2018-05-25 10:35:272018-05-23 08:33:20Reddit Reader Puts Together Side Effects from Drugs Used for Hair Loss
Reddit readers post his views on the action of Merck in hiding information about post Finasteride Syndrome
You mentioned that you were confused by the Reuters article so I thought it would be worthwhile to send you some of the highlights to break it down. These are all based on objective facts that can be verified in the documents.
When you look at the current Propecia label, Merck discusses the sexual side effects from their original clinical trials and reports that “Resolution occurred in men who discontinued therapy with Propecia”. Seems simple enough. You’d think from reading this text that Merck found no evidence of PFS in their clinical trials. This language has been in Merck’s label from 2002 onward.
However, if you go all the way back to their 2001 label, the label says “Resolution occurred in all men who discontinued therapy with Propecia”. If you read this one, you’d also assume that Merck did not have subjects develop PFS during the trials.
But why is this interesting? If you look closely, you’ll see Merck took the word ALL out of the label all the way back in 2002. But why did they change the language?
Fortunately, we have an accidentally unsealed deposition with Charlotte Merritt, the Merck woman who oversaw regulatory activity related to Propecia so we can see what her answer is on page 52.
Some paraphrasing to get to the point…
Q: So the word “all” has been removed in this label… why is that? A: Well, as you saw, there were some men in whom after some period of time the AEs did not resolve so this is — so the word “all” was no longer factual as it relates to the longer term data beyond the initial period of the trial.
Q: There was nothing that prevented Merck, which as we agreed is responsible at all times for its label, from putting into this 2002 label that it now had information for over a year, at least as early as November 2000, about the lack of resolution upon discontinuation in some patients in the clinical data, right? A: Merck didn’t feel at the time that that was something that needed to be put in the label. FDA apparently agreed. This is the label that was, you know, the results of that submission and we can’t comment any further.
Later on there is a reference to the “Ruane memo” that was sent to top Merck executives that discussed the details about what they knew about persisting adverse events and what they were going to do about it. This memo still remains under seal but Reuters has done some great investigative work and has filed to have it unsealed for the sake of public safety. The law says that these documents should never be filed under seal except for very narrow exceptions and public embarrassment to a company does not fall into that category.
If you look more deeply in the documents which I suggest you do, you’ll see they had gathered internal market research that showed 50% of potential customers who were aware of REVERSIBLE side effects, would be unwilling to take the drug due to that risk. One can only imagine how high that number would go if Merck properly warned about the data they found about irreversible side effects. There are also more detailed descriptions about the test subjects who developed persistent side effects and how they were excluded from what was reported.
I saw you refer to this as “speculative” on your blog today but this is all fact based and verifiable, much of it confirmed by Merck employees. It’s undeniable that Merck had clinical trial subjects that developed persisting sexual AEs since 2000 and never reported this to the public.
I have the link to the full court document below. Merck tried to file this under seal away from the public eye and this is very common feataure of how the legal system operates even though it isn’t supposed to be that way. The Reuters article says that this document was accidentally filed publicly so that is the only reason the public gets to see this information that would have been otherwise buried.
A Second Reader posted this:
https://www.statnews.com/pharmalot/2019/09/12/merck-side-effects-opioids/
I just saw that StatNews reported on the same story last week too. Ed Silverman is another very credible journalist and in fact was a finalist for the Pulitzer for his work on explanatory reporting in the pharmaceutical industry.
If you still are confused, I suggest that you read the two primary source documents from the Reuters article which you may have missed. In fact I believe it is your moral responsibility to do so given many people look to your blog for medical advice about Propecia. The links are below.
The document in the first link was meant to be filed under seal which would have made it hidden from the public. You will see why Merck wanted it sealed after you read it.
The document in the second link was filed publicly but with redactions. You can remove the redactions by copy and pasting those sections into word.
Happy reading 🙂
A Third Reader posted this:
Thomson Reuters is as authoritative and respected as they come. It is one of the two major global news agencies along with AP. They report on the facts and the facts support PFS. You can review the underlying documents that are publicly available on the article.
You can do a quick internet search to see how people rank Reuters and it is always among the most objective, often above agencies like NYTimes, WSJ, CNN, Fox which have some editorializing.
2019-09-20 03:05:042019-09-19 21:16:16Reddit readers post his views on the action of Merck in hiding information about post Finasteride Syndrome
Reddit Reader Comments on a Baldingblog Post
The post he commented on is the following: https://baldingblog.com/new-report-that-finasteride-does-not-cause-sexual-side-effects/
Comment: This survey method is so flawed that its ‘findings’ are not just unhelpful, but actually misleading. It’s really quite simple actually.
