Boston Scientific (Again) Settles - This Time, Charges of Kickbacks Disguised as Clinical Studies

One would think that the stories about bad behavior by health care organizations would quiet down just before Christmas, but no...

As reported by the AP:

U.S. attorneys in Boston said Wednesday heart device maker Boston Scientific will pay $22 million to resolve allegations its Guidant division paid kickbacks to doctors to get them to use its heart devices.

The U.S. Department of Justice said Guidant paid physicians $1,000 to $1,500 each in 2003 and 2004 to participate in four studies, called RaCE, RaCE II, RaCE III, and MERITS. It said the studies were designed to increase sales of pacemakers and defibrillators.

Federal officials said the company targeted doctors who favored products made by other companies, hoping the payments would induce them to use Guidant devices more often. They said Guidant submitted claims for payment on the devices to Medicare.

Boston Scientific did not admit wrongdoing as part of the civil settlement. Under the agreement, its cardiac rhythm management division will have to publicly disclose payments to physicians on a Web site. Boston Scientific also entered into a corporate integrity agreement.

So here we have an example of a "seeding study," that is, a marketing effort to persuade physicians to prescribe a product disguised as a clinical research study, but for medical devices, not drugs.  Seeding studies seem to combine multiple kinds of unethical behavior, deceptive marketing and manipulated research.  There had been some question in the past whether seeding studies exist, but this is the second recent example to come to light, suggesting that not only do they exist, but that they are used by device as well as pharmaceutical companies.

Note that, as Bloomberg reports, this is the third major settlement of allegations of bad behavior made by Boston Scientific,

The company agreed last month to pay $296 million to settle a Justice Department probe into Guidant’s handling of heart devices and restated third-quarter results. [See post here.] In 2007, Boston Scientific agreed to pay $240 million to settle more than 8,000 lawsuits claiming Guidant hid defects in defibrillators, which are devices that shock the heart back into regular rhythm.

Cataloging legal settlements seems to be a useful way to assess the sorts of bad behavior manifested by large health care organizations (see some posts here). However, as we have said frequently, such settlements, including the "corporate integrity agreements" now frequently attached to them, seem to have done little to deter bad behavior.  Usually, the companies involved only need to pay fines, and no individual who performed, directed or approved unethical or illegal acts will suffer any negative consequences. I submit once again that such fines are viewed merely as costs of doing business by the affected companies, and do not deter future bad behavior.

I submit that would-be health care reformers who want to improve care, reduce costs and improve access should advocate for real negative consequences for people who implement, direct or approve the various versions of fraud, kickbacks, and miscellaneous corruption and malfeasance we have discussed on Health Care Renewal.

By the way, the board of directors of Boston Scientific includes two noted academics with leadership roles in academic health care.  Marye Anne Fox is the Chancellor of the University of California - San Diego, and hence the leader of a major medical school and academic medical center.  The university's mission statement, alongside which sits her picture, proclaims it "strives to maintain a climate of fairness, cooperation, and professionalism." Uwe Reinhardt, Professor at Princeton, is a noted health care economist, and blogger on the Economix blog for the New York Times.  Perhaps such august academic personages could tell  us how they are assuring that the company they are paid well to oversee upholds, rather than undermines professionalism and fairness.

ONC Defines a Taxonomy of Robust Healthcare IT Leadership

As in my post "More On Healthcare Management By Domain Neutral Generalists", Roy Poses' post "Health Care Leaders: Don't Know Much About Health Care" and many others on the topic of ill informed healthcare management (query link) at Healthcare Renewal, a common theme is lack of appropriate education and background in many of today's healthcare leaders.

ONC, the Office of the National Coordinator of health IT at HHS, has apparently now defined a taxonomy of health IT leadership in their funding opportunity announcements (FOA's).

