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Conflicts Of Interest In Guideline Development: A Dirty Little Secret Gets Aired Again

By DAVID WILLIAMS

An Archives of Internal Medicine article (Conflicts of Interest in Cardiovascular Clinical Practice Guidelines) is getting a lot of notice this month. In essence, many of the physicians who develop guideline that influence practice patterns and payment decisions have conflicts. The authors recommend only allowing those without conflicts to write the guidelines.

This isn’t a new issue. In 2006 I wrote a piece (Another dirty little secret is out in the open) and am reposting it below because it’s timely:

A year ago in Time to deal with medicine’s dirty little secrets?, I wrote about a variety of practices that are relatively well-known in the health care field but would be shocking to outsiders. Industry often takes the blame for “aggressive marketing tactics,” and no doubt some of that is deserved. But physicians are also culpable.

The open secrets include the ghostwriting of journal articles by industry sponsors, physicians and academic medical centers holding ownership stakes in companies whose products they are researching, the clinical role sometimes played by orthopedic sales reps, and perhaps the most egregious example: physicians who set guidelines having financial relationships with the companies that benefit from how those guidelines are set.

Now we have a new example, which is even more serious than usual. A recent New England Journal of Medicine article blames Eli Lilly for overzealous promotion of Xigris. According to the Boston Globe:

Eli Lilly and Co. funded medical guidelines created for the treatment of [sepsis] in an effort to boost sales of a drug with questionable benefits. The allegation was made by senior scientists at the National Institutes of Health. [They] said Lilly tried to shape the guidelines for use of the drug Xigris by sponsoring a three-pronged marketing campaign

The first two phases are by now almost standard practice in the industry:

  1. Lilly paid a task force to spread the word that hospitals were rationing Xigris because of its cost, which forced docs “to decide who would live and who would die”
  2. Lilly “orchestrated” the development of practice guidelines to treat sepsis that called for early use of Xigris (an example of the phenomenon I have described before)

But then Lilly allegedly took a third step, which was a little shocking even to me:

Now, Lilly is sponsoring lobbying efforts to turn the guidelines into quality standards. Hospitals that follow such quality measures receive higher payment from insurers.

What’s happening here? Basically, an influential group of doctors is being lazy and greedy, and Lilly is enabling their behavior. The doctors put their fingers in the cookie jar and Lilly keeps restocking it. The public is paying for the cookies –in the form of higher product sales and sub-optimal health care– and should get fed up!

I have no problem with companies using legal means to promote their products, even if their tactics are “aggressive.” They owe it to their shareholders to maximize return on investment. But it isn’t in their long-term interest to push things as far as the medical profession often lets them.

Industry leans on the reputations of individual physicians (aka “key opinion leaders”), medical societies (aka guideline writers), and journals to legitimize their marketing messages. It’s up to the medical profession to scrutinize industry claims and issue independent guidelines and quality standards. Sometimes these claims hold up and deserve to be propagated. Sometimes they don’t. If the docs and journals don’t do their jobs they deserve to lose credibility.

It’s hard to know the extent to which medical guidelines are already corrupted. The situation is a bit like the incident when the Chinese President’s plane was refitted. In the process of fixing up the plane someone inserted a bunch of listening devices (presumably at no extra charge). When the Chinese checked out the plane and realized it was bugged they had to rip the whole thing up. That’s something like what is going on within the major payers. They’ve stopped treating journal articles and guidelines as objective and have started doing their own analyses. But do we really want to leave health care decisions just to them?

