Physicians For Provenge? A New Lobbying Tactic
26 CommentsBy Ed Silverman // February 7th, 2008 // 10:47 am
It had to happen sooner or later. Prostate-cancer patients have filed lawsuits and furiously lobbied their congressional reps to investigate FDA review of Dendreon’s Provenge vaccine. Now, several doctors, who have already been actively involved in the battle, have formed a new ad-hoc group in hopes of finding another way to generate attention to the controversy.
The controversy, by the way, erupted last spring. An FDA advisory panel recommended approval, but then two FDA panel members wrote the agency urging delay and the FDA agreed. However, patient advocates filed a lawsuit against the FDA, charging the panel members held undisclosed financial conflicts of interest and alleged a Byzantine power play involving a key FDA official who sought to sway the approval.
For the moment, Physicians For Provenge is nothing more than a handful of individuals, but creating such a group is, of course, a means to attract other docs to the cause. In their first move, they have written a letter to members of the House Energy and Commerce Committee, urging an investigation into the FDA, something several other congressmen have already done. Here’s the letter.
“If a medicine can obviate or at least reduce the use of a toxic drug, such as chemo, then it would noticeably affect the pain and suffering I witness and treat,” Charles Bennett, a Fond Du Lac, Wisconsin, anesthesiologist, who says he often treats terminal cancer patients for chemotherapy side effects, among other things. “This is something that needs to be addressed. And I’m not just talking about Provenge, but the way the FDA looks at making medications available to patients. As far as I’m concerned, this is a sin of omission. The FDA approves drugs, such as Vioxx or Avandia, that have problems, and these get all the attention. Here, men are dying. In some ways, it’s much more heartbreaking.”
The letter, by the way, is also being used to circulate a petition seeking FDA approval.
Richard Jaeger
My brother has an advanced/aggressive form of prostrate cancer that is no longer responding to hormone treatments. After receiving an infusion of three units of blood on 2/1, he started chemo on Monday 2/4. Had Provenge been rightfully FDA approved last Spring, he could have started treatment and his prognosis for survival would have been greatly improved. Now due to greed and malfeasance on the part of at least two FDA panel members, my brother has been given a death sentence. He will not see his 65th birthday and leaves a devoted wife and three children.
Thanks FDA. Richard N Jaeger.
Rick Wilson
Bravo doctors! May truth prevail and those guilty of derailing provenge for financial gain serve time.
Giancarlo Nicoli (Pharm. D.)
I’m a pharmacist. I know a thing or two about health issues and medications as well.
Please add my signature to the ones listed in that letter.
Thank you.
Regards,
Giancarlo Nicoli, Pharm. D.
Appiano Gentile
Italy
Paul
What an elegant letter!
Peter C. Lee, MD
Please add my name to this fine letter.
Provenge now!
Teddyboy
On behalf of all advanced prostate cancer patients, I want to say, “thank you” to these men of integrity.
May God Bless You All,
Ted Girgus
David
Thanks Ed. As usual you are right there with your reporting. I can only add my agreement with all of the above and thank the M.D’s. for the letter.
Scott
Thanks for covering this tragic story. We forget that democracy works only when the people make it work. For that to happen, the people must be informed. These doctors did their part. You did yours. Now, will Congress respond? If, in a compelling case such as this, Congress cannot act swiftly and decisively, we are in big trouble.
Paul
I’m very supportive of the efforts to get Provenge and other drugs like it into the hands of patients with terminal conditions like advanced PC. The FDA is way behind in the processes it uses to balance risk and reward in these cases. I’m also an investor in Dendreon, the company that manufactures Provenge.
Since the request for congressional hearings is largely about concerns over conflict of interest it would seem appropriate for the doctors who signed this letter to make some sort of declaration about their own interests in Dendreon. I’d like to think this was an oversight and hope they will make some sort of statement that helps assure everyone concerned (especially Representative Dingell’s office) that no such conflict of interest exists on their part.
Lucy
A fiduciary duty is the highest standard of care imposed by law. As employees of the FDA, Howard Scher, Maha Hussain, Richard Pazdur and Andrew von Eschenbach each have a fiduciary duty up hold to all Americans. As ordinary citizens, you and I are not held to the same high standard. As a employee of the FDA, each are expected to be loyal to and act in the best interests of all Americans. They each must put aside their own personal interests and must not profit from their position. The foundation of their position is based upon good faith, loyalty, and trust. A fiduciary must not put themselves in a position where their interest and duty conflict. Howard Scher and Maha Hussain each should have recused themselves from the Provenge Advisory Committee.