Note the formal educational recommendations I've highlighted. Seems they’ve heard the message about the importance of cross-disciplinary -- and formal -- education for health IT leaders and even lower level workers:

From the Founding Opportunity Announcement "Program of Assistance for University-Based Training" at http://healthit.hhs.gov/portal/server.pt?open=512&objID=1428&mode=2

... Targeted Information Technology Professionals in Healthcare Roles

The six types of roles targeted by this FOA are:

(i) Clinician/Public Health Leader: By combining formal clinical or public health training with training in health IT, individuals in this role will be able to lead the successful deployment and use of health IT to achieve transformational improvement in the quality, safety, outcomes, and thus in the value, of health services in the United States. In the health care provider settings, this role may be currently expressed through job titles such as Chief Medical Information Officer (CMIO), Chief Nursing Informatics Officer (CNIO). In public health agencies, this role may be currently expressed through job titles such as Chief Information or Chief Informatics Officer. Training appropriate to this role will require at least one year of study leading to a university-issued certificate or master’s degree in health informatics or health IT, as a complement to the individual’s prior clinical or public health academic training. For this role, the entering trainees may be physicians or other clinical professionals (e.g. advanced-practice nurses, physician assistants) or hold a master’s or doctoral degree(s) in public health or related health field. Individuals could also enter this training while enrolled in programs leading directly to degrees qualifying them to practice as physicians or other clinical professionals, or to master’s or doctoral degrees in public health or related fields (such as epidemiology). Thus, individuals could be supported for training if they already hold or if they are currently enrolled in courses of study leading to physician, other clinical professional, or public-health professional degrees.

(ii) Health Information Management and Exchange Specialist: Individuals in these roles support the collection, management, retrieval, exchange, and/or analysis of information in electronic form, in health care and public health organizations. We anticipate that graduates of this training would typically not enter directly into leadership or management roles. We would expect that training appropriate to this role would require specialization within baccalaureate-level studies or a certificate of advanced studies or post-baccalaureate-level training in Health Information Management, health informatics, or related fields, leading to a university-issued certificate or master’s degree.

(iii) Health Information Privacy and Security Specialist: Maintaining trust by ensuring the privacy and security of health information is an essential component of any successful health IT deployment. Individuals in this role would be qualified to serve as institutional/organizational information privacy or security officers. We anticipate that training appropriate to this role would require specialization within baccalaureate-level studies or a certificate of advanced studies or post-baccalaureate-level training in health information management, health informatics, or related fields, leading to a university-issued certificate or master’s degree.

(iv) Research and Development Scientist: These individuals will support efforts to create innovative models and solutions that advance the capabilities of health IT, and conduct studies on the effectiveness of health IT and its effect on health care quality. Individuals trained for these positions would also be expected to take positions as teachers in institutions of higher education including community colleges, building health IT training capacity across the nation. We anticipate that training appropriate to this role will require a doctoral degree in informatics or related fields for individuals not holding an advanced degree in one of the health professions, or a master’s degree for physicians or other individuals holding a doctoral degree in any health professions for which a doctoral degree is the minimum degree required to enter professional practice.

(v) Programmers and Software Engineer: We anticipate that these individuals will be the architects and developers of advanced health IT solutions. These individuals will be cross-trained in IT and health domains, thereby possessing a high level of familiarity with health domains to complement their technical skills in computer and information science. As such, the solutions they develop would be expected to reflect a sophisticated understanding of the problems being addressed and the special problems created by the culture, organizational context, and workflow of health care. We would expect that training appropriate to this role would generally require specialization within baccalaureate-level studies or a certificate of advanced studies or post-baccalaureate-level training in health informatics or related field, but a university-issued certificate of advanced training in a health-related topic area would as also seem appropriate for individuals with IT backgrounds.

(vi) Health IT Sub-specialist: The ultimate success of health IT will require, as part of the workforce, a relatively small number of individuals whose training combines health care or public health generalist knowledge, knowledge of IT, and deep knowledge drawn from disciplines that inform health IT policy or technology. Such disciplines include ethics, economics, business, policy and planning, cognitive psychology, and industrial/systems engineering. The deep understanding of an external discipline, as it applies to health IT, will enable these individuals to complement the work of the research and development scientists described above. These individuals would be expected to find employment in research and development settings, and could serve important roles as teachers. We would expect that training appropriate to this type of role would require successful completion of at least a master’s degree in an appropriate discipline other than health informatics, but with a course of study that closely aligns with health IT. We would further expect that such individuals’ original research (e.g. master’s thesis) work would be on a topic directly related to health IT.

