Thursday, May 17, 2007

Drop in Use of Stents Following Study Showing Little Advantage Over Drug Therapy

Article in the Wall Street Journal -- Stent Implants Declined in April: Doctors Attribute Drop To Study Showing Drugs May Have Similar Benefits, by Keith J. Winstein.  Here's an excerpt:

The number of coronary stents implanted in the U.S. dropped sharply in April, according to a leading market researcher, in what doctors said was an unusually quick response to a study showing the devices provided little advantage over drug therapy in some patients.

The new figures are the latest evidence that the tiny scaffolds used to prop open arteries are no longer a powerful growth engine for the medical industry. Americans spent at least $14 billion on coronary-stent procedures last year, including surgical and hospital fees. World-wide sales of the devices totaled about $6 billion.

Doctors performed about 71,200 stentings in April, according to estimates from Millennium Research Group, a Toronto firm that surveys about 140 U.S. hospitals. That was down more than 10% from March and down more than 15% from a year earlier.

Boston Scientific Corp., one of the three main stent makers, said it believed that the effect would be temporary. Abbott Laboratories, of Abbott Park, Ill., said it hadn't seen a decline in its own market data, and Johnson & Johnson, based in New Brunswick, N.J., declined to comment on the new figures.

BGS

May 17, 2007 in Medical Devices - Misc. | Permalink | Comments (0) | TrackBack (0)

Wednesday, May 16, 2007

FDA Had Proposed Reform, But HHS Rejected It

Article in the Wall Street Journal -- FDA Stymied In Push to Boost Safety of Produce: Amid Rise in Outbreaks Of Illness, Agency Urged New Rules, Monitoring, by Jane Zhang.  Here's an excerpt:

The Food and Drug Administration, under fire for a string of illnesses caused by contaminated vegetables, earlier this year came up with an ambitious, industry-endorsed plan calling for tough new regulations on the handling of fresh produce.

But the plan went nowhere after it got a cold reception from FDA's parent agency, the Department of Health and Human Services. And even today, amid continuing concern about the safety of the nation's food supply, efforts to address the problem remain in limbo.

People close to the FDA say HHS officials led by acting Deputy Secretary Eric Hargan rejected the FDA plan, which was presented in February at HHS headquarters. At the meeting, the FDA warned that its current approach to protecting the safety of fruits and vegetables, which relies on the industry following voluntary guidelines, was failing to stop an increase in foodborne illnesses, according to people familiar with the matter. Those in attendance included Robert Brackett, director of the FDA's Center for Food Safety and Applied Nutrition.

Among other things, the FDA outlined a three-year effort that would pump $76 million into its coffers to monitor produce safety and impose stringent rules on growers and processors to prevent contamination. Such a campaign could cut produce-related outbreaks of illness in half, the FDA officials said.

BGS

May 16, 2007 in E Coli, FDA | Permalink | Comments (1) | TrackBack (1)

Tuesday, May 15, 2007

Oxy Morons

Commentary in the Wall Street Journal -- Oxy Morons, by Sally Satel.  Here's an excerpt:

It is a bad time to be in pain. Last week, the maker of OxyContin, a high-strength narcotic analgesic, agreed to pay $635 million to settle charges of "misbranding" brought by the attorney general of West Virginia.

"Scores died as a result of OxyContin abuse and an even greater number of people became addicted," said Attorney General John Brownlee. The drug company, Purdue Frederick, admits that its sales force underplayed the abuse potential of OxyContin. And, yes, the company should have acted more quickly to clamp down on overpromotion and to issue strong warnings in the face of overdose deaths.

But the real public-health damage here comes from the pitched campaign conducted by zealous prosecutors and public-interest advocates to demonize the drug itself. This is tragic because OxyContin has been a godsend for millions of patients with searing, unremitting pain from chronic back problems, rheumatoid arthritis, neurological disorders and other dire afflictions.

This latest bad rap for OxyContin threatens to inflict more pain. Doctors already wary of scrutiny by the Drug Enforcement Administration will become even more skittish about giving adequate doses of OxyContin or prescribing it at all. And patients will be rightly scared of losing access to the medication that made their lives livable again.

BGS

May 15, 2007 in Pharmaceuticals - Misc., Settlement | Permalink | Comments (0) | TrackBack (0)

States Revise Policies on Outside Counsel

In a number of mass torts -- including tobacco, handguns, lead paint, and Oxycontin -- states and municipalities have brought lawsuits for money damages, seeking compensation for funds spent responding to harms caused by the various products.  While some of these government entities have handled their own legal work, and other have received pro bono assistance from law firms, many of them have turned to outside counsel.  Indeed, many of the nation's most prominent mass tort plaintiffs' lawyers have represented states and municipalities in recent years.

An article in this week's National Law Journal -- AGs Review Hiring of Outside Counsel -- looks at states that are reviewing or revising their policies on such hiring:

Attorneys general in seven states -- some of whom have retained plaintiffs law firms to bring high-profile lawsuits involving lead paint and the painkiller OxyContin -- are instituting new policies or facing legislative pressure to make the hiring of outside legal counsel more transparent.

The changes come as several tort reform groups, particularly the Institute for Legal Reform, an affiliate of the U.S. Chamber of Commerce, have been appealing to attorneys general for more transparency and accountability in how they retain outside law firms.

Plaintiffs lawyers said the moves toward transparency are assaults by business groups on attorneys general who bring damaging cases against them.

