Zantac Lawsuit


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Tuesday, July 13, 2010

SSRIs Render Unfriendly Skies - By Evelyn Pringle





Some of you may know that last month I received a 58 page document from the Federal Aviation Administration. It was regarding a Freedom of Information request I had submitted in relation to a proposal that will allow pilots to control aircraft whilst on certain SSRi medications.

Much of the month of June was taken up with me reporting on the Sara Carlin inquest, to be honest, I reached the point of burn-out once the inquest had finished.

I therefore forwarded the 58 page document on to a Evelyn who is a terrific writer. I didn't really know anyone else who could do it justice.

Here is the result of Evelyn Pringle's study of the 58 page document:





SSRIs Render Unfriendly Skies - By Evelyn Pringle

The SSRI antidepressant makers are desperate to find new customers, so they recently have been focusing on capturing groups for which the drugs were usually considered off limits. The latest marketing coup managed to open up sales to roughly 614,000 American pilots.

Under a new policy announced on April 5, 2010, pilots diagnosed with depression can seek permission from the Federal Aviation Administration to take one of four SSRIs, including Eli Lilly’s Prozac, Pfizer’s Zoloft, and Forest Laboratories' Celexa and Lexapro.

"The FAA should reverse its ruling before it's too late and hundreds of lives are lost when a pilot becomes impulsive, suicidal or violent--or just loses his sharpness--under the influence of antidepressant medication," said SSRI expert, Dr Peter Breggin, in an April 19, 2010 Huffington Post commentary.

The Citizens Commission on Human Rights is also calling on the FAA to rethink allowing pilots to take SSRI in light of a new report issued last month by the National Transportation Safety Board, on a February 1, 2008 plane crash in North Carolina, by a crazy acting pilot on Zoloft, that killed all six persons on board

The report said the pilot failed to maintain control of the plane during instrument flying conditions and "deliberately descended below the minimum descent altitude." The plane stalled and crashed while circling after an aborted landing.

"Review of the cockpit voice recorder (CVR) audio revealed that the pilot had displayed some non-professional behavior before initiating the approach," the NTSB reported.

The CVR recorded the pilot singing: “Save my life I’m going down for the last time," before beginning a commentary in which he told passengers: "If anybody back there believes in the good Lord, I believe now would be a good time to hit your knees."

A review of medical records documented that "from December 4, 2006 through December 31, 2007, the pilot had filled 6 prescriptions for 30 tablets of 50 mg sertraline (Zoloft)," the report said.

The records indicated that he had been treated previously with two other antidepressant medications for “anxiety and depression” and a history of “impatience” and “compulsiveness,” the NTSB noted.

An investigation of another plane crash, resulting in two fatalities in Kingsport, Tennessee, in August 2003, found Zoloft in the blood and liver of a private flight instructor, according to an accident report by the NTSB.

In the policy statement published in the Federal Register, the FAA seems to justify the use of these drugs via the fully debunked "chemical imbalance in the brain" theory when writing: "All these medications are SSRIs, antidepressants that help restore the balance of serotonin, a naturally occurring chemical substance found in the brain."

"Increasingly accepted and prevalently used, these four antidepressants may be used safely in appropriate cases with proper oversight and have fewer side effects than previous generations of antidepressants," the FAA wrote, with no citation to any scientific paper to back up this assertion.

In fact, the current labels on SSRIs warn that "anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients treated for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric."

"Even when not severe, these reactions impair judgment and increase the likelihood of accidents and violence," according to Dr Breggin.

CCHR has set up a great website with a one-of-a-kind search engine that allows the public and officials to access the database on side effects reported to the FDA on SSRIs, and every other psychiatric drug. The site also has a search engine to access all the International warnings and studies on psychiatric drugs which have been summarized so they are easy to understand, even to a lay person

Input Only From the Choir

On April 6, 2010, Bob Fiddaman, author of the long-running popular website and blog, "Seroxat Sufferers," sent a request to the FAA, under the Freedom of Information Act, seeking information on the change in policy.

In the Federal Register, the FAA claims it came to its decision after "careful consideration." However, in the 58 pages of documents sent to Fiddaman on June 9, 2010 (and kindly shared with this author), there is no mention of consultations with any of the prominent SSRI experts who may have offered a contrary view. Like Peter Breggin for instance.

The FAA's response to Fiddaman shows the agency has been discussing the policy change since at least 2008. In response to a request for "minutes of meetings where the change in the policy was on the agenda," as well as a list of "members present and a declaration of interests of each of the members," the FAA sent a copy of a July 18, 2008, Memorandum, with a summary from one consultants meeting. Three outside experts attended but there were no declarations of interests, or lack thereof, by anyone at the meeting.

The summary noted that the consultants "unanimously agreed that the concept of allowing certain airmen taking antidepressant medication was reasonable and safe." But the "unanimous consensus" was that only Prozac and Zoloft "were appropriate medications due to the longevity of their use and overall safety."

"They also felt that only these two should be considered initially, and no other medications considered at this time," the summary reported.

In responding to the question of whether the new policy would apply to Air Traffic Controllers, the FAA said the "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."

In response to a request for any information "given to FAA from outside parties that relate to the FAA'S recent change in policy regarding pilots on antidepressant medication," the FAA sent copies of documents received from the Aerospace Medical Association, the Airline Pilots Association Aeromedical Office, the International Airline Pilots Association, and the United States Army.

