Lawsuits claim baldness drug Propecia causes sex problems, depression. The judge sealed evidence – viewed by Reuters – suggesting the maker downplayed risks. A widow wants the truth out.
www.reuters.com
"More than 1,100 Propecia-related lawsuits filed across the U.S. against Merck were consolidated before Judge Cogan in so-called multidistrict litigation (MDL). Merck agreed to settle most of them last year for $4.3 million, to be divided among the plaintiffs. Prior to the settlement, plaintiffs’ lawyers cited internal company communications to allege that in revisions to the drug’s original label, Merck understated the number of men who experienced sexual symptoms in clinical trials, and how long those symptoms lasted. Merck settled before responding to the allegation in court."
Reuters asked a U.S. judge on Thursday to unseal documents filed in court regarding potential risks associated with Propecia, Merck & Co's popular baldness drug.
www.reuters.com
If you want to get into technicalities regarding the definition of a settlement, if Merk or Propecia actually won, they wouldn't have made a settlement and paid people out even $1. But here they are paying $4.3 MILLION dollars. You can say it's technically not a "win" but for most, I see it as a loss for Propecia.
Furthermore, Merck intentionally leaving out the other side effects on Finasteride was not a small thing as forgetting. They knew well what these side effects were bu left them out because they knew it would negatively affect sales. These are major major major problems because you can't just get away with that without paying people to keep quiet, paying scientists and FDA to keep quiet and also secretly funding "independent" studies because there's so many studies that contradict these "independent studies" that portray Finasteride in a less harmful light.
"
The sealed document also cites a 2016 sworn deposition in which a plaintiffs’ lawyer asked former Merck marketing vice president Paul Howes: “So you knew internally that if these sexual adverse events were prolonged or lengthened or never went away, that that would be something that would impact sales in a negative way. Right?”
“Yes,” Howes said.
Howes, who held that marketing job from 1998 until 2001, declined to comment for this article.
SALES DOWNER: In a 2016 deposition Reuters reviewed, former Merck marketing executive Paul Howes testified about the business risk posed by Propecia’s possible side effects."
No you're wrong again, there's actually a plethora of studies that show Finasteride is actually way worse, I'll cite you more stuff:
"The rate of sexual dysfunction was “significantly higher” in men who took finasteride compared to men who took the placebo, according to the study’s authors.
Impotence occurred in *15.8 percent* of finasteride users while 6.3 percent of placebo users reported the issue. The study’s authors published the results in the November 1996 issue of Canadian Medical Association Journal.
Also in 1996, a much larger observational cohort study published in British Journal of Urology used prescription-event monitoring to gather information on 14,772 patients. ED was the *most frequently reported side effect with finasteride*. It was also the most common reason for stopping the medication.
*Persistent Erectile Dysfunction* :
In March 2017, a Northwestern Medicine study found that some men who took finasteride suffered persistent erectile dysfunction in which they were not able to have normal erections for months or years after stopping the medication.
Out of 11,909 men who took finasteride or dutasteride, 1.4 percent developed persistent erectile dysfunction that continued for an average of about 1,350 days after stopping treatment, according to the study. "Young men who had more than 205 days of exposure to the drug had nearly five times higher risk of persistent erectile dysfunction than men with shorter exposure.*
Researchers published their findings in the open access journal PeerJ. "
" *Loss of Libido* :
Another side effect reported with Propecia use is a reduced interest in sex. In fact, *loss of libido was the most common sexual side effect reported in a 2011 study of finasteride users* published in the Journal of Sexual Medicine.
Researchers from the George Washington University School of Medicine interviewed 71 patients who experienced sexual side effects after using finasteride. The researchers found that *94 percent of men experienced a decline in libido.*
“Such significant and undesirable complications in relation to sexual function produce a well-documented negative impact on quality of life.”
Source: August 2003 review in International Journal of Impotence Research"
"*Problems Continue After Drug Use Stops* :
Following the early drug trials, both Merck and the FDA assured men that the sexual complications would resolve once they stopped taking the drug, but later evidence would prove the contrary.