They've also called on Community Colleges to take the lead in producing worker bees:

http://healthit.hhs.gov/portal/server.pt?open=512&objID=1414&mode=2

It is also recommended that the teachers of these worker bees have a formal cross disciplinary background.

These are encouraging signs, as they lend significant formalism to the current marketplace where, completely alien to the culture of medicine itself, anyone of any educational background (or no educational background) can be a healthcare IT / informatics "expert" and leader.

Even with these definitions, doing health IT "right" is still far, far harder than it looks, but at least the rigor of medicine is starting to be applied to the "anything goes" world of healthcare IT and IT workers in healthcare-related roles.

That domain has long suffered striking inattention to education and qualifications requirements, and a healthcare-dyscompetent leadership that I believe has significantly fueled healthcare IT difficulty and failure.

This is a helpful stance against devil-may-care attitudes such as those of major health IT leadership recruiters. From an article a number of years ago in the journal “Healthcare Informatics”:

I don't think a degree gets you anything," says healthcare recruiter Lion Goodman, president of the Goodman Group in San Rafael, California about CIO's and other healthcare MIS staffers. Healthcare MIS recruiter Betsy Hersher of Hersher Associates, Northbrook, Illinois, agreed, stating "There's nothing like the school of hard knocks." In seeking out CIO talent, recruiter Lion Goodman "doesn't think clinical experience yields [hospital] IT people who have broad enough perspective. Physicians in particular make poor choices for CIOs. They don't think of the business issues at hand because they're consumed with patient care issues," according to Goodman.

Now, if only ONC's thinking can percolate to the highest levels of healthcare and pharmaceutical leadership, including the "C" level and the boards of directors.

-- SS

How to Give a Course on Corruption in the Health Sector

Just out from the U4 Anti-Corruption Resource Center is a brief paper on "Approaches to teaching and learning about corruption in the health sector."  (Note that U4 has a very useful web-page on corruption health care, also now appearing in the links in our side-bar.)

The paper begins by describing the overall goals of such a course:

The overall goals for training in anti‑corruption in health are to help people develop the knowledge, skills, and attitudes they will need to identify and understand problems of corruption in health, design anti‑corruption strategies, strengthen health systems for good governance,
transparency, and accountability, and advocate for integrity in governance. An additional goal is to prepare people to respond to individual experiences they may have with corruption, such as how to react when they suspect someone has engaged in corruption, when they are asked
to pay or accept a bribe, or other situations.

Then it lists a set of learning objectives:

- Define corruption.
- Identify the types of corrupt activities that occur in the health sector, and their scope and seriousness.
- Explain why corruption occurs, applying principles of economics, governance, and crime prevention to understand the issues involved.
- Assess risks and vulnerabilities which make corruption more likely in certain settings.
- Identify the consequences which can result from corruption.
- Discuss cultural differences in defining morality and corruption, including the blurred line between corruption and trading favours, giving gifts, using contacts, etc.
- Describe the core elements of corruption prevention and control programmes.
- Given a particular country situation or programme, explain how corruption can be reduced in drug supply, financial systems, and delivery of health services.
- Become an effective advocate for anti‑corruption strategies and reforms to promote accountability and transparency in health programmes.

The rest of the paper was devoted to specific content that might be included in such courses, and various activities that could facilitate learning.

Although the paper seems to be aimed at people in developing countries, I would submit that its content, and the sort of courses it proposes, would be equally useful in developed countries, including the US.  After all, Transparency International has pointed out that health care corruption seems to plague most countries regardless of income, level of economic development, or type of organization of health care systems.  The details of how corruption occurs just vary from country to country according to these factors.  On Health Care Renewal, we certainly have documented some striking instances of corruption in developed countries, mainly in the US, as well as corruption's little siblings, conflicts of interest and self-interested mismanagement.

However, I suspect that courses about health care corruption are rare, if not completely non-existent, in US medical schools, as are courses about corruption occuring "within country" at US public health schools.  In fact, the only "politically correct" way to talk about health care corruption in most developed countries is to talk about how it affects other, usually less developed countries. 

