Spinal fusions jumped 1,500% among Medicare patients between 2002 and 2007. The explosion had nothing to do with changes in prevalence of the conditions for which the complex surgery is performed. It had everything to do with the release of Infuse, a bone growth stimulator that reduces the complexity of the procedure.

Infuse (pictured) is marketed by Medtronic. It was approved by the FDA in 2002, specifically for spinal fusions of the lumbar (lower) spine using a particular surgical technique: the frontal approach. Soon after the FDA green-light however, surgeons began using it for other kinds of lumbar fusions and cervical (neck) fusions as well. Peer-reviewed studies of these non-approved uses helped drive the explosion in spinal fusions. Now, remarkably, off-label use accounts for 85% of Infuse use. The biological garners nearly $900 million in annual revenues for Medtronic.

There’s More to the Story
Unfortunately, newer studies of spinal fusion have found it to be no more effective for common back pain than physical therapy. Use rates of Infuse have not responded to this growing literature.

Beyond this, the off-label use studies mentioned above were sponsored by Medtronic and led by scientists that received tens of millions of dollars’ worth of royalty payments and consulting fees from Medtronic. It has recently been alleged that these scientists knew about certain complications caused by Infuse, and either failed to disclose them or de-emphasized them in their write-ups.

The complications include some that are potentially fatal– neck swelling severe enough to compromise breathing, and possibly an increased cancer risk, for example. They also include sterility in men, a complication Medtronic and surgeons with financial ties to Medtronic appear to have been aware of—but did not report–since 2002.

These alleged shady behaviors came to light just recently, when researchers re-examined data from the Medtronic sponsored trials. The data was submitted to the FDA, but never made it into the literature that spawned widespread, off-label use of Infuse.

The matter has now escalated all the way to the Senate Finance Committee. In a letter to Medtronic last week, Committee members Max Baucus and Charles Grassley claimed that “doctors conducting clinical trials examining the safety and effectiveness of Infuse on behalf of Medtronic (knew that Infuse could) cause medical complications, but failed to report this in the medical literature.” The senators asked Medtronic to send them all documents and communications relevant to these studies, as well as a detailed account of payments made by Medtronic to all surgeons involved in the studies.

The run-in with Senate Finance is just the latest in a series the company has had with federal officials. In 2008, the Justice Department opened an investigation to determine whether the company illegally promoted off-label uses of Infuse. A year later, an Army investigation found that a former Army surgeon, paid by Medtronic, had falsified the results of a study involving Infuse. That’s not counting recently unsealed testimony given in a 2002 lawsuit filed by a former Medtronic lawyer which alleged that the company illegally gave surgeons incentives to use its products.

What Do We Make of This?
Senators Baucus and Grassley have turned harpooning the business practices of companies that profit from health care into an art form. They’re particularly adept at selecting issues that garner popular support. In this case, they argue that patients and physicians have a right to expect that the information on which they rely is accurate, unbiased and comprehensive. Applying that thesis to the Medtronic situation, the point is that when studies of drugs or devices are published by scientists with financial ties to the company that markets the product in question, this needs to be disclosed, even if the payments aren’t linked to the product being evaluated. We couldn’t agree more.

Then again, Senate Finance isn’t equipped to take-on more than a few of the many egregious spectacles in which health companies have recently become enmeshed. More potent lines of defense include the editors of peer reviewed journals, who need to re-evaluate their disclosure policies. They also include physicians, who must step to the plate more often in a watchdog role, alerting others in the profession about potentially unsavory behavior or previously unreported complications associated with drugs and devices. Finally, as Maggie Mahar points out, the mainstream media also plays a role by continuing to pursue the story of money-driven medicine.

“The repetition is crucial,” she said. “Education depends on repeating the same message, and making it clearer over time.”

iPhone Can Diagnose Stroke Quickly, Accurately. Doctors that evaluate iPhone displays of CT scans and CT angiogram tests can diagnose a stroke with the same accuracy as if they had viewed the images on a medical computer workstation, a study showed.

Birth Control Pills Mask Signals That Draw the Sexes Together. New studies suggest that hormonal contraceptives disrupt women’s production of and responses to pheromones. This affects their attractiveness to men and their preferences for romantic partners.

Scientists Use Twitter to Document H1N1 Disease Activity. Retrospective review of Twitter feeds during the Swine Flu pandemic allowed US researchers to track disease burden in local communities and its spread throughout the nation.

