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

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.

rt.com

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.

drugwatch.com

"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.