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Mark2010

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Posts posted by Mark2010

  1. 20 minutes ago, j1mmy said:

    Nobody is saying that they know such a thing "doesn't" exist. Rather, it is no different than the various birth control pills. A minority of women suffer side effects, and some experience no doubt long-lasting side effects. Drugs are approved based on clinical trials, and their safety profiles. There is a reason dutasteride was dropped by Merck for the treatment of hair loss. 

    Let me ask you this, have you thought about how many people you are essentially giving side effects, potentially permanently, by spreading scare media? 

    You are going about it in the wrong way, and you are harming people, Mark.

    I don't see how Merck could have dropped dutasteride since they don't even make the drug ?

    The percentage of people who get permanent side effects from Finasteride is over 1% if I had known that I would never have taking it.

    https://www.nbcnews.com/health/mens-health/hair-loss-drug-propecia-carries-risk-losing-something-else-n731841

     

     

     

  2. 16 hours ago, j1mmy said:

    I'm sure this guy is a little special, but humour me, I was curious. I looked at his posting history, his first threads on the same day in 2010 were about taking saw palmetto, taking finasteride, taking some other non-FDA item, and then a couple of weeks later asking whether his swollen lips were caused by finasteride. Inferring the issue but don't get me started. 

    He returned 5 years later, to just make regular threads quoting scare media about propecia, not seemingly interacting with posters.

    This is why people don't take you seriously @Mark2010, If you want to be taken seriously, you should interact with people and share your feelings, if you want to help people. Right now you just seem like the crazy drunk guy people avoid.

     

    PFS is very real there is no point of me trying to engage with people who want to deny reality.

    Reuters even reported that Merck covered up Proepcia's side effects.

    They would not have needed to do that if Propecia was really that "safe".

    https://www.reuters.com/investigates/special-report/usa-courts-secrecy-propecia/

  3. Quote

    (Reuters) - Newly unsealed court documents and other records show that Merck & Co and U.S. regulators knew about reports of suicidal behavior in men taking the company’s anti-baldness treatment Propecia when they decided not to warn consumers of those potential risks in a 2011 update of the popular drug’s label.

     
     
    FILE PHOTO: A bottle of Propecia is seen on a pharmacy shelf in New York City, U.S., August 8, 2019. REUTERS/Zachary Goelman

    Internal records from Merck were made public in late January, when a federal magistrate in Brooklyn, New York, granted a 2019 Reuters motion to unseal 11 documents filed in years of litigation alleging Propecia caused persistent sexual dysfunction and other harmful side effects.

    Since the 2011 decision on the warning, the FDA has received more than 700 reports of suicide and suicidal thoughts among people taking Propecia or generic versions of the drug. Those included at least 100 deaths. Before that, in the first 14 years the drug was on the market, the agency received 34 such reports, including 10 deaths.

    Annual U.S. prescriptions of finasteride, as the drug is known, for hair loss increased to over 2.4 million in 2020, more than double the number in 2015, according to health data company IQVIA.

    European and Canadian regulators, citing similar reports among men taking finasteride, require a warning of suicidal thoughts on the label, though they note that research has not proved that the drug causes such thoughts. To this day, the U.S. label contains no mention of suicide or suicidal thoughts.

    As early as 2009, Merck knew of more than 200 reports of depression, including suicidal thoughts, in men taking Propecia, according to an internal “risk management” assessment from that year. The company decided there were too few reports of serious depression and suicidal behavior and not enough specifics about those cases to warrant more than “routine” monitoring of safety data.

    In 2011, two years after the Merck risk analysis, the FDA was weighing a company request to add “depression” to the drug’s label as a potential risk, with no warnings related to suicide. FDA analysts disagreed about adding a warning related to suicide, according to previously unreported government documents. But the regulator ultimately agreed with Merck’s request on the grounds that the number of suicides was lower than one would expect in this group of patients.

    CALLS FOR TRANSPARENCY

    Some medical researchers and patient advocates said Merck and the FDA have left American consumers in the dark about potentially life-threatening dangers associated with finasteride.

     

    “No family should ever have to learn about this after the fact,” said Kim Witczak, a consumer advocate who serves on an FDA advisory panel for psychiatric drugs. She has called for drug companies and regulators to issue stronger warnings after her husband died from suicide in 2003 five weeks after being prescribed an antidepressant for insomnia. Merck “had an opportunity to put suicide on the label, but they didn’t want to do that because it’s all about sales.”

    Michael Irwig, an endocrinologist and Harvard Medical School faculty member whose own research has found possible links between finasteride and suicidal behaviors, said Merck’s handling of the risk analysis and the FDA’s inaction keep critical information from the public. Merck “definitely should have provided a more complete picture,” Irwig said.

    In a statement to Reuters, Merck said that “the scientific evidence does not support a causal link between Propecia and suicide or suicidal ideation and these terms should not be included in the labeling” for the drug. “Merck works continuously with regulators to ensure that potential safety signals are carefully analyzed and, if appropriate, included in the label for Propecia.”

    Merck has said in past statements that Propecia has been prescribed safely to millions of men since the late 1990s. It also has argued in court that “premature hair loss itself, the very condition for which Propecia is prescribed, is associated with low self-esteem, poor body image, and depression.”

    In a statement, FDA said it “continues to monitor postmarketing safety data for Propecia.” Overall, the agency noted that the presence of a report in the FDA database “does not mean the drug caused the adverse event” and medical problems may stem from the “underlying disease being treated, caused by some other drug being taken concurrently, or occurred for other reasons.”

    FDA declined to comment further about its handling of Propecia and reports related to suicide.

    Merck’s analysis of a potential suicide risk stayed secret in court for over three years -- and only became public after Reuters intervened in the proceeding. The insights in the recently unsealed documents echo findings from Reuters’ 2019 investigation, “Hidden Injustice,” which revealed how U.S. judges routinely allow makers of consumer products to file under seal in lawsuits information that is pertinent to public health and safety. They often do so without explanation, though in most jurisdictions, they are required to provide one.

    The Reuters investigation found that hundreds of thousands of Americans have been killed or seriously injured in recent decades by allegedly defective products -- including drugs, cars and medical devices -- while evidence that could have alerted consumers and regulators to potential danger remained hidden.

     
     

    Slideshow ( 2 images )

    In granting Reuters’ motion to unseal Merck documents, U.S. Magistrate Judge Peggy Kuo last month ruled that the company’s arguments for continued secrecy “are so weak that they would not overcome even a low presumption of access under the common law.”

    INTERNAL DIFFERENCES

    In addition to the risk management plan, Kuo unsealed other Merck documents including an internal marketing report from prior to the drug’s launch and some communications with regulators regarding sexual dysfunction. Reuters obtained the FDA documents discussing suicide from a separate online repository maintained by the agency.

    In 2010, while reviewing Merck’s proposal to add potential depression risk to Propecia’s label, an FDA safety evaluator recommended also adding a warning for suicidal thoughts and behavior, noting nine suicides and reports of other suicidal behaviors among patients who took finasteride, the FDA documents reviewed by Reuters show.

    The reports of suicidal behavior analyzed by Merck and government regulators, known as “adverse event” reports, are filed by consumers, doctors and other members of the public. They are compiled in a public database by U.S. regulators, as well as drug-safety agencies in other countries.

    In her November 2010 report, FDA safety evaluator Namita Kothary wrote that the nine suicides were difficult to assess due to incomplete information. “However, we cannot exclude that finasteride may have contributed to the events,” she wrote. Kothary did not respond to requests for comment.

    Two other FDA reviewers disagreed. The two physicians -- Amy Woitach and David Kettl -- said the data supported adding depression to the label. Suicidal ideation, however, should be left off because the number of suicidal thoughts, attempts and deaths was “lower than would be expected in this patient population,” according to their December 2010 report. Kettl and Woitach did not respond to requests for comment.

    The European Medicines Agency found the relationship between finasteride and depression was hard to assess, but still required a warning about suicidal ideation in 2017, in part because Propecia is not prescribed for a serious condition, according to EMA committee meeting minutes. Doctors and patients generally weigh risks differently for a drug to treat a life-threatening health problem, versus something less severe.

     

    When Health Canada required its warning in 2019, it noted 368 international reports of suicidal events reported in patients treated with finasteride through September 2018. Merck did not respond to questions about these regulatory moves.

    The FDA approved Propecia in 1997, and sales climbed steadily through the 2000s, peaking at $447 million in 2010. Soon after, Merck’s patent expired. Overall sales of finasteride have remained strong as cheaper generic versions have hit the market.

    PERSISTENT DYSFUNCTION

    The new information regarding a potential suicide risk emerged as a result of longstanding controversy about sexual problems associated with the drugs.

    From the beginning, Merck’s label said Propecia caused sexual dysfunction in nearly 4% of its clinical study participants. However, the 2009 risk management report also shows that the company was aware of reports that those sexual problems continued for some men after they stopped taking the drug.

    The FDA in 2012 approved Merck’s request to add a warning of erectile dysfunction that continued after stopping the drug, as well as “libido disorders, ejaculation disorders, and orgasm disorders.” Even so, Merck at the time said scientific evidence did not establish that Propecia caused persistent sexual dysfunction.

