Friday, August 31, 2007

Conflicted View on the Pitfalls of Government-Sponsored Comparative Effectiveness Research

Many have raised concerns that physicians too often favor the latest, most expensive, most high-technology, and sometimes most invasive treatments, contributing to the high costs and often bad outcomes of health care. One solution would be better research comparing the various possible treatments for particular problems. Yet some worry that this approach, too, has its problems.

The Wall Street Journal just printed a commentary warning about the dangers of government-sponsored studies comparing treatment effectiveness, written by Dr Scott Gottlieb, described as "a physician and resident fellow at the American Enterprise Institute, ... a former senior official at the Food and Drug Administration and the Centers for Medicare and Medicaid Services."

Dr Gottlieb raised some good points about pitfalls to be expected when comparing alternative treatments. These include:
  • The need to do very large (and hence expensive) studies to have sufficient statistical power to determine if the treatments really are different, "detecting small clinical differences between two active drugs, such as whether one pill lowers blood pressure more than another, requires very large studies...."
  • The tendency of investigators not to share results, making them harder to verify.
  • The danger that results that fit preconceived notions will be too readily accepted.
  • The danger that government-funded studies might be influenced by the government's need to control medical costs, and thus favor cheaper treatments. "Medicare is no ordinary payer: It dictates decisions made in the private market. So as the government begins tying its own payment decisions to the results of its own studies, there's a great temptation to selectively interpret data and arbitrarily release results. Clearly, this obvious conflict of interest demands even more outside scrutiny and transparency than has been the usual fare when it comes to government research."

Of course, these also are pitfalls of studies comparing active treatment to placebo, and of studies funded by not-for-profit organizations or commercial firms.

In fact, Dr Gottlieb's essay seemed to do its best to raise suspicions about government-funded comparative effectiveness research while neglecting that the alternatives may be worse.

The evidence-based medicine paradigm, to which I obviously subscribe, suggests that physicians should make decisions about treatment based on a critical review of the best available evidence from clinical research, informed by their knowledge of biology and the medical context, and taking into account patients' preferences and values.

Where can physicians get the best available evidence from clinical research now, in the absence of many government-funded studies of comparative effectiveness? In most cases, the best they can do is to look at results of studies sponsored by the manufacturers of the drugs and devices they evaluated, often compared to placebo.

Dr Gottlieb used a few examples of government-sponsored comparative studies to illustrate their potential problems. But most of these problems have affected commercially sponsored studies even more severely.

Dr Gottlieb asserted that early results of the Women's Health Initiative "were rushed to print with a cleverly orchestrated PR blitz." Yet pharmaceutical, biotechnology, and device companies make huge marketing efforts to rapidly publicize results of the trials they sponsor that are favorable to their products. (This is so glaringly obvious that it needs no web-link.)

Dr Gottlieb accused the researchers who ran the Women's Health Initiative of refusing "to share bottom-line results, even with outside academics or the companies that manufactured the drugs." Well, at least the researchers had their own data. There have been noteworthy cases of researchers running commercially sponsored studies who were unable to access the data they collected, which were kept secret by the commercial sponsor. See, in particular, the case of Dr Aubrey Blumsohn, who was unable to analyze the data he collected in a trial of Actonel because the company's sponsor, Proctor & Gamble, refused to let him have it. (See this link on Dr Blumsohn's blog for numerous posts, and our most recent posts here and here.) And we have posted about a New England Journal of Medicine study(1) which showed that US medical schools are often quite willing to let commercial research sponsors maintain control of the data collected by academic researchers.

Dr Gottlieb worried that studies funded by the government might be biased to favor less expensive drugs. Yet there is copious evidence that commercially sponsored studies favor their sponsors' projects.(2-3)

Dr Gottlieb worried that government-funded comparative effectiveness studies might be too small to generate precise enough results. Yet there is considerable evidence that the design and implementation of commercially-funded are often manipulated to increase the likelihood that the studies' results will favor the sponsors' products. (4-6)

Finally, and most ironically, Dr Gottlieb worried that Medicare sponsorship of studies would constitute a conflict of interest. We have posted before about previous commentaries by Dr Gottlieb in which he failed to reveal his past ties to industry, including his past consulting work for a large public relations firm that has many pharmaceutical companies as clients, and a firm that recruits physicians to advise about particular health care related investments. Dr Gottlieb also failed to reveal his apparent current role as a "counsel" to a major pharmaceutical company.

Most recently, Dr Gottlieb was just appointed to the board of directors for a biotechnology firm, Molecular Insight Pharmaceuticals. Thus he now has responsibility to the share-holders of this firm to maximize its profits, profits which presumably would be at risk if a government-sponsored comparative effectiveness study were to find that one of its products were not as good as expected.

I would be more inclined to credit the comments of people who have financial ties to health care corporations if they revealed these ties when making public comments. It amounts to stealth health policy advocacy for someone with multiple ties to the pharmaceutical and biotechnology industries to write in the guise of a think-tank intellectual.

ADDENDUM (4 September, 2007) - See also Aubrey Blumsohn's comments on the Scientific Misconduct Blog here.


1. Mello MM, Clarridge BR, Studdert DM. Academic medical centers' standards for clinical-trial agreements with industry. N Engl J Med 2005; 352: 21. (available here)

2. Bekelman JE, Li Y, Gross CP. Scope and impact of financial conflicts of interest in biomedical research: a systematic review. JAMA 2003; 289: 454-465.

3. Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. Brit Med J 2003; 326: 1167-1170.

4. Bero LA, Rennie D. Influences on the quality of published drug studies. Int J Technol Assess 1996; 12:209-237.

5. Brophy JM. Selling safety - lessons from muraglitazar. JAMA 2005; 294:2633-5.

6. Smith R. Medical journals are an extension of the marketing arm of pharmaceutical companies. PloS Medicine 2005; 2: 364-366.

