Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements.
Twitter: JjrkCh

Wednesday, April 16, 2014

Implant Manufacturers Have Overwhelming Control of AAOS? Choosing Wisely!

KHN Staff Writer
APR 14, 2014

This KHN story was produced in collaboration with the Chicago Tribune.
When America’s joint surgeons were challenged to come up with a list of unnecessary procedures in their field, their selections shared one thing: none significantly impacted their incomes.
The American Academy of Orthopaedic Surgeons discouraged patients with joint pain from taking two types of dietary supplements, wearing custom shoe inserts or overusing wrist splints after carpal tunnel surgery. The surgeons also condemned an infrequently performed procedure where doctors wash a pained knee joint with saline. 

Scott Weingarten, chief clinical transformation officer at Cedars-Sinai Health System in Los Angeles, says his hospital has embraced the Choosing Wisely recommendations by adding them to the computerized patient record system. When doctors order something on the list, they are warned by the computer about the procedure (Photo by Jeff Lewis/AP Images).
"They could have chosen many surgical procedures that are commonly done, where evidence has shown over the years that they don't work or where they're being done with no evidence," said Dr. James Rickert, an assistant professor of orthopedic surgery at Indiana University. "They chose stuff of no material consequence that nobody really does."
The medical profession has historically been reluctant to condemn unwarranted but often lucrative tests and treatments that can rack up costs to patients but not improve their health and can sometimes hurt them. But in 2012, medical specialty societies began publishing lists of at least five services that both doctors and patients should consider skeptically. So far, 54 specialty societies have each offered recommendations and distributed them to more than a half-million doctors.

Hospitals that have deployed the lists, including Cedars-Sinai Medical Center in Los Angeles, report that the frequency of superfluous procedures has dropped. Consumer Reports, AARP and Univision are some of the influential organizations that have been part of a broad campaign to educate patients about the questionable items. Dr. Donald Berwick, a former head of Medicare, heralded the "Choosing Wisely" campaign as "a game-changer" because the "advice comes not from payers or politicos, but from pedigreed physician groups."
Yet some of the largest medical associations selected rare services or ones that are done by practitioners in other fields and will not affect their earnings. "They were willing to throw someone else’s services into the arena, but not their own," said Dr. Nancy Morden, a researcher at the Dartmouth Institute for Health Policy & Clinical Practice in New Hampshire.
Some specialists did target their own money-makers. Gastroenterologists, radiologists and clinical pathologists all placed their own tests on their lists. The Society of General Internal Medicine recommended against the annual physical exam, a mainstay of American health care.
Other specialty groups said they did not include their own procedures where there are concerns of overuse, such as stents for heart patients and spine surgery, because the evidence is murky and the procedures are right for some patients. "What we did when we made up the list was to start with more straightforward situations and hopefully expand that later," said Dr. F. Todd Wetzel, a member of the board of directors of the North American Spine Society.
Those societies tended to focus on limiting testing that others do. In an article in the New England Journal of Medicine, Morden examined all the items on the first 26 Choosing Wisely lists. She found that 83 percent of the items targeted radiology, medications and cardiac and lab tests—not physician services.
Stenting Gets A Pass
The American College of Cardiology opted to list the use of cardiac testing in four circumstances. But the college did not tackle what studies suggest is the most frequent type of overtreatment in the field: inserting small mesh tubes called stents to prop open arteries of patients who are not suffering heart attacks, rather than first prescribing medicine or encouraging  a healthier lifestyle. As many as one out of eight of these stent procedures should not have been performed, according to a study in Circulation, the journal of the American Heart Association.  At hospitals where stenting was most overused, 59 percent of stents were inappropriate, the study found.
"Let's face it, angioplasty and stenting is a big business, it's highly profitable for hospitals, and it's highly remunerative for physicians," said Dr. William Boden, a New York cardiologist who oversaw the first large trials that found no advantage for stents for patients who are not in acute distress. "There's a tremendous impetus to not rock the boat and not to call attention to the fact that we do too many procedures in stable patients for whom outcomes would be the same if not even better if treated medically."
Dr. William Zoghbi, a Houston cardiologist who was president of the college when the list was announced in 2012, rejected the suggestion that stenting procedures should have been more broadly questioned, saying "the vast majority" of stents "are quite appropriate for the condition." He said cautious choices for the initial list made sense because a campaign like Choosing Wisely is unfamiliar to doctors. "You have to walk before you run," Zoghbi said.
The cardiologists did discourage one specific use of stenting, where doctors opening a clogged artery place additional stents in other places where screenings have spotted the starts of blockage. Dr. Vikas Saini, a Massachusetts cardiologist and president of the Lown Institute, which advocates for more restraint in treatments, said, "in 20 years of practice that’s not something I would have thought is standard and if people are still doing it, that’s a shame."
Stents are a profit center for the group of cardiologists who perform procedures, often known as invasive cardiologists. They earned a median salary of $488,000, according to the Medical Group Management Association. Orthopedic surgeons do even better: half earned more than $538,000 in 2012, according to the MGMA’s income survey.
The orthopedic academy defended its Choosing Wisely selections, writing in a statement that "our recommendations are limited by the existing evidence regarding the effectiveness of various treatment options for musculoskeletal conditions, which we are seeking to improve." It noted that its recommendation against the dietary supplements could save patients $750 million a year spent on these drugs.
The orthopedists' selections did not impress critics. Rickert, the Indiana orthopedist, noted that discouraging dietary supplements affects revenue for health stores and other retail outlets, not surgeons. Both he and Morden said saline injections to treat knee pain are seldom done. Morden said when she searched 2011 Medicare billing records for the procedure, "I found zero claims."
"That's how pathetic that item is," she said.
Dr. Augusto Sarmiento, a former president of the academy and retired chairman of orthopedics at the University of Miami Miller Medical School, said there were more significant overused procedures the academy omitted, including replacing hips and knees when the patient’s pain is minimal and can be managed with medicine.

