The SEAS study sought to test Vytorin’s effectiveness as an alternative to surgery in reducing arterial clogging caused by high cholesterol. The results, which were announced in a July 2008 press conference, did not favor the drug. Not only did researchers find that Vytorin worked no better than cheaper, generic statins, they also discovered that patients taking Vytorin experienced 50 percent more new cancer cases and cancer deaths than the subjects who took placebos.

Merck and some of the researchers connected to the SEAS study dismissed the results as a “fluke,” while many physicians and medical researchers not connected to the drug company remained skeptical and cautioned consumers to stick with traditional statins to control cholesterol levels. For instance, Merck’s Zocor, taken alone, was shown to be more effective than Vytorin and cost about one-third as much because it had become available as a generic drug.

That research promoted many municipalities that had included Vytorin in their health plans to file lawsuits against Merck, essentially asking for their money back. Vytorin and its sister drug Zetia, made by Schering-Plough, brought in sales of more than $5 billion at their peak. The sales have fallen but continue to earn $4 billion annually.

Vytorin is a hybrid drug which combines Merck’s Zocor with Schering-Plough’s Zetia to combat both dietary and hereditary cholesterol. The FDA said that ample evidence exists showing Zocor to be safe, but insufficient evidence exists on Zetia to “rule out a cancer risk at this time.”

Two additional Vytorin studies known by the acronyms SHARP and IMPROVE-IT are ongoing and scheduled to end in 2010 and 2012.

SOURCE: Vytorin Recall › FDA says it finds no Vytorin-cancer link, but unsure

Merck

The Enhance study revealed that the pairing of Schering-Plough’s Zetia and Merck’s Zocor, which constitutes Vytorin, to be no more effective and possibly even less effective than Zocor alone or other much cheaper, generic statins in treating arterial plaque.

But more than the disappointing results, there was the delay in making this information public. Results of the Enhance trial were completed in April 2006 but were not released until January 2008, after mounting pressure and suspicion over the delay.

Many plaintiffs, including a number of municipalities, sued Merck and Schering-Plough upon discovering that the drug makers knew the results of the Enhance trial but withheld them from the public for up to 2 years. The trial revealed Vytorin to be no more effective than cheaper generic statins in controlling cholesterol.

Nevertheless, the drug makers forged ahead with aggressive marketing campaigns for Vytorin, earning billions while allegedly knowing about the drug’s shortcomings.

Last month, Merck and Schering agreed to settle with attorneys general from 35 states who claimed the drug makers improperly marketed Vytorin and Zetia. Merck agreed to pay the states $5.4 million for costs accrued in investigating the potential violations of consumer-protection laws.

The settlement announced this week resolves all of the lawsuits seeking class-action status that were filed in New Jersey federal courts by consumers who bought and used Vytorin or Zetia. Many of the complaints sought compensation for personal injury caused by the drugs. The SEAS trial uncovered a possible link between Vytorin and higher cancer risks.

Lawsuits against the companies over securities law violations are still pending, as is the U.S. Department of Justice’s investigation into whether the drug makers’ marketing tactics led to false claims being submitted to federal healthcare programs. Moreover, congressional committees continue to inquire about the companies’ handling of the Enhance trial.

SOURCE: Vytorin Recall › Merck and Schering pay $41.5 million to settle NJ lawsuits

Not surprisingly, Merck and Schering-Plough have been taking hits quarter after quarter because of Vytorin’s disastrous performance in clinical trials. Nearly a year ago, Schering-Plough promised to provide regular reports on the performance of its anti-cholesterol market. Their last update, which was filed with the Securities and Exchange Commission in mid November, indicates that Vytorin’s plunge has actually leveled off.

Much speculation has been made about where Vytorin and Zetia (Zetia is a component of Vytorin, as well as a freestanding prescription drug) would bottom out. The total number of prescriptions written in October was 2,186,000, which represents a slight increase over September’s figure of 2,171,000.

Despite the slight gains, however, the chances of a future Vytorin / Zetia freefall still look good. In 2009, many Medicare Part D changes take effect, and many of the providers have kicked Vytorin down to Tier-3 status or worse in their formularies based on the clinical evidence that Vytorin is no more effective than cheaper, generic statins. Therefore, Vytorin will become a much more expensive option for patients. In today’s economy — and most likely even in tomorrow’s economy — a prescription that costs much more than generics yet performs on par with them or even worse than them, is not likely to be winner.

