Cancer Drug Compendium Violates CMS Guidelines
6 CommentsBy Ed Silverman // May 19th, 2008 // 10:13 am
Medicare is nearing approval of three additional drug compendia that can be used to justify reimbursement for off-label use of cancer drugs, including one that violates agency guidelines on conflict-of-interest disclosure, according to Integrity in Science Watch.
The National Comprehensive Cancer Network’s Drugs and Biologics Compendium, which is drawn from its Clinical Practice Guidelines, fails to disclose corporate ties of the 20 to 24 experts who sit on its 44 guideline-writing panels. Instead, it lists all the companies which gave money or research support to any committee member without listing any specific member or the amount given, ISW writes.
In 2006, the Medicare Evidence Development and Coverage Advisory Committee recommended that any new compendia approved by the Center for Medicare and Medicaid Services carry public identification of “potential conflicts of interest of the compendia’s parent and sibling organizations, reviewers, and committee members,” ISW continues.
The NCCN website doesn’t disclose that Robert Motzer, an investigator at Memorial Sloan-Kettering Cancer Center who chairs the NCCN kidney cancer guideline writing committee committee, receives research support from Genentech, according to ISW. The NCCN Compendium listing for Genentech’s Avastin was recently updated to include its use in slowing tumor progression in kidney cancer, although the med wasn’t approved by the FDA for that indication.
In addition to the NCCN drug registry, CMS early next month may approve Elsevier’s Clinical Pharmacology and Thomson Healthcare’s DrugDex and its companion DrugPoints, ISW writes. The Elsevier publication relies on in-house scientist-writers who are prohibited from accepting any “gifts or benefits” from drugmakers.
Thomson uses outside experts supervised by its oncology advisory board, many of whom have ties to industry that are disclosed on its web site, ISW writes, citing Thomas Marsland, a Florida community oncologist who chairs the advisory board and reports owning stock in Genentech, as an example.
All three compendia received a critical review from the Agency for Healthcare Research and Quality’s technology assessment program, which analyzed the compendia’s reviews of 14 on- and off-label indications for commonly used anti-cancer drugs.
“Compendia claim to use evidence-based methods in their evaluation of therapeutic agents, (but) cited literature was often neither the most recent nor the most valid in terms of study design,” the reviewers noted. DrugDex was more likely than the others to list off-label indications, while the NCCN compendium was chastised for failing to discuss adverse effects.
“There’s an inherent bias in an organization that gets the majority of its funding from pharma,” Thomas Kaye, senior pharmacy director at Passport Health Plan in Kentucky, tells ISW. “Negative things do not get published. We deal a lot with access to care issues, and when we have limited dollars, we want to make sure we’re providing the most value for what we have. I would not like to see NCCN become an official compendium because of possible bias.”
NCCN, a free-standing non-profit created by prestigious medical centers like Sloan-Kettering, M.D. Anderson Cancer Center in Houston, and the Fred Hutchinson Cancer Research Center in Seattle, acknowledged “support from many companies.” Its web site lists 25 drug company supporters, but not the amounts given. NCCN ceo William McGivney was unavailable for comment, ISW writes.
The NCCN Clinical Practice Guidelines and Compendium, which is published by a consortium of 21 leading cancer treatment centers, follows the same policy as the American Society of Clinical Oncology. The ASCO disclosure form lists companies providing funding to researchers, but doesn’t say which companies gave how much money to which researcher, ISW notes.
ASA
Don’t let NCCNs non-profit designation fool you–they are more interested in profiting from their guidelines and compendia than actually advancing cancer care. Just take a look at the language in their end user licensing agreement:
3. Restrictions on Use.
You may not copy, transfer, reproduce, or create derivative works from, any part of the Guidelines for any reason. You may make and retain file copies of “Insubstantial Portions” of the Guidelines solely for your internal purposes. “Insubstantial Portions” means a quantity of data from the Guidelines that would not reasonably substitute for a comprehensive copy of the Guidelines and would not prejudice or diminish NCCN’s advantage in licensing the Guidelines for commercial gain.
The purpose of any clinical practice guideline is to improve patient care and outcomes–not to fatten the wallets of McGivney and his cronies at NCCN. Also note that their annual meeting and offical jounral JNCCN profits from drug industry funding.
It would be damaging if CMS were to use these guidelines as a basis for reimbursement, as private payers usually follow the government’s lead.
Lilli
NEW YORK (Reuters) - Sales of cancer drugs will grow at nearly double the rate of the global pharmaceutical market and could reach $80 billion by 2012, according to IMS Health, which tracks prescription drug sales.
IMS anticipates and expects cancer to be the Number 1 drug money maker.—–Perhaps our government should change that—and work on projects to prevent cancer.
Lilli
Jack2
ASA you could make the same attack on any scientific journal. Some company wrote those compendia, and they need to pay their employees. Do you go to work for free?
Gregory D. Pawelski
I find the Medicare Demonstration Project in Oncology that entails reimbursement to oncologists who report whether their treatment of patients adheres to recommendations in nationally recognized practice guidelines published by either NCCN or ASCO disingenuous. Protecting the status of treatments which are only marginally, minimally and inconsistently effective, prevents serendipitous and fortuitous discovery.
Sometimes I question an occasional guideline message on the basis of profit conflicts. Specialty medical societies work to insure their specialist members get reimbursement for common procedures/treatments, the drug industry works to produce evidence statements that promote use of their brands. I am not comfortable that many clinical trials are unobjective and balanced.
How long would a drug company pay researchers who continued to disappoint with poor drug efficacy trial results? And we know that poor outcomes in drug trials are often not reported to the FDA or the public.
I just love the way medical journals and medical education companies simply list the faculty physicians/authors with their pharmaceutical payment (conflict) history, like this makes every little statement authored, squeaky clean.
If so-called respectible Journals won’t publish articles because they have a lock-up on information, don’t lay blame on me for my thoughts. The use of clinical trials to establish prescribing guidelines for evidence-based medicine is highly criticized because such trials have little relevance for the individual patient in the real world, the individuality and uniqueness of each patient.
According to the chair of the Community Oncology Alliance’s QSP Committee, ASCO has technology assessments that are very limited and updates which are not timely, and NCCN guidelines are fine but many practices use other guidelines or develop evidence-based treatment guidelines for their own individual practices or modify guidelines based on evidence which they use as their defined evidence-based standards for their practices.
It’s a lousy system in cancer medicine. The best reform to the system is to totally remove the profit incentive from chemotherapy administration. Take medical oncologists out of the retail pharmacy business and force them to be doctors again. Continuing to do so is egregiously poor scholarship and an egregious disservice to cancer patients.
ASA
Jack2 my issue with NCCN is not that they pay MDs to write the compendia–it’s how protective and restrictive they are on the use of the product. They are soley trying to profit from the guideline and compendia development–improved patient outcomes is an afterthought.
Chip Reuben
If medical information was all bottlenecked by the FDA, we would progress more slowly than we already do.