Catastrophic FAIL: Easier to Recall Spinach Than Medical Implants

Effort to improve tracking of medical devices divides industry, consumer groups

By Joe Carlson OCTOBER 21, 2017 — 2:00PM

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Fictitious medical device label is shown for unique device identifier information.

In March 2015, Target Corp. alerted customers to throw out certain 10-ounce bags of organic chopped spinach because they were potentially contaminated with listeria bacteria, which can cause serious health problems.

The recall notice, filed with the U.S. Food and Drug Administration, urged people who bought the spinach to check UPC codes and a special nine-digit tracking code called the DPCI that Target includes on its sales receipts. The recall was routine, and no illnesses were publicly linked to the incident.

No such system exists for medical device consumers, however.

In fact, proposals to give insurers and patients access to the serial numbers on their implanted medical devices remain controversial.

Manufacturers say it would cost additional time and money with no guarantee of benefit to put the device serial numbers into insurance claim forms. Consumer safety officials and auditors argue the move would improve patient safety and enhance accountability.

To patient advocates like Lisa McGiffert, director of the Consumers Union's Safe Patient Project, omitting device serial numbers from an insurance claim would be like buying a car without getting its VIN number.

Doesn’t Add up: The medical industry is divided over adding a unique device identifier (UDI) to devices, which would make it easier to locate a device but at a higher cost for companies.

"We don't even have the make and the model" in insurance claims, McGiffert said. "We can put it on a car — why shouldn't we have it on a hip that you're putting in my body?"

Thousands of medical devices are recalled each year, but it can be hard to track them. In 2005, former Minnesota device maker Guidant Corp., now part of Boston Scientific, urgently recalled thousands of pacemakers because excess moisture could seep inside the life-preserving devices and ruin them.

A handful of patients with the devices went into cardiac arrest or experienced heart failure, and one death may have been linked to a pacemaker failure. Yet the Government Accountability Office (GAO) reported in 2011 that 1,732 of these recalled pacemakers were never recovered because there was "no implant record available."

Medicare, which pays hospitals to implant such devices in patients aged 65 and older, had no direct way of tracking down which of its patients may have gotten those 1,732 leaky Guidant pacemakers — nor, for that matter, any of the hundreds of thousands of other heart devices that have been recalled by the medical device industry in the years since then, critics inside and outside the government say.

Congress mandated a system of serial numbers to track medical devices known as UDIs, or unique device identifiers, back in 2007, and the Food and Drug Administration has been rolling out rules for how and when to use them ever since.

The med-tech industry and some doctors have fought hard to keep them out of Medicare claims and private insurance bills.

A two-year investigation by Medicare's inspector general office recently concluded that the publicly funded health insurer spent an estimated $1.5 billion over 10 years on surgeries and follow-up care for patients who had one of seven specific heart devices made by Minnesota manufacturers. The review did not include the Guidant pacemakers mentioned by the GAO and didn't examine other widely recalled types of devices, like metal-on-metal hip implants.

John Boujoulian, senior auditor on the Medicare inspector general investigation, said the lack of UDI numbers in Medicare claims makes it harder to locate patients affected by medical device recalls. But as it stands, Medicare would have to do a detailed review of medical records to find the UDIs to track down devices that it pays to have implanted or replaced.

"We had to go through all the medical records to find out," Boujoulian said in an interview about the audit. Using subpoenas to the device makers, "we had lists of all the people who had the medical devices implanted and the specific models, and we had to go through them all to see which ones had issues."

But going through the detailed medical records of patients is exactly what the medical device industry advocates.

"We support the collection of the UDI in the electronic health record, where it can actually be used to really help track patient outcomes and be used in a more proactive way around postmarket surveillance," said Don May, executive vice president for the Washington-based medical device manufacturer trade group AdvaMed. "If we are really concerned about patient safety, then let's go to the tool that makes the most sense."

Industry officials say the codes are too long and varied to put into insurance claims. AdvaMed says hospitals would have to invest in new bar code scanners and come up with ways to accurately transmit the data to payers. The American Medical Association says reporting UDIs in insurance claims would be cost prohibitive and insufficient for detecting widespread problems.

