Monday, November 16, 2009

BLOOD SUCKERS part #2 Questions About Cholesterol Drug’s Benefit

Study Raises Questions About Cholesterol Drug’s Benefit NYTimes NATASHA SINGER

ORLANDO, Fla. — For patients taking a statin to control high cholesterol, adding an old standby drug, niacin, was superior in reducing buildup in the carotid artery to adding Zetia, a newer drug that reduces bad cholesterol, according to a new study.

The results of the study, published in The New England Journal of Medicine, were presented here Sunday night at an annual meeting of the American Heart Association.

The study has been a polarizing topic here and has also attracted the attention of a powerful senator who has been investigating the conduct of two drug makers, Merck and Schering-Plough, in relation to their sales and marketing of Zetia and a combination cholesterol drug, Vytorin, which includes Zetia. The drug makers merged this month.

The small study, with only 208 patients, has attracted outsize attention because the researchers did a head-to-head comparison of niacin and Zetia, which has been heavily marketed.

The Food and Drug Administration approved Zetia in 2002 to lower bad cholesterol, a risk factor for heart disease. But the drug has not yet proved to have a longer-term clinical benefit in reducing heart attacks and deaths. Merck, the maker of the drug, is conducting a clinical trial on that issue involving up to 18,000 patients. Statins like Lipitor have proved in studies to significantly lower the risk of heart attack.

Some cardiologists here hailed the study as an indication that the popularity of Zetia and Vytorin, which had combined sales last year of about $4.6 billion, has far outstripped their evidence of a concrete benefit on heart health. Other doctors here dismissed the study because it did not directly measure the drugs’ effects on reducing heart attacks.

Nevertheless, this study has the potential to make big waves in the use of cholesterol drugs.

“It will certainly strengthen the idea that, after you give a statin, the weight of the evidence is that, as a second agent, you should give niacin,” said Dr. Roger S. Blumenthal, a professor of medicine at the Johns Hopkins University Medical School. “That is the implication of the study.”

But Dr. Peter S. Kim, the president of Merck Research Laboratories, said Sunday in an interview that the study was limited because it did not compare the groups of patients taking a statin and a second drug to a placebo group. Furthermore, he said, a drug’s ability to improve artery-wall thickness has not been proved to automatically correlate with a reduction in heart attacks.

Zetia, he said, lowers bad cholesterol and lowering bad cholesterol is a known good.

The study results “should be compared to the overwhelming body of evidence that lowering LDL cholesterol is an important thing to do to improve cardiovascular health,” Dr. Kim said.

The study randomly assigned patients who were taking a statin and who had heart disease or a risk of heart disease to additionally take either Zetia or Niaspan.

Statins are a class of drug which lowers LDL, known as bad cholesterol because it can cause arterial thickening and lead to heart problems. The drugs work by inhibiting the production of cholesterol in the liver.

Zetia, which inhibits the absorption of cholesterol in the intestines, lowers bad cholesterol.

Niaspan is a prescription extended-release form of niacin, not the over-the-counter vitamin. Niacin increases HDL, known as “good cholesterol.” Niaspan is made by Abbott Laboratories, which financed the study.

Over the course of the 14-month study, the bad cholesterol of the patients on Zetia decreased by 19.2 percent, but the patients’ arterial wall thickness stayed the same, the study said. In the niacin group, good cholesterol increased by 18.4 percent and the carotid wall thickness decreased.

By itself, the study does not have major significance, said Dr. James H. Stein, a professor at the University of Wisconsin medical school. But taken in the context of more than 30 years of research on and use of niacin, he said, the study adds to the weight of evidence that it can a great benefit to patients with heart disease, he said. “Compare that to Zetia where there is not a shred of evidence that it does anything good for blood vessels or heart disease,” Dr. Stein said.

On Friday, Senator Charles E. Grassley, Republican of Iowa, wrote to the Department of Health and Human Services, asking its director, Kathleen Sebelius, what action she intended to take in light of the study results. Mr. Grassley sits on the Senate Finance Committee which has jurisdiction over Medicare and its drug spending. In 2006 and 2007, the drug makers made more than $300 million through Medicare Part D in sales of Vytorin, a drug that combines Zetia and a statin, Mr. Grassley wrote.

In response to a query from a reporter, a Merck spokesman said the small trial did not change the company’s belief in the demonstrated ability of Zetia and Vytorin to reduce bad cholesterol.


