Medical Ethics - Advertising
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Medical Ethics and Advertising
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25 Shocking Facts About the Pharmaceutical Industry
Antidepressant Trial Results Exaggerated “A new study shows a problem with past reporting of antidepressant research. The analysis finds selective publication in reporting exaggerates the effectiveness of antidepressants.”
Dannon Sued Over "Probiotic" Bacteria Claims “A proposed class action filed on Wednesday in California accuses The Dannon Co Inc of mounting a massive false advertising campaign to convince consumers to pay more for yogurt containing "probiotic" bacteria because of the products' health benefits. The lawsuit, filed in a Los Angeles federal court, said Dannon's own studies failed to support its advertised claims that its Activia, Activia Lite and DanActive were "clinically" and "scientifically" "proven" to have health benefits that other yogurts did not.“
Doctors Say ‘I’m Sorry’ Before ‘See You in Court’
Don't become a victim of medical marketing
Drug Makers Make Name Games Big Business
Drug Makers’ Push Leads to Cancer Vaccines’ Fast Rise “Merck’s vaccine was studied in clinical trials for five years, and Glaxo’s for nearly six and a half, so it is not clear how long the protection will last. Some data from the clinical trials indicate immune molecules may wane after three to five years. If a 12-year-old is vaccinated, will she still be protected in college, when her risk of infection is higher? Or will a booster vaccine be necessary? Some experts are concerned about possible side effects that become apparent only after a vaccine has been more widely tested over longer periods. And why the sudden alarm in developed countries about cervical cancer, some experts ask. A major killer in the developing world, particularly Africa, where the vaccines are too expensive for use, cervical cancer is classified as very rare in the West because it is almost always preventable through regular Pap smears, which detect precancerous cells early enough for effective treatment. Indeed, because the vaccines prevent only 70 percent of cervical cancers, Pap smear screening must continue anyway. “Merck lobbied every opinion leader, women’s group, medical society, politicians, and went directly to the people — it created a sense of panic that says you have to have this vaccine now,” said Dr. Diane Harper, a professor of medicine at Dartmouth Medical School. Dr. Harper was a principal investigator on the clinical trials of both Gardasil and Cervarix, and she spent 2006-7 on sabbatical at the World Health Organization developing plans for cervical cancer vaccine programs around the world. “Because Merck was so aggressive, it went too fast,” Dr. Harper said. “I would have liked to see it go much slower.” “
Experts Conclude Pfizer Manipulated Studies “The drug maker Pfizer earlier this decade manipulated the publication of scientific studies to bolster the use of its epilepsy drug Neurontin for other disorders, while suppressing research that did not support those uses, according to experts who reviewed thousands of company documents for plaintiffs in a lawsuit against the company. Pfizer’s tactics included delaying the publication of studies that had found no evidence the drug worked for some other disorders, “spinning” negative data to place it in a more positive light, and bundling negative findings with positive studies to neutralize the results, according to written reports by the experts, who analyzed the documents at the request of the plaintiffs’ lawyers. One of the experts who reviewed the documents, Dr. Kay Dickersin of the Johns Hopkins Bloomberg School of Public Health, concluded that the Pfizer documents spell out “a publication strategy meant to convince physicians of Neurontin’s effectiveness and misrepresent or suppress negative findings.” “
Ex-drug salesman: We lured docs with gifts: Companies recruit ‘beautiful people’ as reps “We all want to think that our doctors prescribe pain pills for our aching backs because it’s what we need, and not because a charming ex-cheerleader turned drug company sales rep has invited him to a Red Sox [team stats] game. But, according to a former drug salesman, that second scenario may be closer to the truth. “We were the beautiful people,” Shahram Ahari, a former Eli Lilly “drug detailer,” told a group of Boston University medical students last week. … The group contends that aggressive marketing to physicians by pharmaceutical companies creates conflicts of interest in the medical profession and raises questions about the appropriateness of treatment choices. Many blame drug companies’ aggressive marketing efforts for a portion of the rise in health-care costs, because physicians are swayed into prescribing newer, more expensive medicines instead of older, less expensive brands. To push their products, Ahari said, drug companies hire former models, cheerleaders and athletes to promote the new drugs to doctors. His co-workers, he said, “were all beautiful, vivacious and fun,” but none of them had more than a high-school level science education. Still, each day, they’d visit scores of medical offices, armed with gifts for the doctors, their staff and their family members, and samples of the drugs they were pushing. When they weren’t treating the entire office to lunch, or handing out free tickets to sporting events, they’d wine and dine the doctors. Ahari said he was allowed to spend $60,000 a year on meals.“
FDA: 2 Bayer Aspirin Products 'Unlawful' “Bayer is "illegally marketing" and making "misleading" claims about two "misbranded" aspirin products, the FDA warns. The products are Bayer Women's Low Dose Aspirin + Calcium and Bayer Aspirin with Heart Advantage. Both are sold over the counter. According to the FDA: • Bayer Women's combines aspirin with calcium. Its label suggests it will strengthen bones and fight osteoporosis. • Bayer Heart Advantage combines low-dose aspirin with phytosterols. Its label suggests it will lower cholesterol. • Both products' labels suggest they will reduce the risk of heart disease. The FDA says that drugs claiming to "fight" or otherwise treat osteoporosis require official approval. And FDA says the claim to lower cholesterol is a claim to treat or prevent heart disease and high cholesterol levels -- both of which require new drug approval. The FDA also says the drugs are "misbranded because their labeling lacks adequate directions for use by consumers." That's because the FDA believes the safe use of the drugs requires diagnosis and supervision by a health care professional -- something it is "not possible" for the labels of over-the-counter drugs to ensure.”