In addition, Sarmiento said too many surgeons operate on simple fractured collarbones, inserting metal plates, rather than letting the injury heal with the help of a sling. "The abuse of surgery is due to the overwhelming control of the profession by the implant manufacturing companies," he said.

Spinal Fusions Spared
The median compensation of a spine surgeon is more than $730,000, according to MGMA's survey. It is unclear how many spine surgeons are still performing a procedure the North American Spine Society placed on its list: using bone growth material in spinal fusion in the neck. The Food and Drug Administration issued a safety alert against this in 2008, noting that the procedure had led to the swelling of neck tissue that compressed patients' airways, making it hard to breathe or speak.
"I think the use for that purpose has already fallen off substantially," said Dr. Richard Deyo, a professor at Oregon Health & Science University and spine researcher. "They've taken on the easy things."
The only other procedure the society mentioned was spinal injections, but it was to expand, not restrict their work: They encouraged doctors to do their injections with the help of imaging, which would tack on another expense. The group also did not address spinal fusion, which has more than doubled in frequency between 1998 and 2008, faster than most procedures, one study showed.  Other research found that patients with back pain were increasingly likely to get a physician referral, "presumably for consideration of treatments such as injections and surgery" while referrals for physical therapy stayed flat over a decade.
Wetzel, the spine society official and an orthopedic surgeon at Temple University Medical School in Philadelphia, said that since spinal fusion has been shown to be useful "under very specific circumstances," the society "didn't feel comfortable making any kind of blanket statement."
The importance of which items are included is not just an academic debate, because where the lists have been actively embraced, the rate of those services has dropped. Last year, the Cedars-Sinai Health System in Los Angeles added 120 Choosing Wisely recommendations into its computerized patient records so that they would pop up on a screen whenever a clinician tried to authorize one.
"The alerts fire about 100 times a day," said Dr. Scott Weingarten, Cedar-Sinai's chief clinical transformation officer. For example, he said, there has been a decrease in the use of benzodiazepines and other sedative-hypnotics to treat the elderly, as they result in more falls, following a recommendation from the American Geriatrics Society for Choosing Wisely.
"We've got a bunch of other countries knocking on our door," said Dr. Richard Baron, president of the ABIM Foundation, which solicited the Choosing Wisely lists from the specialties. "There's a Choosing Wisely Canada.  There are health systems using it, insurers are using it."
Dr. John Santa, medical director for Consumer Reports, said reducing tests is a worthy goal because test results often prompt patients to get procedures. He cited electrocardiograms, which are used to measure the heart’s electrical activity to diagnose heart disease.  "Some people would say, it’s a $50 test, it's harmless," Santa said. "The false positives you get from EKGs can cause significant downstream problems. You may think you may have just been brilliant in detecting some abnormality. That's how stents get put in."
In Annapolis, Md., the Anne Arundel Medical Center broadcasts "Choosing Wisely" lists on hospital television screens, places posters on the walls of doctors' offices and discusses the lists in its magazine that it mails to county residents. The lists are also embedded as links in electronic patient records so physicians can easily review them.
Dr. Barry Meisenberg, an oncologist in charge of the hospital's quality efforts, said the lists are helpful when he is trying to explain to disappointed patients why he is not ordering a particular test. "It does help that’s not just this guy’s opinion, it actually has the imprimatur of a society," he said.