Organizations including Centers for Medicare and Medicaid Services and the Medicare Payment Advisory Commission have supported adding a short section of the UDI known as the "device identifier," or DI, to Medicare claims forms.

The full UDI, however, can run to 75 characters and comes in three different formats used by three different standards organizations. The full code contains not just model numbers, but batch and lot numbers, dates of manufacture and other information that would identify which specific devices are affected by problems.

AdvaMed Associate Vice President Zach Rothstein, who advocates on medical device regulation involving the FDA, said researchers who use just snippets of the UDI codes may draw inaccurate conclusions about devices that could negatively affect both medical device makers and patients.

"Think about all the food recalls where you go to your freezer and say, 'Well, was this done in that time frame and in that plant?' And the news gives you the code. It's not just this was Tyson chicken," he said. "Without [the full serial number], you just don't know."

Advocates say patient safety would benefit from the added transparency, dismissing arguments that it's too difficult or expensive. Ben Moscovitch, manager, health information technology at Pew Charitable Trusts, noted that the FDA's Sentinel program to root out problems with prescription drugs is based largely on claims data, which incorporates 10-digit National Drug Codes.

"Many of the safety challenges that occur with devices occur across the entire product line," Moscovitch said, "and to evaluate the safety of products in that capacity requires only the brand and model of the device, and not the production information that is included in the [full UDI]."

The three companies that made the recalled or defective heart devices that led to $1.5 billion in Medicare spending documented in the inspector general's report — Boston Scientific, Medtronic and St. Jude Medical owner Abbott Laboratories — all declined to comment for this story.

Asked whether the medical device companies' opposition to including UDIs in Medicare-claims forms was related to financial concerns like lost sales or increased litigation, May noted that product recalls are already costly.

"From a litigation perspective, I think malpractice attorneys are very aggressive in a lot of ways, and this just becomes one additional data source," May said. "But if you've got a product that is recalled, my guess is the company is already feeling a financial impact because it's a product that they've had to recall."

joe.carlson@startribune.com 612-673-4779 _JoeCarlson

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Held hostage by medical device cheerleader: Representative Erik Paulsen (R-MN)

Push to kill medical device tax isseen as way out of shutdown

Article by: KEVIN DIAZ , Star Tribune Updated: October 2, 2013 - 10:14 PM

FiDA highlight

WASHINGTON – A small group of rank-and-file House members trying to break through the impasse in the government shutdown revived talks on Wednesday aimed at repealing a health care tax that falls heavily on Minnesota’s medical device industry.

The effort is being led by Minnesota Republican Erik Paulsen, who has cast himself as the champion of an industry estimated to employ 35,000 in Minnesota. Paulsen said he discussed his proposal Wednesday with Republican House Speaker John Boehner hours before House and Senate leaders were scheduled to meet at the White House with President Obama.

“I said this can and should be part of the solution,” said Paulsen, one of about a dozen House Republicans who have signaled their willingness to drop GOP demands of defunding or delaying the Affordable Care Act, often called Obamacare, as a condition of keeping the government open.

Paulsen sponsored a measure to repeal the medical device tax as part of a GOP government funding proposal that got 17 Democratic votes over the weekend. The Democratic-led Senate stripped the language as part of a broader dispute over Republican efforts to derail the Affordable Care Act, which rolled out this week.

Minnesotans in Congress from both parties have been pressing to undo a $30 billion medical device tax levied under Obama’s health care overhaul. But the two sides have been unable to agree on a way to make up the lost revenue.

Now, with both sides looking for an end to the government shutdown, the repeal effort has been caught up squarely in the protracted politics of the standoff.

Democrats, including Minnesota Sens. Amy Klobuchar and Al Franken, have said they are unwilling to repeal the tax as part of any GOP funding measure that delays implementation of Obamacare as the price for keeping the government open.

“I continue to believe that the current continuing resolution is not the best place to work out a medical device tax repeal that the president would sign into law,” Franken said. “I think the surest way to quickly reopen the government is for the House to vote on the Senate-passed bill to fund the government at its current levels. But I will take a careful look at any proposal that emerges.”

