Haaretz: Israeli Victims of Propecia Speak Out: 'I Woke Up Into a Nightmare'

Any other sexual dysfunctions not properly addressed by medical science.
Brain food
Posts: 323
Joined: Sat Aug 15, 2020 9:54 am
Contact:

Haaretz: Israeli Victims of Propecia Speak Out: 'I Woke Up Into a Nightmare'

Unread post by Brain food »

Israeli Victims of Propecia Speak Out: 'I Woke Up Into a Nightmare'
By Ronny Linder
Sep 18, 2022 2:57 pm

Erez put an end to his life 10 months after first taking the Merck medication to treat hair loss. Gil lives with chronic fatigue, erectile dysfunction and depression: this is how Finasteride has ruined lives in Israel

Uri (a pseudonym), 35, began to experience hair loss eight years ago, and decided to try medical treatment. He made his way to the office of his HMO dermatologist with a specific request. “I asked him to prescribe me Propecia,” he says. “I’d heard about it from the advertisements and I had read a little bit about it. He prescribed it for me without hesitation, and did not say anything special about it. I knew from my own preliminary reading that on rare occasions it causes problems in sexual function, but I decided to take the risk.”

And what happened?

“I started taking the drug, and already in the first week some erectile dysfunction began. Right away, I made the connection between that and the medication, but I continued to take it because it wasn’t serious enough for me to stop. I continued to take it for about 10 months.

"Looking back, it was during this period of time that the psychological problems began. These pills suppress hormones that affect a lot of things, not only the hair. I would walk around like a zombie. I didn’t feel anything. I experienced a certain phenomenon that appeared during this period of time, and I did not associate it with the medication – thoughts that got stuck in place, instrusive thoughts. Something that didn’t use to happen to me.”

What made you understand that there was a problem?

“The anxiety attacks that began after about 10 months, and brain fog, a feeling that I was like an emotionless zombie, for better or for worse. I would talk with people, but I wasn’t really there. Then I told myself that maybe it’s the pills, and that I should stop taking them.”

And what happened once you stopped?

“It didn’t end. I went into years of anxiety attacks, in certain periods even several attacks a day. I also had a long period of depression, with suicidal ideation. The zombie sensation stayed with me for at least six months. I stopped working. I would change my place of work over and over again. It took a great deal of time until the body found some sort of balance, and unfortunately I still haven’t completely recovered. It changed my life, I don’t want to say ‘destroyed’ because I don’t want to feel as if I am a victim. I am trying to learn to live with it.”

Propecia, which was approved for sale in Israel in 2007, was marketed in two major – and successful – advertising campaigns. The first, which began in 2009, was its “shalechet (fall of autumn leaves) campaign,” in which a man could be seen with his hair falling off like autumn leaves from a tree. The second campaign, which began in 2012, was the “skeptics campaign,” which included billboards, advertisements and commercials on television and radio.

The two campaigns were based on the fear of balding, or as it was later described by the publicist responsible for the campaign: “Just like wrinkles and cellulite for women, the phenomenon of balding has become tragic for men. The desire to look young has become a sort of obsession. Among men, the hairline has become a stigma on our foreheads that moves higher and higher. Many balding men are in a state of despair from the phenomenon and admit that it affects their self-image and self-confidence.”

The marketing was a success. In an article written by the publicist who was behind it, he described just how effective it was. “Merck MSD’s marketing campaign was more resounding than even our greatest expectations,” the publicist wrote. “Within only a few months, ‘skepticism’ became an idiomatic phrase – on the street, on social media and in all media… The campaign succeeded in generating a significant shift in attitude, and motivated many people to take action. Based on the surveys we conducted, the campaign led to a 75 percent increase in the number of people who believed in a medical solution to baldness, and to a 37 percent increase in willingness to be examined by a dermatologist.”

'Two or three weeks after I started, I had a sensation as if a splint had been inserted in my head, and my libido was gone. I told myself, ‘Something is wrong here.''