SOURCE: Vytorin Recall › Have Vytorin’s falling sales finally stabilized?

The answer is a surprising, and disconcerting, NO.

Trials for new prescription drugs that are vying for a place in the market focus on efficacy rather than safety. If pre-market clinical tests find a drug to be effective and that drug does not appear to be unsafe, then the FDA typically approves the drug and that drug enters the market. Many pre-market studies, however, simply are not large enough to allow researchers to gauge the safety of a new drug. A determination of safety is made usually after thousands of people have taken the drug. That is to say, the safety of a new drug is only fully known once it has been widely available to consumers.

Taking new prescription medicines makes the consumer an unwitting guinea pig of sorts. The hybrid anti-cholesterol drug Vytorin, for instance, was prescribed to millions of people before the ENHANCE trial found it to be effective in lowering LDL cholesterol levels but ineffective in preventing cardiac events, which is its ultimate purpose. Another trial named SEAS later suggested that Vtytorin increased the odds of developing and dying from cancer. Vytorin continues to be sold while researchers continue probing its effectiveness and safety. The results from larger tests aren’t expected until 2012.

Currently, the rights of consumers who have been harmed by toxic prescription drugs and faulty medical devices are standing on unsteady ground. The issue of pre-emption, the legal notion that FDA approval of a drug trumps state laws concerning safety, efficacy, and proper labeling, is now before the United States Supreme Court. Diane Levine, a musician from Vermont, sued Wyeth earlier this month over inadequate labeling of the drug Phenergan, which caused her to lose part of her right arm. Wyeth’s defense argues that the company shouldn’t be held responsible by state laws because the drug met federal standards by gaining FDA approval.

If the Supreme Court rules that federal standards do supersede state laws, or if it throws the case out altogether, then many people may have no legal recourse should they ever fall victim to risky drugs and medical devices.

Keeping the issue of pre-emption in the public eye as the Supreme Court mulls the Levine case, a non-profit group called Alliance for Justice has created a documentary about pre-emption. A trailer for “Access Denied: The Fight for Corporate Accountability” can be viewed here. The video can also be viewed in its entirety by going here.

SOURCE: Vytorin Recall › Will FDA regulations and pre-emption silence Vytorin victims?

Most analysts expected the market for Vytorin to bottom out over the summer after the SEAS results became public — an event that many felt would deal the already wounded Vytorin a coup de grace. Not so, however. Vytorin refuses to assume its place on the list of has-beens with grace. Instead, it continues to stumble, choke, and flail.

The latest monthly data for Schering-Plough shows that Vytorin prescriptions continue to decline. Prescriptions for Vytorin were down 3.7 percent in September, and the drug’s share of the cholesterol market dropped from 6.4% to 6% in August. Before the SEAS and Enhance trials, Vytorin took about 8 percent of the total cholesterol market.

At the same time, prescriptions for Zetia, Schering-Plough’s half of the dualistic Vytorin, dropped 1.5% in September. Merck’s Zocor comprises the other part of Vytorin. Together, Schering-Plough and Merck shared 15.2% of the cholesterol management market last January. By June their share had fallen to 12.1 percent. Last month, the share dropped further to 10.8 percent.

Since Vytorin failed to meet it primary endpoint in the SEAS trial, was shown to be no more effective than cheaper generic statins, and has been linked to increased cancer risks, it makes you wonder why it’s being prescribed at all.

SOURCE: Vytorin Recall › Vytorin loses market strength … again

New Haven City Hall spent more than $400,000 on Vytorin and Zetia (ezetimibe) prescriptions for members of the city’s healthcare plan when it could have spent a fraction of that amount for cheaper generic statins that have proven to be as or more effective and less risky.

Zetia is Merck’s anti-cholesterol drug that works by blocking absorption of cholesterol in the digestive tract. It is combined with Schering-Plough’s statin drug Zocor, which targets cholesterol produced by the liver, to form Vytorin – a drug that works to diminish cholesterol on both hereditary and dietary fronts. Studies have shown, however, that cheaper generic statins are in some cases more effective and safer than the Vytorin cocktail.

