Overview of rHGH therapy

January 14, 2015- Interviewed by Steven E. Greer, MD

We interviewed Dr. Shlomo Melmed, Director of the Clinical Research Institute and Dean of Faculty at Read more »

Long-term contraception is effective and underutilized

October 1, 2014- Interviewed by Steven E. Greer

Jeffrey F. Peipert, M.D., Ph.D. of Washington university discusses his original article in the NEJM that studied a large cohort of young females who were given free long-term birth control. The results were a dramatically lower incidence of birth and unwanted pregnancies compared to the overall population. He then discusses why the effective contraception methods are underutilized.

The CDC discusses Gardasil HPV vaccine safety

Produced and interviewed by Steven E. Greer, MD

Dr. Barbara Slade of the CDC discusses her recent JAMA article on the safety and adverse event reports for Merck’s HPV cervical cancer vaccine Gardasil. Back in 1976, a swine flu vaccine caused Guillain-Barrė syndrome and this has led to subsequent vaccines being under scrutiny for any neurologic adverse events.

Exclusive: The Plan B contraceptive issue was not a miscommunication between FDA and HHS Secretary

December 8, 2011

By Steven Greer, MD The Healthcare Channel

The media has reported on the overruling of the FDA by HHS Secretary Sebelius, a decision that continues the ban of over-the-counter (OTC) status for the Plan B contraceptive pill to be limited to girls over the age of 16, as if it were a miscommunication or disagreement between the FDA Commissioner, Dr. Margaret Hamburg, and Secretary Sebelius. Both of those individuals are widely regarded as competent. Based on the history of Plan B and the extreme high-profile nature of this issue, we believe that the recent press coverage is possibly what President Obama wanted.

The Plan B pill has been the downfall of many an FDA official, such as Commissioner Jane Henney. Dr. Henney was fired by newly elected President Bush in 2001 after she allowed Plan B to be approved in 1999. Given that Dr. Hamburg seems quite politically savvy, and is on good terms with Secretary Sebelius, and both are pro-choice, it is inconceivable to us that Commissioner Hamburg allowed her staff to plan to approve Plan B for younger age groups without The White House and HHS knowing about it.

A spokesperson for the FDA told us, “There was no miscommunication. (The White House and HHS Secretary) were notified (of the FDA’s pending actions).” When asked why this decision was not simply delayed until after the 2012 elections, the spokesperson replied, “There was a pending (December 7th) PDUFA date (On Teva’s application) and a court action.”

That court case is Tummino v. Torti, 05-CV-366, U.S. District Court, Eastern District of New York (Brooklyn) and the FDA will be in court again on December 13th. Given that this case is a decade old and the HHS has successfully stalled it, it seems unlikely that the pending December court date forced the hand of the FDA to make a decision now. Moreover, PDUFA dates are routinely ignore and missed by the FDA.

So, why might the Obama administration have desired to have such a fiasco in the press? We believe that this could have been a face-saving way for the administration to maintain the scientific standards of the FDA while also appealing to the large conservative-leaning independent voters who helped him get elected. Given the recent political fallout from Texas Governor Perry’s decision to allow the Gardasil HPV vaccine to be administered to girls, it is clear that a sizable portion of the electorate do not want anything related to sex be given to their children without parental supervision. An approval of OTC Plan B could have been a tremendous political misstep for President Obama.

It is unknown at this time whether the courts forced this decision from President Obama, his FDA Commissioner, and his HHS Secretary, or whether it was staged to allow for politically popular move. Either way, the decision seems to be a net positive for President Obama at the expense of his extreme liberal constituents.

This move is consistent with his recent failure to back stricter emission standards under the Clean Air Act. President Obama clearly needs to appeal to the middle class this time around.

James Evans, MD, PhD: Genetic testing for breast cancer screening

With advances in genetic testing to determine high-risk mutations such as BRCA, can genetic tests available now help determine which women do not need routine mammography versus those who need early and aggressive screening? James Evans, MD, PhD, Editor-in-Chief of the journal “Genetics in Medicine” discusses the matter.

Avastin approved for ovarian cancer

October 29, 2010

In Part 4 of the Weekly Summary show, Samer Schuman, MD, specialist in gynecologic oncology from The University of Miami Miller School of Medicine, leads the roundtable discussion on the recent FDA approval of Avastin (bevacizumab) as maintenance therapy to treat ovarian cancer.