Friday, September 10, 2004

Better a Depressed Child Than a Depressed Stockholder 

Still clinging to that archaic paradigm under which government regulatory agencies were charged with protecting the welfare, health, and safety of the general public? Get with the program! Here in BushWorld, the only thing a regulatory agency regulates is the flow of information that might depress corporate profits:
The chairman of a House committee angrily accused the Food and Drug Administration on Thursday of withholding documents on the effects of antidepressants on children.

Holding a copy of an e-mail message from an agency official instructing others in the agency not to unearth the documents, Representative Joe L. Barton, Republican of Texas and chairman of the House Energy and Commerce Committee, said it demonstrated that the agency was deliberately defying the panel. He threatened to ask police officers to go to the agency's offices to retrieve the records.

"The F.D.A.'s lack of cooperation with the committee in obtaining relevant and responsive information in a timely fashion on a matter that involves the safety of our children leaves me wondering whether this is sheer ineptitude or something far worse," Mr. Barton said.

The warning came at a hearing of the Energy and Commerce Subcommittee on Oversight and Investigations into why the agency and seven drug makers had failed for years to warn doctors and patients that most antidepressants have not proved effective in treating depression in children and that some studies suggest they may cause some children to become acutely suicidal. In 2002, nearly 11 million prescriptions for the drugs were given to children, 2.7 million of them to children under 12 . . . .

The hearing comes in the midst of a growing controversy about not only the safety of antidepressant therapy in children but also the drug industry's longtime tendency to suppress the results of clinical trials that might undermine the sales of their drugs.

Seven top executives from drug giants like Pfizer, Wyeth and GlaxoSmithKline were sharply questioned about why the companies had collectively failed to publish or publicize results of studies showing that their drugs had not proved effective in treating teenagers and children.
By coincidence, Janet Maslin earlier this week reviewed a new book by Marcia Angell, M.D., entitled The Truth About the Drug Companies: How They Deceive Us and What to Do About It:
Arguing that in 1980 drug manufacturing changed from a good business into "a stupendous one," thanks to changes in government regulations, [Angell] adds, "Of the many events that contributed to their sudden great and good fortune, none had to do with the quality of the drugs the companies were selling."

In the past, drug discoveries made through government research remained in the public domain. Beginning in 1980 those breakthroughs could be patented, even if their research was sponsored by the National Institutes of Health. As a consequence, Dr. Angell says, patent shenanigans have reshaped the drug business, as have the recent government regulations that expedite direct-to-consumer drug advertising. "Once upon a time, drug companies promoted drugs to treat diseases," Dr. Angell writes. "Now it is often the opposite. They promote diseases to fit their drugs."

"The big drug companies are competing not so much to find new drugs but for the limited number of drugs to license," she argues. The enormous research-and-development budgets that are invoked to justify high drug prices, she claims, also pay for questionable forms of education for doctors and all manner of barely concealed incentives for them to prescribe certain drugs.
Maslin does not name the key piece of legislation that started us down the road to this particular suburb of hell: the Bayh-Dole Act, passed in 1980, signed into law by President Jimmy Carter.

Bad Ralph Nader discussed Bayh-Dole at length in his 2000 book Cutting Corporate Welfare. In the late seventies an alliance of business interests and major research universities persuaded Congress that discoveries made through federally-sponsored research should be exclusively licensed to corporations, "to spur private sector innovation and development." Bayh-Dole was the result, and in 1983 Reagan followed up with a presidential memorandum directing that individual contractors be granted the rights to any and all taxpayer-funded inventions.

The upshot? You the taxpayer lay out the dough to develop a new drug through, say, the NIH; a pharmaceutical company, which often takes no part in the research process beyond supplying sample quantities of the drug for clinical testing, receives the exclusive rights. Big pharma then turns around and sells the drug for up to twenty times what it costs to manufacture (paying, of course, no royalties to the government, which originated the product). In fact, the customer who gets gouged the worst is often, as you might expect, Uncle Sam himself -- who has to buy his own drugs back, at exorbitant prices, through Medicaid, the V.A., etc.

And is then expected to intercede on behalf of the drug companies when third-world countries that can't afford retail drugs beg for generics in hopes of saving a few additional lives.

Is that sweet or is it sweet?

| | Technorati Links | to Del.icio.us