Testimony Submitted to the FDA Oncologic Drugs Advisory Committee Meeting , May 10, 2007
Maryann Napoli, Associate Director,
The Risks of Erythropoiesis-stimulating Agents For Use In The Treatment Of Anemia Due To Cancer Chemotherapy
I’m Maryann Napoli, associate director of the Center for Medical Consumers in New York City. We have never taken pharmaceutical industry funding. (No drug company has ever wanted to give us any.) I write often about cancer and drugs because our mission, as an organization, is encouraging people to look for and to understand the evidence that supports their treatment decisions.
The story of these anemia drugs and how they were oversold to the public and how financial incentives encouraged oncologists to overprescribe them is truly outrageous. Like me, many Americans probably first became aware of them while watching the evening news. Those ubiquitous Procrit TV ads all had the same scenario – the cancer patient undergoing chemotherapy cannot continue the work he or she loves because of disabling fatigue. Procrit quickly turns things around, and the cancer patient is back on track enjoying work again.
Who among us on chemotherapy would not ask their doctors for this drug? And even if you didn’t have cancer at the time of this ad campaign—very likely the message would stay with you. There is a drug that quickly cures chemotherapy-caused fatigue.
Imagine my surprise when I read two months ago of a FDA press briefing about the new warnings to be added to the labels of all anemia drugs. Dr. Richard Pazdur announced that there has never been any evidence to support the claims that anemia drugs can increase energy or ease fatigue in patients undergoing cancer chemotherapy.
Why, then, did the FDA allow Johnson & Johnson to run those Procrit ads?
I’m glad that the FDA sent warning letters to members of professional organizations, but what about the cancer patients? There are numerous cancer patient groups across the country. Surely, they should have been notified, too.
I’m glad the FDA held that press briefing. But what about the TV-watching public? That is the majority, after all. As a result of the press briefing, some articles appeared in the print media. But the newly identified risks of anemia drugs and the circumstances in which they are likely to occur are simply too complicated for TV medical reporters. They would have to explain off-label use; and how the greatest harm appears to be associated with off-label use; that raising hemoglobin isn’t equivalent to reducing fatigue; how anemia can be caused by chemotherapy or the cancer itself; that deep-vein blood clots and heart damage occur when anemia drugs are given in excessively high doses.
Weigh these complicated concerns against that simple TV message about Procrit. No Procrit ad that I ever saw had a cancer patient saying, “This drug helped me avoid a blood transfusion.”
Johnson & Johnson was allowed to train current and future cancer patients to demand these expensive drugs for what we now know is an evidence-free indication. Given what we now know about the increase in deaths, deep-vein blood clots, and heart damage associated with anemia drugs, the FDA should require J & J to run a corrective ad campaign. These ads should be run on prime time TV—shows with the same demographics as the evening TV news and at the same frequency.
The huge expense and the range of pricing of these anemia drugs are troubling, especially since the FDA views the three as equivalent. From what we have known for years about financial incentives—that is, the deep discounts offered by the drug companies for the most expensive drugs to oncologists in outpatient practices —it is likely that these discounts have fueled the inappropriate use of anemia drugs, which are among the 20 highest-expenditure drugs covered by Medicare
And we know from a 2006 study in Health Affairs that these deep discounts achieved what the drug companies had in mind. They increased the use of the most expensive drugs. This is due to the fact that the most costly drugs came with the largest discounts, and therefore the most generous profit margins for oncologists in outpatient practice.
Federal laws may prohibit drug companies from paying doctors to prescribe drugs given in pill form that are purchased by patients at the pharmacy. But companies are allowed to rebate part of the price of the drugs given by injection or intravenously in doctors’ offices. Doctors receive the rebates after they buy the drugs from the companies. In other words, they receive reimbursement from Medicare or private insurers for the drugs, often at a large markup over the doctors’ purchase price. And on top of that, the oncologists get rebates (i.e., kickback) based on the amount of drugs they have purchased.
Oncologists are, in effect, running their own pharmacies. Consumers would naturally be suspicious of the herbalist recommending and selling his own herbal medicine or the vitamin doctor selling vitamins to her patients. It’s time for the public to understand that things are far worse at the oncologist’s office.
Fifteen years after these anemia drugs went on the market, we learn that they can hasten death and cause severe injuries. Why did it take so long to know this?
The situation points to the necessity of major changes. The FDA should be given the power to require better safety studies in the pre-approval process, and the agency must have the power to exact a large penalty on any drug company that does not follow through on FDA recommendations, such as those made at the Oncologic Drug Advisory Committee’s 2004 meeting.
Thank you for giving me this opportunity to speak.
1. GAO Report-01-1118 Medicare payments for drugs exceeds providers’ cost. September 2001.
2. Jacobson, Mireille. Does reimbursement influence chemotherapy treatment for cancer patients? Health Affairs, Mar/Apr 2006
3. Berenson A, Pollack A. Doctors reaping millions for use of anemia drugs. New York Times, May 9, 2007.
