Call for Resignations of FDA/CDRH Directors Shuren and Maisel

Jeffrey Shuren, FDA/CDRH Director

Allison Shuren, wife of FDA/CDRH Director

William Maisel, FDA/CDRH Deputy Director

PREVENTABLE Patient Harm from lax FDA/CDRH regulation

Metal-on-metal hips  500,000

Pelvic Surgical mesh 70,000

Bayer Essure 20,000

Power Morcellator for pelvic surgeries

Duodenoscope infections

Bard 'Recovery' Blood Clot Filter fatalities

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

Toxic medical device cartel penetrates government at the highest levels.

 May 13, 2013 by Brian Johnson

J.C. Scott, SVP, government affairs for AdvaMed is named one of the top lobbyists in theBeltway by CEO Update, a publication covering trade councils

AdvaMed's government affairs guru J.C. Scott has been named a "top lobbyist" by CEO Update, a publication that covers the trade association industry.

Scott received praised by the publication for his work on efforts to repeal the medical device tax,. He was one of only two healthcare related lobbyists on the list.

"[Scott] built bipartisan support for repealing the medical device tax, resulting in a nonbinding 79-20 Senate vote,"the publication wrote. "Helped lead Hill efforts to reauthorize user fees, and then to allow FDA to spend the full amount collected."

AdvaMed hired Scott away from the American Council of Life Insurers 2 years ago. He is a Capitol Hill veteran, having cut his teeth on the Hill as deputy director for policy at the House Republican Conference and in a number of capacities for Rep. Deborah Pryce (R-Ohio) before spending seven years at ACLI.

His predecessor, Brett Loper, left Advamed in early 2011 to become the policy director for House Speaker John Boehner (R-Ohio).

Is there proven value in high cost hip/knee implants?

Breaking the chain

Hospitals set supply cost-cutting targets, push physicians to change behavior

By Jaimy Lee  Modern Healthcare     FiDA highlight added

Posted: August 17, 2013 - 12:01 am ET

Tags: Hospitals, Purchasing, Special Feature, Specialty Hospitals, Supply Chain, Systems, Top Stories

Patients with a new cardiac pacemaker have an advantage over patients who have received standard pacemakers: they can undergo MRI scans as a part of their care without the risk of adverse events.

But the new device costs hospitals $1,300 to $3,000 more than a traditional pacemaker and could cut into a hospital's margin because Medicare and other insurers pay the same rate for implanting MRI-compatible pacemakers as they pay for the standard pacemakers. From a clinical perspective, physicians are put in the position of having to predict which patients are likely to need an MRI and should receive the new pacemaker.

It's one of many supply-chain decisions hospital administrators have to make where they must weigh the benefits of a new technology—such as the fact that the new pacemaker doesn't improve immediate outcomes for the patient but may have additional benefits in the long term—against its higher costs.

These executives face similarly difficult decisions to slash millions of dollars in supply expenses each year. In the case of the MRI-compatible pacemaker, one executive says his system likely will pay more for the new pacemaker when appropriate and seek offsetting cost reductions elsewhere in the supply chain.

“It's one of those things where to make the quality of life better for our patients, we're going to incur new costs,” says William Mosser, vice president of materials management at Franciscan Missionaries of Our Lady Health System in Baton Rouge, La.

Facing declining revenue and reimbursement, hospital systems across the U.S. are making it a priority to sharply reduce spending on supplies including gloves, syringes and hip implants. Supplies typically make up hospitals' second-largest expense, after labor costs. Hospitals spent about $255 billion on supplies and nonlabor services in 2011.

Budget pressure has led to increased scrutiny of the costs, clinical outcomes and utilization of products. Many hospitals are setting cost-reduction targets, evaluating the effectiveness of their group purchasing organizations, and pushing for better data and analytics on products to persuade physicians to accept changes to the types of devices or supplies being purchased.

More than 60% of the hospital supply-chain executives who participated in Modern Healthcare's 2013 Survey of Executive Opinions on Purchasing said they were very satisfied or satisfied with their primary GPO. About 40% were somewhat satisfied or not satisfied. Meanwhile, 59% of respondents said their primary GPO was very effective or effective in controlling costs; the remaining 41% said their main GPO was somewhat effective or not effective.

Cost reduction, clinical integration

“Everyone that we deal with at the hospital level today is focused on cost reduction and clinical integration and managing patients to outcomes with a bent toward resource reduction,” says John Bardis, chairman, president and CEO of MedAssets, one of the nation's largest GPOs.

But many hospital executives say there are cultural and operational challenges that can slow these kinds of cost-cutting initiatives.