French consumer report slams branded drug spending “waste”
Group Urges Ban on Medical Giveaways ““Such forms of industry involvement tend to establish reciprocal relationships that can inject bias, distort decision-making and create the perception among colleagues, students, trainees and the public that practitioners are being ‘bought’ or ‘bribed’ by industry,” the report said.”
Huge Medical Bills You Shouldn't Pay “Burdick hired two billing investigators. After demanding an itemized accounting, health care navigators Lin Osborn and Beth Morgan believe Burdick was overcharged by $40,000, for items like six surgical screws - at $1,750 each. They say overbilling is now the norm.”
Merck to pay $58m in settlement over rofecoxib advertising
Merck, Schering-Plough Sued Over Cholesterol Drugs Marketing “The makers of popular cholesterol drugs Vytorin and Zetia are being sued in at least four states over allegations that Merck & Co. and Schering-Plough Corp. misled consumers into thinking the drugs were more effective than generic ones.”
Pfizer hit by whistleblower lawsuit on Lipitor “Polansky claims Pfizer encouraged off-label use of atorvastatin via "unrestricted educational grants" to companies providing continuing medical education (CME) programs. … Polansky's suit claims that educational programs encouraged doctors to prescribe atorvastatin for people at moderate risk of coronary heart disease—an unapproved indication—and that they also included "deliberate misinformation promoting the idea that kidney-disease patients may need to be treated with statins." “
Pfizer to End Lipitor Ads by Jarvik “ … the campaign had come under scrutiny from a Congressional committee that is examining consumer drug advertising and has asked whether the ads misrepresented Dr. Jarvik and his credentials. Although he has a medical degree, Dr. Jarvik is not a cardiologist and is not licensed to practice medicine. One television ad depicted Dr. Jarvik as an accomplished rower gliding across a mountain lake, but the ad used a body double for the doctor, who apparently does not row. … The committee has also contacted at least one former colleague of Dr. Jarvik’s who contended that he was not the actual inventor of the artificial heart, as stated in the ads. In a letter to Pfizer in August 2006, three former colleagues of Dr. Jarvik’s at the University of Utah complained that the ads erroneously identified Dr. Jarvik as “inventor of the artificial heart.” That distinction, they said, should go to Dr. Jarvik’s mentor, Dr. Willem J. Kolff, and his associate, Dr. Tetsuzo Akutsu.”
Should Doctors Be 'Selling' Drugs For The Pharmaceutical Industry? “Pharmaceutical companies regularly sponsor leading specialists with "generous fees to peddle influence" and promote drugs to the profession and the public, writes Moynihan. Drug companies will pay influential doctors up to $400 an hour to act as key opinion leaders, and some doctors earn more than $25,000 a year in advisory fees. Kimberly Elliot, a former award-winning drug company sales representative interviewed by Moynihan, reveals that drug companies desperately need key opinion leaders in order for doctors to believe what they are saying and prescribe their products, because drug representatives are often not believed. Essentially, she says, key opinion leaders are just salespeople. “
Some Medical Education Unknowingly Sponsored By Drug Companies
Tighter drug trial laws promised “It comes after the drugs regulator announced GlaxoSmithKline would not face criminal proceedings over claims it withheld information on Seroxat. But they warned GSK should have been quicker to raise the alarm on the risk of suicidal behaviour associated with the antidepressant in the under-18s. GSK has rejected claims it improperly withheld drug-trial information. … A BBC Panorama investigation last year reported that secret e-mails showed the drug company distorted trial results, covering up a link with suicide in teenagers.”
