No Harmed Patient/Stakeholder at the WSJ Roundtable Discussion on Medical Device Regulation

Do the FDA’s Regulations Governing Medical Devices Need to Be Overhauled?

Most products get to market via a fast-track process; three experts debate whether the current system makes sense

By THOMAS M. BURTON  FiDA highlight added

March 22, 2015 11:00 p.m. ET

Medical devices can save lives, but in recent years it has become clear how hazardous they are when they malfunction: metal hips that fail; bloodstream filters that fracture and prove lethal; defibrillator wires that break down.

The Food and Drug Administration works at striking the proper balance between insisting on safety but not standing in the way of innovative products that promote health and well-being. In doing so, it’s dealing with increasingly complex products of the software and digital age, including some aimed directly at consumers, such as medical apps.

The vast majority of medical devices still get to the U.S. market through an abbreviated pathway, called 510(k), in which companies need only show that a new device is substantially the equivalent of a device already legally marketed.

Joining our round-table discussion on medical-device safety are Scott Gottlieb, former FDA deputy commissioner and a resident fellow at the American Enterprise Institute; Rita Redberg, cardiology professor at UC San Francisco; and Bradley Merrill Thompson, device attorney in Washington, D.C. with Epstein, Becker & Green. Edited excerpts follow.

Does the system work?

WSJ: Does the FDA’s approach stymie innovation, or do patients need more protection?

DR. GOTTLIEB: FDA’s approach to regulating devices, in contrast to its requirements governing drugs, was designed by Congress to recognize that not all devices pose the same degree of risk. Therefore, the volume of data that the FDA requires should be closely matched to the risk of the product in question.

The problem today is the FDA has deviated from the original spirit of that idea. It’s trying to apply a much more uniform and druglike approach to its regulation of medical devices, increasing the hurdles that new products must clear. At the same time, the FDA is treating more low-risk devices like they were high risk.

One example where the FDA is trying to apply a more druglike approach to devices is in the growing use of “sham” surgeries. The FDA literally asks device makers to randomly assign patients to either get a new medical product, or undergo a fake surgery [as a placebo] to simulate the same procedure. In a recent trial, involving a device for the treatment of high blood pressure, patients were asked to undergo an angiogram—a procedure with risks—without knowing if they’d get the real treatment.

The FDA began asking some medical-device makers to use dummy surgical procedures a few years ago, to make its review of medical devices more like its review of drugs. Only in the case of devices, having a placebo group often can mean obligating a patient to a fake surgery. In that setting, consumers are being asked to take a risk without any prospect of a benefit. That seems unethical, and unnecessary.

The FDA also is showing a desire to classify more things that merely inform consumers as medical devices. One example is seen in the FDA’s approach to consumer apps, like those found on an iPhone. A lot of these apps are really low risk.

MR. THOMPSON: While there are certainly some incidents of the FDA regulating devices too stringently, they are by and large the exception. You mention placebo-controlled device trials. In the example you cite, however, the FDA did not order the company to use a placebo control. That was the company’s idea. The fact that the FDA permits the use of placebo controls is hardly evidence that the FDA is overregulating.

You suggest the FDA overregulates mobile apps. In the last couple of years, it has sought to reduce, not enlarge, its regulatory oversight. For example, it has deregulated the hardware and software that takes data from medical devices like a blood glucose meter and transmits it for storage and display. That was a big step forward.

Instead of sweeping, fundamental reform to either clamp down or loosen up FDA oversight, I favor continuous improvement guided by continuous review of agency performance data as well as marketplace and scientific trends.

DR. REDBERG: As a cardiologist taking care of patients every week, I see too many whose lives have been harmed and who have suffered greatly from untested or inappropriate devices. And that doesn’t begin to address the billions of dollars these devices add to health-care bills.

Only a few percent of all devices on the U.S. market go though the only pathway that requires any clinical data. And even that most-stringent pathway doesn’t require two randomized clinical trials. In fact it doesn’t even require one; this most rigorous evidence standard can and frequently is met by non-randomized trials without controls, or by case-series or even expert opinion.

