Report doctors with fraudulent medical device investments.

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

Federal regulators: Beware doctors pushing medical devices

March 26, 2013, 4:28 PM

By Russ Britt

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

Legal crime? Profit trumps patient harm.

http://www.nytimes.com/2012/11/27/business/st-jude-medical-suffers-for-redacting-a-product-name.html

NEWS ANALYSIS

A Name Blacked Out, a Reputation at Risk

By BARRY MEIER  FiDA highlight

Published: November 26, 2012

Peter Muhly for The New York Times

Dr. Ernest Lau holds a Durata lead from a St. Jude Medical Fortify ICD, an implanted heart defibrillator.

                       

IS covering a product’s name in a public document a sign that a company has something to hide? And how should doctors, patients and investors react if the product at issue is one on which peoples’ lives and a company’s fortunes depend?

Such questions now loom over St. Jude Medical after the disclosure last week that its executives had blacked out the name of a heart device component when they released a critical federal report involving the product. The value of St. Jude has since plummeted more than $1 billion, or 12 percent. But the company’s actions may have a more lasting impact on its reputation and the health of patients, some experts say.

Last week’s incident was the latest development in a controversy involving the component, an electrical wire that connects an implanted defibrillator to a patient’s heart. St. Jude officials say the wire, which is known as the Durata, is safe. But uncertainty about the company’s statements is growing, underscored by its handling of the report, which involved a Food and Drug Administration inspection of a plant that makes the Durata.

St. Jude released that report in October as part of a filing with the Securities and Exchange Commission. The F.D.A. provides device makers with the reports in an unaltered form, and they may contain criticisms of a company’s procedures.

But the version of the report that St. Jude filed with the S.E.C. left some doctors and analysts uncertain about which company product or products were at issue for a simple reason — St. Jude had redacted, or blocked out, all 20 references to the Durata in it.

Company executives said they had done so based on their “good faith” interpretation of how the F.D.A. would act if it publicly released the report under the Freedom of Information Act. But both an F.D.A spokeswoman and a lawyer who specializes in medical devices took exception with that view, saying that names of approved products typically do not qualify as the type of confidential business information that the F.D.A. would redact.

Among other things, F.D.A. inspectors found significant flaws in the company’s testing and oversight of the Durata. It was those revelations and the implications that the problems could lead to further F.D.A. action against St. Jude that led to the sharp fall last week in its stock price.

In 2005, Guidant, a device maker that no longer exists, also found itself under scrutiny. Back then, its executives decided not to tell doctors that one of its defibrillators could short-circuit when a patient needed an electrical jolt to save a life. The expert who brought the Guidant problem to light, Dr. Robert Hauser, a heart specialist in Minnesota, has also raised concerns about the St. Jude wires, adding that he believes that its executives have been less than forthright.

“Patients and physicians would appreciate more information,” Dr. Hauser said.

Craig Lassig for The New York Times

Dr. Robert Hauser, a cardiologist who studies heart devices, has raised concerns about wires in defibrillators from St. Jude.

In an earlier interview, St. Jude’s chief executive, Daniel J. Starks, said the company had hidden nothing about the Durata or another heart wire named the Riata, which it stopped selling in 2010.

“We’ve been more transparent than others,” said Mr. Starks, referring to company competitors like Medtronic.

Still, some Wall Street analysts share Dr. Hauser’s view. And if one St. Jude executive can claim credit for shaping their opinion, it would be Mr. Starks.

Earlier this year, he sought, among other things, to have a medical journal retract an article written by Dr. Hauser that was critical of the Riata. The publication refused.

Now, after St. Jude’s latest misfire, Wall Street analysts, who usually agree more than disagree, are placing wildly differing bets on St. Jude, with some valuing it at $48 a share and others at $30. On Monday, St. Jude closed at $31.86 on the New York Stock Exchange.

