DC Medical Malpractice & Patient Safety Blog

Medical providers, insurance companies and well-informed medical consumers know that drugs, devices and treatments aren’t considered best-practice—or even credible—unless and until research has been conducted, the results reviewed by scientific peers and the results published in a reputable journal.

So how was it, health reporter Martha Rosenberg asks on KevinMd.com, that blockbuster drugs such as Vioxx (an arthritis drug withdrawn from the market in 2004 because of heart risks) and Baycol (a cholesterol drug withdrawn in 2001 because of muscle degeneration) were deemed safe, and that their benefits outweighed their risks?

These, and many others, Rosenberg writes, passed peer muster after journal reports were published that were written by drug companies or their hired writing hands. Gee, if you’ve spent millions developing a drug and you’re given license to appraise its effectiveness and safety, wouldn’t you make sure the story had a happy ending?

We regularly write about drug company conflicts of interest, and Rosenberg’s post adds to this stinky body of “knowledge.”

“Scratch the surface of many blockbuster drugs that went on to be discredited, or even withdrawn as risks emerged,” she writes, “and an elaborate ‘publication plan’ emerges, developed by the drug company’s marketing firm. For example, at least 50 articles promoting hormone replacement drugs like Prempro were planted in medical journals by Pfizer’s (then Wyeth) marketing firm DesignWrite…” You can read that document, courtesy of the University of California, San Francisco’s Drug Industry Document Archive.

One of DesignWrite’s articles published in the Journal of Women’s Health was called “Is There an Association Between Hormone Replacement Therapy and Breast Cancer?” The answer was “no.” Another DesignWrite offering appeared in the Archives of Internal Medicine, “The Role of Hormone Replacement Therapy in the Prevention of Postmenopausal Heart Disease.”A third, also from DesignWrite, in the Archives of Internal Medicine, championed “The Role of Hormone Therapy in the Prevention of Alzheimer’s disease.”

Rosenberg calls the marketing firm’s so-called science “egregiously flawed.” Hormone therapy has a demonstrable association with breast cancer, heart disease and Alzheimer’s. Still, the papers have not been retracted from the journals, two of which are published by the American Medical Association.

Parke-Davis/Pfizer also engaged in planned research plants with regard to its anti-seizure drug Neurontin. It wanted to expand the drug’s use to people suffering from migraines, bipolar disorder and other problems for which it had not been given FDA approval. Such “off-label” uses are the prerogative of practitioners, but manufacturers are not allowed to promote them for any use not approved by the FDA.

We wrote about the unethical use of fake Neurontin trials a couple of years ago in our blog, “The Difference Between Pharmaceutical Research and Marketing Blurs Yet Again.” Rosenberg notes that within a three-year period, Parke-Davis planted 13 ghostwritten articles in medical journals promoting off-label uses for Neurontin, and made 43,000 reprints from one for dissemination by its sales representatives.

“Researching, writing and submitting papers to medical journals — and reworking and finessing them if accepted — is a demanding, time consuming job which drug companies have made into pay dirt. … ‘publication plans’ for their products —elaborate grids with the names of journals where papers have run, are slated to run, have been submitted and have been resubmitted, the marketing firms apparently not taking ‘no’ for answer. Do the journals know they are part of such machinations?” Rosenberg asks.

Not only is iffy science given cred by these journals, the stench of conflict grows stronger when you realize that journals make money off such dreck when they license reprint rights for drug company promotion.

Several years ago, when it came to light that some researchers were subsidized by companies whose products they were testing, journals loudly announced they were raising their standards, scrutinizing submissions and adding disclaimers to address even the appearance of conflicts of interest. But, says Rosenberg, “Often the disclosures are relegated to a barely readable paragraph linking authors identified by initials, not names, to 60 or more drug companies. Worse, the disclosures don’t appear in abstract databases like PubMed but are hidden behind a financial firewall available only to paid subscribers who have access to the full articles.”

So if John Q. Public wants to read a full study, he must shell out a meaningful amount. And that’s for only one journal.

Rosenberg is not optimistic that this status quo can be changed any time soon. The problem, of course, is that it’s just too lucrative for both journals and drug companies to stop scratching each others’ backs at the cost of patient safety.

She highlights a well-established class of drugs called TNF blockers that includes Humira, Remicide, Enbrel and Cimzia. They treat various forms of arthritis formerly considered fairly rare, but promoted to “under-diagnosed” by their manufacturers in the hope of enlarging their market to people with a tenuous, at best, connection to them.

She warns consumers about taking their planted “quizzes” to encourage self-diagnosis, and practitioners about ghostwritten journal stories that minimize the drugs’ dangerous side effects, including suppression of the immune system.

As Rosenberg writes, “Recently, research by drug industry-funded authors has appeared in medical journals to dispel data linking TNF blockers to increasing incidences of hospitalizations, malignancies, cardiovascular events and Herpes zoster. Looks like another publication plan.”

And another strike against patient safety.

When you read an enticing ad for a weight loss product that effortlessly melts away fat, bear in mind, before you get out your credit card, that the product may be running a few steps ahead of the law. Never assume, just because the ad is out there in public, that the product really works.

Last week the Federal Trade Commission (FTC) published its annual report, FTC Highlights, covering a range of activity by the federal agency charged with protecting consumers and promoting competition.

Two sections of the report might be of particular interest to medical consumers: “Containing Health Care and Drug Costs,” and “Challenging Deceptive Advertising and Marketing.”

As noted on FDA Law Blog, “[T]he FTC remains as focused as ever on health-related advertising – especially where advertising allegedly promotes products for weight loss or disease treatment or prevention.”

A summary of significant advertising matters litigated or settled by the FTC’s Bureau of Consumer Protection (BCP) is included in the report, and, as usual, big players last year were advertisers of weight-loss products. Products that purported to treat and/or prevent disease—food and dietary supplements, toning sneakers and smartphone apps and exercise equipment—also made their legal mark.

As Law Blog notes, a settlement over advertising for toning sneakers was the second highest amount: $40 million; a settlement over alleged order violations by a weight-loss marketer was third: $3.7 million. To satisfy the FTC, health-related product claims must show reliable, relevant supporting science.

Although many people have suffered from allergies as long as they can remember, others are new to this often annoying and, at times, potentially lethal immune response. You can develop an allergy any time, even to something that never used to bother you.

A common later-onset allergy is latex. As discussed in the Harvard Men’s Health Watch newsletter, people who develop an allergy to latex usually have had repeated exposure to certain proteins in natural rubber that their bodies perceive as threatening. Accounts of latex allergies boomed in the 1990s, the newsletter suggests, as increasing numbers of people in health care and associated professions were required to wear gloves in many situations as a measure of infection control.

But if you think the label “latex-free” is your ticket to product security, think again: As the newsletter notes, a consumer update by the FDA says “There’s No Guarantee of ‘Latex Free.’”

Latex is a component of many useful products—adhesive bandages, condoms, balloons, rubber bands, elastic socks and waistbands, baby bottle nipples, pillows …

As many as 12 in 100 health-care workers and 6 in 100 people in general have a latex allergy or sensitivity, according to the newsletter.

No test exists to verify that a product is completely free from latex. “Labeling that suggests a product doesn’t contain the substance could cause trouble for individuals with a latex allergy or sensitivity,” the newsletter warns.

You can be sensitive to an allergen without actually having an allergy. You might get a rash, sneeze and have watery eyes—irritating, but you’re not in danger of anaphylactic shock. That’s a life-threatening, whole-body reaction to an allergen in which the lips and throat may swell, and airways become restricted. (See our blog, “Doctors Often Fall Short in Treating Anaphylactic Allergy Attacks”.)

As the Harvard newsletter notes, even products made without latex can threaten people with latex allergies because sometimes they’re contaminated with latex proteins during the manufacturing or packaging process.

To better inform consumers of what they’re buying and using, the FDA wants to replace “latex free” and “does not contain latex” labels with ones that say “not made with natural rubber latex.” As the newsletter says, because it’s not possible to certify something as truly “latex-free,” those labels still would leave some people at risk, but at least products wouldn’t be promising something they cannot deliver.

Learn more about latex sensitivity and allergy on the websites of the Asthma and Allergy Foundation of America and the American Academy of Allergy, Asthma and Immunology.

Beyond unpleasant itchy, teary eyes, runny nose and mild headache, be aware of the signs of a dangerous allergic response. Seek immediate medical help if you have:

• hives or welts


• swelling of the lips, face or throat


• abdominal cramps


• chest tightness, wheezing, or shortness of breath.

Whether it’s Fritos, Corvette or iPod, certain products have undeniably wonderful names crafted by deep-thinking marketers. The drug industry is no different in hoping that the names they give their creations will resonate with doctors and, sometimes, consumers.

An interesting story recently published on Reuters.com explained how prescription drugs get their names, and how the sexiest letters in the alphabet often are the key. Big Pharma, it seems, is partial to names beginning with X and Z because they are unusual—that is, they don’t appear in many words—and therefore are memorable. Also, they have the quality of being “fricative,” a wonderful word that means they have a sense of speed or fluidity.

(Why being fast or fluid translates into good, or effective, is something that escapes us. But we’ll just roll with it for now.)

A professor of psychology and linguistics told Reuters that manufacturers who want to appeal to the psyche need memorable, distinctive names not only in terms of sound, but appearance. That’s why drug names like Xtandi (lung cancer), Zytiga (prostate cancer) and Zoloft (anxiety/depression) are hot.

Since 1995, Reuters says, 15 drugs whose names begin with X have been approved by the Food and Drug; seven were launched in the last 2 ½ years.

But most kids can’t be named Rainbow Moonbeam without some social backlash, so names for drugs also must be practical. Both the FDA and regulators in Europe have guidelines for acceptable names for medicine. Manufacturers are not allowed to call their drugs by a name similar in sound or appearance to another drug because somebody might take the wrong medicine by mistake. Also, a pharmacist might mistake a doctor’s handwriting on the prescription and dispense the wrong drug. Drugs with letters including X and Z are less likely to be misinterpreted.

Pronunciation seems to be a decidedly lesser consideration. The novelty of a name is more important than someone’s ability to pronounce it. Call it “the artist formerly known as Prince” phenomenon.

But mostly, patients don't choose these drugs, their doctors do. So manufacturers coin their names for that group, rather than the general consumer. If a consumer product like an eyelash builder is named Latisse because it sounds lush and consumers can ask for it, Reuters says, a cancer drug must appeal to oncologists and its name indicate something about its medical/scientific basis.

For example, a new Pfizer drug, Xeljanz, is approved to treat rheumatoid arthritis. One branding expert told Reuters that it perfectly represents both innovation and ability. "It includes both X and Z ... and the name is really key to the product profile," he said, explaining that the drug works by blocking certain molecules known as Janus kinases.

"For a doctor who is anticipating this product, when they see that JAN that might be the light bulb."

This whole discussion is amusing, but kind of creeps us out. Prescribing or taking a drug because you like its name is like buying a car because you like the color. Except that there’s far more potential for harm.

Or are we just over-thinking this?

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.

GlaxoSmithKline paid $3 billion.

Abbott Laboratories paid $1.4 billion.

Pfizer paid $2.3 billion.

Eli Lilly paid $1.4 billion.

And now, Amgen will pay $762 million for, as a U.S. attorney in New York said last month, “pursuing profits at the risk of patient safety.”

Yes, folks, once again a major player in the pharmaceutical industry has been caught engaging in criminal behavior, thanks in part to a former employee who couldn’t tolerate its utter disregard for the law, and blew the whistle.

We regularly cover the misdeeds of Big Pharma (here, here and here), and everyone aware of this history of settlement payments understands that to the drug industry, they’re merely the cost of doing business.

The Amgen settlement, as reported by the New York Times, resulted from federal charges to which Amgen pleaded guilty. The company illegally marketed Aranesp, which is approved by the FDA for chemotherapy patients. But that wasn’t enough for Amgen, who promoted it to treat anemia in cancer patients. That’s an “off-label” use, or one for which the medicine was not approved.

Amgen also was charged with promoting larger doses of Aranesp than the label directed. That enabled the drug to be used less frequently, which, according to The Times, made it more attractive to doctors and patients than a rival’s anemia drug.

Doctors are allowed to use drugs for off-label use, but companies may not promote them.

