose the best option for a given case. And in the case of colonoscopy, an invasive procedure whose benefits vs. risk we’ve addressed before, this expert has a boatload of doubt.

As described by Gary Schwitzer on HealthNewsReview.org, Kirsch’s essay “Is Colonoscopy the Best Colon Cancer Screening Test?” manages to address “medical conflicts of interest, comparative effectiveness research, the medical arms race, medical marketing and more,” all within a few hundred words.

Kirsch starts by describing the absolute adoration his profession has for the latest medical tool or technology, and how this lust is ripe for conflict of interest. “In medicine, every heath care reform, new medicine, new medical device or revised medical guideline is at some constituency’s expense,” he says. “Recognizing and dismantling conflicts of interests is one of our greatest challenges and threats. “

Practitioners and medical facilities love new medical developments not only for their therapeutic potential, but because they can be used to market somebody’s practice or hospital. “Large medical institutions will spend mightily for the latest high-tech robotic laser shooting burger-flipping tumor ray gun, even if (especially if) the competitor across the street already has one,” Kirsch writes. That, he says, is a “model of overtesting and overtreatment,” and leads to a “culture of excess.”

In the case of his field, gastroenterology, Kirsch is clear. Age 50, he says, is when “we pounce upon you to scour your colon to remove cancers-in-waiting. While we champion this test, and sincerely believe in its worth, it is not ideal.”

If the benefit is possible diagnosis of potential cancer, here, according to Kirsch, are some drawbacks:

• the pre-colonoscopy cathartic cocktail;


• anxiety;


• discomfort (it’s not always painless);


• cost;


• risk of complications (like a perforated bowel);


• high rate of negative results;


• loss of a day’s wages;


• the need for a driver to bring you home.

Unlike a colonoscopy, which involves inserting a probe in the rectum and snaking up through the bowel, a CAT scan is not invasive—it takes pictures (cross-section X-rays) while the patient lies motionless on the table.

Right now, colonoscopy is winning the match because patients who choose the CAT scan option still have to swallow that gacky laxative before the test, and if polyps are discovered, they can’t be removed—patients have to undergo another treatment. So colonoscopy has the advantage now because nearly all polyps discovered can be removed during the test.

But, Kirsch writes, “If radiologists perfect the technique of performing a CAT colonography without any required laxatives, then the scales may tip in their favor.”

And he believes that both colonoscopy and CAT colonography will lose favor while he’s still practicing medicine. “Colonoscopy,” he suggests, “will still be performed, but only when some kinder and gentler screening test indicates that an individual has a high probability of harboring polyps. It will no longer be wielded in a buckshot fashion. The number of colonoscopies being performed will be decimated.”

“When that happens,” he concludes with refreshing honesty, “it will not be good news for the Kirsch family. But, it will be greater good news for everyone else’s family.”

Although it has many supporters (also known as nicotine addicts), the tobacco industry has few friends. That’s not only because it markets a lethal product, but because of its inability to cop to its health-corroding properties and its history of lying. According to the Centers for Disease Control and Prevention (CDC), tobacco use kills more than 400,000 people every year in the U.S.

Under the Master Settlement Agreement in 1998, as described by the California Department of Justice, seven tobacco companies agreed to change the way their products are marketed and pay the states an estimated $206 billion. They agreed to finance a $1.5 billion anti-smoking campaign, open previously secret industry documents and disband industry trade groups that state attorneys general said conspired to conceal damaging research from the public.

Fourteen years after the settlement, the annual study sponsored by the Campaign for Tobacco Free Kids reports that “states continue to spend only a minuscule portion of their tobacco revenues to fight tobacco use. The states have also failed to reverse deep cuts to tobacco prevention and cessation programs that have undermined the nation’s efforts to reduce tobacco use.” This is so even though in this budget year the states will collect a record $25.7 billion in revenue from the tobacco settlement and tobacco taxes.

The study concluded that states:

• will spend only 1.8 percent of the $25.7 billion ($459. 5 million) on programs to prevent kids from smoking and help smokers quit—that’s less than two cents of every dollar in tobacco revenue spent to fight its use.


• have failed to reverse deep cuts that reduced tobacco prevention funding by 36 percent from fiscal year 2008 to fiscal year 2012. The $459.5 million the states have allocated this year is the second lowest amount they have spent on tobacco prevention programs since 1999, when they first received settlement funds.


• are falling woefully short of recommended funding levels for tobacco prevention
  programs set by the CDC—only 12.4 percent of the $3.7 billion the CDC
  recommends for all the states combined.

In the last four fiscal years, federal funds for smoking prevention amounted to about $522 million. As The Times notes, tobacco companies spend $8 billion a year promoting their product.

Public health officials strongly believe that anti-smoking programs work. California’s smoking rate was above the national average 20 years ago; today it’s the second-lowest in the country. Officials attribute that decline to, as The Times puts it, “modest but consistent spending on programs that help people quit and prevent children from starting.”

According to the report, Washington State saved $5 in tobacco-related hospitalization costs for every $1 it spent during the first 10 years of its program.

But thanks to budget cuts, some states have as much as abandoned their efforts to curb smoking. State financing for North Carolina’s program has been eliminated, Ohio has not allocated any funds for its once-successful program and for three successive years Washington State has cut its program by about 90 percent.

Another threat to what has been a promising national effort to reduce smoking and its ill effects came in a court ruling earlier this month. An appeals court in Washington, D.C., reaffirmed a decision that forcing tobacco companies to put graphic warnings on cigarette packages violates their free-speech rights (see our post from August).

You might recall the shock value of the labels at issue—they included images of sewn-up cadavers and diseased lungs and gums. The images were approved by the FDA in 2011 and were to appear in September.

According to the Winston-Salem Journal, the court denied the FDA’s request to reconsider affirming the earlier ruling to block the images with a two-sentence order. “[T]he government has failed to carry both its burden of demonstrating a compelling interest and its burden of demonstrating that the rule is narrowly tailored to achieve a constitutionally permissible form of compelled commercial speech.”

“The graphic images are neither factual nor accurate.”

The FDA has 90 days to appeal, and if it does, the case goes to the U.S. Supreme Court.

In what some people might call an only-in-America episode, an Ohio federal appeals court in March upheld use of the graphic labels. Tobacco manufacturers, of course, have petitioned the U.S. Supreme Court to review the Ohio decision. The feds have until Dec. 26 to file a response, and it could be February at the earliest before the justices decide whether to take the case.

'Tis the season, apparently, for adjudicating tobacco cases. In November, a federal judge ruled that tobacco companies must spend their own money on an advertising campaign telling people that they lied about the dangers of smoking cigarettes. As described in a story by Reuters, this might be the harshest sanction arising from the 1999 Justice Department case accusing tobacco companies of racketeering.

The campaign will appear in various media for as long as two years. If that seems extreme, consider that the court referred to “past deception” by cigarette makers dating to at least 1964.

The judge ordered the advertising campaign in 2006, and six years later the companies are still arguing about the wording. And the tobacco companies could always appeal this decision, too. So it will be a while before any public act of contrition occurs. But here, according to Reuters, are a couple of the potential apologies:

• "A federal court has ruled that the defendant tobacco companies deliberately deceived the American public by falsely selling and advertising low tar and light cigarettes as less harmful than regular cigarettes."


• "Smoking kills, on average, 1,200 Americans. Every day."

If anyone still doubts that tobacco and tobacco smoke are harmful, consider a story recently published on ScienceDaily.com. “It is a known fact that active maternal smoking during pregnancy has negative effects on child health, such as attention deficit and hyperactivity disorder (ADHD),” it said, and “new research suggests that second-hand smoke, or environmental tobacco smoke (ETS), may be just as harmful.”

The study by researchers at the University of Pennsylvania School of Nursing examined data from 646 mother-child pairs in China, where more than 7 in 10 men smoke. One in 4 children whose mothers were exposed to smoke exhibited behavior problems compared to 16 in 100 children of unexposed mothers. The children whose mothers were exposed to passive smoke performed worse on speech, language skills and intelligence tests. They also showed more conduct disorders.

As the study’s lead author said, "The key message for pregnant women is to protect their growing fetus from exposure to second-hand smoke."

Stay tuned—although there is no doubt tobacco is a deadly product, the powerful forces that turn it into consumer goods have lots of money to indulge their irresponsible and venal instincts.

Chemotherapy, a frontline treatment for many forms of cancer, uses chemical agents to stop fast-growing cells from multiplying. That includes cancer cells, but also other fast-growing cells, which is why it has so many side effects. The chemicals do not discriminate between what’s cancer and what isn’t. Although chemotherapy sometimes can halt the progress of cancer, sometimes it can only slow it.

Sometimes cancer patients don’t understand the difference. Sometimes it’s because they don’t want to—they are in denial—and sometimes it’s because their doctors don’t communicate well. In the case of a terminal disease, this is very difficult conversational terrain, but it’s part of the job of a caregiver.

A recent story by Jane Brody in the New York Times put a fine point on this unpleasant situation.

She told the story of a woman dying of cancer whose oncologist considered delivering chemotherapy directly to her brain despite its significant risks and the fact that he knew it couldn’t help her. His explanation of what purpose a futile therapy would serve was, according to Brody, “I don’t want Judy to think I’m abandoning her.”

Dr. Diane E. Meier, an expert on palliative care, analyzed his approach. “To avoid feeling that they’ve abandoned their patients, doctors throw procedures at them,” she told The Times.

The instinct is compassionate, but it doesn’t, ultimately, help the patient. As Meier said, a better approach is to “restore the patient to the center of the enterprise.” Not only is it the right thing to do to help patients and their loved ones plan and prepare for the likely outcome of their illness, but it helps to stem the tide of overtreating and overspending on health care.

Dr. Marty Makary, author of “Unaccountable: What Hospitals Won’t Tell You and How Transparency Can Revolutionize Health Care,” pointed out that doctors also might be encouraged to prescribe chemotherapy because they get a commission.

A study recently published in the New England Journal of Medicine showed that many patients with incurable cancer don’t understand that chemotherapy does not cure the disease, that it’s only a palliative treatment; that is, one that relieves a problem, but doesn’t solve it.

The study, “Patients’ Expectations about Effects of Chemotherapy for Advanced Cancer,” involved nearly 1,200 patients with incurable lung or colon cancer. All were receiving chemotherapy. Seven in 10 of the lung cancer patients and 8 in 10 of the colon cancer patients didn’t understand that chemotherapy was unlikely to cure their cancer.

They were asked how well their doctors communicated with them. The chances of misunderstanding were twice as high among patients who rated their communication with their physician less favorably than it was among those who rated it favorably. The researchers concluded that “Many patients receiving chemotherapy for incurable cancers may not understand that chemotherapy is unlikely to be curative, which could compromise their ability to make informed treatment decisions that are consonant with their preferences. Physicians may be able to improve patients’ understanding, but this may come at the cost of patients’ satisfaction with them.”

As Brody explained in The Times, doctors who care for people with an incurable or terminal illness often suffer as well. If your job is to heal, or at least make someone feel better, and you can’t, it’s only natural for anyone with a shred of humanity to feel like a failure, to feel frustrated and helpless. And sometimes, to grasp at straws; to mislead patients.

Some doctors might respond by visiting their patients less often, they might not return phone calls. It might not be intentional, but the patients, understandably, feel rejected in their greatest time of need. Brody says that “can exacerbate illness and pain and even hasten death.”

Ultimately, the oncologist who wanted to give his terminal patient a course of chemo to her brain realized that what she needed most at the end of her life was not more chemo, as Brody wrote, “but for him to sit down with her, to promise to do his best to keep her comfortable and to be there for the rest of her days.”

If you or a loved one is unlucky enough to be stricken with a chronic or terminal illness, make it clear to all of your medical providers what would help you most. For help organizing your thoughts, wishes and to formulate a strategy, see my newsletter “When a Conversation Can Save a Life,” and blog post, “Planning for the End: An Essential Piece of Quality Health Care.”

Another study examining the benefits and risks of routine mammograms has confirmed earlier concerns that, in many cases the tests at best complicate the assessment of breast health and at worst pose significant harm for people whose results show the presence of a small mass.

Writing in the New England Journal of Medicine, the researchers conclude that, “Despite substantial increases in the number of cases of early-stage breast cancer detected, screening mammography has only marginally reduced the rate at which women present with advanced cancer. Although it is not certain which women have been affected, the imbalance suggests that there is substantial overdiagnosis, accounting for nearly a third of all newly diagnosed breast cancers, and that screening is having, at best, only a small effect on the rate of death from breast cancer.”

Although many members of the medical community—radiologists and the American Cancer Society—continue to support regular mammograms for all women 40 and older, it seems that, absent a higher risk for the disease, most women needn’t have the regular screenings. And those who do might benefit more from “watchful waiting” than aggressive treatment for small tumors.

Women at higher risk are those with a family history of breast cancer, those who have genetic mutations known as BRCA1/BRCA2 and those with dense breasts. “Watchful waiting” is monitoring something identified on a screening test that may or may not become dangerous.

Readers of this blog are familiar with the to-and-fro surrounding the wisdom of people at low risk of having both mammograms and prostate tests. The new study says that approximately one-third of the tumors found in routine mammograms probably won’t develop into cancer.

The researchers say that the tests are overused and that improving survival rates from breast cancer are mostly the result of better treatment, not of discovering small tumors earlier through imaging.

The researchers “estimated that breast cancer was overdiagnosed (i.e., tumors were detected on screening that would never have led to clinical symptoms) in 1.3 million U.S. women in the past 30 years. We estimated that in 2008, breast cancer was overdiagnosed in more than 70,000 women; this accounted for 31% of all breast cancers diagnosed.”

As explained on NPR, this means that although mammography is good at catching early tumors, it isn't catching many advanced breast cancers. Some early tumors never progress to malignancy; they resolve on their own.

So the harm of “overdiagnosis”—treating something that doesn’t need to be treated—is not just the fear that a positive test indicates a probability for cancer, but the risk of false positives that lead to additional tests with their own risks, such as radiation exposure and infection from biopsies. Not to mention the additional cost.

The new study looked at 30 years of breast cancer data.

One breast imaging specialist interviewed by NPR said, "What my friends … want to know is, 'Should I have a screening mammogram?' And ... this kind of study sometimes raises more questions than it answers."

A breast surgeon who acknowledges that women might be hopelessly, frustratingly confused about regular screening says it depends on the individual’s medical profile. Women at lower risk might forgo frequent screening, and everyone—women and their doctors—should accept that not all diagnosed breast cancers should be treated to the max.

She used the example of ductal carcinoma in situ (DCIS), when the abnormal cells haven’t spread beyond the milk ducts. It’s often treated with surgery, hormones and radiation, when the patient might do just as well with watchful waiting.

The best way to disperse the fog surrounding the question of whether or not to have regular mammograms is knowledge and communication: Know your family’s medical history, know your own anatomy, know all the risks and rewards of screening and have frank discussions with your doctor. If he or she is unwilling to engage, it’s time to see someone else.

In what’s becoming a pattern of late, another cancer screening test has been deemed overused and unnecessary by the U.S. Preventive Services Task Force (USPSTF). The independent group of experts in prevention and evidence-based medicine has determined that tests for screening healthy women for ovarian cancer are more harmful than beneficial, and should not be routinely performed.

The screenings involve a blood test to detect the presence of substances linked to cancer and ultrasound scans that examine the ovaries. The USPSTF concluded that not only do they set off many false alarms (false-positives), they don’t lower the death rate from the disease.

If this sounds familiar to you, it’s probably because the same body has concluded the same thing recently about screenings for prostate and breast cancers. And several months ago, our blog “Medical Boards Advise Fewer Tests for Many Patients” discussed how the medical community enumerated 45 procedures whose routine use should be limited.

“There is no existing method of screening for ovarian cancer that is effective in reducing deaths,” Dr. Virginia A. Moyer, chairwoman of the expert USPSTF, told the New York Times last week. “In fact, a high percentage of women who undergo screening experience false-positive test results and consequently may be subjected to unnecessary harms, such as major surgery.”

The panel made clear that the advice to decline these screening applies only to healthy women with an average risk of ovarian cancer. For some people, such as those with suspicious symptoms, family history of the disease or who have certain genetic markers, the potential benefit to screening can outweigh the potential harm.

The panel’s research was published in the Annals of Internal Medicine, and, as The Times points out, its conclusions are based on medical evidence, not cost. And this isn’t the panel’s first such warning: It’s reaffirming its own advice from 2004.

“Although the task force has sometimes drawn fire in the past,” The Times noted, “particularly with its stand on mammograms, it has plenty of support in this case. Other medical groups, including the American Cancer Society and the American Congress of Obstetricians and Gynecologists, have for years been discouraging tests to screen for ovarian cancer.”

But some doctors still advise patients to have the screenings, and many patients ask for it in the hope test can detect the presence of disease early enough to save their lives. “We are fueled by hope,” Moyer told The Times. “It’s such a terrible disease. Almost everyone knows somebody’s who’s had it, and that means somebody who’s died of it. You get the feeling you should do anything possible to avoid that situation, but it’s easy to forget that what you do to avoid it can make matters worse.”

Ovarian cancer usually is fatal, and, from the time of diagnosis, quickly—by the time it’s diagnosed, usually it’s quite advanced. According to the American Cancer Society, more than 22,000 women will be diagnosed this year, and 15,500 will die.

The panel found a recent, large study particularly persuasive: As published last year in The Journal of the American Medical Association (JAMA) half of more than 78,000 women ages 55 to 74 were screened and half were not. Screening was ultrasound exams and blood tests for elevated levels of a factor called CA-125, which can be a sign of ovarian cancer.

The death rate from ovarian cancer, after 11 to 13 years, was the same for both groups.

Among the screened subjects, nearly 1 in 10 had false-positive results. More than 1,000 of those women had surgery, usually to remove one or both ovaries. After the surgeries it was clear that they had been unnecessary. And at least 15 in 100 of the surgical subjects experienced at least one serious complication, such as blood clots, infections or surgical injuries to other organs.

To find one case of ovarian cancer, 20 women had to undergo surgery.

Screening is not definitive—or, clearly, often even helpful; CA-125 can be elevated, as The Times explains, by conditions other than cancer, and ultrasound can reveal ovarian disorders that aren’t threatening but also indistinguishable from cancer unless surgery is performed to remove it.

Reader comments to The Times’ story, as might be expected, confirmed both the wisdom of the panel’s recommendation, and the personal experience of individuals who got screened and were grateful they did.

One commenter who identified himself as a cancer professor said, “Pretty much any adult has at least one, probably multiple cancerous tumors somewhere in their body. Scary but true. The large majority of them won't ever grow much, and something else will kill you long before it will. With bad luck one of yours will be aggressive and make itself known. Remember, most tumors have probably been growing in your body for many years,…”

“Now enter new, much more sensitive screening technologies, both imaging and biochemical. Guess what? We start removing all of those little tumors that will never kill you. Sure, some of them might kill you. But statistically you are more likely to get screwed up and die from surgery/chemo/radiation than you are the small chance that we detected the tumor earlier. It's all odds. Psychologically it may make you feel better to be doing something, but every shred of medical evidence argues that it is better to avoid a procedure unless that procedure is PROVEN to have a substantial benefit…”

“Just because you can find a tumor doesn't mean you should remove it. There are a lot of great new targeted drugs coming out, and we're starting to tailor them to the genotype of tumors. That's the ticket.”

If you’re in good health and don’t have any of the risk factors, the best advice doctors have for women concerned about ovarian cancer is to pay attention to first-warning symptoms. Contact your doctor if you have:

• persistent bloating;


• pelvic or abdominal pain;


• a feeling of fullness early when you eat; and/or


• the need to urinate frequently.

Breast cancer is insidious. It’s not necessary to manipulate the truth to convince people that the disease should be eradicated.

Why, then, did its most prominent adversaries feel the need to mislead and deceive in order to promote breast cancer awareness and screening?

According to a story published in the British Medical Journal, (BMJ) Susan G. Komen for the Cure, the world’s largest breast cancer charity, misstated survival differences between women who receive mammograms and those who don’t. In advertising for Breast Cancer Awareness Month in 2011, Komen claimed that almost every breast cancer patient survives five years if her disease is caught early through mammography screening, but that only slightly more than 1 in 5 survive that long if it wasn’t.

But as we have written repeatedly, and as the BMJ researchers said, for most women, promoting routine mammograms ignores "a growing and increasingly accepted body of evidence [showing] that although screening may reduce a woman's chance of dying from breast cancer by a small amount, it also causes major harms."

"This benefit of mammography looks so big that it is hard to imagine why anyone would forgo screening. She'd have to be crazy," wrote Drs. Steven Woloshin and Lisa M. Schwartz of the Dartmouth Institute for Health Policy and Clinical Practice. "But it's the advertisement that is crazy."

Woloshin and Schwartz regularly write about exaggerations, distortions and selective reporting, and their broadside against Komen’s tactics was just the latest example of fake statistics used to persuade people to undergo what might well be unnecessary tests.

This year in the U.S. there are 175 officially designated “national health observances,” including rabies day, sleep awareness week and numerous observances for heart disease. Disease awareness is big, and no organization has done more to promote breast cancer awareness than Susan G. Komen for the Cure. It’s the outfit that created the pink ribbon signifier. Last year, we wrote about one of its more curious (some would call it hypocritical) promotions—a pink rifle.

Komen’s efforts “to save lives, empower people, ensure quality care for all and energize science to find the cures,” the writers say, are laudable. But it’s best known for promoting mammography screening. How can such a powerful voice continue to spread misinformation when an increasingly accepted body of evidence shows that although screening may reduce a woman’s chance of dying from breast cancer by a small amount, it also causes major harms?