Monday, April 7, 2014

Plaintiff awarded $1.2M by Texas jury for defective surgical mesh product

 April 04, 2014 at 11:38 AM

Johnson & Johnson was ordered by a Texas jury to pay $1.2 million to a woman who alleged one of the company’s lines of vaginal-mesh implants to treat incontinence was defectively designed, in the first verdict against the company over those devices.
Jurors in state court in Dallas concluded the design of the TVT-O mesh sling implanted in Linda Batiste was flawed and the 64-year-old woman deserved $1.2 million in compensatory damages, her lawyers said. They argued Batiste suffered pelvic pain when the device eroded inside her.
J&J, based in New Brunswick, faces more than 12,000 lawsuits accusing its Ethicon unit of making improperly designed vaginal inserts, such as the slings, that damaged women’s organs and made sex painful. Most of the cases have been consolidated before a federal judge in West Virginia for pretrial information exchanges while other cases are being heard in state courts.
The U.S. Food and Drug Administration has ordered J&J, C.R. Bard Inc. and 31 other vaginal-implant makers to study rates of organ damage and complications linked to the implants after manufacturers faced a wave of lawsuits over the devices.
Doctors inserted more than 70,000 mesh devices in the U.S. in 2010 alone, threading them through incisions in the vagina to fortify pelvic muscles that failed to support internal organs or to treat incontinence, according to court filings.
Appeal Planned
J&J officials noted the Dallas jury rejected Batiste’s claims that Ethicon didn’t provide proper warnings about the slings’ health risks and declined to award punitive damages.
“The jury’s verdict on design defect is disappointing, and we believe we have strong grounds for appeal,” Matthew Johnson, an Ethicon spokesman, said yesterday in an e-mailed statement.
J&J officials decided in 2012 to stop selling some lines of vaginal-mesh implants after being hit with a wave of lawsuits over the devices. The TVT-O sling Batiste, a former nurse, received is still on the market, Thomas Cartmell, one of her lawyers, said in a phone interview.
“This verdict represents the first time an impartial jury had the opportunity to decide whether Ethicon’s sling products are defective and they found exactly that,” Bryan Aylstock, a plaintiffs’ lawyer helping to oversee cases gathered before U.S. District Judge Joseph Goodwin in West Virginia, said in a phone interview. “We believe this is the first of many more verdicts to come over this dangerous product,” he added.
NJ Verdict
Last year, a New Jersey jury ruled J&J must pay $11.1 million in damages to a woman who blamed a Prolift device for her injuries in the first case over any of the company’s implants to go to trial. The Prolift implants help support sagging organs.
Lawyers for J&J, the world’s biggest maker of medical products, argued in court papers that the TVT-O slings are safe and effective and the company properly warned consumers about their risks.
In February, Goodwin threw out a woman’s claims that another line of the company’s sling inserts was def

Wednesday, April 2, 2014

Conflict of Intere$t: Medical Leader$ are Conflicted!

