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- Will Lilly's Survey Have the Desired Effect on Cialis? [view article]
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loading ...Recent SGP Articles
- Merck/Schering-Plough's Heart Drug Couldn't Have Done Worse
- Clarifying the Vytorin Situation: Three Key Questions
- Wall Street Breakfast: Must-Know News
- Roche's Genentech Offer Sends Ripples Through Biotech
- Monday Options Outlook: SGP, MRK, AZN, AMGN, CELG, BBH, BAC, KRE, XLF
- Earnings Preview: Schering-Plough Corp.
- Will Lilly's Survey Have the Desired Effect on Cialis?
- Do Tell, Intel - Fast Money Recap (7/15/08)
- S&P's Poor Standard - Fast Money Recap (7/9/08)
- End of Quarter Window 'Un-dressing'
- Full List of Articles »
Merck/Schering-Plough's Heart Drug Couldn't Have Done Worse [view article]
The author of the long piece is clearly a conspiracy theorist. Investigation of ENHACNE has not yielded any wrong doing. Sure some trial end up bad. Most importantly Lipitor and Crestor the other statins on the market also failed at what Vytorin failed at in Enhance, which is not relevant to LDL and subsequently 20 years of scientific knowledge that lower cholesterol is better and that is why you take these meds for. ReplyMerck/Schering-Plough's Heart Drug Couldn't Have Done Worse [view article]
Published on brainblogger.com:A Failed Attempt to Improve Misperceived Greatness: The ENHANCE Trial
While it seems that pharmaceutical company 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. The trial was named the ENHANCE trial, and possibly this trial was initiated 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 everyone.
Don’t just say something. Have something to say- to the right people, with conviction and with others who share your views.
“Try not to become a man of success, but rather try to become a man of value.” --- Albert Einstein
Dan Abshear
Author’s note: What you have read is based upon information and belief. Thank you
Reply
Merck/Schering-Plough's Heart Drug Couldn't Have Done Worse [view article]
Either you are not educated or a fool, the cancer stuff has already been proven by Dr. Peto of oxford to be due to chance after his meta analysis, do plz get a grip on reality and read before you sensationalize this madness. ReplyClarifying the Vytorin Situation: Three Key Questions [view article]
Seems like Vytorin's just one glitch in what is overall a solid company.PFE has a flawless 41-year history of dividend growth and stands to benefit big, along with the entire drug industry as Medicare Part D kicks in over the next few years.
Here's an article by PFE supporter if you're interested in the dividend and management.
www.greenfaucet.com/tr...
Anyone else have any good information about PFE before I jump in? Reply
Clarifying the Vytorin Situation: Three Key Questions [view article]
Merck and Schering Plough delayed issuing results of the Enhance study for nearly two years and tried to change the primary endpoint in the late stages. To the extent that coverage is at all unfair to them, they brought it on themselves. And as this article shows, the press has consistently noted that Vytorin lowers LDL, while also noting that lowering a marker but not necessarily treating disease may no longer be good enough. This has been since seen with diabetes drugs as well, and even for cancer drugs, the FDA is looking for survival benefit rather than another proxy for efficacy.www.findingdulcinea.co... Reply
Clarifying the Vytorin Situation: Three Key Questions [view article]
Vytorin DID not result in decrease in intimal thickening of carotid arteries in edperimental group. #2) Increased incidence in cancer in experimental group. Perhaps the following excerpt will get your attention:www.pubmedcentral.nih....
Mark R. Goldstein, et al:
"...Close inspection of statin trials reveal the specific populations at risk for the development of incident cancer with statin treatment. These include the elderly8–10 and people with a history of breast or prostate cancer11,12. Furthermore, statin-treated individuals undergoing immunotherapy for cancer may be at increased risk for worsening cancer13.
The elderly are relatively immunosuppressed and are more likely to harbour occult cancers14. In the prosper (Prospective Study of Pravastatin in the Elderly at Risk) trial8, a 3.2-year prospective study of pravastatin for cardiovascular disease prevention in the elderly (mean age at trial entry: 75 years) at high risk for cardiovascular disease, cancer incidence was significantly increased in subjects randomized to pravastatin. In fact, the increase in cancer mortality equalled in magnitude the decrease in cardiovascular disease mortality in the statin-treated patients, leaving all-cause mortality unchanged. Likewise, post hoc analysis of the lipid study9, a 6-year prospective trial of pravastatin in individuals with cardiovascular disease, revealed a significant increase in cancer incidence in the elderly subjects (age: 65–75 years) randomized to pravastatin. In a secondary analysis of the tnt (Treating to New Targets) study10, elderly subjects randomized to high-dose atorvastatin (80 mg daily) versus low-dose atorvastatin (10 mg daily) demonstrated a trend toward increased death, largely from an increase in cancer mortality. Therefore, the increase in incident cancer in the elderly might be dose-related. It is highly plausible that the elderly are particularly sensitive to a statin-induced increase in Tregs, further impairing their immune response to cancer.