Woloshin and Schwartz note that the timing of breast cancer diagnosis has little influence on long-term survival; evidence shows that mammography reduces a 50-year-old woman's risk of dying of breast cancer in 10 years from just over half of 1 percent to just under half of 1 percent.

"Five-year survival is all about what happens from the time of diagnosis," Woloshin and Schwartz write. "It is the proportion of women who are alive five years after diagnosis. Because screening finds cancers earlier, comparing survival between screened and unscreened women is hopelessly biased."

This isn’t new; what’s newsworthy is that the organization to whom many people turn for enlightenment and advice about breast cancer is selling, if not snake oil, something just as oily. Komen, the authors say, should be enlightening people not only about the potential benefits of mammography, but the possible risks.

As many as 20 to 50 in 100 women screened annually for a decade will experience at least one "false alarm" that leads to a biopsy. For every life saved by mammography, the procedure overdiagnoses 2 to 10 women. Many of them will undergo unnecessary interventions and treatment.

"Women need much more than marketing slogans about screening," Woloshin and Schwartz wrote. "They need -- and deserve -- the facts. The Komen advertisement campaign failed to provide the facts.

"Worse, it undermined decision making by misusing statistics to generate false hope about the benefit of mammography screening. That kind of behavior is not very charitable."

It’s about as charitable as a life-promoting organization making money by selling death-inducing rifles.

For many people, the word “melanoma” often prompts the same response as the word “snake”— fear and, if announced as a personal warning, panic.

Indeed, the worst form of skin cancer can be deadly if ignored or treated improperly. Several years ago we sued a dermatologist whose dereliction in treating a patient with moles led to his death. But like so many other kinds of cancer, many people are harmed because their symptoms or their disease is overtreated by fear-mongering surgeons. This was the case in a story published in the Archives of Internal Medicine called “What the Surgeon Should Have Said to My Patient with Thin Malignant Melanoma.”
The writers, two medical doctors, explained how the patient presented with a colored lesion on his shoulder. A simple biopsy revealed a stage 1A malignant melanoma which, on a relative scale, is a small, early-stage cancer. This one was 0.5 mm deep. It had no ulceration nor evidence of palpable lymph nodes, either of which should have raised more questions. The surgeon, who specialized in oncology, played the fear card in encouraging the patient to have a procedure known as a sentinel node biopsy.

According to the authors, he said, “It is up to you, but you have a risk that there is spread into your lymph nodes. It has been shown that patients with nodal disease operated on at an early stage do better than those having total lymph node resection at a later stage when an enlarged lymph node is palpable. By doing this procedure, I could save your life.”

A sentinel node biopsy involves injecting a radioactive substance, dye or both near the tumor. Then the surgeon uses a probe to locate the lymph node(s) containing the injected marker—that’s the “sentinel.” The affected nodes are removed and analyzed for the presence of cancer cells. The point is to see where cancer cells are likely to spread from the primary tumor.

As noted in a companion story in the same publication, performing sentinel node biopsy on patients with early-stage melanomas is not considered best practice. But nearly 1 in 10 such melanomas are overtreated with such invasive procedures. About 30,000 of these melanomas are diagnosed every year, so thousands are overtreated in this way.

The risks of sentinel node biopsy include:

• infection;


• hematoma (swelling of clotted blood caused by a break in a blood vessel wall);


• nerve damage.

In addition, the procedure can cost about $15,000.

Patients in the only scientifically sound study on sentinel lymph node biopsy had lesions that measured at least 1.2 mm. The death rate from malignant melanoma was nearly identical in the group with sentinel lymph node biopsies compared with those whose lymph nodes were biopsied only if enlarged. But patients with microscopic disease did better than those with lymph nodes that were enlarged and palpable.

The journal writers note that it’s wrong to compare outcomes of patients with palpable nodes with those who have normal-sized lymph nodes, because the latter group’s disease is at an earlier stage, and when it’s discovered incidentally is usually less aggressive. In short, it’s possible that their positive sentinel nodes might not progress because of the body's natural immunity. “The unambiguous finding of this trial,” the writers reported, “is that there was no advantage of sentinel node biopsy over observation.”

The surgeon in this case not only was too eager to practice his skills, he was malfeasant; he neglected to discuss treatment options with his patient and their possible side effects weighed against their benefits.

According to the journal authors, the surgeon should have said, “A wide excision alone [cutting around the lesion] gives you an excellent chance of cure. No studies have shown that sentinel node biopsy will improve your chances, and we do not know if you would benefit from the discovery of microscopic lymph node disease.”

If you want to more about melanoma and how to assess the value of treatment options, link to the website LifeMath.net, which tries to make sense of “the enormous number of fundamentally discrete events that occur among the many molecules, genes, and cells of which we are comprised.” Click on the cancer and melanoma tabs.

Here's a discussion on our firm's web site about the vital issue of "informed consent" in medicine.

It has been 10 years since the U.S. Preventive Services Task Force (USPSTF) raised a red flag of concern for women who take hormone replacement therapy (HRT). A systematic review of scientific research published on the subject since 2002, the task force concluded last week, confirms the initial call for caution.

HRT is most often prescribed to alleviate the symptoms of menopause, including hot flashes, vaginal dryness, sleep disturbances and mood swings. Although HRT might be appropriate for people in this situation, the task force said that the risks for most women taking HRT for the long term still outweigh any benefits it confers in preventing chronic conditions.

As reported widely, including on MedPage Today, the hormones at issue—estrogen and progestin—do help prevent bone fractures, used alone and together. But they increase the risk of stroke, thromboembolisms (blood clots that dislodge and move through the circulation system), gallbladder disease and urinary incontinence.

The review of HRT was published on the Annals of Internal Medicine.

Most women prescribed HRT are given estrogen plus progestin because unalloyed estrogen increases the risk of uterine cancer, so plain estrogen is generally prescribed only for women who have had a hysterectomy. The new study indicates that the estrogen/progestin compound also increases risk for breast cancer and dementia. Estrogen alone decreases the risk for breast cancer.

In 2002, the USPSTF recommended against routine, long-term HRT use, and in 2005 recommended against long-term us of estrogen alone. The recommendations did not address short-term use of HRT to relieve menopause symptoms.

The new review of nearly a decade’s worth of clinical studies evaluated HRT’s effect on cardiovascular disease, cognitive decline, osteoporosis (thinning of the bones) and cancer.

Use of estrogen alone showed significant decreases in invasive breast cancer and mortality. Use of estrogen/progestin showed significant decreases in diabetes. Bone fractures were reduced significantly with both hormone regimens in some studies but not others.

But the harms significantly increased by one or both hormone replacement regimens were:

• invasive breast cancer (estrogen plus progestin);


• stroke (both);


• deep vein thrombosis (DVT/blood clot—both);


• pulmonary embolism (blood clot in the lung—estrogen plus progestin);


• breast cancer mortality (estrogen plus progestin);


• lung cancer mortality (estrogen plus progestin);


• gallbladder disease (both);


• probable dementia (estrogen plus progestin);


• urinary incontinence (both).

The corresponding numbers for estrogen plus progestin, according to the study, were just as unfavorable.

There might be benefits worthy of HRT (and different harms) for certain people with certain conditions, for which the study was inconclusive. Such different results could occur because of differences in age, type of hormone therapy, natural versus premature menopause or other medical conditions.

But the bottom line for most women is that hormone replacement therapy generally should be used only for short-term relief of menopausal symptoms. Individuals should discuss its suitability for other concerns only in the context of a complete medical history and an understanding of the risks.

Just in time for summer the FDA has granted manufacturers of sunscreen an extension for complying with new rules for labeling.

The decision to delay for six months imposition of rules that would have compelled manufacturers to be more truthful about the capabilities of their products reflects a concern that products will bear misinformation and that there will be a shortage of product. Some manufacturers said they wouldn’t be able to complete testing in time to accurately label all of their products.

As reported on MedPage Today, last summer the FDA said that sunscreens with SPF-15 or lower would be required by this summer to warn users on the packaging that they’re not getting as much protection as they might think.

The new rules were supposed to take effect June 17, and require manufacturers not to refer to their products as "sunblock," "waterproof" and "sweatproof," or as providing "all day protection." The FDA says such claims are inflated.

Now, it will be December before the changes take effect. Small companies get an additional year.

Manufacturers of lotions and sprays with an SPF—sun protection factor—of at least 15 may claim on the label that they protect against sunburn, early signs of aging and skin cancer. And if a sunscreen offers adequate protection against ultraviolet B (UVB) as well ultraviolet A (UVA) rays, they may be labeled "broad spectrum."

UVB rays are responsible for burns. UVA rays penetrate deeper and are responsible for wrinkling and other signs of aging. Both contribute to the risk of skin cancer. (To learn more about melanoma, or skin cancer, link here.)

The numerical value of a sunscreen is a measure of time. The numbers denote how long someone is expected to be protected from sunburn. They are NOT a measure of the strength of the compound’s protection. Different people require different periods of exposure to burn.

Someone with fair skin who begins to burn after five minutes would be protected, theoretically, for 75 minutes with use of an SPF 15—5 x 15. Someone with darker skin might get twice as much protection with the same application. Women’s skin is thinner, and burns more quickly then men’s. Black skin also burns, but it takes longer.

The intensity of UV radiation varies across the course of a day. Other factors influence the efficacy of sunscreen:

• user’s skin type;


• activities in which the user engages (swimmers, for example, lose efficacy sooner than sedentary sunbathers);


• amount of lotion the skin has absorbed.

Use a broad spectrum product and read the labels, misleading though they may be until the end of the year. For maximum UVA protection, look for these ingredients: zinc oxide, avobenzone and/or ecamsule.

Contact the Skin Cancer Foundation for more information about the risks of sun exposure and how to minimize them.

In October, we reported that the U.S. Preventive Services Task Force was recommending that routine screening for prostate cancer be suspended for most men. Last week, after six months of reviewing nearly 3,000 public comments, the task force confirmed its initial finding.

The discussion of prostate screening for cancer, as well as that of routine mammography, have helped raised consciousness that overtesting and overtreatment compromise the quality of health care.

The task force’s study was published in the Annals of Internal Medicine.

The PSA test, in which blood is tested for the presence of elevated levels of an enzyme that helps liquefy semen, exposes men to far more harm than it helps. Although elevated levels can indicate the presence of a cancer, research studies have shown that, at best, one life is saved for every 1,000 people screened over a 10-year period. But more than 100 of those 1,000 men will produce suspicious results when there is either no cancer or a cancer that is growing so slowly (or not at all) as to produce no threat. Forty of those 1,000 patients will become impotent or suffer urinary incontinence.

For most men, a positive test means having a biopsy, which carries its own risks such as pain, fever, bleeding, infection and hospitalization. If cancer is detected, 9 in 10 men will be treated surgically or by radiation even when the tumors are not life-threatening. The possible side effects are impotence, urinary incontinence, blood clots and other harms that the panel concluded are overwhelmingly persuasive in removing the PSA test from routine care.

Men concerned about prostate health and age-related problems such as reduced or intermittent urinary flow, should discuss them with their doctor for diagnosis and treatment other than PSA testing. The scientific evidence is overwhelming that it causes more harm than good -- for most men, and that means it's still worth a discussion to find out if you're in the group that may need closer watching.

The list of medical procedures no one welcomes is long and varied, but pretty much everyone would opt never to have a colonoscopy if it weren’t necessary.

It’s not so much the procedure that’s a problem, it’s the preparation—a diet restricted to clear liquids for 24 hours, and the ingestion of a nasty bowel-clearing drink no one will ever confuse with refreshment.

We recently wrote about the mixed messages that surround colon cancer scans, but they’re advisable for many people. Thanks to recent research, things could be looking up for the colonoscopy crowd.

As reported on MedPage Today, virtual colonoscopy, in which the lower intestine and colon are scanned externally by CT technology instead of viewed with an invasive probe, correctly identified 9 in 10 patients with larger adenomas—masses, or polyps, that aren’t cancerous but carry that potential. Standard optical colonscopy generally detects 9½ out of 10 such polyps.

Smaller masses, however, might not be be detected as successfully with virtual colonoscopy.

The study results were published in the Annals of Internal Medicine.

The less invasive procedure eliminates the need for the laxative that precedes traditional colonoscopy, but patients still ingest a solution; it contrasts stool on the image as different from other bowel contents. The interpretive software digitally erases the stool from anything a radiologist needs to see.

Although virtual technology does not appear to depict polyps smaller than 10 mm as reliably as larger masses, the vast majority of polyps that lead to cancer and affect survival outcomes are larger than 10 mm. For people who can’t—or won’t—tolerate the laxative bowel preparation, the CT scan might be the only way they get screened.

The study involved multiple facilities and 605 adults 50 to 85 years old who were at average to moderate risk for colon cancer. All were screened by both methods. Only four of the 26 lesions detected were smaller than 10 mm. All of the confirmed cancers were larger than 10 mm.

More than 6 in 10 study subjects said they’d opt for the virtual procedure over standard colonoscopy in the future. About 5 in 100 received additional diagnostic tests because something other than suspicious polyps were detected.

In addition to the loathsome preparation, traditional colonoscopy has inherent risks, primarily perforation of the bowel. Some people also might react to the sedative.

If you’re scheduled for a colonoscopy, discuss the pros and cons of each type of screening, including sigmoidoscopy, which is invasive, but requires less preparation than colonoscopy and usually no sedation. But it views only the lower part of the colon instead of the whole thing. So a lot of specialists liken it to undergoing mammography of just one breast.

Despite the news on virtual colonoscopy, for most people, conventional colonoscopy remains what doctors call the "gold standard."

Since 2009, when the U.S. Preventive Services Task Force threw a grenade into the “mammograms for everyone” approach to women’s care, researchers, doctors and women have been wondering just who should get a mammogram, when and how frequently.

As widely reported last week, the results of new studies are helping to tease out the variables in this equation. Thanks to a greater appreciation that more tests don’t necessarily render better care, and that such overuse can cause patient harm, people are learning that customized medicine is superior medicine.

As the Los Angeles Times noted, “Of the various recommendations put forth by the U.S. Preventive Services Task Force in 2009, none generated more ire than the suggestion that annual mammograms could do more harm than good for most fortysomething women, who are far less likely than older women to get breast cancer….

“The new research was designed to identify women who could benefit the most from having mammograms early and often.”

The task force, an independent panel of health experts which advises the federal government, suggested more than two years ago that women older than 50 should have a mammogram every two years instead of annually, and that most women in their 40s should bypass the test altogether. Until then, women over 40 routinely were advised to have a mammogram annually.

The new research found that among women 50 to 74, for every breast cancer death averted by screening, 146 women received a false-positive reading -- a false alarm -- on a mammogram. And for every year of life someone gained thanks to a mammogram’s early detection of breast cancer, 8.3 false positives led to unnecessary biopsies, weeks of worry and sometimes surgical complications.

Two markers stood out for researchers as indicators that a 40-year-old should have regular and more frequent mammograms: a woman whose mother or sister was diagnosed with breast cancer, and women with unusually dense breast tissue.

These people, the studies concluded, carry at least twice the average risk of developing breast cancer in their 40s. For such women, according to the study in the Annals of Internal Medicine, routine screening outweighs the risk of false alarms and unnecessary, often invasive and uncomfortable tests.

One of the studies combined and analyzed data from 61 previously published studies. The other employed computer models to predict the health outcomes of approximately 44,000 simulated women who had their first mammogram at 50. The simulation was revised to show their outcomes had they begun screenings at 40. Then it compared the rates of false alarms, breast cancer diagnoses and mortality in both groups.

For the younger group, researchers found that the only ones who stood to benefit to a similar degree were those whose breast cancer risk was roughly double the norm for their age group. Having a first-degree relative — a mother or sister — with a breast cancer diagnosis more than doubles a 40-year-old's own risk of developing the disease. Two or more first-degree relatives with breast cancer bump up the risk nearly fourfold.

Increased risk also was seen in women whose breasts are composed of significantly more glandular than fat tissue. That also doubled the risk of breast cancer risk for someone in her 40s.

The confounding element here is that dense breasts make mammograms harder to read: Cancerous tumors aren’t as apparent within glandular tissue as they are within fat. Radiologists, who review mammograms, and doctors lack established standards to define and grade breast density.

Other risk factors identified in the new studies were:

• biopsies--women whose breast biopsies were benign have an 80 percent greater risk of getting cancer in their 40s;


• oral contraceptives—30 percent greater risk;


• never having given birth—25 percent;


• first child after 30—20 percent increased risk.

As the whys and wherefores of mammograms evolve, women and their doctors should focus on two things: getting an accurate family history, and understanding their individual breast anatomy. The state of the art today makes those the drivers of when to begin and how often to get a mammogram.

A recent study published in Health Affairs either proves the superiority of U.S. medical care for cancer, or illustrates again how ignorance of basic statistical principles can lead to wrong conclusions.

The study found that U.S. cancer patients who were diagnosed between 1995 and 1999 lived, on average, 11.1 years after their diagnosis. Similar patients from 10 European countries lived an average 9.3 years. By 1999 (the last year the researchers analyzed), the average U.S. expenditure per cancer case was $70,000. That was nearly 50 percent higher than the cost in 1983. The cost in Europe was $44,000—16 percent higher for the same interval. Using standard figures for each extra year of life, the researchers concluded that the value of the U.S. survival gains outweighed the cost by an average $61,000 per case. They pronounced the additional spending on cancer care in the United States "worth it."

But a Reuters story analyzing the research begged to differ. "This study is pure folly," Dr. Don Berry, a biostatistician at MD Anderson Cancer Center in Houston, told Reuters. "It's completely misguided and it's dangerous. Not only are the authors' analyses flawed but their conclusions are also wrong."

Reuters also found the credentials of the study’s lead author, Tomas Philipson of the University of Chicago, wanting. He’s a health economist who served in the administration of President George W. Bush and advised the McCain presidential campaign on health-care issues. The point? The research might not be as unbiased as science demands.

Thirteen common cancers were examined in the study. Researchers analyzed survival—how long a patient lived after being diagnosed—in the period from 1983-1999. They looked at survival gains, or how long patients diagnosed in later years lived compared with those diagnosed earlier in the period. Those gains, they said, demonstrate the progress countries made in treating cancer.

Sounds reasonable. But survival data are tricky; they’re not cold, irrefutable numbers that can quantify success, thanks to something called lead-time bias.

Take two hypothetical people who both get the same kind of cancer on the same day. One of them gets an immediate diagnosis and lives another two years. The other is diagnosed eighteen months after the first, and lives only six months. Patient No. 1 had a "better" survival rate -- two years compared to the six months of Patient No. 2, but she didn't live any longer. She just knew she was sick earlier. Both patients lived two years. That's "lead-time bias" at work.

That’s why, as the Reuters analysis says, “Crediting medical care with ‘improving survival’ is therefore misleading, cancer experts have long argued. Lead-time bias makes it seem patients live longer, but the only thing that is longer is the number of years they know they have cancer…”

But Philipson’s team based its conclusions on survival data, arguing that because U.S. cancer mortality rates declined faster than those of Europe, they’re evidence of survival gains.

Berry articulated a related point with which readers of this blog will be familiar: that overdiagnosis is a problem. Cancer screening, particularly for breast and prostate cancers, is more common in the U.S. than in Europe, and the more testing, the more cancer will be found. But as Berry noted for Reuters, "These are cancers that tend to be slowly growing and many would never kill anyone."

Link here and here to read our posts about the misguided use of screenings for breast and prostate cancers, respectively.

If, in a diagnostic procedure, you find what you’re looking for, does that denote a successful test? Not if it makes a healthy person a cancer patient if the tumor otherwise is not life-threatening. Including such cases, whose numbers are higher in the U.S. than in Europe, makes survival data bogus.

The Health Affairs study showed survival gains in the U.S. versus Europe were greatest for prostate cancer; breast cancer claimed the second-best U.S. survival data--the two cancers where lead-time bias figures most prominently in overdiagnosis.

It’s interesting that Europe had the survival edge in data for melanoma and colorectal and uterine cancer survival gains.

According to Reuters, U.S. cancer mortality places the U.S. in the middle of countries reporting to the Organization for Economic Co-operation and Development.

If that’s not enough to prompt questions about the “Spend More! Live Longer!” theory of cancer survival, consider this: Even the study’s researchers concede that it’s impossible to state that improved survival is a direct result of spending money on cancer care. It might result from improved screenings that detect the “pseudo-disease,” or nonaggressive, nonthreatening tumors that artificially enhance survival data.

And Philpson said, “In the last decade, spending in the U.S. has increased more than in Europe. I would be extremely surprised if the survival gains haven't continued. But it is a much more open question whether that additional spending has been accompanied by an increase in longevity."

According to Reuters, in 2004 (the last year for which figures were available), the U.S. spent $72 billion on cancer care. It also noted that Philipson’s research was supported in part by Bristol-Myers Squibb Co. That company makes a melanoma drug, Yervoy, that costs $120,000 for a full course of treatment.

Certainly the cost of cancer drugs have increased. Dendreon Corp. makes Provenge for prostate cancer at $93,000 per treatment. Bristol and Eli Lilly and Co. make Erbitux at $100,000 per year. The researchers said their analysis "does not imply that all treatments are cost-effective."

Remember, Philipson is an economist. His scholarship concerns how much an additional year of life is worth. His researchers assumed the value to be $150,000 to $360,000.

No wonder economics is referred to as “the dismal science.”

