ENHANCE trial - mystery solved: CEO sees outcome in piece of toast

PRESS RELEASE
Schering Plough CEO Sees Image of ENHANCE Trial Outcome in Piece of Toast

For Immediate Release: 20 February 2008
Amazing Toast provides explanation

(PMPA-London) There has been much excitement over the mysterious prediction of the Vytorin clinical trial (Enhance) and how and what Schering Plough knew and when. Schering Plough has been dogged by accusations and questions about predictive sales of stock, reporting delays and misconduct. There have been questions about mathematical expertise and honesty. Now it appears that the mystery is solved.

An unnamed insider initially reported that a Schering Plough executive was about to eat his breakfast, when an unusual toast pattern caught his eye. "I was about to butter my toast when I realized that there was an unusual pattern of darker crumbs which meant that the Enhance trial was a bust". "It was the beginning of the end, and I immediately went out and sold £25,000,000 worth of my company stock" the executive added.

The actual piece of toast has been retained by Congressional and State investigators and the original toast is copyright to Schering-Plough CEO Fred Hassan. We can therefore only show this image of an unmanipulated slice of toast.

Ever since news of the parallel scientific universe of the ENHANCE study made headlines, Schering Plough and Merck have been inundated with requests to explain several mysterious events. "Now we are satisfied that everything is fully explained" said Hassan. "There has been no fraud. We need to look at the totality of the evidence, including the toast."

"This is astounding news" said Dr Nissen, "seeing is not believing".

"God in heaven forbid that a company profit from helping sick people" said a spokesperson from the Center for Medicine in the Public Interest (Drug Wonks). "Why don't we just not offer any treatment and then we will never have to worry about being accused of conducting shoddy science". "We'll just have thousands of people dying of heart attacks all over the place. Of course there will be arguments about the meaning of the toast. It remains a pity, though, that so much premature confusion has been created in the minds of the public simply by individuals who want science to work in the way it has traditionally worked".

If you'd like more information about this topic, or to schedule an interview with Fred Hassan, please call Carrie Cox at 666/25-MILLION or E-mail Carrie at carriecox@transparency.com

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Comments on: ENHANCE trial - mystery solved: CEO sees outcome in piece of toast

 

Blogger insider said ... (February 21, 2008) : 

Looking at the picture of the toast I can clearly see a "double bump" in the crust!

 

Blogger Pharma Giles said ... (February 21, 2008) : 

Toast is amazing stuff...

http://newsbiscuit.com/article/image-of-a-piece-of-toast-seen-on-face-of-the-virgin-mary

http://newsbiscuit.com/article/virgin-discovers-image-of-slag-on-piece-of-toast-290

 

Blogger Stephany said ... (February 23, 2008) : 

this is just damn funny

 

Anonymous Anonymous said ... (February 23, 2008) : 

MSP will soon be toast.

 

Anonymous Anonymous said ... (February 23, 2008) : 

Liars all of them

 

Anonymous Anonymous said ... (May 24, 2008) : 

Published on www.brainblogger.com:

A Failed Attempt to Improve Misperceived Greatness: The ENHANCE Trial

While it seems that sponsors of clinical trials usually end up with results that clearly favor their meds studied in their trial, there are rare exceptions, and Merck and Schering proved that with their disappointing ENHANCE Trial, which many have heard about through the media not long ago. The drugs studied were Vytorin, which was compared with Zocor
Vytorin is a combination med for high cholesterol and contains Merck’s Zocor, which is now generic, and Schering’s Zetia, which works differently than Zocor, which is one of many statin drugs. Both Vytorin and Zetia are co-promoted by Merck and Schering. So, several years ago, an outcomes study was initiated to prove superiority of Vytorin over Zocor as monotherapy. The trial was named the ENHANCE trial, possibly because Zocor is generic now, and not a priority from a profit paradigm of its creator.
After several years passed, a disappointment arrived for the sponsors of this trial, which was first brought to the attention of Schering in March of 2007, yet the results existed since the spring of 2006, I believe upon information and belief.

The disappointment is that Vytorin lacked anticipated benefit or superiority over Zocor. Since about 1 million scripts were written for both Vytorin and Zetia every week in 2007, combined with what I believe was about 5 billion in revenue for these two drugs that year, this was a problem for the drug makers, meaning a fear of shareholder reaction. Perhaps for Schering in particular, it was more of a calamity, since over half of their profits and earnings were from these two drugs with Schering, I understand.