A majority of men will suffer at some stage of their lives froms some degree of baldness or hair thinning, in rates that increase with age. Statistics refer to 80 percent of men suffering from some baldness by age 70, but many men begin to grow bald as early as their 20s and 30s.

Gil (a pseudonym), 42, was the perfect target audience for the campaign. In 2012, he was a young man of 31, whose fear of baldness began to consume him: “I had slight hair loss along the sides at the top of my head. I went to a dermatologist at my HMO and asked if she thought it was hair loss. She examined me and said that yes, it was, and that if I didn’t do something about it then I would go bald.

"At that same appointment she prescribed Propecia for me, with which I was well familiar from the advertisements and from the HMOs promoting of it. At the time, the HMO was selling it at a discount. I had a friend who’d taken it for a few months and didn’t have any problem at all. He was pleased. He pressured me to take the medication because he saw that I was wavering.”

Why were you undecided? Did you know about possible side effects?

“I knew that I was taking something hormonal and I had certain concerns, but the doctor didn’t warn me of any side effects. The friend said that he was taking it and everything was fine, and on the other hand another friend told me that her husband had lost all of his hair, and in the end I was more concerned about the hair loss than about anything else. My hair is extremely important to me.”

And what happened after you started taking the medication?

“Very quickly, two or three weeks after I started, I had a sensation as if a splint had been inserted in my head, and my libido was gone. I told myself, ‘Something is wrong here,’ but figured that it was probably just a passing phenomenon, and if I continued to take the medication it would get better. But it didn’t end and after two or three months I decided that I was done with it, that I no longer wanted to take this medication. I stopped taking it all at once.”

Gil says that stopping the medication was actually a negative turning point. “The second I stopped, there was a complete reversal: I began to feel extreme sexual arousal that I’d never experienced. I felt it had to do with stopping the medication, that something strange was happening to me, that my body was not in balance and out of tune. That feeling ended a week later, but a gradual deterioration ensued. I felt increasingly worse.

"There was a consistent decline of my mood, of my ability to be sexually aroused, of all of my sensations. I felt that the medication had left me in a poor state, that I was increasingly deteriorating. After about a month, I went for a swim in an attempt to get out of it, to wake myself up. I remember that after that I went to sleep and then woke up into a nightmare. Afterward, when I began to look at internet forums, I discovered that that is a situation that occurs to many people with this medication – a ‘crash.’”

What is a crash?

“It’s the most horrific feeling you can imagine – as if all of the systems in my body have shut down. The entire body feels like it is being electrocuted; everything is burning and hurting. I felt like I was going to die. I had never felt anything like it. In the emergency room, they didn’t know what was happening, they didn’t do any hormonal tests; they released me and sent me home. I was stuck in this condition for several months. It was awful. Reality seemed like a movie, everything felt like a nightmare, all the time. I was in a state of depression that is hard to describe, everything hurt, I lost a ton of weight. I didn’t want to live even a second more, didn’t want to eat, nothing. I was living with my parents and I was an absolute emotional wreck. I stopped working for a while, and when I went back, I still felt terrible.”

Did you have suicidal ideation?

“Yes, a lot. At the peak of the crash, that is all I wanted to do, and afterward, as well. I spoke about it a great deal. I feel that in a certain sense, I lost my life. I did not continue my studies. I didn’t have a partner. My career is stuck – I have been in the same job for many years. I am not at all optimistic. And the worst part is that I am not alone – there are entire forums online where when you get into them, it is like entering hell. People describe how they are fighting and trying so hard to get back to what they once were, and are not managing to do so. Their doctors don’t know how to help them. It is hard for them to absorb the fact that the medication has such a long-lasting effect.”

‘People don’t know’

In the past few weeks, we have spoken with and read the personal accounts of dozens of young men who took Merck’s Propecia medication or its generic equivalents and who reported similar symptoms at various levels of severity.

When it comes to one case, there is no longer anyone to interview: Erez (a pseudonym) killed himself after, he said, he could no longer stand the medication’s side effects.

