Thursday, November 29, 2007

Creating a RUCkus

The outing of the RUC (RBRVS Update Committee), the secretive committee that has so much influence over how Medicare reimburses physicians, and hence bears much blame for the decline in US primary care, continues. (Our most recent post on this subject is here.)

First, on the Movin' Meat blog, Shadowfax, an emergency department physician, took up the issue. He emphasized how poorly the RUC represents the overall population of US physicians. Most seats on the RUC go to particular medical societies, regardless of their size. So there is a one seat for the 6,000 member American Society of Plastic Surgeons, and one seat for the 124,000 member American College of Physicians. Furthermore, Shadowfax charged that an informal alliance of sub-specialty surgeons and procedurally oriented medical sub-specialists dominates the agenda.

Also, DB's Medical Rants takes up the subject again, noting that the way the RUC works seems to reflect an American bias to reward doers more than thinkers.

In my humble opinion, the government needs to rethink how Medicare reimburses physicians before primary care vanishes entirely. Furthermore, someone ought to investigate how federal policy, in this case, Medicare reimbursement became so beholden to a single private committee, and why such policy has been set in such an opaque manner. Not only are the proceedings of the RUC confidential as Medical Rants noted but the AMA does not see fit to disclose the identities of the people who sit on the RUC. (This appears to be as close as the general public, or the general AMA membership is going to get.)

Student who worked on health IT at center of worldwide hacking investigation

This is concerning regarding healthcare information security and integrity. Could software in health IT projects worked on by this student be compromised, e.g., by "back doors", trojans, etc.? (See last paragraph.)

With all the recent problems with healthcare and other confidential, potentially harmful information subject to misuse being leaked, I believe an audit of the companies and health IT projects/products he worked on would be an appropriate due diligence.

I've emailed Assistant U.S. Attorney Michael Levy on this issue and inquired if this angle is being or has been pursued.

-- SS

Penn student at center of worldwide hacking investigation

A computer system failure at Penn led investigators on a global chase. A Penn student has been charged.

By John Shiffman

Inquirer Staff Writer

When a suspicious computer server crash at the University of Pennsylvania last year denied service to 4,000 students, faculty and staff, technicians called the FBI - triggering a case that would take agents around the world and lead to the arrest of a brilliant but brash Penn junior.

Ryan Goldstein, a 20-year-old bioengineering major, conspired with a New Zealand hacker known as AKILL to use Penn's computer system as a staging ground for a 50,000-computer attack against several online chat networks, authorities said.

The FBI and Secret Service are expected to announce indictments today against Goldstein, a Florida man, and three others. Police recently executed related raids in New Zealand, Florida, California and Pennsylvania. The latest came Tuesday near Philadelphia. An FBI agent from the region is in New Zealand this week, and more arrests are possible.

"We've been executing search warrants all over the world in this case," said Assistant U.S. Attorney Michael Levy.


Goldstein, who has no prior criminal record, appears to be an accomplished engineering student. According to a detailed resume posted on a Penn-hosted Web site, Goldstein has received a slew of computer-related honors - including the National Technology Achievement Award and the St. Joseph's University Presidential Scholarship.

The resume, which appeared to have been updated this month, said that Goldstein had worked on sophisticated software programs on medical-related projects for major area companies.

-- SS

Wednesday, November 28, 2007

More Research Needed to Prove That Designing Clinical IT Without Knowing What You're Doing May Have Unintended Consequences?

In the article "Design of Patient Tracking Tools May Have Unintended Consequences" excerpted below, researchers found that technology designed by technologists without adequate domain expertise, especially in complex domains such as hospital emergency departments (ED's), often does not work as expected. It can interfere with staff communications, for example - a potentially disastrous consequence in an ED environment where patients can be highly unstable.

A PI in the study observed that "the results provide an important case study of what can happen when new technologies are developed without sufficient understanding by designers of the nature of the work in which they will be used."

AHRQ has provided funding to develop simulations of proposed electronic patient tracking systems in order to better evaluate and match them to the needs of hospital emergency departments.

This raises several questions:

1. How many more case examples are needed to convince technologists that the finest "process" in the world, the world's finest generalists, and the most ingenious theories of "management mysticism" will not help in the quest for automated production of Mozart symphonies, or interplanetary travel via hot air balloon?

2. AHRQ has provided funding to fix a symptom , but not the disease. Where is the funding for further study and change of the attitudes and ideologies in the technology fields that cause real systems to be developed for healthcare (among other areas) that " are developed without sufficient understanding by designers of the nature of the work in which they will be used," such as CPOE systems designed for calm, solitary office environments , "appalling" EHR systems where vendor and subcontractors had not listened to end users , and ED virtual whiteboards that interfere with intra-staff communications?

-- SS

Design of Patient Tracking Tools May Have Unintended Consequences

Proper design of computational tools is critical if they are to be used with success in patient-care settings, particularly in hospital emergency rooms, a field study conducted by researchers at the University at Buffalo and other institutions recently revealed.

Newswise — Proper design of computational tools is critical if they are to be used with success in patient-care settings, particularly in hospital emergency rooms, a field study conducted by researchers at the University at Buffalo and other institutions recently revealed.

Nationwide, electronic patient tracking technologies are replacing traditional, dry-erase patient status boards, according to the UB researchers, who conducted the study with colleagues at the University of Rochester and the University of Florida, Jacksonville. The results were presented last month by the UB researchers at the annual meeting of the Human Factors and Ergonomics Society.

The researchers studied how new electronic patient-status boards were functioning in the emergency departments of two busy, university-affiliated hospitals. Overall, the UB researchers found that the computational tracking systems tended to affect how health-care providers communicate information and track activities regarding patient care, which can cause providers to change the way they work.

The results provide an important case study of what can happen when new technologies are developed without sufficient understanding by designers of the nature of the work in which they will be used, according to Ann Bisantz, Ph.D., associate professor of industrial and systems engineering in the UB School of Engineering and Applied Sciences, and a co-investigator on the study.

"Research in human factors, the study of the interactions between humans and technology, has shown that in complex workplaces where safety is critical, such mismatches between the way practitioners work and the technologies that are supposed to support them can have unintended consequences, including inefficiencies and workarounds, where the technology demands that people change their work method," said Bisantz.

... According to Bisantz, manual whiteboards perform a critical, central function for emergency departments, providing not just patient names and demographic information, but also a means for health-care workers to share information on patient complaints, vital signs, lab tests, consultations, dietary and allergy alerts, and notices about patient rooms that need to be cleaned.

The results revealed that the innate flexibility of the manual whiteboard allowed health-care providers and other emergency department staff to use it to communicate with one another ... "With a computerized system, providers have to find an available computer terminal and log-in," she said, noting: "The providers can't just walk up to the whiteboard and make a notation."

In some cases, providers noted that computer systems hid some of the information; if only three comments could be viewed per screen, they had to click to get to another screen, requiring them to search for information that might demand immediate attention. [A truly remarkable design flaw for an ED system - ed.]

... "If you don't understand the underlying structure of the work that is being done in a particular setting, then you cannot design the technology that will best support it," Bisantz said. [Doh! - ed.]

... The UB researchers have now received funding from the Agency for Healthcare Research and Quality (AHRQ) of the U.S. Department of Health and Human Services to develop simulations of proposed electronic patient tracking systems in order to better evaluate and match them to the needs of hospital emergency departments.

Health Wonk Review, Health Care Renewal Style

Welcome to Health Care Renewal. Health Care Renewal was the product of brain-storming by some physicians and health care researchers who wondered why as health care costs inexorably rose, access decreased, and quality remained stagnant. With health care reform again looming, no one seemed to be able to explain this, much less have any solutions.

We found we all knew stories that suggested systemic problems with health care that provided some explanations, but seemed rarely to be discussed in polite conversation.

Basically, the problems arose from concentration and abuse of power. As health care organizations grew ever larger and more powerful, their governance became more unrepresentative of their constituencies, secretive and opaque, unaccountable, and unethical and amoral.

Resulting practices were marked by conflicts of interest, deception and dishonesty, intimidation and coercion, and sometimes outright corruption, bribery, fraud, and other criminal behavior.

Although many physicians knew of local examples of these issues, and some cases had been described in the local news media, they produced few echos. In particular, discussion of them in academia and the medical and health care and policy literature seemed taboo. We called this the "anechoic effect."

