A Medical Device Daily

Financial markets have been in a state of turmoil often described as the most severe since the Great Depression, but the medical device industry had escaped any damage up to last week, when shares of Boston Scientific (Natick, Massachusetts) went up for sale in connection with the decline of one of the major investment banks.

Two of Boston Scientific's founders, Peter Nicholas and John Abele, apparently used some of their shares of the company's stocks as collateral for loans from Lehman Brothers Holdings (New York), which sold 13 million of those shares due to the investment bank's bankruptcy proceedings. The Oct. 9 statement posted on Boston Scientific's web site also indicated that "there may be additional automatic, involuntary selling today or in the near future," and its shares were down to $8.51 in afternoon trading Thursday. At press time last Friday, the firm's shares were trading at $7.11, which would set a 52-week low assuming it held that price to the end of the day. More than 50 million shares of the company's stocks traded hands on Friday.

Abele said in the statement that the automatic sales "are disappointing and beyond our control," but he asserted that his confidence "in the company and its long-term prospects remains undiminished."

The sale of stocks held by Nicholas, Abele and a trust for Abele's children accounted for 13 million of a total of 38 million Boston Scientific shares that hit the Nasdaq board last Thursday. Nicholas characterized the activity as "involuntary and related to personal planning objectives and the current extraordinary circumstances in the financial markets." He said, however, that the sales "in no way reflect on the company."

NIH restricts resubmissions of grants

The National Institutes of Health has been flooded with applications over the past few years in connection with the doubling of funding of the agency between 1997 and 2003, and to make better use of its resources, applicants will be able to amend their grant applications only once starting Jan. 25, 2009. According to the Oct. 9 NIH statement, any new and competing renewal grants received prior to that date "will be permitted two amendments," but those grandfathered amendments have to be filed by January 7, 2011.

NIH described the policy as part of "a continuing series of changes to the NIH peer review system following an in depth review and a year long self-assessment that concluded in June," with the hope that the new policy "will help ensure earlier funding of high-quality applications and improve efficiencies in the peer review system."

NIH director Elias Zerhouni, MD, said in the statement "over the past several years, the number of applications submitted each year to NIH has doubled and the number of investigators applying for grants has increased by [more than] 75%." The torrent of grant applications "has led to scientists spending more time rewriting their applications and undue delays in the funding of outstanding projects," he said.

NIH's numbers indicate that an investigator had a 17% chance of scoring a grant upon the first submission of an application in 2002 "compared to a 7% chance in 2006." However, the agency did not indicate whether poorly written grants were part of the reason for the slowdown in first-application approvals.

OIG: NIH scientists need closer scrutiny

Conflict-of-interest issues abound in connection with modern medical science, and a recent report on scientists working for the National Institutes of Health indicates that those working for the agency need more supervision.

According to a report filed last week by the Office of Inspector at the Department of Health and Human Services, an audit of ethics files dated between Jan. 1, 2006, and June 30, 2007, indicated that "the most common allegations involved NIH employees not completing required ethics training or ethics forms." Violations of ethical policy for these two accounted for a total of 490 cases.

Less frequent but more serious ethical lapses included one case that might be described as a "no-brainer" in ethical terms. The OIG report states that an employee of NIH "served as a director of a company that submitted an application for an exclusive license to develop and commercialize a drug privately while participating as an NIH employee in research and data collection for that same drug." In another instance, an employee of NIH is said to have used his/her position "and influence to encourage an NIH board of scientific directors to deny funding to an intramural research program investigating a drug because of the employee's financial ties with a pharmaceutical company developing a competing drug."

OIG recommended that NIH develop a formal, written policy spelling out how allegations of conflicts of interest and ethics violations would be coordinated between NIH's ethics office, the National Institute of Health Ethics, and two other offices, including the Office of Management Assessment. In an Aug. 25 letter to Daniel Levinson, the inspector general at HHS, NIH director Elias Zerhouni, MD, agreed with the recommendations, noting that "we have already fully implemented [the changes] when we published a policy that incorporates" both the recommendations.

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