Clearly, Glaxo, Abbott, Pfizer, Lilly, Amgen and who knows how many others don’t care. These companies believe the rules were written for everyone but them. Amgen had tried to obtain FDA approval for the less frequent dose, but was denied. The FDA called the company’s studies inadequate. So what? was Amgen’s response--according to federal charges, the company continued to promote the off-label dosing after the denial.

One federal prosecutor told a judge, The Times reports, that “in certain instances, Amgen employees were so thoroughly indoctrinated to sell the drug for off-label uses that they did not, in fact, know that the drug had not been approved for the use for which they were selling it.”

Sales representatives, according to The Times, were not supposed to initiate discussions of off-label uses, but they were trained in ways that would prompt doctors to ask certain questions that opened the door for the reps to offer the docs “studies” supporting the off-label use. Amgen calls this approach “reactive” marketing. Federal prosecutors called it illegal.

A story in the Los Angeles Times recounted how one former Aranesp product manager filed suit against Amgen, alleging that, among other inducements to use the product, it gave “liquid kickbacks” to doctors. She charged that Amgen overfilled vials of Aranesp so doctors got more medicine without paying the additional cost. She said the company encouraged the docs to bill Medicare and private insurers for the surplus, thereby scamming the system and lining their pockets.

Why does Big Pharma continue to get away with criminal behavior? Because the fines, as huge as they are, don’t begin to threaten the companies’ huge profits—at one point, Aranesp earned Amgen more than $4 billion a year. Critics, according to the New York Times, say that the companies won’t be deterred until their executives are held personally responsible.

The U.S. attorney said that there was insufficient evidence to charge individuals at Amgen. But the company did agree to sign a corporate integrity agreement requiring execs and board members to personally certify compliance with regulations, which would make it easier to prosecute individuals if the company violated the law again.

Not that it’s suitable redress for Amgen’s despicable behavior, but Aranesp, which once was Amgen’s biggest seller, has declined in popularity. Studies, the New York Times says, show that high doses can lead to blood clots and the worsening of cancer. Sales of Aranesp in the first nine months of 2012 were $1.55 billion.

A few months ago, my monthly "Better Health Care" newsletter focused on genetic testing. While we all can appreciate the idea that knowing your own DNA can (eventually) lead to health advances, I also discussed how this abundance of genetic information can cause not only unnecessary expense and worry, but can yield painful knowledge for which there is no treatment or cure.

One of the companies mentioned in the newsletter that offers direct-to-consumer genetic testing, 23andMe, is the subject of a recent post on HealthNewsReview.org, a site devoted to the dissemination of accurate information about medicine and health care. A post by Alan Cassels, a drug policy researcher and founder of Media Doctor Canada, another organization devoted to science-based health news, grappled with the fact that, in an effort to “land in the black,” 23and Me is raising venture capital from the pharmaceutical and biotech industries by selling the DNA information it has gathered from the public.

According to Cassels, more than 150,000 people have paid $100 to have their saliva analyzed for genome sequencing.

So after capturing $15 million in revenue, the company hasn’t made a profit? As Cassels succinctly wonders, “What gives?”

“Surely providing personal genetic profiles (so people can learn deep dark secrets of their ancestral past or their lifetime likelihood of developing Type 2 diabetes), is worth a lot? Apparently not,” Cassels writes, “but it will be after the DNA in all that spit is repackaged and held up as bait to the drug companies.”

Cassels’ point is that the value of someone’s—or hundreds of thousands of someones—genetic information isn’t worth much until it’s monetized and generates profit.

As we all know, Big Pharma loves profit. Loves it more than integrity, loves it more than patient safety. By marrying 23andMe’s huge database with Big Pharma’s research and marketing resources, 23andMe will be able, as the company says, to “empower people to take control of their health destinies rather than becoming slaves to the health-care system.”

Cassels, and anyone looking objectively at this situation, questions whether people will be released from servitude or will only be switching masters. Monetizing “all that spit they’ve collected,” Cassels says, is just another way of saying 23andMe will mine the data for even the tiniest of nuggets so it can patent new products to sell back to people encouraged to be concerned about genetic traits that, left unrecognized, might never require medical attention.

In May, Cassels notes, 23andMe got a patent for the discovery of a gene that might protect someone from getting Parkinson’s disease. It would be impossible to understate the worth of something of that magnitude. So, with that as a target to develop a drug, 23andMe pretty much would corner the market on both the test and the drug.

Don’t be fooled—what the company claims as consumers’ rights to know their full medical profiles and control the health-care costs to address them is just a business growth plan. It’s about, as Cassels puts it, “cold hard cash.”

Genetic testing can be a valuable and useful tool for diagnosing and treating medical conditions. But as we said in the newsletter, it’s also a minefield for miscommunication, overtesting, over treatment and emotional turmoil.

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.

As the New York Times reported earlier this month, the settlement gave states total freedom about how to spend the money. Many use the dough to fund programs unrelated to tobacco, and to plug budget holes. Public health observers decry the fact that there’s no guarantee any money is earmarked for tobacco prevention and cessation programs.

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."

As a spokesman for Tobacco-Free Kids told Reuters, "Requiring the tobacco companies to finally tell the truth is a small price to pay for the devastating consequences of their wrongdoing."

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.

Last week a federal appeals court made a ruling that chips away at a fundamental aspect of the FDA's gatekeeping function with new drugs. The court tossed a conviction of a drug sales representative who was promoting drugs for uses the FDA had not approved. Two of the three judges on the panel said such restriction was a violation of the drug rep’s first amendment rights.

“Off-label” use of drugs is not illegal—doctors often prescribe a medication for a purpose other than what is specifically approved by the FDA. But pharmaceutical companies are prohibited by law to advertise or market them for such “customized” purposes. Because doctors understand the individual needs of their patient, they are in a unique position to know when off-label use might be appropriate—sometimes, such treatment is part of the art of medicine.

Big Pharma appreciates this art not because it’s creative and useful, but because it sells product.

A story in the New York Times said the court’s ruling “could have broad ramifications for the pharmaceutical industry.”

No kidding. Many companies have suffered huge financial penalties when they got caught and punished for off-label promotion. As we wrote in July, GlaxoSmithKline agreed to fork over $3 billion for promoting the antidepressant Paxil for treating depression in children and adolescents despite reports of increased suicidal tendencies among teens who took the drug. It promoted Wellbutrin, also an antidepressant, for weight loss, substance addiction, attention deficit hyperactivity disorder (ADHD) and sexual dysfunction. Then, the sales reps’ description of it as “the happy, horny, skinny pill” was deemed illegal. Now, it’s a free-speech issue.

Another company, Johnson & Johnson, settled a consumer fraud problem for $181 million after it fudged the marketing of Risperdal, an antipsychotic drug.

John R. Fleder, an attorney who formerly represented the FDA, told The Times, “Most if not all of these cases have been based on a central premise: that it is unlawful for a company and one of its employees to be promoting a drug or a medical device off-label. And this decision hits at the heart of the government’s theory.”

This case involved Alfred Caronia, a former sales rep for Orphan Medical, later acquired by Jazz Pharmaceutical, and the drug Xyrem, which had been approved for narcolepsy, a sleeping disorder whose victims experience uncontrollable attacks of deep, if brief, sleep. Caronia allegedly promoted it to doctors as a treatment for insomnia, fibromyalgia (chronic musculoskeletal pain and fatigue) and other conditions. In 2005, The Times reports, he was taped discussing such uses with a doctor who was a government informant. He was convicted by a jury in 2008.

He appealed on the basis that his First Amendment rights were restricted illegally.

At least one of the appellate judges retained her wits. Dissenting Judge Debra Ann Livingston vigorously argued, according to The Times, that by tossing Caronia’s conviction “the majority calls into question the very foundations of our century-old system of drug regulation,” she said. “[If drug companies] were allowed to promote FDA-approved drugs for nonapproved uses, they would have little incentive to seek FDA approval for those uses.”

Gerald Masoudi, a former counsel of the FDA, tried to split the difference between a truthful discussion of off-label drug uses and a misleading or false discussion. He told The Times that anyone except pharmaceutical companies could discuss off-label uses, and that the ruling is significant “because it’s going to make FDA, in its promotion cases, focus on the kinds of speech that are more likely to harm consumers, such as false or misleading marketing versus something that is not approved.”

This isn’t over until it’s over, which might not be until the government decides whether to request a rehearing before a full panel of judges, and after that, it could land in the lap of the U.S. Supreme Court.

The only saving grace at the moment, as noted in The Times’ story, is that because the ruling applies only within the Court of Appeals for the Second Circuit in New York, pharmaceutical companies that sell their wares far and wide won’t be making wholesale changes to their marketing policies. More likely is that the FDA will chill on the pursuit of similar cases until resolution.

Americans love technology. We love our iPods, our tablets and our smartphones. At the swipe of a finger, we can map a route, make a reservation, buy a pair of boots and, now, cure what ails us.

Or can we?

Published in the Washington Post, an investigation by the New England Center for Investigative Reporting not only calls into question the quality of much of the health information available via phone app, but sounds an alert about the risks of such “flimsy science.”

As the story notes, “When the iTunes store began offering apps that used cellphone light to cure acne, federal investigators knew that hucksters had found a new spot in cyberspace.” The Federal Trade Commission (FTC) shuttered two such apps, and the FDA is now grappling with how to regulate the industry. “[B]oth the iTunes store and the Google Play store are riddled with health apps that experts say do not work and in some cases could even endanger people,” the story says.

Who wouldn’t jump at the chance to lose weight, relieve arthritis pain, cure a stutter with a quick-fix treatment delivered on your phone? But if the prescription isn’t based on established medical practice and tested by professional researchers whose work is reviewed by their peers, like traditional medical interventions, their patients are, at best, delaying appropriate treatment, and, at worst, threatening their health.

The cost of health apps range from minimal (or free) to hundreds of dollars. The Center reviewed 1,500 health apps available since mid-2011; more than 1 in 5 claimed to treat or cure a medical problem. More than 4 in 10 of the 331 therapeutic apps relied on cellphone sound; 12 required the light from the phone; 2 used phone vibrations. “Scientists say none of these methods could possible work for the conditions in question,” the story says.

The Center makes clear that many outstanding health apps are available, especially for health-care providers. For example, the story recommends:

• Lose It for weight loss;


• Azumio to measure heart rates;


• iTriage to check symptoms and locate hospitals with the shortest emergency room wait times.

But in the absence of government oversight and objective testing of product claims, patients have no way to confirm the useful from the bogus. Reliance on product promotion and online reviews are hardly the gold standard of standards. But, really, common sense is all you need to assess most of these tools.

Satish Misra, a physician at Johns Hopkins Hospital and the managing editor of iMedicalApps, which reviews medical and health-care apps, told the Center that he’s concerned most about apps that claim to test or treat people for serious diseases. Not only can they give inaccurate information, they can encourage patients to ignore symptoms they shouldn’t.

Cardiac Stress Test is once such app, according to the Center. It promises to clear you to participate in sports or not after you do 30 squats in less than a minute, then enter your heart rate into the calculator. As Misra notes, assessing cardiac status is more complicated than just computing heart rate.

In the case of the “cure acne with your cellphone light,” the FTC “false or misleading” charge reflected this product claim: “Rest the iPhone against your skin’s acne-prone areas for two minutes daily to improve skin health without prescription drugs.” Still, according to the FTC, the app was downloaded 11,600 times.

Other apps advise the use of cellphone lights to treat seasonal affective disorder (SAD), a type of depression that strikes in the low light of winter. Although SAD is treated with light therapy, people who treat the disorder, according to the story, say cellphone lights are far too weak to treat depression. Even its manufacturers know they’re dishing out a load of bunk: There’s a disclaimer on the iTunes site that reads, “IMPORTANT. The iSAD Lamp is meant for entertainment purposes … We are not responsible for any misuse or failure.”

Talk about entertainment—Breast Augmentation is positively laughable. It’s based on the fact that breast-feeding women have larger breasts. Duh … they’re filled with milk. But the app claims that women can become better endowed by listening to the sounds of a crying baby at least 20 times a day.