One of those bearish analysts, Matthew Dodds of Citigroup, said he thought the Food and Drug Administration might act soon on Durata. “I believe that a lot of their actions have made the situation worse, ” he said of the company’s executives.

A St. Jude spokeswoman, Amy Jo Meyer, reiterated the company’s stance that it had interpreted agency rules in “good faith” when releasing the redacted report about the Durata. An F.D.A. spokeswoman, Mary Long, said the agency did not consider the names of approved products to be confidential. And a lawyer, William Vodra, said that while device makers try to make a confidentiality argument for product data they consider embarrassing, like injury reports, they rarely succeed.

“In my experience, the F.D.A. consistently rejects” such arguments, Mr. Vodra wrote in an e-mail.

For patients, the dilemma may become more excruciating. The company’s earlier heart wire, the Riata, has begun failing prematurely in some of the 128,000 patients worldwide who received it. And those patients and their doctors face a difficult decision: whether to leave it in place or have it surgically removed, a procedure that carries significant risks.

St. Jude executives say that the Durata, which uses a different type of insulation than the Riata, is not prone to such problems.

And with the Durata already implanted in 278,000 people, many heart specialists certainly hope they are right.

Selling Sickness: People Before Profits

http://sellingsickness.com/medical-devices-under-scrutiny/

Selling Sickness 2013


People Before Profits


February 20-22, 2013
  
register today!

Hyatt Regency Washington on Capitol Hill
 

Washington D.C.

MEDICAL DEVICES UNDER SCRUTINY

Overtreatment, over-marketing, conflicts-of-interest and all the trappings of disease-mongering pertain not just to medical treatments, education, publishing, screening and drugs, but, increasingly, to medical devices, both the kind that are used IN the body and ON the body. It is clear from current scandals and investigations in the US and UK that the device approval and oversight systems are, according to the BMJ, “fragmented, poorly regulated [and] market driven,” and that, shockingly, “financial incentives prioritize manufacturers’ interests over those of patients, with no requirement for clinical evaluation of a devices’ safety or effectiveness.”

Digging into the background of medical devices is eye-opening for someone already familiar with medicines and their scientific and regulatory problems. It’s a whole new world of engineering and chemistry, radiation and plastics, chips and tags, etc.

What isn’t new is the revelation of a patchwork and antiquated approval and regulatory system based on levels of risk that seems more appropriate to tongue depressors than hip implants. We’ll be sure to take a look at this topic next February at “Selling Sickness, 2013.”

FDA responsible for patient safety: not jobs! NEJM article

http://www.nejm.org/doi/full/10.1056/NEJMp1204170#t=article

Perspective

Patient Access to Medical Devices — A Comparison of U.S. and European Review Processes

Saptarshi Basu, M.P.A., and John C. Hassenplug, M.Sc.

N Engl J Med 2012; 367:485-488August 9, 2012

Interview with Dr. Rita Redberg on the approval process for medical devices in the United States and in Europe. (23:44)

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 The U.S. process for approving innovative, high-risk medical devices has been criticized for taking longer than the European approval process.1 This contention is often used to support the argument that the Food and Drug Administration (FDA) should lower its standards for approving medical devices, since a slow approval process is delaying Americans' access to innovative and lifesaving technology. But a review of the data, using appropriate end points, suggests instead that it takes the same amount of time or less for patients to gain access to innovative, high-risk medical devices in the United States as it does in the four largest European markets (Germany, France, Italy, and Britain)2 — largely because patient access is generally delayed until reimbursement decisions are made, which often takes substantially longer in Europe than in the United States.

To compare the United States and Europe fairly on this front, three criteria must be considered: the level of device innovation, equivalent start and end points, and patient access as defined by time to reimbursement. First, we focused on innovative, high-risk devices because in the United States such devices require the strongest evidence of clinical benefit and are the subject of most debates about the relative effectiveness of approval processes in different countries. Furthermore, previous studies have shown that lower-risk devices achieve market access in a similar amount of time in the United States and in Europe.

