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Jul-07-2016 11:07printcomments

FDA Approves a Dangerous Opioid Based on Cheap Party Study!

The US is #1 in the world in opioid use. Disturbing and true!

opioid brain
Because prescription opioids are similar to, and act on the same brain systems affected by, heroin and morphine, they present an intrinsic abuse and addiction liability, particularly if they are used for non-medical purposes. Image: drugabuse.gov

(MYRTLE BEACH, S.C.) - The FDA advisory committee strikes again and recommended approval of Vantrela ER (Teva Pharmaceuticals), a new hydrocodone bitartrate extended-release tablet with abuse-deterrent capabilities.

As the U.S. is fighting a devastating epidemic of prescription opioid/heroin addictions and deaths, the FDA approves yet another opioid. Maybe someone should ask the FDA "how many opioids does it take to devastate every state in the country?"

The US is #1 in the world in opioid use followed closely by Canada.

The FDA's reasoning in addressing the prescription opioid epidemic and approving yet another extended release opioid is because it has "abuse-deterrent capabilities".

Teva officials described the finished product as a “gooey mess” when people try to alter it in any way. The FDA advised that Teva used a new and unique technique in the design of Vantrela ER. Oh yes it is unique, quite unique and quite disturbing.

Ready for disturbing?

Teva conducted studies under the guidance of the FDA indicating how its technology would reduce abuse of their opioid.

The studies were conducted in healthy college-age students who admitted to using recreational drugs, according to Lynn R. Webster, MD, the vice president of scientific affairs at PRA Health Sciences in Salt Lake City.

Dr. Webster said the participants liked the effects of opioids, but were not dependent. In addition, they were given naloxone so that they had an intolerance to opioids. A urine test was conducted during every encounter to ensure that they did not use other drugs during the study according to Dr. Webster.

The drug was altered in various ways, and the participants were asked whether they liked the drug and would use it again. Most said they would not.

I have written several articles over the years about Lynn R. Webster, MD dubbed "Dr. Death" by CNN News in coverage of him. This is a link to my article regarding Dr. Webster and his "studies": The Smoking Gun Series.

At the time, I had no idea that Webster and his disturbing studies would serve to influence the FDA in their approval of Teva's opioid, Vantrela ER.

Webster’s pain clinic in Salt Lake City, Utah was raided by the Drug Enforcement Agency (DEA) in 2010 for up to 100 deaths in his clinic. An investigation into Webster’s prescribing practices was launched. There were malpractice lawsuits filed against him and settled.

The Utah U.S. Attorney failed to charge Webster for the deaths in his pain clinic which the doctor attributed in many cases to suicide. Webster’s pain clinic closed and his ability to write opioid prescriptions was reportedly rescinded. But did that end Webster’s lucrative association with the pharmaceutical industry?

No, he reinvented himself as pharma’s golden “recreational drug use clinical trial researcher.”

Disturbing? You have no idea because the FDA formed an alliance to a "cheap party" non-scientific study jeopardizing the lives of potentially millions of people.

“We need new ways to prevent people from harming themselves essentially” Webster said as he heads a pharmaceutical paid trial on new abuse-deterrent drug formulations.

He further stated “One approach is to come up with a new kind of pain pill that’s hard to abuse, and pay individuals to use them to see if they can get high.”

At PRA Health Sciences in Salt Lake City, where Webster is VP of Scientific Affairs, this unique approach is underway. Hundreds of recreational drug users pass through the doors of the clinic to test out the next generation of prescription pain pills.

These studies are funded by pharmaceutical companies who are looking to make abuse-deterrent formulations. The pills are designed with tamper-proof technology. The goal is to see if real-life recreational drug users enjoy taking them as much as they do current pain pills.

The hope is that they won’t. If the pills are successful in deterring abuse, they can receive a special drug label. The U.S. Food and Drug Administration has strongly encouraged pharmaceutical companies to conduct these studies. The FDA is not conducting these studies. If a new pill can show it has abuse deterrence, it can receive a special marketing label from the FDA based on pharma’s own studies.

The clinical trials do not enroll addicts, who are screened out using a “special protocol.” Thanks to the FDA and the National Institutes of Health, the identities of the recreational drug users are protected and kept confidential from law enforcement.

Most recruits are young, and male. They hear about the Human Abuse Liability studies through friends and word of mouth.

“Many of them will come in with their friends and this becomes a cheap party where they can earn some money,” said Dr. Webster.

Participants get paid between $250 and $300 a day. They cannot leave the premises until the drugs have cleared their system. Some trials last up to a month. Subjects are housed in special dormitories and are paid well. One participant likened it to being on “a paid vacation where we’re treated like kings and fed well.”

Dr. Webster is clear that these tamper-proof or abuse-deterrent drugs won’t solve America’s addiction and abuse problem. He further states that in 70% of the cases, "leftover prescription drugs" are stolen from the medicine cabinets of loved ones. Addicts will just swallow more pills and wait for them to take effect.

No, Dr. Webster, 70% of cases are not leftover prescription drugs stolen from medicine cabinets as you are paid by pharma to tell the medical profession. Most overdoses and deaths are caused by exactly why your pain clinic was raided by the DEA, and why you can no longer prescribe painkillers — the over-prescribing of dangerous opioids for chronic pain long-term resulting in deaths. The disease is “addiction” not “medicine cabinets”.

If after reading the above, you are not disturbed by the FDA and Lynn Webster's "cheap party studies" leading to approval of yet another dangerous opioid by the FDA -- you might want to sign up for future studies conducted by the infamous Dr. Webster -- and be treated like a king. Disturbing? You decide.

LP - Who first talked about the hotness of the heat in the summer? Love my infinity angel and a very special gathering.

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Julie July 12, 2016 11:29 am (Pacific time)

Marianne - thank you for sharing this information, although incredibly disturbing. It seems like for every promise to do the right thing (ethically) to battle the Opioid Epidemic, both Pharma and the FDA fall short. It makes me sad and angry. Our son died of an Oxycodone overdose in 2014 ... I've been researching and advocating for awareness of the Opioid Addiction and Overdose Epidemic ever since.

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