Provenge, The Lawyer And The Cancer Letter
5 CommentsBy Ed Silverman // November 30th, 2007 // 6:13 pm
For the past few months, a vociferous non-profit group known as 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. You can read about the details in the lawsuit, which by the way was largely dismissed.
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.
Now, in a development that threatens to distract the Provenge advocates from their cause, The Cancer Letter is seeking sanctions against the lawyer for Care To Live who, over the past few months, has aggressively 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. The lawyer, Kerry Donahue, contends that any effort to impede Provenge approval amounts to a death sentence against thousands of men with prostate cancer. The newsletter couple, however, claim journalistic privilege and argue Donahue failed to follow federal rules for subpoeanas. They also cite e-mails from Donahue that their lawyer described as threatening, according to court documents.
For instance, Donahue wrote Paul Goldberg, the newsletter editor, an e-mail last August saying he planned to quickly book a flight from Ohio to Washington and show up to search the newsletter offices with a computer expert in tow, according to court documents. He wrote Goldberg that his teenage daughter lied about her parents’ whereabouts when a process server knocked on the door (they were away on vacation). In one e-mail, court documents state, Donahue writes: “Why are you fighting this so hard? You know we are going to get the information we are looking for sooner or later.”
Donahue has taken unusual steps before. Around the same time, he posted details about searching for the Goldbergs on the Investor Village web site: “Last night, the Goldbergs hid in their basement and refused to answer their door to accept CareToLive subpoenas. Today, they left town in order to avoid further service…Today, they were served by personal process service on their household to a person over age 18. The Goldbergs thought they escaped town and avoided legal process. WRONG!”
For his part, Donahue wrote us to say this: “I think it is a very cruel thing for Mr. Goldberg to do, considering we are advocating on behalf of terminal patients for access to a treatment and the only reason the process was made difficult was because Mr. Goldberg (instead of contesting the subpoenas) dodged service of them…We do not believe the information is at all privileged, because it was obtained in violation of the law and is evidence of unlawful acts of FDA employees…It’s an ego thing. Mr. Goldberg was made fun of on the internet and it bruised his ego…CTL believes that Mr. Goldberg was a co-conspirator in this case with the FDA…Mr. Goldberg could be helping cancer patients this holiday season and, instead, he has chosen to attack them in order to massage his own ego.”
Attorneys are expected to be aggressive advocates for their clients, and Donahue shows no sign of backing down, which no doubt pleases many Provege enthusiasts. But while this sideshow is unlikely to overwhelm the main event, it does raise the possibility that the pursuit of Provenge may be sidetracked as these distracting legal skirmishes are sorted out.
Kerry Donahue
The Goldbergs were never threatened. CareToLive seeks the truth. Those that seek to HIDE THE TRUTH to protect the unlawful actions of Scher, Hussain, Pazdur and the FDA only aid and abet the wrongdoers and help to insure that the CTL patient members don’t get acess to Provenge. Provenge is a safe and effective therapy for AIPC patients, denied them for indivisuals power and money.
Mr. Goldberg and his insider FDA friends act to deny this treatment to the patients who deperately need it.
Goldberg can seek all the money he wants but CTL will never stop fighting him and the FDA to disclose the truth about what they did to cancer patients. This is not about money its about Provenge for the Patients NOW.
Happy holidays Paul, from the cancer patients you keep attacking.
PS Paul could have avoided this BY JUST HAVING his attorney accepy the supboena (if he wanted to contest the subpoena thats fine do it but don’t dodge service). I talked to Paul on the phone before I even sent the first subpoena in an effort to be friendly and civil. He lied to me then and he lies now.
I will file my response in a week. It will state the real circumstance.
ED, ASK PAUL WHO SENT HIM THE LETTERS AND WHAT AGREEMENT HE MADE IN RETURN AND HOW HE PROFITED FROM THEM AT THE EXPENSE OF CANCER PATIENTS. ASK HIM WHAT WAS SAID AND WHEN HE WAS SUPPOSED TO PUBLISH THEM AS PART OF THE SABOTAGE PROVENGE CAMPAIGN. ASK HIM WHO HIS INSIDERS AT THE FDA THAT REGULARLY LEAK HIM INFO FOR PROFIT ARE. HOPEFULLY THE SEC WILL GET INVOLVED.
phil_vardena (Pharm. D.)
