Threat to prescribed pain relief for failed device?

http://bit.ly/LzyYVT

How to intelligently prevent opioid abuse

by GEORGE LUNDBERG, MD AND MARIA A. SULLIVAN, MD, PHD | in MEDS |  (FiDA blog bold)

Acute and chronic pain is bad. Proper pain management is essential and has been strongly emphasized by the American medical establishment for the past nearly two decades.

Simultaneously, during these years, both the quantity of opioids prescribed by physicians and dentists has increased dramatically and prescription opioid abuse has escalated at an alarming rate among chronic pain patients and the general population. Opioid analgesics now result in more American overdose deaths than cocaine and heroin combined.

What should physicians do? For treatment of chronic pain, non-opioid analgesics should be the first-line agents.

Physicians and nurses must discuss with patients common opioid side effects such as constipation and sedation, other risks such as addiction and overdose, and potential long-term risks such as hyperalgesia and sexual dysfunction.

Short-acting opioids such as Dilaudid (hydromorphone) and Vicodin (hydrocodone/paracetamol) may be helpful for initial pain relief, but longer-term dosing can lead to breakthrough pain and withdrawal, and these agents carry a relatively high abuse potential.

Oxycontin (oxycodone CR) is also widely abused, especially in rural areas; its elevated dosage means it is highly addictable, and coverage by insurance makes it cheaper than heroin.

Longer-acting opioid analgesics such as Suboxone (buprenorphine), methadone, and fentanyl have a much lower abuse liability. However, methadone is found in more overdose deaths than any other prescription opioid and should not be prescribed for opioid-naive patients. Because analgesic effects of methadone are of shorter duration (6 to 9 hours) than its half-life (36 hours), levels may accumulate, leading to respiratory suppression or cardiac events.

Patients should be instructed to keep controlled substances safe in a locked location to prevent use or sale by others.

If a physician intends to prescribe opioids for chronic pain, a narcotic protocol – medication contract, psychological evaluation, and urine toxicology – should be considered. Monitoring both urine toxicology and aberrant behaviors will detect more opioid abuse than either strategy alone.

Combining a clinical interview and the SOAPP (Screening and Opioid Assessment for Patients with Pain) yields the highest sensitivity (.90) for abuse detection.

A “universal precautions” approach to minimizing risk includes asking patients about history of substance abuse, written informed consent, and ongoing reassessment of the benefits of opioid therapy. Clinicians can thus triage patients to low-, medium-, and high-risk addiction potential. Treatment agreements should delineate rules such as having no early refills and requiring urine toxicology.

For patients who develop opioid addiction, substitution with buprenorphine or another abuse-deterrent formulation and adherence monitoring can be implemented.

The medical establishment should develop and use effective analgesics with lower abuse potential. Current research efforts to identify better methods to detect patients at heightened risk for developing addiction should be supported.

All prescribers of opioids must actively manage pain control while aggressively and intelligently attempting to prevent opioid abuse.

George Lundberg is a MedPage Today Editor-at-Large and former editor of the Journal of the American Medical Association. Maria A. Sullivan is an Associate Professor of Clinical Psychiatry in the Division on Substance Abuse at Columbia University and the New York State Psychiatric Institute.

 Comment by Joleen Chambers (FiDA blog)

So . . . those innocent patients who received prescription pain medication (e.g. long-term maximum dose hydrocodone) will be side railed into a "new" medical plan to EVALUATE their pain/addiction level (eliminate the current prescription).  How is this new program customized to a victim of a failed implanted medical device (FDA MedWatch #5009052)? The cascading damage of failed device, pharma evasion of untreated serious dry mouth side-effect on dental health,  medical abandonment, insurance abandonment, inaccessible justice, and now potential coercion into withdrawal or alternate medication so that the medical community can move on.  How is this patient-centered? The prescribing doctors need to experience this kind of treatment:  they have no concept.    

Marketing patient harm: implanted medical devices.

LINK

AP News  Bloomberg Business Week

FDA panel sees little use for metal-on-metal hips

By Matthew Perrone on June 28, 2012  (FiDA blog bold)

           

WASHINGTON (AP) — Government health experts said Thursday there are few reasons to continue using metal-on-metal hip implants, amid growing evidence that the devices can break down early and expose patients to dangerous metallic particles.