Public Health & Policy

Following the Money: Gold in Ivory Towers
Published: Apr 1, 2014

By John Fauber, Reporter, Milwaukee Journal Sentinel/MedPage Today

Academics who moonlight for drug companies have faced intense scrutiny in recent years, but new research suggests much larger sums of money are being paid to their bosses -- the leaders of medical schools and hospitals who serve on drug company boards.
Looking at the world's 50 largest drug companies, researchers found that 40% had at least one board member who held a leadership position at a U.S. academic medical center -- including medical school deans, chief executive officers, department chairs, and university presidents.
The average annual compensation from the drug companies was $313,000, according to the paper published today in the Journal of the American Medical Association.
"These relationships present potentially far-reaching consequences beyond those created when individual physicians consult with industry or receive gifts," the researchers wrote.
Big Jobs, Big Bucks
Others who were not involved in the study said such lucrative moonlighting for drug companies with vested interests simply should not be done by university leaders who oversee independent research and the instruction of medical professionals.
"I don't know how they can manage a conflict like that," said Susan Chimonas, PhD, who frequently writes and lectures on conflicts of interest in medicine. "My gosh, there is so much money they are making for a little side job."
Serving in dual roles raises so many potential conflicts that it would be wiser to eliminate them, said Chimonas, associate director of research for Columbia University's Center on Medicine as a Profession.
Unlike faculty or staff, top leaders of academic medical institutions are involved in business decisions and corporate partnerships, said Paul Levy, the former president and CEO of Beth Israel Deaconess Medical Center in Boston, which is affiliated with Harvard University.
Those decisions and partnerships could include performing clinical trials for drug companies, allowing drug samples to be given out in hospitals and clinics, allowing doctors to engage in drug company promotional speaking, endorsing and offering drug company funded continuing medical education (CME), and deciding what drugs to allow on a hospital's formulary, said Levy, who headed Beth Israel Deaconess from 2002 to 2011.
"You cannot serve two masters, even if you are highly intelligent," said Levy, who now blogs about the health industry and serves as senior adviser at Lax Sebenius, of Concord, Mass. "In fact, if you are highly intelligent, you will rationalize the problems away by saying that you cannot be personally corrupted."
By the Numbers
The JAMA paper did not list individuals, though it did name medical schools, universities, and academic hospitals whose officials served on drug company boards of directors. It also named drug companies, including Pfizer, Merck, GlaxoSmithKline and Johnson & Johnson.
For the study, the researchers only looked at the year 2012.
The Journal Sentinel and MedPage Today used proxy statements filed by the companies to identify some of the board members and find out how much they were paid.
From the Yale School of Medicine in New Haven, Conn., to the David Geffen School of Medicine at UCLA in Los Angeles, the institutions include some of the most prominent academic medical centers in America.
For instance, Robert Alpern, MD, dean of the Yale School of Medicine received $259,000 in total compensation serving on the Abbott Laboratories board of directors in 2013, according to the company's proxy statement.
As of Jan. 1, 2014, he also held 11,656 shares of restricted Abbott stock.
In its proxy, Abbott said Alpern's relationship did not impair his independence.
In an email, Karen Peart, a spokeswoman for Yale, said Alpern would have no role in any of the above decisions such as clinical trials, drug samples or drug formularies.
"If ever he had the opportunity to be involved in a decision affecting Abbott, he would recuse himself," she said.
She said the university encourages its faculty to consult widely and to engage in activities that may benefit the university and the public.
A. Eugene Washington, MD, dean of the UCLA School of Medicine, joined the Johnson & Johnson board of directors in November 2012. In 2013, he was paid $261,000 in total compensation by the company, according to its proxy statement. As of Feb. 25, 2014, he was listed as the beneficial owner of 5,129 shares.
In an email, a spokesman for Washington said UCLA does not allow drug companies to provide samples and prohibits faculty from promoting drugs.
"Dr. Washington manages any potential conflict of interest in accordance with university policies and makes no decisions regarding the purchase of pharmaceutical products or clinical trials," Dale Triber Tate, a UCLA spokesman said.
Mary Sue Coleman, president of the University of Michigan, also serves on the Johnson & Johnson board and was paid $276,000 in total compensation in 2013, according its proxy statement. As of Feb. 25, 2014, she was listed as the beneficial owner of 34,465 shares. That stock was worth nearly $3.4 million at Tuesday's price of about $98 per share.
In an email, Kelly Cunningham, a spokeswoman for the university, said the university already has banned drug company funded doctor education and drug samples from all companies.
She said Coleman is not involved in decisions involving Johnson & Johnson purchases or investments.
"The University of Michigan does not see President Coleman's service on the Johnson & Johnson board as a conflict of interest," Cunningham said.
In its proxy statement, Johnson & Johnson said it sells healthcare products and services to both UCLA and the University of Michigan. It also listed research grants and consulting fees with Michigan. It said neither of its board members from those institutions had any "direct business relationships" with the company.
The company also said its board determined that neither of the relationships conflicted with the interests of the company or impaired "the relevant nonemployee director's independence or judgment."
"It is a potential conflict of interest that is not often discussed," said senior author Walid Gellad, MD, with the VA Pittsburgh Healthcare System and an assistant professor of medicine at the University of Pittsburgh. "If a pen or a $150 dinner presents a conflict for a doctor, what does it mean if you get $300,000?"
Gellad noted that the research only involved drug companies. It did not include medical device companies and health insurance firms.