    The warning prompted more than 1,100 lawsuits against Merck by men alleging their sexual problems lasted long after they stopped taking Propecia. Merck in 2018 agreed to settle most of the lawsuits consolidated before Judge Brian Cogan in Brooklyn federal court for a combined $4.3 million.

    Reuters reported in 2019 that prior to the settlement, plaintiffs’ lawyers had alleged that Merck, when revising the drug’s original label, understated the number of men who experienced sexual symptoms in clinical trials and how long those symptoms lasted. The allegation was part of a sealed court brief a Reuters reporter was able to read because of a redaction error. The brief cited internal Merck communications, filed under seal. Reuters intervened in the case, seeking to unseal those communications.

     

    “IMPORTANT POTENTIAL RISK”

    The 2009 risk management report unsealed last month shows that while depression did not emerge as a risk in clinical trials, Merck deemed it an “important potential risk” after the company received 218 global reports of depression from 1998 to 2008. Of those, 10 involved serious depression, and an additional nine involved suicidal behavior.

    Merck noted limitations with both the depression reports and the nine involving suicidal behavior. Four provided “insufficient information to allow a full evaluation.” Three of the men had other medical conditions, and for two, the symptoms developed after they stopped taking the drug.

    “One fatal report was received from a sheriff’s office and described a male who committed suicide by shooting,” according to the report. “The medical examiner did not think this event was related to Propecia, in addition, the report provided insufficient information to allow for assessment.”

    The report contained no additional details about the patient’s identity or the medical examiner’s investigation. Merck did not respond to questions about what steps it took to learn more about the case.

    In its statement to Reuters, Merck said adverse event reports reflect only the opinions of the person who files them. “While consumers and healthcare professionals are encouraged to report adverse events, the reaction may have been related to the underlying disease being treated, or caused by some other drug being taken concurrently, or occurred for other reasons,” the company said.

    Dr W. Vaughn McCall, chairman of the Department of Psychiatry and Health Behavior at the Medical College of Georgia, agreed that relying on adverse event reports to monitor drug safety has its limitations. However, he said one of those limitations is that injuries and deaths are often underreported because people aren’t familiar with the process or don’t have time to examine a specific case.

    He said there is a plausible biological explanation for a potential link between Propecia and suicidal thoughts. The drug reduces a testosterone-related hormone, which in turn could impact an anti-depressive steroid produced in the body.

    “There is a reason to be suspicious,” McCall said.

    Reporting by Dan Levine in San Francisco and Chad Terhune in Los Angeles. Editing by Janet Roberts and John Blanton.

    https://www.reuters.com/article/us-merck-propecia-suicide-exclusive-idUSKBN2A32XU?fbclid=IwAR3A6PAdUFF4r5mwJwuITe42m8PBLpBDFcXpqGJnzicT14qUtxvPRtqK9Dc

  4.  

    1 hour ago, Mycroft said:

    Not surprised, but to be completely blunt, nothing in the widow's story seems to implicate the drug as the cause. There are any number of reasons her husband could have fallen into a depression at age 40 (midlife crisis?) And lack of interest in sex goes hand in hand with depression. I think it's much easier for us to blame some pill than to acknowledge that the human brain is a horrifyingly complicated thing that we really don't understand and often don't know how to "fix" in cases like this.

     

    Other than drugs like Finasteride I don't know of any other cases were someones sex drive is turned down to Zero for no apparent reason.

    In my case when I was in my 20s I lost my sex drive over night when I came off Finasteride  and "crashed".

    It was like a switch had been turned off and I was never the same since.

     

  5. Quote

     

    Court let Merck hide secrets about a popular drug’s risks

    Lawsuits claim baldness drug Propecia causes sexual problems and depression. The judge sealed evidence – uncovered by Reuters – suggesting the maker downplayed the side effects. A widow wants the truth out.

    PARK CITY, Utah — By the time Kelly Pfaff got home from driving her son to school that morning, it was too late.

    Her husband, John, was supposed to be taking their 4-year-old daughter to school. But the girl and the nanny were still at the Pfaffs’ house near San Diego. So were John’s wallet, cellphone and wedding ring. John was gone.

    Kelly was alarmed, but not surprised. For four years, she had watched her husband, once a successful information-technology executive, avid skier and doting father, spiral inexplicably into despair.

    It had started with dark, sulking moods. Then he lost interest in sex. His wife asked him if he was having an affair. “No … Something’s just not right down there,” Kelly said her husband told her. Panic attacks set in.

    He suspected the cause might have been Propecia, the popular Merck & Co drug he had been taking to treat hair loss since around the time his problems started. He quit the pills, but still he couldn’t sleep, and he flashed random anger at the children. He started talking about killing himself.

    On the morning of March 5, 2013, about 45 minutes before his wife got home, John Pfaff stepped onto the railroad tracks a block away and into the path of a southbound Amtrak train. He was killed on impact.

    Kelly Pfaff blames Merck for her husband’s death at age 40. In a lawsuit filed in 2015, she alleges that the pharmaceuticals company for years knew but concealed from the public that Propecia could cause the persistent sexual dysfunction and depression that led to her husband’s suicide about a year after he quit taking the drug.

    John Pfaff wasn’t the only man who experienced sexual problems after taking Propecia. His widow’s lawsuit was one of more than 1,100 filed across the United States and consolidated in so-called multidistrict litigation (MDL) in federal court in Brooklyn, New York. They accuse Merck of not adequately warning patients of the drug’s possible side effects and their duration.

    Merck has denied the allegations in court filings and declined to comment further on Pfaff’s case. In a statement to Reuters, Merck said it “stands behind the safety and efficacy of Propecia,” noting that the drug has been prescribed safely to millions of men since the late 1990s. While the drug’s label lists erectile dysfunction and other sexual problems as possible side effects among a small percentage of men, the company rejects allegations that Propecia causes those problems to persist after men stop taking it or that it can lead to mental health issues. Merck says the symptoms themselves could be caused by a variety of other factors.

    However, confidential documents reviewed by Reuters accuse Merck of exaggerating the drug’s safety record.

    Citing internal company communications, these legal briefs filed by plaintiffs’ lawyers allege that in revisions to the drug’s original 1997 label, Merck understated the number of men who experienced sexual symptoms in clinical trials, and how long those symptoms lasted. Other documents show that Merck knew roughly 20 years ago that sales of the drug would suffer if the public became aware of Propecia’s possible long- term effects on men’s sexual health.

    A redacted section of one plaintiffs’ motion, reviewed by Reuters, cites correspondence from a Merck executive in which he objected to what he described as “misleading” information about the incidence of sexual dysfunction in men taking Propecia. That information was placed on the drug’s label despite his comments, the court document says, and it remains there today.

    Merck said that Propecia’s label has always accurately reflected data from the company’s clinical trials and that it disclosed all data to the U.S. Food and Drug Administration (FDA). Merck also said the executive’s “misleading” comment was taken out of context in the court filing.

    The documents reviewed by Reuters were filed under seal or heavily redacted by plaintiffs’ lawyers – not Pfaff’s – in federal court in Brooklyn. Merck had marked the documents confidential when sharing them with the plaintiffs’ lawyers, and those lawyers didn’t push to file them openly on the public docket. Judge Brian Cogan allowed the medical secrets contained in the documents to be kept out of public view. Reuters is able to report this confidential information now only after discovering filing errors that left some of it exposed.

    Still under seal in Cogan’s court are the internal Merck documents on which plaintiffs’ lawyers based the allegations they made in the legal briefs Reuters reviewed.

    Such court-sanctioned secrecy has become the lethal norm in product-liability litigation in the United States. As Reuters reported in June, judges in large product-liability cases routinely seal evidence relevant to public health and safety. As a result, hundreds of thousands of Americans have been killed or seriously injured by allegedly defective products — cars, drugs, guns, medical devices — while evidence that could have alerted consumers and regulators to potential danger remained under seal.

    Dangerous convenience

    Court secrecy has become pervasive even though, as a matter of law, court records are presumed to be public. Though exceptions can be made when national security, individual privacy or company trade secrets are at stake, the principle of open justice is rooted in American law. In most U.S. jurisdictions, judges are supposed to weigh a litigant’s request for secrecy against the broader public interest in being able to see the evidence, and they must explain on record any decision in favor of secrecy.

    They rarely do. Secrecy is convenient — for judges concerned about efficiency, for corporate lawyers concerned about protecting their clients’ reputations, and for plaintiffs’ lawyers seeking speedy resolution for their clients.

    The Propecia case in federal court in Brooklyn has followed this familiar pattern. Judge Cogan has, without explanation, allowed Merck and plaintiffs’ lawyers to keep information submitted in court confidential.

    Some of these documents slipped through cracks in the wall of secrecy. One was inadvertently entered into the public record, staying in the open for a year before being sealed, but in the meantime, it made its way into an obscure public filing, where Reuters found it. The other was faultily redacted, making it possible for this reporter to read it. The contents of both are reported here for the first time, more than two years after the first was filed in Cogan’s court.