Neither Apple nor Google would discuss with Center reporters their apps or app development. Apple’s guidelines for app developers, according to the story, “say it will reject apps that crash, have bugs, do not perform as advertised or are sexually explicit.” Google’s guidelines ban “sexually explicit material, gratuitous violence or anything that may damage users’ devices.”

In bureaucracy-as-usual, proposed FDA regulations requiring health apps to get government approval are mired in debates, hearings and deep-thinking about whether government oversight would stifle innovation

If you want to learn more about a health app, visit iMedicalApps, an online resource for both medical professionals and patients. Its producers are health-care professionals with no commercial app interests. They follow strict conflict-of-interest policies in order to provide an unbiased view of mobile medical technology.

Another resource identified by the Center, Happtique, comes from the Greater New York Hospital Association. Once launched, it will be the first app certification service for evaluating safety and effectiveness.

Generally, when a prescription drug becomes available over the counter (OTC), it’s a good thing—it’s less expensive and available more quickly. But as a recent report on MedPage Today explains, often, something gets lost in the translation from Rx to OTC. And that loss has the real potential to harm patients.

Advertising for the newly prescription-free drug is much less likely to warn about potential risks, according to research published in the Journal of the American Medical Association (JAMA).

In the study, 7 in 10 ads for four prescription medications explained the drugs’ potential harms; only 11 in 100 ads for the same four drugs did so once they became available without a prescription.

As the study authors wrote, "Pharmaceuticals do not lose their capacity for harm after moving from behind the pharmacist's counter to in front of it. Closer attention should be paid to how such drugs are promoted to consumers."

Regulatory oversight for prescription medicine, including advertising claims, is the responsibility of the FDA. When the same drugs move to over-the-counter status, that oversight shifts to the Federal Trade Commission (FTC). Those agencies have different standards when it comes to product promotion.

The FDA requires that ads contain a "fair balance" of risks and benefits; the FTC demands only for a "reasonable consumer" standard of truthfulness. That excuses manufacturers—and their advertising copywriters—from explicitly describing both harms and benefits. So guess what? The promo balance tilts noticeably to the benefits side of things.

The researchers studied all print and broadcast ads from four commonly used drugs that moved from prescription to OTC status: the antihistamine loratadine (Claritin); the gastroesophageal reflux medicine omeprazole (Prilosec); the weight-loss medicine orlistat (Alli); and the antihistamine cetirizine (Zyrtec).

They analyzed advertising that ran two years before and six months after the drugs achieved OTC status. Once they were available over the counter, nearly 100 percent of the ads described the drugs’ benefits, versus slightly more than 8 in 10 when they available only by prescription.

So the gap in mentioning potential harms—from 7 in 10 prescription drugs to 11 in 100 OTC—was huge. Except for print ads for orlistat, the researchers said, no OTC ads mentioned contraindications or adverse effects.

And if someone wanted to research drug effects, his or her ability to get complete information is complicated by the fact that the OTC drug information was less likely to mention the generic names. As the researchers wrote, those are "key tools for consumers seeking independent information on risks, benefits, and costs."

The small sample of only four products might not represent how all prescription-to-OTC drugs are described in their promotional efforts. The researchers note that even the FDA’s direct-to-consumer advertising regulations "do not necessarily result in balanced presentations of
risks and benefits, and these guidelines are known to be inconsistently enforced."

Couple that with the less-information-is-more-sales behavior of Big Pharma, and the researchers conclude that patients get "even less information for making an informed decision, at a time when [they] must have more knowledge of whether their medications' potential benefits are worth their risks and costs."

To learn more about the risks of drug treatment, whether by prescription or over-the-counter medicine, see our backgrounder about medication errors.

Heart disease is the No. 1 killer in the U.S. for both men and women—more than 600,000 deaths every year. The estimated annual cost of heart disease in the U.S. is more than $316 billion for health-care services, medications and lost productivity, according to the Centers for Disease Control and Prevention (CDC).

You’d have to be a recent transplant from Saturn not to know that diet plays an important role in heart health. Eating too much of certain kinds of fat can boost blood cholesterol levels and the possibility of atherosclerosis (blocked arteries), which can cause a stroke as well as heart attack. Eating too much sugar and processed foods packs on the calories, and often the pounds. Too much weight, again, puts your heart at risk. Eating too much sodium (salt) can increase your blood pressure and your risk for a heart attack and stroke.

So what in the world was the American Heart Association (AHA) thinking when it sold Frito-Lay the right to distribute its highly processed, salty snack food at the AHA Dallas Heart Walk?

The question, posed on WeightyMatters.ca, which raises consciousness about healthful eating and Big Agri, makes you wonder if nothing, not even your core message, is more important than exploiting a money-making opportunity.

The walk, like similar events all over the country, raises money to fund heart disease research. According to WeightyMatters, it raised more than $4 million this year, and drew a huge crowd.

In exchange for its “generous” donation of Cheetos to the assembled masses, Frito-Lay got to:

• Tie their brand to the positive emotions of the walk—joy, hope, charity, community spirit. Never mind that a heart attack is the last thing that would make you happy.


• Target their marketing to the large contingent of youngsters in attendance (who got to meet and greet Cheetos mascot Chester the Cheetah) in hopes of converting them into brand-loyal consumers.


• Promote the idea of junk food as a part of daily life that has the blessing of the American Heart Association.

An organization devoted to healthful behavior and saving life should be ashamed for betraying its message for 30 pieces of silver.

Sadly, it’s the American way. Remember our blog earlier this year about the breast cancer foundation’s unholy alliance with a firearm vendor? And, as one person who commented on the WeightyMatters site put it, “[M]y kids came home outraged last year after the Heart & Stroke Foundation came to their school to launch the Hoops for Heart program. Apparently the kids had been told, among other things, to watch less TV & play fewer computer games. The big prize for the kid raising the most money? An Xbox.”

If you’re more interested in doing the right thing, see our recent newsletter, “A Healthy Heart: Unlocking the Key to Long Life.” And to learn more about a heart-healthy diet, see this backgrounder from the CDC.

We’ve all seen, heard or read the pitch: “Get a bone density screening this weekend!” a typical radio promo might say. Such offers might be extended by churches, pharmacies, fitness clubs and shopping malls in conjunction with companies that provide the technology. Local hospitals, academic medical centers and physician groups are often advertising sponsors, lending them a sense of credibility.

Such direct consumer marketing of medical procedures offers convenience and lower cost than those prescribed by a clinician. But, as regular readers of this blog would know, just as there is no such thing as a free—or cheap—lunch, there is no such thing as a risk-free medical screening.

Some routine screenings are unquestionably good and relatively low tech. Checks for hypertension (blood pressure), dyslipidemia (abnormal cholesterol or blood fats), diabetes and tobacco use—combined with lifestyle modification and medications—can prevent more than half of all heart attacks and strokes, according to a recent article published in the Annals of Internal Medicine.

But, write Drs. Erik A. Wallace, John H. Schumann, and Steven E. Weinberger, “[T]he increasing availability of direct-to-consumer screening tests is undermining physician efforts to provide high-quality, cost-conscious screening services to patients through shared decision making.”

They’re particularly concerned about the misapplication of technology—using hi-tech equipment such as ultrasonography to assess carotid arteries for blockage, for example. Physicians and medical facilities like these tools (and often feel the need to use them liberally to justify their cost), and many patients believe they’re getting a higher level of care with fancy tools. But, as the writers point out, their widespread use contributes to substantial increases in health-care costs.

And, the writers warn, “When screenings are provided in a church and sponsored by a trusted medical organization, consumers may have a false sense of trust in the quality and appropriateness of services provided. Consumers are generally unaware of the potential harms of screening.”

They note that when the screening tests are purchased and performed, the tech companies tell consumers to share any “abnormal” result with their personal doctors. As we’ve discussed, and the journal writers reinforce, most of these tests are not medically indicated in the first place; their questionable use is not disclosed to consumers; and there is no discussion about the possibility of consequences or additional costs.

The harms of unnecessary screening, as we regularly remind, include:

• unnecessary worry and emotional upheaval;


• false positives (the indication of a problem when there isn’t one) that often lead to invasive, uncomfortable, additional testing that can bring complications such as infection, impaired function, loss of work time … and expense.

Absent individual counseling about the potential risks of an “abnormal” result by the purveyors of direct-to-consumer tests, the consumer won’t know that following up with their medical caregivers could invite what the journal writers call “a Pandora’s box of referrals and additional testing to monitor or treat these abnormal findings.”

Advocates of the generous use of screening technology like to promote the idea that someone who knows he has a disease or shows a predisposition to disease is more likely to make lifestyle changes that benefit his health.

That’s fiction. “[E]vidence does not support this hypothesis,” say the journal authors.

They cite the example that although patients who smoke and are interested in quitting have a high incidence of atherosclerosis (narrowing of the carotid artery), people whose carotid ultrasonography results are abnormal are no more likely to quit smoking than those with normal results or those who did not have the test. And the U.S. Preventive Services Task Force recommends against screening the general adult population for atherosclerosis, thanks to a fair certainty that there is no net benefit.

Commercial medical screening is just a Pollyanna way of getting consumers to sample something merchants would like to sell them in perpetuity. From their standpoint, it’s best not to muddy the “information is powerful” message with reality.

That reality, the journal writers say, is that claims such as, “the ultrasound screenings we offer can help save your life” are coercive, unsubstantiated, misleading statements that escape the regulatory control imposed when pharmaceutical companies try to sell drugs directly to consumers. Those companies are required to disclose the potential risks of taking a medication, which is why the possible side effects listed ad nauseum in their TV commercials often take more time than the drug pitch.

When the mobile ultrasonography screening van stops at your local library in the hope of testing the health of your carotid arteries, the journal authors believe, it, too, should “be obligated to disclose from published guidelines the recommended indications and benefits of testing, as well as the potential risks and harms.”

It’s a question not only of patient safety, but ethics. The writers say that:

• Companies offering such screening tests should fully inform customers of the potential risks of positive or negative screening test results before the test is performed.


• Medical organizations, hospitals and physicians should refrain from sponsoring health screenings with commercial companies that offer unproven or harmful testing because it represents a conflict of interest.

If screening someone who shows no symptoms of disease with a test not indicated for their situation is not medically beneficial and doesn’t increase the chances of a positive change in behavior, the writers ask, “how can it be ethical to allow marketing of such tests to the public?”

You cannot make an informed choice about your medical care if you don’t have all the information. And, despite their claims that screening gives you information you need, direct-to-consumer screening operations give you only half the story.

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.

Three anemia drugs--Epogen, Procrit and Aranesp--have generated more than $8 billion in U.S. sales. Epogen became the single costliest medicine under Medicare, and taxpayers shell out as much as $3 billion a year for these drugs.

A growing body of research has shown that the drugs’ benefits, including quality-of-life issues such as “happiness,” are seriously overstated. Worse, according to a long story in The Washington Post, their potentially lethal side effects, including cancer and strokes, were long overlooked.

Anemia occurs when the body produces too few red blood cells, which carry oxygen from the lungs to the rest of the body. The drugs are artificial versions of a natural hormone called erythropoietin, which stimulates the body to produce red blood cells. Before the drugs’ advent, patients were given transfusions of red blood cells, a cumbersome process that can take hours.

Epogen and Procrit were approved by the FDA in 1989 for patients with kidney disease. Amgen manufactured both; Procrit was licensed by Johnson & Johnson. Amgen’s Aranesp was approved in 2001.

Last year, an 84-page Medicare research study determined that among most kidney dialysis patients, who compose the drugs’ largest market -- the kidneys are where the natural hormone is made -- there was no solid evidence that they made people feel better, improved their survival or had any “clinical benefit” except a higher red blood cell count. As The Post said, “It was a remarkable finding of futility: While drugmakers had seen billions in profits over 22 years, much of it from taxpayers, millions of patients had been subjected to dangerous doses that might have had little advantage.”

One of those patients was Jim Lenox. On the day the frail cancer patient received his last injection in 2008, he was awaiting discharge from the Baltimore Washington Medical Center. Then a nurse said he needed another dose of anemia drugs.

His wife, Sherry, wondered why, because his blood readings had been close to normal. But the Lenoxes deferred to the professionals and accepted an injection of Procrit, which his cancer clinic normally billed for $2,500 each.

Hours later, Lenox was dead.