In recent months, attorneys general in Ohio, New Jersey and California have instituted new policies that would require law firms to bid publicly for work or would reduce confidentiality in the hiring process.

Legislators in Mississippi and West Virginia recently introduced bills, backed by tort reform groups, that would create oversight committees to review contracts between the state's attorney general and law firms.

Other efforts in Kansas and Nevada are aimed at reducing the use of outside counsel.

The use of outside counsel by government plaintiffs has been controversial.  Some of the controversy pits the usual combatants making the usual arguments about tort liability.  Unsurprisingly, the Chamber of Commerce disfavors the use of contingent-fee outside counsel for state tort claims, while trial lawyer groups favor it.  But there are interesting aspects to the issue that are unique to government litigants.  In addition to pay-to-play concerns about links between public contracts and campaign contributions, the use of contingent-fee lawyers for government plaintiffs also raises separation of powers concerns because it allows attorneys general to sidestep the legislative branch's control of the purse strings.

HME

May 15, 2007 in Ethics, Lead Paint, Procedure | Permalink | Comments (0) | TrackBack (0)

Monday, May 14, 2007

Minnesota Legislature Passes Smoking Ban

Article in the Washington Post -- Minnesota Lawmakers Pass Smoking Ban, by the Associated Press.  It seems to me that a free-market solution would work better.  Why not allow bars and restaurants to promote themselves as either smoker-friendly or smoke-free?  Customers can seek their preference for dining/drinking, and employees can do the same, also weighing the compensation offered.  Including the preferences of smokers to smoke in the utility calculus, one could argue that permitting bars and restaurants to allow smoking serves social utility, as well as respects personal autonomy.  Here's an excerpt from the article:

Minnesota would ban smoking in bars, restaurants and other establishments under a bill approved by the Legislature.

The bill passed the state House by an 81-48 vote early Saturday, hours after the state Senate approved it 43-21. It now heads to Gov. Tim Pawlenty, who has said he will sign it.

Minnesota would become the 20th state to prohibit smoking in bars and restaurants. Violations would carry fines of up to $300 for smokers and business owners who allow smoking. The ban would start Oct. 1.

BGS

May 14, 2007 in Tobacco | Permalink | Comments (0) | TrackBack (0)

NYT Editorial on Problems with Aranesp, Epogen, and Procrit

Editorial in the New York Times -- The Danger in Drug Kickbacks.  Here's an excerpt:

The explosion in the use of three anti-anemia drugs to treat cancer and kidney patients illustrates much that is wrong in the American pharmaceutical marketplace. Thanks to big payoffs to doctors, and reckless promotional ads permitted by lax regulators, the drugs have reached blockbuster status. Now we learn that the dosage levels routinely injected or given intravenously in doctors’ offices and dialysis centers may be harmful to patients.

As Alex Berenson and Andrew Pollack laid bare in The Times on May 9, wide use of the medicines — Aranesp and Epogen, from Amgen; and Procrit, from Johnson & Johnson — has been propelled by the two companies paying out hundreds of millions of dollars in so-called rebates. Doctors typically buy the drugs from the companies, get reimbursed for much of the cost by Medicare and private insurers, and on top of that get these rebates based on the amount they have purchased.

Although many doctors complain that they barely break even or even lose money on the costly drugs, for high-volume providers the profits can be substantial. One group of six cancer doctors in the Pacific Northwest earned a profit of about $1.8 million last year thanks to rebates from Amgen, while a large chain of dialysis centers gets an estimated 25 percent of its revenue, and a higher percentage of its profits, from the anemia drugs. It seems likely that these financial incentives have led to wider use and the prescribing of higher doses than medically desirable.

BGS

May 14, 2007 in Pharmaceuticals - Misc. | Permalink | Comments (0) | TrackBack (0)

NYT Review of Post-9/11 Lack of Safety for Rescue Workers

Article in the New York Times -- Ground Zero Illnesses Clouding Giuliani’s Legacy, by Anthony DePalma.  Here's an excerpt:

Anyone who watched Rudolph W. Giuliani preside over ground zero in the days after 9/11 glimpsed elements of his strength: decisiveness, determination, self-confidence.

Those qualities were also on display over the months he directed the cleanup of the collapsed World Trade Center. But today, with evidence that thousands of people who worked at ground zero have become sick, many regard Mr. Giuliani’s triumph of leadership as having come with a human cost.

An examination of Mr. Giuliani’s handling of the extraordinary recovery operation during his last months in office shows that he seized control and largely limited the influence of experienced federal agencies. In doing that, according to some experts and many of those who worked in the trade center’s ruins, Mr. Giuliani might have allowed his sense of purpose to trump caution in the rush to prove that his city was not crippled by the attack.

Administration documents and thousands of pages of legal testimony filed in a lawsuit against New York City, along with more than two dozen interviews with people involved in the events of the last four months of Mr. Giuliani’s administration, show that while the city had a safety plan for workers, it never meaningfully enforced federal requirements that those at the site wear respirators.

At the same time, the administration warned companies working on the pile that they would face penalties or be fired if work slowed. And according to public hearing transcripts and unpublished administration records, officials also on some occasions gave flawed public representations of the nature of the health threat, even as they privately worried about exposure to lawsuits by sickened workers.

BGS

May 14, 2007 in 9/11 | Permalink | Comments (0) | TrackBack (0)