Cancer Alliance To Disclose Conflicts Of Interest
17 CommentsBy Ed Silverman // June 13th, 2008 // 1:13 pm
In response to criticism, the National Comprehensive Cancer Network, which is an alliance of 21 leading cancer centers, has decided to expand its disclosure policy and make public all potential conflicts of interest of all individual expert panel members by the end of 2008.
The move, which was made last week, followed complaints that the NCCN’s Drugs and Biologics Compendium for failing to disclose corporate ties of the 20 to 24 experts who sit on 44 guideline-writing panels. Instead, the NCCN listed all companies that gave money or research support to any committee member without listing any specific member or the amount given. The compendium may be used by Medicare to justify reimbursement for off-label use of cancer drugs.
Historically, the NCCN has disclosed the names of companies with whom there are relationships,” William McGivney, NCCN’s ceo, in a statement. “We now will apply that to individuals so that the public may better use the scientific, evaluative information that we provide.”
This is a win for Integrity in Science Watch, an advocacy group, that tracks, among other things, conflicts of interest in the science and medical communities and that had first criticized the NCCN for failing to provide greater disclosure.
“Now that NCCN is finally going to reveal the conflicts of interest of its guideline writers, let’s hope that the American Society of Clinical Oncologists starts doing the same,” Merrill Goozner, who directs the Integrity in Science Watch, writes us. It is completely outrageous that none of the abstracts released just before ASCO’s annual meeting in Chicago contained any information about the financial relationships to the drug industry of the individual authors.”
“But transparency only goes so far. Long-term, what patients and community oncologists deserve is guideline-writing committees at NCCN that have fewer ties to industry,” he continues. “Before the government, insurers and sick cancer patients…begin shelling out big bucks that companies are demanding for these drugs, it would be nice to know that their off-label uses were included in compendia like NCCN’s based on recommendations that came from guideline-writing committees where none of the physicians had direct financial ties to the companies that make the drugs.”
Paul
Congratulations to Integrity in Science Watch! This is just plain common sense! Shame on ASCO.
Paul G
Just to be clear, we must have two different Pauls. From now on I will post as Paul G.
I agree that disclosures are good, but also do not agree with the belief that all of this should happen with zero direct or indirect industry involvement. These are the same world-class experts who do clinical trials on new treatments.
The downstream consequence that I worry from all the extremist advocacy is:
- True world experts will continue to do the basic and clinical research that is funded by industry.
- Over time, those world-class experts will be prohibited from doing medical education, advising the FDA, sitting on guidelines committees, etc.
- Therefore all these important activities will be performed by the second tier people who can teach and write but do not have hands on expertise with the new science.
Talk about throwing out the baby with the bathwater. That’s why disclosures work and restrictions don’t.
HorusCat
Paul G,
There is also the jump to the conclusion that if a POTENTIAL COI exists, actual corruption must be occurring. Underlying that exercise in solipsism is the assumption that the industry and anyone connected to it is motivated only by profits and not by any altruism, and therefore is always greedy, evil and perverted. In fact, wasn’t it Adam Smith or another great philosopher/economist who noted that self-interest coinciding with altruism works wonders?
Sisyphus
There should be 2 types of “experts.”
Experts with drug-company ties should be just what they are…”paid experts.” An analogy is like paid experts in a trial. They are “experts,” we listen to them, but the decision makers (ie, those who write the final guidelines) should not be paid (ie, not have a conflict of interest.
It is arrogant to think that there are not enough unpaid experts who know how to listen to the paid experts, evaluate the published evidence, and make the right decision. Judges and/or jurors should not be paid by those trying to plead their case.
CMC guy
Paul G & HC thank you for well stated views on COI. I am amazed that the anti-pharma prejudice immediately jumps to corruption and conspiracy rather than believe people can act appropriately. If applied to other groups it would not be tolerated (e g racial profiling). I know it does happen but to categorize the entire industry because the misbehavior of a few is not a correct position.
Sisyphus you use a trial analogy but fail to mention the lawyers, who are the ones doing the pleading. In general lawyers frequently have COIs that are accepted since they are bound by a code of ethics and are largely self regulating. I think others can likewise act accordingly.
HorusCat
CMC guy,
Bravo. I agree. I would jump on my favorite hobby-horse and add that if individuals had to pull money out of their wallets to pay for their care, despite whatever guidelines are in place, they would make wise decisions about risk/benefit.