Thursday, August 30, 2007

On Sleep Deprivation and Medical Education

On the Over My Med Body Blog, see this eloquent rant about what it is like to begin a sub-internship. A sub-internship is an experience for (usually fourth year) medical students during which they function like interns, and hence functions as an introduction to the world of post-graduate medical training. Sub-interns, and later interns and residents are up at all hours of the night, taking care of often severly ill patients, with little experience and less sleep. Yes, they do have various forms of back-up, from sub-specialty fellows to seasoned faculty. But nothing can make up for the cloud of cotton wool that fills one's head after being up all night.

It's a sad testimony to our training system that the experience described is little different from the one I went through just about 30 years ago.

But now the intrepid blogger of Over My Med Body may be getting an inkling why doctors who have had years of training like this can get so upset when their dedication, knowledge, or work habits are questioned by some "suit" with a six-, seven-, or eight-figure income, a "suit" who is comfortably in bed every night of the week, and who never has to handle an emergency, much less a patient throwing up blood, hallucinating, and febrile at three in the morning.

But perhaps some of the money going to pay for those "suits'" fancy salaries could be used to pay for more hands on care givers in teaching hospitals, alleviating the need for those sub-interns, interns, and residents to work so many hours straight.

BLOGSCAN - Make a Drug An "Orpha," Raise the Price 20x

On the Health Business Blog, David Williams posts about how Questor Pharmaceuticals got an "orphan drug" status for its formulation of ACTH (adrenocorticotrophic hormone) to treat a form of seizures that occur in early childhood. After doing so, the company will increase the price of the drug, which has been on the market a long time, 20x, that is, 2000%. Somehow methinks that this was not what the orphan drug law was meant to do.

Tuesday, August 28, 2007

Nissen and Califf on the Avandia Case, and the Evils of Suppressing Data from Clinical Research

We have posted quite a bit about the controversy sparked by a meta-analysis of the cardiovascular adverse effects of rosiglitazone (Avandia, by GlaxoSmithKline) by Nissen and Wolski. (For example, see this post.)

Medscape just published a conversation between Dr Robert Califf and Dr Steven Nissen. (Nissen, who wrote the controversial meta-analysis, is at the Cleveland Clinic, while Califf is at Duke.) Much of the discussion addressed technical and methodologic aspects of the Avandia controversy. But I was struck by what the two had to say about suppression of clinical research.

Starting with Dr Nissen, edited for clarity:

I believe that if you ask human subjects to participate in an experiment that the results of that experiment belong to the public. That it is not acceptable to do such an experiment and then to deep-six the results. And I want that to be a matter of law. I think if it's not a matter of law, we will continue to see negative publication bias where the studies that get published are the ones that show favorable effects of drugs. Things have gotten out of balance, Rob. We hear about the efficacy of drugs through media, on television, through advertising, detail people, CME, but we need to see all of the data in order for us to make good clinical judgments.

Response by Dr Califf:

I've asked the question: 'Will everyone in the room who's in favor of secret human experimentation please raise your hands?' And so far I haven't really had anyone -- well, maybe one exception, but I don't want to reveal who that was -- say they're in favor of that.

The definition of research ... is something that's done to create generalizable knowledge. And generalizable knowledge to me can't be present if the result is kept from the public if it's negative.

Back to Dr Nissen:

Well, ... [companies] argue that the data is proprietary. And they have gotten a lot of traction in the Congress. The companies have said through their lobbyists and so on that when they spend the money to run a clinical trial that they own those results and they should be free, in a free enterprise system, to do whatever they want with those results. And if they don't like them and they want to put them somewhere other than in the public domain, that should be their right.

And from Dr Califf:

while there are lobbyists arguing that, there are many good people in companies who feel quite differently and would like to have permission, as you say, with regard to their corporate boards, who are always looking after optimal profitability, they'd like to have that happen.

The fiduciary responsibility of the corporate board is to not do things that damage the profitability of the company, and that leads, I think, to a very distorted perspective on the ethics that are involved.

Although in the past the argument has been made about trade secrets and so on and so forth, but when you get into the human experiment arena, if we level the playing field so all companies are working under the same rules, then the best products will win out because the public will have better information and people will make better decisions about what to do.

So let's summarize the main points:
  • People participating in clinical experimental research are told that their participation will benefit science and patient care.
  • This benefit could only occur if the results of the research are made public, even if they go against the commercial (or idological) interests of the people who paid to have the research done.
  • For the financial supporters of research to keep data they do not like secret violates the trust of the research subjects.
  • However, if hiding data has no negative consequences, commercial sponsors will continue to hide data unfavorable to their interests.
  • Government regulation would be one way to impose negative consequences for hiding data.
  • Preventing the suppression of data from clinical research ultimately will favor the products that are actually best for patients, which would be good for patients, and, incidentally, good for companies that make the better products.

Sounds good to me. But will any politician have the courage to advocate the punishment of companies that hide data they don't like?

Another solution would be to ban research on humans done or supported by those who have financial interests in the products or services tested by such research. That would require some massive redirection of the flow of money that supports human research.

I am wondering when some clever attorney will figure out how to sue a company on behalf of a research subject in a trial whose results were suppressed by its commercial sponsor. That particular sledge hammer might prompt some re-thinking of the issue.

BLOGSCAN - Maggie Mahar's Health Beat Blog

Maggie Mahar, author of Money-Driven Medicine, one of the best of the current crop of books about the dysfunctional US health system, now has a blog. It's called Health Beat, and went live August 7, although most posts on it were from yesterday. Maggie had previously guest-blogged on The Health Care Blog. We welcome her feisty voice in the health care blogsphere.

BLOGSCAN - Dilbert in Medicine

On Retired Docs Thoughts, this post takes off with a commentary on the recent New England Journal of Medicine article on the rush to do "quality improvement" without evidence that it works to address the rise of the business culture in health care. The best part was:

Twenty years ago when I began to do some consultative work with the corporate world,I felt rather smug that my field (medicine) was immune to the Dilbert like silliness that seemed to pervade the corporate culture. However,medicine has become more and more corporate and the business school belief that one does not need know a business to run it is increasingly applied to medical practice . The business-speak jargon now echoes through the hospitals and clinics and we talk about vision statements and leveraging this and that and the suits with MBAs are no longer minor distractions but are in control. What the Dilbert cartoons depict are as applicable to much of medicine as they are to the bureaucratic world of big business.