“This drug doesn’t work. Period. It just doesn’t work,” Steven Nissen, head of cardiology at the Cleveland Clinic, told Forbes magazine.

Merck and Schering-Plough are under Congressional inquiry for possibly withholding study data that indicated Vytorin was a flop while collecting billions in sales from the drug. The companies collected windfall profits knowing that cheaper and possibly more effective drugs were on the market.

Growing controversy over Vytorin’s performance and the way its makers have handled both past and ongoing studies have spawned a number of class action lawsuits. New Haven wasn’t able to find a suit that it could join, so it’s striking out on its own.

SOURCE: Vytorin Recall › New Haven wants to recover Vytorin money

MK-0524A, as the new drug is called, is the subject of a study based in Oxford University in England. Merck submitted the drug to the FDA for approval, but it was rejected last April. The FDA wanted results from the study known as THRIVE (Treatment of HDL to Reduce the Incidence of Vascular Events) before it made another ruling.

The study already involves 20,000 people from the UK, Scandinavia, and China who are taking the experimental drug. The problem for Merck, however, is the timeline. The study began in 2006 and is set to end in January of 2013. Sufficient data wouldn’t be available until 2010.

To speed the study along, Merck will increase the number of participants in THRIVE to 25,000. Merck hopes that having more trial participants will amount to obtaining results several months earlier.

In a statement issued by Oxford University, Professor Jane Armitage, one of the principal investigators of MK-0524A sounded hopeful about the study’s expansion, saying that “In terms of numbers, bigger is very much better.”

“This enhancement will give us a more powerful tool with which to assess this intervention for the benefit of heart patients everywhere. The study is scheduled to end in 2013, but with these additional patients, we hope that it will be able to report sooner,” she said.

Merck expected the new drug to stimulate its share of the cholesterol market, which suffered a serious blow when Vytorin was revealed to be first a dud and then a danger. Researcher claim that by speeding up the THRIVE trial, they will be able to help people with vascular disease sooner. For Merck, it’s likely to be a matter of replacing lost profits and establishing a pipeline that’s more appetizing to investors.

SOURCE: Vytorin Recall › Merck speeds trial of new cholesterol drug

Suffolk County joins Congress and a growing number of individuals and municipalities in claiming it had been ripped off by the pharmaceutical giants. Suffolk County’s case states that Merck and Schering-Plough engaged in a “scheme … calculated to ensure that Plaintiff would pay for Zetia and Vytorin despite cheaper and effective alternatives.

However, Suffolk County has added a little more heft to its lawsuit than other similar suits filed against the drug companies. On page 25 of the deposition, Suffolk County claims:

“Defendants have conducted and participated in the affairs of the Enterprise through a pattern of racketeering activity that includes acts indictable under 18 U.S.C. ++ 1341 and 1342 (mail and wire fraud) …”

Confusion and outrage have surrounded the ENHANCE trial results and the way in which Merck and Schering-Plough officials released the results, sparking Congress to launch an investigation. The Suffolk County lawsuit, however, goes further than just accusing the companies of negligence; it claims the companies may have acted criminally. In this lawsuit we see phrases indicating some serious charges:

“…concealing from Plaintiff and physicians, and the public the results of the ENHANCE study …”

“… deliberately misrepresenting the efficacy of Zetia and Vytorin …”

“publishing or causing to have published materials containing false information …”

“… pattern of racketeering activity …”

SOURCE: Vytorin Recall › Suffolk County NY sues for return of Vytorin money

To be completely fair, pharmaceutical companies continually develop vaccines and medicines that improve the quality of life for millions of people throughout the world. Many modern pharmaceuticals also extend and save lives. In the western world, we can’t imagine life without these modern medicines.

However, events surrounding the drug Vytorin have cast into doubt the intentions – and the integrity – of pharmaceutical giants Merck and Schering-Plough. As marketing expert Rob Frankel recently told Advertising Age magazine, “The pharmas are in big trouble in terms of credibility. They’re just above congress and used-car salesmen.”

Why?

