Write to the inventors of Finasteride

There is a great article in Vice telling the story of the invention of Finasteride.

Julianne Imperato-McGinley was the scientist who first discovered the role of 5-alpha-reductase in male development, as lack of the enzyme was found to result in pseudo-hermaphroditism. Her discovery was picked up by Dr. Roy Vagelos, head of research at Merck, to develop Finasteride. Vagelos eventually became Merck’s CEO and lead the company until 1994. Proscar was released in 1991.

In 2017, Vagelos donated $250 million to Columbia University’s College of Physicians and Surgeons, which was renamed Roy and Diana Vagelos College of Physicians and Surgeons.

I couldn’t find a way to contact Dr. Roy Vagelos, but Dr. Imperato-McGinley’s contact information can be found at her academic website:

http://vivo.med.cornell.edu/display/cwid-jimperat

The website touts Dr. Imperato-McGinley’s contribution to the development of Finasteride:

“A clinical and translational researcher with over 30 years of NIH funding Dr. Imperato-McGinley first published her landmark paper in Science in 1974. She defined a previously unrecognized clinical disorder - inherited 5α-reductase deficiency. Eventually the clinical implications of her research were translated into treatment of human disease and led to the development of the first medical therapy (finasteride) for prostate enlargement, and subsequently, for the treatment of male-pattern baldness.”

Dr. Imperato-McGinley has authored numerous articles on finasteride. One of her co-authored articles, titled Long-term (7 to 8-year) experience with finasteride in men with benign prostatic hyperplasia, concluded that “Long-term finasteride treatment was safe and generally well tolerated.”

Now, the question is, if a sufferer of PFS were to write to Dr. Imperato-McGinley, what would they say?

4 Likes

Dr. Roy Vagelos discusses a loss in confidence in the pharmaceutical industry.

1 Like

Imperato McGinley is aware of Post Finasteride Syndrome. She was subpoenaed by the courts for the Propecia litigation and so dismissive to the point that the courts threatened to hold her in contempt. I don’t remember exactly what she refused to do or what she ignored since it has been awhile. It is my opinion that she sold her soul to the pharmaceutical industry and should have known there would be serious risks to inhibiting 5AR based on the pseudohermaphrodites she studied in the Carribbean. I wouldn’t expect her to answer any emails from PFS patients.

Vagelos is much more ethical in my opinion. You have to keep in mind that during his time finasteride was only approved for BPH in older men which makes much more sense than for hairloss in young men. He has publicly spoken out about his disappointment in what Merck had become after he left the company. He was asked about the Vioxx scandal in the book All the Justice Money Can Buy of which he had no role. You’d have to expect he would be more defensive about a drug that was developed under his watch but he is aware that Merck developed problems later on.

5 Likes

Those f… just wanted to find something to destroy men. And BHP and hairloss is just camouflage. M.wanted to give fin even to teenagers. I dont need to tell you what I think about M. and Vangelos. They knew exactely what a dht reduction (the! male hormon) would mean. Nobody of those are taking it. Neither do docs.

This man should go into jail. What a liar.

2 Likes

I think they just wanted to make money and they were willing to do whatever it took, including destroy men, as is customary for pharma companies. It is the same old rape, pillage and murder behavior of the past but in a modern, more sophisticated form. If they can get away with it, they would do anything to steal your money, even at the cost of your life. This is what I find most abhorrent - that they don’t take into account in their cost/benefit calculus the damage they would do to other people, only the risks to themselves. If they can get one dollar from a person and kill the person, but nobody finds out - they would not hesitate to do it for one second. It is easy to vilify just the pharma companies for doing that but I am afraid the same is true in all industries and for most people. That’s our species.

1 Like

It is not just our species. But one thing is right: everybody will die one day.

I doubt Vagelos is in anyway ethical.

You have to a be a sociopath to get to the top of the pharmaceutical industry.

2 Likes

What actually happened with this whole Propecia debacle is more nuanced than “everybody at Merck is evil”. There were specific actors that hid information from the public, the FDA, and their supervisors at Merck just like in virtually any corporate scandal. Sometimes it originates at the very top of the organization, but in this case it is less clear what happened since finasteride had already been approved by the FDA. It wasn’t until finasteride was tested in younger men that the risks of permanent side effects became more apparent.

Remember it was Ray Gilmartin and not Vagelos who was running Merck when both Vioxx and Propecia were submitted to the FDA. Hopefully, we’ll one day be able to publicly name and shame the individuals directly accountable for deceiving patients, doctors, and the FDA about the risks of this drug.

2 Likes

All of them knew what reducing of dht levels means. Showed in the studies of those pseudohermaphrodites. Nobody of them would have taken that shit. Nobody did.

1 Like

Why is the world still so evil? I always wanted a family and thought most people are good. Now i dont want kids anymore and my trust in humanity is gone. Humanity killed me.

2 Likes

If you give up now you’ll never be better, have faith brother, there are many good people on this earth, just hang in there.