Drug Makers Raise Prices in Face of Health Care Reform

Even as drug makers promise to support Washington’s health care overhaul by shaving $8 billion a year off the nation’s drug costs after the legislation takes effect, the industry has been raising its prices at the fastest rate in years.

In the last year, the industry has raised the wholesale prices of brand-name prescription drugs by about 9 percent, according to industry analysts. That will add more than $10 billion to the nation’s drug bill, which is on track to exceed $300 billion this year. By at least one analysis, it is the highest annual rate of inflation for drug prices since 1992.

The drug trend is distinctly at odds with the direction of the Consumer Price Index, which has fallen by 1.3 percent in the last year.

Drug makers say they have valid business reasons for the price increases. Critics say the industry is trying to establish a higher price base before Congress passes legislation that tries to curb drug spending in coming years.

“When we have major legislation anticipated, we see a run-up in price increases,” says Stephen W. Schondelmeyer, a professor of pharmaceutical economics at the University of Minnesota. He has analyzed drug pricing for AARP, the advocacy group for seniors that supports the House health care legislation that the drug industry opposes.

A Harvard health economist, Joseph P. Newhouse, said he found a similar pattern of unusual price increases after Congress added drug benefits to Medicare a few years ago, giving tens of millions of older Americans federally subsidized drug insurance. Just as the program was taking effect in 2006, the drug industry raised prices by the widest margin in a half-dozen years.

“They try to maximize their profits,” Mr. Newhouse said.

But drug companies say they are having to raise prices to maintain the profits necessary to invest in research and development of new drugs as the patents on many of their most popular drugs are set to expire over the next few years.

“Price adjustments for our products have no connection to health care reform,” said Ron Rogers, a spokesman for Merck, which raised its prices about 8.9 percent in the last year, according to a stock analyst’s report.

This year’s increases mean the average annual cost for a brand-name prescription drug that is taken daily would be more than $2,000 — $200 higher than last year, Professor Schondelmeyer said.

And this means that the cost of many popular drugs has risen even faster. Merck, for example, now sells daily 10-milligram pills of Singulair, the blockbuster asthma drug, at a wholesale price of $1,330 a year — $147 more than last year. Singulair is now selling at retail, on, for nearly $1,478 a year.

The drug companies “can charge what they want — it’s not fair,” Eric White, the 42-year-old owner of a small jewelry store in Queens, said as he left a pharmacy recently.

Despite having drug insurance, Mr. White says he now pays $110 a month out of pocket for two brand-name allergy medicines, even as he has cut prices in his jewelry store by at least 40 percent to keep customers coming through the door.

He shook his head. “What can I do?” he said. “I need my medicines.”

The drug industry has actively opposed some of the cost-cutting provisions in the House legislation, which passed Nov. 7 and aims to cut drug spending by about $14 billion a year over a decade.

But the drug makers have been proudly citing the agreement they reached with the White House and the Senate Finance Committee chairman to trim $8 billion a year — $80 billion over 10 years — from the nation’s drug bill by giving rebates to older Americans and the government. That provision is likely to be part of the legislation that will reach the Senate floor in coming weeks.

But this year’s price increases would effectively cancel out the savings from at least the first year of the Senate Finance agreement. And some critics say the surge in drug prices could change the dynamics of the entire 10-year deal.

“It makes it much easier for the drug companies to pony up the $80 billion because they’ll be making more money,” said Steven D. Findlay, senior health care analyst with the advocacy group Consumers Union.

Name-brand prices have risen even as prices of widely used generic drugs have fallen by about 9 percent in the last year, Professor Schondelmeyer said. But name brands account for 78 percent of total prescription drug spending in this country. And as long as a name-brand drug still has patent protection it faces no price competition from generics.

Ken Johnson, senior vice president of the industry association — the Pharmaceutical Research and Manufacturers of America — criticized the analysis Professor Schondelmeyer had conducted for AARP, saying it was politically motivated.

“In AARP’s skewed view of the world, medicines are always looked at as a cost and never seen as a savings — even though medicines often reduce unnecessary hospitalization, help avoid costly medical procedures and increase productivity through better prevention and management of chronic diseases,” he said.