These devices cannot be removed without significant risk of serious morbidity or death, as has been learned by the many women who received pelvic mesh, or had their uteri removed with the aid of morcellators, for just two of many possible examples. Yet another example of a high-risk implanted device entering the market without clinical studies is the inferior vena cava filter, which for some models, studies have shown that 1 in 4 fracture after implantation in the major blood vessel entering the heart and are risky to remove. And after metal-on-metal hips, touted as a great innovation, entered the U.S. market without clinical studies, many Americans learned the hard way that they have a fourfold increased revision rate compared with other artificial hips and leak metal ions into the bloodstream.

WSJ: Brad and Scott, isn’t it clear that too often, devices get on the market with minimal evidence of safety?

DR. GOTTLIEB: My concern is that a lot of the fundamental questions about device safety turn on issues of biomechanical performance. For example, some common questions are how resilient an implanted valve will be to the shearing effects of blood flow, a joint to constant stresses, or the durability of a pacemaker’s circuits.

The FDA is trying, in too many cases, to answer these questions by requiring longer and larger trials in people and large animals like pigs and sheep.

The issue at the heart of the tragedy with [uterine] morcellators [in hysterectomies] is a different one. Here there was a much more fundamental misunderstanding about the biology of a disease state. The FDA didn’t fully appreciate the risk of certain kinds of cancer, and how frequently they occurred.

MR. THOMPSON: The truth, I think, lies somewhere in between the extremes that [Dr. Gottlieb] and [Dr. Redberg] have staked out. I agree with [Dr. Redberg] that sometimes unsafe or ineffective products reach the market. Morcellators are indeed a recent example. That’s regrettable. However, that fact, by itself, doesn’t mean we should fundamentally change the system.

Out of all of the thousands of medical devices that the FDA clears each year, how many turn out to be unsafe or ineffective? Not many. But further, and equally importantly, how effective are alternative regulatory systems in approving important new medical devices in a timely way? Changing the system in a way that delays or even forecloses the sale of safe and effective breakthrough medical devices hurts patients, too.

Preventing failures

WSJ: In one of the worst failures, a Medtronic defibrillator wire, the company relied on stress testing, not a clinical trial; 268,000 patients were exposed to a wire that led to multiple deaths.

MR. THOMPSON: That problem was found eight years ago. The fact you need to go back that far speaks to the overall robustness of the FDA process.

DR. GOTTLIEB: The failure of any defibrillator lead is tragic, but to portray the malfunction of Medtronic’s lead as an example of a device failure that could have been avoided through a bigger clinical trial gives short shrift to the basic science and engineering challenges that permeate this type of problem, and how one tries to prevent it from occurring.

Keep in mind that 99.8% of all medical devices have no serious adverse events associated with them. The U.S. is the gold standard when it comes to device safety. There are always opportunities to enhance the process. For example, the FDA is implementing a unique device identifier [UDI] system to better track device performance [after approval].

DR. REDBERG: Only a few percent of all medical devices enter the market via a pathway that requires at least some clinical data.

Simply put, for the vast majority of medical devices, there is NO requirement to demonstrate safety and effectiveness.

We must have national, publicly available registries of devices and procedures, so that we can track in real-time the outcomes, and then truly know the benefits and the risks.

Mr. Burton is a reporter in the Washington bureau of The Wall Street Journal. He can be reached at tom.burton@wsj.com.

My comment:

"The Wall Street Journal and Thomas M. Burton have my gratitude for tackling this issue, but my dismay for having a ‘roundtable’ discussion that does not include the patient perspective.  

You do not need to go back eight years to find implanted medical devices failing.  Nearly 70,000 women are in federal court in an MDL lawsuit for failed pelvic mesh sold by more than a half dozen U.S. medical device makers.  14,000 women have met on Facebook Essure Problems to provide mutual support and begin the legal and legislative process of removing this dangerous Bayer ‘permanent’ birth control product from the market.  The company is profiting while they suppress information and harm more young women and their families.

