How To Anger Prostate-Cancer Patients
5 CommentsBy Ed Silverman // September 19th, 2007 // 9:50 am
Not that there’s good reason to do so, but Maha Hussain may have found a way. Who is she? The University of Michigan oncology professor is best known as one of two FDA panel members who last spring voted against recommending Dendreon’s Provenge prostate-cancer vaccine. She then became notorious after she and the other panel member wrote letters to FDA staff arguing against approval.
Since then, a growing number of prostate-cancer patients (and Dendreon investors) have railed against her and the other panel member, Howard Scher of Memorial Sloan-Kettering Cancer Center, for alleged conflicts of interest. At a subsequent oncology meeting, the pair complained of threats and bodyguards were hired. Meanwhile, a lawsuit was filed against the FDA and sources familiar with this mess say the FDA is looking at the conflicts of interest issue.
Now, though, Hussain is likely to incur still more wrath. She is one of several co-authors of a study in the latest issue of the Journal of Clinical Oncology. And what is the subject? “Living With Prostate Cancer: Patients’ and Spouses’ Psychosocial Status and Quality of Life.” The purpose of the study: To examine the quality of life of men and their spouses during the various phases of prostate cancer. Their conclusion? Different phases require different programs.
That’s a no-brainer. Many prostate cancer patients are likely to tell you that. Many are also likely to say she is the last person they would want to hear from on this subject, since some believe their quality of life may be worse without Provenge. Whatever Hussain’s reasons for rejecting Provenge - and we are not questioning her right to vote her mind - her name on this study may add insult to what some patients say is injury.
MyPharmalotID
Dr. Hussain never should have participated in the March 29, 2007, Advisory Committee meeting on Provenge. She clearly was there to further Dr. Richard Pazdur’s agenda, which was to derail the approval of Provenge and ensure that CDER retained oversight of cancer drug approvals. That she is a consultant to Novacea, which competes with Dendreon in the prostate cancer space, represents a serious conflict of interest (COI), which was not declared on her waiver request.
FROM THIS LINK: http://www3.extendmed.com/prostate/cme.html
Faculty Disclosure Declarations
The following program faculty have reported financial relationships with commercial pharmaceutical, device or biotechnology companies as noted: Robert Dreicer: Berlex: consulting; Bristol-Myers Squibb: consulting; Eli Lilly: consulting; Novartis: Speakers’ Bureau; sanofi-aventis: Speakers’ Bureau. Maha Hussain: Abbott: research support; Bristol-Myers Squibb: research funding; Centocor: consultant/advisory board; Elan: consultant/advisory board; Merck: research funding; Novacea: advisory board, consultant; Pfizer: consultant/advisory board, research funding; sanofi-aventis: research funding. Philip W. Kantoff : Abbott: advisory board; Amgen: advisory board, clinical trials; ArQule: advisory board; AstraZeneca: advisory board; Bayer: clinical trials; Bristol-Myers Squibb: advisory board, clinical trials; Celgene: advisory board; Genentech: clinical trials; Genzyme: clinical trials; GlaxoSmithKline: clinical trials; Glycogenesis: advisory board; Novartis: clinical trials; OSI: advisory board; Pfizer: advisory board, clinical trials; sanofi-aventis: advisory board; TAP: advisory board; Watson: advisory board; Wilex: clinical trials. William K. Oh: Amgen: Speakers’ Bureau; AstraZeneca: Speakers’ Bureau; Abbott: consulting; Bristol-Myers Squibb: research support; Celgene: research support; Genentech: research support; Novacea: consulting; Novartis: consulting; Roche: research support, consulting; sanofi-aventis: research support, Speakers’ Bureau; Schering AG: consulting.
Three weeks after the FDA sent Dendreon its Complete Response (CR) letter, Novacea signed a co-development with Schering Plough for $440M to develop Novaca’s lead drug Asentar for prostate cancer.
Note, too, that Dr. Hussain was one of two AC members (Dr. Howard Scher was the other) who took the highly unusual step of writing letters to the FDA, arguing against the approval of Provenge. Her letter, as well as Dr. Scher’s (and another written by Dr. Thomas Fleming), was leaked to the non-peer-reviewed The Cancer Letter by party or parties unknown. The FDA has yet to identify who asked Dr. Hussain to write her letter (Dr. Scher has admitted to collegues that he was asked to write his letter), whether or not Dr. Hussain had assistance in writing her letter, what the COIs may have been reegarding anyone who assisted her in writing her letter, and who leaked her letter from the FDA to The Cancer letter.
Dr. Hussain also failed to declare the work of Dr. Salam Jafar (Hussain), her husband, in her waiver request. This work pertains to prostate cancer trials (Phase III Randomized Study of Docetaxel and Prednisone With Versus Without Bevacizumab in Patients With Hormone-Refractory Metastatic Adenocarcinoma of the Prostate). Trials such as this might have been impacted if Provenge had been approved.