    Had he known the additional information about Merck’s clinical trials, Nelson Novick, a dermatology professor at Mount Sinai School of Medicine in New York, said he would have been more cautious when prescribing the drug for young men. “I would have appreciated being apprised of this information earlier,” Novick said.

    Novick said any medical information about Propecia still being kept secret in court should be unsealed. “It goes without saying that the more information a physician has, the more he can share with the patient and the more informed the decision-making process becomes,” Novick said.

    Use of the drug remains widespread. It is now sold as Propecia and, since 2013, in generic versions under the chemical name finasteride. Last year alone, finasteride was prescribed for hair loss more than 1.6 million times in the United States, according to healthcare data company IQVIA. U.S. President Donald Trump has taken it, according to summaries of his past two annual physical exams.

    From 2009 to 2018, the FDA received about 5,000 reports of sexual side effects or mental health side effects – and in many cases, both – occurring in men who took Propecia. Of those, about 350 reported suicidal thoughts, and about 50 said a patient committed suicide. The data do not show whether the symptoms resolved after stopping the drug.

    Pfaff is among a small group of plaintiffs who haven’t accepted settlement offers from Merck. She said she is pursuing her lawsuit not just for monetary damages, but also to bring to the public’s attention anything Merck knows about mental health problems, particularly suicidal thoughts, that may be associated with Propecia. “If I can save a family from losing their husband, if I could just save one, that would mean the world to me,” she said.

    Judge Cogan did not respond to questions about why he has allowed the court filings to remain secret.

    Resolved in ‘all men’

    Merck developed finasteride in the 1980s. The drug reduces a testosterone-related hormone in certain tissues, including skin and the prostate gland. Merck initially obtained FDA approval in 1992 to market finasteride in a five-milligram pill called Proscar to treat enlarged prostate. Five years later, the FDA approved a one-milligram version, which Merck named Propecia, to treat male pattern baldness.

    From the beginning, Merck knew that Propecia could cause sexual dysfunction. In three clinical trials Merck conducted prior to receiving FDA approval of Propecia, 3.8% of the hundreds of men who took the drug experienced sexual side effects, including erectile dysfunction or decreased libido.

    That result has appeared on Propecia’s label since the drug hit the market in 1997. The original label, based on a year of clinical trial results, also said the symptoms resolved in “all men” once they stopped taking the drug.

    That’s a crucial point for doctors and patients when considering a drug for treating a cosmetic problem. Even a slight risk of sexual dysfunction could give some doctors pause, but they would be reassured if a patient could reverse the problem by no longer taking the pills, said Dr Jerry Avorn, a professor at Harvard Medical School.

    The distinction was also important to Merck, according to a sealed document Reuters was able to review because it was filed publicly elsewhere. A 1999 internal marketing study cited in the document found that 40% of men who had heard of Propecia were aware of potential sexual side effects, and that such knowledge would prevent half of those men from taking it. The court document does not say how many men were surveyed.

    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.

    Research subjects dropped

    In 2002, more than four years after Propecia hit the market, Merck revised the drug’s label to reflect the results of a study that expanded upon two of the drug’s three original clinical trials. The original trials were one-year studies; the extended trials covered four additional years. All were conducted by Merck in the mid- to late 1990s.

    The revised label retained the original label’s statement that 3.8% of the 945 men taking Propecia in the first year of research experienced sexual side effects. But the company added that, among the 323 men who took the drug for all five years of the extended study, “the incidence of each type [of sexual side effect] decreased to no more than 0.3% by the fifth year of treatment.”

    A 60-page motion plaintiffs’ lawyers filed in Cogan’s court alleges that Merck’s 0.3% figure on the revised label underreports the number of men who experienced sexual side effects during the extended study. The passages of the motion pertaining to the study were redacted. However, Reuters was able to view the blacked-out material after copying it from a digital version of the motion and pasting it into a document in a different format.

    The motion cites an email in which a Merck analyst tells executives that 23 men taking Propecia experienced sexual side effects during the final three years of the expanded study. That phase comprised 922 men who took the drug for varying lengths of time, according to a 2002 article Merck published in the European Journal of Dermatology.

    The label, as revised in 2002, omits the experiences of nearly all of those men, reporting only on sexual dysfunction in men who took Propecia in the first year of research and in those who took it continuously for all five years. Merck didn’t include the experiences of men who finished the study before the fifth year or who were given placebo doses earlier in the study. The revised label also omitted information about six men who dropped out of the study during the final three years due to sexual side effects.

    It is impossible from the numbers Merck has published to tell what percentage of men experienced sexual dysfunction over the full five years.

    It is “not fair or standard practice” to report results from only a portion of a multi-year study because it systematically underestimates the risk of any side effect, said Avorn, the Harvard pharmacoepidemiologist who reviewed the court filing and Merck’s statements at Reuters’ request.

    Before the 2002 label change, Dr Keith Kaufman, clinical head of Propecia, discussed different ways of interpreting clinical trial data, the plaintiffs’ court filing says. The 0.3% figure is “totally misleading” because, by the fifth year, “you have weeded out the dropouts with the sexual [adverse experiences],” the motion quotes him as saying. The legal filing does not specify who received Kaufman’s correspondence.

    Kaufman referred Reuters’ questions to Merck, which said his remarks were unrelated to the language on the label. Merck said that he was referring to a flawed report submitted by an outside expert and that the company settled the litigation before it could provide proper context for Kaufman’s comments.

    Plaintiffs’ lawyers filed Kaufman’s original correspondence in court under seal, and it thus cannot be viewed. Merck declined to waive its claims of confidentiality to share that filing and the Merck analyst’s memo with Reuters.

    The redacted motion argues that Merck not only underreported the number of men who experienced sexual dysfunction while taking Propecia, but also concealed the duration of those problems. Citing the Merck analyst’s memo, the motion says that of the 23 study subjects who experienced sexual side effects during the last three years of the study, seven continued to experience symptoms when they completed it. The symptoms of nine others resolved after they stopped taking the drug, but the time it took was unknown, the motion says. And of the six men who dropped out of the study, it says, one still had symptoms at least 66 days after stopping treatment.

    Merck didn’t know if some of these men’s symptoms resolved, Kaufman said in a deposition.

    None of this data described in the plaintiffs’ motion was included on the revised 2002 label. Instead, Merck made a small but significant change to the label’s language: Symptoms stopped in “men” who went off the pills, the label now said, rather than “all men.”

    Merck told Reuters that it followed up with patients who dropped out “in accordance with the protocols for the study.” It said it has “consistently maintained that the available evidence does not establish that finasteride … causes sexual dysfunction which persists after drug discontinuation.”

    Merck said it provided its five-year trial data to the FDA, which approved the revised label.

    The FDA declined to answer questions about what Merck shared with the agency or how it evaluated specific information the company submitted about its Propecia clinical trials. It said it “takes very seriously its role in continuing to monitor and regulate the safety of drugs both before and once they are on the market.”

    Dr Michael Irwig, an endocrinology professor at George Washington University who has studied Propecia, reviewed the faultily redacted court filing for Reuters. He said Merck’s numbers “look much better” by excluding men who dropped out, and the difference reflects an overall lack of transparency regarding subjects who experienced sexual side effects, he said.

    In 2008, after Swedish regulators investigated reports that sexual side effects continued in men after they stopped taking the drug, Merck changed Propecia’s label in that country to warn that erectile dysfunction had been reported to persist after stopping the drug.

    The same year, Kelly Pfaff told her husband about Propecia. John’s hair had started to thin on top. “For whatever reason, it bothered him,” Kelly Pfaff said. She said she encouraged him to look into Propecia because she knew a friend was taking it and had hair “like a Chia Pet.” She now regrets her advice. “I have to sleep with that every night,” she said.

    The label prominently warned pregnant women to avoid handling the drug. Kelly was pregnant with their daughter at the time, and she said John warned her not to touch the pills. She said he didn’t mention any other risks.

    Reports of depression in men taking Propecia were added to the U.S. label in 2010. This disclosure appeared in the “Postmarketing” section of the label, below the much more favorable description of Merck’s clinical trial results added in 2002.

    Meanwhile, the FDA had begun an inquiry after Merck changed its label in European countries to warn about persistent sexual dysfunction. In April 2012, the agency approved another change to the U.S. product label. The agency said at the time that “clear causal links” between the drug and sexual dysfunction had not been established. But, for the first time, the Propecia label acknowledged reports that a range of men’s sexual problems persisted after the men stopped taking the drug.

    A patient advocacy group, the Post Finasteride Syndrome Foundation, petitioned the FDA in 2017 to either withdraw Propecia from the market or add a black box warning for sexual and mental health side effects. The FDA has not yet responded to the request.

    Merck blames baldness

    The 2012 label change came as John Pfaff was hurtling toward his final crisis. He quit Propecia that spring, four years after starting treatment. Kelly Pfaff said her husband’s decision to go off the drug wasn’t prompted by Merck’s label change, but more a process of elimination of possible culprits. She and her husband entered therapy together.

    In a rambling email to his colleagues, he abruptly quit his job in January 2013. Two months later, he was dead.