But Professor Schondelmeyer’s analysis — which found prices for the name-brand drugs most widely used by the Medicare population rising by 9.3 percent in the last year, the fastest rate since 1992 — is in line with the findings of a leading Wall Street analyst, too. The report was released on Monday.

Catherine J. Arnold, a drug industry analyst at Credit Suisse, said her latest study of the nation’s eight biggest pharmaceutical companies showed markedly similar results: list prices rising an average of 8.7 percent in the 12 months ending Sept. 30 — the highest rate of growth since at least 2004.

As does Professor Schondelmeyer, Ms. Arnold based her price calculations on reported wholesale prices and a formula that puts more emphasis on each company’s best-selling drugs.

Ms. Arnold said the prospect of cost containment under health care reform, as well as the tougher business environment, entered into the decisions of manufacturers to raise prices this year.

The industry stands to gain about 30 million customers with drug insurance from the legislation pending in Congress. But the industry also faces the prospect of tougher negotiations from both public and private buyers as the government tries to squeeze savings out of the health system.

“If you’re going to take price increases,” Ms. Arnold said, “here and now might be the place to do that, because the next year and the year after that might be tough.”

Mr. Johnson did not dispute the Credit Suisse study or deny Ms. Arnold’s finding that American drug makers have raised prices at the fastest rate in five years.

He said both studies were incomplete by failing to include rebates that drug makers give distributors. But Ms. Arnold, Professor Schondelmeyer and a 2007 Congressional study of Medicare said the rebates often accrue to the middlemen, not consumers, and higher manufacturer prices lead to higher retail prices.

And the drug industry’s own major consulting firm, IMS Health, has also reported a significant run-up in prices. Back in April, IMS predicted that United States drug sales might actually decline this year.

Billy Tauzin, president of the industry’s trade association, highlighted the gloomy prediction in a June 1 letter to President Obama shortly before striking the deal to cut drug costs by $80 billion. In negotiating the deal, the drug makers argued that they could not afford to give up more than that.

But in October, IMS made an unusual change in the middle of its forecasting cycle, saying it now believed United States sales would grow at least 4.5 percent in 2009 — or $21 billion more than expected six months earlier.

A major reason, IMS said, was higher-than-expected price increases for drugs in the United States.

For Some Smokers, Even Home Is Off Limits


The movement to ban smoking in New York City has grown so quickly that no place seems immune — certainly not restaurants or bars, and public beaches and parks may not be far behind. Now the efforts are rapidly expanding into the living room.

More landlords are moving to prohibit smoking in their apartment buildings, telling prospective tenants they can be evicted if they light up in them.

This month, the Related Companies will ban smoking at some of its downtown apartment buildings because of health concerns about secondhand smoke, according to company officials.

Smokers who already live in any of these buildings will not be affected, according to Jeff Brodsky, a president of Related, which is a national developer with 17 buildings in Manhattan.

But any new renters must promise not to smoke at home, even if they continue to elsewhere.

Kenbar Management, a local developer, is going a step further. When its new project, 1510 Lexington Avenue, opens in December, smoking will be banned in all 298 units, in addition to private and shared terraces.

And the typical smoker’s refuge — directly outside the building — is also off limits; tenants must agree not to smoke on any of the sidewalks that wrap around the building, which takes up most of a block in East Harlem, according to Kinne Yon, a Kenbar principal.

The trend has predictably divided smokers and nonsmokers in New York.

“I think it’s absolutely absurd,” said Bryan Marx, 53, a cabinetmaker who has lived at Tribeca Park, a Related building on Chambers Street, since 1999. He smokes hand-rolled cigarettes in his apartment, but said that he cut back on a cigar habit a few years ago to appease a neighbor.

“How about a little tolerance?” Mr. Marx added. “Smokers have become the whipping boys for everything that’s unhealthy about living in New York City.”

Across the country, the movement to ban smoking in residential buildings is gaining traction. The Department of Housing and Urban Development has strongly encouraged public housing agencies to ban smoking in some or all of their units.

So far, about 50 public housing agencies have now forbidden smoking, according to Betsy Feigin Befus, a lawyer with the National Multi Housing Council, a landlord trade group that has tracked the efforts.

Other cities, through legislation or by initiatives of developers, have taken similar steps. In California, for example, all apartments and condos in Richmond, near San Francisco, must outlaw cigarette smoking, according to an ordinance passed in July. Across the bay in Belmont, a ban on smoking in apartments took effect in January after a 14-month grace period, with $100 fines possible for offenders.