At least the author of the paper, Taryn Vian, has the courage to teach her course in the US, at the Boston University School of Public Health.  (She also drew on experience giving professional workshops in several countries.)  However, while the course does include examples from the US and developed countries, it is aimed at students interested in international public health.  I would guess that no one has invited Ms Vian to each the course for US medical students at BU or elsewhere.  (And if anyone knows about similar courses taught at US medical schools, US public health schools directed at in-country problems, or at medical or public health schools in other developed countries, please let us know.) 

It is a striking example of the anechoic effect that corruption in health care is not considered an important topic for US medical schools.  Of course, as long as we do not talk about the problem, we can pretend it does not exist.  Is it any wonder that our health care continues to get more expensive and less accessible?

Spun Silly: Academic Medical Center Cancer Treatment Advertising in the Era of Hype and Flim-Flam

Over the weekend, the New York Times reported on how prestigious academic medical centers advertise cancer care.  Here are some examples,

Prostate Cancer Surgery at Mount Sinai

A print advertisement for prostate cancer surgery at Mount Sinai Medical Center in Manhattan is typical of the way many elite research and teaching hospitals sell hope to the public.

'Our newest prostate specialist, Dr. David Samadi, has pioneered a minimally invasive approach that allows him to retain the highest cancer cure rates with the lowest risk of side effects,' says the ad.

Highest cure rates. Lowest risk. What evidence does the medical center have to back up such superlatives?

The ad’s claims are based on the successful results of Dr. Samadi’s operations and testimonials from his patients, said Jane Zimmerman, Mount Sinai’s chief marketing officer.

However, the article noted that the hospital could provide no studies that showed that its or Dr Samadi's results were superior to those of other hospitals or other surgeons.

... the ad with the superlative prostate cancer claims ... was later revised to say that Dr. Samadi’s approach gives 'high rates of success coupled with lowered risks of side effects.' Ms. Zimmerman said Dr. Samadi was not available to be interviewed.

Also,the people who concocted the advertisement said it was not really meant to tell prospective patients that the surgeon had better results than all others:

But marketing executives defend their approach, saying cancer treatment ads tend to play more heavily on emotion than on medical statistics because the ads are not intended to inform people who already have the disease. They are meant to make an impression on future patients, who may decide on treatments years after they have seen an ad, or to sway influential people who might advise a future patient.

'This isn’t retail advertising,' said Ellis Verdi, president of the DeVito/Verdi Agency in Manhattan.

The agency produced the Mount Sinai ad, which ran in The New York Times, and has created cancer ads for other hospital clients. 'This is reputation advertising,' Mr. Verdi said. 'There is a very big difference.'

But the advertisement said that the hospital's prostate cancer specialist had the highest survival and lowest adverse event rates.  How would a patient with prostate cancer realize that the advertisement was only meant to enhance the hospital's reputation, but not meant to speak to him?  

Radiation for Brain Tumors at Massachusetts General Hospital

'We gave Nick something he couldn’t find anywhere else in the Northeast. Life without cancer.'

That was the text of a print ad last year by the Massachusetts General Hospital Cancer Center in Boston, promoting its $50 million center for proton beam therapy, a kind of high-energy radiation to treat brain tumors and other cancers.

The hospital was the only medical center in the region with a proton therapy center, the ad said, enabling doctors there to successfully treat the brain tumor of a young man named Nick.

The ad’s concept was that Nick had a greater chance of survival because the precise proton beam could destroy malignant brain tissue while leaving surrounding healthy brain tissue intact, said Jodie Justofin, the marketing director at Mass General’s cancer center.

Dr. Thomas F. DeLaney, the medical director of the Francis H. Burr Proton Therapy Center at Mass General, said he had no involvement in the ad and did not have any information about Nick.

However, the article also noted that "no rigorous studies have shown that proton beam therapy has higher brain-cancer cure rates than other treatment methods, said Dr. [John D] Birkmeyer of Michigan [a professor at the University of Michigan and cancer outcomes researcher]. 'The ad might be accurate that they are the only hospital in the Northeast with this particular widget,' he said. 'But it could be misleading that the availability of this particular widget gave this patient better odds of survival.'"

Again, the advertisement said that the patient got "life without cancer," something he could not get anywhere else in the Northeast.  How would a patient with a brain tumor realize that the advertisement was merely based on a "concept," rather than scientific evidence that his  or her only hope for "life without cancer" could come from proton beam therapy at the Massachusetts General Hospital?