Footnote: Here is a good explanation from "the Incidental Economist" blog of the "lead-time bias" problem in medical statistics and why the correct number to focus on is death rates, not survival rates. However, important caveat from the same blog: Survival rates are very important to any individual patient, because they can tell you how long YOU might live with a particular cancer at a particular stage. The importance of death rates is on the macro level: Does early screening bend the death curve down, or not?

A couple of weeks ago, a study published in Health Affairs reinvigorated the conversation about the usefulness of screenings for lung cancer. We have been among the voices questioning the widespread use of certain screenings because, in many cases, they are inappropriate, unnecessarily expensive and possibly harmful.

Now, another voice of reasoned consideration and moderation has reinforced the growing belief that for too long many diagnostic tests have been conducted not because they signify the best in medical care, but almost by habit bolstered by studies that seem significant but, on closer inspection, don't measure up.

Writing on HealthNewsReview.org, Harold DeMonaco, director of the Innovation Support Center at the Massachusetts General Hospital, said that the study authors provided some interesting numbers to back up their conclusion that insurers should screen high-risk individuals (long-term smokers who are at least 50) with low-dose spiral CT scans. That technology creates multiple images of the entire chest via X-rays, whereas a standard chest X-ray is a single snapshot of the entire chest.

“Of the 18 million or so smokers who fall into their eligibility criteria,” DeMonaco wrote, “they showed a potential for … 130,000 additional survivors of lung cancer due to early detection. It’s hard to argue that saving this many lives is not important. But the study does not look into the negative aspects of the double-edged sword that is lung cancer screening. While we are constantly berated for being anti-screening, it is important for people to understand what the risks and benefits are for any medical procedure including screenings.”

He referred to a large study funded by the National Cancer Institute (NCI) to determine whether screening with low-dose CT, as compared with chest radiography, would reduce mortality from lung cancer among high-risk smokers. We reported on that as well.

The NCI study, DeMonaco said, was sufficiently similar to the one reported by Health Affairs for its data to be relevant now. About 1 in 4 people who got spiral CT scans tested positive. If extrapolated per the current study, the numbers add up to 4.32 million positive findings. But more than 9 in 10 of those proved to be false positives. (See our post about the perils of false positives and false diagnoses.)

In revisiting this unwelcome scenario in this application, DeMonaco explained “that 4,086,720 people screened would have a false positive result. All would likely suffer from some degree of angst. Of those with false positive findings, 0.06 percent had a major complication possibly related to subsequent invasive procedures in the NCI sponsored study.”

So 108,000 people would experience a serious adverse event resulting from a procedure they had because the original scan showed falsely positive. Said DeMonaco: “Those events need to be considered when thinking about the 130,000 potential lives saved through screening. Few medical procedures are without risk and each should be viewed as a double-edged sword. Benefits as well as risks need to be considered. Reporting on just the benefits provides readers with only half the story.”

If your doctor prescribes a screening test, ask:

• What are the possible benefits?


• What are the possible harms?


• How often do harms occur?


• Are there alternative tests?

Old habits die hard, and in this regard the medical profession is no different from any other. Researchers at the Yale School of Medicine were surprised, though, at the results of their study showing that despite the fact that radiation has limited benefit for some older women with breast cancer, the treatment is still being prescribed.

A large clinical trial conducted by the National Cancer Institute (NCI) concluded that radiation for some women older than 70 with early stage, low-risk breast cancer offered limited benefit. So significant was the 2004 NCI trial that breast cancer treatment guidelines were changed to place radiation therapy in the “optional” category for these patients.

But the Yale researchers found that in the years following implementation of the new guidelines, there has been minimal change in the clinical care of older women with breast cancer. Their report was published in the March Journal of Clinical Oncology along with an editorial echoing our feeling that the perpetual motion treatment machine needs to be overhauled.

"[T]he medical community may react differently to withholding a treatment than to adding a new treatment,” it read. “Adding a new treatment with the possibility of improving patient outcomes is likely more motivating than the ability to omit a treatment without harm."

“… Some older women with breast cancer are clearly being overtreated. Offering radiation therapy to a woman with a good-prognosis tumor and a life expectancy of less than five years does not seem indicated, yet more than 40 percent of such women were treated with radiation. These women were at risk for unnecessary adverse effects, inconvenience of treatment and possibly increased personal costs for a treatment that was unlikely to offer them any benefit.”

The complication, as the editorial points out, is that identifying patients unlikely to survive five years is tricky. Still, there must be a greater acceptance that “The cost of whole-breast irradiation is more than $7,000 per patient, and the benefit in this group of patients is small. In our current health-care system, physicians are incentivized to favor treatment over no treatment, particularly when either option is considered appropriate."

Medicare beneficiaries diagnosed with early stage breast cancer were studied before and after the large NCI clinical trial was published. Nearly 8 in 10 patients received radiation before the study, and 3 in 4 received it after.

Even among the oldest women (85-94 years), the use of radiation decreased only four percentage points, from 37 percent before the study to 33 percent after.

Typically, older women with early stage breast cancer receive breast-conserving surgery followed by radiation therapy. The latter is designed to reduce recurrence of the disease. But many older women have less aggressive tumors; they are at lower risk for tumor recurrence.

“Clinical trials are considered the gold standard of medical research and in this case the trial was influential enough to lead to a change in treatment guidelines,” said Yale’s lead author. “We expected it to have more of an impact on clinical care at the bedside.”

It’s time to for this proven theory to be put into practice. As the researchers noted, the U.S. government invested more than $1 billion in comparative effectiveness research as part of the American Recovery and Reinvestment Act of 2009. The point of such efforts, which we’ve discussed before, is to choose the most effective, cost-efficient treatments for a given disorder; they’re meant to overrule the default of “just in case” treatments.

“Our societal interest in funding this type of research is appropriate,” Yale’s researchers concluded, “and the need is great, but we must ensure that the results of such research extend beyond the journal page and are actually incorporated into clinical decision-making.”

To learn more about breast cancer treatment, see our guide.

A recent series of articles published in the New England Journal of Medicine (NEJM) presented a less than clear picture of colon cancer screening. Gary Schwitzer, writing on HealthNewsReview.org took on the muddled message offered by the science journal, and the popular media’s woeful effort to offer context and meaningful advice to consumers. We’ve tackled the topic before as well.

Here's the latest advice from our Better Health Care newsletter on how to sort out your colon cancer screening options.

As Schwitzer notes, one NEJM study championed the benefits of colonoscopy screening, one trumpeted the potential benefits of a blood stool testing procedure called Fecal Immunochemical Testing (FIT) and an editorial pondered both.

Readers interested in seeing how medical journalism grapples with material that requires some depth might enjoy HealthNewsReview’s explanation of who went right, who went wrong and who is wandering around in the middle. But if you’re looking for the best, most concise information to enable you to take care of yourself, Schwitzer, a widely respected health news analyst, points to the Reuters coverage. We agree.

Its take-away message, gleaned from the NEJM editorial and explained with additional interviews, was that the best colon-health practice appeared to be colonoscopy screening for everyone who’s 60. The results would tell you if you're high risk or low risk. High risk people get regular colon follow-ups; everybody else stops worrying.

Here’s how a competent report helps readers objectively judge the information: Reuters was the only news organization that quoted the FIT researchers about their study as much as it allowed the colonoscopy researchers to tout their work. According to the FIT researchers, “the numbers of subjects who needed to be screened to find one colorectal cancer were 191 in the colonoscopy group and 281 in the FIT group, and the numbers who needed to be screened to find any advanced (cancer) were 10 and 36.”

This simple numerical analysis reflects a larger discussion we had in a recent edition of our patient safety newsletter about a concept called “numbers needed to treat”.

As Reuters notes, such objective qualities are important because the FIT test is much less expensive than a colonoscopy. “This simple, noninvasive and cheap test is equally good at detecting colorectal cancer and identifying the high-risk individual that should undergo a colonoscopy.”

Reuters also explained that the complication rate—bleeding, low blood pressure and slow heartbeat—was nearly five times higher in the colonoscopy group.

And just as important is the percentage of patients who follow the advice to get one or the other screening techniques. In both screening tests, the follow-through rate is low -- understandably, because the tests are bothersome and unpleasant at a minimum. But the FIT test was more popular than colonoscopy -- one in three patients went ahead and got the FIT test while only one in four got a colonoscopy.

Schwitzer’s report included further analysis from Harold DeMonaco, director of the Innovation Support Center at Massachusetts General Hospital. Of particular note for people considering colonoscopy or other colon diagnostic measures, he said:

• Early detection and removal of adenomatous polyps (benign tissue with the potential to become malignant) appears to reduce the risk of colon cancer. A considerable minority of adults will have adenomatous polyps on colonoscopy, including as many as 1 in 4 males.


• Colon cancer grows slowly. Good followup for people who have had an adenomatous polyp removed appears to reduce the risk of dying from colon cancer over several decades of observation.


• FIT appears to be as useful as a screening tool for colon cancer, but it’s not as good in detecting existing adenomatous polyps.


• FIT is easier, much less expensive and does not have the rare but important potential complications associated with colonoscopy.


• The right combination of colonoscopy and FIT remains unclear, as does the role of CT colonoscopy.

If a conclusive approach to colon polyps screening remains elusive, at least some things are clearer, and patients can make more informed choices.


Posted by Patrick A. Malone | Permalink | Email This Post

Posted In: Cancer , Testing

We’re well into the new year, and by now many of your resolutions may have been consigned to the “next year” bin. But if you’re trying to quit smoking, no time is better than the present. Every year nearly half a million people die prematurely from smoking-related illnesses including lung cancer, heart disease and pulmonary disease. Smoking is the No. 1 cause of preventable death in the U.S.

And let’s not forget, as the Centers for Disease Control and Prevention point out, that it’s not just about you: Approximately 88 million nonsmokers, including more than 5 in 10 children ages 3 to 11, are exposed to secondhand smoke, a particularly ominous reality. Even brief exposure can be dangerous because nonsmokers inhale many of the same poisons in cigarette smoke as smokers.

Seven in 10 smokers want to quit, and as noted in a recent story on Kaiser Health News, most smokers need help. That might mean counseling, support groups or a variety of nicotine-replacement products whose efficacy we examined last week.

And the FDA is convening a panel to study yet another tobacco delivery system called “dissolvables”—melt-in-your-mouth tobacco products some observers believe help people quit, and others say are a gateway to greater tobacco use that pose cancer risks of their own.

We spend nearly $100 billion every year on health-care problems related to tobacco, yet in this country 1 in 5 adults still smokes, a ratio that hasn’t changed in years. Why?

It's been known for a century how hard it is to quit smoking. As Mark Twain said with a twinkle in his eye: "Giving up smoking is the easiest thing in the world. I know because I've done it thousands of times."

Now modern life gives us another thousand reasons why quitting tobacco takes a back seat to other government priorities. KHN noted, “Scrambling to address budget problems, states this year will spend less than 2 percent of their tobacco-tax and tobacco-settlement billions on programs to help people quit smoking or prevent them from starting, according to a recent report by a coalition of public-health organization. In the past four years, state spending on tobacco prevention and cessation has declined by 36 percent, to $457 million.”

The State of Tobacco Control, a recently released report by the American Lung Association, confirmed the grim news about waning public interest in anti-tobacco measures. It graded the federal government, all 50 state governments and the District of Columbia to determine if tobacco control laws are adequately protecting citizens from the enormous toll tobacco use takes on lives and the economy.

They’re not. According to the ALA:

• Tobacco prevention and quit-smoking programs in several states were stung by funding cuts or were virtually eliminated, including a highly successful program in Washington State.


• Higher cigarette prices keep kids from starting to smoke, but for the first year since the Lung Association began releasing the report in 2003, no state raised its tobacco tax significantly. New Hampshire actually cut its cigarette tax by a dime per pack.

Only four states received all passing grades, while six states received straight Fs on the report card. To see how your state rated, click here.

As public funding diminishes, corporate attention is growing. Last year 2 in 3 companies with more than 200 employees offered them smoking cessation programs, and so did nearly 1 in 3 smaller companies. Nearly 1 in 4 companies with more than 20,000 employees charge smokers more for health insurance premiums

That’s not necessarily a good idea, some public health authorities say, because it can encourage smokers to drop their coverage. But employers say asking them to pay more for coverage is only fair. "The cost of medical care for smokers is considerably higher," Helen Darling, chief executive of the National Business Group on Health told KHN. "Employers are increasingly saying that if someone costs the pool more, they should pay more."

The Affordable Care Act (ACA), the federal health law passed in 2010, expanded coverage for smoking cessation. States must provide tobacco-cessation coverage for all pregnant women in their Medicaid programs at no cost. Anti-smoking activists, of course, want much broader coverage, especially for Medicaid recipients; almost 3 in 10 of adults living below the poverty line are smokers.

The ACA also requires new health plans to screen adults for tobacco use and provide free stop-smoking interventions. Specifics, though, are wanting—advocates hope federal guidelines will provide coverage for more than a single four-session counseling module, for example, or a standard 12-week round of medication.

We’re determined to keep covering the toll of nicotine addiction, the companies in whose interest it is to keep you hooked and the legislative efforts to address tobacco and health care. If you’re determined to quit, here are some suggestions for getting help.

• The online stop-smoking program Legacy is a nonprofit created under the settlement between the states and the tobacco industry.


• Another free program whose scientific credentials are acknowledged by the American Cancer Society is, EX, is a project of the National Alliance for Tobacco Cessation.


• A national toll-free number, (800) QUIT NOW, routes callers to free support services including medication in the handful of states that provide it.

Surgery with the da Vinci robot to remove a cancerous prostate gland is guaranteed to dazzle the patient with the high-tech wizardry of it all. Problem is the outcomes in side effects that can disable men after prostate surgery -- incontinence and sexual dysfunction -- are no better than with conventional surgery. And the robot costs a lot more.

The latest of several studies to reach the same conclusion about the robot being less than it's cracked up to be is published in the Journal of Clinical Oncology. The authors randomly surveyed men who had had either robot or traditional surgery and found that both had high rates of sexual and urinary complications, with no advantage for the robot.

Dr. Michael Barry and his co-authors questioned whether this might be a case of "gizmo idolatry," the tendency in medicine to adopt new and expensive technology before there is real evidence of improved patient outcomes.

We've written before on our patient safety blog about benefits of the robot being oversold. Another critical issue for patients is the experience of the surgeon; the robot takes a lot more practice to get up to speed and reduce complication rates than does ordinary surgery.

As health care journalist blogger Gary Schwitzer notes, the marketing of the surgical robot gets hyped even more by naive news coverage with headlines like:

* Robot doctor – surgery of tomorrow
* Da Vinci puts magical touch on the prostate
* Cancer survivors meet lifesaving surgical robot
* Robotic surgeon’s hands never tremble
* Da Vinci is code for faster recovery

Once again, the take-home for patients is: Don't be dazzled by technology. What you want is a surgeon with a proven track record. Ask pointed questions, and don't assume that machines work better than experienced hands.

Article first published as Robot Surgery of the Prostate: No Evidence of Better Outcomes for Patients on Technorati.

Most of the recent media conversation about breast cancer prevention has concerned the topic of screening, and whether and when mammography is routinely appropriate.

Last week, the Institute of Medicine (IOM), a National Academy of Science panel that advises government and the public on issues of health and medicine, garnered front-page headlines with its study about risks for breast cancer. In comparison to most media outlets, which took a “Now Hear This!” approach, the New York Times’ coverage seemed … underwhelming.

“An exhaustive new report meant to address public fears about possible links between breast cancer and the environment,” it began, “finds evidence strong enough to make only a few firm recommendations, most already well known and none with a large proven benefit.”

Where some media framed the report’s conclusion as—if not revelatory, at least significant—The Times was measured. After enumerating the factors that appear to contribute to increased risk of the disease, The Gray Lady suggested that people in search of definitive information about exposure to chemicals, pollution, cosmetics and drinking water would be disappointed. The report, the paper said, “is based largely on a review of existing research, and its limited advice reflects the lack of solid scientific information in many areas of concern to the public.”

Subsidized by $1 million from Susan G. Komen for the Cure, an advocacy group dedicated to eradicating breast cancer, the IOM committee’s chairwoman said it could not “identify a bunch of environmental factors” that might contribute to breast cancer.

According to the report, data did indicate that women could reduce their risk by limiting or avoiding:

• unnecessary medical radiation;


• hormone treatments that combine estrogen and progestin;


• alcohol consumption; and


• weight gain (especially for postmenopausal women).

In terms of radiation, the report called out the overuse of CT scans, which deliver relatively higher doses of radiation. But it did say that mammograms, which deliver smaller doses, are not of concern.

Cancer in general is a hot medical topic because of its intractability, its invasive and side-effect inducing treatments, its many varieties and the massive amounts of dollars devoted to its treatment and eradication. So any news that seems to be maybe groundbreaking often is translated by the media as definitely groundbreaking.

This news isn’t.

The Times describes why. The disease is difficult to study because suspect chemicals cannot ethically be given to people to see if they cause cancer, and studying people who were exposed in the past yields unreliable information about the dose and timing. Animal studies don’t always apply to humans. And people are exposed to various mixtures of chemicals that may interact differently and with effects that may also vary according to an individual’s genetic makeup.

Also, the panel noted that the effects of various environmental exposures differ depending on someone’s age. Breast tissue may be affected differently in the womb, during childhood, adolescence and adulthood and before and after pregnancy. To state definitively that a certain chemical in a certain environment will pose a certain risk to all breast tissue is false and irresponsible.

The IOC panel noted that even if a woman is scrupulous in eliminating the outlined risks, her risk is subject to the usual vagaries of cancer. “The potential risk reductions from any of these actions for any individual woman will vary and may be modest.”

And some of the behaviors to be avoided might be helpful if someone is facing a different disorder or disease. Moderate drinking might help prevent heart disease; if someone forgoes a CT scan, she might deny herself a valuable diagnostic tool.

As always in the face of breathless medical “news” reporting, before you swallow the message, read the whole story.

In 2009 the U.S. Preventive Services Task Force recommended against routine mammograms for women in their 40s. That caused a political firestorm then, with ill-informed politicians claiming that bureaucrats were trying to hold back a lifesaving test to save money. The truth was, and is, that mammograms cause more harm than good unless the women being tested are already at significant risk.

Now, Canadian health-care watchdogs have echoed the U.S. opinion, and for the same reasons.

As reported in CMAJ, the Canadian Medical Association journal, the Canadian Task Force on Preventive Health Care says routine mammograms for women 40-49 are not necessary if they are at average risk of contracting the disease. Women with a personal/family history of breast cancer, or who have the BRCA1/BRCA2 gene mutations are at higher risk, and should be screened more often.

The report concludes that although mammography screening can reduce death from breast cancer among women aged 40–74 years, “the absolute benefit is small — especially for younger women — and is partially offset by harms caused by unnecessary intervention.”

Those harms include false positives, which prompt additional screening or tests that usually include more radiation exposure, uncomfortable biopsies and high anxiety. The disease is relatively rare in younger women, and their higher breast density compromises the ability of mammograms to be fully useful. So the Canadian report says that for women at average risk, an interval of two or three years is sufficient for mammography screening.

Like the earlier U.S. task force, the Canadians emphasize that providers and patients consider the benefits-harm trade-off when deciding about having a mammogram.

We have repeatedly covered this topic, as well the often-conflicting opinions always generated when a former standard of care gets called into question.

In addition to questioning the wisdom of screening younger women via mammography and magnetic resonance imaging, this task force also said that there is no evidence that “clinical breast examination or breast self-examination reduces the risk of mortality or other clinically relevant adverse outcomes.”

Here’s what the Canadian task force recommends for mammography screening for women at average risk, by age:

• 40–49 years, no routine screening;


• 50–74 years, routine screening every two to three years.

Some things you just can’t make up.

A website is promoting breast cancer research through sales of its product. So far, so normal. But consider that the site, The Firearm Blog, “is dedicated to all things firearm related. If you are into AR-15 and AK carbines, skeet shotguns, self defense pistols or hunting rifles then there will be something here for you.”

And here’s the “good works” pitch: “DPMS have teamed up with Gun Broker to auction off a pink version of their Lite 16" rifle. 100% of the proceeds with go towards Susan G. Komen for the Cure, an organization which supports breast cancer research.”

Does anyone see anything amiss about an effort to eradicate a disease that kills by promoting a product that kills?

The offer prompted some lively commentary from the site’s readers; well, “lively” is one way to put it:

• "Perfect gun for a shoot-out at the Pepto-Bismal Corral."


• "Girls usually stop dressing all-pink before they’re 12, so what makes these manufacturers think that adult women would refuse to be seen in the woods without a pink gun and matching pink-shaded camo clothing?"


• "If there’s any one organization that hopes they never cure Breast Cancer, it’s the Susan G. Komen for the Cure foundation. These people make money off of every single pink item in the world. Who knew you could make money off of a color and a cause? … I think we should outlaw toy guns so that when children pick up a gun, they know it’s real. Even idiots deserve to live to voting age, apparently."

Some people think so, and they are calling it “breast cancer pinkwashing.” As noted recently on MedPage Today, several media outlets suggested that the pink ribbon campaign has gone too far; that “pink ribbon fatigue” has set in, and when an arms dealer gets attention by painting a rifle pink, you have to wonder if they’re right.

“Pinkwashing” refers to commercial interests promoting breast cancer awareness while also profiting from pink-themed products. As noted in the Boston Globe last year, “The application of pink—in the name of raising money and steering women toward the radiologist’s office—does seem to get broader and cheerier each year. Now, we have NFL balls decorated with pink ribbons and world landmarks bathed in pink light, from the White House to the Ancient Mayan pyramids of Chichen Itza.”

