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 29, 2013

Gummy Bear Breast Implants




February 22, 2013 Written by Diana Zuckerman  FiDA highlight
Do you like your body?   If there was a simple way to change it, with no risks, would you do it?
If making that change meant you would put your health at risk and have multiple surgeries for the rest of your life, would you hesitate?
Most women say they don’t like their bodies, and research shows that dissatisfaction usually starts during the middle school years and may never go away.  For many of us, it eases up a little in young adulthood as we come to appreciate our attributes and accept any “flaws,” but insecurities rev up again as aging takes its toll.  It seems ironic that we long to regain the body that seemed so imperfect when we were younger.
In the U.S., there are thousands of products and procedures that feed on women’s insecuritiesMost are ineffective – the pills and products that promise to melt fat away without diet or exercise, or to make cellulite or wrinkles disappear.  But only a few are actually dangerous to our healthBreast implants are one of those.
The FDA just approved a new kind of breast implant, which many plastic surgeons promise will be safer and better than other kinds of breast implants.  It is made of thick silicone gel (nicknamed “gummy bear implants” for its consistency), which is supposed to prevent it from breaking, leaking, or wrecking havoc with your body.
What’s the proof that this product is safer, or even safe at all?  Apparently, that’s a secret.
When breast implants were first sold in the U.S. in the 1960s, no testing was required to make sure they were safe.  For the next 30 years, more than a million women in the U.S. got breast implants, not realizing that studies on women had never been done to prove they were safe or to determine how many months or years they would last.
In 1990, I was working as an investigator in the U.S. House of Representatives when a Senate staffer called me.  She told me that her mom had gotten breast implants after a mastectomy, which had resulted in terrible problems including silicone leaking out of her nipples.  Her mom was cured of cancer but the implants had put her through hell.  I was sure that the FDA had very strict rules about safety testing, but I promised I’d look into it.
I found out that I was wrong: the FDA had never required clinical trials for breast implants.  We held a Congressional hearing, I continued my investigation, and soon my office – and the media – was full of horror stories about women whose health had been ruined by breast implants.
Thanks to Congressional and media pressure, the FDA changed their policies.  They eventually required breast implant companies to conduct studies on hundreds of women with breast implants, to find out how safe their products were.  Public meetings were held so that women could testify about their experiences, scientists could openly discuss the research, and the media could report what was said.  Some companies failed to do the newly required research and their implants were no longer allowed to be sold in the U.S.  And, although all breast implants were found to have high complication rates, the FDA, under tremendous pressure from implant companies and plastic surgeons, decided that women were capable of making an informed choice about the risks they were willing to take.
I have no doubt that women are capable of making an informed choice.  But the FDA is still not providing the full information that women need to make an informed choice, and neither are the plastic surgeons.
In a giant step backwards, some FDA officials are reverting to their old ways.  They approved “gummy bear” implants with no public meeting and they have not made the study findings public.  Instead, in a press release that the agency quietly released on February 20, they report that the new breast implants have the same kind of complications as other types of implants – such as hard, painful, or lopsided breasts and the need for additional surgery – but don’t say how often those complications occur.  They also reported a new complication: the silicone gel in these new implants can crack.  What happens to women when that happens?  The FDA isn’t saying.
Since I did my investigation in 1990, I have been one of the FDA’s strongest critics and biggest fans.  I have often been horrified by some of the decisions FDA makes to approve unsafe or inadequately tested medical products, but I also know that when the FDA does its job well, it can save millions of lives.
When I did the Congressional hearing on breast implants, I was 7 months pregnant.  My son is now a college senior.  In those 22 years, the FDA regained and is now again at risk of weakening its public health focus, as Congressional pressure on the FDA to protect patients has been replaced by Congressional pressure to get products to market as quickly as possible and thus “create jobs.”  Whether it is breast implants, riskier birth control pills, TB drugs that do more harm than good, or sleeping pills with questionable benefits, the FDA is allowing drugs to be sold that do a lot of harm.  And when the FDA fails to hold medical products to a high standard, it is women – the consumers of most medical products – who are harmed the most.
For more information about the FDA’s recent decision on Allergan breast implants, see Statement of Dr. Diana Zuckerman on FDA approval of new Silicone-Gel Breast Implant Natrelle 410 and for more information about the risks of breast implants, see www.breastimplantinfo.org
Diana Zuckerman is the president of the National Research Center for Women & Families. She received her PhD in psychology from Ohio State University and was a post-doctoral fellow in epidemiology and public health at Yale Medical School.  After serving on the faculty of Vassar and Yale and as a researcher at Harvard, Dr. Zuckerman spent a dozen years as a health policy expert in the U.S. Congress and a senior policy adviser in the Clinton White House.  She is the author of five books, several book chapters, and dozens of articles in medical and academic journals, and in newspapers across the country.