His widow, Galia, says that unlike many others, Erez immediately made the connection between his symptoms and the medication. “He was 49 years old, and took only seven pills over the course of a single week, and immediately began to feel very severe symptoms of anxiety and sleeplessness,” she says. “So bad that he could not sleep at all for long periods of time – weeks and months – even when he did not take any medication. The system that was damaged is hormonal, so even drugs that are generally taken to help with anxiety and sleeplessness did not help. He associated it with the medication due to the immediacy and the intensity of the symptoms and because it was happening to a healthy individual who had never known a bad day in his life.”

Erez put an end to his life in May 2016, 10 months after first taking the medication. The suicide note that he left was damning: “Until late July 2015, I was a very healthy individual, optimistic and strong, creative and warm, a devoted father and husband to my children and my wife. I had a successful career and I was always surrounded by friends and professional colleagues. But everything changed the day that I started to take a pill called Propecia, a medication that in retrospect destroyed my life at age 49,” he wrote. In the letter, he described a long series of serious side effects that included anxiety, depression, sleeplessness, impaired memory and ability to concentrate, unremitting thoughts, and poorer eyesight, among others.

“I lost most of my social abilities, my professionalism and my enjoyment of life. I lost my self-confidence, my sense of self-worth, which along with the physical symptoms created in me a cycle of immense frustration and fear of the future. I lost myself along the way, as a result of the medication. I changed in every possible way, and therefore I have decided not to go on living.”

“Where are the gatekeepers?” asks Galia. “A person has hair loss, he goes to a doctor. Who tells him that this medication is liable to cause sterility? To cause impotence? Severe depression and anxiety attacks? People don’t know they are playing a game of Russian roulette. It may be that everything will be fine, but it also may be that your life will be destroyed.”
Low testosterone

Accounts such as those of Uri, Gil and Erez may be found in the hundreds and thousands in internet forums. The physical and psychological symptoms they report received, as early as 2015, an official description and name: Post-finasteride syndrome, named for the active ingredient in Propecia. The syndrome has been added to the U.S. National Institutes of Health’s list of rare genetic diseases and is recognized by health authorities worldwide.

It is described as prolonged and severe side effects that persist long after the drug has ceased to be administered, and includes, among other things, a decline in libido, erectile dysfunction, depression, suicidal ideation, anxiety attacks, chronic testicular pain, damage to the muscles, cognitive impairment, sleep disorders and gynecomastia (growth of breast tissue in men). Some of these side effects may be irreversible even after the drug is no longer administered, and in some individuals they can appear a very short time after the initial use.

An immense online message board, propeciahelp.com, operates for those negatively affected by Propecia from all over the world. It includes personal accounts, discussions and shared observations, connects researchers with those affected, and provides advice on subjects such as “how to make people believe I have PFS” and “how to speak with your physician about PFS.”

Indeed, the suspicious and at times dismissive attitude of the medical establishment toward those who feel they have been harmed by the medication is reiterated in personal accounts. Uri and Gil say that the doctors they turned to were helpless in the face of the situation, with which they were unfamiliar at best. In the worst case, they did not believe there was any link between the medication and the patients’ condition.
“I went to see so many doctors — GPs, dermatologists, psychiatrists, and several endocrinologists. They did not know how to help me,” Uri says. “The blood tests were normal, and since most of the problems were emotional – depression and anxiety – they didn’t really believe me. In the end, there was one doctor who said to me: ‘It could be that we don’t really know.’
“At the same time, I began to look on international websites, and I discovered that there were a ton of men from all over the world reporting on the abnormal phenomena. All of a sudden I was reading the same exact things I was feeling, and also about how the doctors don’t know how to help. It shook me up. It was obvious to me that the pill was the trigger that had caused an outburst. Life changed the minute I began to take it.”

