TCS Daily

Risky Business

By Roger Bate - January 22, 2002 12:00 AM

Trial lawyers have brought a civil suit in Maryland's Montgomery County Circuit Court against Pfizer Inc. - claiming that the drug company put profits ahead of patient welfare with its diabetes drug Rezulin. Monica George died in 1998 from liver failure, and her daughters claim that the drug caused her death.

While there is little evidence that Rezulin caused the specific liver complaint from which Mrs. George died, that may not stop the daughters from receiving compensation. Plaintiff lawyers know that Pfizer, like other companies in the same position, may well want to settle rather than incur more bad publicity -- especially since the Washington Post, which broke the Rezulin story, seems intent on tarnishing the drug industry in general, and Pfizer in particular.

The Post's anti-drug industry campaign is not confined to the United States. Towards the end of 2000 the Post published a series of articles on the drug industry, one of which discussed the 1996 meningitis epidemic in Nigeria. At that time, Pfizer offered its new meningitis drug, Trovan, to health authorities in Nigeria, to be tested under controlled conditions. In the story, the Post published claims by pressure groups that the testing of Trovan might have cost lives. But Pfizer insisted the Nigerian trial furthered knowledge about Trovan, which was subsequently approved for use in the United States.

Testing a drug during an epidemic in a poor country under scientifically valid -- but less stringent -- trials regulations than in the home market, may appear opportunistic, but the Nigerians had the choice and considered that the potential benefits to patients were worth the risk of uncertainty. On the whole, trial procedures were strictly adhered to, but emotions often run high in trials. There is always a dilemma in giving placebos in desperate situations. That is why the best trials are double-blind so even the doctors themselves don't know who gets what. But these potential trial shortcomings are universal and have to be lived with, not flung at drugs companies to defend.

In both the above cases involving Pfizer drugs, it's far from certain that the drug led to any harm. But even if the drugs did cause the alleged affects, as a society we might well have to accept these risks. Drugs and vaccines, whether tested on malnourished babies in Africa or healthy women in the U.S., always carry some degree of risk. The important question is whether or not potential benefit outweighs the risk. After all, risk-aversion can result in a wonder drug being held up for years in the approval process while it could have been saving lives.

As Sam Kazman of the Competitive Enterprise Institute has noted, the real and substantial risk for patients is in the slow approval process for new drugs. And he is not alone. In a survey of oncologists done recently by The Polling Company, over three quarters of those asked said that the Food and Drug Administration (FDA) was too slow in approving new drugs. Furthermore, over 60% were in favour of a change in the law that would allow them to prescribe unapproved medicines, if they thought they were in their patients' interest. And these are doctors who know they might be sued by patients if drugs cause harm.

The situation on vaccines may be even worse. In Britain, families are seeking compensation from vaccine makers, such as GlaxoSmithKline, for alleged harms (inflammatory bowel syndrome and autism) from the measles, mumps and rubella (MMR)triple vaccine, even though the British Department of Health and the Medical Research Council dismiss such allegations. As one industry insider put it to me, "is it any surprise that fewer and fewer European drug companies are working on vaccines?".

In the U.S. the situation is arguably worse still. The inhalation anthrax saga has led to the possibility that manufacturers of existing drugs -- such as Bayer's Cipro -- could have their patents attenuated - in the name of the public good. Furthermore, the Gilmore Commission, established by the Bush administration to advise on terrorism, recommends "the establishment of a government-owned, contractor-operated national facility for the research, development and production of vaccines for specified infections."

Unfortunately, governments are notoriously bad at developing vaccines and will crowd out private research that might. In all the years that governments have devoted to finding vaccines for parasitic infections, like malaria and dengue fever, they have failed to develop any. It's probable that new genomic knowledge will increase the possibility of discovery, but innovation is far more likely from the private sector.

To develop future vaccines and drugs it is essential that venture capitalists, drug companies, doctors and patients take risks (and government stays out of the mix as much as possible). Patients legitimately harmed by drugs should be compensated. But ambulance-chasing lawyers and scare-mongering journalists reduce the acceptability of any risk. The result is more patients dying from lack of discovery or non-availability of new medicines.

Dr. Roger Bate is a Director of the International Policy Network in London.

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