I was contacted by the author of this news article last week. The article recently came out in Israel’s “Hayom” newspaper, the biggest and most popular newspaper in Israel. There is now a class action lawsuit brewing in Israel as well.
Digital Edition (Hebrew)
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pg. 12-19
Google English translation:
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[Size=4]“Bald industry”: side effects not find you [/size]
From: Michal Jacob Isaac, Israel today
Friday, February 10, 2012, 6:04
When pressing the TV commercials most sensitive point, balding man Israel will not sit idly by, and buy medicine to prevent baldness. The risks and side effects - he finds out alone.
Dry statistics will tell you that Israel is a superpower baldness. 30 percent of men by age 30 already bald, another 20 percent will join them until the age of 50. By age 70, well, 70 percent of men reading this article do not need a comb. I really did not really have the stats: enough to enter the bar, the gym or for a family event and look Bfdhot of those present. “The bald industry” roll half a billion shekels a year - drugs, hair transplants and wigs. World, by the way, investors bald drugs much more money than drugs slightly more important issues, malaria for example. The reason is simple: bald would shed a lot of money to fight bare fell on them.
The Israeli market leader today, “Propecia”, a drug made by Merck - the international pharmaceutical giant Merck, Sharp and Dohm. This drug advertisements H"skftim behind “television, which claimed that” more and more men are now no longer skeptical, "and customers are sent details of their dermatologist. Ensures Propecia stop hair loss, and in some cases even grow new hair. On How effective is almost no one denies; According to reports, hair loss in most people actually brake. The problem is that the side effects, and these, naturally, prefer to MSD to raise: the lack of sexual desire, erection problems, decreased semen quantity and quality, impotence, testicular pain and depression to suicidal thoughts - these are just some of the symptoms which reported those taking Propecia. Recently, the name of the drug binds with prostate cancer. Lack of clinical studies that validate sharply - cut the link between fertility problems and taking Propecia, as well as being the only drug approved for baldness by the U.S. Drug Administration (FDA) make it difficult for professionals to challenge openly.
Drug counseling unit at Assaf Harofeh Hospital since 2008 were received dozens of reports of side-effects associated with Propecia. Such testimonies are also online forums about health. Dr Abdul - Magid Triis, researcher from the Department of Biochemistry and Urology at Boston University School of Medicine, discovered the effect of profession is not limited to its target tissues, but it is also the chemical processes in the brain. An interview with CBS in Philadelphia in May 2011 claimed Triis that the study demonstrates that in Some people damage continues even after they stopped taking the medication - and it may be permanent. "We do not understand why, but some men taking the drug’s effect is permanent. Is not easily resolved, and may not ever be solved. It’s like something off a biological, and remains so. "
[Size=4]“Diminished sperm” [/size]
“No one in Israel starts a little balding and Propecia advertisement does something to him,” said M., who took the drug for more than a year. “After all, no man would sit idly aside and let his hair fall out when a drug might be able to keep the hair on your head.” Four years ago, mid-twenties, from 'notice that his hair bays depth. He was looking for a preparation to help him prevent baldness so young. "I consulted with a dermatologist, and he recommended the profession. He told me the medicine is safe and has no side effects irregular. Despite the opposition of my girlfriend at the time, who later became my wife, I take a pill a day, for over a year. Dropout was arrested, but not I grew new hair. Over time I began to notice that the amount of my sperm significantly decreased, but did not attach much importance, that the PI stated that the drug can harm sperm quantity. not written anything about the quality of sperm. In addition, it was explained to me that the symptoms disappear when you stop taking the drug, but I did not want to stop, because I knew that once you stop, hair loss and renewable. "
Why your wife objected to take his medication?