As a trained FDA Patient Representative (9/2010) I learned what little regard the clearance process had for PREVENTABLE harm to patients.  In the ‘Informed Consent’ there is no access to non-proprietary patient outcome research on the device and no discussion of the impact of “Riegel v Medtronic” and pre-emption on the civil rights of the patient should he/she be harmed.  There is no product warranty and hospitals and doctors have a back-door way of dealing with the complex medical issues of a FAILED device:  the patient is referred for psychiatric help, a pain clinic or the doctor/patient relationship is severed by the doctor.   Harmed patients are buried alive by the perpetrators-in plain sight.”  This is legal, thanks to aggressive lobbyists for the medical device (petroleum, chemical, metals) industry.  

http://www.wsj.com/articles/do-the-fdas-regulations-of-medical-devices-need-to-be-overhauled-1427079649?KEYWORDS=FDA

J&J $100,000 conflicted FDA panel member on morcellator device?

	JjrkCh #morcellator First speaker at #fda Advisory today defended #surgical mesh at Batiste trial in Dallas: http://t.co/L3HoWtjxeO 7/10/14, 8:06 AM
	JjrkCh #morcellator #fda More on Piet Hinoul at Batiste surgical mesh trial. http://t.co/AklVXmrvfx 7/10/14, 8:09 AM

http://online.wsj.com/articles/doctor-quits-uterine-device-safety-panel-over-conflict-1405013226

U.S. NEWS

Doctor Quits Uterine-Device Safety Panel Over Conflict

Move Comes Before Hearing on Cancer Risk From Morcellation Procedure

By JENNIFER LEVITZ And JON KAMP CONNECT

Updated July 10, 2014 3:25 p.m. ET

SILVER SPRING, Md.—A member of an independent panel weighing the safety of a medical device that can spread cancer in women stepped down after the U.S. Food and Drug Administration reviewed consulting fees he had accepted from a device manufacturer, the agency said Thursday.

San Francisco gynecologist Andrew Brill removed himself from the 16-member panel before two days of hearings on the device were set to begin Thursday, an FDA spokesman said. Dr. Brill didn't respond to requests for comment.

In 2013, he received nearly $100,000 in consulting fees from Ethicon, a Johnson & Johnson JNJ -0.08% subsidiary that is by far the largest manufacturer of a tool known as a laparoscopic power morcellator. The advisory panel is expected to make a recommendation to the FDA about whether morcellators, used in an estimated 50,000 hysterectomies a year, should be more tightly regulated or even used at all.

"The FDA has a rigorous conflict of interest process in place designed to ensure the integrity of our meetings. During the course of the agency's review and in consultation with Dr. Andrew Brill, it was determined that the financial information he disclosed was just above the threshold established for panel members to participate in one of our meetings," an FDA spokesman said.

The Wall Street Journal first asked the FDA and Dr. Brill about the consulting fees on Tuesday after comparing publicly released names of the members of the panel with a list of paid consultants on J&J's website and other public documents. The agency declined to speak until Thursday morning.

J&J, the only manufacturer that releases names of its paid consultants, said Dr. Brill has done professional education consulting for them in their women's health and energy businesses and that he is a recognized leader in the field.

At least two other gynecologists on the panel have had financial ties to manufacturers, according to J&J's website and other public documents. The FDA declined to release its own disclosure statements submitted by panel members, citing privacy laws for advisory-committee members.

Michael P. Diamond, a Georgia gynecologist and acting chairman of the FDA panel meeting on morcellators, was previously a consultant for Ethicon and received a grant from the company, he said Thursday in response to a question from the Journal. He declined to say the amount he received.

Keith Isaacson, a Boston gynecologist, received nearly $12,000 in consulting fees from Ethicon in 2013. His work for the company has been as a "professional-education consultant," a J&J spokesman said. A spokesman for Dr. Isaacson wasn't available for immediate comment.

Both doctors remain on the panel.

Laparoscopic power morcellators are used to cut up common uterine growths called fibroids, often in a hysterectomy, so they can be removed from the body through small incisions. But in some instances, the devices can spread a rare but dangerous cancer that masquerades as benign fibroids.

