SUMMARY:  Merck faced with their block-buster statin, Zocor (simvastatin) was about to go off patent, so they teamed up with Schering-Plough for to market a combination drug, Vytorin, touted as better than either drug.  Their study of this combination drug was showed it to be ineffective was not, completed in April of 2006, however, the study was not released until January of 2008.  Second impropriety, the supposedly neutral American Heart Association (AHA) is financially connected to Big Pharma:  its directors are employed by Big Pharma, including their president who is a  consultant for Merck (the maker of VIOXX and Zocor); second the AHA receives millions form Big Pharma, and finally, a page on the  AHA website that appears to be authored by the AHA was in fact authored by Merck.  The net result was hundreds of millions in sales for Vytorin, which costs over $100 per month to take.  These people could have been taking a generic version of Zocor for under $10/month--jk. 

From FiercePharma, a industry website

http://www.fiercepharma.com/story/vytorin-defenders-funded-by-drugmakers/2008-01-24?utm_medium=nl&utm_source=link

Remember how the American Heart Association rushed to the defense of Vytorin after the results of the Enhance study were released last week? The group issued a statement saying that the study showed the drug to be as safe as the competition, and patients shouldn't rush to judgment.

Well, now several news outlets are pointing out that the association gets almost $2 million annually from Merck and Schering-Plough, which make Vytorin; that AHA president Dan Jones has been a Merck consultant; and that among the $2 million in contributions was a $350,000 sponsorship of a cholesterol page on the association's website--a page that was difficult to distinguish from AHA's other content. In response, the association revamped that web page to make its sponsorship more evident

Too late, though, for the House Energy and Commerce Committee, which now says it will probe the relationship between AHA and Merck/Schering-Plough. The committee also plans to look into links between the companies and the American College of Cardiology, which also issued a statement last week telling patients not to stop taking Vytorin without consulting a doctor. For the record, both groups say their drug company funding had nothing to do with their public statements.

Heart Group Backs Drug Made by Ally

New York Times, at http://www.nytimes.com/2008/01/24/business/24heart.html?_r=1&oref=slogin

By Stephanie Saul, January 24,2008

After a study last week showed Vytorin, an expensive combination of two drugs for cholesterol, worked no better than cheap Zocor alone in reducing artery plaque that can lead to heart attacks, the American Heart Association came to the drug’s defense.In a statement issued on Jan. 15, the day after the report’s release, the heart association said the study was too limited to draw conclusions about Vytorin’s ability to reduce heart attacks or deaths compared to Zocor alone. The group advised patients not to abruptly stop taking it without consulting their doctors.  What the association did not note in its statement, however, was that the group receives nearly $2 million a year from Merck/Schering-Plough Pharmaceuticals, the joint venture that markets Vytorin. Dr. Daniel W. Jones, the president of the American Heart Association, who was quoted in the Jan. 15 statement, said Wednesday that his group did not typically mention its drug company sponsors when issuing news releases with advice to patients.

The House Energy and Commerce Committee plans Thursday to send letters to the association and Merck/Schering-Plough asking about their relationship, a spokeswoman for the committee said. A letter will also be sent to the American College of Cardiology, a much smaller group, which also receives drug industry money and which also released a statement last week advising patients not to stop taking Vytorin without consulting their doctors.

Both organizations said Wednesday that the industry financing had nothing to do with their statements, which they said they issued in response to public confusion about the meaning of the Vytorin study. Merck/Schering-Plough also said it had played no role in the statements by the two groups.

The letters from the Energy and Commerce Committee are part of a broader committee investigation into the research and marketing of Vytorin.

Vytorin, which can sell for more than $100 for a 30-day supply, combines the widely used cholesterol-lowering drug Zocor with another cholesterol-lowering drug, Zetia. Zocor alone is available in a generic form that can sell for less than $6 for a 30-day supply.

The medical study, called Enhance, was the subject of a front-page article in The New York Times on Jan. 15. The article also reported that Merck and Schering-Plough were being criticized for not releasing results of the Enhance clinical trial sooner. The trial ended in April 2006.

