Lawyer For Provenge Activists Sanctioned By Judge
8 CommentsBy Ed Silverman // February 26th, 2008 // 7:04 pm
In the latest setback to a vociferous non-profit group that is battling the FDA over the Provenge prostate-cancer vaccine, the group’s lawyer was just sanctioned for his behavior. In an 8-page ruling, US District Court Judge Greg Frost chided Kerry Donahue, who represents Care To Live, for “unreasonable conduct” and ordered him to pay $6,000 to a newsletter that published controversial letters concerning the FDA handling of the Dendreon vaccine.
You may recall that Care To Live has waged a lawsuit against the FDA for failing to approve Dendreon’s prostate-cancer vaccine, Provenge, after an agency advisory panel last spring issued a recommendation. The FDA move came after two dissenting panel members wrote the agency to go slow, prompting outcries from cancer patients and Dendreon investors, who later accused one panel member of undisclosed financial conflicts of interest.
One aspect of this melodrama has been an effort by the non-profit to learn more about the behind-the-scenes dealings that prompted the panel members to write their letters. The non-profit alleges the panel members were encouraged by Richard Pazdur, who heads the FDA’s Office of Oncologic Drugs, as part of a Byzantine power play, and that the letters were subsequently leaked to The Cancer Letter, an influential industry newsletter, as part of an effort to gain broader support for delaying Provenge approval.
The Cancer Letter, however, sought sanctions against Donahue who sought to compel the newsletter editor and publisher - a husband-and-wife team who work out of their Washington, DC, home - to disclose their sources. Donahue contended that any effort to impede Provenge approval amounts to a death sentence against thousands of men with prostate cancer. The newsletter couple, however, claimed journalistic privilege and argue he failed to follow federal rules for subpoeanas. They also cite e-mails from Donahue that their lawyer described as threatening, according to court documents.
Frost agreed. “The court concludes that because of Donahue’s unreasonable conduct, Goldberg was forced to incur expenses in responding and corresponding with regard to these invalid subpoenas. Moreover, Donahue was informed on several occasions as to the invalidity of the subpoenas, but failed to correct them…Moreover, it is clear that at least some of Donahue’s behavior was meant to harass…This court has no hesitation concluding that Donahue’s conduct is sanctionable…”
In a brief statement, Donahue says: “I won’t be deterred from continuing to represent vigorously my clients and all the other 90,000 men who are suffering from advanced prostate cancer. With 80 men dying a day, I feel it’s my duty to be aggressive and push this case forward as quickly and efficiently as I can.”
For prostate-cancer patients and investors who have supported Care To Live, this is the latest development to dampen their spirits. Frost previously tossed most of their lawsuit and, more recently, the House Energy and Commerce Committee declined to investigate the FDA decision and charges of undisclosed financial conflicts of interest among some FDA panel members.
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[...] Drug S wrote an interesting post today onHere’s a quick excerpt [...]
MikeK
Hey Ed,
Vociferous was a good choice of words because that is exactly how Scher, Hussain, Fleming, Pazdur and the Goldbergs played it. I can’t say I blame the CTL lawyer for aggressively going after them right away. It would have been great to see the e-mails or the envelopes the letters came
in when they were sent from the FDA to The Cancer Letter. I think the hasty pursuit of these was definitely necessary before someone might have filed them in the proverbial garbage can or possibly hit the delete key.
More important than that is the fact that this is an emergency! Men are dying everyday from prostate cancer, a lethal disease Dr. Scher called it, with no other options. At least they would have had a fighting chance with a treatment Drs. Scher and Hussain said was safe. Dr. Hussain even said in her testimony that she saw the survival, “it is clear that there is a survival difference, so we’re not disagreeing on that.”
I wish I could give the Goldbergs the luxury of hiding behind journalistic privilege but I don’t see them as journalists in this case. They knew exactly what they were doing here. I would like to know who TigerFund was on the Investor Message Board who leaked the first letter for all the world to see on April 13th. Maybe the Goldbergs can tell you.
