News Briefs: March 22, 2010

Set Back in Diabetes Treatment
Paulina Zheng

The fight against heart disease in diabetics has taken a disheartening stumble, according to new studies. Although diabetic patients suffer from a plethora of other medical ailments as a result of their bodies’ resistance to insulin, they remain most vulnerable to heart disease. The high blood sugar levels, associated with Type 2 diabetes, contribute to increased risk of heart disease. However, the control of these blood sugar levels had little to no effect in these individuals, leading to a change in the search. Researchers chose to examine other risk factors – including cholesterol levels, weight, and high blood pressure – that exist in these patients. As such, researchers’ studies focused on the effects of low blood pressure as well as cholesterol and triglyceride levels on the prevention of heart disease. These studies also failed to demonstrate a significant impact on the manifestation of heart disease in diabetic patients. This suggests that researchers must again look elsewhere in their battle against heart disease. In the meantime, doctors must re-evaluate their recommendations to patients. “Lower,” as Dr. David Nathan of the diabetes center at Massachusetts General Hospital said, “is not necessarily better.”

Reference: Kolota, Gina. (2010, March 14). Diabetes Heart Treatments May Cause Harm. The New York Times. Retrived March 22, 2010 from http://www.nytimes.com/2010/03/15/health/research/15heart.html?ref=health.

Doctors Foregoing Their Practices for Drug Companies
Hoai Le

As more and more universities are establishing conflict-of-interest restrictions preventing their academic physicians from being employed by drug companies, there is a growing trend to hire community doctors to speak at promotional talks. Last year, Cephalon, GlaxoSmithKline, Lilly, and Merck spent tens of millions of dollars to pay doctors for promotional speaking. Some of the highest paid doctors, such Tara Dall, MD, earn $45,000 in just three months of speaking. Critics, however, argue that the talks are biased and may add to increasing healthcare costs by promoting the use of more expensive drugs. Proponents, on the other hand, say that the talks help deliver the latest medical findings. Drug companies have no other choice but to rely on private practitioners because of growing university bans. After all, they claim, physicians often learn best from their colleagues, not sales representatives. Critics, nonetheless, believe physicians can get information on new drugs through many other sources besides dinner talks. Doctors are "clearly being used" for a reason. There are also unintended consequences to these promotions, including doctors leaving their primary occupations rather than forego their secondary job as a speaker for drug companies. In January, Lawrence DuBuske, MD, one of GlaxoSmithKline's top-paid speakers, chose to leave his position at a Harvard training hospital rather than quit his job with GSK, which paid him $99,000 during the second quarter of last year. After all is said and done, one thing we can all agree on is that with possible cuts in Medicare reimbursements happening in the near future, it is difficult to pass up such a tempting source of income.

Reference: Fauber, John. (2010, March 13). On the Stump: When Academics Are Out of the Picture. MedPage Today. Retrieved March 22, 2010 from http://www.medpagetoday.com/PublicHealthPolicy/Ethics/18989.

Questioning the Implications of and FDA Approved Treatment
Eriene-Heidi Sidhom

Currently, there is a discrepancy between the implication of a newly approved treatment and the actual guidelines for a approval and rejection. To the public, an approval implies that this new treatment is more effective over older treatments. However, new drug approval is actually only based on efficacy over randomized clinical trials (RCTs) in comparison with a placebo. Therefore, it does not determine efficacy relative to current treatments and raises questions about the clinical significance of these new treatments. This can result in patients receiving these new treatments, due to effective marketing, but also receiving the high costs associated with them as well as the higher risk for a poor outcome. To close this gap between the public perception and the actual guidelines for approval, two solutions have been proposed: First, Alexander and Stafford recommend that the FDA "incorporate the principles of comparative effectiveness research throughout the process of approval and regulation." This will reduce needs for comparative effectiveness research later on. However, companies may choose to compare their products to a second or third-line drug or simply state that there is little known about the comparative efficacy of the treatment. The second solution, recommended by the European Medicine Agency (EMA), suggests that trials are conducted with both active-comparator and placebo control groups. The EMA then makes decisions based not only on the efficacy of new treatments but makes a holistic decision, including risks and benefits of the new drug. Regardless of the route taken, it is necessary that the FDA reevaluate its approval guidelines.

Reference: JAMA. 2010;303(10):979-980.

Eriene-Heidi Sidhom is the 2009-2010 News and Analysis Editor.