The mission of Health Care Renewal is to discuss these problems, end the anechoic effect, and help find solutions. We present this edition of Health Wonk Review in this spirit, and with an organizational framework derived from the discussion above. We feature submissions by many HWR regulars, but also note posts in many of the newer blogs that too are concerned with the dark side of health care.

Health Care Reform and Policy in General

On the Health Care Policy and Marketplace Review, Bob Laszewski noted the lack of differences among the health care reform proposals of the current US candidates for the presidency, suggesting "that you not cast your caucus or primary vote for a candidate based upon their health care reform plan because from 'thirty thousand feet' there isn't all that much difference" among them.


On Health Care Renewal, we have posted frequently on payments made by medical device companies to physicians and health care organizations. Of particular interest is the money that companies who make to artificial joints have been giving to the major national orthopedic associations and to some of their leaders, raising questions of whose interests these organizations really care about. (See posts here and here.) A recurring theme on Health Care Renewal is the pervasiveness of conflicts of interest that raise questions about whom health care professionals really work for, and what interests health care organizations really serve.


On the Canadian Medicine blog, Sam Solomon addressed the controversy about Canadian physicians' new practice of outsourcing their billing for uninsured services, and its implications for patient privacy.

On the Health Beat Blog, Maggie Mahar pointed out how Wall Street seems not to care about the ethics of health care corporations, "the Street doesn’t care about the ethics of what the company is doing; investors care about whether or not the company is making a profit." But, "meanwhile, both companies and individuals in our for-profit health care industry continue to engage in criminal activities."

Zagreus Ammon on the Physician Executive blog presented his "hyper realist" take on the Avandia controversy. Forgive me if I fear this "hyper realism" shades into the cynicism. For example, he asserted, "pharmaceutical companies insist on controlling and potentially suppressing clinical information about the drugs they wish to sell. This is natural and indignation is laughable." It may be natural, but it can harm patients by depriving them and their physicians of the accurate evidence they need to make decisions. It is also an ethical affront to the patients who participate in clinical research thinking they were taking part to advance science and patient care. For the latest Health Care Renewal discussion of the Avandia case, go here.

On the other hand, Dr Aubrey Blumsohn on the Scientific Misconduct Blog analyzed the shenanigans now going on in the analysis and reporting of the ENHANCE trial of ezetimibe (Zetia, and an active ingredient in Vytorin). Further commentary on this issue can be found in the Hooked: Ethics, Medicine and Pharma blog by Dr Howard Brody, and in the Medical Evidence Blog by Dr Scott Aberegg. This is just the latest of many examples of how health care corporations who "sponsor" clinical research may try to make sure the results favor their products.

A graphic example of the sorts of people some pharmaceutical companies hire to perform clinical research appears on the Clinical Psychology and Psychiatry blog. Warning, it includes how a pharma-sponsored physician researcher managed to personally give two of his patients genital herpes simplex infections.

Dr Daniel Carlat on the Carlat Psychiatry Blog reprised (here and here) his New York Times Magazine article on his brief career as a part-time paid pharmaceutical company lecturer. The article provided a vivid narrative showing the ethical challenges of one pharmaceutical company's stealth marketing practices. See also comments on Dr Carlat's article on the Health Care Organizational Ethics blog.


Dr Adam J Fein at Drug Channels examined "how the upcoming disappearance of Average Wholesale Prices (AWP) will affect Pharmacy Benefit Managers (PBMs). He argues that PBMs should not be materially impacted by a shift in the drug pricing benchmark from AWP, especially as private payors start using the new CMS benchmark called Average Manufacturer Price."

Jason Shafrin on the Health Care Economist blog analyzed the reasonableness of expecting physicians to compete on the price of procedures. He noted that this may work for very routine, low risk procedures, but may not make sense in more complex situations in which outcomes are unpredictable.

Rob Cunningham on the Health Affairs Blog reported that "Congressional Budget Office Director Peter Orszag warns that policymakers have 'misdiagnosed' the biggest problem facing both Medicare and the health economy in general by overstating the projected impact of population aging and the impending retirement of the baby boom."

On GoozNews, Merrill Goozner provided an example of how expensive procedures are hyped, while the shortcomings of the evidence supporting the procedures, and the conflicts of interest of the hypers are buried.

The next three posts related to the seeming irrationality of how government agencies pay for procedures versus "cognitive" services.

David Harlow at HealthBlawg noted that the "CMS efficiency and effectiveness machinery turns its attention (again) to diagnostic imaging, field-testing four measures which will eventually be used in denials," and "asked what about bringing the same brains and brawn to bear on the CMS approach to physician compensation generally, rather than on one piece of ancillary income?"

Henry Stern at the InsureBlog wrote "One criticism of nationalized health care is that care may be rationed. But what about paying for procedures with no health benefits at all? InsureBlog's Henry Stern has the story of how one system pays for elective hymen-replacement surgery."

Jon Coppelman at the Workers' Comp Insider blog looked "at the pending Full Parity for Mental Illnesses bill that is before Congress, and explains why it is unlikely we will see parity for occupational injuries and illnesses any time soon."

Some insights on why US government reimbursement is so seemingly irrational and inexplicable come from this post on DB's Medical Rants. The anonymous DB reminds us that all US Medicare physician reimbursement is heavily influenced by a secretive AMA committee called the RBRVS Update Committee (RUC), whose membership is not public, but seems to be dominated by proceduralist physicians. Similarly, James Gaulte on the Retired Doc's Thoughts blog explained how the RUC undermined the rationale for setting up the RBRVS (Resource Based Relative Value System) in the first place, to more equitably reimburse primary care and "cognitive" services.

On the Covert Rationing Blog, DrRich wondered if a lawsuit trying to void Medicare's irrational physician reimbursement could succeed.

On the other hand, David Williams at the Health Business Blog addressed how the US government funds, or does not fund, small health care businesses. He interviewed "BIO's Alan Eisenberg re: SBIR grant eligibility for majority-VC [venture capital] backed companies, [letting] ... Eisenberg tell BIO's side of the story."

One post addressed the weirdness that seems to infect normal people when they try to write about health care costs. On the Health Beat Blog, Maggie Mahar critiqued the "muddle" that a New York Times editorial produced when it addressed health care costs, weaving "truth and error together in such a way that it would take a knitting needle to separate the two." and finally collapsing "into a confusion of contradictory clichés." Unfortunately, the same could be said about a lot that is written about health care policy, particularly the cost side, (but not by our HWR bloggers).


Loraine Lawson on the Good Ideas That Work blog asked, "Want to know how to curtail the spread of AIDS? Ask Brazil, where, in the early 1990s, health authorities feared the epidemic could 'grow out of control' (whatever that means). According to Reuters, new AIDS cases in Brazil fell to 17.5 per 100,000 people, which is down considerably from the 22.2 per 100,000 recorded in 2002."


Ian Walsh at the Agonist blog observed that problems with health care access may arise because those who make health care policy, for example, the US Congress, have a special deal on health coverage that mean they do not have to struggle with the problems ordinary citizens face, "the fact that they live in a privileged bubble and that the reason they don't even try to fix the problems of ordinary Americans is because they don't share them."

On the Managed Care Matters blog, Joe Paduda examined how US universal coverage plans could deal with illegal immigrants, but noted that meanwhile, Mexico may come up with a universal coverage system before the US does.

Louise Norris on the Colorado Health Insurance Insider blog discussed obstacles to mandatory health insurance, noting the need to trim costs, starting with amazingly well paid hospital and managed care CEOs.

Anthony Wright on the Health Access WeBlog reviewed "two articles on the SCHIP fight, California’s pending decision as a result to disenroll kids from coverage, and why the problem is both worse than we think (violating 10 years of outreach and trust) and better (there’s a certain political resolution)."

Thanks again for visiting Health Care Renewal and perusing the Health Wonk Review. The Health Wonk Review web-site is here. Also, see our side-bar for a nearly complete listing of previous Health Wonk Review editions.

Tuesday, November 27, 2007

A (Well Deserved) Rant about the RUC

On DB's Medical Rants, the nominally anonymous blogger took on the RUC (RBRVS Update Committee).

