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The new information was contained in e-mail messages to executives at Schering-Plough that were released by Sen. Charles Grassley (R-IA), the ranking Republican on the Senate Finance Committee. The committee has been investigating the delay in the release of the Enhance trial results.
A day earlier, a panel of cardiologists called on physicians at the annual meeting of the American College of Cardiology to sharply curtail their use of Vytorin and Zetia, following a formal presentation of a study that reinforced the case against their widespread use in fighting cardiovascular disease, “The Wall Street Journal” reported.
The Enhance investigator, John Kastelein, M.D., also complained last July that Merck and Schering had not consulted him on the reasons for the delay and he threatened to resign as the main study investigator.
A spokeswoman for Schering-Plough said the messages had been presented out of context and that Kastelein’s complaints had been resolved months ago, The Journal reported.
Kastelein is a Dutch cardiologist and scientist whom Merck and Schering hired to conduct the Enhance trial, which consisted of images of the arteries of 720 patients taking either Vytorin–the combination of Zetia and Zocor–or Zocor alone. Because Vytorin lowers cholesterol more than Zocor alone, the companies expected that the trial would show that patients who took Vytorin had less growth of plaque in their arteries than those who took Zocor.
The trial ended in April 2006, and its results were initially expected in late 2006 or early 2007. The companies repeatedly delayed releasing the results of the trial, however, saying publicly that many of the images of the arteries were unclear and might need to be re-examined.
By July, Kastelein was privately furious with the companies for the delays, his messages show. “Is it correct that SP has decided not to present at AHA?” he said July 6 in an e-mail message to Rick Veltri, M.D., a vice president at the Schering-Plough Research Institute, referring to the American Heart Assn. conference in November. “If this is the case, our collaboration is over,” he wrote, adding, “This starts smelling like extending the publication for no other [than] political reasons and I cannot live with that.”
Harlan Krumholz, M.D., a cardiologist at Yale, said Kastelein’s messages raised new concerns over the nearly two-year delay in the release of the Enhance results.
“What raises concerns here is the possibility that the delay was being imposed by the companies against the wishes of the principal investigator, who should be the leader of the study,” Krumholz said. “I hope that there was a good scientific explanation, endorsed by a steering committee of credible scientists at the time of the decision to delay, which explains why the public and the profession had to wait so long.”
Krumholz and three other cardiologists told an audience of more than 5,000 people at the annual American College of Cardiology scientific convention that Vytorin and Zetia should not be used except as a last resort.
The two major cardiology associations seconded those recommendations the next day. Prescriptions for the medicines have already dipped about 15% since January, when preliminary results from the Enhance trial were first disclosed. Still, the drugs are widely used, with about three million prescriptions written each month in the United States alone.
LDL cholesterol is known as a risk factor for heart disease, so doctors have generally assumed that lowering LDL cholesterol by any means would reduce the risk of heart attacks and strokes.
But proving that a drug actually cuts those risks requires an expensive, multi-year clinical trial enrolling 10,000 or more patients. Those outcomes trials have been conducted for statins, and have proved that patients taking those drugs do have a reduced risk of heart disease. No such outcomes trials exist for Vytorin and Zetia.
In 2006, four years after Zetia reached the market, Merck and Schering began enrolling patients in their own outcomes study, which compares people taking Vytorin with those taking Zocor alone. But the results of the trial are not likely to be available until 2012, or possibly later.
COPYRIGHT 2008 Washington Information Source, Inc.
COPYRIGHT 2008 Gale, Cengage Learning

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The companies are developing a cholesterol-lowering drug called Zetia that would be used in combination with Zocor.
COPYRIGHT 2002 Racher Press, Inc.
COPYRIGHT 2008 Gale, Cengage Learning

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The wave of litigation started building in courts across the country earlier this year after the drug companies released long-awaited results of a small study that showed Vytorin did not reduce plaque build-up in the arteries. The disappointing study, known by the name Enhance, was completed in 2006.
“By failing to timely release the results of the Enhance trial, which demonstrates that Zetia does not reduce or slow the build-up of arterial plaque, defendants reaped billions of dollars in profits that they otherwise would not have obtained,” the lawsuits allege.
In addition, the plaintiffs claim they might not have purchased the pricey drugs if they had known they didn’t work any better than the generic form of Zocor, which is much less expensive.
In a statement, Merck said it would “vigorously defend” itself against the allegations.
“Vytorin and Zetia have been shown to reduce LDL cholesterol in numerous clinical studies, and they have been approved by the FDA for that indication,” Merck said.
COPYRIGHT 2008 Washington Information Source, Inc.
COPYRIGHT 2008 Gale, Cengage Learning