Boston Scientific Chief Resigns. J. Raymond Elliott announced he will step down at the end of 2011 after less than two years in charge of the device maker. The move shocked investors and sent the company’s shares sliding.

Hospitalist Management Companies Finalize Merger. The tie-up between Hospitalists Management Group and Cogent Healthcare forms the largest private hospitalist company in the US.

More than 70% of all medical devices that have been recalled by the FDA for safety concerns were not subjected to rigorous clinical testing before the agency approved them, according to a new study.

The study authors were Diana Zuckerman and Paul Brown from the National Research Center for Women and Families, a consumer group, and Steven Nissen, a cardiologist at Cleveland Clinic.

The authors reported that overall, the FDA recalled 113 medical devices between 2005 and 2009. Of these, 21 had been approved on the basis of rigorous clinical trial data. Eighty others had been approved under a less stringent, expedited approval process known as 510K, in which a device maker needs only to show that its new product is substantially similar to one already on the market. An additional 8 devices were exempt from FDA regulations, and 4 more were either counterfeit or classified as “other.”

Devices approved using the 510K approval process included mechanical ventilators, insulin infusion pumps, artificial hips and knees, and external cardiac defibrillators. The more rigorous process is typically reserved for life-supporting devices like implanted cardiac defibrillators. In the latter process, device makers must sponsor trials designed to prove their products are safe and effective.

Last summer, the FDA announced it was implementing some steps to “strengthen” the 510K process, but it deferred on a complete overhau pending the release of a report on the matter by the Institute of Medicine. The report is due later this year.
 In an interview, Zuckerman said her group’s findings suggest that the FDA’s actions to date on 510K aren’t adequate. Device manufacturers have managed to expand the concept of “similar” well beyond the FDA’s original intent when the 510K law went live in 1976, Zuckerman explained. “The law has gotten looser and looser over time.”

The FDA blew-off Zuckerman’s findings as old news. According to a statement by the agency, the data had been presented by Zuckerman last year at a public meeting sponsored by the IOM.

For its part, the Advanced Medical Technology Association, a device industry trade group, said the study was misleading. It wasn’t surprising that 510K-approved devices accounted for most of the recalls, the group said, because most FDA-approved devices have gone through the 510K process.

Stephen Ubl, the Association’s CEO added that the study was “fundamentally flawed” since it focused “on the total number of recalls and ignored the fact that there are over 50,000 devices on the market.”

Ubl added that the percentage of products recalled for serious health problems or deaths was substantially below 1%. He added that an overly strict regulatory process would hinder innovation and prompt device manufacturers to move product development to other countries where regulatory scrutiny isn’t as intense.

Zuckerman’s write-up appears in the Archives of Internal Medicine.

Aortic Stenosis (AS) is a condition caused by progressive narrowing of the valve that governs blood flow from the heart to the brain and most other internal organs. About 1.5 million Americans have AS, one-fifth of whom have a severe form that is life-threatening.

Traditionally, the treatment for severe AS involves open heart surgery, an expensive procedure that is associated with its own risks and contraindicated in frail, elderly folks…just the kinds of people that develop the condition in the first place.

Now, scientists have shown that a relatively non-invasive treatment for severe AS may obviate the need for open-heart surgery.

The new approach involves attaching a replacement valve to a catheter, and then threading it through blood vessels to a place where it can serve the role of the malfunctioning valve. 

The replacement valve is produced from cow tissue and is housed within a metal frame. 

A study of the new device was published 2 weeks ago in the New England Journal of Medicine. In the study, a group of elderly patients received the catheter-placed device while others received various other non-surgical interventions.

The one-year mortality rate for people that received the replacement-valve was 31%. This was lower than the 51% mortality observed in controls. Of note, the study also revealed a higher incidence of early strokes (5% vs. 1%) in patients who received the new device. The increased stroke risk was nevertheless deemed “an acceptable price to pay” by Craig Smith, a study co-author.

The study was funded by Edwards Lifesciences, the same company that designed the valve. Several authors have financial ties to the company. Catheter-delivered valves “should be the new standard of care” for patients with severe AS that can’t tolerate open-heart surgery, they concluded. 

Edwards hopes to gain FDA approval for its device in 2011.