Erez also went to several doctors. “We saw the best doctors: psychiatrists, an endocrinologist, the family doctor. We told all of them that it happened after he took Propecia,and almost none were familiar with its side effects,” says Galia, his widow. “The first psychiatrist was the only one who was familiar. He was given the ordinary treatment for depression, although it didn’t really help, because the disturbance is hormonal in nature. And it went on that way for 10 months, during which he did not go back to his usual self, not even a little, until finally he couldn’t bear it any longer.”

Gil says that only after he insisted, and even begged, did he receive a referral for hormone tests. “In the testosterone test, they found that my testosterone was very low, more like that of a 90-year-old man. And because I’d done this sort of test two years earlier and was then in the high range, they were able to see how it had plummeted. Over time it went back up, but it was still very low.”

He says those suffering with PFS are not rushing to speak out. “There is a lot of shame and concealment going on here – this is a medication against baldness that causes sexual dysfunction, as well as depression and anxiety. For men, it is sometimes too difficult to talk about it.”

Reports flowing in

Propecia was initially approved for use in the U.S. in 1998 for the treatment of mens’ baldness at a dosage of 1 milligram. It was approved in Israel in 2007, and two generic versions are also now sold in Israel. The active ingredient of the medication, finasteride, hinders an enzyme responsible for the conversion of testosterone, and causes a reduction in levels of DHT – a derivative of the hormone that leads to male baldness in high concentrations. In short, the chemical interferes with the balding process by intervening in hormonal activity.

The medication, which is administered orally (one pill a day), is considered effective for treatment of slight or moderate balding, primarily among young men; it costs 150 shekels ($45) a month. It is also profitable for a pharmaceutical company: the duration of treatment is unlimited, and ceasing treatment triggers a renewal of hair loss within a few months. Although Propecia is a prescription medication with a problematic reputation of side effects, Israeli HMOs encourage their policyholders to purchase it by offering substantial discounts of 30-50 percent to those covered by their complementary insurance plans.

Finasteride has millions of users worldwide and tens of thousands in Israel, but hovering over its safety record is a dark cloud that has kept growing over the years. Reports of side effects such as persistent sexual dysfunction and depression began to appear during the initial years of its sale, but it took them a long time to trickle into the consciousness of the public and doctors in an official capacity. In 2008, the medication’s packaging insert, which contains information about the drug, was modified in Sweden, Italy and the U.K. to include a warning about potential irreversible damage to sexual function.

Based upon internal Merck documents, which were revealed last year by the Reuters news agency, as far back as 2009, the company knew of more than 200 instances of depression and suicide attempts among men treated with the drug, but decided, in conjunction with the U.S. Food and Drug Administration that the number was small enough that it did not obligate Merck to inform the public.

In 2011, the FDA updated the medication’s packaging insert to include warnings about depression and persistent sexual dysfunction even after administration of the drug is ceased, but not about the risk of suicidal ideation. In fact, only this year – 11 years later – and in the wake of heavy pressure from victims who had formed pressure groups, did the FDA add to the insert the potential side effect of “suicidal ideation and behavior.” Up until then, for nearly 20 years, the FDA had received at least 700 reports a year about incidents of suicide and suicidal ideation among people taking the medication and its generic equivalents worldwide, including in Israel.

Europe woke up to the issue long before the U.S.: in 2009, the European Medical Association created a risk-management program for the medication, following information on the potential risk of depression and irreversible harm to sexual function. In 2017, in the wake of a recommendation by the EMA, Belgium, the U.S, Germany, Denmark, the Netherlands and other countries added warnings to the medication’s insert regarding depression, anxiety and suicidal ideation. Meanwhile, countries around the world have adopted a variety of measures to warn both doctors and the public of the dangers posed by use of Propecia, especially once PFS syndrome was recognized in 2015.

In Israel, however, it took much longer to update the inserts and inform the doctors and the public. Over the years, the inserts were updated to add information about side effects related to sexual function on two occasions. In 2012, a warning was added about reduced libido persisting even after termination of the medication; in 2014, against the backdrop of a class-action suit, warnings were added regarding difficulties in sexual function. But it wasn’t until 2020, three years after the inserts in Europe were modified, that there was a substantial expansion of the list of warnings in the insert, with emphasis on the psychological symptoms.