Thursday, March 28, 2013

Report doctors with fraudulent medical device investments.

https://oig.hhs.gov/fraud/docs/alertsandbulletins/2013/POD_Special_Fraud_Alert.pdf



The Health and Human Services Inspector General’s office issued a fraud alert Tuesday, warning consumers and medical professionals about physician-owned groups that get kickbacks from medical device companies in exchange for pushing the devices on to patients.
The warning doesn’t name names but says these so-called physician-owned distributorships “produce substantial fraud and abuse risk and pose dangers to patient safety.” In particular, the warning addresses implantable devices used in procedures either at hospitals or ambulatory surgical centers.
Of concern is whether patients get inappropriate medical referrals or recommendations influenced by financial incentives. Such practices violate the Social Security Act, which prohibits doctors to recommend devices for any Medicare or Medicaid program where they would get reimbursed. Further, regulators don’t believe disclosure by the doctor is enough, since it’s often used as an added incentive for patients to use a particular product or facility.
You can read the full warning here.
Follow Russ Britt on Twitter @russbrittmktw
Follow Health Exchange blog on Twitter @MWHealthBlog

Wednesday, March 27, 2013

Patients Deserve to Know: Medical Device Ownership




Posted: March 26, 2013 - 12:30 pm ET      FiDA highlight

Doctors who hold part ownership in medical device companies, beware: people in HHS' inspector general's office are watching you. And they don't like what they see.

The inspector general's office published a special fraud alert Tuesday (PDF) on the rapidly growing phenomenon of physician-owned distributorships, or PODs, saying, “OIG views PODs as inherently suspect under the anti-kickback statute.”

The office is already investigating physicians who hold ownership stakes in spinal-implant businesses, and whether those doctors practice at hospitals whose Medicare patients receive a higher-than-average proportion of spinal-fusion procedures. That case may also widen to include doctors with stakes in cardiac-device makers, the office's 2013 work plan says.

The alert follows a letter from five bipartisan members of the Senate Finance Committee in June 2011 (PDF) that said a Senate investigation had turned up evidence physicians were being pressured into taking on lucrative ownerships in device companies because of a dearth of federal rules on the topic left it open to abuse.

Under federal law, it may be legal for a surgeon to hold shares in a company that manufactures devices that the doctor prescribes for his patients, even if it's a small company that manufactures a product not widely used outside of the hospital where the doctor practices. But such arrangements are risky and easy to abuse, the alert says.

Medicare's Anti Kickback law makes such arrangements illegal if even one of the doctors' motives in prescribing devices he has ownership in is personal profit. Those risks are particularly acute, the alert says, for physicians who own stock in companies that make surgically implanted medical devices, because hospitals typically listen to doctors' preferences when making purchasing decisions about those devices.

In figuring whether a particular arrangement may be illegal, the inspector general considers, among other factors, whether the profits gained from device-maker ownership are out of proportion to a small investment by the doctor; whether the price of the stock varies depending on how much prescribing the doctor is expected to do; and whether doctors have to sell their ownership if they change specialties.

Failing to report an ownership interest is also a red flag, the alert says.

“This is important guidance for providers who legitimately want to avoid getting into difficulty with the federal Anti Kickback law,” said Don White, a spokesman for the inspector general's office.

The senators' 2011 letter said that such specific guidance was needed by physicians who were being encouraged to enter physician-owned distributorships of uncertain legality. The letter cited specific feedback from doctors: “One surgeon who was pushing back against his colleagues pressuring him to join a POD wrote that those colleagues were citing the absence of any prevailing guidance specifically on point on this topic as a reason for joining a POD venture, and that 'this sort of thought is what prevails unless OIG takes a stand.'”

The HHS inspector general's office is slated to release its sweeping investigation of PODs later in 2013, according to the office's work plan.

“Anytime a few bad actors determine the treatment and care of patients, as this warning makes clear, patient safety is put at risk and millions of dollars are lost to fraud. This is simply unacceptable,” said Sen. Orrin Hatch (R-Utah), the ranking Republican on the Senate Finance Committee.

Hatch, who released a critical report on PODs in June 2011, was joined by committee chairman Max Baucus (D-Mont.), who said the alert raised serious questions about the practice.

Patients have a right to know they're getting treatment that's tailored to them – not someone else's bottom line – but physician-owned distributorships may put that guarantee in doubt,” Baucus said in the emailed statement.

