Cultivating Astroturf

We have previously posted about "astroturf movements," defined as artificial grass-roots movements bankrolled by corporations, and their applications in health care. It seems to be the season to cultivate astroturf (it is the US football season).

The Wall Street Journal reported how Amgen "is pouring millions of dollars into a lobbying campaign to get Congress to change a Medicare rule that dealt a big blow to the company's lucrative anemia drugs." Part of this effort appeared to be an astroturf campaign,

Since the summer, the company has run an Internet-centered campaign, Protect Cancer Patients, that tries to capture the feel of a grass-roots effort by encouraging cancer patients, survivors and family members to send in their stories and to upload video and audio testimonials. The Web site also encourages individuals to phone members of Congress.

"We were very interested in making sure that the Medicare beneficiaries had a vehicle to make their voices heard," says Josh Ofman, Amgen's vice president of global reimbursement and payment policy. The company says it has already generated hundreds of emails and phone calls to lawmakers.

But on Friday Amgen said it had suspended the site as part of a re-evaluation of its online campaign. The company said the decision was unrelated to a report in the Cancer Letter, an influential newsletter, suggesting that testimonials on the site advocating off-label uses of the drug could violate Food and Drug Administration marketing rules. [NB - the web-site now appears to be down. But a cached version is still found here.]

And Johnson & Johnson is up to something similar,

Last week, Johnson & Johnson launched a similar effort for its anemia-fighting drug, Procrit [epoetin alpha], with a Web site, www.voiceforcancerpatients.com, that allows individuals to send emails to the Center for Medicare and Medicaid Services and contact their representatives in Washington. The site doesn't include patient testimonials.

The Wall Street Journal report did not call these astroturf campaigns, but used the euphemism, "indirect grass-roots campaigns,"

Indirect grass-roots campaigns have become a popular tactic among lobbyists because they focus the issue away from a powerful entity and toward ordinary people who would ostensibly suffer if the government fails to respond. In this case, the front group is especially sympathetic.

Astroturf by any other name is still artificial.

Meanwhile, as reported by Ed Silverman on PharmaLot, there is opposition to Consumer Union's (CUs) hilarious counter-advertisement on restless legs syndrome (RLS). A video of the counter-advertisement appears here.

The Executive Director of the Restless Legs Syndrome Foundation, Georgianna Bell, wrote a letter to CU harshly critical of its counter-advertisement. She did not point out in the letter that her organization receives major funding from the manufacturers of drugs for RLS (see previous post here). GlaxoSmithKline (GSK) contributed over $250,000 a year over the most recent two years covered by the Foundation's annual reports (2006 and 2005). GSK, of course, makes Requip [ropinirole]. Boehringer Ingelheim Pharmaceuticals Inc, the manufacturer of Mirapex [pramipexole] approved in 2006 by the US Food and Drug Administration to treat RLS, gave over $150,000 in the most recent year.

Once again, you can't tell the players in health care without a scorecard. I see nothing wrong with commercial health care firms expressing their point of view. But astroturf campaigns are fundamentally deceptive. If biotechnology, pharmaceutical, device and other health care companies do not want to be regarded as "shifty," they ought to cease such stealth marketing and stealth health lobbying, and stop cultivating astroturf in particular.

Physicians and Contracts: A Cautionary Tale

A conversation yesterday with one of my colleagues reminded me of this issue. So forgive me if I reference some articles that are a few weeks old.

The relevant news article by Lisa Girion was in the Los Angeles Times the beginning of November. The issue was that a major California insurer, Blue Cross of California, a subsidiary of Wellpoint Inc, was accused of putting a confidentiality provision into its contracts with physicians and hospitals that prevented them from consulting lawyers for their help in contract negotiation:

The state stepped into a bitter battle Thursday between Blue Cross of California and the doctors, hospitals and medical labs that serve about 700,000 people covered by the state's largest health plan.

At issue is the contentious financial relationship between medical providers and Blue Cross, which the state's top HMO regulator warned might worsen the plight of California's struggling hospitals.

The dispute began this year when Blue Cross sought to require hospitals, physicians and labs to sign a confidentiality agreement that would prevent them from publicly discussing fee negotiations.

But the providers balked, saying it prevented them from using lawyers and other outside consultants to represent them in fee negotiations, a routine practice.

If they refuse to go along with the rules Blue Cross lays down for the negotiations, the providers say, the health plan threatens to stop sending them patients.

On Thursday, the Department of Managed Health Care issued a cease-and-desist order forbidding Blue Cross to continue its efforts.

This tactic seems, at a minimum, grossly unfair to the physicians and hospitals. It is not the first time a Wellpoint insurer has been accused of unfair practices that seem to contradict its high toned statement of "commitments"

Note that a recent American Medical News article discussed some of the technical aspects of confidentiality provisions that may appear in contracts.

But the larger issue here to me is the problems physicians have when confronted with the prospect of signing contracts. As Lisa Girion wrote in the LA Times article,

Francisco Silva, a legislative advocate for the California Medical Assn., said the physicians' organization was disappointed that the order failed to address contracts that already had been signed by providers.

'We were hoping for something broader,' he said of the order. 'While it clearly indicates that the confidentiality agreement in the contracts was illegal, it did not go back and declare the existing contracts void.'

Silva said he believed hundreds of physicians had signed contracts that they negotiated on their own because they felt they had no choice. 'For some of these physicians, particularly if they are small offices, they don't have the ability to negotiate with the most powerful insurance company in the state,' he said.

This alludes to two linked phenomena:

• Physicians are often confronted with contracts that others, including large and powerful organizations, wish them to sign.
• Physicians often feel they MUST sign these contracts, even if they do not understand them, or fear they contain provisions that will disadvantage the physicians or their patients.

This was discussed in a Medscape article on physicians' learned helplessness [Bond C. The training of the "helpless" physician. Medscape General Medicine 2007; 9(3):47] that we posted about here:

In place of old-fashioned fee-for-service medicine in virtually every medical market in America, the economic lifeblood of today's medical practice depends almost entirely on contracts. Almost all of a physician's private patient flow depends on his or her contractual relationships: Private patients are provided either under an employment contract with an employer or they come into the practice through a contract between the physician and a health maintenance organization (HMO) or preferred provider organization (PPO). However, few young physicians are trained in how to analyze contracts, or when, where, and how to get the appropriate help with their contracting relationships. Instead, unfortunately, they are blithely following the model of older physicians who literally signed away fee-for-service medicine and continue, for the most part, to accept what health plans offer without significant legal or economic scrutiny.

In fact, yesterday my colleague told me yesterday about a case in which some physicians were handed a contract, and they "just folded," in her words, signing the contract without completely understanding it, even though it probably contained objectionable provisions.

I have personally witnessed several other anecdotes in which seemingly smart, dedicated physicians were willing to sign complex contracts which they clearly did not understand, usually with the excuse that "we would not be given this contract to sign if it were not in our best interest." The contracts were long, written in complex legalese, and contained numerous questionable provisions, including provisions about confidentiality.

In the words of my son, "what were they smoking?"

Maybe it was because I grew up in a family full of lawyers, but I always thought one should never sign a contract when in doubt about any aspect of its meaning, and one should never feel compelled to sign a contract.

What is going on here? Were the physicians so conditioned by their prior hierarchical, ascetic training (as described in the Bond article above) that they really believed no one would ever give them a contract to sign that was not in their and their patients' best interests? Were they too busy and tired to put in the effort to read the contract? Were they embarrassed to admit they did not understand it? Were they too conflict averse to contemplate refusing to sign the contract until they understood it and found it satisfactory?

As Bond wrote, I believe we physicians let many aspects of the health care system go bad because we were too busy, too embarrassed, or too intimidated to refuse to sign contracts that were bad for us or our patients.

So here is my (non-legal) advice to all physicians.

• Read fully any contract which you are asked to sign
• If you do not fully understand it, or have trouble reading it, do not sign it. (Hint, it is likely that any contracts longer than 1-2 pages single spaced in 12 point font may be difficult to understand.)
• If you still think there may be value to you in signing it, consult a lawyer and again, do not sign the contract unless the lawyer can explain it to you, and his or her explanation leaves you with confidence that signing it would be good for you and your patients.
  

ADDENDUM (19 November, 2007): see comments here on the Covert Rationing Blog.