The story behind the anemia drugs is long and complicated, and illustrates how the financial incentives that are integral to the U.S. health-care system contribute to its inefficiency and lethal potential. We wrote about this smarmy situation last year.

Drug trials conducted by both Amgen and Johnson & Johnson missed the dangers and promoted the benefits that years later would be deemed unproven. The companies took more than a decade to fulfill their research commitments. And when bureaucrats tried to curb the largest doses, Congressional lobbyists were successful, and regulators opened the spigot.

The fault of dangerous drugs being promoted on the open market is shared by doctors, clinics and hospitals, whose budgetary pressures contribute to a “more is more” philosophy. The more they treat, the more they earn, the bigger the dose, the bigger the payoff.

Unlike medications you fill at a pharmacy, drugs administered by physicians, such as the anemia group, can be profitable for them.

Big Pharma offered doctors incentives to give large doses and they offered volume discounts. Most critical, The Post says, was the lobbying pressure, under which Congress and Medicare administrators forged a system in which doctors and hospitals were reimbursed more for the drug than they paid—as much as 30 percent, according to the Medicare Payment Advisory Commission, a group that advises Congress. The markup on patients covered by private insurance was even larger.

At the peak of the drugs’ use in 2007, more than 8 in 10 Medicare dialysis patients were receiving the drug at levels higher than the FDA now considers safe, according to federal statistics. (Other patients got the drugs, but records kept on dialysis patients are better.)

“An oncologist could make anywhere from $100,000 to $300,000 a year from this alone. And all the while they were told that it was good for the patient,” Charles Bennett, from the Medication Safety and Efficacy Center of Economic Excellence at the University of South Carolina, told The Post.

During his cancer treatment, Jim Lenox was given Aranesp several times at a clinic. The insurance company reimbursed it about $900 for each, although the clinic would have paid about $600.

The profit margin for Amgen was far higher than the industry average. Much of it came from the pockets of taxpayers. A Washington University professor of medicine who had been paid by Amgen to promote the drug, called its success “a paradigm for the pharmaceutical industry.” He later turned critic after Aranesp’s dangers became known while Amgen continued to promote higher doses.

Both companies declined the paper’s requests for interviews and claimed that their primary interests were serving patient needs and providing consumer information.

The market expanded to nearly all dialysis patients, not just the estimated 16 in 100 who require blood transfusions, and the size of the average dose more than tripled. The FDA approved the drugs to treat anemia in cancer and AIDS patients, as well as those getting hip and knee surgery.

The drugmakers agreed to conduct safety studies, but the full results were never published. Amgen filed a “clinical study report” with the FDA in 1995, claiming its research commitment was fulfilled. The FDA did not deem the study completed until March 2004, almost 15 years after the company agreed to conduct it.

Another study in conjunction with the drugs’ approval was supposed to have 400 patients. Eleven years after initiating it, Johnson & Johnson said it was having difficulty recruiting enough, so statistically significant conclusions were elusive. And the FDA said significant amounts of data were missing.

With FDA approval, Johnson & Johnson halted the study in 2004. Medicare researchers later noted that patients in the trial who took the drugs appeared more likely to die than those who took a placebo, or fake, inert drug.

The drugmakers committed to doing another study, which was supposed to be completed by 2008. It still isn’t finished and Amgen doesn’t expect to finish until 2017 — nearly 25 years after the drug was approved for use in cancer patients.

Still another study funded by Amgen involved dialysis patients with a history of heart trouble. It was supposed to study the effect of the drugs in boosting certain blood levels close to normal, instead of simply higher than the anemic levels, which had been medically acceptable. That trial was stopped three years after it began because patients in the “normal” higher-dose group were dying or having heart attacks at a higher rate than those in the lower-dose, lower-level group.

What should have been a clear warning wasn’t: The FDA didn’t limit the recommended dosing levels, and the reason for the “increased mortality” at the higher doses, according to the label, “is unknown.”

In 2006, a study published in the New England Journal of Medicine reported that kidney patients taking higher doses were linked to higher risks of hospitalization, strokes and death. Some Danish researchers stopped a trial of Aranesp in cancer patients because of an increase in deaths and tumor growths.

Finally, the FDA ruled out the drugs’ use for cancer patients considered curable and for patients considered only slightly anemic. Maximum recommended doses were lowered, and the agency told doctors to use the smallest amount possible to avoid a blood transfusion. The agency removed the quality-of-life claims from the label.

Last year, nearly two decades after the Office of the Inspector General first suggested it, economic incentives to use more of the drugs on patients in dialysis were withdrawn. Medicare implemented a system under which health-care providers are allowed a certain amount of money per dialysis patient, rather than more money for each dose.

“The effects were immediate,” The Post reports, “suggesting again that health is not the only factor that doctors weigh in treating patients. After a quarterly sales plunge in April, Amgen chief operating officer and President Robert Bradway blamed the drop on the new payment scheme.”

Still, no major class-action lawsuits have been mounted, presumably at least in part because the patients taking the drugs were already ill. Amgen has been hit with whistleblower lawsuits alleging that the company engaged in illegal sales tactics.

But for people like Sherry Lenox, questions remain: Although her husband’s death certificate says he died of cancer, did he? Or was he he killed by the drugs he took to treat it?

We couldn’t have said it better than the Los Angeles Times: “ Television is great for sports, reality shows and reruns of ‘The Big Bang Theory,’ but if you're getting your health information from TV, you might not be as well-informed — or as healthy — as you could be.”

We would add that you also might be courting harm. See our newsletter, “Those TV News Doctors: Good Advisors or Fear Mongers?”

Whether it’s “Celebrity Rehab with Dr. Drew” or “The Doctors,” America can’t seem to get enough of practitioners giving medical advice, especially if they’re dishing dirt on famous people or strutting hunkily in their scrubs. They have medical degrees, they’re confident and articulate, and it’s a whole lot easier to flick on the TV than schedule a doctor’s appointment, and sit in the waiting room 30 minutes beyond the time you were supposed to be seen about your upset tummy.

There’s a problem with seeing doctor TV as an authority rather than entertainment, Dr. Steven Woloshin, professor of medicine at the Dartmouth Institute for Health Policy and Clinical Practice, told The Times. Sometimes, TV doctors who are accomplished in one field might be discussing topics beyond their areas of expertise or certification.

Dr. Mehmet Oz is a practicing cardiothoracic surgeon and a professor of surgery at Columbia University who gained media fame appearing on the Oprah Winfrey show. Photogenic and warm, he inspires responses from his audiences to his advice on how to keep a great head of hair as much as on ability to repair somebody’s heart.

Americans are desperate to lose weight, so nutrition is a frequent topic on these shows. But, "Just because someone's on TV, just because they're wearing scrubs, doesn't mean they're an expert on nutrition," Woloshin, a specialist in internal medicine, said.

Oz recently told his TV viewers that coconut oil is a "super food" that "helps you lose weight.” He got all science-y, demonstrating that the fatty acids in coconut oil dissolve easier than the saturated fat in meat. But Christine Tenekjian, a dietitian at the Duke University Diet and Fitness Center, pointed out that the considerable caloric load of coconut oil would override the modest benefits it might have on metabolism. “We have people who come in with all sorts of misconceptions that they heard on TV,” she told The Times. “They cling to it as gospel.”

In the spring, “The View” aired an episode with Dr. Steven Lamm, who, not coincidentally, was promoting his book, “No Guts, No Glory.” The professor of medicine at New York University championed several probiotic and nutritional supplements from a company called Enzymedica Inc., guaranteeing that "… in three to five years, everyone is going to be on a probiotic, everyone is going to be on a digestive enzyme."

He said these products are crucial to overall gut health. He must know something nutritional scientists don’t. "There's no evidence that probiotics improve your health if you take them every day," Lynne McFarland, a probiotic researcher at the VA Puget Sound Health Care System in Seattle, told The Times.

Some people, such as those with pancreatic disease, are prescribed digestive enzymes. But to pop them like cough drops is simply a fad.

We reported last week how Pinsky was paid by pharmaceutical company GlaxoSmith Kline to promote its antidepressant Wellbutrin. Guess who paid Lamm for his consulting services? Enzymedica. Although he told The Times that he has no financial stake in the company's products, don’t you think TV viewers deserve to know that his advice might have been less than objective?

As publisher of Health News Review, Gary Schwitzer is a frequent critic of shallow health journalism and how it engenders the gullibility of consumers. He said “The View” illustrated another problem with health-as-entertainment – the show's hosts constantly interrupted Lamm, so even if he had a helpful, coherent message he was given little opportunity to share it. "It's like getting your health information by listening to people talk on the train," he told The Times.

Sometimes, nutrition advice purveyed on TV isn’t just questionable, it’s dead wrong. “The Talk” is another daytime talk show directed toward a female audience. Early this year, it fed viewers’ celeb-and-weight-loss lust a segment featuring so-called “celebrity nutritionist” Cynthia Pasquella. She touted apple cider vinegar as “very alkalizing for the body, which promotes weight loss.”

Woloshin begs to differ, noting that all vinegars are acidic, which is the opposite of alkaline. And that even if you could “alkalize” yourself via salad dressing, there’s no evidence that it confers a benefit. Tenekjian agrees, saying no studies suggest that vinegar helps with weight loss.

Then there’s advice to boost your sex life. TV land found the perfect doctor to deliver this information in Travis Stork, the hunky ER doc on “The Doctors.” Last winter he told viewers about a “love potion” called Oxytocin Factor , an over-the-counter version of the hormone oxytocin. The ob-gyn doc on the show, Dr. Lisa Masterson, described oxytocin as the hormone that promotes the bonding of babies to their mothers and of women to their men. She put a few drops of Oxytocin Factor on pediatrician Dr. Jim Sears, who joked, “I feel like bonding right now.”

This isn’t medicine, this is sophomoric posturing. Commented Dr. David Feifel, a professor of psychiatry at UC San Diego, “[The segment] was pretty ridiculous and irresponsible, in my opinion." He told The Times that real oxytocin can promote bonding when delivered directly to the brains of people or animals, but had "no idea" where anyone got the notion that a few drops on the back of the neck would do anything at all.

A spokeswoman for Nutriceuticals Inc., manufacturer of Oxytocin Factor, said the doctors on the show didn't use the product as directed; it’s delivered via either nasal spray or oral drops.

Oh, that makes it better.

If you enjoy watching doctors on TV, stick to reruns of “ER,” where you know the stories and most of the medicine is fiction. If you want to see real doctors wearing their scrubs on a TV set rather than in an OR theater, fine—just don’t confuse what they say as medical advice to live by.

Last week we reported about the widely publicized criminal behavior of pharmaceutical giant GlaxoSmithKline, and the $3 billion fine it will pay for its crimes. Thanks to Kaiser Health News (KHN), consumers can get the gory details of just how Big Pharma inflates drug sales and the cost of health care.

It’s about doctors who leverage their medical celebrity into roles as drug shills. It’s about doctors who accept fancy trips and recreational pursuits from the companies who supply their wares It’s about spinning research results into fictional scenarios that make a great story and really bad patient care.

Courtesy of KHN, here are some of the players and their playgrounds with which Glaxo promoted the depression drugs Paxil and Wellbutrin and the diabetes drug Avandia.

• Glaxo paid Dr. Drew Pinsky (radio call-in show “Loveline,” reality TV show “Celebrity Rehab with Dr. Drew”) $275,000 to promote Wellbutrin “in settings where it did not appear that Dr. Pinsky was speaking for” Glaxo.


• On a radio show Pinsky said the active substance in Wellbutrin “could explain a woman suddenly having 60 orgasms in one night” even though Wellbutrin was approved to treat only major depression.


• Glaxo promoted Wellbutrin “knowing that much of the cost of the unapproved, nonmedically accepted and/or inappropriate uses would be borne by federal health care programs.”


• In 2000 and 2001, Glaxo flew psychiatrists to resorts (El Conquistador in Puerto Rico and Renaissance Esmeralda in Palm Springs, Calif.) to promote Paxil for children, even though it was unapproved for that use. “Results suggest that the Paxil Forum had a significant impact on Paxil market share in the months after attendance,” according to a Glaxo memo.