I am starting to believe that the distortions of physician reimbursement orchestrated behind the scenes by the shadowy RUC are one of the main reasons US health care is in such a mess. We had posted about the RUC, based on some important articles published this year that first brought its machinations to light (1,2,3) here and here.

A new article just appeared in JAMA on the topic(4) by the perspicacious Dr John Goodson, which provided a focus for what was really a Medical Rant:

The story of the RUC often reminds me of conspiracy theories. They (we never really know who they are) determine the fate of the world (or at least the economy). The RUC has disproportionate power and has apparently taken a reasonable idea (RBRVS) and corrupted it. If you want to know who to really blame, it is the RUC. I blame the AMA for developing a committee which does not represent the interest of overall health care, but rather the interests of subspecialties.

I do believe that the RUC has done more to negatively impact outpatient continuity, chronic care than any single entity.

This issue deserves more attention. We must expose this problem and make it reach the national conscious. I fear that it is important but a bit obtuse. I cannot imagine a sound bite approach to the evil the RUC has wrought.

1. Bodenheimer T, Berenson RA, Rudolf P. The primary care-specialty income gap: why it matters. Ann Intern Med 2007; 146: 301-306. (link here)
2. Maxwell S, Zukcerman S, Berenson RA. Use of physicians' services under Medicare's resource-based payment system. N Engl J Med 2007; 356: 1853-1861. (link here)
3. Newhouse JP. Medicare spending on physicians - no easy fix in sight. N Engl J Med 2007; 356: 1883-1884. (link here)
4. Goodson JD. Unintended consequences of Resource-Based Relative Value Scale reimbursement. JAMA 2007; 298(19):2308-2310. (link here.)

The Most Popular "Dr Drug Rep"

"Dr Drug Rep," the New York Times Magazine article by Dr Daniel Carlat about his brief career giving pharmaceutical industry sponsored talks, apparently is creating quite a buzz. (See our previous post here.)

On the Hooked: Ethics, Medicine and Pharma Blog, Dr Howard Brody wonders about the reason Wyeth paid Dr Carlat so generously. Was it really because he was so good at persuading other doctors to prescribe Effexor? Or was it "to pay him $30K in bribes to get him to prescribe more Effexor in his own practice?"

On the Carlat Psychiatry Blog, Dr Carlat himself went over some of the comments he has been getting since he published his article. Some were hostile, calling him a "hypocrite," etc. There were equally hostile comments on some of the other blog posts on this topic. This is not very surprising. Dr Carlat's article raised ethical questions about marketing practices frequently used by pharmaceutical companies (and probably also biotechnology companies and device manufacturers). A lot of people make a lot of money from these practices, not only the well-paid physician speakers, but the drug reps who recruit them, and the marketing executives who are responsible for the whole mess. I bet they are not all happy with their exposure in the NY Times Magazine. Recall a quote I posted from the Aspen Health Forum, " there are powerful economic forces invested in this current culture. It would be foolish and naive to think they won't resist change."

Some of Dr Carlat's commentators thought he should return the $30K he got as a "lunch and learn" speaker. Maybe so. But Dr Carlat has clearly done a lot to atone for his previous mistakes. Not only did he write "Dr Drug Rep," but he now produces the Carlat Psychiatry Report, which is independent of pharmaceutical funding, and he periodically skewers unethical practices on the Carlat Psychiatry Blog. Thus, he is devoting a lot of effort to becoming the antithesis of a "drug lunch" speaker. More power to him, I say.

More power to him, especially since this post on the PostScript blog (by the Prescription Project) noted that Carlat's article yesterday was the most frequently emailed NY Times article. (Right now it is the #3 emailed and the #7 blogged article.) The post hopefully concludes,

Does all this add up to our nation taking stock, just as Carlat did, about the ethics and consequences of our relationship with medicine and the pharmaceutical industry, and the relationship we permit between the two? Perhaps. Or perhaps it’s too a big leap to see the patchwork of moves by individual, corporate, academic, and public healthcare stakeholders as the actions of a united, albeit clumsy, moral agent. Either way, it seems we can read the growing policy and media attention—measured in bills and newspaper inches and airtime—like a loudening macro version of the silent internal dialogue Carlat describes having with his conscience after each Wyeth talk he gave.

It will be interesting to follow this story and see whether this interplay among policymakers, press and the public concludes, as Carlat’s tale did, in a collective, incremental 'No Thanks.'

Again, I can at least dream that that this marks the beginning of the end of the "anechoic effect." Again, bravo, Dr Carlat.

Monday, November 26, 2007

Is it Medical Education, or is it Pharmaceutical Marketing? - the Case of "Dr Drug Rep"

Even though many other bloggers have commented on it, I must note an article just published in the New York Times Magazine by Dr Daniel Carlat, editor of the Carlat Psychiatry Report and blogger on the Carlat Psychiatry Blog.

Dr Carlat recounts what inspired him to produce a newsletter on psychiatry treatment that is supported by no pharmaceutical company money, and to blog acerbically about the influence of vested interests on medical education.

It seems that in 2001, he became, as the article is entitled, "Dr Drug Rep." One of the local drug reps enticed him into giving "educational" lectures, over drug company supplied lunches, to physicians and others in their offices. The lectures, of course, were mainly positive about the drug company's product (a serotonin and norepinephrine reuptake inhibitor used to treat depression, venlafaxine, Effexor by Wyeth).

Dr Carlat described the lavish meeting at which he was prepared for his new part-time job. He was provided with a "slide deck" of company approved slides, and heard lectures by famous psychiatrists who, of course, found little not to like about Effexor. Dr Carlat gradually began to realize that the evidence which he was taught to provide in support of Effexor was not as convincing as it first appeared. He became concerned about how much drug reps knew about other physicians' prescribing, and the degree to which his own lectures were being monitored by drug reps. After encountering some skeptical physicians in his audiences, he began to realize that he was not as convinced about what he came to be selling as when he started. Finally, when he modified his presentation to be more honest about the benefits and harms of the drug, the local district manager for the pharmaceutical company inquired, "have you been sick?" That is when he quit his part-time Dr Drug Rep job.

The extent that pharmaceutical manufacturers (and other companies such as biotechnology firms and device manufacturers) disguise marketing as "education," and recruit physicians and academics to do marketing in their guises as "thought leaders" should come as no surprise to readers of Health Care Renewal and some of the other blogs listed on our side-bar. However, this topic is addressed not as often as it should be in the medical and health care literature, and in medical school and house staff training. Furthermore, the public hears far more from the corporate marketers and those who work for them than from the skeptics like Dr Carlat.

That this clearly written and entertaining article appeared in an outlet with the circulation and prestige of the New York Times Magazine means that we really are making progress in making the public aware how deception, dishonesty, and unethical behavior in general may be responsible for much of the current health care crisis. Kudos to Dr Carlat.

See also discussion on the Carlat Psychiatry Blog, the Clinical Psychology and Psychiatry Blog, the Health Care Organizational Ethics blog, the PharmaGossip blog, the PharmaLot blog, and the Retired Doc's Thoughts blog.

No Questions Answered, but Targeted Genetics Gene-Therapy Trial to Resume

We previously discussed, most recently here, the unfortunate and unexplained death of young patient after an injection of an experimental gene-therapy agent. To summarize the case thus far, a young woman received a dose of an adeno-associated virus carrying a gene that was meant to have a local immune suppression effect, tgAAC94, made by Targeted Genetics, directly into her joint as part of a phase I study meant to assess the safety of the treatment. Soon after the treatment, she became ill, then very ill, and ultimately died in an intensive care unit.

Whether the treatment had anything to do with her illness and death were initially unclear. A hearing by the US National Institutes of Health (NIH) Recombinant DNA Advisory Committee did not reach any conclusions about what caused the patient's death. (See post and here.) The NIH panel "said it was too early to conclude that the gene therapy had not been a factor, perhaps by suppressing ... [the patient's] immune system," (per the International Herald Tribune.) I should also note that even apparently innocuous viruses sometimes are not. The US Center for Disease Control (CDC) recently warned of cases in which people have died after infection with a type of virus, a type 14 adenovirus, that usually just produces a mild upper respiratory infection.

Nonetheless, now the US Food and Drug Administration (FDA) is allowing Targeted Genetics to restart the trial. The company's CEO, H. Stewart Parker, is claiming "this is a vindication for the product, the company and the field of gene therapy," (per Bloomberg News. There is a similar quote in a Seattle Times article.)

