FDA Panels: When Is A Conflict Not A Conflict?
20 CommentsBy Ed Silverman // May 29th, 2008 // 8:56 am
The agency will hold an advisory committee meeting tomorrow to review Promacta, an experimental med for short-treatment of chronic ITP, which is being developed by Glaxo and Ligand Pharmaceuticals. And as documents show, waivers were granted to two panel members holding conflicts of interest. The agency, of course, is allowed to do so, although the practice is controversial and, in response, the FDA proposed new rules that specify when exceptions can be granted.
In the latest instance, the FDA issued waivers to two people on its Oncologic Drugs Advisory Committee. One is Gary Lyman, director of health services and outcomes research in oncology at Duke University, who earns less than $10,000 annually as a speaker for an unnamed rival, according to the FDA waiver form.
The other is Maha Hussain, a University of Michigan professor of medicine. According to her form, she holds stock in one of the sponsoring companies that is worth between $50,000 and $100,000, in addition to stock worth between $5,000 and $25,000 in seven other drugmakers, as well as shares in yet another drugmaker worth up to $5,000.
In both cases, waivers were granted because the need for “the individual’s service outweighs a potential conflict of interest created by the financial interest involved.” In Hussain’s case, specifically, FDA deputy commish for policy Randy Lutter says Hussain’s stock holdings “are not so substantial to preclude her participation,” she has unparalleled experience and committee attendance is expected to be poor. In addition, a fiduciary third party has complete management control over her stock holdings.
Lutter, no doubt, believes such an exception is justified. But it does appear to run contrary to the agency proposal issued last March, which would forbid anyone who has financial ties with industry worth more than $50,000 from serving on advisory committees. It would also deny voting rights to advisers with lesser conflicts. Even though a fiduciary may exercise control over her stock holdings, Hussain is clearly aware of what she owns and the panel decision will likely affect its value. Of course, the new rules are not yet finalized, so as of now, her holdings are apparently moot.
This is not the first time this issue has engulfed Hussain. For the past year, she has been caught up in controversy over Dendreon’s Provenge prostate cancer vaccine. The same committee voted to approve Provenge, but Hussain and another panel member not only dissented, but later wrote FDA officials to urge a go-slow approach. Approval was delayed. Upset prostate cancer patients and Dendreon investors subsequently charged there were undisclosed financial conflicts of interest.
Tony F
Ed,
You’re not going soft on Hussain and the FDA just because this is a short, holiday week are you?
How laughable the FDA is… they promulgate rules… taking their own sweet time to implement them… then give Hussain a pass against their own rules and serve it all up with the ludicrious statement that panel “attendence is expected to be poor”.
Does this mean that, no matter what “rules” are, the FDA will still take just any old body to fill its AC in order for them to appear to be judicious in their decision-making?
If “attendance is expected to be poor”, then why even have an AC meeting? As I recall, the FDA is NOT bound to abide by or give credence to its own Advisory Committee votes, so why spend the taxpayers funds to hold one… especially if the FDA is expecting poor attendance?
2. Ed, Ed, Ed… you wrote everything about the “2nd” Provenge member who appears to have told the FDA he had but 3 Conflict of Interests while internet research suggests he has up to 17 Conflict of Interest and who joined Husain in a post-AC negative letter writing campaign against Provenge which CONFIDENTIAL letters to the FDA were somehow mysteriously leaked to a Washington rag puplication–non-peer reviewed– run by a Russian immigrant and his wife out of their base…… except his name.
That’s our ol’ good buddy, Howard Isadore Scher, from Sloan Kettering in NYC.
Reminding those who don’t recall…. Scher’s 17 COI found on the internet are:
1. NOVACEA: Grants & Research support; STUDY CHAIR of DN-101
… a DIRECT competitor to Provenge
… DN-101 failed its clinical trial
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; 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. CONFOMA THERAPEUTICS: Scientific Advisory Board
14. DEPARTMENT of DEFENSE: Principal Investigator PC Clinical Trials-P1 and P2
15. AMBRILIABIOPHARMA INC: Principal Investigator PCK3145, Phase I/II
16. MEDIVATION, INC: Principal Investigator MDV3100
17. PROQUEST INVESTMENTS,
… Board of Directors
… Advisor
… INVESTED in Novacea.