• Glaxo paid what prosecutors described as kickbacks to doctors in the form of consulting fees, entertainment, travel and “sham advisory boards.” It tracked their prescribing habits. A Glaxo memo emphasized that only “KEY Customers” (high-prescribing doctors) should get free tickets to Boston Bruins and Celtics games.


• “When I asked for the business he laughed,” one Glaxo sales rep said of a doctor whom he had treated to a St. Louis Cardinals baseball game. “I didn’t really see the humor in it. How could he think I wouldn’t ask for the business when I’ve treated his family to a day at the ball park.”

Most doctors who accept this graft would say that they wouldn’t prescribe a drug they didn’t believe in, so as long as they do anyway, what’s the harm in being treated well by its makers? We think it’s the patient’s decision, not the provider’s, as to what is and isn’t a conflict of interest.

So if you’re going to accept gifts, people should know about it. The 2010 health-care reform legislation supports that notion, and as of next year, the Physician Payment Sunshine Act will require doctors to disclose such activity.

In the meantime, you can look up any number of palm-crossing transactions between doctors/researchers and the medical drug and device industry on the “Dollars for Doctors” page of ProPublica, a nonprofit investigative news operation.

Should anyone doubt that these professional courtesies have the potential to affect someone’s health adversely, consider this comment posted at the end of the KHN story earlier this month:

“I’m on a brand medicine that has a generic. The brand drug is at least ten times the cost of the generic. I have asked my doctor to switch me to the generic and he refuses. He always says to me, ‘I’m the doctor. If you don’t like how I do things, there’s the door.’ The trouble with making my exit is that I’m not sure I can find another doctor that takes Medicare and I’m sure my current doctor will put me on the black list. He’s done to his other patients and I’m sure he’ll do it to me.”

Many health and medical journalists, and watchdogs of the practice of medicine, have noted a peculiarly American phenomenon: “disease mongering.” As defined by journal PLoS Medicine, disease mongering is “the selling of sickness that widens the boundaries of illness and grows the markets for those who sell and deliver treatments.”

We’ve discussed the topic before, and no doubt will again because it’s found in several guises.

Instead of preventing disease and maintaining health, disease mongering is about conflating common complaints into pathology; it’s about fear and overtreatment, about selling drugs and therapies to “patients” who, by more measured analysis, are really just people with transient or nonexistent problems.

A recent post on KevinMd.com by Dr. Edward Pullen discussed a current representative of disease mongering: low testosterone. “It seems like every day in the office I see at least one man concerned about testosterone deficiency. If you look at the symptoms of testosterone deficiency, most of us have one or more of these symptoms at least some of the time. Fatigue, depression, weight gain, lack of energy, reduced sex drive, loss of physical strength and moodiness are all described as symptoms typical of testosterone deficiency.”

True testosterone deficiency, as defined by the National Institutes of Health, is known as hypogonadism, and can be related to dysfunction in the brain or the testes. It can reflect genetic disorders, or result from trauma, radiation or chemotherapy. It’s common among people with diabetes, chronic pain, metabolic syndrome, inflammatory arthritis, chronic obstructive pulmonary disease (COPD) and kidney disease. But absent a clinically diagnosed reason for flagging testosterone, is it a medical problem worthy of treatment?

HealthNewsReview.org doesn’t think so. It recently alluded to a couple of studies in the Medical Journal of Australia about low-testosterone campaigns (here and here) in a country that has seen at least a twofold increase in total expenditure on testosterone prescriptions in the last two decades, and where direct-to-consumer marketing is not permitted (unlike in the U.S.). Those researchers, finding an insidious effort to juice the drug market despite no medical necessity, called for strict enforcement of the law and sanctions for companies that violate it.

As Pullen explained, defining “low” in testosterone levels is tricky—population estimates range from nearly 3 in 100 men to nearly 40 in 100, the latter figure reflecting people with the diseases mentioned above. Even if it seems appropriate to prescribe testosterone (known as hormone replacement therapy, or HRT), there is cause for pause, because the long term effects are unknown. Some men who take testosterone create additional red blood cells, a condition called polycythemia, that can cause lead to stroke. Although some dire risks are apparent, who knows about the potential for heart disease, prostate enlargement or cancer, all of which are of concern?

It’s reminiscent of the situation with female HRT when, after decades of treatment primarily to relieve the symptoms of menopause, scientific studies showed an increased risk of breast cancer and cardiovascular disease that prompted most practitioners to cease prescribing hormones for most women except for short-term treatment.

Do most of the common, if unpleasant, side effects of menopause really constitute a disorder? Or is pandering to temporary discomfort, even if extreme, more a matter of disease mongering than a reasonable medical response?

Other factors enter into the decision about male HRT. It can be expensive (one review yielded a cost of $330 per month for one brand name), and the the dose delivery can be erratic. Also, according to the Mayo Clinic, common if not life-threatening side effects of testosterone replacement therapy can include:

• sleep apnea — a potentially serious disorder in which breathing repeatedly stops and starts during sleep;


• acne or other skin reactions;


• enlarged breasts;


• limited sperm production or testicle shrinkage.

As Pullen concluded, “[W]e are really left to decide on a case-by-case basis whether to start men on testosterone replacement therapy. In cases where the testosterone levels are very low and the symptoms are typical I feel pretty good about starting therapy. In cases where testosterone levels are only modestly low or are at the low end of normal but symptoms are present it is much less clear when therapy is indicated. I often feel like my arm is being twisted by some men desperate for some help with their symptoms, and we have to decide on the risk-benefit balance best for them.”

If you wonder if HRT might address symptoms you think are testosterone-related, the first step is to get a blood test identifying your levels. The next step is to ask these questions of your doctor:

1. What is a normal testosterone level for me? Are my symptoms from low testosterone or something else?
2. Are my symptoms temporary and/or intermittent?
3. If I take HRT to alleviate my symptoms, what are the risks?
4. Will I have to take HRT indefinitely?
5. What are the alternatives?

And ask yourself: Am I responding to an advertising campaign? Am I experiencing a natural part of life that requires not medicine but coping skills?

We’ve written a lot about pharmaceutical company misbehavior because pharmaceutical companies misbehave a lot, and their actions can pose serious health harms.

One such breach of decency and law was so monumental that last week it made top-of-the-news headlines across all media. GlaxoSmithKline, manufacturers of well-known drugs including Flonase, Levitra and Zantac, agreed to plead guilty to three criminal misdemeanor charges of illegally marketing some of its other drugs and withholding safety information from government regulators.

In November, it had agreed to pay $3 billion to settle several lawsuits over its antidepressants Paxil and Wellbutrin, and its diabetes drug, Avandia. It was the largest health-care fraud settlement in U.S. history. But not until last week did the company plead guilty to the criminal charges, and the details of the complicated case emerge. The fine represents $1 billion in fines and $2 billion to settle civil liabilities.

As noted in the Wall Street Journal, it was the fourth time Glaxo has settled with the U.S. government in recent years. This was not only its most expensive resolution, it was the most far-reaching.

The illegal activity for the depression drugs involved promoting them for uses that hadn’t been approved by the FDA, a practice called off-label marketing. Glaxo also withheld data that showed that Avandia had been linked to an increased risk of heart problems.

Using outside ghostwriters to prepare a medical journal article falsely reporting that Paxil was effective in treating depression in children, Glaxo then used the piece to promote it for the adolescent market, never mind reports of increased suicidal tendencies among teens who took the drug. Glaxo promoted Wellbutrin, which was approved only to treat depression, for weight loss, substance addiction, attention deficit hyperactivity disorder (ADHD) and, most colorfully, for sexual dysfunction. Sales reps referred to it as “the happy, horny, skinny pill.”

All false claims, and all dangerous, especially when you consider that the robust marketing effort financially rewarded sales people according the number of prescriptions they persuaded doctors to write.

And get this: Prosecutors don’t know how much money the company made by promoting the drugs off-label for so many years, so it’s possible the revenue from dirty deeds exceeded even the $3 billion the company will pay. Is it a penalty or an investment?

Avandia, like Paxil and Wellbutrin, remains on the market in the U.S., but the packaging now bears a black-box warning about heart risk. (European regulators deemed it too risky for everybody, and withdrew it from the market in 2010.)

The settlement also addresses conduct the Justice Department says resulted in the overpayment of public funds for drugs issued via programs such as Medicaid. That included kickbacks paid to doctors. At some point do you start to wonder which organization is capable of whacking more people, the Mafia or Big Pharma?

Settlement terms include an “executive financial recoupment program” requiring changes in Glaxo’s executive compensation policies. They permit the company to recoup bonuses and incentive pay from employees who engage in significant misconduct. This seems thin: How about using docked pay to compensate victims?

In 2003, some company insiders filed a lawsuit against Glaxo under the Federal False Claims Act, which prohibits people or businesses from defrauding the government. The whistleblowers, whose information was critical to the government’s case, will receive a handsome share of the settlement penalty.

The rest of us will benefit, one hopes, from the hammer coming down hard, and the rest of the world hearing about it. But we agree with Dr. Sidney Wolfe, director of the Public Citizen Health Research Group: “Until more meaningful penalties and the prospect of jail time for company heads who are responsible for such activity become commonplace, companies will continue defrauding the government and putting patients' lives in danger.”

Like hemlines, nutrients are subject to the whims of fashion. Lately, Vitamin D has taken center stage.

In excerpting a piece originally posted on The Scientist, Health News Review recently noted that U.S. consumer sales of vitamin D increased fivefold from 2005 to 2010. Caregivers are embracing doses higher than the 400 to 600 International Units (IU) the government recommends for maintaining healthy bones.

Readers of MedPage Today are largely medical professionals and people interested in their affairs—health media, the pharmaceutical and medical device industries, health-care administrators and insurers, as well as interested medical consumers. A recent poll of those readers confirmed the vitamin’s popularity. Most respondents were certain that supplementing one’s diet with vitamin D and calcium was a good idea.

Given the sketchy evidence, you have to wonder why.

As The Scientist article noted, hype is a constant companion to nutrient/supplement claims. Vitamin E’s anti-cancer properties were undermined by a 35,000-person clinical trial that was terminated prematurely after people taking the supplements showed a slightly higher risk of developing prostate cancer than the control group. Large clinical trials studying beta-carotene and its conversion into vitamin A found an increased risk of lung cancer and heart disease.

Said one Harvard Medical School epidemiologist, “You have to look at these previous randomized trials as cautionary tales because they show that time and time again, everyone jumped on the bandwagon and then the randomized trials did not have favorable results, and in fact, the risks outweighed the benefits.”

We broached this topic a while ago.

Under some circumstances, according to a new study, high doses of vitamin D do seem to prevent bone fractures among the elderly. (That study, however, was unable to determine the role of calcium, which its participants also took, and which could be a critical component of the benefit.) And last month, the U.S. Preventive Services Task Force said that, contrary to popular belief, low doses of vitamin D and calcium do not reduce the risk of bone fractures for older women. It also found insufficient evidence that higher doses protect the bones of postmenopausal or premenopausal women, or reduce the risk of cancer, which are among the reasons people give for taking them.

More than half of the 1,686 MedPage Today survey respondents said they would advise patients to take both supplements, although nearly 1 in 3 said no vitamin or mineral supplementation was necessary if patients ate a balanced diet.

Comments among respondents included advice to eat calcium-rich foods, and take small doses of calcium supplements as well as vitamin D; that eating sufficient amounts of vitamin- and mineral-rich food is difficult because their nutritional value has declined substantially before food is served; that only a particular form of vitamin D is beneficial.

It all speaks to the notion that people are routinely vitamin D deficient, because of poor diet, insufficient sunlight, winter, sunscreen … take your choice.

People with certain disorders do need nutritional supplementation, and some people are vitamin deficient. But it’s not a blank-check situation. The nutrient to be supplemented and the amount necessary depend on the disorder, the patient’s diet and other medications taken.

But as noted in a story on NPR, vitamin D deficiency is hardly a scientifically proven problem in the U.S., and the task force’s recommendations reflect reality more than fear.

The task force didn’t rule out that higher doses might confer some benefits, but there’s no question that they present certain risks. Kidney stones is one. The risk is small, but is that excruciating pain worth it for an otherwise healthy person who downs a couple supplements as poor-diet insurance?

At high doses, vitamin D can be toxic, and prompt nausea, vomiting, muscle weakness, dehydration and constipation.

