Senator Joe Manchin, of WV outraged by FDA approval of OxyContin for children

Senator Joe Manchin photo courtesy: home.cableone.net

Senator Joe Manchin photo courtesy: home.cableone.net

Manchin angered by OxyContin maker Purdue Pharma’s efforts to push deadly drug on kids while the FDA sealed the deal!!!

Marianne Skolek Global News Centre

(MYRTLE BEACH)   In the past few days, I have written two articles for Global News Centre regarding the FDA approving the dangerous opioid, OxyContin for children.  The FDA gave the green light on the use of OxyContin on children based on studies conducted by Purdue Pharma — maker of OxyContin.  Here are the links to those articles http://www.globalnewscentre.com/fda-has-purdue-pharma-conduct-its-own-studies-on-children-being-prescribed-oxycontin/#sthash.a1Ny7sN9.yJr4BYZr.dpbs

The outrage of the FDA’s approval has reached Senator Joe Manchin of West Virginia who wrote the FDA today and demanded a Senate investigation.  Senator Manchin and I have locked horns in the past, but I am willing to forego those difference and work with him in exposing the FDA for using “studies” by the maker of OxyContin, Purdue Pharma, convicted felons, to approve the dangerous opioid for the use in children.

In Senator Manchin’s letter to the Acting Commissioner of the FDA, Stephen Ostroff, MD he condemns the agency in approving OxyContin for children.  Manchin stated in his letter:

“This recent decision by the FDA to prescribe OxyContin to children as young as 11 years old is a horrifying example of the disconnect between the FDA approval process and the realities the deadly epidemic of prescription drug abuse are having on our communities, We have years of evidence that shows that drug use at an early age makes a child more likely to abuse drugs later in life. We don’t sell cigarettes or alcohol to minors, we should treat prescription drugs the same and protect our children from these harmful drugs.”

“The people of my state of West Virginia and around the country are drowning under the weight of the prescription opioid abuse epidemic. We are losing too many Americans – young and old – and robbing many, many more of their potential. We must be doing everything in our power to stop the flow of these devastating drugs into our communities; it seems that the FDA is grossly out of touch with the epidemic facing our communities and is working to do the exact opposite.  I will be calling for a Senate investigation into this decision and the FDA’s other actions to approve dangerous and addictive opioid drugs. I cannot sit by while an agency of the federal government facilitates the poisoning of our children.”

I will take it one step further Senator Manchin and provide every family in the country affected by the FDA’s criminal behavior in their actions, the email address of the Commissioner of the FDA to express their outrage.  Dr. Ostroff’s email address is:  Stephen.ostroff@fda.hhs.gov.  Also here is the email address of the acting director of the pain and analgesic division of the FDA, Sharon Hertz, MD who played a big part in giving Purdue Pharma the green light to conduct their own studies on OxyContin and its use in children.  Her email address is:  Sharon.hertz@fda.hhs.gov.

Senator Manchin please do not allow the FDA to slide on this one.  We cannot continue to lose family members — and this time our precious children’s lives because of the FDA’s indifference to an ever-growing prescription opioid health crisis in this country.  A Senate investigation is long overdue on the FDA and its financial ties to the pharmaceutical industry.

Here is the text of the letter from Senator Manchin to Stephen Ostroff, MD:

Dear Acting Commissioner Ostroff:

I am disgusted by the Food and Drug Administration’s (FDA) recent decision to approve OxyContin for use for children as young as 11 years old.  The FDA should be absolutely ashamed of itself for this reckless act.  Today, there are 2.1 million Americans abusing or dependent on opioids.  In addition, 44 people die every single day as a result of a prescription opioid overdose. These drugs are destroying lives and devastating communities.

I have pleaded with your agency since I became a Senator almost 5 years ago to cease the flood of painkillers that is killing so many people in my state and around the country.  Instead, you continue to ignore the agency’s purpose and show allegiances with everyone but the people you are charged to protect. It took almost 3 years for the FDA to finally agree with my initial demand to reschedule hydrocodone, even as abuse and overdose deaths rose dramatically. Then, within a day of agreeing to reschedule, your agency approved Zohydro, a pure hydrocodone drug, despite your own advisory committee strongly voting against approval by a vote of 11 to 2 because of the danger of overdose and death. Just when I thought the agency could not be any more reckless, the FDA decides to double down on its ill-advised ways.  The decision to approve OxyContin for those as young as 11 is just as foolish and just as deadly as all the other actions for which I’ve demanded changes.  Your callous recommendation endangers the lives of our most precious asset and the nation’s future: children.