Being the responsible corporations both companies are, of course, alterations occurred after such events were discovered that fractured numerous rules and regulations with clinical trials, possibly in illegal and unethical tactics.

The trial sponsors delayed the release of the trial results for secrecy reasons, it has been speculated. Results from the trial existed, yet were not disclosed at the time of their discovery. After several months of possessing these trial results that were only known to the manufacturers, they created or implemented some atrocious tactics to improve the trial’s unimpressive results following the original results of this ENHANCE study. At the end of 2007, the companies changed the primary endpoint of the trial, which is what the results were measured upon during the entire course of the trial. Sort of like sorting cards to make a good hand not dealt to you. Anyway, since their deliberate concealment of these trial results was clearly wrong, to respond to those who asked where the results were actually as they had been anticipated for quite some time, and while such trial manipulation was occurring and results were being kept secret, Schering stated that continued data analysis from the trial results was the etiology for the delay.

With clinical trials, case report forms are used to record data from the trials, and are created in a manner where further analysis is not normally necessary, as such forms are quite clear and often not subject to interpretation as implied by the trial sponsors, one could conclude. So at the end of 2007, both Merck and Schering got the attention of relevant government officials who contacted both companies regarding this ENHANCE trial due to such suspicions on the facts known and presented, and an investigation began into the activities of both companies regarding this trial at that point.

This became a catalyst for the ENHANCE trial results to be finally released at the beginning of 2008, which caught the attention of major media organizations, as expected. In the spring of 2008, a very large cardiology meeting was held, where the audience was told, I understand, to stick with statins due to this trial’s lack of outcomes for Vytorin, when the ENHANCE trial was discussed at this meeting. Furthermore, it has been said that a cardiologist at this meeting also suggested that a moratorium should occur with the utilization of Vytorin by prescribers, since statins are much less expensive, and are highly regarded, as they have been available for a couple of decades, starting with Mevacor in the 1980s. Of course and as expected, Merck and Schering were not pleased, nor were they surprised at the review of Vytorin at this particular meeting. The following month after this cardiology meeting, Schering’s earnings dropped by 48 percent, as I recall. Also during much of this year, Schering in particular blamed the media for amplifying the situation regarding the ENHANCE trial.

Now, these cholesterol drugs promoted by Merck and Schering, Zetia and Vytorin, were aggressively marketed in a number of ways, including investing I believe about 200million dollars in 2007 for DTC ads for these products. To add to this, and soon after both meds were launched, reps from both companies made inferences to doctors about outcomes regarding plaque accumulation and how Vytorin was superior in that area, which, of course, this ENHANCE trial proved it is in fact not the case whatsoever. It did not matter, apparently, to both Merck and Schering that such claims were is entirely void of proof, which is not unique to any pharma rep, in my opinion. No remorse or regret from the makers of these drug makers, either, which did not shock many. Yet what is known now is that these companies, as stated by other researchers, performed junk science with their deliberate manipulation of this ENHANCE trial using such tactics. Also, last year, Zetia and Vytorin had about 20 percent of the cholesterol lowering market. It does not seem that there will be an increase of this percentage because of this scandal. Possibly if they presented the truth, the future of these meds might be better than what is anticipated presently.
Worst of all regarding this ENHANCE trial scandal is the harm caused to both doctors and patients. The ENHANCE trial concerned and confused both of these participants in the health care system. Furthermore, it’s likely they were devastated by being so clearly misled by the marketing of both Merck and Schering regarding the false benefits of Vytorin they were led to believe by the companies that promoted them- the health care providers in particular.

This whole situation is another example of the progressively frequent discovery of corruption of the scientific method by placing profits over the well-being of patients, which harms the well being of patients. In addition, most were shocked by Merck behaving in such a way in particular because of what use to be their excellent reputation as an ethical pharmaceutical company. And this alone shows the progression and infiltration of such damaging ethical atrophy that desperately needs to be stopped and corrected for the sake of others. For the sake of everyone.

Don’t just say something. Have something to say- to the right people, with conviction and with others who share your views.

“Waste no more time arguing what a good man should be. Be one.” --- Marcus Aurelius

Dan Abshear

 

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