The Food and Drug Administration asked its 18-member panel to recommend guidelines for monitoring more than a half-million U.S. patients with metal hip replacements. The devices were originally marketed as a longer-lasting alternative to older ceramic and plastic models. But recent data from the U.K. and other foreign countries suggests they are more likely to deteriorate, exposing patients to higher levels of cobalt, chromium and other metals.

While the FDA has not raised the possibility of removing the devices from the market, most panelists said there were few, if any, cases where they would recommend implanting the devices.

"I do not use metal-on-metal hips, and I can see no reason to do so," said Dr. William Rohr of Mendocino Coast District Hospital, who chaired the meeting.

For decades nearly all orthopedic implants were coated with plastic or ceramic. But in the last 10 years some surgeons began to favor all-metal implants, after laboratory tests suggested the devices would be more resistant to wear and reduce the chances of dislocation.

But recent data gathered from foreign registries shows the devices fail at a higher rate than older implants. That information comes on top of nearly 17,000 reports to the FDA of problems with the implants, which sometimes require invasive surgery to replace them.

The pain and inflammation reported by patients is usually caused by tiny metal particles that seep into the joint, damaging the surrounding tissue and bone. The long-term effects of elevated metal levels in the bloodstream are not clear, though some studies have suggested links to neurological and heart problems.

About 400,000 Americans get a hip replacement each year to relieve pain and restore motion affected by arthritis or injury. Metal hips accounted for about 27 percent of all hip implants in 2010, down from nearly 40 percent in 2008. Doctors have begun turning away from the implants amid several high-profile recalls, including J&J's recall of 93,000 metal hips in 2010.

FDA's experts said Thursday that patients complaining of pain and other symptoms should get regular X-rays and blood testing for metal levels. However, panelists pointed out the problems with the accuracy of blood tests and the difficulties of interpreting the results. There are no standard diagnostic kits for sale that test for chromium and other metals

For patients who are not experiencing pain, panelists said annual X-rays would be sufficient to monitor their implants.

If the FDA ultimately follows the group's advice, U.S. recommendations would be less involved than those already in place overseas.

Earlier this year U.K. regulators recommend that all people who have the implants get yearly blood tests to make sure no dangerous metals are seeping into their bodies.

FDA regulators have suggested they want to take more time to sort out the differences between various implants and patient groups before making recommendations.

"The truth is there are different types of hips and different types of patients," said Dr. William Maisel, FDA's chief scientist for devices, in an interview last week. "Understanding the characteristics of patients who experience adverse events is very important."

Women and overweight people are among the groups that are more likely to have an implant failure.

With little definitive data on U.S. hip implants, the agency has asked manufacturers like Johnson & Johnson, Zimmer Holdings Inc. and Biomet Inc. to conduct long-term, follow-up studies of more than 100 metal-on-metal hips on the U.S. market.

FDA scientists say the studies will help "fill in the blanks" on a number of scientific questions, including the long-term effects of metal particles.

But public health advocates say it could take a decade before that information is available.

"Keeping these metal-on-metal hips on the market for the next five to 10 years while research is conducted is not ethical," said Diana Zuckerman, president of the National Research Center for Women & Families, during a public comment session at the meeting. "If the companies want to sell metal-on-metal hips, they should be required to prove their safety first."

Citizen claims right to safer implant devices.

LINK

 Medical devices need impartial oversight

JUNE, 27 2012

MARY BOLAND

POST INDEPENDENT

GLENWOOD SPRINGS, CO COLORADO (FiDA blog bold)

My husband has a full hip joint replacement, the kind where they lop off the bone and replace it with a metal rod and ball. Fortunately an easier procedure is now available where they just recoat the ball in the hip joint. But we thank our lucky stars that his metal hip joint is, so far, not causing any problems that we know of.

Many people who underwent the same procedure as my husband have had major problems, requiring repeated surgeries and causing long periods of, if not permanent, immobility.

And that is why I was particularly interested to read an article In “Public Citizen Health Letter” about the $350 billion medical device industry's “massive lobbying campaign to weaken the already lax oversight of medical devices and to accelerate the already too-quick review of high-risk medical products.”