"In developing the new policy, the FAA also utilized a variety of medical research literature available in the public domain," the response said. "We used internet sites such as, but not limited to: The National Library of Medicine PubMed site and the FDA Medwatch."

The documents Fiddaman received show consideration of a 2003 study of aviation accidents that found SSRIs in 61 pilot fatalities between 1990-2001, in which the psychological condition and/or the drug use was determined to be the cause, or a factor in 16 of the accidents, or 31%.

However, there was no mention of a later November 2006 study titled, "Pilot Medical History and Medications Found in Post Mortem Specimens for Aviation Accidents," led by Dennis Canfield, from the FAA’s Civil Aerospace Medical Institute, in the "Aviation, Space, and Environmental Medicine" journal.

For this study, toxicological evaluations were performed on 4,143 pilots involved in fatal aviation accidents during the period between January 1, 1993, through December 31, 2003, to identify all pilots found positive for medications used to treat cardiovascular, psychological, or neurological conditions.

The evaluations found one-hundred dead pilots with SSRIs in their systems including forty with Prozac, twenty-six with Zoloft, twenty-one with Paxil, and thirteen with Celexa.

Less than a month after the new policy was announced, in "Aviation International News," on May 1, 2010, Matt Thurber reported that in a review of 127 accidents in the NTSB database since 1991, containing the word “antidepressant,” only three were nonfatal.

"In 124 of those accidents, 211 people were killed," Thurber said. "In accident after accident, antidepressants ... were found in the tissues of dead pilots, and the pilots had falsified their medical certificate applications to show that they had never been treated for psychiatric problems."

Drug Free For All

No doubt in large part to Fiddaman's multi-year non-stop campaign to inform the world about the dangers of Paxil, pilots will still not be allowed to use it.

However, some of the people who submitted comments to the FAA on the new policy thought the agency should open up the friendly skies to more psychotropic drug use. For instance, on June 16, 2010, a person commenting under the name, Anonymous, told the FAA: "This review should be expanded to include ADHD medications."

"Many pilots are diagnosed as having ADHD and take medication to assist them. Many of the medications used today to assist adults are derivatives of drugs issued to military pilots to remain alert during missions," Anonymous said. "I strongly encourage the FAA to review the use of ADHD medication so the pilots using medications to manage their symptoms can finally come out of the shadows."

On June 23, Gregorio Guillen wrote and asked: "How about those pilots wanting to take prescription low dose Sertraline to treat premature ejaculation and not necessarily depression?"

Gregorio wants to whether they "are going to be affected by this rule?"

A pilot named, Paul Reed, asked the FAA to: "Please consider allowing migraine treatments with anti-depressants to be included in this rule," on June 17.

But on the other hand, on June 17, Patric Barry wrote: "If the pilot population is permitted to use such medication, the temptation to increase the dose when a pilot is feeling "a little off" is too great a risk - to amend the rules to allow an inch, some pilots will feel compelled to take a mile."

"That is simply an unacceptable risk to the general population and passengers relying on the stability of the pilot group to safeguard and protect public safety," he told the FAA.

Dr Jeffrey Welker also believes it is "a bad idea to allow individuals being treated for depression with medications to hold a current valid medical," and "we should be looking very close at these individuals after treatment for mental stability."

"I base this opinion on my professional and personal observations of 25 years in practice," he said in a comment on June 25.

All of the comments submitted can be found by going to the FAA's Regulations and Policies Web page.

SSRIs Impair Roadways

It makes no sense to put planes full of people at risk by allowing pilots to fly on SSRIs when a study as far back as December 2006, in the "Journal of Clinical Psychiatry," reported that about seven out of every ten people who take antidepressants have impaired driving ability in a car, and 16% have severe motor impairments.

In addition, "reckless driving is one of the most commonly reported adverse effects of antidepressants," Dr Breggin reports.

"After taking antidepressants, disinhibited, agitated or angry drivers find themselves exploding into road rage or using their cars as instruments of suicide," he says. "This is one of the first antidepressants reactions that clinicians like myself began noticing soon after Prozac hit the marketplace."

In his book, "Medication Madness," Dr Breggin describes how an ordinarily calm, model citizen became suicidal on Paxil and drove his car into a helpless policeman in order to knock him over and get his gun so the man could kill himself with it. Although the man seriously injured the cop, he failed to get the gun.

In another case, a man described as kind and gentle turned psychotic while on Zoloft and drove his automobile into a barrier in attempt to kill his passenger wife because he believed her body was harboring an alien beast that wanted to destroy him and all of humanity.

"The other part of this story that the FAA seems to be missing is that for all but the most extreme cases of depression, antidepressant drugs have been scientifically proven — through multiple clinical trials — to work no better than placebo," says Mike Adams in the April 5, 2010 report, "Medicated in the Cockpit."

"These pilots would do just as well taking capsules filled with olive oil as they do on patented, monopoly-priced SSRI drugs," he points out.

The current price of the four SSRIs at DrugStore.com, for 90 pills at a middles dose, is $600 for Prozac, $365 for Zoloft, $320 for Celexa, and $270 for Lexapro. Much to the delight of the SSRI makers, the FAA's new policy will likely encourage pilots to keep paying for their useless drugs forever.

The 58 page document can be viewed HERE

(Evelyn Pringle is a journalist focused on exposing corruption in government and corporate America)


Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

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