Was The FDA Given A Secret Vytorin Report?
9 CommentsBy Ed Silverman // September 2nd, 2008 // 2:45 pm
Two weeks ago, the House Energy & Commerce Committee stepped up its probe of the controversial cholesterol pill by demanding Merck and Schering-Plough, which jointly market Vytorin, turn over documents relating to the SEAS trial and its analysis. This trial, you may recall, turned up an unexpected link to cancer and cancer-related deaths (back story).
In particular, the committee wanted the analysis by Oxford University’s Richard Peto, who is running one of two larger Vytorin trials and maintains the cancer findings are a bizarre fluke. His report, which the drugmakers insist they did not underwrite, was submitted to the FDA. But the drugmakers refused to provide the report without “assurances” it wouldn’t be released to the public. Instead, the committee was told to get the report from the FDA, since Peto provided a copy to the agency.
And so in a letter to Schering-Plough ceo Fred Hassan and Merck ceo Dick Clark, John Dingell, who chairs the committee, and Bart Stupak, who heads the Subcommittee on Oversight and Investigations, write that, in July, they were told Peto’s report would provide a “complete assessment” of the SEAS study and provide a “full review of available data.”
But, they write, “after reviewing the five-page report…we were somewhat surprised to discover that the report contains little more than the information that was presented at the July 21, 2008, press conference announcing the SEAS results. We are also at a loss to understand why this report was kept by you from our committee and the public.
“We are concerned that an esteemed scientific consultant to Merck and Schering-Plough may have generated a secret report to FDA - a report whose contents may have been misrepresented to our staff as the report itself appears to contain information which is publicly available.”
And so, they want to know whether the report they received was the whole shebang that Peto gave the FDA and still want to know why his study not made publicly available. They’ve also asked when Merck and Schering-Plough staffers or representatives first contacted Peto about his consultant report; when his report was submitted to the FDA; and whether his report was reviewed or edited prior to its submission to FDA by anyone from or connected to Merck or Schering-Plough.
And finally, they ask Clark and Hassan whether Peto prepared any other analysis of the association , or lack thereof, between Vytorin and cancer for any other regulatory agency or peer-review journal, and whether Merck or Schering-Plough people played a role in preparing his report and decision to submit it to the FDA.
Dan A.
Would anyone be suprised if the FDA was given a secret Vytorin report?
Piper
I’m confused. No wait, Stupak and Dingell are confused. Because I understood back in July that the Oxford analysis was done. Or so I assumed, based on the rather lengthy PowerPoint presentation they had posted on their website. So what exactly were Stupak and Dingell expecting? MSP didn’t run SEAS (they funded $$$) and they didn’t run the cancer analysis. They also didn’t write (ghost or otherwise) the NEJM articles/analyses published today, which showed the same unfavorable conclusions we saw a month and a half ago. I think Sir Peto was correct in saying Dingell’s committee action amounts to “harassment”. It seems they have lost all objectivity at this point….if they ever had any.
Dan A.
Is anyone really suprised about this allgation?
Condor
Again, Ed is all over it — like white on rice!
Piper — I guess you ARE confused. Five pages can’t possibly be a “complete report” or a “full assessment”.
See — here’s how it works: these Congressional Committees share jurisdiction with the FDA over the pharma industry.
The sooner CEO Fred Hassan accepts that reality, the better for Schering’s long term interests.
This sort of obstinence/sand-bagging will not play well in the new Administration’s view of Schering.
Condor
As a service to the readership — I’ve set today’s Congressional letter, in full text, right here:
http://shearlingsplowed.blogspot.com/2008/09/ed-silverman-on-secret-seas-report-to.html
Cheers!
SP 2
Probably. Virtually nothing with SP is completely up-front and complete - spin rules!
LILLI
I really do not know th purpose of Pharmalot! As a child I learned that when problems
occur we worked at fixing the problems—not just discussing. America’s health care
management system is corrupt. One day we are told this medication will help us, a Month
or years later we are informed that the medication caused serious problems, yet our
elected and appointed officials do not repair the problems and allow the general public to
endure serious illness that has cause many unnecessary fatalities.
Chris
LILLI -
What exactly are you proposing? Taking all drugs with side effects off the market? By firing all pharma management? How would you suggest we ‘repair the problems’? Many people benefit with these drugs, typically some have side effects.
Piper
How about this reality: it is not biologically plausible that ezetimibe caused or promoted the cancer growth in SEAS. Does it block plant sterols? Sure, in the genetically unique individuals with sitosterolemia. But those poor folks would die if it didn’t. For the rest of the hypercholesterolemia patient population, it doesn’t HAVE TO block plant sterols. Why? Cholesterol is the sterol synthesized and utilized by mammals. Mammalian cells cannot use plant sterols, which possess an additional carbon group, thereby preventing their efficient absorption in the human intestines. In sitosterolemia, patients have defective cellular machinery that cannot differentiate between plant and animal sterols - these patients go on to accumulate large amounts of plant sterols in their tissues and die of coronary heart disease at an early age.
As for Dr. Bradford, which the NY Times cited for his work with plant sterols, his first two trials were done in vitro, such that the obvious intestinal barriers were removed. The third trial, in hamsters, clarified that the beneficial effects of phytosterols were not observed with FREE plant sterols and stanols (hmm, I wonder why). The logic behind Nissen and Fleming’s theory for ezetimibe’s carcinogenic properties is just the wishful thinking of two spotlight loving cardiologists that apparently want to be oncologists. Should you not believe me, feel free to look it up in your old college Biochemistry book; or better yet, look it up in Cell, Science, the ASNS……
On an obvious side note, cancer is a mutation. Skin cells, prostate cells, stomach cells all take time to mutate (Those were the three areas where Vytorin outweighed the placebo in SEAS). Lung cancer is the deadliest of all cancers (has the lowest survival rate). The incidence of lung cancer was higher in the meta-analysis of IMPROVE-IT and SHARP and subsequently, so was the death rate. Lung cancer doesn’t develop overnight, but it will kill you in no time. Is that ezetimibe’s fault? People get lung cancer years after they quit smoking….who is to blame then? If you were diagnosed with cancer, where would you turn for help - your cardiologist?? the NYT?? No. An oncologist, maybe an epidemiologist, but not the other guys. Anyone that can turn a cholesterol absorbing drug into the equivalent of asbestos, while ignoring the fundamental basics of biology and oncology, shouldn’t be quoted over and over again like the god of all things good in health care.