Archive for April, 2015

Does Oprah Have More Integrity Than the Columbia College of Physicians and Surgeons?

April 30th, 2015

Oprah Winfrey has dumped Dr. Oz’s radio show from her media empire after numerous challenges to his scientific integrity, according to the New York Daily News story. This move comes after months of criticism of Dr. Oz’s endorsement of quack cures, often for weight loss.  Oz has hailed the discredited Ducan Diet,  and numerous other weight loss schemes. He defended a dubious clinical trial before a skeptical Senate Committee which was slammed by John Oliver.

Dr. Oz told the Senate that his on-air clinical trial of one weight loss product was exempt from the Institutional Review Board procedures of his employer, the Columbia College of Physicians and Surgeons. After this, I wrote to Brenda Ruotolo, Executive Director, Human Research Protection Office. Columbia University College of Physicians and Surgeons asking if the Columbia IRB had exempted this research and, if so, on what basis. She responded,

“Dear Mr. Downey, Thank you for contacting us regarding your concerns. We have looked into the matter of whether Columbia IRB approval is required for activities conducted on the Dr. Oz show. The purview of the Columbia IRB is articulated in the Standard Operating Procedures for the Columbia IRB, which you referenced in your June 25 email. Because activities in which Dr. Oz engages on his show are not conducted in accordance with his institutional responsibilities, those activities do not fall under the scope of the Columbia IRB.”

Gee, I don’t think his research was conducted under auspices of Oprah’s radio shows, but that didn’t stop her for standing up for integrity.


EEOC punts on Employer Wellness Regulation

April 17th, 2015

The Equal Employment Opportunity Commission (EEOC) has finally issued proposed amendments to the Americans with Disability Act (ADA) regarding employer wellness programs.

The proposed regulations are very disappointing. They re-define “voluntary” participation in a wellness program to mean being penalized 1/3 of an employee’s health insurance premium cost. The average cost of single coverage is $5,615, with employees paying $951 out of pocket. More and more of the cost is being shifted to employees. Many employees, especially white women, suffer a wage penalty because of their weight. And most employees’ health insurance plans do not cover the costs of FDA approved medicines for weight loss, bariatric surgery or intensive behavioral interventions.

In particular, the proposed regulations do not require employers to tell employees of the availability of alternative avenues to receive the reward or avoid the penalty. They do not require employers to leave the final word on alternative avenues with the employee’s physician, which is required in the DOL/HHS regulations. There is no obvious penalty if the employee’s personal health data is not adequately protected by the employer and personal health data is used to an employee’s detriment. On the other hand, one useful provision limits the penalty/reward to 30% of the premium cost of a single person. Obviously, this is lower than the cost of family coverage. Industry is sure to fight this limitation, as they want to increase the size of the penalty/reward.

Comments are open until June 19,2015.

See EEOC press release here. See proposed regulations here. For additional information, see Ted Kyle’s blog here, and Tim Jost’s blog in Health Affairs here.

In the meantime, the federal government’s Office of Personnel Management (OPM) has told federal agencies to promote workplace wellness programs.


FDA Spikes Concerns Over Dangerous Dietary Supplements

April 8th, 2015

Anahad O’Connor, writing in the New York Times, discloses an upsetting picture of the Food and Drug Administration inaction on policing an amphetamine-like substance in dietary supplements. The article describes how the leadership of the FDA division responsible for policing dietary supplements has been and is led by highlevel executives from the Natural Products Association, the trade association representing dietary supplement makers.