R. Alan Satterly M.D.
What hypocrisy.
Hussain went out of her way to defeat a product, Provenge, which an FDA-sponsored AC Committee found, by a WIDE margin, to be safe and substantially effective for treatment of men with advanced stage prostate cancer. Then co-authors a paper lamenting the great difficulties faced by the same men and their families.
And to think that her brand of PCa treatment, chemotherapy, causes much of the “quality of life” issues for which the authors, including Hussain, are concerned.
So tell me, Dr. Hussain……why you couldn’t “Give Provenge A Chance?”
Pure hypocrisy.
I choose to support CareToLive!!!
Tony F
Isn’t there an old axiom reportedly existing in the Ivy Halls of higher learning of “Publish or Perish”?
Seems to me to be just another way for this “infamous” person to cut another notch in her publication count. The synopsis is clearly non-Earth shaking in its proposition and conclusion, isn’t it?
I’ll tell you that I still remain in shock over the laizze-faire attitude of the FDA in accepting, at face value without verifying, whatever one of their Advisory Committee members puts down on their Waiver application….. good ole boy Scher is THE prime example with his 3 “listed” COI’s to the FDA while net research suggests he has, at current count, 17 COI… and the 17 COI do not include that he’s reported to be on the Board of Directors at Sloan Kettering “and” an “Executive” of that fabled institution.
For Hussain to have neglected to include her hubby’s financial and profession associations–as if she didn’t live with him or as if she does share in the financial rewards he gains from his doctoring activities–is just plain nutzo.
Where is the FDA’s investigative arm in allowing Scher and Hussain to take such apparent nefarious actions without–thus far–any consequences: big or small?
Great piece, Ed, on this continuing saga…. hey, why don’t you consider writing an expose of the Provenge story? You’ve got the gist of what’s happening, a series of artciles and a lot of posts replying to your articles with info attached… investigative journalism at its finest…. give it a thought and put terror into the consciences of those who have good reason to fear exposure of their actions and associations!
Hussain… choose carefully as your actions and association can be tracked on the net easily… just like your good old buddy, Scher, whose 17 COI’s are becoming legendary!
mskccheats
TO: Human Resources, Employee Relations, Memorial Sloan Kettering Cancer Center (MSKCC)
RE: Sloan Policy on Conflict of Interest [COI]/clinical trials
FROM: Bioorganic Chemistry Laboratory, Sloan-Kettering Institute
Please clarify Sloan’s policies relative to the following Conflict of Interest [COI]/ethics issues: On occasion [e.g. when an article appears in the lay press] an intuitive (and persistent cancer) patient (or their proxy) accesses the Bioorganic Chemistry Laboratory via phone, seeking information about (and participation in) epothilone clinical trials conducted at MSKCC. In the past the non-clinician Ph.D. Administrative Manager [AM] (the spouse of the Principal Investigator [PI] who is also a Professor of Chemistry at Columbia University) of the high profile Bioorganic Chemistry Laboratory has instructed me (a junior, but not direct report) to keep secret (withhold/embargo) known information relative to the availability of clinical trials conducted at MSKCC on a (Bristol Myers Squibb [and/or possibly Novartis’] – developed epothilone derivative) drug candidate(s) that compete(s) directly with an epothilone analogue candidate that emanates from the Bioorganic Chemistry Laboratory, in variance with the above-mentioned queries and the fact that the AM had actually apprised me that a clinical trial on the competitor’s drug candidate(s) was or were commencing (or had commenced) at Sloan and then instructed me to embargo this information. The AM subsequently attempted to cloak her motives by stating “ours are better than theirs,†invoking early, at that point unverified comparative in-vitro and/or in-vivo data points (supplied by a colleague whose scientific methodology had been questioned on more than one occasion by disparate, mutually exclusive researchers, (grant and other) administrators and/or industrial courtship candidates who did not know of each other’s concerns about the Sloan colleague researcher). At that point in time the Bioorganic’s candidate was ~ an estimated 1 year from the start of a proposed and hoped for clinical trial (which has apparently since begun [off site, and possibly at Sloan]). The lab had smarted, being bested (and dropping out of a front-runner position) in a high profile natural product synthesis race when a staff process chemist charged with supplying an already solved piece of the puzzle reportedly used the wrong racemer of a reagent that was not checked appropriately by the A team prior to utilization, dooming an otherwise successful virtually complete synthesis to failure. Germane is a financially significant, development / rights purchase of a Bioorganic Laboratory epothilone drug candidate by Roche via Kosan (its licensee). Although one can understand the premise of not promoting a competitor’s product, that business tenet would clearly not be applicable in this situation at Sloan. Though I have been warned on more than one occasion to not report these problems by Sloan employees I’ve felt uncomfortable misleading seemingly desperate cancer patients or their proxies and I have always referred these queries to either the MSKCC