Guidant

The Justice Department has launched an investigation into possible violations of anti-fraud and anti-kickback laws by leading medical device manufacturers. Medtronic, Guidant and St. Jude Medical are the focus of an investigation headed by the US attorney's office in Boston into possible improper payments made to doctors. With competition in the market for defibrillators and pacemakers intense, some critics have questioned the tactics companies use to win customers. In September, The …

> The Department of Veterans Affairs bowed to pressure from Congress and awarded full control over the agency's $2.1 billion IT budget to its CIO. That makes current CIO Robert McFarland a fairly influential dude. Article

> A rare shot in the arm for Guidant as regulators reportedly weigh approving Medicare coverage for carotid stents, a development which is seen as potentially good news for the company. …

Johnson & Johnson is probably not planning on backing out of its merger with Guidant, according to insiders close to the transaction. Instead the company wants to renegotiate the $24.4 billion price tag it agreed on earlier for the Indianapolis-based device maker. The tough tactics may backfire, however, and lead to a legal battle between the two companies. The clear factor behind the decision, according to most analysts, was this summer's recall of 88,000 defibrillators and nearly …

Johnson & Johnson CFO Robert Darretta told analysts that his company expects Federal Trade Commission approval for its acquisition of Guidant but that it is considering "alternatives" to the blockbuster deal. Observers immediately interpreted that to mean that the company is considering either renegotiating a new price in light of the device maker's recent problems or abandoning the deal altogether. Guidant's shares fell nearly 10 percent in morning trading. The company has been hard …

Guidant paid doctors to participate in an evaluation of a new component that works with its pacemakers and defibrillators, a practice which some critics say raises ethical issues. The New York Times reports that the company paid doctors a fee of $1,000 if they agreed to implant a new version of a lead that connects its implant to the heart and complete a survey detailing their reactions to the technology. According to critics, Guidant's goal was to boost sales of its most …

The Wall Street Journal reports that closer FDA scrutiny of Guidant's product lines led to yesterday's recall of its Insignia and Nexus pacemaker models. The paper says the problem was uncovered during last week's FDA inspection of the Guidant plant in St. Paul Minnesota. Initial evidence suggests the defects are non-fatal and have led to only a few hospitalizations.

- see this  …

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Following a day long meeting of leading cardiologists in Washington sponsored by the Heart Rhythm Society, Medtronic announced that it is considering making public the performance data on its defibrillators. No other major announcements came out of the meeting, but insiders say reporting rules changes are likely given concerns about the recent increase in defibrillator defects. A government study released at the conference found that the number of problems has risen sharply over the last …

The Food and Drug Administration is expected to release new data this morning which shows that the number of problems with defibrillators rose sharply between 1992 and 2002. According to the FDA, pacemakers have shown an improvement over the same time frame, with the number of problems reported showing a decline. Between 1990 and 2002, the agency said 62 people died as a result of the failure either pacemakers or defibrillator failure.  

Some observers are pointing at …

On Wednesday, Sen. Charles Grassley (R-Iowa) and Rep. Edward Markey (D-Mass.) said they will call for new rules requiring the FDA to collect more data on defibrillators and pacemakers. Critics have charged that not enough information is gathered from manufacturers, making it difficult for regulators to reliably assess the risks involved with specific models. Health plans and other providers have argued for a long time that they need access to the information in order to better compare …