Saturday, March 15, 2014
It’s called Zohydro.
Clinical Psychiatry News (3/13) has the story. West Virginia Senator Joe Manchin is protesting FDA approval of the drug. He’s written a stunning letter to US Health and Human Services head, Kathleen Sebelius.
“…Sen. Manchin noted that the FDA approved the drug ‘despite strong opposition from its own Anesthetic and Analgesic Drug Products Advisory Committee.’”
This is highly significant. The FDA turned its back on its own panel of new-drug reviewers.
Senator Manchin continues:
“Simply put, the FDA’s approval of Zohydro ER, in its current form, must be stopped before this dangerous drug is sold to the public… [Zohydro] has up to 10 times as much hydrocodone as Vicodin and Lortab and will come in a formulation that can be easily crushed, snorted, and injected.”
In other words, Zohydro, used as a pain killer, is a nightmare. If you’ve ever taken Vicodin, imagine a pill with ten times the strength.
“In his letter, Manchin raised questions about the drug’s approval. ‘I am deeply troubled that the reason for Zohydro ER’s approval may be linked to allegations that the FDA gave manufacturers of prescription drugs the opportunity to pay thousands of dollars for the privilege to attend private meetings with FDA officials,’ he wrote, citing news reports. ‘Allegations have been raised that a new, scientifically questionable methodology for drug approval was created at these pay-to-play meetings.’”
“The FDA has denied any improprieties regarding those private meetings, which the agency has said were intended to help the FDA better evaluate evidence from clinical trials.”
Then let’s see every word of those private meetings. The FDA is a public agency. Let’s see exactly what went on in those secret meetings.
For background: On July 29, 2012, Martha Rosenberg published her interview with former FDA drug reviewer, Ronald Kavanagh, for Truthout. The subject was FDA retaliation against its own people who didn’t follow orders on approving new drugs, but instead relied on evidence.
Kavanagh: “…widespread [FDA] racketeering, including witness tampering and witness retaliation.”
“I was threatened with prison.”
“One [FDA] manager threatened my children…I was afraid that I could be killed for talking to Congress and criminal investigators.”
Kavanagh reviewed new drug applications made to the FDA by pharmaceutical companies. He was one of the holdouts at the Agency who insisted that the drugs had to be safe and effective before being released to the public.
But honest appraisal wasn’t part of the FDA culture, and Kavanagh swam against the tide, until he realized his life and the life of his children was on the line.
What was his secret task at the FDA? “Drug reviewers were clearly told not to question drug companies and that our job was to approve drugs.” In other words, rubber stamp them. Say the drugs were safe and effective when they were not.
Kavanagh’s revelations are astonishing. He recalls a meeting where a drug-company representative flat-out stated that his company had paid the FDA for a new-drug approval. Paid for it. As in bribe.
He remarks that the drug pyridostigmine, given to US troops to prevent the later effects of nerve gas, “actually increased the lethality” of certain nerve agents.
Kavanagh recalls being given records of safety data on a drug—and then his bosses told him which sections not to read. Obviously, they knew the drug was dangerous and they knew exactly where, in the reports, that fact would be revealed.
We are not dealing with isolated incidents of cheating and lying. We are not dealing with a few isolated bought-off FDA employees. The situation at the FDA isn’t correctable with a few firings. This is an ongoing criminal enterprise, and any government official, serving in any capacity, who has become aware of it and has not taken action, is an accessory to mass poisoning of the population.
Fourteen years ago, the cat was let out of the bag. Dr. Barbara Starfield, writing in the Journal of the American Medical Association, on July 26, 2000, in a review titled, “Is US health really the best in the world,” exposed the fact that FDA-approved medical drugs kill 106,000 Americans per year.
In interviewing her, I discovered that she had never been approached by any federal agency to help remedy this tragedy. Nor had the federal government taken any steps on its own to stop the dying.
And now we have Zohydro, a new drug ready to hit the streets. You’ll know it when you see more zombies walking.
Senator Manchin has just introduced a bill to slap down the FDA approval of Zohydro (official press release and copy of bill here).
Here are official black-box warnings contained in Zohydro packaging:
* Long-acting hydrocodone exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death.
* Serious, life-threatening, or fatal respiratory depression may occur.
* Instruct patients to swallow Zohydro ER capsules whole; crushing, chewing, or dissolving capsules can cause rapid release and absorption of a potentially fatal dose of hydrocodone.
* Accidental consumption of even 1 dose of hydrocodone, especially by children, can result in a fatal overdose of hydrocodone.
* For patients who require opioid therapy while pregnant, be aware that infants may require treatment for neonatal opioid withdrawal syndrome.
* Prolonged maternal use during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening and requires management according to protocols developed by neonatology experts.
Your FDA at work.