The study will apparently resume with many of its previously identified problems unaddressed. Questions were raised about the conduct of the trial, including:

  • whether the patient was lead to believe she might benefit from it, even though the study was meant only as an initial, Phase I, safety assessment;
  • whether she was influenced to participate because her rheumatologist was an investigator, and he administered the informed consent form, without disclosing he was paid to participate in the trial;
  • whether she found the consent form understandable;
  • what institutional review board (IRB) reviewed the trial; and
  • whether Targeted Genetics unduly delayed reporting the patient's condition to the US Food and Drug Administration (FDA)?

None of these questions have yet been answered, However, Per the Washington Post,

Kyle Hogarth, an intensive-care unit physician at the University of Chicago who cared for Mohr and was involved in the investigation, said yesterday that he feels reasonably certain that the treatment did not kill her. But he is still bothered by the study's design, he said, because it allows participants to keep taking prescription medications that cannot be distinguished from the immune-suppressing protein made by the treatment's gene-modified viruses.

That makes it impossible to fully sort out whether problems that arise during the experiment may be caused by the treatment or the drugs the subjects are taking, he said.

Although conventional arthritis medications can, on rare occasions, make patients especially susceptible to fungal infections, Hogarth and others have questioned whether the gene treatment left Mohr especially defenseless.

'I think they have a horrible design,' Hogarth said. 'It muddies the picture.'

Hogarth also echoed a concern raised by others in the course of the investigation: that Mohr was recruited into the study by her personal physician, who stood to profit from each new patient he enrolled. Medical ethicists have criticized such arrangements as posing a potential conflict of interest.
So, what is the big hurry to resume this trial? We still don't know whether the trial intervention was responsible for the death of a patient who, although she had arthritis, appeared nowhere near chronically ill enough so that her death was expected. The treatment has no claim to be life saving, or likely to be so much better than old treatments that it is worth facing a risk of death to take it. The trial is already known to have multiple design defects. I fear that the hurry is generated, as we said before, by the belief held by many people involved with this trial that their new treatment was safe in the absence of much evidence one way or the other. Such a belief may have partly been influenced by their vested interests in their product's success. As Osagie K. Obasogie wrote, "It's also about how profit motives embedded in the clinical trial process can undermine patient safety."

Health Plans Programs Cancelled for Refusing to Reveal What They Pay Doctors

The Hartford Courant reported last week how the state of Connecticut has stopped four managed care organizations/ health care insurers from running its HUSKY state insurance program for poor children.

Escalating a long-running battle over the state's Freedom of Information law,the state is yanking the primary management of the HUSKY health insurance program for poor children out of the hands of four insurance companies.

The announcement Monday by Gov. M. Jodi Rell marked the latest stage in a battle that has lasted more than two years over whether the private companies could be forced to comply with public FOI disclosure laws.

The HMOs have refused to reveal the rates they pay to doctors for various services, saying the information is proprietary. Legislators have also complained that the insurance companies have refused to reveal how often they deny payments for prescription drugs and which drugs are rejected.

The two largest companies in the HUSKY program — Anthem Health Plans Inc. and Health Net — have repeatedly rejected Rell's demand that they comply with the disclosure law, and have said they are willing to drop their contracts if the FOI disclosure is required.

'These companies refuse to abide by our public disclosure law, despite being required to do so, and they were also willing to walk away from providing services to our children if they had to live up to this requirement,' Rell said Monday. 'They may have been willing to walk away, but I am not. We spend over $700 million a year in taxpayer money to provide these services under the HUSKY program to children and parents in Connecticut's working families. It is only right to fully disclose how this money is spent.'

Both the state's Freedom of Information Commission and Superior Court Judge George Levine have upheld the request for disclosure, ruling that the private companies are performing a public function by managing the state's Medicaid program for about 325,000 people. One of the four companies — WellCare Health Plans Inc. of Florida — did not join with the other three in appealing the Superior Court ruling to the state Appellate Court.

Low-income HUSKY patients were having difficulty getting appointments with specialists, and some believed that the appointments were blocked because reimbursement rates were so low, officials said.

This is a reminder that for many large health care corporations, transparency aren't us. So how are we supposed to let the "free market" improve health care, when no one knows what prices anyone pays for health services?

Note that we have also posted about how Health Net Inc is in trouble with California state health insurance regulators for concealing information from them and retroactively cancelling individual health policies after their holders got sick. We have also posted about how Blue Cross health insurance operated by WellPoint Inc is in trouble in California also for retroactively cancelling sick people's individual health policies. Anthem Health Plans are subsidiaries of WellPoint. Is there anyone left that believes US for-profit managed care organizations' warm and fuzzy statements (like Wellpoint's advertised commitments discussed in this post) about how they are out to improve health and help policy holders?

A little more truth and transparency would go a long way to improving the mess that is now US health care.

Is it (Clinical) Research, or is it (Pharmaceutical) Marketing? - the ENHANCE Trial of Ezetimibe

The story of the delay in reporting results of the ENHANCE trial of ezetimibe (Zetia, by Schering-Plough, and one component of Vytorin, by Merck) was reported by Matthew Herper in Forbes, Alex Berenson in the New York Times, and and MedScape. Then several prominent skeptical bloggers, including Howard Brody on the Hooked: Ethics Medicine, and Pharma blog, Dr Aubrey Blumsohn on the Scientific Misconduct Blog, and Dr Scott Aberegg on the Medical Evidence Blog analyzed the situation. Therefore, I need not post a lot of detail.

Basically, although ezetimibe has been shown to reduce LDL ("bad") cholesterol, it has never been shown that using the drug to do so produces any clinical benefit, e.g., prevents heart attacks or strokes, prolongs life, etc. The ENHANCE trial was designed to determine whether the drug at least reduced arterial obstruction, thought to be a good predictor of bad clinical events. After reporting of the trial's results was delayed, it became evident that:
  • The trial's Principal Investigator had no access to the trial's original data, and no control over how the data was analyzed.
  • The data was owned and analyzed by the drug companies that nominally "sponsored" the trial.
  • The same drug companies decided to change the trial's endpoint after the trial was implemented and the data was collected.
  • The companies justified the decision as coming from an expert panel they convened (and presumably paid for.) However, they did not reveal who was on the panel.

As Doctors Brody, Blumsohn, and Aberegg pointed out, this trial is just the latest poster child for how pharmaceutical manufacturers (and other health care corporations) can manipulate the design, implementation, analysis, and reporting of clinical research they sponsor so as to make their products look as good as possible. Is it (clinical) research, or is it (pharmaceutical) marketing?

My main addition to the expert commentary already made about this trial is that not only does the control of clinical research by organizations with vested interests in having the research turn out a certain way challenge the research's validity. It also is an affront to the research subjects who thought they were participating in a study meant to advance science and possibly health care.

Friday, November 23, 2007

BLOGSCAN - The Dwindling of Primary Care

On the Retired Doc's Thoughts blog, Dr James Gaulte tied the dwindling of primary care to how Medicare controls physicians' reimbursement. Furthermore, he ties the continuing imbalance between the generally poor reimbursement for primary care and other cognitive services and the much better reimbursement for procedures to the influence of the shadowy RUC (RBRVS Update Committee), a topic which I have also ranted about (here and here). Kudos to Dr Gaulte for trying to keep a flame under this pot.

Wednesday, November 21, 2007

BLOGSCAN - Another Case of (Attempted) Ghost-Writing

A little late for Halloween is this post on the WSJ Health Blog describing a vivid anecdote of an unsuccesful attempt by a medical education and communication company (MECC) to generate a ghost-written abstract for a medical scientific meeting. (Our most recent post on ghost-writing and related pheonomena was here, summarizing an article by Moffatt and Elliott that characterized ghost-writing as harmful to people and undermining science.)

More About Surgeons Who Received Large Payments from Joint Implant Manufacturers

The story about artificial joint manufacturers' payments to orthopedic surgeons and others just keeps bubbling along. We have previously posted (here, here, 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.

A few intrepid reporters have pursued this story by looking for local surgeons on the lists. First, Bill Toland in the Pittsburgh Post-Gazette found some recipients of the companies' largesse, and what he learned from one was typical,

In Pittsburgh, Dr. James D'Antonio, of Greater Pittsburgh Orthopaedic Associates, has received $850,000 to $875,000 through the first 10 months of 2007 from Stryker. On his extensive resume is the development of a new alignment system for artificial knee joints, femoral research, and two decades of experience in knee and hip replacements, performing them at several regional hospitals.

