FDA responds to the Citizen Petition of the Post-Finasteride Syndrome Foundation

[SSRIsAreEvil]

The FDA’s response is very disappointing and they are taking a much weaker position than the European Medicines Agency in regard to requiring warnings for Finasteride. You can read the article below but these two sentences capture pretty much everything; “In a response this week, the FDA said the group’s petition “does not provide reasonable evidence” of a causal link between Propecia and persistent sexual problems, depression or suicide. However, based on patient reports, the FDA said it is “requiring the addition of suicidal ideation and behavior” to the adverse reactions listed on Propecia’s label.”

I think that now would be a good opportunity to get media coverage for PFS. Most mainstream media will probably ignore this story, but some doctors and journalists who are skeptical of big pharma might be willing to criticize the FDA.

FDA requires disclosure of suicide risk for anti-baldness drug

[mstone]

for the first time required patient notification about reports of suicidal behavior in men taking the drug.

Swing and a miss.

[overkilled]

Expect this information will end up buried in the “postmarketing reports” section of the FDA label, which next to no pharmacy will bother to reprint. I believe such a change will dissuade very few men.

What’s really required here is a boxed warning, but the odds of the drug receiving one now look even slimmer.

[Erik]

What we ultimately need is more research to demonstrably prove the causation. At that point it won’t be necessary to petition.

[M_C]

@Erik

What we ultimately need is more research to demonstrably prove the causation. At that point it won’t be necessary to petition.

Couldn’t agree more.

I understand why the foundation would be interested in protecting the public from this drug, but I think it’s hard enough for us to finance and coordinate research into the mechanisms of the disease. The disease itself should be the focus – I don’t think we should use our time and energy on doing the regulator’s jobs for them.

[Scotsman]

I’ve not read the FDA’s response to the Foundation’s Citizen Petition beyond this thread, but I have read the petition itself. As others have said, it is clear now the only way to go is in the funding of research which will hopefully help when it comes to the FDA actually giving a damn, although that is only a secondary goal when all everyone wants is a cure. At the same time I am both not surprised yet saddened by this, as from the perspective of someone who explicitly knows of the profound harms that this drug causes, not just personally but in witnessing the painful testimonies of so many others over the years, the petition was excellent in presenting not just the real risks, but the deficiencies and duplicities in its approval. For the FDA to throw all of this out with such an anodyne response speaks volumes, as the case the petition presented wasn’t just factually sound, but also profoundly morally so. I feel so sorry for Dr Santmann and everyone involved in compiling the petition as the response must add to their pain, a bit like someone accused of manslaughter shrugging his shoulders to the family of one of his victims. Fuck it. It’s not a bit like that. It is that exactly.

One thing to say, despite the petition not bearing fruit, it is an excellent document in and of itself and expertly corrals the many deficiencies in the history of finasteride’s approval. A valuable resource.

[Frustrated]

The FDA was really incompetent and negligent in how it reviewed the Citizen Petition. I’m not really sure what to do think about this yet but it surprised me the degree to which a large government bureaucracies can really fuck up basic important tasks. Very disappointing but it is the reality of the challenge this community faces.

[Mark2012]

The FDA are just a front for big pharma who are worse than useless.

If they were even half competent Propecia (at least for hair loss) would have been pulled off the market decades ago.

[Erik]

Yeah it’s not incompetence. It’s corruption.

[Frustrated]

There’s no proof that there was any corruption in this decision but corruption can mean a lot of things. One reason why this community has struggled to gain credibility for so long as it that people make these extreme claims without having any evidence to back it up so it results in self-sabotage.

[Erik]

I didn’t mean overt corruption involving bribery, but it’s quite clear their main interest is not public health and safety. If it were they would have taken this matter much more seriously and acted appropriately. FDA management have a track record of working for big pharmaceutical companies. There isn’t a clear and respected boundary between them which would be necessary for the interests of the public to be safeguarded.

[Greek]

“In 2011, two years after the Merck risk analysis, FDA analysts disagreed about adding a warning related to suicide, but the regulator ultimately agreed with Merck that the number of suicides was lower than one would expect in that group of patients. Since that decision, the FDA has received more than 700 reports of suicide and suicidal thoughts among people taking versions of the drug.”

If the fda banned every drug that got 700 reports of side effects you’d probably not be able to buy a cough syrup.

I assume someone at Reuters is very much on our side and thank God they are, because we need all the help we can get.

I have to say that as a community we need to normalise reporting symptoms.

[LazarusRy]

@Greek

have to say that as a community we need to normalise reporting symptoms.

So much under reporting its ridiculous. Sufferers complain on here continuously yet not many report their symptoms. it should be a pre requisute to being a member of this group.

[Wintermoon]

I think the problem with ‘suicidal thoughts’ and especially ‘suicide’ is that the people who really suffer from those things are struggling to survive, and less likely to report they’re going through those things. Obviously someone who committed suicide is dependent on loved ones for reports.
Also I think if you would look at the numbers of ‘depression’ or ‘severe depression’ being reported then it would probably be much higher than 700 cases, when those symptoms are just as likely to result in eventual suicide or suicidal thoughts.

It is a skewed and sneaky way of making the problem less prominent than it is, imho.

[Erik]

Another thing is that suicidal thoughts obscures the issue, making it sound like some sort of abstract voice in one’s head. If they said suicidal thoughts resulting from severe multisystemic endocrine disruption one would have a clear and accurate view of what’s at stake.

[Cbrandel]

Rather than seeing it as a loss, we should see it as a small victory in my opinion.

Let’s be honest, FDA pulling it off the market without any hard evidence was never going to happen. Best case scenario they would put a black box warning, like the one on Accutane.

I’m sure we all wanted “more” but a little is more than nothing. Even with baby steps we will reach the destination given enough time.

[mstone]

Bingo. Two articles have been posted now about this decision and both perpetuate the already publicized notion that simply ingesting Propecia can hypnotize weak-minded fools into killing themselves while continuing to ignore the catastrophic post-drug condition that forces victims down that path.

Every instance of missing the point is a step in the wrong direction IMO and all this does is formalize one very big missed point.

[Exsexgod]

Pharma rent boys!! But our life’s are violated against our will!!

I’ll once commit suicide because of complete Lobotomization and chemical castration from finasteride. I was a very healthy man before I took finasteride and I had enjoyed my life!!

So FDAs and other regular agencies I wish once you’ll or your sons get PFS, than you stopp denying this inhuman biohazard and it’s suicidal side effects.

[SSRIsAreEvil]

The FDA seems totally inconsistent in their standards for pulling products off the market. In the case of Finasteride, they claim that there isn’t reasonable evidence of a causal link between Propecia and persistent sexual problems, but they recently decided to pull Juul e-cigarettes off the market because there isn’t evidence that they are safe. Seriously, look at this article.

"The FDA acknowledged that it “has not received clinical information to suggest an immediate hazard associated” with the use of Juul’s devices or pods, but said the agency issued its marketing denial orders (MDOs) against the company because “there is insufficient evidence to assess the potential toxicological risks” of using the products.``

FDA bans Juul e-cigarette products

[mstone]

The FDA, in its press release, directed smokers who want to quit to consider using other e-cigarette products the agency has authorized for use, such as R.J. Reynolds’ Vuse projects.

WOW. Unless they’re prepared to say what R.J. Reynolds provided that Juul hasn’t, I think it’s safe to assume what R.J. Reynolds provided that Juul hasn’t.