    Kelly Pfaff’s lawsuit cites a peer reviewed study by Irwig, the academic endocrinologist, that found overlap between persistent sexual dysfunction and mental illness among 61 former finasteride users. In the study, 64% of men who experienced sexual problems after they stopped taking the drug also demonstrated moderate-to-severe depression, compared to none of a control group of men with hair loss who hadn’t taken the drug. Forty-four percent reported having thoughts of suicide, compared to none in the control group.

    Irwig found these rates to be higher compared to other studies of depression among men with sexual problems. He acknowledged he did not have specific comparative data on bald men experiencing sexual dysfunction. Other published studies have found that Propecia can lead to decreased levels of neurosteroids that act as natural antidepressants.

    Some dermatologists have questioned whether selection bias tainted Irwig’s findings and suggested that publicity and lawsuits could be artificially inflating the number of people reporting Propecia side effects. Merck said the study is “flawed” due to several factors, including a small sample size.

    Nicole Rogers, a dermatology professor at Tulane University, said she counsels men on the possibility of side effects and tells them harmful impacts will go away if they stop.“For people who have a long family history of [hair loss], who are we to tell them they can’t do it?” Rogers said.

    After reviewing the information Reuters found on the Merck clinical trials, Rogers said the sexual problems the men reported could have been caused by other factors, including smoking.

    “It goes without saying that the more information a physician has, the more he can share with the patient and the more informed the decision-making process becomes.”

    Nelson Novick, dermatologist, Mount Sinai School of Medicine

    Rogers’s assessment echoed Merck’s position. “Premature hair loss itself, the very condition for which Propecia is prescribed, is associated with low self-esteem, poor body image, and depression,” Merck’s lawyers wrote in a 2017 court filing. “Rather than attribute their sexual difficulties to the common reasons why young men with premature hair loss experience these problems, Plaintiffs instead assign blame to a drug that, once discontinued, is no longer pharmacologically active in the body.”

    Sales of Propecia climbed steadily through the 2000s, peaking at $447 million in 2010. Soon after, Merck’s patent expired, but use of finasteride remained strong as cheaper generic versions hit the market.

    By then, hundreds of men were suing Merck over Propecia. In 2012, their lawsuits were consolidated before Judge Cogan.

    As part of the discovery process, the early phase of litigation when opposing sides request information from each other, the court issued a routine protective order, allowing each side to designate discovery material as confidential before sharing it. The plaintiffs then filed a small handful of those documents in court under seal, citing the protective order as justification for the secrecy.

    Once evidence hits the courthouse, however, appellate courts have ruled that judges are required to conduct their own analysis of whether the secrecy outweighs the public interest in transparency. Cogan never did so.

    reuters investigates

     

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    https://www.reuters.com/investigates/special-report/usa-courts-secrecy-propecia/

  6. 7 hours ago, hairman22 said:

    article is bs

     

    And finasteride does work for male pattern baldness, improving hair growth within months, according to multiple studies. The effects last as long as the man continues to take the drug.

     

    not true

     

    The side affects listed are all true.

     

    You can recover though just takes time.

     

    I'm off Finasteride 7 years and have still not fully recovered from the side effects.

  7. Quote

     

     

    The drug that banishes baldness can ruin a man's love life: Hair loss drug finasteride is used by millions, but men say it has devastating side-effects such IMPOTENCE - that can last years after you've stopped taking it 

    • Global market for hair loss treatments is valued at an extraordinary £5.6 billion
    • However, the cost for many men is infinitely higher as it can destroy their libido  
    • Many people report that Finasteride-related impotence never fully goes away 

     

    To many men, it’s a wonder drug that has helped halt their baldness. 

    Others, however, say it has had a devastating effect on their lives, causing a range of crippling side-effects including impotence, infertility, insomnia, anxiety, depression and, in some cases, suicidal thoughts — even years after they stopped taking it.

    The drug is finasteride, sold under the brand name Propecia, which is used to treat male pattern baldness. Donald Trump and Wayne Rooney are reportedly two of the millions who have used it in the hope of reversing a receding hair line or bald spot.

    Globally, the market for hair loss treatments is valued at an extraordinary £5.6 billion, with male pattern baldness accounting for 90 per cent of that, and finasteride the most commonly used treatment.

    And finasteride does work for male pattern baldness, improving hair growth within months, according to multiple studies. The effects last as long as the man continues to take the drug.

    In simple terms, it stops hair loss by reducing the conversion of the male hormone testosterone into dihydrotestosterone (DHT). High levels of DHT cause hair follicles on the scalp to shrink, leading to hair loss. Finasteride not only prevents this, it has also been shown to encourage regrowth.

    In the UK, when it comes to treating hair loss, the drug is available on private prescription only — from doctors since 1999 and, since 2014 and with a prescription, from a pharmacist. 

    It is, however, available on NHSprescription under the brand name Proscar — and at a higher dose: 5mg compared with 1mg for hair loss — to treat an enlarged prostate, a common condition that affects many men with age, causing problems with urinary flow.

    That’s because reducing levels of DHT can also help shrink the prostate, stopping it pressing on the bladder and urethra.

    Finasteride is, by any measure, a hugely popular drug, with more than 3.3 million prescriptions issued for prostate problems alone in England and Wales in 2017, which is double the number just ten years earlier.

    But there is another side to this apparent success story — the drug’s potential side-effects.

    DHT influences other male characteristics and interfering with its production can lead to sexual dysfunction, including difficulties achieving an erection, reduced desire and reduced semen.

    Less frequent problems can include infertility, testicular pain and anxiety.

    And since 2017, following a ruling by the European Medicines Agency, finasteride patient information leaflets must also now carry warnings about the risk of depression and, in rare cases, suicidal thoughts.

    Merck, which manufactures Propecia, says up to only one in 100 people is affected by sexual dysfunction, although it does now acknowledge in patient information leaflets that this can persist after coming off the pills.

    In the U.S., Merck has paid out more than £3 million in total to hundreds of men who have claimed side-effects have persisted after they stopped taking Propecia.

    Meanwhile, growing numbers of British men say they have been affected by persistent side-effects — one of them is Ryan Clark, 52, an operations manager from North Tyneside, who says the drug has wrecked his libido and left him with reduced fertility and depression.

    After taking finasteride on and off for 18 years, he says he is still plagued by side-effects, despite stopping for good two years ago.

    ‘I QUICKLY LOST ALL INTEREST IN SEX’

    Ryan started taking finasteride after noticing a tiny bald spot on his crown. ‘I was only 31 and didn’t want to go bald at such a young age,’ he says. He had read about Propecia and thought it sounded like ‘a miracle cure’. Ryan’s GP prescribed the drug privately and he began paying £30 a month for the daily pill.

    ‘In terms of treating my hair loss, the drug worked brilliantly and the gaps on my crown filled in within three months,’ he says. ‘However, within weeks I lost interest in sex and my libido didn’t return. I didn’t connect it with finasteride as this side-effect was never mentioned.

    ‘Within three months, I began to feel anxious and to suffer insomnia. I’d always been confident, happy and positive, but suddenly I became withdrawn and irritable.’

    Ryan, who married Lyndsey, 42, in 2010, went back to his GP ‘multiple times’ about his various health problems. ‘They treated each one individually,’ he says. ‘I was offered medication for sleep and depression, but I refused them.’

    His list of symptoms continued to grow. ‘I developed dry skin, sore, red eyes and heart palpitations, muscle loss and weight loss.’

    Then, in 2010, tests showed he had poor-quality sperm with low motility and he was told he and Lyndsey were unlikely to conceive naturally. Their son, Joshua, now six, was conceived through IVF.

    Throughout all this, Ryan continued to experience symptoms. ‘I felt that people thought I was a hypochondriac,’ he says. ‘I’d see my GP, but all I got was a roll of the eyes. How I wish now I’d never been so vain about losing my hair.’

    SIDE-EFFECTS THAT JUST GO ON AND ON

    Two years ago, a desperate Ryan searched his symptoms online and came across post-finasteride syndrome (PFS) — a collection of symptoms that include sexual dysfunction, infertility, anxiety and depression, which persist long after finasteride is discontinued.

    The side-effects may be the result of changes to hormone receptors in the body, suggests Professor David Healy, a psychiatrist at Bangor University and founder of RxISK, a pressure group that campaigns to highlight drug side-effects.

    ‘Finasteride doesn’t just act on the hair growth and shrink the prostate, but has effects throughout the body,’ he says.

    ‘As with a whole bunch of other drugs, such as SSRI antidepressants and the acne drug Roaccutane, we don’t know why these effects persist in some people.’

    When Ryan read about PFS, ‘suddenly everything clicked into place — I had virtually all the symptoms listed and they had all started after I began taking Propecia,’ he says.

    ‘There were 5,000 men, many of them from the UK, like me on a website, all describing how their lives had been wrecked by the drug.

    ‘I stopped taking the pills, but none of the symptoms have gone away in the two years since. In fact, I’ve developed neuropathy [nerve damage, causing pins and needles] in my hands and feet, too.