Second, an accurate comparison of time to market access requires measurement of the total time that elapses between application submission and market access. Previous studies have compared the chronologic dates of application submission and market access, but the date an application is submitted varies from country to country.

Third, patient access should be equated with the availability of reimbursement rather than with device approval, because broad patient access to a new device doesn't occur until reimbursement by a national or third-party payer is available. Previous comparisons of the U.S. and European systems have used the approval date to measure process duration, but innovative, high-risk devices don't reach a market where most patients can benefit from them immediately after gaining regulatory approval, though they may be accessible to patients who can afford to pay out of pocket. Rather, there is a second level of review through which public or private insurers decide whether and at what price they will pay for a device. Generally, public systems take longer than private insurers to make reimbursement decisions, and significantly more Europeans than Americans have public insurance. Two thirds of the U.S. population is covered by private health insurance, whereas only a fifth receives publicly funded reimbursement, primarily administered by the Centers for Medicare and Medicaid Services (CMS).

For both private and public systems in the United States, the pathway to patient access to a device starts with the submission of an application to the FDA. The FDA reviews innovative, high-risk devices for safety and effectiveness (clinical benefit) under the premarket approval (PMA) process, and information on the duration of reviews is publicly available. In fiscal year 2011, the FDA approved 40 applications for PMA. The average review time was 13.1 months, with 8.4 months attributed to FDA review time, and 4.7 months to the time the agency waits for the sponsor to address deficiencies in the application (“sponsor time”).3 CMS provides reimbursement for the majority of devices when they earn FDA approval. For a limited number of devices each year, however, CMS conducts a national coverage determination in response to external requests for validation or for devices that have limited or conflicting evidence of clinical benefit. This process averaged 8.6 months over the past 5 fiscal years.4 Although it is difficult to obtain data on how long private insurers take to make coverage decisions, anecdotal information from private insurers suggests that decisions are made within a few weeks to a few months after FDA approval, depending on the amount and quality of evidence of clinical benefit.

In Europe, by contrast, most of the 27 member countries of the European Union (EU) have publicly financed health care systems; such systems cover approximately four fifths of the populations of the four largest device markets. All EU countries require devices to first obtain a Conformité Européenne (CE) marking, which refers to a symbol shown on products that indicates market approval throughout the EU. The CE marking process is conducted by for-profit, third-party “notified bodies” that have been accredited by a member country to assess device safety and performance but do not evaluate effectiveness (which requires more clinical data). Although publicly available data are limited, anecdotal information from notified bodies suggests that the process takes 1 to 3 months, excluding sponsor time.

Most European patients do not have access to innovative, high-risk devices as soon as the devices receive a CE marking. Each country must first make a decision about reimbursement, a process that varies substantially among countries.5 Though a CE marking can be granted on the basis of fewer clinical data than are required for FDA approval, European standards for reimbursement are often similar to or higher than those that the FDA imposes for device approval. European countries may require additional data on the device's safety and effectiveness, as well as on cost-effectiveness.

In France, a centralized body makes reimbursement decisions after assessing the safety and effectiveness of individual devices. Reimbursement decisions in Italy are devolved to the various regions, and Britain and Germany conduct broader assessments of device types or procedures, rather than of individual devices. Typically, innovative devices not covered under an existing diagnosis-related group (DRG) require review under the lengthier Health Technology Assessment process, which assesses safety, clinical benefit, and cost-effectiveness. Government-provided information on time to reimbursement varies by country. Estimated time frames are an average of 71.3 months in Germany, a range of 36.0 to 48.0 months in France, a range of 16.4 to 26.3 months in Italy, and an estimated 18 months in Britain.

Using this information, we determined that the time it takes to bring innovative, high-risk devices to patients in the United States is similar to or shorter than that in the top four European markets (see figure

Missing graphic:  Comparison of Time to Market in Premarket Approval and Reimbursement Processes.

