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Mar-22-2014 19:30printcomments

Now it's personal FDA Commissioner Margaret Hamburg -- You think being responsible for countless deaths is a joke! It's not!!

Is there a "pay to play" involved between the FDA and the maker of Zohydro?

FDA Commissioner Margaret Hamburg
FDA Commissioner Margaret Hamburg

(MYRTLE BEACH, SC) - At a conference for investors in New York on Nov. 29, 2011 Zogenix's chief executive Roger Hawley said the FDA was not pressuring Zogenix to put an abuse deterrent in Zohydro. (aka heroin in a capsule).

"We would certainly consider later launching an abuse-deterrent form, but right now we believe the priority of safer hydrocodone - that is, without acetaminophen - is a key priority for the FDA," Hawley said.

FDA spokeswoman Erica Jefferson said the agency would not comment on its discussions with drug companies, citing the need to protect trade secrets.

Zohydro ER

There has been quite a bit of press about the FDA's approval of the deadly opioid, Zohydro or "heroin in a capsule" by prescription. All the press and outrage at the FDA allowing this dangerous opioid to devastate people in every state in the country fell on deaf ears to the head of the FDA, Margaret Hamburg. Zohydro has hit pharmacy shelves throughout the country and will soon cross the border to Canada for them to deal with massive loss of life and addiction.

Is there a "pay to play" involved between the FDA and the maker of Zohydro? The above transcript highlighted in "blue" dating back to 2011 between the maker of the drug and the FDA sure has me questioning the game the FDA is playing with our lives, but more on that next week.

Mrs. Hamburg I am going to appoint myself the voice for those who no longer have a voice -- and their loved ones who grieve the loss of their children, spouses and parents to the opioid epidemic ravaging the U.S. -- in particular OxyContin and heroin. And thanks to your "pay to play" with the pharmaceutical industry your approval of Zohydro will hold you personally responsible for thousands and thousands of deaths and addictions. You approved Zohydro against the recommendations of your own Advisory Committee who had major concerns about it being prescribed for pain -- pure hydrocodone and no abuse resistant formula built in to the medication.

So what does our country see in major newspapers all over the country this past week -- a photo of you riding a unicycle Mrs. Hamburg. I refuse to call you Dr. Hamburg because you do not know the meaning of the words "first do no harm" as a physician. You are jeopardizing tens of thousands of lives by allowing Zohydro to line the shelves of pharmacies all over the country. And why are you photographed riding a unicycle? Because you support the first lady of the U.S., Michelle Obama's "children eating healthy diets" campaign. Children eating fresh vegetables is more important to you and the first lady than saving the lives of our children from heroin addiction and death from opioids you approved.

You defended Zohydro's approval by saying it fills an "important and unique niche" for treating chronic pain. Give me a break Mrs. Hamburg. How many more painkillers do we need for you to approve for financial gain by the pharmaceutical industry?

In the meantime, Senator Joe Manchin of West Virginia is not riding a unicycle and has introduced a bill to force Zohydro off the market as well as any similar medications that do not have a tamper-resistant formula built in.

"I have tried reasoning with the FDA, and I've repeatedly requested the agency change its course on this dangerous drug," Manchin said in a statement. "Because of this painkiller's high potential for misuse and abuse, Zohydro poses a severely dangerous threat to our communities in West Virginia and across our country."

This past week a Senate committee hearing was held and Hamburg was confronted by Senator Manchin about the FDA's  approval of Zohydro.  Manchin brought up the alleged pay to play meetings that were financed by drug companies to Mrs. Hamburg.  Meetings which were attended by pharmaceutical executives and DA upper management potentially influencing FDA policy on the development of new pain treatments.  The private meetings were the subject of a Milwaukee Journal Sentinel/MedPage Today investigation. One initiative that sprang from the meetings was a controversial new way to test pain drugs. The method, known as enriched enrollment, was used to win approval for Zohydro.  Enriched enrollment allows the pharmaceutical industry to weed out people who don't respond well to a drug or who can't tolerate taking it before the actual clinical trial begins.

Senators David Vitter (R-La.) and Mike Lee (R-Utah) also have cited the Milwaukee Journal Sentinel article in a letter requesting an investigation into the meetings.

Sen. Tom Harkin (D-Iowa), chairman of the Health, Education, Labor and Pensions Committee, began the hearing last week stating that in approving Zohydro the FDA did not follow the vote of its own advisory committee not to approve Zohydro because of the risks to the general public. Harkin also referenced the dramatic increases in opioid prescriptions and overdose deaths in recent years. "I didn't realize we were so painful in this country. What's happening to the doctors in this country?"

Hamburg responded by saying the treatment of pain is a complex issue. Is the death of tens of thousands of people a complex issue Mrs. Hamburg? Because you are allowing the deaths to mount. Still think that unicycle photo portrayed you as the "watchdog of the American people" -- or did you look like a circus clown?

U.S. Senator Tammy Baldwin (D-Wis.)

Another member of the U.S. Senate at the hearing last week was U.S. Sen. Tammy Baldwin (D-Wis.). But Senator Baldwin did not raise questions about Zohydro. Bet there are people in Wisconsin who would like to know why Senator Baldwin is not voicing outrage at this drug invading her state. So here's my idea --

I urge people to look in Facebook for "The Addict's Mom" and join the organization. They have chapters in all 50 states and will be a force to reckon with when they descend at the doors of their state congressmen/women, senators, attorneys general and law enforcement agencies demanding that the heroin/opioid epidemic be taken seriously and those minimizing the urgency of it -- be removed from their positions. You see Commissioner Hamburg -- they are sick of burying their loved ones while you ride a unicycle.

