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

Friday, March 27, 2015

"one of the worst offenders" orthopedic surgery overuse . . .



Orthopedists' Financial Conflicts Can Hurt Patients, Surgeon Says

Cheryl Clark, for HealthLeaders Media , March 17, 2015  FiDA highlight added

It is financially compelling for many doctors to do things that aren't really going to help their patients, says an orthopedist who is leading a campaign against surgical overuse.
Financial conflicts of interest often drive physicians to perform worthless surgeries, but the field of orthopedics "is one of the worst offenders," says an Indiana orthopedist who has launched a "moral persuasion" campaign to persuade his colleagues to stop.
"It's really hard for doctors to acknowledge this and change their ways," says James Rickert, MD, who years ago founded the Society for Patient Centered Orthopedic Surgery to address the problem.
It's especially tough for doctors who own related businesses that depend on surgical volume, which puts even more pressure on them to "be more like businessmen instead of doctors," he says.
A lot of orthopedic surgeons "own part of the distributorships that sell the total hip or knee implants to the hospital, and they'll make a ton of money on that. Or they own the imaging center they send their patients to. They own a piece of the surgical center. They know if they're not doing a lot of surgery, they may lose money on their overhead," Rickert says.
A series of four reports from the Government Accountability Office documents greater numbers of procedures referred by physicians who own providing businesses, compared to referrals from non-owners.
"That makes it really compelling for doctors to do things that aren't really going to help their patients. They become more like salesmen, saying things like, 'Well, it might help.' Or, 'We don't have much to lose, let's try it,' knowing full well the data shows there's very little chance the procedure will help and some evidence the patient could be hurt."
Rickert has long been aware of surgical overuse, including his own. But he didn't work hard to stop it until he himself got sick. He was diagnosed with non-Hodgkin Lymphoma at age 42, underwent chemotherapy, bone marrow, and stem cell transplants, recurrences, and foul-ups in his care. Now 54, he's been cancer free for five years. 
"I was accessing the system every day for months as a very sick person, having a lot of problems. I started to think about patient-centered care expectations and how different that is from reality."
As he got better and returned to his Bloomington practice, he founded the society to appeal to surgeons' consciences. So far, 14 fellow orthopedists have joined his effort.

Performing unnecessary surgeries, he says, "is not [necessarily] below the standard of care. For example, the doctor can usually say, 'Hey, he had a torn medial meniscus and here's an MRI that proves it,' even though it was not the right thing for a severely arthritic patient."
"I certainly have a lot of patients referred to me from nearby. And when I look at the surgery and pathology they had, I just know that there was no way that doctor really thought that was going to help them."
At the Lown Institute conference in San Diego last week Rickert described one of many sad cases. Two decades after performing a successful knee scope on a patient, the now severely arthritic patient returned, seeking another scope. Rickert advised that it would not help and could cause problems.
The patient went to another orthopedist and had the procedure. This surgeon thought the worst that would happen would be the patient wouldn't be any better, but would at least be satisfied that the doctor had tried to help. "Instead, the patient gets a deep vein thrombosis that turns into a pulmonary embolism, and two days later he's dead," Rickert says.   
For doctors, it's like an inside secret, he says. "We know about these risks, but the patients don't."
Rickert and some of his colleagues also criticize the American Academy of Orthopedic Surgeons' Choosing Wisely list of five procedures doctors and patients should avoid. None on the academy's current list is especially common or very important, Rickert says. 
Kevin Bozic, MD, chair of the AAOS Council on Research and Quality, said via email that the Choosing Wisely list was created from systematic reviews of the literature and is limited to available evidence that various treatment options for musculoskeletal conditions are effective, "which we are seeking to improve." AAOS is working to define appropriateness criteria incorporating patient preferences and values into medical decision-making, he said. Since it submitted its list of five practice guidelines in 2012, AAOS has published four more to be reviewed for possible inclusion in a second Choosing Wisely list.
At the conference, Rickert and Rob Rutherford, MD, an orthopedic surgeon from Coeur d'Alene, ID, presented what they say is a more relevant list of procedures that are frequently performed, usually unnecessary, high cost, and sometimes harmful:
1. Vertebroplasty
Cost: $10,000
 
The percutaneous injection of cement into a fractured vertebra. The procedure, done in about 100,000 patients a year, is falsely marketed as relieving pain quickly. But in clinical trials, pain relief was similar to that seen in patients who underwent sham surgery. The procedure's risks include compression fractures in adjacent vertebrae, dural tears, infections, cement migration, and nerve pain that requires subsequent surgery.

