By DAMIAN TROISE
NEW YORK (AP) — Shares of Merck & Co. and Schering-Plough Corp. fell to record lows Monday, as analysts warned new clinical data would cause sales of their blockbuster cholesterol drug Vytorin to fall further.
The companies market Vytorin through a joint venture, but earlier this year, partial results from a clinical study showed that it was no more effective at limiting plaque buildup than Merck’s Zocor, a drug that is already available in generic form. Full results of that study were released Sunday.
Vytorin is a combination of Zocor and Schering-Plough’s drug Zetia.
Schering-Plough shares plunged as low as $14, touching their lowest levels since August 1996. Merck shares fell as low as $36.82, their lowest since June 2006.
Leading physicians are now recommending the use of older drugs called statins before putting patients on Vytorin. Many physicians had prescribed Vytorin in lieu of higher doses of statins because of what some said was an undue fear of side effects.
“There was an irrationality to begin with,” said Dr. John LaRosa, president of State University of New York Downstate Medical Center.
One ultimate result of the outcome could be a tightening of regulatory standards at the FDA when it comes to approving cholesterol drugs, LaRosa said.
Wall Street, meanwhile, expects prescriptions of Vytorin to decline further in the wake of a recommendation to use the drug only after initial therapy with older drugs like Pfizer Inc.’s Lipitor and AstraZeneca PLC’s Crestor.
Lehman Brothers analyst Charles Butler downgraded Schering-Plough shares on the news, and cut his price target on the stock by more than 40 percent.
He said prescriptions of Vytorin will keep falling, and because Schering-Plough relies heavily on the joint venture, he slashed his profit estimates over the next five years.
Besides the Vytorin news, Merck also halted enrollment in a study for the cholesterol drug Cordaptive, which uses the same ultrasound measurement from the now-failed Vytorin study.
In a separate statement, the company said high doses of the experimental obesity treatment taranabant are being cut out of a late-stage study because of higher rates of gastrointestinal side effects, depression and anxiety. The high doses were no more effective than low doses, the company said.
AP Business Writer Marley Seaman in New York contributed to this report.
By Anna Boyd
New research has revealed that mobile phones are more injurious to people’s health than smoking. Why is that? It seems that mobile phone usage and brain cancer are linked to each other.
According to one of the world’s top neurosurgeons, British Vini Khurana, using mobile phones for 10 years could double the risk of brain cancer. “This danger has far broader public-health ramifications than asbestos and smoking,” he told the Independent of London.
Dr. Khurana based his assessment on the fact that three billion people now use the phones worldwide, which is three times higher than people who smoke. Smoking kills some five million globally each year.
Dr. Khurana reviewed more than 100 previous studies on the effects of mobile handsets and concluded people should avoid using cell phones whenever possible and called on governments and industry to take “immediate steps” to reduce radiation exposure through the devices.
“In the years 2008-2012, we will have reached the appropriate length of follow-up time to begin to definitively observe the impact of this global technology on brain tumor incidence rates,” he said.
The French government has already warned against mobile phone use, particularly by children. Also, Germany and the European Environment Agency have urged its people to minimize their exposure to mobile handsets.
The Mobile Operators Association, last week, rejected Dr. Khurana’s study as “a selective discussion of scientific literature by one individual.” It “does not present a balanced analysis” of the published science, and “reaches opposite conclusions to the World Health Organization and more than 30 other independent expert scientific reviews.”
Dr. Khurana posted his analysis on a neurosurgery Web site and a paper about his research is currently under peer review for publication in a leading scientific journal.
[Source: efluxmedia.com]
By Matthew Herper
CHICAGO -
Merck and Schering-Plough had hoped new results presented Sunday would ease worries about the usefulness of their cholesterol drugs, Zetia and Vytorin. Instead, for many researchers, anxiety about the medicines is deepening.
The companies’ share prices have fallen 25% since part of the data was released in January. They counted on the full release of the study, called ENHANCE, to restore investor confidence in their $5.2 billion cholesterol franchise. The opposite is now likely.
“It’s going to temper the use of these drugs, there’s no doubt in my mind,” says Douglas Weaver, a cardiologist at Henry Ford Hospital and the president of the American College of Cardiology, which is meeting in Chicago this weekend. Says Harlan Krumholtz, of Yale University, a member of an expert panel that will discuss the drugs at the ACC meeting: “The burden of proof is on the companies to prove Zetia and Vytorin are safe and effective. They have not done that yet.”
The New England Journal of Medicine, which published ENHANCE Sunday at 1 p.m. Eastern, took the unusual step of printing not one but two editorials about the study, both recommending doctors only turn to Zetia and Vytorin after they had exhausted all other options. Another study, by Krumholtz, found the drugs–which are much more expensive than rival generics–are prescribed four times more often in the U.S. than in Canada, where direct consumer advertising is banned.