Meanwhile, Republicans have used the issue to attack Minnesota Democrats who voted against the repeal of the medical device tax as part of a GOP funding measure that puts off the health care law.

Despite the discord, Paulsen said the repeal effort represents the best opportunity for compromise. “The number one provision in this entire debate that has brought the most bipartisan support is repealing the medical device tax,” he said. “So we’ve got an opportunity to make that the linchpin as part of a solution.”

Paulsen said he has been in talks with a group of Republican and Democratic House members, including Wisconsin Democrat Ron Kind, an opponent of the medical device tax. Kind, however, has been working on a way to offset any lost revenues that might result.

Optimism from the industry

Industry leaders expressed guarded optimism about the new push on the medical device tax, which already has collected more than $100 million.

“There is reason for optimism that there is a critical mass and bipartisan support for repealing the tax,” said J.C. Scott, chief lobbyist for the Advanced Medical Technology Association.

The House voted last year to repeal the 2.3 percent excise tax on medical device makers like Minnesota-based Medtronic, which has said the tax could cost it $175 million annually. But efforts to win passage in the Senate have been stymied by Democratic concerns about losing one of revenue streams to pay for Obama’s 2010 health care law intended to cover some 40 million uninsured Americans. The repeal measure also has faced a White House veto threat.

White House officials contend that medical device makers will benefit from the new business created by the expansion of coverage to Americans who are now uninsured.

Where state’s senators differ

While Franken and Klobuchar have vowed to get the repeal through the Senate, they differ on a key sticking point: how to make up for the revenue.

Last year’s House-passed bill would have offset the lost taxes by shrinking insurance subsidies for low- and middle-income workers under the health care law. Franken said the GOP plan would undermine the goal of affordable health care.

Klobuchar said Wednesday that she is committed to repealing the medical device tax. However, she said, “the president has made clear that he will not accept changes to the Affordable Care Act as a condition for opening the government.” That doesn’t prevent a repeal in future negotiations, she said, adding that “the best way to get there is for the House to take up the Senate bill to reopen the government so we can have those negotiations.

Paulsen said House members are working on new revenue measures. “It’s definitely something that’s being conducted by rank-and-file members looking for a way out and a solution with bipartisan support,” he said.

Even if enough Democrats come on board, Paulsen’s greatest challenge may be convincing other Republicans.

“I would call it a win,” Paulsen said. “It would be a major accomplishment that helps the economy.”

explanthis

Oct. 3, 13

1:12 PM

The medical device industry is poorly regulated. I have been a patient advocate on the federal level for nearly 5 years, testifying at FDA meetings about the high rate of failure of implanted hips, knees and surgical mesh. The industry has fought UDI (unique device identification), legal protections for harmed patients, transparency of doctor/device mfg. financial relationships and independent outcomes registries to adequately inform patients and their providers. Right now, in WV federal court there are nearly 50,000 harmed women fighting for their civil rights and compensation for 'morbid disfigurement' from multiple manufacturers of surgical mesh. The 2.3% tax is warranted and capitulation to this entitled industry by our elected representatives is undemocratic. Research on 'Failed Implanted Medical Devices'.

Caution to Boomers: implants do not have a warranty and divorce is not an option!

Boomers' embrace ofdevices gives rise to new med-tech age

•                Article by: JAMES WALSH and JIM SPENCER , Star Tribune Updated: September 15, 2013 - 12:23 PM  FiDA Highlight

Rapid growth of medical devices in middle-age patients renews lives, remakes industry and raises worries over long-term use.

•                7

Jay Alva’s sneakers pounded the treadmill, set to the speed of a brisk walk. Sweat dripped off the 53-year-old as he hit a groove during a recent workout.

For almost two decades, the youth soccer and football coach from Eagan moved like a man who needed a walker. A degenerative hip condition prevented Alva from running with his players or even doing basic things like tying his shoes.

Brushing off a doctor’s advice that he was “too young,” Alva got artificial hips four years ago. Now pain-free, he moves with the energy of a man in his 30s, amused at the notion that he wasn’t old enough for such treatment.

“I am living so much better now in my 50s than I did in my 40s,” Alva said.

