Monday, November 26, 2007

Vytorin Study Stallin' - Notes from the Field Hands

As reported on Forbes.com (see "The Vytorin Question"):
"Every day millions of people swallow Zetia and Vytorin in the hopes of reducing their risk of heart attacks and strokes, generating $5 billion a year in sales for Merck and Schering-Plough, which produce them.

Do they work?

Despite millions of prescriptions, no study has ever shown that these $3-a-day pills prevent heart attacks, strokes or deaths any better than just taking older, cheaper drugs like Pfizer's Lipitor or Merck's off-patent Zocor, even though they're proven cholesterol fighters. That's why a two-year delay in a 900-person study aimed at clarifying the issue has cardiologists expressing skepticism and spinning conspiracy theories. If the news were good, the companies would rush it out, the thinking goes. Delay doesn't bode well."
At issue here is whether or not adding Zetia to a statin (as in Vytorin, which combines Zetia with Merck's Zocor) reduces plaque in arteries and therefore would help prevent heart attacks and strokes. Zetia has been shown to further reduce bad cholesterol in the blood when combined with Zocor; ie, "In a clinical study, people who added ZETIA to their statin medicine reduced their Bad Cholesterol by an additional 36 points (25%) compared with 6 points (4%) in people who added a placebo (a pill with no medicine)," according to information on the Zetia Web site.

These days, reducing bad cholesterol is not good enough, especially with the FDA more focused on improving real outcomes -- ie, reducing death rates. Hence, the ENHANCE study, which was designed to get a new indication for Zetia -- reduction of plague in arteries.

As this story wends its way around the Pharma Blogosphere, I thought it would be interesting to see what the Schering-Plough and Merck sales reps are saying about this over at Cafe Pharma. A list of recent threads suggest the general tenor:
Here are some tidbits:
"Nice explanation 'there are confounding variabilities in the observation of the target arteries and we needed to streamline the observation process'

Translated for all of you kool aid drinkers:

The initial blinded readings of the target lesions showed no benefit in terms of progression of disease by being on the Vytorin 10/80 vs. Zocor 80mg, therefore we fired all of the idiots that read the imaging studies without bias and hired some folks that know how to look for some frickin' benefit in those Vytorin patients" . Now the first time the new folks looked at the data they found "some" benefit but we informed them that there was "MORE" benefit to be found. So we shipped their asses out to a "RE-Training Facility" in Fargo, ND last December and made sure they understood "where & how" to find that slowing of progression and regression. Now we expect the NEW Findings to be presented at the Acclaimed ACC meeting in March 2008."
"In today's environment Merck will not pull this off. The days of spinning the data are over. If anything they will just try and make the data go away so as not to disrupt the current revenue stream. Changing the end point is not a good idea, ethically or politically."
"I used to have high respect for Merck reps and I competed against you, didn't always win didn't always lose but I knew one thing the reps were ethical and stand-up. Merck used to have the highest ethical, scientific base from which to stand and look down on the rest of Pharma (especially Pfizer) for just being "MARKETERS", looks like that Moral high ground is starting to shift. I use as examples the disgraceful coverup and minimalization of the VIGOR data and APPROVE data and NOW ---- ENHANCE."
It does appear that Merck is attempting to squeeze some positive data from the study by selection of new endpoints. It's a similar ploy to the one currently being used by the Bush administration to prove "success" in Iraq! Note to self: Find out if Merck is a big supporter of the Republican party and past Bush presidential campaigns.

But the following comment about how this affects the credibility of sales reps in the field really struck a chord with me:
"I used to believe everything we did was for the better science but after getting blasted by a cardiologist today because the pfizer rep had just told her all about "Merck suppressing bad data for Vytorin to milk more $$ out of the drug before the truth is released" I really just want to kick someone in the nuts for doing the damn study in the first place.

BTW since when has a coverup EVER been better than just telling the truth the first time? Answer=NEVER

Idiots in HQ don't mind sacrificing the reps' credibility who cares about the long term trust btwn dr. and rep anymore."
This is just another example of how the pharmaceutical industry shoots itself in the foot. As a side note, it is also a good example of why the pharmaceutical industry can never ever be trusted in a social networking environment.

The industry is doing a lot of hand-wringing about diminishing access to physicians. Sales tactics are being altered and consultants are being hired to "solve" this problem. But the best solution -- providing docs with honest, up-to-date information about medications -- seems to be taking second place to providing Wall Street investors a plausible reason to invest in the company stock.

One final comment.

The Zetia TV ad that features a group of residents talking about the drug's major side effects while going through hospital rounds with a teaching physician was touted as an example of how marketers are becoming "more creative in using physicians as authority figures in broadcast spots" (see here).

I wonder what real teaching physicians are saying about Zetia these days?

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