“She told me it was not invented the ball used by the day - daily over a long period will not cause side effects. It so that it will work is to disrupt the body’s natural activity. Now I know she was right.” Nearly a year after that for the newlyweds could not get pregnant, suspicious of m, and he decided to make sperm count. The test results indicated low count normal range. Only after he stopped taking the drug, could the wife of M. conceive. "All the people who take this medicine take it to solve an aesthetic problem, it’s not life-saving drug. So if only you had told me with side effects so severe, will accompany me when I stop using it, obviously I would not take it. The more and how if I know it can be difficult to have children in the future. I’m angry about the company, that’s how plays in the lives of millions of people around the world. "
[Size=4]“Surprised that men who take it” [/size]
M one of its presenters of the class action lawsuit against the request Merck. The request, filed last year and half by employees lawyers Gabai, Michael Dvorin and Ovadia Cohen from them Dvorin Cohen, still being debated in Jerusalem District Court. When looking at the fine print attached that appear PI drug since 2009, reveal the following: “certain sexual side effects were observed in less than two percent of men in the study and disappeared when the men stopped taking the drug.”
But one of the main arguments raised again and again among men with whom we spoke is that the side effects continue to accompany them a few years after stopping use. Another argument was that advertising on the side effects Updated all European countries in 2008, but Israel is entered only in September 2011. Publications about the side effects appear in the world, and class action lawsuits were filed against the company in Israel, Canada and the U.S… In 2003 the U.S. a few men banded affected long-term side effects of Propecia and set up a dedicated forum. Today, after several members of the forum was the Alps, they established a site called propeciahelp.com, which can be updated at any side effects and new studies published on the subject. Although some American doctors went to the media with new studies, validate the feelings of users, and called for new studies will examine long-term side effects.
Dr. Yigal Madjer, male fertility unit director Sheba Medical Center Tel Hashomer, says that every year come to about 50 patients Propecia with fertility problems. "Appears in some improvement after a lapse in medication, and in some not. It should be done extensive research on the influence of the drug on fertility in men. "
You were taking the medicine or recommend someone close?
“As a person who knows that a change in testosterone levels - as does Propecia - bring change in the level of sperm, the answer is no. I do not recommend, and I am very surprised that men who take it for a continuous period of five years or more”.
However, the Ministry of Health Israel argue that apart from one report of decreased libido, there were no reports of side effects that disappear when you stop using this medication.
[Size=4]Millions of users around the world [/size]
The active ingredient in Propecia is finasteride. Its ability to affect hair loss found in the case: in the past can be Finasteride at a dose of 5 mg for men suffering from benign enlargement of the prostate gland, and one side effect was a reduction in hair loss, and in some cases re-growth. Revealed that Finasteride blocks the enzyme that converts the male hormone hormone testosterone to DHT, which causes baldness. once that conversion is not performed, hair growth is not compromised.
Early 90s, after the sensational discovery, clinical research MSD has lasted five years, and which tested the influence of Finasteride on balding men. The study involved 1,500 men ages 18 to 45 who have suffered hair loss, Propecia and end proved to be effective treatment for baldness: among 90 percent of men in the study dropout was arrested, and in 65 percent of them resumed growth. The only side effect was reported to decrease libido in about two percent of men in the study, and according to the report, she was gone when you stop taking the drug. In December 1997 the FDA approved the use in the U.S. profession, and in 1999 the Israeli Health Ministry approved the drug in Israel.
Gospel magic bullet that prevents baldness spread wings and he has become more popular. Millions of men around the world use it regularly, of which about 100 thousand in Israel. Profession sold only by prescription. One pack 28 balls with just a month, and cost 272 dollars, almost 10 dollars a ball. Take one pill a day. When the drug is stopped, renewable enzyme activity which it blocks, and with it dropping out.
Complaints about side effects of losing their fertility began to emerge in the early years of the drug, and there was associated with increased odds of prostate cancer a violent species. According to Merck’s reports, complaints relating to prostate cancer Finasteride valid only for a dose of 5 mg and 1 mg, as there is Propecia.