What troubles me is that those who leaked the letters are not subject of investigation from the proper authorities.
I mean, Dendreon is a stock market listed Company! The act of leaking the now famous letters should be treated like an attempt to move the stock price. Insiders profited from the manipulation.
Think about this: the Advisory Committee panel voted 17-0 Provenge is safe and 13-4 (2 of the 4 ‘no’ votes came from highly conflicted members) it works. Never before the FDA overturned an AC panel recommendation. Between the AC panel recommendation and the FDA decision, the short interes INCREASED. Wow, this is foresight!
Dear Ed, thanks for you honest reporting.
Regards,
phil
Kerry Donahue
Paul Goldberg would be happy if CareToLive went after Commissioner von Eschenbach. Paul Goldberg hates him. After all von E cancelled the NCI subscription to Goldgergs “newletter” and began an NCI newsletter. Paul Goldberg in a fit of anger said that the cost of his newsleter to NCI was “chump change”. Goldberg contacted his attorney and made like they were going to take legal action against NCI and von E but then he figured that he best not disturb those that butter his bread. After making accusations through his counsel against von E (and NCI)they changed their tune recognizing that biting the hands of those that improperly feed him inside info would not be smart.
However, CTL has targeted Goldbegrs cohorts Scher and Pazdur which Goldberg and Pazdur don’t like. Pazdur vs. von E is what this is really about. Thats part of the internal FDA bickering that cost AIPC access to Provenge.
Pazdur cannot attack CTL directly so he has his cronies like Goldberg do it. Since Goldberg hates von E as much as Pazdur hates von E, they make a formidable yet puny and weasel like team. If the fight hurts the advancement of cancer treatments they care not. Goldberg has previously stated that he thinks von E’s plan to make cancer a treatable condition by 2015 was impossible. He and Pazdur wi do all they can to show that they were right and von E was wromg…even if it menas assisting to see that cancer is NOT a made a treatable condition by 2015.
By sabotaging Proveneg they made progress in their goal of proving von E wrong.
For more info go to CareToLive.com.
Colson
Ed: “The Cancer Letter is seeking sanctions against the lawyer for Care To Live…”
Thanks, Ed, for stating the facts. Mr. Donahue would have others believe that the Goldbergs are seeking sanctions against CTL’s prostate cancer victims. Nothing could be further from the truth. The Goldbergs are seeking sanctions against a lawyer whose “methods” appear to be immature, unskilled, unprofessional, if not unethical. In my opinion, Mr. Donahue has done nothing to help bring Provenge to market. I applaud the Goldbergs for trying to stem his wild accusations. A lawyer who cannot stay within the law is no lawyer, in my opinion.
Kerry Donahue
Colson
The Goldbergs absolutely seek sanctions against cancer patients, their advocates (caretolive) and their pro bono counsel. Read their motion, its at caretolive.com. Their attacking of patients and their advocates is just plain wrongful and inhumane.
I am not sure what “methods” you speak of but all I, the pro bono counsel for cancer patients, did, was to try to serve a simple subpoena on Paul that he was intent on dodging…and for which he instructed his attorney NOT TO ACCEPT SERVICE OF.
Next time if he wants to object to a subpoena because he claims to be a “journalist” he would be well advised to accept the subpoena then make his arguments rather then just avoiding service and instructing his attorney not to accept service. All that followed was all the fault of Paul Goldberg.
Myself and Mr Lieberman his attorney agreed before the date set for the inspection of the documentas that I would not be coming to do so. All actions after that were just showmanship by Goldbegrs and their attorney. Remember this side attack really comes at the request of his friends Scher and Pazdur.
Mr. Goldberg does not wish the sordid details of his arrangement with FDA insiders to become public. That is particualry true because it might be Richard Pazdur himself who is responsible for the FDA leaks (again).