The joint venture of the companies, formed in 2000, helps underwrite the budget of the American Heart Association, and its nearly $2 million a year in contributions includes $350,000 to sponsor a cholesterol page on the group’s Web site, according to Dr. Rose Marie Robertson, the association’s chief science officer.

Dr. Sidney M. Wolfe, the head of the Public Citizen’s Health Research Group, a consumer advocacy group, noted that the drug industry underwrites many professional medical organizations and said such funding raised questions about the groups’ objectivity.

“The American Heart Association gets paid and essentially does the company’s bidding,” Dr. Wolfe said.

He also criticized the link between the American Heart Association Web site’s “cholesterol” page and another page: “Food & Family, the 2 sources of bad cholesterol.” Only a reader who looks carefully realizes he has moved from a nonprofit site to the site of a corporate drug maker. Another click and the “Food & Family” page viewer is on the Vytorin Web site.

Both Dr. Jones and Dr. Robertson, who said the association’s Web site was being changed Wednesday night to make the sponsorship clearer, said the organization strived for transparency on its Web page.

“We actually have a policy,” Dr. Robertson said. “You’ve got to have two clicks before you get to any drug information.”

Dr. Jones, who is also dean of the school of medicine at the University of Mississippi Medical Center, said: “We certainly don’t want to ever give the impression that any content that’s put in any place by a pharmaceutical company is delivered or endorsed by the A.H.A. If there is a lack of clarity on that, I will work with our team to make it clear.”

Combination statin and an azetidinones which blocks absorption of cholesterol in the small intestine has been shown to be good at two things:  causing more side effects and improving the bottom line of Merck and Schering-Plough.  For nearly two years the FDA allowed the companies to sit on the results of a trial study which showed that the combination was no better than the statin alone. 

http://www.worstpills.org/public/page.cfm?op_id=78

Drug Companies, FDA Lagged in Warning Public About Zetia, Vytorin

Jan. 14, 2008

Statement by Sidney Wolfe, M.D., Director of Public Citizen’s Health Research Group

Users of the prescription cholesterol medicine Zetia and Vytorin received some troubling news from the makers of the drug today: Although the pills they’re taking lower their cholesterol, there is no evidence that they reduce the risk of heart attacks and strokes, and may, in fact, be putting them at risk.

We first warned against using Vytorin, a combination of Zetia and the cholesterol drug Zocor (now generically available as simvastatin), in December 2004 on our Web site, WorstPills.org. At the time, we said that people should wait at least seven years before taking this new drug, considering that Vytorin wasn’t a “breakthrough” drug, which offers a documented advantage over older, proven drugs.

The Food and Drug Adminstration’s (FDA) own pharmacology reviewer recommended against approval of Vytorin, warning that tests showed serious toxicity in laboratory animals, regardless of how small of an amount of this combination drug was used.

Now, a clinical trial by Merck and Schering-Plough adds to our concerns. It is disturbing that the companies completed the trial in April 2006 but found excuse after excuse not to release the unfavorable results to the public until today.

Unfortunately, we are not surprised. There’s a $20 billion market for cholesterol-lowering drugs and companies will do whatever it takes to get as much of that market as they can, even if it means letting people continue to take prescription drugs that they know are not beneficial and that even may be harmful.

Merck and Schering-Plough offer the excuse that their data are complicated and their analysis of the clinical trial took much longer than anticipated. We’re not convinced. What’s much more likely is that the companies put their stockholders above their responsibility to public health.

We wish we could say this is an isolated case but there are too many other examples of negative findings being buried in the FDA’s files. This year, the drug industry gave $400 million to the drug division of the FDA, which   funds most of the salaries of those scientists who review drugs. You would have to be living on a cloud to think that the money doesn’t have an impact on the FDA’s drug approvals or regulation of the industry.

At the very least, what we learned today is that people who have been taking Vytorin should talk with their doctors and find a better medication.