Healthy Skepticism Library item: 135

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Drug companies blinded by quest for profit
Montreal Gazette 2004 Nov 19

Full text:

I am one of the 80 million people worldwide who took the anti-inflammatory Vioxx before it was pulled from the market on Sept. 30 as a health hazard.

Several years ago, I tore a muscle in my shoulder while trying to learn to roll a kayak, and a doctor recommended Vioxx because its reputation was for providing effective pain relief while having a lower risk of side effects like ulcers or bleeding.

It never occurred to me to go hunting for unpublished scientific papers to find out whether Merck & Co., Vioxx’s manufacturer, might be keeping anything from doctors or patients. Nor was there any reason for my doctor to assume the drug he was prescribing had a hidden, potentially deadly, side to it.

In a moment of temporary insanity, you could almost feel sorry for Merck & Co. On Sept. 30, it was lauded for its prompt action in removing Vioxx from the marketplace after “discovering” it doubled the risk of heart attacks and strokes. But here we are a few weeks later and it is under criminal investigation by the U.S. Justice Department, as well as being probed by the U.S. Securities and Exchange Commission.

On the civil side, as of Oct. 31, Merck had been named in no fewer than 375 lawsuits representing 1,000 plaintiff groups whose members allege they suffered side effects from Vioxx. Merck’s stock price has fallen more than 40 per cent since it pulled the drug from the market. How misplaced would one’s pity be? Merck is expected to have $20 billion in sales and $6 billion in profits next year.

Its chief executive, Raymond Gilmartin, said this week he has no regrets over how he and his company handled Vioxx. No regrets? He should be crippled with remorse. People have died because of how his company handled Vioxx.

Reports this month show evidence was available as early as 2000 of the unacceptably high risks of Vioxx. According to the Wall Street Journal, e-mails confirmed Merck executives knew about Vioxx’s risks at the same time they tried to gloss over them in their public statements.

Maybe a drug company could convince itself its prize drug – Vioxx was bringing in $2.5 billion by the time it was taken off the market – was sort of safe. But a world-renowned regulatory agency such as the U.S. Food and Drug Administration should not have been influenced by a drug’s profitability or popularity.

Yet earlier this month, The Lancet, Britain’s top medical journal, criticized “lethal weaknesses” in the FDA’s regulatory oversight of Vioxx. It described the licencing and continued use of Vioxx “in the face of unambiguous evidence of harm” as public-health catastrophes, leading to a continued erosion of trust.

The saga of Vioxx goes a long way in demonstrating the drug industry is a business first and foremost and one that should come under much closer scrutiny. Too often, a drug company such as Merck behaves as though the vast and unknowable demands of its business puts it beyond the understanding of the ordinary citizen – and, thus, beyond regulation.

Over the years, the pharmaceutical industry has barricaded itself behind layers of myth: Surely the public realizes the cost of bringing a new drug to market! The research involved!

This year, the American Journal of Bioethics drew up a list of drug-industry myths and debunked them. Chief among the myths is the cost of doing research. It is much less than the drug industry claims.

In the U.S., drug companies claim to spend 17 per cent of domestic sales on research and development, but according to data from the U.S. National Science Foundation in 2003, they spend only 10 per cent. Since barely 18 per cent of the drug industry’s research funding goes into basic research for breakthrough drugs, this means only 1.8 per cent of sales goes to research for breakthrough new drugs.

In Canada, brand-name drug companies promised in 1987 they would spend 10 per cent of their revenues on the research and development of new drugs. The promise was in exchange for a new law granting 20-year patent protection, along with permission to produce “me-too” drugs, variations on an existing drug designed chiefly to keep generic manufacturers at bay.

In both the U.S. and Canada, taxpayers pay for most research costs, either directly through universities or indirectly through enormous tax breaks.

The drug industry has for years claimed it must cover $800 million U.S. for research to bring a new drug to market. But about half that sum is “opportunity costs,” a rather startling concept in which the industry calculates the profit it would have realized if it had invested in the stock market instead of spending on research and development. (This would presumably preclude investing in a company that suffered sharp, unexpected reverses – Merck, for instance.)

For a new (not me-too) drug, the true costs are estimated to be about $108 million U.S., 93 per cent of the time.

Greed is something the public understands perfectly well.