[Size=4]Dangerous even with a low dose [/size]
But the drug can impair detection of prostate cancer in its early stages and critical. “The problem a little more severe than that Merck is trying to show,” says Prof. Eli Sprecher, chief of dermatology at the Medical Center Ichilov. “Hormonal intervention should only affect hair loss there are many phenomena that are beyond the hair follicle. Just three months ago the FDA issued a warning about using finasteride decrease the prostate gland. Warning also applies Finasteride 1 mg (Propecia) and Finasteride 5” c ". FDA warning is based on two major studies showed that although the drug cut the risk of prostate cancer overall - they raised the risk that if a tumor, its malignancy level will be high.
“To be given 5 mg finasteride cause the DHT level of the spinach, then the fact difficult to grow prostate cells to grow because they lack the hormone they build it to proliferate,” says Sprecher. "The moment it does not exist, develop cells that can exist without the hormone - such as cancer cells. "
Everything you said applies even lower dose of Finasteride?
“There is no evidence of long-term follow-up be let it past. By my professional logic, with 1 mg This may take a bit longer.”
[Size=4]“I’m a walking dead man” [/size]
Studies, as noted, are inconclusive. A study of 181 men aged 19 to 41 and was published in 1999 the American journal “Urology” found that using finasteride one mg dose does not affect sperm production in men. Study included 48 weeks on the drug and 60 weeks without medication . found that among men who took Propecia decreased by 11 percent in volume emission, compared to 8 percent among men who took a dummy pill (placebo). that concluded that Propecia does not affect sperm production. other hand, a study published last year in the journal "Journal of Sexual Medicine ", with 71 healthy men, found that the side effects while taking the drug began or after the break taking over. authors admitted that he does not prove one - cut the drug is the source of the problems investigated, but noted that it raises cause for concern.
B (33) is one of three Israelis in this study. “Propecia was the mistake of my life,” he says. “I took the drug for almost two years. Besides hair loss, I was a strong, successful, independent business owner. After the drug became very weak, damaged my self esteem and memory, not to mention the damage to sexual function. Can not say I’m a walking dead man” .
Why not stop using this medicine?
“PI list the side effects, but explain that they disappear with time, or when you stop taking the drug. When my hair started to grow and I looked really good, all the time I calmed myself and said it would go away”.
[Size=4]“Better to be bald” [/size]
M stopped taking the drug two and a half ago, but says he still could not recover from side effects. "I live in a nightmare, I lost everything I had. I can not tell you I never thought about suicide several times. I do not know what will happen to me in the future, but if I can make people think twice before they take the drug - so I think I did mine. "
Dr. Michael Irwig, principal investigator and endocrinologist at George Washington University in the U.S., argues that many who suffer from these symptoms. “Until my research and its partners was generally assumed that all side effects that the company declares them disappear with the end use of the drug. Study we found that they persist long beyond the moment when the patients stopped taking the drug, also five and ten years, which makes think that the side effects can be fixed” .
What makes you think Propecia is why the side effects?
“In trying to deny anyone else. All participants were completely healthy, they were not suffering from hypertension, diabetes, sexual or psychological problems.”
How do you explain the differences in the rate of side effects with the drug maker’s research and your research?
"Merck Research published in 1998 Journal of the American Academy of Dermatology, and since the results showed less than two percent of participants with adverse sexual side effects, they are not kept track of those participants to see if the symptoms do disappear. The only way to assess with certainty the number of people adverse events did not go away is to follow all the people who take Propecia. Unfortunately, no one did. drug has become so popular, so even if only a small percentage suffer from side effects, it is still a huge number of victims. "
How the company responded to the results of your research?
“My research was published in June 2011, and at that time were a large number of lawsuits against Merck in the U.S. and Canada, so they did not respond to the study and did not contact me”.
Suicides were after the drug?
“Some users actually suffer from depression to suicide, and all that a drug intended to prevent dropouts. My recommendation to people is to learn to live with baldness - It’s better than who will suffer from sexual dysfunction to permanently”.
