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Tuesday, August 14, 2007

Northwest Under the Hammer

Surprise! The lawyers are out to get Northwest Biotherapeutics—on behalf of their disgruntled shareholders—for the “materially false and misleading statements” issued in that July 9 press release.

Northwest, or their comms department, definitely messed up—we blogged the dodgy release and its subsequent clarification here, and claim no prizes for predicting that something like this would happen. This is not a case of suing McDonalds for serving hot coffee—the lawyers, for once, have a reasonable point. Northwest declared that the world’s first therapeutic cancer vaccine was available to patients. It wasn’t. The experimental substance was allowed into Switzerland—conditionally.

Acting on behalf of “defrauded investors,” law firms like Hagens Berman Sobol Shapiro can see good business in the inherently risky, volatile biotech sector. They’re slapping suits about everywhere, it seems, including recently on GPC Biotech and Dendreon, allegedly for misleading investors over their cancer candidate’s progress.

Blaming the management is not always justifiable—especially at young firms trying to get their first drug through the FDA maze. Stuff can go wrong in drug development; investors not ready for that should choose another sector.

Trouble is, the Northwest saga will mean yet more lawsuits, and probably make these actions even more part of the biotech landscape than they already are. That doesn’t seem the best way to encourage transparent communication between management and regulators, and management and their investors.

2 comments:

Tony F said...

Congratulations and
Thanks to "IN VIVO" for getting reliable info out into the public's view.

Now if Hagens et al or some other group of attorneys or the MEDIA will look into the Dendreon's Provenge Conflict of Interest (COI) saga.. particularly that concerning Howard Scher of Sloan Kettering... maybe TERMINAL cancer victims can get much access to potential life extending treatments.

A compilation of Conflict of Interest (COI) for Scher who sat on the Provenge March 29 FDA Advisory Committee and who voted “YES” that Provenge was substantially safe and “NO” that is showed substantial efficacy. Sources are public information available on the internet.

Scher reported only 3 COI’s to the FDA in his Waiver Application permitting him to sit in judgment of Provenge’s FDA AC which appears to be composed of ownership of 1 stocks and 2 competing industry interest.

Internet research shows the following for Scher thus far:

1. NOVACEA: grants & research support; STUDY CHAIR of DN-101; Direct competitor to Provenge

2. GPB BIOTECH: financial conflict of interest per Scher in MedPage

3. PHARMION: financial conflict of interest per Scher in MedPage

4. SANOFI-AVENTIS: grants & research support

5. BRISTOL MYERS SQUIBB: consultant, grants & research

6. MILLENNIUM PHARMCEUTICALS: grant of research support

7. COUGAR BIOTECHNOLOGY: principal investigator; advisory board;

8. INNOVIVE PHARMACEUTICALS: principal investigator

9. INFINITY PHARMACEUTICALS: principal investigator

10. BIOGEN-IDEC: jointly held stock with spouse

11. PFIZER: jointly held stock with spouse

12. GENTA: scientific advisory board (as of March 6, 2007; since removed from web, but cached)

13. DEPARTMENT of DEFENSE: Principal Investigator PC Clinical Trials-P1 and P2

14. MEDIVATION, INC: principal investigator MDV3100

15. AMBRILIA BIOPHARMA INC: Principal Investigator PCK3145, Phase I/II

16. PROQUEST INVESTMENTS: consultant, scientific advisory board; LIMITED PARTNER FINANCIAL interest

There appears to be a significant and disturbing difference between his 3 disclosures to the FDA and the alleged 16 COI’s found so far on the internet. It seems incomprehensible for someone with the training and education Scher has to “forget” so many apparent COIs… that is simply beyond all reasonableness and suggests intentional dishonesty or deceit.

Even more disturbing is the FDA’s Office of Inspector General and others at the FDA to whom this information has been supplied and their apparent failure to investigate these charges that Scher has more COI’s than he disclosed to them. When such information is provided and such allegations of potential federal law violation is involved, any ordinary citizen has the right to expect our government to investigate such allegations timely and thoroughly.

As a “temporary government employee” at the FDA, he is obligated, under Federal law, to provide full and complete disclosure. If he didn’t, he may have the potential for liability for law violation(s) as well as for providing false data to the FDA under which he secured a waiver in order to participate on the Provenge AC meeting March 29th.

Cancer advocates are Rallying at the FDA in Washington Sept 18th-10 a.m. Details are at www.caretolive.com

Come support cancer victims then or volunteer in your own community in support of those striken by this terrible disease!

Thank You! for continuing to expose problems in the biotech area!

Chris Morrison said...

thanks Tony. But your comment is quite a ways off topic and so won't stay here for long. There has been plenty of thoughtful discussion on the Provenge situation elsewhere--see for example Pharmalot's great post at http://www.pharmalot.com/2007/08/provenge-and-the-private-eye