Written by: Heather Helmendach, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
Article 1 - Creating a Clinical Disorder for Profit
Article 2 - The Devastating Side Effects
Article 3 - Are the Current FDA Label Warnings Enough?
To start my blog series on Yaz, Yasmin, Ocella, Gianvi, Safyral, and Beyaz, I will focus on Yaz in particular, and one of the conditions that it is prescribed to treat.
Though drugs are generally created for the purpose of treating existing medical conditions, this is not always the case. In fact, corruption in the system can sometimes result in the creation of a medical condition after the approval of the drugs designed to treat it. This provides drug companies with a way to deepen their pockets by expanding the market potential of their drugs.
This very phenomenon occurred with the treatment of "premenstrual dysphoric disorder" (PMDD) by prescribing Yaz and several antidepressants. More details are provided in the article "Lowering the Bar: How PMDD Went from an Idea to a Diagnosis" by John Faubner, whose information is referenced and summarized in this post.
PMDD is a severe form of PMS, and Faubner provides the following information in his article:
"According to the DSM, which recognized PMDD as a disorder in 2013, the condition is defined as having at least 5 of 11 symptoms, which include feeling angry, irritable, depressed, or anxious, and having mood swings.
Several antidepressants were approved for the treatment of "the not-yet-existent diagnosis of PMDD in 2000"; just two years after a private meeting was paid for by the drug manufacturer, Eli Lilly, and conducted by four of its executives along with various researchers and six FDA officials. Yaz was later approved as a treatment for PMDD in 2006.
However, PMDD was not formally considered a distinct psychiatric condition by the American Psychiatric Association until 2013. Even then, its validity was still questioned by some medical professionals, and the majority of the members on the panel responsible for the decision had ties to drug companies.
In addition, the numbers of women who supposedly had PMDD were severely inflated. While initial reports in 2011 touted that 30% of women have PMDD, later studies determined that only 1.3% of premenopausal women have PMDD. That means that initially, 6 million women were thought to have PMDD, when in actuality, the number was just under 1 million.
The previously-referenced article by Faubner includes the following information provided by Amanda LaFleur, executive director of the National Association for Premenstrual Dysphoric Disorder:
[For] many women the only other approved drug, Yaz, only made symptoms worse.
In two clinical trials, Yaz reduced PMDD symptoms, but not a lot more than a placebo.
Women who took Yaz showed a 37.5-point improvement on a symptom scale that had a maximum of 126 points, but those who get a placebo had a 30-point improvement.
And the drug's effectiveness beyond three menstrual cycles is not known.
Faubner also includes statements by Diana Zuckerman, PhD, president of of the National Center for Health Research:
Treating PMDD with birth control pills, such as Yaz, that include the drug drospirenone is especially concerning...
The drug's label warns that women over 35 who smoke should not use Yaz, because of the risk of clots and the increased likelihood of a serious cardiovascular event.
"Safer drugs are available to effectively treat PMDD," Zuckerman said. "How bad is your PMDD that you are willing to put your life at risk?"
The next article in my Yaz, Yasmin, Ocella, Gianvi, Safyral, and Beyaz series will provide information on some of the lawsuits that have previously been filed due to complications of these drugs following their approval for PMDD treatment.
In the meantime, we will continue to monitor the medical literature concerning these drugs, and more information can be found on our website.
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