Update to free speech case...
Does the FDA defy National Physician Guidelines? Yikes...this happens to be in the new Legislation that should pass this year.
DECLARATION OF DR. ERIC M. RISHE IN SUPPORT OF PLAINTIFFS’ MOTION FOR A PRELIMINARY INJUNCTION
I, ERIC M. RISHE, declare:
1. I am a board-certified physician specializing in internal medicine, hematology, and oncology. I graduated from the Sackler School of Medicine at Tel Aviv University in 2001 and completed all of my medical training at Mt. Sinai Beth Israel Medical Center in New York, New York. I am a member of the American Board of Internal Medicine (ABIM) and have been practicing medicine for 13 years.
2. I have been licensed to practice medicine in the State of New York since 2004. I live in Manhattan, and my office is in the Bronx. I am an Assistant Clinical Instructor at Columbia Presbyterian Medical Center in Manhattan.
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3. Many of my patients are at high risk of developing cardiovascular disease, including those with elevated triglycerides (200 milligrams of triglycerides per deciliter of blood or higher). Some of my patients have very high triglyceride levels (500 mg/dL or higher)—a condition known as severe hypertriglyceridemia.
4. It is my general practice to treat certain patients at risk of cardiovascular disease—including those with high and very high triglyceride levels—with drug therapy to lower their triglyceride levels. While there is not yet definitive proof that lowering triglycerides through drug therapy reduces the risk of cardiovascular disease, my practice is consistent with several published clinical guidelines and position papers recommending drug treatment for patients with elevated triglycerides (i.e., those with triglycerides of 200-499 mg/dL). For example, the NCEP/ATP III Guidelines clearly recognize that non-HDL cholesterol (which includes triglycerides) and triglycerides are independent risk factors for cardiovascular disease. See Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) Final Report, 106 CIRCULATION 3143 (2002). Given that the NCEP/ATP III Guidelines recommend targeting triglyceride levels and non-HDL cholesterol for patients with elevated triglycerides (200-499 mg/dL), I proactively treat this patient population with known triglyceride-lowering therapies, which include drugs like Vascepa®. This patient population constitutes a significant number of my patients.
5. I frequently prescribe Vascepa® to patients with triglyceride levels of 200-499 mg/dL, as I am legally allowed to do. I understand that, at this time, FDA has only approved Vascepa® for treatment of patients with severe hypertriglyceridemia (i.e., triglyceride levels over 500 mg/dL). Even though my use of Vascepa® to treat patients with triglyceride levels of 200-499 mg/dL is “off-label” or not approved by FDA, it is, in my medical judgment, entirely appropriate as specified in paragraph 4 above. Given Vascepa®’s effect on triglycerides, it is my
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medical opinion that Vascepa® is clinically appropriate to lower triglyceride levels in patients with levels between 200-499mg/dL.
6. In my medical judgment, patients with triglyceride levels of 200-499 mg/dL often benefit from taking Vascepa® because it lowers their triglyceride levels and improves other lipid parameters.
7. For most of my patients with triglycerides of 200-499 mg/dL, I prefer to prescribe Vascepa® as opposed to other medications available to lower triglycerides, because Vascepa® is not associated with an increase in low-density lipoprotein (LDL) or “bad” cholesterol, as some other such medications are. In addition, other currently approved medications for lowering triglycerides in patients with triglycerides of 200-499 mg/dL often have unwanted side effects that limit patient compliance. Clinical trial data clearly state that Vascepa® does not have those side effects and thus has a higher rate of patient compliance.
8. Even though I am already prescribing Vascepa® to patients with persistently high triglyceride levels of 200-499 mg/dL (i.e., those whose triglycerides stay high despite statin therapy) to reduce their triglyceride levels, because FDA has not approved Vascepa® for that indication, Amarin and its representatives may not speak freely with me about the risks and advantages of using Vascepa® to treat these patients. Although I can ask questions of Amarin about this clinically relevant off-label use, Amarin cannot volunteer information to me without fear of criminal prosecution or liability. This impedes my practice of medicine.
9. I understand that FDA and its regulations are the source of this prohibition. Again, this confounds me because I am still permitted to prescribe Vascepa® for the very use that Amarin cannot freely discuss with me.
10. FDA’s regulations severely restrict my ability to have a full and free dialogue with Amarin about the risks and advantages of using Vascepa® for all uses, including clinically
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relevant off-label uses. This harms both my patients and me and deprives me of reliable information that would help me make informed medical decisions for my patients.
11. I understand that FDA regulations are not even consistently applied, in that any lay person can purchase an omega-3 supplement that contains EPA and DHA from the supermarket and that states on the label that “Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease. (FDA approved health statement).” I understand that FDA has allowed this qualified health statement to be made for such omega-3 supplements.
12. If Amarin’s representatives made similar statements to me about Vascepa®— which consists of EPA, one of the omega-3 fatty acids covered by the health statement in the preceding paragraph—they could be prosecuted for doing so. This makes no sense. FDA allows lay people to be told that omega-3 fatty acids “may reduce the risk of coronary heart disease,” while prohibiting Amarin from making similar and other truthful statements to sophisticated doctors like me. The use of dietary supplements to treat ASCVD and lipid disorders may actually be harmful to patients. Recent studies have shown that there is an inconsistency between labeled and actual ingredients.
13. Because I am legally allowed to prescribe Vascepa® to patients with high triglycerides (i.e., 200-499 mg/dL), Amarin should be able to speak freely with me about the findings of studies on Vascepa® and provide me with truthful information about the potential benefits and risks of treating my patients with Vascepa®. If FDA trusts me to take care of patients with high triglycerides (i.e., 200-499 mg/dL) using Vascepa®, it should also trust me to make an educated decision once I have full information from Amarin regarding all clinically relevant data that they can offer about Vascepa®. These limitations on the information I can receive from Amarin about Vascepa® harm my patients and me.
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