More About Hospital's "A-Lists"

We previously posted about how one well-reputed US state-supported academic medical center allegedly maintained an "A-list" of donors and other VIPs who received additional amenities, and easier access to health care. One of our readers responded to it thus:

The 'A list' idea is a very common practice. I've always found it
offensive, intrusive and detrimental to patient care. Of course it suggests
that the UIP's (unimportant persons) get lower quality treatment.

Our hospital has a program that is almost like calling a 'code.' When a
patient on the list is admitted, the administrator on call is paged and the
administration people then proceed to make a nuisance of themselves. I have
actually had the chief of staff of the hospital poking around in the
patient's chart and giving the patient's family his card so that they were
calling the administration about routine issues that should have come to me.
In one case, the VP of nursing was pacing the floor outside the patient's
room watching everything that was going on.

He then asked,

It might be interesting to find out exactly how widespread this practice is.
Perhaps what's needed is a public statement about how inequitable it is and
that it's not in the patient's best interests.

In fact, the Dallas News decided to see if the practice is common at least in Texas. However, it appeared that it is not, at least in the UT Southwestern version. For example, the reporter asked about the Baylor Health Care System,

'What they're doing is unusual. It sounds to me like they have a prospective list rather than people they already know through volunteers, board relations, donors or something like that,' said Jennifer Coleman, senior vice president of Baylor Health Care System.

'Most [hospitals] do keep track of board members and donors, but we do not have a target list,' Ms. Coleman said. 'What they are doing is something I've never heard of.'

At Baylor Health Care System, Ms. Coleman, the senior vice president, said free parking programs and expedited paperwork are available – to anyone who signs up.

Re M. D. Anderson Cancer Center in Houston, also part of the University of Texas system,

M.D. Anderson Cancer Center in Houston, which, like UT Southwestern, is part of the University of Texas system, has a separate development office outside the hospital that deals with fundraising activities.

'What they do is build and cultivate relationships of people who they believe may be potential donors,' said Wendy Gottsegen, director of external communications. 'That's common practice.'

But the fundraising does not cross over into the care that donors and potential contributors would receive at the hospital. 'Absolutely not. I want to be 100 percent clear,' Ms. Gottsegen said.

Re Presbyterian Hospital of Dallas,

Presbyterian Hospital of Dallas is a nonprofit hospital and does track its donors. But that does not translate to any special perks or levels of patient care, said spokesman Stephen O'Brien.

'We do not have a VIP list,' he said. 'Our foundation has a list of members, but it's not a list that is cross-checked with the hospital. We are sometimes made aware if a donor is in the hospital. We will stop by to say hello; that's the extent of it.'

Mr. O'Brien said influential or well-known patients are not flagged by the hospital. 'We're not dismissive of any one class of patients,' he said.

The article reiterated that people on the "A-list" not only get amenities, but enhanced access to physicians and care,

They do get a personal greeting upon arriving at the medical center for an appointment. Most also get an escort to their appointment and free parking.

A more select group receives extensive personal attention and a streamlined process for contacting doctors. The dedicated program acts almost like a concierge service for these people.

People in the program know they are on the list, because they are sent a letter informing them about the special services they can receive. To make appointments, they can use an unlisted phone number to reach the Special Assistance Office. The hotline is also available for reaching a doctor on weekends and after hours.

A UT Southwestern physician will promptly return such calls, said Dr. McConnell. If necessary, the doctor will also meet the patient at the hospital "and introduce the patient" to the emergency room staff at UT Southwestern's St. Paul building or at Parkland Memorial Hospital, Dr. [John] McConnell [executive vice president for health system affairs] said.

The process is different for those not in the special assistance program. Those who call the medical center's main phone line after hours will be referred to the general answering service, he said. A responding doctor might refer these callers to one of the emergency rooms, but would not automatically meet them there, he said.

So it would seem that other hospitals and medical centers may have "A-lists," but the practice is not universal.

As noted before, the practice does raise troubling questions, especially whether it may violate the organizations' missions. As noted earlier, the University of Texas Southwestern mission statement specifically included the goals of improving "medical care in our community," and "focusing on quality, safety, and service."

Howard Brody Explores Darkest CafePharma

On the Hooked: Ethics, Medicine, and Pharma blog, Howard Brody posted about his foray into the world of the CafePharma bulletin board, and focused on a debate - that is a polite term for it - which started when an anonymous person asked "do you ever mess with the food [provided free to a medical office] before lunch?" This produced a lively and scatalogical exchange, made livelier, if that is the word, by the participation of PandaBearMD (who blogs here). Since nearly everything on this bulletin board is anonymous, it is a bit hard to determine which stories are true, and which rants are authentic. But Brody summarized his thoughts thus:

I have tried hard in my own work never to villainize reps. As I see it, reps have an impossible job. From the company's point of view, they have one function only, to move product. I ask at every opportunity for someone to tell me about a single rep who was ever paid a single bonus for anything other than quantity of drug sales--and no one has ever given me an example.

The other part of their job is to lie about this. They have to lie to two people. First they have to lie to us, because we demand it. We will not easily and comfortably take all the goodies they shove our way, unless they keep repeating over to us the soothing rationalization, "It's education, not marketing." Second they often have to lie to themselves because they can live with themselves much easier if they can see themselves as educators and not as mere salespeople. Or at least they can lie to us more glibly if they lie to themselves first.

In one respect, I can concur completely with the blog postings, as much as I am repulsed by the packaging. If I sort through the obscenities, one basic idea seems to stand out. These reps despise docs and office staff who first scarf up their food and other goodies whenever they get the chance, and then believe that they can turn around the treat the reps who brought the stuff like dirt.

And I would like to believe that this posting really was heart-felt:

What ever happened for our respect for the doctors AND their respect for us. At some point this has fallen by the wayside. No wonder why no one likes us or respects us anymore.

If a doc lets us into his/her office, then they should expect to be 'sold' or 'pitched' on a product. This would be an intellegent discussion between two educated professionals. We feed them as a 'thank-you' for their business and for listening to us.

We have to realize that we can't get all docs to write all of our products all of the time! If they don't like us or do not want to be 'sold', then PLEASE - just don't let us in. That simple. Don't eat or accept our food either. Simply divorce yourselves from us.

Perhaps if we all have this understanding, we can begin to respect each other once again.

Insurance Company Employees Got Incentives to Cancel Policies After People Got Sick

The Los Angeles Times just published a story about one health insurance company's attempts to cancel individual health care insurance policies after their holders became sick. Internal company documents became available in the course of a law-suit, and provided some important revelations.

Health Net's disclosures Thursday provided an unprecedented peek at a company's internal operations and marked the first time an insurer had revealed how it linked cancellations to employee performance goals and to its bottom line.

The bonuses were disclosed at an arbitration hearing in a lawsuit brought by Patsy Bates, a Gardena hairdresser whose coverage was rescinded by Health Net in the middle of chemotherapy treatments for breast cancer. She is seeking $6 million in compensation, plus damages.

Health Net had sought to keep the documents secret even after it was forced to produce them for the hearing, arguing that they contained proprietary information and could embarrass the company. But the arbitrator in the case, former Los Angeles County Superior Court Judge Sam Cianchetti, granted a motion by lawyers for The Times, opening the hearing to reporters and making public all documents produced for it.

At a hearing on the motion, the judge said, 'This clearly involves very significant public interest, and my view is the arbitration proceedings should not be confidential.'

The description given of how the company handled individual policies was disturbing.

The documents show that in 2002, the company's goal for Barbara Fowler, Health Net's senior analyst in charge of rescission reviews, was 15 cancellations a month. She exceeded that, rescinding 275 policies that year -- a monthly average of 22.9.

More recently, her goals were expressed in financial terms. Her supervisor described 2003 as a "banner year" for Fowler because the company avoided about "$6 million in unnecessary health care expenses" through her rescission of 301 policies -- one more than her performance goal.

In 2005, her goal was to save Health Net at least $6.5 million. Through nearly 300 rescissions, Fowler ended up saving an estimated $7 million, prompting her supervisor to write: 'Barbara's successful execution of her job responsibilities have been vital to the profitability' of individual and family policies.

We have previously discussed allegations that other California health insurers retroactively cancelled policies of people who became sick here.

As we said then, health insurance that is liable to be cancelled soon after the policy-holder gets sick and makes a significant claim hardly deserves to be called "insurance."

This seems to be another example that what you see is not what you will really get in our current dysfunctional health care system.