Senator Max S. Baucus
202.224.2651
max@baucus.senate.gov
511 Hart Senate Office Bldg
Washington, DC 20510


Monday, March 25, 2013

Invest in Hopeful Documentary on Patient Harm: Breaking the Wall of Silence



1.  Click Here!  Documentary director, Carolyn McCulley from CityGate Films talks about the project


2.  Click Here!  Invest today:  

Kickstarter campaign ends on March 31, 2013


http://www.leanblog.org/2013/03/podcast-168-carolyn-mcculley-breaking-the-wall-of-silence/

 Notes and links:
                The book upon which the title of the film is based (as a homage, not a direct translation of the book into film): Wall of Silence: The Untold Story of the Medical Mistakes That Kill and Injure Millions of Americans
                The book by Dr. Marty Makary she mentions: Unaccountable: What Hospitals Won’t Tell You and How Transparency Can Revolutionize Health Care
                Statistics on patent safety and quality problems
                Past episode with Sorrel King
                Earlier podcast with Clare Crawford-Mason that includes a discussion of her film “Good News…How Hospitals Heal Themselves
                Episode with Dr. Richard Shannon talking about Lean and infection reduction
                The “seven pillars” approach to improving patient safety
For a link to this episode, refer people to www.leanblog.org/168.
For earlier episodes, visit the main Podcast page, which includes information on how to subscribe via RSS or via Apple iTunes.
You can use the player (use the VCR-type controls) at the top of the post to listen to a streaming version of the podcast (or click here for the streaming audio and RSS subscription). The streaming link is faster for one-time listening (hardly any delay to start listening). Or you can use the download link to put it on your iPod or other MP3 player.
A new way to listen to free streaming episodes of the podcast: Download the free Stitcher app and use promo code LEANBLOG for a chance to win $100.
If you have feedback on the podcast, or any questions for me or my guests, you can email me at leanpodcast@gmail.com or you can call and leave a voicemail by calling the “Lean Line” at (817) 776-LEAN (817-776-5326) or contact me via Skype id “mgraban”. Please give your location and your first name. Any comments (email or voicemail) might be used in follow ups to the podcast.


About LeanBlog.org: Mark Graban is a consultant, author, and speaker in the “lean healthcare” methodology. Mark is author of the Shingo Award-winning book Lean Hospitals and Healthcare Kaizen. Learn more about Mark’s on-site and public workshops. He is also the Chief Improvement Officer for KaiNexus

Monday, March 18, 2013

Mayo Clinic: Selling Sickness or Reform Leadership?