The risk had been known for years but was believed to be extremely small. In April, the FDA said the risk was higher than previously thought and discouraged doctors from using morcellators while it considered a more permanent position on the tools.

The hearing drew a crowd of patients, relatives, doctors and industry representatives.

"Because morcellation upstaged her cancer, Elizabeth never had a chance," Joanne Jacobson told the panel about her sister, who died from cancer in January 2013 following a morcellation procedure, according to her medical records.

JoAnn Trainer urged a ban on cutting tissue inside the body while speaking on behalf of her daughter Amy Reed, a Boston physician whose post-morcellation cancer case triggered alarm that led to this week's meeting. Dr. Reed, sitting in the audience with her family, plans to speak Friday.

The head of the influential American College of Obstetricians and Gynecologists argued that taking away morcellators will drive more women to elect open abdominal surgery, which carries its own risks, such as bleeding and infection. "It is unacceptable that in an effort to avoid one risk, we subject women to another," ACOG Chief Executive Hal C. Lawrence III told the panel.

J&J halted all sales shortly after the FDA advisory in April. Piet Hinoul, vice president of medical affairs at J&J subsidiary Ethicon and a gynecologist, told the panel the company stands by this decision until there is consensus in the medical community about how to mitigate the risk.

He also argued against tougher regulation, which the panel is expected to discuss Friday. Dr. Hinoul urged instead efforts to better identify women who could be more at risk of harboring cancer. The cancer can't be reliably detected before surgery.

Write to Jennifer Levitz at jennifer.levitz@wsj.com and Jon Kamp at jon.kamp@wsj.com

Wall Street Journal on Surgical Mesh Post-Market Surveillance Study

Updated May 14, 2013, 4:08 p.m. ET

Outcomes Are Mixed for PelvicProcedure

By SHIRLEY S. WANG   Wall Street Journal   FiDA highlight

A new study finds that long-term benefits are limited for many women who undergo an operation to treat a common condition called pelvic organ prolapse, which can lead to urinary problems and discomfort.

The surgery, called abdominal sacrocolpopexy, has been the standard treatment for the gynecological condition for more than three decades, but its outcomes rarely have been studied systematically beyond two years. In addition, there isn't agreement among doctors about what constitutes success for the procedure.

In pelvic organ prolapse, the uterus or vaginal walls "drop" after childbirth and sometimes protrude into or out of the vaginal opening. Most women who have had children vaginally have some degree of prolapse but may not notice symptoms, which can include feeling a bulge in the vagina, a delay in urinary stream and difficulty with defecation.

For some 225,000 women a year in the U.S., the symptoms become so problematic that they get surgery.

Two procedures, abdominal sacrocolpopexy and a type of vaginal surgery, are used to prop up or anchor the organs to keep them in place, sometimes with the use of synthetic mesh. A third operation, used only rarely for older women, closes up the vagina.

The new study, published Tuesday in JAMA, the Journal of the American Medical Association, followed the outcome of more than 200 women for an average of seven years after sacrocolpopexy surgery. It is one of the longest follow-ups to date of such patients.

The study showed that many women receive short-term relief from symptoms and most don't need repeat surgery, but a substantial portion—some 25%—see some symptoms recur over time, and more than 60% develop urinary incontinence, sometimes as a result of the surgery itself.

"Surgery for pelvic organ prolapse isn't perfect," said Ingrid Nygaard, first author on the study and a professor of obstetrics and gynecology at the University of Utah School of Medicine. "It is very good at alleviating symptoms and improving quality of life, but the results may not last forever."

For those who had mesh implanted as part of the procedure, some 10% experienced movement of the mesh from its original location, which "may cause problems for years down the road," said Dr. Nygaard.

The use of synthetic mesh in a related pelvic organ prolapse procedure, in which the mesh is inserted through the vagina rather than through the abdomen, is the subject of hundreds of product-liability lawsuits against mesh makers. The suits allege the women were injured when the mesh failed.

Mesh contraction can occur in the vaginal procedure and cause pain, but mesh movement with the abdominal surgery is unlikely to be painful, according to Dr. Nygaard, who has no ties with mesh makers.