Oh, btw, Ed… continued THANKS! for keeping this information and these folks and the FDA in your sights… let sunshine into the FDA and its processes….
“poor attendance”, indeed!!!!
Seeks The Truth
Dr. Hussain’s involvement with Drs. Howard Scher and Richard Pazdur to ensure that DNDN’s Provenge would not get FDA approval will eventually be outted. The AC committee that Hussain and Scher served on voted 17-0 that PV was SAFE and 17-4 that the product was “substantially effective,” the FDA STANDARD for approval. Of course, Hussain and Scher were two of the nay votes.
As a result many thousands of men with advanced PCa have not benefitted from Provenge treatment. What a pitiful situation.
We know why Scher was desperate to sink Provenge.
He was LEAD investigator and an investor in a competing
company to DNDN. Ironically, his pet competing product filed miserably. Othet COI’s were also demonstarted.
Hussian’s reason for trying to prevent Provenge from coming to market are less obvious. I think it’s because she is not so secretly trying to protect the world of Ca chemotherapy
treatment, a HUGE industry that will suffer multi-BILLION dollar losses when Ca immuno-therapy, led by DNDN’s PV, eventually hits the markets.
Or was she “beholdin’ to Scher and Pazdur?
Who knows?
But we do know that men afflicted with PCa are dying every day….deprived of a treatment that surely would have bought more time for many of them.
What a tragic story.
Phil Vardena (Pharm. D.)
The FDA chose not to approve Provenge, even though it was advised by its appointed panel of Oncologists, Urologists, and Immunologists, all experts in the fields of immunotherapy and oncology, that Provenge is unquestionably safe (100% of the experts voted yes on safety) and that there was “substantial evidence” of the drug’s effectiveness as required by FDA regulations (76% of the experts voted yes on substantial evidence of effectiveness).
Among the NOs, Dr. Sher and Dr. Hussain.
Provenge achieved a 200% increase in overall survival measured at 3 years… with multiple recipients alive and well over 6 years later.
27,000 men with end-stage prostate cancer will die needlessly early (some will die needlessly period) each year the Provenge is delayed by the FDA.
Certainly FDA has approved drugs against the recommendations of its advisory panel, but I am not aware of a decision to overrule a strong positive panel vote for a terminal illness that has no really acceptable treatment options. This decision would appear to be unprecedented, and calls for a full and open public statement of why the FDA disagrees with this panel and cannot make this drug available to terminal patients. We know of course it was not due to safety concerns. Also, if FDA found the clinical trial data submitted by Dendreon (Provenge producer company) to be insufficient, why did it even submit the data to a panel of experts for their opinions?
Some of those doctors that voted “NO” as to the effectiveness evidence even had letters (urging the FDA NOT to approve Provenge) “leaked” to the media. They were Dr. Sher and Dr. Hussain. I let you judge on the ethics of this behaviour.
On May 30, 2007, news was that Schering-Plough Corp. said it had agreed pay Novacea Inc. up to $440 million for rights to develop the smaller drugmaker’s prostate cancer treatment, causing Novacea shares to double.
Both Dr. Sher and Dr. Hussain are Novacea consultants.
Do you think Schering-Plough would have paid $60 million immediately and an additional $380 million to Novacea if Provenge was on the market?
Why the FDA - for the first time in its history - did not approve a drug deemed safe and effective by its own panel?
How is that Dr. Sher and Dr. Hussain - with their obvious and enormous conflicts of interest - took part in the panel?
Who did choose Dr. Sher and Dr. Hussain?
We already have proof that Provenge works (two phase III trials). Many people are going to die due to the delay. Who is accountable?
Why isn’t this revolutionary and extremely safe treatment available NOW?
I can’t imagine the motives are about monetary gains.
Are you kidding me??
“….and committee attendance is expected to be poor.”
Well, WHY is “committee attendance expected to be poor?
Is it because the FDA doesn’t give a damn about the AC committees anyway??
Is it because they know that Pazdur, head of ODAC, is going to decide what HE wants and get his way, or else??!!
Is it because Von E is a LAME DUCK and will be out of job after November?
Or is it because the members are going to PROTEST Hussain’s previous effort to derail a valuable anti-cancer immunotherapy by voting with their FEET??!!