The law setting the Federal Drug Administration's user fees and regulation requirements for both new medical device applications and ongoing oversight is up for renewal this year. And already the members of Congress who have received the most campaign finance help from the industry have introduced 14 bills aimed at easing regulation and weakening measures intended to ensure patient safety.

That patient safety measures need to be strengthened, not weakened, may be inferred from the substantial increase in recalls in recent years. Recalls of devices posing high risk to patients have doubled between 2007 and 2011, and recalls of devices posing moderate risk have increased sevenfold.

And the growth of recalls cannot be explained by any increase in the number of new medical devices, whose number has been stable or declining in recent years.

Among recently recalled devices are:

• Faulty implanted heart defibrillators that incorrectly deliver dangerous electrical jolts to the heart.

• Surgical clips that pop off, causing patients to bleed to death internally.

• Artificial hips that shed metal fragments into the bone and surrounding tissue, causing extreme pain and restricting mobility.

• Infusion pumps that shut down unexpectedly or dispense incorrect intravenous medicine doses.

In the face of this record, the medical device industry spent $33.3 million on lobbying in 2007. In the third and fourth quarters of 2011 there were at least 225 of these lobbyists hard at work, including 107 who had previously worked for the federal government.

Interestingly, one of the bills introduced in Congress would weaken the financial conflict of interest prohibition against individuals with industry interests serving on the FDA advisory committee overseeing medical device approvals.

Members of a key House health subcommittee with jurisdiction over medical devices have received campaign contributions from the industry double those of the average House member. And actual sponsors of the House bills seeking to weaken regulation and oversight have received about three times more.

Public Citizen asserts that in addition to allowing far too many dangerous devices to reach the market, the FDA has inadequate post-market surveillance for adverse advents. The FDA primarily depends on manufacturers and hospitals to report incidents of serious injuries or deaths related to these devices. It is not in the manufacturers' or hospitals' interest to do so.

Furthermore, Public Citizen points out, the Republican-dominated Supreme Court held in 2008 that manufacturers of FDA approved devices cannot be held liable for harms. Congress should restore patients' rights to sue in such cases.

Public Citizen calls on Congress to replace the current weak medical device regulatory regime with a process that requires the same scrutiny as that given to new drugs, particularly for moderate and high-risk devices that are permanently implanted in the body.

The whole situation is just one more sad example of our desperate need to amend the Constitution to overturn the Supreme Court's disastrous Citizens United ruling that corporations are people and the Constitution's free speech guarantee protects their right to spend all the money they want to influence Congress.

Only then can we revamp our election process to get campaign contributions out of the picture. And only after that is done, could legislation possibly be enacted to end the “revolving door” between industry regulators and lobbyists.

For further details, go online to www.citizen.org/hrg. And write your representatives and senators.

— “What Do We Really Want?” appears on the second and fourth Thursdays of the month. Mary Boland is a retired teacher and journalist, a proud grandmother, and a longtime resident of Carbondale. Follow her on twitter@grannyboland.

500,000 failed hips-WHY? Consumers Union to FDA

Safe Patient Project

http://safepatientproject.org/posts/3357-consumers-union-comments-to-fda-advisory-panel-on-metal-on-metal-hip-implants

June 28, 2012

Lisa McGiffert, Director of Consumers Union’s Safe Patient Project comments to the FDA advisory panel on metal-on-metal hips, June 28, 2012.  

The most confounding question yesterday was asked several times: “Why were these devices implanted in 500,000 people without safety testing? It should have been tried but not on this scale.”

Consumers Union learned a lot in Congress’s User Fee Act debate – that there are many counterforces to creating a common sense system that would prevent this kind of thing from happening again. Recalls, guidances, and post-market studies take a long time during which unsuspecting patients are having devices implanted in them that don’t have the science backing up their widespread use.

Here’s what I learned yesterday: It seems that making a metal-on-metal hip safer is not a solvable problem. There are no benchmarks, too many variables, and too many questions that will take too long to answer.