"I would say this is just the tip of the iceberg," he said.

Profitable Innovations: But Is Your Implanted Medical Device Safe?

The Device Makers’ Shortcut
By RONI CARYN RABIN MARCH 31, 2014, 4:31 PM 16 Comments
A few years ago, the Food and Drug Administration announced a stunning recall, saying that electrical wires in some St. Jude Medical heart defibrillators, which were implanted in tens of thousands of people, were defective. It was a rerun for cardiac patients: In 2007, Medtronic recalled its Sprint Fidelis cardiac devices because of faulty wires.

In both cases, the F.D.A. warned that the wires could cause painful shocks or fail when needed, and patients were left to choose between living with the leads under close monitoring or having dangerous surgery to replace them. Both companies reported deaths linked to the flawed leads.
Now a new paper by Harvard researchers, using records only recently made available by the F.D.A., explains how the faulty leads got onto the market, shedding light on a little-known process used by manufacturers to alter medical devices without putting them through human trials. (An approval pathway for lower-risk medical devices, called the 510(k) clearance, has received more public scrutiny, including harsh criticism from the Institute of Medicine.)
For so-called high-risk devices like heart defibrillators, the F.D.A. typically requires proof of safety and effectiveness in clinical trials with real patients under real-life conditions. But once such a device receives initial approval, the researchers found, an administrative maneuver permits companies to tinker with it — making the electrical wire thinner, for example — without testing the changes in a single patient.
The process, called a premarket approval supplement application, allows manufacturers to get upgrades and improvements to patients faster, medical device companies say. The application is “intended for a change to an already approved P.M.A. that has met the agency’s rigorous requirements for safety and effectiveness,” said Janet Trunzo, senior executive vice president for technology and regulatory affairs with AdvaMed, a trade association. She noted that the F.D.A. could require a more rigorous review process if necessary.
The problem is that a device can be modified over and over, even dozens of times, without ever being put through new trials in patients. From 1979 and 2012, the researchers found, the F.D.A. approved 77 new cardiac-implanted electronic devices like pacemakers and defibrillators. During that same period, the agency approved nearly 6,000 supplement applications.
A spokesman for Medtronic said the company did test the Sprint Fidelis’s new leads in patients, but the trials were begun in November 2003, around the time the company also filed its supplement applications, and the resulting data were not shared with the F.D.A. before the thinner leads went on the market. The study was published only in 2007, shortly before the recall.
For each device that went through the full premarket approval process, 50 subsequent changes were made, researchers also found.
“Over time, the accumulation of changes may lead to a device that is substantially different than the original product,” said Dr. Aaron S. Kesselheim, senior author of the paper, published in JAMA, the journal of the American Medical Association.
“Most of top-selling devices that are out on the market now have all been approved via supplements for the last 10 years,” he said. They are “substantially different” from the versions originally approved, he said.
While some of the supplement changes were minor, like rewriting instructions or changing the color, 37 percent involved a change to the device’s design, Dr. Kesselheim and his colleagues said. Companies are not required to mention the changes on the package labels, and generally do not.
As a result, doctors are often unaware which version of the device they are implanting, said Dr. Rita Redberg, a cardiologist and professor at University of California, San Francisco, who has written on the topic. “These supplements are not just flying under patients’ radar screens, they’re flying under doctors’ radar screens,” Dr. Redberg said.
The recalled wire in St. Jude’s defibrillator was approved as a supplement to a device whose original design had been approved in 1996 but had undergone 78 supplementary revisions, according to the research. The recalled Sprint Fidelis lead was approved as a supplement to a device originally approved in 1993 and modified 91 times.
“These leads may have worked in the lab, but that is very different from what happens inside a human blood vessel,” Dr. Redberg said. “People move around, they’re very complex, and the lead is going to be exposed to a lot more stress and forces of resistance.”
Clinical trials don’t always find rare complications. But the failure rate in St. Jude’s device was high enough that it would have been noticed in a trial, she said.
The pace of supplements has increased significantly during the past decade, to 704 a year from 77, the researchers found. The last time an implantable cardioverter defibrillator went through a full rigorous premarket approval process was in 2000, the researchers said, “indicating that all models released since then have been supplements” to existing models.
But since a Supreme Court decision in 2008 determined that manufacturers were immune from liability for personal injuries as long as their devices had been approved by the F.D.A., injured patients who want to sue face an uphill battle. Dr. Kesselheim and his colleagues put forth several proposals in their article, suggesting the F.D.A. convene a panel of experts to review approved medical devices every five to seven years and determine whether the clinical data from the older models still applied to the newer versions.
But the agency appears to have rejected the idea. An automatic advisory panel review is not “a necessary or efficient use of F.D.A. or taxpayer resources,” said Susan Laine, a spokeswoman.