Strategies to prevent pelvic organ prolapse center on pelvic-muscle exercises and childbirth through cesarean section. Some studies have shown such exercises to be effective, and one large epidemiological study in Sweden suggested a link between C-sections and lower risk of the condition. But the preventive effect of C-sections hasn't been studied in a randomized trial.


Further reading:

Jane Akre:  Mesh Device News Desk
http://meshmedicaldevicenewsdesk.com/featured-articles/mesh-fails-25-percent-of-time-in-vaginal-prolapse-repair/

 Ingrid Nygaard:

http://healthcare.utah.edu/fad/mddetail.php?physicianID=u0513310
Study Press Release:
http://www.eurekalert.org/pub_releases/2013-05/tjnj-sel050913.php
JAMA study:
http://media.jamanetwork.com/news-item/study-evaluates-long-term-effectiveness-of-surgery-for-pelvic-organ-prolapse/

Patient Harm by design: justice is unattainable!

  Wall Street Journal

           BUSINESS  

            April 4, 2013, 7:17 p.m. ET

St. Jude Hit by Suits

Cases Challenge Liability Protection Enjoyed by Device Makers

By CHRISTOPHER WEAVER and JENNIFER SMITH

A raft of lawsuits filed Thursday against St. Jude Medical Inc. STJ -0.99% over an implanted heart device could challenge the broad liability protection that medical-device makers have enjoyed since a key Supreme Court ruling in 2008.

The lawsuits, filed both in Los Angeles Superior Court and federal court in the Central District of California, claim that problems with the manufacturing and oversight of Riata defibrillator "leads" injured or killed more than 30 patients. Faulty leads, which connect the heart to defibrillators that zap irregular heart rhythms back to normal, caused the devices to fail or needlessly deliver blasts of electricity, the suits allege.

One plaintiff, Rebecca Clawson, said in an interview that she was shocked several times over 25 minutes while in bed at her Orange County, Calif., home last November. Her lead was surgically removed and doctors said it displayed faulty wiring, said Ms. Clawson, who is 55 years old.

"As a matter of policy, we generally don't comment on pending litigation," a St. Jude spokeswoman said.

If the new cases succeed, they could help reopen a closed-off corner of the law that has left people who believe they were injured by medical devices with little recourse—and tempered the business of both plaintiff and defense lawyers who once earned hefty fees from device cases.

In recent years, the legal landscape has shifted against would-be plaintiffs injured by devices that go through the Food and Drug Administration's premarket approval process, lawyers specializing in device cases say.

The 2008 Supreme Court ruling, Riegel v. Medtronic, MDT -1.78% shielded makers of such devices from most product-liability claims, which are governed by state law, so long as the companies had complied with the federal standards of the FDA, including those for manufacturing, labeling and device monitoring. That meant that even if such devices were later found to be defective, companies are protected from many suits.

A 1976 law governing medical devices generally prohibits states from attempting to regulate devices, which are subject to federal rules, but Riegel broadly interpreted those provisions in a way that plaintiffs' attorneys say made it much harder to pursue claims.

To push cases through, lawyers generally must find state laws that specifically address violations of the FDA's requirements.

"Riegel was basically a graveyard for" device cases, said George Conk, a professor at Fordham Law School in New York and former product-liability attorney. In 2010, an appeals court upheld the dismissal of more than 8,000 cases alleging that a Medtronic Inc. defibrillator lead had injured patients, after the firm argued Riegel protected it. The company, though, had agreed to pay $268 million to settle the cases days earlier.

Medtronic said that without such protections from state law, "there would be no central standard for device safety, effectiveness, testing, labeling and marketing, which would ultimately be detrimental to patients."

Lawyers in the new Riata cases are alleging that St. Jude violated both the FDA's requirements for the company to report device flaws to the agency, along with state product-liability laws, an emerging approach to clearing Riegel's hurdles that has been buttressed by several recent appeals-court rulings.

They will also attempt to show St. Jude erred in manufacturing the devices in accordance with FDA rules, the approach favored in most device cases since Riegel.