What can the FDA do to undo this misstep? Three things:

1) Put out an alert immediately: Women should not get metal-on-metal hips, with a strong warning for those of childbearing age. I’m heartened by the discussions of panel members yesterday who kept bringing up the findings of poor outcomes for women. The alert: every woman with a metal-on-metal hip should be aware of possible issues and get a check up. Tell them what to monitor and what symptoms to watch for. Enlist the media, organizations (medical societies, consumer, community), social media (email lists, Facebook, Twitter). Spread the word as if you really want the public to know

2) Don’t count on doctors or hospitals to give potential patients enough information up front. Informed consent does not work. Doctors don’t know or don’t tell or leave it up to someone else who doesn’t do it either. We need a public version of informed consent, an unbiased source. Patients don’t get the kind of information they need to be clear about the risks so they can make informed decisions to opt for safer devices or safer alternatives. I have heard this countless times from people harmed by health care and you heard it yesterday: “If I had known then what I know now, I would never have chosen a metal-on-metal hip.”

3) Make sure that doctors don’t embrace future devices without sufficient evidence that those devices are better or more durable than existing ones.  Ensure full disclosure to doctors of the limitations of the process that brings devices to the market. Doctors should get notice when post-market studies are ordered at clearance/approval and they should have to disclose that information to patients before surgery. There is so much marketing to use the newest product, we need a counterbalance and FDA needs to be that with clear and concise information delivered in an effective manner.

Consumers Union  supports a national Registry and it should be a top priority. It could begin with implants and high risk devices. It should be comprehensive and neutral, with FDA having full access to all information in it. It should not be run by manufacturers who produce each device.  Another vital function of registries that no one mentioned yesterday: to notify patients and doctors when things go wrong. If we had one in place today, we would be able to easily tell all of those women with metal-on-metal hips about the danger signs they should watch for.

The Sentinel Initiative was not mentioned yesterday. The User Fee bill just passed added devices to this post market system for drugs. It could be an option for answering some of the questions posed yesterday.

Thank you for the opportunity to speak to you today.

Device Industry self-inflicted injury-stop whining!

http://www.stthomas.edu/mc/nihp/20120627/default.html

BI-PARTISAN SELF-INTEREST TRUMPS OBAMACARE FINANCING

The ACA, a.k.a. Obamacare, expands insurance coverage to life-saving health care and medical technology to 32 million of some 50 million uninsured Americans. Every segment of the health care industry has agreed that the benefits of expanding coverage far outweigh the costs of some financial concessions they have made to achieve it, which is usually in the form of financial reimbursement changes. The exception is the medical device industry, which has fought making any concessions, and its congressional proponents who are currently engaged in repealing the one concession forced on them, an effective 1.5% profits tax for 10 years on companies with annual sales over $5 million. Democrats in Minn. such as Senators Klobuchar and Franken, and Congressman Tim Walz, oppose repeal of the law they voted for but favor gutting it of the revenue required to make it work. The StarTribune, which regularly publishes the self-serving opinions of the industry about how the FDA is driving U.S. jobs and innovation overseas, and only rarely digs deeply into the genuine health and safety issues associated with a local industry that some time ago passed from real medical innovation to iterative invention, editorializes here clearly on this bit of congressional double-speak.

Commentary from Dave Durenberger
Wednesday, June 27, 2012________________________

http://www.startribune.com/opinion/editorials/158245155.html

Jerry Holt, Star Tribune

Editorial: If device tax is lost, special interests win

•                June 9, 2012 - 6:00 PM

The Minnesota-led congressional charge to repeal a new tax on the medical-device industry that will help defray the cost of health care reform is another example of the outsized influence of special interests in Washington.

Instead of acceding to yet another demand by the device industry -- which has already had the tax halved, and recently won favorable regulatory reforms -- Congress needs to tell firms the hard truth.

Hospitals, drug companies and insurers have agreed to shoulder some health reform costs. The device industry isn't being singled out, especially when the 2010 Affordable Care Act will likely benefit its bottom line by expanding coverage to up to 33 million uninsured Americans. The proposed 2.3 percent device industry excise tax, which will raise about $2.9 billion a year when it kicks in next year, should not be repealed.

Minnesota Republican Rep. Erik Paulsen is a champion of a U.S. House bill that would repeal the tax. Minnesota's Democratic Sens. Amy Klobuchar and Al Franken also support repeal.