Physician Referral help line or to administrators or nurse clinicians affiliated with the clinician under whose aegis the BMS [and/or possibly the Novartis] trial (and possibly, now, the Bioorganic candidate’s study) is apparently conducted at Sloan) for proper vetting. That the Administrative Manager would place her own potential financial successes and results above the content of the character of the Sloan-Kettering Institute does not surprise me. That she instructed (and expected me) to abet this initiative was out of line and evidence of a lack of respect for the Institute and for myself. I did not think that the AM would go so low as to expect me to do her dirty work or to drop her guard to the point that she’d expose herself, the lab and Sloan to this type of ethics liability, considering that the Bioorganic compound(s) might very well prove to be the best of the epothilone class, after proper clinical trial vetting. Such a tack, if followed would be in variance with that espoused [by Varmus, Nurse, Mendelsohn and/or Abeloff] on the “Titans of Cancer†television special. My parent’s first child died of complications from childhood leukemia at Memorial Hospital two years before I was born. A child with this affliction today stands a good chance of survival due in no small part to the therapeutic advances fomented at Sloan and other like-minded Institutions, yet if the above-mentioned bio-ethically challenged tack were allowed to continue unchecked, it would tarnish the otherwise important science and medicine that emanates from MSKCC and instead of properly steeling hope, Sloan Kettering would merely be stealing hope, one clinical trial enrollee at a time. There is a difference between proudly standing behind one’s brilliant work product and bending the rules when convenient for oneself, especially when lives may be in the balance and when the professionals bending rules are people and/or Institutions who clearly know better and who claim to be standard bearers of higher ethical practice. A US Army General (possibly a War-College dean/affiliate) has stated (I paraphrase) that Harvard MBA candidates learn to overcome ethics while pursuing a profit. Such an MO may be in variance with the COI and ethics policies of MSKCC. The above mentioned instance of craven self-servitude is coupled with other episodes of intermittently palpable disingenuousness at Sloan (e.g. that the AM is considered a “full time†employee, yet is often on campus perhaps 50% time and has had the temerity to complain during work hours via phone from off-campus that she could not check her stocks, peculiar acts of self promotion (e.g.: arranging for one’s own nomination for scientific accolades and acting surprised and naïve when awarded them), a protégé professor who fellowshipped in the Bioorganic Lab involved in his own hubris inspired imbroglio (retraction of multiple tenure facilitating papers and allegations of having an affair with a student and of her “irreproducible†data); the Bioorganic PI had reportedly been barred from consulting at a branch of a NJ based major pharmaceutical company, concerns about the efficacy of laboratory notebook record keeping and the egregious physical plant shortcomings at the Institute (a confluence of bizarre design, building/construction and facilities management flaws in the RRL laboratory building that intermittently, inappropriately render the RRL a toxic firetrap [whose cover-up (and the ruse invoked while duping a rightfully concerned local community, the community board and the city relative to systemic infrastructure problems in the RRL and safety issues at MSKCC that affect employee and community safety) that allowed for the hurdling of impediments to the construction of the new/replacement Sloan research tower and the granting of a zoning variance has included the conjuring and synchronizing of cover stories (as well as threats against employees who appropriately report environmental health and safety (EH&S) problems at Sloan) by MSKCC (facilities management and other Sloan administrators). Sloan had to previously abandon a building due to facilities/infrastructure problems that allowed for its employees to be exposed to unsafe levels of poisonous carbon monoxide]; these and other infrastructure problems affect reaction conditions and therefore stand to impeach the credibility of research conducted at Sloan (e.g.: cross contamination between supposedly mutually exclusive fume hoods and ductwork whose controls were unfathomably, yet knowingly, not installed properly by MSK). It has also been reported that the PI of the Bioorganic Laboratory has attempted to leverage (to the point of irritating) the clinician overseeing clinical trials at Sloan to continue and/or increase enrollment in a trial of the above-mentioned bioorganic drug candidate in variance with the clinician’s concerns about the bioorganic drug candidate’s efficacy and patient safety. This is significant because very large milestone dependent royalty payments are contingent upon continued enrollment of patients and/or completion of a clinical trial’s “Phase.