Monday, August 27, 2007

No Confidence Vote for NIEHS Leader

We have posted frequently (e.g., here) about conflict of interest issues affecting the flagship US biomedical research organization, the National Institutes of Health. Most recently, our focus was on happenings at the National Institute of Environmental Health Sciences (NIEHS), whose director was just forced to temporarily step down.

The Scientist (UK) reported more trouble:

More than 100 tenured and tenure-track scientists at the NIH's environmental agency say they no longer have confidence in the leadership of David Schwartz, embattled director of the National Institute of Environmental Health Sciences (NIEHS).

A senior NIEHS researcher, who asked not to be identified, provided to The Scientist the results of a secret ballot held by NIEHS's Assembly of Scientists at the request of assembly members. The group consists of tenured and tenure-track professors at the agency. Out of 146 NIEHS researchers who voted, 91 voted that Schwartz no longer had their support and 99 voted that their morale was negatively affected.

The researcher said that 'the morale is as low as it can go,' at NIEHS. 'We're devastated down here,' the researcher said from the agency's Research Triangle Park, North Carolina headquarters.

The senior researcher who provided the ballot results said that Schwartz diverted money away to his own research program and that the researcher therefore lost funding.

The senior NIEHS researcher interviewed by The Scientist said that ethical problems extend all the way to the top of the NIH hierarchy. 'The things that Dr. Schwartz did, he got approval for,' the researcher said.

This story is not yet over, as a Congressional enquiry is underway.

It is very sad to continue to hear stories like this about an organization that is responsible for so much important science, and which used to have a sterling reputation. This story teaches an important lesson about the demoralizing effect of bad leadership of health care organizations on the people who actually make these organizations run. Maybe some of the recruitment problems that federal health care organizations have had are due to problems with the integrity of their leadership, rather than employees' diminishing prospects of private gain.

BLOGSCAN - An Alternative to the Usual Left- vs Right-Wing Rhetoric on Health Care

On the Hooked: Ethics, Medicine and Pharma blog, this post by Howard Brody covers the debate between Arnold Relman and Richard Epstein as yet another of the unenlightening left wing vs right wing (or "you bloody fascist" vs "you stupid communist") debates that have failed to advance health care much. (See our post here for another example.) But for a more productive discussion, Brody's new suggested reading list looks promising.

BLOGSCAN - New CME Policies Dissected

On the Carlat Psychiatry Blog, this post dissects the new rules for providing continuing medical education (CME). My favorite was the re-definition of "commercial interest" that still does not define a for-profit medical education and communication company (MECC) as "commercial."

BLOGSCAN - More on Collaborating with UnitedHealth for the "Advanced Medical Home"

A number of medical/ health care bloggers have kept at the story of various medical societies' (including the AAFP, AAP, and ACP) questionable collaboration on a pilot project for the "advanced medical home" with UnitedHealth (see our post here). Retired Doc's Thoughts first took it up here, and then here continued to ask tough questions in particular about the ACP's role. The Covert Rationing Blog suggested that the pilot project was just managed care with better makeup, and was echoed by KevinMD. Outside of the blogsphere, however, I can't find any discussion of the issue.

BLOGSCAN - How Aggressive Treatment of Anemia was "Earmarked"

On GoozNews, Merrill Goozner just posted at length about a hidden "earmark" he discovered in the S-CHIP bill, one that would reward dialysis units for very aggressively treating their patients' anemia. There has been a lot written (our meager contributions includes posts here and here) about how the previous dogma that aggressive correction of hemoglobin in patients with chronic renal failure proved to be unreliable, and about how Amgen, maker of products frequently used to effect this correction, e.g., epoetin (Epogen) aggressively marketed its wares. Now Merrill Goozner has disclosed how the "earmark" process seems to have been used to add federal muscle to the push for aggressive treatment of anemia, even if such treatment is not good for patients. How this was orchestrated remains unclear. Stay tuned....

Wednesday, August 22, 2007

Minnesota Medicaid, Big Pharma and Delusions about Conflict of Interest

Roy Poses posted previously at "US States Using Pharmaceutical Company Funded Program to Influence Physicians' Prescribing " on how Minnesota, and other US states, use a program funded by Eli Lilly & Co which is meant to reduce physicians' supposedly inappropriate use of anti-psychotic medications. Eli Lilly is also the manufacturer of one such medication, olanzapine (Zyprexa). The source article noted that states that use the Lilly program seem to have adopted policies that tend to favor Lilly and its products, and that neither Minnesota nor the other states that use the Lilly program uses prior authorization schemes to limit drug use.

More on Minnesota today.

In "Drugmakers' deep pockets linked to decision-makers", Martiga Lohn today describes the effects of a new Minnesota law: shining of a rare light onto the big money that drug companies spend on members of state advisory panels who help select which drugs are used in Medicaid programs for the poor and disabled.

The article is striking in several respects.

Drugmakers' deep pockets linked to decision-makers

By Martiga Lohn, Associated Press

ST. PAUL, Minn. - A groundbreaking Minnesota law is shining a rare light onto the big money that drug companies spend on members of state advisory panels who help select which drugs are used in Medicaid programs for the poor and disabled.

Those panels, most composed of physicians, hold great sway over the $28 billion spent on drugs each year for Medicaid patients nationwide. Yet only three states - Maine, Vermont and Minnesota - require drug companies to report payments to doctors for lectures, consulting, research and other services.

A review of Minnesota records found that a doctor and a pharmacist on the eight-member state panel simultaneously got big checks - more than $350,000 to one - from drugmakers for speaking about their products.

The online version of the story does not contain a chart in the print version entitled "Tracking Spending on Advisry Panels" that lists the major pharmas and their payments to two people, Dr. John E. Simon and pharmacist Robert Straka.

From 1998-2006 Dr. Simon, a psychiatrist, received $582,469.97 (over $350,000 from 2004-6 alone as a member of the panel) and Mr. Straka $85,807.95 (served on the panel from 2000 to 2006, and collected $78,000 during that time from various drugmakers), according to the article and chart.