Many of the MedPage survey respondents dismiss most vitamin D studies because, they claim, the doses were too low. They say the higher levels that would confer benefits are similar to what the human body would make from sun exposure.

Maybe. But we’re circling back to the original concern: Are doctors and patients misled into thinking there’s an epidemic of vitamin D deficiency whose putative solution potentially disposes healthy people to risk?

No one can draw solid conclusions about whether to take vitamin D, and how much, as noted on Health News Review, until studies address the factors related to prevention trials of nutrient supplements:

• Doses are too small.


• Doses are too risky.


• Outcomes are too uncertain (an increased risk of disease, rather than the disease itself).


• The study period is too short.


• There are too few participants.


• The treatment regimen is incorrect.


• Participants are not random, but cherry-picked. participants.


• There’s poor participant compliance.

Here is the latest chapter in the long-running saga of snake oil treatments in the health and self-improvement market.

TV advertisements for a product called Lumosity suggest that you can “reclaim your brain” by engaging in mind games at the bargain price of $15 a month. With a scientist’s dubious perspective, John M. Grohol, founder and editor-in-chief of PsychCentral.com, looked at Lumosity’s research and website to vet the claim.

Would it surprise anybody to learn that it wasn’t exactly a model of scientific rigor?

Grohol wanted to see if these kinds of cognitive games help normal adults—not seniors or people suffering from cognitive impairment. He examined the company’s “select” list of studies supposedly supporting Lumosity’s brain benefit. He found that exactly none of them was scientifically sound in terms of studying a large and representative enough population of normal, healthy adults.

One study included normal adults, but involved college students whose results weren’t replicated within other populations. That’s a “caution” sign right there. Another study included subjects who were self-selected—that is, not a random group of people, which is the gold standard for population studies—and the sample was small; only 23 subjects. That study also was published in a journal not known for original, peer-reviewed research.

A third study was presented at a professional conference, but not as a published, peer-reviewed article; it was in the form of a poster. Its subjects, again, were college students, and only 26 of them. The results? Subjects who received Lumosity training had significantly enhanced self-esteem relative to those who didn’t get the training.

Psychologists measure self-esteem on something called the Rosenberg Self-Esteem Scale. The difference in self-esteem scores of the subjects who had Lumosity training versus the control group was about 3/4 of a point. The Rosenberg scale barely would consider that measurable, much less significant: Its range is from 10 to 40. In addition, Grohol points out, “[W]ithout knowing the actual score means, we don’t know whether the people already had good self-esteem which improved slightly, or lousy self-esteem which was still lousy, but slightly less so.”

This study’s trained subjects also had better emotion regulation (whatever that is) and reduced ruminative thinking (some people might call this “brooding”). The measure used for the latter was neither statistically nor clinically significant, meaning that there was no real difference between the two study groups.

This isn’t science, it’s advertising.

Grohol isn’t opposed to playing games you believe might improve your memory. He thinks they can be fun. He also agrees that some reasonable professionals and researchers might support Lumosity’s claim that users will see “dramatic improvements” in memory and cognitive skills.

But he objects to the implication that the company’s product has a solid scientific foundation, has sufficient data to claim that it can help normal adults improve how their brain works and that it’s leveraging an association with prestigious institutions including Harvard and Stanford universities “to enhance [its] shine.”

If you like brain games, play them. But don’t allow a $15 monthly fee to convince you that they’re medicine or even vitamins for your brain.

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.

In general, if you spend any time at all in the sun, even indirectly, such as driving, use sunscreen with at least an SPF of 15. Apply it 20 minutes before exposure, and every two hours thereafter—more frequently if you’re swimming or sweating.

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.

Who doesn’t like a good deal? The popularity of Groupon, the online deal-of-the-hour/day/week service has spawned a whole family of mimics. Unfortunately, suggests Gary Schwitzer on Health News Review, it’s a dysfunctional family when it comes to dubious medical treatments.

In the space of mere days, irresistible deals were available for:

• laser toenail fungus treatment;


• MRI for “headache prevention screening”;


• -lipolaser treatments;


• botox;


• B12 injections or allergy test.

Never mind that the evidence for lasers eradicating toenail fungus is sketchy, that the claim that an MRI can prevent headaches is positively ludicrous and the lipolaser might be performed by a guy with less training than your dentist.

But Schwitzer was amused most by an offer from Living Social for Colon Hydrotherapy:

“The foliage may be in bloom outside, but if you’re feeling less than fresh inside, today’s deal could help you stem the problem: Pay $35 and get one colon hydrotherapy session (a $75 value). Colon hydrotherapy is a safe, effective method of cleansing the large intestine using water instead of drugs. The gentle infusion of warm filtered water moves naturally through your large intestine, leaving you feeling cleansed and refreshed. The treatment is safe, quick and pain-free. The certified staff uses an advanced state-of-the-art technology to provide you with natural wellness therapies. Don’t be a shrinking violet — nab today’s deal before it goes to seed.”

Commented one guy on the Health News Review site, “Personally, I await the Groupon lobotomy offer…”

Absent pernicious anemia, almost no one needs injections of B12. And no one’s colon is crying out for cleansing. But … got a coupon for hype eradication? We’re in!

Using what some observers might describe as systemic loopholes, Abbott Laboratories used lawsuits and minor reformulations of TriCor to hold off generic competition to its cholesterol- and triglyceride-lowering drug. We recently wrote about Eisai and Pfizer pulling the same stunt with its Alzheimer’s drug, Aricept.

The study, published in the Archives of Internal Medicine, estimated that the prolonged exclusivity of brand-name formulations of fenofibrate cost the U.S. health-care system approximately $700 million per year.

Sometimes, drug companies pay off potential competitors to buy extra time for their brands. That cost to consumers also is considerable.

As reported on MedPage Today, generic versions of fenofibrate have been available for more than a decade. When the generic product was developed, Abbott sued, alleging patent infringement. Such lawsuits, per FDA rules, require a 30-month delay in approval of the generic.

The interlude enabled Abbott to reformulate TriCor by slightly revising its dose and presenting the re-branded “Trilipix” (fenofibric acid) to the FDA as bio-equivalent to the original version. By the time Abbott had Trilipix on the market, pharmacists, by law, were unable to substitute a generic because of the dosing difference. Brand-name sales tripled from 2002 to 2009.

The researchers said that Abbott had used the delay tactics twice to protect TriCor from generic competition, and that the company had presented clinical trial results indicating that the reformulations were not more effective or safer. So in addition to higher expense, patients get the short end of this corporate-shenanigans stick for its diminished therapeutic value.

Last year, the FDA required Abbott to relabel Trilipix to reflect the trial results. The agency also ordered that a new clinical trial be conducted.

An editorial accompanying the research study acknowledged that Abbott’s gaming of the system was “perfectly legal,” but that the real news is that the company’s methods “"exposed many patients to a drug with high costs, known risks and little or no clinical benefit."

In addition to the always-possible allergic reaction, TriCor’s risks include rare but severe muscle or joint pain, headache, nausea, chest and stomach pain, confusion, irregular heartbeat, persistent sore throat, coughing up blood, skin problems, dizziness or lightheadedness, shortness of breath and unusual bruising or bleeding.

As readers of this blog know, Abbott is hardly alone in putting its financial interests ahead of medical need. To remedy the situation of Big Pharma fending off competition at significant cost to patients, the researchers suggest:

• allowing pharmacists to substitute bio-equivalent generic drugs, even if the dosing is different;


• requiring companies to seek approval for a dosing change to settle any patent infringement suits before approval, which would allow the generic and the new brand-name version to compete immediately;


• requiring companies to market such reformulations under different brand names.

If your doctor prescribes a brand-name drug, ask if there’s a generic equivalent. If there is, ask why he or she believes the brand name version to be superior. If you’re not satisfied with the answers, request the generic.

Find out more about prescription drug reports from the FDA, and more basic information from Drugs.com.

In some ways, Alzheimer’s is like arthritis. Its symptoms can wax and wane, making it difficult to determine if a particular treatment is successful. Who’s to say if a symptom subsided because a drug worked or because it was going to diminish anyway?

And, like arthritis, Alzheimer’s cannot be cured, only moderated. That can lead sufferers and the people who care for them to become desperate for any new treatment—what have they got to lose?

So dementia leaves its victims particularly vulnerable to new, if not improved, ways to treat it, and one such recent attempt raised the ire of two professors at Dartmouth’s Institute for Health Policy and Clinical Practice. As reported by Merrill Goozner, Drs. Lisa Schwartz and Steven Woloshin claim that the FDA has “breached [its] own regulatory standard” in approving a new dosage of a best-selling Alzheimer’s drug.

Aricept, whose generic name is donepezil, is earning its manufacturers $2 billion a year for improving memory lapses in the short term. With its patent about to expire (Aricept was introduced in 1996), and generic manufactures poised to compete with their own versions, manufacturers Eisai and Pfizer were motivated to keep the cash flowing. They appealed to the FDA to approve a higher dosage, claiming that a trial of 1,400 patients demonstrated improvements in the ability to think. The feds gave the drug makers three more years to market the stronger drug exclusively.

But as Schwartz and Woloshin wrote in the British Medical Journal (BMJ), patients had only slightly better cognition on the higher dose, and it had absolutely no effect on day-to-day functioning, the measure by which caregivers determine disease status. Unfortunately, the stronger Aricept conferred significantly negative side effects, including nausea and vomiting. For patients with dementia, that can lead to pneumonia. The FDA had told the trial sponsors that the drug wouldn’t be approved unless it had a positive impact that patient caregivers could notice.

So at best, the contrary approval makes the FDA look dysfunctional; at worst, it looks incompetent and corrupt.

Aricept’s manufacturers went merrily along their marketing way, their advertisements implying to consumers that the drug helped the Alzheimer brain function better, but not mentioning the severity of side effects. And the ads aimed at doctors, Schwartz and Woloshin charged, were worse: “[They contain] a stunningly erroneous statement in a large bold font: ‘Patients on Aricept 23 mg/day experienced important clinical benefit on both measures [cognition and overall functioning],’ which is simply not true. In fact, this statement is directly contradicted by a statement in a smaller plain font that says that the results for global function ‘did not show statistical significance.’”

That doctors are considered easy marks for Big Pharma is depressingly old news.

Unless drug company labels make inaccurate claims, the FDA does not intervene, even if a drug's risks, benefits and uncertainties aren't communicated.

As explained in the Los Angeles Times, drug companies commonly respond to an expiring patent with a practice called "evergreening." To prolong the profitability of successful drugs, they make a slight change to a drug's formula or dosage, or combine it with another drug. These are legal measures that require FDA approval.

Aricept’s new 23-milligram tablet, The Times story explained, “created a dose that couldn't be reproduced by any combination of Aricept's existing 5- and 10-milligram pills, making the product new enough to win a three-year reprieve from low-cost competitors.”

Dr. Howard Brody, a medical ethicist at the University of Texas Medical Branch in Galveston, told The Times that the Aricept 23 case is “a perfect storm” of commercial marketing and regulatory failure whose victims are patients who are desperate, discouraged and vulnerable.

As Dr. Marcia Angell, former editor of the New England Journal of Medicine, told the newspaper, Big Pharma’s manipulative ads illustrate “very well how drug companies exaggerate the benefits of their drugs, minimize the side effects and through misleading marketing to both doctors and the public convince them that a new version of a drug, with a new patent, is better than the old one, whose patent has expired."

If your loved one is prescribed Aricept for his or her Alzheimer’s disease, ask the doctor what is the dose. If it’s 23 milligrams, ask for a lower dosage. It’s just that simple.

First published on Technorati.

A rare verdict for punitive damages and fraud against a Florida hospital opens a window on the big business aspects of weight loss surgery, which can be unsafe for patients especially when the surgeon lacks experience. The verdict also has lessons for how patients can protect themselves.

A jury in Jacksonville ordered Memorial Hospital to pay $10 million in punitive damages for what amounted to false advertising about its weight loss surgery "Center of Excellence" designation. The same jury said that Clay Chandler, a county deputy sheriff, should be paid $168 million in compensatory damages for brain damage that happened to him as a result of uncorrected leakage in his abdomen after a weight loss procedure in 2007 with surgeon John DePeri, MD.