MJ
Absolutely ridiculous. The fact that Hussain is back serving on a FDA panel with conflicted interests just goes to show you that the FDA is all talk and NO ACTION.
Hussain has a lot of nerve. What a sad, sad person. I hope she goes to jail one day.
Lawremce
I can’t wait when the time comes when many with the FDA are doing HARD TIME in a Jail Cell. I want some REAL Justice.
ps..Kerry Donahue with CTL is my HERO!
Prostate Cancer Survivor
“the individual’s service outweighs a potential conflict of interest created by the financial interest involved.”
AND
“she has unparalleled experience and committee attendance is expected to be poor.”
AND
“Maha Hussain, a University of Michigan professor of medicine. According to her form, she holds stock in one of the sponsoring companies that is worth between $50,000 and $100,000, in addition to stock worth between $5,000 and $25,000 in seven other drugmakers, as well as shares in yet another drugmaker worth up to $5,000.”
AND
“In advance of an advisory committee meeting on Friday, an FDA review finds that Promacta, an experimental drug for boosting platelets, failed to control bleeding any better than a placebo.”
Now what are the chances Promacta gets an objective and unbiased review from the “only physician left in America with such impeccable experience?” Hmmmmmmmmm!!
UN–BE–LIEV–ABLE!!
Frank Burroughs, Abigail Alliance
The Abigail Alliance met with Randy Lutter two months ago and presented our list of important reforms that need to be made regarding the FDA’s advisory committee process. We have a follow up telecon today with Lutter to see if we have made any inroads. It is one of many tough FDA battles, but the Abigail Alliance doesn’t give up easily.
MikeK
Hey Congressmen Dingell & Pallone?!
Didn’t you say you fixed this?!
<>
And, am I reading this right? On her waiver it says,
Type of Interest
Stock
Involvement
Sponsor
Magnitude
Valued from $50,001 to $100,000
So she is invested in the Sponsor? Is she going to vote it down and hurt her investment which ranges from $50,001 to 100,000?
<>
Might that be her husband, Mr. Sal Jaffar (Hussain), who she claimed managed her portfolio when she helped derail Dendreon, leaving 30,000 American men a year to die without a viable treatment, while she, Howard Scher, Thomas Fleming, and Richard Pazdur sabotaged the immunotherapy Provenge which was voted overwhelmingly safe and effective by the panel. Some men are living today because they got Provenge!
CareToLive just lost another member to prostate cancer (see http://www.caretolive.com). It appears sabotaging valid treatments has been lucrative for some people.
What can you expect when it appears that according to the FDA there are only a few people around capable of being FDA puppets worth listening to.
So let’s review the law again:
Section 208(b)(1) provides that a waiver may be granted upon a written determination that the financial interest involved is not so substantial as to be deemed likely to affect the integrity of the service that the government may expect from the employee.
I really don’t know how these people get away with this.
Pixie
I find it ridiculous that an institution with as much power as the FDA does not have solid ethical rules embedded in the whole process of appraising potential drugs. Hussain should never have been on the Provenge panel with her overt COIs, and after her dissention (even going as far as writing a post advisory meeting letter against Provenge)even considering sitting on this panel exhibits a complete lack of ethics, as well as an abrasive arrogance.
The whole argument that there is no more qualified candidates than her is laughable. Is she an immunologist (concerning Provenge)? There must be countless others who know the intricacies of this drug as well, if not better, than Maha. Gimme a break.
The FDA is an utter failure. As an institution to serve the American public it should be completely transparent. Why is there no abject condemnation of this type of unethical behaviour within the FDA? Because the FDA has become ethically bankrupt. Not responding to FOIAs, continually lagging on novel, safe drugs; making many poor decisions that have adversely affected thousands of suffering people; and absolutely no accountability for the above.
As far as Von E is concerned FDA is still building bridges and leading the world in providing…blah blah blah. Von E is a crat’, his skills are double speak and political spin.
The most notable act during his whack at Commish is sending thugs to investigate flowers that were sent to him. This was done immediately, efficiently. Way to go Andy!
The corruption of the FDA is so rampant that I shamed by their “representation”. Maha, Howard Scher, Pazdur, and yes, Andy need more than a “skinning” from Rep. Dingell. They need to be held accountable for their reprehensible actions. Their actions need to be investigated immediately, at every level.