Eli Lilly was the largest single contributor, having given psychiatrist Dr. Simon $488,952. Merck and Schering-Plough were the largest "contributors" to Straka, having given $24,623 and $36,745 respectively.

Back to the article:

Both said the money did not influence their work on the panel, and spokesmen for the drug companies said their payments had nothing to do with the members' roles.

Let's put, say, $489 thousand dollars into perspective. What might that amount buy?

Assuming after taxes that a bit over $300,000 were left:
Dutch automaker Spyker makes several different editions of its C8 supercar. The most expensive one is the $326,000 C8 Double 12 S.

Rolls-Royce Phantom: MSRP: $333,350. The 2007 Phantom is a 4-door, up to 5-passenger luxury sedan, available in one trim only, the Sedan. Upon introduction, the Phantom is equipped with a standard 6.75-liter, V12, 453-horsepower engine that achieves 12-mpg in the city and 19-mpg on the highway. A 6-speed automatic transmission with overdrive is standard.

Aston Martin DB9 MSRP $169,750 - $183,250 (Name's Bond. James Bond. why settle for one when $300K+ can buy two!)

For the numismatists among us:
Large One-Cent Pieces, Flowing Hair, Chain Reverse 1793 Periods $304,000
Half-Cent Pieces, Liberty Cap 1796 With pole $303,000
Half Eagles ($5.00 Gold Pieces), Capped Bust 1797 Large eagle $301,000
Silver Dollars, Flowing Hair 1795 $299,000

And for the boaters among us:
30 Express Rampage Sportfishing Yacht $200,000-$300,000

Those who say that this amount of money from pharma "did not influence their work" on such decision-making committees are either in serious denial, deluded or dishonest, in my opinion. It is risible to say that these amounts could not influence decisions - or not be perceived to influence decisions by the reasonable man or woman.

Those who think that payments like this do not present a most disastrous appearance are certainly in denial or deluded about issues of public trust:

The advisory panel's recommendations to the Minnesota Human Services Department are almost always followed. The panel guided $240 million in spending on drugs for 202,000 patients last year - slightly less than a third of all the state's Medicaid patients.

The top drugs for Minnesota Medicaid patients covered by the panel's advice in recent years have been for schizophrenia - Eli Lilly & Co.'s Zyprexa, from 2000 to 2004, and AstraZeneca PLC's Seroquel, in 2005 and 2006.

About a third of the drugs on the state's preferred list are made by companies that paid Simon, Straka or both.

Here's another major part of the problem:
The lack of recorded votes in meeting minutes makes it difficult to track any link between payments and policy.

That is simply incredible. In Minnesota, not only were these activities conducted with little or no public scrutiny before the new law went into effect, but also minutes were not taken to see who was voting for what.


... State officials said they would examine the panel's past actions for any bias tied to the payments, and they would start screening appointees to two dozen advisory councils for similar links. They will also require the Drug Formulary Committee to record how members vote.

Other states need to do likewise. Fast.

A List of drug companies' payments to doctors in Minnesota is also available.

-- SS

Tuesday, August 21, 2007

Why is the NIH Monitoring Its Employees' Communication with Congress?

We have posted quite a bit (recently here) about conflicts of interest affecting top US National Institutes of Health (NIH) officials. In 2005, the NIH director reinstated strict rules about conflicts of interest. Last month, we noted that allegations of conflict of interest at the Institutes continue, most recently involving the head of the National Institute of Environmental Health Sciences (NIEHS), Dr David Schwartz.

The Associated Press (here via the San Diego Union-Tribune) just reported the case's latest ramifications.

First, Dr Schwartz has temporarily stepped down from his position, pending an investigation:

The NIH is beginning its own review of the management and leadership of the institute, NIH director Dr. Elias Zerhouni announced Monday. The embattled director of the institute, Dr. David Schwartz, is stepping aside for the duration of the review.

Meanwhile, the AP reported that the NIH has seemingly gotten very concerned about communication by its employees with the US Congress.

Employees of one of the National Institutes of Health are being asked to report all contacts with Congress – a request that one lawmaker suspects is an attempt to flush out would-be whistle-blowers.

Managers distributed 'record of congressional inquiry' forms to employees of the National Institute of Environmental Health Sciences, one of the 27 institutes and centers that make up the NIH. At least one of those workers reported being made 'nervous' by the form – and forwarded it to congressional investigators probing allegations of conflicts of interest, excessive spending and other management issues at the institute.

The form asks for details of each telephone call from the offices of members of the House or Senate, including on the information sought.

Asking employees to document such contacts is highly irregular.

Logging and reporting such calls is standard procedure in the congressional affairs offices of federal departments and agencies. But the forms don't appear to be something given out to 'regular' employees, said Sen. Charles Grassley. Their distribution came in the midst of multiple and ongoing investigations by Congress, including by the Iowa Republican's staff. Nor do the forms appear to have been distributed elsewhere within NIH.

'Hopefully, the intent of this form was not to discourage or intimidate NIEHS employees from talking to Congress; but I must admit, the timing is curious,' Grassley wrote Zerhouni in a letter, sent late Monday, seeking details of the circumstances of the form's distribution. It is illegal to deny or interfere with a federal employee's right to provide information to Congress.

The letter and NIH review are the latest salvos in an ongoing series of investigations of the institute. Grassley and other lawmakers have relied on federal whistle-blowers in conducting oversight of the institute.

Previously, those whistle-blowers have told Grassley's staff of employee discussions with institute management 'that left them with the impression that there would be retaliation if it was discovered that they had provided information to among others, congressional investigators,' the lawmaker wrote Zerhouni in a July 11 letter.

This case now seems to combine several elements familiar to readers of Health Care Renewal. Initially, it involved allegations of important conflicts of interest affecting the top leadership of an important health care organization. Now, it also involves allegations about intimidation of those attempting to blow the whistle about these conflicts.

The case now reminds me of arguments that I just made at a meeting convened by the International Council on Human Rights Policy about the relationship between corruption and violations of human rights: people involved in activities that might embarass them if reported in the media may often try to silence those who might try to make such reports. And it further reminds of the slogan favored by FIRE in their campaign for individual rights in education:

Sunlight is the best disinfectant.