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* Comment: Treatment with Zetia, which blocks cholesterol absorption in the intestinal tract, reduces LDL cholesterol by about 20%. The effect “is additive to statins…and is comparable with tripling the dose of the statin, as far as efficacy is concerned,” said Dr. Michael Davidson, director of preventive cardiology at Rush-Presbyterian–St. Luke’s Medical Center, Chicago. He expects Zetia to be used mostly in combination with a statin, not only for getting patients to National Cholesterol Education Program II target LDL cholesterol goals, but also to be used as monotherapy or for patients intolerant of statins.
Dr. Davidson was an investigator in an 8-week study of more than 700 patients with primary hypercholesterolemia with coronary heart disease or multiple cardiac risk factors, who were taking a statin but had nor met their LDL cholesterol goal. Among those who had Zetia added to their treatment, 72% reached their goal, vs. 19% of those given a placebo. In trials, Zetia was well tolerated and easy to use, he noted.
Zetia costs about $1.93 per pill (catalog price for direct purchasers). This is “roughly equivalent” to adding 80 mg of a nongeneric statin to 10 mg of the same statin, and provides similar efficacy, said Dr. Davidson, who is on Merck’s speakers’ bureau.
COPYRIGHT 2002 International Medical News Group
COPYRIGHT 2008 Gale, Cengage Learning

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COPYRIGHT 2006 International Medical News Group
COPYRIGHT 2008 Gale, Cengage Learning

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The discovery of the unpublished research comes as Merck and Schering are already under criticism for not yet releasing data from an important Zetia study, called Enhance, that they completed early last year.
The Enhance data may also contain important information about Zetia’s liver risks. At least some patients were dropped from the Enhance study after testing revealed that they had elevated liver enzymes, a Schering-Plough spokesman confirmed in December.
But a full report on that trial, including the number of patients who had liver problems, will not be available until March.
Doctors say that by failing to disclose promptly all their research, Merck and Schering-Plough may be leaving the public with a misleadingly favorable view of Zetia’s safety and benefits.
“You don’t want to have data missing,” said Bruce Psaty, M.D., a professor of medicine and epidemiology at the University of Washington. “When there have been adverse effects, when the benefits don’t look impressive, those are the trials that historically don’t make it to press.”
A Schering executive, when asked by a reporter about the unpublished studies, confirmed their existence. But the executive, Robert Spiegel, M.D., said the companies had not considered the studies scientifically important enough to publish their findings. Some may eventually be published, he said.
“We’re pretty comfortable that people don’t have trouble tolerating Zetia,” said Spiegel, the chief medical officer of the Schering-Plough Research Institute.
Schering also stated that FDA had reviewed the data from the unpublished studies and had approved Zetia for use alongside statins. But experts on drug safety say that the agency has been slow to issue warnings about many widely used drugs that have turned out to carry serious risks, including the painkiller Vioxx, the diabetes medicine Avandia and the anti-psychotic drug Zyprexa.
COPYRIGHT 2008 Washington Information Source, Inc.
COPYRIGHT 2008 Gale, Cengage Learning

Denver, CO - LegalView recently added another new practice area relating to potentially deadly side effects of giving children of a certain age over-the-counter cough and cold medicine. The U.S. Food and Drug Administration (FDA) recently released findings in a public health advisory of, which found that giving over-the-counter cold and cough medication to infants and children under the age of two can cause serious and potentially life-threatening side effects. LegalView’s children’s cough medicine information portal offers readers updated news stories and information from the FDA.

The FDA has yet to complete the review about the safety of over-the-counter cold and cough medication for children ages 2 through 11, but they have acknowledged that serious side effects have been reported for children 2 and older. Some of the children’s cough medication side effects can include overdose and drug toxicity. It is important for parents and caregivers to contact an attorney experienced in dealing with potential children’s cough medicine death to ensure that the proper steps to quality care are taken.

The FDA recommended that if nonprescription cough and cold medicine must be given to children that parents and caregivers use exact measuring spoons or cups to measure the drug as well as follow the appropriate guidelines based on a child’s weight and age. The FDA also suggested that individuals be sure to watch frequency and amount of medication given to a child in order to avoid overdose. Additionally, it is advisable to read the active ingredients of medication and to store medications out of a child’s reach. For individuals who have used over-the-counter cough or cold medication on their child and are concerned with potential harm done, contact an experienced attorney through http://childrens-cough-medicine.legalview.com to learn about the possibility of building a case and receiving compensation.

In addition to this new practice area, LegalView also recently unveiled two new practice areas on drugs Vytorin and Zetia. Vytorin is cholesterol reducing oral medication with one of its active ingredients being Zetia, which is also used in a variety of other cholesterol reducing medications. A recent study of the two drugs found that they were nearly three times more expensive but no more effective than the generic versions. Vytorin and Zetia were also found to be less likely to reduce plaque buildup within the arteries, which could potentially lead to a heart attack. To learn more about the drugs or to contact a Vytorin lawyer or Zetia law firm. For more information on other medical conditions and legal issues, such as the possible connection between the diabetes drug Avandia and osteoporosis visit http://www.LegalView.com.

Also at http://www.legalview.com/, readers can learn about mesothelioma cancer, which is a rare and deadly lung disease that occurs when asbestos fibers and dust are inhaled and cause the creation of cancerous cells on the interior lining of the lung. Asbestos has been previously used to in the construction of government buildings, homes, schools, universities as well as many other structures. If you or a loved on is suffering from mesothelioma cancer or may have previously been exposed to asbestos fibers, contact a mesothelioma law firm to learn about receiving compensation for your case.

