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The Drug Debate Continues

The Drug Debate ContinuesWithincreased scrutiny on both the federal government and drug companiesin the wake of the controversy surrounding various prescriptionpain relievers, Tufts experts say that both groups need to bemore diligent.Boston

Boston [02.28.05] Amid recent safety concerns over potentially fatalside-effects from a class of anti-inflammatory pain relievers,both the pharmaceutical industry and the government oversightgroup have come under fire for missing the warning signs thatthe drugs might be dangerous. The problems, say several Tuftsexperts, suggest that change is needed in the way drugs are approvedand monitored.

"Thewhole system needs to be looked at," Tufts' SheldonKrimsky, a scholar of science and ethics and author of Sciencein the Private Interest: Has the Lure of Profits Corrupted BiomedicalResearch, told the Newark Star-Ledger. "Untilwe have a firewall between the manufacturers of drugs and thepeople who test them, we're going to continue to see these problems,regardless of putting more people in the FDA(US Food and Drug Administration) or trying to be more transparent."

Pain relieverslike Vioxx and Celebrex, which are in a class of medications calledCOX-2 inhibitors, have been shown in studies to be associatedwith an increased risk of heart attack and stroke.

Tufts ProfessorJerome Kassirer – whose book On The Take criticizesthe role of the drug business in medical practice – saysthat drug companies have influenced the FDA's approval process.

"Before1992, the funding or the expense of all that approval processwas paid for by you and me, the taxpayers," Kassirer toldNational Public Radio. "What it allowed was pharmaceuticalcompanies to pay the FDA large sums of cash… to speed upthe approval process. One of the questions is whether or not Congresswill be willing to pick this up after these hearings and makejudgments about what the future of the FDA should be."

As the discussionover safety continues, drug companies are simultaneously re-evaluatingthe ways in which clinical trials are conducted in order to putmore drugs on the market.

"They'resaying let's redesign the process of clinical trials to make itmore streamlined and efficient," ChristopherMilne – associate director of Tufts’Center for the Study of Drug Development (CSDD) – toldThe Boston Globe.

Drug companiesare also considering a proposal to create a registry of ongoingdrug trials. But Milne doesn’t ultimately believe that sucha registry would emerge as a major competitive issue between drugcompanies. "They live or die by their innovations,"he told the Associated Press.

As the prescriptiondrug market evolves and safety concerns persist, experts say vigilanceis key.

"No drugis ever brought to market without being an experiment on the public.The real issue is that we have to pay more attention to adverseevents. We have to be serious about looking hard for them,"Krimsky told the Star-Ledger.

Experts notethat part of the problem is that doctors often fail to reportthe occurrence of potentially harmful side effects they observein their patients to whom they have prescribed certain drugs."For many physicians, it's simply not a part of their jobdescription," the Tufts professor added.

To make mattersmore complicated, Tufts medical professor JosephLau says that companies don’t always provide doctorswith the latest data. "The problem is that doctors oftendon't have the right information," he told Business Week.

But even greateroversight by the FDA does not rule out the possibility of a drughaving negative, unintended effects.

"It'sa common misperception that the FDA approves drugs that are safeand effective," CSDD Director KennethKaitin told The Christian Science Monitor. "TheFDA actually approves drugs where the expected benefits outweighthe expected risks of that drug. It's always a risk-benefit analysis.”

In addition,the drug approval process is not static across time. Certain trendsemerge, Kaitin explained to the Monitor – suchas the cautious attitude of the 1970s and early 1980s that wasreplaced by a speedier process when the AIDS crisis emerged inthe 1980s. With no epidemics looming, he told the newspaper, safetyconcerns are returning to the fore.

PresidentBush's recent budget proposal boosts by 25 percent the amountof money dedicated to the monitoring of drugs after they havebeen approved by the FDA. Krimsky told the Star-Ledgerthat while it is a start, more must be done.

"It isonly one step in a larger overhaul that has to be done to developa system that really has the confidence of the public."









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