Surgery for Cervical Cancer at Memorial Sloan-Kettering Cancer Center

'Cancer, You said I’d never bear children,' reads the handwritten letter, held out by a pretty, healthy-looking woman, as a toddler peeks from behind the paper. 'My daughter says you’re wrong.'

That recent print ad from Memorial Sloan-Kettering Cancer Center in Manhattan tells the story of Michelle Rogala, a patient with cervical cancer.

Ms. Rogala’s hospital in New Jersey could offer her only a hysterectomy, an operation that would have left her unable to have children. Instead, she went to Memorial Sloan-Kettering, where she entered a clinical trial that was studying less invasive surgery. Ms. Rogala now has a little girl named Maddie.

Ellen Miller-Sonet, vice president for marketing at Memorial Sloan-Kettering, said consumers seeing the ads realizes that these were individual stories. 'They know that no two people are the same,' she said.

However, Ms Rogala told the NY Times, "hers had indeed been a special case. She had early-stage cervical cancer, she said, making her eligible for a novel operation that has now become a standard treatment at the center. After her operation, doctors told her she would need fertility treatments to conceive. But she said she turned out to be one of the few patients in the study who did not need radiation — which can cause fertility problems. She later became pregnant without medical intervention."

Again, why "consumers," much less patients with cervical cancer, would realize that the advertisement was just an "individual story," not a promise that the hospital's treatment of cervical cancer would not prevent future pregnancies, was entirely obscure.

Summary

The three advertisements described in the NY Times article had some features in common. All seemed to promise exceptional results. None were based on clear scientific evidence. All seemed to have been products of marketers and advertising agencies working without input from the physicians who actually provide the treatments they were advertising. All the marketers defended their work by saying that the advertisements did not actually mean what they appeared to mean.

My most obvious comment is that hospitals, even the most prestigious teaching hospitals, now seem to be willing to market their services like the used car salespeople seen on late night television.  Such advertisements, of course, are unseemly and undignified coming from such august institutions.  Worse, they seem to promise more than what these or any hospitals can be proved to deliver, and the only defense of the marketers who produced the advertisements were that they did not mean what they seemed to mean.

This shows the sad, and ultimately deceptive and unethical effects of turning the leadership of our best medical institutions over to businesspeople with little knowledge or understanding of the values of  health care.

It also shows what has happened to health care in an age of hype, scam, sham, spin and flim-flam.  It all seems part of what Frank Rich just wrote about in the NY Times:

If there’s been a consistent narrative to this year and every other in this decade, it’s that most of us, Bernanke included, have been so easily bamboozled. The men who played us for suckers, whether at Citigroup or Fannie Mae, at the White House or Ted Haggard’s megachurch, are the real movers and shakers of this century’s history so far. That’s why the obvious person of the year is Tiger Woods. His sham beatific image, questioned by almost no one until it collapsed, is nothing if not the farcical reductio ad absurdum of the decade’s flimflams, from the cancerous (the subprime mortgage) to the inane (balloon boy).

What makes the golfing superstar’s tale compelling, after all, is not that he’s another celebrity in trouble or another fallen athletic 'role model' in a decade lousy with them. His scandal has nothing to tell us about race, and nothing new to say about hypocrisy. The conflict between Tiger’s picture-perfect family life and his marathon womanizing is the oldest of morality tales.

What’s striking instead is the exceptional, Enron-sized gap between this golfer’s public image as a paragon of businesslike discipline and focus and the maniacally reckless life we now know he led. What’s equally striking, if not shocking, is that the American establishment and news media — all of it, not just golf writers or celebrity tabloids — fell for the Woods myth as hard as any fan and actively helped sustain and enhance it.

People wanted to believe what they wanted to believe. Tiger’s off-the-links elusiveness was no more questioned than Enron’s impenetrable balance sheets, with their 'special-purpose entities' named after 'Star Wars' characters. Fortune magazine named Enron as America’s 'most innovative company' six years in a row. In the January issue of Golf Digest, still on the stands, some of the best and most hardheaded writers in America offer 'tips Obama can take from Tiger,' who is typically characterized as so without human frailties that he 'never does anything that would make him look ridiculous.'