DePeri, testimony revealed, had performed at most 21 bariatric surgeries before he operated on deputy Chandler. To meet the standards of the American Society Bariatric Surgery’s Center of Excellence seal, he was required to have performed 50 and to have completed at least 20 hours of bariatric education courses. He had taken one.

Memorial Hospital used that accreditation seal in pamphlets given to potential surgery patients of its Bariatric Surgery Center. The seal also was featured on documents DePeri used when speaking at informational forums at the hospital.

The jury found that use to be fraud. It said that the hospital knowingly allowed DePeri to perform paid surgeries for which he was not accredited.

The malpractice verdict was reported by the Florida Times Union.

Chandler is now brain damaged and confined to a wheelchair. The day after his surgery in 2007, Chandler was placed into critical care with respiratory failure and signs of fluid leakage into his abdomen. Eight days later DePeri operated to repair the leak. Even the hospital’s own expert witness testified that most doctors would have addressed the complication much earlier.

It was too late for Chandler, who suffered a stroke and was comatose for more than two weeks. He also suffered a permanent loss of eyesight from a burned retina because he was not given the basic care of lubricating eye drops while he was on the respirator.

The damage to Chandler, said his attorney, Tom Edwards, “occurred because you had a relatively inexperienced doctor doing this surgery and managing the patient.”

DePeri has since been accredited by the bariatric surgeons' program. But it's too late for patient Chandler.

What are the lessons for other patients who want to prevent this from happening to them?

In this case, deputy Chandler would have had to do a fair amount of research to find the 50-case minimum standard of the bariatric surgeons. If he did, of course, he could have asked Dr. DePeri up front how many he had done, and DePeri presumably would have told the truth.

But even without that level of research, here are the kinds of questions any patient can --and should-- ask any surgeon, as I explained in a recent issue of my firm's Better Health Care newsletter, on the topic: Talking to Your Surgeon: What You Need to Ask.

"Is there anyone at your institution (in your partnership, in my town, etc.) who does these procedures more than you do? If so, would you mind if I speak to him or her?" (A defensive response to this question is a red flag.)

Another question that gets at the experience issue:

"Who would you ask to do the operation on a close family member of yours if you couldn't?"

Surgical volume is important to hone a doctor's skills in the operating room. It's the old idea that practice makes perfect. But with bariatric surgery in particular, one of the key issues is being able to quickly recognize and correct surgical complications afterwards. That is where Dr. DePeri fell down, with the long delay in returning his patient to the OR. Leaks themselves happen sometimes with this surgery, even in the best of hands; it's the response that is key to a good outcome for the patient.

Surgical volume is also important for the hospital, because the more nurses and other caregivers have seen patients just like you, the more equipped they are to make sure the post-op recovery period goes smoothly.

See our newsletter for more important questions up front for your surgeon. I called this issue of the Patrick Malone patient newsletter: "When a Conversation Can Save a Life." The Florida story shows how true that is.

For a couple of years now, Southern California drivers have become used to seeing
billboards for a medical procedure that promises to turn overweight people into the thin creatures they want to be. By calling 1-800-GET-THIN, you could sign up for a gastric Lap-Band surgery at an outpatient facility and change your life. So they claimed.

Several people who took up the offer did change their life—they died.

Last week the FDA finally noticed. The agency issued a warning letter to eight of the surgical centers promoted on the oversized advertisements. The feds told GET-THIN to stop posting misleading advertisements. It’s a violation of federal law for advertising to minimize significant risks and complications of a procedure. It’s also illegal to fail to make clear that for Lap-Band to be truly effective, it must be accompanied by a significant change in the patient's eating habits and lifestyle.

Los Angeles Times columnist Michael Hiltzik said it was about time. “For nearly two years, my colleagues and I have been reporting on the 1-800-GET-THIN ad campaign,” he wrote. “In my very first column on the topic, in February 2010, I identified the people behind it as brothers Julian and Michael Omidi, and reported that Julian's medical license had been revoked by the Medical Board of California and Michael's medical license had been placed on probation. (Michael's probation has since expired.)”

The L.A. Times has reported the deaths of local patients after their surgeries were performed at advertised clinics, and on the lawsuits and coroners' reports that detailed them. “So far," Hiltzik wrote, “the known toll is four, with a coroner's ruling still pending on the death of a fifth patient, who expired after being rushed to a hospital in September from the surgery center where she had just undergone the procedure.

"We've reported on the shocking sanitary and safety conditions at one of the surgery centers affiliated with the ad campaign, and noted questions about whether the surgery centers' insurance billing has been proper.

"And we've reported that effective oversight of a potentially life-threatening procedure has been hampered by California's patchwork system of medical regulation, in which the medical board and the state Department of Public Health essentially pass the buck to each other over who should keep an eye on non-hospital surgery clinics like these.”

The Lap-Band is a cinch placed around the upper part of the stomach creating a smaller organ that minimizes the amount of food you can ingest. Although the procedure is approved by the FDA, and often is preferable to the more invasive and complicated weight-loss surgery that diverts food from being absorbed in the small intestines, it is not without risks that can be exacerbated if it’s performed in facilities whose personnel are less than vigilant or qualified.

Complications include the band moving out of position and eroding through the stomach wall. Nausea, vomiting, difficulty swallowing, gastroesophageal reflux disease (GERD) and pain can result. One study said as many as 1 in 3 10 Lap-Band patients experience band erosion and almost half will have the band removed.

Still, in some circumstances and for some people, it’s a suitable treatment for obesity.

But not the way GET-THIN promotes it. The billboards have included disclaimers that Lap-Band surgery has certain "risks, side effects, and contraindications," and that you should check with your own doctor before undergoing the procedure. That caution was too feeble for the FDA, especially because the disclaimers appear in such tiny type that they're "illegible."

The California insurance commissioner is investigating the Lap-Band industry for alleged fraudulent billings and misrepresented charges. Patient deaths and injuries have prompted a series of wrongful-death and personal injury lawsuits against GET-THIN, its affiliated surgery centers and doctors who performed the procedures. And a class-action lawsuit accuses GET-THIN of false advertising for failing to adequately disclose risks of the surgery and disciplinary problems of some of its doctors.

Hiltzik reported that the director of the L. A. County Department of Public Health complained about GET-THIN to the FDA, and the Omidis filed an administrative complaint against him, asserting that he was biased against them because he was a shareholder in Johnson & Johnson, which markets a competing weight-loss device they don't use. The director recused himself from matters involving weight-loss devices.

When the county coroner blamed the death of a Lap-Band patient at least partially on the "suboptimal" care she had received at a clinic affiliated with GET-THIN, the clinic accused the coroner's expert of a conflict of interest because she had once worked at UCLA, which they claimed was Lap-Band competitor.

As Hiltzik notes, the Omidis are less concerned about quality of care than they are in suing anybody who challenges their shaky performance. “[T] hey've sued me and my colleagues at The Times for reporting about them. So far, three of these lawsuits against us have been thrown out of court by state and federal judges. The plaintiffs have appealed the dismissals and filed more suits against us and commenters on our website.

"The public record is brimming with material — including complaints of wrongful death, negligence and irregularities in billing practices — that could fall well within the jurisdiction of several state regulatory agencies. It may be that the FDA has fired the first shot in what could be a barrage.”

Although this is a local issue, the fact that the Feds have finally taken notice is a cautionary lesson for anyone in search of an invasive weight-loss treatment. Often, these patients are desperate, depressed and vulnerable to claims that aren’t true, or only under certain conditions.

Always research the procedure to be informed about whom it suits, and what are the risks. Always investigate the background of the surgeon with your state medical board. Always investigate the facility at which it is to be performed with your state health department and insurance provider.

Another chapter in the book of “Big Pharma Behaving Badly” is being written, courtesy of a story by Bloomberg News. The news service obtained Bayer company emails reportedly showing executives discussing ways to illegally promote a long-controversial drug.

The suspect drug, Yaz, is a member of the family of birth control pills knows as Yasmin, which several studies suggest carry elevated risks for blood clots, and, possibly, pulmonary embolism, deep vein thrombosis and other life-threatening injuries. As noted on AboutLawsuits.com, an FDA advisory committee is supposed to review the data about the risks of Yaz and Yasmin next month.

The Bloomberg report charges that Bayer may have sought to market the birth-control pills for unapproved—or “off-label”—uses, misleading women about the health risks the drug posed. Specifically, Bayer is alleged to have discussed promoting the contraceptive Yaz to treat several types of premenstrual syndrome (PMS). The FDA has approved Yaz only for the most severe form of PMS.

Doctors are not prohibited from prescribing drugs for off-label uses, but manufacturers are not allowed to promote their drugs for any use other than what the FDA has approved. Earlier this month, we wrote about a large legal settlement paid by GlaxoSmithKline over its off-label marketing of a diabetes drug.

In the Bayer emails, a consultant allegedly suggested how the company’s sales representatives could converse with doctors in a way that invites them to conclude that Yaz is suitable for off-label use: asking doctors, for example, what percentage of their patients had common PMS symptoms, then asking what effect they thought Yaz might have on those situations.

An even bolder, in-your-face repudiation of federal law reflected in another email supposedly came from an executive promising that a doctor under contract to a Bayer unit would promote off-label use of Yasmin on the “Today” show.

According to AboutLawsuits.com, the FDA has warned Bayer at least three times in recent years about problems with Yasmin or Yaz advertisements. Bayer has been busted for its misleading ads overstating the efficacy and benefits, and minimizing the risks of Yaz and Yasmin.

“In 2009, Bayer was forced to run a $20 million corrective advertising campaign to address problems with Yaz advertisements that stressed the potential benefits in treating acne and symptoms of PMS, while minimizing the potential risk of blood clots and other side effects of Yaz,” the website reports.

As additional punishment for its loathsome marketing behavior, Bayer must get any U.S. advertisements for Yaz approved in advance by the FDA.

The legal process of suing someone or some organization involves “discovery,” in which both sides look for evidence from each other supporting their arguments. The Bayer emails were unearthed during the discovery process in numerous lawsuits involving Yaz and Yasmin filed against Bayer by women who took the medicine and suffered blood clots, strokes and gallbladder problems.

If a product is so great, why does its manufacturer have to bypass law and common decency to spread the word?

There’s ignorance, and then there’s dangerous, irresponsible, willful ignorance.

In a series of posts, the website HealthNewsReview exposed the bone-headed actions of Delta Airlines in showing an onboard video sponsored by an anti-science organization minimizing the importance of flu shots. The video “urges viewers to become informed about influenza and how to stay well during the flu season without resorting to the influenza vaccine.”

As you might imagine, the response has been vigorous, including an online petition to “tell Delta Airlines to stop putting their passengers’ health at risk.” The medical establishment weighed in formally in a letter to Delta CEO Richard Anderson from Dr. Robert W. Block, president of the American Academy of Pediatrics (AAP). He wrote:

“The American Academy of Pediatrics (AAP) objects to the paid advertisement/public service message from the National Vaccine Information Center (NVIC) being shown throughout the month of November on Delta’s in-flight programming….
While hand washing and covering sneezes are parts of a larger strategy to prevent the spread of influenza, influenza vaccine continues to be the best way to protect against the disease. It is especially important in enclosed settings where disease droplets can easily spread to passengers sitting in close quarters, especially infants and children and those with special health care needs.

The AAP and many other child health organizations have worked hard to protect children and their families from unfounded and unscientific misinformation regarding vaccine safety. The influenza vaccine is safe and effective.

By providing advertising space to an organization like the NVIC, which opposes the nation’s recommended childhood immunization schedule and promotes the unscientific practice of delaying or skipping vaccines altogether, you are putting the lives of children at risk, leaving them unprotected from vaccine-preventable diseases. Diseases like influenza can have serious consequences. From September 2010 to August 2011, 115 children died from influenza disease, most of whom were unvaccinated.”

Another physician, Val Jones, blogged about this dereliction of corporate responsibility as well, noting that the airline had ignored the righteous outcry and committed to running the video ads through November.

“Every year the influenza virus kills as many as 49,000 Americans and 500,000 individuals world-wide,” she writes. "… I don't understand why Delta, having been duly informed of their mistake, would continue to run ads from a group that misinforms Americans about vaccine-preventable illness. I wanted to believe that they would do the right thing….”