One may learn a great deal about the Merck’s conduct in the face of these reports from the following story. As early as 2010, a class-action suit against Merck was filed in Israel, alleging that the company had not issued the required warnings of known side effects of impaired fertility and sexual dysfunction, and that there were differences between the inserts in Israel and abroad. The suit ended with a financial settlement in 2018, in which the company paid 5.7 million shekels to the plaintiffs and agreed to update the consumer insert. However, Merck continued to deny the allegation that the medication caused harm. The official grounds for its agreement to pay compensation was its desire “to avoid additional expenses, discomfort and the confusion that would be caused by burdensome and extended legal wrangling.”

Bureaucracy in reporting

How is it possible that there are abundant reports on these side effects, but that this information does not always make it to the doctors, and, through them, to the public? How is it possible that side effects are updated in inserts distributed to doctors and the consumer many years after they have appeared? How is it possible that different countries publish different information and inserts at different times about the same medications? It would seem that the case of Propecia reveals overt failures when it comes to the discovery and reporting of medications’ side effects – and underscores the extent to which the existing tools are inadequate when it comes to warning of potential dangers in a timely manner.

The first failure is that the primary responsibility of tracking, reporting and publicizing side effects of medications once they have begun to be marketed is placed on the pharmaceutical companies – the ones who have the most to lose from the side effects being widely known. The Health Ministry is tasked with approving a pharmaceutical firm’s request to update the insert. However, if the Health Ministry receives a troubling report about a medication through other channels, like information received from abroad, it is supposed to consider taking a number of actions, including changing the insert.

Dorit Dil Nahlieli, who established and directed the Health Ministry’s drug safety division, explains: “In Israel, regulations were issued in 2013 that obligate all of the pharmaceutical companies to appoint an individual to be responsible for pharmaceutical supervision, to collect information on side effects and to issue a comprehensive report to the Risk Management and Drug Information Department at the Health Ministry.”

In contrast, she explains, “reporting by medical staffers is on a voluntary basis. In the past, there was an attempt to obligate them to submit reports, but it didn’t work; it generated antagonism. We found that what does work is raising awareness of the importance of reporting.”

But most people go to a doctor or to a hospital, and report the side effects to them. Who would even think of reporting them to the pharmaceutical company?

“True, it is a complex world, which is why we engage in public awareness activity and educate physicians and medical staff on the importance of reporting [side effects] and its effectiveness, and how in every medical institution there is someone responsible for medical follow-up who is responsible for raising awareness. And there are still quite a few obstacles: the bureaucracy of the reporting system – medical staff are extremely busy, and this requires filling out another form. Or if they don’t consider it important enough, they won’t report it. But at the end of the day, there are quite a few reports from medical staff, including significant reports, which led the ministry to take action.”

The pharmaceutical companies have no incentive to report on side effects. It’s like the cat guarding the cream, isn’t it?

“That isn’t precisely true, because they must operate in accordance with regulations, and if they do not make reports then we can take sanctions against them. Also, it is important to them to assure the safety of their formula. From my experience, the companies make as great an effort as possible to make reports. In the U.S., enormous penalties are imposed on anyone who conceals side effects, although in Israel that isn’t yet the case.”

The insert, then, is the main mechanism by which the public and the physicians can be informed about newly discovered side effects. But that there are no clear criteria for adding side effects to an insert, and there is no uniformity between inserts for the same medication in different countries.

How is it nevertheless decided to add information about a new side effect to an insert in Israel?

“The information about side effects that flows in from the field is discussed in advisory committees within the Health Ministry, and for the most part the change is made as a result of accumulation of new information or in accordance with changes made by another regulatory agency,” says Dil Nahlieli. “As soon as there is a sufficient level of conclusiveness, concern and the basis for a connection between the medication and a side effect, it is added to the insert as a side effect or warning.”

