FDA approves a dangerous opioid based on “cheap party” study! Disturbing and true!

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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.

Marianne Skolek-Perez Global News Centre

(MYRTLE BEACH) 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 in November 2015 regarding Dr. Webster and his “studies” http://www.globalnewscentre.com/first-in-a-series-the-smoking-gun-in-the-prescription-opioidheroin-death-toll/#sthash.RrFHfddc.dpbs. 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.

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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skolek-new-photo-700Global 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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