Here’s some free advice to the different players in health care:

  • Industry: Feel free to market your products and services aggressively, but don’t take things too far. If you do you’ll end up killing the goose that lays the golden eggs. No one will trust doctors, guidelines or journals anymore
  • Physicians: Remember that pharma and device companies are not stupid. If they spend money supporting your research or sending you to conferences or sponsoring continuing medical education it’s because they expect to get a return on their investment. It’s awfully hard to remain objective in such instances. Your job is to adopt the best medical practices and put the patient first –sometimes that requires expensive new treatments and sometimes old, cheap standbys are better
  • Payers: Go ahead and challenge the objectivity of journal articles and guidelines. On the other hand, don’t pretend that low cost is always synonymous with best treatment. Expect physicians to keep you in line on that.
  • Patients: You need to look out for yourself. Find a good, honest physician. Take a look at who’s sponsoring the educational materials you receive. Ask your physician about alternative treatments and do some research yourself

Emotional Automation Revisited

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By JOSEPH KVEDAR, MD

Last week we all watched in awe as the IBM computer, Watson, trounced two of Jeopardy’s finest.  This event has been much heralded but it is worth stopping for just a minute to reflect on the experience of watching Jeopardy those three nights.  I had no trouble rooting for Watson, feeling disappointed or embarrassed when he missed a question and chuckling when he displayed any behavior that seemed the least bit human.  I knew the whole time, on one level, that Watson is a computer.  On another level though, I bonded with him and felt a good deal of emotion regarding his success.

MIT Prof. Sherry Turkle recently released a book entitled Alone Together.  She was also interviewed recently on TechCrunch.  Turkle puts forth the view that technology is a poor substitute for interaction with a human being. However, she notes that when technologies (robots, relational agents and the like) respond to us, they push “Darwinian buttons,” prompting us to create a mental construct that we are interacting with a sentient being.  This brings a host of emotions to the communication including affection.  Turkle makes an argument that in the realm of human relationships this phenomenon is unhealthy for our species.

I’d like to bring in principles from behavioral psychologist, Robert Cialdini, who has authored several books on the psychology of persuasion.  Cialdini offers simple tools that can be used in everyday life to persuade others to adopt one’s point of view.  In doing so, he lays out solid experimental evidence that these tools are effective, in most cases without the recipient being aware.  Continue reading…

OCR Imposes $4.3M Penalty for Violation of HIPAA/HITECH Privacy Rule

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By BOB COFFIELD

UNTIL TODAY, many health care providers questioned whether HHS and the Office of Civil Rights (OCR) would ever issue any significant penalties for violations of the HIPAA Privacy Rule. However, will OCR ever be able to collect the penalties.

Today, HHS Office of Civil Rights (OCR) announced a civil money penalty (CMP) of $4.3 million against Cignet Health of Prince George’s County, MD for violating the HIPAA Privacy Rule. This is the first ever civil money penalty issued by OCR for a violation of the HIPAA Privacy Rule. It is significant not only because it is the first – but also because of the size of the penalty and the basis for the violation.

OCR issued a Notice of Final Determination on February 4, 2011, outlining the procedure for payment of the $4.3 million civil money penalty. The Notice of Final Determination also indicates that Cignet failed to request a hearing on the matter or reach settlement with OCR. Prior to the issuance of the final notice, OCR had issued a Notice of Proposed Determination on October 20, 2010, which details the basis for the penalty, details the findings of fact, grounds for violation of HIPAA, and calculation of the penalty amount.Continue reading…

What’s Yours Is Actually Mine

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By LISA SUENNEN

Imagine someone you barely knew came to your neighborhood and took a picture of you playing with your kids at the park and then turned around and used it in an advertisement to promote a product they developed.  How would you feel?  Presumably you would be highly perturbed.  You might even want to sue them for invasion of privacy.  Most likely your case would turn on the violation of your right to publicity, which is, according to the Citizen Media Law Project (CMLP): the right of a person to control and make money from the commercial use of his or her identity.   It probably wasn’t illegal for that person to take your picture since you were in a public place, but their use of it in a money-making endeavor changes the rules.

CMLP goes on to say that if someone “sues you for interfering with that right [of publicity]” they “generally must show that you used his or her name or likeness for a commercial purpose. This ordinarily means using the plaintiff’s name or likeness in advertising or promoting your goods or services, or placing the plaintiff’s name or likeness on or in products or services you sell to the public.” In order to be a protected use in that advertising scenario, the photographer would have had to get your permission to use the photograph for that purpose.