As Karuna Jaggar, executive director of Breast Cancer Action, told MedPage, “At one time, pink was the means. Now, it’s almost become the end in itself. In its most simplistic forms, pink has become a distraction. You put a pink ribbon on it, people stop asking questions.”

Research is based on asking questions. Cures and treatments for dread diseases are based on research.

According to the National Cancer Institute, more than 230,000 women will be diagnosed with and nearly 40,000 will die of breast cancer in 2011. Barbara Brenner, former executive director of Breast Cancer Action, once questioned all the money being raised during breast cancer awareness promotions. “If shopping could cure breast cancer,” she said, “it would be cured by now.”

Last year, KFC initiated a campaign to donate 50 cents to the Komen Foundation (the largest breast cancer foundation in the world) from every pinkwashed bucket of chicken sold. Now, fried chicken isn’t as lethal as a rifle, but given that obesity is a risk factor for the disease, does it strike you as an appropriate cross-promotion?

If you want to support businesses that do good works without selling out your health-promotion principles, Breast Cancer Action suggests you ask yourself these questions before spending your charitable dollars:

1. How much money from your purchase actually goes toward breast cancer? Is that amount clearly stated on the package?
2. What is the maximum amount a company will donate?
3. How are the funds being raised?
4. To what breast cancer organization does the money go, and what types of programs does it support?
5. What is the company doing to assure that its products are not actually contributing to the breast cancer epidemic?

There’s nothing wrong with wearing a pink ribbon or paying extra for a breast cancer postage stamp. But if colorizing the world prevents it from seeing clearly, it’s time to engage common sense in common cause.

Article first published as Breast Cancer Awareness: Too Much of a Good Thing? on Technorati.

A new study might add to the perception that U.S. medical care is uncontrollably expensive thanks in part to unnecessary tests. “Screening by Chest Radiograph and Lung Cancer Mortality" concludes that people who have an annual chest X-ray do not have a significantly lower mortality rate than people who don’t.

The study, whose lung data are part of a larger investigation into cancers of the prostate, colon/rectum and ovaries, examined people who were given either annual chest X-rays (chest radiography) or standard medical care without screening. In the 13 years’ of the study, 1,696 lung cancers were detected in chest radiograph group and 1,620 lung cancers in the control group. The radiograph group reported 1,213 lung cancer deaths, and 1,230 in the control group.

The results weren’t really a surprise; researchers said the study confirmed expectations rather than setting new ones.

Some healthy patients believe that safeguarding their good fortune means having any screening that can yield information. Often their physicians accommodate them out of an abundance of caution, a desire to please the customer or a fear (usually irrational) of being sued if they are perceived to have practiced poor medicine.

But as with recent guidelines announced by the U.S. Preventive Services Task Force (USPSTF) about Pap tests, mammograms and prostate-specific antigen tests, sometimes a test, especially for generally healthy people, serves little purpose other than addressing professional insecurity and reducing one’s bank account. And in the task force cases, it can cause harmful side effects.

A smoker or someone with a family history of lung cancer might not qualify as someone who can ignore advice to get screened. But now, the best practice for people at risk for lung disorders might not be a chest X-ray. The recent National Lung Screening Trial concluded that early detection of lung cancer from a spiral CT scan reduced the risk of mortality.

A spiral CT uses X-rays to generate multiple images of the entire chest; a standard chest X-ray generates a single image of the entire chest in which parts of the anatomy overlie one another.

The National Cancer Institute study involved current and former smokers, and compared a CT scan group with a chest X-ray group, not people with no known lung problems or those who hadn’t been screened at all. Still, the best way to diagnose lung cancer doesn’t seem to be with a chest X-ray, and unless you’re having a respiratory issue, you don’t need one as part of your annual physical exam.

The question will never be answered with any certainty. But it's worth thinking about, because many of us will eventually be required to make our own hard choices about what kind of treatment to get for a scary disease.

The known facts about Jobs are these. He had an unusual form of slow-growing cancer of the cells in the pancreas that make insulin. His kind of cancer is called an "insulinoma" or an islet cell cancer. When the cancer was first found in 2003, he put off surgery to cut it out for nine months, while he tried dietary treatments advocated by his friend and diet doctor Dean Ornish.

Ornish is a controversial physician with one foot in the camp of scientific medicine but the other dipping deep into the stream of unproven, "alternative" therapies. He advocates a vegan diet that most people find very difficult to adhere to.

Did the delay in surgery doom Jobs to an early death? The best answer seems to be, "Hard to say, but it didn't help him any in the long run." A blog called Science-Based Medicine, written by oncologist David Gorski, has some interesting thoughts. I enjoyed his piece, and especially his back-and-forth with a commenter on his site who identified himself as a medical oncologist. Here is Gorski's bottom line about the allure of "magical thinking:"

Just eat this root, do these colon cleanses, let this healer manipulate your energy fields, and everything will be fine. No nasty invasive surgery that will permanently alter your body and how it functions. No poisonous chemotherapy. Unfortunately, reality doesn’t work this way, no matter how powerful the reality distortion field. Ultimately, reality intrudes, as it did for Jobs. When it did, when a followup scan apparently revealed that his insulinoma had grown, Jobs realized he had made a horrible mistake and tried to correct his course by undergoing surgery right away. It’s not clear whether his time in his self-created medical reality distortion field ultimately led to his demise or whether his fate was sealed when he was first diagnosed. Again, there’s just too much uncertainty ever to know for sure, and even if Jobs did decrease his odds of survival significantly it’s impossible to say whether the delay meant the difference between life and death in his specific case. What is clear is that no reality distortion field can long hold cancer at bay. Reality always eventually wins over magical thinking, no matter how much it might appear that magical thinking is winning at any given time.

My own take is this:

Cancer is scary, and even brilliant patients like Steve Jobs can become desperate, and tempted into trying an unorthodox treatment – remember laetrile? And although many cancer treatments have terrible side effects, at least they are based on science, not wishful thinking. Before you or a loved one decides to depart from what established medicine recognizes as the best practice for your diagnosis, learn about the science, not the magic, involved in those choices.

To help separate reality from fantasy, consult Quackwatch.com, a nonprofit resource that addresses health-related frauds, myths, fads and questionable therapies.

The relentless campaign to convince every American woman of her imminent risk of fatal breast cancer doesn't measure up to any calm review of the numbers on who dies from what in the United States. And the value of regular mammograms for women is coming under increasingly skeptical scrutiny.

The latest skeptical report on breast cancer screening with mammograms comes this week in the "Well" column in the New York Times. According to the Times, of the 39 million women who undergo mammograms this year, somewhere between 4,000 and 18,000 of those will be helped by getting earlier diagnosis of a cancer that otherwise might have gotten out of control.

Last year at this time in this blog, we reviewed the numbers comparing breast cancer risk to those of other big killers. We showed that the usual statistic that most Americans have heard, that one in eight women will get or die from breast cancer, is wildly wrong. The numbers still are accurate today.

The point is not to pooh-pooh breast cancer. It's a terrible disease, and nobody should die from it. But nobody should be unduly scared of it either, when the odds are that many other ailments will kill you first.

Should you get a regular mammogram? It's a personal decision depending on your own family history and your own risk tolerance. Just don't let anyone tell you that you're being suicidal if you decide to skip it.

The problems with the cancer drug Avastin are never ending. The FDA has issued a another warning about the drug’s dangers, this time involving ovarian failure, jaw necrosis (bone decay), blot clots and excessive bleeding.

We’ve written about Avastin as well, most recently last week in regard to its use as an injectable drug for macular dengeration, and about the risks it poses for breast cancer patients.

To explore just one of the reasons for the new warning, consider a study that found that 34% of women treated with Avastin during chemotherapy suffered ovarian failure, and most have not recovered their full fertility; only 2% given chemotherapy alone experienced ovarian failure.

Avastin was approved by the FDA in 2004 to treat nonsmall cell lung cancer and colorectal cancer in combination with chemotherapy. It received approval in 2008 to treat breast cancer, but that was revoked in 2010, and reconfirmed in June of this year.

When used for its original purpose, Avastin’s side effects can include high blood pressure, heart attacks, heart failure and the development of holes in the nose, stomach and intestines. All drugs carry the risk of side effects. Sometimes, they’re worth it. Increasingly, expanded use indicates that that’s not the case with Avastin.

... goes to Skip Lockwood, head of a prostate cancer advocacy group called Zero. When the US Preventive Services Task Force recommended against routine screening of men with the PSA blood test, Lockwood said the PSTF's advice "condemns tens of thousands of men to die this year and every year going forward..."

Prostate cancer kills about 30,000 American men a year, so if Lockwood is right, that means the PSA test would have prevented MOST of those deaths. If it was that obviously beneficial, why would so many doctors and health care leaders have such doubts? Last year, in a less publicized statement based on the same research studies, the American Cancer Society also pulled the plug on its advice for screening with the PSA test.

The fact is that fears of just this kind of over-the-top reaction caused the PSTF to delay its advice for two and a half years after definitive studies came out from Europe and the US showing that PSA testing just doesn't do the job of putting any measurable dent in the death rate from prostate cancer. The PSTF was cowed by the blowback to its last big recommendation: that the numbers don't justify routine mammograms for women in their 40s.

PSA testing has generated a billion dollar industry of urologists doing surgery on men, with high rates of impotence and incontinence in their wake. At the risk of making a bold statement in the opposite direction of Mr. Lockwood's, it's almost malpractice now to put men into routine prostate cancer screening when the odds are much greater for harm than help.

Even the inventor of PSA testing came out last year against its routine use in low-risk men. The test is best reserved for high-risk men who need monitoring after they've already had prostate cancer and need to know if it's coming back.

But don't try to confuse the advocates with scientific facts. They'd rather play on emotions.

Article first published as The Award for Most Fear-Mongering Health Care Statement of the Year ... on Technorati.

No healthy man should get the PSA blood test to screen for prostate cancer, says the influential US Preventive Services Task Force in a new, strongly worded recommendation. As readers of this blog know, this recommendation has been a long time coming.

Prostate removal surgery, even in the most skilled hands, has a high rate of causing incontinence and impotence in the patient. So a test that detects early prostate cancer is valuable only if it prevents early death. The problem is the PSA test can't tell the difference between cancers that are so slow-growing they will never kill a man and those that can be deadly. Hence it directs millions of men to biopsies and extensive operations of uncertain value.

We reported in 2009 that two huge studies were published that year that found zero benefit for PSA testing in one American study and only a tiny benefit, but much more harm, in the European study. Seven lives were saved for every 10,000 men tested, but in the same 10,000, forty-eight were harmed by unnecessary surgery.

Last year, also as we reported, the inventor of the PSA test decried its widespread use and said it should be limited to monitoring men who already have had their prostates removed and need a marker of possible return of the disease.

The scourge of cervical cancer -- a leading cancer killer of women in the third world without access to Pap smears and HPV vaccinations -- is being whipped with an unlikely low-tech, low-cost preventive treatment: Ordinary vinegar plus freezing of the cervical warts before they turn cancerous.

The vinegar is brushed on the cervix by a nurse and any areas of abnormality turn white. It's not perfectly accurate -- sometimes spots turn white and they are totally benign. But the treatment of the white spots is low-pain and cheap -- and highly effective: freezing of the white spots with a metal rod dipped in liquid carbon dioxide (available from the nearest Coca Cola plant).

Read more about this public health innovation that was co-invented by American and Indian doctors, and spread in Thailand, in this New York Times article.

Earlier this month NBC news reporter Andrea Mitchell announced on network TV that she was among the 1 in 8 women who had been diagnosed with breast cancer, and that she was being treated successfully. Then she added, "For you women out there and for the men who love you, screening matters. Do it. This disease can be completely curable if you find it at the right time."

No one with half a heart would wish Mitchell anything but the best, but for people who believe in accurate medical and health information, and for people who believe that misinformation can be dangerous, her proclamation was problematic.

As respected health media watchdog Gary Schwitzer wrote on MedPage Today, "when journalists use their national television platform to make healthcare claims or to give advice, those claims and that advice should be scrutinized."

And they were. One breast cancer survivor-blogger admonished, "Early detection is not a cure. ... 'Completely curable' is a like a fat man wearing a hockey jersey. It covers a lot of ground. You have access to the top medical experts in the world -- ask them what 'cured' means in the setting of breast cancer."

Another woman with a similar background chimed in, "Wishing you the best Ms. Mitchell. ... [But] what you said about breast cancer is harmful and untrue. You should correct it immediately."

Others took issue with her oft-repeated and misguided claim that 1 in 8 women contract breast cancer. It's fuzzy math that the National Cancer Institute (NCI) has tried to correct. As explained on its website, women born now have an average risk of 12.2 percent (often expressed as "1 in 8") of being diagnosed with breast cancer at some time in their lives. [But] the chance that they will never have breast cancer is 87.8% (expressed as "7 in 8").

That is a lifetime risk. Risk increases with age, so, as Schwitzer points out, the NCI provides a more helpful way of looking at it. A woman's chance of being diagnosed with breast cancer is:

• .43% (often expressed as "1 in 233") from 30 through 39


• 1.45% (often expressed as "1 in 69") from 40 through 49


• 2.38% (often expressed as "1 in 42") from 50 through 59


• 3.45% (often expressed as "1 in 29") from 60 through 69

A more accurate way Mitchell could have handled the message that also would help others assess their situation, Schwitzer says, goes something like this:

"And now a personal note. I don't believe that journalists' personal lives should become part of stories, but I am making this announcement to avoid the possible spread of any rumors or misinformation.

"I've been diagnosed with and treated for breast cancer. I'm confident in my course of treatment but I don't wish to discuss details because my case may not be representative of what other women face. My decisions are mine and should not influence others just because I'm on TV.

"As you can see, I'm already back at work and have been told my prognosis is terrific."

The comments from readers of the MedPage Today post confirmed the wisdom of Schwitzer's suggestions. One "been there" expert elaborated:

• "Mammography's effectiveness in pre-menopausal women is very questionable. There are facts out there to prove it and I lived it.


• "Mammography is not the same as 'early' detection. By the time a tumor can be felt or seen on a mammogram, it has likely been growing for years, probably five years.


• "An early-stage breast cancer, as Ms. Mitchell has indicated she has, can still return as Stage 4 cancer. The idea that that an early stage is the same as a cure is flat-out inaccurate. ... even before a cancer is detected, the seeds of metastases have already been planted in the rest of the body. The problem is that we don't know how to detect those, or why this happens, or how to stop those seeds from turning into a deadly disease."

"[E]ven after all the walks, races and pink products sold 'for the cure,' there isn't one for breast cancer," read one. "For any journalist with a body of solid research at her disposal to suggest there actually is just isn't cool.

"Really, it perpetuates the stereotype that this disease is cute and beatable -- so long as it is caught at an early stage and the doctors get it all. Nothing is further from the truth. So here is the truth: there is no rhyme or reason to breast cancer. Folks can be diagnosed at Stage I and end up a few years later with a recurrence or metastasis. It can't be cured.

"Please tell the whole truth when you decide to tell your personal story, especially when you have a platform like a national news program. To quote half-statistics and 'I'm cured!' rhetoric does nothing more than sell the myth that breast cancer is cute, pink and oh-so-special. She and every other journalist deciding to tell this story must do better."

We couldn't agree more.

In 1999, the FDA approved the drug Actos for Type 2 diabetes. Its popularity grew substantially after its primary competitor, Avandia, was linked to increased risk of heart attack. In 2010, the drug generated $3.4 billion in sales for its manufacturer, Takeda Pharmaceuticals.

Now, Actos is under fire, too.

The drug was recalled this summer in France and Germany in the wake of increased incidents of bladder cancer among people who took Actos. Similar reports have occurred in the U.S., where the FDA has allowed the drug to remain on the market provided warning labels are added to the packaging.

Earlier this month, the first lawsuits over Actos’ alleged role in bladder cancer were filed in the U.S., and many more are expected to be forthcoming. The lawsuits charge that Takeda failed to disclose data showing an increased bladder cancer risk.

If you are a diabetic who takes this drug, notify your doctor immediately if you develop:

• blood in your urine;


• an urgent need to urinate;


• pain during urination; or


• pain in the back of lower abdomen.

“The consensus,” he said, “already is that (Actos) should only be considered ... after patients have exhausted all other options."

The U.S. faces a growing shortage of the low-profit but vital generic drugs that cancer patients and other desperate folks rely on. These drugs are made in places like India and China in plants that the Food and Drug Administration lacks power to inspect.

Meantime, Big Pharma focuses on new high-profit but low-benefit drugs. The latest examples of new FDA approvals: Provenge, a drug for prostate cancer which on average extends life by four months at a cost of $93,000, and Yervoy, a melanoma drug with a price tag of $120,000 for a similar average benefit of four more months of life.

As reported by Gardiner Harris in the New York Times, a lot of solutions are being proposed to the crisis that has been brewing for the last few years, ranging from creation of a government stockpile of drugs to a requirement that drug makers give an early warning to the FDA of inability to keep up with demand for drugs.

Good luck getting any of these passed by a Congress whose loudest members reflexively say the government is the problem, not the solution. But as many Times readers noted in comments on the new article, this story is another example of why we need smart government, not no government, to address the many failures of the free market when it comes to vital services like health care.

Hold your cellphone against your head too long and you can get a brain tumor. Text too often and you can forget how to spell. Converse on your Bluetooth while waiting in line and annoy everyone around you.

One of those statements is undeniably true, one could be true, and one—about brain tumors—is probably false, according to a new study in Environmental Health Perspectives.

Because data is sparse about cellphone use by youngsters and about use periods longer than 15 years, be prepared for ongoing speculation about how cellphones affect your brain. And be mindful, the study says, that "Research cannot in principle prove the complete absence of an effect, but only place limits on its possible magnitude.”

Still, the conclusion is fairly compelling: “Although there remains some uncertainty, the trend in the accumulating evidence is increasingly against the hypothesis that mobile phone use can cause brain tumours in adults.”

Of course, we can’t promise that somebody won’t whack you in the head if you text and chat during the movie.

The Centers for Disease Control and Prevention (CDC) reports that the rate of death from colorectal cancer has fallen substantially in recent years. It also noted that the decline could be even greater if more older adults were screened for colon polyps with colonoscopy.

National death rates from colorectal cancer dropped by 3% annually between 2003 and 2007. The national rate fell from 19.0 per 100,000 population to 16.7 per 100,000 during that period. The screening rate for people 50 to 75 years old was 65% in 2010, an increase from the rate of 52% in 2002.

The CDC says that one-third of the target population still is being missed.

The No. 1 reason why? Doctors fail to recommend screening to their patients.

Sometimes the failure to recommend colonoscopy is just a one-time oversight. Other times, it can amount to medical malpractice, especially when the patient is in a high-risk group such as someone who has had blood in their stool with no clear reason for it. On the Patrick Malone law firm website, we have an extensive discussion of colon cancer and medical malpractice, plus an important patient safety tip on why full colonoscopy is superior to sigmoidoscopy in screening for cancer.

Nobody wants to get lung cancer. Nobody who has it looks forward to the radical treatment such a diagnosis usually demands. But a recent research study lifted a bit of the dark cloud hovering over these patients. It found a significant decrease--20%--in deaths among lung cancer patients screened annually for three years with a certain type of CT scan compared with conventional chest X-rays.

This being lung cancer, and this being an evolving technology, caveats are in order: More than 90% of positive screening tests using both techniques were false positives, and the study did not assess the costs of false positive tests.

The high rate of false-positive results carries the potential for overdiagnosis and overtreatment. "Before public policy recommendations are crafted, the cost-effectiveness of low-dose CT screening must be rigorously analyzed," Christine Berg, M.D., of the National Cancer Institute, and co-authors wrote in their discussion of the results in the New England Journal of Medicine. "The reduction in lung-cancer mortality must be weighed against the harms from positive screening results and overdiagnosis, as well as the costs."

Approximately 157,000 Americans die from lung cancer every year; the study suggests that as many as 27,000 of them might be saved by CT screening. And although the key finding was that the technology resulted in fewer deaths, the study is notable as well for demonstrating no significantly harmful side effects. The landmark nature of the science was described by some authorities, including Dr. Otis Brawley, chief medical officer of the American Cancer society, as second in significance only to the surgeon general's 1964 report linking smoking to lung cancer.

Critical scrutiny now shifts from "does it help?" to "who does it help and how much does it cost?" Medicare pays about $300 for a CT scan, but positive results in lung cancer patients prompt additional testing, and where that ends is anybody's guess.

One observer casting a wary eye over not over the science but how it is represented to laypeople is Gary Schwitzer, blogging at MedPage Today. His beef isn't solely with the unknown costs of the increased use of CT scans, but in how the media chooses to present the findings with, in his estimation, little regard for the full story. Exemplary of such shoddy coverage, he says, is a national TV broadcast network for failing to offer any discussion of false positives and cost but sparing nothing in the hyperbole department. The network, he said, called CT scans "simple," a term with which he takes issue. Also, he said, "it cited a cost of a 'mere $99'--not to be matched in many locations across the U.S. and failing to take into account the follow-up costs of the considerable number of false positives."

Schwitzer claimed that the network "promoted screening advice that simply hasn't been established and didn't cite the source of that advice." He said it "offered to help viewers find hospitals who could scan them--journalism or advertising?"

Raising the flag of skepticism higher in hopes that the technology's end user--you, the patient--salutes, Schwitzer quotes Harry Demonaco, director of the Innovation Support Center at the Massachusetts General Hospital. The study, Demonaco says,"is really a tour de force that was masterfully crafted and operationalized. The authors presented the results in a well-balanced fashion. Unfortunately, the [broadcast news] report did not.