However, updating the insert is only one link in a chain: even after the insert’s update, numerous patients in Israel and the rest of the world attest, many doctors are still unaware of the side effects, or may cast doubt on their very existence, and the same is true for new patients. How can one bring this change to the attention of physicians who are inundated daily with new information of various levels of importance? How many of us read the fine print on the insert that comes with a medication?

“That is a sensitive spot, because these are things that should undergo a profound change,” says Dil Nahlieli. “Change is indeed happening in Israel and there has been improvement, but there is more information being updated than medical staff are capable of absorbing, due to the heavy workload and the way it is being disseminated.

“It is common practice to issue letters informing of changes in the insert. They are publicized in the press, and doctors receive emails about them. The better thing to do, in my opinion, would be to inform the doctors by means of a computerized system, in a more focused manner, at the time that the change is being made, when it is relevant to the patient. There are hundreds of medications and thousands of side effects that people should know about – and the information is found only in inserts.”

Several doctors with whom we spoke, dermatologists as well as general practitioners, played down the severity and frequency of the side effects, or spoke about the sexual effects but seemed to be completely unaware of the medication’s psychological effects. Some of them claimed, as does the pharmaceutical company, that studies on the medication’s side effects are scant and that there is no conclusive proof of a causal relationship between it and the side effects.

A., a senior physician at a hospital in central Israel, casts doubt even now on the destructive effects of Propecia. “The issue of damage to sexual function is not entirely clear,” he says. “The medication affects the conversion of testosterone to its specific derivative, and in so doing is liable to damage sexual function. Nevertheless, most of the studies demonstrate relatively low rates of damage caused to sexual performance. It may be that this is merely a handy excuse: people may want to blame their sexual dysfunction on something.”

He has similar things to say about the reports of psychological symptoms: “There are a lot of people who have disorders with a psychological basis, and then look for something to put it all onto. Due to the fact that those who take Propecia are young, healthy people and aside from Propecia are not taking any other medication, the suspicion falls on it, even if there is no actual connection between the two.”

So what is the frequency of the side effects caused by the drug? It is difficult to answer this question with any precision, because there are no controlled studies with multiple participants. The studies conducted prior to the medication’s approval are focused on examining its effectiveness and not its safety, and therefore side effects are oftentimes revealed only after the medication begins to be sold, through cumulative experience and reports by patients.

In addition, it is hard to disregard a certain inherent problem that repeats itself: a majority of the studies on medications are funded by the pharmaceutical industry, which is the last to have any interest in finding and revealing side effects. A meta-analysis of studies of Propecia from 2016 showed that 56 percent of them were underwritten by the pharmaceutical company, and in 35 percent of them, the source of funding was not disclosed.

Nevertheless, in the past decade there has been an increase of academic articles worldwide about patients who developed serious psychiatric symptoms, extending to suicidal tendencies, following treatment with Propecia. The most well-known study is one by Dr. Michael S. Irwig and his research partners dating to 2012, which examined 61 former Propecia users and demonstrated a significant increase in frequency of depression and suicidal ideation among Propecia users as opposed to a control group. In the wake of this study, awareness of the symptoms increased, and with it reports on them from all over the world. In 2020, Irwig and his colleagues published a review of six cases of suicidality following use of Propecia, and found a similar pattern of symptoms leading up to suicidality: insomnia, severe sexual dysfuntion, fatigue, depression and anxiety.

Dr. Shahar Kol, director of the in-vitro fertilization unit at Elisha Hospital in Haifa, personally chanced upon damage caused by the medication in his patients. “I treated several cases of couples who already had a child or two trying over the course of a year or two to become pregnant again, but without success,” he recounts. “And then I examine both partners, send the man for a sperm test, and a significantly abnormal test result comes back – a low sperm count that requires IVF because the chance of a natural pregnancy is too low. And then you ask what he is taking, and it turns out he is taking Propecia.”

