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Context of '1990-2000: Clinical Research Studies Being Done Increasingly by Private Firms instead of Universities'

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During this period, pharmaceutical companies begin hiring fewer and fewer universities to perform the clinical research studies for their drugs, contracting instead private research firms or conducting the studies themselves. In the early 1990s, roughly 75 percent of drug companies’ clinical research budgets went to universities. By 2000, this figure drops to only 34 percent. [New York Times, 11/22/2002]

Timeline Tags: US Health Care

Research done by Dr. Garrett FitzGerald suggests that COX-2 inhibiting drugs, like Vioxx and Celebrex, increase the risk of cardiovascular problems. FitzGerald believes that COX-2 inhibitors block the production of a substance called prostacyclin, which leads to blood vessel constriction and clotting. His research is dismissed by Merck, the maker of Vioxx. Vioxx’s only selling point is that it causes fewer gastrointestinal problems than other pain killers on the market. But according to FitzGerald, the mechanism that makes the drug gentler on the stomach is also responsible for causing the cardiovascular problems. [MSNBC, 10/6/2004] FitzGerald’s research is later published in two studies, one in 1999 and another in 2001. [Associated Press, 6/22/2005]

Entity Tags: Merck, Garrett FitzGerald

Timeline Tags: US Health Care

Omnicom, one of the world’s largest advertising firms, pays $20 million for part-ownership of Scirex, a research firm that conducts clinical studies on drugs to determine their effectiveness and safety. Thomas L. Harrison, a top executive of the company, says he expects Scirex’s studies to provide positive results for its clients in the drug industry. “Our goal is to help ensure that all clinical studies and each patient accrued into a study can be assessed to support the NDA submission.” [New York Times, 11/22/2002]

Entity Tags: Omnicom, Scirex, Thomas L. Harrison

Timeline Tags: US Health Care

The Journal of the American Dental Association publishes a study concluding that Bextra, a new drug manufactured by Pharmacia, offers relief to the acute pain patients feel after dental surgery. [Daniels et al., 2002] Just six months before, the FDA investigated the claim and found no evidence to support it. [New York Times, 11/22/2002] Bextra is only approved to treat pain caused by arthritis or painful menstrual cycles. [US Food and Drug Administration, 11/22/2002] During the three-month period following the article’s publication, Bextra sales increase by 60 percent. It is later learned that the authors of the article were not independent scientists, but rather employees of Scirex, a research company owned partially by Omnicom, one of the world’s largest advertising firms. When the New York Times asks three doctors to review the Scirex article, the doctors say its conclusions are not persuasive. “All three said that one of Scirex’s conclusions was insignificant: that one dose of Bextra worked longer than a single dose of a medicine containing oxycodone and acetaminophen, a combination often sold under the brand name Percocet. Patients rarely receive just one dose of that combination drug, the doctors said, because it wears off in four to six hours.” One of the doctors, Eric J. Topol, says the studies cited in the article make “a contrived comparison.” He notes that patients in the study had an average age of 23, which is not representative of the age group that would mostly likely use the drug. Judy Glova, a spokeswoman for Pharmacia, denies in a statement to the New York Times, that the article was an attempt to bypass the FDA regulation. And Pat Sloan of Omnicom insists the company has “nothing to do with the design of clinical studies.” [New York Times, 11/22/2002]

Entity Tags: Pharmacia & Upjohn Inc, Eric Topol, Omnicom, Scirex

Timeline Tags: US Health Care

David Graham, associate science director for the FDA’s Office of Drug Safety, appears before the Senate Committee on Finance to testify on the agency’s ability to protect the American public from harmful drugs. Graham, a twenty-year veteran of the agency, tells the committee that “the FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless.” Graham was an early critic of Vioxx, a painkiller that was recalled in September (see September 30, 2004) because of its link to heart problems. Graham recounts how in August (see Mid-August 2004), the FDA tried to suppress a study he led which found that “nearly 28,000 excess cases of heart attack or sudden cardiac death were caused by Vioxx.” He says the study’s findings were “extremely conservative” and that “a more realistic and likely… estimate ranges from 88,000 to 139,000 Americans” of which “30-40 percent [or 26,400-55,600] probably died.” He notes that this figure is the “rough equivalent of 500 to 900 aircraft dropping from the sky… [or] 2-4 aircraft every week, week in and week out, for the past 5 years.” [US Congress, 11/18/2004 pdf file] The remainder of Graham’s testimony focuses on problems within the FDA’s Office of Drug Safety (ODS). He makes the following points:
bullet The Office of New Drugs (ONS), which approves all new drugs, is the same division that is responsible for taking regulatory action against those drugs after they have been released on the market. This is an inherent conflict of interest, he notes, because when a problem arises, recognizing it would require the ONS to acknowledge that it had made a mistake. Instead, the office’s “immediate reaction [to a problem] is almost always one of denial, rejection, and heat.” [US Congress, 11/18/2004 pdf file]
bullet The Office of Drug Safety (ODS) is subordinate to the Office of New Drugs, and consequently the management of the former sees its mission as pleasing the latter. [US Congress, 11/18/2004 pdf file]
bullet The culture of the FDA’s Center for Drug Evaluation and Research (CDER) “views the pharmaceutical industry it is supposed to regulate as its client, over-values the benefits of the drugs it approves and seriously under-values, disregards, and disrespects drug safety.” [US Congress, 11/18/2004 pdf file]
bullet The Office of New Drugs refuses to take regulatory action on any drug unless it can be shown with 95 percent or greater certainty that it is unsafe. However “to demonstrate a safety problem with 95 percent certainty, extremely large studies are often needed… [and] those large studies cannot be done.” Graham suggests the 95 percent rule makes as much sense as a person with a 100-chamber pistol loaded with 90 bullets saying that the gun is safe. “Because there is only a 90 percent chance that a bullet will fire when I pull the trigger, CDER would conclude that the gun is not loaded and that the drug is safe.” [US Congress, 11/18/2004 pdf file]

Entity Tags: David Graham

Timeline Tags: US Health Care

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