"There are 94 million smokers at risk for lung cancer in the United States today. According to the [study's] authors, only about 7 million of them would meet the eligibility criteria to have been included in the study. This is important because the results may not be generalizable to the remaining 87 million smokers."

Schwitzer concludes, "We know that journalists struggle with screening stories. A simple reminder may help them do a better job: All screening tests do harm; some may also do good. If you don't reflect that in your story, you're probably doing harm as well."

And might we just add: Harm comes in many forms--physical, financial and emotional. As a medical consumer, we hope you try to stay abreast of developments in medicine and technology that affect you and the ones you love. Remember, like everything else, if you read or hear news about something that seems to good to be true, you might not have the full story.

Doctors who aren't directly involved in patient safety issues often sail through their careers without much awareness of how commonly errors and malpractice infect hospitals, clinics and medical offices. Then they become patients, and suddenly their world is turned upside down.

Itzhak Brook, M.D., has been a doctor for more than 40 years. He is an infectious disease pediatrician at Georgetown University Hospital in Washington, D.C. Then he got throat cancer a few years ago.

His cancer was successfully removed, but then it came back. He had to have his voice box -- the larynx -- removed, and the throat was reconstructed.

It was then that the errors began to pile up, or, as he puts it, “mistakes occurred at all levels of my care.”

Dr. Brook recorded these incidents before, during and after his surgery:

* Surgeons had failed to timely diagnose the recurrence of his cancer. It was finally observed by an astute resident via a basic procedure that allowed visualization of the pyriform sinus, which was where his tumor was located. Had his experienced surgeons done the same basic procedure, his tumor most likely would have been observed and removed much earlier.

* Surgeons mistakenly removed scar tissue instead of the cancerous lesion. A week after the surgery, pathological studies revealed that the tumor was actually farther down in the pyriform sinus. This error could have been avoided if frozen sections of the lesion itself, not just its margins, had been analyzed in the operating room. As a result, he had to undergo additional surgery to remove the tumor, which was more difficult because of swelling and changes to the surgical site due to the original operation.

* While still in the ICU one day after surgery, he experienced an airway obstruction and couldn’t find his call button, which had fallen on the floor. Though he was only a few feet away from the nurses station, he was unable to get the attention of staff but was ignored. (He couldn’t call out because he no longer had a larynx).

* In what was probably the most serious error, he was fed soft food by mouth far too early, which, following laryngectomy with flap reconstruction, can lead to failure of integration by the flap. It took 16 hours before the feeding was stopped, and only after Dr. Brook brought this to the attention of a senior surgeon. The error occurred because the order to start feeding was in fact intended for another patient.

In addition, nurses and other staff:

Did not clean or wash their hands.

Did not use gloves.

Took oral temperature without placing the thermometer in a plastic sheath.

Used an inappropriately sized blood pressure cuff (which produced alarming readings).

Attempted to administer medications by mouth intended to be given by nasogastric tube.

Dissolved pills in hot water and fed them through the feeding tube (thus irritating the esophagus).

Delivered an incorrect dose of a medication.

Connected a suction machine directly to the port in the wall without a bottle of water.

Forgot to rinse the hydrogen peroxide used for cleaning the tracheal breathing tube (causing
severe irritation).

Did not write down verbal orders.

Fortunately, despite all these errors, Dr. Brook did not suffer any long-term consequences. Still, his experience made him realize that a hospital is the least safe place for patients, and that all hospitalized patients should have a dedicated patient advocate such as a family member or a friend at their bedside.

Dr. Brook writes extensively about his experiences as a throat cancer patient on his blog. He also lectures to medical groups to try to get doctors and nurses to understand the human costs of the epidemic of medical error.

You can also read Dr. Brook’s account of his hospital experiences in the Journal of Participatory Medicine.

Children at emergency departments in the U.S. had five times as many CT scans in 2008 as they did in 1995, according to a recent study, increasing not only risks associated with radiation exposure but also risk of “incidentalomas," the term physicians use for incidental findings that could be (but probably aren't) cancer.

In addition, the study, published in the journal Radiology, found that 6% of pediatric visits to the ER involved a CT scan, while an earlier study by the same research group, led by Dr. David Larson at Cincinnati Children's Hospital Medical Center, found an even greater rise in scanning during adult ER visits, with 25 percent of patients age 65 and older and 12 to 16 percent of younger adults getting a CT scan in 2007. CTs of the abdomen and pelvis were the most likely to turn up an incidental finding.

An earlier study published in the Archives of Internal Medicine found that nearly 40 percent of CT and MRI scans performed for research purposes at the Mayo Clinic from January through March 2004 turned up at least one incidental finding. In the 35 patients in whom doctors took further action (i.e. additional testing, specialist consultation, or surgery), only six were judged by researchers to have clearly benefited from an investigation, while in the rest there was no clear benefit or clear harm, such as complications from surgery for a benign tumor.

In response to growing concern about the rising numbers of incidentaloma, the American College of Radiology recently published detailed guidance for clinicians about how to approach such findings, and warns physicians that “subjecting a patient with an incidentaloma to unnecessary testing and treatment can result in a potentially injurious and expensive cascade of tests and procedures." The college advises physicians to carefully consider an individual patient's risk for cancer in deciding whether or not to recommend further evaluation.

It also advised patients who are told about an incidental finding to seek a second opinion to verify that the radiologist's interpretation of their scan is correct, to adopt a "healthy skepticism" about testing, and only to consent to scans absolutely necessary to establish a diagnosis or plan of action, rather than to those ordered “just to be sure.”

Source: U.S. News & World Report

Yet more evidence that expensive technology drives treatment decisions in medicine: A new survey of prostate cancer treatment shows that once a hospital invests the $1 million to $2.5 million it takes to get a surgical robot, men in the area start to get a lot more prostate removal surgery than they otherwise would.

Although heavily marketed, robotic surgery has never been proven to reduce the two big risks of prostate removal: incontinence and impotence. And each surgery with a robot is about $2,000 more expensive than those done the traditional way.

An excerpt from a New York Times piece on the new study:

One reason for the increase in operations in hospitals that own a surgical robot may be that the technology helps a hospital lure potential surgical patients away from the competition. But the data also suggest that once a hospital obtains a robot, patients who might be candidates for nonsurgical options are more likely to be steered toward robotic surgery instead.

“This may be the medical embodiment of the phrase, ‘If you’re a hammer, everything looks like a nail,’”said the lead study author, Dr. Danil V. Makarov, assistant professor of urology at New York University’s Langone Medical Center. “If you have the technology, it will get used.’’

...

“If you’re a hospital and you get a robot, clearly you want to use it,’’ said Dr. David Penson, a study co-author and director of the Center for Surgical Quality and Outcomes Research at Vanderbilt University. “There are some real pressures here that have nothing to do with science,” he said. “We have this interplay of patients’ fascination with technology coupled with business interests on the part of the hospital and device makers, pushing people to try a new technology perhaps before it’s been fully tested.’’

And here's a good bottom line point for patients, also from the Times article:

“For patients, there are a lot of choices in prostate cancer,’’ said Dr. Makarov. “Knowing that technology can influence both what they want and what their physician may advise them should make them a little more skeptical and maybe make them ask a few more questions.’’

The medical community is waking up to an enormous problem with radiation – mainly X-rays and CT scans — used to diagnose disease and injury. Patients are getting too much radiation, and the excess itself causes injuries, many years down the road, in a big uptick in the risk of cancer.

Even a “routine” CT scan of the abdomen, ordered thousands of times every day in the United States for patients with belly pain, carries a large risk of downstream cancer, just from that single scan.

Dr. Rebecca Smith-Bindman, MD, of the University of California San Francisco, estimates a 20-year-old woman who undergoes a CT scan of the abdomen and pelvis has a one in 250 chance over her lifetime of getting cancer just from that single dose of radiation. This number was in a talk she gave recently at UCSF, as reported by her colleague Bob Wachter, MD, a patient safety expert at UCSF.

More scary statistics are in two articles Dr. Smith-Bindman and her colleagues published in Archives of Internal Medicine in 2009. There, they estimated that a single CT scan of the heart’s arteries (called a CT coronary angiogram, and promoted as being safer than the usual test called a cardiac catheterization) would cause cancer in one in 270 women and one in 600 men who underwent the test at age 40.

One problem is a huge range in the amount of radiation used at different facilities. Dr. Smith-Bindman’s group found a 13-fold variation from the lowest to the highest radiation exposure between scanners running the exact same imaging study.

She blames lax regulation by the Food and Drug Administration and lack of aggressive self-regulation by the medical physicists, working in hospitals, who are supposed to protect patients.

Most patients have no idea of the amount of radiation in one CT scan. It’s estimated to be about 200,000 times more than the radiation you get from going through an airport whole-body scanner, or about 450 times more than a simple chest X-ray.

Once people start to appreciate the risk, they realize that the pretty pictures produces by CT scans can have a very expensive cost down the road. It's something to remember the next time you see a billboard advertising “whole body scans” for healthy checkups, or “virtual colonoscopies” (to pick two examples of the heavily hyped types of CT scans now available).

Article first published as The Coming Cancer Epidemic from Overuse of CT Scans on Technorati.

A physician who gave nearly 100 veterans with prostate cancer incorrect doses of radiation has been sanctioned by the Nuclear Regulatory Commission (NRC). The errors involved the incorrect placement of iodine-125 seeds in patients to treat prostate cancer.

Out of 116 such brachytherapy procedures performed at the facility between 2002 and 2008, the VA reported that 97 were carried out incorrectly. The NRC investigation found that Dr. Gary Kao, a radiation oncologist at the VA Medical Center in Philadelphia, took part in 91 of the 97 incorrect procedures. In several cases, the incorrect doses were caused by Kao having implanted the seeds in nearby organs or surrounding tissue.

As a result, the NRC ruled that Kao cannot take part in agency-related activities without undergoing more training. The NRC also issued a separate order requiring Gregory Desobry, a medical physicist who worked at the same facility, to notify the agency if he accepts employment in that capacity involving NRC-regulated activities within 20 days of beginning such work. Last year, the NRC fined the Philadelphia VA hospital $227,500 over the incidents.

Source: Philadelphia Inquirer

To view a copy of the NRC decision, click here.

Most breast lumps found in women need to be looked at under the microscope to make sure they're not cancer. But new research says too many women are getting unnecessarily aggressive open biopsies, which produce a scar, when most of them could get enough tissue for sampling with a simple needle stick.

About 1.6 million breast biopsies are done every year in the United States, with about 200,000 of those resulting in a diagnosis of invasive cancer, which requires more treatment. That means that about seven in eight women who undergo biopsy receive the good news of no cancer (or the pre-invasive diagnosis of ductal carcinoma in situ).

Needle biopsy is the gold standard for the initial investigation of most suspicious breast lumps, except for those that a needle cannot reach. It can be done with numbing local anesthetic and a quick needle stick, which sometimes needs to be guided by x-ray imaging when the lump cannot be felt. In that case the needle biopsy is done by a radiologist, not a surgeon.

An open biopsy requires a one-inch incision, which leaves a scar, and must be done with either general anesthesia or sedation. It costs about twice as much as a needle biopsy, both for the surgeon's fee and the hospital's fee. And that could be the economic motivator for the persistently high rates of open biopsies still done in the U.S., according to researchers.

The new study of breast biopsies in Florida found that three in ten were done by the more expensive and scarring open technique, when the rate should be less than one in ten.

A New York Times piece on the new study quoted Dr. Melvin J. Silverstein, a breast cancer surgeon at Hoag Memorial Hospital Presbyterian in Newport Beach, Calif., as saying it was “outrageous” that 30 percent of breast biopsies were done by surgery. The article went on:

He said some of the unnecessary procedures were being performed by surgeons who did not want to lose biopsy fees by sending patients to a radiologist.

“I hate to even say that,” Dr. Silverstein said. “But I don’t know how else to explain these numbers.”

Many women with early breast cancer do not need to have their armpit lymph nodes removed, according to a new study. Currently, this painful procedure has long been routine, as physicians believed it would prolong women’s lives by keeping the cancer from spreading or coming back. However, the study shows that removing the cancerous lymph nodes is unnecessary when women receive chemotherapy and radiation, which wipes out most of the disease in the nodes.

The study indicates that for about 20% of women (40,000 women a year in the U.S.), the removal of the cancerous lymph nodes doesn’t (a) alter the treatment plan for the patient; (b) improve survival rates; or (c) make the cancer less likely to recur. And it has a downside, since it can cause complications like infection and lymphedema, a chronic swelling in the arm.

Experts say that the new findings, combined with similar ones from earlier studies, should change medical practice for many patients. However, they warn that change may come slowly because the notion that the nodes must be removed is very deeply ingrained.

The current approach to surgical treatment of breast cancer is to cut out obvious tumors — because lumps big enough to detect may be too dense for drugs and radiation to destroy — and to use radiation and chemotherapy to wipe out microscopic disease in other places. Until now, physicians believed that even microscopic disease in the lymph nodes should be cut out to improve the odds of survival.

The new results do not apply to all patients, only to women whose disease and treatment meet the criteria in the study, which were:

Early tumors at clinical stage T1 or T2 (i.e. less than two inches across).

Biopsies of one or two armpit nodes found cancer, but the nodes were not enlarged enough to be felt during an exam, and the cancer had not spread anywhere else.

The women had lumpectomies, and most also had radiation to the entire breast, and chemotherapy or hormone-blocking drugs, or both.

The study included 891 patients with their median age in the mid-50s. After an initial "sentinel" node biopsy, the women were assigned at random to have 10 or more additional nodes removed, or to leave the nodes alone. In 27 percent of the women who had additional nodes removed, those nodes were cancerous. But over time, the two groups had no difference in survival: more than 90 percent survived at least five years. Recurrence rates in the armpit were also similar, less than 1 percent.

Dr. Grant W. Carlson, a professor of surgery at the Winship Cancer Institute at Emory University, who authored an editorial that accompanied the study, said that by routinely taking out many nodes, “I have a feeling we’ve been doing a lot of harm.”

Source: The New York Times

You can read an abstract of the study here.

The Third Circuit Court of Appeal in Louisiana has ruled the state’s $500,000 malpractice cap to be unconstitutional.

Joe and Helena Oliver had sought relief from the Louisiana Medical Malpractice Act, which shrank the damage award their daughter received for disfiguring injuries from $6.2 million to $500,000.

Their daughter, Taylor, developed severe injuries after she was treated by a “grandfathered” nurse practitioner who was practicing with only a high school diploma. Susan Duhon, a registered nurse practitioner and sole owner of the Magnolia Clinic, treated Taylor for vomiting, nausea and diarrhea. Taylor visited the clinic 32 times, and Duhon prescribed more than 30 medications. Duhon had a statutory duty to consult a physician, but Taylor never saw one during any of her visits.

When Taylor was 14 months old, another hospital diagnosed her with neuroblastoma, a childhood cancer. One of the signs is severe bruising around the eyes, a symptom Taylor had presented with at the Magnolia Clinic when she was 6 months old.

If neuroblastoma is diagnosed within the first year of life, the child has a 90 percent chance of an event-free recovery. But because of the delayed diagnosis, the quality of Taylor's life has been severely diminished. Though she survived the cancer, the tumor caused her head to become misshapen. In addition, her eyes are abnormally large and she is legally blind.

The Olivers won their medical malpractice lawsuit, but their $6.2 million award was cut to $500,000 under Louisiana state law. The appeals court ruled that the cap on malpractice damages is unconstitutional, noting that “the cap discriminates against Taylor and her parents by limiting their general damage recovery to a single $500,000 payment, while allowing other less severely injured victims to fully recover their general damage awards."

In another case, the same appeals court reversed a jury decision and awarded $400,000 in damages to a man who lost all vision in one eye after a cataract operation. The case involved cataract surgery performed in 2002 by ophthalmologist Ernesto Kufoy on Ronald Bianchi. During the surgery to remove the cataract and implant an artificial lens, the lining of the old lens was torn and a second artificial lens was implanted.

After the surgery, Bianchi reported worsening pain and vision loss. After a malpractice suit was filed in 2002, a medical review panel found malpractice on Kufoy’s part. (Kufoy did not chart his treatment of Bianchi and had no medical records to support his testimony.)

A jury trial in December 2009 determined that Kufoy had breached the standard of care, but the jury did not award damages because it did not find proof of cause. However, the Third Circuit Court of Appeal found there was no factual basis to support the jury’s verdict and called it “manifestly erroneous.”

The court overruled the jury’s verdict and awarded Bianchi and his wife $100,000 for past and future medical expenses and $300,000 in general damages. The cost of the appeal also was assessed to the defendant.

Sources: Beauregard Daily News for the Bianchi case.

Courthouse News Service for the Oliver case.

The news about a major government study that found 20 percent fewer deaths in a group of heavy smokers who got annual CT scan screening for lung cancer has a few more statistics that are sobering for the rest of us who pay the price as a society for this screening.

The study enrolled 50,000 smokers and gave half of them CT scans and half regular chest X-rays, every year for three years.

All enrollees had to have had at least a thirty pack year history of smoking (that's the same as one pack a day times thirty years, or two packs a day times fifteen years).

After three rounds of screening -- a total of 75,000 CT scans in 25,000 patients -- they found a total of 18,000 suspicious findings that needed follow-up -- biopsies with long needles or some other kind of surgery. That was about a one-in-four incidence of suspicious findings per screen.

In those 25,000 people, eighty-eight lives were saved from lung cancer death. (The lung cancer deaths totaled 354 people in the CT group versus 442 in the control group of another 25,000 patients who got chest X-ray only for comparison.) That's where the 20 percent number came from for the headlines.

So, bottom line: take 25,000 people, give them 75,000 CT scans, do further testing and surgery and more followup on 18,000, and save 88 lives.

Now, those are 88 very hideous deaths prevented. Lung cancer is one of the worst. But the delicate problem is that it's also self-induced by smoking most of the time.

So who should pay for all this testing? That's the kind of thing we need to have a national conversation over -- not hysterical shouting about so-called "death panels" -- but what can we really afford?

You can read the data from the government agency here.

And to see how the news media handle the story, contrast the AP story "CT scans modestly cut lung cancer deaths," with the Washington Post ("significantly cut..."). Which is more accurate? It depends on how you focus your microscope. My vote is with the AP's writer.

As we near the end of Breast Cancer Awareness Month, it's time to speak the truth about how the cancer advocacy industry overly hypes and scares the American public about this disease. The much bandied number "one in eight" gives a good window into this.

When I tuned in CBS 60 Minutes the other night, the first advertisement after the opening teasers said:

Marg Helgenberger (CSI: Crime Scene Investigation): "You know what's a real crime, one in eight women will be diagnosed with breast cancer this year. We don't know how to solve it yet, but this "Warriors in Pink" scarf was created to help." Narrator: "You can make a difference in the fight against breast cancer, visit Fordcares.com"

One in eight this year! The reality is more like one in 813 - a hundred-fold less.

(The National Cancer Institute's SEER program puts out these figures. You can see the table for all cancers here. The numbers are expressed in new diagnosed cases per 100,000 women, and the estimate of 123 new cases per 100,000 translates to one in 813.)

Cancer advocates who are a little more careful than the CSI actor say that the one in eight number means "lifetime risk" of a woman getting cancer. That number is sort of accurate -- but also wildly misleading. If a woman reaches age 85, her cumulative lifetime risk of getting breast cancer (not dying of it) is one in eight. But it's not a number that is useful to anyone.

By age 85, a woman has escaped the risk of early death from breast cancer that so worries everyone. So what is the point of even talking about what an 85-year-old's risk is? Maybe because it's an arresting number, and a lot scarier than the real age-related numbers that count.

Here's a table of the risk of being diagnosed with cancer depending on a woman's age (also from the National Cancer Institute ):

A woman's chance of being diagnosed with breast cancer is:
• from age 30 through age 39 . .. 1 in 233
• from age 40 through age 49 . . .1 in 69
• from age 50 through age 59 . . .1 in 42
• from age 60 through age 69 . . .1 in 29

The chance of dying prematurely from breast cancer is, fortunately, even less. Here's a table giving those odds by age: (these are in five-year increments, also from the government SEER data; click here to see the source data)

• from age 35 through age 39 . .. 1 in 12,987
• from age 40 through age 44 . . .1 in 6,993
• from age 45 through age 49 . . .1 in 4,348
• from age 50 through age 54 . . .1 in 2,980
• from age 55 through age 59 . . .1 in 2,062
• from age 60 through age 64 . . .1 in 1,618
• from age 65 through age 69 . . .1 in 1,372

So the death risk is nowhere close to one in eight.

When you compare breast cancer to the other major killers, you can calculate the likelihood of death in any given year by type of disease.

A woman's chance of dying in any one year (combining women of all ages) is:

• All causes: 1 in 155
• Heart diseases: 1 in 475
• All cancers: 1 in 661
• Lung cancer: 1 in 2,500
• Chronic obstructive lung disease: 1 in 2,777
• Accidents: 1 in 3,876
• Alzheimer's: 1 in 4,016
• Breast cancer: 1 in 4,367
• Diabetes: 1 in 5,128
• Colon cancer: 1 in 6,944
• Pneumonia: 1 in 7,092

(This is based on government "age-adjusted" data from the CDC's last report earlier this year. Here is the table.)

None of this is to say that breast cancer isn't an important worthy target of research and education. It just should not be blown out of proportion with statistics that are very, very far off the mark.

Responsible cancer advocates never use the one-in-eight number because they know how misleading it is. Dr. Susan G. Love says flatly on her website: "The one in eight statistic doesn't accurately reflect breast cancer risk."