Hat tip to the Health Care Blog.

An Academic Medical Center with an "A List?"

The Dallas Morning News just printed a story about one hospital's alleged "A-list."

UT Southwestern Medical Center at Dallas keeps a detailed list of wealthy, high-profile and influential people and their family members to ensure that they get favored treatment if they become patients.

Here is what is known about the people on the list.

The News reviewed a list dating from 2003 and found a virtual "Who's Who" of Dallas and the region. The list is maintained by UT Southwestern's Special Assistance Office and appears to identify wealthy and influential people who either are or might become major donors to the university. The list also includes family members, employees, friends and even one prominent person's maid.

Business titans Trammell Crow, T. Boone Pickens and H. Ross Perot appear on the list along with members of their families. Others include social event planners, fashion designers, several former Dallas mayors and current Mayor Tom Leppert.

The list also includes executives and several nonmanagement employees of The News and its corporate parent, Belo Corp.

Politicians at all levels of the country's government made the list. They include Vice President Dick Cheney and his wife, Lynne, as well as current and former members of Congress and their family members, including Sen. Kay Bailey Hutchison and her husband; Rep. Eddie Bernice Johnson; and former U.S. Rep. Martin Frost.

State officials include Sen. Royce West and House Speaker Tom Craddick and his wife. Local names include former Dallas Mayor Laura Miller and her husband, former state Rep. Steve Wolens; and the late Dallas County Commissioner Chris Semos.

Dr. Ron Anderson, president and chief executive officer of Parkland Memorial Hospital, is also on the list.

What are the alleged advantages of being on the list?

Dr. John McConnell, executive vice president for health system affairs at the medical center, said people on the list only get a personal greeting when they arrive at the medical center, might get a special escort to their appointment, and sometimes get free parking.

He also said some people on the list could have a doctor come to the emergency department, even in the middle of the night, to admit a patient who needed immediate care.

"There are patients who are friends of the university, including major donors. Like every other hospital, we have an ability to make sure they don't have any service letdowns," Dr. McConnell said. "We are not ashamed of having this program. If you have people who are important to your business, you're going to treat them well when they walk through the door."

Dr. McConnell did not deny that patients on the list could readily get appointments at UT Southwestern's prominent clinic, the James W. Aston Ambulatory Care Center. But he also said that any patient who complained could also get similar treatment.

This story at least raises the suspicion that people on the alleged "A-list" may get not only some extra amenities, like valet parking, but also better access to care than the average patient.

This seems to imply some slippage from the mission of a partially publicly supported medical school and medical center. For example, the UT Southwestern mission statement is [with italics added for emphasis]:

* To improve health care in our community, Texas, our nation, and the world through innovation and education.
* To educate the next generation of leaders in patient care, biomedical science and disease prevention.
* To conduct high-impact, internationally recognized research.
* To deliver patient care that brings UT Southwestern's scientific advances to the bedside — focusing on quality, safety and service.

Unfortunately, too many of our revered not-for-profit health care institutions seem to be lead in ways that do not always honor their missions

The leaders of these organizations should remember the duty of obedience, the legal requirement that the board of the organization (and hence its leadership) be faithful to the organization's mission.

Hat tip to blog.bioethics.net.

BLOGSCAN - The WHO, NGOs, and the Pharmaceutical and Biotechnology Industries

On PharmaLot, Ed Silverman wrote about claims that most of the non-governmental organizations (NGOs) offering comments at a World Health Organization meeting designed to boost innovation in treatment of neglected diseases like tuberculosis and malaria were from organizations with financial ties to pharmaceutical manufacturers and biotechnology companies.

The AAOS Responds to Disclosure of Payments to Orthopedic Surgeons

We have previously posted ( here, here, and here) about the payments, often huge, that five manufacturers of prosthetic joints ((Biomet, DePuy Orthopaedics (a unit of Johnson & Johnson), Stryker Orthopedics,a unit of Stryker Inc, Zimmer Holdings, and Smith & Nephew) just revealed they made to orthopedic surgeons and various academic and other organizations. The lists are here: Biomet, DePuy, Smith & Nephew, Stryker, and Zimmer.

The American Academy of Orthopedic Surgeons and the American Association of Orthopedic Surgeons (AAOS) have responded, first with a letter by President James H. Beaty MD. Dr Beaty's main points were:

• Disclosure is important, up to a point. "AAOS supports appropriate financial disclosures to patients regarding relationships between orthopedic surgeons and implant manufacturers."
• There are good aspects to relationships between doctors and device manufacturers. "Many of our AAOS colleagues choose to work in partnership with implant manufacturers to provide consulting advice, conduct research, and educate orthopaedic surgeons and the public. A number of AAOS members are engaged in developing new medical devices to better serve patient needs."
• It is not necessarily bad for physicians to receive money from commercial firms. "The appearance of a physician's name on any disclosure filing referenced above indicates only that he or she has received compensation from the implant manufacturer."
• More detailed disclosure might be good. "Financial disclosures that display only the name of the physician and the aggregate dollar amount received without any explanation of the nature of the relationship and without educational context may be confusing and misleading to the public and patients."
• In the future, AAOS members should better understand these issues. The letter alluded to a "webinair" on the subject to be conducted in November. It also alluded to a new patient discussion guide (found here). (I may discuss that guide further in another post.)

In my humble opinion, the letter was most remarkable for what it did not say.

Although it sought to justify why orthopedic surgeons should work with manufacturers, it did not explain why these relationships should include payments by the manufacturers to the physicians.

It did not discuss whether disclosures of these financial relationships were made in the time up to the release of the lists by the companies. It did not discuss disclosure to learners in the context of teaching, to readers of articles or attendees of talks, or to subjects in research trials. It did not criticize surgeons who had not disclosed prior to release of the lists.

Although the letter suggested that more detailed disclosure might be better than that which has taken place so far, it did not suggest that doctors who have received money should make such detailed disclosure, or criticize doctors who have not made such detailed disclosure in the past.

Finally, the letter did not advocate that doctors who receive payments from device manufacturers or other commercial firms actively disclose these payments going forward.

All in all, Dr Beaty's letter seemed to avoid more issues than it addressed. It was not exactly a ringing call for greater transparency, much less a condemnation of the opacity of past practices.

I could not help but notice that the letter was written on AAOS letterhead which listed current officers and board members. Ironically, several of these people appeared on the companies' payment disclosure lists. These include:

• Dr Joseph Zuckerman, Second Vice-President, who was listed as the "individual provider" for the Musculoskeletal Research Center, which received $1-25,000 from Smith & Nephew (see list here.)
• Dr William L Healy, Treasurer, received $25,001-$50,000 from DePuy (see here)
• Dr Richard F Kyle, Past President, received $25,001-50,000 from Smith & Nephew (here) and $715,163 from Zimmer (here)
• Dr Joseph C McCarthy, Chair, Board of Specialty Societies, received $475,000-500,000 from Stryker (here)
• Dr William Robb III, Secretary, Board of Specialty Societies, received $75,000-100,000 from Smith & Nephew (here)
• Dr Kevin J Bozic, Member at Large, received $2750 from Zimmer (here)
• Dr Christopher D Harner, who was listed as rendering services for the University of Pittsburgh Department of Orthopedic Surgery, which received $100,000-124,999 from Biomet (here)

As we have noted before, " people who have conflicts of interest often find giving clear advice (or opinions) particularly difficult."

That is yet another argument for avoidance of the sorts of conflicts copiously disclosed in the lists of payments made by device manufacturers.

Clinical Trial Results Lost in the MIST

We have been preoccupied on this side of the pond with the release of lists of more than a thousand orthopedic surgeons who received payments, often huge, from manufacturers of joint prostheses (see posts here, here, and here). Meanwhile, another important story involving medical devices has surfaced.

A detailed version was reported by TheHeart.org, and summarized by Dr Aubrey Blumsohn on the Scientific Misconduct Blog. So I will just try to do a shorter summary that does it justice. (Quotes are from TheHeart.org unless otherwise indicated.)

The Migraine Intervention with STARflex Technology (MIST) trial was meant to determine if closing a patent foramen ovale (PTO), a defect in the wall separating two heart chambers, would reduce migraine headaches. This study question was based on the finding that patients who had their PTOs closed after a stroke had fewer migraines. Initially, the trial had two principal investigators, Dr Peter Wilmshurst, "cardiology principal investigator," a noted British cardiologist, and Dr Andrew Dowson, "lead headache specialist," who is "not in fact a neurologist," and who has "'undertakings,' or restrictions [on his practice] relating to past research misconduct." The trial was sponsored by NMT Medical, the manufacturer of STARflex.