They just surveyed a bunch of guys who had been taking Propecia for hair loss and compared it to presumably random guys who were not on Propecia. If you develop side effects from Propecia, which often happens fairly early on, you are going to stop the drug quickly. 85% of the guys surveyed had taken Propecia > 12 months so you can be sure they didn’t have side effects. Even the other 15% would have likely filtered out most of the guys with side effects.
That’s why the authors erroneously conclude finasteride use resulted in no connection to sexual dysfunction. Their own data doesn’t even show that. Their data shows the finasteride group had a lower incidence of sexual dysfunction but that is only after you naturally exclude people who quit due to side effects. To say this study is controversial would be to give it way too much credit. It’s just flawed.
2020-01-13 04:00:122019-11-05 10:13:16Reddit Reader Comments on a Baldingblog Post
Reddit poster comments that there is no direction connection between Creatine and Hairloss
First, it’s not a study directly correlating creatine and hair loss. You’re assuming that the findings of the difference in DHT: T ratio and the increased DHT value from creatine consumption means it will lead to hair loss. Also, there’s been several other studies (listed below) showing that creatine doesn’t affect testosterone levels, and with DHT being a metabolite of testosterone, it’s doubtful it would cause an increase in DHT. Another factor to consider is that strength training has been correlated with increasing testosterone
Steroids in creatine? Why? What benefit does a supplement company gain from mislabeling? They have more to lose by incorrectly labeling a product. Oral steroids have been shown to be dangerous on the liver. Also, creatine would be more costly if steroids were placed into the product.
Here are the others studies showing that testosterone does not get affected with creatine consumption:
https://www.ncbi.nlm.nih.gov/pubmed/24633488
https://www.ncbi.nlm.nih.gov/pubmed/21324203
https://www.ncbi.nlm.nih.gov/pubmed/12945829
https://www.ncbi.nlm.nih.gov/pubmed/19741313
https://www.ncbi.nlm.nih.gov/pubmed/17136944
2019-12-02 08:22:352019-12-02 08:22:35Reddit poster comments that there is no direction connection between Creatine and Hairloss
Reddit Post: Homeless man with lots of hair
When the homeless drug addict who eats rat droppings and dumpster meat has a nw0 and no hair loss and you gotta take pharmaceuticals and rub growth juice in your head every night and live in a clean room and he lives under a subway from tressless
Everyone always talks about homeless men with lots of hair, but homeless men with lots of hair are a subset of the population and these same men exist everywhere. You are lucky because you didn’t inherit the balding genes.
2020-11-20 01:28:032020-11-19 11:33:58Reddit Post: Homeless man with lots of hair
I have had red spots on my hairline for 3 months, what should I do
Of course my answer would always be to go back to see your doctor. These red spots are suggestive of some type of inflammatory process or infection.
Red spots after transplant
I have been touching and scratching my recipient area for the past month since the transplant was done. Should I worry about these red dots?
Red dots can be folliculitis which follows touching and/or scratching the recipient area. You need to see your surgeon, as folliculitis can kill the grafts
I Have Red Scalp After My Hair Transplant, Is It Infected? (Photo)
Some people develop a pink color due to their skin type, if they have histamine positive skin. I usually find out ahead of time by having the patient use their fingernail to scratch their forehead. If it turns pink in the first few minutes, I tell the patient that he or she will have a pink wound after the surgery, as you seem to show. If you are worried about having an infection, go back and see your doctor. However, if this is just a histamine response, it will resolve in time (sometimes it takes weeks or in a few patients, a few months). Going back to your doctor is your best bet.
What Are These Red Marks on My Skin After My Hair Transplant?
These are scabs (crusts) from the recipient site grafts. They should have been washed off within the first day and the following day after the surgery.
Now, you must wait 12 days to remove them. You should leave shampoo on the area for 10 minutes then gently rub it with your fingertips. As the scabs loosen, they will come off slowly. Repeat this twice a day until they come off. Don’t pick them off.
2018-11-12 06:53:222018-11-01 06:46:05What Are These Red Marks on My Skin After My Hair Transplant?
Recurring Hair Loss That Starts as a Pimple at the Hairline
Hi Doc
I have been having recurrent hair loss since i was 18 (now 23). It starts with a pimple which doesn’t itch but the area is tender with fine hairs at the bottom of my head also around the hairline.
Infected cysts can cause hair loss (sometimes temporary and sometimes permanent). Your history is too sketchy to make much sense out of it for me. You need to have a doctor examine these ‘pimples’ to see if this is acne or something else.
2007-02-28 08:35:172007-02-27 10:58:01Recurring Hair Loss That Starts as a Pimple at the Hairline