I see this with myself–my FP wants me to use hormone creams to deal with the inevitable inconveniences of peri-menopause. My insurance won’t pay the $70 per month for this–and I would have to drive across town to a compounding pharmacy to get it. I have decided it is not worth the time and the money. I’ll just wash my sheets more often after the night sweats! On the other hand, I would gladly pay out of pocket for my Lipitor (since despite being a madly-exercising vegetarian, my cholesterol is well over 300) and my Zoloft (since my life insurance won’t pay my husband if I commit suicide, and when I don’t take it, he considers homicide!). The problem is we don’t have a system where people are forced to make these decisions. When nobody pays, everybody pays.
HorusCat
What does CMC stand for? Horus is my cat. Well, obviously, I guess. Although I was accused of Satanism and other things when I first started posting.
Paul G
HorusCat and CMC,
Congratulations on your well-reasoned and balanced arguments. Maybe bit by bit reason will take over instead of allowing the extremists to hijack the debate.
Yes, there are problems, yes there are POTENTIAL conflicts of interest, yes there has been wrongdoing…but this does not mean all drug company employees are crooks, nor it means that every doctor hired for their knowledge and experience automatically becomes a crook when the check comes from a corporation.
HorusCat
Thanks, Paul G. I always have to check myself for hematomas after being on this site for awhile–the level of rancor and venom never ceases to amaze me. Then I go out and do my job and rediscover that the vast majority of Americans appreciate the medical care they receive, and the majority of physicians believe I have value to them, their patients and their staff.
CMC guy
HC, I ‘m a bit surprised being in the industry you do not know CMC is Chemistry, Manufacturing and Controls and is what I am involved in (started using on in-the-pipeline where mostly med chem/discovery discussion). I have accepted that this area is often under appreciated by discovery side as well as the commercial/marketing side but am confident in knowledge that CMC is critical backbone to efforts of other parts. As I touch or am directly involved with many of those other parts of pharma functions my interest’s spans the spectrum.
BTW I appreciate your willingness to confront errant people on this site although I have mostly given up since many are intransient bashers (plus my mother taught me if you can’t say anything nice…).
HorusCat
CMC guy,
Wow. I didn’t know that. You know us sales folks–it’s all about us. :+)
Did you mean intrasigent? Because they are that indeed. I stick around only because of people like you, Justice, Atlex, etc.
And I find it interesting sociologically. I find the obtuse obstinance to be similar to what I with politics–mostly “progressives.” There was a website I visited some months ago: Stuff White People Like. Or something like that. Hating corporations was one of those things. American progressives will kill the goose that lays the golden eggs, even as Western Europe and England begin to find that they cannot sustain the societies THEIR progressives have built.
CMC guy
HC, thanks you provide correct word, brain-keyboard disconnection with tendency not to proof read.
Being in R&D I view Sales/Marketing as a “necessary evil”.
HorusCat
CMC,
Necessary evil? Ha! The engine that drives the company!!! What would we do with all your R&D without sales? Who would pay your salary? <:+) I think it would be valuable to have a tour around all the company facilities, because so much goes on that we don’t know about!
CMC guy
HC, hi again: Yes paying for R&D is the “necessary” part of the equation however I would suggest sales closer to the fuel to run the company. I agree that it would be of great benefit for different functions to see and learn about activities of others areas since ultimately is takes combination of all to be successful. That aspect probably is biggest advantage of small companies where interactions are usually broader and more direct so can have greater understandings and less tension when working together.
Jordan Baker
It is ridiculous to suggest that “Long-term, what patients and community oncologists deserve is guideline-writing committees at NCCN that have fewer ties to industry.” Patients, community oncologists, and everyone using guidelines such as the NCCN guidelines to help make coverage and care decisions deserves that the people writing the guidelines are the absolute top experts in an area. Is it any wonder that groups such as NCCN and companies seeking speakers and researchers go to the top people in oncology to get their information? If guideline-writing committees were full of people with no ties to industry, they would be full of medical residents and fellows, perhaps. All of us who are in the world of medical research know that the reason the top researchers and experts have ties to industry is because industry is the group that has the funding and is able to provide financial support for research to happen. If the government or other groups stepped up to provide funding, researchers would be able to have fewer ties to pharmaceutical companies.
Tony F
Rather than talking in the abstract, let’s look at a concrete example of a Conflict of Interest story…
March 07, the FDA held an Advisory Committee meeting on Provenge, a treatment for TERMINAL prostate cancer. 17 members made up this AC.