                Article by: PAUL JOHN SCOTT  , Star Tribune Updated: March 16, 2013 - 7:50 PM
The question about Mayo’s plan for a Destination Medical Center isn’t whether it makes sense for Rochester and for the state. (It does.) The question is whether Mayo will seize this moment to lead change in an industry gone awry.
Rochester – At the forum a couple weeks ago to discuss the big news, they did not plan for the mad crush of bodies. They booked a too-small room, and the mob spilled out the door. Open meetings around here are usually a snore, but the surprise announcement of the Mayo Clinic’s plan for a Destination Medical Center drew the largest crowd to ever show up for one of these things. Judging by some of the faces, the proposal is especially inviting to the city’s growing corps of creatives, culture mavens, biotech wonks, coastal transplants and TED Talk fans. We in Rochester know this is a critical moment that may not come our way again, and it feels close. Nearly everyone in the room wanted this thing to happen.
Chances are the Legislature is going to come around to the DMC idea as well — if not for its merits, simply because of the way privately funded construction budgets with a B in them have a way of focusing lawmakers’ minds. The numbers are unprecedented: The plan promises $3.5 billion in local capital investments by Mayo over the next 20 years. It promises $2 billion in Mayo-leveraged private investment in urban living, entertainment, dining, arts and cultural amenities. It promises 30,000 new jobs. The catch: When new tax revenues from this expansion are produced, it asks for 10 percent of those funds, roughly $585 million over 20 years, for roads, sidewalks, parking, transit and sewers needed to support the new buildings.
So it’s not a handout, not by any stretch. Mayo is planning on growing faster than the tax base can keep up, and has figured out a novel way to get around the problem. The financial model is a first in the nation.
What’s not to like? Critics have objected to diverting any revenues, even hypothetical ones, toward a prosperous city when state revenues are scarce as it is. They object to the granting of special treatment to one employer over others, even if that firm plays an outsize role in the state economy. (With 30,000 employees, Mayo is the largest private employer in the state.)
Others see trouble ahead, given the likelihood of the need for eminent domain or the forced sale of private property through court-appointed means. (To be honest, a lot of buildings in this town make a good case for eminent domain.) One could also ask why the state should subsidize Rochester’s new plazas in exchange for new Mayo expansion when the clinic was on track to spend $5 billion over the next 20 years anyway, given its current spending patterns.
This presumes a bit. Mayo could always build elsewhere (even if last month there were four tower cranes over its two Rochester campuses). The complaint expressed by House Tax Committee chair Rep. Ann Lenczewski that the project is a “massive public subsidy” that will somehow cause “a tax increase for everyone else” is consistent with her view on projects like this in the past. But it doesn’t track with the reality of the bill.
The state loses no money; it only gets less new money. She is essentially complaining about getting a little bit less of funds the state was never going to get in the first place.
Now there’s an argument to make a Democrat wince.
These criticisms may sound high-minded, but there is a football stadium ready to break ground that suggests any pushback to Mayo DMC has less to do with the sanctity of the public purse than with residual regional rivalries too tedious to mention. In other words, if you support the state of medical practice today, it’s a no-brainer to support Mayo DMC. And I don’t say that just because I want more public sculpture at the base of my street.
But the moment bears mention for reasons other than Rochester’s options when it comes to sushi. Mayo says it is asking for this partnership in order to retain its position in an evolving health care marketplace. The clinic says there are 13,000 people coming into Medicare coverage every day, 30 million new enrollees in private insurance next year, and a future in which a small handful of global brands will serve patients who travel to destination cities for their health care. It has watched competitors in Baltimore, Houston and Cleveland engage in an arms race to attract these patients, and is determined to ensure its place on that list.
At the recent meeting, a Mayo spokesperson could not spell out the precise use of the $3.5 billion in new buildings the clinic plans to create — she only knew that more buildings will need to be built. So this seems less like a need in front of Mayo officials than like a strategic decision to stay in front by staying big.
Going big may make sense in a rational marketplace, but medicine is no rational marketplace. We’re not talking here about the usual problems one associates with health care — the lack of transparency in pricing, the lack of negotiated drug buying power in the government, and the problems with fee-for-service medicine. Those are all drags on the system, but they miss a deeper issue.
The market Mayo now seeks to dominate is that of serving sick people, and if one is honest about it, these are strange times to be fighting for market share of sick people. The reason: We have witnessed a near complete takeover of medicine by private industry. The product of this takeover — let’s call it the medical-industrial complex — has shown that if its market is sick people, it will not hesitate to create new customers.
How does the medical-industrial complex create new sick people? Not by making people sick — not intentionally, anyway. It markets sickness. It lowers the threshold for being diagnosed with an illness.
It broadens the symptom profile of an illness. It encourages doctors to treat symptoms as one would an illness that meets the formal criteria of diagnosis. It develops tests that trigger unnecessary procedures. It funds patient advocacy groups to “raise awareness” about the need for ineffective screening methods and expensive treatments. It funds medical societies, medical journals, clinical trials, the FDA, individual doctors, health systems, magazine ads, television spots, social-media campaigns and political campaigns in both parties, and it feeds illness-pushing stories to overworked health reporters.
I know, because I have written a few of them myself.
Private interests have merged with the very organizations Mayo finds in its path to customers. The massive Cleveland Clinic complex that has placed Mayo on its heels — it was going to be called a “Medical Mart” until someone thought better of it — includes a facility built by GE Heathcare, makers of our ubiquitous screening technologies. But as Peter Gotzsche of the Nordic Cochrane Center has demonstrated, 80 percent of Denmark has gone without mammograms for decades, while 20 percent of the country has been screened regularly. This “makes for the perfect control group,” he says, and when you compare the Danes who had mammograms with those who did not, there is no difference in mortality. Both groups experienced a drop in mortality around the introduction of drugs like Tamoxifen, yet mammograms got all the credit. This is comparable to the way in which device makers have taken credit for a drop in heart disease mortality during a period in which millions of Americans quit smoking.
You don’t need to visit a specialist — you can see the takeover of medicine during an hour in the office of your primary care provider.
The creation of clinical practice guidelines, directives conceived by doctors being paid by industry, has turned family medicine away from listening to the experiences of patients and toward the monitoring of blood markers denoting overblown risk factors for disease, surrogates for illness that can then be controlled by expensive drugs. Some of the most widely used drug treatments today serve the needs of the drug industry, not patients. They lower cholesterol or blood sugar without reducing the incidence of disease, and yet they are the sort of reasons we are so often told to “Know Your Numbers.”
We cannot count on the medical literature to clear up the problem.
Years of abuse have made it a repository of spin. Clinical trials that used statistical slight of hand to make failed trials look successful (see “Bad Pharma,” by Ben Goldacre). Review articles on new drugs or illnesses written by drug industry ghostwriters, signed for pay by influential doctors, then placed by professional publication planning agencies into credulous journals in exchange for hefty reprint orders. Industry-funded clinical trials of new drugs in which doctors never saw patient reports, only summaries of data they were asked to trust.
And as government lawyers given access to industry e-mails have learned, if a study still somehow failed to show that a new drug is safe or indeed works, it was often either shelved, or intentionally published in academic Siberia. In its own journal, Mayo Clinic Proceedings, Mayo recently published a proposed reform of these practices, but it was written by representatives from the very ghostwriting and drug companies that created the problem.
Disclosure of doctors’ conflicts was supposed to reform the system, but since the new disclosure rules, something funny has happened: Within medicine, long lists of side money have become a badge of honor.
As health policy expert Rosemary Gibson argued last month at “Selling Sickness: People before Profits,” a global meeting organized by Minneapolis health activist Kim Witczak, the problems in medicine today share disturbing similarities with banking. Too big to fail. Inflated salaries. Toxic assets, price bubbles, sophisticated products marketed to unsophisticated buyers and subsidized profits followed by socialized losses.
The Mayo Clinic did surely not create this environment, and when it comes to steering clear of unnecessary treatments and resisting the influence of industry, it does many things better than most. But Mayo is about to take a bold step forward within a system that has lost its moorings.
Let’s hope that as it does so, it seeks a way to reform, rather than simply prevail.
 -------
Paul John Scott is a writer in Rochester.