2. Rotator Cuff Repairs in Elderly Patients
Cost: $15,000
About 600,000 such surgeries are performed in the U.S. each year. The number of surgeries increased by 141% between 1996 and 2006. This surgery is vastly overused on patients who are asymptomatic. Complications include infection, bleeding, re-rupture of the rotator cuff, nerve damage, blood clots, and the need for repeat surgery to correct the first procedure.
3. Clavicle fracture repair or "plating" in adolescents
Cost: $13,000
This procedure is performed in a small percentage of adolescents each year to improve function. "I don't know of any good indication, especially with conservative care being so successful" and rarely does the surgery benefit, Rickert says.  

Regardless of patient age, type of sport, and final clavicle shortening, there's no differences in pain, strength, or range of motion. But there is a risk of deep infections, pneumothorax, and other complications. 
4. Anterior Cruciate Ligament Tear Repair in Low-Risk individuals
Cost: $10,000
ACL surgeries are performed in 100,000 patients a year and carry high risks but demonstrate no difference in rates of return to pivoting-activity sports one year later than conservative rehabilitation and activity modification. Complications include infection, instability, stiffness, pain, patellar fracture and growth plate injury in children.
5. Surgical Removal of Part of a Torn Meniscus 
Cost: $6,000
Annually, this surgery is performed in 700,000 patients with knee arthritis and no mechanical symptoms. But it does not provide significant benefit compared with sham surgery in patients with degenerative meniscal tears. There's equal pain relief and functional status.
Rickert, who is on the faculty of the Indiana University School of Medicine, emphasizes that IU Health has a policy forbidding its doctors from accepting money or gifts from the pharmaceutical or medical device industries.
He says his specific orthopedic group does not own an MRI or an orthopedic surgery center. And he acknowledges that he gets "e-mails and grouchy comments from doctors [at other organizations] who want me to not do this [campaign]."  
"There's still a lot of resistance from entrenched interests. But we have to show doctors the data, studies that show this doesn't work, and then ask, 'why are we still doing this?' We have to confront them with the data."

Cheryl Clark is senior quality editor and California correspondent for HealthLeaders Media. She is a member of the Association of Health Care Journalists. 

Tuesday, March 24, 2015

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

Saturday, March 21, 2015

Harm by "innovation" and irrational exuberance: a home grown threat.


“Irrational Exuberance”: A homegrown threat to our nation’s health



Hooman Noorchashm, M.D., Ph.D. and Amy Reed, M.D., Ph.D.
Check Up
Posted: Friday, March 20, 2015, 9:56 AM FiDA highlight added


Our prevailing model of medical progress, innovation and research centers on the concept of "benefit". Doctors, in both academic and corporate medicine, are focused on developing novel therapies to benefit our patients beyond the existent standards of care. This noble intent has evolved from our profession's desire to heal our patients and to create a healthy society.
Once the benefit of a novel approach is either demonstrated (or agreed upon) by expert consensus, new standards of care are established and funded by our health insurance infrastructure. This is the awesome power of American healthcare and our insurance infrastructure in the 21st century.
However, a very serious and insidious deficit also plagues our optimistic, "benefit-oriented" outlook on innovation and progress in corporate medicine. We do not always place sufficient emphasis on the concept of "harm". That is, in our quest to save lives and innovate, the cost to those who do not benefit is often disregarded or minimized.
We do not focus enough on whether the harm brought about by our 'beneficial advances' could have been avoided - nor do we evaluate the tangible and intangible costs of advancement when we construct our new standards of care.



