Drug approvals have always been somewhat political, and very much influenced by whether pharmaceutical companies could schmooze all the right people to accelerate the approval of a new drug.
Long ago and far away, I worked as a financial analyst on Wall Street. Though I followed the Chemicals Industry, a couple of the companies had big pharmaceutical divisions. The topic of approvals and the FDA's occasionally whimsical and always phenomenally bureaucratic approach to new drugs was often
lamented loudly at industry meetings. The sheer volume of paperwork was daunting; the amount of time you had to wait for something to be approved was insane.
It was no secret that drug companies spent a chunk of their R&D on wooing doctors, politicians, analysts, and anyone else who could potentially smooth the way for approval and then ensure it got to the people it was developed for (i.e., you the patient). They spend big on conferences and junkets for medical professionals, sponsor studies and press conferences, and once the drug is out, pass around all kinds of knick-knacks and freebies (you've probably all seen the pen-holder, desk clocks, and other tchotchkas at your doctor's office advertising this depressant or that anti-cholesterol drug: the drug reps hand those out like jelly beans. What you don't see are the more expensive gifts they send directly to the doctors or the invitations to plush, all-expenses paid conferences).
All of these have long been a cost of doing business for drug companies, and usually figure into their overall budget, along with the actual research and development conducted by both their in-house scientists and the scientists they sponsor to do "independent" research.
When you pay $2-$5 per pill of your prescription medication, most of that staggering price doesn't pay for the drug itself but for the costs of bringing that drug to market--from the original research, to tooling their machines to produce the pill, to the immense costs of advertising, promoting, and schmoozing. And that includes the Prozac pencil-holder on your doctor's desk.
But this is so far beyond the pale that it's scary.
The National Institutes of Health: Public Servant or Private Marketer?
...At least 530 government scientists at the NIH, the nation's preeminent agency for medical research, have taken fees, stock or stock options from biomedical companies in the last five years, records show.
NIH Director Dr. Elias A. Zerhouni has told Congress that outside work should be allowed if "the scientist is giving advice in an area … that is not part of his official duties."
Information gathered by a congressional committee, in addition to company records and 15,000 pages of government documents obtained by the Los Angeles Times under the Freedom of Information Act, shows that NIH researchers have repeatedly crossed Zerhouni's line.
For example:
• Dr. P. Trey Sunderland III, a senior psychiatric researcher, took $508,050 in fees and related income from Pfizer Inc. at the same time that he collaborated with Pfizer — in his government capacity — in studying patients with Alzheimer's disease. Without declaring his affiliation with the company, Sunderland endorsed the use of an Alzheimer's drug marketed by Pfizer during a nationally televised presentation at the NIH in 2003....
Recent Comments