Hat tip: to Effect Measure. And also see this post on Effect Measure (just up).

US States Using Pharmaceutical Company Funded Program to Influence Physicians' Prescribing

The Pioneer Press just reported on how Minnesota, and other US states, use a program funded by Eli Lilly & Co which is meant to reduce physicians' supposedly inappropriate use of anti-psychotic medications. Eli Lilly is also the manufacturer of one such medication, olanzapine (Zyprexa).

One of the nation's largest drug companies is helping Minnesota cut costs and reduce questionable prescriptions of psychiatric drugs to poor and disabled residents.

Officials with the Minnesota Department of Human Services defended the program, which is funded by Lilly but run by an independent contractor, Comprehensive NeuroScience. State officials believe CNS has saved money for Minnesota's fee-for-service health plans, but more important, it has corrected some questionable prescriptions of expensive and powerful psychiatric drugs.

'Cost is an issue, certainly, but what is most important is that we get the right health care for patients,' said Brian Osberg, assistant commissioner of the human services department.

Twenty states have contracts with CNS, which identifies doctors who are prescribing psychiatric drugs outside of recommended guidelines for safety and effectiveness. A common problem is patients taking two or three antipsychotic drugs at once, despite an increased risk of side effects and no evidence that patients benefit by taking multiple drugs.

The states then send warning letters to doctors, who can decide whether to alter their prescriptions.

The article noted that states that use the Lilly program seem to have adopted policies that tend to favor Lilly and its products. In particular, neither Minnesota nor the other states that use the Lilly program uses prior authorization schemes to control drug use.

Opponents believe states are paying Lilly back for this help by keeping its drugs off prior-authorization lists. Such lists prohibit doctors from prescribing drugs without first gaining permission from the state.

Lilly is the manufacturer of Zyprexa, a top-selling antipsychotic drug. Minnesota's fee-for-service health plans spent more than $28 million on Zyprexa in 2005, and $103 million on antipsychotics in general. That more than doubled the 2000 total of $43 million for the plans, which cover 200,000 poor and disabled Minnesotans.

While other states have used prior authorization to curb these soaring costs, Minnesota has not. In fact, none of the states with Lilly partnerships use prior authorization to manage antipsychotic drugs.

Wisconsin had a contract with Lilly until last year, when the state's Medicaid agency placed antipsychotic drugs, including Zyprexa, on the prior authorization list. State officials were informed shortly thereafter that Lilly was canceling the program.

A Lilly spokeswoman acknowledged that the company is trying to discourage states from using prior authorization.

Furthermore, another of Minnesota's policies seems to tilt toward Zyprexa.

In February, Minnesota encouraged patients to split cheaper double-strength pills instead of taking multiple smaller-dose pills, which can save money for the state at the expense of drugmakers.

The 'dose optimization' strategy was required for Abilify, Geodon and Seroquel - which are competing antipsychotic drugs - but not for Zyprexa.

'Pure coincidence that dose optimization and tablet splitting are utilized exclusively for Eli Lilly's competitors?' asked Ben Hansen, who has sued to expose Michigan's partnership with Lilly. 'I don't think so.'

Human services officials replied that there was no financial benefit to placing Zyprexa on the pill-splitting list.

The program has its local critics:

If the state 'asks Eli Lilly to help decide how to buy prescription drugs, or even General Motors to help decide how to buy a car, I guess I'm going to be concerned about that,' said Ronald Hadsall, assistant dean of the University of Minnesota College of Pharmacy. 'That just smacks of conflict to me.'

A state's program to make physician prescribing more appropriate already threatens physician autonomy, but could be justified if physicians' relevant current prescribing is clearly not in patients' best interests, and if the program would clearly suggest prescribing more in patients' interests. However, the threat to autonomy cannot be justified for the sake of a program supported by a single drug company which seems to tilt the playing field in that company's favor. The state's use of this program seems to be participation in a stealth marketing scheme, made worse by its association with the aura of government power

Hat tip to Kaiser Daily Health Policy Reports.

Monday, August 20, 2007

More Details and Concerns About the Death of a Gene-Therapy Patient

Details continue to come out about the death of a woman who was participating in a gene-therapy trial of an agent made by Targeted Genetics meant to treat joint symptoms of rheumatoid arthritis. We posted about the case here and here.

Almost two weeks ago, the Seattle Times reported on the company's response to initial news stories about the case.

Chief Executive H. Stewart Parker said in an interview that the company has always applied 'the highest rigor in clinical trials' and that it behaved properly.

The company said it reported the incident to the FDA 'within 24 hours' of determining that the patient's illness was possibly related to the drug. A chronology released by the company shows that occurred 18 days after the patient was injected, in the wake of her admission to a hospital.

Staff at the hospital where Mohr was being treated was the first to alert the FDA, Parker confirmed in the interview.

Targeted Genetics said the patient received a second dose of the arthritis therapy on July 2. On July 10, the company learned that she and another patient suffered nausea, fever and vomiting. The other patient recovered, but Mohr was hospitalized on July 13. The clinical investigator thought it unlikely that the symptoms of both patients were related to the drug, the company said in a statement.

On July 17, the investigator told the company that Mohr's condition 'was deteriorating,' but that it was unrelated to the therapy. The next day, Targeted Genetics notified the chairman of the independent data safety-monitoring board that supervised the study, and on July 19 determined that the incident was possibly related to the therapy.

On July 20, the company informed the FDA.

Last week, the Washington Post reported more details about the demise of the patient.

The 36-year-old Illinois woman who died last month after being treated with an experimental gene therapy was infected with a fungus that usually causes only a mild illness. But the infection spun out of control and ravaged her organs, suggesting that her immune system was seriously impaired, said a doctor who is part of the medical investigation.

The woman's body was also teeming with a cold-sore virus that the body normally keeps in check, another indication of a faltering immune system. And because of a tear inside her abdomen -- perhaps caused by infection, perhaps by injury -- she had an internal blood clot the size of a watermelon.