Jason
FDA SAYS, “WAIT” TO DYING MEN
COAST-TO-COAST PROSTATE CANCER DEMONSTRATIONS ON MAY 30th IN PROTEST OF FDA FAILURE TO APPROVE SAFE, EFFECTIVE IMMUNOTHERAPY
On May 30, 2008, CareToLive will take to the streets with coast-to-coast protests in Chicago, New York, Philadelphia, Cleveland, Madison, Atlanta, Seattle, Dearborn, and Tampa. Joining us will be the Cancer Cure Coalition, the Abigail Alliance, and A Right To Live. We are asking all patient advocates to come out and attend a protest.
1 in 6 men get prostate cancer. 75 American men die from it every day. The FDA has not approved a treatment for stage IV prostate cancer in over 43 years.
CareToLive, a not for profit corporation, seeks transparency and accountability from the FDA, as to why they disregarded the advice of their hand selected Congressionally mandated Advisory Panel of experts, who voted Provenge overwhelmingly safe and effective. Without cause or explanation, in an unprecedented action, the FDA denied licensure. We are seeking immediate access to Provenge for all men with end stage prostate cancer.
Over a year has passed, and 27,000 American men have died without hope, since the FDA denied the licensure of Provenge, an immunotherapy the FDA panel voted 17-0 safe and overwhelmingly voted effective. This is a noninvasive, non-toxic, immune building treatment, which works by employing your own body’s healthy cells to fight the cancer.
Men like Eduardo Garcia, who have had the 3 treatments, have gone from being incapacitated, to living healthy, productive lives, for as long as seven years and counting. Dendreon, the company that perfected this treatment, also has similar treatments for breast, ovarian, colon, lung, kidney, and cervical cancers, in their sights.
The dysfunctional FDA’s reason for delay has never been explained, as it was not science based, since survival and safety have been clearly demonstrated.
CareToLive filed a Citizens Petition for the FDA to reconsider the wrongful denial, (the only recourse the FDA allows), on July 26, 2007. The FDA has failed to follow Federal regulation and to this day they have not properly responded to our Petition, which seeks immediate access to Provenge for these desperate men. The FDA also refuses to respond to the CareToLive Freedom of Information Act request, which they know would prove that a few FDA insiders, who cared more about serving their own interests, rather than the best interest of the patients, purposely sabotaged Provenge.
“In memory of our members who have recently passed away, never having been given the chance Provenge recipient Eduardo Garcia had, we will continue to fight on, every day, in every way we can. Please come out and join us,” CareToLive spokesperson, Mike Kearney, said.
LOCATIONS:
Seattle, Washington — 1 PM PDT
Westlake Park (Downtown) — 400 Pine St
Coordinator - Jason Burdine jnaburdine@comcast.net
Chicago, Illinois — 3 PM CDT
ASCO / McCormick Place — 2301 S. Lake Shore Drive
Coordinator - Sean Morgan - morgan2174@yahoo.com
Co-coordinator - Arnie Mass - Ammass14@aol.com
Cleveland, Ohio — 4 PM EDT
Public Square outside terminal tower — downtown
Coordinator - Kerry Donahue - bedonwahoo@aol.com
Co-coordinator - Mike Bauman - jmb15mjb4@gmail.com
Dearborn, Michigan — 3 PM EDT
Rep. John Dingell’s Office — 19855 West Outer Drive — Suite 103-E
Coordinator - Gregg Burch - ctl-dearborn-rally@live.com
Madison, Wisconsin — 4 PM CDT
Wisconsin State Capitol Building — 2 East Main Street
Coordinator - Melody Davis - MDavis@caretolive.com
Tampa, Florida — 3 PM EDT
H. Lee Moffitt Cancer Center & Research Institute
University of South Florida
12902 Magnolia Drive
Coordinator - Ardeis Scott, MD - ardeisfka@aol.com
Philadelphia, Pennsylvania — 2 PM EDT
2 PM Assemble and pass out flyers at 12th & Market Street for march to FDA at
4 PM — 200 Chestnut Street U.S. Customhouse Building
Coordinator - Mike Kearney - publicrelations@caretolive.com
Co-coordinator- Rory Kearney - rk@caretolive.com
New York, NY — 9 AM ESDT
Memorial Sloan-Kettering Cancer Center — 1275 York Avenue
Co-Coordinators - Leslie Mulkey - lhrmulkey@aol.com
Kevin Ward - kward3@nyc.rr.com
Atlanta, Georgia — 3 PM EDT
Atlanta FDA Regional Office — 60 Eighth St. N.E.