Tuesday, March 12, 2013

Proposed: National Drug and Device Safety Board


March 11, 2013 by Arezu Sarvestani  FiDA hightlight

Veteran cardiologist and patient safety advocate Dr. Robert Hauser tells MassDevice.com about his new vision for healthcare surveillance, his long struggle to spur change at the FDA and what FDA regulators can learn from aviation regulation.
Veteran cardiologist Dr. Robert Hauser is eager for change, even if he has to go straight to Capitol Hill himself to make it happen.
The patient safety advocate and vocal critic of the FDA announced at this year's American College of Cardiology conference that he's working on a proposal to fundamentally change the way federal regulators monitor medical devices and drugs once they hit the market.
He's looking to "recruit a couple people and go to Congress" with a proposal that would separate the FDA's approval functions from its surveillance functions, he told MassDevice.com here in San Francisco yesterday.
In an in-depth interview, Hauser, a prominent cardiologist from the Minneapolis Heart Institute, told us about his drive to protect patients from faulty devices, his disappointment with the FDA and what healthcare regulators can learn from their counterparts in aviation.
Inspiration and disappointment
Hauser's passion for healthcare safety was inspired in part by an experience he had in the mid-1970s, when a patient died when the pacemaker that he was dependent on short-circuited, he told us.
"A 40-year-old guy dropped dead on the doorstep of his home. His wife found him," Hauser said sadly. "We then found out that it was due to moisture getting into the electronics through a defect in the circuit that the manufacturer knew about."
At the time the FDA was considering what would become the Medical Device Amendments of 1976, which put into place the 3-tiered class system by which FDA assesses the potential risk and regulatory pathway for medical devices. Hauser "totally supported the amendment" at the time, he said, in part because of his experiences with faulty pacemakers. But in the intervening 40 years he's grown pessimistic about the FDA's ability to satisfy its duty to protect U.S. patients from potentially dangerous products.
He's made it something of a life goal to promote changes at the FDA, but is growing increasingly discouraged, he told us.
"I've done everything I can to encourage the FDA to change. Nothing changes."

Hauser has been instrumental in several discussions surrounding medical device risks and recalls, most recently in the January issue of the Journal of the American College of Cardiology, in which he warned physicians clamoring over Boston Scientific's (NYSE:BSX) "leadless" implantable defibrillator to curb their enthusiasm.
He was also at the center of an April 2012 scandal over St. Jude Medical's (NYSE:STJ) recalled Riata defibrillator leads, in which the medical device maker called for the retraction of a Hauser study attributing 22 deaths to failures in the Riata or Riata ST leads.
Hauser was also 1 of the physicians who helped uncover problems with Guidant Corp.'s pacemakers after a patient he was treating died. Boston Scientific, which acquired Guidant for about $26 billion in 2006, is still dealing with the legal fallout from those issues.
"I've done everything I can to encourage the FDA to change," Hauser told us. "Nothing changes."
His remaining alternative, as he sees it, is to change the fundamental structure of medical device and drug surveillance in the U.S.
Even as he prepares to advocate for a new regulatory agency to take some responsibility away from the FDA, Hauser is acutely aware of the hurdles that stand in his way, perhaps foremost among them "inertia" at the FDA.
"There's 1 chance in 100, but it's worth taking the chance," he said. "It's worth the effort, because maybe in the conversation something will happen that'll change things."
And the FDA under the Obama administration has not welcomed recommendations for change. When the Institute of Medicine recommended in 2011 that the federal watchdog agency completely scrub its 510(k) fast-track review of medical devices, the FDA quickly responded that it was "not bound to adopt IOM recommendations."
The agency has since signed, and the White House approved, new deals with the medical device industry that raise the fees companies pay for agency review in exchange for the FDA meeting performance goals and getting applications out the door more efficiently.
What's the hurry?
Medical device companies and lawmakers often chide the FDA for taking too long to get new, potentially life-saving products to the U.S. market. The agency frequently finds itself defending its timelines or promising to improve them.
The federal watchdog agency is regularly cited as the biggest hurdle delaying new products from reaching the market and industry advocates in Congress occasionally prod the FDA to speed the review process
"I don't think we really help people by making drugs or products available more rapidly."

