A JAMA study by Ellen W Freeman shows that Lexapro is “marginally” more effective than placebo for Hot Flashes. This is laughable, and surely you must be joking? The authors received money from Forest labs, the makers of Lexapro for a “seeding study”. This is a form of marketing, designed to convince doctors to prescribe the drug for non-approved usage. Last year, Forest Labs paid a 313 million dollar fine for Lexapro fraud. They haven’t learned their lesson or changed their behavior. This Lexapro study is another example of corruption in medical research. The Lexapro study should have been rejected from the start by the NIH and the ethics review board of the hospital. Using an SSRI antidepressant such as Lexapro for women with hot flashes is an outrage and a form of medical victimization. Prescribing Lexapro or any other psycho-active drug for menopauseal hot flashes is NOT FDA approved, and is OFF-Label use. This practice should be discouraged.
Regarding SSRI drugs for depression (drugs like Prozac, Zoloft, Lexapro, Paxil, Wellbutrin, etc) SSRI drugs were shown to be no better than placebo for most people with depression (reference: JAMA 2010;303 ).
Medical Research Reaches a New Low Point
SSRI antidepressant drugs are addictive, dependency type drugs with adverse side effects including loss of sexual function, agitation, movement disorder, violence and suicide. Abrupty stopping Lexapro (Escitalopram) may cause withdrawal symptoms such as “electric shock” sensations (also known as “brain shivers” or “brain zaps”), dizziness, acute depressions and irritability, as well as akathisia. Lexapro is manufactured by Forest Labs, a company guilty of fraud in marketing of Lexapro.
In 2009, Forest Labs was accused of fraud by the US Justice department for illegally marketing Lexapro for unapproved uses in children and teenagers, even though studies showed the drug was ineffective and harmful. The company also ran “seeding studies”, or drug trials that were really a form of marketing to promote Lexapro use by doctors, same as this new JAMA study using the drug for menopausal symptoms of Hot Flashes. Forest labs admitted guilt and settled the criminal and civil complaints for a 313 milion dollar fine in Sept 2010.
Dr Barbara Mintzes of the Therapeutics Inititiative Speaks Out:
Barbara Mintzes , an assistant professor with the Therapeutics Initiative at the University of B.C. Mintzes called the results “underwhelming to the extreme.” She also said the difference on the “hot flash bother” scales between the two groups was below a level that would be considered clinically relevant. 55 per cent of the women in the Lexapro drug group versus 36 per cent in the placebo group reported a decrease of at least 50 per cent in “hot flash frequency. These are “manipulated numbers”.
This JAMA study is an outrage, a cruel farce and a hoax. The funding for this Lexapro JAMA study came from the NIH. Why is the NIH using public funds for this kind of study? What will they study next? Rat poison or drain cleaner for relief of hot flashes? This JAMA study reveals that medical research has reached a new low point in the history of western medicine.
Why spend time effort and money trying to show an ineffective addictive dangerous psych drug is more effective than placebo for a non-FDA approved indication – ie. Treatment for hot flashes? Number one, the SSRI drugs were shown to be no better than placebo for depression. Number two the drug makers are looking for another use for the SSRI family of drugs. Number three: the drug makers are paying a lot of money for this type of nonsense research. Number four: This is a “seeding study”, a form of marketing intended to convince doctors to use the drug for a non-approved use. As such, it is “easy money” from drug makers.
The JAMA Authors Financial Disclosures:
Dr Freeman receives money from Forest Laboratories (maker of Lexapro), Wyeth, Pfizer, Xanodyne Pharmaceuticals. Pherin Pharmaceuticals and Bayer.
Dr Cohen recieves money from Forest Labs , Astra-Zeneca ; Sepracor; Bayer HealthCare; Bristol-Myers; Stanley Foundation; Ortho-McNeill Jansen; Pfizer. Eli Lilly; GlaxoSmithKline; JDS/Noven Pharmaceuticals; Wyeth-Ayerst Pharmaceuticals; Eli Lilly, GlaxosmithKline; Pfizer, Inc, and Wyeth-Ayerst Pharmaceuticals.
Dr Joffer receives money from Forest Labs, Astra-Zeneca, Bayer HealthCare, Eli Lilly, GlaxoSmithKline, Sanofi-Events, Sepracor, Inc, and Wyeth-Ayerst Pharmaceuticals
Hot Flashes Are Caused By Hormone Deficiency of Menopause
Menopausal symptoms are not caused by a Lexapro deficiency. They are caused by hormone deficiency. SSRI drugs are addictive Psychiatric drugs that do not address the hormone deficiency of menopause. To suggest them as a treatment for hormone deficiency is ludicrous, and creates a new population of women as medical victims.
Safe and Effective Treatment : BioIdentical Hormones
The safest and most effective treatment for menopausal symptoms of hot flashes a biodentical hormone program. Progestins and other synthetic hormones are associated with increased risk of cancer and heart disease. On the other hand, progesterone and Bioidentical Hormones are safe, effective and are not associated with increased risk of cancer or heart disease. That is why bioidentical hormones are the preferred treatment .
Would you trust a person who admits guilt and pays a fine for fraud? Of course not. The behavior is likely to be repeated. Why take a chance? Why would anyone trust Forest Labs’ Lexapro? Don’t be a medical victim. Avoid the SSRI for menopause trap.
Dr. Jeffrey Dach and TrueMedMD receive NO funding from the pharmaceutical industry or government. Dr. Dach is an advocate of patients’ rights and supports informed consent.
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Disclaimer
The reader is advised to discuss the comments on these pages with his/her personal physicians and to only act upon the advice of his/her personal physician. Also note that concerning an answer which appears as an electronically posted question, I am NOT creating a physician — patient relationship. Although identities will remain confidential as much as possible, as I cannot control the media, I cannot take responsibility for any breaches of confidentiality that may occur.
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To read more on Dr Dach’s work please visit his website at www.jeffreydach.com and if you have any questions or comments on his articles you can contact him via the website.