Coordinator- Bob Madden - rjmcanoe@aol.com
For more information go to http://www.CareToLive.com
Brad
You have got to be kidding me??? She is still allowed back on an AC panel, again with these conflicts of interest? Is she an expert in this field of chronic ITP? The last I checked, she was an oncologist, not an immunologist. Sound familiar?? Another prime example of these doctors who say they are protecting the public when actually they are more concerned with protecting their investments and research. Why have an AC meeting in the first place? Where is the backbone of the FDA to not allow these conflicts? Absolutely disgusting!
Chandler
How can you have a stock that’s worth fifty thousand to one hundred thousand dollars? This is just a way of watering down the true value of the stock that she has in the company which is probably closer to the $100,000.
Matt
The FDA needs an outside agency to monitor its ethics and conflicts of interest. It’s absurd to think the FDA can do anything about its own ethics issues.
MyPharmalotID
Oxymoron of the Year: FDA Ethics
This would be a good time to ask what, exactly, the following individual, does for a living, day after day:
Vince Tolino
Director, Ethics and Integrity Staff
Office of Management Programs, OM
vincent.tolino@fda.hhs.gov
ethics@oc.fda.gov
Certainly, there’s been no evidence that his office has been doing it’s job since early in 2007…unless you call “rubberstamping” specious waiver requests heavy lifting in the ethics arena!
If he were doing what your and my taxes allegedly are paying him to do, we might see some resolution to the well-documented conflicts of interest (COIs) cases surrounding Drs. Scher and Hussain, beginning (?) with their participation in the Provenge Advisory Committee meeting on March 29, 2007.
Can I please have a tax refund?
Moonshooter
Maha Hussain just keeps rollin’ around like a bad penny looking for a place to rest. She keeps company with a few other bad pennies.
“and committee attendance is expected to be poor.”
Really! Would anyone wonder why after the way the opinions of the excellent experts who attended the Provenge AC were dissed and tossed aside like onion peels from grandma’s kitchen.
THE FDA NEEDS TO ACQUIRE SOME CLASS! TIME FOR CHANGE!
kyoto27
Let’s not be hard on Maha:
She may just be ‘captured’? And in exchange for bowing to folks like Richard Pazdur and the FDA party line, she gets the inside track on who Dick Pazdur will let Pass Go, which companies she can overweight in her stock portfolio and guarantees herself and family a good lifestyle? What’s wrong with that? And can we really fault Randall Lutter, Vince Tolino, Michael Ortwerth and Igor Cerny who need to grant waivers to avoid having the FDA embarrassed by any real opinions by doctors who may not want to show up just to play the party line? Or God forbid, to enrich themselves?
Wasn’t it Dr Maha Hussain and Dr Howard Scher who sat on the FDA’s Provenge AC and apologized for not knowing a damn thing about cancer immunotherapies like Provenge …but said they knew a bad thing when they saw it? Or were told to say it was bad? And then kept on saying it over and over and over again?
And why should Maha and Howard worry about doing the right thing when the FDA, DOJ, SEC, GAO, JAG could care less how the Mahas and Schers vote, or their COIs?
Our regulators know the country is losing its edge in technology and they also know it’s only a matter of time before we end up in the toilet –after all, they’re the ones leading us there. So you can’t blame them for wanting to get it now while the getting is good? Since when is it wrong in America to be just looking out for yourself because you can’t depend on Government? And who would know that better than those in our Government?
What a shame, what a tragic farce….
Poop Doggy
Hey, why not Cindi Lauper or Tiger Woods on the AC? I bet that either of them have as much or more recent experience with hematology than our favorite urologic oncologist, MaHaHa. How long…if ever…will we learn the REAL reason she was seated on this panel…and who paid to make it happen…
MyPharmalotID
The Greatest Performing Artists of All Times at the FDA, for your viewing pleasure (from InvestorVillage MB)
http://www.jibjab.com/starring_you/receipt/2111682
Jason
http://www.investorvillage.com/smbd.asp?mb=971&mn=199584&pt=msg&mid=4888767