In the case of Howard Scher, his fiduciary duty at the FDA also interfered with his fiduciary duty at Proquest Investments. This is like a lawyer representing both the plaintiff and the defendant in the same legal matter. The lawyer cannot make the either the plaintiff or the defendant’s interests a top priority if both the plaintiff and the defendant’s interests are diametrically opposed.
bullit18
Paul,
Wow. Did you question Fleming’s lack of disclosure in his letter but of course a gov’t employee with influence on a regulatory body AND COI’s AND a history of being kicked off AC’s for COI’s(which is pretty impressive BTW) is comparable?!?. Next time you dial 911, be sure to disclose any investments in refiners, motor companies or ammo stocks before you ask them to rescue you or your neighbors. And if you’re soooo concerned, call the doc up interviewed in the pharmalot article yourself and ask him. No? I figured as much. Just a game to you.
MyPharmalotID
Paul, Just because someone owns Dendreon stock doesn’t mean they shouldn’t pursue the injustice that’s been done as a result of the collusive activity within the FDA and NCI to derail Provenge approval. Look at what’s happened this way.
Let’s say I am part owner in a business. One day, a man and a woman come in, in full view of everyone, and rob my establishment. They take everything I need to run my business for at least a year! They aren’t wearing masks; it’s easy to see who they are. I easily can identify them to the authorities. In fact, the local cop was right outside, eating donuts and, in general, not paying much attention to what’s going on in the real world at all. I even caught the entire license plate of the car in which this man and woman drove off with all my inventory.
To add insult to injury, the next morning, I awoke to find that this man and woman planted a Letter to the Editor in the local newspaper, accusing me of all sorts and manner of less then acceptable behavior in the community…charges that will keep me busy for at least a year while I try to clear my good name and restore my business.
Am I not to pursue these two people with all avenues open to me, within all options that society offers? Or do I just sit back and accept their unethical and illegal behavior, hoping that within a year or so, if I can survive, I might be able to open my doors again?
What would you do?
Craig
Thanks Ed for continuing to grant coverage to this story, it is truly a matter of life and death. Every now and then in life we are presented the opportunity to step up to the plate for our fellow man and go the extra mile, to really make a difference; yourself, the physicians who wrote and are supporting the “letter”, and all those who have championed the cause to right this terrible FDA injustice have all answered ‘the call’ in a magnificent manner…Thankyou so much.
Paul
bullit18 & MyPharmalotID,
I’m afraid you both missed my point entirely. I’m not personally calling into question the motives of these doctors. I believe them to be sincere and commend them for speaking out for a cause that they believe in, beliefs which I share.
My point is simply that the letter is offered as a form of testimony to a committee that has been asked to look into conflict of interest charges. If the authors are asked to provide direct testimony at such hearings it would be expected that any financial interest they have in the outcome would be made clear. By including the information in the letter itself the authors could have clarified an obvious question up front.
It is not necessarily a bad thing for a doctor to hold stock in a company that provides treatments they believe are effective or promising. In fact, it seems like a logical investment to me. The issue is transparency. Let us not pretend that such information is unimportant when considering testimony about an issue already focused on conflict of interest.
Lucy
Paul,
I don’t not see the need for the doctors who signed this letter to make some sort of declaration about their own interests in Dendreon. The difference being that as employees of the FDA, Howard Scher, Maha Hussain, Richard Pazdur and Andrew von Eschenbach each have a fiduciary duty up hold to all Americans. As ordinary citizens, you and I are not held to the same degree of prudence and caution required as an employee of the FDA. The doctors may have some bias, but certainly do not have the same legal obligation as either Howard Scher, Maha Hussain, Richard Pazdur and Andrew von Eschenbach each have who have a special duty of care of all Americans.
Separately, as I recall, Dr. Fleming’s letter to the FDA against Provenge had no disclosure whatsoever of his own coi’s that he felt were significant enough to recuse himself from consideration and participation in the Advisory Committee of Provenge.
paul_1149
This is an absolutely great idea. The regulatory gatekeepers are in the hands of special interests, as we have all too clearly seen, and the FDA shows absolutely no internal interest in cleaning house. Physicians are left as pawns in this corrupt game, forced to watch helplessly as their patients die agonizing - and often unnecessary - premature deaths. This gives them a voice with which to fight back.
Now let’s get the word out so other doctors and medical professionals can get onboard. Only by all segments working together will reform be forced on what is clearly a most regressive agency, the FDA.
p.
Paul
Lucy,
You write, “The doctors … certainly do not have the same legal obligation as (the special employees of the FDA)”
This is true without question. Absolutely.
Again, the issue is transparency, credibility and conflict of interest. I have no reason to question any of these fine doctors. It is simply that their input to the committee carries more weight if they have no financial interest in the success of the treatment outside of their practice. If any of them do then its not a crime, its just better to have it out in the open. They are not obligated in the least. Its that simple.
