Congress To Probe Vytorin Chatter On CafePharma
As early as last spring, there was scuttlebutt about the controversial Vytorin data - the bet-the-franchise study that failed to find any statistical advantage over the much cheaper Zocor in reducing arterial plaque. The results were delayed for nearly two years while the primary endpoint was briefly changed by Merck and Schering-Plough without consulting the lead investigator.
Meanwhile, Vytorin and Zetia (which, along with Zocor comprise the Vytorin combo therapy) were heavily promoted. And concerns that Schering-Plough execs sold lots of stock last year have sparked investigations by Congress and two state attorneys general. This has all led to the ‘Who knew what and when?’ line of skepticism toward Schering-Plough and Merck, its Vytorin joint venture partner.
The drugmakers have repeatedly argued its execs knew nothing of the results until early last month, going so far as to release a chronology, but skepticism remains that the results were rumbling around months ago among untold numbers of people in and out of the drugmakers’ buildings. In fact, all sorts of interesting remarks appeared months ago on Cafe Pharma, the site where detailers love to dish (look here for the examples).
And so the House Energy & Commerce Committee is adding these intriguing CafePharma threads to its widening investigation into the handling of the Vytorin trial and the marketing of the cholesterol med. A letter was sent to the drugmakers asking whether the posts were investigated and for all records relating to the gossipy web site, along with another letter raising questions about the chronology and seeking still more trial records. And this letter went to the FDA in search of the statistical analysis and other trial-related data.
The committee also wants CafePharma to turn over names, addresses, phone numbers, and e-mail and Internet provider addresses of anyone who posted about the Vytorin Enhance trial, which should cause a ruckus on the site where most everyone remains anonymous. However, the letter seems to give the web site an out if its policy is not to disclose such information.
UPDATE: We neglected to mention that the CafePharma chatter was first reported by BrandweekNRX (we did mention the site the first time around, though).
Dan
The smarter ones who wish to post something questionable on CafePharma have been known to post from providers at such places as public libraries so it is not directly traceable.
Justice in Michigan
The letter is a bit incoherent - if info not available, what is policy, etc.
I find the request inappropriate. But it leads to the inevitable question for Ed and posting here.
Ed, if you received such a request from the same folks, would you provide the information requested?
Sorry to put you on the spot, but I think it’s important for people who post here.
Justice in Michigan
BTW, I can see the argument in both directions, particularly re: a direct request from Congress. If it seems wisest not to answer in this context, I can understand that too.
Janet
I also find the request inappropriate. Perhaps a better option would be to provide contact information so people willing to share information on a confidential basis could come forward voluntarily.
Insider
I agree with Janet.
Whistleblowers should be encouraged to come forward.
The recent Merck case should help! ;-)
Pip pip!
Justice in Michigan
Agree with above, but there is a difference between being a whistleblower and sharing bits of things overheard, etc.. The bar for success as a whistleblower is much higher, and the act much riskier (even if potential reward is there).
The majority of whistleblowers now do so anonymously - perhaps not ideal, but understandable.
Ed Silverman
Hi Justice,
To answer your question about providing info about the folks who post comments here, the short answer is I’m not interested in passing that along to anyone. And I would resist.
Hope that helps,
ed
Justice in Michigan
Thanks, Ed. That helps and is appreciated.
I think everyone understands that life does not come with “firewalls” (kinda like “all drugs have dangers”) so that discretion often advisable, and our responsibility, too. Even more, truth!
Peter Rost
And, let’s not forget who first reported about the CafePharma posts . . . BrandweekNRX.
And who first reported the suspicious Schering-Plough insider trading . . . BrandweekNRX.
Digging for the truth. Every day. BrandweekNRX.
Pharma Boy
Cafe Pharma is really more entertainment than fact. Its a online place where people who work outside an traditional office environment (e.g. pharma sales reps) get to gather around a virtual water cooler and bitch. I am sure that this is very therapeutic for them. Like any message board a great deal of the things that are said are untrue, unprofessional and outlandish. That the govt. would think this could be a credible source of information is humorous at best. While I appreciate that its an election year and dumping on big pharma is fun and all…I hope that the off color musings of sales reps of cafe pharma are taken as gossip written on a virtual bathroom wall.
Justice in Michigan
Pharma Boy - I’m not thrilled about going after people’s identities. But when the writing on the bathroom wall appears to point fairly specifically to facts that the folks who own the bathroom have formally denied (over and over) knowing… it is hard to see the “humor.”
Pharma Boy
Justice:
Cafe Pharma is not owned by a pharma company; it is not their bathroom to police.
Some things to think about here; from a precedent view
Do allegations (or even observation) of sexual harassment within pharma companies that appear within Cafe Pharma get investigated by the govt? How about the pharma companies?
What happens when false data or rumor is posted and it comes out that it comes from a competitive company posting as someone else. Who gets sued now? Who is at fault?
What happens when people complain about the meds they take online in other forums and say things like taking drug X turned my hair purple; is this an adverse event and should be observed by the pharma company and reported to the FDA? Should the FDA be skimming all of the web for this information? Should the ‘Health’ Media?
This whole thing makes for nice sensational journalism. I mean some people (whom we really do not know who they are) posted some things about a clinical study on a bulletin board system that has time/date stamps and said some potential damming things with crass language, it makes for a nice story. That all of this appears in the press is to be expected (and fine we live in a free society). However that the Govt. (any part of the govt.) feels that this type of information can serve as some kind of proof well I guess we have to agree to disagree.
PharmaBoy
FAM
I have to agree that CafePharma is not a reliable place to be looking for definitive facts. The well-publicized postings only serve to confirm that here was a strong undercurrent inside SP that the ENHANCE study was in deep trouble. Whether this was second-hand or hear-say, it does not appear to have come from any of those who really knew. They are the individuals that ran the study, collected and looked at the data, analyzed it, and then reported their findings to executives within the company. Who they reported to and when will have to come directly from them. If the Congress and other parties want to know what really happened, then they need to question those individuals who were involved, whether they say they were or not. This line of investigation is the only one that has a chance of bearing any fruit in this situation.
Skeptical
Some of the posts on CafePharma border on committing fraud–the AZ posts encouraging sales reps to submit bogus safety reports about Crestor to Public Citizen to tie up investigative time. If it’s not fraud, it’s certainly unethical.
For the most part, it’s mostly whining & character assassinations. Sophomoric but commonplace
Justice in Michigan
PB - You’re right about the bathroom. Shows the limits of metaphors.
I don’t think anyone suggested that anything on CP was “proof.” Dingell, et. al. are interested in investigating whether there is anything going on (which, I agree, could include sabotage by a competitor). As conveyed, my personal hope is that CP not reveal the identities of any such posters.