 The public (CMS) process in the United States takes approximately as long as those in Italy and Britain, approximately half as long as that in France, and less than a third as long as that in Germany. The difference in time to market access is even greater when it comes to private insurers (covering the majority of the U.S. population), which often make reimbursement decisions within a few months after FDA approval.

To further illustrate this point, we compared the time to approval for five innovative, high-risk medical devices available in France, Italy, and the United States (see table

Missing graphic: Comparison of Time to Market Access for Five Innovative Devices in France, Italy, and the United States.

These case studies indicate that the average time to market access for these devices was 26.3 months in France, 30.8 months in Italy, and 15.3 months in the United States.

These numbers may not fully capture the reasons why a device reaches the market more quickly in one country than in another and do not reflect experiences with all innovative, high-risk devices. However, unless one uses equivalent standards in terms of the level of risk, the start and end points of the process, and the key end point of market access, accurate comparisons cannot be made.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

This article was published on August 1, 2012, at NEJM.org.

SOURCE INFORMATION

From the Office of Planning, Office of the Commissioner, Food and Drug Administration, White Oak, MD.

Please power my advocacy!

Your vote is very valuable to me.   All it takes is a daily quick positive comment and clicks on the “like” and/or “tweet” button at the bottom of my essay page.

Three winners will have travel and costs covered to attend the 4th annual Mayo Clinic Social Media Summit October 15-19, 2012 in Rochester, MN 

Registration costs $1200 (not including travel/lodging/meals) so most patients/caregivers and patient advocates cannot afford to attend.

Contest ends August 4, 2012.

Thank you!

http://socialmedia.mayoclinic.org/2012/07/16/joleen-c-scholarship-contest-essay/    

More scientific rigor picking out a garbage disposal!

http://ctwatchdog.com/health/more-women-need-to-be-involved-in-medical-device-trials

More Women Need To Be Involved In Medical Device Trials

June 8, 2012

By Ct Health I Team

Written by Rochelle Green  (FiDA blog bold added)

Hundreds of thousands of women at risk for irregular heart rhythms have a battery-powered, iPod-sized gadget embedded in their chests. The implantable cardioverter defibrillator (ICD) can be a lifesaver, shocking a dangerously fast heartbeat back to normal.Yet the actual benefit to women is uncertain, because ICDs were approved by the Food and Drug Administration (FDA) based on clinical trials made up mostly of men.  That’s typical of testing of many high-risk devices, according to medical reports. And even in the clinical device trials that do include women, generally the outcomes aren’t reported by sex.

The result is a critical gap in the data doctors rely on when making decisions about a treatment’s benefits and risks for women. It can also pose troubling dilemmas later on, said cardiologist Rita F. Redberg, a professor of medicine at the University of California, San Francisco. That was the case in 2009, when data pooled from clinical trials showed that ICDs were no better than drugs at reducing a woman’s risk of death.

“The time to collect data in both sexes is before FDA approval,” said Redberg. “Especially with implanted devices, where there’s no going back.”

Only recently has the FDA proposed guidelines to improve the representation of women in clinical device trials. Intended for the medical device industry, which sponsors most of the research submitted for review, the guidelines are expected to become final by year’s end. Similar standards for drug testing were put in place some 20 years ago, following a long period during which women of childbearing age were explicitly excluded from most studies.

The proposed FDA guidelines are nonbinding, however, and some experts who favor the new recommendations are skeptical that the medical device industry will comply.

“Industry is always most attentive to the bottom line,” said Christine Carter, vice president for scientific affairs at the Society for Women’s Health Research (SWHR) in Washington, D.C. “So companies will continue to lament that trials are expensive and that recruiting more women is a problem.” Device makers will change their study protocols just enough to meet FDA requirements, Carter predicted, but protocols will be “less than ideal for those of us concerned with sex differences and women’s health.”