Most of the money received this year, more than $600,000, was for royalties on intellectual properties he helped to develop.

'I could do a lot more surgery if I didn't do this for Stryker,' Dr. D'Antonio said in a phone interview. He also said that he's not beholden to Stryker's products because of the fees he collects.

'I use other implants,' he said. 'I don't hesitate to use other companies for a minute,' if they carry a product he feels is better suited for a surgery.

Toland recorded several other denials that the payments influenced which artificial joints the recipients chose to implant in patients, for example,

Zimmer, the largest of the joint manufacturers, paid out the most to Pittsburgh doctors, $1.16 million through Oct. 31.

Together, the nonprofit clinic and health provider AMD3 and its founder, Dr. Anthony M. DiGioia III, received at least $437,000 from Zimmer.

'As an independent physician, I am not rewarded by either the hospital or the implant company for using any specific products,' Dr. DiGioia said. He is not 'obligated or rewarded to use any of Zimmer's products.'

This week, Lindy Washburn of the North Jersey Media group looked into the situation in her area. Again, she found several surgeons who received large payments. They turned out to be involved with the design of particular devices,

Michael A. Kelly, chairman of the Department of Orthopedic Surgery at Hackensack University Medical Center, and Mark Hartzband, director of its Total Joint Replacement Service, were among the highest-paid consultants nationwide at Zimmer Inc. They also were the highest- paid New Jersey consultants to any orthopedic company.

Both were involved with the development of Zimmer's "female knee."

Zimmer paid Kelly, who is president of the American Knee Society, $1,043,028. It paid Hartzband $995,739, along with $20,619 to his Hartzband Joint Replacement Institute in Paramus.

Kelly and Hartzband, for example, both were listed as members of the design team for Zimmer's "female knee," introduced last year. They were involved in the clinical trials that led to federal approval for the device, and travel around the world to lecture and demonstrate surgical techniques. Hartzband also was a pioneer in minimally invasive hip replacement surgery, which Zimmer introduced in 2003.

HUMC, where the two operate, uses joints from three different companies, including Zimmer. Kelly, as chief of the department, plays a role in choosing the suppliers and is required to disclose any conflicts of interest, said Robert Garrett, the hospital's executive vice president and chief operating officer.

Hartzband, as a private practitioner, is not required to make such a disclosure, and Garrett said he was unaware of the amount Hartzband received.

Neither surgeon responded to messages left at their offices.

"Our policy has always been to get competitive bids on a product and get the best-quality products," Garrett said. "I don't have any reason to believe there's any kind of kickback involved. Dr. Kelly has always acted on behalf of patients and what's best for the patients -- the fact that we have three vendors is testament to that."

Then, John Dorschner of the Miami Herald reported from South Florida. Not surprisingly, he found one local doctor who received large payments, which again turned out to be related to his involvement in the development of a specific device.

A well-known Miami doctor who did Heat Coach Pat Riley's hip replacement surgery has received nearly $600,000 this year in fees from a company that makes artificial hips, according to documents published in connection with a federal kickback investigation.

Carlos Lavernia, medical director of the Orthopaedic Institute at Mercy Hospital, received $586,863 through Oct. 31 from Zimmer, an Indiana company that makes hip and knee replacements.

Lavernia received the most fees of doctors in South Florida, based on lists that revealed the fees of hundreds of doctors nationwide.

Lavernia said he has done nothing wrong. Zimmer is paying him royalties for a hip and knee implant system he designed. He is not paid royalties on devices he implants himself or any implants bought by Mercy, he told The Miami Herald in an e-mail. He said he uses products of all manufacturers, depending on what's best for the patient.

Lavernia told The Miami Herald he is 'currently in the process of developing a patient disclosure letter,' discussing his relationship with Zimmer.

Lavernia and Zimmer are closely connected.

He has given speeches at Zimmer's corporate headquarters in Warsaw, Ind. One of the talks he gave urged surgeons to better understand insurance reimbursement rates for implants so that they can get paid better.

According to a Zimmer press release, Lavernia co-authored a research paper that reported major advantages for Zimmer's Quad-Sparing Knee Replacement Procedure.

Mercy spokeswoman Rey said the hospital had no comment because it was a matter between Zimmer and Lavernia.
All these news reports suggest that the doctors who received the largest payments from the manufacturers of artificial hips and knees were involved in the design of specific products, and often received payments in the forms of royalties, presumably based on licensing agreements for patents they held. Apparently, most such agreements do not pay royalties for devices the surgeons personally implanted, and perhaps for any devices implanted at their hospital.

So far, discussion in the media of possible conflicts of interests caused by the device manufacturers' payments to surgeons has centered on concerns about whether surgeons who got payments from particular companies were more likely to to choose those companies' products for their patients. Some surgeons have denied conscious bias, and it appears that some of their royalty agreements were structured so that they were not paid directly for implants they themselves chose, or were chosen at their hospital.

However, an important issue that has so far not been discussed is the extent that the surgeons who received payments may have influenced other surgeons to use the products of the companies who paid them. It appears that many of the surgeons who got large payments were very well known, and some held prestigious academic posts. Some were in positions to influence trainees (medical students, interns, residents, and fellows) through their teaching. Some could influence the broader community of orthopedic surgeons by speaking and writing. There were examples above of payment recipients touring internationally to speak and teach about the joint implants they had designed, touring nationally to speak about reimbursement for joint implants, and authoring journal articles reporting research on the implants for which they received royalties. Whether the payment recipients revealed to their audiences the magnitude of the payments they were getting, or whether the payments were based on the number of devices the companies sold, which presumably is usually how patent royalties are paid, are all unknown.

The Miami Herald article stated, "for years, there have been unconfirmed rumors and rumblings about device companies paying doctors fees, sometimes for consulting, speaking or doing research on particular devices." This suggests that it was not exactly common knowledge that prominent orthopedic surgeons who taught or wrote about joint implants and related topics were being paid generous royalties by the companies who made the implants for each device sold.

Thus, it appears that surgeons who may have been paid royalties every time a specific device was sold may have had opportunities to influence the surgeons who made decisions about which devices to use. The surgeons who were paid royalties may not have let these decision-makers know their financial stake in the companies selling more devices.

We suspect that all the extent and magnitude of conflicts of interest generated by the the device manufacturers' payments have yet to be revealed.

Tuesday, November 20, 2007

Nature Takes on the Biases of Pharmaceutical Sponsored CME: Is the Anechoic Effect Starting to Fade Away?

In Nature, a news article by Jim Giles focused on potential biases of pharmaceutical company funded continuing medical education (CME). We had previously posted about an illustrative case, in which GlaxoSmithKline funded speakers seemed to favor clinical policies which would promote increased use of its drug valacyclovir (Valtrex) for genital herpes infections. Giles also used that case for illustrative purposes in a sidebar entitled "Smokescreens."

Giles then described two relevant, but unpublished studies. The first was by Jatinder Takhar

Takhar and her colleagues went on to develop a standardized checklist of potential problems to be used for measuring bias in CME, which they published in June (J. Takhar et al . J. Cont. Educ. Health Prof. 27, 118-123; 2007). The team then applied its checklist to 17 company-sponsored CME events. Nine of these were found to be biased and should not have been approved, Takhar says. Some focused only on the sponsors' product and ignored rival treatments. In others, information on side effects associated with the sponsors' drugs was reduced to small print.

The second was by Daniel Carlat,

Another study, by Daniel Carlat, a psychiatrist at Tufts University School of Medicine in Somerville, Massachusetts, looked at printed CME material — typically, medical articles followed by a written test. Carlat asked his colleagues to remove information about the sponsor from exercises sent to his office during 2005 and 2006. He then calculated the ratio of positive to negative statements made about every drug mentioned in the exercises. In 14 of the 15 exercises he looked at, the drug that received the highest ratio turned out to have been made by the firm sponsoring that exercise. He is preparing his paper for submission to the American Journal of Psychiatry.