Lately, the Food and Drug Administration has been receiving increased numbers of reports describing  problems with insulin pumps, those small devices used by diabetics to deliver insulin without the need for injections.

The FDA noted that various hardware and software issues have resulted in 18 device recalls during the last 5 years.

“Device problems…exist across manufacturers,” the agency noted. 

In response, FDA has convened an advisory panel to recommend actions to “minimize risks associated with the devices in these recall situations,” according to its Web site.

Insulin pumps are typically used by patients with Type I diabetes, in which the pancreas produces little or no insulin. Type 1 diabetics rely on exogenous insulin for survival.

According to the FDA, the number of people in the US who used insulin pumps increased from 130,000 in 2002 to 375,000 in 2007.

The FDA requires pump makers to report problems and potential problems associated with the devices. The agency received 17,000 such reports in the 3-year period ending September 30, 2009. Such reports don’t necessarily mean the pump caused a problem but usually merit further investigation. Patients can misuse a properly functioning pump, for example.

Roughly 12,000 reports to the FDA were associated with a patient injury (which typically involved gyrating blood glucose levels). Deaths occurred 310 times.

In these instances, the FDA said information provided by pump makers “was typically incomplete.” In 225 of these reports, the manufacturer listed the device problem as “unknown.” In many of these cases, the device wasn’t returned to the manufacturer for follow-up investigation.

In 41 reports involving a patient death, the circumstances included diabetic coma and other problems typically associated with severe abnormalities in blood-sugar levels, which suggests possible device malfunctioning.

Boston Scientific Corp. has agreed to cut a $716 million check to Johnson & Johnson to settle more than a dozen patent infringement lawsuits, including one in which a judge had already ruled in favor of J&J.

The settlement wraps up all but 3 stent-related lawsuits involving the two companies. Stents are cage-like metal struts that prop open partially blocked arteries.

Stents are most frequently used in the coronary arteries, but they can be used in other arteries as well.

The market for cardiac stents now exceeds $4 billion. Boston Scientific leads the pack in this field, but J&J owns the original patents on the medical devices after acquiring them from Julio Palmaz, the radiologist who invented them.

Nine years ago, a judge ruled that a Boston Scientific stent known as the NIR infringed on one of J&J’s patents. Boston Scientific appealed, but announced last year that it expected to fork over more than $700 million to settle the claim. That includes interest dating from the original verdict.

Boston Scientific announced it will pay the settlement from cash holdings, which amounted to $1.2 billion as of last June.

The market for stents has leveled off in recent years after studies showed they weren’t that effective in many instances, and other studies raised concerns about bleeding from the anti-platelet therapy that is normally prescribed after stents are placed.

The J&J settlement comes shortly after Boston Scientific settled separate stent-related claims with Medtronic. For its part, Medtronic recently paid $400 million to Abbott Laboratories to settle a patent infringement case regarding…you guessed it, stents.

Not long ago, FDA deputy commissioner Joshua Sharfstein criticized the process his Agency used to approve ReGen’s Menaflex knee device,  claiming that “extreme” pressure from New Jersey Congressmen had compromised its integrity.

He added that the skullduggery was a factor in prompting his decision to review the FDA’s 510 (k) program, which fast-tracks approval of medical devices by requiring less rigorous clinical testing than the standard process.

“It’s autumn, and change is in the air. This is particularly true for our 510k program,” echoed Donna-Bea Tillman, head of the device evaluation office, in an email to her staff that was obtained by The Wall Street Journal.

The very thought of change to 510k goes over like a lead balloon for device makers like Johnson & Johnson, who warn that tampering with it would end up robbing the public of rapid access to a stream of live-saving, quality improving (not to mention money making) instruments.

J & J spokesperson Carol Goodrich said that 510k streamlines clearance for devices deemed “substantially equivalent” to those on the market, “builds on ever-expanding knowledge,” and accelerates innovation.

Tighter approval standards, she said, “would raise development costs substantially while also creating barriers to market entry that would reduce competition.”

About a third of J & J’s $64 billion in annual world-wide revenues derives from the sale of medical devices and diagnostic equipment.

The FDA’s move was just the latest bad news for the device industry.

Congressional Democrats for example, are pitching a tax on device makers to help pay for  health reform. If passed, the proposal could cost the industry $40 billion over 10 years.