Hundreds of thousands of Americans are receiving medical devices that were once considered nearly exclusive to the elderly. The shift is profoundly changing patient care and expanding the fortunes of the medical-technology industry while amplifying concerns over the safety and oversight of some products.

The movement is so dramatic that the futures of major medical device companies such as Medtronic, St. Jude Medical and Boston Scientific — corporate giants in Minnesota — are increasingly tied to younger groups and the new markets they represent.

Middle-age Americans, in particular, are driving this trend as they seek ways to remain physically active. The number of patients ages 45 to 64 who had a hip replacement more than doubled from 2000 to 2010, according to a Star Tribune analysis of data from the U.S. Department of Health and Human Services. The increase was more pronounced for knee replacements, rising 213 percent.

“This is huge,” said Dr. Robert Hauser, a cardiologist at the Minneapolis Heart Institute who has studied the safety and effectiveness of heart devices for years. “I think it’s a tremendous step forward, but there are issues that need to be dealt with.”

Though widely celebrated, some treatments have been shadowed by reports of devices or other medical products faltering — defective wires in defibrillators, failing artificial hips and leaky drug pumps, among them. Patients have suffered complications, severe pain and even death. Every year, 25 to 40 medical devices are recalled due to high risk — meaning a patient’s life could be in jeopardy.

Device companies are facing thousands of patient lawsuits challenging the safety of some devices, and federal regulators are under greater pressure to intensify their oversight. At the same time, device makers are spending millions to promote their products to doctors and patients while simultaneously pushing to simplify governmental reviews to quicken their products’ path to market.

Doctors and device makers are converting technology to regulate heart rhythms or treat diabetes into new tools for a wider range of ailments, including overactive bladders, anxiety and migraines. The result is a wider range of devices and other medical products being implanted or connected to more nonelderly patients.

But this growing use of medical hardware should be tempered by a call for safety, public disclosure and caution, consumer advocates say.

“We’re not talking about computers or cars or toasters,” said Lisa McGiffert, director of the Consumers Union’s Safe Patient Project, a group that campaigns for better medical practices. “We’re talking about things that go inside people’s bodies.”

Replacement parts — for the body

No area of medicine is seeing more younger patients turn to medical devices than orthopedics.

In 2000, one-third of the estimated 157,000 Americans who had hip or knee replacements were younger than 65. Ten years later, the number had nearly tripled to 430,000, meaning almost half of those procedures were performed on nonelderly patients.

Two contradicting forces are pushing patients toward artificial joints. The rising rate of obesity has led to more cases of deteriorating hips and knees from excess weight. And yet, more Americans are playing sports or exercising in their 30s, 40s and 50s, which puts more wear and tear on their joints.

To get active again — and quickly — patients are more willing to consider joint replacement at a younger age than they were a decade ago, said Dr. Daniel Berry, chairman of orthopedic surgery at the Mayo Clinic in Rochester.

“We’re seeing higher demand,” Berry said of younger patients who want a new hip. “And they are going to use it a lot harder than somebody who is older.”

Patients who get a device at a younger age usually must replace it more often. Each replacement means an expensive surgery, possible complications and significant rehabilitation.

“You have to find a happy medium,” Berry said. “Think about it like the tires on your car. There’s no point in getting new tires if you’re not driving … but if you speed up, they wear out faster.”

Medical device companies are working to create joints that are more durable and feel more like the original. Stryker, an international medical device company based in Michigan, had younger customers in mind when it developed hip and knee products that have more natural range in motion, said Joe Cooper, Stryker’s director of global communications.

“Designing implants that return this active and high-demand patient population to their lifestyles and everyday activities is a priority,” he said.

TGS Knee Innovations, a start-up device company in Plymouth, created a partial-knee replacement system that is designed to be a good option for younger patients facing a knee replacement, said Wesley Johnson, the company’s co-founder.

TGS has a relatively “small footprint” in the orthopedic field, but Johnson sees a future filled with youthful patients who want new knees to do more than they did before.

“For orthopedics, that tidal wave is a broader patient population with higher expectations,” he said.