One, Dr. Howard Isadore Scher of Sloan Kettering in NYC certified to the FDA that he had 3 COI which enabled him to sit in judgment of Provenge that day.
The AC voted 17-0 that Provenge was “safe” and 13-4 that it showed “substantial efficacy” with Scher being 1 of the 4 No votes.
Immediately after the AC meeting when Provenge was overwhelmingly voted favorably that that the FDA consider APPROVAL for Provenge, Scher and others began a writing campaign which consisted of 3 individuals each writing a CONFIDENTIAL letter in opposition to the FDA against Provenge Approval… nicely spaced 1 week apart and all 3 were “leaked” to a cancer publication run out of the basement of a Washington DC home.
Internet research has shown that instead of the 3 COI Scher reported to the FDA, he has at least 17 as the allegations against him state. They are and please particularly note #1 and #17:
1. NOVACEA:
… Grants & Research support;
… STUDY CHAIR of DN-101, Asentar-since HALTED as ineffective
… 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 MYERS SQUIBB: Consultant, Grants & Research
6. MILLENNIUM PHARMCEUTICALS: grant of Research support
7. COUGAR BIOTECHNOLOGY: Principal Investigator; Advisory Board;
8. INNOVIVE PHARMACEUTICALS: Principal Investigator, Scientific Advisory Board
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 (March 6, 2007; since removed , but cached)
13. CONFOMA THERAPEUTICS: Scientific Advisory Board
14. DEPARTMENT of DEFENSE: Principal Investigator PC Clinical Trials-P1 and P2
15. AMBRILIA BIOPHARMA INC: Principal Investigator PCK3145, Phase I/II
16. MEDIVATION, INC: Principal Investigator MDV3100
17. PROQUEST INVESTMENTS:
… Consultant;
… Scientific Advisory Board;
… Limited Partner FINANCIAL interest.
There is a dire need for having Conflict of Interest regulations AND for enforcing them.
CMC, in an early post, seems to have rose-colored glasses on… there is plenty of COI going on and he’s proof it 1.
CMC guy
Tony F I almost missed your snide comment since followed another one of your lame repetitive posts that due to the dark glasses of suspicions you wear misses the inconsistencies of most of your list. I think you express the extreme view that mere existence of ties is negative, that is worrisome. A potential COI does not necessarily mean it always controls ones actions. I agree that disclosure is good, to help understand possible motivation, but when presuppose people can not act without evaluation to avoid improper influence that smacks of prejudice. There where a number of Immunologists on the AC so by your rationale they have COI (in favor) so votes should be ignored (please provide list all their connections if you want to fairly contrast).
Your list can be viewed in different light:
Stock ownership in or Consulting for or Grants from Pharma in and of themselves do not automatically entail an blocking COI (if it did there would be few truly qualified candidates for ACs, first rule in investment is to do so in areas one knows- MD know pharma).
Not sure how to classify DoD Prostate Cancer Study and even though believe some of the other studies do involve “competitors” in Prostate Cancer you over inflate the meaning/role of PI or SAB (its variable but in many cases they are somewhat figurehead type roles that is much less then a consultant function). Where any/all of these competing studies even active when the AC was held? Don’t know the rules however if have to list all previous interactions again think would rule vast majority out of participating.
NOVACEA/ProQuest are linked so should be single entry. Do you know which COIs where reported and that this was not one (I don’t think is public unless through a lawsuit)? If this was provided then point is moot.
So most of your list is weakly supportive of COI unless you wish to assume the negative.
In fact I am actually not attempting to defend Scher but your list suggests someone highly active and familiar in Prostate Cancer. I believe Hussan, another dissenter, was also directly involved in this field. You assume COI motivated however could it be that they have seen such promising data in other studies that did not hold up? How many others on the AC had direct experience in Prostate cancer and could make such a judgement? A PI from Provenge study did speak and offered positive report but he was paid Dendreon consultant, so should he be ignored?
Unfortunately Provenge fell to approvable level on the 2 failed studies (not meeting endpoints) and insufficient data to verify the potential promise it seems to offer. Blaming this on AC members does not tell the correct story and detracts from other issues involved such as apparent Dendreon missteps (studies too small and improperly targeted, CMC issues?) and overly rigid statistical standards currently applied by FDA (post-hoc analysis burden too high).