This tendency to downplay the harm done by innovation, in favor of marketing real or perceived benefit, has turned our healthcare establishment into a self-congratulatory and “irrationally exuberant” one.
So on the backs of those harmed without consideration, we may be on an “irrationally exuberant” path to financial and spiritual ruin in medicine, despite our best intentions. Our financial markets have demonstrated this phenomenon repeatedly over the past three decades in America. As it is said, "the road to hell is paved with good intentions".
Of course, this irrational exuberance in American medicine stands to be dramatically worsened by medicine's corporate nature today. After all there is a lot of money to be made in saving lives. And our health insurance infrastructure is designed to pay for benefit-driven, "life-saving" interventions. Most individuals are willing to pay a high price for the promise of staying alive - no one wants to die.
Of course, our corporations capitalize on this fact. They market and advertise increasingly sophisticated, expensive and "beneficial" therapies. The harm done and its cost is not part of the corporate marketing label - at best, it is a footnote and at worst it is censored.
Corporate forces in medicine are only too willing to use the banner of benefit and safety to acquire revenue and profit. And when there is money to be made, dwelling on the cost of harm, especially if it is to a minority subset of patients, is downplayed and even ridiculed - because it gets in the way of lucrative business and cash flow.
Most tragically, our federal government, whose responsibility it is to protect the forgotten minority of people in harm’s way, seems to have lost its existential purpose. Congress, and our public health agencies, are increasingly influenced by corporate lobby power and special interest groups – not patients and their advocates. Because most of those harmed go home, go bankrupt or die – they very certainly do not lobby lawmakers and federal agencies in any effective manner. And while healthy, most people never imagine themselves being in harm’s way. So not enough people rally behind solid patient safety initiatives and legislative actions proposed by cogent politicians.
Instead of being true to their constitutional mission to protect every American citizen from harm, our federal public health agencies, notably the FDA, have accepted corporate America as being an equal stake-holder to individual citizens and residents of our land. This is a massive regulatory error that has resulted in very notable failures – and these will recur until citizens and legislators of reason and courage drive necessary improvements to our flailing federal system.
As a prominent example, the 510(k) legislation governing approval of the majority of medical devices by the United States Food and Drug Administration does not require any definitive pre-market safety testing and it provides no consistent “risk assessment” mechanism; nor does 510(k) definitively require active surveillance or consistent reporting of adverse outcomes by doctors, hospitals or manufacturers to FDA.
Of course most Americans find these lax safety standards in the medical device industry hard to believe. Some even think our critique is too much of a "blanket statement" about a very complex regulatory process. But it really is that simple: corporate forces have breached the FDA and have deviated its public health and patient safety mission in the medical device space. Most citizens have no idea that this is the case. In fact, most of us trust that our government and our healthcare establishment is there to protect us from harm – but that is simply not a guarantee, especially on issues and practices that are not clearly in the public eye.
Unless, as patients and doctors, we shed our irrational exuberance about medical benefit and the infallibility of our healthcare establishment, and instead empathetically focus on the possibility of harm and its systemic and personal costs…Unless, as citizens, we demand that our federal government realign itself with the people’s interests instead of corporate and special interests…we will continue to accept the unacceptable from the medical establishment and from our federal government.
We may even manage to drive our society’s health and healthcare establishment into irrecoverable bankruptcy - both financial and ethical.

Hooman Noorchashm and Amy Reed, husband-and-wife physicians, have campaigned to ban electric morcellators since December 2013, soon after Reed’s unsuspected uterine cancer was spread by the device during a routine hysterectomy.



Read more at http://www.philly.com/philly/blogs/healthcare/Irrational-Exuberance-A-home-grown-threat-to-our-nations-health.html#FtrFfIsWqQMVcurX.99



Read more at http://www.philly.com/philly/blogs/healthcare/Irrational-Exuberance-A-home-grown-threat-to-our-nations-health.html#qfiOq2L7FXx8VkU7.99

Friday, March 20, 2015

Bribery, probation, corporate recidivism: Biomet medical device giant.

New Bribery Evidence Adds a Year to Biomet’s Probation

By BEN PROTESS   MARCH 17, 2015  FiDA highlight
Life was supposed to return to normal for Biomet, the giant medical devices manufacturer accused of foreign bribery, when its federal probation expired next week. But on Tuesday, Biomet disclosed that prosecutors would extend its probation another year as they investigate new evidence of wrongdoing at the company, the Justice Department’s latest attempt to stem a widening pattern of corporate recidivism.
The Justice Department is investigating whether Biomet helped bribe government officials in Mexico and Brazil, a painful reminder of an earlier bribery case that Biomet settled in 2012. To resolve the first case, Biomet paid $17 million and struck a so-called deferred prosecution agreement that withheld criminal charges as long as the company behaved during three years of probation.

