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Nov-11-2014 00:28printcomments

Bob Rappaport, MD, Division Director of Anesthesia, Analgesia and Addiction Products at FDA Retires

What if the head of the division of the FDA responsible for opioids being approved is not a "watch dog" to the American people, but rather is a "lap dog" to the pharmaceutical industry?

FDA drug applications
According to the FDA, original drug and biologic applications submitted for review increased by over 50 percent between 1993 and 2004. This increase occurred primarily for drug, as opposed to biologic, applications. Overall, most applications are for drugs. Source: FDA report

(MYRTLE BEACH, SC) - The retirement of Dr. Rappaport was announced by the FDA at the end of September. Sharon Hertz, MD was named "Acting Division Director" filling Rappaport's position.

Strange though, it is now into November and emails sent to Rappaport, do not direct the sender to Dr. Hertz with her email address. Rather, the following email is returned to the sender:

Delivery has failed to these recipients or groups:
bob.rappaport@fda.hhs.gov
The e-mail address you entered couldn't be found. Please check the recipient's e-mail address and try to resend the message. If the problem continues, please contact your helpdesk.

One of Dr. Rappaport's biggest contributions to the American people before the FDA announced his retirement was an opioid called Zohydro ER.

Zohydro ER will be the first hydrocodone-only opioid in doses of 5 to 10 times more heroin-like narcotic than Vicodin. The FDA disregarded their own Advisory Committee who voted 11-2 not to approve the opioid because of the Committee's concerns about the potential impact on public health.

How could the FDA approve Zohydro ER when there is no abuse deterrent built into the drug so when it is crushed, chewed or mixed with alcohol -- the high probability of death exists?

Didn't the FDA violate their own directive that opioids would only be approved by them if there were a built-in abuse preventative in the drug? Dr. Rappaport was quoted as saying the FDA did not want to be seen as "punishing this company (Zogenix) and this drug (Zohydro ER) because of the sins of other companies and their product."

After Zohydro ER was approved by the FDA, Purdue Pharma, of OxyContin fame, prepared to have their equivalent of Zohydro ER approved by the FDA.

Purdue Pharma has been granted Priority Review status by the FDA for its New Drug Application (NDA) for extended-release hydrocodone bitartrate, called Hysingla/ER. Hysingla/ER, although crush-resistant, may be more dangerous than Zohydro ER because it is a once-a-day pill, packing more than twice as much hydrocodone in a maximum dose of 120 mgs compared to 50 mgs for Zohydro ER.

So we have two pharmaceutical companies competing for long term chronic pain treatment in an opioid nicknamed "heroin in a pill."

How could these two competitors profit individually in pushing Zohydro ER and Hysingla/ER to the medical profession? Easy.

This past week the makers of Zohydro ER and Hysingla/ER exchanged waivers of regulatory exclusivity for extended-release products which includes $10 million in payments and potential sales royalties from Purdue Pharma. A copy of the filing to the "FDA" is shown here: http://www.sec.gov/Archives/edgar/data/1375151/000137515114000025/ex104-2014930.htm.

As a bit of a background on the FDA, it was founded in 1906 and was supported by the U.S. Treasury. In 1992, this funding changed to new drug applications funding coming from the pharmaceutical industry. In other words, if you want your drug reviewed by the FDA -- the pharmaceutical industry is the bank.

In October 2013, John Fauber wrote an article for the Milwaukee-Wisconsin Journal Sentinel about a "pay to play" with the FDA by the pharmaceutical industry.

The link to his article is here: http://www.jsonline.com/watchdog/watchdogreports/emails-point-to-troubling-relationship-between-drug-firms-regulators-b99113286z1-226692641.html

Here are some highlights of Fauber's writing:

Since 2002 drug companies have paid up to $35,000 each to send a representative to meetings of an organization called IMMPACT, where they could discuss clinical trial testing procedures with officials from the FDA and other government agencies. The goal of IMMPACT is to improve the design of clinical trials conducted to develop new pain treatments.

It became known as a "pay-for-play arrangement where pharmaceutical companies could buy their way into "invitation only" meetings with the FDA and in essence affect FDA pain drug policy. Here is IMMPACT's website http://www.immpact.org/. The two heads of IMMPACT are Dennis C. Turk, PhD and Robert H. Dworkin, PhD.

Back to the esteemed Dr. Rappaport's "retirement." The FDA proudly announced that Rappaport would be the recipient of the "John and Emma Bonica Public Service Award honoring outstanding contributions by an individual or an organization to the field of pain through public education, dissemination of information, public service, or other efforts to further knowledge about pain."

Dr. Rappaport will receive this award at the 2015 annual American Pain Society meeting to be held in Palm Springs, California on May 13 - 16, 2015.

The American Pain Society is under U.S. Senate investigation for their involvement in the opioid epidemic reaching epic proportions in the U.S.

Here is a list of some of the past recipients of this "esteemed" award:

2014 Award Recipients
Robert H. Dworkin, PhD
Dennis C. Turk, PhD

Some Past Award Recipients
Robert Kerns, PhD, 2010
Perry Fine, MD, 2008
Scott M. Fishman, MD, 2004
David E. Joranson, 1999

Here are links to articles I have written about the above recipients and their part in the national health crisis of over-prescribing of opioids: http://www.salem-news.com/articles/november172013/dod-pay-play-ms.php
http://www.salem-news.com/articles/november252013/pain-profits-ms.php
http://www.salem-news.com/articles/august122012/perry-fine-folo-ms.php
http://www.salem-news.com/articles/september092012/prescription-disaster-ms.php
http://www.salem-news.com/articles/april222011/pain-studies-ms.php

Somehow I don't think Dr. Rappaport will be spending his "retirement" gardening. Time will tell if he will have a corner office in the pharmaceutical industry -- wearing his gold watch from the FDA.

LP -- Good thing you know when "after thought" should be humble. Love you yup!

____________________________________

Marianne Skolek is an Investigative Reporter focusing 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.

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 also downplayed the risks of addictive opioids in books as authors. These books are still available for sale and promoted to the medical profession.




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Craig Dickinson DAAD November 15, 2014 2:14 am (Pacific time)

Denile There are many different stats claiming % of addicts...mine show 80% of AMERICAN adults addicted to something, while 20/25% admit it's a problem... Denial is prevalent, in most seem content they can continue ? Continuing as an active addict is what we do until we find recovery...unfortunately , many or most won't seek it until tragedy strikes them.. Be it a DWI involving accident or injury or both, an overdose, a job loss or accident ,and most common family intervention ... The effect of A persons addiction usually becomes a factor to those around them, before its recognized as as a problem themselves. Therefor the vast masses continue to use , function and go about their lives as they believe normal and as if no one knows their using...being successful at life while addicted is being done all around us...Being a success / functioning addict is denial that brings most everyone to their knees, to ,jail, a hospital or cemetery....that's the reality... I'm sorry to say, there's addiction unrecognized that renders the addict successful in his mind, and years may go by making their monthly bills....the tolls are usually paid with terrible consequences at the end of that road...that's the fact Craig/Dad-2 https://www.facebook.com/pages/DAAD-Drug-Addicts-Against-DRUGS/827943680551991

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