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:
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.