They don’t last forever

Most artificial hips have a life span of 15 to 20 years, depending on how much patients weigh and how hard they push their bodies. Some companies developed a hip that used all-metal components in the belief it would improve durability. It didn’t necessarily turn out that way.

Many patients reported problems that have included loosening of the hip, dislocation and metal particles circulating in the bloodstream. They question whether the U.S. Food and Drug Administration, which has oversight of medical devices, adequately scrutinized the devices before approval.

Terri Wagner-Morley of St. Paul had what is commonly referred to as a metal-on-metal hip — produced by DePuy Orthopedics Inc. — implanted in 2008. Within two years, the hip began “popping.” Soon, the pop turned to pain.

Wagner-Morley had the hip removed, but infection prevented doctors from putting in a new one. Plastic “spacers” were implanted instead, and she was bedridden. Last summer, she had a metal and ceramic hip implanted, but a stress fracture during rehabilitation has left the 55-year-old woman limping and angry. She remains disabled and without a job.

“I have had four surgeries now,” Wagner-Morley said. “As I get older, I’m probably going to be wheelchair bound. I might have a positive view, but really, I’m pissed off.”

In 2010, DePuy recalled the hip that had been implanted in Wagner-Morley.

That same year, hospitals, patients and med-tech companies reported 230,000 adverse events involving medical devices. About 30,000 of those incidents resulted in hospitalization, according to an analysis by DeviceMatters, a company which interprets data on medical devices.

“You’ve got to get this right — or people are going to suffer,” said Hauser, who discovered flaws in the wires of some defibrillators that led to a major recall.

Alva said he doesn’t worry about complications or the durability of his new hips. Being able to pace the sideline of his son’s games, ride a bike or refinish his floors overrides such concerns.

“When I need [new hips] again, I’m confident the technology will be better,” Alva said. “How can it not be?”

Something old, something new

Minnesota’s med-tech giants — Medtronic, St. Jude Medical and Boston Scientific — have generated billions in sales over the past 15 years through the development of devices and technology designed to keep the heart beating in aging patients.

Now they are expanding those innovations to treat a variety of other ailments, many afflicting patients who haven’t reached their golden years.

Brent Peterson, a former professional hockey player and coach who lives in Nashville, relies on a small, pacemaker-like gadget to calm his Parkinson’s symptoms by sending a stream of electricity to a spot deep within his brain.

The 55-year-old is a special adviser to the Nashville Predators of the National Hockey League. He learned that he had Parkinson’s disease more than a decade ago. At one point, he was taking 25 pills a day.

When Peterson’s device was implanted in 2011, his hands immediately relaxed, and his movements steadied. “The day they turned it on, I knew I didn’t want to be without it ever again,” he said.

Medical device makers didn’t set out to adapt pacemakers to treat other parts of the body, but it made sense to expand the technology as doctors explored what else could be treated with an electrical pulse, said Martin Gerber, senior research and development director at Medtronic.

Peterson’s device, a Medtronic Activa neurostimulator, can be programmed and adjusted to change as his symptoms evolve. More than 100,000 patients worldwide have received Medtronic’s deep-brain stimulation therapy.

The treatment is part of what is called neuromodulation. Implanted devices are used to send medication or electrical pulses into the brain or to the spine to block pain, relax overactive bladders by targeting nerves near the tailbone or ease chronic migraines at the base of the skull. Researchers are exploring electrical stimulation to treat epilepsy, obsessive-compulsive disorder and severe depression for those who have not responded to medication.

The emerging innovations are expanding the products and profits for medical device makers.

At Fridley-based Medtronic, the world’s largest medical-technology company, nearly half of its $16 billion in revenues last fiscal year came from treating something other than the heart, its core market. And at St. Jude Medical, based in Little Canada, officials expect sales from the company’s nonheart rhythm products to surpass the heart rhythm business this year.

Med-tech executives say they are not specifically targeting young patients with these technologies. But they acknowledge these new treatments are attracting younger patients.

“It’s a tremendous growth opportunity,” St. Jude Medical Executive Vice President John Heinmiller said. “How can we innovate those technologies to attack these expensive epidemic diseases that are out there? We are looking at investments that treat a broad patient population.”