I bring this up because I got to thinking about the topic after finishing a terrific book called The Immortal Life of Henrietta Lacks by Rebecca Skloot (Amazon’s Number 1 book of 2010).  The book is about a poor black woman from Baltimore who, in the 1950’s, has cancerous tissue removed from her body and, while she goes on to die from the cancer itself, the harvested tissue lives on in perpetuity, becoming the first “immortal” human cell line used in medical research, first by Johns Hopkins and later by the worldwide scientific community.

Henrietta’s cells, called the HeLa cell line, were removed from her with her permission (of course she wanted the cancer out), but the subsequent use of her tissue for research purpose occurred without her permission.  And now, more than 60 years later, her cells are still in wide use in scientific laboratories worldwide, producing literally billions of dollars in revenues for those who either packaged and sold the cells for commercial use or used the cells themselves to develop drugs and diagnostics.  If that ain’t using someone’s likeness in a product or service you sell to the public, I don’t know what is.  And yet Ms. Lack’s heirs were never even informed about the tissue repurposing and they certainly never received a dime in recompense.  In fact, according to author Skloot, the family members were contacted to provide additional medical tissue samples to augment the research record and weren’t even told that was the purpose of that exercise.  They are understandably a bit perturbed.Continue reading…

Survivor

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By MICHAEL TURPIN

“In the long history of humankind (and animal kind, too) those who learned to collaborate and improvise most effectively have prevailed”  Charles Darwin

As the legislative reform volcano rumbles and angrily spews magma into the Washington night, nervous industry stakeholders competing for survival on this unstable island of American healthcare are still betting that the seismic activity is merely a false eruption.

Survivor contestants are using every possible means to ensure they are not voted off the island.  The stakeholders are a veritable who’s who of personalities – the powerful, the wealthy, the prima donnas, the tough love advocates, the national health zealots, the well-intended academics, the bellicose politicians, the under-employed, the overweight, and the disenfranchised. It remains to be seen whether Congress, market forces or the American people will be the ultimate judge of who stays and who goes.

If the contestants cannot change in the next five years, 2015 will find them staring at a terrifying wall of regulation and governmental intervention that will be more destructive than the changes from the 2010 proposed legislation.Continue reading…

Robert Reich Connects the Dots

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By JANE SARASOHN-KAHN

“I’m not a class warrior. I’m a class worrier,” Robert Reich told a standing-room only crowd of thousands of health IT geeks as he delivered the first keynote address of the annual meeting of HIMSS, the Healthcare Information Management and Systems Society. This year’s crowd will have reached about 31,000 people interested in health information technology’s transformative role in health care. The 31K represents an 18% increase in attendance from last year’s crowd. The HIMSS economy is strong.

Robert Reich warns, however, that the U.S. macroeconomy is far from healthy…and health care costs will be a long-term threat to the nation’s economy unless policymakers slow them down.

Reich, who has served under 3 Presidents, written 14 books, and has been named one of the 10 most successful cabinet members, told the HIMSS audience that not only did “the great recession wear me down,” noting his small stature, but that the “gravitational pull of the great recession wore everything down.”

He noted that “We have two economies” in America: one is doing well, with the Dow hitting 12,000, corporate profits up, and companies sitting on about $2 trillion worth of cash.Continue reading…

THCB @ HIMSS11

This week we’ll be reporting live from HIMSS11 in Orlando. We’ll have backstage access to some of the biggest names at the conference, plus posts by surprise guests.

Coverage from the show is underwritten by Xerox Corporation, with areas of focus including meaningful use and EHRs, Health Information Exchanges and Health 2.0.

Find out more about the partnership here: http://bit.ly/f7vdh8.

What’s In a Word?

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By MARK FRISSE

The Health Information Exchange (“HIE”) at HIMSS11 appears noticeably different than the “HIE” of HIMSS past. HIE will be ubiquitous. It is not just a topic for a Sunday session any more. Of the 26 sessions that listed HIE as a topic, only eight were specific to the topic. The dedicated Sunday session seemed informative but predictable. Speakers provided perspectives from the federal government, states, and stakeholders. The session also included a Town Hall Meeting, a treatment of consumer engagement, and  – my favorite topic  – financial sustainability.