An alarming increase in breast cancer incidence, some of which were recurrences, was seen in women randomized to pravastatin in the care trial11 Thereafter, cancer was an exclusion criterion in randomized statin trials. In clinical practice, however, it is not infrequent to find an association between recurrence of breast cancer and concurrent statin therapy15. Long-term follow-up (10 years after trial completion) of woscops (West of Scotland Coronary Prevention Study), a 5-year prospective trial of pravastatin in hypercholesterolemic men, revealed an increase in prostate cancer in the men who were randomized to pravastatin therapy12. That finding indicates that cancers may become evident a decade or more after treatment with statins. Treg increases have been associated with both breast and prostate cancers16,17, and therefore, it is highly plausible that the increase in cancers seen with statin therapy is related to a statin-induced increase in Tregs.
Statin therapy has been associated with tumour progression leading to radical cystectomy in patients treated for bladder cancer with bacille Calmette–Guérin immunotherapy13. That association may be likewise due to a statin-induced increase in Tregs, resulting in impaired host antitumour immunity.
Statin trials have typically randomized subjects free of prevalent cancers and have been about 5 years in duration. Long-term follow-up data are limited, particularly for the development of cancer. Statins are now promoted for widespread use in adults of all ages and at high doses18, potentially for decades. Importantly, they are used in individuals with other significant comorbidities such as cancer. Unfortunately, the post-market surveillance of drugs has been poor19. Because cancer is highly prevalent in the population, particularly in the elderly, a statin-induced increase in cancer incidence will likely go unrecognized..."
you may read the rest of the article at your leisure.....
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Eli Hoffmann
Wall Street Breakfast: Must-Know News [view article]
PJ568, thanks for your feedback. We largely report adjusted earnings. This is due to the fact that analyst consensus estimates, which are the gauge by which many judge whether a given company has beaten or missed expectations, are formulated based on adjusted earnings. ReplyRoche's Genentech Offer Sends Ripples Through Biotech [view article]
If Roche versus DNA doesn't progress, expect professional dweeb carl Icahn to come in and stamp his feet, and pound his fists, and hold his breath until some under-worked reporter converts his simple-minded proposals into a quick headline. ReplyWall Street Breakfast: Must-Know News [view article]
Many of the numbers referenced above appear to be adjusted and not actual. WB and BSX are two that jumped out as being off. One would expect adequate disclosure from the SA Editor about the numbers being referenced. Constantly reporting and discussing adjusted numbers is a sign of weakness that shouldn't be ignored. ReplyMonday Options Outlook: SGP, MRK, AZN, AMGN, CELG, BBH, BAC, KRE, XLF [view article]
Saw that the housing sector was the big winner last week and did a little more research on it. This article (www.greenfaucet.com/fa...) argues that housing may finally have reached a bottom. Check it out if you're interested in buying. Replyancisco
Wall Street Breakfast: Must-Know News [view article]
It is amazing that so much of the financial health of the western world hinges on the performance of these public / private entities Fannie and Freddie. I was once a stockholder (liked the dividend), but sold when it became apparent to me a few years ago that I did not understand who the management worked for. If they are a cornerstone of the economy, the performance of their management needs to be judged by a standard of security, not growth of EPS, which drove them away from their government mission toward chasing the returns of sub-prime loans. Then the government wanted them to broaden the size of loans that they would handle. Despite hating a larger role for government, I have reluctantly come to the conclusion that they neeed to be publicly owned and directed. Ugh. I can't believe that I said that. ReplyWall Street Breakfast: Must-Know News [view article]
why pay attention to moody,s? why pay attention to anybody? all have an agenda & its not to put money in your pocket.once you know that selfserving lying & greed is the game you should think for yourself. ReplyWall Street Breakfast: Must-Know News [view article]
well looks like Moody's go unlished playing the rating game again without foundation or facts and just based on speculation. They need to reinstate triple A ratings on some of the bond insurers that were downgraded unjustifiably ReplyWill Lilly's Survey Have the Desired Effect on Cialis? [view article]
Mr. Huckman may be correct with regards to the difficulties men face when trying to discuss Erectile Disfunction with their physicians, but he hasn't done his homework regarding the clinical attributes of the three ED products. Cialis & Levitra are clinically far superior to Viagra (efficacy,side effect profile,restrictions) and Levitra is anything but " a also-ran, me-too ED drug." Keep pushing that Lilly stock Mr. Huckman!! ReplyEarnings Preview: Schering-Plough Corp. [view article]
I am long the common from the $14-$15 range and long even more of the Preferred B in the $150 range, gotta love a 10% yield and a 25% upside in about 5-6 months, is convertible into between 750 and 900 shares of common depending on avg. price for 20 days before exp. in late '09. It was issued at $250 with an 6% ($15) yield initially Reply