Most patients — more than 14,000 estimated in 2010 — who turn to spinal, brain or other stimulation devices are well below retirement age. Of those patients who had a spinal cord stimulator implanted, an estimated 69 percent were younger than 64, with more than 21 percent between the ages of 18 and 44.

Dr. Mehul J. Desai, director of spine, pain medicine and research at Metro Orthopedics & Sports Therapy in Silver Spring, Md., believes the numbers will continue to climb.

“There has been a push by clinicians to think about these therapies earlier on,” he said.

Marketing vs. patient demand

Medical device makers invest heavily to promote their devices to doctors, health organizations and patients.

The average marketing budget for companies of various sizes was $14.4 million in 2013, according to a survey of medical device executives by Medical Marketing & Media.

Most of those funds will not be spent on consumer education, according to the marketing survey. Instead, promotional budgets will focus on persuading health care professionals to use a particular brand of device on their patients.

Medtronic’s advertising and promotional spending in 2012 exceeded $128 million, according to Carol Greenhut, president of Schonfeld & Associates, which produces reports on medical device marketing for clients. That same year, Greenhut said, St. Jude Medical spent nearly $45 million and Boston Scientific $20 million.

Medtronic and Boston Scientific declined to confirm those figures, offer their own or discuss their marketing strategies. A St. Jude spokeswoman said Schonfeld & Associates’ figure “significantly overestimates our advertising and marketing expenses,” but she declined to provide an alternative.

Advocates for more extensive testing say device makers’ promotional emphasis remains on sales, not safety.

“One thing is obvious: They spend a lot more on advertising and lobbying than they spend on testing,” said Diana Zuckerman, president of the National Research Center for Women & Families.

But it remains unclear whether corporate marketing is driving the expanded use of medical devices. Certainly, more doctors are willing to consider them before other options have been exhausted.

In many cases, doctors remain hesitant because they simply don’t know how long a device will last and under what conditions, said Joseph Galato­witsch, president of Dymedex, a consulting firm that works with medical technology companies.

“The tension is that clinicians want to use these technologies in younger patients,” Galatowitsch said. “But they feel frustrated because they feel forced into weighing the risk versus the benefit.”

In the spine business, where many patients begin experiencing pain in their 40s and 50s, Medtronic is seeing a growing demand for more options, depending on their activity, said Rob Fredericks, vice president of global marketing, R&D and strategy for Medtronic Spinal.

For some, the stability of spinal fusion, in which vertebrae are fused together to relieve back pain after a disc has been damaged, might be the way to go. For others who seek greater range of motion, artificial discs may be the best option.

“They want to get back on their feet, back to work, back to activity — more quickly,” Fredericks said. Doctors say a patient’s age — and how the patient intends to spend his or her remaining years — weighs heavily over the decision to implant a device.

For Doug McConnell, that meant finding a way back into the water. The 55-year-old from Barrington, Ill., is an open water swimmer, swimming hours at a time through tough waves and inclement weather. So, when he suffered two herniated discs in his neck in late 2009, he wanted alternatives to the lengthy downtime and loss of mobility from spinal fusion.

“Quite apart from swimming, I wanted to be able to stay active — work in the garden and play catch with the kids,” he said. Then a Chicago physician suggested he try “this whiz-bang thing from Medtronic.”

An artificial cervical disc — the Prestige — was implanted. Six weeks after surgery, McConnell was back in the water. Eight weeks after that, he finished a 10-kilometer race.

A year after surgery, McConnell swam across the English Channel.

“It never occurs to us that we have to dial back our activities or interests,” he said. “We can anticipate living a lot longer than our parents … and we want to be able to take advantage of that.”

‘You gave me my life’

Peter Quimby of Plymouth likes to say that he’s “the healthiest dying person you’ll ever know.”

Quimby is waiting for a heart transplant. He received an implanted defibrillator and a left ventricular assist device in 2011 to help his weakened heart pump blood. Doctors told him not to overexert himself — don’t run, just shuffle.

To hell with that, Quimby says. The former paratrooper and college baseball player who graduated from West Point uses the devices to get in a good workout — and prove a point.

