In late January, Obama administration officials announced that they were very concerned about the slow pace of new drugs coming from the pharmaceutical industry. They should be concerned. The number of new chemical entities (NCEs) launched in recent years is near historic lows. And there are many unmet medical needs for which no therapies are available or on the horizon.
The administration’s “solution” to this problem was to create a new branch of the National Institutes of Health (NIH) dedicated to working (presumably in cooperation with the drug companies) to do pharmaceutical discovery research. We can use all the help we can get, and I wish them well, but there are so many reasons why this won’t work that I don’t know where to begin.
First, know-how — the NIH has virtually no expertise in doing what it takes to initiate pharmaceutical work. The pharmaceutical industry is the riskiest industry in the world, and for good reason. Between the first test tube and the actual bottle of pills lies such an incredible obstacle course of scientific hurdles that I sometimes wonder how anyone ever successfully produces a new drug.
And they don’t very often. It is estimated that it takes between 5,000 and 10,000 new chemical compounds to make one new drug, assuming that you have about fourteen years and $1 billion to play with. And this is with the benefit of a huge number of experienced scientists and the proper infrastructure — things the NIH lacks. Asking the NIH to develop a drug is a little like going to Jiffy Lube to have your appendix removed. It might work.
Second, funding — $1 billion was allotted for this initiative. While this may sound like a lot, it amounts to less than 2 percent of the more than $60 billion that drug companies spend on research and development every year. It’s a bit like getting a Yugo to help a bulldozer push a rock uphill. Even with the best scientists and equipment, it is difficult to imagine how $1 billion is going to make a difference. Pfizer, the world’s largest pharmaceutical company, alone spends about $8 billion per year and has been spectacularly unsuccessful at discovering new drugs over the past decade.
Speaking of which, it was this lack of success that prompted Pfizer to acquire Wyeth last year — not for Wyeth’s research, but for its product line. This resulted in 19,000 layoffs. In recent months, another 3,500 scientists in the U.S. and the U.K. have been laid off, including the entire Pfizer antibiotic research group, which will be re-established in Shanghai. Pfizer is not alone in this approach — every company is doing it.
Shortly before the layoffs were announced, the FDA rejected Pfizer’s obesity drug Contrave, which had not only successfully made it through human clinical trials but also was recommended for approval by the FDA’s own advisory panel. While the timing of these events is probably coincidental, it is nonetheless emblematic of what Pfizer and the rest of the industry are up against — an FDA that has become so overly cautious that it seems to reject anything with the slightest risk, regardless of its benefits. Two other new obesity drugs were rejected this year and one more, Meridia, which had been on the market since 1997, was pulled last year. And this is just for obesity, which is somewhat ironic, considering this is the first lady’s number one issue.
So, in order to address a real problem, our government is looking in the wrong place. Instead of funding an agency that is ill-equipped to fulfill its mandate, we ought to be looking at a different agency — the FDA, which seems to be doing its job too well, but unwisely.
Dr. Josh Bloom, a chemical and pharmaceutical expert, is the Director of Public Health at the American Council on Science and Health. Prior to joining the organization in 2010, Dr. Bloom was a research chemist at Wyeth (now Pfizer) for more than two decades.