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Posted by medconsumers on September 1, 2003

Conference Addresses Corporate Influences on Medical Research

By Maryann Napoli
(September 2003)

The American public is concerned about the fact that many physicians and scientists have financial ties to the drug and device industries, and most people want the news media to do a better job disclosing these ties whenever experts are quoted. These results, from a survey conducted by the Center for Science in the Public Interest (CSPI), led this advocacy group to convene a recent conference in Washington, DC, entitled, “Conflicted Science: Corporate Influence on Scientific Research and Science-Based Policy.” The speakers were primarily researchers and investigative journalists who have written articles about this topic, which has become the focus of mounting concern for editors of medical journals.

Michael Jacobson, CSPI’s executive director, set the tone for the conference: “The corporate world seeks to influence science and science policy at many different levels, from the sponsorship and design of university research to the creation of scientific journals; from placing sympathetic scientists on federal and international advisory committees to generating publicity in the mass media; from influencing major health charities to creating their own friendly nonprofit organizations.” As he turned the program over to the speakers, Jacobson said that he had asked them not only to express their concerns, but also to suggest remedies.

Passive smoking is one major area followed by Lisa A. Bero, PhD, Center for Tobacco Control Research and Education, University of California, San Francisco. “Researchers funded by the tobacco industry were nine times more likely to find no relationship between ill health and passive smoking,” she found. When a 1981 study showed a link between lung disease and non-smoking women living with smokers, Dr. Bero said that the tobacco industry created its own study to refute it. For example, the industry funded studies found ill effects of other sources of indoor air pollution to distract from the importance of secondhand smoke, reported Dr. Bero. Another common tactic was to create doubt in the media about the studies that showed adverse health effects associated with smoking and to characterize such findings as “controversial.”

Drummond Rennie, MD, deputy editor of the Journal of the American Medical Association, pointed out that drug companies often set up comparison trials designed in such a way that their products are bound to come out on top. He gave as example the clinical trial Pfizer designed for its oral drug fluconazole (Diflucan), which treats yeast infections and toenail fungus. To prove that fluconazole is best at treating the potentially fatal funguses that afflict people with AIDS, Pfizer tested its drug against oral versions of competitors’ antifungal drugs-one of which should have been given only intravenously and the other already known to be ineffective in people with AIDS.

Secretiveness is also a major problem. To the drug industry, “everything is a trade secret, even the very existence of a clinical trial,” Dr. Rennie said, referring to the fact that industry-sponsored trials that produce negative results often go unpublished. The remedy for this problem, he said, would be the required registration of all trials at inception. That way a drug company cannot hide the number of trials that come up with results unfavorable to their products. As for the common problem of university researchers with financial ties to industry, Dr. Rennie noted, wryly, “What is called conflict of interest is called synergy by Wall Street.”

Dr. Rennie alluded to two high-profile cases in which researchers found that the cheaper, older drug was not only more effective, but also safer than newer products. In both cases, the drug companies whose products were in danger of losing market share attacked the researchers’ credibility and initiated lawsuits to stop them from going public with the results.

Two weight loss drugs sold in the combination called “fen-phen” made news in the 1990s because they caused heart valve damage. Investigative reporter Alicia Mundy, who wrote a book on the topic, told the conference how much she learned about the use of medical studies as public relation tools while searching the files of Wyeth-Ayerst Laboratories. Her book Dispensing With the Truth “documents how this drug company and its partners knew about the diet drugs’ links to an increasing number of deaths from a lung disease and to major heart valve damage, and did not reveal this to doctors, to the press, or to the FDA.” About 7 million people took the drugs from 1994 to 1997.

After the diet drugs Redux and Pondimin (the “fen” of the “fen-phen” combination) were withdrawn in 1997 at the urging of the FDA, the manufacturers put their considerable resources toward damage control. A 1998 front-page story in USA Today proclaimed, “Study: No heart damage from diet drug.” The source of the headline was a study presented by Dr. Neil Weissman at an American College of Cardiology conference, and the upbeat news was also reported in The New York Times. Mundy said that her investigative work led her to this scoop: After the conference, Dr. Weissman sent his study to The New England Journal of Medicine, which provisionally rejected it. Mundy found that the Journal editor had sent a letter to Dr. Weissman, telling him to recalculate his results using a methodology suggested by the Journal’s reviewers.

