If the FDA under Woodcock’s direction is to be the “watchdog” of the American people in keeping them safe from dangerous drugs, maybe it’s time for the pit bull to be terminated in the interest of saving innumerable lives.
Marianne Skolek Perez, Investigative Reporter
(MYRTLE BEACH) Janet Woodcock, MD is the Director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). CDER determines what drugs are safe and effective to improve the quality of life for people in the United States and is promoted as overseeing testing in clinical trials. However, clinical trials are more often than not conducted in the labs of the maker of the drug — not in the labs of the FDA. The FDA relies on the pharmaceutical testing lab to advise of the outcome of their clinical trials.
Dr. Woodcock previously served as FDA’s deputy commissioner and chief medical officer. She also led CDER as director from 1994–2005. Woodcock’s tenure with the FDA coincides with that of David Kessler, MD, Commissioner who was featured on a recent CBS 60 Minutes expose wherein he admitted that Purdue Pharma’s highly addictive opioid, OxyContin was not approved for long-term chronic pain use. Here is the link to the CBS 60 Minutes broadcast. https://www.cbsnews.com/news/opioid-epidemic-did-the-fda-ignite-the-crisis-60-minutes/?fbclid=IwAR1NE6eT42Whms-e5h5Qju0_mSUGFjODklv2HqemrUKIyR3E2Q0L0mnNXzU.
Woodcock has been quoted as saying “I am continually challenged to make sure that FDA’s regulatory process remains the world’s gold standard for drug approval and safety.”
I encourage people who have lost family members to addiction and death under Dr. Woodcock’s reign of power to read a book entitled “Big Pharma, Big Greed - the inside story of one lawyer’s battle to stem the flood of dangerous medicines and protect public health” written by Stephen A. Sheller, Esq. One of the statements in Mr. Sheller’s book that should challenge Woodcock’s “gold standard for drug approval and safety” under her leadership is the following:
On the FDA’s role in the drug development process, Woodcock has likened the agency’s oversight to that of a building inspector saying “Someone else builds the building according to code. The FDA writes the code, and then comes in at the end and inspects the results to make sure they’re up to code.”
Mr. Sheller counters Dr. Woodcock’s analogy on the drug approval process by saying “In my view, the problem is the code is flawed from the start and the inspectors are in cahoots with the builder. One reason is the revolving door between the FDA and the pharmaceutical industry.”
On January 24, 2004 then Attorney General (AG) Richard Blumenthal of Connecticut (now US Senator of Connecticut) submitted a Citizen Petition (CP) to the FDA entitled “Petition to Require Purdue Pharma L.P. to Revise the Labeling of OxyContin Tablets to Strengthen Warnings of the Greater Potential for Developing Side Effects and Adverse Drug Reactions Due to Prescribing Dosing Frequencies in Excess of the Recommended Guidelines.”
Although the FDA had two conflicting dates on their website as to the time frame to respond to a Citizen Petition of 5 months or 6 months, Janet Woodcock, MD did not respond to Blumenthal’s 2004 Citizen Petition until 2008. Way beyond the 5 to 6 months the FDA is required to respond. Provided below is a link to Woodcock’s response to Blumenthal — all 18 pages of it.
See: https://www.scribd.com/document/328752805/Blumenthal-Cp-Woodcock
One of the comments Dr. Woodcock stated in her reply was that “…..although higher total daily dosages were associated with fatal outcomes, it cannot be concluded that the higher total daily dosages are causally associated with fatalities given the other variables have not been measured.” Further she writes “…there is no maximum dose for opioids.”
So answer me this Dr. Woodcock — how many lives could have been saved when AG Blumenthal sent the FDA his Citizen Petition in 2004 if you had acted on it in a timely and scientific manner? What do you think? Hundreds? Thousands? Tens of Thousands?
If the FDA under Woodcock’s CDER direction is to be the “watchdog” of the American people in keeping them safe from dangerous drugs, maybe it’s time for the pit bull to be terminated in the interest of saving innumerable lives.
Marianne Skolek Perez
Consultant to attorneys on opioid lawsuits filed throughout the country
Investigative Reporter covering the opioid epidemic writing for
Global News Centre, Salem-News.com, Sons of Liberty Media, The Washington Standard and Freedom Outpost
908-285-1232 - cell
Global 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