The industry defends Riegel and its broad protections. "There is no absolutely safe medical device," said Ralph Hall, a Minnesota lawyer who has worked with device makers. "Making risk-benefit determinations in any design is FDA's job," he said.

St. Jude's Riata problems led to a recall of the leads in late 2011, and researchers have attributed at least 20 deaths to problems with the leads. Wires inside the Riata leads can break through their insulation, becoming exposed and potentially leading to electrical problems.

Some patients with the leads have seen their cases turned down by lawyers. Greg Jessee, 51, the general manager of a hydraulics-repair firm in Portsmouth, Va., was shocked three times before his heart briefly stopped during his son's football game in late 2011. He consulted an attorney last year to consider suing St. Jude, but the lawyer declined the case. "He studied it and came back to me to say he has found no way around" the protections, Mr. Jessee said.

The lawyer, Duncan Garnett, of Newport News, Va., didn't immediately respond to a request for comment.

Since the ruling "we've had numerous clients—including clients who have had Medtronic devices implanted in them—who have been reluctant to bring a case," said Brian J. McCormick Jr., a partner with Sheller PC, a Philadelphia law firm that specializes in cases involving defective products, drugs and medical devices.

Attorneys at large law firms that once made a lucrative business of defending the industry also say the Riegel ruling affected their businesses. "It has narrowed the playing field by 75%," said one defense lawyer specializing in devices who declined to be named because he still represents the industry in some matters.

Appeals courts are now split on the breadth of claims that Riegel blocks. A January ruling, for instance, in the Ninth U.S. Circuit Court of Appeals, which includes California, found Medtronic wasn't protected from liability related to a Medtronic pain-medicine pump malfunction, in part because the plaintiff, a patient named Richard Stengel, alleged the company failed to warn the FDA about known risks.

Medtronic said it disagreed with the January ruling.

The lawyers in the newly filed cases are hoping such rulings could propel their cases.

"What the judges are recognizing now is that there's no recourse for consumers, and that's changing," said Reza Torkzadeh, a Los Angeles attorney representing the plaintiffs in the new cases.

Write to Christopher Weaver at christopher.weaver@wsj.com and Jennifer Smith at jennifer.smith@wsj.com

Joleen Chambers                          
The medical device industry actively obscures the cascade of harm (and cost) when their products do not perform as advertised. Long-term post-market surveillance that is available in other countries via national registries are proprietary silos here in the U.S. Patients cannot access basic information prior to surgery about which devices perform best. Purchasing a toaster oven is more predictable. And when a device fails the debilitated patient is expected to go to federal court to face a lawyered-up industry. The aviation industry stops everything for a battery issue in a new airplane, Lulu-lemon gets national attention for failed fabric in their yoga pants but vaginal surgical mesh, ICD leads, joint replacement failures: silence! Why is the medical device industry "special"? Follow the money and see the cost of the entitlements to this small segment of our national economy! It is costly and immoral.

Wall Street Journal : FDA vote this week

Lawmakers To Vote On FDA Clout

by Thomas M. Burton  Wall Street Journal Saturday/Sunday, May 19-20, 2012 (FiDA blog added bold.)

New Prescription

The legislation proposing to renew regulations for pharmaceuticals and medicla devices would:

• Make it easier for federal regulators to inspect overseas drug-ingredient makers
• Require drug makers to warn authorities early if they expect drug shortages
• Set a deadline to create a new system to track safety problems with medical devices

The Senate could vote as soon as next week on whether to give the Food and Drug Administration broader regulatory authority, including new powers to prevent prescription drug shortages, inspect overseas drug facilities and more closely track medical devices for safety flaws.

The legislation, which is expected to pass, would renew a broad law that determines how much drug companies and medical-device makers pay the FDA to review their products. 

brand name drug companies are expected to pay about $4billion in user fees over the five-year law, an increase of about 6% from the current law.  Medical device companies would pay about $600 million over the same period, which is about double the current rate.