1 Like

Stay strong Darkparadise. Go to a good psycholoog. You’re at your deepest now and things will get better. Also trust there will be things you don’t imagine by now.

What happened in this Propecia debacle is not nuanced at all. Merck has an obligation - legal and ethical - to ensure that their medicines are safe, starting from the day they conceive of a possible new drug. In the case of finasteride, Merck decided to block the major androgen in the male body claiming in their FDA submission that “DHT has no known function in the adult male”. You don’t have to be a PhD in endocrinology to know this is absurd, and they have many many many of those on their research teams.

Before Finasteride started to be tested on humans it underwent extensive animal testing. All animal studies showed without any doubt that male mammalian sexual function critically depends on DHT, including for maintenance of tissue. For more details about these studies, read Prof. Traish review here:

Another researcher, Prof. Belknap has stated publicly that Merck should have foreseen the problems of Finasteride. Let me quote from the Vice article I posted earlier in this thread:

<<In 2015, a review in JAMA Dermatology called into question whether Propecia should have been approved in the first place. Of the 34 clinical trials looking at it for hair loss, “none” adequately assessed safety, the authors said. More than half were funded by pharmaceutical companies. “You are giving a drug that is replicating this pseudo-hermaphrodite pattern of sex steroids in the blood,” explains Steven Belknap, a dermatology professor at Northwestern University Feinberg School of Medicine and the lead author of the study. "Long before this drug was approved, you could have anticipated that sexual dysfunction was potentially a problem. Here we have a drug that you are giving to men for long durations purely for a cosmetic purpose and, after 20 years, we have no evidence it’s safe.>>

One of the top PFS researchers whom I won’t name here has shared with me in private correspondence the following opinion:

“The medical research enterprise has let you down and that is shameful. It seems inconceivable to me that the researchers who developed finasteride and dutasteride were unaware that these drugs would cause severe sexual adverse effects in some men. After all, if finasteride and dutasteride shrink the prostate, one would expect these drugs to shrink other important sexual organs as well.”

Yet, despite years and decades of mounting evidence (evidence that Merck itself should have been collecting because they are obligated under law to conduct post marketing monitoring of their drugs) Merck continues to this date to DENY that PFS exists. I believe they refer to it - if they utter the words at all - as “the so called Post Finasteride Syndrome”.

Here is an article from 2012, where there is a statement from Merck:

<<In a statement, Merck said no evidence has proved a causal relationship between Propecia and long-lasting sexual dysfunction.

A spokesman said: 'Merck believes that PROPECIA (finasteride) has demonstrated safety and efficacy profiles and that the product labeling appropriately describes the benefits and risks of the drug to help inform prescribing.

‘A causal relationship between the use of PROPECIA and continued sexual dysfunction after discontinuation of treatment has not been established. We encourage patients to talk with their doctor if they have any questions or concerns about their health, or about PROPECIA.’>>

Their most recent statement, which I believe still stands, is the following:

“Nothing is more important to Merck than the safety of our medicines and the people who use them. Merck stands behind the demonstrated safety and efficacy profile of PROPECIA (finasteride), which has been prescribed to millions of men since its FDA approval in the U.S. in 1997. Merck conducted well-designed clinical trials on the product and stands behind the results, which were reported to the FDA and regulatory agencies around the world.”

Everybody at Merck is guilty - their executives, their PR department, their researchers, their sales reps, and frankly everybody who works there in any role. They are guilty now and they have been guilty from the the first day they conceived of Finasteride in the 1980s.

Finasteride is a modern-day thalidomide and one day it will be the textbook case for iatrogenic harm, corruption, and corporate greed.

4 Likes

Very interesting your post! As I said, they knew it before. BHP and Hairloss is Camouflage. DHT is very important - also for the mental part. People do not realize that. M.is lying. Period.

1 Like

Side Effects: The Case of Propecia

Selling Propecia was a difficult marketing task for Merck & Co., and was recently the subject of a case study debated by Harvard Business School alumni.
by Sean Silverthorne

You are the marketing director of Propecia, a new drug for hair restoration that’s about to hit the market. But the drug can only be purchased via a physician’s prescription. So do you advertise directly to balding men? Do you concentrate on targeting physicians? How about attempting to influence the wives or barbers of balding men?

All these issues and more faced Tom Casola, who in 1997 was heading the Propecia marketing effort for the drug maker Merck & Co. The case was discussed by audience members at the 5th Annual Alumni Healthcare Conference on November 6, 2004; HBS assistant professor Marta Wosinska led the conversation.

The Propecia launch came at a time of regulatory change, which made advertising of prescription drugs to consumers more feasible. But Casola had to consider three limitations on such advertising:

  1. A “product claim” ad could mention both the brand name of the drug and the problem it could correct, but would also have to include a list of major side effects. Trying to put side effects into context in a 30-second TV spot was next to impossible.
  2. “Reminder” ads could mention the brand of the drug, but not mention what the drug was for.
  3. “Help-seeking” ads allowed for un-branded ads that would encourage men to seek a doctor’s advice if they were concerned about hair loss.

