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|Pfizer was accused by the FDA of submitting these adverse reports through “improper channels” that made it impossible for the agency to determine that so many serious adverse reactions to Chantix® were occurring.45,47 Thomas J. Moore, an official at the non-profit Institute for Safe Medication Practices stated “We’ve had a major breakdown in safety surveillance.”45 In sworn testimony, Chantix® was described as causing twice as many reported fatalities as any other drug. Pfizer responded by stating there is no proof that Chantix® causes suicides or other side effects.45,46|
FDA Black Box Warning
|In response to increased suicides in children (and adults) prescribed certain anti-depressant drugs, the FDA has mandated the following warning: |
Contact your doctor if your child experiences any of the following while taking antidepressants:
- Thoughts about suicide or dying
- Attempts to commit suicide
- New or worse depression
- New or worse anxiety
- Feeling very agitated or restless
- Panic attacks
- Difficulty sleeping (insomnia)
- New or worse irritability
- Acting aggressive, angry or violent
- Acting on dangerous impulses
- Extreme increase in activity or talking
- Other unusual changes in behavior or mood
|Life Extension Magazine March 2012|
|Crooked Practices That Are Destroying Our Health Care SystemBy William Faloon |
|FDA's Response to Pfizer's MisdeedThe FDA’s response to this latest scandal was to force Pfizer to resubmit all reports of adverse reactions through the “proper channel” that would enable the agency to identify serious problems such as suicide, depression, and other psychiatric disorders induced by Chantix®. |
FDA officials said these new reports did not change the agency’s position on the risks and benefit of the controversial drug, which received a black box warning that included suicide—the strongest caution possible—in 2009. In other words, other than warning of the lethal side effects a user of Chantix® faces, the FDA has no plans to withdraw it from the market.
FDA officials did say they are considering changing regulations to allow expedited reports of suicides and other serious problems. This change was first proposed by the FDA in 2003, but is still pending. This is just another example of the glacial pace at which the FDA moves even as body counts pile up from side effects inflicted by prescription drugs the agency erroneously approves and then allows to remain on the market far too long.
A one-month supply of Chantix® costs about $179, which is typical of what patented drugs now sell for.
Pfizer Seeks to Delay Sales of Generic Lipitor® According to the New York Times, the largest introduction of a generic drug in history is being impeded in another devious scheme perpetrated by Big Pharma.
Suicide Risk of Chantix® Higher than Expected
|As we were finishing this article, a new study found that Chantix® was 8 times more likely to result in reports of suicidal behavior or depression compared to nicotine-replacement products.48 |
The findings contradict those of the FDA that found Chantix® did not increase the risk of being hospitalized for psychiatric problems such as depression.
The authors of this new study stated that the FDA hospitalization studies were flawed because they could not capture most of the serious psychiatric side effects, including suicide, depression, aggression, and assaults.
Another reason FDA failed to ascertain the magnitude of the problem with Chantix® is they omitted suicidal and depression events that did not lead to hospitalization. These can be catastrophic events but do not normally result in hospitalization.49
Lipitor® is the best-selling drug of all time, generating sales of $106 billion over the last decade. Pfizer has told financial analysts it is preparing for the loss of Lipitor®’s patent with a variety of business moves to preserve market share.
In a letter to pharmacists, Pfizer is asking many drugstores to block prescriptions for a generic version of Lipitor®. This cholesterol-lowering drug lost patent protection on November 30, 2011.50
One of the nation’s largest pharmacy benefit managers issued instructions seeking to have pharmacists keep filling prescriptions with the more expensive Lipitor® for six months. Pfizer will provide large discounts to benefit managers that block the use of generic versions of Lipitor®.
This tactic will benefit Pfizer and benefit managers at the expense of employers and taxpayers, who are on the hook for paying more than they should for an off-patent drug.
Pharmacy benefit managers function as middlemen between drug companies and insurers and employers that sponsor health insurance plans. In too many cases, these “pharmacy benefit managers” function as shills for pharmaceutical companies to cause more expensive name-brand drugs to be used in place of low-cost generics.
How Generic Price Gouging Impacts Members Through the International Strategic Cancer Alliance that was founded five years ago, we at Life Extension are constantly interacting with patients who utilize off-label drugs to better control their disease. Since insurance does not fully cover these medications, patients are finding it difficult to afford the cost of their medications. Here is an email excerpt from a prostate cancer patient regarding a generic medication he is using:
“Cabergoline is very costly, around $600 for 60 days’ supply. This has eaten up my insurance allowance for drugs. Your latest email indicates necessity, but is it possible to lessen amounts taken without hindrance to outcomes?”
Cabergoline is a generic drug that suppresses prolactin release from the pituitary gland. Life Extension has long recommended this drug to certain cancer patients, though it is not recognized by the FDA for this purpose.55 Prolactin makes prostate cells more sensitive to the growth-promoting effects of testosterone. By reducing prolactin levels, cabergoline has a potential role in prostate cancer treatment. In addition, lowering prolactin results in a reflex increase in dopamine, which has the beneficial effect of inhibiting angiogenesis—the formation of new blood vessels that facilitate the growth and spread of most cancers. Furthermore, increased dopamine enhances neurotransmission which improves clarity of thinking or cognition. Therefore, cabergoline is a true multi-tasking pharmaceutical agent that increases the therapeutic index or ratio.
The patient who sent us this email concerned about the high cost of cabergoline may risk his life by taking a lower-than-recommended dose because he can no longer afford it. Yet this is an off-patent generic drug that should cost only a fraction of what is being charged. Generic drug prices change daily, so by the time this article is published, generic cabergoline might once again be affordable, or it could cost even more.
A physician on the Life Extension’s Scientific Advisory Board wrote us about eye drops he needs for glaucoma that will cost $99.20 a month for the rest of his life, despite having Medicare and AARP. That’s $1,200 a year just for eye drops. This physician wonders how our health care system can tolerate such blatant price gouging. A calculation of the price for the generic version of this eye drug is $2.50 per drop, which prompted the dispensing pharmacist to say to the doctor, “This is a license to steal.”