    ‘Yes, the patient information leaflet does mention sexual dysfunction but it doesn’t stress how serious and long-term the problems can be.’

    YOUNGER MEN AT GREATER RISK

    The threat that finasteride poses to fertility should be stressed to younger men, suggests Allan Pacey, a professor of andrology at the University of Sheffield.

    ‘I ran an andrology laboratory in Sheffield for 25 years and I would regularly come across men who had poor or no sperm,’ he says. ‘They would reluctantly admit to using anabolic steroids — which was obvious anyway because of their appearance — or taking finasteride.’

    Professor Pacey explains the effect on sperm is because both finasteride and anabolic steroids lead to the shutdown of the crucial hormone produced by the brain which tells the testicles to produce sperm.

    The body is fooled into thinking the testicles are working harder than they actually are because the level of testosterone in the blood is increased.

    ‘The data seems to show that when a man stops [taking the drugs], he recovers the ability to produce sperm, but it may take many months.’

    DANGERS MUST BE EMPHASISED

    Dr David Edwards, a GP in Chipping Norton and past president of the British Society for Sexual Medicine, agrees that the potential side-effects, and the fact they can be long-lasting, should be made clearer to patients.

    ‘If you asked the average practice nurse, pharmacist or GP about this, I don’t think they would know about the risk of side-effects such as sex problems and depression,’ he says. ‘There needs to be more education about the risks.’

    Tom, 45, a former teacher from Cheshire who spoke on condition of anonymity, couldn’t agree more.

    He took Propecia eight years ago for only three months, but says as a result he’s lost his career and relationship and is now living with his parents and working part-time in retail.

    ‘My relationship crumbled under the pressure of the sexual problems and I haven’t had another relationship since,’ he says. ‘I had to give up teaching because of memory and fatigue problems.

    ‘It’s not the life I imagined I would be living. And I only took the pills after some guys I knew took the mickey out of a bald spot I had developed.’

    His GP agreed to write a private prescription for Propecia. ‘He did mention impotence could be a side-effect, but being young I don’t think I quite understood what this meant.

    ‘In the third month, my libido just dropped and I started to experience erection problems. I felt incredibly tired and had memory issues.

    ‘I stopped taking the pills and hoped it would all stop — but it didn’t.’

    Tom’s GP said the symptoms weren’t connected to the drug and said he had prescribed finasteride at a higher dose to patients with an enlarged prostate with no ill-effects.

    ‘I later saw an NHS endocrinologist who said the same thing, as did two more I paid to see privately. They told me I had depression, which I didn’t think was correct.

    ‘Four months ago, I experienced new neurological symptoms including increased anxiety, head pressure — like I had concrete inside my head — headaches, total impotence and terrible insomnia.’ Those affected say the medical profession’s refusal to acknowledge that finasteride can cause such side-effects is particularly hard to take.

    Ryan says: ‘I have seen two endocrinologists who say my hormone levels are normal, and my symptoms are not connected to finasteride.’

    PEOPLE TAKE THEIR OWN LIVES

    The online support group Propecia Help says it has 5,000 members and that men are joining at the rate of 100 a month from across the globe. It reports that 59 suicides have been associated with the drug globally.

    ‘People need to be specifically warned about these side-effects so they can weigh up the risk versus the benefits,’ a spokesman told Good Health.

    ‘A man losing a bit of hair can’t be expected to imagine that he is risking a horrifying condition beyond current medical understanding when neither the prescriber nor the leaflet emphasises the risks sufficiently.’

    Professor Healy also stresses the need for more recognition of the risks.

    ‘People kill themselves after taking this drug,’ he says. ‘I had a colleague who took his own life 15 years ago, so I know it happens — and so many people with the same symptoms can’t be wrong.

    ‘People take their own lives because of the effects of the drug, but also because they can’t get through to anyone and they are not believed.’

    For men taking the drug at larger doses for an enlarged prostate, the benefits are thought to outweigh the risks.

    Professor Roger Kirby, a prostate surgeon and president of the Royal Society of Medicine, says Proscar is a good treatment for older men with enlarged prostates who aren’t too concerned about potential effects on their sex life.

    ‘But I tend not to prescribe finasteride to younger men with benign prostate disease because of the sexual side-effects. There are alternative treatments that can be prescribed for younger men.

    ‘I think younger men worried about hair loss are better off having a hair transplant.’

    Merck, however, emphatically defends Propecia’s safety record. ‘Propecia (finasteride) has been prescribed to millions of men worldwide since its approval, and has been the subject of extensive clinical trials, reported to regulatory agencies around the world,’ says a spokesperson.

    ‘The safety and efficacy of our products is paramount.

    ‘We continuously monitor the safety profile and update the safety information which is included in both the summary of product characteristics (intended to inform health professionals) and the patient information leaflet (or ‘packet insert’, intended for patients).

    ‘The potential for erectile dysfunction and depression to occur as an adverse reaction with finasteride treatment, although uncommon, is documented in both the Summary of Product Characteristics and the Patient Information Leaflet.

    ‘Anxiety is another potential side effect which is listed.’

    For more information visit propeciahelp.com

     

    https://www.dailymail.co.uk/health/article-7274057/How-baldness-drug-ruin-mans-love-life-Finasteride-devastating-effects.html

  8.  

    Quote
    Vive la France!
     
    This time we call your attention to a PFS report last week on 66 Minutes, which models itself after the iconic American news magazine 60 Minutes and boasts a Sunday-evening audience of two million viewers.
     
    The 14-minute segment, titled Is This Hair-loss Drug Dangerous? (English-subtitled version here), features an interview with François Desgrandchamps, chairman of the Urology Department at Saint-Louis Hospital in Paris.
     
    “I think this is a potentially dangerous drug. Twenty percent of men who take Propecia see their sexual function diminish,” he tells producer Paul Gasnier.
     
    “I even told my brother-in-law to stop taking it,” adds Dr. Desgrandchamps, who's among the PFS Foundation's global team of Medical Professionals offering support to PFS patients.
     
    The 66 Minutes story comes on the heels of two important PFS news events:
     
    “Last Friday, the esteemed medical journal Préscrire published its seventh annual list of drugs that are more harmful than helpful. Among them is Propecia,” host Xavier de Moulins reports at the top of the program.
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    Later in the show, Gasnier notes that “the mass of side-effects reports [about finasteride] is worrying ANSM, the French National Agency for the Security of Medication… In October 2017, it ordered all manufactures selling the drug to add psychological troubles to its insert as a possible side effect.”
    
    And of course, as we recently told you, ANSM dispatched a second finasteride alert (Regulatory Update: France’s FDA-Equivalent Agency Reissues Finasteride Warning) in a letter to more than 100,000 health professionals on Feb. 1 of this year.
     
    Also interviewed on the 66 Minutes segment are PFS Foundation CEO John Santmann, whose PFS-afflicted son Randy took his own life in 2008, and Sylviane Mathieu, whose PFS-afflicted son Romain took his own life in 2016. Mathieu has since founded Aide aux Victimes du Finastéride (AVFIN) to promote PFS awareness in France. (And is doing a superb job at it.)
     
    “On average, we get a call a day, from all over the world, from the United States, Mexico, Latin America, Europe, Asia,” says Santmann. “When they call, they're desperate—and frankly, we didn’t expect to become a suicide hotline.”
     
    “We have to tell people, we must cry out, we must do something, we need people to know that this drug can—not in all cases, but in some—drive someone to his death,” says Mathieu.
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    Anyone living in the US who suffers from PFS should report his symptoms to the US Food and Drug Administration; anyone living outside the US who suffers from PFS should report his symptoms to the US Food and Drug Administration as well as to his national drug-regulatory agency, as directed on our Report Your Side Effects page.
     
    Finally, if you or a loved one are suffering from PFS, and feeling depressed or unstable, please don’t hesitate to contact the PFS Foundation as soon as possible via our Patient Support hotline: social@pfsfoundation.org
     
    Thank you.

     

  9. Quote

    We are supporting a new research project on the persistent side effects experienced by men who have used and discontinued finasteride (brand name Propecia or Proscar) and subsequently committed suicide.  The research is led by Dr Michael Irwig, Associate Professor of Medicine at George Washington University in Washington DC.

    Dr Irwig’s project will identify cases of patients who suffered persistent health problems following use of finasteride prior to their suicide. This will add further recognition of the persistent physical, sexual and neurological problems that do not resolve following discontinuation of the drug through publication in a peer-reviewed medical journal.  It is hoped this will increase awareness amongst the medical profession of Post-Finasteride syndrome and bring publicity to the potentially tragic effects of finasteride.

    Dr Irwig intends to review the medical records of these patients, to consider their medical and psychiatric diagnoses when starting finasteride (Propecia). This means Dr Irwig needs to identify patients who have taken their own lives following the persistent health problems and lasting side effects induced by use of finasteride, which is why we need your help.

    Action Needed

    If you are a relative, friend or partner of someone who had side effects from Finasteride (Propecia) that did not resolve or developed after use of the medication and subsequently took their own life, please contact Dr Irwig directly.  His email is propeciastudy@gmail.com, or alternatively contact him via post to: 1711 Willard Street NW, Washington DC 20009, United States of America.