I would note that the health care precursor to all this was how the former CEO of the Allegheny Health Education and Research Foundation (AHERF), the biggest health care system in Pennsylvania in the 1990s, was hailed as a visionary in the medical press and scholarly literature, which later ignored AHERF's bankruptcy and its former CEOs criminal conviction (see post here.)  So my one disagreement with Mr Rich is that the problems are much older than the 21st century.
Rich concluded,

after a decade of being spun silly, Americans can’t be blamed for being cynical about any leader trying to sell anything. As we say goodbye to the year of Tiger Woods, it is the country, sad to say, that is left mired in a sand trap with no obvious way out.

The way out of our sand trap in health care, of course, is to refuse to be spun any more. We need to stop believing the hype propogated by all the clever marketers, and all the self-interested CEOs who hire them.

Meanwhile, I would suggest to any cancer patient who failed to get the wonderful results promised by some slick hospital advertisement, there may be some lawyers who with whom you ought to speak.

Addressing Drug, Biotechnology, and Device Companies' Payments to Physicians: the Thai National Health Assembly

We have frequently discussed how financial relationships among physicians, other health care professionals, and health care academics, on one hand, and drug, biotechnology, medical device and other health care corporations may have adverse effects on patient care and medical teaching and research.  A first step towards addressing these relationships would be their full disclosure.  Here in the US, Senators Grassley (R-Iowa) and Kohl (D-Wisconsin) have been pushing for a Physician Payments Sunshine Act which would require all such companies to disclose all such payments.  Whether it will become law, as part of health care reform legislation or independently, is now anyone's guess.

Since we are based in the US, we tend to discuss such issues from a US viewpoint.  Just to show that these problems are global, and that some countries may have more fruitful approaches to them than others, see a recent article from the Bangkok Post on the run up to the Thai National Health Assembly:

Over-prescription of pills and medicines by doctors under pressure from pharmaceutical companies is being condemned by senior doctors ahead of a national health assembly on the issue this week.

In some cases, drug sales representatives were criticised for wearing 'inappropriate outfits' and offering gifts to secure orders.

Doctors say they are quite prepared to join any public sector moves to end unethical drug promotion to protect patients and cap soaring national health care costs and irrational drug use.

At a forum on ethical criteria for promoting medicines, physician Prasert Palittapongarnpim, of Chiang Rai's Prachanukroh Hospital, said big pharmaceutical firms use many different methods to encourage doctors to prescribe their drugs.

They range from small gifts and stationery to lucrative luncheon lectures, seminar sponsorships and overseas trips.

Dr Prasert said he was once offered a huge sum of cash by a drug salesperson to change his drug order.

Some senior doctors also tell their medical students to buy drugs of smaller dosages so they can increase the size of their orders.

At the close of the Assembly, the Bangkok Post reported:

Curbing the influence of pharmaceutical firms on doctors topped the agenda of the three-day National Health Assembly which ended yesterday.

A better regulation was needed to govern the promotional activities and the sale of medicine to solve the problem of unnecessary and excess drug prescription by physicians, the annual health forum was told.

Unethical sales of drugs were among 11 health-related issues discussed during the second National Health Assembly (NHA2009).

Suwit Wibulpolprasert, the assembly's chairman, said the problem of over-prescription was rampant and worrying.

There are doctors who only place orders with a firm offering them lucrative inducement packages in return, such as overseas trips and expensive gifts.

'We need to have a regulation which would require these drug firms' sponsorship to doctors to be made public,' said Dr Suwit. He said a group of experts were working on a bill to prevent a conflict of interest between doctors and pharmaceutical companies. When ready, it would be submitted to the national drug system development panel, chaired by the prime minister, for consideration.

Dr Suwit has recommended that an independent body be set up to monitor and report the unethical behaviour of doctors and concerned agencies until the enforcement of the new law.

One would think that having a National Health Assembly would orient health policy more towards the issues concerning people and patients rather than those pushed by health care corporate CEOs (as we discussed here).  Of course, here in the US, we have nothing that resembles the Thai National Health Assembly.  Maybe if we did, legislation like the Sunshine Act would get a more favorable reception.