No Chair Throwing Allowed At FDA Panel Meetings
12 CommentsBy Ed Silverman // July 3rd, 2008 // 12:04 pm
Most days, an FDA advisory committee meeting would not be mistaken for an episode of one of those talk shows where the guests - and maybe even the host or audience members - will curse, trade punches and throw things at one another. True, a member of the public can sometimes bring the FDA gathering to tears with harrowing stories of overwhelming side effects. But mostly, these are staid events.
Just the same, a threatening rant by an apparently intoxicated speaker during a May 2007 open public hearing has prompted the FDA to tighten security at its meetings, according to The RPM Report. A formal announcement hasn’t been made, but John Jenkins, who heads the Office of New Drugs, discussed the new procedures at the Drug Information Association’s annual meeting last week.
“We have put in place some new measures to help improve security at meetings,” Jenkins reportedly said. “If we anticipate that there may be an increased need for security at a particular meeting because it is a particularly controversial topic, we may have additional security procedures.”
And so, the FDA is creating a physical barrier by roping off the committee from the public. The intent, Jenkins said, is “to put some separation between those who might become agitated in the audience and committee members.” The agency is also increasing the presence of security guards - uniformed and plain clothes - in the committee room. And a satement will be read at the start of the meeting about “good rules of behavior,” according to RPM.
By the way, the May 2007 incident involved Maha Hussain of the University of Michigan who, shortly after this occurred, alleged she received threats for her role in convincing the FDA to delay approval of the Provenge prostate cancer vaccine being developed by Dendreon.
kyoto27
Interesting that the FDA now wants to hold the ‘public’ to higher standards of conduct than it demanded from the likes of Dr Howard Scher – especially in the not so grey area of “proper ethical conduct.” Dr Scher’s conflicts of interest are a matter of record in the Dendreon/Provenge AC panel review.
In that light, I guess it makes a lot of sense for the FDA to consider conducting all of its AC panel hearings in a hermetically sealed environment…free from public contamination.
Better yet, why not eliminate the unnecessary preambles (the Advisory Committee hearings) and cut to the chase:
The FDA’s ‘Final Decision’ making meetings; in short, when the FDA wants to overrule a positive AC panel ruling how does it do that? Is it politically incorrect for America to ask the FDA how those ‘final decisions’ are made? Would it be insensitive for our Congress ask the FDA to provide them with a transcript of who attends those final mettings; how they voted and a transcript of the arguments presented in favor of their ‘yeh/nay’ votes? Are votes even taken? Or is it just winks and nods?
I would think even the Big Pharma companies would support such an open record –especially if they were concerned about whether they are targeting the right people with all those lobbying bucks.
So yes, let’s address the FDA’s concerns about security and public behavior at the AC meetings and let the FDA also address America’s concerns about their ‘public behavior’ —–or why they prefer to operate behind closed doors, and drawn curtains?
FDA, say it ain’t to ‘insure security?’
Respectfully would ask if anyone can answer that question.
Tony F
LOL! Super GREAT post, Ed!
So, let me see if I get the gist of your and RPM’s articles… the FDA is now more concerned with security of their “experts” with the danger coming from the general public than the FDA is concerned about the CONFLICTS OF INTEREST of the actual panel members which, of course, endangers the general public and, specifically, TERMINAL cancer patients.
If you and your readers recall, both Maha Hussain of Univ of Michigan and Howard Scher of Sloan Kettering are alleged to have significant and UNdisclosed COI.
Hussain had undisclosed COI to include stock holdings by her husband… also an oncology physician.
Scher, as I’ve previously alleged, has 17 Conflicts of Interest; he disclosed 3 to the FDA when he certified his COI to the FDA in order to sit in judgment of Provenge last year at its AC meeting.
Recently, an 18th COI for Scher has been suggested, but I haven’t confirmed it as yet. However, I do allege Scher has these 17 COI.
1. NOVACEA:
… grants & research support
… STUDY CHAIR of DN-101 which is …
… a 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 MYERSSQUIBB: consultant, grants & research
6. MILLENNIUM PHARMCEUTICALS: grant of research support
7. COUGAR BIOTECHNOLOGY: principal investigator; advisoryboard;
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. CONFOMA THERAPEUTICS: scientific advisory board
14. DEPARTMENT of DEFENSE: Principal Investigator PCClinical Trials-P1 and P2
15. AMBRILIABIOPHARMA INC: Principal Investigator PCK3145, Phase I/II
16. MEDIVATION, INC: principal investigator MDV3100
17. PROQUEST INVESTMENTS:
… member Board of Directors
… Scientific Advisor
… INVESTED in Novacea.
83 men die each 24 hours, 7 days a week, 52 weeks a year from Prostate Cancer….
…. some 30,000 men each YEAR!
Is it no wonder the “general public” is up in arms over these conflicted doctors who appear to work for their own financial interests against dying cancer patients and their families?
Jason L
Couldn’t agree with you more Kyoto. I think it rather hypocritical to tighten up on public participation when the FDA is already hermetically sealed regarding high level decisions. Maha’s had egregious COIs and yet here she is chairing this meeting. Maha, with her hand in derailing Provenge has abetted in denying many, many, many suffering men from improving their lives. Also, she is complicit in stalling Neuvenge, perhaps derailing that as well.