While other agencies of our government, including the Centers for Disease Control, the National Institute on Drug Abuse, and the Substance Abuse and Mental Health Services Administration, are speaking loudly about the desperate need to do everything in our power to stop the scourge of opioid abuse, the FDA has carelessly continued to approve these addictive and deadly drugs. This recent decision, which will increase the likelihood that children as young as 11 years old will be prescribed OxyContin, is a horrifying example of the disconnect between the FDA approval process and the realities of this deadly epidemic.

An 11 year old’s brain has another 14 years before it is fully developed. We have years of evidence that shows that drug use at an early age makes a child more likely to abuse drugs later in life. You have ignored all of this. Instead, under your new guidance, we are literally poisoning our children’s brains and setting them up for future drug abuse.

This decision does not increase access to these drugs for young cancer patients or others who may need this drug. Pediatricians prescribe medications that are not specifically approved for use in children all the time. Instead, this decision gives Purdue Pharma – a company that has already pled guilty and paid $635 million in fines for deceiving doctors regarding the addictiveness of OxyContin – the legal right to begin advertising to pediatricians about the use of OxyContin to treat 11-16 year olds under certain circumstances. We have seen the devastating impact of this targeted advertising as the number of opioid prescriptions quadrupled between 1999 and 2012 with a corresponding quadrupling in the number of opioid overdose deaths. Any argument that this is unlikely to increase the number of prescriptions of this drug for these kids is absurd.  The FDA is mindful in a variety of contexts, such as tobacco, about the dangers of advertising to children, and yet it ignores all that wisdom with this decision.

Furthermore, this decision – like too many in the past year – was made without the advice of an independent advisory committee. Under the FDA’s own regulations, your agency is required to convene an advisory committee when a matter is of significant public interest, highly controversial, or in need of specific type of expertise. There is no sound argument to be made that this decision does not meet every single one of those criteria. Given the extraordinary public health crisis that we are facing and the well-documented damage that dangerously addictive drugs like OxyContin can do to a developing brain, it is difficult to believe that an independent panel of experts would have recommended the approval of this drug in children. Given your agency’s decision to bypass this critical step, we will never know.

The American people and the people the state of West Virginia are drowning under the weight of the prescription opioid abuse epidemic. We are losing too many Americans – young and old – and robbing many, many more of their potential. We must do everything in our power to stop the flow of these devastating drugs into our communities, but the FDA is working to do the exact opposite.

I will be calling for a Senate investigation into this decision and the FDA’s decisions to approve dangerous and addictive opioid drugs. I cannot sit by while an agency of the federal government facilitates the poisoning of our children and their parents and grandparents. I hope that you will reconsider this decision and begin to work with me and with the other federal agencies that are trying stop the opioid epidemic.

I look forward to hearing from Senator Manchin on this critical and life saving issue — our children becoming addicted and dying from OxyContin.  We do not need any proof that this will happen — we have an out of control epidemic in all 50 states as a result of this highly dangerous drug.  I encourage everyone to follow Senator Joe Manchin on his Facebook page to stay aware of his holding the FDA accountable.  I also encourage Senator Manchin and families affected by this prescription opioid epidemic leading to an upsurge in heroin use to “demand” a Senate investigation as to how the FDA allowed Purdue Pharma to conduct their own studies on the safety of OxyContin for children.  Convicted felons conducting a study for an agency set up to protect the American people should never have been a consideration.

__________________________________________________________

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

– See more at: http://www.globalnewscentre.com/2014/06/06/no-accountability-in-the-opioidheroin-epidemic-results-in-dangerous-false-prophets/#sthash.mMTdZITB.dpuf

– See more at: http://www.globalnewscentre.com/2014/06/06/no-accountability-in-the-opioidheroin-epidemic-results-in-dangerous-false-prophets/#sthash.mMTdZITB.dpuf

– See more at: http://www.globalnewscentre.com/2014/06/06/no-accountability-in-the-opioidheroin-epidemic-results-in-dangerous-false-prophets/#sthash.mMTdZITB.dpuf

– See more at: http://www.globalnewscentre.com/2014/06/06/no-accountability-in-the-opioidheroin-epidemic-results-in-dangerous-false-prophets/#sthash.mMTdZITB.dpuf

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