Six days a week, he sweats through intense workouts. He teaches a spinning class at the Andover YMCA. Recently, he finished the Minneapolis Duathlon, which combines a 15-kilometer bike race with two 5K runs — all while wearing a cumbersome device with wires that extend from his abdomen and batteries tucked into a shoulder holster.

Nobody knows whether the devices will hold up. Quimby said he won’t stop. “You didn’t give me a life,” he tells doctors and device makers. “You gave me my life.”

Federal regulators say their primary mission is to determine whether a technology is safe and saves lives — not address longevity or durability, said Christy Foreman, who directs the Office of Device Evaluation in the Center for Devices and Radiological Health at the Food and Drug Administration (FDA).

“The pacemakers that we had in 1976 were often times implanted in the abdomen because they were so big. And their battery didn’t last as long,” Foreman said. “We wouldn’t say no to the pacemaker … because we thought it was too big or didn’t last the entire patient life because we know that it is lifesaving technology. So we have to review it for what it is.”

The FDA also doesn’t regulate how physicians use medical devices. By law, doctors are allowed to use devices in any way they think will benefit their patients, even if the FDA never approved or cleared the device for that purpose.

Ralph Hall, a University of Minnesota law professor who has worked as a liaison between medical technology companies and the FDA, said the current regulatory approach will have to change as the trend toward younger patients builds momentum. It may not have been critical to assess how long a device would last in an older patient population, he said, but a wave of younger patients requires new ways of determining the life span of devices. The marketplace will demand it.

“This is going to require changes in testing methodology — less on human clinical study and more on bench testing and computer simulations and other types of tools assessing long-term performance,” Hall said.

Ultimately, it is up to the patient to decide whether to follow a doctor’s orders or the manufacturer’s recommended ways to use the device.

Dr. David Feldman, Quimby’s cardiologist, is seeing more young patients who need heart devices. Many want a treatment that will last forever.

Feldman explains that medical devices don’t work that way.

“What electronic piece of equipment that you buy now do you expect to last more than five years?”

Staff writer Glenn Howatt contributed to this report.

jwalsh@startribune.com • 612-673-7428

jim.spencer@startribune.com • 202-383-6123




Exposing device/physician financial relationships!

For doctors and med firms, a new eraof disclosure

•                Article by: JIM SPENCER , Star Tribune Updated: July 28, 2013 - 11:53 AM

FiDA highlight added

New federal law will expose ties to medical device, drug companies.

WASHINGTON – The nation’s medical device makers and drug companies will begin collecting this week what is expected to become a massive stockpile of data on their financial relationships with doctors, researchers and teaching hospitals.

A new federal disclosure law mandates that an array of pharmaceutical and medical manufacturers report payments to physicians, hospitals and other health care businesses that are more than $100 a year. Payments can include travel expenses, entertainment, consulting fees and research support.

The new rules emerged after six years of legislative and regulatory battles to address growing concerns that health companies were gaining inappropriate influence over research, education and clinical decisions. The provisions were eventually folded into the Affordable Care Act in 2010.

“Patients should have the right to know if their physician is getting paid by a certain drug company or has a financial interest in something that they are prescribing,” said Sen. Amy Klobuchar, D-Minn., who co-sponsored the 2007 bill to require disclosures.

Executives within Minnesota’s multibillion-dollar medical technology sector, as well as other health-related companies, say they hope the data will dispel worries that their financial ties with doctors and researchers lead to unethical behavior or unsafe patient outcomes.

“We need to restore public confidence in why a company like [ours] would be interacting with doctors,” said Tom Schumacher, vice president of ethics and compliance at Medtronic Inc.

Those ties lead to innovation and better care, said Chris White, the general counsel for the Advanced Medical Technology Association (AdvaMed). “The public needs to understand the value of these relationships,” he said.

A recent case that highlighted worries over doctor payments involved Fridley-based Medtronic, one of the world’s largest device makers.

The U.S. Senate Finance Committee alleged in October that Medtronic heavily influenced the content of medical-journal reports about its spinal fusion product, Infuse. The committee questioned whether doctors who supervised the studies understated Infuse’s risk and overstated its benefits while receiving $210 million in royalties and consulting fees from Medtronic over a 15-year period.