The disclosure that the Justice Department will extend that agreement — and keep an independent monitor installed at the company — amounts to a double-edged sword for the company. The foreign bribery investigation has loomed over Biomet’s $13.35 billion merger with its rival Zimmer Holdings, raising concerns that criminal charges for Biomet could prompt Zimmer to reconsider.
The Justice Department’s decision to extend the deferred-prosecution agreement, rather than rush out a new criminal case, suggests that the merger appears poised to close.
But the Justice Department’s action also signals that prosecutors consider the new evidence troubling enough that a fuller investigation is warranted, a blemish on Biomet’s reputation whatever the outcome of the case. And the extension of the deferred-prosecution agreement, known as a D.P.A., props open the door for prosecutors, once their investigation is complete, to bring a new round of penalties.
“The D.O.J. has informed Biomet that it retains its rights under the D.P.A. to bring further action against Biomet relating to the conduct in Brazil and Mexico,” the company disclosed in a regulatory filing late Tuesday, adding, “The D.O.J. could, among other things, revoke the D.P.A. or prosecute Biomet and/or the involved employees and executives.
The Biomet case reflects a subtle yet significant shift in the Justice Department’s strategy for combating corporate repeat offenders. Grappling with repeat offenses on Wall Street and across the corporate world, the Justice Department’s criminal division is exploring a different approach, beginning with the extension of some prominent deferred-prosecution agreements.
Biomet is the latest company to have its agreement extended. Last year, the Justice Department added three years to an agreement with Standard Chartered, the big British bank accused of doing business with Iran. And as evidence mounted that banks were colluding to fix the price of foreign currencies, prosecutors extended earlier nonprosecution agreements with Barclays and UBS over their manipulation of interest rates.
The extensions are hardly the harshest option, and critics will most likely argue that anything short of an indictment is a slap on the wrist. Yet the extensions are not intended as the government’s final say on a case but rather a warning to the company and a chance to gain time for prosecutors.




“Make no mistake: The criminal division will not hesitate to tear up a D.P.A. or N.P.A. and file criminal charges where such action is appropriate and proportional to the breach,” Leslie R. Caldwell, head of the Justice Department’s criminal division, said in a speech on Monday. “Just like an individual on probation faces a range of potential consequences for a violation, so, too, does a bank that is subject to a D.P.A.”
In the speech, Ms. Caldwell outlined her policy on repeat offenders in significant new detail. Noting that “we have a range of tools at our disposal,” she said the Justice Department could extend the term of a deferred-prosecution agreement while prosecutors investigate “allegations of new criminal conduct.” And when a breach has occurred, she said, “we can impose an additional monetary penalty” and “most significantly, we can pursue charges based on the conduct covered by the agreement itself — the very conduct that the bank had tried to resolve.”
The ultimate outcome of the Biomet case is unclear.
According to lawyers briefed on the matter, the Justice Department has discussed the possibility of reaching a new deferred-prosecution agreement with Biomet. With that idea, which was preliminary and may change now that prosecutors are extending the original D.P.A., the prosecutors might impose criminal charges on Biomet’s Brazilian and Mexican subsidiaries and any employees at the center of the bribery case.
The problems came to light through an email from an anonymous whistle-blower who reported that distributors Biomet had hired to sell its orthopedic devices were “paying kickbacks” to government doctors. The company disclosed the email to the government, opened an internal investigation and ultimately fired employees viewed as culpable.
Biomet also disclosed the thrust of its problems to Zimmer before striking the merger. And Zimmer, which agreed to pay $13 billion to Goldman Sachs and a handful of private equity firms that own Biomet, showed no sign of backing away.

The deal is expected to close this month or in early April.

Thursday, March 19, 2015

Is your legislator on "the list"? Patient safety at risk by political lobby $$$.

Who are medtech's favorites in Congress?

March 17, 2015 by Brad Perriello  FiDA Highlight
Republicans, mostly, as the GOP got the lion's share of the more than $4.5 million in donations the medical device industry gave legislators last year, according to OpenSecrets.org.

The medical device industry doled out more than $4.5 million to legislators on Capitol Hill last year, with most of the donations going to Republicans and incumbents, according to the Center for Responsive Politics' OpenSecrets.org website.
Senators and representatives from the Grand Old Party received more than $2.7 million from medtech last year, compared with just more than $1.8 million for Democrats (and just $2,000 for "others"), according to the nonpartisan website.

Incumbents also took in more than 1st-time candidates, pulling in $4.0 million of the total donated. 
In the U.S. House of Representatives, 158 Republicans received an average contribution of $10,625, compared with an average of $6,842 sent to some 140 Democratic representatives (and no independents). 