For balance, Giles asked Jennifer Page, communications director at the Pharmaceutical Research and Manufacturers of America (PhRMA), for comment, but she "said only that drug companies do adhere to her organization's CME guidelines. Those standards require a firewall between pharmaceutical firms and medical-education companies. Drug companies can recommend speakers for events, for example, but CME providers select the physicians best suited for the job and are not obliged to follow a sponsor's suggestions."

However, Jerome Kassirer, former editor of the New England Journal of Medicine countered, "that the provider-sponsor firewall is easy to subvert, because CME providers do not need to be explicitly told to produce biased programmes. 'They know that if they don't provide what the company wants then they're never going to be hired again,' he claims."

This news article is particularly significant because it opens mainstream discussion of how pharmaceutical (and other) companies can do stealth marketing in the guise of sponsored CME.

On Health Care Renewal, we have noted how local physicians may grumble about stories about the dark side of health care, but these stories rarely make it into the medical and health care literature, and hence rarely provoke widespread discussion, much less any action. We dubbed how stories like this cause no echoes the "anechoic effect." (See relatively recent post here, and earliest discussion on Health Care Renewal here.)

Now one of the foremost science journals in the world has published a major news story on commercially biased CME. Maybe now there is hope that the anechoic effect may be starting to fade away.

Note: see discussion on PharmaLot here.

ADDENUDM (21 November, 2007): see discussion on the Carlat Psychiatry Blog here.

Monday, November 19, 2007

More About Who Had to Call Off the Dogs on an Avandia Critic

"Twice I have with my own ears heard the sound which resembled the distant baying of a hound." [The Hound of the Baskervilles: Another Adventure of Sherlock Holmes By Arthur Conan Doyle]

We just posted about a report by the US Senate Finance Committee charging that top executives of GlaxoSmithKline had tried to silence an critic of rosiglitazone (Avandia, by GlaxoSmithKline). (For our earlier discussion of the Avandia controversy, see this post and older links.) The Wall Street Journal just published a news article on Finance Committee report which provided a few more details.

Over a period of several years, drug maker GlaxoSmithKline PLC was so concerned about a prominent physician's negative views of its diabetes drug that it engaged in a concerted effort to intimidate him and stifle his opinion, a report by the U.S. Senate Finance Committee found.

The report offers a window into the rarely acknowledged practice among drug companies of monitoring and seeking to influence the opinions of leading physicians, who can make or break a drug's sales. The report alleges that Glaxo Chief Executive Jean-Pierre Garnier and former research chief Tachi Yamada were involved in the intimidation.

[The report] said it feared the Avandia case was part of a 'troubling pattern of behavior by pharmaceutical executives.'

'The effect of silencing [Dr. Buse's] criticism is, in our opinion, extremely serious,' the report concludes, noting that patients may have needlessly suffered heart attacks during the period. 'Had GSK considered Avandia's increased cardiovascular risk more seriously when the issue was first raised in 1999 by Dr. Buse, instead of trying to smother an independent medical opinion, some of these heart attacks may have been avoided,' the report says.

A Glaxo spokeswoman, Nancy Pekarek, said the company strongly disputes the committee's conclusions. She said Glaxo had tried to correct Dr. Buse's 'inaccuracies' about Avandia but had never tried to intimidate or silence him. 'People at the time were very passionate about this new medicine and could perhaps have handled the interactions with Dr. Buse better,' she said. 'We did apologize to Dr. Buse for the tone of some of the conversations, and he accepted that apology eight years ago.'

She said Dr. Garnier had no additional comment. Dr. Yamada, who is now president of the global health program at the Bill & Melinda Gates Foundation, was traveling Friday and unavailable for comment, his assistant said. In an interview last month with Nature magazine, Dr. Yamada said that he never pursued any 'diabolical plot' against Dr. Buse. Dr. Buse was also traveling Friday and unavailable for comment.

The Nature interview with Dr Yamada is here. In it, Dr Yamada denied threatening Dr Buse with a lawsuit, “Nor did I ever discuss a lawsuit with anybody else … I wouldn't want the media to think it's some diabolical plot hatched by me against Dr Buse, because nothing could be further from the truth.” On the other hand, Dr Yamada favored a strategy "to launch a well-planned offensive on behalf of Avandia." Dr Buse acknowledged, "I don't think that Dr Yamada is the bad guy in this story,” but turned to Dr Yamada with his request to "call off the dogs."

Whatever the details, whether anyone threatened a lawsuit or not, it seems like Dr Buse clearly felt that someone let the dogs out to get him, and attributed to Dr Yamada the power to reduce this pressure. The Senate Finance Committee report put it a lot more strongly than that.

Therefore, this anecdote seems to demonstrate the flip side of the pharmaceutical (and biotechnology and device) industries' fascination with the use of well-paid "thought leaders" to promote its products. "Thought leaders" who criticize their products are liable to hear the dogs baying in the distance.

So, once more, with feeling, if the pharmaceutical (and biotechnology and device) industries do not want to be regarded as "shifty," (see post here) they should argue with, but not try to pressure, intimidate, threaten, or let the dogs out on people who criticize their products.

Furthermore, consider the Gates Foundation's stated guiding principles which include:

- We advocate—vigorously but responsibly—in our areas of focus.

- We must be humble and mindful in our actions and words. We seek and heed the counsel of outside voices.

- We demand ethical behavior of ourselves.

- We treat each other as valued colleagues.
Hopefully we will hear more from Dr Yamada about upholding these principles so that no one has to ever ask him again to "call off the dogs."

"We heard the hound on the moor, lo I can swear that it is not all empty superstition." [The Hound of the Baskervilles: Another Adventure of Sherlock Holmes By Arthur Conan Doyle]

ADDENDUM (20 November, 2007) - see additional comments on the Health Care Organizational Ethics blog.

Health Net Statements Inoperative in California and Connecticut

A little while ago we posted about accusations that Health Net Inc, a for-profit managed care organization, cancelled individual health insurance policies after the policy-holders became ill and filed claims. Now the company is also accused of trying to conceal related information from state regulators.

The San Francisco Chronicle reported that

State health regulators fined Health Net Inc. $1 million Thursday for lying to investigators about paying employees bonuses based on the number of contracts they canceled after those policyholders got sick.

The penalty was the first levied on a health insurer for withholding information about incentives given to its employees.

Health Net, along with other major health insurers, is being investigated for combing through applications of members after they have filed claims to find mistakes or omissions that would justify revoking policies. Insurers say they resort to rescinding policies only when members lie about their health histories, but consumers say the questionnaires often are vague and misleading.

As part of the investigation, state regulators asked Health Net officials on two separate occasions whether the company gave financial bonuses to its employees for rescinding policies. State law prohibits tying compensation to claims decisions. Both times, plan officials denied doing so.

Health Net executives apologized Thursday for 'any misunderstanding' with the state regulators. The company, based in Woodland Hills (Los Angeles County), accepted a consent agreement and promised to stop compensation practices linked to rescission.

Meanwhile, in Connecticut, the state subsidiary of Health Net has also been accused of deception. According to the Hartford Courant,

Health Net of Connecticut is under fire from state officials for sending pharmacies fraudulent computer messages that deny some low-income children medications, and for allegedly misleading a state inquiry into thinking it didn't use the messages.

Attorney General Richard Blumenthal, who has initiated an investigation into the matter, said Wednesday he is calling for sanctions against Health Net.

'The claims are credible and compelling, and so serious and significant and so egregious it could require very strong remedies and sanctions,' Blumenthal said.

Health Net, one of four managed care organizations that provide health care to Medicaid recipients, uses a 'not covered' pharmacy computer message that falsely leads some pharmacists to believe prescriptions aren't covered when all that is required is prior authorization from the insurer.

During a DSS investigation earlier this year into the computer messages of the state's four managed care organizations, Health Net misled the state into thinking that its primary message read by pharmacists wasn't a 'not covered' message, [Connecticut Legal Services attorney Randi] Mezzy said.

Alice Ferreira, a spokesperson for Health Net, said the company did not intentionally mislead the state and that it will correct the problem immediately.

It seems that Health Net operations in at least two states have a problem with producing "inoperative" statements, in the immortal words of US President Nixon's former press secretary.

To extend an argument I have made before about the pharmaceutical industry, if health care insurers and managed care organizations want to be regarded as trustworthy, perhaps they ought to consider actually acting in ways that might inspire trust.