Medtronic has denied that it improperly influenced peer-reviewed reports or sought to minimize potential harm.

Sen. Chuck Grassley, an Iowa Republican who was the principal sponsor of the original bill, said Americans need a way to assess whether there’s an unethical relationship between a doctor advocating a product and the company that makes it.

“[Infuse] is an example of what this is aimed at, but it isn’t just aimed at Medtronic,” said Grassley, adding that his staff has found many other instances.

Dr. Eugene Carragee, a Stanford University surgeon and editor of the Spine Journal, was among those who revealed the links between Medtronic and the Infuse scholarship. “If your main mission is taking care of patients, you have an obligation not to be so financially vested in the outcome of the ­equipment you’re using,” ­Carragee said.

The new law doesn’t outlaw payments or business deals between companies and doctors or teaching hospitals, but it makes those transactions easily accessible to all Americans.

Starting Thursday, drug and medical companies must track transactions with doctors, teaching hospitals and some other health-related businesses. The first round of data must be submitted to federal regulators by the end of the year and will be made public by next September.

The new law comes with fines of up to $1.15 million for companies that fail to disclose. It also requires senior managers to sign off on the data, making them personally accountable to the Centers for Medicare & Medicaid Services, the agency compiling the information.

The federal disclosure law is much broader than a Minnesota one that since 1993 has banned certain gifts and required drug companies to reveal certain payments to doctors. The federal rules require disclosure of various forms of compensation to doctors or their immediate family members, including consulting fees, speaking fees, gifts, charitable contributions, royalty or license fees, stock options or other investment incentives. This includes payments of more than $10 or payments under $10 that together top $100 in a year.

“Virtually every interaction with a covered recipient has to be kept and analyzed,” said AdvaMed’s White.

Medtronic has spent more than a year and an estimated $10 million preparing to track interactions with an estimated 60,000 physicians.

Medtronic had to integrate and make adjustments to computer systems to make sure they capture information consistently. In particular, it meant identifying doctors who might have done business with different departments or company locations.

Schumacher said some doctors have told the firm they are uncomfortable with the change, saying “it’s not worth the stigma of having their income posted on a website.”

A greater concern may be that doctors don’t realize those dealings with will now be tracked.

The American Medical Association has a website devoted to the change and the AMA president posted tips in a blog.

Schumacher believes that may not have been enough. “I’m not sure the physician community knows this is coming,” he said.

At Advanced Circulatory, a 25-person company in Roseville, CEO Mike Black had to create a system for gathering payments and other valuable transfers to doctors or their immediate families. That includes more than software: It means making sure salespeople get information they never had to gather before.

Black estimates that the adjustments will cost his firm $20,000 a year to implement.

He already has heard from doctors who don’t want to participate in his company’s symposiums because they are afraid the free lunch might land them in a government database. Black worries that the new law will cause doctors “to shy away from perfectly legitimate educational opportunities” about his products, which are used to increase blood circulation.

Black has his doubts that many Americans will make use of this new trove of information. “I don’t believe the average consumer is going to take the time to go look at a database for a particular device or a

particular company,” he said.

Grassley counters that even if individuals don’t, the media will. Concern about negative publicity will discourage doctors from giving biased information, the senator said.

Doctors may not like it, Carragee acknowledged, but the law should help ensure that “research done with industry financing will have to be vetted.”

That’s “how science is supposed to work,” Carragee added.

Jim Spencer • 202-383-6123

gemie1

Jul. 28, 13

12:27 PM

Excellent! The patient has a right to know the relationship between a doctor and the manufactures of drugs and medical devices. A patient or a consumer has the right to know that their doctor does not have a conflict of interest when prescribing medical care.

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explanthis

Aug. 1, 13

1:05 PM

The legislation is commendable if data is accurately compiled and shared with patients. The resistance to transparency is understandable, given the easy access that pharma and medical device industry operatives had to doctors for so many years. The conflicted doctors that miss this cozy relationship are not the doctors I wish to support with my trust and tax dollars. Thank you, Jim Spencer and StarTribune for reporting on this important story.