To be sure, the Advanced Medical Technology Association, a lobbying group that represents device makers, is working overtime in Washington to set things straight on both counts.

The new deputy commissioner of the Food and Drug Administration has criticized his Agency’s approval of ReGen’s Menaflex knee device last December in a report claiming that “extreme” pressure from New Jersey Democratic Congressmen compromised the integrity of the process.

In his report, Joshua Sharfstein asserted that the Congressional heat was “the most extreme (the FDA’s Congressional liaison) had seen. In addition, “the FDA’s acquiescence to (ReGen’s) demands was unprecedented.”

The events undermined the Agency’s ability to “counter the suggestion that lobbying on behalf of ReGen affected the decision,” according to the report which was obtained by the Wall Street Journal.

The Congressmen, Senators Robert Menendez and Frank Lautenberg, and Representatives Frank Pallone Jr. and Steve Rothman apparently encouraged the Agency to hasten its review of New Jersey-based ReGen’s device, which is a collagen meniscus implant designed to guide new tissue growth following surgical repair in patients with tears or loss of meniscus tissue.

Sharfstein added however, that his report does not constitute grounds for Menaflex recipients to panic and that the device remains on the market. The Agency, he said, will begin a review to determine whether that continues to be the case.

The 4 Congressmen countered that their involvement was a simple case of helping a constituent get fair treatment from the FDA.

The case could have far-reaching implications for the medical device industry. It is one reason why the FDA has undertaken a comprehensive review of the 510 (k) program which fast-tracks approval of medical devices by requiring less rigorous clinical testing before approval is granted.

ReGen claims that its product is safe and effective. Former FDA Commissioner Andrew von Eschenbach wasn’t available to comment.

Here’s an idea that might not be too hard to swallow. Proteus Biomedical, a Silicon Valley start-up has developed a tiny microchip that can be attached to pills and signal caregivers when patients have swallowed them.

At the same time, sensing devices on the skin can relay information regarding the patients vital signs using wireless technology.

The combo technology could help physicians monitor compliance with prescribed dosing, assure the patient takes the proper dose, and provide early warning about untoward physiologic effects.

The chips have been shown to be safely digestible. In commercial production, they would cost less than a penny per pill.

www.youtube.com/watch?v=3o8vsU0Dw-4

Proteus is one of many companies using micro chips and wireless technology to create new medical tools. Triage Wireless, for example is testing a wearable device that can transmit continuous blood pressure readings in hospitalized patients, while Corventis has a sensor that measures respiration, fluid status and movement.

The potentially huge health care market for wireless devices has prompted larger companies to enter the fray as well. Qualcomm for example, is developing chips that can be used in various wearable medical applications.

Similarly, Intel is developing “magic carpet” devices to be deployed in the homes of senior citizens to track movement and prevent falls, a major cause of morbidity in the elderly.

Wireless networks, of course, are already in widespread use to support the 4 billion cell phones sold to date. The same networks can be used to transmit medical data.

According to Eric Topol, a Scripps Institute cardiologist, remote monitoring devices could save $10.1 billion in the care of patients congestive heart failure alone.

Republican Senator Charles Grassley has been all over the medical device industry for years.  Why just a month ago he called out the University of Wisconsin in the Zdeblick-Medtronic debacle.

“I am concerned that Wisconsin’s reporting requirements do not go far enough to fully capture a physician’s potential conflict of interest,” he said a moment after revealing the surgeon had pocketed $19 million, most of it undisclosed from Medtronic, the nation’s largest spinal device producer.

That was quite a performance, but now Grassley is movin’ in for serious carcass. Last week, he and Herb Kohl, who ironically is a cheesehead, reintroduced legislation that would require device makers and Big Pharma to list all financial ties with physicians on a .gov Web site.

The public is clamoring for transparency,” Kohl said of the Physician Payments Sunshine Act.

And other parts of the government are providing precision support for the senators on multiple fronts. 

In 2007 for example, the Justice Department forced knee and hip makers to accept its oversight as a quid pro quo for not looking further into allegations they bribed physicians to use their stuff.

In fact Justice already requires knee and hip makers to disclose all payments to physicians on corporate Web sites and has capped per-day consulting payouts to physicians at a measly $500.

Even some hospital systems are getting into the act. Kaiser Permanente for example does not permit its physicians to accept income from the private sector and requires that device makers compete for contracts on price, perish the thought.