Hassan Blames Ultrasound Data For Vytorin Flap
7 CommentsBy Ed Silverman // January 3rd, 2008 // 11:34 am
Speaking at a Morgan Stanley investor conference today, Fred tries to downplay the controversy over the cholesterol pill that Schering-Plough sells in conjunction with Merck as part of a joint venture, Reuters reports.
The two drugmakers made themselves look very questionable two months ago when they announced a progress report on their Enhance study, which was completed in April 2006 but never released, prompting speculation about the findings. To top it off, an expert panel, which was entirely anonymous, recommended changing the study endpoint to speed things along. Last month, they backpedaled and agreed to leave the endpoint alone. But by then, the damage was done - a Congressional committee is investigating a “manipulation of trial data” and the drugmakers were skewered for undermining public confidence in the way pharma conducts clinical studies.
Vytorin, by the way, is a combination of Zetia and Zocor. And the Enhance trial was designed to show that Zetia and Zocor together would reduce the growth of plaque in blood vessel walls more than Zocor alone, which is an important way to gauge whether a cholesterol med is effective. [UPDATE: We have edited the description of the trial for the sake of accuracy and clarity compared with our earlier attempt].
To fend off the criticism, Hassan today insists the poor quality of ultrasound images impeded the progress of the Enhance trial, and stressed that the controversial study involved only a “narrow population” of patients. “There are some quality challenges” with the ultrasound data, he tells the investor conference in New York. The trial “was designed with good science in mind,” but involves a “narrow population of people with high cholesterol levels,” says Hassan, according to Reuters. The Enhance trial tested Vytorin among patients with a genetic predisposition to dangerously high cholesterol levels.
Schering-Plough now plans to present data from both the original endpoint and the newer endpoint at a medical meeting in March. You can listen to Fred’s presentation here.
Jimbo
You may want to check your facts on this one - the ENHANCE trial looked at the build-up of plaque in the carotid arteries of patients with familial hypercholesterolaemia ie people with extremely high cholesterol who are likely to die of CV disease in early adulthood. It’s a surrogate end-point using ultrasound scans - nowhere in the protocol is there any mention of preventing heart attacks (check clinicaltrials.gov for the full protocol if you don’t believe me). It was scientifically interesting but commercially irrelevant because it was carried out in such a specialised patient population. There’s no denying it has been a PR disaster but to call it a medical scandal is way OTT.
Insider
Jimbo
It IS a medical scandal.
You should never ever change the endpoint once the trial has started.
And that’s not just my view!!
“John P. Kastelein, a cardiologist at Academic Medical Center, Amsterdam, and principal investigator of the study, said he breathed a “sigh of relief” when the companies told him last week they were reversing course.
“It’s never, ever right to change the primary endpoint of a study,” especially after all the data are in, he says. “It is statistically not good and it gives the wrong impression to the outside world.”
BUSTED!
BPW
Jimbo is way off base and should read about the trial.
Merck and Schering-Plough want people to believe that the trial was not important to them. This is a bunch of stuff. The trial was intended to demonstrate the value of Zetia in reducing the progression of hypercholesterolemia in a familial heterozygous hypercholesterolemia population that was chosen because atherosclerosis progresses faster in these patients. It was their only study for an indication in atherosclerosis and they failes miserably.
Hassan wants to blame it on the images. Crap! Clark now insists that the trial is only one of four. More Crap! The truth is that there is no existing evidence that Zetia affects atherosclerosis. As for cardiovascular events, nobody will know until IMPROVE-IT comes out in 2010 or later. Unless there are issues with that study, and then it’ll probably be 2015!
These two companies need to be investigated! The CEOs are just trying to squash all the outrage! The companies are laughing all the way to the bank. Patients are taking meds they don’t need with no proven benefit that is much more expensive than generic statins, which have been shown to impact atherosclerosis and save lives! The cost to the American public as well as insurers and the government is absolutely outrageous. Do you want to spend $2-3 a day for Zetia or Vytorin, which have not been shown to do anthing but lower cholesterol, or about $0.10 a day for a product that has been shown to work?
Meanwhile, Merck and Schering-Plough are splitting $5 billion a year!!!!!
Dr. Remulac
BPW is right. Hassan calls the patients studied in ENHANCE “a narrow population of people.,….”. Interesting. Heterozygous FH affects about 1`in 500 people, so that’s about 600,000 Americans, and even more worldwide (in some countries/ethinc groups, the prevalence is nearly twice that). Gee Fred, I’m guessing that the results of ENHANCE certainly matter those people, and I’m quite sure to many others as well. ENHANCE was designed so as to have the greatest likelihood of showing benefit: using a high LDL-C population to test a potent LDL-C lowering strategy; heteroFH patients have lots of vascular disease easily detected by ultrasound, and it is know to progress very rapidly - this increasing your chances of detecting a change with therapy. Bottom line is that they KNOW the top-line results and that there is no overall effect on the primary endpoint. Now Fred and Dick and their minions are doing advance spinning to discredit the trial by pointing out problems with the endpoint detection technology, and even more to their shame, saying it’s a small population that doesn’t really matter anyway. So much for “earning trust each day”, eh boys?
CV MD
Typical Fred Hassan and Schering-Plough! Twist the facts to your own advantage! Got to protect that $5 billion dollar franchise driven by a drug that’s never been shown to do anthing but reduce cholesterol a little bit more than statins alone.
There’s absolutely no eveidence whatsoever that ezetimibe does anything to atherosclerosis or cardiovascular events. And there won’t be any for years. Doctors practice according to evidence-based medicine and SP has no evidence to support this drug. The government, insurance companies and HMOs are paying a premium price. And Schering-Plough simply wants us to believe that it works becuase they say it does. Imagine, $5 billion for a drug that is no different than placebo for the really important endpoints, atherosclerosis and cardiovascular events. The OIG and the OAG should jump on this!
MDMD
I agree with DR. R. I think SP needs to think about changing it’s current theme song to:
We are not a new kind of healthcare company! We operate with complete lack of integrity. We earn mistrust each and every day. We are not to take any responsibity for our actions. We don’t demonstrate leader behaviors and we regularly try to buy business.
We are committed to the healthcare of people worldwide as long as we can make piles of money. We have a robust compliance program, but we really don’t know what it means to be compliant. We push our employees as hard as we can until they break. If they’re not blindly loyal to executive management and the company, then we fire them.
We are Schering-Plough - standing for all that is bad about the pharmaceutical industry!
CAB MD
Hassan’s comments are nothing but a devious distortion of the truth in an attempt to get his unethical company and its’ flagship multi-billion dollar franchise out of really hot water! Have we seen any other company with more bad press in the past 2 months? Schering-Plough executive management is nothing but a bunch of brainless sycophants who follow the lead of Fred Hassan and Carrie Cox. They aren’t allowed to think for themselves and all must ignore ethics lest they be terminated.