KLOBUCHAR'S VIEW"I congratulate Representative Paulsen on this vote. While the administration's statement that the president will veto this bill means that changes will likely need to be made, I will continue to pursue all options to get this done. I have long worked to get this tax reduced or eliminated, including a $20 billion reduction from the original proposed tax in 2010."-U.S. Sen. Amy Klobuchar

Paulsen, whose district is home to many device firms, has proposed offsetting the lost device industry tax revenue by recovering some subsidies given to individuals to help buy health insurance.

That proposal would result in needy people ponying up to cover the cost of special treatment given to a wealthy industry. Last week, the White House sensibly threatened to veto Paulsen's legislation, which passed the House on Thursday in a 270-146 vote. It's not clear when the Senate will take up the issue.

While the device industry trade organization is predictably predicting massive job losses if the tax is not repealed, independent analysts have cast serious doubt on research the industry commissioned to support its catastrophic claims.

A 2012 Bloomberg Government analysis said industry claims of up to 43,000 jobs lost are simply "not credible." The research "exaggerates the degree to which spending on health is affected by price increases" and ignores "positive effect of new demand [for devices] created by the law,'' according to Bloomberg analyst Christopher Flavelle.

There's further reason to be skeptical about the push for repeal. A Standard and Poor's industry report noted that the 2013 start date gives the industry time to adjust to the new tax. Because the tax can be used as an income tax deduction, the net increase is just 1.5 percent, the report found.

The tax is also structured so that it doesn't give companies an incentive to send jobs offshore. "The tax applies equally to imported and domestically produced devices, and devices produced in the United States for export are tax-exempt,'' wrote Paul Van de Water, an analyst with the Center on Budget and Policy Priorities.

The device industry faces many challenges -- many of them self-inflicted. High-profile recalls of flawed devices have given the industry a black eye. The Standard and Poor's report notes that the industry has produced "little in the way of new products that would be considered revolutionary.'' The tax will add to firms' challenges, but it certainly can't be blamed for all the industry's woes.

There's legitimate concern about the tax's effect on small- to medium-sized firms, which are developing products that aren't yet profitable. While some of the costs can be passed along to the device's end users -- patients, in other words -- these firms may be unduly burdened by the new tax, which is on revenue, not earnings.

Policymakers and the industry should have pushed for an exemption for these smaller firms instead of a total repeal -- this revamped option deserves consideration. It would minimize the loss of tax revenue, yet protect a vulnerable industry sector important in Minnesota and elsewhere. A trade group estimates that the 10 largest device firms will account for 86 percent of the new tax's revenue.

Unlike the new Medicare drug coverage passed under President George W. Bush, the Affordable Care Act at least attempted to provide new benefits without adding to the nation's debt. The amount of money generated by the device tax is a relatively small contribution to health reform's overall cost.

Still, it's helping to defray the cost. Given the nation's mounting long-term debt concerns, politicians need to find more ways to pay for promised benefits, not vote away one substantive way of doing so.

---------------------------

FDA: Metal on Metal Hips, higher failure rates for women

FDA Panel Discussing Safety of Metal-On-Metal Hip Implants

Published June 27, 2012

Dow Jones Newswires

The Food and Drug Administration on Wednesday convened a two-day advisory panel meeting to discuss the safety of metal hip implants, amid concerns there are more side effects than with implants made out of such materials as ceramic or plastic.

The advisory panel is being asked to make recommendations whether additional warnings and other information is needed for metal hip systems, and to make recommendations about which types of patients would benefit the most from metal implants as well those who shouldn't get them. The panel is not being asked to discuss regulatory changes like requiring the devices to go through more stringent clinical testing.

In 2010, Johnson & Johnson's (JNJ) DePuy Orthopaedics Inc. recalled 93,000 of its ASR total hip implants after they were linked to higher failure rates than other implants. The ASR device is no longer sold but is still implanted in many patients, and the company faces about 6,000 lawsuits.

One of the safety concerns involves the wear on the implants and its breaking down of the metal, which in some patients causes joint and muscle destruction and other health problems.

Elizabeth Frank, an FDA medical reviewer, said Tuesday that patients vary in their reactions to metal particulate, with some having a severe inflammatory response to having no reaction.

