DC Medical Malpractice & Patient Safety Blog

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.

... 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.

Common sense says that putting stents into blocked arteries in the brain should help prevent strokes, just like propping open heart arteries cuts heart attacks.

But Medicare asked for a scientific study before it started paying for widespread use of the brain stents. So doctors tested stents versus medical therapy in high-risk patients. After one month, a dramatic answer: in one group, 6 in 100 patients got a stroke, but in the other group, 15 in 100 had strokes.

Problem is that the stent group was the one that had more than double the strokes of the medical treatment group.

The result was so big that doctors pulled the plug on the study, as they could no longer ethically put patients into the stent group.

This is yet another example of how therapies that seem like they should work, based on our knowledge of the body and medicine, turn out not to work. We have a lot left to learn.

In the case of brain arteries, bypass surgery to put in a new artery to go around blockages, also similar to what's done in the heart, also has failed to prove out in scientific studies.

You can read the new stent study in the New England Journal of Medicine.

Check out this graphic display of some of the statistics of hospital hazards. Infections, malpractice, errors due to poor record keeping, medication errors, mistakes due to sleep deprivation of trainee doctors: It's all displayed here, courtesy of a group called Medical Billing and Coding Certification.

Testimonials from satisfied customers sell products. Every marketer knows that. But testimonials from patients are the wrong way to decide if a drug deserves an endorsement worth billions in sales from the Food and Drug Administration.

Why? Because, as a Virginia cancer doctor explains in a new article, the testimonials from happy cancer patients mask the fact that many other patients were not helped, or worse, were killed by the drug.

The drug now being pushed to the FDA by the testimonial technique is called Avastin. It's been proven to help patients with some kinds of cancers: colon, brain, lung and kidney cancers which have spread beyond their first site of discovery. It doesn't cure the cancer, but it can strangle a tumor's blood supply and thus shrink a cancer.

Avastin was tried with advanced breast cancer, but rigorous studies found that it didn't help quality of life for patients with breast cancer, and it didn't extend their lives, even measured by months. Plus it comes with serious side effects, the most prominent being the potential to cause a hole to suddenly develop in the stomach or intestines, which can be fatal.

So the FDA said the manufacturer couldn't market it for breast cancer.

Now Genentech, the maker of Avastin, is taking another run at the FDA, using testimonials from patients and treating doctors to try to get the agency to change its mind.

Dr. Frederick C. Tucker Jr., an oncologist in Fredericksburg, Virginia, wrote an "op-ed" piece in the New York Times commenting on this stratagem by the drug company:

[A]necdote is not science. Such testimonials may represent the human voices behind the statistics, but the sad fact is that there are too many patients who have been treated with Avastin but are not here to tell their stories.

Avastin will not disappear because of the F.D.A. decision. It remains available for treating other cancers, and research to find its appropriate role in breast cancer treatment continues. In the meantime, the F.D.A., which is expected to make its decision in September, needs to resist Genentech’s attempt to have it ignore scientific evidence.

Serious progress in the treatment of cancer will not be the result of polemics, lobbying or marketing. Genentech’s money and efforts would be better spent on research for more meaningful treatments for breast cancer.

The Avastin website has photos of real patients who Genentech says have been helped by the drug. These photos tug at viewers powerfully. But they don't substitute for hard statistical analysis.

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.

Patient safety advocates like me have long dreamed of cracking open for the public the vast trove of data the government collects on doctors, so patients could figure out who gets the best outcomes and guide their doctor choices accordingly. Medicare was supposed to start down that path with its new "Physician Compare" website, but alas, it has a long way to go.

One critic says the new site "is confusing and unfriendly to consumers, painfully slow and, worst of all, factually unreliable. Put bluntly, the agency ... has produced a consumer tool that practically shouts, 'We couldn't care less whether any consumer ever uses this.'"

The quotation is from Michael L. Millenson, President of Health Quality Advisors LLC, writing on the Kaiser Health News website.

The Medicare site has basic information about doctors, like their practice address, but misses out on many tidbits that consumers want to know:

* Hospitals they practice at

* Malpractice history

* Where they trained

* Board certification.

Those kinds of things can be found at commercial sites like healthgrades.com for a small fee. Or you can search one of the sites that lists doctors' board certifications, like
the American Board of Internal Medicine, which certifies internists.