The trial failed to show any advantage due to PTO closure. One theory raised to explain this was that patients often still had shunt flow across heart chambers after the procedure. Dr Wilmshurst was sent all patients' echocardiograms for independent review. Wilmshurst did find a high rate, about one-third, of patients had residual shunt flow. Wilmshurst said a second review by Dr Luke Missault produced similar results.

According to TheHeart.org, " while a higher rate of residual shunts would help explain the negative outcome in MIST, it has much larger implications for a device already marketed in Europe for the treatment of cryptogenic stroke."

After Wilmshurst found this high rate of residual shunt flow, he claims he was prevented from revieiwing the trial's data set. "Wilmshurst and colleagues at Shrewsbury, including Dr Simon Nightingale, who is also on the MIST steering committee, have also repeatedly asked for the complete line data collected in the MIST trial. According to Wilmshurst, the data they have seen, most of it already analyzed and compiled by the clinical research organization (CRO), are simply inconsistent with what they themselves saw at their own clinic. They were given access to some of the line data, but never the complete data set, he told heartwire."

In fact, "Wilmshurst states that all communications with NMT ground to a halt after he told the company the results of his review of the residual shunts."

Since then, NMT has denied that Wilmshurst was ever a co-Principal Investigator for the trial. The company claimed that his hospital was dropped from further trials as a research center, but Wilmshurst claimed he was never informed of any protocol violations. When asked about these alleged protocol violations, [NMT vice president and chief financial officer Richard] "Davis replied, 'I won't get into that....'" Wilmshurst said that recently "the company has responded to his emails only by threatening him with legal action and telling hime he is forbidden to speak publicly about the trial.

Wilmshurst only found out that data from the MIST trial were going to be presented at the TCT 2007 meeting when he arrived there and saw the program. At the meeting, "Dowson reported that the closure success rate was 94%, according to the implanting physician - in other words, a residual shunt rate of 6% for the trial," sharply contradicting the results of Wilmshurst's review.
Finally, Wilmshurst claims he has been cut out of the preparation of the first major article to come from the trial. "According to Dowson, the study has been accepted by Circulation, and he expects it to be published in a matter of weeks. Wilmshurst, who has been involved in the planning and execution of this trial from the outset, learned that the study had been accepted for publication only when he returned from the TCT; an email notifying him of its acceptance was sent to him while he was out of the office the previous week. He states that he never saw the final version of the paper before it was submitted, although he had initially contributed to its first draft-literature search, methods, discussion, etc-before the final results were in and had commented extensively on an earlier version of the paper. "

Note also that "Wilmshurst notes that he and Nightingale turned down 'large' consultancy payments from the sponsor; Dowson acknowledged during his TCT presentation that he has received funds from NMT, and Davis estimated that up to 10 investigators or steering committee members receive consulting fees from the company."

So let's see, in this case we have allegations that a medical device company that sponsored a research trial attempted to suppress a re-analysis of the data that showed its device in an unfavorable light; prevented a respected co-Principal Investigator from seeing all the trial data, and cut him out of the preparation of the key results paper; and tried to prevent him from talking about the trial in public.

Dr Aubrey Blumsohn commented, " In fact it seems hard to know whether this is science or black magic."

What is most troubling here to me?

• Suppressing data about clinical trials that is unfavorable to a sponsor's product deprives patients and physicians of information that would have helped them make better decisions about health care.
• In particular, suppressing data that suggests a device may not be as effective as previously thought means that some patients may undergo unnecessary, useless or even harmful procedures.
• Suppressing data about clinical trials that is unfavorable to a sponsor's product violates the trust of the trial subjects who thought that the data their participation generated would go to advance science and improve medicine.
• Finally, physicians and scientists who personally receive payments from sponsors may be less inclined to criticize these sponsors or their products

Again, this is a reminder about why we ought to reconsider whether to let those with vested interests in having clinical research come out a certain way control how this research is done.

One More Payment to an Academic Health Care Leader by an Orthopedic Device Company

An article in the Detroit Free Press provided another telling anecdote about the many, often huge payments to orthopedic surgeons that some orthopedic device manufacturers just revealed. (See previous posts here and here.)

Michigan orthopedic surgeons and health systems performing hip and knee replacements received more than $1 million from five medical device companies, according to a landmark settlement of allegations of kickbacks by the companies.

Michigan's highest-paid consultant in 2007 is Dr. Lawrence Morawa, an orthopedic surgeon in the Oakwood Healthcare System and newly named chair of orthopedic surgery at the Wayne State University School of Medicine.

Morawa received $275,000 to $375,000 from Stryker Orthopedics Inc., a New Jersey subsidiary of Kalamazoo-based Stryker Corp.

Stryker said Morawa received the money for royalty income from inventions, consulting income, research and reimbursements for travel. Morawa said in a statement to the Free Press that the compensation was for 'my time and intellectual property to help design and refine products that improve patient outcomes.' He said he used products from many manufacturers, not just Stryker, 'depending on the specific patient need.'

I have not yet seen any comprehensive analysis of the information provided in the lists released by the device manufacturers. My quick perusal revealed a number of prominent academic orthopedic surgeons who received very large amounts, some much bigger than $375,000.

Academic physicians and surgeons take care of their own patients, but can widely influence health care and the care of many patients by their teaching of trainees, and their talks, publications, and national and international visibility.

The case of the orthopedic device manufacturers' payment suggests that even more academic leaders get even larger payments from health care corporations than was heretofore believed. This suggests that the influence of such corporations on health care is even greater than was heretofore believed. And how many more hidden payments have yet to be revealed.

At the very least, the argument gets ever stronger to require full disclosure of all payments by health care corporations and other organizations with vested interests in health care to physicians, health care academics, and other health care decision makers. Obviously, up to now, such disclosure has been honored more in the breach.

A Few Answers, and Many More Questions About Device Manufacturers' Payments to Orthopedic Surgeons

With a big of digging, I have found some more media coverage of the story that began with deferred prosecution agreements a US Attorney made with four makers of orthopedic devices (Biomet, DePuy Orthopaedics (a unit of Johnson & Johnson), Zimmer Holdings, and Smith & Nephew), and an agreement allowing federal supervision of Stryker Orthopedics (a unit of Stryker Inc). The companies were charged with violating anti-kickback laws by paying orthopedic surgeons as "consultants" to use their products. The companies have all posted on their web-sites lists of physicians and physicians groups receiving such "consulting" payments this year. (The links: Biomet, DePuy, Smith & Nephew, Stryker, and Zimmer.) We posted about the initial coverage of these lists here.

There has been subsequent media coverage of these lists. David Voreacos reported for Bloomberg, first on the general context:

The five biggest makers of hip- and knee-implant devices disclosed the names of 1,805 medical consultants they paid this year, including 46 doctors or organizations that got $1 million or more.

The companies posted the names on their Web sites yesterday under Sept. 27 agreements with U.S. prosecutors to settle claims that they paid kickbacks to surgeons who used their products.

Biomet, a Warsaw, Indiana-based company taken private this year, hired 241 consultants, including three who made more than $1 million.

Johnson & Johnson's Depuy Orthopaedics Inc. paid more than $1 million to 10 consultants. Depuy ... listed 469 consultants.

Stryker, of Kalamazoo, Michigan, paid 201 consultants, including six who got more than $1 million.

Zimmer Holdings Inc. paid more than $1 million this year to 21 consultants. Zimmer paid 603 consultants.

The companies supply 95 percent of hips and knees used annually in 700,000 replacement surgeries in the U.S.

The hip and knee industry will generate about $9.7 billion in worldwide sales in 2007....

U.S. Attorney Christopher Christie said on Sept. 27 that the industry 'routinely violated the anti-kickback statute by paying physicians for the purpose of exclusively using their products.' He said 'a significant minority' of doctors got kickbacks for using company products.

Bloomberg noted some of the companies' responses, which were not terribly informative, e.g.from Biomet:

'Without consultant intellectual property, it would be impossible for us to deliver the products that we do,' [Biomet spokesman Bill] Kolter said.