She can sit in her high chair and demand order, but it is my supplicative hope that a critical, and questioning public question her COIs at EVERY turn. If she has nothing to hide…answer the questions…transparency should be held to the highest degree for these so called experts who are above the very rules they create to subvert questioning of their own actions.
John Mack
Have no fear! FDA Intern is on the case! See http://pharmamkting.blogspot.com/2008/07/fda-intern-vs-inebriated-advisory.html
MyPharmalotID
The fact is, had the FDA acted in good faith prior to the Provenge AC meeting, it would have rejected Drs. Scher and Hussain’s waiver requests.
A study published by BioCentury, The Bernstein Report On BioBusiness®, March 26, 2007, noted the following regarding new COI rules that were under consideration even before the Provenge Advisory Committee meeting:
“Under the draft guidance, Scher either would be prevented from voting or excluded from the meeting.”
As regards to Dr. Maha Hussain:
“The waiver notes that Hussain is the principal investigator on a research contract awarded by a competing company for a product that is not related to Provenge. Under the draft guidance this probably would not be considered a conflict. However, the fact that her husband owns stock in three competing companies, valued at $15,000-$300,000, would at minimum prevent her from voting. If the total value of the stock exceeds $50,000, Hussain wouldn’t even be at the table if the new policy were in effect.”
Vince Tolino, Director, Ethics and Integrity Staff, FDA, should never have forwarded Scher’s and Hussain’s waiver requests to Randall Lutter, Ph.D., Associate Commissioner for Policy and Planning, FDA, and the latter never should have approved them.
There still is no indication that the proposed revisions to the FDA COI rules have been adopted.
What a pitiful excuse for a Federal agency. As for their Office of FDA Ethics, one has to wonder whether or not anyone is minding the store! The same may be said of HHS’ Office of the Inspector General! The failure to pursue the obvious COI provisions represents a total failure of the agency, right up to the very top of the leadership ladder.
kyoto27
FDA Intern: Thank God someone is protecting the FDA from itself! Bravo. It is not in the public interest for the public to learn that the FDA is not–in fact, a science based agency. Congress allows the FDA to operate behind closed doors because watching the FDA struggle in its determined effort to put a round peg in a square hole is too much to bear even for this do-nothing Congress.
And thank God also, for the Ed Silvermans of this world.
Seeks the Truth
There is a reward of AT LEAST $2000 on the Investorvillage DNDN site for anyone who can actually PROVE that Hussain or Dr. Howard Scher ever actually received serious “threats.”
It’s always easy to claim being a “victim” and garnering appropriate sympathy. It’s another, of course, to produce the FACTS and corroborating e-mails, letters etc.
Scher and Hussain have played the “victim” role to the hilt while shamelessly helping to deny FDA approval of DNDN’s product, Provenge.
Meanwhile, the REAL victims are the THOUSANDS of men with advanced prostate cancer who might have benefitted from Provenge injections.
But I forgot, Hussain and Scher are both staunch advocates of CHEMOtherapy for PCa.
Approval of a revolutionary vaccine with very few side-effects and survival benefits would certainly jeopardize all the money from Big Pharma that flows their way.
There is no PROOF yet that Hussain/Scher ever got any real serious threats. But one could imagine such circumstances, especially from a desperately sick man, father, brother, husband or grandfather who was denied a chance for prolonged survival by their shameful actions.
The $2000 reward remains unclaimed!!
Kerry Donahue, Esq.
I think the FDA is worried that some CareToLive demonstrators will show up.
MyPharmalotID
The reward for verifiable proof that a threat actually was made against either Dr. Scher or Dr. Hussain following the Provenge AC meeting (actually, for a threat made against either one during the period from the Provenge AC meeting through the June 2007 cancer symposium at which they showed up with bodyguards) is $3000. It will be paid to charity, once the documents provided (e.g., a police report) have been verified as legitimate.
Margaret
There has been a Nazi-like statement on the FDA website, ordering around those who give their allotted three minutes of public testimony. It must come from this “incident”, and is a very threatening document about public behavior.
Once, having testified several times, I finally said something like “It must be the culture of the FDA to never give eye contact to a family member whose son was killed by Zyprexa, to never offer condolences or a handshake, to never comment on the story of the death, to sit like zombies waiting impatiently for the minute time limit to be up. I thought this agency was about the PUBLIC HEALTH”. Well, after that outburst, for the one and only time, every member of the panel (risk communication, I think) came up and shook my hand, gave me a card, a condolence, etc. It was the darndest thing. And it hasn’t happened since. During public testimony, FDA behavior is usually look down at the table stonefaced.
Hard Ball
It’s the same ‘ol SpIn that every government agency is taught in “Spin 101″, a required and basic course of federal employment. The higher you rise is correlated directly to the degree of effective spin used by you to government advantage.
In this case, as with so many others, it’s the public that probably needs protection from the over-empowered officials at the FDA but then that is called just another conspiracy theory. They will now read rules so that the public becomes arrestable if they speak up during the meetings.
Sadly, there is no arm of the government, no office or branch that is left uncorrupted by the temptations of power and influence and of the inherent ability to profit by your position. In the FDA’s case, it is merely rampant.
Lisa Van S
FDA wore “BULLET PROOF VESTS” during the 1991 Prozac Hearings. How ironic that they chose to protect themselves from a Prozac Induced Violent Person, and refused to disclose the Violent side effects to the public.