Sunday, August 22, 2004

Review of drug industry book by Dr. Marcia Angell in Chicago Sun-Times


From the review:

We've made a devil's bargain with the industry. Drug companies spend millions of dollars to research and develop new drugs. In exchange, we give them patents and exclusive marketing rights for a number of years. During this period, the manufacturer has a protected monopoly and can charge whatever the market will bear for its drug.

But rather than produce truly innovative medicines, the industry mostly makes me-too drugs. When Schering-Plough's patent on the allergy drug Claritin expired, it tried to switch consumers to its copycat drug, Clarinex. The active ingredient of Clarinex [Desloratadine] is the molecule that Claritin [Loratadine] turns into after it's swallowed.[NOTE: meaning that Claritin is what is called a prodrug; Clarinex is an active metabolite of Claritin. Fexofenadine (Allegra) is a metabolite of Seldane, just as desloratadine (Clarinex) is a metabolite of Claritin] It's essentially the same drug, but with a brand new patent. [NOTE: not really the "same" drug.] The same is true of the copycat heartburn drug Nexium, which replaced Prilosec after Prilosec's patent expired. [NOTE: Nexium is an enantiomer to Prilosec being a racemate (a mixture of enantiomers). Thus, "the same is NOT true. Prilosec and Nexium are not related as prodrug and metabolite. Chemically, they are the same drug.]

And Prozac Sarafem, approved for severe PMS, is the same drug and same dose as regular Prozac, "but priced three and a half times as high as generic Prozac at my local pharmacy," Angell writes. Of the 415 drugs approved by the FDA from 1998 to 2002, Angell writes, "only 14 percent were truly innovative." [NOTE: Yes, here they are the same drug, but used for different indications.]


The book review continues:

Angell developed her jaundiced view of the industry during 20 years as an editor at the New England Journal of Medicine, one of the world's premier medical journals. Fortunately she has left the medical journal jargon behind. Her prose is clear and readable, although she tends to repeat herself.

It's disappointing that Angell didn't include a chapter on the industry's relationship with medical journals, which publish influential studies that can make or break a drug. Angell surely had run-ins with drug companies that are forever trying to put their spin on journal articles. If so, she has decided to keep such disputes private.

The New England Journal and other journals have made modest attempts to reign in industry abuses by, for example, listing consulting fees, research grants and other financial ties authors have with drug companies. But while Angell sensibly argues that medical societies and FDA advisors should not accept industry funding, she does not suggest the same principle for medical journal authors.


The review concludes:

But while her revelations aren't new, Angell does an excellent job assembling them into a convincing case against Big Pharma. And she suggests some eminently sensible reforms, including these four:

1. The FDA should require that new drugs be "compared not just with placebos, but with old drugs for the same conditions."

2. The FDA needs more independence. For example, it should not be funded by industry user fees.

3. Drug trials should be sponsored, not by drug companies, but by a government Institute for Prescription Drug Trials.

4. Advertising drugs to consumers should be banned. "There is no way consumers can evaluate clinical claims in a thirty-second TV advertisement," Angell writes.


Of the relationship between the drug industry and medical journals, the Sun-Times review overlooked a prior event involving Angell as editor of the New England Journal of Medicine:

From the Los Angeles Times via the Baltimore Sun (24 February 2000)

One of the world's most influential medical journal has admitted to an extraordinary betrayal of its own ethics, saying that nearly half the drug reviews published since 1997 were written by researchers with undisclosed financial support from companies marketing the drugs.

The New England Journal of Medicine, in an unusual internal inquiry published in today's edition, found that 19 of about 40 drug therapy reviews violated its tough conflict-of-interest policy. The policy bars researchers with ties to pharmaceutical companies from writing reviews or editorials about company products.

Journal editors conducted the audit in response to reports last fall in the Los Angeles Times identifying eight drug therapy articles that broke the journal's conflict-of-interest rules. In a terse letter, the journal confirmed those findings and noted 11 additional articles that violated the policy.

"We regret our failure to apply our policy correctly," says the letter. It was signed by editor in chief Dr. Marcia Angell, deputy editor Dr. Robert Utiger, and the editor of the drug therapy reviews, Dr. Alastair J. J. Wood.

"We were careless," Angell said in an interview. The editorial staff has "heightened vigilance" to the problem and has implemented new disclosure policies to guard against it, she said.

"They set up an admirable policy, and it's a pity they didn't follow up on it," said Dr. Drummond Rennie, an editor at the Journal of the American Medical Association who has written on ethical dilemmas in publishing.

For a premier journal to err on a basic matter of editorial integrity raises questions about the quality of medical data in lesser publications. In fact, most medical journals would not consider the violations identified by the New England Journal to be a problem.

[Angell stepped down as Editor-in-Chief of the New England Journal of Medicine on June 30, 2000.]


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