    If you are a patient who knows of someone suffering persistent health problems following finasteride use who took their lives, please get in touch with the Propeciahelp.com team.  Even if you only know the basic details of the person, such as a forum username, get in touch via private message.  All details are helpful and we would like to assure you of our discretion and gratefulness for your time.  This will help us to do the necessary unearthing and collate more cases for this important research.

    IrwigPublicationLetter

    Practical Action on Finasteride (Propecia) Lasting Side Effects and Suicides

    Propeciahelp.com’s support for this research is further practical effort to address what is currently termed the Post-Finasteride Syndrome.  We are also running a genome-wide association study involving 23AndMe SNP analysis. This is a project open to patients with lasting health problems following discontinuation of Finasteride (Propecia), Isotretinoin (Accutane) and SSRIs. Your support with these projects will help us work towards a desperately needed etiological understanding of PFS and ultimately a treatment.

    We’re grateful for your help.  If you are a patient suffering following use of the aforementioned substances, talk with us on our forum and get involved.

    https://www.propeciahelp.com/propecia-suicide-research-project/

     

     

     

  10. https://medium.com/s/story/my-life-has-been-ruined-by-an-anti-baldness-propecia-finasteride-side-effects-ed8b2fcd1e90

     

     

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    My Life Has Been Ruined by an Anti-Baldness Drug

    I’ve endured depression, anxiety, headaches, memory loss, insomnia, blurred vision, and impotence since I was 19.

    It sucks to be a teenager losing your hair. You start to notice your friends’ eyes darting up to your hairline. You become the butt of jokes. You feel marked out, as if the gene gods have tagged you as defective and old before your time.

    I was 17 when I noticed the hair on my temples was receding. It was disconcerting but felt okay—until it didn’t feel okay. There came a point when there was just too much of my head showing, when my faithful hairstyle became tenuous. I felt that everyone, much to my unending embarrassment, must have noticed.

    A girlfriend commented on it when I was 19. An American friend told me that my once full and floppy fringe had started looking wispy at 22. A girl who liked me was teased by a friend on Facebook because of my receding hairline and either didn’t know or didn’t care that I would read it. Six months later, it looked worse, and six months after that, worse still. Like most young men dealing with baldness, I was confronting a future image of myself that I really didn’t like.

    By 2016, the World Health Organization had recorded that 59 men had killed themselves because of the side effects of finasteride, an anti-baldness drug. The drug doesn’t kill directly, but the profound physical and psychological damage it can cause makes it difficult for people to live a normal life. I know this because I am one of them.

    In 2012, when I was 19 years old, I took finasteride in the form of Propecia tablets: one a day for just 21 days. I got them from The Belgravia Centre in London, a hair-loss clinic that advertises its services vociferously across the city’s public transport. I remember feeling uneasy and a little skeptical about relying on a drug, possibly for the rest of my life, for a nonmedical issue. But I thought that I could stop my hair from falling out, perhaps regrow some that I had lost, and have a good head of hair in adulthood.

    The symptoms started almost as soon I started taking Propecia. I noticed a dull, persistent headache. I became anxious, depressive, and my sleep was nonexistent. My penis totally changed in character and just wasn’t the same; touching it was like touching my elbow or some other less sensitive body part, and erections weren’t real erections anymore, if they happened at all.

    I quit the drug three weeks later when I realized the symptoms weren’t shifting. But even after I stopped taking the pills, I still had the arsenal of debilitating cognitive, mental, physical, and sexual side effects, most of which weren’t on the label and nearly all of which weren’t thought to be permanent—and of all of which were. Needless to say, I hadn’t been taking it long enough to notice any difference in my hair.

    When I was buying the drug at The Belgravia Centre in 2012, I remember my clinician reassuring me about the side effects and dismissing stories of lasting adverse reactions. I was left with the impression that claims of long-term sexual issues stemming from Propecia were a myth.

    Six years later, I still have all the same symptoms. Every day when I wake, I feel like my head’s been filled with noxious gas. It’s like my brain (not to be confused with my mind or my soul, though both have suffered too) is dehydrated or lacking some essential element. You can’t ignore an aching brain; the pain sits among your thoughts and emotions, tucked behind your eyes, decoloring your life.

    The brain is the fragile colliery where your conception of yourself and the world are furrowed, and mine aches all the time. Another sufferer once described this kind of “brain fog” as having your brain wrapped in plastic wrap, slightly apart from yourself and insulated from the world, making everything delayed, confused, abstract. I have lost fluency in my speech and find it difficult to maintain my train of thought while speaking, which is either related to my poor memory or a result of it. And I often find it hard to recall words and names.

    Then there’s the sexual issues. My penis still doesn’t operate as it should. I don’t get full erections. It’s noticeably lighter in weight and cold, as if the blood flow’s been switched off. I have the libido (and mind) of a person in extreme decline, which makes sex difficult to impossible. Women my age aren’t as receptive to this as you’d hope. I also have an intrusively enlarged prostate. Finasteride’s primary function was to battle enlarged prostates, but it had the inverse effect on me. And recent research has also raised concerns that it can mask the symptoms of prostate cancer.

    In February 2012, soon after experiencing what’s termed the “crash”—when all or most of the symptoms come on suddenly during or after quitting the medication—I stumbled across propeciahelp.com, a site dedicated to men with my condition that was set up back in 2003. The more I read, the more my hope faded. Some guys were describing how they’d suffered this for 10 years or more. The thud-thud-silence of my heart’s contractions reverberated in my ears as I sat up in bed alone that night feeling nothing but dread and the memories of myself as I was, locked away somewhere in the interstices of my mind, unreachable and apparently now set to self-destruct.

    I set up a profile under the username “pursuit_of_happiness” and stalked the forum year after year; it became the only real point of information and community for me. There was all the information I could want, every type of person from every sort of job across the world all describing the same problems I had. When I was trying to feeling positive, I read the “Recoveries” section about the handful of guys who felt they’d cured themselves through a diverse range of regimes including intense exercise, restrictive diets, and combinations of supplements and exotic hormonal or medical-grade drugs. But there was only a handful of these recovered men among 4,000 members on the site, and many said the regimens weren’t working for them.

    Because there seemed to be limited research, many sufferers like me leaned heavily on pseudoscience or the findings of other scientifically minded sufferers. I once went without food for a whole week—something known as “water fasting,” which over a stretch of years, I became obsessed with as my panacea—but it didn’t help.

    I was at university while this was going on and read page after page posted by miserable men bemoaning their decision to use the drug. Some had lost jobs, credibility; they’d become shadows of themselves. There were suicide threats from desperate souls and consoling messages urging them to see out the year. Previously vocal forum members would stop posting and others would wonder what happened to them. At college, I kept my contributions in seminars down to a few lines as I knew my brain would stop sketching a path for me after a few seconds. What should have been my “best years” were my worst.


    Post-finasteride syndrome (PFS) is the name given to my condition. It covers a range of sexual, physical, and mental side effects that afflict people like me after they’ve discontinued 5-alpha reductase inhibitors (drugs specifically used to treat enlarged prostates and male pattern baldness) such as finasteride. The first comprehensive studies looking into the condition were published in 2011, and PFS remains poorly understood, as are the predispositions that lead to a subset of men being affected in this way, sometimes from as little as one pill.

    Finasteride is available worldwide, from specialist hair treatment centers like the one I visited in London to online pharmacies and conventional doctors. Even Donald Trump is reportedly a user, his physician revealed in 2017. Merck reported Propecia sales of $183 million in 2015, down from a peak of $447 million in 2010. Health market research firm IQVIA says that approximately 570 million finasteride pills were dispensed in the United States alone between April 2017 and April 2018.

    A conservative estimate by academic researchers put the number of Propecia users with persistent erectile dysfunction at 1.4 percent, although not everyone with PFS will have sexual side effects. PFS has a “traditionally counterintuitive clinical presentation given the condition’s persistence and even worsening after the causal medication has left the patient’s system” reads a summary on Propecia Help. “This atypical presentation of side effects and the broad spectrum of treatment-resistant and often permanent health problems caused by exposure to finasteride have resulted in sufferers facing great difficulty in achieving the necessary acknowledgement of medical professionals.”

    And therein lies the problem with this drug. Though apparently responsible for 59 suicides, finasteride is not killing people directly and often fails to leave any clues in blood tests. This is why Merck, the pharmaceutical company that still manufacturers and sells it, has gotten away with it for so long and with such a margin of plausible deniability of negligence.

    In 2017, researchers at the University of Milano-Bicocca and University of Milano published a significant study into PFS. Baldness is caused by testosterone combining with an enzyme to create the hormone dihydrotestosterone (DHT), and finasteride works by blocking the creation of the enzyme. The trouble is that finasteride appears to alter other neurosteroids, which can have an attendant effect on neurotransmitters—the critical chemical messaging system in our brains.

    If you were to analyze my cerebrospinal fluid, some of the irregularities you would find include, as the study found, decreased levels of the hormones progesterone and pregnenolone and increased levels of testosterone and dehydroepiandrosterone. Researchers concluded that finasteride had “broad consequence on neuroactive steroid levels of PFS patients.” These imbalances seem to explain the problems sufferers experience with brain function, mood swings, thought processing, and profound psychological anguish.