From Smith&Nephew,

'Some of them have certain intellectual property that is part of the product, and some of the payments become royalty payments,' said David Shapiro, a spokesman for Smith & Nephew of London. 'Some of them are for training other doctors. Obviously, royalty payments are going to be larger than just compensating somebody for a couple of days of training.'

From Stryker,

'The services that physicians rendered in helping develop products and educate people about those products are valuable,' Stryker Chief Financial Officer Dean Bergy said.

From Zimmer,

'We are not elaborating beyond what we've posted, and what we've posted is pursuant to the deferred prosecution agreement,' Zimmer spokesman Brad Bishop said. Zimmer paid 603 consultants.

Bloomberg also reported on some particularly noteworthy payments, e.g., by DePuy which

paid between $6.675 million and $7 million each to Drs. Richard Scott and Thomas Thornhill of Brigham and Women's Hospital in Boston. Scott and Thornhill said they get royalty payments for the licensing of a total knee replacement prosthesis in 1986 and a hip replacement prosthesis in 1991. They said almost 2 million of the knee devices have been implanted.

'Neither of us keep any of the money we receive from consulting,' they said in a statement. 'Any money we have received from consulting is donated to charity.'

Depuy spokeswoman Sarah Colamarino said surgeons typically don't get royalty payments when he or other doctors implant a device for which that surgeon gets royalty payments [sic]. Scott and Thornhill said they get no royalties for implants by surgeons at Brigham and Women's Hospital.

Note that the surgeons did not state what charity received their "consulting" payments, what proportion of the money they received were royalties, and whether they kept these royalties, as opposed to "consulting" payments. Also note that the response by the DePuy spokeswoman as printed made no sense. The news article did not rule out that Thronton and Scott kept the bulk of the money paid by DePuy in 2007, conceivably more than $6,000,000 a piece.

Bloomberg also investigated a single large payment by Stryker,

Stryker paid more than $3 million to Dr. Anthony Hedley of the Arizona Institute for Bone & Joint Disorders in Phoenix. He referred a call to Yin Becker, a company vice president who didn't return a call.

The Bloomberg reporters attempt at investigation obviously did not get very far. The reporter had no more luck investigating a large payment by Zimmer,

The company paid $5.5 million to Dr. W. Norman Scott of New York, who wrote 'Dr. Scott's Knee Book' and was the doctor for the New York Knicks in the National Basketball Association for 27 years. Scott didn't immediately return a call for comment.

If nothing else, Bloomberg's reporting confirms that some orthopedic device companies paid out exceedingly large amounts to individual orthopedic surgeons. Some proportions of these payments were ascribed to consulting, educational activities, or royalties or licensing payments for patents or intellectual property. Some of the surgeons who received payments are very well known and influential.

The extent that the recipients were influenced by the often fabulous payments they received from the device companies remains unknown. Whether the recipients of these payments made any significant disclosures of these financial relationships is also an open question. The concerns are that some surgeons may have failed to disclose these financial relationships:

• to patients for whom they made decisions about use of device
• when teaching about the diagnosis, prognosis, or treatment of conditions for which these devices may be used
• when writing or speaking on related topics

This story is a huge reminder about how conflicts of interest pervade current health care. It further illustrates that the size of some of the financial relationships that constitute such conflicts may be far larger than anyone previously thought.

As noted before, some people are concerned by how physicians may be influenced by gifts of pens, coffee mugs, and pizza lunches. If we should be concerned about coffee mugs, how much more should we be concerned by multi-million dollar royalties or consulting payments?

Note that the Bloomberg article apparently was the basis for a blog posting on GoozNews by Merrill Goozner. I took down a previous blog posting which covered some of the news reported above, because it was based on the erroneous assumption that Goozner himself had made the enquiries to physicians who received the payments reported in the Bloomberg article.

Ex-Ballplayer Says Hospital Marketing Hits One Foul

The World Series is over, and now Newsday reports how a former major league baseball player claimed a local hospital's fund raising falsely used his endorsement.

After having shoulder surgery at Long Island Jewish Medical Center, former Mets star Ed Kranepool spoke glowingly of his doctor.

'I couldn't have asked for better,' Kranepool said in the spring newsletter of the hospital's parent company, North Shore-Long Island Jewish Health System Foundation.

But Kranepool, 62, says North Shore went too far when it then used his photo and repeated his surgery story without permission on a fundraising postcard sent in July. He is suing in federal court for $12 million, charging that his medical information was used to create a false endorsement.

According to the lawsuit, the postcard violated federal privacy laws, 'diluted' Kranepool's trademark and 'irreparably harmed and injured' his ability to garner future endorsement deals.

'At no point did he ever intend, nor was he ever asked, to give his endorsement of the hospital,' said Baron. 'It affects his control of who and what he is.'

Sent to about 25,000 households in the New York City area, the postcard does not explicitly say Kranepool endorses the hospital.

'The treatment received at LIJ restored him to full mobility and today he's back on the golf course, the tennis court -- and the backyard, tossing around a baseball with his grandson,' the postcard says.

"Say it ain't so." It is sad that it is now difficult to distinguish hospital fund-raising from endorsements of athletic shoes.

Howard Brody on "Bribery" and on Spending on Research vs Marketing

On the Hooked: Ethics, Medicine, and Pharma blog, Howard Brody finished up this week with a bang.

First, he addressed the issue of gifts given to doctors meant to induce them to change their professional decision making. On the heels of a report by Consumers International entitled "Drugs, Doctors and Dinner: How drug companies influence health in the developing world," he noted that some media reports are starting to talk about pharma giving bribes, not just gifts to doctors. Brody acknowledged that he, and many others (yours truly included) have refrained from using such a direct word. But after all, a bribe is "money or any other valuable consideration given or promised with a view to corrupting the behavior of a person, esp. in that person's performance as an athlete, public official, etc." Could a gift given to a physician "corrupt" their behavior? Brody noted that is not an outlandish consideration. He concluded, "So, if the goodies dangled before physicians by the drug companies are in fact bribes, why have we been giving them a free ride for so long and using euphemisms?"

His most recent post dealt with the oft-repeated dogma that the pharmaceutical industry spends more on research than on marketing. He cited a report from the Global Forum for Health Research that suggested all the ways pharma can re-classify what appears to be spending on marketing as spending on research.

Orthopedic Device Makers Reveal "Consulting" Payments to Doctors

We recently posted about deferred prosecution agreements a US Attorney made with four makers of orthopedic devices (Biomet, DePuy Orthopaedics (a unit of Johnson & Johnson), Zimmer Holdings, and Smith & Nephew), and an agreement allowing federal supervision of Stryker Orthopedics (a unit of Stryker Inc). The companies were charged with violating anti-kickback laws by paying orthopedic surgeons as "consultants" to use their products.

As reported by the Dow Jones news service, as part of these agreements, the companies have all posted on their web-sites lists of physicians and physicians groups receiving such "consulting" payments this year. Here are the lists: Biomet, DePuy, Smith & Nephew, Stryker, and Zimmer.

Although we have frequently talked about the pervasiveness of conflicts of interest in health care, rarely are the details of such conflicts reported. Journals sometimes require authors of articles and continuing medical education (CME) courses require speakers to divulge what commercial health care organizations have paid them, and the general nature of these payments, e.g. consulting, service on advisory panels, service on speakers' bureaus, etc. However very rarely are the amounts paid, or the nature of services rendered detailed.

These web-sites at least show to whom how much was paid in 2007 by these manufacturers of orthopedic devices.

Per the Dow Jones report, there were some striking revelations:

Zimmer Holdings Inc. (ZMH), the largest pure-play maker of replacement hips and knees, reported 21 instances of payments topping $1 million, more than double the number at any other company.

Zimmer, of Warsaw, Ind., issued 14 pages of itemized payments to consultants. The biggest payment, at $8.67 million, went to Massachusetts General Hospital Corp.

Disclosures of payments were also made by rivals Stryker Corp. (SYK), Johnson & Johnson (JNJ) unit DePuy, Smith & Nephew PLC (SNN) and privately held Biomet.

The biggest consulting payment from J&J's Warsaw-based DePuy, which was listed in a range of $6.725 million to $6.75 million, went to Thomas S. Thornhill, who chairs the department of orthopedic surgery at Brigham and Women's hospital in Boston.

Stryker, of Kalamazoo, Mich., made its biggest payment so far this year to Anthony K. Hedley, a surgeon and president of the Institute for Bone and Joint Disorders in Phoenix, at $3.025 million to $3.05 million.

