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

Dr. Scannell said the drug made her list as a result of two studies that revealed Vytorin, which is a combination of simvastatin (Zocor) and ezetimibe (Zetia), did not reduce artery-clogging plaque buildup, although tests showed it reduced “bad” cholesterol levels.

However, she said Vytorin’s bad year wasn’t all bad for consumers, as research from the study revealed a fundamental benefit of statin drugs to people with normal cholesteral but high indicators of inflammation. She says the Vytorin failure also brought to light “the importance of knowing how new drugs actually affect the people who take them – not just their blood tests.”

Dr. Kate Scannell is an East Bay physician and syndicated columnist.

SOURCE: Vytorin Recall › Vytorin No. 3 on list of Top 10 medical stories of 2008

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?

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

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

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

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

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