Others, however, print up T-shirts with the number, name websites with it, and use it in many other ways, like the PSA on 60 Minutes the other evening.

So maybe it's time to bury this overly scary, misleading number.

It was nearly a year ago that the U.S. Preventive Services Task Force caused a huge uproar with the mildest imaginable recommendation about mammograms, and now two physician researchers say it might be time to point out that certain emperors are wearing no clothes.

In their Sounding Board article in the New England Journal of Medicine, Drs. Kerianne Quanstrum and Rodney Hayward note that some of the harshest cries against the Preventive Services Task Force came from those doctors with the highest vested self-interest in maintaining the importance of mammograms: radiologists with the Society for Breast Imaging. Yet nobody seemed to notice the obvious conflict of interest.

As the authors note:

When a given service is successfully extended to more people with more intensity, the profession providing that service tends to grow in importance and profitability. In the United States, where medical specialists often enjoy an exalted status in the minds of the public, if experts shout loudly that every woman 40 years of age or older must be screened annually for breast cancer, then breast cancer must be important, screening must be a basic human right, and doctors who provide this service must have great value and authority.

But what if those experts are basing their recommendations on more than the interest of patients alone? In any other industry, we accept the idea as natural that those providing a service or product hold their own and their shareholders' interests as a primary objective. Why have we failed to acknowledge that the same phenomenon occurs in health care? Although it is true that individual medical providers care deeply about their patients, the guild of health care professionals — including their specialty societies — has a primary responsibility to promote its members' interests. Now, self-interest is not in itself a bad thing; indeed, it is a force for productivity and efficiency in a well-functioning market. But it is a fool's dream to expect the guild of any service industry to harness its self-interest and to act according to beneficence alone — to compete on true value when the opportunity to inflate perceived value is readily available.

The objective facts, as Quanstrum and Hayward point out, are that the well known economics law of diminishing marginal returns applies in health care as much as anywhere. In mammograms, as the rareness of the tested condition increases, the hidden costs of the test goes up and the value goes down.

So for women between ages 60 and 69, you can save one life by subjecting only 400 women to mammogram screening (in the process of 5,000 screening visits and 400 false alarms in the same group over 13 years of follow-up). That's enough of a benefit to encourage everybody in the age group to get annual screening.

But in women between ages 40 and 49, the data show that to save a single life, you need to subject 1,900 women to screening and endure 20,000 screening exams with 2,000 false alarm tests during eleven years of follow-up. That puts the risk-benefit equation in more of a gray area where you cannot say definitely that no one should have it, or that no one should not have the screening.

And that was exactly the point of the Preventive Services' recommendation: To put the issue into the hands of individual doctors and patients and let them decide if family history or individual anxiety are enough to make the patient want to have the test. That's not a cop-out, it's a prudent bow to individual self-determination.

Here's another quote from Drs. Quanstrum and Hayward:

We must acknowledge that just as in any other profession or industry, self-interest is unavoidably at work in health care. Rather than even acknowledging practice guidelines offered by vested experts, we ought to borrow from the wisdom of sound governance and implement a system of checks and balances when it comes to the interpretation and application of medical evidence. At the same time, we need to recognize that these two tasks are distinct. Although the interpretation of medical evidence is (or ought to be) a scientific exercise, the application of that evidence, as in guideline formation, is ultimately a social exercise.

Decisions regarding practice guidelines can, and certainly should, be informed by evidence. But they will always require value judgments regarding how much evidence is sufficient to dictate care, for example, or whether and to what degree costs should be considered. By separating the processes of evidence review and guideline formation, fair disagreements about the quality or substance of the evidence can occur separately from, and before, disagreements about the implications for clinical care.

If you're a man over age 60, remember this number: 2. That's likely to be the new cutoff number that shows if your PSA test needs followup.

The PSA blood test for screening men with high risk of prostate cancer has come under a lot of criticism for subjecting thousands of men to biopsies and surgeries that cause impotence and incontinence without any proven benefit of longer life expectancy.

But a new research study says that a simple cutoff number on the PSA test predicts quite accurately which men are likely to get aggressive prostate cancers that need to be cut out. The number is 2.0. It's not a perfect predictor, but it does put a man in a much higher risk category if he has that result after age 60.

As reported in the New York Times:

About one in four men will have a P.S.A. score of 2.0 or higher at the age of 60, and most of them will not develop prostate cancer, said the study’s lead author, Andrew Vickers, associate attending research methodologist at Memorial Sloan-Kettering. But the score does put them in a higher-risk group of men who have more to gain from regular screening, he concluded.

The higher the score at age 60, the greater the long-term risk of dying from prostate cancer, Dr. Vickers and his colleagues found. Men with a score of 2.0 or higher at age 60 were 26 times more likely to eventually die of the disease than 60-year-old men with scores below 1.0.

Still, the absolute risks for men with elevated scores were lower than might be expected. A 60-year-old man with a P.S.A. score just over 2.0 had an individual risk of dying from prostate cancer during the next 25 years of about 6 percent, the researchers found. A 60-year-old man with a P.S.A. score of 5 had about a 17 percent risk.

“Most of those men are going to be absolutely fine,” said Dr. Vickers. “But they can be told they are at high risk and they need screening.”

Men with a P.S.A. score of 1.0 or lower at age 60 had a very low individual risk of death from prostate cancer over the next 25 years, the study found: just 0.2 percent.

Now, what if you're in the middle group -- with a PSA between 1.0 and 2.0? That puts you in a low risk group -- but not so low that you never need to worry. The decision to get the PSA test should depend on your family history and your own fears and concerns.

Some cancer screening tests have been so well proven to save lives, like the colonoscopy, that if you don't get one, you need more than your colon examined (to borrow from an old Cancer Society slogan about mammograms). But it's now clear that mammograms don't fit into guilt-trip status anymore. Using radiation to find lumps in the breast that are too small to feel with your hands has only a slight benefit.

Here are the numbers from the latest analysis in the New England Journal of Medicine. For every 2,500 women in the prime screening age group -- 50 to 69 -- you would need to give all 2,500 a mammogram at least every couple of years for ten years to save a single life. And in the process, 1,000 of the same women would turn up with a suspicious result, 500 of those would need a surgical biopsy, and five to fifteen of those would get cancers removed, and maybe entire breasts, that if left alone would never threaten the patient.

The medical journal analysis was written by Dartmouth medical school Dr. Gilbert Welch, who has long been a skeptic of the mammogram as a sacred cow of must-do medicine.

That means that the decision to have a screening mammogram is very much up to the individual. Some may want to take the risk of becoming an unnecessary patient to avoid the deadly but small risk of a preventable death from breast cancer. Others will prefer the option that seems to work better: Good vigilance and attention to small lumps, and then if a cancer develops, make sure you're in the hands of a multi-disciplinary team of cancer doctors who specialize in the latest treatments.

Here's an article by Gina Kolata about the latest study from Norway, in the New York Times.

And here's what the National Breast Cancer Coalition has to say about the myths and truths of breast cancer.

A new book by a prostate cancer survivor and his physician casts yet more doubt on the necessity of surgery for most prostate cancer patients.

Invasion of the Prostate Snatchers, by Ralph H. Blum and Dr. Mark Scholz, an oncologist who has treated the disease exclusively since 1995, examines available prostate cancer treatments as well as the multibillion dollar prostate cancer industry. Blum, a cultural anthropologist and writer, has lived with prostate cancer for 20 years without radical treatment.

As many as 200,000 new cases of prostate cancer are diagnosed each year in the U.S., most of which are overtreated, the authors maintain. Most men, they say, would be better served having their cancer managed as a chronic condition, with “active surveillance” the most effective initial treatment in most cases.

The book notes that only 1 in 7 men with newly diagnosed prostate cancer are at risk for a serious form of the disease. According to Scholz, that means that most men diagnosed with prostate cancer would live just as long without surgery, and “don’t need to have their sexuality cut out.”

A recent study in the New England Journal of Medicine appears to support Scholz’s contention, suggesting that radical prostatectomy – still the most often recommended treatment – extended the lives of just one patient in 48.

Side effects of radical prostatectomy include incontinence, impotence and shrinking of the penis.

Source: The New York Times

You’ll find more information about the book here.

Recent news reports suggest that getting only part of your colon scoped for precancerous lesions might be a good enough way to prevent colon cancer. But the real story is that whatever test you get, there is a wide variation in the quality of the colon examinations that doctors do, and out of hurry or poor training, some doctors miss a lot of lesions that should be taken out.

So if you want to have a safe, effective -- and potentially life-saving -- exam, you need to do some simple doctor screening to make sure the doctor is right for you.

The good news is it's not that hard. Research has found that two simple questions will bring out what you need to know to assure that all the trouble you're going through to get your colon examined will be worthwhile.

Before I lay out the questions, some quick anatomy to make this easy to understand:

The food we eat passes through the stomach and then through nearly thirty feet of small intestine before hitting the large intestine, or colon. The place where the small intestine joins the colon is called the ileocecal valve. It connects the ileum, the final part of the small intestine, to the cecum, the first part of the colon. The cecum is also where your appendix dangles off the end of the colon. In most people, the cecum and the appendix are in the right lower section of your abdomen. Intestinal contents travel from there vertically, in the ascending colon, up your right side toward the liver. The colon then turns 90 degrees to cross your belly from the right to the left. This section is called the transverse colon. Then the colon turns south in the descending colon, which runs down the left side of your abdomen. Finally it moves sideways one more time, in the sigmoid colon, which then reaches the rectum and the anus.

A colonoscopy uses a flexible telescope inserted through your anus to travel the entire length of the colon, to where it ends at the cecum. Most of the visual inspection by the doctor is done while the scope is being pulled back from the cecum to the exit at the anus.

A sigmoidoscopy, by contrast, only inspects the first foot or so of your colon. In some people, that's enough to find most precancerous growths. But in many, it's not. African-Americans, for example, have a higher rate of colon cancer in the further reaches of the colon beyond where the sigmoidoscope looks.

So the smart choice is to go with the full colonoscopy, even though the bowel preparation you have to undergo is more burdensome. That's the recommendation of the American Gastroenterological Association, the doctors' group that specializes in the intestines.

Now for the two questions to get the best chance of a good colon exam:

First, ask the doctor:

What is your detection rate of precancerous polyps?

(These are technically called adenomas). The rate should be at least 20 percent -- or 25 percent in men patients and 15 percent in women patients. A lower rate means the doctor is very likely missing precancerous lesions that are waiting to turn into cancer -- when the whole purpose of the colonoscopy is to find them and snip them off before they go bad.

The second question for the doctor:

What is the amount of time you typically take to inspect the entire length of the colon?

This answer should be at least six minutes. It takes that long to adequately inspect all the nooks and crannies.

Both these questions get at the same issue. You want to minimize the chance that a hurried examination will give you a clean bill of health by mistake.

How often does that happen? Frightfully often. In research published this year, the rate of colon cancers in people who had had a colonoscopy within the previous five years was ten times higher when the doctors who did the colonoscopy had a detection rate of ten percent or less, compared to doctors who had a detection rate of twenty percent or more.

Dr. Douglas Rex of Indiana University has written guidelines for his fellow gastrointestinal doctors about how to do an adequate colon exam. Dr. Rex is an advocate for careful comparison shopping by patients. In an article he wrote for fellow practitioners, he estimated that the doctors with the lowest detection rates are missing 75 to 90 percent of precancerous growths in the colon.

That's a huge number. But patients can do their part to make sure their colon cancers aren't missed by asking these simple questions before they undergo a colonoscopy.

A long article in the New York Times brings home the dangers of women undergoing disfiguring surgery or radiation for breast cancer they never had. The story is a familiar one to malpractice attorneys but not well enough known to the public: The critical job of determining if breast tissue is cancerous or not is sometimes left in the hands of inexperienced pathologists who are prone to error.

The problem is worse with diagnosis of "ductal carcinoma in situ" (DCIS), an early form of cancer that may or may not progress to truly invasive cancer. The criteria for DCIS are sometimes subtle and not all pathologists agree on them.

What can patients do to protect themselves?

As I write in my book, "The Life You Save," you should never have any kind of cancer surgery without at least one second opinion on the biopsy. You can have a top cancer pathologist review your tissue slides for a cost of at most a few hundred dollars, and it might even be covered by your insurance.

Second, make sure the pathologist who interprets your specimen has enough experience. The College of American Pathologists now says 250 cases a year are the minimum for competence in this field, and it is starting a special certification program for breast cancer pathology.

The Times' article features Monica Long, a nurse in northern Michigan who had disfiguring breast surgery for DCIS, only to learn later that she never had it. She also learned too late that the pathologist at her hospital had only seen 50 cases a year and was not yet certified in any kind of pathology when he gave the reading on her tissue.

Some women get so scared by the diagnosis of DCIS that they have BOTH breasts removed. As previously reported in this blog, having a healthy breast removed does not improve a woman's statistical odds of survival. And as many as two out of three cases of DCIS never progress to full-fledged cancer. But such is the power of the "C" word to frighten people into doing anything -- even undergoing mutilation unnecessarily -- to try to stay alive.

This makes it all the more imperative for the pathology community to develop better criteria for the diagnosis of DCIS, and to improve the certification program so that this scary diagnosis is not made unless it's truly warranted.

The Times' "Well" blog has compelling accounts written in by other patients. Click here to browse them.

Reading these stories compels me to make another point: Unless you are financially destitute, I think it's a bad idea to let insurance coverage drive important medical decisions. If the insurance company won't pay for getting a second reading on the biopsy, scrape up the dough and get it done yourself. You'll be glad you did.

Among other second opinion providers, the Armed Forces Institute of Pathology in Washington, DC, gives second readings at a modest cost.

More and more women with cancer in one breast are now opting to have the other healthy breast removed as well, even though the statistics show survival odds don't improve by having both breasts removed and most patients end up with chests that are numb to sensation.

Peace of mind is cited by many of these cancer patients for their decision.

A new report by Tara Parker-Pope in the New York Times details this trend, and the Times' "Well" blog has a number of interesting comments from women and cancer experts.

As many as three in ten breast cancer surgeries in large urban cancer centers are for preventive removal of the healthy breast, the Times reported.

But what is prevented, exactly?

The only women who get a very slight survival bump from having their healthy breast removed are patients under age 50 who have estrogen-negative cancers that don't respond to drugs like Tamoxifen. For everyone else, there is no real advantage in having the second breast removed. When the second breast gets cancer, as happens sometimes, that is not "spread" from the original cancer but is a new, unrelated cancer.

The real risk that women face from the original cancer is that it has already spread beyond the breast, but removal of the second breast doesn't help that risk.

The most striking evidence of how afraid of cancer women are is with DCIS: ductal carcinoma in situ, which is not even considered true cancer by many experts because it either disappears or never progresses in two-thirds of women. Yet still many women with DCIS are electing to have not just the one breast removed, but both.

Ultimately, this is an intensely personal decision. But it helps to get the true facts first.

The man who discovered the PSA test for prostate cancer now says the test is so overused it has become a public health disaster with an annual price tag of $3 billion in wasted testing.

Dr. Richard Ablin writes an op-ed piece in the New York Times calling for the test to be abandoned for routine cancer screening for men over age 50. At most the test is useful in men with a family history of prostate cancer and also useful to detect cancer coming back in men who have already has their prostates removed for cancer.

Dr. Ablin notes that the appropriate use of the test is a tiny portion of the amount of testing now occurring, driven by those who profit from use of the test. He concludes:

I never dreamed that my discovery four decades ago would lead to such a profit-driven public health disaster. The medical community must confront reality and stop the inappropriate use of P.S.A. screening. Doing so would save billions of dollars and rescue millions of men from unnecessary, debilitating treatments.

As this blog noted in an entry a year ago, large studies have been published showing that the PSA test saves very few, if any lives, when used for routine screening, and it causes many men to undergo unnecessary, painful and potentially harmful biopsies and surgery.

The political brouhaha that followed the new guidelines on mammograms has now died down, maybe enough so that patients can start to absorb the quiet truth about breast cancer and the role of mammogram screening.

The National Breast Cancer Coalition has worked since 1991 to get Congress to fund research and appropriate treatment for this disease. The Coalition believes in sticking to the facts and analyzing closely the research studies that have been published about what mammograms can and cannot do for women who aren't aware of a lump in their breasts.

Here is an excerpt from their discussion of the US Preventive Services Task Force recommendations:

Has breast cancer screening had a significant impact on mortality from breast cancer?

No, over 40,000 women continue to die of breast cancer each year, despite the emphasis on breast cancer screening in our country. To change this, we must address the facts about breast cancer and not simply accept what we want to believe. The fact is that all breast cancers are not equal and that we don’t currently have tools for “early detection” that are good enough for the life-threatening breast cancers.

But doesn’t early detection save lives?

Not necessarily. Some breast cancers are slow-growing and have a good prognosis, whenever they are found, whether small or large. Other breast cancers are aggressive and fast growing, and we don’t have the tools to catch them early enough or treatments that will work.

Why doesn’t mammography work as well for women in their 40s?

Younger women have more dense breast tissue, making mammography less accurate. Also, mammography is better at detecting slower growing tumors more common in older women, than the fast-growing, aggressive tumors more often found in younger women. And the balance of benefit vs. harm changes as women get older since the likelihood of breast cancer increases with age. The disease is relatively rare in younger women.

But shouldn’t a woman in her 40s have a mammogram if she feels a lump?

Certainly. The Task Force recommendations are meant to be guidelines for broad public health policy for healthy women with no symptoms, and an average risk for breast cancer. These guidelines are not meant for any woman with an increased risk or for any woman who feels a lump or change in her breast. Women who have any concerns need to visit their doctors and may need diagnostic mammograms. Mammograms taken to assess a problem are not the kind of mammograms we are talking about with these guidelines.

What’s the harm in trying to detect breast cancer early, even if our methods don’t work that well?

The harms from screening too early or too often include increased false positives, leading to increased imaging and radiation exposure, biopsies and scarring that can affect the accuracy of future mammograms, and anxiety. There is also the harm of overdiagnosis of breast cancer. This would involve treatment of cancers that would never be life threatening, and treatment of cancers that may regress, or go away on their own. The treatments for breast cancer are not aspirin, they are toxic and can be life threatening; the scenario of overdiagnosis should not be taken lightly.

The cancer coalition supports the Task Force's recommendation that women who are not in a high risk category (from a family history or presence of the BRCA gene) start thinking about mammograms around age 50, not age 40.

Here is another useful summary from the National Breast Cancer Coalition: 31 Myths and Truths about breast cancer. You can read it here.

We have discussed the statistics behind breast cancer screening in several entries on this blog. Read them here and here and here. My belief is that women need to understand the numbers and then make a personal choice. Politicians don't need to enshrine mammograms as some sort of constitutional right, as happened in the US Senate not long ago. We need more compelling evidence before this screening device goes onto the "do not touch" pedestal.

Several thought-provoking letters appear in the New York Times responding to the recent piece about the cancer treatment industry's advertisements. One letter was from Dr. James Rickert, of Bloomington, Ind., president of the Society for Patient Centered Orthopedics:

To the Editor:

As a cancer survivor who has faced recurrent bouts of disease, I agree that the intense marketing campaigns used by cancer centers only heighten the stress and anxiety of the difficult treatment decisions that all cancer patients face. It becomes nearly impossible, at a time when one feels that any poor decision could be fatal, to wade through all the non-science-based claims for success.

As a physician who treats many patients with terminal metastatic disease, I have seen that this marketing often leads to heart-wrenching guilt and second-guessing by patient and family alike when treatments fail. Rather than being allowed to accept that their disease was incurable despite the best medical care, patients often feel that they are somehow to blame for choosing the wrong institution in which to receive treatment.

This is a distressing example by our nation’s finest medical centers of the shameful practice of placing financial concerns before the needs of the patients that they claim to serve.

If our academic medical centers cannot offer better patient-centered, evidence-based care than this, where in the world shall the medical community look for leadership?

Dr. Rickert makes an even better case than I could about the dangers of relying on advertising to make important decisions.

The ads are striking: Handsome, smiling people, very much alive, victors over cancer -- thanks to their choice of a prestigious cancer center for their treatment. But are they true?

The cancer centers -- with brand names like Sloan-Kettering and Massachusetts General -- cannot prove that the patients are alive because of something unique about their institutions. But they don't have to prove anything, under the law. If a drug manufacturer wanted to make a similar claim, it would have to line up statistical evidence, and the ads would have to have a lot of disclaimers. The ads from the cancer centers have no such disclaimers, and little to no backup from statistics.

Natasha Singer has a thoughtful article in the New York Times exploring these ads and what patients who are looking for cancer treatment should do.

The marketing executives who craft these ads say they're not even aimed at current patients -- but are more "reputation advertising," as one told the Times.

The article has a good sidebar that gives tips for how patients should shop for cancer treatment.

A regular community hospital can be fine for common cancers like colon, but for anything unusual, it's best to look for a center that sees a lot of that condition.

The National Cancer Institute designates Comprehensive Cancer Centers for their scientific excellence and comprehensive approach. Here is a list from the NCI. Ironically, these are some of the same centers with the heavy advertising budgets.

In my book, "The Life You Save: Nine Steps for Finding the Best Medical Care -- and Avoiding the Worst," I discuss the importance of a multi-disciplinary approach where doctors from different specialties collaborate together on figuring the best line of attack to a particular patient's cancer. Most advanced centers have "tumor boards," where these collaborative discussions occur, usually at no extra charge to the patient.

A drug that can cut a woman's risk of breast cancer in half when taken regularly is proving to be a tough sell when women have a chance to fully understand the pros and cons of the medication.