    That same study also clinically confirmed erectile dysfunction, while another study in the Journal of Sexual Medicine estimated that 5–23 percent of Propecia users suffer from sexual dysfunction, with half of those permanently affected. Other studies, too, are slowly beginning to corroborate the cognitive, mental, and sexual complaints of PFS sufferers.

    In short: A few sympathetic doctors and scientists in the United States and Europe are confirming that the nervous systems of sufferers are seriously, and quite possibly irreversibly, fucked.

    Merck is one of the world’s five biggest pharmaceutical companies, carrying a market cap of $185 billion as of this writing. In 2017, it reported $35.4 billion in revenue from its pharmaceutical wing. Along with Propecia, the company sells the cancer immunotherapy drug Keytruda, HPV vaccine Gardasil, and diabetes pill Januvia, among many other medications.

    A more sinister picture of Merck and the wider pharmaceutical industry has begun to come into view. There have been several recent cases of drugs hurried to market while crucial data about side effects or efficacy was withheld from regulators by drug companies (Paxil and Reboxetine) or with regulators withholding information from doctors (Orlistat and Rimonabant). Many similar cases have taken years to be rectified, if at all.

    More than 1,400 lawsuits have been filed against Merck in the United States and Canada since 2011, claiming permanent sexual problems, cognitive impairment, and depression. In 2012, the company was forced by the FDA to change the wording on Propecia’s label fromtemporary” to “persistent (see permanent).” Temporary and permanent are just words, but the semantics are important.

    Hundreds of YouTube videos variously show vloggers experimenting with, warning about, or showing off new hair growth they credit to Propecia, while Merck’s public literature and official PR continues to discount victims’ testimony regarding permanent side effects. Merck has consistently denied any causal links and did not amend labelling until 2008 in Sweden, 2011 in the rest of Europe, and 2012 in the United States in response to regulators.

    When asked to address these concerns, Merck said: “Merck does not believe that reliable scientific evidence supports the existence of Post-Finasteride Syndrome. Merck stands behind the efficacy and safety profile of Propecia. For your convenience, please see our prescribing information.”

    When presented with my story, The Belgravia Centre said that Propecia is a licensed and regulated drug issued in accordance with legal requirements:

    One sufferer, Kevin Malley, went on a hunger strike for several weeks in 2012 outside Merck’s plush hexagonal headquarters in Kenilworth, New Jersey, one of a steady flow of reports helping to keep the problem in the public consciousness. A small foundation is fundraising for research into finasteride in the hope of finding a cure for PFS. An activist site called Rxisk, which supports people who have suffered side effects at the hands of big pharma, is raising money to put a $100,000 reward up for anyone who can find a cure.

    For now, there is no cure for PFS and it is probably incurable. It has left me saddled with depression, general anxiety, and anhedonia: the inability to feel pleasure from normally pleasurable things. When I ran a marathon, I mostly derived contentment from knowing how it ought to feel.

    There are other peculiar side effects that don’t really fit into any recognizable schema. Despite having 20/20 vision, my eyesight became almost immediately blurred and out of focus when I started taking finasteride. I find it hard to hold eye contact with someone, something often interpreted as a kind of shorthand for being untrustworthy. It’s an odd, otiose consequence of a hair loss drug. I also find myself clenching my jaw. I get “brain zaps,” which are like galvanic spasms in my cerebrum, and I have permanent dark circles under my eyes. Like many other sufferers, I’m unable to sleep deeply. I wake up multiple times a night, and in the morning, I feel as though I’ve been hit by a truck filled with Ambien or ketamine. For me, there is no rest or feeling rested.

    A specific prognostic sort of anxiety sets in at night sometimes when I think about the lives of the people I love moving along while I’ve only been partially here. It’s one thing cursing the passage of time, but quite another being barely present to experience it. I carry a deep longing and a sadness for who I could have been and how my life might have turned out. As my friends blossom into fully functioning adults, I sometimes feel some contempt toward them living and thriving as they should.

    For a long time, I worried about losing someone I love and not being able to fully feel it. That I wouldn’t be able to tap into the correct emotional response and it would feel like a simulation—a total erasure of all the love and attachment I’d harbored to those close to me. As if my vanity betrayed my childhood innocence, exchanging it for chemically-induced indifference.

     

     



     

     

    • Like 1
  11. Quote

     

    Canada has taken an important first step toward keeping its citizens apprised of finasteride’s many potentially serious and persistent side effects.

    In the June edition of its Health Product InfoWatch , Health Canada (Canada’s version of the US Food and Drug Administration) reported that “New information regarding the risk of muscle-related disorders has been added to the Post-Market Adverse Drug Reactions and Consumer Information sections of the Canadian product monographs for Proscar and Propecia.”

    01-Health-Canada-Infowatch-June-2018-1.pThe “key messages for healthcare professionals,” as added to the Proscar and Propecia labels by Merck Canada, are:

    —“Rare cases of muscle-related disorders, such as rhabdomyolysis, myopathy, myalgia, myasthenia, and creatine kinase elevation, have been reported in patients treated with finasteride.”

    —“In some cases, these disorders were found to be reversible with discontinuation of finasteride therapy.”

    (It seems safe to assume that if “some” reported cases of muscle-related disorders returned to normal after quitting finasteride, other cases remain persistent.)

    Details on the five muscle disorders, according the Mayo Clinic, are as follows:

    Rhabdomyolysis
    Myopathy
    Myalgia
    Myasthenia
    Creatine kinase elevation

    This recent finasteride label change comes one year after Health Canada’s safety review of the drug, which assessed the potential risks of serious muscle-related side effects. Based on adverse drug-reaction (ADR) reports by 11 Canadian patients, the review concluded that “the risk of serious muscle-related side effects with the use of finasteride could not be ruled out.”

    We thank Health Minister Ginette Petitpas Taylor for ensuring that Health Canada is taking proper action in response to consumer-safety feedback.

     

    http://www.pfsfoundation.org/news/regulatory-update-muscle-related-disorders-added-canadian-finasteride-label-response-report-fda-equivalent-agency/

  12. https://www.vice.com/en_au/article/43bm3m/i-need-to-quit-hair-loss-drugs-before-they-kill-me?utm_campaign=sharebutton

     

    I was in high school when I started going bald. I remember hanging out on the sports field, lounging about on my stomach, when someone standing above me said: “Man, what’s up with your hair? You’ve got a bald spot.”

    And just like that, I had the hair equivalent of an eating disorder. From then on I’d tune out of conversations to inspect friends’ hairlines. I developed a bat-like awareness of anyone approaching from behind or standing above. And I’d spend hours in my parents' bathroom, using a hand mirror to scrutinise this miserable little clearing on the top of my head. I became obsessed, angry, and adamant that I’d try every hair loss medication in the universe, regardless of what it cost me.

    A week later I was at Ashley and Martin hair clinic getting quoted $4,000 for a year’s worth of pharmaceuticals. At the time I was 17 and finishing school, and had zero money. But the following year I deferred from university so I could wash dishes in a restaurant and save for meds. This brought me to June of 2005, when I paid for a daily course of one milligram of a hormone-suppressant called finasteride, bookended by a millilitre of a hair-stimulant called minoxidil, which I smeared onto my scalp morning and night.

    I’m now 31. I’ve dropped the minoxidil, but I’ve been on finasteride for 13 years, which has seemingly made my eyes yellow and created a mystery pain in my groin. Several doctors and an array of tests have declared the pain “unknown,” but it flares up 20 minutes after every dose and lasts a few hours, before fading until the next one. The doctors suspect it’s the finasteride, but the choice is either that or baldness, so I keep eating the pills. And actually, I’m one of the lucky ones.

    Google “Post-Finasteride Syndrome” and you’ll find horror stories. Stories of young men who took the drug for a few weeks and still can’t get an erection, years later. Others describe a seemingly irreversible “brain fog,” with long periods of catatonic depression. And then there are suicides, to which the World Health Organisation attributes finasteride in 55 cases internationally.

    But in my experience finasteride is the only chemical that works. The other one, minoxidil (sold as Regaine), works for many people but not me. And that’s the full list of non-surgical options. In 2018, the world has only two drugs that have been proven by the US Food and Drug Administration (FDA) to reverse hair loss, and both of them are sledgehammers for what should be a delicate and precise operation.

    So I’m pissed off. I’m pissed off at hair loss, and I’m pissed off at the glacial rate of medical advancement, and I’m pissed off at the prospect of looking like my maternal grandfather, who in my opinion looked like a thumb. But I can’t keep going like this, so I’ve decided to get off the drugs and write about what I’ve learned. About hair loss, and vanity.

     

     

    Both men and women experience baldness. Around 16 percent of of men experience moderate to extensive hair loss by the age of 29. By the age of 49, that number has risen to 53 percent. In women, serious hair loss is experienced by around three to 13 percent of the population by the age of 40.