Because hip implants were on the market before FDA started regulating medical devices in 1976, such companies as DePuy and Wright Medical Group Inc. (WMGI) only need to show a hip implant is similar to a device already on the market and don't need to conduct clinical studies showing safety and effectiveness, a process that has been criticized by some policy makers and many patients.

Major changes to devices, however, do require additional testing, and hip resurfacing systems, including ones made by Smith & Nephew PLC (SNN), are required to go through FDA's premarket approval process, which requires companies to conduct clinical studies in humans looking at the devices' performance. The FDA said other companies with metal hip implants on the market include Biomet Inc., Zimmer Holdings Inc. (ZMH) and Encore Medical L.P.

There are about 400,000 hip implant surgeries in the U.S. each year. About 25% of surgeries involve metal-on-metal implants, according to recent U.S. government data.

Information from patient registries outside of the U.S. suggest more patients need to have the metal implants fixed than other types of implants. The U.S. doesn't have a national registry and studies looking at implant failure rates in the U.S. have been mixed. Some data suggest women have higher failure, or revision rates, compared to men while other data suggests there might be more problems with implants that have a larger component, called the femoral head, than smaller components.

"Could it be the size of the head when we are attributing all the problems to metal?" said Raj Rao, a panel member from the orthopaedic surgery department of the Medical College of Wisconsin.

Although the panel had not formally started addressing FDA's questions Wednesday, preliminary discussion suggests the panel may struggle to adopt clear recommendations given the number of products and conflicting data.

"I don't believe the failure mechanism of these devices is the same," said Edward Cheng, a panelist from the University of Minnesota Medical School and Cancer Center.

Information prepared for the meeting by the FDA showed there's been almost 17,000 adverse-event reports submitted to FDA involving the metal-on-metal implants from 1992 through 2011. There were 22,000 for nonmetal hip implants. Of the metal-on-metal reports, about 12,000 were submitted in 2011 with 9,000 attributed to the DePuy ASR. The reports cited problems including the need for revision--or additional surgery to fix or replace the implant--pain, dislocation and bone infections.

In a presentation to the panel, Paul Voorhorst, the director for biostatistics and data management for DePuy Orthopaedics, said not all "metal-on-metal implants are the same and each should be evaluated on its own merits." Mr. Voorhorst didn't specifically mention the recalled ASR product and instead focused on another product. However, he said the company believes all patients with joint replacements need to be monitored.

Read more: http://www.foxbusiness.com/news/2012/06/27/fda-panel-discussing-safety-metal-on-metal-hip-implants/#ixzz1z3LUiUKx           LINK

J&J ignores FDA rules: women outraged!

J&J Sold Vaginal Mesh Implant After Sales Halt Ordered LINK

By David Voreacos and Alex Nussbaum on June 26, 2012  Bloomberg News

Manufacturers including J&J sold about $175 million worth of prolapse mesh worldwide and another $295 million for incontinence treatments in 2010, C.R. Bard executives estimated on a conference call that year. Even for top sellers of the devices, the products made up no more than 2 percent of company sales, said Michael Matson, a Mizuho Securities USA analyst in New York.

The numbers declined as lawsuits were filed, he said in a phone interview.

“The doctors aren’t implanting them,” Matson said. “The patients don’t want them.”

On June 5, J&J said it will stop selling four vaginal mesh implants including the Prolift. The move wasn’t a recall and J&J remains confident in the safety and effectiveness of the devices, Johnson said. The company will not withdraw the Prolift before its “planned discontinuation” of the mesh products over the next three to nine months, he said.

“Our decision to discontinue these products is based on their commercial viability in light of changing market dynamics,” he said.

16 Questions

In letters to state and federal judges, the company said that it will update labeling for one device, the Gynemesh, to allow only abdominal, not vaginal, insertion.

The FDA learned of the Prolift after J&J cited it in an application to sell a related device, the Prolift+M, Liscinsky said. The agency told J&J to file for the Prolift as well, and it combined the review for both devices before the August 2007 letter.

“Due to the complexity of this procedure and potential high risk for organ perforation, bench testing is not sufficient to demonstrate device safety and efficacy,” the FDA said in the letter. Bench testing refers to laboratory testing to determine how a device will function in a person.

