How the ''Gatekeeper'' and His ''Trailblazers'' Paved the Way for Zohydro ER (Heroin in a Capsule)

How did we become victims of the greatest marketing ploy ever created by the pharmaceutical industry, physicians working for these pharmaceutical companies, the financially rewarded pain foundations set up by pharma and last, but not least, the FDA?

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(MYRTLE BEACH, SC) - The U.S. and Canada are waging a war against death, addiction and abuse to the over prescribing of prescription drugs as well as the lack of facilities to treat those victims who become horrifically addicted to these painkillers. We are now facing yet another killer opioid hitting the pharmacy shelves this month called Zohydro ER or as it is popularly known "heroin in a capsule."

The FDA approved Zohydro ER against their own Advisory Committee ruling who voted it not be approved because of the severe risks of death and addiction to the painkiller. The FDA overrode their Advisory Committee saying "the benefits of Zohydro ER outweigh the risks."

How did we become victims of the greatest marketing ploy ever created by the pharmaceutical industry, physicians working for these pharmaceutical companies, the financially rewarded pain foundations set up by pharma and last, but not least, the FDA? The marketing ploy was called "the under treatment of pain" in the U.S. and Canada.

The U.S. Senate is investigating pharmaceutical companies, paid physician spokespersons representing pharma, pain foundations funded by pharma and books written by physicians encouraging the use of opioids and minimizing the risks of addiction and death. Why isn't the U.S. Senate investigating the FDA by their aiding and abetting in more deaths and addictions and approving Zohydro ER?

J. David Haddox, DDS, MD

I will lay out below how the "under treatment" of pain in the U.S. and Canada has resulted in a Holocaust in every sense of the word -- beginning with "the gatekeeper", J. David Haddox, DDS, MD, an executive with Purdue Pharma - maker of OxyContin.

In 1989, Haddox and another physician named Weissman, coined a word called "pseudo-addiction" which they referred to as a syndrome resulting from poorly treated pain. The term "pseudo-addiction" was as a result of one medical case -- a 17 year old teenager who was supposedly wrongly diagnosed by physicians and nurses as displaying traits of addiction to the painkillers treating his leukemia, pneumonia and chest wall pain. Haddox and Weissman wrote a case study and documented in the study that rather than addiction, the patient needed more opioids and it was not addiction, but rather "pseudo-addiction."

Keep in mind, "pseudo-addiction" was as a result of only one case study and Haddox ran with it -- to the medical profession. Pseudo-addiction took on a life of its own in the prescribing of opioids. If a patient exhibited signs of addiction, physicians were being encouraged to increase the dose of opioids -- compliments of the marketing efforts of Dr. Haddox.

In 1996, the American Academy of Pain Medicine and the American Pain Society, organizations that receive substantial funding from drug companies, issued a joint statement endorsing the use of opioids to treat chronic pain and claiming the risk of addiction was low. This was right around the time Purdue Pharma launched their killer drug, OxyContin.

The chairman of the group that issued the statement was the infamous J. David Haddox, DDS, MD. Three years after making the chronic pain statement, Haddox became an executive with Purdue Pharma.

The American Academy of Pain Medicine and the American Pain Society are under U.S. Senate investigation to determine if they profited financially from pharma in the opioid epidemic. Unfortunately, "the gatekeeper" Haddox was not named in the U.S. Senate investigation, but hopefully they will correct this oversight and look into Haddox's lucrative marketing strategy - the under treatment of pain in America and pseudo-addiction.

Now for the "Trailblazers" set up by the "Gatekeeper" to minimize the risks of opioids in addiction and death:

Russell Portenoy, MD

Physicians had been afraid of the risks of opioids and reserved the use of opioids to cancer patients. Dr. Portenoy argued that they could also safely be taken for months or years by people suffering from chronic pain. Among the assertions he and his followers made in the 1990's was less than 1% of opioid users became addicted, the drugs were easy to discontinue and overdoses were extremely rare in pain patients.

Russell Portenoy, MD

Many of those experts now say those claims were not based on sound scientific evidence. "I gave innumerable lectures in the late 1980's and 1990's about addiction that weren't true," Dr. Portenoy said in a 2010 videotaped interview with a fellow physician. Dr. Portenoy said it was "quite scary" to think how the growth in opioid prescribing driven by people like him had contributed to soaring rates of addiction and overdose deaths. "Clearly, if I had an inkling of what I know now then, I wouldn't have spoken in the way that I spoke. It was clearly the wrong thing to do," Dr. Portenoy said in the video.

Dr. Portenoy did have an "inkling" though to the soaring rates of addiction and overdose deaths in the late 1980's and 1990's -- he only had to read newspapers that covered the epidemic in every state in the country as it spiraled out of control. So Dr. Portenoy -- you are under scrutiny of the U.S. Senate in their investigation. Hopefully they will have an "inkling" of your part as a trailblazer as will the medical profession you misled.

Lynn R. Webster, MD

Lynn R. Webster, MD

This trailblazer was quoted as saying "Because true opioid addiction affects only about 1% of the general population and up to perhaps 5% of the chronic-pain population, it is clear that most people who take medications for pain will not become addicted to them."

Webster is also under U.S. Senate scrutiny and has the distinction of being investigated by the Drug Enforcement Agency (DEA) for unexplained deaths at his pain clinic in Utah.

Scott M. Fishman, MD

Scott M. Fishman, MD

Trailblazer Fishman wrote a book entitled "Responsible Opioid Prescribing - A Physician's Guide" sponsored by the Federation of State Medical Boards. Fishman's book was distributed to medical boards in all 50 states and Canada and became the holy grail of prescribing opioids to physicians. One of the statements made in Fishman's book is "Another risk posed by non treatment or under treatment of pain affects the physician but not the patient directly. Physicians have been successfully sued for not treating pain aggressively." Fishman is under U.S. Senate scrutiny and his book is under U.S. Senate investigation as is the Federation of State Medical Boards for possibly profiting financially from pharma in the opioid epidemic.

Perry G. Fine, MD

Perry G. Fine, MD

Fine is under U.S. Senate scrutiny for his ties to pharma and possible financial gain This trailblazer also was a "defense expert" in the cause of celebrity Anna Nicole Smith's death. Fine testified that Smith's consuming 1,500 painkillers a month did not make her an addict.

In addition, this trailblazer made a video referenced below - #11 entitled Medications - Opioids" wherein Fine states "True addiction -- a small portion of the population and the risk of addiction to opioids is extremely low."

http://www.painmed.org/pain-awareness/
#11 - Medications - Opioids
 

Curtis Wright, IV, MD

Curtis Wright, IV, MD

Wright is one of the original trailblazers in the opioid epidemic.  While employed by the FDA, he was on the review panel and approved the drug OxyContin for the treatment of severe pain.  He subsequently left the FDA and violated their protocol by becoming employed by the maker of OxyContin, Purdue Pharma.

In 2007, Purdue Pharma pleaded guilty in Federal Court to misleading the medical profession about the addictive qualities of OxyContin.

Margaret Hamburg               Bob Rappaport            Douglas Throckmorton