While there is no question about the dangers of secondhand smoke, there is debate about whether the amount of smoke that may be transmitted from one apartment to another is harmful. A recent study by New York City’s health department found that about 57 percent of nonsmokers had been exposed to substantial levels of cigarette smoke, raising suspicions among experts that apartment dwellers might be susceptible to secondhand smoke from their neighbors.

New York City has been at the forefront of efforts to ban smoking in bars and restaurants, and the city’s health commissioner, Dr. Thomas A. Farley, said in September that he supported a ban on smoking at city beaches and parks. But the city, he said, has no plan to push for a smoking ban in public housing developments.

The city did help Related research the health effects of smoke in apartment buildings, Dr. Farley said, adding, “Our focus would be on individuals having their homes smoke-free.”

Pan Am Equities, a real estate management company, may have been one of the first in New York to introduce a smoking ban to an apartment building. About 18 months ago, the company asked new renters to promise not to smoke; the ban did not affect existing tenants, according to David Iwanier, a company vice president.

All of Pan Am’s rentals — which include 270 Park Avenue South, 145 West 67th Street and 60 West 23rd Street — are affected, though Mr. Iwanier would not discuss the reasons for the ban.

“It was just something we decided to do,” he said. And in terms of lease renewals, he added, “we’ve not had any negative feedback.”

Mr. Brodsky, of Related, said that existing tenants would be reassured that they would not be evicted or pressured to leave. He would not specify which of the developer’s buildings are in line for the ban, saying only that they are among the six in or near Battery Park City and Chelsea. Those include Tribeca Park; the Caledonia, which abuts the High Line park; and Tribeca Green in Battery Park City, which bills itself as “New York’s most environmental rental.”

“I think it’s a bloody good thing,” said Dale Smith, 41, a Broadway producer who formerly worked in the health care industry. A resident of Tribeca Green for nearly three years, Mr. Smith, who does not smoke, said he had complained to his landlord about secondhand smoke in his apartment.

“A policy that is in place because something has proven to be hazardous in eating establishments should be effective in the home,” he said.

Experts say there is no known law in the United States that prohibits landlords from banning smoking in their buildings, and many trial judges have sided with the nonsmoker. In New York, for example, a 2006 decision found that tenants had the right to break a lease because the landlord failed to safeguard an apartment from secondhand smoke.

Co-ops and condominiums have been somewhat slower to embrace such bans, according to real estate lawyers.

In interviews with several lawyers who represent real estate concerns, only one, Stuart Saft, knew of any buildings that had instituted a smoking ban. He said that of the 100 or so co-op buildings he represents on the Upper East and West Sides of Manhattan, only two have banned smoking outright in the last few years.

A poll commissioned by the NYC Coalition for a Smoke Free City suggested that a residential smoking ban might not hurt rentals or sales. The survey of 1,000 New Yorkers, which was administered by Zogby International in July, found that 58 percent would pay more to live in smoke-free housing; 68 percent might not live in a smoking building in the first place.

Yet some real estate brokers question the wisdom of instituting a smoking ban during a housing downturn, with vacancy rates climbing.

That 950,000 New Yorkers — or 16 percent of the population — call themselves smokers, according to the city’s health department, is not insignificant, said Daniel Baum, chief executive at the Developers Group/The Real Estate Group of New York, a brokerage that focuses on rentals.

“I think in general it’s probably not an ideal time to try to limit potential tenants,” Mr. Baum said. “Every occupied apartment counts.”

And Audrey Silk, the founder of Citizens Lobbying Against Smoker Harassment, a nine-year-old advocacy group, said the trend was troubling from a civil liberties perspective.

“If we’re talking about annoying odors, where do you draw the line?” she said. “What about cooking odors, from fish or curry?”

Yet some smokers seemed resigned to their fate. Brian Mossotti, 28, a day trader, moved into the Pan Am-run building on 23rd Street 14 months ago, after the developer’s ban had taken effect. After receiving three warnings from management about fumes in the hallway, including a stern letter in September, Mr. Mossotti finally agreed to take his two-a-day cigarette habit to the sidewalk, he said.

“You can’t smoke in bars because of the whole secondhand smoke thing, so it doesn’t surprise me,” he said. “But it is irritating.”