The Antidote to Big Pharma
GeneWatch Interviews Marcia Angell
by Evan Lerner

GeneWatch: In your book, you argue that drug companies are “Waiting for Godot,” that is, they are staking their futures on something whose nature and time of arrival can only be guessed. In your estimation, what does this “Godot” look like, and why is it so troubling?

Marcia Angell: Godot is the fruit of any research that can lead to innovative drugs. That research is almost always done at universities, the NIH, or small biotech companies. Big pharma then builds on that research, sometimes quite late in the development process. Many of its most innovative drugs are licensed outright from smaller companies. That may be fine, but big pharma expects to be rewarded as though it were the source of innovation, which it isn’t.

Robert Klein, a sponsor of Proposition 71, the California proposal that will allocate $3 billion to stem cell research, has claimed that he and his fellow sponsors rejected donations from pharmaceutical firms. What do you see pharmaceutical companies doing to get a stake in this proposed research?

Big pharma will acquire the fruits of stem cell research in the same way as it does from small researchers now. I should say, however, that I believe this research will not lead to new treatments in the near future. It is being hyped by both its proponents and opponents.

Another potential “Godot” is racially-targeted drugs. Apparent successes like BiDil, the heart-failure medication geared towards African Americans, seem commerically promising. Do you think the pharmaceutical industry is invested in the racialization of medicine? What about the prospect of individually tailored medicines?

I am very skeptical about drugs that are said to be effective in one group but not another, yet treat the same disease. Medically, people are more alike than they are different. But whatever the case, I think it’s unlikely drug companies will be very interested in making drugs for small populations. It’s just not profitable, compared with targeting drugs to the biggest populations possible—as, for example, in the case of drugs for “erectile dysfunction,” which essentially target all men.

You have leveled criticisms at Big Pharma for manipulating the duration of its patents. Do you have other concerns about the pharmaceutical industry’s use of intellectual property?

In 1980, Congress enacted legislation that permits publicly funded research to be patented, then licensed exclusively to drug companies. Before then, this research was in the public domain. At about the same time, patent law was relaxed, so that discoveries could be patented even if they had no practical use—including genes and snippets of genes. Patents used to be awarded only to inventions that are “useful, novel and non-obvious” in-and-of themselves, now they merely have to be useful in further research. The result is more and more patents on “upstream” research, which sets up a thicket of licenses that have to be negotiated to use the discoveries in “downstream” research. Paradoxically, measures meant to speed the translation of basic research to practical treatments may do the opposite.

You also claim the pharmaceutical industry no longer focuses on developing innovative or life-saving drugs, but on minute variations of pre-existing drugs that treat things like heartburn or seasonal allergies. Is this also a byproduct of patents-run-amok? What can be done to entice drug companies to make drugs we actually need?

The major output of big pharma is not innovative drugs, but trivial variations of top-selling drugs, called “me-too” drugs. There are whole families of these. For example, the top-selling drug in the world, Lipitor, is one of six cholesterol-lowering drugs of the same type, called Statins. The cornucopia of me-too drugs is made possible by the fact that companies don’t have to show new ones are better than old ones. They merely have to show that they’re better than placebos — that is, that they are better than nothing. For all we know, each successive me-too drug in a family is worse than the one before.

The relaxation of patent law feeds into the problem. The US Constitution states that “Congress shall have power…to promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries.” But now nearly anything can be patented, whether it represents progress or not.

The FDA should require as a condition of approval that a me-too drug is compared not just with a placebo, but with the old drug at an equivalent dose. Overnight, that would force drug companies to shift from me-toos to innovative drugs.

An off-shoot of this problem seems to be the pharmaceutical industry’s “medicalization” of certain conditions, such as heartburn, generalized anxiety and aging.

The pharmaceutical industry is interested in this process because the biggest market is essentially normal people. There are many more of them than there are sick people. So in its marketing, big pharma tries to make people believe that the ordinary ups and downs of life constitute medical conditions that need treatment. For example, nearly everyone experiences heartburn from time to time, and it will go away on its own or with an over-the-counter antacid and perhaps more moderate eating habits. Drug companies would like us to believe ordinary heartburn is “acid reflux disease” and requires expensive prescription drugs. By expanding the market, there is more room for all the me-too drugs.
I do worry that the increasing use of multiple drugs—called polypharmacy—is dangerous. Drugs are usually tested alone, not in conjunction with other drugs, so we really know very little about the consequences of taking several drugs at once. The rate of this goes up as more drugs are being prescribed for normal, everyday occurrences.

Medicalization and marketing seem to go hand-in-hand—drug companies must alert the public about its new disease’s symptoms before the public will purchase the drugs. To what degree are the public-relations aspects of drug development taking precedence over actual scientific research?

Marketing certainly takes precedence over research, judging by the budgets of the major drug companies. They spend over twice as much on marketing and administration as they do on research and development, and the lion’s share of M&A is marketing. It’s probably about 85 percent. Since pharmaceutical companies don’t compare me-too drugs head-to-head, they rely on their marketing muscle to convince doctors and patients that one is better than the others.

The counter to this argument is that the free market has allocated drug development spending to where the public wants it most; i.e., if the public so badly wants to buy heartburn medication , who are we to tell drug companies not to produce so many varieties of it? How do you respond to these arguments?

Prescription drugs are not ordinary consumer goods like DVD’s. They are necessary to treat medical conditions, and they require doctors’ prescriptions. The problem with regarding them as ordinary consumer goods is that we have serious shortages of life-saving drugs and vaccines, like the flu vaccine, even while we have a surfeit of me-too drugs. It is also ironic to talk free market rhetoric, while big pharma is feeding off government-funded research and dependent on government-granted monopoly rights.

The conclusions of your book suggest that the pharmaceutical industry can be saved from itself if the patenting process and conflict-of-interest, among other things, can be reformed. How can all of us help in this effort?

Big pharma supports most medical education in the use of prescription drugs, and in many other ways, it bestows its largesse on doctors and their professional institutions. It also supports most clinical trials of drugs, and increasingly ties strings to that support. In that way, it biases both doctors’ practice and clinical research. The medical profession needs to break its dependence on the pharmaceutical industry. It should take responsibility for its own education. Researchers, for their part, should not carry out clinical trials unless they design the studies, analyze the data, and have the right to publish the results, whether they are favorable or not.