Once Dr. Weissman complied, Mundy said, his results were quite different. A significant link was shown between heart-valve damage and the drug Redux. Two other studies eventually found the same link, but when the recalculated study was eventually published by The New England Journal, the revised findings never got the same media attention. “No one noticed,” observed Mundy, that the lead researcher was the same Weissman who, only six months earlier, had dismissed the heart-valve problems.

“We don’t hear much about the fen-phen story anymore,” noted Mundy, explaining the reason. The people who brought lawsuits against Wyeth-Ayerst because they had been harmed by these diet drugs had to sign confidentiality agreements that prevent them from warning others.

One common way drug companies can easily get free air time for their sales pitches is the video news release (VNR), which is an ad disguised as objective reporting. TV stations love these VNRs because they save them money and feed the desire for news with a positive spin, according to Trudy Lieberman, a journalist and director of the Center for Consumer Health Choices at Consumers Union. She tracked the Cytyc Corporation’s VNRs for its new Pap test technology called ThinPrep. “It followed the standard VNR formula,” explained Lieberman, “It is patient-based, always positive and always provides a take-away message: have this test, buy this product, ask your doctor.”

Lieberman encountered the same “patient” in dozens of stories in print and TV. Her name is Peggy Smith, and she tells women that ThinPrep had saved her life. What harm do these disguised ads cause, asked Lieberman, rhetorically. “There is no evidence that this technology saves lives, though ThinPrep does generate a lot of false-positive results and unnecessary investigations,” she said, “And the people viewing these VNRs probably do not have a clue that they are ads.”

Of the remedies suggested by the speakers, full disclosure was on everyone’s list. One can’t help but notice, however, that the media are currently doing an uneven job in this regard. For example, last November, The New England Journal of Medicine published a major study that found testing people for C-reactive protein might be more useful in determining heart disease risk than cholesterol screening. The media were filled with upbeat quotes about the importance of C-reactive protein testing from the lead author, Paul M. Ridker, MD. However, virtually all the news stories left out the information that Dr. Ridker holds a patent on the new test, a fact disclosed in small print at the end of his study in The New England Journal of Medicine.

On the other hand, some journalists are doing their jobs. When the National Cholesterol Education Program revised their guidelines in 2001 by lowering the level at which people were considered to have dangerously high cholesterol, Thomas Burton and Chris Adams of The Wall Street Journal noted that 36 million people now had high cholesterol which automatically triples the number of Americans who are candidates for cholesterol-lowering drugs. Burton and Adams also noted that five of the 14 members of the committee that made this decision were either consultants to, or had received honorariums from, companies that made cholesterol-lowering drugs.

Though people often view non-profit health organizations as objective, many take industry funding that could compromise their advice to the public. To let consumers and journalists know who takes money from whom, the conference sponsor, Center for Science in the Public Interest, or CSPI, has compiled a long list of non-profit professional organizations and charities with ties to industry. For example, the American Heart Association accepted $400,000 from Merck, makers of a top-selling cholesterol-lowering drug, to teach 40,000 doctors to treat cholesterol according to guidelines.

For a copy of “Lifting the Veil of Secrecy: Corporate Support for Health and Environmental Professional Associations, Charities, and Industry Front Groups,” send a $15 check to CSPI, 1875 Connecticut Ave., Ste 300, Washington, DC 20009-5728. Attn: Adam Pearson.

For a copy of “Lifting the Veil of Secrecy: Corporate Support for Health and Environmental Professional Associations, Charities, and Industry Front Groups,” send a $15 check to CSPI, 1875 Connecticut Ave., Ste 300, Washington, DC 20009-5728. Attn: Adam Pearson.

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