Hauser fundamentally disagrees with those efforts, he told us, challenging the underlying assumption that faster is better.
"I don't think we really help people by making drugs or products available more rapidly," Hauser said. "There are occasional drugs and devices that really are game-changers, that deserve expedited study and review and approval. Many, many drugs and devices are incremental improvements – or they are in competition with other drugs or devices that are safe and effective.
"Thank God we've got pharma, thank God we've got the medical device companies. There have been revolutionary products, there will continue to be revolutionary products," he added. "But there's rarely great urgency to get something into the marketplace."
The healthcare industry thrives, Hauser said, by pushing out new products and marketing incremental differences, no matter how small, in order to get a leg up on the competition.
Part of that is sustained by what he called "loopholes" in the FDA's approval process, problems that Hauser said go beyond the scope of an independent monitoring authority.
The FDA's unintended loopholes
"There are other issues that need to be addressed, separate from a National Drug & Device Safety Board," Hauser told us. "We need to get rid of these loopholes that allow drugs or allow devices to get approved without adequate testing."
He named the FDA's premarket approval supplement system among the vulnerabilities in the agency's review that allow potentially dangerous products to reach patients.
"Supplements to the original PMA allow manufacturers to make changes to medical devices that presumably improve design, manufacturing or labeling," Hauser told an audience during a presentation at the ACC meeting on Saturday. "However, the PMA supplement has been employed – I should say abused – to introduce essentially new products that are significantly different than the original PMA devices.
"This is another pathway whereby high-risk Class III devices have been FDA-approved for widespread use without clinical trials or any human testing," he added.
A classic example of how that process may fail, Hauser said, involved medical device giant Medtronic (NYSE:MDT) and its Sprint Fidelis ICD lead. The Sprint Fidelis, which was approved as a supplement to the Transvene lead, was the cause of a high-profile, precedent-setting recall after it had already been implanted in some 268,000 patients.Medtronic pulled the Sprint Fidelis in 2007, when it was announced that they were prone to fracture – meaning they could either fail to deliver life-saving therapy or else send unneeded shocks.
The defective leads were implicated in more than 100 deaths, although Medtronic has said that only 13 fatalities listed the leads as a "possible or likely contributing factor."
Hauser further targeted the FDA's popular 510(k) medical device fast-track as an antiquated system that has outlived its usefulness. He agreed with a 2011 report released by the Institute of Medicine, the culmination of nearly 2 years and $1.3 million dollars, which recommended that the FDA scrub the 510(k) program completely.
The institute took issue with the foundation of the 510(k) program, that devices which are "substantially equivalent" to already-approved products (so-called "predicate devices") need not be subject to the more stringent pre-market approval process required for entirely new medical technologies.
The IOM report also found that 3 out of 4 devices recalled between 2005 and 2009 had been approved under 510(k) applications or had escaped review entirely.
The FDA's failure to respond to recalls
The FDA has the authority to mandate recalls and investigate medical devices and drugs after they have been cleared for the U.S. market, but it rarely does so, Hauser explained.
"It's a passive regulator," he told us. "It tends to wait for manufacturers to voluntarily recall devices rather than pro-actively compelling manufacturers to take their products of the market or even, perhaps, to stop distributing while the potential problem is investigated."
"How objective can a group be, inside the agency, when it's discussing, potentially, the performance of another group inside the agency?"