Under the proposed legislation, the generic drug industry would, for the first time, pitch in about $1.5 billion in user fees to pay for faster product reviews.  Also new are proposed user fees for companies making "biosimilar" drugs or knock-offs that could mimic complex drugs such as erythropoietin for anemia and Herceptin for cancer.  

Lawmakers say the effort has prompted little partisan sparing. A version of the legislation moving through the House is largely similar to the Senate's.

Still, drug makers are concerned Congress could get stalled and not pass a final bill before the current law expires Sept. 30.  That would leave the agency without funding and "have catastrophic effects on the FDA's ability to carry out its essential function," said Matthew Bennett, a senior vice president at the Pharmaceutical Research and Manufacturers of America.

J.C. Scott, chief lobbyist for medical device trade industry group AdvaMed, said the industry is concerned about a Senate provision that would make it far easier for the FDA to subject class of medical devices to more intensive clinical studies.

But the group supports the bill and has successfully won provisions requiring the FDA to have more meet ins with companies to keep them informed while their devices are going through the approval process.

In both the House and Senate versions of the legislation, some of the most important powers of the FDA would gain involve regulatory authority of foreign raw materials for drugs.  About 80% of the raw material used in drugs now comes from overseas, especially China and India.  Currently, the FDA has limited ability to require safety inspections of foreign drug facilities. This hampered the agency's response to gained heparin blood=thinner derived from China in 2008.  In that incident, 81 patients died an the agency wasn't able to discern where adulteration of the medicine occurred.

Both the House and Senate bills wood give the agency power to block products' entry into the U.S. if the FDA were refused admission to fully inspect facilities, and put the burden on companies to ensure the integrity of their supply chains.  Also, the FDA would get the authority to fix a huge disparity: that U.S. plants are inspected about every two years, and ones overseas every nine years.  Te legislation would give the FDA broad discretion to focus on the most risky products, anywhere in the world.  

"FDA's current drug-safety authorities are decades old and were never intended to address todays global market," said Deborah M. Autor, the agency's deputy commissioner for global regulatory operations.

The FDA has struggle to avert shortages of prescription drugs. The agency often doesn't know of production shutdowns that can lead to shortages until too late.  The Senate and House bills would require manufacturers to notify the agency early on if they believe a shortage is about to happen.

Patient Harm: Riata ICD leads unreliable

link

Agonizing Choices for Heart Patients

By CHRISTOPHER WEAVER

Michael W. Minton has a device in his chest that could save his life by helping his heart beat properly. Or not.

A retired factory worker from Joelton, Tenn., Mr. Minton is one of 79,000 U.S. patients implanted with the troubled Riata defibrillator lead from St. Jude Medical Inc. STJ -0.64% The lead, a set of insulated wires, is threaded into the heart and connected to a defibrillator that zaps the heart into normal rhythm. But in a number of cases, the devices' wires are breaking through their insulation.

Doctors say the protruding wires could be a sign of dangerous electrical problems that could cause the lead to malfunction, shocking or even killing the patient.

Mr. Minton is one of those cases, though his device is still working properly, and now he's faced with a decision: Should he have the failure-prone heart device cut out, even though the procedure carries significant risk, or wait and hope that the Riata holds up.

After seeing an X-ray image of his lead that he said looked like an appliance wire stripped of its insulation, Mr. Minton, 58 years old, decided, "I want that thing out."

A small but growing number of patients are starting to agree. At a handful of institutions, including Vanderbilt University Medical Center, Brigham and Women's Hospital and the Minneapolis Heart Institute, doctors are starting to remove even some functioning Riata leads when the devices show signs of wear. So far, Vanderbilt doctors have used X-rays to identify 29 leads with significant insulation problems, and removed one-third of them, beginning with those that are also malfunctioning.

The full scope of the problem is unknown, though by some counts, involving small groups of patients, as many as one-third of Riata's leads have protruding wires. That lack of clear information creates "much uncertainty for physicians, patients and patients' families," wrote a group of U.S. senators in a May 7 letter seeking details of St. Jude's handling of the Riata situation. St. Jude said it is responding to the letter.

link

St. Jude's share price plunged 10% after public attention focused on the Riata leads a month ago. The stock fell 25 cents to $38.88 in 4 p.m. trading Friday on the New York Stock Exchange. Heart-rhythm devices, including defibrillators and leads, made up more than 50% of St. Jude's $5.6 billion in 2011 sales.