“Which means that I will NOT be flying Delta in the foreseeable future and I hope you won't either. When US physician organizations are flat out ignored by corporate executives, it leaves us with only one choice—to speak with our feet. Sadly, the bottom line may matter more to them than the health and safety of their passengers.”

If you wish to sign the online petition, link here. You may also Tweet your feelings to #DontFlyDelta hashtag.

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."

Which brings us to the topic of when a cause becomes a joke. Has the breast cancer lobby undermined its honor by pinkifying the world so much that people stop paying attention?

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.

Here’s another chapter in our ongoing (never-ending?) story of media complicity in spreading fake health “news.”

As noted on HealthNewsReview, a website that examines, exposes and debunks junk health news, last month MSNBC.com committed an act of disease-mongering in a story headlined “Plastic surgeon wants to fix your ‘runner’s face.'"

Like every human we've met, runners have faces, but there’s no such thing as a disorder whose symptoms are purely aesthetic and ascribed solely to people who run. Tellingly, the term was coined by … a cosmetic surgeon who is marketing a “treatment” for what isn’t a medical problem.

But when you’re selling something, especially something you made up, you have to use florid language that draws attention and stimulates response. But do the news media have to spread the colorful message in mindless repetition completely devoid of critical thinking?

Instead of calling out “runner’s face” for the bogus condition it is, MSNBC promoted the cosmetic surgeon’s treatment for the condition he invented. As HealthNewsReview commented, “This is what is called ‘advertising’ – not ‘journalism.’”

The story offered no information on the potential harm of the surgeon’s treatment, nor any sense of what it costs. The story offered no scientific data to underpin the story because there isn’t any. But it did pretend to be authoritative:

“Runner's face generally occurs in both men and women ages 40+ who exercise to improve their body, and in doing so end up with a skeletal and bony face,” pronounced MSNBC.com. “When exercising, an athlete burns off fat beneath the layers of his/her skin. The marked loss of fatty tissue results in a loss of volume which leads to a prominent appearance of the bones, accelerated development of skin laxity and deepening of wrinkles. Though you may look like a 20-year-old from the neck down--your face will easily give away your age.”

The “treatment” for the non-disorder effects a purely cosmetic result -- inject a combination of Botox-Restylane to smooth wrinkles and plump up the face.

If this is a health-care intervention, if this is a news story, then Kim Kardashian is a marriage counselor. With an advanced degree.

Article first published as The New "Disease" of Runner's Face on Technorati.

Perhaps you’ve heard the buzz about “bioidentical” hormones; that they’re safer and more effective than FDA-approved hormones.

Uh, no, says Harvard Women’s Health Watch. The buzz is not about health, it’s about hype.

Bioidentical hormones generally are described as compounds with the same chemical and molecular structure as those produced by the body. And, generally, they’re available by prescription: Estrace, Vivelle and Estring, for example, are drugs often prescribed as female hormone replacement therapy.

The “bioidentical” claims Harvard calls into question include:

• As replacement therapy, they’re not drugs but molecular copies of natural hormones. As the Harvard report says, “This is not true. Drugs are substances (other than food) that are intended to affect the structure or any function of the body. If custom-compounded hormones have effects in the body, they’re drugs.”


• Bioidenticals are safer than synthetic hormones. Harvard says, “Unknown. [They] haven’t been tested in large, long-term trials.”


• Estriol (a weak estrogen used in compounded hormones) offers women protection from breast cancer. Harvard says, “There is no evidence that this is true.”


• Saliva and blood tests are reliable indicators of hormone levels. Harvard says, “ This is not true. Such tests can only tell a women’s hormone level at one moment in time and thus are not useful for setting hormone doses.”



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

Posted In: Advertising , Product Safety

The chemical triclosan has been a popular ingredient in many household cleaning products despite the fact that its supposed antibacterial properties have not been proved. Making a questionable claim is one thing; promoting an ingredient that also might have harmful side effects is quite another.

Triclosan is found in so many products ranging from soap to toothpaste to cutting boards that a survey by the Centers for Disease Control and Prevention found traces of the chemical in the urine of 3 in 4 people older than five.

That’s a pretty heavy concentration for a chemical that might pose hormonal problems, make bacteria more resistant to antibiotics and pose an environmental hazard. That’s why both the FDA and the Environmental Protection Agency are studying its effects. In April 2010, the FDA announced that “in light of animal studies raising questions about triclosan’s safety, the agency is engaged in an ongoing scientific review to incorporate the most up-to-date data and information into the regulations that govern consumer products containing triclosan. … For some consumer products, there is clear evidence that triclosan provides a benefit. For other consumer products, FDA has not received evidence that the triclosan provides an extra benefit to health. At this time, the agency does not have evidence that triclosan in antibacterial soaps and body washes provides any benefit over washing with regular soap and water.”

Manufacturers, as expected, disagree, and are lobbying hard to protect the $750 million they earn every year in sales of antimicrobial and antibacterial hand soaps. Some consumer groups and congressional representatives want an outright ban of triclosan in antiseptic products such as hand soap.

Recently, the FDA announced it was extending its scrutiny of triclosan. As reported by the New York Times, concern centers around studies showing that triclosan might alter hormone regulation in laboratory animals and/or promote resistance to antibiotics.

You have to wonder why, if soap manufacturers were truly sold on the safety of triclosan, a major player like Colgate-Palmolive would reformulate its Antibacterial Dish Liquid and Softsoap products, claiming that “changing consumer preferences” were responsible.

Dr. Douglas Throckmorton, the FDA’s deputy director for regulatory programs who was interviewed by The Times, said the ongoing review focused on hand soaps but could extend to other consumer products if the agency determined that triclosan raised health concerns. That apparently does not include Colgate Total, a toothpaste whose triclosan content helps fight gingivitis.

But soap? Because the FDA believes that traditional soap is just as effective as an antimicrobial variety, and because the possibility of hormonal disruption and the fostering of antibiotic-resistant bacteria are of much greater concern than whether your cleansing agent is trendy, you might think twice before washing up with triclosan.

Anyone who watches TV has been bewildered/amused/confused/annoyed by pharmaceutical ads that begin by explaining how your life can be perfect if you take this drug, and end with a rushed recitation of all the things that can go wrong if in fact you do take the drug.

Drug companies, of course, are obliged by the FDA to include potential side effects when they’re trying to sell you their products. But as proved by a recent study in PLoS ONE (a journal for peer-reviewed scientific and medical research), Big Pharma pretty much thumbs its nose at the FDA when it advertises in medical journals, where it's trying to sell its wares to doctors.

Among the nine publications reviewed by researchers were such mainstream journals as Annals of Internal Medicine, New England Journal of Medicine and Journal of the American Medical Association. About half of the ads reviewed violated at least one FDA rule, and about one-third were “possibly” out of compliance because of missing information. More than half of the drug ads failed to quantify serious risks. Fewer than 1 in 5 adhered to all FDA guidelines.

As explained by MedPage Today, the pharmaceutical industry spends $58 billion on marketing; the FDA’s division of marketing and advertising has $9 million. So what are the chances a miscreant marketer will get caught?

To help bridge the budget gap, the FDA recently implemented the “Bad Ad” program, asking physicians to report nonadherent or misleading ads. But that’s like asking the playground monitor to report bad behavior – what’s bad to one monitor is just kids being kids to another. As the researchers noted, the guidelines are difficult to enforce, don't emphasize transparency and ignore basic information relevant to prescribing.

The most common breaches or possible breaches of rules were:

• misused references to the scientific literature;


• misleading use of graphics;


• failure to cite references;


• overrepresentation of the experience with the drug.

By medical specialty, at least one FDA rule was broken by ads for:

• 6 in 10 hematology/oncology products;


• 5 in 10 cardiovascular and diabetes products;


• more than 4 in 10 psychiatric products.

As the researchers wrote, “Advertisements do a poor job of conveying basic information necessary for safe prescribing, with the majority failing to quantify serious risks.”

Despite their concerns, they said that “most advertisements we reviewed satisfied the majority of FDA guidelines.” It makes you wonder, though, about the squishy nature of the guidelines – the researchers also noted that an ad that makes no specific claim about efficacy and does not quantify drug safety is still in compliance.

The study recommends that the FDA update and simplify ad regulations, and require ads to explain risks clearly, offer information on absolute benefits and verifiable references and identify the appropriate population for the drug’s use.

All of that seems like a no-brainer. And another reason why, when your doctor prescribes a drug, you should ask what are the potential side effects and risks, and why he or she has chosen it over others. Read the patient information that’s included in the drug packaging.

Last November, the FDA ruled that tobacco manufacturers must include on their packaging graphic depictions of the horrors smoking can wreak. The new packaging was to take effect in autumn 2012.

Five tobacco companies now have taken the FDA to federal court, challenging the regulations. Among other things, they claim that the depictions:

• would unfairly dissuade adults from using a legal product;


• would cost millions;


• violate the First Amendment;


• “do not further any compelling governmental purpose”; and


• “would have few if any benefits.”

In case you're feeling the slightest twinge of sympathy for the tobacco makers, here's what Dr. Howard K. Koh, writing in the New England Journal of Medicine, says.

“A decade of experience in more than 30 other countries has demonstrated that such graphic warnings lead to an array of public health benefits. The warnings are more likely to be noticed than text-only labels, are viewed as more effective in communicating health risks to smokers and are associated with increased motivation on the part of smokers to quit smoking.”

Dr. Koh is assistant secretary for health in the U.S. Department of Health and Human Services. So he's defending his own decision. But knowing what we know about how tobacco poisons work throughout the human body, is this even a close question?

To see a slide show of the text and images for the new packaging, click here.

And if you want to harken back to the olden days before we had any warnings on cigarette packs, and when the manufacturers liked to use doctors to promote their smoky poisons, check out this tour through nostalgia.

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.

Several Supreme Court justices strongly suggested recently during oral arguments that Vermont’s attempt to restrict the use of drug prescription records for marketing purposes violates corporate free-speech rights. Vermont’s law is aimed at so-called data miners, companies that buy prescription records from pharmacies — minus patient identifying information — and sell them to drug makers.

The drug companies use the information to target doctors to try to persuade them to order the companies' products. Vermont Assistant Attorney General Bridget C. Asay told the court that the state’s interest is to “allow doctors to decide whether this information that they’re compelled to provide to pharmacies may be used in marketing that is directed at them.”

But skeptical justices hurled a barrage of questions in return, asking whether the state’s goal was simply to make it harder for drug manufacturers to convince doctors that their drugs should be prescribed instead of cheaper generic drugs.

“The state is interested in promoting the sale of generic drugs and correspondingly to reduce the sale of brand-name drugs,” Justice Ruth Bader Ginsburg said. “And if that’s the purpose, why doesn’t that run up against what this court has said — that you can’t lower the decibel level of one speaker so that another speaker, in this case the generics, can be heard better?”

Asay insisted that drug manufacturers are still free to pitch any message they want, but that doctors don’t want their histories of prescriptions to be used to target them. The Vermont law lets individual doctors "opt out" of having their prescription histories sent to the drug manufacturers.

There’s no doubt that pharmaceutical companies have an easier time if they have such information, she said, but “they have no First Amendment right to demand it, just as they have no right to demand access to the doctor’s tax returns, his patient files, or to their competitors’ business records.”

The federal government and 35 states are siding with Vermont in the fight, which has split lower federal courts.

The case is Sorrell v. IMS.

Source: The New York Times

A subway station might seem an unusual place to try to educate the public about protecting the rights of injured patients -- but maybe not so much when that station is the nearest to the Capitol building in Washington, D.C., and is traveled by thousands of staffers who work on Capitol Hill.

"Tell Congress to put patients first," the ads say. "There are 98,000 reasons why you should. 98000reasons.org."

The number refers to an oft-quoted report from the National Academies issued ten years ago that estimated that 98,000 patients died unnecessarily each year from medical errors.

Since then, as this blog has reported, the estimates of preventable deaths have climbed, despite a spate of efforts to make medical care safer.

The new ads are sponsored by the American Association for Justice, the lawyers' group that includes attorneys like me who represent patients in malpractice lawsuits. The ads are discussed in an article by Elizabeth Olson in the New York Times.

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.