SWHR and other groups have urged the FDA to strengthen the document by finalizing it as a rule. The debate highlights the competing interests that the agency struggles to balance, with industry and some lawmakers in one camp, demanding faster approvals and “less burdensome” regulation, and health advocates in another, warning that patient safety is at risk.

To U.S. Rep. Rosa DeLauro, the issue is science, not politics. “We know there are real medical distinctions between genders that must be recognized when the government is deciding whether to approve a new device,” she said.

Opening A Window On Women’s Health

Until the mid-1980s, clinical trials were practically a men’s only club. Studies funded by the National Institutes of Health (NIH) and pharmaceutical firms—the largest contributors to biomedical research in the United States—drew subjects primarily from a pool of white males. The first randomized trial using estrogen to prevent heart disease consisted entirely—and counter-intuitively—of men.

Women were considered too complicated to study, given their cycling hormones and the chance that those of childbearing age could expose a fetus to unintended risk, said SWHR’s Carter. Gender wasn’t yet recognized as a factor in health and illness, and it was assumed that study results in men would be just as useful for women.

As biomedical research advanced, however, women began to suspect that their health needs were being left behind, experts say. The results of clinical trials in men weren’t always extended to women, depriving them of powerful new treatments like cholesterol-lowering drugs, according to an Institute of Medicine report. And the male model didn’t always correspond to women’s experience of health and disease.

In the early 90s, women’s health advocates began to mobilize, according to Carolyn Mazure, director of Women’s Health Research at Yale. “They took it to Congress,” she said, educating key legislators about the exclusion of women from medical research and the lack of information about gender differences related to health.

In 1993, Congress passed legislation requiring that women and minorities be included in all NIH clinical research. The FDA reversed its policy barring women of childbearing age from certain drug studies, encouraging their inclusion in all clinical drug trials. The measures also required study results to be analyzed by sex.

As an NIH researcher at the time, Mazure witnessed history in the making. “The idea that we now needed to include women and minorities in our research—we found it revolutionary,” she recalled. Her program at Yale promotes research on gender differences in health by providing seed money to get innovative projects off the ground.

In the past 20 years, scientists have discovered that sex differences are significant at every stage of life and at every biological level, from the single cell to the whole body. Gender influences how people experience disease, metabolize drugs, respond to pain, and much more. While the findings support the need for sex-based research, the going is slow, said Carter.

“There’s still only 30 percent—maybe up to 40 percent—of women involved in clinical trials, and too often their data isn’t analyzed separately from men’s,” she said.

A major challenge is changing the mindset of researchers, she said.  She described how, at a recent SWHR roundtable with more than a dozen Alzheimer’s disease experts, she had asked about the sex differences they had found in their research. Almost all responded that they hadn’t looked at the data that way.

“We’re finding this over and over, with experts in different fields,” she noted. “If you’re not aware that there are biological differences between the sexes, you don’t look for it in your data.” With each roundtable, however, she convinces more scientists to look at outcomes based on sex. “It’s time to make this more mainstream,” she said.

In the meantime, the effects of the old mindset are still in evidence: in one example, women account for just 30 percent of subjects in the clinical trials supporting the American Heart Association’s 2007 guidelines for cardiovascular disease prevention in women. Twenty of the 156 studies were men-only, according to a published gender analysis of the studies from which the guidelines were drawn.

The paucity of women “wasn’t a big surprise,” said Dr. Chiara Melloni, assistant professor of medicine at the Duke Clinical Research Institute in Durham and lead author of the analysis. But it’s a reminder to design studies with gender differences in mind, she said.

Bringing Device Studies Up To Speed

If the FDA’s device center has been slow to tackle the gender gap, its new guidelines are a prescription for change, agency officials say.

In a key provision, researchers are advised that men and women should be enrolled in proportions that reflect the gender distribution of the underlying disease. Cardiovascular device studies, for example, should enroll men and women in equal numbers, since each sex is equally at risk for the disease. Until now, most such studies have included just half as many women as men, according to an FDA review of cardiovascular devices approved in a recent five-year period.

