December 21, 2007
What Happens When Drugs Become Supplements
Two items from yesterday's news:
* Unpublished studies on the Food and Drug Administration's website show Merck and Schering-Plough's combo cholesterol-lowering pill -- Zetia -- poses liver risks, the New York Times reports.
* A former Pfizer physician has sued the company for off-label marketing of Lipitor, the world's best-selling cholesterol-lowering drug, the Wall Street Journal reports.
The Journal's Health Blog gives reporter David Armstrong an outlet for fascinating details from the wining and dining that took place. He accompanied whistleblower Jesse Polansky, who now works for the Center for Medicare and Medicaid Services, to several "educational events" where the allegedly illegal off-label promotion of Lipitor took place. The physician presenters at the events suggested the drug was useful for patients with chronic kidney disease, which is not an approved indication under the National Institute of Health's National Cholesterol Education Program (NCEP) guidelines.
A few years ago, I helped organize more than 30 prominent physicians to protest the guidelines because 1) they were written by a group of physicians who with one exception were all on Big Pharma's payroll as consultants; and 2) they expanded use of the drug into populations for which there was no medical evidence that there would be any benefit.
Today, there are millions of these "moderate risk" patients -- people with slightly elevated cholesterol levels but no other risk factors for heart disease -- taking Lipitor and other statins. The evidence that it lowers their risk of heart attack is weak to nonexistent, depending on which subgroup of patients you look at.
Polansky is trying to drag this medically wasteful -- and potentially dangerous, since there is a small but well-established risk of muscle pain and wasting (rhabdomyolysis) -- into the open. It's a shame that CMS and its government lawyers did not back the suit. Many of those millions are on Medicare and Medicaid, and taxpayers pick up the tab for a lot of that waste.
Posted by gooznews at December 21, 2007 07:57 AMHi, Thanks for writing this post. I write about natural ways to heal pain and also try to tell my readers about the dangers of taking everything offered by physicians. When I was in chronic pain and diagnosed with several chronic ailments the doctors told me I would never get better and to manage my pain with pain pills. If I had listened I would probably be in a wheelchair today as they predicted instead of feeling healthier than I have my whole life. I don't discount conventional medicine because I know it has many beneficial uses. I know Big Pharms are putting money in Drs. pockets for presribing certain meds. and medications are being prescribed MUCH more often than needed. Thank you this specific instance as an example. I am VERY grateful! Jenny
Posted by: Jennifer Mannion at December 21, 2007 02:18 PMHere's a link to the complaint:
http://www.hbsslaw.com/files/Amended_Complaint_secured1198189024452.pdf
Actually, I don't think there's much doubt that statins lower the risk of a first heart attack in moderate risk people. The main argument is over whether they lower overall mortality among certain categories of patients (mostly women and the elderly). In addition, the number of people you need to treat to prevent each first heart attack is very high in people who are not in a high risk category, due to the fact that we aren't very good at predicting first heart attacks. Many people would decline to take a statin if they were given the information on NNT. People vary in their preferences, however.
The risk of rhabdomyolysis is very small, but muscle pain is actually quite common with statins.
I can readily believe that Pfizer's "unrestricted grants" to fund CME were part of their marketing strategy (off-label or otherwise). Whether that is actionable or not, I do not know.
It is important to emphasize that the suit is *not* about whether Lipitor should be used off-label. Doctors are permitted to prescribe drugs off-label and it happens all the time. The suit is about whether Pfizer's funding of CME where (allegedly) presentations were given promoting off-label uses of Lipitor is a violation of law.
Posted by: Marilyn at December 21, 2007 03:13 PMHas anyone noticed that all the Lipitor ads (TV & print) and their website claim that Lipitor has been shown to prevent heart attacks in people with certain risk factors.... then they go on to list the 5 risk factors. HIGH CHOLESTEROL is ***NOT*** one of the risk factors??? In fact *LOW CHOLESTEROL* (low HDL) is one of the risk factors.
Is there another example where a drug is designed to do something... it is marketed to do that thing...if you have that condition you take that drug... but the drug does not work by doing what people take it for?
Ron, High LDL is discussed in other places on their website. That list you're talking about refers to risks factors other than high LDL. I agree it is not stated very clearly. Lowering LDL is almost certainly one of the ways Lipitor lowers the risk of heart attacks and strokes, although it and other statins appear to work partly through mechanisms unrelated to LDL-lowering ("pleiotropic effects").
Posted by: Marilyn at December 22, 2007 05:28 PMI want to clarify a couple of points.
1. Although you are not in favor of the guidelines, prescribing under the guidelines would not be off-label.
2. A person with slightly elevated cholesterol (say, between 130 and 160) and no other risk factors would be low risk, and the guidelines would not call for statin therapy for such a patient. For a person with no risk factors other than LDL between 160 and 189, statin therapy is optional. The guidelines call for statin therapy in people whose LDL is 190 or above with no other risk factors.
3. It is true that many low risk people are on statins. This is off-label prescribing. Whether Pfizer is to blame for the off-label prescribing may be hard to prove. As you know, most cardiologists and many other physicians are pretty enthusiastic about statins anyway.
4. Polansky's suit does not question the appropriateness of the guidelines. What it questions is alleged promotion by Pfizer that went *beyond* the guidelines. According to the complaint, this included inaccurate risk calculators, handouts and other materials that misrepresented what the guidelines said, and funding of CME presentations where off-label use was promoted. Among other things, the complaint alleges that Pfizer blurred the distinction made in the guidelines between "cutpoints" and LDL targets. A cutpoint is an LDL level above which statin treatment should be initiated, given a patient's risk factors. The LDL target is the LDL level that the patient should try to achieve once treatment is initiated. The complaint also alleges that Pfizer's materials did not distinguish between the two different levels of "moderate" risk in the guidelines (i.e., 10-year risk 10-20% v. 10-year risk < 10%). The importance of this is that the two different levels of moderate risk have different cutpoints for initiation of drug therapy (130 and 160).
Marilyn
Posted by: Marilyn at December 26, 2007 09:55 AMHere's a good summary of the allegations in the complaint:
http://brodyhooked.blogspot.com/2008/01/alleged-off-label-lipitor-marketing.html
Posted by: Marilyn at January 2, 2008 12:35 PM