Democrats did better in the Upper Chamber, with 41 receiving an average of $17,460, compared with 37 Republicans who got an average of $16,896 from medtech's coffers, according to the website.

Not surprisingly, Rep. Erik Paulsen (R-Minn.) received the most from the medical device industry in 2014, at $93,049. Paulsen has long been a friend to the sizeable medtech cluster in the North Star State and has spearheaded efforts in the House to repeal the medical device tax. He's the lead sponsor of H.R. 160, the "Protect Medical Innovation Act of 2015."
Interestingly, another medical device stalwart, Sen. Orrin Hatch (R-Utah), does not appear on the list of the top 20 recipients of medtech's largesse. Hatch is the sponsor of the Senate's companion bill for repealing the medical device tax, S. 149 or the "Medical Device Access & Innovation Protection Act."

Here's a look at that top 20 list, from both the House and Senate and whether they've signed on to the medtech tax repeal bills in their respective chambers:


Rep. Erik Paulsen (R-Minn.)
$93,049
sponsor of HR 160
Sen. Mitch McConnell (R-Ky.)
$86,323
has not signed S 149
Sen. Ed Markey (D-Mass.)
$76,100
has not signed HR 160
Sen. Kay Hagan (D-N.C.)
$73,761
did not win reelection
Sen. John Cornyn (R-Texas)
$64,950
has not signed S 149
Sen. Ron Wyden (D-Ore.)
$63,150
has not signed S 149
Rep. Ron Kind (D-Wis.)
$59,900
has signed HR 160
Sen. Lamar Alexander (R-Tenn.)
$58,500
has signed S 149
Rep. John Boehner (R-Ohio)
$56,100
has not signed HR 160
Sen. Rob Portman (R-Ohio)
$53,949
has not signed S 149
Sen. Al Franken (D-Minn.)
$49,199
has not signed S 149
Rep. Anna Eshoo (D-Calif.)
$48,909
has not signed HR 160
Rep. Fred Upton (R-Mich.)
$48,750
has signed HR 160
Ryan, Paul (R-WI)
$43,197
has not signed HR 160
Sen. Amy Klobuchar (D-Minn.)
$41,900
has signed S 149
Rep. Marsha Blackburn (R-Tenn.)
$40,100
has signed HR 160
Rep. David Joyce (R-Ohio)
$37,700
has signed HR 160
Rep. Tim Scott (R-S.C.)
$37,300
has not signed HR 160
Rep. Kevin McCarthy (R-Calif.)
$37,000
has not signed HR 160
Sen. Joe Donnelly (D-Ind.)
$35,900
has signed S 149

Friday, March 6, 2015

Johnson and Johnson Legacy: public drugging and shoddy products.



