Merck and Scherin-Plough today issued a statement, after ten days of unrelenting press, Congressional investigations and a 40% loss in stock price for SGP.
As is often the case, what the companies don't write is just as important as what they write, since anything they say can later be used against them.
So let's pick apart a few of the paragraphs:
WHITEHOUSE STATION, N.J., KENILWORTH, N.J., Jan. 25, 2008 - Merck and Schering-Plough said today that they strongly object to mischaracterizations about the ENHANCE (Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia) trial.
What mischaracterization are you referring to in the press? That there was no statistical difference between expensive Vytorin and cheap generic Zocor, which is part of the combination product Vytorin? Conclusion: Huff and puff.
"While the ENHANCE trial was time consuming and took longer than originally anticipated to complete, our companies acted with integrity and good faith in connection with the trial. We took numerous actions to assure the quality of the reading of the ultrasound images," said Thomas Koestler, Ph.D., president, Schering-Plough Research Institute.
Well, we hardly expected you to say you didn't act with integrity and good faith. Please note that the following sentence claiming they took "numerous actions to assure the quality" didn't say these actions delayed the trial; they are using the placement of this sentence following the prior admission, to try to give the impression that this was the reason for the delay, but they don't say it. Conclusion: Since they didn't say it, these "actions to ensure quality" are just a smoke screen, and had nothing to do with the delay.
VYTORIN® (ezetimibe/simvastatin) and ZETIA® (ezetimibe) have been studied extensively in patients with elevated cholesterol. Clinical studies conducted to date have demonstrated that VYTORIN and ZETIA significantly decreased LDL cholesterol in patients with elevated cholesterol, along with a healthy diet. In addition, the safety and tolerability profiles of VYTORIN and ZETIA are set forth in the approved labeling. The approval of VYTORIN and ZETIA in many markets around the world is based on their demonstrated safety and tolerability profiles, and ability to lower LDL-cholesterol.
This is a really cool paragraph intended to make you, the reader, believe Vytorin is safe and effective and will help patients. But that is not what they are saying. They are simply saying Vytorin lowered cholesterol; this is not the same thing as saying that Vytorin had any clinical impact on cardivascular disease in patients. In fact, they have never been able to prove that this is the case. Some drugs lower lipids and may reduce number of heart attacks. As far as Vytorin goes, we have no idea what it does, clinically. Conclusion: The companies have no idea if Vytorin and Zetia does anything to actually help patients live longer and avoid disease.
"We stand behind VYTORIN and ZETIA and stand behind our science that has brought these cholesterol-lowering medications to millions of people around the world," said Peter S. Kim, Ph.D., president, Merck Research Laboratories.
What Kim is saying is that millions of people have taken the pills and they did it because of science. So why did you guys spend twice as much on marketing as you did on science, Kim? Conclusion: Marketing brought the pills to millions of patients, not science.
Many patients with elevated cholesterol cannot achieve their cholesterol treatment goals with diet and exercise. Many of these patients also cannot achieve their treatment goals with statins alone.
True. And so you are implying that because of this, there is a need for Vytorin, which has never been proven to have any clinical efficacy, i.e., reduce cardiovascular disease.
Clinical studies, which are included in the attached prescribing information, have demonstrated that VYTORIN lowered patients' LDL cholesterol more than atorvastatin, rosuvastatin, or simvastatin at the doses studied. When added to a statin, ZETIA provided additional LDL-cholesterol lowering compared to the statin alone. Unlike some statins, ZETIA has not been shown to prevent heart disease or heart attacks. VYTORIN contains two medicines: ZETIA and Zocor® (simvastatin). It has not been shown to reduce heart attacks or strokes more than simvastatin alone.
Hallelulja! Admission! ZETIA provided additional LDL-cholesterol lowering compared to other statins, but this doesn't mean sh-t, because "Unlike some statins, ZETIA has not been shown to prevent heart disease or heart attacks." And we all would prefer to take a statin that has been shown to prevent heart disease or heart attacks. And then comes the whopper, "VYTORIN contains two medicines: ZETIA and Zocor® (simvastatin). It has not been shown to reduce heart attacks or strokes more than simvastatin alone." So when Zetia, which has not been proven to have any clinical efficacy, is added to Zocor, which has been proven to reduce heart attacks, the combination doesn't work better than Zocor. BECAUSE ZETIA DOESN'T WORK. Except it lowers lipids, but who cares if that doesn't result in fewer heart attacks?
"More than 20 years of clinical research has demonstrated that lowering LDL cholesterol, along with a healthy diet and other therapeutic lifestyle changes, is the cornerstone of lipid treatment for patients at risk for heart disease," said Dr. Koestler. "VYTORIN and ZETIA are important treatment options that can help appropriate patients lower their LDL cholesterol."
Yawn . . . you've said that a few times. We know. It lowers lipids and has no proven clinical efficacy.
/SNIP/ (this part just got too boring)
Until December 31, 2007, the study remained blinded; that is, neither the patients nor the researchers nor the companies knew the group of patients that received each therapy. On that date, statisticians for Schering-Plough Research Institute first became unblinded. Additional personnel at the companies were made aware of the findings during the first two weeks of January, 2008.
And by this you are implying that no one could have known anything when Carrie Cox dumped $28 million worth of stock last year, right? Plausible deniability, right? Well, let us ask you this, how come you guys planned on changing the primary endpoints last year? After all, that's the kind of stuff unscrupulous drug companies play around with after they found out the study didn't work!
Did someone peak at the blinded data? Had a tiny look? Did someone come up with a way to tell which patient got which drug? Did someone cheat? Or did you simply know, looking at all the images (you had them all along), that the study was a mess and very likely wouldn't show any difference and that this would be a disaster. You can't get out of the fact that you knew enough to try to change the endpoints, which essentially means you tried to change the rules after the game was over.
Kind of like disqualifying anyone who didn't take a drug test right before the race, although that hadn't been a requirement before the race started.
See how bad this looks? And that indicates you knew the race didn't work out as you had hoped . . . even though you imply you had no idea who won, after all, why would you have messed around with the primary endpoints, if you didn't know there was a problem?
On January 14, 2008, the companies announced the results of the primary endpoint and other results.
Yes you did and because of your conduct, not because of the results, you are now in deep doo-doo that won't go away for a long time to come.