Since medical device studies have traditionally been small, the new enrollment goals will likely require more women, and possibly bump up the number of subjects overall. The guidelines provide strategies for recruiting female subjects, and advice on examining data for potential differences by sex. And they call for sex-specific outcomes to be reported on device labels, a practice that consumer health groups have been advocating for years.

In practice, the vast majority of medical devices reviewed by the FDA are cleared for use without human testing, if they are deemed “substantially equivalent” to devices already on the market. Only 1 percent of devices undergo rigorous review and clinical trials before they can be marketed.

Even so, the new guidelines for device trials are an important advance, experts say. Dr. Patrice Desvigne-Nickens, a program director at the National Heart, Lung, and Blood Institute, praised the FDA for alerting device makers to the new imperative in clinical research. “To not look for gender differences is unacceptable,” she said.

Joleen Chambers on June 11, 2012 at 4:14 pm

Thank you for this excellent and informative article. Sadly, if a woman researches any implanted medical device she will find that data is hidden behind a barrier of “proprietary” claims by the industry. She is more likely to find hard data about any kitchen appliance than an implanted medical device. Gender clinical studies are another layer of insufficient scientific rigor.

Medical Malpractice: Apology substitutes for justice?

LINK 

Say You're Sorry And Get A Pass?

By ALAN BAVLEY

The Kansas City Star

(FiDA Blog bolded)

Should apologies to injured patients be enough to keep malpractice cases off a doctor’s record?

A campaign has gotten under way to make that happen. And patient safety advocates are raising red flags.

Leading the campaign is an organization called Sorry Works! — yes, the exclamation point is part of its name.

Sorry Works! started as an advocacy group promoting apologies and disclosure of mistakes as a way to defuse the anger and bewilderment of injured patients that often lead to malpractice suits.

It’s a persuasive idea.

Many patients who sue their doctors say they wouldn’t have felt a need to go to court if they had gotten an explanation and an apology. Hospitals have tried full disclosure with offers of compensation and seen declines in lawsuits or the amounts paid to settle claims.

But about five years ago, Sorry Works! changed from a coalition of doctors, lawyers, insurers and patient advocates. Now it’s a commercial consulting firm. Founder Doug Wojcieszak offers training to hospitals and doctors. And he has started crusading for new immunity for doctors who apologize.

The National Practitioner Data Bank is a federal record of doctors’ dirty laundry — license suspensions, health care fraud convictions, malpractice payments. State medical boards consult it before granting licenses. Hospitals check it before offering staff privileges.

Wojcieszak wants the data bank to keep malpractice payments secret in many cases when doctors make apologies and disclosures. Further, he wants doctors shielded from medical board discipline on these cases.

Doctors would get a pass on two cases over 10 years; a third case during that time would open the files.

Wojcieszak considers this only fair for doctors who risk their reputations by admitting to errors.

Two cases may not seem like a lot, but it is. While working on a story last year, I found that most doctors never face more than one lawsuit, and most suits are dropped or dismissed.

Doctors who cross Wojcieszak’s disclosure threshold are rare. For example, Massachusetts regulators estimated that of the 34,000 physicians licensed in the state, fewer than 100 will make more than two payments on malpractice claims over 10 years.

More than two dozen patient safety advocates and organizations like Consumers Union say Wojcieszak’s proposal would give doctors who were going to settle a suit anyway an incentive to apologize just to keep it off their record.

This would gut the data bank as a tool for protecting the public and tie the hands of medical boards by putting many questionable doctors out of reach.

Wojcieszak has gotten some support for his campaign: The Sorry Works! website lists donations from the CEOs of a health care staffing company and an organization that deters “frivolous malpractice claims.”

To reach Alan Bavley, call 816-234-4858 or send email to abavley@kcstar.com.