Part of the problem is that the FDA is responsible for both approving devices and as well as monitoring them for problems, creating a fundamental conflict of interest within the agency, as Hauser sees it.
"Right away, you have a conflict because the group that approved the drug is going to question the group that is now criticizing the drug," he said. "They're all in 1 agency, and I doubt that the lines of authority, responsibility, accountability are clear. How objective can a group be, inside the agency, when it's discussing, potentially, the performance of another group inside the agency?"
Hauser's solution is to separate those responsibilities and task a new healthcare regulatory organization with monitoring and investigating healthcare products after the FDA has cleared them for the U.S. market. Lucky for Hauser, a model exists that exemplifies the segregation of approval and monitoring: the U.S. government's regulatory oversight of the airline industry.
Learning from the FAA and the NTSB
The FAA and the National Transportation Safety Board are 2 sides of the same coin, regulating the aviation industry and monitoring it for issues, but the agencies are entirely separate. The NTSB has independent authority to investigate potential issues and reports only to Congress.
The pair of agencies were originally lumped into a single authoritative body that Congress later separated on the grounds that "no federal agency can properly perform investigatory functions unless it is totally separate and independent," Hauser highlighted in his Saturday ACC presentation.
The NTSB has no regulatory authority and can't induce airline companies to make changes or ground flights. It conducts investigations and makes recommendations, leaving it up to the FAA to take action.
That's precisely what Hauser prescribed for U.S. healthcare regulation.
"We need an independent organization to look at major adverse events associated with drugs and devices, separate from the FDA and which has no regulatory authority, whose only job is to investigate and then report their findings," Hauser said. "The other thing NTSB does that we need on the medical side is they then share what they've learned about an accident with all the stakeholders. That doesn't happen now with drugs and devices."
He proposed that the NTSB participate in post-market studies, watch registries from around the world and make the data completely transparent and available to the public at large.
Hauser's National Drug & Device Safety Board
Hauser aims to form the new healthcare regulatory agency by spinning out the FDA's post-market surveillance efforts into an independent body modeled after the NTSB in purpose and structure.
"There would be a chairman appointed by the president and 4 board members, all of whom would have 3-5 year terms," he told us. "The chairman would report to Congress, the board would report to Congress. They'd be an organization separate from any agency in the federal government, entirely independent."
The new bureau would include engineers, scientists, statisticians and administrators to help monitor healthcare products on the market and collaborate with registries around the world to create a global network and public database of medical device and drug information.
The database might confer an added benefit for medical device companies and drug makers, giving them access to a comprehensive database of adverse events to help them avoid similar problems in newer products, Hauser noted, but the boon to industry is incidental to Hauser's goal.
"It's the end user that we're really concerned about," he said. "I'm not interested in helping the companies, necessarily. I'm interested in making a safer device or drug for a patient."