[Size=4]Three years after Europe[/size]
Only in September 2011, three years after the warning on side effects was published in Europe and three months after it was published in the U.S., the warning was published in the PI. Now displays the following text: "In general usage, side effects were reported rarely, ejaculation problems , testicular pain, difficulty reaching an erection that lasts even after cessation of drug use, male infertility and / or poor sperm quality. Sperm quality improvement after discontinuation reported. In rare cases, breast cancer in men ".
II do not understand why it took three years before anyone bothered to warn the Israeli consumer public. “I submitted my application a claim only in 2010. If I knew that already in 2008, people have reported such side effects, I was away from the drug and not touching it. I believe that many would have done so”. In A, Student center of the country, side effects were reflected in terrible pain in the testicles and decreased libido. “At that time I worked a little in the modeling and the outlook was very important to me,” he explains. "When I saw I begin to form bays indicate the onset of baldness, I decided to take Propecia. Four months after the introduction of unbearable pain began testicles. Doctors did not know the pain Propecia tie, but when I stopped taking the pills because I went abroad for three weeks, the pain ceased . After several months I was tempted to take the pills again, and the pain returned. Today, a year after I stopped, still not fully functioning. "
Also in p (34) a similar story. He married at 27 and his wife became pregnant. A few months later started taking Propecia to stop suffering from dropping out. Trying to conceive for the second child, their luck was not very fortunate, which led them to undergo extensive testing to find the problem. “At first I sent my wife for tests, because I did not believe that I have a problem. After her tests were normal, I checked myself, then I realized the problem for me.”
And why did you think this is because the profession?
"At first I did not know. Only after the doctor tried to ask me what has changed in recent years, I told him I was taking Propecia, and he immediately told me to stop, because this could be the cause of the problem of productivity. According to the doctor, not possible that a sperm count so low that my wife got pregnant For the first time, then the profession has changed everything. I was a sexually active, and I lost my sex drive. life without sex leaving you empty inside as if they turned me something inside. my wife began to undergo fertility treatment and goes through hell, all because of my mistake. If only I knew, if only someone had warned me, I would not touch this thing. I see the advertisement of ‘skeptics’ runs all night on TV, and I’m furious. time has come for someone to tell the truth about this drug. "
[Size=4]Not withhold information [/size]
Mr. Ovadia Gabbay, applicant class action lawsuit, saying that their discovery of side effects is damage to the right of the public to know. "I would expect from MSD, a huge and respected, not to hide such an important information on side effects. When a person decides to smoke, he knows cigarettes can lead to lung cancer. Written warning on the box. So why side effects of Propecia, already known in other countries, are not reported? Why the information contained in the information that appears different doctors PI? "
According to attorney Michael Dvorin, an associate of Mr. Gabay lawsuit, producer herself admitted in answer to a claim that infertility was observed in men taking finasteride. “It had to be explained and declared, and the company would disclose the information public as soon as he learned it.”
Merck, Sharp and Dohm is considered one of the world’s largest drug companies, and branches spread across some 120 countries. The company defines itself as a global pharmaceutical company focused on research, and it manufactures and markets a wide range of drugs, including human papilloma virus vaccine, which causes cervical cancer. Dismay of many skeptics emerged Propecia, the drug can be found quite a few supporters, who argue that it fulfills what was promised in advertisements, without side effects. C (34) using Propecia for over three years to day basis - daily, and very pleased with the results. He said he did not have a lack of libido and fertility issue not examined. “I’m still not married, so I have no idea what my sperm quality,” he admits, “but I can tell you that many of my friends use Propecia, some have small children, or hear them on this or that problem”.
You’re not scared by reports of users for damaging fertility?
"Before I started taking the medication, my doctor informed me about the side effects associated with decreased libido. Did not know about fertility problems until recently. Present state of my hair so well, I do not think I’ll stop. According to the reports of the company, a one percent suffer symptoms. So I hope I do not this percentage, if so, I’m sure today’s medicine had have solutions. "
Also D does not understand the fuss. Use this medicine for a year and not felt or experienced any side effects. On the other hand, also did not stop hair loss. “Apart from the damage to my bank account, have not seen any improvement restoration, and I had no side effects. So finally I decided to stop and come to terms with hair loss.”