The drug is tamoxifen. For women at high risk of breast cancer (who have a gene associated with it or a close relative with breast cancer), tamoxifen can reduce the odds of developing breast cancer by 50 percent. Yet recent studies show that when the statistics are laid out for women to make an informed choice, only one in 100 actually fill the prescription.

Are the women who decline to take tamoxifen being illogical? Or just making their own personal choices about what is important to them?

Tamoxifen interferes with the body's use of estrogen. That can lower the risk of estrogen-dependent breast cancers but can increase the risk of other estrogen-related side effects like cancer of the endometrium (the lining of the uterus), blood clots and sexual dysfunction.

Here is how the numbers were spelled out to women in a recent study at the University of Michigan, as reported by Tara Parker Pope in the New York Times:

The risks of breast cancer vary with age, family history, and age of first childbirth. So a 52-year-old woman who had her first baby after age 30 and whose mother had breast cancer, has about a 1.9% risk of developing breast cancer over the next five years. If 1,000 women just like this 52-year-old took tamoxifen over those five years, the research says that here is what would happen:

* Of the nineteen women (same as 1.9%) who otherwise would have developed breast cancer, nine will not develop breast cancer. (Thus the statistic about lowering the odds by half.)

* Thirteen women would avoid broken bones from osteoporosis, another benefit of tamoxifen.

* Twenty-one women would develop endometrial cancer (typically more treatable and less deadly than breast cancer if caught early).

* Twenty-one women would develop blood clots.

* Thirty-one women would develop cataracts.

* Twelve women would experience sexual problems.

* One hundred twenty extra women would get hot flashes and other menopausal symptoms (in addition to those who would get such symptoms anyway).

Behavioral economists might say this is an example of "omission bias," where we are more worried about a small risk from doing something new (taking a pill) than we worry about a larger risk from doing nothing. Put another way, we often see the status quo of doing nothing as safer when it really isn't.

At least that's how the researchers quoted in the NYT article explained the unpopularity of tamoxifen. But for readers who posted comments on the newspaper's blog, they tended to see the women voting against tamoxifen as being quite sensible. It just doesn't sound worth the downside.

Part of the problem is the apples-to-oranges comparisons involved when a fatal condition is compared to a non-fatal one. As one commenter posted:

What might make women make better choices is if they had data on whether the pill reduced the risk of DEATH from all causes. If only some of the breast cancers avoided would have resulted in death but all of the endometrial cancers aquired resulted in death, women might make the choice to avoid tamoxifen. If the risks were reversed, they might choose to take tamoxifen. We have to move beyond a discussion of risk of cancer and towards a discussion of risk of cancer DEATH. http://www.medpie.com — Barbara Lock, MD

If we had the same careful discussion about mammograms, women likely would opt for far fewer of these tests, which save lives on a similar scale as tamoxifen, with plenty of downside.

My conclusions from this debate:

* Patients need to know there are no magic bullet drugs that are all gain, no pain. Tamoxifen interferes with estrogen, which is good for some diseases, not so good for others. This is typical. Each drug must be carefully weighed for its pros and cons.

* We're all better off with a full exploration of the odds and then make our own decisions. There is no right or wrong.

* The best way to understand risk is the way it's spelled out here: with numbers of actual people in a given standard-sized group. It's too confusing when we talk about percent this and percent that.

I tell readers how to do this technique of "counting the people" in my book: The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst.

The new breast cancer screening guidelines demonstrate yet again why savvy patients need to understand the numbers behind risk/benefit studies before making the very personal decision about whether and how often to get a cancer screening test.

The recommendations of the U.S. Preventive Services Task Force that women hold off on routine mammograms until age 50, and then get one every couple of years instead of every year, are based on sophisticated statistical modeling that aimed to get the most benefit at the least harm. The benefit is saving lives. The harm is overdiagnosing, overtreating, and needlessly frightening women who receive "false alarms" with mammograms.

The key fact that women -- and all patients -- need to understand is that your risk of a "false alarm" depends on your risk for the disease. The lower your natural risk of disease, the higher the risk of a false alarm, and vice versa. The reason the task force said that women between ages 40 and 49 don't need screening is that with the low risk of disease in that age group, the chance of needless false alarm is much higher, and the benefit of discovering the occasional cancer is much lower.

For example, one statistical model, called the Stanford model, which the task force looked at, concluded that if women between ages 40 and 69 got mammograms every year, there would be on average 2,250 false alarms -- "false positive" results -- in every 1,000 women -- an average of two per woman tested over ten years. On the other hand, there would be a total of 164 years of life gained among these 1,000 women. When the mammograms were reduced to every other year, and only given between ages 50 and 69, the years of life gained were 99 and the false alarm rate went down to 780 per 1,000. That is the tradeoff.

Those extra 65 years (164 versus 99) of life gained among the 1,000 women also come at an economic cost: if 1,000 women have to get 10 mammograms each over 10 years, that cost is around $10 million (assuming $1,000 per mammogram).

We don't like to think about "rationing" medical care, but sensible decisions on both a personal and societal level have to take into account how much we're spending for how much gain, and what else the same amount of money could be spent on.

In my book, "The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst," I have an extensive chapter on the risks and benefits of breast cancer screening at different ages. Here is an excerpt:

What about saving lives with screening tests intended to catch early cancers? Here is how that statistic of a 25 percent reduction in deaths translates in the real world. If you thought that means that of every 100 women screened, 25 of them would be saved by mammograms, you would be making a natural assumption that many others have made, but you would be very far off the mark. The actual numbers come from a series of studies in Sweden involving some 280,000 women. Of those over age forty who did not undergo mammograms, 4 in 1,000 died of breast cancer over the ten years of the study. Of those over age forty who did have mammograms, 3 in 1,000 died of breast cancer over the same ten years. The reduction from 4 to 3 per 1,000 is where the 25 percent number comes from. Put another way, for every 1,000 women who participate in mammogram screening for ten years, 1 of them will be saved from dying of breast cancer.7 The odds of saving 1 life are a little improved if screening begins only at age fifty instead of forty. Of every 270 women who start screening mammograms at age fifty and undergo one every other year for the next twenty years, 1 life will be saved—or about 4 in 1,000, which is a lot more than the 1 in 1,000 lives saved for starting mammograms at age forty.

The new statistics from the Preventive Services Task Force concluded that the benefit from mammograms in women aged 40-49 was even lower than the Swedish estimates -- more on the order of one life saved for every 1,900 women screened, instead of one in 1,000.

Here's the bottom line, as I put it in my book:

Are those kinds of odds worth it to undergo the trouble of regular screening? That is a personal decision. My only point is that to make that decision rationally and realistically, you need to look at the numbers with eyes wide open.

Patients with newly diagnosed cancer often feel that they have been uprooted from home and tossed into a foreign land -- with strange landmarks, foreign language and more than enough fear and anxiety for a lifetime. It's very useful to have guidance from a cancer survivor who has been there. A new article by a cancer survivor and professional advisor does just that.

The article by Kathryn Gurland, "A Survivor's Compass," has eleven helpful tips for negotiating this new foreign territory. She starts with the helpful reminder that a cancer diagnosis is not a medical emergency, and you don't need to rush into treatment before you thoroughly educate yourself on all your options.

Other advice includes:

* Make sure you are memorable to the care providers, and not just "another cancer patient." Small things like wearing distinctive clothing, showing your sense of humor, talking about current events -- all can help make you stand out from the crowd, and thus form a better bond with the providers.

* Never be shy about asking for the help you need, and also making clear what you DON'T need.

Read more here.

Ms. Gurland's advice echoes that in Patrick Malone's book, "The Life You Save," which helps patients understand the vital need to get second and third opinions before they undertake cancer treatment. The heart of good care, as Mr. Malone teaches, is clear communication and complete understanding by the patient and the family of everything that is going on.

"Amenable mortality" is a body count of unnecessary deaths due to lack of preventive health care. The latest measure is not flattering to the American health care system.

Researchers count these deaths by looking at premature deaths in areas like these:

* Adults who die from breast or colon cancer before age 75, indicating lack of timely mammograms or colon screens or care. * Children who die before age 14 from vaccine-preventable or easily treatable illnesses such as coughs, measles, asthma, and other respiratory problems. * Diabetics who die before age 50 from complications that could easily have been prevented with proper medical management. * People who die from infections or hypertension before age 75, a symptom of lack of preventative and appropriate care, including blood pressure control.

In the mid-1990s, the U.S. ranked 15th out of 19 industrialized nations in its death rate from "amenable mortality." Now the figures have been updated, and America is in last place -- 19th out of the same 19.

France, Japan and Australia do the best in this ranking. The United Kingdom used to be worse than the U.S. but has gotten a lot better.

Consumer Reports has a chart of the latest data here.

Everyone has seen the ads: for cancer of the breast, prostate, colon and now thyroid cancer -- urging Americans to get a test to see if they have cancer and can get early life-saving treatment.

The new thyroid campaign says: "Don't forget to check your neck." However, it's a rare disease that kills about 1,600 Americans a year, but that many millions now may worry about because of this well-meaning campaign.

The trouble with cancer screening, as previously discussed in this blog about mammograms and prostate cancer PSA screening, is that in completely healthy people who have no symptoms and no special risk factors, screening can turn up far more false alarms and bring about dangerous and unneeded treatment, than the good that is done when a few cancers are caught.

A new article by Natasha Singer in the New York Times makes this point about the new thyroid media campaign, plus a proposal by Florida Congresswoman Debbie Wasserman Schultz to spend $45 million in federal money on a campaign to teach women under age 40 about how to examine their breasts. Critics of that proposal, including cancer surgeon Susan Love, say there is no benefit in early testing of women in their 20s and 30s for breast cancer. Dr. Love wrote the congresswoman: "Once you have made women more 'aware' of their potential risk, you will have nothing to tell them to do!"

The U.S. Preventive Services Task Force, a group of independent experts, recommends routine screening for only a few kinds of cancers, and breast mammograms for women under age 50 are the weakest of their recommendations. According to the article:

for otherwise healthy people with no symptoms,[Dr. Ned Calonge, chairman of the Task Force] said, only a few routine tests have proven to significantly reduce cancer deaths among certain age groups. The task force recommends pap smears for cervical cancer beginning no later than age 21; regular mammograms to screen for breast cancer in women starting at age 40; and tests for colon cancer starting at age 50. And the task force notes that the evidence supporting the breast cancer screening is not as strong as for cervical and colon cancers.

Most other types of screening, meanwhile, have not been proved to reduce the death toll from cancer, said Dr. Kramer at the National Institutes of Health.

“You need a high bar of evidence to start advertising screening to healthy people, most of whom will not benefit,” Dr. Kramer said.

One important caveat: Nobody should ignore symptoms. Once something bothers you or changes or seems unusual, you are no longer in the category of routine screening. Your risk is much higher and you should be checked promptly.

I discuss the reality behind cancer screening numbers in Chapter 8 of my new book on health care, "The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst." The title of Chapter 8 is: “Should I Be Tested?” Why Understanding the Numbers Is Crucial.

A good book entirely focused on this topic is by Dr. H. Gilbert Welch of Dartmouth, called "Should I Be Tested for Cancer?: Maybe Not and Here's Why."

At the annual conference of the American Society of Clinical Oncology, scientists presented a new study that found certain antidepressants may interfere with the effectiveness of tamoxifen, a drug commonly taken by breast cancer survivors to keep the cancer from coming back, according to an Atlanta Journal-Constitution article.

Tamoxifen has been used for decades to treat breast cancer and, for the survivors, to prevent tumors from forming again. One of the most common side effects of tamoxifen is hot flashes, which can be controlled by SSRI (selective serotonin reuptake inhibitor) antidepressants such as Paxil and Prozac. The new study shows that this cocktail of drugs seems to account for a higher recurrence rate of breast cancer. The study followed almost 1,500 women whose average age was in the early 50s. Researchers found that women who took both tamoxifen and the SSRI antidepressants were almost twice as likely to have their breast cancer return within two years.

At the same ASCO conference, another paper was presented that found no correlation between breast cancer recurrence rate and use of antidepressants. However, authors of this second study pointed out that this study included a much smaller pool of subjects, and they join authors of the first study in recommending that other options should be considered to treat hot flashes.

The received wisdom of cancer treatment in the United States is that early detection and early treatment save lives. But this is not always true with some types of cancer. Sometimes the early detection of a cancer just means the patient lives longer with the knowledge of having cancer, but their life span is the same as it would have been with later detection.

A new study of women with ovarian cancer has found that women who undergo blood tests every few months to check for early signs of recurrence of the disease do not live any longer than women who wait until they feel symptoms from the cancer's return. The test is called CA125.

As reported by Andrew Pollack in the New York Times, the new study was presented at the annual meeting of the American Society of Clinical Oncology.

The reason that the CA125 test doesn't help is that some cancers are resistant to chemotherapy, so whenever treatment is started, it doesn't matter, and others are very sensitive to chemotherapy, so that they can be knocked back whether treatment is started early or a few months later. This is according to the lead author of the study, Dr. Gordon Rustin of the Mount Vernon Hospital in Middlesex, England.

Peace of mind is an important related issue. A lot of patients experience anxiety when they are waiting for the results of the periodic tests. For some, the knowledge makes them feel in control; for others, the anxiety is too much and they would prefer not to know. So getting the test becomes a very individual decision.

Since the 1970’s, gynecologists would generally advise women who are hysterectomy candidates to also have their ovaries removed, along with the uterus. The idea was to prevent ovarian cancer, which is difficult to detect but often deadly. However, Roni Rabin reports in a New York Times story that a new study finds compelling reasons for women to keep their ovaries.

The study, published in the May issue of the journal Obstetrics & Gynecology, tracked almost 30,000 women over the span of 24 years. It found that women who had their ovaries removed were at a greater risk for heart disease and lung cancer, and were more likely to die of cancer than those who left their ovaries untouched. For women who had their uterus and ovaries removed before they turned 50 and did not take estrogen, these risks were even higher. Scientists believe the continued production of estrogen may be the reason why women who kept their ovaries tended to live longer.

The lead author of the study, Dr. William H. Parker of the John Wayne Cancer Institute in Santa Monica, CA, explained why women should consider keeping their ovaries because although ovarian cancer is difficult to detect and treat, it is much rarer than heart diseases. Every year, heart diseases kill more than 20 times the number of women than ovarian cancer.

Of course, there are women who will benefit from removing their ovaries, especially those who are at high risks of getting ovarian or breast cancer. A patient with strong family history of either cancer should definitely consult with their doctor to decide the best course to take.

Widely hailed for saving lives through early detection of breast cancer, mammography may in fact “do more harm than good,” writes Roni Rabin of the New York Times. Rabin reports that British health care advocates and experts complained in a letter to The Times of London that candidates for mammography receive informational fliers that exaggerate the exam’s benefits and neglect to advise patients of potential harms.

Mammography detects cancers indiscriminatingly, picking up aggressive tumors as well as those so slow-growing that they present no health risks for women who have them. As a result, for every woman saved from deadly breast cancer by routine mammography, at least one other woman would have her life unnecessarily disrupted by overtreatment of a slow-growing cancer that’s not life-threatening.

Mammograms also often result in "false positive" reports which scare women who think the test has shown they have a deadly cancer when further testing shows they have no disease. This is particularly a problem when mammograms are used in low-risk groups like women under age 50.

Further, early detection of the deadly form of breast cancer may not necessarily be life-saving, says Dr. Ned Calonge, chairman of the United States Preventive Services Task Force, which writes consensus reports on all sorts of screening tests, because the cancers are too aggressive to treat even when found early.

In addition to unnecessary emotional distress and extraneous treatment and related costs, other potential harms of mammography include exposure to radiation during the exam.

On the other hand, many doctors, including the director of cancer screening for the American Cancer Society, still believe mammography should be recommended to women of normal risks for breast cancer (e.g. over 50 years of age, family history of the cancer), preferring overdiagnosis to delayed diagnosis.

Before a more definite conclusion is reached within the scientific community, patients should educate themselves about the benefits and harms of mammography, because the ultimate decision of whether to be screened is in their own hands.

The PSA screening test for prostate cancer causes far more men to undergo unnecessary and harmful treatment than it saves lives, according to two large new studies. As reported by Gina Kolata in the New York Times, one study that followed 77,000 American men for a decade found zero benefit in lowered death rates, while the other study, which followed 182,000 Europeans for nine years, found that only seven lives were saved for every 10,000 men screened with the blood test.

And for every one of those saved lives, forty-eight men were told they had cancer and underwent unnecessary treatment. That treatment can cause impotence or incontinence if it involves surgery, or problems with bowel elimination if it involves radiation.

The problem is not so much the test but the disease. Prostate cancer is usually very slow to grow, and in the cases where it is aggressive, it may already be too late to save the patient when it is discovered.

Both studies were published in the New England Journal of Medicine.

The same issue, on a less dramatic scale, applies to mammography screening for breast cancer. According to Dr. Michael Barry, who wrote an editorial in the NEJM accompanying the research studies, about ten women receive a diagnosis of breast cancer and undergo needless treatment for every one woman whose life is saved after having a mammogram. Breast cancer is much more dangerous than prostate cancer, so screening can still be warranted.

What doctors need, and still do not have, is a way to sort out cancers that would be deadly without treatment from those that would not.

The bottom line for patients is to ask careful questions of your doctor and understand the numbers before you decide whether cancer screening is right for you. Patrick Malone's new book, The Life You Save, has a chapter that helps patients sort through the statistics of cancer screening.

A study published in February 2009 in the Journal of the National Cancer Institute reports that low levels of alcohol consumption may be responsible for about 5% of cancers in American women (or 30,000 cases a year), Thomas Maugh writes in a Los Angeles Times story. This newfound risk of low or moderate consumption of alcohol may offset its cardiovascular benefits.

For more than seven years, the British-led research followed more than 1 million women between ages of 45 and 75. That is one in every four U.K. women in their age group. The study found that “[h]aving a daily drink was associated with 11 additional breast cancers per year per 1,000 women, one additional cancer of the oral cavity and pharynx, one additional cancer of the rectum, and 0.7 additional cases each for esophageal, laryngeal and liver cancers.” Two drinks a day doubles the cancer rates, and a third drink triples the figure.

Leader of this research, Naomi E. Allen of the University of Oxford, thinks it’s too soon to draw a conclusion on whether women should abandon their daily drinks. Allen is working on a separate study of potential cardiovascular benefits using the same group of study subjects, which she and other scientists hope will bring the overall benefits and risks of alcohol consumption to light.

One of the less common forms of cancer, oral cancer was diagnosed in about 35,300 Americans last year and caused the death of 7,600 people. Although oral cancer is one of the easiest to detect and diagnose, the five-year survival rate is only 59%, and more than 60% of cases are diagnosed in the late, incurable stages – which may be a result of people not regularly visiting their dentists or not asking to have visual exams, reports Laurie Tarkan of the New York Times.

The most effective way to screen for oral cancer is to carefully look for it. The dentist or dental hygienist should examine the cheeks, the gums, the floor of the mouth, the area behind the teeth, the palate and the tonsil area (pulling the tongue forward), and should feel the lymph nodes of the neck. Such visual exams are found to reduce mortality by 34% in a study done in India. Emerging on the market are alternative tests and devices that may be more sensitive than the traditional visual exams. However, no decisive study has been done to prove that the more expensive tests are necessarily better.

Dentists encourage patients to get a thorough visual exam every year, and they recommend it not only to the high-risk groups (smokers and heavy drinkers) but to every adult, because oral cancer has recently been linked to oral HPV, which is transmitted through oral sex.

When a doctor knows that his patient would receive better care elsewhere, should he inform the patient and send him to another provider? While this question is yet to be settled among bioethicists and physicians themselves, authors of an article published recently in the journal, Public Library of Science Medicine, think doctors have an ethical obligation to tell patients that better care is available to them, according to the New York Times’ Denise Grady.

Research has shown that facilities that perform high volumes of a certain procedure do it better than those that perform the procedure less frequently. The difference is substantial, especially in surgeries of pancreatic and esophageal cancer, although “the experience of the surgeon and the whole medical team [is] important in any major cancer surgery.”

Only a few courts around the country have decided whether doctors have a legal duty to inform patients that another doctor might have more skill and experience performing a planned surgery. One of them is Maryland's highest court, the Court of Appeals, thanks to a client of Patrick Malone named Billy Boone who suffered brain damage after an ear surgeon punched a hole into Mr. Boone's brain.

Mr. Boone's case shows that surgeons' skills make a difference in much more than cancer surgeries. The Maryland Court of Appeals decided that Boone had a legal right to know that his surgeon did not have extensive experience doing the ear surgery that Mr. Boone underwent.

Mr. Boone had an outpatient surgery in January 2000, to remove a benign growth from the mastoid cavity behind his left ear. Dr. Seth Goldberg, an ear nose throat surgeon, performed this surgery, called a mastoidectomy. Seventeen years before, Mr. Boone underwent the same procedure, in which another surgeon drilled out the same mastoid to remove a cheesy growth of skin debris called a cholesteatoma. Unknown to Boone, the surgeon had become lost at one point during the procedure and drilled a hole in the skull just above the mastoid, near the bottom of the brain's temporal lobe. But nothing happened to his brain, which was protected by the tough fibrous shell below the skull called the dura. Years later, when Dr. Goldberg prepared for the new surgery, he took some CT scan pictures of the bone anatomy and saw the pencil-sized hole in the side of the skull.

Dr. Goldberg's surgery seemed uneventful, but after Boone went home, he developed a short-term memory problem that ruined his ability to do carpentry; worse, he developed a problem controlling his temper that unleashed itself at stressful moments on whoever happened to be nearby. Later, his neurologist explained to the jury that Boone's outbursts could be traced to injury in the limbic system that modulates emotional response.