Happy Birthday RW Johnson! A Legacy

Friday, 20 February 2015 10:38 
By Kathleen Sharp, Truthout | News Analysis
Today (February 20) is the 170th birthday of one of history's most influential drug salesmen, Robert Wood Johnson, co-founder of the health-care giant Johnson & Johnson.
This event comes on the heels of decades of fraud and injury claims against J&J, along with billion-dollar payouts. It's not as if J&J is alone: Virtually every pharmaceutical firm has been probed, sued and fined for fraud and wrongful death cases. Indeed, there is growing evidence that many modern drugs obtained regulatory approval based on faulty "scientific" and "optimistic" studies conducted by their manufacturers.
A quick review of the life of RWJ makes one realize that the dodgy origins of the pharmaceutical business are, a century and a half later, still with us.
To be fair, RWJ didn't actually start J&J. His younger brothers, James and Edward, formed the firm after seeing a huge demand for pain relief and energy concoctions. The brothers had worked as medicinal "travelers" in the antebellum days, selling bottles and tinctures from the back of a wagon or a train. It was the 1880s, an era of patented "medicines," whose secret ingredients often included morphine, opium and 40-proof alcohol. The Johnsons knew there was money to be made in such hokum, but they weren't cut out for sales. Mild-mannered and middle-aged, they had failed at other businesses and had little to show for their long hours on the road. Then, they spied an abandoned factory on the banks of New Jersey's Raritan River. Borrowing $1,000, they moved into the top floor of a former wallpaper factory, and, in February of 1886, started manufacturing medicinal plasters.
But they were no match for their snake-oil competitors. Johnson & Co., as it was then called, floundered for months until big brother Robert stepped in. He'd been working as a wholesale druggist and was a brash businessman, with Wall Street ties and investments. That autumn, he took control of the company, infused it with $100,000 (equivalent to about $2 million today) and started to "borrow" liberally from the ideas of Joseph Lister, a famous British surgeon who believed that airborne germs were "invisible assassins" and who advocated sterilizing surgical instruments.
RWJ never signed a licensing agreement with the doctor, but he slapped Lister's name on many of his products, from fumigators and plasters to even dog soap. Wily Robert also slashed prices lower than that of his scrappiest rival. As he told one salesman: "We have concluded to stick the knife right into the bowels of the plaster business." And he did.
At the turn of the 20th century, the average American apparently needed extra vigor and pain relief, symptoms of toiling six or seven days a week for robber barons. Many a shrewd "traveler" promised a quick fix: The Wyeth brothers sold Sun Opium Tablets; Mr. Bayer unrolled the Heroin Cough Suppressant and Parke & Davis pushed their patented Cocaine Injection Kit.
To keep pace, RWJ imported Tasmanian poppies and 100,000 pounds of belladonna a year, so much belladonna, that he decided to grow the exotic plant himself. He advertised his "extra high grade" of plant, which he sold only to J&J "friends" at the "highest prices in the world," $2 a pound, with a limit of three jars a friend. From the first day of business, horses and wagons lined up at Johnson's Bellevue Farm to cart away as much of the dangerous nightshade as their drivers could stomach, according to a company-approved biography. Sales of belladonna liver poultices and "female remedies" boomed.
But RJW's genius was hiring a clever apothecary and ad man, Fred Kilmer. Kilmer wrote effusive, sometimes fictitious, claims about J&J products. He called himself a doctor, stole the distinctive Red Cross brand from its founder Clara Barton and published a newsletter called the Red Cross Messenger. In it, "Dr. Kilmer" advertised new J&J products such as Vino Kolafra, an invigorating mix of cola nuts and cheap sherry. Upon experimenting with it, Dr. Kilmer recommended the stimulant for bicyclists on long runs and for doctors making late-night collections.
But an alarming number of people fell sick from these concoctions. Young mothers grew ill from the belladonna "remedies;" husbands hid their flasks of heroin-laced medicine; children grew addicted to spiked sarsaparilla and babies died after ingesting opium cough syrups.
In 1905, finally, Collier's Weekly magazine published a muckraking piece that exposed the industry's chicanery in all its sordid details. "Legislation is the most obvious remedy," Samuel Hopkins Adams wrote, and the series so outraged the public, Congress passed the first federal drug law. The Pure Food and Drug Act of 1906 banned the manufacture and sale of poisonous patent medicines, but alas, the law had no teeth. Narcotic cures and dangerous substances continued to fly out of J&J warehouses.
Even so, the press had put America's "public druggers" such as J&J on notice. More deaths triggered a 1912 law that required all drug makers to list the contents of their products on the labels­­­­, a requirement that remains to this day. In 1938, Congress passed the Food, Drug, and Cosmetic Act ,which finally put some bite into consumer protection laws. Uncle Sam could now seize any drug it suspected of being dangerous, and, soon, over-the-counter opium tablets and cocaine vino went the way of hoop skirts and buggy whips. For the first time in US history, the burden of proof of a medicine's safety shifted to its manufacturers, and evidence-based scientific studies became the rule.
For 50 years, these laws helped usher in a string of life-saving treatments, which were supported by real science; medicines such as penicillin; an antibiotic for tuberculosis; and vaccines against polio, measles and mumps. Rather than hurt the drugmakers, regulations actually helped them. J&J, Merck and Parke-Davis (now called Pfizer) produced so many innovative products that profits boomed and people respected these brands. J&J, for one, became one of the most admired companies in the world.
By the late 1980s, however, drug companies became too dominant, and US regulators lost clout. J&J and its rivals began engaging in fraud and shoddy practices, according to dozens of lawsuits and federal plea deals. The US Food and Drug Administration (FDA) launched multiple investigations of J&J, tied to its illegal marketing and advertising ploys, and the relatives of deceased loved ones have sued the firm for its dangerous, lethal products.
For example, Natrecor was approved for acute heart failure, but J&J marketed it for chronic heart conditions, despite its severe side effects.  J&J's Ortho Evra birth control patch contained dangerously high levels of estrogen and was 12 times more likely to cause strokes than birth control pills. The poorly tested patch killed healthy young women, according to dozens of suits.
During the aughts, tens of thousands of kids were given J&J's antipsychotic Risperdal, sometimes illegally, which caused teenage boys to grow breasts, girls to gain weight, and many to contract diabetes. Even so, J&J continued pushing the drug illegally by telling their sales force to "butter up doctors" with free golf trips and bags of "Risperdal Popcorn," according to one former employee