Along with that, several physicians with whom we spoke say they have their concerns about the medication, but feel almost obligated to prescribe it to patients who ask for it, highlighting another failure that leads to an overly light trigger finger in writing prescriptions: the message that they are receiving from patients and from HMO administrations is to satisfy the wishes of patients at any cost.

R., a general practitioner from central Israel, says: “There are a lot of patients who demand the medication, and I know that my colleagues prescribe it with great ease. The hair transplants in Turkey have not reduced its use, and perhaps the opposite – a lot of people do transplants there and then receive instructions to take Propecia afterwards so that their hair will grow, and that’s for the rest of their life. Early on, I kept copies of an article about the risks and the side effects and I would show it to patients, but usually it does not persuade them. They insist on taking the medication, because baldness is more frightening to them. Just this week, a patient told me that if he had sexual performance problems, then he would simply take Viagra.”

She says that physicians often skip over even this conversation as well as a preliminary meeting with the patient, and write the prescription almost automatically through the HMO’s app, for fear of angering their patients. “I would not agree to prescribe a medication such as this without a regular appointment and without explanations,” she says. “It isn’t always pleasant, because there are some people who get impatient with me for wasting their time; they may even switch to another doctor.”

D., another general practitioner, explains that patients put pressure on him to prescribe the medication. “I barely ever prescribe it, but if patients really twist my arm and demand a prescription – because I do not believe in treatment with medication for conditions like balding, which is not a disease but a lifestyle condition – in these isolated circumstances, I insist they come in for an appointment so that I can explain the dangers to them. Is it at all surprising that when you give something to a man that interferes with the effects of testosterone, side effects = occur? We’re playing with people’s hormones, and people need to understand that, but the average doctor is busy and depressed and receives a request through an app, and the message that he receives from the system is ‘prescribe it for him, don’t make him come to you for an appointment,’ and the patient is liable to respond angrily to being given the run-around. But a responsible physician will stop, ask the patient to come in, and will speak with him.”

The outdated current model

Prof. Mayer Brezis, an internal medicine expert at the School of Public Health and the Faculty of Medicine at Hebrew University of Jerusalem (and a former director of Hadassah University Hospital’s Center for Quality and Safety), believes that the case of Propecia drives home the point to which many long years can sometimes pass pass until deadly side effects of a new medication come to light.

“It always takes a long time for a consensus to form on a causal relationship between side effects and a medication, and opponents will crop up along the way – forces that usually have a connection to the industry. It is a gradual process, because at first people do not tend to make the association between a medication for baldness and the symptoms that are happening to them, like depression, anxiety or sexual dysfunction, and the doctors are also unaware of any connection. Slowly but surely, reports and research studies and awareness increase – and from there begins a snowball effect of exposing the intensity and extent of the symptoms.”

In his opinion, the existing model – exposure of side effects by means of reports of the pharmaceuticals industry and publicizing in inserts – is outdated, unsatisfactory and vulnerable to the manipulations of the industry. “For example, in proving a causal relationship between the medication and the symptoms when it comes to suicide or severe depression, it’s always possible to claim that there may not be any connection, that these are anecdotal accounts and not a controlled trial, enabling the company to buy time and to continue to sell within the period of the patent,” Brezis says.

Brezis conducted a survey of his own through the data bank of FDA reports on side effects, and found numerous reports on Propecia side effects. Next, he compared the extent of reports on side effects of the medication with reports on another popular anti-balding medication, Rogaine (generic name minoxidil), and found 10 to 20 times the number of reports of depression, anxiety, insomnia, fatigue and suicidal ideation. Similar findings arose in comparison with a medication for hypertension called Propanolol (inderal), which has been linked to risk of suicidal behavior. Similarly, in this comparison, there were many more reports involving Propecia.

