April 25, 2024
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Study validates existence of bisexuality in men, complaints soar on hip implants, a Ticketmaster competitor unveils a new site and other consumer-focused news from The New York Times.
Article source: http://feeds.nytimes.com/click.phdo?i=b69b6e35841013833b29794427792366
The scientific group, the Institute of Medicine, is scheduled to release a report on Friday that could propose a tougher approval process for a wide range of devices like hip implants, hospital pumps and external heart defibrillators. The report, commissioned by the Food and Drug Administration, comes after several well-publicized recalls in recent years of devices that have failed in thousands of patients, causing numerous injuries.
But a business group and others have taken the highly unusual step of making a pre-emptive strike, arguing that the report is biased. That attack began even before the study panel finished its review, and has intensified in recent weeks.
Device producers have also released a series of their own reports that say more regulation would slow innovation, harm patients and cost jobs. An official of a group that represents surgeons who implant hips and other artificial joints has also voiced support for a recent filing by a pro-business organization that challenged the scientific report’s credibility and argued that the F.D.A. was statutorily required to ignore it.
Christine Stencel, a spokeswoman for the Institute of Medicine, which is part of the National Academy of Sciences, said the group was unaware of a previous instance in which one of its reports, sight unseen, was the target of a similar effort to invalidate it.
Dr. Sheldon Greenfield of the University of California, Irvine, who has served on several Institute of Medicine panels, said he was surprised by the campaign’s intensity. “It is pretty audacious,” he said.
The challenge to the panel has been led by Ralph F. Hall, a professor of law at the University of Minnesota and a device industry lawyer, who said the criticism was not an attempt to front-run the report’s conclusions but rather to air legitimate concerns about how the review had been conducted.
“I could have waited until the report came out,” Mr. Hall said in an interview. “That seems intellectually less than satisfactory with me.”
Medical experts said the institute’s study, regardless of how it falls, was likely to have a significant impact on patient safety, device effectiveness and the speed at which new products reached the market.
With millions of dollars of product sales at stake, the experts said, it is not surprising that the device industry and others would want to avert what they see as potentially restrictive new rules. Still, the lobbying has taken on a tone akin to Washington infighting over an issue like bank regulation, rather than patient health, they said.
“We are trying to get to good policies, and the spin game doesn’t help us,” said Dr. Harlan M. Krumholz, a professor of medicine at Yale who has served on a different Institute of Medicine panel.
The Institute of Medicine is a widely respected organization that assembles experts to study a range of health-related issues, often at the request of government agencies. In 2009, the F.D.A. contracted with the group to review the adequacy of one of the two regulatory pathways though which it approves medical devices, a process known as 510K.
Some devices, like implanted heart defibrillators, undergo clinical trials in patients before they can be sold. But most medical devices, including implanted hips, go through the 510K route. Under that pathway, a producer need show only that a new product is “substantially equivalent” to one already sold to gain approval.
For example, so-called metal-on-metal artificial hips, which are currently the subject of scrutiny and lawsuits, appeared to work well when tested only on mechanical simulators but then failed disastrously when implanted in patients.
The 12-member review panel assembled by the Institute of Medicine included physicians, academics and two lawyers who had worked for device makers on regulatory issues. Another lawyer on the panel, Brian Wolfman, who once worked for Public Citizen, a consumer advocacy group, has come under particular attack by business-affiliated groups.
Mr. Wolfman and several other panel members declined to be interviewed for this article or did not respond to telephone calls or e-mails.
Article source: http://feeds.nytimes.com/click.phdo?i=a4a09b82056292c8ab8f01044a4c547f
Intriguingly, prosecutors said that Johnson Johnson had provided “significant assistance” in their investigation of others in the industry, resulting in a reduced criminal fine for the health conglomerate. At least a dozen other major drug and device makers are under investigation for similar crimes.
A criminal complaint filed by the Justice Department against a Johnson Johnson subsidiary that makes knee and hip implants quoted internal company e-mails as stating that providing “cash incentives to surgeons is common knowledge in Greece,” and that, were the company to stop paying bribes, “we’d lose 95% of our business by the end of the year.”
In a written statement, the company said that it originally reported its illegal marketing activities to the government in 2007. “We are deeply disappointed by the unacceptable conduct that led to these violations,” said William C. Weldon, the company’s chairman and chief executive. Indeed, Johnson and Johnson’s admission appeared to have set off the industrywide inquiry.
Officials at the Securities and Exchange Commission said that Johnson Johnson’s bribes might have harmed public health in several European countries. For years, the company tried to hide its illegal activities by “using sham contracts, off-shore companies and slush funds to cover its tracks,” said Robert Khuzami, director of the Securities and Exchange Commission’s division of enforcement.
The case is the latest in a string of criminal investigations into illegal marketing practices by drug and device makers. Companies have repeatedly settled allegations that they paid kickbacks to doctors in the United States to induce them to prescribe drugs for, or implant medical devices in, patients who are unaware of their doctors’ financial incentives.
With the settlement agreement from Johnson Johnson, prosecutors have now begun penalizing companies in foreign bribery cases as well. Some top executives in the drug industry have suggested in recent months that the industry’s marketing practices may need to undergo wholesale changes.
According to statements by the Justice Department and the Securities and Exchange Commission, the payments violated the Foreign Corrupt Practices Act, which outlaws bribes paid to foreign government officials, because doctors in many other countries are government employees.
For Johnson Johnson, the settlement comes at a difficult time. The company has issued more than 50 product recalls since the start of last year involving such household brands as Tylenol, Motrin, Rolaids and Benadryl. Last year, it recalled two popular hip implants that a recent study suggested might fail soon after surgery in close to half of the patients who received them.
Mr. Weldon has denied that the company’s many missteps suggest broader problems in management or in the company’s structure as a set of loosely affiliated subsidiaries.
Also on Friday, Johnson Johnson agreed to pay $7.9 million to settle bribery allegations with the United Kingdom Serious Fraud Office. And it admitted as part of its deferred prosecution agreement with the United States government to having paid kickbacks to the Iraqi regime of Saddam Hussein under a United Nations oil-for-food program that investigations have since found was rife with fraud.
According to a criminal complaint here and a case summary in Britain, Johnson Johnson undertook an elaborate scheme to pay about 20 percent of the price of the company’s devices to Greek surgeons.
Such bribes were so routine in Greece, according to the document, that an accountant for the company’s Greek sales agent had trouble understanding why he had to disguise the purpose of the money in his statements to Johnson Johnson.
A December 2001 e-mail from a top Johnson Johnson executive stated that he was “very disappointed to read in your proposal references” to bribes “which cannot be mentioned in written correspondence.” Executives debated how to bring its bribes into compliance with the law, with one executive writing, “when we abandon the consultancy, we might as well abandon the business.”
The company also paid bribes to Polish doctors and administrators who served on hospital committees that made purchasing decisions for medical equipment. Some of the bribes included paying for travel arrangements for doctors to attend medical conferences, a common practice throughout the industry. The company also bribed doctors in Romania who prescribed the company’s drugs.
Article source: http://www.nytimes.com/2011/04/09/business/09drug.html?partner=rss&emc=rss
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