In the August 2007 letter, the FDA asked 16 questions about the Gynemesh and Prolift, which are made of the same nonabsorbable polymer. The Prolift kit includes pre-shaped mesh and instruments to help surgeons implant the device.

Infection, Abscess

One FDA query was about a “significant number” of complications from 2004 to 2007 on the earlier device, the Gynemesh. The agency got 174 such reports, including for infection, abscess and organ perforation. Most of the cases required additional surgery.

The agency’s letter also found that labeling for the Prolift+M device was deficient because it couldn’t support claims that the mesh has “elastic properties that allow adaptation to physiological stresses.” In its response, J&J agreed to remove that claim.

Many of the documents unsealed last month include e-mails between J&J and the FDA over the wording of product labeling about the benefits and risks.

Six days before the FDA cleared the Prolift, J&J agreed in a written response to say in the label that the safety and effectiveness of the device, compared to conventional surgical repair without mesh, “have not been demonstrated in randomized controlled clinical trials.”

Rather, J&J wrote, the substantial equivalence to earlier approved devices had been demonstrated through other tests.

The federal cases are In re Ethicon Inc., Pelvic Repair System Products Liability Litigation, 12-md-2327, U.S. District Court, Southern District of West Virginia (Charleston).

To contact the reporters on this story: David Voreacos in Newark, New Jersey at dvoreacos@bloomberg.net; Alex Nussbaum in New York at Anussbaum1@bloomberg.net

To contact the editors responsible for this story: Michael Hytha at mhytha@bloomberg.net; Reg Gale at rgale5@bloomberg.ne

Comment by retrievethis (FiDA blog/Joleen Chambers)

I am outraged that Congress will not remove the legislative loophole that allows untested medical devices to be implanted in the human body and has removed citizen rights to justice by providing "cover" for the industry.  Congress also has withheld adequate funding for the FDA so that it is weak and filled with industry insiders who have little compassion for the patient harm that is produced.  Consumer beware!

Failed metal on metal hips: U.S. lab rats!

FDA probes safety issues with metal hip implants

By Matthew Perrone  Boston Globe

AP Health Writer / June 25, 2012  (FiDA blog bold)

WASHINGTON—Metal hip replacements implanted in a half-million Americans may be failing earlier than expected, but it could be years before U.S. health regulators have a clear picture of the problem.

The Food and Drug Administration holds a two-day meeting starting Wednesday to scrutinize the safety of metal-on-metal hip implants, following years of patient reports of pain and swelling that sometimes requires removal of the devices. It is a challenging, but familiar, predicament for the FDA: reviewing the safety of a device that was expected to be superior, but which may actually be more dangerous than what came before.

For decades nearly all orthopedic implants were made from plastic or ceramic. But in the last 10 years some surgeons began to favor implants made with metal stems and sockets. Laboratory tests suggested the devices would be more resistant to wear and reduce the chances of dislocation.

But recent data gathered by surgeons in the U.K. appears to show just the opposite.

In March, British experts at the world's largest artificial joint registry told doctors to stop using metal-on-metal hip replacements, citing an analysis showing they have to be replaced more often than other implants. Hip replacements are supposed to last between 10 to 15 years, but more than 6 percent of patients with metal hips needed them replaced after less than five years. That compared with just 2 percent of people who had ceramic or plastic joints. Both types of devices are prescribed for people suffering hip pain and limited movement due to arthritis or injury.

British regulators now recommend that people who have the implants get yearly blood tests to make sure no dangerous metals are seeping into their bodies as the components rub against each other.

The FDA has not made any recommendations of its own for the estimated 500,000 American patients with the devices.

FDA scientists say they want to consider all available information before making their recommendations -- not just the data from the U.K.

"Why look at a single registry when there's data from around the world?" said Dr. William Maisel, FDA's chief scientist for medical devices, in an interview with the Associated Press. "This is an opportunity for us to look at all the available information so that we can have a thoughtful conversation about what clinical recommendations can be made."

Maisel said the FDA is working to combine data from foreign countries and the U.S. to determine which groups of patients and implants are most problematic. On Wednesday and Thursday the FDA will ask a panel of experts to recommend the best practices for monitoring patients with the devices. Panelists will consider blood tests, medical imaging and laboratory tests.