In addition to marketing directly to consumers, Casola would also consider strategies for Merck’s more traditional marketing channel of selling direct to physicians, using the company’s army of field representatives. The problem of so-called “detailing” to physicians was that the sales reps have literally a few minutes or even seconds to pitch directly to the doctor, and are selling three Merck drugs at a time.

Direct To Consumers

Given the Food and Drug Administration’s advertising restrictions, what kind of advertising should Merck pursue, Wosinska asked the audience: product claim, reminder, or help-seeking?

Most attendees thought the product claim approach was the way to go, creating a strong brand awareness motivation for consumers to approach their doctors for a prescription. After all, it was not likely the doctor on his or her own would bring up the subject of hair loss with a patient. “Hair loss is not a disease, but you need to make it a credible condition for the physician,” one audience member said. Physicians could be enticed with promises of increased business.

Another advantage to the product claim route: Merck could boast greater success with patients than its chief drug competitor in the market, Rogaine.

One audience member noted that up to 40 million men in the U.S. have male pattern baldness, but only 2.5 million had used Rogaine at that time, leaving a large market to be addressed. “My approach would be, ‘If you have never tried [a hair replacement drug] before, here is your first step.’”

But several speakers thought the requirement to include side effects in product claim ads—in Propecia’s case, a less than 2 percent possibility of sexual dysfunction—was too big a turnoff to address in a 30- or 60-second ad.

Another dilemma facing Merck was the fact that patients most likely to be helped by the drug were men just starting to lose their hair—and the greater the hair loss, the less effective the drug. The problem for Merck, Wosinska said, was that this group was not likely to realize they have a problem. They are only compelled to action after the hair loss is obvious. So the consumer most likely to buy the product would see fewer benefits.

Thus, a marketing plan to go after “trusted advisers,” namely wives and hair stylists who can see problems early on, could be an option. “It’s a waste of time to try and get men to go to their doctors,” one female audience member said. Instead, Merck should target wives. “Women are the healthcare managers” in families, she said.

The Doctor Is In

And if a balding man could be persuaded to pay a visit to the physician’s office, would the doctor necessarily write a prescription? Doctors are comfortable treating medical conditions, not vanity problems, said Wosinska. How could Merck convince doctors to support Propecia?

One audience member said Merck has to sell the efficacy of the drug to physicians; doctors have to believe it’s going to regrow hair and that the potential side effects are small, he said.

Hair loss is not a disease, but you need to make it a credible condition for the physician.

But there was disagreement with that tactic. The goal should be to create brand awareness with men and get them into a doctor’s office. “Seventy to 80 percent of physicians will write a prescription if a drug is requested by name by the patient, unless there are overriding health concerns,” said an audience participant.

Is a doctor really going to write a prescription for something as medically non-serious as hair loss if there is a chance, admittedly a small one, of sexual side effects?

Propecia Hits The Market

So what did Merck in fact do? Its consumer ads did pursue a product claim strategy, risking the question of side effects in favor of attempting to convince men that they had a problem and Propecia was the answer.

Wosinska said that even before marketing began, the drug had high ambient awareness—35 percent. And by the end of the first year there was a “staggering” 90 percent brand awareness, she said. The problem: some of that awareness was driven by the much-publicized side effects issue. It was difficult for the drug maker to convey the true risk information necessary to blunt the side effects buzz.

The company did not go after hair stylists or wives, believing such campaigns would not be cost effective. As Wosinska put the problem: “How does a pharma talk to barbers?”

In the end, first-year sales beat internal estimates, thanks to pent-up demand. Propecia is now a $250 million brand: It is a good number, but lower than expected by the company, Wosinska said.

As to the question of whether direct-to-consumer advertising (DTCA) ultimately works to sell prescription drugs, Wosinska said studies indicate it creates market growth for all players, but not much market share improvement for any particular company. To do that, detailing is 5 percent to 7 percent more effective in driving share growth, she said.

And what about that claim that 75 percent of doctors will write a prescription if the patient asks for it by name? “Not really,” Wosinska said. DTCA creates drug awareness in physicians as well as patients, so doctors are probably already aware of the drug by the time a patient comes into the office. There is a correlation, not a causation, Wosinska said.

1 Like

@Darkparadise, who has commented on this thread, has not logged in in 11 months. Before that he has talked about suicide on multiple occasions. Has anyone been in touch with him in private or outside of the forum?

1 Like

If his last sign in is indicative of that being what’s happened, he only gave himself 5 months from developing PFS before killing himself. A strong reminder that we must all look out for each other.

I sincerely hope he’s out there and doing better, if anyone has any contact with him, please ask him to check in.

6 Likes

I have known him personally. Hes very close to me. He is now at a better place !

3 Likes