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BAD DATA FROM DRUG COMPANIES--Scientific American Article.

 Results of trials for new drugs are flawed because the companies that develop new drugs are permitted to both do the research or fund the trials and own the results of the trials, which they present for approval to the FDA.  The article below is illustrative of a common problem.  Scientific American is a primer per-review journal.  This article about two drugs can be generalized to all drugs.  The Prescription Drug User Fee Act, passed in 1992. The act requires firms to pay the almost $500,000 in to­tal fees for each approved drug.  How objective can the FDAs review be?



Bad Medicine




etting drugs on the market means play­ing games. So says Peter Lurie of Public Citizen, an interest group founded by Ralph Nader and based in Washington, D.C. Of course, its the agencys mission to be leery. But lately pharmaceutical companies are giv­ing groups like Luries more to be leery about. Drug firms now wield a great deal of control over their research, Lurie charges, and they are frequently manipulating their data or withholding unfavorable results entirely.


One of Public Citizens latest battles is over a drug for irritable bowel syndrome (IBS). Three years ago the Food and Drug Administration approved Lotronex (alosetron hydrochloride), the first agent to treat the dis­order specifically. As published in the Lancet, clinical trials in women revealed that 41 percent taking the drug felt some relief, as did 29 percent taking a placebo.*


The data, Lurie insists, "are incredibly misleading. One figure, for example, plots percent change on one axis and time on the other." First, plotting percent change instead of absolute change makes the effectiveness of the drug appear large. Second, the graph omits data from the first month, during which the drug and placebo worked almost identically.  Public Citizen reported the data using ab­solute values. The graph, which the Lancet published in a letter, better represents the drugs "marginal" efficacy, the group argues.


"I don't understand the accusation," re­sponds Michael Camilleri of the Mayo Clin­ic in Rochester, Minn., who led the study. Such presentation is standard and accepted in peer-reviewed scientific journals. The data clearly show that the drug was better than the placebo for months two and three.


But many observers believe that drug companies go too far. It shouldn't happen in the scientific literature, insists Bob Good­man, founder of New York Citybased No Free Lunch, which is focused on reining in the marketing ploys of drug companies. "Doctors should be able to decide the appropriateness of a drug. But how can they when drug com­panies leave out crucial information?" he asks. Goodman is referring to another com­mon practice: excluding data.


Illustrating the point is the ongoing con­troversy over Cox-2 inhibitors, touted as a safer alternative to nonsteroidal anti-inflam­marories such as ibuprofen. Sales of one, Celebrex, reached a whopping $3 billion in 2001. But last year the Washington Post re­vealed that Pharmacia, the drugs maker, had published just six months of results. Data for the next six months indicated that patients on Celebrex suffered complications such as stomach ulcers at the same rate as those tak­ing older medications. This information be­came public only because one of the paper's reviewers happened to be on the drugs FDA review committee. Pharmacia says that the data for the last six months were too flawed to include them.


There are also rumblings that even though the FDA is aware of such practices, the agency is increasingly acting more favorably toward drug companies. The Lotronex story again provides the spark for that charge. After the drug hit the market in February 2000, the FDA assigned Paul D. Stolley of the University of Maryland to review the drugs side-effects profile. Stolley noticed a distressing pattern. Day after day he would see reports of patients being hospitalized, presumably because of Lotronex. "This for a disease that never leads to hospitalization, never perforates your colon and is not life-threatening," Stolley points out.


GlaxoSmithKline, the drugs maker, pulled Lotronex off the shelves in November 2000 after 49 reports of ischemic colitis and three deaths. A few months later, responding in part to requests from IBS advocacy groups, the company appealed to the FDA to bring the drug back. That move alarmed Stolley, who felt that the risks far outweighed the drugs marginal benefit. But when he spoke up, he was shut out. "FDA personnel were told not to discuss the case with me," complained Stol­ley, who had consulted for the FDA for the past 30 years. Others were opposed to the drug, but "they were intimidated," says Stol­ley, who now works for Public Citizen.


Some scientists argue that the FDA has be­come so chummy with the drug industry partly because of the Prescription Drug User Fee Act, passed in 1992. The act requires firms to pay the FDA almost $500,000 in to­tal fees for each approved drug. Such fees ac­count for almost half the agency's cost of re­viewing drugs.


"I was shocked the FDA buckled even af­ter they'd seen the obfuscation and the at­tempts to hide data. They seemed more com­fortable working with the company than with their own staff," Stolley grouses. Lotronex is now back on the market. But only authorized doctors can prescribe it, and patients must sign an agreement staring that they fully un­derstand the hazards. Here's hoping that for them, it is truly a risk worth taking.


Gunjan Sinha is based in Frankfurt, Germany.


FEBRUARY 2003   Scientific American, P. 15-16.


 *  There are significant problems with the placebos used by drug companies, for they can often be identified as sucha topic which I will later publish on. 


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