But some U.S. orthopedic specialists say they have already reached their own conclusions about metal hips.

"In my personal opinion there is very little room, if any, for metal-on-metal implants because the alternatives we have on the market are likely safer and as effective," said Dr. Art Sedrakyan, professor of public health at Weill Cornell Medical College in New York.

The FDA's deliberative approach to tackling the hip implant issue is in some ways a necessity. Unlike other countries, the U.S. has no national registry to track the performance of implants over time.

The FDA received 16,800 negative event reports involving metal hips between 2000 and 2011, but regulators stress that number is not very useful. Many doctors do not report problems to the FDA, and the volume of reports is influenced by news reports on safety issues.

A registry set up by Minnesota's HealthEast Care System recorded four times as many replacement surgeries for patients with metal-on-metal hips as those with other implant types. However, a similar registry set up by health care provider Kaiser Permanente found no difference between the two groups.

With little definitive data on U.S. hip implants, the agency has asked manufacturers like Johnson & Johnson, Zimmer Holdings Inc. and Biomet Inc. to conduct long-term, follow-up studies of more than 100 metal-on-metal hips on the U.S. market.

FDA scientists say the studies will help "fill in the blanks" on a number of scientific questions, including the effects of metal particles that often seep into the bloodstream as the implants wear down.

But Sedrakyan and others say it could be a decade or more before that information is available. In a commentary published last week in the New England Journal of Medicine, Sedrakyan and two co-authors pointed out those studies must run at least eight years to return the information FDA is seeking. Based on the authors' analysis of FDA records, the FDA has reached agreements on the design of less than 25 percent of the studies, and it's unclear whether any of the studies have actually begun. The FDA notified the companies last May.

The prospect of safety findings arriving in eight or 10 years is little comfort to patients like Mary Weaver, 48, who had both hips replaced with a metal implant from Johnson & Johnson in 2007 and 2008. J&J recalled the ASR hip replacement in 2010, after reports that it was failing in some patients after only a few years of implantation.

Due to increasing pain and elevated metal levels in her blood, Weaver had both implants removed in 2011. She was let go from her job due to the time needed to undergo both surgeries, and is currently unemployed.

"I hope that no one has to go through this -- it's frustrating, it's emotionally draining," said Weaver, who lives in Mount Jackson, Va. "It's not just hard on you, it's hard on your whole family because your quality of life is not what it used to be."

Like 90 percent of medical devices sold in the U.S., most metal-on-metal hips were approved via the FDA's fast track program for medical devices. Under the so-called 510k system, the agency waives clinical testing requirements for devices which appear similar to others already in use. Since plastic and ceramic hip replacements had been on the market since the 1950s, most metal hip replacements were approved without new clinical testing.

"I am so furious they would use my wife as a lab rat, along with the other 500,000 people who don't have a clue what is happening," said Dwight Schrag, 69, of Bellevue, Wash. Schrag's wife Mary received J&J's ASR hip in 2006 and had it removed due to pain and other side effects in 2010. Schrag is one of a number of speakers who have signed up to speak during a public comment session at the FDA meeting.

It's not the first time the FDA's fast-track program for clearing devices has come under fire.

Last summer the Institute of Medicine said in a report that the FDA should abandon the 35-year-old system because it provides little assurance that the implants are actually safe. The Institute is composed of medical experts who advise the federal government.

Although the FDA itself requested the report from the Institute, agency officials rejected the group's conclusions, saying the 510k system works well for the vast majority of devices.

explanthis comment:   FiDA blog/Joleen Chambers
The profitable medical device industry has conflated justice so completely that the American citizenry blindly pays for the #1 expenditure of Medicare:  joint replacements.  The industry has so many entitlements:  no warranty on product, no clinical testing, no national registry, no need to report adverse events, pre-emption in state court because of FDA, no compensation to victims of failed products without a David/Goliath courtroom battle and unrestricted direct-to-consumer marketing.  Even with all these advantages, the industry fights a tax that would help fund the FDA/CDRH.  Do they not have faith that they can make $$ and produce a safe and effective product?  Consumer beware!

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