An Articular Surface Replacement or A.S.R., all-metal artificial hip device made by the DePuy orthopedics unit of Johnson & Johnson, that was removed from a patient, March 31, 2010. A jury in Los Angeles on March 8, 2013 ordered Johnson & Johnson to pay more than $8.3 million in damages to a Montana man in the first of more than 10,000 lawsuits pending against the medical products maker in connection with the now-recalled artificial hip all-metal device. (Joshua Borough/The New York Times)

Faulty hip replacement systems,  risky blood boosters, Rolaids heartburn products with metal particles inside,  tainted Children's Tylenol . . .   Even Baby Shampoo at one point was found to have had carcinogenic chemicals.  It's as if a century after RJW's glory days, a whiff of hucksterism still trails J&J like sawdust at a traveling medicine show.
Earlier this year, Science News published a story about how too many pharmaceutical company drug studies cannot be replicated when tested by independent scientists. Randomized controlled clinical trials have long been the gold standard for evaluating medicine, but when you can't replicate these studies in independent settings, you might as well sell sugar pills. "There's a community sense that this is a growing problem," Lawrence Tabak, deputy director of the National Institutes of Health told the magazine.

It's as if RWJ is still running the world's biggest health-care company.

Thursday, March 5, 2015

Jury Verdict: Johnson and Johnson to pay for 'malice' toward patient.


UPDATE 2-Johnson & Johnson ordered to pay $5.7M in California mesh trial

Thu Mar 5, 2015 4:04pm EST

By Jessica Dye
(Reuters) - A California jury on Thursday ordered Johnson & Johnson's Ethicon Inc unit to pay $5.7 million in the first trial over injuries blamed on the TVT Abbrevo, one of numerous transvaginal mesh products that are the subject of thousands of lawsuits.
Following more than three days of deliberations in Kern County, California, jurors found Ethicon liable for problems with the TVT Abbrevo's design and for failing to warn about its risks, according to a lawyer for plaintiff Coleen Perry.
Perry was awarded $700,000 in compensatory damages and an additional $5 million in punitive damages after jurors in the Bakersfield court found Ethicon's conduct amounted to "malice," her lawyer said.
The verdict is the fourth win for plaintiffs suing Ethicon over transvaginal mesh. More than 36,000 lawsuits have been filed against Ethicon in state and federal courts over the devices, which are used to treat stress urinary incontinence and pelvic organ prolapse.
The Abbrevo, one of Ethicon's newer models of mesh products, was cleared for sale by the U.S. Food and Drug Administration in 2010 to treat stress urinary incontinence. Perry, who was implanted with it in 2011, said she began experiencing a "pulling-type" pain almost immediately after surgery.
Perry said the mesh began to erode in her body, causing pain that she said she expects to last the rest of her life, according to testimony Reuters saw on Courtroom View Network.
Ethicon's lawyers said the product was thoroughly vetted before it hit the market and that doctors considered the mesh used in the Abbrevo to be the "gold standard" for incontinence treatment.
Peter de la Cerda, a lawyer for Perry, said the verdict sent a "clear message to Ethicon" about its "improper conduct in designing and marketing the Abbrevo."
Ethicon spokesman Matthew Johnson said the company believed it has strong grounds for appeal. Ethicon stands behind the safety and effectiveness of the Abbrevo, as well as its development and marketing, he added.
Ethicon won one trial over mesh in federal court in West Virginia, where another trial over its mesh products started on Monday.
Ethicon, Boston Scientific Corp and C.R. Bard are among seven companies facing more than 70,000 mesh injury lawsuits in federal court and thousands of additional cases in state courts.

The case is Perry et al v. Luu et al, Superior Court of the State of California, Kern County, No. 5-1500-CV-279123. (Reporting by Jessica Dye in New York; editing by Chris Reese, Alexia Garamfalvi and Lisa Von Ahn)