Merck (nyse: MRK - news - people ) and Schering-Plough (nyse: SGP - news - people ) disagreed with the contention that use of Zetia and Vytorin should be limited. “What we do not agree with is that it should be used as a second- or third-line therapy,” says Enrico Veltri, the Schering-Plough vice-president in charge of heart disease drugs. “We don’t think it needs to be a last resort.”
More than a dozen cardiologists reviewed the New England Journal publications for Forbes. The vast majority expected use of Zetia and Vytorin would decline following the release of the data.
Zetia is approved for lowering cholesterol, but there is no evidence it prevents heart attacks and saves lives like the statin drugs, including Lipitor and Zocor. Guidelines from the ACC and the American Heart Association say that Zetia should only be used in patients who can’t get their cholesterol down far enough with statins. Vytorin is a combination of Zetia and Zocor.
“The willingness of U.S. physicians to so rapidly adopt an unproven therapy is worrisome,” says Paul Ridker, a cardiologist at the Brigham and Woman’s Hospital in Boston. “The questions patients with high cholesterol should ask their physicians is simple: Will the drug you are giving me lower my risk of heart attack or stroke? If not, why are you prescribing it?”
In the artery study, doctors gave 720 patients with a genetic disease that causes high cholesterol either the Vytorin combination pill or just the Zocor component. Researchers then used ultrasound devices to measure the thickness of the arteries in their neck and leg. Atherosclerosis, the disease that leads to heart attacks and strokes, causes arteries to thicken, so the patients on Vytorin should have had skinnier artery walls than those on Zocor alone because of their lower cholesterol levels. They didn’t.
Instead, the arteries of patients on Zocor became 0.006 millimeters thicker, compared with 0.01 millimeters for Vytorin. The difference is so small as to be unimportant, says John Kastelein, the University of the Netherlands doctor who led the trial. “This is a zero trial,” he says, that neither shows harm nor benefit.
In the New England Journal and in an interview, Kastelein argued part of the reason for the decline was that these patients have been treated with statins for decades, and now their arteries are almost as thin, given their genetic illness. “It was a failure of us as investigators,” says Evan Stein of the Metabolic Research Laboratories in Cincinnati, who worked on the ENHANCE study. He says the problem was “somewhat akin to trying to show one antibiotic is better than another, or even placebo, but selecting a population with no infection.”
But Kastelein himself says he’s not certain this accounts entirely for the surprising result. He will continue to prescribe the drug to his patients, who all suffer from the genetic illness familial hypercholesterolemia and desperately need their cholesterol lowered, but he wants more evidence about how Zetia works before a big study of the drugs benefits concludes in 2012, at least a year later than originally expected.
“I need to be convinced that this drug indeed confers vascular benefit,” Kastelein says. He calls on Merck and Schering to fund more molecular biology, chemistry and imaging studies of Zetia. “What we need now is some really good science.”
William Boden of the University of Buffalo says the idea that the arteries were thin does not explain away worries about Zetia’s effectiveness against heart attack-causing atherosclerosis. “There’s not a hint of things moving in the right direction,” says Boden. He predicts “a significant dampening of enthusiasm” for Zetia and Vytorin until the companies have data to show whether they affect heart attacks and strokes.
Either the imaging technique doesn’t predict whether drugs prevent heart attacks and strokes, or Zetia isn’t going to prevent heart attacks and strokes, says Prediman K. Shah, a researcher who studies cholesterol at Cedars-Sinai Medical Center. “I’m confused,” he says, because reducing low-density lipoprotein (LDL), or bad cholesterol, is such a cornerstone of cardiology. But he is reluctant to apply “magic” properties to statins. “I’m going to give up medicine if it turns out that a statin is the only way to get an LDL reduction that reduces events,” he says.
Some researchers now wonder whether Zetia may have subtle, negative effects that counteract its LDL-lowering ability. Paul Thompson, director of cardiology at Hartford Hospital, says he will still use Zetia when statins aren’t enough to lower cholesterol. But now there are questions about the drug that weren’t being asked before. “What other things was it doing that you didn’t know about?” wonders Thompson. “That is the issue.”
Allen Taylor, chief of cardiology at Walter Reed Army Medical Center and co-author of one of the editorials, says he worries that Zetia “does things its not intended to do,” affecting the way Zetia works. “It’s uncomfortable because it’s a widely used drug, and there’s a lot of conjecture.”
For some, the data in ENHANCE are just too weak to draw any conclusions. Eric Topol of Scripps Health says his concerns would be the same whatever the outcome of the study. Says Elliott Antman of Harvard University: “It provides very limited information about one way of looking at the problem of atherosclerosis.” Adds Valentin Fuster, dean of academic affairs at Mt. Sinai and past president of the AHA: “This study doesn’t have power. This study doesn’t tell me much because I don’t have confidence in what is happening.”