 FiDA comment
The JAMA article concludes by highlighting the importance of rigorous post-market data gathering to bolster the FDA assurance of ‘safe and effective’.  This could be done by PCORI (Patient Centered Outcome Research Institute) which is a new government non-profit agency commissioned and funded by Congress.  However, though the omission of implanted medical device patient outcomes research has been demanded by harmed patient and patient advocates, PCORI has resolutely avoided this responsibility.

Aaron Seth Kesselheim M.D., J.D., M.P.H.

Assistant Professor
Department of Medicine
Harvard Medical School
Discipline: Medicine, Drug Development, Law

Investigator Award
Award Year: 2009
How can the engine of pharmaceutical innovation in the United States, sluggish now despite substantial investment, be jump-started again? Whether the right pathway involves increased government support of basic research or a transformation of industry product development and clinical trial work, patent law will play a key role. Aaron S. Kesselheim, M.D., J.D., M.P.H., explores a number of questions related to this issue, including how basic, translational, and product-development research combine to create breakthrough drugs and how patent-based incentives facilitate or impede drug development. His project, Sources of Transformative Innovation in Medication Development, will identify the most transformative drugs that have emerged in the past 25 years, examine their scientific origins, and assess the intellectual, social, and financial factors that influenced their development. Dr. Kesselheim also will analyze whether patents have rewarded the most important contributors to new pharmaceutical breakthrough products and test an alternative to the current patent system. His project addresses whether new legal or resource-allocation strategies are needed to reinvigorate pharmaceutical innovation and how possible reforms might encourage drug development, apportion rewards more appropriately, and help contain research costs.

Aaron S. Kesselheim is an assistant professor of medicine at Harvard Medical School, based in the division of pharmacoepidemiology and pharmacoeconomics, department of medicine, Brigham and Women?s Hospital (BWH). He graduated from Harvard College and received his postgraduate training at the University of Pennsylvania School of Medicine and Law School, and most recently at the Harvard School of Public Health. He is board-certified in internal medicine, serves as a primary care physician, and attends on the general medicine inpatient service at BWH. He is a member of the New York State Bar and is a patent attorney. His research focuses on the effects of intellectual property laws and regulatory policies on pharmaceutical development, the drug approval process, and the costs, availability, and use of prescription drugs both domestically and in resource-poor settings. He received a career development award from the Agency for Healthcare Research and Quality to study comparative evidence, regulation, and trends related to prescribing off-label drugs. He has contributed commissioned works on market-based incentives for pharmaceutical R&D to the Institute of Medicine and the Robert Wood Johnson Public Health Law Research Program. He has also investigated other issues at the intersection of law and public health, including health care fraud, expert testimony in malpractice cases, and insurance reimbursement practices. His numerous articles and book chapters related to these topics have appeared in leading medical and health policy journals, including the New England Journal of Medicine, JAMA, and Health Affairs. In 2010, he received the Alice S. Hersh New Investigator Award from AcademyHealth, the main professional organization for health services/policy research. The Hersh award is given annually to an outstanding health services researcher under age 40 in the U.S. In addition to his research, Dr. Kesselheim has taught on law and public health issues at Harvard Medical School, Law School, and the School of Public Health. He has testified before the U.S. House of Representatives and addressed different state legislatures on drug policy matters, and he has consulted for the federal government?s clinical trials registration website ( He has also served as an ad hoc peer reviewer for numerous medical and scientific journals (earning a commendation for his work from Annals of Internal Medicine in 2009), the Harvard Law Review, and the London School of Economics.