Prostate Cancer Survivor
Paul,
Your way of thinking seems to suggest that everyone on the E&C Committee should disclose their conflicts of interest, as well. Will you be asking the committee if they are investors? Where do you draw the line?
bullit18
Paul,
Your (at best)naivete is missing the key points. First is that these docs play no role in the regulatory process. So pushing this issue is simply a smokescreen used by those with conflicts of interest(and didn’t disclose them) and then obstensibly manipulated the system in which they were required to disclose COIs(just like the mayor whose brother-in-law gets the big public works contract). Second, they made it quite clear they would prescribe the drug to some of their patients-so I think that answers your question in any event. Third, what about those with the ultimate conflict of interest-survival? Wouldn’t that lead to biased input? So shouldn’t people dying and wanting this drug disclose that when writing their congressperson? Sounds pretty silly to me but it sounds as though you would ask these docs to disclose whether they themseves(or a family member) are dying from cancer and want to try this drug.
You clearly believe the system we have now with full disclosures, transparency blah blah works. It doesn’t.
Full Disclosure: I’m a fringe fan of those who question authority(because of an endless stream of gaffes like this one) and skeptical of the power brokers who endlessly commit them.
Howard
I think that Pharmalot should disclose all his stock holdings and investments. How do we know that you are not in bed with those entities against the pharmaceutical industry?
Idle Observer
It’s not Ed, it’s the lunatic fringe that dominates the replies.
bullit18
Peter C. Lee, MD.
Click here to add your name: http://www.petitiononline.com/provenge/petition.html
Ed Silverman
Hi Howard,
As a journalist, I don’t invest in the companies that I write about. This is a commonly accepted rule aong journalists.
I’m not sure what you mean by ‘entities against the pharmacetical industry.’ But to keep it simple, I don’t contribute to organizations that exist to promote or criticize the industry.
Hope that helps,
ed
Paul
bullit18 -
It appears that you don’t understand what conflict of interest means. Your suggestion that patients somehow have a COI simply because they have an interest in alternative treatments makes this clear. On the contrary, their interest are directly and visibly aligned with their actions.
Also, your assumptions about my beliefs are presumptuous and incorrect. You state; “You clearly believe the system we have now with full disclosures, transparency blah blah works.” If you had been paying attention here you would understand that I believe that we do not have enough transparency and that full disclosure is good, and something we need more of. Full disclosure allows us to make better informed decisiions.
Note that Ed does get it. His simple statement above makes it easier for us to conclude that his reporting is not influenced by any direct financial interest in Dendreon or other companies he reports on.
Finally, please note that I have never said that the doctors who signed the letter ‘must’ disclose financial interest in Dendreon, or that they are legally obliged to. I simply said that it would strengthen the weight of their input considerably if they provided such reassurance. Its really quite simple.
Mad Jayhawk
Are the doctors who are willing to sign any petition to get this drug approved also willing to pay the drug company’s defense costs out of their own pockets if the drug is rushed through the regulatory process and is later found to be a significant safety risk to patients? Anyone can sign letters and petitions. Their assets and reputations aren’t on the line are they?
The doctors involved in pressuring the government have probably not read all the studies submitted to the FDA. If they haven’t how can they make an informed decision as to the efficacy and safety of the drug?
Lucy
Jayhawk,
The question is not one of safety. Provenge has undergone 3 1/2 phase III clinical trials. The most commonly reported adverse sided effect is transient fever and chills (like those you would expect with any blood transfusion). Never before in the case of a life threatening illness, has the FDA decided counter to the approval recommendation of its own Advisory Committee and delayed a safe and effective therapy from reaching the terminally diseased where there are no superior alternative forms of treatment.
Provenge works, in the opinion of the country’s leading immunotherapy experts, and in the opinion of NCI scientists who published their opinions in a peer reviewed journal last July, and in the opinion of leading urologists who have been involved with the clinical trials.
Undisclosed conflicts of interest (and FDA infighting) delayed Provenge approval. Every day this drags on unaddressed, means more patients die needlessly. Public attention to this shameful tragedy is growing. There are growing numbers of outraged family members and other citizens who are going to hold our government accountable.
Provenge is qualitatively different from, and should be judged by different criteria than, survival data from chemotherapy drugs (as recognized in a July 1st National Cancer Institute research report by Jeffrey Schlom, Ph.D., chief of the Laboratory of Tumor Immunology and Biology at the National Cancer Institute).
There must be standards to public duty and there must be accountability and consequences for failure to meet the necessary high standards. Maintaining the integrity and dignity of the FDA is essential for maintaining high levels of public confidence in our institutions of government.