“The insert is a clumsy and unuseful tool,” says Brezis. “It is an exercise in legally covering their butts. People don’t read it, and if they do read it, usually they do not understand it correctly. When a person is looking for a cosmetic drug to improve their quality of life, there is an obligation to warn him of the risk liable to actually harm his quality of life. An insert is not enough to allow the kind of reflection that is needed for an educated choice. The doctor who offers a medication is obliged to share with the patient the risks and alternatives for treatment, as obligated by the law on patient rights. That does not happen when for the most part, the doctors themselves lack the information, not to mention the time to impart it. What’s necessary is a revolution in the realm of friendly explanation. With a dangerous medication such as this, there needs to be a process of conscious agreement before it is prescribed.”

Brezis says there also needs to be a revolution in the system of reporting side effects, which needs to be adjusted to the present era. “We have to start listening seriously to patients,” he says. “It took two decades to understand the severe dangers from Propecia, with the help of reporting and monitoring. Now, in the era of big data, it is possible to speed up this procedure by partnering with the patient: We have to build a user-friendly, smart online reporting system already at the stage of research on a new drug, and then following its approval for sale. Connecting these reports with the HMO’s databases would enable analysis of the connection between side effects and taking the medication, by comparing patients with similar characteristics who are not taking it.”

Through Jonathan Davies, a medical malpractice attorney, Galia, Erez’s widow, has filed a lawsuit against Merck, the HMO and the doctor who prescribed the medication to her husband without warning him of the risks. “As far as I’m concerned, they killed him the day he started taking the medication,” she says. “He was someone who was so happy, content, optimistic, who built a career for himself and was an exemplary family man – and then it all came crashing down. He would not meet with people, he kept his distance from them – the gap was too wide. He was unable to come to terms with the situation.”

Last year, Davies filed a request for a class-action suit against the three pharmaceutical companies that market Propecia and its generic equivalents in Israel, on behalf of those affected. Davies says that after the media reported that he had submitted a class-action suit, he was astounded by the dozens of inquiries he received from men who had been harmed by Propecia. “Within days, we received applications from a great deal of young men with side effects of depression and anxiety that significantly affected their quality of life, to the extent that some of these instances justify submitting personal lawsuits, due to the significant damage caused to them,” he says.

“At the end of the day, we are speaking of a cosmetic medication, not a life-saving medication, and the caution with which one must act when prescribing it is at a higher threshold. But in actual fact, the trigger finger on writing prescriptions is so light, and the information about the dangers does not trickle down to physicians and to patients.”

Davies says that “the entire chain that is meant to protect the patient did not function: the pharmaceutical firms have an interest in selling as much as possible are concealing information, the Health Ministry is not supervising the companies, and the HMOs are not doing enough to inform the doctors and warn them of the risks of providing a cosmetic medication. The physicians are trapped between their obligation to be loyal to their patients and the fact that there is no system capable of adequately updating them on side effects. It is a system-wide failure that does harm to public health.”

When we asked Merck for a response, the company directed us to Organon, the company that was awarded the rights to market the medication in Israel last year. Organon’s response was that “Propecia has been approved by the FDA and the Israeli Health Ministry since 1998. The medication’s safety and effectiveness have been proven in controlled clinical studies, and over the years it has been used safely by millions of men worldwide. The scientific findings do not support a causal relationship between the medication and suicidality. As stated above, the company is compliant with all of the demands of the health authorities on the issue of the inserts. As for the suit referred to here, the company rejects the charges in the lawsuit, but due to strict adherence to medical secrecy and in view of the confidentiality injunction, the company will submit its detailed position to the court.”

https://www.haaretz.com/israel-news/202 ... 6d6ba00000
ElaineBenes5
Posts: 39
Joined: Thu Jul 14, 2022 6:09 pm
Contact:

Re: Haaretz: Israeli Victims of Propecia Speak Out: 'I Woke Up Into a Nightmare'

Unread post by ElaineBenes5 »

So the man who committed suicide may have also been taking an antidepressent, as his widow explains. Why is there no mention of PSSD and the possibility that turning to the "ordinary treatment for depression" made matters worse? Uffa.
Post Reply

Who is online

Users browsing this forum: No registered users and 0 guests