Releasing Vytorin Data Is A No-Win Proposition
11 CommentsBy Ed Silverman // September 3rd, 2008 // 10:13 am
First, Schering-Plough and Merck get excoriated and investigated for continually delaying the release of the Enhance trial results, especially after the data raised substantive doubts about the effectiveness of the heavily advertised and expensive cholesterol pill.
Now, the drugmakers are being chastised for moving too quickly to release the results of the SEAS trial, which found a surprising number of cancer and cancer-related deaths. One can imagine, of course, Schering-Plough and Merck were eager to avoid a fresh round of accusations that negative data was being suppressed, since the results were not due to be unveiled until November.
Terje Pedersen, the lead investigator of the SEAS study tells Forbes he had no choice but to release the results early, even though he “wanted to do this in peace and quiet” and present the full results at the annual meeting of the American Heart Association this fall. But the drugmakers told him they needed to release the results both to the FDA and, at least in a minimal way, to investors.
There is also criticism leveled at Oxford University’s Richard Peto, who is running one of two larger Vytorin studies and presented the main defense of the SEAS trial, calling the cancer findings a ‘bizarre’ fluke. To do that, he looked at the data from those two trials before completion. Cleveland Clinic’s Steve Nissen, who conducts trial of cholesterol pills made by other drugmakers, tells the mag sneak peeks can provide bad info and change the final result by making docs aware of a drug’s actions.
The decision to unblind the studies, however, was done to ensure patients aren’t harmed, according to Harvard’s Eugene Braunwald. This poses an interesting conundrum. If Merck and Schering-Plough waited until November, they may have been skewered for putting patients at risk. Yet their approach is being questioned. What do you think?
Should the drugmakers have waited to release the SEAS results?
- No (73%, 82 Votes)
- Yes (27%, 31 Votes)
Total Voters: 113
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Lipid Doc
For once they did the right thing.
Former SP
You’re right, but it’s totally against their character!
Marilyn Mann
I think that instead of waiting until November, they should have waited until the ESC Congress, with simultaneous publication in the NEJM (accompanied by an editorial). Holding the press conference in July, with the Peto analysis based on short-term data from two on-going trials, allowed the sponsors to control the spin. People were in the position of commenting without having had the benefit of reading a peer-reviewed publication.
Unblinding the cancer data from SHARP and IMPROVE-IT was not necessary to protect the patients in those studies, because the data safety and monitoring boards already are supposed to be doing that. And, at least in my view, it didn’t really help us answer the question of whether ezetimibe causes or promotes cancer. We are still left with an unanswered question of whether or not there is a safety problem. It’s one more reason for people to stay away from the drug until more data are available.
Salmon
If any of the deaths were in Europe the data had to be unblinded to evaluate the safety in order to be in compliance with European Regulations.
Unfortunately drug makers do this in Europe find out information about the safety of a drug but don’t report it to the FDA.
Salmon
Condor
Marilyn Mann actually said it all.
Schering-Plough and Merck are now getting reamed for trying to “spin” the science, IMO. This isn’t so much about the “timing” of Peto’s analysis — as it is about “[whole]-truth-telling” — whenever one decides to tell it.
Again, that is just my view.
Why didn’t Schering allow time for a full-peer-review of Peto’s work? Because, it says, it was in too big of a hurry to get the information out. SEC rules and all.
I simply don’t buy that.
Now add to the equasion that Reps. Stupak and Dingell were apparently promised more (FULL) data by Schering’s counsel (see Ed’s, of yesterday) — and they DIDN’T get it — and you have ANOTHER five-alarm PR fire on your hands, Mr. Hassan. [And Mr. Clark.]
Just my $0.02.
SP 2
The top management of Schering-Plough (fred, carrie and overpaid cronies) have made their own bed and now must deal with it. Virtually noboby trusts them anymore after everything that has come out in the past 9 months. There is no earning trust, leading with integrity or any other of Fred’s mantra lines in effect at this company. IMO, he is a big fraud and has been found out!
Dan A.
The relase is probably due to the issues they have in the past with Vytoin, and perhaps felt it is better to be safe than sorry- now that the promoters are in the radar.
Steven Walker
I am perplexed by these comments. Patient protection both inside and outside trials is of critical importance, and looking at the developing data from the ongoing trials, even though not yet “statistically” mature, was the only way to determine quickly if the startling signal seen in the SEAS trial was a real concern. The difference in cancer incidence in the SEAS trial was so great that, if true, it would almost certainly have shown up at some level in an interim analysis of the other trials. As for compromising participation in those trials, or influencing physicians to practice medicine differently, I have not seen any data reported from those interim looks other than the conclusion that the results do not support a link between cancer and Vytorin, so how would medical practice be affected, except inappropriately based on bad data if the companies had not done what they did?
We have descended into some kind of method driven madness in which a cult-like belief in the purity of an archaic, ineffective and unscientific statistically-driven clinical trials and approval system has caused us to forget why we do medical reserach in the first place. It’s for the patients stupid! We have a slew of statistics advocates and drug safety fanatics crawling all over the system, thinking that their narrow view of the system is the only one that matters, and many “experts” who think that the rote pursuit of perfect statistics from endless clnical trials is the only thing that matters, even trumping the value of human life and any attempt to act responsibly.
Really? the drug companies shouldn’t have done the most definitive thing possible to determine if they had uncovered a serious safety issue associated with an approved drug?
Really?
Piper
Let’s say they had waited until ESC to release the cancer analysis, et al (b/c that’s how long it took to write up the peer-reviewed articles - which were, btw, two months earlier than expected). And let’s also supposed that A) MRK still rescinded its guidance, but now couldn’t give a reason, and B) SGP still reported better than expected earnings, but the stock went up from $22, instead of down (b/c there was no negative SEAS news to take it there). Both companies would knowingly be in violation of the SEC’s rules covering the release of significant non-public, inside information. Stupack and Dingell are already on a witch hunt, with or without just cause. By withholding relevant information, from both a health and securities regulation standpoint, our fine Congressional leaders would finally have a leg to stand on in their bizarre pursuit of M-SP and their demonized cholesterol absorption inhibitor. I hate this story - every time I see Vytorin in the news, I wonder what has happened to make us love to hate so much. Because let’s face it, we do. We really, really do.
Paul G
Face it, they are the whipping boys of the industry and no matter what they do, someone will attack them. Damn if they do, damn if they don’t.
Anon
The cartoon is a very nice caricature of a very flustered Fred Hassan!