One major factor is that physicians often have relationships with particular medical device manufacturers or have used certain devices for a long time and are resistant to changing to other devices. Another is that the higher costs of new technologies touted as improving quality of care can set back savings efforts. And in many cases, there is a lack of validated clinical data that can definitively prove whether a particular product yields better results for patients.

“The biggest hurdle we have is there is not a consistent and large enough base of validated evidence,” Mosser says.

Like many other hospitals, Franciscan is undertaking an initiative to cut millions of dollars in annual supply expenses as it faces the prospect of significantly lower reimbursement rates in the coming years. The program, which it calls Healthy 2016, aims to cut $165 million in operating expenses, including $31 million in medical and surgical supplies and purchased services, over the next three years.

Related Content

Download the 2013 Modern Healthcare Survey of Executive Opinions on Purchasing charts.

Other hospital systems have implemented cost-cutting initiatives similar to the one at Franciscan. Over five years, Lahey Health, based in Burlington, Mass., plans to cut

$40 million out of the $300 million it spends each year on medical and surgical supplies. BJC HealthCare, a 12-hospital system based in St. Louis, plans to reduce its $850 million in annual supply spending by $54 million this year, and it's seeking to cut out an additional $150 million over the next three years.

“This is a primary focus across the system, from the CEO down,” says Nancy LeMaster, BJC's vice president of supply chain. “In the last three years, as the reimbursement pressures have been getting tighter and tighter, people have really started to see how this could impact us. We call (supply chain) a sustainable advantage rather than just a back-office function.”

Hospitals are undertaking a number of strategies, including standardizing the types of products clinicians use, optimizing appropriate utilization by physicians, nurses and other staff, and continuing to negotiate lower prices for supplies. Many but not all hospitals have value-analysis teams in place.

Focus on physician preference

A big area of focus is usually physician preference items, such as hip or knee implants as well as stents and other cardiac rhythm management devices. These are some of the costliest purchases hospitals make.

BJC is focused this year on reducing costs associated with spine implants. “This is an area of focus where the pricing does not appear correlated to the cost to manufacture and sell the product, but rather has historically been based on what the market would bear,” LeMaster says in an e-mail. “The market can no longer bear this level of pricing.”

The system's strategy focuses on first achieving market-competitive pricing with the spine vendors, and then taking on utilization management and possibly standardization.

Franciscan is supporting a clinical variation project led by chief medical officers at its five hospitals in Louisiana that seeks to better align the clinical protocols of spine surgeons. That could reduce the number of vendors of spine surgery products the system works with, from about 20 now.

“Spine surgeons across our health system do things differently,” Mosser says. “Some might overutilize. Some might underutilize. Some might use generic products, and others are using different types of techniques. Our chief medical officers are working down a path of aligning both the protocols and the practices from a clinical perspective that will allow us to minimize (the) number of those vendors.”

GPOs say their core business is still supply contracts, but the other services and technologies they offer to hospitals to help address a number of financial pressures are increasingly becoming of interest to their members.

“You've got to look at best demonstrated practices,” says Ed Jones, president and CEO of HealthTrust, a Brentwood, Tenn.-based GPO that is part of HCA's Parallon Business Solutions. “You've got to look at reducing clinical variability. You've got to look at streamlining your sourcing decisions.”

Nearly half of the hospital supply-chain executives who participated in Modern Healthcare's purchasing survey said they planned to increase their use of GPO contracts in 2013. Only 7.6% said they planned to decrease their use of GPO contracts.

“If a big system feels like their GPO can give them access to scale and aligns that scale to drive better value than they can do on their own, they will tend to work more with the GPO,” Jones says. “If the larger systems are in a position where their GPO is not as effective in that regard, they're probably going to do it on their own.”

Smaller health systems and hospitals are generally more inclined to work with GPOs and increase their spending with them to gain the scale and volume that they provide, Jones says. In other instances, contracts with higher commitment levels also are generating more interest because they often deliver better pricing, he adds.

Lahey Health says it plans to review its current GPO relationships with Novation, a GPO based in Irving, Texas, and MedAssets and then sign a contract in October with a single GPO that will handle at least $180 million of spending.

“It's a partner to help us meet our margin targets as we worry about declining reimbursements,” says Eric Berger, Lahey's vice president of supply chain. “We really need to look at expenses, so having a GPO partner will help us do that.”

Looking at the data

As hospitals dive deeper into the supply chain searching for ways to reduce spending, new areas of focus are emerging. Not only are some hospital systems bringing distribution in-house, but they are also hiring new talent, investing further in data and analytics tools, and some are even forming their own GPOs.