Top Psychiatrist Didn’t Report Drug Makers’ Pay “One of the nation’s most influential psychiatrists earned more than $2.8 million in consulting arrangements with drug makers from 2000 to 2007, failed to report at least $1.2 million of that income to his university and violated federal research rules, according to documents provided to Congressional investigators.”
Without TV ads, restless legs may take a hike “Restless legs syndrome leapt into public consciousness thanks to a multi-million-dollar advertising campaign by drugmaker GlaxoSmithKline. Now that the FDA has approved generic versions of Requip, attention to the disorder is likely to fade, experts say. … Television ads touting ropinirole hydrochloride, a drug originally used to treat Parkinson’s disease, sent jittery patients to doctors’ offices to demand the brand name medication called Requip. … But the possible change heartens critics who cite restless legs syndrome as a prime example of “disease mongering,” in which promoters such as drug companies deliberately enlarge the market for a product by convincing people that they’re sick and need treatment. … Schwartz and her husband, Dr. Steven Woloshin, also at Dartmouth, say that drug company promotions, combined with uncritical media reporting, have exaggerated the prevalence of restless legs syndrome and led to over-diagnosis and over-treatment with powerful brain-altering drugs. If the generic switch leads to fewer ads, that should decrease patient demand for diagnosis and treatment, leaving only the most serious sufferers to weigh the benefits of the drugs against the risks of potentially severe side effects. … “There’s such a huge placebo effect,” Schwarz said. … At the same time, the side effects of the drugs can be considerable. Patients taking the drugs were about 35 percent more likely to withdraw from trials because of problems than those taking the placebo, the study showed. The biggest problems included debilitating nausea, dizziness and falling asleep during daily activities. Other studies have shown the drugs can cause compulsions such as gambling or sexual promiscuity. … For many patients, however, the medications provide significant relief from a debilitating condition, said Zee. “In my opinion, in general, the benefits outweigh the risks,” she said. “Now, you have to individualize. If they’re so bad with the disease, most of these side effects won’t matter.” “
ARTICLES:
Physicians for Sale: How Medical Professional Organizations Exploit Their Members
Say no to drug ads, doctor warns “Abramson was a family doctor practising in a bedroom community north of Boston when Washington relaxed its advertising rules. He watched his patients turn into supplicants for heavily marketed drugs. "They kept coming in, asking for – and often demanding – expensive drugs they didn't need. I couldn't talk them out of it." He was a medical researcher when Vioxx, a new arthritis drug, was being tested for widespread use. He watched America's leading medical journals publish incomplete and misleading data about its risks. He watched the media spread this information uncritically and the manufacturer launch a massive advertising campaign. "What's printed in these journals is accepted as truth. … The pharmaceutical industry in the U.S. spends $4.8 billion a year on direct-to-consumer advertising. … He cites three principal reasons to avoid the path taken by his country: The first is patient safety. Information disseminated by the drug companies is designed to increase corporate profits, not to give consumers the facts they need to choose the best treatment option. A succession of heavily promoted drugs – painkillers, anti-psychotics, hormone replacement medications – has been pulled off the U.S. market because of inadequate testing or undisclosed risks. The second is cost. Pharmaceutical spending in America has ballooned since Washington opened the floodgates to consumer advertising. It's partly because doctors are prescribing more drugs and partly because patients are insisting on expensive brand-name medications they've seen on TV. The third is the distortion of the doctor-patient relationship. People come into their physician's office with a pre-set idea of the drug they want. They aren't ready to discuss lifestyle changes. They aren't willing to entertain the possibility that they don't need a pill for restless leg syndrome, social anxiety disorder, menopause, baldness or loss of libido. The best hope for his country, Abramson says, lies in better patient education and a new federal agency empowered to certify that drug research is properly conducted before the results are published.”
JOURNAL ARTICLES:
Direct-to-consumer advertising for bleeding disorders: a content analysis and expert evaluation of advertising claims. (J Thromb Haemost. 2008) “Conclusion: As measured by our methods, print DTCA for bleeding disorders may not reach the FDA's standards of truth and fair balance.”
Is Content of Medical Journals Related to Advertisements? Case-control Study. (Croat Med J. 2007) “CONCLUSIONS: The strong relatedness between the content of the articles and advertisements placed in 3 of 7 journals and explicit placement of the advertisements face to face or overleaf the related research articles support the hypothesis that journal content is manipulated to place more emphasis on the advertisements.”
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