About LegalView:

LegalView.com is a public service brought to you by Legal WebTV Network, LLC, a Limited Liability Corporation created by a group of the nation’s most highly respected law firms: Anapol Schwartz; Brent Coon and Associates; Burg Simpson; Cohen, Placitella and Roth; James F. Humphreys and Associates; Lopez McHugh; and Thornton and Naumes. For more information on the accomplishments and track records of LegalView.com’s superior sponsoring law firms and to get in touch with LegalView attorneys, visit LegalView at www.LegalView.com.

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Sales declines experienced since the release of clinical data from the ENHANCE study in January moderated late in the first quarter of 2008, but may trend downward depending on the application by cardiologists and primary care physicians of a recommendation by a panel of physicians at the recent American College of Cardiology (ACC) meeting. The ACC panel suggested that Vytorin and Zetia should be used only after patients fail to achieve cholesterol reduction goals with other statins and ‘proven’ medicines, including lower-cost generics. The Rating Watch Negative will likely be in place over the next few quarters as more clear evidence of the extent of sales erosion becomes available.
The company’s credit profile is highly sensitive to changes in equity income from affiliates, mainly derived from the Merck and Co, Inc. (Merck)/Schering-Plough joint venture, responsible for the marketing of Vytorin and Zetia. Demand pressures for the drug products directly negatively affect equity income derived from the Merck/Schering-Plough joint venture. Potential significant declines of equity income would compress EBITDA margin, reversing the solid operational performance achieved by the company over the past few years. EBITDA margin increased annually to 23.7% for 2007 from a low of 7.1% in 2004.
Schering-Plough is also in the midst of integrating Organon Biosciences. Fitch recognizes that in the first year of operating the new businesses, additional integration costs may weigh on the company’s credit profile and that synergies may not outweigh integration costs in the intermediate-term. Additionally, litigation and government investigations surrounding the release of the ENHANCE study data add a layer of risk to the credit profile.
Schering-Plough maintains solid liquidity provided by a new $2 billion revolving credit facility and sustained free cash flow generation. Free cash flow was $1.51 billion for the full year of 2007 and $1.29 billion in 2006. Additionally, the company had cash and equivalents and short term investments of $2.31 billion at the end of 2007.
Fitch has placed the following ratings on Rating Watch Negative:
— Issuer Default Rating (IDR) ‘BBB’;
— Senior unsecured debt rating ‘BBB’;
— Bank loan rating ‘BBB’;
— Convertible preferred stock rating ‘BBB-’
— Short-term IDR ‘F2′.
— Short-term debt rating ‘F2′.
Fitch’s rating definitions and the terms of use of such ratings are available on the agency’s public site, www.fitchratings.com. Published ratings, criteria and methodologies are available from this site, at all times. Fitch’s code of conduct, confidentiality, conflicts of interest, affiliate firewall, compliance and other relevant policies and procedures are also available from the ‘Code of Conduct’ section of this site.
COPYRIGHT 2008 Business Wire
COPYRIGHT 2008 Gale, Cengage Learning

Heparin is an anticoagulant that is often used during surgical procedures such as kidney dialysis or heart surgery. It thins the blood in order to avoid the development of deep vein thrombosis, which can be deadly in surgery. Heparin is derived from pig intestines and has been imported, predominately from China, since the 1930s.

Manufacturers of the drug, Baxter International Inc., issued the Heparin recall in January but have since been battling with Chinese regulators who claim the Baxter Heparin contamination occurred at the Baxter New Jersey factory. Chinese officials have said that the Heparin was manufactured and sent to several other countries who had not reported the side effects that the Baxter Heparin victims did. However, the FDA claims, upon the results of their investigation, that the tainted Heparin went to 12 countries. The FDA also explained that the side effects did occur in individuals in Germany, but were more prevalent in the United States because of the practice among U.S. surgeons to use more Heparin in patients.

For more information on this or other pharmaceutical complications, visit http://www.LegalView.com, where individuals can find information on a range of issues such as details of a potential Zetia lawsuit, mesothelioma litigation or construction accidents.

Zetia is a prescription medication that can be used to treat dyslipidemia, occurring when the amount of lipids in the bloodstream becomes imbalanced, thus increasing the amount of bad cholesterol among an individual. A study that was released evaluating the drug found that the drug was actually less beneficial than generic versions, despite being more than three times as expensive. To learn about a Zetia lawsuit contact a pharmaceutical law firm in your area.

Individuals needing help locating mesothelioma lawyers or a construction accident attorney can use the mesothelioma practice area at http://mesothelioma.legalview.com and for construction accidents, visit http://construction.legalview.com/.

About LegalView:

LegalView.com is a public service brought to you by Legal WebTV Network, LLC, a Limited Liability Corporation created by a group of the nation’s most highly respected law firms: Anapol Schwartz; Brent Coon and Associates; Burg Simpson; Cohen, Placitella and Roth; James F. Humphreys and Associates; Lopez McHugh; and Thornton and Naumes. For more information on the accomplishments and track records of LegalView.com’s superior sponsoring law firms and to get in touch with LegalView attorneys, visit LegalView at www.LegalView.com.