Q. Does the spate of drug approvals that have been withdrawn recently suggest there is a problem with the Food and Drug Administration?
A. There is. A lot of these drugs were fast-tracked originally. The larger problem is commercial. Where does the FDA get money to evaluate these drugs? Forty percent is from makers of drugs, which I see as a conflict of interest. A lot of these drugs should never have been approved in the first place. FDA evaluators often warned from the very beginning that the drug was harmful, and they have been ignored.
Q. Are you saying the FDA is a corrupt agency?
A. I didn't say that, but somebody could easily infer that from the book.
Q. There are a lot of villains in Deadly Monopolies. Who are some of the heroes?
A. One of the heroes is U.S. Sen. Charles Grassley [R-Iowa] — a very impressive person. I spoke to him last year, and the whole time, I kept thinking of that movie Mr. Smith Goes to Washington. There have been quite a few medical research abuses that he has pointed out.
Q. For example?
A. When Northfield Laboratories tested their blood substitute, PolyHeme, Grassley became very concerned about the law that said that Americans can be enrolled in medical research without their knowledge and consent in the case of trauma. He has had much better success in going after people who've taken money from corporations, then lied about it.
Q. Other heroes?
A. Bill Gates and the Bill Gates Foundation. They are focusing on the development of medical miracles to benefit people in the developing world — and, more to the point, inspiring other people to do the same.
Q. Why should we care about biocolonialism?
A. Biocolonialism is the exploitation of people and living things in the developing world solely to meet the needs of affluent people in the Western world. First of all, we should care about this because they're human beings. We should also care about this because of medical interdependence. The spread of HIV should have taught us that no catastrophe that strikes part of us leaves the rest of us unaffected.
Q. It seems extraordinary that Western companies have been able to patent — and control access to — substances already in use elsewhere.
A. Amazing, isn't it? I call it the theft of the intellectual property of the developing world.
Q. Are there efforts to address any of these issues legislatively?
A. Xavier Becerra [D-Calif.] and Dave Weldon [R-Fla.], two congressmen, introduced a bill to ban gene patenting. It didn't make it out of the House. Pharmaceutical companies are going to fight it tooth and nail.
Q. What other measures do you favor?
A. We should repeal the Bayh-Dole Act. It has proven to be deleterious for health care. The profit motive has supplanted the university research culture, with the result that our medications are for more trivial illnesses and are more expensive.
Q. What can readers do?
A. There are many points of action: The law that allows medical research with trauma patients needs to be rolled back. So, in my opinion, do laws that allow tissues and organs to be taken after death without consent. Support the organizations that are working to address some of these problems.
Q. For instance?
A. The American Civil Liberties Union and the Public Patent Foundation, which coordinated the legal challenge to BRCA genes; American College of Medical Genetics; the Association for Molecular Pathology; the College of American Pathologists; the American Society of Clinical Pathology; Breast Cancer Action; the Boston Women's Health Book Collective. California congressman Xavier Becerra introduced anti-patent legislation in the past and is considering doing so again. He should hear from people who are concerned about the marketing of life, no matter what state you live in.
Julia M. Klein is a cultural reporter and critic in Philadelphia and a contributing editor at the Columbia Journalism Review.