Tuesday, November 28, 2006

FDA and Pharma: Bed Partners?

After my Plaquequest post yesterday, I looked into the partnership arrangement between the FDA and BG Medicine a bit more today and found this statement from the FDA's own press release:
The agency ... concluded an agreement with BG Medicine, a biotechnology research company, to collaborate on discovering signs of liver toxicity in the initial stages of drug development.
BG Medicine's press release was a bit more detailed:
25 Oct 2005: BG Medicine, a Massachusetts-based biotechnology research company, today announced the submission of a Cooperative Research and Development Agreement (CRADA) with the Food and Drug Administration's National Center for Toxicological Research (NCTR), to jointly conduct a liver toxicity study designed to overcome one of the primary obstacles to the efficient development of safe and effective drugs. The study, Liver Toxicology Biomarker Study (LTBS), aims to discover biomarkers of human hepatotoxicity in the standard test used by pharmaceutical manufacturers in the initial stages of drug development.

Liver toxicity is the most common biological reason for drug failure in the development of new pharmaceuticals, affecting one in six drugs in development. The toxicity tests currently in use by drug companies have been unchanged for at least 40 years and often fail to identify human liver toxicity issues. Consequently, liver toxicity is often detected for the first time when drugs are in phase 2 of clinical testing after tens of millions of dollars or more have been spent on a drug.

On March 16, 2004 the FDA released a report, "Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products," describing the "urgent need to modernize the medical product development process -- the Critical Path -- to make product development more predictable and less costly." The proposed project addresses the liver toxicity issue highlighted in the Critical Path document as one of the obvious and priority areas for innovation.

The CRADA process is a standard procedure for studies the FDA undertakes in collaboration with private companies. The liver toxicity study has been designed by BG Medicine and the FDA with input from a number of pharmaceutical companies. The study will be funded by and conducted in collaboration with pharmaceutical manufacturers. (Emphasis mine)

The research project leverages NCTR's and BGM's systems biology platforms for functional genomics, proteomics, metabolomics and computational analysis.

The LTBS will be conducted at the FDA's NCTR laboratory in Jefferson, Arkansas and at BG Medicine in Waltham, Massachusetts. The study is open to participation by all pharmaceutical manufacturers. Participating companies will receive a paid-up perpetual license to any biomarkers discovered and access to all project data.
Now I'm not sure what I think about this. The FDA is supposed to assure the safety of pharmaceuticals to the public. While the bureaucratic quagmire called the FDA certainly needs to streamline their approval of drugs, are they able to maintain their objectivity regarding drug evaluations when they've become "best buddies" with the pharmaceutical industry by using Big Pharma's funds and facilities like this?

I wonder.

Sure makes those pens and lunches from drug reps seem like chump change, doesn't it?

Anybody else want to weigh in on this?

-Wes

2 comments:

Daniel Haszard said...

Investors watch Eli Lilly shares drop $2.80 post election.

My issue is Zyprexa which is only FDA approved for schizophrenia (.5-1% of pop) and some bipolar (2% pop) and then an even smaller percentage of theses two groups.

So how does Zyprexa get to be the 7th largest drug sale in the world?

Eli Lilly is in deep trouble for using their drug reps to 'encourage' doctors to write zyprexa for non-FDA approved 'off label' uses.

The drug causes increased diabetes risk,and medicare picks up all the expensive fallout.There are now 7 states (and counting) going after Lilly for fraud and restitution.

---
Daniel Haszard

DrWes said...

Daniel-

Thanks for exposing this, but I am interested that the text of this note is exactly like that on this other posting elsewhere on the web and I noticed on your article here that you have a website www.zyprexa-victims.com (just letting my readers know...). Yours is a certainly a tough situation. I hope your efforts all work out for the best in the long run...

While I know little about the legal issues that Lilly faces regarding their medication, Zyprexa, it seems in the context you've written that you might like the FDA to do post-market monitoring of drugs. If so, fine.

Unfortunately, whether Lilly is marketing their drug irresponsibly AFTER FDA approval is not the focus here - I'll leave that one to the courts. Certainly doctors can use any drug "off label" if they feel it's in the best interest of the patient, and have justification to do so and such justification (with its attendant risks) are reviewed with the patient (certainly liability risks increase here). For me, the issue here is, should the FDA use Pharma funds and assets to help their approval process?