Senate: Medtronic shaped articles promoting InFuse

WASHINGTON (AP) — Medical device maker Medtronic Inc. helped write and edit medical journal articles attributed to outside physicians, which downplayed the risks of the company’s best-selling bone graft, according to a report by Senate investigators.

The Senate Finance Committee said Thursday that the world’s largest device maker did not disclose its role in shaping 13 key studies of InFuse, which helped turn the bone graft into an $ 800-million a year product. The studies, funded by Medtronic, failed to mention serious risks of InFuse including male sterility, infection and increased back and leg pain.

Senate investigators also reported that Medtronic paid the study authors $ 210 million in consulting fees for unrelated work over 15 years.

“Medtronic’s actions violate the trust patients have in their medical care,” said Sen. Max Baucus, D-Mont, in a statement. “Medical journal articles should convey an accurate picture of the risks and benefits of drugs and medical devices, but patients are at serious risk when companies distort the facts the way Medtronic has.”

The Minneapolis company said it disagrees with many of the findings in the report.

“Medtronic vigorously disagrees with any suggestion that the company improperly influenced or authored any of the peer-reviewed published manuscripts discussed in the report, or that Medtronic intended to under-report adverse events,” the company said in a statement.

InFuse has been used in a half-million patients and had sales of about $ 800 million in fiscal 2011, according to Medtronic reports.

The committee’s report is the latest in a series of federal inquiries into Medtronic’s promotion of InFuse, which is widely used for procedures not deemed safe or effective by federal health authorities. Earlier this year the Department of Justice closed a four-year investigation into InFuse, after first subpoenaing the company in October 2008.

The Food and Drug Administration approved InFuse in 2002 for use in spinal, oral and dental graft procedures, but most of the time it has been used in neck surgeries and other procedures. Physicians are allowed to use drugs and medical products off-label as they see fit, but companies cannot market their products for off-label uses. Use of InFuse in neck surgeries can lead to problems swallowing, breathing and speaking. Some patients had to have other surgeries because of those problems.

Senate investigators said Medtronic staff inserted language into studies of InFuse suggesting the product was less painful than alternatives. In one 2005 incident, a Medtronic staffer helping draft a medical journal article recommended against publishing “significant detail” about adverse events reported with InFuse.

The Senate‘s findings echo earlier reports published in The Spine Journal last year, alleging researchers involved in key studies of InFuse did not disclose serious side effects. The Spine Journal is the official publication of the North American Spine Society

The group said in a statement it is “hopeful that future research sponsored by Medtronic and others will adhere to much higher standards.”

The Senate Finance Committee launched its investigation in June 2011, following the publication of The Spine Journal’s report. Senate investigators say Medtronic cooperated with the investigation, turning over 5,000 documents.

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Networks, AP changing exit poll strategy

NEW YORK (AP) — A growth in early voting and tough economy for the media are forcing changes to the exit poll system that television networks and The Associated Press depend upon to deliver the story on Election Night, all with the pressure-filled backdrop of a tight presidential race.

The consortium formed by ABC, CBS, CNN, Fox News Channel, NBC and the AP is cutting back this year on in-person exit polls while upping the amount of telephone polling. This is to take into account more people voting before Nov. 6 and households that have abandoned land lines in favor of cell phones.

“It makes it trickier,” said Joe Lenski, executive vice president of Edison Research, the company that oversees the election operation for the news organizations. “It means there are a lot of different pieces to keep track of.”

On a perfect Election Night, Americans who are tracking results won’t notice all the work being done behind the scenes. The Associated Press reports actual vote counts nationwide and news organizations use those numbers, plus the exit polls, results from precinct samples in some states and telephone polls of absentee voters to do their own race calls.

But things haven’t always gone perfectly. The news organizations completely rebuilt their exit poll system after the 2000 embarrassment, when TV networks mistakenly called the race for George W. Bush when it wasn’t decided until a month later (the AP mistakenly called Florida for Bush, retracted it but, unlike the networks, never called the overall race for Bush). In 2004, early exit poll results overestimated the strength of Democrat John Kerry.

To save money this year, the consortium is doing bare bones exit polling in 19 states. Enough voters will be questioned in those states to help predict the outcome of races, but not enough to draw narrative conclusions about the vote — what issues mattered most to women voting for Mitt Romney, for instance, or how many Catholics voted for Barack Obama.

The affected states are: Alaska, Arkansas, Delaware, Georgia, Hawaii, Idaho, Kentucky, Louisiana, Nebraska, North Dakota, Oklahoma, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, West Virginia and Wyoming, along with the District of Columbia.

Each is considered a non-battleground state with polls showing a strong advantage for one of the presidential candidates. Some non-battleground states will get the full exit poll for other reasons, like Massachusetts and its hotly contested U.S. Senate race between Scott Brown and Elizabeth Warren.

“What we are doing is taking our resources and using them where the stories are,” said Sheldon Gawiser, NBC’s elections director and head of the steering committee for the AP-network consortium.

Spending figures were not made available. News organizations have had a tough few years financially, but the consortium noted that it is interviewing a total of 25,000 voters this year, up from 18,000 in 2008.

Because of early voting, there are no traditional exit polls in Oregon, Washington and Colorado. A phone poll is done prior to Election Day in those states, taking in a mixture of people who have and haven’t voted. Others states have a mixture of telephone polling and exit interviews. California, North Carolina and Arizona are among the states where the percentage of telephone polls has grown because of more people voting early.

More people are interviewed on cell phones because it is the primary way to contact them. The consortium said cell phone interviews are twice as expensive as those on land lines because of manpower costs, in large part because it is harder to reach people and federal law requires the phone numbers to be manually dialed instead of done by computers.

In addition to the exit poll changes, the news organizations are taking steps to improve their ability to include actual vote counts in their decisions on when to call particular states as a winner for either candidate. This usually involves collecting sample precincts that reflect a state’s demographics.

Even this is complicated by local customs. Some states report precinct results more quickly than others. New Mexico, for example, sets up polling places where anybody from a particular county can cast a ballot; while this makes voting easier, it makes projections based on precinct samples more difficult.

Television viewers may notice that networks are being slower than in the past to project winners in certain states, but the consortium believes people won’t see a difference.

If the actual election is as close as the pre-election polls are suggesting, it will be a long night, anyway.

With all the factors increasing the difficulties and costs associated with exit polling, it’s worth wondering whether a time will come that the news organizations abandon them in favor of the pre-election polling. The experts say that time is nowhere near.

“One of the great advantage of exit polls is you don’t have to worry about who voted. You don’t have all of these ‘likely voter’ issues that you have now,” said Lee Miringoff, a pollster at Marist College.

Gawiser noted how the minds of voters can change, even up until the last possible minute.

“It’s a story we want to be able to tell on Election Night and we want to be able to tell it accurately and rapidly,” he said. “I really don’t think it’s much different than any other story we tell.”

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