The picture will be complicated, however, because Mohr was also taking conventional immune-suppressing drugs for her arthritis. One of those in particular, adalimumab, whose brand name is Humira, is known to make patients susceptible to histoplasmosis, the kind of fungal infection that Mohr had. Inexplicably, Mohr suddenly became ill in July even though she had been taking that drug for years and the fungus that causes histoplasmosis is ubiquitous in the area where she lived.

Meanwhile, a columnist in the Seattle Post-Intelligencer wondered about the implications of the case.

Those tragedies reflect one of the more troubling regulatory failures in the U.S. health care system: the inability to develop sensible and enforceable rules to oversee a growing biotech industry that is using humans to test what it hopes will become the next big moneymaker -- all without having much of a clue as to gene therapy's long- or short-term impacts.

When a federal committee charged with reviewing gene therapy trials evaluated Targeted Genetics' arthritis study in 2003, members openly questioned its justification, as it involved patients who were not very ill and evidence from animal studies didn't seem all that promising. They also worried it could trigger dangerous immune responses and questioned the informed consent documents' clarity. But as they have no binding authority or enforcement powers, Targeted Genetics was free to continue as it saw fit.

But this isn't simply about regulatory failure. It's also about how profit motives embedded in the clinical trial process can undermine patient safety. Pharmaceuticals had the fifth-most profitable return on revenues of any industry in 2006; the top five drug companies took home close to $30 billion in profits. Such companies as Targeted Genetics hope gene therapy and other biotech products will help them tap into and expand those markets. To be sure, Targeted Genetics CEO H. Stewart Parker told the P-I in 2005 that arthritis treatment could be 'a $7 billion market ... by 2011' and that the gene therapy used in the clinical trial that may have led to Mohr's death might help the company capture '15 percent to 40 percent of that opportunity.'

Time is money; in the rush to get products to market, patient safety can inadvertently take a backseat. And the fact that Targeted Genetics doesn't currently have any products on the market suggests that it has a significant financial incentive to stop hemorrhaging cash -- financial reports indicate it has lost $8 million this year alone -- and do everything possible to quickly get its products out of the clinical trial phase.

Time will tell whether gene-therapy caused this death. It very well may not have.

However, in my humble opinion, the most troubling aspect of this case so far is how people involved with this trial seem to have believed that their new treatment was safe in the absence of much evidence one way or the other. In particular, they seemed to persist in their disbelief that the new treatment could have had anything to do with the patient's unexplained rapidly deteriorating condition. Why were they so confident that their new treatment could not have been responsible?

This treatment was not merely new, it was a new variant on a broad class of new treatments, genes delivered by viruses, which are not yet in clinical use because no treatment in this class has been proven safe and effective. Furthermore, a few previous attempts at gene-therapy have produced very bad results, most notably in the unfortunate case of Jesse Gelsinger. Thus, one would expect that people setting up a new trial of gene-therapy would be properly cautious, and concerned that the new treatment might have unanticipated kinds of risks.

In my humble opinion, it is all too possible, as suggested by the op-ed above, that financial concerns have pushed manufacturers, researchers, and physicians into believing that the new treatments they are developing just have to be safe and effective.

This is another argument that clinical research, that is, experiments on humans to evaluate new tests or treatments should not be designed, implemented, or reported by people who have a financial stake in the success of the product bying evaluated.

Friday, August 17, 2007

Who's responsible for that prescription denial? If an MD has trouble finding out and is insulted in the process, what's a layperson to do?

I pity non-medical laypeople trying to navigate the mess that is called "the healthcare system." I've just had a most spectacular and bizarre encounter myself. The left hand does not know what the right hand is doing, which does not know what the foot is doing ... and the foot despises the body it's supposed to support for good measure.

Over the past few years, I've put on extra pounds. Way too many. My BMI has climbed to unhealthy proportions and I hit the big five-oh in age recently. After using sheer willpower to diet and exercise to drive my weight down 15 lbs. in a month, I had my blood work checked and parameters are decent. However, I need to repeat the weight reduction accomplishment a few more times over before I am back at a desirable BMI. It is not easy.

My personal physician (yes, doctors go to doctors) prescribed Meridia 10 mg daily, an Abbott drug in the Serotonin Reuptake Inhibitor (SSRI) class, and that's where this bizarre encounter with the "non-system" began.

The active ingredient in MERIDIA, sibutramine, works in the area of the brain that signals the sense of fullness (satiety). Meridia does not suppress appetite, which is your signal to start eating.

Meridia blocks the re-uptake of the brain chemicals (serotonin and norepinephrine) which help regulate the sense of fullness. Fullness is your signal to stop eating. Having a sense of fullness, or satiety, means you may feel satisfied with less food.

When I went to my neighborhood pharmacy a.k.a. megastore, I was told my health plan did not cover this medication. I possess a BC/BS PPO and Medco card through my employer, a university. The cost of a month's supply of the medication was approximately $160. The pharmacist suggested I contact Medco to find out why Meridia was not covered.

I did, which started a string of phone calls ending in my being seriously insulted by a service rep at Medco! The account (best as I can recall from memory, as things got convoluted) is as follows:

A Medco representative told me Medco is only a contractor and plan administrator to "my insurer" and does not make such decisions. However, the rep did not know who did.

I next contacted BC/BS. Their rep told me they only covered medical care and not medications, and suggested I call Medco. When I mentioned Medco told me they did not make such decisions, the BC/BS rep had no suggestions.

I called Medco back. The Medco rep this time told me I could appeal the denial and was sending me an appeal form that I should mail back to - Medco. Now, I was really confused.

I inquired why Medco gets an appeal form for denial of coverage if Medco did not make the decision. The rep did not know. I asked for the name of a person at the organization where the form would go. Again, the rep did not know.

I finally called my university's benefits management contact, yet another contractor company (it seems everything is handled by third parties - just a little bit of administrative overhead there?), and that is where this already confusing matter took a very deep turn directly south.

The rep at the university's Benefits Management contractor said that he believed Medco was the responsible party. I informed him Medco said they were not.