[Size=4]“The company must publish side effects” [/size]
Dr. Alex Ginzburg, a dermatologist and director of the Hair Transplant Unit Sheba Medical Center Tel Hashomer, not thrilled by all the studies and changes in the company’s brochures. Experience, he says, teaches a very effective drug and there is no fear using it.
"Changing the leaflets is routine, and soon received reports of adverse events or other such, the company must publish them in the PI sheet. Medicine, clinical studies that determine, not personal experience and reports of users who tested. I distribute thousands of prescriptions propecia and taking care of her for more than than 12 years, and I can say that it completely safe to use. Over the years I’ve come across maybe five people who reported decreased libido. Nobody told me his fertility after the drug hit. What is - after the use of five years, has down 20 percent efficacy. "
Prof. Motti Ravid, a specialist in internal medicine at the University of Tel Aviv Medical Center and director of “Maayanei salvation”, do not understand why young people take the risk. “When I give a chemical treatment to a person with cancer, I realize that the treatment of serious side effects, but I’m taking into account that without treatment the patient will die,” says Ravid. “But when you take medicine to prevent hair loss, improper and inappropriate risk risk young people”.
[Size=4]Comments:[/size]
Merck said in response: "Propecia is a drug approved by the Ministry of Health for dealing with baldness male. Safety and efficacy have been demonstrated, it is logged by doctors and used by millions of men worldwide for more than 13 years. Propecia is by prescription physician and patient terms read the leaflet drug whole carefully before using this medication. PI sheet set from the start that in addition to the desired effect of the drug, may appear side-effects, and that clinical trials of Propecia, a small number of men experienced side effects certain sexual. side these effects in men who stopped taking passed Propecia and disappeared in most men who continued taking Propecia.
"Drug bulletins are updated periodically as part of an ongoing commitment to monitor Merck drug use phenomena. Latest update newsletter propecia consumer includes, in addition to sexual side effects observed in placebo-controlled clinical studies which addressed the issue from the beginning, a reference to rare spontaneous reports of male infertility and / or quality of sperm Della, from post-marketing drug. This does not mean that the drug causes infertility man. As explained in the brochure to the doctor, after reports spontaneous ones are not reported in clinical trials but voluntarily population size is not known with certainty, is not always possible to estimate reliably the incidence or causal relationship to the drug.
"There are many different factors infertility man. Reports from post-marketing drug has limitations, they do not always contain enough information to evaluate properly the phenomenon. Are obtained directly from health professionals (doctors, pharmacists, nurses and others) and consumers (patients, family of patients, lawyers and others). there is no certainty that the phenomenon reported actually occurred because of the drug, and in general, the effects reported spontaneously may be caused by disease background, a genetic condition, medicine, medicines, parallel, or events background that may occur simultaneously in any population. many factors may affect whether or not the reported event, such as duration of product marketing and publicity about the phenomenon. therefore, can not use these reports to calculate the incidence of side effects in the population.
"The product is longer than the market in various countries around the world, the greater the number of specific regulatory examination conducted in each country. Sometimes these assessments lead lingual leaflets, ie, there may be added the adverse events reported spontaneously by a specific bulletin, at the request of the regulatory authority state. with time, if more than a few types of these changes are made to specific countries, you may want to make harmonization of leaflets globally and update the leaflets accordingly. Merck is working in full cooperation with the Ministry of Health and maintains all requirements of the law and regulations. "
Ministry of Health spokesperson said: "According to existing regulation, with the registration of drugs bound to inform the ministry about any serious side effects, were brought to their attention in patients in Israel. Companies also serve periodic updates to the information accumulated from the world and update the leaflets as required. With the registry must notify the office Health on anything related to the drug that was not known when you register, including reports of unusual side effects, warnings and so on. also doctors, pharmacists and public patients report side effects from drugs. "