Featured Research
from universities, journals, and other organizations

Many cardiac devices approved by process that often does not require new clinical data
January 21, 2014

The JAMA Network Journals

Many cardiac implantable electronic device models currently in use were approved via a Food and Drug Administration review process in which the models were assumed safe and effective based on approval of prior versions of the device, according to a study.

Many cardiac implantable electronic device models currently in use were approved via a Food and Drug Administration review process in which the models were assumed safe and effective based on approval of prior versions of the device, according to a study in the January 22/29 issue of JAMA.

"In the United States, the Food and Drug Administration (FDA) reviews high-risk medical devices -- those that support human life, prevent illness, or present an unreasonable risk -- via the premarket approval (PMA) pathway, through which manufacturers collect preclinical and clinical data as necessary to provide 'reasonable assurance' of the device's safety and effectiveness," according to background information in the article. That process has attracted attention in recent years after recall of device components, like leads from Medtronic Sprint Fidelis and St. Jude Medical Riata implantable cardioverter-defibrillators (ICDs), that were not tested clinically in human trials prior to approval because they were design changes to prior-marketed devices and considered 'supplements' to PMA applications submitted almost a decade earlier.
The process of approval by premarket approval supplement "allow[s] patients to benefit from incremental innovation in device technology by providing efficient and inexpensive FDA review pathways for smaller device changes. Supplements may include major or minor design changes as well as routine changes in labeling, materials, or packaging. By statute, the FDA must seek only the 'least burdensome' supporting data necessary for review."
Benjamin N. Rome, B.A., of Harvard Medical School and Brigham and Women's Hospital, Boston, and colleagues used the FDA's PMA database to review CIEDs (including pacemakers, ICDs, and cardiac resynchronization therapy [CRT] devices) approved as PMA supplements from 1979 through 2012. They identified the number of supplements to each original PMA and characterized the nature of the changes in each supplement.
Seventy-seven approved PMA applications for CIEDs (46 pacemaker devices, 19 ICDs, and 12 CRT devices) were the basis for 5,829 PMA supplement applications, with a median (midpoint) of 50 supplements per original PMA. In the last decade, the number of approved supplements annually increased to 704. Excluding manufacturing changes that do not alter device design, the number of supplements approved each year averaged 2.6 per PMA per year.
Thirty-seven percent of supplements represented at least minor alterations to the device's design or materials. Among 180-day supplements (a type of FDA review process) approved between 2010 and 2012, 23 percent included new clinical data to support safety and effectiveness.
"… Our results should not be interpreted to indicate that the FDA is failing to review PMA supplement applications to determine safety and effectiveness," the authors conclude. However, clinicians and patients should … be aware … that clinical data are rarely collected as part of PMA supplement applications prior to marketing. The recalled Medtronic Sprint Fidelis and St. Jude Riata ICD leads were both PMA supplements -- Fidelis a 180-day supplement and Riata a real-time supplement [a type of FDA review process]. Neither lead was studied in human trials prior to FDA approval. The FDA's approval of many supplements without new human trials, as in the case of these recent ICD changes, highlights the importance of collecting rigorous postapproval performance data," the authors write.

Story Source:
The above story is based on materials provided by The JAMA Network Journals. Note: Materials may be edited for content and length.

Journal Reference:
Benjamin N. Rome, Daniel B. Kramer, Aaron S. Kesselheim. FDA Approval of Cardiac Implantable Electronic Devices via Original and Supplement Premarket Approval Pathways, 1979-2012. JAMA, 2014; 311 (4): 385 DOI: 10.1001/jama.2013.284986

Cite This Page:
The JAMA Network Journals. "Many cardiac devices approved by process that often does not require new clinical data." ScienceDaily. ScienceDaily, 21 January 2014. <>.