Conflicts of Interest in Cancer Care

The architects of the Medicare Modernization Act wanted to remove the financial incentives that influenced oncologists prescribing patterns, and they’ve pretty much accomplished that task. But have they done the same to the drug industry’s ability to influence the way doctors prescribe drugs?

With nearly 700,000 senior citizens diagnosed with cancer every year, it’s obvious that the new Medicare drug benefit – just past its second open enrollment season – is playing a bigger role in the care of cancer patients. A recent study in the influential policy journal Health Affairs sampled the 3,000 Medicare drug plans that are available across the United States and found that virtually 100 percent of generic anti-cancer drugs were covered by the plans. And while one-quarter of brand-name anti-cancer drugs were not covered, most of those had generic equivalents.

The insurance companies had little wiggle room in drawing up the plans. The MMA specifically required coverage for “all or substantially all” chemotherapy drugs. So with most seniors now covered for outpatient drugs, and most of the profit wrung out of infusion drugs because of the switch from the “average wholesale price” reimbursement system to the “average sales price” system, it may change the way community-based oncologists treat their patients.

Why do I say that? In the “bad old days” of AWP, there’s little doubt that the system’s financial incentives influenced prescribing patterns. Another Health Affairs study in March found no evidence that reimbursement incentives under Part B affected oncologists’ decision when to administer chemotherapy to metastatic cancer patients.

But once that decision was made, they were more likely to use more expensive treatment regimens. “Oncologists are loath to acknowledge that financial motives can affect treatment decisions,” the University of Michigan/Harvard University authors wrote, (but) “it appears to affect the choice of drugs used.”

ASP plus Plan D should change that pattern. “These changes should make choice of agents based more on clinical considerations and patients’ preferences and less on reimbursement decisions,” they wrote.

Now I’m sure there are a more than a few oncologists out there who at this point are fuming. “How dare these researchers assert that I choose drugs for my patients based on how I’m reimbursed! I follow the guidelines. And if I use a drug off-label, I have to justify that on my Medicare claim with a published study showing it will help patients.”

True enough. But who writes the clinical practice guidelines and the medical literature? For instance, the American Society of Clinical Oncologists recently published updated guidelines on the use of white blood cell growth factor to prevent febrile neutropenia in patients on chemotherapy. I have no reason to question the guidelines. But as a layperson, I found it disturbing that nine of the 21 members of the committee had financial ties to Amgen, which manufactures the leading drug for this condition.

Indeed, Dr. Howard Ozer of Oklahoma University, who was the third author on this paper and the lead author of the previous set of guidelines issued in 2000 earned somewhere between $10,000 and $99,000 in consulting fees, somewhere between $10,000 and $99,000 in honoraria and somewhere between in $10,000 and $99,000 in research contracts from Amgen.

The second author on the paper, Dr. Gary Lyman of the University of Rochester, had a similar set of financial arrangements with the firm. Couldn’t ASCO find physicians without Amgen entanglements to write the guidelines that will have a major impact on how much drug the company sells?

The medical literature is similarly influenced by the pharmaceutical industry, as every physician knows. Medicare lists 15 journals that it finds acceptable as outlets for studies that can be used to justify the off-label use of anti-cancer drugs, ranging from the New England Journal of Medicine to ASCO’s Journal of Clinical Oncology.

ASCO recently recommended that Medicare add another eight journals to the list. These journals do not have uniform policies on letting their readers know if the authors of studies that appear in their pages have financial ties to industry. Many do not adhere to the International Committee of Medical Journal Editors’ guidelines requiring that any trial that leads to a published article must be registered in a publicly accessible database before enrolling patients.

This allows peer-reviewers to compare the endpoints in the published study to the original protocols for the trial (a good way to check for bias). Three of the eight journals proposed for inclusion in Medicare’s list do not automatically publish conflict of interest disclosures. None require clinical trial registration. Even ASCO’s JCO didn’t require clinical trial registration until it was brought to their attention.

If Medicare is going to allow published studies to determine payment policy, the least the agency can do is ensure that readers of those studies know who stands behind them. And when it comes to writing clinical guidelines, which ultimately are much more important in determining the protocols that physicians use, sponsors like ASCO should insist that the guideline researchers and writers be people without skin in the game.

This column originally appeared in the December issue of Bay Area Oncology News.

Posted by gooznews at January 3, 2007 09:11 AM