Biomet, another Warsaw-based company, topped out with a $2.4 million to $2.425 million payment to Alabama Medical Consultants Inc. U.K.-based Smith & Nephew's biggest consulting tab this year is with Ramon Gustilo, an orthopedic surgeon and co-founder of the Midwest Orthopaedic Research Foundation in Minneapolis, at $3.125 million to $3.15 million.

So there were lots of payments to these "consultants." Some made eye-popping amounts of money for "consulting." What any of these physicians or medical groups actually did for this money is unclear. How these payments could be justified by the work these physicians did, and how an argument could be made that they did not influence these physicians' judgments and decisions is beyond me.

Remember, a physician's first responsibility should be to take the best possible care of each of his or her patients. An academic physician should also do his or her best to seek and/or disseminate the truth.

It might be difficult for a physician to make dispassionate decisions about orthopedic devices when one or more of the companies which make such devices is paying the physician thousands, hundreds of thousands, or millions a year. It may be similarly difficult to do impartial research or to do unbiased teaching when receiving such payments.

As noted many times (e.g., here), there has been considerable public concern about relatively small gifts, like pens, coffee-mugs, and pizzas, given by pharmaceutical, biotechnology, and device companies to physicians. If the effect that a coffee-mug might have on physicians' judgments and decisions is of concern, what about a million dollar plus consulting payment?

It is high time for all the payments made for "consulting," advisory boards, speakers' bureaus, etc, etc, etc by commercial health care corporations to physicians and other who make decisions about health care and health policy to be divulged. I suspect that if the public had any idea how many payments of what size were being given out, they wouldn't further stand for such nonsense.

A hat tip to, and see also discussion on the PharmaLot blog and the WSJ Health Blog.

BLOGSCAN - the Avastatin/ Lucentis Controversy

On the Hooked: Ethics, Medicine, and Pharma blog, Howard Brody discussed the Avastatin-Lucentis controversy, concluding with an integrity award to the opthamologists who pushed to use tiny doses of Avastatin to treat macular degeneration, and resisted the marketing of similar but very expensive Lucentis for the same problem. Meanwhile, on the Health Business Blog, David Williams interviewed a Genentech spokesperson.

BLOGSCAN - Former TAP Pharmaceuticals Manager Sentenced for Perjury

A former manager of TAP Pharmaceuticals was sentenced to jail for perjury in connection with her testimony to a grand jury that was investigating alleged kickbacks by the company to doctors and hospitals, as covered by Ed Silverman on the PharmaLot blog, by PharmaGossip, and by Dr Peter Rost on BrandweekNRX.

"Mandatory" "Treatment" of University of Delaware Students

This case is already all over the web [starting here], but it has an unusual health care slant which has heretofore not been covered, so....

The University of Delaware, a large, state-supported US university, which includes a College of Health Sciences, recently instituted a new "treatment"program for university students, described in the draft of a detailed report. [Following page references are from that report.] (References to the program, also described as a curriculum, as a "treatment" are on page 8, 10, and 14) Subjects will be exposed to educational and behavioral interventions, the latter described in one document as that which will "leave a mental footprint on their consciousness." An example of one behavioral intervention requires subjects to line up, then step forward or backward in response to questions about their social identities [see p. 2 of this letter.]. The program will be subject to "action research" [p. 3], which "is generally distinguished by being practioner based, focused on actual existing practices, and using data to improve existing practices," [p. 4] and possibly also "summative, research style studies" [p. 3] Outcomes to be assessed include "behavioral changes in reaction to ... educational strategies." [p. 5] Data collection methods include "surveys, formal inteviews, focus group[s]" [p. 11] Subjects with the worst outcomes in particular groups would be individually identified, and subject to additional interventions [see p. 3 of this letter.] The investigators claimed the research "would qualify for an exemption from full [institutional review] board review." [p. 12]

So far, this sounds unremarkable, but, just has been extensively reported by the Foundation for Individual Rights in Education (FIRE), the subjects of this "treatment" program are all students living in all University of Delaware dormitories, not patients with any defined conditions or diseases. Furthermore, as the FIRE case file makes very clear, participation is mandatory. Not only is consent not required for participation, students must participate in the "treatment" and in the associated "action research" study whether or not they want to.

As FIRE noted in a letter to university president, there are a set of objections to all this based on the content of the intervention, which seems to designed to inculcate political beliefs, rather than to educate, and which requires students to affirm beliefs they may not actually hold. For a government institution to expose students to what seems to be mandatory political indoctrination, and to require students to express beliefs which are not theirs raise major constitutional issues.

Setting those aside, this program seems to profoundly violate some fundamental values of health care and of human research. Except in very particular cases of incompetent patients or patients who are at immediate risk of harming themselves and others, no one should be subject to a treatment without his or her consent. In such a situation, compelling subjects to participate in associated research is equally unethical.

Some may argue that the university's description of this project as "treatment" was metaphor or rhetorical excess. However, the repeated use of that term, plus description of the project in behavioral terms, and the clear human research component invite viewing the project as a treatment intervention and associated human research plan.

For an American state university to have gone so far in a plan for mandatory behavioral "treatment" of students without their consent is chilling. It is a reminder that something has clearly gone very wrong in health care and academia, and that the problems are clearly not at all limited to the for-profit corporate sector.

ADDENDUM (3 November, 2007) - the University of Delaware has cancelled its mandatory "treatment" program, as covered by FIRE.

For Halloween, Reports of Spooky Finances at UMDNJ and Other Academic Institutions

We have done a long series of posts about the troubles at the University of Medicine and Dentistry of New Jersey (UMDNJ), the largest US health care university. The university now is operating under a federal deferred prosecution agreement under the supervision of a federal monitor (see most recent posts here, here, here, here and here.)



We had previously discussed allegations that UMDNJ had offered no-bid contracts, at times requiring no work, to the politically connected; had paid for lobbyists and made political contributions, even though UMDNJ is a state institution; and seemed to be run by political bosses rather than health care professionals. (See posts here, and here, with links to previous posts.) A recent development (see post here with links to previous posts) was that UMDNJ apparently gave paid part-time faculty positions to some community cardiologists in exchange for their referrals to the University's cardiac surgery program, but not in exchange for any major academic responsibilities. Another was some amazingly wasteful decisions by UMDNJ managers leading to spending millions of dollars for real-estate that now stands vacant (see post here). Another was the indictment of a powerful NJ politician for getting a no-work job in the system, and the indictment of the former dean of the university's osteopathic medicine school for giving him the job (see post here). Most recently, we found out that UMDNJ had named one of its teaching hospitals for a pharmaceutical company in 2001 (see post here), and that the federal monitor accused the dean of one of the UMDNJ campuses of fixing students' grades (see post here).



In response to this debacle, the New Jersey State Commission of Investigation (SCI) investigated financial practices at multiple state institutions of higher education, including UMDNJ. As compiled from articles in the (central New Jersey) Home News Tribune, and the (North Jersey) Record, the main points were

• Even after all the scrutiny given to UMDNJ, the SCI found new problems there, for example, its report alleged "a contract for janitorial and housekeeping supplies wasted $1 million over six years at UMDNJ because of overbilling. The vendor also gave liquor, meals and Yankees tickets to key UMDNJ staff." [Home News Tribune] "The company even sprang for $800 in food costs for a 60th birthday party for ... [the head of ] UMDNJ's office of supplier diversity and vendor development." [Record] Also, a construction company founded by a former UMDNJ plumber billed more than $2.8 million over seven years. The work was overseen at UMDNJ by the former plumbing partner of the construction company boss. The company built the UMDNJ official "a 400-square-foot wooden deck on his Oxford, N.J. home, free of charge. Three years later, when [he] ... decided to convert the deck into a sunroom, [the company owner] ... paid the bill."