by JAMES WALSH , Star Tribune Updated: April 28, 2012 FiDA highlight
St. Jude Medical Inc. isn't the only medical device manufacturer to chafe at Dr. Robert Hauser's scrutiny -- just the latest.
In 2005, the Minneapolis Heart Institute cardiologist blew the whistle on a defective defibrillator made by Guidant after it failed to revive a young patient. In 2007, Medtronic Inc. pulled its Sprint Fidelis lead off the market after a study by Hauser found that some of the wires, used to connect a defibrillator to the heart, failed. Aggrieved patients eventually won a $114 million settlement from the Fridley-based company.
Now, St. Jude and its recalled Riata defibrillator leads are facing questions after Hauser last month published an article in Heart Rhythm Journal tying the lead to at least 20 patient deaths. St. Jude has assailed Hauser's research as biased and flawed and asked for a retraction. Hauser and the editor of the online publication refused, saying they stand by the findings and that the work was peer-reviewed. The week after St. Jude made its request and disputed Hauser's findings, the Little Canada-based company's stock price fell 10 percent.
Hauser has made a career out of monitoring and sometimes challenging the medical device industry over the safety of its products. It's a role that has repeatedly brought him into conflict with the industry, several of whose biggest players are in Minnesota.
Ask Hauser to describe his role, and his answer is basic: "I am an advocate for patients."
Even his targets say they respect his work, even if they don't always agree with his findings.
Those who have worked with Hauser during his four decades of prodding device-makers and the U.S. Food and Drug Administration toward greater safety and accountability use other terms to describe him -- ethical, passionate, persistent.
"It's not anything against any company. He is out to find the truth to serve patients best," said Dr. William Katsiyiannis, director of clinical electrophysiology and vice chairman of cardiology at Abbott Northwestern Hospital's Minneapolis Heart Institute. "I think it takes quite a man to stand up for that and to keep your head down and do the right thing."
Years fighting
Hauser's passion for medical device safety began, he said, when he was a cardiology fellow in Chicago more than 40 years ago. He participated in a research project involving nuclear battery pacemakers with the help of funding from the National Institutes of Health.
"We were told, 'Go ahead and test them and write a favorable report,'" Hauser said. "All of them failed."
Hauser later started a program at Rush University Medical Center in Chicago to follow pacemaker recipients and a registry to keep track of how they're doing. In 1987, Hauser left Rush to join Cardiac Pacemakers Inc. and served as its president and CEO from 1988 to 1992 -- before it was acquired by Guidant. Guidant would later be purchased by Boston Scientific.
In 1992, Hauser joined the staff at the Minneapolis Heart Institute and used seed money to start an Internet-based device registry. He has continued his advocacy for patient safety and device accountability, conducting his own research and challenging a device establishment that he says sometimes puts profits ahead of prudence.
"It's not good business to put bad devices out there," he said.
Linda Callinan has worked with Hauser for 25 years, since starting a pacemaker follow-up program at the Minneapolis Heart Institute.
"He's got drive that is unbelievable," she said of the research that he often does on his own time.
Hauser, 72, doesn't wait for the FDA or device-makers to spot issues. Callinan said their program actively follows about 6,000 patients with pacemakers and defibrillators from a variety of manufacturers, alert for signs of problems.
Hauser acknowledges that devices aren't perfect -- and likely never will be. Still, he said, in a marketplace where manufacturers feel pressure to quickly develop devices to grab market share, the FDA has an obligation to remain vigilant. The agency should require more premarket testing of lifesaving devices and enact more stringent post-market surveillance of implanted devices, he said.
"You have to go out and look for problems," Hauser said. "If you wait for problems to come to you, it's too late."
Of course, he was saying the same thing back in 2005.
Going public
In March 2005, Joshua Oukrop, a 21-year-old college student from Grand Rapids, Minn., was on a spring break bicycling trip in Utah. He took a break from a ride, saying he was tired. He then collapsed to the ground and died.
Oukrop, who had a genetic heart disease, had a Guidant defibrillator. But the device short-circuited and failed to keep the young man alive.
Oukrop's doctors, Hauser and Barry Maron, later learned that Guidant had known that some devices short-circuited years before Oukrop collapsed. Guidant had changed its manufacturing processes to fix the problem.
But, after the company failed to disclose the problem to doctors and patients who still had the device, Hauser and Maron took their concerns to the media. Guidant eventually recalled the device.
Boston Scientific Corp., which acquired Guidant in 2006, paid $240 million in 2007 to settle lawsuits brought by patients. In 2011, the company pleaded guilty to federal charges, including making false statements to the FDA about the devices' safety, and paid a $296 million fine.
Oukrop's father credits Hauser and Maron for fighting for greater device oversight.
"If it hadn't have been for those two, it would have just blown over and nothing would have happened," Lee Oukrop said. "He has the courage of his convictions."
Sally Hauser knows all about her husband's persistence. More than 50 years ago, he saw her climb a hill at the University of Cincinnati and wanted to get to know her better. A year later, they eloped.
She also knows what kind of doctor he is.
"It's all about integrity," she said.
Fighting to get information into patients' hands about the devices in their bodies has been his passion -- even at the expense of friendships over the years. Not all doctors, many of whom are paid consultants to device-makers, have been willing to take the stands her husband has, she said.
"You lose friends. People are really funny," Sally Hauser said one day last week. "You know what the bottom line is? It's money."
Dr. Paul Friedman, a heart rhythm specialist at the Mayo Clinic in Rochester, has collaborated with Hauser on several studies.
"He has a passion for improving patient care and providing information to guide caregivers," Friedman said. "I think he has demonstrated that when you are committed to a goal, if you are persistent and consistent, I think with time you can lead to important changes."
Work continues
Hauser's most recent work has led to a public tussle with St. Jude Medical.
In December 2010, St. Jude discontinued selling its Riata lead after studies showed that the wires could work free from their outer insulation. Last December, St. Jude told doctors that the problem was more prevalent than previously thought. The FDA recalled the device.
In an article posted March 26, Hauser said he found least 20 deaths caused by high-voltage failures in the Riata leads.
St. Jude quickly went on the offensive, calling Hauser's report biased and inaccurate. It asked Heart Rhythm Journal Editor Douglas Zipes to retract the article. Zipes refused.
In recent weeks, St. Jude's rhetoric has softened a bit. St. Jude CEO Dan Starks said in a recent earnings conference call that "very sincerely, we have a lot of respect for Dr. Hauser's contributions over the years to raising awareness about medical device safety issues."
Starks said in a recent e-mail that he had not spoken to Hauser about his study, but "that my sense is that we have agreed to disagree."
He added that "St. Jude Medical shares Dr. Hauser's focus on patient safety and on getting as much accurate information as possible to physicians to help them make the best decisions for their patients."
Sally Hauser admitted that she and her husband are relying on that commitment to safety. Robert Hauser had a St. Jude heart valve implanted last May.
"He said to me: "Well, I guess I really have to trust them that it's a good valve,'" she said, smiling.
James Walsh • 612-673-7428