The procedure to remove leads, which can tear heart tissue or leave broken pieces of the wire inside veins, is controversial. Guidance from St. Jude, which stopped selling Riata-series leads in 2010, recommends against removing the devices before they malfunction, because the risk of complications is considered high. One study of a favored lead-removal technique, in 2010, found a 1.5% chance of major complications, which can include death.

St. Jude said in a statement that its guidelines were devised with help from an independent physician advisory panel. Physician opinions may differ, and clinical decisions in general should be made on a patient-by-patient basis, it said.

The company will release a 700-patient study in June that could offer doctors more information about the risks of leaving leads with insulation flaws in place. Each patient will be X-rayed to look for the protruding wires, a St. Jude spokeswoman said.

The Heart Rhythm Society, a medical group, hasn't advised doctors whether to remove the leads, and is awaiting further data. Its president, the Cleveland Clinic's Bruce L. Wilkoff said he has removed some leads that didn't have electrical problems.

Defibrillator leads are often bound to the walls of veins and the heart by scar tissue, an obstacle that worsens with time. To remove them, doctors slide sheaths over the wires and scrape the scar tissue away, freeing the lead. The tip of the wires can become anchored in the heart wall, and removing them can tear a hole.

At Vanderbilt, Mr. Minton's doctor, Christopher R. Ellis, said his group decided to recommend to patients the removal of all leads with frayed wires visible on X-rays, even if they work.

Dr. Ellis acknowledged that the Vanderbilt approach is aggressive, but he said the group's rate of complications appears lower than the risk of Riata problems. "I don't see anything good that can happen from leaving all these leads in," he said.

Riata was recalled in December after St. Jude's medical advisers noted a higher-than-normal rate of an insulation failure, called externalization. The leads are also prone to other types of failures, and in March a study linked the devices to 20 deaths caused by short circuits. Not all externalized leads also short circuit, but new data suggests it is a sign of the problem.

In research presented Thursday at a Heart Rhythm Society meeting in Boston, 110 patients at seven hospitals who were checked with X-rays showed a 25% rate of externalized leads. Nearly one-third of those leads also had electrical problems, said Raed Abdelhadi, a Minneapolis Heart Institue doctor who presented the finding. Vanderbilt contributed to the study.

If future studies confirm those problem rates, Dr. Abdelhadi said, "If I were a patient, I'd know what I'd want."

Doctors should await additional data, said Raymond H.M. Schaerf, a Burbank, Calif., surgeon who removes leads, but who has counseled his patients against extractions when leads are functioning properly.

"When doctors get over aggressive, patients suffer more from the extraction than the actual lead," Dr. Schaerf said.

In previous recalls, such as the 2007 recall of Medtronic Inc.'s MDT -1.02% Sprint Fidelis lead, more patients were harmed by overzealous doctors than faulty leads, he said. It is not yet clear how Riata will compare with Fidelis, he said.

Laurence Epstein, chief of cardiac arrhythmia at Brigham and Women's Hospital in Boston, said that because the true risks of Riata are unclear, he leaves the choice up to his patients. After seeing loose wires in their hearts in X-ray images, some choose the extraction, Dr. Epstein said. "People don't like that time-bomb thing," he said.

"If it is externalized, in my mind, the lead has failed," said Dr. Epstein, who like others called for more data to gauge the risk.By nature, Mr. Minton, Dr. Ellis's patient, said he was inclined to deal with his Riata problem upfront, even if the procedure brings its own risks. "I'm not the type to stand in the closet for a couple of hours because there is a tornado warning," he said.

Write to Christopher Weaver at christopher.weaver@wsj.com

A version of this article appeared May 12, 2012, on page B1 in some U.S. editions of The Wall Street Journal, with the headline: Agonizing Choices for Heart Patients.

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