• There were "questionable payouts to employees, including $3 million in bonuses in 2004 to UMDNJ administrators and lump-sum payments to departing officials." [Home News-Tribune]


• However, similar problems were found at other institutions. For instance, the report alleged Rutgers University paid for expensive trips, meals, and alcoholic beverages. Also, "vast amounts of money were moved through 'emergency accounts' including a $5,000 liquor bill for an anniversary celebration at the Camden campus." [Record]


• The report found instances of excessive political influence on the academic institutions, even though they had been freed from centralized state supervision in 1994. For example, "One former trustee at The College of New Jersey said he was told then-Gov. James E. McGreevey wouldn't reappoint him because 'he criticized the administration's approach to the New Jersey business community concerning taxes.' A Ramapo trustee said he resigned after state officials tried to make then-Sen. Joseph Doria Jr., D-Hudson, president of the college. [Home News-Tribune]

Although some may argue that New Jersey has uniquely bad problems, this report raises the possibility that sleazy accounting and budgeting practices may be widespread at US academic institutions, particularly but not exclusively those involved in health care. The finances of US private not-for-profit academic health care institutions are generally completely opaque. Almost never do such institutions publish detailed budget, or subject themselves to outside audits. This opacity may make it easy for such practices to flourish.

(For those who don't believe that statement, try to find a clear, detailed budget for any local health care not-for-profit. Further, try to find the results of any outside audit of any such institutions. You may need to dig much deeper than the usual glossy institutional publications and their state-of-the-art web-sites. Let me know of any success.)

Given that tuition for higher education, including health care professional education, and the costs of health care have been rising much faster than inflation for a long time now, there is reason for concern that a good chunk of the cost increases are due to questionable payments and financial practices. But until the organizations involved make their finances public and allow detailed audit, that is all conjecture.

WHAT CAN BE DONE:

Insist that your local hospitals, academic medical centers, medical schools, and universities make public detailed budgets, and subject their budgets to periodic audits. "Sunlight is the best disinfectant." But expect lots of resistance...

BLOGSCAN - The Porous Firewall Between MECCs and Commercial CME

On the Carlat Psychiatry Blog, Dr Daniel Carlat argues how porous is the firewall between commercial medical education and communication companies (MECCs) and commercial continuing medical education (CME) providers.

The Funding of "the Mysterious Human Heart" and the Mysterious Financial Arrangements of its Medical Advisors

The US Public Broadcasting Service (PBS) television network just aired a three-part series called "The Mysterious Human Heart." One of our intrepid scouts suggested we should look into it, since it seemed to be funded by two companies which had commercial interests in the subject matter.

Indeed, the PBS Ombudsman was already involved in this case. In his column, Michael Getler wrote,

The main sponsors of the series ... [were] Medtronic, a medical technology firm; AstraZeneca, a pharmaceutical company....

Bruce Halford of Stockton, N.J., wrote to say:

'Medtronic’s role as a principal underwriter of ‘The Mysterious Human Heart’ seems to violate PBS’ perception test for program funding. In Episode 2 of the series, viewers are told that the best treatment for certain potentially deadly heart arrhythmias is an implantable pacemaker. Who’s the leading manufacturer of such devices? Medtronic, of course. But viewers are never told about potential problems with those devices.... In addition, viewers of the episode are not informed about possible financial ties between the series’ on-camera experts and Medtronic, or with another major underwriter, AstraZeneca, which markets a full line of drugs for cardiovascular problems. No question, securing funding for this kind of series is a major challenge. But what’s happened to PBS’ pledge to prevent a blatant corporate tie-in from compromising the editorial content of such a high-profile project?'

The next day, Jeffrey Chester, director of the Center for Digital Democracy, and an ever-vigilant observer of PBS funding arrangements, wrote to ask 'how PBS (and presenting station Thirteen/WNET in New York) sought and publicly promoted the involvement of Medtronic and AstraZeneca as underwriters? As you know, both Medtronic and AstraZeneca have major commercial interests involving heart disease related medical issues, through technology and pharmaceuticals respectively.'

Gettler asked William Grant, director of science, natural history and features programs at WNET [the station that produced the show] about all this, and he denied that specific Medtronic and AstraZeneca products were promoted in the series, or that the companies "had any editorial involvement whatsoever."

Gettler got a response from the program's producer, David Grubin, which included the statement that the program "was never meant to be an investigation of the pharmaceutical or medical device industry."

Gettler ended up concluding that "the responses, especially from PBS, did not address the real conflict, criticism, and questions at issue here" including "the seeming inappropriatement of funders for a number of programs and the residue of dobut that leaves in the mind of some viewers even though one may not see or sense any hint of influence."

In looking over the show's web-site, I discovered another issue not addressed yet by the Ombudsman.

The show's content advisers appear to be Peter Libby, MD, Chief of Cardiovascular Medicine at the Brigham and Women's Hospital in Boston, Massachusetts, Mallinckrodt Professor of Medicine at Harvard Medical School, and director of the D.W. Reynolds Cardiovascular Clinical Research Center at Harvard; and Douglas P Zipes MD, Distinguished Professor of Medicine, Pharmacology and Toxicology at Indiana University, and Director of the Cardiology Division and Krannert Institute of Cardiology. What the web-site, and probably the show did not mention is that

• Libby has received grant support from, consulted for, and served on a speakers' bureau for AstraZeneca (see this link).
• Zipes has received consulting fees or honoraria worth more than $10,000 from Medtronic (see this link).

Thus the show's content was influenced by people with significant personal financial relationships with AstraZeneca and Medtronic.

Again, as noted above, there is nothing to suggest that the show's content directly promoted particular products. But by increasing awareness and concern about cardiovascular disease, and emphasizing its treatability, the show could still have served a marketing purpose for companies that make drugs and devices used to treat cardiovascular disease.

Furthermore, although the show did apparently disclose its funding from Medtronic and AstraZeneca, it did not disclose the funding received by some of its medical advisors from the same company.

One can only wonder why the people who put the show together happened to pick for its two principle medical advisors people who had financial ties with the two sponsoring companies?

I will conclude with a quote from PBS guidelines for funding (as noted by Gettler):

Steps must also be taken to avoid the public perception that program funders have influenced professional judgments. Should a significant number of reasonable viewers conclude that public television has sold its professionalism and independence to its public funders, whether or not their conclusions are justified, then the entire program service of public television will be suspect and the goal of serving the public will be unachievable....

I would also add that at a minimum, physicians and researchers who are in a position to influence how the media discusses medicine and health care should, at a minimum, fully and completely disclose any financial arrangements they have with organizations with vested interests affected by such media discussions.

ADDENDUM (29 October, 2007) - See additional comments by Ed Silverman on PharmaLot.

Arbitrator Finds Yale-New Haven Hospital "Spreading Disinformation"

Several Connecticut newspapers have reported on findings against prestigious Yale-New Haven Hospital, the main teaching hospital for Yale University, by an independent arbitrator. Per the Hartfourd Courant,

Arbitrator Margaret Kern said the hospital ruined any chance for a fair election by intimidating union supporters and spreading misinformation.

She ordered the hospital to pay SEIU $2.3 million, to cover its organizing expenses and $2.2 million to about 1,700 hospital employees eligible to vote in the election. The second figure is the amount Yale-New Haven paid to IRI Consultants to Management Inc., the company it hired to coordinate its campaign against the union.

'Employees were deprived of the right to truthful information, the right to do their job uninterrupted by solicitation, and the right not to participate in captive audience meetings,' wrote Kern.

The New Haven Register reported that after a long standing labor dispute, Yale-New Haven Hospital and the union agreed

not to disparage each other and to conduct a factual campaign. The hospital also committed to not initiate one-on-one conversations with workers; not conduct mandatory meetings; not use consultants to abrogate the agreement, while also promising to abide by the arbitrator’s rulings.

Kern found Y-NH violated all these points, conducting 98 mandatory meetings where workers were forced to listen to managers’ 'feelings and fears' about the union and misrepresentations about the hot button issue of union dues.

She said there was strong evidence that the consultants were keeping a running count of the workers’ leanings and that the violations were not the work of a 'few rogue managers.'

'The employer’s conduct here was a methodical dismantling of the terms and commitments of the election principles agreement,' Kern said.

I can understand that the hospital may have had rational reasons not to want the union to organize its workers. But it seems to make some promises Yale-New Haven makes in its mission statement, including

To provide sensitive, high quality, cost effective health care services to all patients, regardless of ability to pay.

To serve the community as a public health advocate and provide support and services which respond to the area's health care needs through health education, health promotion and access to care.

ring pretty hollow, after the hospital has been found to be "intimidating union supporters and spreading misinformation."

Would you trust a hospital management who spreads "disinformation" as part of a labor dispute to really support the best patient care, teaching, research, and community service?

Spreading disinformation also does not exactly fit with Yale University's motto, "lux et veritas," light and truth.

