Paging Dr. Woodcock...Dr. Janet Woodcock....Do You Have Any Clue What's Happening Inside the FDA?

By PAUL THACKER

There is confusion and then there is confused confusion--a level of incomprehensibility that defies sound, sober attempt at explanation. After confused confusion comes...the FDA.

Case in point: the FDA's dithering over changes to the label of an antipsychotic drug now widely prescribed to veterans with post-traumatic stress disorder. Last October, POGO sent a letter to FDA Commissioner Margaret Hamburg asking her to look into a potentially dangerous interaction of the drugs Seroquel (quetiapine) and methadone that may be putting veterans at risk.

Prescriptions of Seroquel and methadone are at an all-time high for veterans who are suffering extremely high rates of PTSD after combat. An investigation by the Military Times found that military spending on Seroquel almost quadrupled between 2001 and 2009. Many of these veterans are also taking methadone for pain relief and to control anxiety caused by PTSD. The Military Times found that methadone overdose has caused at least 60 deaths in the military—more than any other drug, legal or illegal.

A separate investigation by the Associated Press noted that military expenditures on Seroquel have jumped sevenfold since the beginning of the war in Afghanistan. The military spent $8.6 million on Seroquel in 2009. Physicians said that they are prescribing it to provide relief from nightmares and anxiety caused by PTSD.

The Associated Press also discovered that Seroquel has become the Department of Veterans Affairs' (VA) second biggest drug expenditure since 2007. In 2009, the VA spent $125 million on Seroquel compared to $14.4 million in 2001.

Alerting the FDA to this problem, we also sent a study published in 2007 in the Journal of Clinical Psychopharmacology. This study found that Seroquel significantly increases blood plasma levels of methadone.

How did FDA respond? In April, we received a letter signed by Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) at the FDA. According to Dr. Woodcock, there was nothing to worry about:

After assessment of our evaluations, we believe that a potentially dangerous interaction involving quetiapine and methadone is unlikely, and, therefore, no further Agency action is indicated regarding either a revision in labeling that would include new warnings or cautions, or targeted public and professional communications efforts.

To make sure we got the point, she added:

At this point, there is agreement within CDER that an interaction between quetiapine and methadone that confers unreasonable risks to patients is exceedingly unlikely and, therefore, no further action is indicated regarding the labeling for these products or for related communication initiatives.

Less than two months later, in June, the FDA approved changes to the label for Seroquel to note that the drug “should be avoided in combination with other drugs” such as methadone.

What the hell? This is exactly what we asked them to do. Exactly what Dr. Woodcock said didn’t need to be done.

Can somebody please explain this to me? Please!

Anyways, we are now sending a second letter to the FDA asking them, as we did in October, to please issue an action alert to inform patients and prescribers. There is a potential for people to die if they are on Seroquel and methadone, and it seems highly improbable that a military doctor treating veterans with PTSD has the time to read the entire 73 pages of the Seroquel label.

That’s right. It's 73 fricking pages!!!

That’s not a label, that’s a novella.

We hope the FDA agrees to send out an action alert. But maybe we’ll get a letter from Dr. Woodcock saying that everything is okay, and no further action is indicated…and there’s no need to alarm people by sending out an action alert….

And then they’ll send it anyways.

Paul Thacker is a POGO Investigator.

Image: FDA.

Comments

[Dr. Jeff Condit]

Thanks for staying on top of this initiative. I am a former combat veteran, a specialist in the treatment of PTSD and now a retired VA mental health care provider. I saw firsthand the intrusiveness of the drug industry at the VA and the industry's incredible lack of clinical sensitivity and concern. These were well-dressed, highly paid company shills who had products to push in order to make handsome profits. Their motivation was not to take care of sick veterans. They spent large amounts of money wining and dining physicians in order to convert them to use their companies' products. I formally objected to our Chief of Staff about this practice. (She apparently disagreed and regularly partook in the drug company perks to include paid vacations ). Over the course of my 17 year career I developed a deep suspicion of what these folks did and said. I had no confidence in the alleged efficacy of the products they pushed. Keep an eye on these vermin.

[Daniel Haszard]

Eli Lilly Zyprexa,Risperdal and Seroquel same saga

The use of powerful antipsychotic drugs has increased in children as young as three years old. Weight gain, increases in triglyceride levels and associated risks for diabetes and cardiovascular disease.
The average weight gain (adults) over the 12 week study period was the highest for Zyprexa—17 pounds. You’d be hard pressed to gain that kind of weight sport-eating your way through the holidays.
One in 145 adults died in clinical trials of those taking the antipsychotic drugs Zyprexa. This is Lilly's # 1 product over $ 4 billion year sales,moreover Lilly also make billions on drugs that treat the diabetes often that has been caused by the zyprexa!
---
Daniel Haszard Zyprexa victim activist and patient who got diabetes from it. http://www.zyprexa-victims.com

[Laurie Smyla]

Thank you for your tenacity regarding this issue. I am in complete agreement that there seems to be an unhealthy alliance between the pharmaceutical companies and the FDA. It is caused by years of insiders hoping back and forth between the so called drug regulatory agency, (FDA) and the pharmaceutical industry.

[Paul Thacker]

Thanks. We're going to push the FDA to watch this issue.

[Wife of Veteran who almost died from these drugs for PTSD]

This needs to be an alert but NOT just for methedone either...remember there are 12 other drugs listed it should not be taken in combination with. Central Nervous system depressants being the biggest! Many veterans and soldiers that have died in their sleep while on this drug were taking Paxil and Lorazepam, not to mention a few others...what is even worse this is the ONLY anti-psychotic being approved by the DoD to to used in a combat zone by our troops for sleeping..it is NOT a sleeping pill and should NOT be prescribed as one either!!! The VA and DoD get around this because they will state they are not prescribing this to treat PTSD, which is partly true...they will say they are using it to treat a symptom...those symptoms being ones that accompany PTSD...like the inability to sleep...the bottle will be labeled for mood or sleep, not PTSD...off label at it's best and dangerous! This new label is to cover someones bottom and your right without a huge bulletin alert the doctors in the VA and DoD will just keep handing it out....