    In both cases, hair loss happens when hair follicles get increasingly smaller until they completely fail to emerge. The process is called “miniaturisation” and the catalyst responsible is a sex steroid and hormone called dihydrotestosterone (DHT), which is converted by the body from testosterone.

    Now, the human body is full of cells that bind and respond to sex steroids. Most of them are found in glands and organs associated with reproduction, but for some reason there’s a bunch of receptors clustered around hair cells. So while DHT is flowing around a guy’s body and stimulating chest hair and prostate growth, it’s also binding with his head hair and instructing follicles to shrink.

    DHT is the culprit behind hereditary hair loss in both men and women, although men have a whole lot more of the stuff. And so by interfering with the production of DHT, pharmacists discovered they could halt baldness in men, and in some cases actually regrow it, which is how finasteride came about.

    In 1992, the business section of the the New York Times published an article called “Keeping the Pipeline Filled at Merck.” What that headline refers to is the way pharmaceutical giants—just like tech companies and film studios—compete to create the next big thing. And at the time, US company Merck was getting FDA approval on what they expected to be a blockbuster.

    Finasteride was originally designed to treat a condition called benign prostatic hyperplasia (BSH), which describes the swelling of the prostate in older men. If you’ve noticed that old men pee a lot, it’s because they’ve got BSH and their prostates are jammed up against their bladders. Finasteride was proven to shrink the prostate by lowering the body's DHT. But what Merck’s researchers hadn’t anticipated was its effect on hair: when BSH patients started telling doctors about their miraculous hair growth, Merck’s strategists realised they’d achieved the pharmaceutical equivalent of accidentally inventing the iPhone.

    The company got FDA approval to sell finasteride for hair loss in 1997 under the name Propecia, and suddenly millions of men began artificially curtailing their levels of DHT. And so emerged the first signs of trouble.

    Martin* was 22 when a doctor in Brisbane prescribed him finasteride for hair loss. “I was extremely self conscious so I said ‘fuck it,’ and started taking Propecia,” he explains over email. “At the time I was about to finish studying as a journalist and had lined up an internship with the sports team at the Australian.”

    Martin says he’d been on the drug about three weeks and was due to start interning when he started to feel foggy and tired. He revisited his GP, who told him to stop taking the drugs, and at first the symptoms dissipated.

    “Then after a week, I experienced what’s known to Post-Finasteride Syndrome sufferers as ‘the crash.’ Imagine your worst hangover,” he says, “combined with complete loss of sexual function, depression, and suicidal ideation for every single second of your life. I can only describe it as an unimaginable hell.”

    Martin says he could barely get out of bed for the next nine months. He canceled the internship and constantly battled the urge to suicide. “Then, after nine months, things improved, to the point where I can now function on a base level. But life is absolutely terrible compared to what it was.”

    Martin is now 27. He describes himself as “a barely functioning human being,” and says he’s tried hormone replacement as well as a range of various diets and exercise regimes. “Today, I hold down a job and get by,” he says. “But to be honest, life sucks.”

    Martin’s experience with Post-Finasteride Syndrome is typical, although researchers still disagree over its exact mechanism or incidence. One study of 11,909 men on finasteride found 167 of them (1.4 percent) developed persistent problems getting or maintaining an erection. The majority of men can take the drug with few side effects, while for others it’s devastating, permanent, and without cure. As Dr. John Santmann, Post-Finasteride Syndrome Foundation CEO claims, “Of the more than 1,000 PFS patients who’ve contacted our foundation desperately seeking support, 12 felt that suicide was the only escape from the horrors of this condition, and ultimately took their own lives.”

    On April 9 this year Merck agreed to settle with a plaintiff committee of 562 cases, all suing for damages caused by taking finasteride, but Dr. Santmann says that’s not enough. “We’d like to see this drug pulled off the market immediately,” he says. “To prevent thousands more men from having their lives devastated.”

    And yet, I keep taking it.

    My problem with baldness is I think it looks pathetic. Through my self-loathing eyes, I think baldness makes men look old, aggressive, and strangely vulnerabile. There’s this infant-like bulbousness to hairless men, as though they’re bumbling through life, failing to jump hoops, and just never getting laid. I know this is bullshit, but it’s what I see when I look in the mirror and imagine myself in five years.

    Going bald is like getting old at warp speed. You can look at photos from six months earlier and see how your hair was noticeably thicker. You can look at individual hairs and observe how the ends are thicker than the follicles, indicating how they’ve shriveled since your last haircut. And you can find stray hairs on your pillow, desk, laptop, kitchen bench, shirt, sink, and basically every flat surface and foodstuff, all indicating that every minute of every day, you’re losing the battle.

    Scientists don’t even know why we go bald. Some species of primate lose their hair just like humans, so apparently it's pretty ingrained in our DNA. But baldness probably isn’t the marker of attraction we think it is. Certainly, if it was evolution’s way of flagging unattractive men, it would have been bred out of the gene pool millennia ago.

    One interesting theory suggests baldness is a health indicator. Research has identified a link between hair loss and cardiovascular disease, including a recent study in India that found bald men were 5.6 times more likely to suffer from a heart condition. Another study found that men with bald spots at the crown are 1.5 times more likely to contract aggressive prostate cancer than those without.

    So on the one hand, it’s a bummer my long term health prospects are being broadcast to everyone with eyes, but maybe baldness has a silver lining. Because as Dr Charles J. Ryan writes in his book on testosterone, The Virility Paradox, “Baldness is not a disease or even a medical problem per se, yet it seems to be an early warning sign that other problems may loom in the future.”

    With advice like that, looking after my health seems a no-brainer. But as already mentioned, I’m not.

    ***

    At the start of the year I resolved to get off finasteride, so I started looking around for drugs that would stop DHT from binding with my hair, while hopefully, maybe, leaving the rest of me unaffected. This proved to be a fruitless search, but I found a world of experimental drugs and managed to blow several thousand dollars in the process.

    See, online drug sales have spread beyond simple narcotics, and now you can buy anything. This means that balding men in 2018 are no longer limited to drugs with FDA approval, but can now access a veritable graveyard of failed and aborted hair stimulants, most of which never made it past animal trials.

    Take, for instance, a little drug called RU58841. Like finasteride, the stuff works by interfering with the body’s production and uptake of DHT, but with a significantly shorter half life. The chemical was developed in 1980 as an abortion drug by French company Roussel Uclaf, but the patent was dropped during a corporate merger in the 90s, only to be picked up again by Scottish company ProStrakan, who dropped it again in the mid-2000s. So now labs in China synthesise RU58841 and sell to distributors such as the Kane Shop, who sell on to customers for “research purposes only.” Then idiots like me rub it onto our scalps and hope for the best.

    I was on RU58841 for about a week before I realised it was making my eyes red and affecting my sleep. On top of that, the pain in my groin became twice as intense as usual, so I quit the RU58841 and bought something called CB-03-01. But that stuff felt a bit like holding a nine-volt battery to my balls, so I switched to fluridil, and then flutamide, both of which dialed up the prostate pain and made me worry about cancer pretty much 24/7. So now I have about $2,000 worth of research chemicals in my freezer, and I’m back on finasteride, without further ideas.

    And while we’re on the subject, let me just say that all those vitamins and mineral supplements from Chemist Warehouse do nothing. I’ve tried megadosing all of it, including saw palmetto fruit extract, which a lot of idiots in online forums tout as nature’s finasteride. I was taking 15 capsules a day for six months and it achieved nothing more than weird burps.

    And hair clinics? Well, I only went to Ashley and Martin, but I’d describe their service as extortionately overpriced, disgustingly overhyped, and delivered with the kind of used-car touch that makes you feel you’re being constantly lied to in a way you can’t level. Ashley and Martin put me on a course of finasteride and minoxidil, both of which are available from a GP for less than $100. But they charged close to $10,000 over three years and insisted on direct debit, while barely ever explaining what they were prescribing or why. So if you’re considering them, don’t.

    ***

    I know things can’t go on like this. It’d be a terrible irony to lose my hair to chemo, treating a prostate cancer that I’d incubated to avoid hair loss. But then I’m not looking forward to getting all obsessive again. And really, that’s all finasteride has been—a circuit breaker for the mental feedback loop of baldness: I’m going bald, I don’t want to go bald, I’m going bald, I don’t want to go bald, I’m going bald, I don’t want to go bald, I’m going bald, I don’t want to go bald, I’m going bald, I don’t want to go bald etc.

    But still, there’s hope in the future. Dermatologist Dr Rodney Sinclair believes that hair loss is increasingly a choice, provided you’re willing to mix and match enough remedies, including surgical hair transplants. He also insists that hair loss medications will only get better, once scientists figure out a way of capitalising on hair’s proclivity for rejuvenation. “The hair follicle is the only organ in the body that is completely destroyed every time it gets plucked,” he told me. “But then it can completely regenerate again as a three-dimensional structure.”

    He went on to describe how stem cells had been found in large numbers around hair follicles, leading him to consider hairs as “the powerhouse of healing in the body.” And this, he says, offers scope for all sorts of stem cell remedies in the future.

    And, for the moment: “Just shave it all off. Maybe you won’t look as bad as you think.”

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