This seems to be another example of mission hostile management, this time by the leaders of one of America's premier medical centers.

BLOGSCAN - Conflicts of Interest Affecting the Institute of Medicine's New Panel on Conflicts of Interest

On the GoozNews blog, Merrill Goozner discusses the Institute of Medicine's new panel which will develop new guidelines for managing conflicts of interest. According to Goozner, the panel includes three people who were given their own conflict of interest waivers because of their financial ties to drug or device companies, and one other whose ties Goozner claims were not disclosed. The panel includes no prominent advocates of a harder line against conflicts. Goozner asks, "sound fair and balanced to you?"

To angio, or not to angio? Or, "Grandpa died, but it was a good learning experience ..."

I have commented in the past about the overuse of "metrics" from often ill-conceived efforts or biased efforts to find justification for cavalier activities that ignore common sense, but this story may represent a new milestone:

Battle over a key heart procedure (link)

By Josh Goldstein
Philadelphia Inquirer
Tue, Oct. 23, 2007

Is cardiac angioplasty without surgical backup safe? A S. Jersey dispute is part of a major study.

Last year, more than 16,000 patients in the eight-county Philadelphia area had cardiac angioplasty to treat heart disease - many for elective, non-emergency procedures.

Five years ago, virtually no angioplasties were performed at hospitals that did not have on-site open-heart surgery available, in case something went wrong. Last year, more than 700 were done at hospitals without such surgical backup.

The question of whether that was safe is roiling the cardiology establishment in South Jersey, where Virtua-West Jersey Hospital Marlton is participating in a major study that seeks to find the answer.

South Jersey's three hospitals with open-heart programs - Cooper University Hospital, Deborah Heart and Lung Center, and Our Lady of Lourdes Medical Center - are campaigning to block Virtua from expanding into the profitable angioplasty market.

The procedure, in which a tiny balloon is used to open blocked heart vessels, can generate hospital fees ranging from nearly $17,000 to more than $25,000, according to the federal Centers for Medicare and Medicaid Services.

"This is an issue because it is cardiac care and it is lucrative," said James P. Dwyer, Virtua's chief medical officer. [indeed - just a bit of conflict of interest and bias is created by that fact - ed.]

Currently, 23 states allow at least some hospitals to perform angioplasty without surgical backup. The new study at the center of South Jersey's cardiac wars is a nine-state look led by Johns Hopkins University.

Dwyer said the protocols for the research were "appropriate scientifically" and had proper safeguards to protect patients.

At the Christiana Care Health System a decade ago, I led data modeling of invasive cardiology and its procedures down to an extremely fine-grained level of several hundred data elements. I also led development of an information system utilizing this data that could easily show that there were occasions where "the unexpected happened." It took several days just to develop the terminology and dataset on failed angioplasties, what happened to the stent, and what happened to the patient. Ruptured coronary artery, dissection, stent lost in body, and acute myocardial infarction were just a few examples of what can (and does) happen, even under the best of conditions where the patient appears stable and the coronary lesion uncomplicated and easy to approach via catheter.

Without cardiac surgical backup, a patient with an "unexpected event" would have to be rushed by ambulance to the nearest cardiac surgical facility. Until the friendly Asgard provide us with beaming technology, that means time - and the amount of time from the potentially catastrophic invasive cardiology adverse event to the thoracic incision is itself subject to unpredictable variables.

It doesn't matter how good the invasive cardiology team is, either. These events do happen, and there is nothing that can be done about some of them without "open access."

In effect, performing invasive cardiology procedures without onsite cardiac surgical backup is simply asking the patient the question "do you feel lucky?"

The study's opponents contend it is an end run around a New Jersey law that requires hospitals to demonstrate a community's need and to get approval from state regulators before expanding into high-end medical services.

Jan Weber, chief of the division of cardiology at Our Lady of Lourdes, said there was no demand for the expanded services. Few residents of the Garden State live more than 30 minutes from a hospital with an open-heart program, and if the procedures are spread out among many hospitals, the quality of care will suffer, Weber said.

"Our primary concern has been safety," he said.

There has been little controversy in Pennsylvania, where 11 hospitals, including five in Philadelphia and its western suburbs, have permission to perform angioplasty without surgical backup.

I was actually unaware of this. I consider it cavalier at best. Profitable, but quite cavalier.

In heart care, time is critical, and having surgical care available on-site can save lives, said Joseph E. Parrillo, chief of medicine at Cooper.

"You lose heart muscle for every minute of delay," he said. "If that rare emergency case is your wife or your mother, then do you say, 'Too bad?'"

Arup K. Roy, a doctor of internal medicine, says no. Roy contends that his father died as a result of complications from an angioplasty at Virtua.

In an Oct. 14 letter to the New Jersey Department of Health and Senior Services and others, Roy said a series of missteps at Virtua led to his 84-year-old father's death.

Community hospitals are "not capable to handle these sorts of complex procedures, and down the road they will kill more people like my father," Roy said during an interview last week.

I agree with that assessment and sympathize with Dr. Roy. My own father died as a result of malpractice at a large hospital that was fully equipped to do every intervention - but could not diagnose bilateral golfball-sized renal adenocarcinomas in over two years and fourteen trips to the urological O.R. Doing risky procedures in secondary facilities is asking for trouble.

Virtua officials expressed sympathy for the doctor's grief, but insisted that the medical record did not support his conclusion that angioplasty triggered a dissected aortic aneurysm (sic) and caused his father's death.

A dissecting aortic aneuryism is a tear in the layers of the aorta, the body's main artery, creating a "false space" where blood can travel, distort the anatomy, and result in blockage of blood supply to major organs. It is a dire condition and true medical emergency, but can be treated surgically. (The hospital denied there was a dissecting aneurysm, claiming death was due to cancer, but this is to be further investigated.)

Thomas Aversano, the Hopkins interventional cardiologist who is leading the study, said the continued rise in heart disease made it necessary to turn more community hospitals into centers that excel at cardiac care.

The debate reflects not just economics, but a longstanding tension between cardiovascular surgeons, who do open-heart surgery, and interventional cardiologists, who do angioplasty.

"It is difficult in the absence of angioplasty to recruit and or retain the best cardiologists," Aversano said in an interview.

It may be necessary to turn more community hospitals into centers that "excel at cardiac care," but is doing so at the expense of the uncommon patient who dies due to delays in surgical intervention an ethical way to go about it?

Aversano said he would "absolutely" have an angioplasty at one of the hospitals participating in his study.

That's perhaps easy for a Johns Hopkins interventional cardiologist to say, and I'll bet he'd do it - as a last resort. I'd rather suspect he'd primarily desire to be transported to the nearest full-service facility first, unless really in dire straights. On a personal note, when I was faculty at Yale and needed radioablation of my Bundle of Kent, damned if I was going to have it at a secondary facility. My choice was Yale-New Haven Hospital...

Others were not so sure [about angioplasty at a smaller hospital]. "I live in New Jersey, but no, I would not allow myself to have an angioplasty at a smaller hospital until we have proven it is safe," said David L. Fischman, co-director of the cardiac catheterization lab at Thomas Jefferson University Hospital.

That is indeed a more cautious approach. The problem is that it can never be "proven" to be "safe" for those patients who get into serious trouble and die due to time delays to surgery.

The automobile industry once had an analogous ethical dilemma re: the costs of fixing exploding fuel tanks vs. costs of litigation over people injured and killed by same. Does "Pinto" ring any bells?

The financial analysis that Ford conducted on the Pinto concluded that it was not cost-efficient to add an $11 per car cost in order to correct a flaw. Benefits derived from spending this amount of money were estimated to be $49.5 million. This estimate assumed that each death, which could be avoided, would be worth $200,000, that each major burn injury that could be avoided would be worth $67,000 and that an average repair cost of $700 per car involved in a rear end accident would be avoided. It further assumed that there would be 2,100 burned vehicles, 180 serious burn injuries, and 180 burn deaths in making this calculation. When the unit cost was spread out over the number of cars and light trucks which would be affected by the design change, at a cost of $11 per vehicle, the cost [of fixing the design flaw] was calculated to be $137 million, much greater then the $49.5 million benefit [through decreased payouts for driver death and horrendous burn injury - ed].

One can only wonder if such "scientific" (i.e., amoral) financial analyses inform decisionmaking about permitting angioplasty at facilities that do not offer cardiac surgery.

-- SS