In the first actually creative and industrious response from any of these organizations, the rep said he would get a Medco representative on the phone in conference call mode so we might get to the bottom of this.

We got to the bottom all right. The real bottom.

The Medco customer service rep that the University Benefits Management Rep conferenced in was a new individual, not the ones I had spoken to prior. This rep repeated that Medco was just a benefits manager and was not responsible for the denial.

I asked the university's Benefits Management contractor rep if he believed that was the case. He was as confused as I. The Medco rep said I needed to appeal.

I asked the Medco rep for the name or identity of a person or organization where the appeal form would go, so I could contact them directly, as I was a medical doctor with pharma experience as well and wanted to go direct to the source.

The Medco rep replied that "my title would not get me advantage in this matter" or words to that effect.

I again tried to explain that I wished to know exactly who made the appeals decision. The Medco rep started to become patronizing in tone, not letting me get a word in edgewise and calling me "Mr."

I reminded the Medco rep that I was a physician and wished to be addressed more formally, as "Dr." I don't often make this request of anyone, but I was starting to sense something odd here.

The Medco rep again referred to me as "Mr."

I said once again that I wished to be referred to as "Dr."

The Medco rep once again referred to me as "Mr."

I think we went through three cycles of that little skit.

At this point, getting rather angry from this deliberate insult, I asked the Medco rep rather pointedly if her refusal to call me "Dr." was an act of prejudice (my name gives away my religious identity). At that point, the Medco rep hurredly put a supervisor on the phone. I don't think she'd ever been called on such behavior in such un-PC (i.e., unashamedly direct) terms.

The supervisor rapidly answered my question, telling me the University itself was who needed to be contacted. I mentioned to the supervisor that the refusal to call me "Dr." even after I asked for this courtesy was quite disturbing, reflecting at the very least a very bad level of customer service. The supervisor offered agreement.

I emailed the University HR benefits director (finally, a principal, not a contractor!) As it turns out, the University covers drugs, and I was emailed back that "this class of drug is not covered" (I presumed that means the weight reduction class of drugs.) I emailed back a question as to why. I have not yet received a response - and I'm not even going to go there in this posting. (Discrimination against the obese?)

On the other hand, the extremely rude and deliberate refusal of a Medco Customer Service Representative to call me "Dr." even when I asked for this courtesy several times was unbelievable.

I can only wonder what types of attitudes this person held about physicians - and if the company's customer service management or higher shared a similar bias. I also cannot discount other cultural biases. Imagine if the situation occurred in reverse.

I was able to find out very quickly from the Internet and several phone calls to Medco Corporate that the customer service department at Medco reported to the VP of HR. I believe physicians need to start being far more direct and confrontational when they encounter attitudes like this.

In Roy Poses' post "Bling Bling, Political Correctness, and the Anechoic Effect" it was observed that:

In the post-modern academic world, everyone is afraid of saying anything that might be the least bit offensive. (See the web-site of the Foundation for Individual Rights in Education, or FIRE, for some amazing examples.)It seems that that even the most skeptical and iconoclastic health care bloggers may also be fearful of being too politically incorrect.

I agree. And pushback should not just occur after major scandals. After calling the VP's administrative assistant who said she would forward my complaint to the VP if I sent it via email, I passed along details of what occurred as I summarize here (my email was actually a bit more direct):

As former Director of Scientific Information Resources and The Merck Index at Merck & Co. [note - Medco was a Merck subsidiary until a few years ago - ed.], I am familiar with the pharma industry and customer service. I am also a writer for the Foundation for Integrity and Responsibility in Medicine (FIRM) ... The interaction I had this morning (appx. 11:40 AM EST) with one of your customer service reps was so profoundly disturbing I feel you should be aware.

... your service rep was patronizing, would not let me get a word in to clarify my questions, but those were minor issues. When the customer service rep referred to me as "Mr. " I informed her I was an MD and wanted to be addressed as "doctor." The rep deliberately and repeatedly called me "Mr." after being told several times I wished to be addressed more formally. When I expressed my outrage, a supervisor was put on who did help answer my question about my medication coverage. The customer service rep sounded like a minority.

My question to you is: Was this an issue of your customer service rep disrespecting a man of European heritage? Was it religious prejudice, as my name is quite revealing in that regard? Or did it reflect a bias against physicians? Any of these would be a serious matter. I would really like to know why your rep refused to address me formally as I repeatedly requested.

Unsurprisingly, I have not heard back from the Medco VP of HR. I do not expect to. Medco has certainly had more serious fish to fry. Perhaps he will give his service reps some "sensitivity training" - towards physicians.

Finally, I observe that I am a physician and former corporate manager who had the greatest of trouble and frustration trying to navigate the morass of tangled third-parties-for-everything we call a "health care system" over a simple single non life-threatening prescription. I was insulted for my efforts by a pharmacy benefits management company just for good measure.

I can only imagine what Joe and Mary Citizen have to put up with.

(And, I've shelled out the money for the medication, deciding this one was just not worth pursuing further.)

-- SS

Physician ranking shenanigans: do insurers steer patients to cheaper doctors rather than the most qualified?

I've written numerous posts expressing serious concern that executives of large healthcare organizations are strangely reluctant to consider informatics-qualified physicians for leadership positions in healthcare IT, such as at "Leadership Position in Health Informatics: MD's Need Not Apply?" and "Hospital IT: Amateurs welcome."

This observation may unfortunately also apply more broadly. In the Philadelphia Inquirer today, a short summary of a Dow Jones story appeared. The Inquirer article puts the "money question" (pun intended) right up front and is rather blunt about it:

Philadelphia Inquirer, Aug. 17, 2007

Aetna Inc. and Cigna Corp., both Philadelphia, may be deceiving patients who rely on the insurer' physician-ranking programs, steering them to cheaper doctors rather than the most qualified, New York Attorney General Andrew Cuomo said.

The Dow Jones story is a little less blunt than the Inquirer short summary, but nonetheless revealing. Here are some excerpts:

UPDATE: NY AG Cuomo Concerned About Physician Rankings


Attorney General Andrew Cuomo said Thursday that his office has sent letters to units of insurers Aetna Inc. (AET), Cigna Corp. (CI) and UnitedHealth Group Inc. (UNH), raising concerns about their physician-ranking systems.

