From the (London) Times Higher Education Supplement

A slightly edited version of this opinion piece will appear Thursday in the Times of London Higher Education Supplement:

By Merrill Goozner

The senior citizen drug benefit signed into law by President George W. Bush last fall guarantees that Americans will continue to pay the highest prices in the world for pharmaceuticals. Though European, Canadian and Japanese health services establish formularies and negotiate reasonable prices for consumers, the new law specifically prohibited the U.S. government from doing the same.

Why did a government facing enormous deficits deny itself the negotiating power that comes from being the largest buyer in the marketplace? The Washington lobbying muscle of the large pharmaceutical companies played a role, of course. But drug industry pressure wouldn’t work unless it was backed by a powerful argument. Most legislators believe industry when it says that Americans must continue to pay high prices or the research and development that makes the U.S. pharmaceutical industry the world’s most innovative and productive will dry up.

The drug industry’s innovation argument rests on several key assertions. First, it assumes industrial labs are the primary source of medical breakthroughs. It further assumes that new therapies for as yet incurable diseases like senile dementia, many cancers and crippling arthritis inevitably depend on generous funding of industry’s R&D labs. And it concludes with the assertion that it costs on average $800 million to develop a new drug, a number supplied by an industry-funded study.

Each of these arguments is false. In an era dominated by genomics and

microbiology, medical innovation depends more than ever before on early stage research that focuses on understanding of the basic causes of disease. Before developing a drug, scientists must first learn the complex protein chemistry of the disease. Within this cascade of biochemical events, scientists must then identify and validate a molecular drug target. Only then can a drug be developed.

This is arduous work that rarely succeeds. Positive results cannot be willed into existence. Breakthroughs in understanding almost always depend on the unplanned and unpredictable interplay of basic science.

Moreover, virtually none of this work takes place in industry labs. Most takes place at universities, non-profit labs or in the public sector, which in the U.S. are mostly funded by the National Institutes of Health, comparable to Great Britain’s Medical Research Council.

Without this basic scientific understanding, curing disease is impossible, especially when it comes to the degenerative diseases of aging. Yet the global pharmaceutical industry is pouring billions of dollars into research in the name of pursuing cures for these diseases. Where does it go?

For many firms, a primary activity of their R&D labs is developing new drugs that mimic the actions of drugs already on the market. Perhaps the old drug is coming off patent. Or the company needs an entry in a lucrative market now dominated by one of its rivals. A survey of all drugs approved by the U.S. Food and Drug Administration in the 1990s found that more than half fell into this “me-too” category.

In the U.S., a substantial portion of the industrial research dollar also gets devoted to funding clinical trials that provide little meaningful information for physicians. They are designed to get more doctors prescribing the newly approved drug – so-called seeding trials. Sometimes these trials are published in second-tier medical journals, which can then be reprinted and handed out by the some 90,000 sales representatives that visit physicians’ offices in the U.S. every day.

Indeed, if one discounts for wasteful research that adds nothing to physicians’ armamentarium for fighting disease, one could cut the industry’s estimate of what it costs to develop a new drug at least in half.

This is not to say that once government-funded basic science comes up with a valid drug target, industrial chemists do not sometimes play a crucial role in developing a drug that can inhibit that target. And industry largely funds the clinical trials needed to prove a drug’s safety and efficacy. But even in this arena, it’s increasingly the case that publicly-funded researchers are taking the lead in coming up with innovative technologies and using technology transfer laws to funnel their lead compounds, monoclonal antibodies and recombinant proteins to small biotech firms willing to gamble on developing the drug.

The debate over U.S. prescription drug policy has gone global. U.S. trade representatives are now arguing that European consumers are free riding on the U.S. innovation system. They say world prices must rise so U.S. prices can come down. The reality is that the U.S. can lower its drug prices to those of the rest of the advanced industrial world without jeopardizing the hunt for the next generation of cures.

Merrill Goozner, author of “The $800 Million Pill: The Truth Behind the Cost of New Drugs,” directs the Integrity in Science Project at the Washington-based Center for Science in the Public Interest.

Posted by gooznews at April 28, 2004 08:09 PM