Who Do Pharmaceutical Companies Support to Run Clinical Trials?

On the Clinical Psychology and Psychiatry blog, this post discusses an amazing case of a psychiatrist who had his license suspended for giving genital herpes to two patients. Why is that amazing, or relevant to Health Care Renewal?

The psychiatrist also is known for enrolling patients in clinical trials sponsored by no less than 11 well-known pharmaceutical companies (AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Eli Lilly, GlaxoSmithKline, Janssen, Johnson & Johnson, Novartis, McNeil, Pfizer, and Shire) and working with no less than six well-known contract research organizations (I 3 Research, INC Research, Parexel, PPD Development, Quintiles, Rho Inc).

Apparently an FDA investigation of the (not so) good doctor also found he had "imprisoned" one patient, enrolled at least two patients in trials without informed consent, hospitalized patients in unlicensed facilities, and failed to record drug dosages in trials.

Yet, the psychiatrist seems to be regarded as something of a "thought leader," as he claims to be on the speakers bureaus of "Wyeth Pharmaceuticals, Pfizer Pharmaceuticals, Bristol Myers Squibb and others."

But of course, some have argued (e.g., see this post) that the physicians and researchers the pharmaceutical industry recruits as consultants, study investigators, and speakers are nothing but the "best and the brightest." Maybe not always...

At the Aspen Health Forum: Dealing with Dysfunctionality, Perverse Incentives, and Vested Interests

As I posted last month, I had the good fortune to be able to attend the Aspen Health Forum last month, and got to hear some presentations that were remarkably frank about some of the issues facing health care today.

Just before I had to run to try to catch a plane, I attended the session entitled "Health, Humanity and Politics: Prospects for Reform." Again, I found that the speakers were remarkably frank in addressing some of the issues that we discuss on Health Care Renewal. However, many of the comments went by too fast for me to take accurate notes. The Aspen Institute just released video and audio from most of the Forum sessions. So I was able to transcribe some of the relevant thoughts.

Mark Ganz, President and CEO of the Regence Group, a Blue Cross- Blue Shield affiliated health insurance company based in Oregon, describing a typical anecdote representative of the fundamental dysfunctionality of the current system:

We had to accept that we were not in control. The system was in control.

Ganz on fundamental dysfunctionality:

[A system characterized by] economic rules that didn't make sense and a culture that in a great way perpetuated these rules.

People were trapped in processes that they could not defend, much less understand.

Elizabeth Teisberg, co-author of Redefining Health Care, Associate Professor of Business Administration at the University of Virginia Darden Graduate School of Business, on dysfunctionality and perverse incentives:

You can't change incentives in a system that is fundamentally dysfunctional... unless you address the underlying problem. We need systems that are patient-centric and results-driven.

Ganz on the role of industry:

Industry players focus their attention on each other, not on the people they are supposed to serve.

An audience member on the role of pharmaceutical and device companies, and perverse incentives:

The manufacturers of drugs and devices - these are really the companies that have the power.... They really ... put up barriers to a lot of the reform efforts.... The way that they profit is through the inefficiencies of the system, and if you make the system more efficient, it really squeezes their profits. How do you get these companies on board, to be part of the solution not part of the problem?

Ganz on how those with vested interests will resist positive change:

To be sure, there are powerful economic forces invested in this current culture. It would be foolish and naive to think they won't resist change. Even so, our ability to effectively incentivize those with deep economic interests in the status quo to a new way of thinking about control will be essential to the long-term success of any reform effort. We found that the greatest impediment to process is fear, fear of the unknown, and fear up giving up the only way people have known.

There you have it.

  • The system is dysfunctional.
  • Incentives are perverse.
  • Powerful organizations serve their own interests, even if that undermines the core values of health care professionals.
  • People who are currently making a lot of money from the system will resist change.
  • The only way to get them on board is to change their incentives.

Sounds like a start. But heed Mr Ganz's warning. The people who currently make a lot of money from the current system will resist change until their incentives change.

Note: Ganz's written talk is here.

Friday, November 16, 2007

Silencing an Avandia Whistle-Blower

Both Ed Silverman on the PharmLot blog and the Wall Street Journal Health blog covered the report by US Senator Charles Grassley (R - Iowa) about the attempt by GlaxoSmithKline executives to intimidate an early critic of the cardiovascular effects of Avandia (rosiglitazone). As we just noted, apparently chiefly responsible for this whistle-blower intimidation was then GSK executive "Tadataka Yamada, who now heads the global health program at the Bill & Melinda Gates Foundation and today was announced as a board member of the FDA’s new Reagan-Udall Foundation, which is designed to foster drug research," per Ed Silverman (see also our post here.)

Also the WSJ blog noted that Grassley "invited researchers who feel they have been bullied by the industry to contact him. And, he added, 'they can also anonymously provide information and documents by mail or by fax.' Grassley ... even helpfully announced the fax number — 202-228-2131 — on the floor."

Since support for health care whistle-blowers has been sorely lacking, at least the fax number is a welcome development.

Questions About the Board of the New Reagan-Udall Foundation

On PharmaLot, Ed Silverman noted questions raised about the leadership of the new Reagan-Udall Foundation, which is supposed to help the US Food and Drug Administration (FDA) streamline drug and device development. The foundation's financing through the pharmaceutical industry had already raised one obvious set of questions.

New questions were raised by the just announced membership of the Foundation's board. Silverman focused on the presence of Dr Tadataka Yamada, billed as President, Global Health Program, Bill & Melinda Gates Foundation. Dr Yamada, however, was previously a GlaxoSmithKline executive, and had been accused of trying to intimidate one of the early critics of Avandia (rosiglitazone). (See our post here.)

I should also point out that another member of the board is Dr William Brody, billed as President of Johns Hopkins University. But Brody also is a director of Medtronic Inc, a large manufacturer of medical devices, and as such has a fiduciary responsibility for that company's finances and operations. Thus, he seems to represent device manufacturers, but I suspect was not appointed as such. Brody was also recently involved in the creation of a speech-code at his university which threatens punishment of any student who is "rude" or "disrespectful." (See our post here.)

Thus, the leadership of this new foundation seems more tilted towards industry than perhaps it ought to be. Furthermore, it is disturbing that it contains at least two individuals who have been identified with efforts to suppress expression that "our new ruling class" might not like.

Purdue, OxyContin, and the Perils of "Our New Ruling Class"

The Pharma Giles blog is best known for its satirical take on the pharmaceutical industry. So when its anonymous blogger chooses to drop the tongue in cheek approach and get serious, you know something is up.

This week, the subject was whether the punishment of those responsible for the deceptive marketing of OxyContin fit the crime. We noted here that this case was unusual in that some of the corporate leaders involved actually had to face some negative consequences, in addition to the usual fines levied against the company. However, there is an argument that even paying millions of dollars in fines is not that much punishment for extremely well-paid health care corporate executives.

ED Silverman, on PharmaLot, has chronicled the campaign by , an intrepid lady whose daughter died after taking OxyContin, to have "Howard Udell, Purdue’s top lawyer, disbarred, and Paul Goldenheim, formerly Purdue’s medical director, to have his medical license revoked." (See our post here.)

Much of Pharma Giles' rant is worth repeating:

Anyone who comes here regularly might know that beneath the froth and silliness that are my chosen sticks for poking Big Pharma with, one of my recurrent themes is the lack of accountability of Big Pharma executives. One could argue that there’s not a lot funny about people dying as a result of the misdemeanours of our big pharma companies, but I’d like to think that any reasonable person could see that the victims aren’t my targets, despite the hate mail I sometimes get. On the Purdue case, for example, I compared fictitious executives with Tom Lehrer’s “Old Dope Peddler”, which seem to strike a humorously ironic chord with some people, as intended.

Drugs like Vioxx, Oxycontin and possibly Avandia have all recently been launched onto an unsuspecting public in the quest for billion dollar profits, and have gone on to harm tens of thousands, even though there is evidence to suggest that the companies behind them had a pretty good inkling of the potentially lethal hazards and side-effects from data they chose to selectively ignore during trials.

People have needlessly suffered or died, at best because of complacency and at worst because of corporate greed, and as a result public trust in the pharmaceutical industry has never been lower. And because of public mistrust, the regulatory environment has become so tight that it is now much harder to launch new medicines of any sort – a situation which is a constant cause of whining by the pharma CEOs who are, ironically, ultimately responsible for creating the hostile regulatory climate in the first place!