†A high profile researcher/clinician (a deputy physician in chief) at Sloan has been arrested following an SEC investigation for insider (Imclone) stock trading; The former physician in chief committed suicide; Off-scale windfall profits have been available to biotech company insiders at Sloan, perhaps their fortunate tipees (e.g.: Ariad [stock ticker: Aria] whose stock price jumped one hundred (100) times or ten thousand (10,000) percent during a relatively short ~ five (5) month period (10/99-3/00) following assuaging of a “buy†impediment [the former Director of the Central Intelligence Agency, pardoned by President Clinton, has sat on the Board of Ariad]) and perhaps fortunate future tipees, were this type of lightning to strike again. Although the honest application of the forces of commerce (monetary reward for brilliant and properly vetted hard work) are appropriate, inappropriate leverage by a powerful non-clinician possibly resulting in someone being a pawn so that the non-clinician or the Institute could receive a royalty payment that lay in the balance, or the embargoing of known information about the availability of competitors’ clinical trial drug candidates are likely not. Congress has investigated the National Institutes of Health (NIH) relative to ethics/conflict of interest concerns (e.g.: the National Cancer Institute’s (NCI’s) erstwhile Director). So who’s minding the store and who can a desperate cancer sufferer trust if the guardians are equally or more concerned with their own stock portfolios than patient safety and drug efficacy? Some of these issues have been broached in the New York Times, The New York Observer, other press publications and even Michael Moore’s movie “Sicko.†For the protection of the Institute, in these times of heightened corporate, medical and pharmaceutical industry scrutiny and accountability, given that the research conducted in the Bioorganic Chemistry Laboratory is funded in part by government (e.g.: NIH RO1 [discovery] and RAID [scale-up for industrial development (the NIH researcher/administrator who vetted the Sloan epothilone candidate prior to award of an NIH RAID grant has since sat on the Board of Kosan)]) grants and philanthropic (e.g.: MSKCC Major Donor) sources and that MSKCC is reviewed (and accredited) by the Joint Commission on Accreditation of Hospital Organizations (JCAHO), please clarify Sloan’s policy relative to the ethics/conflict of interest awkwardness discussed in this note. One ought to be wary whether a greeting offered by Sloan to a cancer sufferer (especially one who is recruited to join a [lab to clinic] “translational†experimental study) is a compassionate smile or a smirk and whether Sloan is a leader in the fight against cancer or merely a cog in the “cancer racket.†There is a connection between the EH&S and ethics problems as potential and/or realized profit has affected the non-addressment of systemic environmental health and safety issues at Sloan. Has Sloan conjured and synchronized their cover stories relative to these issues as MSKCC has done in the past relative to other white-washes for which Sloan “conducted its own investigation†(eg: EH&S, “drug dealing†in its basement [the General Stores takes up a large portion of the MSKCC basement; yet one must ask how extensive was the compromising of the partially gov’t. subsidized General Stores)]? Is MSKCC following the Hippocratic or Hypocritic Oath? The PI of the lab discussed in this note is ‘predicted’ to win the Nobel Prize this year, see: http://scientific.thomson.com/press/2007/8407285/ People and Institutes capable of performing this level of science clearly know better than to act this way, especially when it is clearly not necessary. Shame on you! How dare you!
B A
Dr. Hussein’s vote concerning Provenge was not a vote against Provenge…read the issue and know what you are talking about.
There is no conflict of interest. She is an Oncologist with a leading University with a very good mind of her own. Yes I kow what I am talking about. I met Dr Hussein 2 years ago as a patient. I had/have an extremely advanced case of metastisized prostate cancer. Not much hope was given from any sources, however I chose to work with her because of the professionalism I encountered from her and her aid.
Nothing short of proffessionalism from then until now. The treatment she prescribed then has worked wonderfully. I am in better shape now than when I came to her. My PSA has stabilized at less than 1, (from a high of 87)and the cancer has not progressed, infact there has been steady improvement.
People who dont know her capabilities as an Oncologist are firing from the hip when the throw around unfounded accusations such as traitor, conlict of interest, & so on and so forth.
Think about this…prostate cancer has the nature of being somewhat gentically inclined. I have 4 sons, ages 12-29. MY sincere hope is that should any one of them incur this disease at any time in their life, It would be great to know that there is a treatment available that has stood the test of time..clinical studies and FDA approval for long term use instead of rushing it to the aid of those who are currently looking for a long shot to extend their life. Let’s take a good long look at our children and future generations onthis matter. Get the product properly tested with no flaws (like Vioxx, etc.) so that their future is brighter than ours. Dr. Hussein has not come out against Provenge. She has stood up for the process by which to prove this drug worthy in the long run to be used by our children and posterity. Stop thinking about yourselves and think about them. Dr. Hussein, do not allow cheap shots and lowlifes to derail you or your beliefs. Stick to what is right and proper. That is what you are made of..tough stuff and I for one think you are the cream of the crop. You’ve got what it takes to make this a great chapter in medicine. Dont back down.
An appreciative patient,
BA Flushing MI