A CT scan showed that a hole had been poked from the pre-existing skull defect into Boone's brain. A small pocket of air could be seen in the temporal lobe, surrounded by a pool of blood. But it wasn't just air in the brain – it was something slightly denser than air, likely surgical gelfoam which could have made its way there only if Dr. Goldberg had pushed it in to try to stop bleeding after he punched the first hole.

The key moment for Mr. Boone came not in the surgery but a month before, when he sat down with Dr. Goldberg to go over the planned operation. Goldberg never volunteered the key information: that with the hole in the skull from the prior surgery, his surgery would be that much more difficult, could even result in an injury to the brain, and Mr. Boone might benefit from consulting with someone who regularly did "revision mastoidectomies," the technical term for this second go-round. A general ENT doctor who advertised his specialty in facial cosmetic work like nose jobs – he named his professional corporation the "Aesthetic Facial Surgery Center of Rockville" – Goldberg only had done occasional revision mastoid surgeries. His operation on Boone proved he wasn't up to the job. On the witness stand, Goldberg admitted he hadn't discussed with Boone the hole in the skull, the chance of brain damage, or the availability of sub-specialists called neurotologists. For Billy Boone, the jury's vote in his favor, and the Court of Appeals' affirmance of the award, gave him some vindication. For other patients, his win makes it easier to demand the information you need to make a sensible selection among surgeons. Of course, if you asked Billy Boone, he would trade in legal vindication for a healthy brain any day. It's too late for him, but not for the rest of us.

(Click here for more information on the Boone case, and follow this link to Mr. Patrick Malone's closing argument.)

Colonoscopy is widely known as a powerful screening/early detection test for colorectal cancer, capable of preventing, or so it was thought, up to 90% of cancers. However, recent studies show that colonoscopy misses many cancers, according to the New York Times in an article by Gina Kolata.

A newly published Canadian study documents the low success rate of colonoscopy in picking up cancer in the right side of the colon, an area where 40 percent of cancers occur. In the left side of the colon, the area directly above the rectum, where cancers should be easier to detect, colonoscopy missed a third of occurrences.

Does that mean patients should dismiss colonoscopy as an ineffective test? Quite the contrary. Although colonoscopy is now found to prevent only 60% of colon cancer deaths, it’s still “a good test,” said Dr. Ransohoff, gastroenterologist at the University of North Carolina. In the Times article, Kolata points out that colonoscopy works relatively well, in contrast with other screening tests: Mammograms prevent 25 percent of breast cancer deaths and the Prostate-Specific Antigen (PSA) test has not been proven to prevent prostate cancer deaths.

In addition, patients can help maximize colonoscopy’s effectiveness by doing their homework. Dr. Douglas Rex, Indiana University’s director of endoscopy and professor of medicine, said that polyps in the colons may be obscured if patients did not thoroughly cleanse the bowels. Taking half of the laxative the night before the test and the other half in the morning – a procedure not always done – can help clear out patients’ systems and improve the visibility of the inner wall of the colon.

Researchers also urge patients to seek out the best colonoscopists who are skilled in performing the test consistently. Patients should ask how many colonoscopies the doctor does each year (a good volume would be three to four colonoscopies a day), what percent of those turn up polyps (it should be around 25% in men and 15% in women; much lower suggests that the doctor is missing some), and how long the scope is in the colon (colonoscopists should take at least eight minutes to withdraw the endoscope; too short a time suggests a hurried look).

A recent medical malpractice lawsuit prosecuted by Patrick Malone & Associates for the victim of a delayed diagnosis of skin cancer highlights the need for annual skin checks by a qualified doctor. Anyone who is fair-skinned, sunburns easily, or has a lot of moles on their skin should see a dermatologist or a good primary care doctor for annual skin checks. These can be part of a routine physical exam. The doctor should measure and do sketches of the moles' location and appearance on your skin, or should take good photographs. A change in a mole is one of the key indicators of potential for malignant melanoma, a skin cancer which is deadly once it gets into the bloodstream but is 100% curable when still confined to the skin. Patients and their families often don't notice subtle changes in a mole -- getting bigger, changing color, etc. -- that health care providers can pick up.

In the legal case of Semsker v. Lockshin, a benign mole on the patient's lower back turned into a deadly melanoma over an eight-year period, during which time the mole's presence and change in size was documented by the dermatologist. The lawsuit alleged the dermatologist should have removed the mole two years before it finally was removed, when it had already invaded the patient's lymph nodes. Mr. Semsker died 14 months after the diagnosis.

In their defense of the malpractice lawsuit, the dermatology practice of Norman Lockshin, M.D., P.A., contended that they would have told the patient to get skin checks even more often than he was (every few years from either his primary doctor or his dermatologist), although this recommendation was not documented in their records.

Regardless, every patient needs to know about the dangers of melanoma and the need for regular skin exams. Exams should focus on the ABCDE's of skin cancer: A for Asymmetry of the mole; B for irregular Borders; C for variegated Color or unusual color in the mole; D for diameter greater than 6 millimeters, and E for Evolution or changes in the mole's size, shape or color.

A new LabCorp blood test called OvaSure is aimed at early detection of ovarian cancer, but OB-GYNs doubt its efficacy and safety, as false positives might lead to unnecessary surgery and extreme anxiety. Ovarian cancer often goes undetected until later stages, by which point it can be too late to treat it effectively. A test that makes early detection more feasible would therefore be a wonderful thing.

From the article:

The need for such a test is immense. When ovarian cancer is detected at its earliest stage, when it is still confined to the ovaries, more than 90 percent of women will live at least five years, according to the American Cancer Society. But only about 20 percent of cases are detected that early. If the cancer is detected in its latest stages, after it has spread, only about 30 percent of women survive five years.

But far from greeting the new test with elation, many experts are saying it might do more harm than good, leading women to unnecessary surgeries. The Society of Gynecologic Oncologists almost immediately issued a statement saying it did not believe the test had been validated enough for routine use.

“You’ve got industry trying to capitalize on fear,” said Dr. Andrew Berchuck, director of gynecologic oncology at Duke University and the immediate past president of the society. “We’d all love to see a screening test for ovarian cancer,” he added, “but OvaSure is very premature.”

The test is good news if it is indeed valid, but raising false hopes and causing unnecessary procedures and stress is an adverse consequence of all this hype.

It is instructive and interesting to read about Senator Edward Kennedy's treatment for his brain tumor.

The linked article describes the change in direction between May 20th of this year, when Kennedy's brain cancer was first disclosed and surgery was not discussed as a possible treatment, and two weeks later, when neurosurgeons performed a "successful" surgery on his brain.

Why the change? From the article:

Precisely why Mr. Kennedy’s treatment course changed is not known; he and his doctors are not talking to reporters.

What is known is that a few days after Mr. Kennedy learned he had a malignant brain tumor in the left parietal lobe, he invited a group of national experts to discuss his case.

The meeting on May 30 was extraordinary in at least two ways.

One was the ability of a powerful patient — in this case, a scion of a legendary political family and the chairman of the Senate’s health committee — to summon noted consultants to learn about the latest therapy and research findings.

The second was his efficiency in quickly convening more than a dozen experts from at least six academic centers. Some flew to Boston. Others participated by telephone after receiving pertinent test results and other medical records.

As the article notes, Senator Kennedy called similar conferences of experts when one of his children was diagnosed with bone cancer and the other with lung cancer. He has been known to advise his colleagues in the Senate to use this method when dealing with an illness in the family.

Obviously, powerful senators can do things the rest of us cannot. Again, from the article:

Mr. Kennedy can tap leading doctors for answers in a way few patients could. His celebrity status aside, he has spent a career promoting insurance and other ways to improve the health of Americans. And he has had a track record of being thorough and diligent in researching medical options when relatives or friends have fallen ill.

Nevertheless, despite Kennedy's power and influence, there are ways in which the average person can imitate his example and seek second and third opinions on their medical care:

Several doctors not connected with Mr. Kennedy’s case said in interviews that they admired his resourcefulness in getting more opinions simultaneously. At the same time, these doctors said many average patients gained competent advice, without a command performance, by sending pertinent records to experts for their opinions.

Many patients search the Internet for medical information and ask that their scans and other data be sent electronically or by overnight services.

Then such patients visit, call or write the consultant.

The potential negative consequence of all this opinion-shopping is that people may focus on what they want to hear and disregard everything else. This is partly why the doctors quoted in the article strongly recommend actually meeting physicians whose advise you intend to take (rather than just sending records and receiving written responses). That way the physician can make sure your expectations are realistic and address your specific concerns.

Unsurprisingly, there are wide global disparities in survival rates of cancer patients. This is partly because of the relative wealth of different countries. However, there are huge disparities within the United States as well:

In the United States, the lowest survival rates are in New York City, except for rectal cancer in women, where Wyoming scores worse. The best survival rate for cancer in the United States is in Hawaii, the researchers found.

Idaho also has a high survival rate for rectal cancer, and Seattle has the highest survival rate for prostate cancer.

But, there's a big disparity in cancer survival rates between whites and blacks in the United States, and it favors whites. The differences range from 7 percent for prostate cancer to 14 percent for breast cancer. This disparity is most likely due to differences in the stage of cancer when it is diagnosed, the researchers said.

We have discussed the impact of race and region on health care quality before on this blog. Unfortunately, not everyone can count on getting the appropriate kind of service from their health care providers depending on their circumstances, as this new study re-affirms.

Laura Landro, in her column "The Informed Patient," discusses the problem of adults neglecting to get vaccinated for new illnesses. Not only that, but adults forget or are unaware that some childhood vaccinations lose efficacy after some time and need to be re-done. Skipping pre-travel vaccinations is also a common error.

Part of the problem is insurance: not only is vaccination for the very young more likely to be encouraged, but it is also more likely to be covered by insurance providers.

The whole column is worth a read, but here are some disturbing statistics Landro cites:

-only 2.1% of adults are vaccinated for tetanus, diphtheria and whooping cough, despite the existence of a combination vaccine for all three.

-only 1.9% of adults have been vaccinated for shingles. The shingles vaccine is recommended for all adults over 60.

-only 10% of women from 18 to 26 have received the vaccine for human papillomavirus, which can lead to cervical cancer, and which most insurance providers will cover.

The NY Times has a long and informative article on the pressures physicians face to give patients with heart problems unnecessary CT angiogram scans, which are very expensive and not demonstrably more effective than cheaper tests.

Aside from the expense, the scans come with radiation exposure equal to as much as 1,000 chest X-rays.

Further, each scan creates an additional lifetime risk of cancer that is somewhere between 1 in 200 and 1 in 5,000, said Dr. David J. Brenner, director of the Center for Radiological Research at Columbia University. Younger patients and women are at higher risk.

Many patients do find it emotionally reassuring to get the results of these tests, since the CT scan allows the patient and doctor to actually see if the heart has any problems. However, perhaps part of the love of these tests stems from what Johns Hopkins professor of medicine Bruce Leff calls (in a letter to the NY Times editor) "gizmo idolatry":

As a geriatrician and health services researcher, I believe that the demand for cardiac CT scans is a textbook example of gizmo idolatry, or the implicit conviction that a more technological approach is intrinsically better than one that is less technological.

The other letters are worth reading as well.

Despite concerns about the efficacy of these tests, many doctors and patients swear by them and they will probably remain popular. As the article notes, Medicare decided to fund these CT scans despite lack of clear evidence of their usefulness, and private insurers will most likely follow suit.

Tara Parker-Pope at the New York Times has an article on how to detect ovarian cancer early.

Ovarian cancer is usually detected in its late stages, when it is the least treatable. Early signs of ovarian cancer exist, but are very common and easily mistaken for other problem. For example, difficulty eating, or increased abdominal size, or feeling full after eating very little can all be signs of ovarian cancer--or of other, less serious ailments.

A new study, described in the article, finds that six key symptoms combined with a blood test can increase early detection of ovarian cancer by 20 percent. Those six symptoms are pelvic pain, abdominal pain, bloating, increased abdominal size, difficulty eating and feeling full quickly. The lead author of the study points out that any new and frequent occurrence of these symptoms may be reason for further testing.

President Jimmy Carter's former chief of staff, Hamilton Jordan, died this week of mesothelioma after 24 years of fighting and surviving cancer four different forms of cancer. His memoirs include a top ten list of recommendations for cancer patients.

The whole list is worth reading, but in principle it could be boiled down to the first item:

No. 1: Be an active partner in the medical decisions that are made about your life. Don’t be passive. Learn about your disease, and participate in the decisions that are made….For example with my lymphoma, if I would have accepted the first treatment offered, I’d be dead today. It was assumed that I only had a mass in my chest. I later learned that the lymphoma was all through my body.

All of the other items on the list elaborate on this one, which is the most basic and the most important.

Tara Parker-Pope discusses a Tower Cancer Research Foundation survey of 500 cancer survivors that showed more than half of them delaying treatment for two months or more after having symptoms. Fifteen percent delayed treatment for one to five years.

Some delayed treatment because of lack of medical insurance, or insufficiency of coverage.

But others had emotional reasons for the delay: a third of them put it down to procrastination, and the most commonly cited reason was that they were hoping the symptoms would just go away. Fear also played a role. Many patients simply did not want to be told the worst. These feelings are obviously natural, but acting on them can prevent the early diagnosis and treatment that saves the lives of so many cancer patients.

Recently on this blog, we discussed the difficulty of diagnosing colon cancer and the problems that can ensue from rushing the colonoscopy procedure.

A lawsuit over just such a missed diagnosis due to a hastily-performed procedure has been settled between the Endoscopy Center in Nevada, one of its doctors and a former patient who now is unlikely to survive the next five years. From the article:

Kevin Rexford, a 46-year-old pharmacist, said Dr. Clifford Carrol, one of the clinic’s owners, missed a obvious colon cancer diagnosis three years ago. The alleged failure allowed the cancer to spread throughout his body and he now has only about a 10 percent chance of living five more years. Rexford is married with two young children....Experts who were paid to review the case on Rexford’s behalf said Carrol took only three minutes — half the minimum recommended time — to examine Rexford’s colon for cancer during a Jan. 28, 2005, procedure. His missed diagnosis allowed the cancer to progress to an incurable stage, the experts said.

The consequences of such haste are clearly severe and patients should be aware of the risks, as we said in our earlier post.

The Endoscopy Center has also been in the news recently because it was shut down earlier this month because it was linked to six cases of hepatitis C.

A new study of colonoscopy suggests that flat, hard-to-spot lesions in the colon are the most likely to become cancerous.

American doctors have been aware of these lesions for a couple of decades. But until recently, there was little reason to think that they were dangerous when occurring in America, although studies done in Japan did reveal dangers. This new American study showed that flat or indented lesions were five times as likely to be cancerous than as polyps, which are much easier for doctors to spot.

From the article:

People who have just had a colonoscopy should not rush to schedule another one just to look for the flat growths, doctors said.

“I don’t think people have to panic that they’ve somehow been neglected and had poor care,” said Dr. David A. Rothenberger, deputy chairman of surgery at the University of Minnesota.

But he and other experts emphasized that people should see a doctor any time they have persisting symptoms that could indicate colon cancer, like rectal bleeding or a change in bowel habits — no matter how recently they had a colonoscopy. The test is highly reliable, but not perfect, doctors say.

Furthermore, some doctors have a hard time spotting even polyps: as the article says, a December 2006 study showed that some doctors are 10 times better than others at finding pre-cancerous polyps, and the difference largely had to do with whether the doctor took care doing the procedure or attempted to rush things.

Unfortunately, it is always difficult and often impossible to find a doctor's track record on this issue. Again, from the article:

The difficulty facing patients is how to be sure their doctors are doing a good job. Professional groups have issued guidelines about the best way to perform a colonoscopy, but they are recommendations, not rules. The groups also urge doctors to track their own success rates at finding precancerous growths to see how they measure up to standards, but even if they do keep track, the doctors do not have to share the data with anyone. And many people are loath to ask about it. The doctor wielding the scope is the last person most patients would want to offend.

“The patient really has no way to act as an informed consumer,” Dr. Smith said. “You can’t call up a facility and say, ‘By the way, is my doctor any good?’ or, ‘Tell me who the best one is.’ ”

It is important to remember that not all doctors are offended by questions about their track records, and that giving offense is less important than safe-guarding your own health. This is especially true if you have a choice of which doctor to go to, because that way you will not be stuck with a health care provider who might have been offended by your inquiries.

Most scientists are extremely unwilling to part with the raw data of the studies they perform on cancer and other life-threatening illnesses.

The author of the article speculates that this reluctance is due to convenience and careerism, specifically the fear of having others (especially layfolk) analyze their work and possibly find flaws in it. This may be an uncharitable speculation but it is difficult to disagree with, especially when one considers the pathetic reasons scientists cite for hiding their data. From the article:

Dr John Kirwan, a rheumatologist from the University of Bristol in England, has studied researchers’ attitudes on sharing data from clinical trials. He found that three-quarters of researchers he surveyed, as well as a major industry group, opposed making original trial data available. It is worth restating this finding: most scientists doing research on how best to help those in pain, or at risk of death, want to keep their data a secret.

Dr. Kirwan went on to ask his subjects why. Their reasons were entirely trivial: one cited the difficult of putting together a data set (wouldn’t this have to be done anyway in order to publish a paper?); another was concerned that the data might be analyzed using invalid methods (surely a judgment for the scientific community as a whole). This is something of a clue that the real issue here has more to do with status and career than with any loftier considerations. Scientists don’t want to be scooped by their own data, or have someone else challenge their conclusions with a new analysis.

As the author points out, however, new analyses are exactly what cancer patients (and patients in general) need. We all need all the information available that pertains to our health, so we can look at it and think about it and use it to safeguard ourselves. This reluctance to part with information is contrary to the spirit of scientific openness and inquiry. It is also unsafe and unfair to patients.

Oral contraceptives significantly reduce risks of ovarian cancer in women, says a new large-scale study. The pill has been linked to reduction in breast cancer rates as well, but not so large as the reduction in ovarian cancer rates.

The risk reduction persists up to thirty years after a woman stops taking the pill, although it declines with time. The risk reduction is also stronger in women who take it for long periods of time.

Furthermore, as the linked article says:

The proportional risk reduction for every 5 years of use was 29 per cent up to 10 years of stopping use, 19 per cent for 10 - 19 years after stopping, and 15 per cent for 20 - 29 years after stopping.

When breast cancer experts recently reassessed their risk-evaluation formulas, they found that they were significantly underestimating the risks for African-American women.

This reevaluation is likely to result in changes in counseling for women in this demographic, including more recommendations to go for mammograms and more encouragement to sign up for studies of breast cancer. This last change is highly important, as assessments of lower risk based on the old formulas meant that African-American women were not selected for studies such as prevention trials. More mammograms and participation in studies will lead to more early detection and prevention, hopefully reducing the number of women who believe themselves to be perfectly healthy and are then blindsided by a breast cancer diagnosis.

Reassessments like this highlight the necessity of researching diverse populations, to make sure that patient care is not compromised by ignorance of group-specific risk factors.

The abstract of this study can be found here: Projecting Individualized Absolute Invasive Breast Cancer Risk in African American Women

The President's Cancer Panel--consisting of Lance Armstrong, Dr. Margaret Kripke and Dr. LaSalle D. Leffall--says, in its new report, that the U.S. government should be doing more to promote environments and lifestyles that prevent cancer and other diseases.

Part of the report's argument is that most federal funding for cancer research goes towards genetic and microbiological solutions, and that macro-solutions involving environmental and social factors are neglected. This is part of a general problem in the philosophy of health care in the U.S., the report says: we are overly focused on treatment rather than prevention.

Of course treatments are important, but the report is right in its criticism of the neglect of the concept of a healthy lifestyle in U.S. health care. Making such lifestyles possible would require social changes as well as personal changes--which may be one reason why the government and our society finds it more convenient to focus on treatment, as treatment will not require systemic overhaul of society. It is more tempting to try and simply patch people up with treatments rather than take the time and effort to ensure that fewer people get sick in the first place.

Here are some examples of environmental and social factors that the report considers responsible for poor American health: lack of fresh food access, lack of access to healthy food in general (for those in poorer socioeconomic conditions), large subsidies to producers of corn and so which are processed into foods that contribute to various diseases, lack of opportunity to exercise and lack of health insurance.

A diagnosis of cancer puts a patient in an extremely frightening and vulnerable position. Unfortunately, there is often little aid for people in this situation. Instead, they are presented with bureaucratic hurdles and confusion about whose advice to follow.

For an example, one could look at the July 29th, 2007 New York Times Magazine section which had an article describing the story of one such cancer patient named Karen Pasqualetto.

There are several insights that can be gleaned from such experiences. First, there is the need for patients to seek second and third opinions—a need that usually goes unfulfilled because most people do not have the insurance or financial resources to cover this.

Second, patients need to educate themselves on standards of care, because otherwise they probably will not be getting it—particularly if they are not white or are low-income. See the National Healthcare Disparities Report from 2005 for disparities related to race and socioeconomic status. The ScienceDaily also has an article about racial bias resulting in poorer treatment for African-American patients.

Third, there are enormous advantages to having a team of doctors who speak to each other rather than a bunch of disconnected specialists who offer competing and contradictory advice. Patients should encourage communication between doctors as much as possible.

Fourth, visiting centers for the study of particular kinds of cancer can be extremely helpful, especially when dealing with the more obscure varieties of the disease. These centers have the aid and cooperation of several doctors, so the opinions given there are more likely to reflect a consensus of experts.