Scratch beneath the surface of most topics, and one may find a bit of HIE. It is central to many strategies including Meaningful Use, e-Referrals, workflow management, regional performance improvement, wired BEACON communities, quality measurement, public health, and it will play a growing role as providers and health plans form new relationships.

Each of the more than 20 sessions that place great emphasis on HIE presents an informative perspective very distinct from all of the others. Each presentation is a small chapter in a book describing the far-larger elephant of health care transformation. Confusion is to be expected; the “exchange” in the term “HIE” has many different meanings.

To some, HIE is a “thing”  – a regional organization providing exchange services or a state-level organization either providing similar services or fostering exchange through other means – this a bit like a “stock exchange.” To others, HIE is the act of communicating information from one point to another in hope of providing additional value to the point of decision-making or care. (This is more akin to an auto parts swap meet.) To Clayton Christensen, Jason Hwang, and others, exchange is an economic model for commerce – this model  – the facilitated user network – is more like Napster.

As a HIMSS attendee or an interested observer, it is important to keep these various models in mind when walking among the vendor exhibits or attending the scientific sessions. It is important to remember that the Electronic Health Record (EHR) is not simply a “computerized record” as much as it is a communications device operating within a vast and increasingly seamless network of commercial and clinical affairs. With or without health care reform, inevitable and consequential reimbursement changes will be taking place.Continue reading…

Two Kidneys and 100,000 Lives

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By PAUL LEVY

This story about a kidney transplant mix-up in California is bound to get lots of coverage. It is these extraordinary cases that get public attention. I am sure it will lead to a whole new set of national rules designed to keep such a thing from happening.

Of course, such rules already exist, and it was likely a lapse in them that led to this result.

Nonetheless, we will “bolt on” a new set of requirements that, in themselves, will likely create the possibility for yet a new form of error to occur.

This kind of coverage and response is a spin-off from the “rule of rescue” that dominates decisions about medical treatment. We find the one-off, extreme case and devote excessive energy to solving it. In the meantime, we let go untreated the fact that tens of thousands of people are killed and maimed in hospitals every year.

Those numbers are constantly disputed by the profession. To this day, many doctors do not believe the Institute of Medicine’s studies that documented the number of unnecessary deaths per year.

And you never hear anyone talking about this 2010 report by the Office of the Inspector General, which concluded:

An estimated 1.5 percent of Medicare beneficiaries experienced an event that contributed to their deaths, which projects to 15,000 patients in a single month.

As the IOM notes, “Between the health care we have and the care we could have lies not just a gap, but a chasm.”

There is an underlying belief on the part of policy makers and public and private payers that the focus on quality is best addressed through payment reform. Let me state as clearly as I possibly can: That is wrong. It is a classic example of the old expression: “When you have a hammer, everything looks like a nail.” Changes in payment rate structures, penalties for “never events,” and the like can cause some changes to occur. Their main political advantage is that they give the impression of action, and their major financial advantage is a shift in risk from government and private payers to health care providers.Continue reading…

HIMSS11 Update from the Chairman

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By C. MARTIN HARRIS, MD

As the Chairman of the board of HIMSS, the Health Information Management Systems Society, which is the largest information technology organization in the world, I’ve been very busy at our annual conference in Orlando, Fla.

As I move through this enormous venue, talking to as many of our 30,000 attending members as possible, I can’t help but think about how much work we all have to do in the coming years.

As healthcare and IT professionals, we are privileged to live at a moment in history when the work we do, the product of our shared passion, the professional discipline to which we devote so much of ourselves, is taking its place as the central catalyst of a transformation in healthcare that is in many ways, unprecedented.

Whereas previous breakthroughs in medical technology, such as the invention of the X-ray or the discovery of antibiotics, have obviously been profound, and powerful; I can think of none that ever impacted the entire medical practice model.

And that is exactly what the technology-driven transformation of healthcare is poised to deliver.Continue reading…

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