Consumer Health Digest #15-31

Your Weekly Update of News and Reviews
August 9, 2015

Consumer Health Digest is a free weekly e-mail newsletter edited by Stephen Barrett, M.D., with help from William M. London, Ed.D., M.P.H. It summarizes scientific reports; legislative developments; enforcement actions; news reports; Web site evaluations; recommended and nonrecommended books; and other information relevant to consumer protection and consumer decision-making.

Court ruling threatens FDA drug regulatory structure. A New York judge has concluded that the FDA cannot stop drug companies from marketing approved drugs for off-label (unapproved) uses as long as the claims are truthful and not misleading. The case concerns the drug Vascepa, a fish-oil product manufactured by Amarin Pharma. The FDA has approved Vascepa for treating people with extremely high blood triglyceride levels (500 mg/dL) but denied approval for treating people with levels between 200 and 499 on grounds that the resultant lowering had not yet been proven to reduce the risk of cardiovascular events. The FDA was willing to permit Amarin to tell doctors about the scientific findings to date as long as it disclosed the reason for FDA's denial. But Amarin would not agree to the agency's proposed wording and sought the court's permission to promote Vascepa with weaker disclosures without fear of criminal prosecution by the FDA. After considering possible wordings, the judge ruled that it would be "truthful and not misleading" for Amarin to inform doctors 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. Vascepa should not be taken in place of a healthy diet and lifestyle or statin therapy.

Vascepa is not FDA-approved for the treatment of statin-treated patients with mixed dyslipidemia and high (≥ 200 mg/dL and < 500 mg/dL) triglyceride levels due to current uncertainty regarding the benefit, if any, of drug-induced changes in lipid/lipoprotein parameters beyond statin-lowered low-density lipoprotein cholesterol on cardiovascular risk among statin-treated patients with residually high triglycerides. No prospective study has been conducted to test and support what, if any, benefit exists.

Recent cardiovascular outcomes trials (ACCORDLipid, AIM-HIGH, and HPS2-THRIVE), while not designed to test the effect of lowering triglyceride levels in patients with high triglyceride levels after statin therapy, each failed to demonstrate incremental cardiovascular benefit of adding a second lipid-altering drug (fenofibrate or formulations of niacin), despite raising high-density lipoprotein cholesterol and reducing triglyceride levels, among statin-treated patients with well-controlled low-density lipoprotein-cholesterol.

The long-term significance of this ruling is unclear. Opening the floodgates to off-label promotion would undermine the incentives for companies to do the studies necessary to win approval for new uses, which would be a serious problem. However, this ruling did not remove FDA's regulatory oversight but held that its standards should be consistent with the marketer's First Amendment rights. The FDA is expected to appeal the ruling. It is also working on new guidelines concerning off-label use that is backed by scientific evidence.

Australian GPs blast homeopathy. The Royal Australian College of General Practitioners has issued a position statement which concludes:

The RACGP supports the use of evidence-based medicine, in which current research information is used as the basis for clinical decision-making. In light of strong evidence to confirm that homeopathy has no effect beyond that of placebo as a treatment for various clinical conditions. . .

  1. Medical practitioners should not practice homeopathy, refer patients to homeopathic practitioners, or recommend homeopathic products to their patients.
  2. Pharmacists should not sell, recommend, or support the use of homeopathic products.
  3. Homeopathic alternatives should not be used in place of conventional immunization.
  4. Private health insurers should not supply rebates for or otherwise support homeopathic services or product.

The statement was a response to the National Health and Medical Research Council's recently released review which concluded that there are no health conditions for which there is reliable evidence that homeopathy is effective as a treatment.

Medline urged to drop low-quality "alternative" medical journals. Edzard Ernst, M.D., Ph.D., who regularly reviews new articles about "alternative medicine," concluded in a recent blog that:

Previous Issue || Next Issue

This page was posted on August 9, 2015.