While many hospitals report that they have met cost-reduction targets ahead of schedule, the cost of high-priced implants remains a big barrier. Hospital and GPO executives bemoan that the implantables market has not become more like the markets for other commodities.

“These innovations in total knee and total hip have been around a long time but they've had a strong hold on high prices compared to the rest of the world, in large part because of physician relationships,” MedAssets' Bardis says.

On the other hand, teaching hospitals and physician-owned hospitals are more likely to continue to allow preference among physicians. “We will tend to give them what they want, regardless of what the cost is, in order for them to want to practice there,” says Bruce Kizzier, director of materials management at seven-bed Lincoln (Neb.) Surgical Hospital, a physician-owned hospital.

He believes his hospital has gotten the best prices, noting that the hospital's physicians have participated in meetings with vendors to ensure that the hospital was receiving competitive pricing.

“More organizations are having these conversations with surgeons,” says Dr. Peggy Naas, an orthopedic surgeon and vice president of physician strategies for VHA, the parent organization of Novation. “More surgeons, seeing the pressure to add value, are asking questions.”

Other supply-chain executives say that while hospitals have done a poor job in the past in educating their physicians about the costs of preference items and keeping supply costs under control, that's changing and doctors increasingly are facing up to the problem.

“They've seen the impact of the sequestration, the federal law changes and reimbursement drops have been very dramatic across the country for every system,” BJC's LeMaster says. “They're really seeing that if we don't get it out of supplies, then we've got to look at labor.”

Read more: Hospitals push docs to change behavior to meet cost-cutting targets | Modern Healthcare http://www.modernhealthcare.com/article/20130817/MAGAZINE/308179905#ixzz2cWhLwahv

?trk=tynt 

Bad Ad: Johnson & Johnson tarnished halo selling new 'product': love!

Have the FDA and FCC approved this ad?  

What product is this corporation selling?

Does it have to disclose that it is being sued by thousands of harmed patients?

(Metal on metal hips and surgical mesh.)

This bad ad will be aired:

History does not match JNJ we have today:

Biomet Failed Metal Hips: Hundreds of Lawsuits

http://bit.ly/X4AqsA

Biomet Metal-on-Metal Hip ImplantLitigation Status Update

Posted on February 6, 2013 by Cal Warriner  

An MDL (multidistrict litigation) was established for the prosecution of individual personal injury lawsuits against Biomet in the fall of 2012. The Judicial Panel on Multidistrict Litigation (JPML) heard attorney arguments on September 20, 2012, at a hearing in New York City. The plaintiffs requested consolidation of the pending lawsuits involving Biomet’s M2a Magnum metal-on-metal hip implants in federal court in New York, Texas, or California, where lawsuits had already been filed by individual plaintiffs. Biomet resisted the establishment of an MDL, but suggested that it be based in New York or New Jersey if the JPML felt that MDL coordination of the individual lawsuits was necessary. The Judicial Panel rejected all of the suggested forums and established MDL No. 2391 before Judge Robert L. Miller, Jr., United States District Court Judge in the Northern District of Indiana. Judge Miller has been a member of the Judicial Panel on Multi-District Litigation since 2003. He was appointed as a federal judge in 1985, and has served as Chief Judge in the Northern District of Indiana since 2003.

As of January 14, 2013, there were 132 individual lawsuits pending in the MDL. Given the large number of adverse event reports filed by patients who suffered harm as a result of being implanted with the defective Biomet M2a Magnum metal-on-metal hip implants, it is anticipated that hundreds of additional lawsuits will be filed by injured plaintiffs in the coming months.

Judge Miller held his most recent monthly status conference on February 4, 2013, in South Bend. The judge is currently considering a number of issues in the litigation, including guidelines on the preservation of explanted hip implants and the forms to be utilized for discovery responses. The Court granted the plaintiffs’ request for another week to prepare a Fact Sheet form that was more comprehensive than the one submitted (but less onerous than the form proposed by the Defendants), in light of the judge’s comments that he would prefer to have a more comprehensive form. The parties are also working on reaching agreements with regard to electronic discovery and predictive coding, the first steps that need to be completed in order for the large-scale production of Biomet’s documents to begin.

At the recent status conference, the court also discussed scheduling issues, including a “science day” to educate the Court on the scientific issues pertinent to the Biomet metal-on-metal hip implant litigation. Those presentations are expected to occur in May of 2013. If discovery proceeds as intended, it is likely that the Court would be in a position to begin the selection of individual cases for case-specific discovery and bellwether trial preparation as early as January of 2014. We anticipate that a number of orders will be entered this month to help streamline the litigation process. The next status conference in the Biomet MDL is scheduled for March 18, 2013.