"*The preapproval trials were not especially reliable, as the information was drawn from a relatively small patient group treated for only six months to one year, and follow-up procedures were unclear.*
*More recent investigations show the drug’s sexual side effects can persist even after a man stops taking the drug. In some cases, the complications are irreversible."*
" The man stopped taking the drug about a month later, and while some side effects disappeared, his sexual function never returned to normal. In a follow-up 11 years later, he still suffered from erectile dysfunction and loss of libido. The researchers published their study in the Journal of Sexual Medicine.
In 2011, George Washington University urologist Michael S. Irwig and his colleague Swapna Kolukula published their assessment of 71 finasteride patients who reported long-term sexual side effects that persisted after discontinuation of the drug.
The selected group of patients (young men between the ages of 21 and 46) took a survey that revealed a wide range of sexual side effects that arose after Propecia use, including problems with erectile function, arousal, sexual desire, orgasm and orgasm satisfaction.
The men had taken the drug for an average of 28 months. The sexual side effects continued for an average of 40 months after the men stopped taking the drug.
Upon following up with 54 of these patients one year later, Irwig discovered that *96 percent of the men were still suffering from the sexual dysfunctions* they initially reported. None of the men reported sexual, psychiatric or medical complaints before taking finasteride.
“The argument that the benefits of these drugs outweigh the risks is slowly eroding in the face of new emerging scientific evidence from preclinical and clinical studies.”
June 2014 study in Korean Journal of Urology
A 2014 review in Korean Journal of Urology found at least four previous studies that reported “persistent or irreversible” sexual side effects. The authors said the studies reported “negative emotional toll and reduced quality of life” for the men affected.
“The argument that the benefits of these drugs outweigh the risks is slowly eroding in the face of new emerging scientific evidence from preclinical and clinical studies,” the authors wrote.
Men who suffered long-term sexual dysfunction after taking Propecia have filed lawsuits against Merck that accuse the company of failing to warn users of the risk.
*Sexual Dysfunction and Suicidal Thoughts* :
Researchers have also found an increased risk of depressive symptoms and suicidal thoughts among men who suffered sexual side effects of Propecia. Irwig reported the connection in a 2012 study in the Journal of Clinical Psychiatry.
Irwig looked at 61 former finasteride users who experienced sexual dysfunction for three months or longer after they quit the medication. He compared them to a control group of 29 men who had male pattern hair loss but who had never used the drug.
He found that *44 percent of the former Propecia patients experienced suicidal thoughts* compared to just 3 percent of men who never used the medication.
*The rate of depressive symptoms was 75 percent in the men who had used finasteride* and 10 percent in the control group. Sixty-four percent of the former finasteride users suffered moderate or severe depressive symptoms. None of the men in the control group experienced the same issues."
" FDA Warns of Additional Problems and Risks
When evidence conflicted with Merck’s original assertion that the sexual side effects of Propecia would stop once treatment ends, the FDA required the manufacturer to revise the drug’s safety label accordingly.
In 2011, the FDA called for a warning that erectile dysfunction may continue after the drug is no longer being used.
The following year, the agency published results from an investigation into the adverse effects of finasteride. Using data collected from 1998 to 2011, the agency identified persistent sexual dysfunction of at least three months in 14 percent of the 421 evaluated cases.
After the April 2012 investigation, the FDA required Merck to change Propecia’s label to include reports of libido, ejaculation and orgasm disorders that continued even after men stopped taking the drug. The label says 1 percent or more of men who used the drug experienced one or more of these three side effects.
The FDA also ordered Merck to add information about reports of male infertility and poor semen quality. The label description included information that the fertility and semen issues improved or returned to normal after men quit taking the drug."
Male-pattern baldness can be treated with Propecia. However, it’s important to understand the side effects Propecia may cause.
www.drugwatch.com
Men who suffered from sexual dysfunction or other side effects after taking Propecia have sued the drug’s maker, Merck & Co.
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