Oh and Mrs. Hamburg and Senator Baldwin -- don't expect celery and carrot sticks from the 50 chapters of "The Addict's Mom" when they come banging on your doors -- expect accountability from you for your total disregard for the lives of their children. I think they have had enough of you making a mockery of their burying children by your actions.

I also further urge everyone to support a FED Up Rally to be held in Washington, DC on September 28, 2014. You can find information about the rally on their Facebook page.

There are wonderful, active organizations that are holding those in public office responsible for the prescription opioid and heroin epidemic. I urge you to connect with them and voice your outrage. Be mad as hell and save the lives of your loved ones.


LP - Always say I am so grateful for the love, peace, faith and laughter -- I left the word patience out.  Thank you always for patience even when the panic button is pushed.



Comments Leave a comment on this story.

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vito October 4, 2014 12:27 pm (Pacific time)

Marianne Skolek Thank God and your parents for making you the motivated leader you are!! You know what's coming don't you and what's coming is so black ugly and frightening that you without flinching are prepared to call out anyone that's OK with allowing a drug so deadly the active junkies are chomping at the bit to flock to the stuff,  because they all think they can push the limit with a hairs length to spare which had it been surpassed would have killed. Me I destroyed everyone and anyone you all have no idea and  I can't paint the picture strong enough with my words of just how destructive opiate addiction is I can't  I wish I had the skill  to explain it in a way that would keep you awake thinking of what i said . Marianne Skolek knows what my wife knows that the release of this drug will absolutely kill thousands maybe 10s of thousands of kids and unsuspecting adults no one is immune from addiction. I am angry at the American mother all of you! You wouldn't hesitate a fraction of a second to give up your life so that your child could live and with that said Why aren't 20 million how about 30 million of you out marching.  But you won't will you? you choose not to be informed whether it be the garbage you feed your family the from fluoride, high fructose corn syrup to GMO foods your all killing the very ones that god entrusted to your care. most of you have no clue that the world laughs at us  our food industy treats you like asses blind stupid and cosume You think nothing of buying foods that are labled Product of China  if you were as informed as a Hungarian Mother you'd know Chinese processed food is toxic trash as example Friday nights Joey likes his calimari  as a side only problem to save 2 cents with your Lousey coupons you buy Chinese processed calimari which by the way isn't calimari  its pig rectum sliced into rings and deep fried!! Hey numb nuts if they would poison childrens toys do really think theyd stop there???and  How is it that GMO food is banned all over the world GMO is a curse word in most of the world in America I bet 90% probly more but 90% of you have no idea what so ever what GMO is. and you just don't care .... Ms Skolek is hot as hell over the death and destruction that's coming to many a mommy out there you'll cry grieve and mourn and the depression will destroy what's left of what may of been an all american household your household well like I said nobody is immune to the euphoric lie that an opiate uses to suck the life and will from your little bobby or Suzy Don't let this shit out on the street  Don't!!! and when you succeed in jamming this approval up Hamburg's ass I want you all to subscribe to the wellness mamma blog shell make sure you feed us right!! throw the lunchables diet juice and god knows whatever else you let them eat. Kids today are like veal calf's they're  white weak and diabetic kids don't play today except the call to duty video gamesv where they learn to murder without conscious  literally100s of people a day all on video games that you buy them???  Are you all insane!!! Mothers of America Please save us!! You all have the power will and energy to make the insanity stop don't wait until you got to kick the bathroom door in to find the child you carried for 9 mos and then endured a physical pain that no man could ever really comprehend or appreciate to deliver and as soon as your eyes locked on your babys. You knew instinctively you would without hesitation fight to the death to protect  the gift god entrusted you to care for  you get my point not easy to see that baby now 16 handsome and strong with so much promise laying there eyes open and dead as the proverbial doornail  I Overdosed  3 times I know I should never have woken up, miraculously I did I have worked my balls off to change and make amends but like I said this stuff hits the street a ton of sorrow comes with it to the few mothers ive offended who are informed I apologize I realize you'll probably cut this post truth is I'm right are kids are the fattest sickest in the world.

Dave April 2, 2014 6:24 pm (Pacific time)

Ms Skolek- Pat Anson answered me- but no dice on including your article on National Pain Report- you can see my comments as "Dave" regarding how the fda and government have let down people in pain. In any event I hope you will continue to inform others about what is happening in pain care as people in pain despite their experiences arent fully informed of the politics of pain care.

dave April 1, 2014 8:38 pm (Pacific time)

Ms Skolek- thanks for this article- i emailed Pat Anson of the NAtional Pain Report to include "the rest of the story" in response to John Burke of the drug diversion investigators, article against the Massachussetts Governors action on Zohydro. I provided Mr Anson a link to this article- keep up the good work!

Mike March 24, 2014 5:33 pm (Pacific time)

Zogenix filed a form 8K with the SEC, first step before filing libel suits against websites such as this for making false statements such as "heroin in a pill". Smart business would remove this article before you are included. Read Zogenix' Form 8K for yourself........

Scare tactics, really?  You don't know us very well, they are a public company and we are news, go back to your books, you closet advocate for "HEROIN IN A PILL".  You should investigate US law, we have this thing called "free speech" - a great concept, study up.

Joanna March 23, 2014 7:12 pm (Pacific time)

I am a member of The Addicts Mom. You will hear us roar, you will see us rally!

ken March 23, 2014 6:42 pm (Pacific time)

Why are you trying to give the impression that the 2011 comments by Roger Hawley are connected to the meetings going back to when Zohydro was developed? Zogenix wasn't even a company yet back then.

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