Attack on Drug Industry Urges Even More Regulation

     Former New England Journal of Medicine Editor Marcia Angell is promoting her new book attacking the pharmaceutical industry and urging added government regulations at the same time. She is already hitting the media circuit as hard as she hits at the industry all part of the book promotion. It is important that reporters be aware of the extent of her aims and problems with her claims.

     Angell, who was editor of the Journal from 1999-2000, has already appeared in The Washington Post, Los Angeles Times, Financial Times and the radical leftwing website Alternet.org to advocate for several new regulations on the pharmaceutical industry. The interviews were helpful for anyone trying to get at the heart of what she hopes for the pharmaceutical industry, such as:

Requiring a drug test registry of all clinical trials by pharmaceutical companies.
Requiring all new drugs be tested not just against placebos, but existing drugs;
Requiring the FDA advisory boards have no ties to the drug industry.
Angell also urges the industry to open its books, even though that would harm the companies by revealing trade secrets. 
Angell also supports drug reimportation, despite FDA opposition to it for being unsafe.

     There are many flaws in Angells basic arguments. One of the biggest is her defense of drug reimportation. Angell calls fears that counterfeit drugs will flow across the border an unlikely worry. The FDA disagrees. The FDA released results of a study in July of drugs purchased from a website advertising Canadian Generics.

     According to the FDA, The firm shipped drugs that were the wrong strength, including some that were substantially super-potent and that pose real health risks as a result, drugs that didnt dissolve properly, drugs that contained contaminants, and drugs that should not have been given because of potentially dangerous drug interactions. Angell is unfazed by such risks. 

     She consistently complains about drugs that duplicate the effort of other drugs. She calls these me-too drugs and says they are a waste. In fact, they are quite helpful. Human beings are far from identical and some respond better to one drug than another. As Janet Woodcock, MD, director of the FDA Center for Drug Evaluation and Research said, The FDA would like to offer patients a choice of drugs within the same class, since not every patient responds to every drug in the same manner.

     In the L.A. Times interview, Angell responded to this criticism by admitting she didnt know whether multiple drug options help or not. My guess is that if the first drug doesnt work, the second one wont work either, since me-too drugs are so similar. But no one can say for sure.

     Angell is quick to criticize the growth of the Pharma industry. She does so, in fact, on the first page after the introduction. From 1960 to 1980, prescription drug sales were fairly static as a percent of U.S. gross domestic product, but from 1980 to 2000, they tripled. Angell appears unimpressed with the many industry successes including drugs to treat AIDS/HIV, Alzheimers or high cholesterol.

     She was also critical of the industrys creation of new drugs by making more people think they need drugs. She complains that drugs for people who have social anxiety disorder or erectile dysfunction are unneeded, although she ignores the enormous popularity Viagra and other drugs have had. In a free market, people have a tendency to buy things they want. Tens of thousands of prescriptions for erectile dysfunction are filled each day, despite Angells view that it isnt a problem.

     Angell harps on the industrys financial performance, saying that it is too profitable. It is difficult to conceive of how awash in money big pharma is. At the same time, she complains that the industry isnt doing well. In her Alternet interview, Angell said, Big drug companies are in serious trouble. They are trolling small biotech companies all over world. They are hovering around academic medical centers hoping someone will come up with something they can license and develop.

     Such confused assessments can happen when you base them on faulty financial information. Angell cites Tufts University research saying it costs more than $800 million to bring a drug to market on average. Rather than accept those numbers, she tries to undermine them. After some fast and loose financial calculations, she concludes, I would guess that the real cost per drug is well under $100 million. Such in depth financial analysis explains why Angell is a doctor, not an accountant.

     All in all, Angell seems to have problems with anything resembling the free market. Certainly, pharmaceutical companies are regulated, but she seems to think a massive increase in regulation will make the industry more cost effective. In reality, it will do just the opposite and destroy incentive to create new drugs that both save lives and make those lives better.

     Angell envisions a world where only one drug is allowed per illness to try and force Pharma to invent other medications. It is a good thing she isnt in the food industry or she would be advocating we choose between Coke or Pepsi, rather than continuing to have many products that serve different needs or desires.