Pharmaceutical giants Pfizer have hit the news...but not in the way they would like. Their anti-smoking cessation drug, Chantix, also known as Champix, is the subject of data being submitted through “improper channels” with regard to its safety and side effects.
Some 150 suicides, more than doubling those previously known, were among 589 delayed reports of severe issues turned up in a new analysis by the non-profit Institute for Safe Medication Practices, writes JoNel Aleccia, a health writer for msnbc.com.
This should come as no surprise for those that write about the pharmaceutical industry and the poor way in which prescription medication is regulated by the powers that be.
In 2008 the Federal Aviation Administration [FAA] took the unusual step of banning the use of varenicline [Champix] after it learned the anti-smoking medicine might lead to safety problems, it ordered pilots and air traffic controllers to stop taking it immediately. Strangely it is called Chantix in the USA.
The FAA took this action one week after a medical safety group, the Institute for Safe Medication Practices, released the results of a study that found evidence for the occurrence of seizures, loss of consciousness, heart attacks, vision problems, and various psychiatric instabilities in individuals who use Chantix.
Chantix was the subject of a freedom of information request I made back in April 2010. I had learned that the Federal Aviation Administration [FAA] had changed their policy regarding pilots being allowed to operate aircraft whilst under the influence of SSRi-type medication.
The FAA responded to my FOI in which I had requested the following:
1. Request for minutes of meetings where the change in the policy was on the agenda. List of members present and a declaration of interests of each of the members.
2. Any information given to FAA from outside parties that relate to the FAA'S recent change in policy regarding pilots on antidepressant medication.
3. A list of SSRi medications that pilots are NOT permitted to use and reasons why you think these SSRi's still pose a threat to safety.
4. A list of anti-smoking cessation drugs that pilots are NOT permitted to use and reasons why you think these still pose a threat to safety.
5. Does the FAA's new policy extend to air traffic controllers, if not, why?
6. An official statement from your CEO that categorically states that the FAA envisage that there will never be any incidents in the future with pilots that can be traced back to any adverse drug reaction from Prozac, Zoloft, Celexa and Lexapro.
Here's the cover letter of their response to me:
Mr. Bob Fiddaman,
Quinton
Birmingham
UK
Dear Mr. Fiddaman,
Re: Freedom of Iformation Act (FOIA) request 10-4122
This responds to your Freedom of Information Act email inquiry of April 6,2010 containing six requests concerning the FAA's recent change in policy regarding pilots being treated with certain select antidepressant medications. The FAA's policy regarding pilots with depression taking antidepressant medication may be found in the U.S. Federal Register Notice of April 5,2010 attached.
1. A records search was conducted at FAA Headquarters - Office of Aerospace Medicine. This office located a Memorandum report of a consultants meeting regarding the proposed policy. A copy of this Memorandum is attached. There are no other records respondent to your request.
2. A records search was conducted at FAA Headquarters - Office of Aerospace Medicine. This offrce located information received from the Aerospace Medical Association, the Airline Pilots Association Aeromedical Office, the International Airline Pilots Association, and the United States Army. Copies of these documents are attached. In developing the new policy, the FAA also utilized a variety of medical research literature available in the public domain. We used internet sites such as, but not limited to: The National Library of Medicine PubMed site and the FDA Medwatch.
3. A records search was conducted at FAA Headquarters - Office of Aerospace Medicine. There are no records responsive to this request. The four SSRI medications that will be considered for possible special issuance medical certifrcation are listed in the U.S. Federal Register Notice of April 5, 2010 attached.
4. A records search was conducted at FAA Headquarters - Office of Aerospace Medicine. There are no records responsive to this request. The only anti-smoking drug permitted for use while flying is nicotine in the form of gum or skin patches. All others are not allowed.
5. A records search was conducted at FAA Headquarters - Office of Aerospace Medicine. There are no records responsive to this request. The FAAs new policy does not presently apply to Air Traffic Control Specialist (ATCS) because the administrative details of the monitoring and follow-up of these employees are yet to be determined. The plan is that ATCSs will eventually be included in a program of this type.
6. This request does not apply under the Freedom of Information Act.
If you owe fees for the processing of this request, an invoice containing the amount due and payment instructions will be enclosed.
The accompanying 58 page document can be viewed HERE
This startling revelation by the FAA was obviously too much for me to handle so I sent the complete document along to investigative journalist, Evelyn Pringle. She, as with everything she writes, did it justice with an eye-opening article entitled, "SSRIs Render Unfriendly Skies"
One has to start asking questions regarding Pfizer's anti-smoking cessation drug. If the FAA deem it unacceptable for pilots to take this medication whilst operation an aircraft then they are sending out a crystal clear message - This drug is dangerous!
My only surprise is that the likes of Patrick McGorry, the Australian psychiatrist who plans to diagnose children as young as three for mental disorders they may get in the future, hasn't picked up on this particular cash-cow. Hey, Paddy, why not screen kids to see if they will smoke in the future? You could always nip it in the bud with a course of Pfizer's Champix.
The article from JoNel Aleccia, 'Smoking-pill suicides overlooked in missing reports', can be read in full HERE.
Pfizer has some questions to answer - don't hold your breath folks.
Fid
Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal
US/CANADA COPIES HERE
UK/IRELAND FROM CHIPMUNKA PUBLISHING
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