Criminal activity inside the FDA? You decide.

Marianne Skolek-Perez Global News Centre

(MYRTLE BEACH)  Is the FDA involved in criminal activity with insider trading?

Here is an excerpt from a recent FDA News Release (complete release shown at end of article).

FDA approves first buprenorphine implant for treatment of opioid dependence.

Expanded use and availability of medication-assisted treatment is a top priority of federal effort to combat opioid epidemic
For Immediate Release

May 26, 2016

Release

“The U.S. Food and Drug Administration today approved Probuphine, the first buprenorphine implant for the maintenance treatment of opioid dependence. Probuphine is designed to provide a constant, low-level dose of buprenorphine for six months in patients who are already stable on low-to-moderate doses of other forms of buprenorphine, as part of a complete treatment program.

Until today, buprenorphine for the treatment of opioid dependence was only approved as a pill or a film placed under the tongue or on the inside of a person’s cheek until it dissolved. While effective, a pill or film may be lost, forgotten or stolen. However, as an implant, Probuphine provides a new treatment option for people in recovery who may value the unique benefits of a six-month implant compared to other forms of buprenorphine, such as the possibility of improved patient convenience from not needing to take medication on a daily basis. An independent FDA advisory committee supported the approval of Probuphine in a meeting held earlier this year.

Opioid abuse and addiction have taken a devastating toll on American families. We must do everything we can to make new, innovative treatment options available that can help patients regain control over their lives, said FDA Commissioner Robert M. Califf, M.D. Today’s approval provides the first-ever implantable option to support patients’ efforts to maintain treatment as part of their overall recovery program.”

Probuphine is marketed by San Francisco-based Titan Pharmaceuticals Inc.

Any word on who the members of the “independent” advisory committee were? That was not a part of the FDA press release.

Interesting that this committee approved Probuphine at the beginning of 2016.

Even more interesting is the fact that on December 15, 2015 one of the top institutional holders purchased 61,913 shares of Titan Pharmaceuticals. The name of the hedge fund institution making the purchase was Renaissance Technologies, LLC.

I have written about Renaissance Technologies (link to article http://www.salem-news.com/articles/april132014/hamburg-addiction-ms.php) and its Co-Chief Executive Officer and Co-President and Director - Peter Fitzhugh Brown. Mr. Brown is a hedge funder and the husband of former FDA Commissioner, Margaret Hamburg, MD. Dr. Hamburg retired as commissioner in March 2015.

Before Dr. Hamburg was confirmed as Commissioner of the FDA in 2009, she and her husband, Peter Fitzhugh Brown had to divest themselves of several hedge-fund holdings as well as some of Mr. Brown’s inherited drug-company stocks so Dr. Hamburg could take the post as the nation’s top food and drug regulator. The couple’s assets were valued at between $21 million and $40 million. Hamburg’s husband had to sell his pharmaceutical stocks in Abbott Laboratories, Johnson & Johnson, Merck and pharmacy-benefits manager Medco Health Solutions. Abbott Laboratories promoted OxyContin, or “hillbilly heroin” to anesthesiologists, surgeons, emergency physicians and pain management teams in hospitals and surgery centers throughout the country beginning in 1996 — while Purdue Pharma marketed OxyContin to all other physicians. Medco Health Solutions is a pharmacy benefits managing company that handles drug benefits for over 60 million people.

Did Hamburg and her wealthy hedge fund husband, in fact, divest themselves of stocks in order for her to become the head of the FDA? Or was it an opportunity leading to insider trading during her tenure and after her retirement?

So who is doing the insider trading within the FDA, or is Dr. Hamburg’s hedge fund husband just clairvoyant in what stocks to purchase for profit as he did with Titan Pharmaceuticals?

Criminal activity inside the FDA? You decide.

LP - Because you are, I am.  Make sense?  Only to me because of the love and peace you have given me.

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Global News Centre’s Marianne Skolek, is an Investigative Reporter who focuses on the Prescription Opioid/Heroin Epidemic in the U.S. and Canada. In particular, Marianne has covered the criminal marketing of OxyContin going back to 1999 and continuing to the present.

In 2002, Marianne lost her daughter, Jill to prescribed OxyContin which her physician referred to as “mobility in a bottle.” It was, in fact, death in a bottle. After doing extensive research on the maker of OxyContin, Purdue Pharma, Marianne began working with the Department of Justice in Virginia in their criminal investigation into Purdue Pharma and in July 2007 was asked by the U.S. Attorney John Brownlee prosecuting the case to testify against the three CEO’s of Purdue Pharma, Michael Friedman, Paul Goldenheim, MD and Howard Udell, Chief Counsel. The CEO’s pleaded guilty to misleading the medical profession about the dangers of OxyContin. Marianne also testified against Purdue Pharma at a Judiciary Hearing of the U.S. Senate in July 2007.

In addition, a dangerous and highly addictive opioid named Zohydro has been approved by the FDA against their Advisory Committee’s advice and Marianne continues to alert Attorneys General, Senators and Congressmen as to the FDA’s irresponsibility in the out of control prescription opioid/heroin epidemic killing and addicting in the tens of thousands each year. Zohydro has been referred to as “heroin in a capsule” and its lowest dosage (10mg) contains twice as much hydrocodone as found in a Vicodin pill. The highest single dose of Zohydro contains as much hydrocodone as 5 to 10 tablets of Vicodin or Lortab. Zohydro mixed with alcohol can be fatal and has no abuse deterrent built in which will make it easy to crush and deliver a fatal dose of the opioid.

Currently Marianne has been instrumental in calling for the termination of Margaret Hamburg, MD, Commissioner of the FDA as well as Bob A. Rappaport, MD and Douglas Throckmorton, MD for their lack of commitment to safeguarding the American public against the prescription opioid/heroin epidemic. Marianne’s research, writing and contact with government agencies and attorneys has also exposed the heavily funded pain foundations set up by the pharmaceutical industry and their paid physician spokespersons who convinced the medical boards in 50 states and Canada that dangerous opioids such as OxyContin were less likely to be addictive. These physicians — in particular Scott Fishman, MD, J. David Haddox, DDS, MD, Perry Fine, MD, Lynn R. Webster, MD, Russell Portenoy, MD also downplayed the risks of addictive opioids in books as authors. These books are still available for sale and promoted to the medical profession.

Here are links to Marianne’s involvement in exposing the national conspiracy of the prescription opioid/heroin epidemic, the FDA, the pharmaceutical industry, their pain foundations and paid physician spokespersons.

http://www.salem-news.com/by_author.php?reporter=Marianne%20Skolek

http://www.youtube.com/watch?v=tmPG1VjD61U&list=UUWoHUEr4ZAbQOfIqtOArjgg&index=6&feature=plcp

https://www.facebook.com/photo.php?v=855537227796352&set=vb.658186307531446&type=2&theater

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