Implant Program for Guidant Heart Device – Research Or Marketing?

The New York Times sheds some needed light on the cute connections between research and marketing in some medical device companies.

“By January, about 80 cardiologists nationwide completed an evaluation run by the Guidant Corporation of one of its products, an improved electrical component, known as a lead, that connects an implanted cardiac device to the heart.”

“The program did generate feedback. But internal Guidant documents and e-mail messages provided to The New York Times suggest that the initiative also had another apparent goal – increasing sales of the company’s most sophisticated and expensive heart devices. Those devices are advanced pacemakers called cardiac resynchronization therapy devices, or C.R.T.’s. They cost about $29,000 each.”

The New York Times sheds some needed light on the cute connections between research and marketing in some medical device companies.

“By January, about 80 cardiologists nationwide completed an evaluation run by the Guidant Corporation of one of its products, an improved electrical component, known as a lead, that connects an implanted cardiac device to the heart.”

“In exchange for implanting the lead in three patients and completing five survey forms, each physician received $1,000 from Guidant.”

“Guidant Documents “The primary purpose of the study was to get feedback on how well the system worked,” said Dr. Wayne O. Adkisson, a cardiologist in Portsmouth, Va., who took part.”

“The program did generate feedback. But internal Guidant documents and e-mail messages provided to The New York Times suggest that the initiative also had another apparent goal – increasing sales of the company’s most sophisticated and expensive heart devices. Those devices are advanced pacemakers called cardiac resynchronization therapy devices, or C.R.T.’s. They cost about $29,000 each.”

[If the name Guidant rings a bell, recall that this same company has recalled thousands of its devices recently.]

“The program proved so successful in increasing Guidant C.R.T. sales that when the survey ended in January, company executives sent around congratulatory e-mail messages, the records show. “It generated 300+ implants,” one January e-mail message stated. “Let’s say that just 25% were incremental … that yields >$2 million in new sales with physicians who are not necessarily Guidant friendly. We paid each physician who completed all five surveys $1,000 so our total cost was $80,000.”

“In a statement, Guidant said that it ran surveys like the lead evaluation to generate data on how doctors use company products so that it could improve future models.” […future profits?]

“Critics of the industry have long charged that some companies have used research studies to mask what are really marketing efforts that provide financial incentives to doctors to get them to use a new drug. Now, the Guidant documents and recent interviews suggest that the line between research and product promotion may also be blurring where heart devices are concerned.” [Has the line blurred or disappeared?]

“The Guidant records indicate that many doctors approached by the company to take part in its lead study were not those who regularly implanted its heart devices, but rather those more apt to use the units of competitors. Though the agreement signed by doctors taking part in the lead evaluation did not explicitly require them to implant a Guidant C.R.T. along with the lead, they effectively had to do so because of software-related issues.” [Just a minor factor, I am sure.]

“One Guidant document is a chart that indicates that, on average, the monthly number of company C.R.T.’s implanted by physicians taking part nearly doubled during the survey period that began last September.”

“In order to respond best to the needs of patients and preferences of physicians, Guidant has sometimes utilized market research and evaluation programs of our F.D.A.-approved and -cleared products,” said Guidant.

“The disclosure of the records comes amid a growing controversy over how heart device manufacturers release data about product failures to doctors and patients. Since late May, Guidant has recalled tens of thousands of heart devices, and some units implanted during the survey were probably among the models affected.”

“The two other major heart device companies, Medtronic Inc. and St. Jude Medical, also said they run product evaluation programs. All three companies said their payments to doctors for taking part in such surveys reflected reasonable compensation for a physician’s time.”

“Any payments made in connection with such surveys are in modest amounts,” Medtronic said in a statement.

“A number of physicians who participated in the Guidant evaluation said their involvement in such reviews did not influence which company’s units they implanted. Still, the Guidant survey and ones like it raise questions about what doctors tell patients about any added payments they may be receiving in connection with a heart product’s use, several experts said.”

“Several doctors who took part in the Guidant survey said that they did not tell their patients about the payments they received.” [What they don’t know won’t hurt them, I guess.]

“It is illegal under federal law in certain circumstances to provide financial benefits to doctors to induce them to use a product or service. In its statement, Guidant said that all of its research and evaluation programs “are intended to comply with applicable laws.”