Pharma industry wonks talk about the “risk/benefit” of new drugs, and yet it seems that these days it’s the public who take the risks and the CEOs and shareholders who get the most benefit.

Executives hide behind the line that they cannot be aware of every little thing that goes on their companies and therefore cannot be responsible for any illegal actions of their underlings. Sorry, guys, but just what do you get paid six, seven or even eight figure "compensation packages" for? By and large, it certainly isn’t for your personalities or good looks, is it?

I certainly believe that, given the magnitude of suffering caused by (at the very least) their inability to control the actions of their underlings, million dollar fines for multi-millionaires aren’t really much of a punishment. Or, indeed, much of a warning to other CEOs to keep a closer eye on what their minions are doing and saying in their name. I wrote a comment along such lines to Ed’s post on the issue, hence the e-mail I got from Ms. Skolek.

There’s a wider issue here, of course. Executives hide behind the superficially reasonable excuse of not being able to constantly monitor illegal activities by their underlings. Yet when employees actually try and tell them, well, we all know what happens to pharmaceutical industry whistleblowers, don’t we? Dr. Rost wrote quite a good book about his experiences. Pharmafraud recently recounted his. There are a host of other similar such tales out there.

If CEOs knew that as a condition of their multi-million dollar salaries, they would be held absolutely accountable for the actions of their companies, then maybe, just maybe, whistleblowers might be treated with much more esteem than they currently are at the moment. And I’m sure that CEOs would have a much greater incentive to ensure that their companies would actually operate in a much more ethical way than they do now.

But perhaps it is too much to ask of our new ruling class that they fully accept the risks as well as the rewards of their multi-million dollar lifestyles…

Hat tip also to the Clinical Psychology and Psychiatry blog. If we do not make sure that the governance of health care organizations is representative, accountable, transparent, and ethical, woe to us all. But on Health Care Renewal, we have documented far too many examples of how our "new ruling class" can be self-interested, unaccountable, opaque, and corrupt. Maybe the last thing we need in health care is a "ruling class."

BLOGSCAN: The ADHD "Feeding Frenzy"

On the Health Beat Blog, Niko Karvounis called attention to a report that suggested the benefits of drug treatment of attention deficit hyperactivity disorder (ADHD) may have been overstated, and dubbed the American approach to drug treatment of ADHD a "feeding frenzy." Karvounis pointed out the role of marketing in this situation, and noted that the major US not-for-profit disease advocacy organization for ADHD gets more than a quarter of its money from the pharmaceutical industry.

BLOGSCAN - More on "Drugs, Doctors and Dinners"

On the Health Beat Blog, Maggie Mahar discussed the November 2007 Consumers International (CI ) study, "Drugs, Doctors and Dinners: How Drug Companies Influence Health in the Developing World," in detail. We had mentioned the report briefly, and Howard Brody's thoughts on it, here. Mahar fleshed out the arguments more, and reminds me that I really need to read the whole 39 page document.

Thursday, November 15, 2007

The AAOS "Patient Discussion Guide" Regarding 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.

We analyzed a letter by President James H. Beaty MD of the American Academy of Orthopedic Surgeons and the American Association of Orthopedic Surgeons (AAOS), and suggested that it was more remarkable for what it did not say than what it did say. We noted that the presence among the leadership of AAOS of many individuals who had received payments, some large, from artificial joint manufacturers may have lead to its lack of clarity.

The AAOS also produced a "Patient Discussion Guide" which was "intended to provide you [orthopedic surgeons] with important facts and information to facilitate discussions with your patients, and to help you answer any questions that you may receive from your patients concerning a settlement announced by the Department of Justice with five medical device manufacturers of artificial hips and knees."

In my humble opinion, the guide, designed in an "FAQ" format, was equally unclear, but did seem to try to minimize the effects of disclosures of payments made to physicians. Let me go through it, question by question.

First, it posed the question, "why is this financial information posted on the websites of these five companies." After giving some dry facts about the settlement, this appeared in bold type,

It’s important to remember that the appearance of a physician’s name on any disclosure filing referenced above indicates only that he or she has received compensation from the manufacturer. It is not an indication that any doctor on the list has broken the law or violated professional standards.

It then asked, "why would a doctor ever take money from implant manufacturers?" The answer included,

The relationships between physicians and device manufacturers have led to many significant developments that have benefited millions of patients.

This was followed by a listing of some examples of such "significant developments." The answer did not contemplate the possibility that there could be a down-side to an orthopedic surgeon being paid by the manufacturer of artificial joints.

Then, "what different kinds of financial relationships do doctors have with implant manufacturers?" The answer in full was,

First, it’s important to understand that not all physicians have financial relationships with implant manufacturers. In fact, we believe that a majority of orthopaedic surgeons do not.

For those doctors who have relationships with implant manufacturers, there are a number of different types of relationships with implant manufacturers that result in compensation, including providing consulting advice, conducting research, developing new products and educating fellow orthopaedic surgeons and the public.

These arrangements have led to a number of important breakthroughs and developments that have helped millions of patients.

Again, the guide included more words about the limited prevalence of the payments and their possible good effects than about the question itself.

The next question was "If these relationships are commonplace, what did these implant manufacturers do that was wrong and that led to the settlements?" The guide noted,

The U.S. Attorney that led the investigation was concerned that some of the payments made by the implant manufacturers to a limited number of physicians were improper.

However, it never really answered the question, and certainly did not suggest that anyone or any organization, manufacturers, orthopedic surgeons, or others, did anything wrong.

The guide did assert that the AAOS just adopted, that is, in 2007, new "Standards of Professionalism on Orthopaedist-Industry Conflicts of Interest that require orthopaedic surgeon members to identify and disclose potential conflicts of interest to their patients, the public, and colleagues." However, it neglected to note that these standards are not yet in effect.

Finally, the guide got to the crucial question, "have you personally taken money from implant manufacturers," but then refused to answer it directly,

Recognizing that the facts, circumstances and contractual provisions governing the relationships between certain member-physicians and medical device manufacturers, are unique and confidential, the AAOS cannot provide members with individualized counsel on how to respond....

It then just advised doctors "to be truthful and factually accurate," and cite the need, according to the new Standards of Professionalism, to disclose conflicts.

So, to be charitable, the Guide, like the letter written by the President of the AAOS, was more notable for what it did not say than what it did say. In particular, it failed to say anything negative about artificial hip manufacturing companies paying orthopedic surgeons, but did defend "relationships" among doctors and these corporations, while trying to minimize their prevalence. The Guide avoided any discussion of how financial relationships among orthopedic surgeons and device manufacturers could have any negative effect on patients. The Guide failed to discuss any effects these relationships could have on orthopedic surgeons' teaching, research, or health care policy.

As we noted before, some of this lack of clarity might have to do with the relationships between individual leaders of the AAOS and the artificial joint manufacturers.

After an opportunity to further peruse the lists of payments made by the five manufacturers, (Biomet, DePuy, Smith & Nephew, Stryker, and Zimmer), I found that the AAOS itself has been paid quite handsomely itself (so far in 2007) by:
  • DePuy, $225,000-250,000
  • Smith & Nephew, $25,001 - 50,000
  • Stryker, $150,000 - 175,000
  • Zimmer, $434,480

Thus, the AAOS received from $834,481 to $909,480 from four artificial joint manufacturers so far in 2007.

Also, note that the related American Orthopedic Association received payments by:

  • Biomet, $25,000-49,999
  • DePuy, $50,000-75,000
  • Zimmer, $200,000

Furthermore, the related Orthopedic Research and Education Foundation received payments by:

  • DePuy, $375,000-400,000
  • Stryker, $25,000-50,000
  • Smith & Nephew, $75,001 - $100,000

So it is not surprising that the AAOS collective response to the release of the lists of payments lacked clarity and failed to address most of the major issues. Not only are some of the top leaders of the organization recipients of payments from the same companies whose disclosures created the controversy in the first place, but also the organization, and some related organizations, get substantial funding from these same companies.

This illustrates the pervasiveness of conflicts of interest affecting medical organizations and their leadership. The fear is that such organizations, rather than being a bulwark of physicians' professionalism, have become just more cogs in the medical - academic - industrial complex.