An immediate result could be that doctors turn more quickly to drugs that lower particles of fat in the blood called triglycerides or raise “good cholesterol” (HDL) instead of just cutting LDL, says Howard Weintraub, a preventative cardiologist at New York University. That would favor the Niaspan and Tricor brands sold by Abbott Laboratories (nyse: ABT - news - people ), and also Lipitor from Pfizer (nyse: PFE - news - people ) and Crestor from AstraZeneca (nyse: AZN - news - people ), statins that also have some effect on triglyceride and HDL.
But those drugs have side effects that make them difficult to take, says Robert Califf of Duke University, who is helping to run the biggest Vytorin study. Tricor is linked to kidney problems; niacin can cause flushing. Some older cholesterol-lowering drugs, called resins, can cause constipation. But he says that if people are using Zetia or Vytorin on patients who could instead tolerate a higher dose of a statin, that’s a problem, because statins have proven benefits and Zetia doesn’t.
“The unpardonable sin is using [Zetia] instead of a statin when somebody can take a statin,” says Califf. “This study should remind people that shouldn’t be done.”
Complicating matters for Merck and Schering is the fact that the companies delayed the release of the ENHANCE trial data by more than a year, releasing it only after inquiries from Forbes. That delay prompted two congressional investigations and ignited a firestorm of media controversy. Kastelein says if he had been in full control of the study, results would have been presented last March. Now doctors are left to ask when they will get more answers about a drug that has become widely used because it cut cholesterol, caused no obvious side effects and was heavily advertised. It won’t happen fast.
One study, called SEAS, is expected in November. But it compares Vytorin with placebo, so it could just show the benefit of Zocor, and is in an odd population: people with a heart artery defect. Another, called SHARP, compares Vytorin, Zocor and placebo in patients with kidney disease. But whereas 4,000 patients get Vytorin and another 4,000 get placebo, only 1,000 get Zocor. So that study might not show researchers if Zetia confers an additional benefit either.
The best hope for a clear answer comes from a study called IMPROVE-IT, which was originally expected in 2011. On Friday, Merck said the researchers running the study enrolled another 8,000 patients, bringing the total number in the study to 18,000 and delaying results by a year. The benefits of cutting LDL may be more subtle than they expected, they say, and they want to make sure they get a clear answer. It took two years for the companies to decide to conduct that study. Many cardiologists now say the Food and Drug Administration should have delayed approve Zetia until plans for the trial were already under way.
“It’s a very good study, it’s just that it got started too late,” says Roger Blumenthal, a preventative cardiologist at Johns Hopkins University, who sees a role for Zetia because of the many patients who get side effects on statins. “That’s where the mistake was. That’s not going to happen again. That definitely is what we’ve learned from this whole debacle.”
[Source: forbes.com]
The search engine aims to reach the 40 million women whose demographic is being described as “Chief Household Officer.”
By K.C. Jones
InformationWeek
Yahoo (NSDQ: YHOO) said it wants to give women a place to shine, with the launch of a new Web site.
Yahoo has launched Yahoo Shine, a site for what Yahoo says is an “underrepresented demographic.” The site will also give advertisers one “lifestyles destination” to reach the 40 million women between the ages of 25 and 54 who visit Yahoo each month.
It will combine Yahoo’s food, astrology, and health, content with fashion, beauty, and parenting sections, stories from publishers like Conde Nast, Hearst, Rodale, and TIME, as well as original content. The site will feature blogs submitted by users, as well sections on work and money and tips for the home.
“We’re executing on Yahoo’s starting point strategy by ensuring that women who start their day with Yahoo! are offered a more relevant experience,” Scott Moore, senior VP and head of Yahoo Media, said in a news announcement. “Yahoo Shine adds an important piece to our media portfolio, which already includes sites that are number one in the News, Sports, Finance and Entertainment categories.”
Yahoo said the site will have “attitude,” “personality,” and humor, while providing advice and secret tips like “a friend.”
Conde Nast Publications Vice President of Editorial Operations, Rick Levine, said the site will use many Conde Nast magazines and Web sites.
“By speaking to Yahoo’s huge audience, this partnership will give our great editorial properties a significant growth opportunity,” he said in Monday’s announcement.
Christopher Johnson, VP of content and business development for Hearst Magazines Digital Media, said that Yahoo is “pioneering a unique way to present content online.”
“With more than 130 million visitors each month to Yahoo in the U.S., Yahoo will become a giant megaphone for us and allow Hearst’s network of bloggers to elevate their voices and be heard by a much larger audience,” he said. “Increasing the visibility of our blog content is a key element in driving additional traffic and converting passive readers into loyal fans.”
Yahoo calls the demographic it’s trying to reach “Chief Household Officers,” or women who usually make household purchasing decisions and use the Internet heavily. The company predicts popularity among advertisers for consumer packaged goods, pharmaceuticals, and retail. The company cited an analysis by TNS Media Intelligence that predicted online ad spending in those categories would total $1.8 billion this year.