The quality information that consumers really crave, such as surgeons' complication rates or incidence of wound infections, lies off in the future somewhere. Medicare says it will begin adding quality data to the site in 2012, with a formal launch date in 2013. Don't hold your breath.

Meantime one surgical specialty group, the Society of Thoracic Surgeons, has collaborated with Consumers Reports to publish quality data on heart and chest surgeons. Read our blog entry on this here.

Tired of reading doctor report cards and not knowing which ones to believe? Now there's an organization that reviews the plethora of health care report cards available online in order to provide you with clear choices about the sites that really do provide accurate and useful information.

The Informed Patient Institute provides detailed analysis of online health report cards – covering nursing homes and physicians for now and other health areas in the future – to show consumers where they can find the best information.

An independent, non-profit organization funded by foundations and individual donors, IPI provides guidance to other consumer-focused organizations, such as Consumers Union, to “facilitate access to credible online information about health care quality and patient safety,” but not by rating individual health facilities or professionals. Instead, IPI evaluates the usefulness of the wealth of online report cards and advocates making more -- and more useful -- health care quality information available to consumers.

Among the best features of IPI's system:

1. It uses a clear rating system. Organizations can receive an A through F grade, with explanations for what each means. IPI always tells you “what we like” and “what we don’t like.” For example, the New York State Health Department’s Nursing Home Profile received one of the few A grades. IPI praises the site for providing a “wide range of information including state survey results, complaints and quality of care provided,” but also notes that it doesn’t “have information on costs, nursing home staffing, or resident or family satisfaction with the home.”

2. It allows for exceptions to the rules. If a site has “unique content” but doesn’t quite make the grade in other criteria, IPI gives the site a “U.”

3. It simplifies users’ options. If you click on a state like Alabama, you will see that the only option for you to click is “Physicians” because there is no nursing home content related to Alabama. California, by contrast has sites that cover both. All the areas that IPI hopes to cover in the future are included in the drop-down menu, but only the topics that have content are clickable.

4. It provides good context. For each state, on the right side of the screen, you will see a Top 10 ranking of the sites IPI has reviewed that contain content about that state.

Source: Reportingonhealth.org

To visit the Informed Patient Institute web site, click here.

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.

Today's news has two reminders of why statisticians are our friends and allies when it comes to getting the right health care and avoiding dangerous and over-hyped treatments.

The headlines:

* Hormone replacement therapy after menopause not only increases the risk of getting breast cancer, but also makes the cancer more deadly. Details here.

* Taking a daily fish oil supplement in pregnancy doesn't make babies any smarter. Details here.

The arc of both stories is similar, and that's no coincidence.

Act One: Medical scientists develop a new treatment that, based on then current knowledge, should work.

In hormone therapy, the idea was that estrogen protected women from heart and blood vessel disease. This was based on a statistical notion -- since proven false -- that there was a big jump in heart attacks and similar disease after menopause, which must mean (so it was thought) that the drying up of estrogen in the body with menopause was depriving the body of a natural protectant.

In fish oil, the idea came from observations that DHA, a key fish oil ingredient, is naturally transmitted to a fetus in the last half of pregnancy and is important to brain development. And premature babies, born with low supplies of DHA, did better in some studies if they received DHA supplements in the first few months of life.

Act Two: Hopeful "observational" studies are published. These involve dozens to hundreds of patients and have very favorable results for the treatment in question.

Act Three: Manufacturers make big bucks pumping the treatment in question.

Act Four: Medical scientists do the hard work of large-scale studies where patients are "randomized" to the real treatment versus a dummy (placebo) treatment.

This takes years of carefully following patients and comparing outcomes.

Act Five: Enter the statisticians.

They come in, crunch the numbers and discover: It doesn't work (see today's fish oil study) or worse, it causes a lot of harm too (today's hormone story).

What's the lesson for the rest of us? As I wrote a few days ago on this blog, it pays to be skeptical of medical research findings, particularly when hyped by commercial interests.

Most people hear about research in the Act One, Two or Three stages.

If you wait till the story plays out in Acts Four and Five, you'll be less disillusioned, and safer and wiser too.

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.

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.