I would like to know how Matt Herper of Forbes got to tell us on April 26th a little after 12 noon, Dr. Hussain’s letter was coming. The Cancer Letter didn’t publish it until April 27th.
I would like to know a lot of things, Ed. And while CTL is getting doors and windows closed in their faces, this group seems deeply committed to finding answers.
A question for you, Ed. If these letters came to your office from the FDA, would you have released them just like the Goldbergs did? Or would you have just put a post out here and said, “You wouldn’t believe what I just got from the FDA today! Without going into all of the details, what do you think I should do about this? One letter…”
And since Scher’s and Fleming’s letters are so much alike, why don’t you ask them what treatment the men would forego if Provenge was approved? What is the name of that treatment? When can we expect that treatment? This is the real reason they wrote their letters.
And as far as Congress is concerned, they gave two weak reasons for denying the investigation. The worst reason was that a new COI law was enacted. This was way after the damage was already done.
The second reason was a preliminary investigation found the FDA was in compliance. I don’t think Congress looked deep enough. I can send you information that clearly presents a strong case showing the FDA was not in compliance.
So keep after it, Ed. CTL is staying after it! This is the way I see it.
kelatious
What a mess! The lawyer is working for free….lol, hit him where it hurts—his pocketbook! I guess that’s how the government does it……shoot the messenger! This story is so sickening on so many different levels
The most important quote from the article is:
[In a brief statement, Donahue says: “I won’t be deterred from continuing to represent vigorously my clients and all the other 90,000 men who are suffering from advanced prostate cancer. With 80 men dying a day, I feel it’s my duty to be aggressive and push this case forward as quickly and efficiently as I can.”]
Kerry Donahue is a hero.
z
this along with the avastin decision should only motivate more to get up and make noise. i still cant believe rep dingell didnt look into this. disgusting
John G
Ed,
First of all thank you for covering this issue. The whole matter is a travesty and to assess a fine on the attorney who is working pro-bono for those who are dying of prostate cancer is outrageous.
This week the FDA approved a drug that the advisory panel recommended NOT be approved, however with Provenge it was denied even though the advisory panel gave the nod with a 17-0 vote for safety?? Go figure.
The winds of change are present however, because as I see it the approval the new drug this week was partially due to the efforts to bring the conflicts of interest and other dirty diapers of the Provenge debacle to light and now the FDA is back peddling.
It’s too bad that the general public is not aware of the smell (corruption and money) that protrudes from this whole issue. Is is truely a sad situation and contrary to what some may believe, it is not the investors who are paying the price, rather it is those dying of prostate cancer.
Tony F
Judge Frost’s responsibility includes assessing sanctions amongst his duties and he called it as he saw it on the defendants complaint to his court. Many of us disagree with a number of his decisions in light of all the facts presented and the belief in the promise of Provenge to the 83 men who die each day from prostate cancer who may have been helped with this treatment… and, at the rate of 83 men daily, that amounts to more than 27,000 men per year who die horribly from this disease.
It’s heartening to see that you report the Provenge saga fairly and accurately; any number of your peers in the media most certainly do not.
While not a member, I’ve read there is a grass roots effort from a number of folks who are contributing funds to pay Mr. Donahue’s sanction not only to support the Provenge legal initiative but also because Mr. Donahue is providing his legal expertise pro bono and they want to help as they can. Interested parties in so doing are directed to the CareToLive website for further info on contributing, finding out more info on this calamity and who may be interested in helping terminal men with prostate cancer.
Keep up your reporting and Thanks for keeping this topic in front of your readers!
Justice will surely prevail… the question really is how many tens of thousands of men are going to continue to be condemned to death because the FDA continues to withhold approval of a treatment found safe and effective by the FDA’s own Advisory Committee.
Akcje
A bad lawyer. What else to say.
Hopefully Provenge will prove to be much better than this lawyer…
gavin ratner
Thankyou Mr Donahue for keeping this story alive.May we soon see the light at the end of the tunnel for us the PC suffers