First there is the ENHANCE study that revealed the pairing of Zetia and Zocor to be no more effective than Zocor alone in treating arterial plaque. But more than the disappointing results, there was the delay in making this information public. Results of the ENHANCE trial were completed in April 2006 but were not released until January 2008, after mounting pressure and suspicion over the delay.

On May 1, 2007, before the ENHANCE results were made public, Schering-Plough’s president Carrie Smith Cox, dumped 900,000 shares of company stock, worth an estimated $28 million. The sale prompted Congress to investigate the upper realms of Schering-Plough for concrete evidence of insider trading.

While ENHANCE data were being withheld, Merck and Schering-Plough continued to heavily advertise Vytorin, spending hundreds of millions on the famous commercials featuring the aunt who looks like a pot roast. The companies knew the results of the study, yet their aggressive marketing raked in $3-5 billion per year since Vytorin’s appearance on the market. Meanwhile, patients continually overpaid for a drug that didn’t do what the ads claimed it would do.

Congress again stepped in to demand answers as to why consumers, including the federal government, had been fleeced for so long. Senator Chuck Grassley of Iowa sent a letter to the top of both companies in which he stated, “I have an obligation to the more than 80 million Americans who receive health care coverage under Medicare and Medicaid to ensure that taxpayer and beneficiary dollars are spent in a fiscally sound manner.” In the same letter, he also pointed out that at, “… a Wal-Mart pharmacy in Iowa City, generic simvastatin costs $54.54 for a month’s supply. On the other hand, Vytorin costs $112.46–more than twice as much.”

The federal government is also investigating why the ENHANCE test results released by Merck and Schering-Plough differ from the information released by those who conducted the study. A letter from the U.S. House of Representatives Committee on Energy and Commerce to Fred Hassan (Schering-Plough) and Richard T. Clark (Merck) states, “The ENHANCE trial was completed in 2006, and yet no data from the trial have been published or presented in their entirety. In fact, it appears that the study itself was not registered with ClinicalTrials.gov until October 31, 2007, a full 18 months after completion of the study. In addition, the endpoint indicated in the ClinicalTrials.gov web site appears to differ from the endpoint described in the initial study design.”

Representative Bart Stupak , D-Mich, told CBS’s Early Show “There’s certainly major misrepresentations not only to the effectiveness of the drug, but manipulating of the scientific data to further promote a product that isn’t doing what it was designed to do.”

With all of the controversy surrounding Vytorin, it would seem that Schering-Plough has sought to earn more mistrust every day and that Merck intentionally put profits before people.

SOURCE: Vytorin Recall › Vytorin scandals evoke mistrust

Merck and Schering-Plough teamed up to create Vytorin, a new cholesterol-fighting drug that combined the power of statins with Zetia, a drug that reduces absorption of cholesterol in the intestine. In this way, the battle against cholesterol would occur on both genetic and dietary fronts.

Data from the ENHANCE study, however, revealed that Vytorin was largely a flop. While it lowered LDL cholesterol, it did nothing to actually reduce plaque in the carotid arteries as promised.

Dr. Harlan Krumholz, a Yale University cardiologist, told the Associated Press that “people need to turn back to statins. We know that statins are good drugs. We know they reduce risks.”

Dr. Roger Blumenthal, a Johns Hopkins University cardiologist and spokesman for the American Heart Association, likewise advised against prescribing Vytorin, at least as the first line of treatment. “A lot of us thought that there would be some glimmer of benefit,” he told the AP, adding that doctors should first prescribe more traditional, proven cholesterol lowering drugs before turning to Vytorin.

Dr. John Kastelein, a Dutch scientist and the primary investigator for the ENHANCE trial, sounded the harshest criticism. The AP report quotes him as saying that Vytorin showed “no result . Zilch. In no subgroup, in no segment, was there any added benefit” in patients seeking to reduce plaque buildup.

Studies of Vytorin continue. IMPROVE-IT, an ongoing trial slated to end in 2012, will compare and measure the primary effects of Vytorin and simvastatin alone in approximately 18,000 patients with acute coronary syndrome. Another trial, SHARP is monitoring the results of Vytorin and placebo in kidney patients.

SOURCE: Vytorin Recall › Doctors say stay with statins