A Medical Device Daily
The fine of roughly $800 million that Siemens (Frankfurt, Germany) announced it will pay may be only the beginning of the company's troubles as investigations continue into the firm's practice of bribery in 10 other nations.
The company has agreed to settle with U.S. authorities to the tune of $450 million to the Department of Justice to clear itself of further action pursuant to a scandal that broke two years ago. The company will pay the Securities and Exchange Commission another $350 million, but the total was far short of the sum of about $2 billion that was floated in discussions by industry analysts. Because that larger sum was already factored into the publicly traded firm's share prices, the company's stock on the New York Stock Exchange rose more than $2 per share to open at $65.92 at yesterday's opening bell.
The company's officials are charged with making more than 4,000 bribery payments between 2001 and 2007 to the tune of $1.4 billion in an attempt to secure various contracts in a number of nations. Among the nations that were the subject of bribery efforts was Russia, which was targeted with $55 million in bribes to secure contracts for the company's imaging equipment, and Israel, where the firm sought to do business in energy markets.
According to wire service reports, authorities in Germany are seeking as much as €400 million to settle similar charges, a sum the firm may have already covered with a set-aside of roughly 11 billion. Siemens is said to have paid German authorities more than €200 million last year after a no-contest plea for bribery charges.
U.S. authorities will allow the company to plead only to lack of internal controls and to book-cooking charges, a move designed to allow the company to continue to bid on government infrastructure contracts. The government's decision is said to stem in large part from the company's cooperation with the U.S. investigation, including steps the company took to preserve documents in addition to the discharge of 11 out of 12 members of the management board.
Female condom gets nod from panel
FDA advisory panels pretty much see and hear it all, and a hearing last week shows how true this is. The obstetrics and gynecological devices advisory committee met last Thursday to review the application for the FC2, a female condom made by the Female Health Company (FHC; Chicago), and gave the product a ringing endorsement via a vote of 15-0.
Ironically, the firm got the agency's nod even though the product seems likely to follow the path of its predecessor, the FC, as a prophylactic destined for more use in the developing world than in the U.S. FHC obtained authorization two years ago from the government of India to distribute the condom (Medical Device Daily, Sept. 22, 2006) shortly after receiving a large order for the condom from the program for prevention of acquired immune deficiency syndrome run jointly by Australia and Papua New Guinea.
The company won FDA's approval for its original, the FC, in 1993 with the indication of prevention of pregnancy and transmission of sexually transmitted diseases, but only about 10% of its 34.7 million unit sales in 2008 were in the U.S. Part of the problem with the domestic market for FHC is that condoms for use by men are substantially cheaper than the FC, which was selling for as much as $4 each. The company's sales strategy is said to involve a lower cost for the FC2 in order to gain market share, however.
According to wire service reports, the FC2 is seen as "quieter" than the original and the newer device's softer material will appeal more to women in the U.S.
64-slice CT gets raves for angiography
Given the continued pace of technological advances, diagnostic imaging will never be cheap, but manufacturers will make the value argument to help sales of their equipment. And sometimes clinicians help device makers make that case. In the Nov. 26 edition of the New England Journal of Medicine, a group of researchers do precisely that.
According to NEJM, an international team led by researchers at Johns Hopkins Hospital (Baltimore) disclosed that their study hints that the latest generation of 64-slice computerized tomography (CT) scanners can identify which patients suffer from coronary artery disease almost as effectively as coronary angiography, a much more invasive procedure that carries substantial surgical risks. According to the authors, 64-slice CT angiography demonstrated 93% of the precision of catheter angiography in depicting the presence of coronary artery disease and was almost 100% accurate in detecting single-artery disease.
Joao Lima, MD, a cardiologist at Hopkins and a senior investigator for the study said high-end CT machines are no substitute for catheterization, but serve ably as an "alternative diagnostic tool" that can help doctors establish the presence (or absence) of coronary blockage when indirect tests, such as cardiac stress testing, yield iffy results. The technology would be especially handy for patients who are physically at risk for performing such tests.
The new CT scans might also beat out some stress tests in straight costs terms, given a typical cost of $700 for the CT procedure vs. $1,000 for many high-end stress tests. The procedure also figures to be over much faster, given the need for up to 45 minutes to perform the test and the hour or more required for the patient to recover. Catheterization imaging procedures can run to as much as $1,500.
On the downside is the fact that the use of CT angiography entails the use of contrast agents, which carry risks of their own, not to mention the risks associated with exposures to X-rays. However, lead investigator Julie Miller is quoted as having said, "CT technology has come a long way in the last decade," and that the time needed for the 64-slice procedure can be as short as six seconds.