Clarifying the Vytorin Situation: Three Key Questions

Ever since the first Vytorin scare in Q1, the financial media, including CNBC, have consistently reported confused and misleading views on the efficacy of that drug. Not only were they missing the medical qualifications to have a balanced opinion, worse still, they had no perspective to even interpret what was being said by the research community.

It is important that we raise the following three questions to help clarify the situation:

1) According to doctors, patients and all independent medical studies published to-date, Vytorin has demonstrated outstanding results for lowering Cholesterol LDL relative to all other alternatives. How many times has this been covered objectively in the media?

2) Some wicked minds are now questioning the cholesterol / cardiovascular correlation while casting the blame on Vytorin. That questioning applies to all statins of all kinds and not just Vytorin alone. Assuming the question needs more studying, shouldn't it be done by the FDA and not the financial media?

3) Relative to a myriad of drugs with significant side-effects, why the infatuation by the press on Vytorin? Is this because they can scare investors more effectively with rumors and negativity? When will news editors learn the notion of accountability without law suits to remind them that they must?

Disclosure: Long PFE and SGP.

Comments

[anonymous41:]

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.....

2008 Jul 22 09:22 PM

[Mark Moran:]

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...

2008 Jul 23 12:16 AM

[morgan77:]

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?

2008 Jul 23 02:48 PM