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?

Think of it as a device that scrubs the blood clean, much like kidney dialysis, except that the machine targets and removes bad LDL cholesterol instead of the impurities removed by dialysis.

The cholesterol machine draws the patient’s blood from one arm. It then breaks the blood down into red blood cells and plasma, sending the red cells back into the patient’s bloodstream. Meanwhile, the machine infuses the blood plasma with the blood thinning drug heparin, which binds to the LDL cholesterol, thereby drawing it out of the plasma. The device then sends the clean plasma back into the patient’s other arm.

The machine removes and cleans 2.5 liters of blood, about half of the body’s blood supply.

This two-hour process is short lived, so it must be repeated every two weeks for effective treatment of high cholesterol. The therapy is also extremely expensive, costing about $3,000 for each session ($6,000 per month), and as such is currently used only as a last resort for patients who have been unable to lower their cholesterol after six months of diet, exercise, and pharmaceutical medicines.

Some people rack up their cholesterol score from the foods they eat. For others, too much bad LDL cholesterol is produced by the liver, thanks to the family genes. For many, elevated cholesterol comes from both sources.

To combat the cholesterol problem on both fronts, Merck teamed up with Schering-Plough to create Vytorin, a drug that combines Merck’s Zocor with Schering-Plough’s Zetia. However, clinical trials revealed that the drug was at best a flop and at most a toxic cancer-promoting drug. In either case, it failed to treat cholesterol any more effectively than cheaper generic statins.

There’s a good chance that most patients who qualify for treatment on the LDL apheresis machine have tried Vytorin first but found it to be ineffective in controlling their levels of LDL cholesterol. Familial hypercholesterolemia, a genetic predisposition for high cholesterol, occurs in approximately 1 in 500 people.

Sources include: http://www.liposorber.com/ldl/index.htm, and http://www.stltoday.com

SOURCE: Vytorin Recall › Lowering LDL by machine vs. Vytorin and Zetia

These newest job cuts come on top of cutbacks that Merck made as part of an earlier restructuring program. Merck began eliminating 10,400 jobs from its global workforce in 2005 and completed that set of cutbacks last month.

Merck’s Chief Executive, Richard Clark, acknowledged the company faced a challenging economic environment in the immediate future.

“Our current sales trends for key products, compounded by known industry and emerging economic factors, have led us to reassess the environment in which we expect to be operating between now and 2010,” he said in a statement.

According to Merck, the 12-percent reduction of its workforce translates to 6,800 employees losing their jobs and some 400 vacancies that will go unfilled. The measures should amount to a savings of $3.8 billion to $4.2 billion by the end of 2013, the company said.

Merck’s embattled cholesterol drugs Vytorin and Zetia continue to earn the company profits, but those profits continually fall as concerns over the drugs’ safety and efficacy rise. Studies have indicated that Vytorin is no more effective than cheap generics and that using it may increase the risk of developing cancer and dying from cancer.

Negative press has knocked Vytorin and its component Zetia, which is also prescribed separately, down from blockbuster status to something more of a financial and legal liability.

SOURCE: Vytorin Recall › Merck cuts more jobs as Vytorin, Zetia sales drop

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

The University of Washington’s Thomas Fleming is one respected statistician and adviser to the FDA who cautions against dismissing Vytorin’s link to cancer as merely an anomaly. Leading researchers involved with the SEAS study, which uncovered a Vytorin-cancer link, maintain that the results were a fluke.

In an editorial published in The New England Journal of Medicine, Fleming says that at this point in time, it’s too early to dismiss the Vytorin-cancer link. He suggests that the drug may have more adverse side effects than actual benefits. “ … There are numerous recent cases in which it has been established or strongly suggested that [side] effects of such [drugs] have adversely altered their risk–benefit profile.”

Scientists quick to dismiss Vytorin’s apparent link to cancer support their case by pointing to two larger ongoing studies that appear to diminish the drug’s risks. According to Fleming, however, “There are clinically important increases in the risk of cancer-related death that are not ruled out by this data.” He also argues that prematurely releasing results from the other tests jeopardizes their conclusions.

Vytorin sales soared to the tune of $5 billion in 2007, but dropped by a third after reports of negative tests began to surface. Considering such profits, altering and masking potentially harmful clinical trial data might seem like a good profit-preserving strategy, but it makes you wonder what it’s like to work in the Public Relations department at Merck and Schering-Plough.

SOURCE: Vytorin Recall › scientist cautions against dismissing Vytorin-cancer link

One recent clinical study revealed that Vytorin and Zetia are no more effective than generic statins, which cost about half as much. Another trial suggested a link between Vytorin and increased risk of developing and dying from cancer. Prescriptions plummeted and along with them, company revenues. Government inquiries about the release and apparent manipulation of clinical data are amounting to a public relations debacle.

Today, Schering-Plough announced that it will eliminate 1,000 positions from its 5,000-rep sales force. The cutbacks are part of a 10 percent reduction of Schering-Plough’s general workforce, which the company announced last April. Altogether, the cuts represent $1.5 billion in savings. Schering-Plough’s purchase of Organon Biosciences for $14.4 billion is another key factor in its decision to cut back and reorganize its workforce. Interestingly, in a statement to the Associated Press, Schering-Plough says the cuts are designed to improve the company’s customer relations.

Merck announced back in May that it was cutting 1,200 sales reps from its work force, on top of already 8,100 additional positions slashed in 2005. Ken Frazier, president of Merck’s global human health unit, issued the following statement regarding the cuts:

“With eight successful launches of Merck products approved in the US since 2006 now behind us, and with an unexpected delay in a new product approval, we decided to accelerate the achievement of efficiencies we anticipate gaining as we transition to our new commercial model in the US.”

Online translation utilities don’t yet include CEO-speak to English, but I’m fairly certain Mr. Frazier’s statement translates to “Merck needs money.”

SOURCE: Vytorin Recall › Vytorin, Zetia squeeze manufacturers

The study, which monitored the progress of 1,873 subjects, found that 37 of the subjects taking Vytorin died of cancer, compared to 20 subjects who died of cancer while receiving a placebo. The data is rightfully alarming, but the study’s leaders maintain that it is a fluke. To support their claim, they point to two larger studies still in progress – SHARP and IMPROVE-IT. Numbers from those studies combined still show a higher rate of cancer among Zetia users, but only enough to be statistically irrelevant or at least inconclusive.

However, some professionals who are following the study, including a panel of doctors from The New England Journal of Medicine, argue that there is indeed a legitimate cause for concern, not the least of which that all three trials revealed more cancer in Zetia users. They also point out that Zetia “interferes with the gastrointestinal absorption not only of cholesterol but also of other molecular entities that could conceivably affect the growth of cancer cells.”

The other “molecular entities” include the tumor-fighting and cholesterol-busting superhero: plant-derived sterols. People ingest sterols every time they eat fruits and vegetables. Because Vytorin interferes with the body’s absorption of sterols, then it may, in theory, promote cancer.

The FDA expects to receive a final SEAS report in about 12 weeks. The agency anticipates it will take another 6 months to review and evaluate the study data, after which it will issue its conclusions and recommendations. In the meantime, the FDA has advised health care professionals to monitor their patients on Vytorin and to report side effects to the agency.

SOURCE: Vytorin Recall › SEAS study may link Vytorin, cancer