In the letters, Cuomo's office said it's concerned the doctor-ranking programs carry "significant risk of causing consumer confusion, if not deception."

"Transparency and accurate information are essential when consumers make health-care decisions," Cuomo said in a statement. "We will ensure that insurance companies are not obscuring important facts at the consumers' expense."

The letters, dated Thursday, were related to Aetna's "Aetna Aexcel" program and Cigna's "Cigna Care Network" system, which have created networks of specialists based on criteria determined by the insurers.

... In both cases, Cuomo's office has raised concerns about the Aetna and the Cigna programs using claims databases to rank physicians - which his office says don't include all relevant clinical data and can be too small to generate reliable rankings.

That's very interesting. The AG is accusing these insurers of very fundamental violations of good medical informatics/information science practices. The article continues:

"We just received the NY AG's letter, and will review the request for information. We will cooperate fully," said Cynthia Michener, an Aetna spokeswoman, in a statement. "Aetna is fully committed to transparency, including publishing the criteria for the selection of specialty physicians on our member and provider web sites.

In the AG's letter, the following is stated:

The attorney general's office also expressed concern that neither the Aetna program nor the Cigna program discloses the data used to rank the doctors, even to the doctors themselves. "As a result, doctors and consumers have no ability to bring errors in the rankings to your attention so that they may be corrected," wrote Linda A. Lacewell, counsel for economic and social justice in Cuomo's office.

As in clinical trials of pharmaceuticals and medical devices, without extremely robust and thorough disclosures of the underlying data and algorithms, there is ample opportunity to "make the data work for you."

Cuomo's concern was met with the following response as cited in the Dow Jones article :

Tyler Mason, a spokesman for the UnitedHealthcare unit, said Thursday that the company responded to the attorney general's request with extensive information and a 25-page cover letter addressing his questions. "The program is designed to raise consumer awareness of differences among health-care practices that can affect both the effectiveness and cost of care and treatment," Mason said. "Understanding how often a physician adheres to evidence-based clinical guidelines, or how well a hospital treats a particular condition, helps consumers select the doctor or facility that best meets their needs." Mason said the program's methodology is based on "rigorous evidence-based guidelines" and has been honed with opinions from UnitedHealthcare network physicians, expert panels and physicians from national and professional organizations.

That all sounds wonderful, but can reflect a veritable information science cesspool that gives meaning to the "lies, damn lies and statistics" refrain if the data content, definitions, collection methods, and algorithms are subject to even slight defects or bias.

I find this situation particularly interesting.

"Who ya gonna believe?"

Here's how I am informed by my own personal experiences:

The Philadelphia-area HQ of Aetna is very close to one of the Merck satellite office sites where I often put in hours, in Blue Bell, PA, and I passed it regularly on the way home, a 15-minute drive. When the Merck 'Equinox' layoffs of 4,400 occurred in late 2003, I naturally applied to several Aetna positions.

A recruiter in the Connecticut HR offices at Aetna wrote this:

In a message dated 11/12/2003 4:32:01 PM Eastern Standard Time, writes:

Hello Scot,

Thank you for your interest in Aetna. Actually there are 3 positions that I feel you are qualified for. Please call me at your convenience to discuss further. Looking forward to speaking to you.



One position called for this:

Position Applied For: "Senior Clinical Outcomes Researcher 14972BR"

Designs, conducts and manages the production of health services research, health related quality of life program impact, economics research, models and publications for plan sponsors ... Supports multi-disciplinary teams, including outcomes research, clinical research and marketing staff to support women's health marketing, quality outcomes and cost-savings analyses.

What are we looking for? Strong interpersonal, communication, consultative, and presentation skills; the ability to collaborate and work within multidisciplinary teams, the ability to interact with colleagues at varying levels ... The ability to write in a clear, concise and effective manner to achieve the highest impact on a wide variety of audiences. Strong ability to convey complex concepts and to address major strategic challenges in writing and verbally. Ability to conduct health care intervention evaluations using economic modeling/analytic tools. Strong knowledge and ability to research a variety of qualitative and quantitative databases. Strong ability to analyze therapeutic area specific information to identify current trends and to address unmet challenges.

What is required? PhD in health services research, medical informatics or similar health related area or a Master's degree with extensive hands-on analytical experience.

I did not even get in for an interview:

Subj: RE: Thanks
Date: 11/13/2003 12:46:43 PM Eastern Standard Time

Hello Scot, I did hear from one of the hiring managers. Unfortunately, he feels you don't have the statistical background he is looking for. In the meantime, I will keep your resume on file and if I see something that is suitable I'll be in touch. Also, you can always check the website for opportunities that may be of interest to you.



I guess nothing "suitable" was ever found, as I didn't hear back from the recruiter.

Another position I expressed interest in was this:

"Business Information Manager"

What are we looking for? Solid understanding of integrated health care data, advanced analytical skills and outstanding consulting skills. Strong, interpersonal, communication, and presentation skills; the ability to collaborate and work within multidisciplinary teams, the ability to interact with colleagues at varying levels. Must be able to describe complex activities and analyses at both a high level and a detailed level for specialized audiences. The ability to write in a clear, concise and effective manner to achieve the highest impact on a wide variety of audiences. Self-starter, creative, resourceful, high energy and flexible.

What are the job responsibilities? Lead or participate in multi-disciplinary teams of clinicians, business and IT managers, and informatics analysts to develop quality metrics, consumer-focused tools for selecting quality health care facilities and providers, and evaluate Aetna's quality, medical management and member-centric programs.

I initially expressed interest in this role but when I discussed its reporting structure in more detail, it being a low-level manager position, I decided against it. I've discussed the issue of marginalization of medical informatics professionals on numerous occasions (ex. here and here) due to defective organizational structures and stereotyping. The question arises as to why a position such as this was graded so low.

Finally, an email I sent a few months later to Aetna's Senior Vice President and Chief Medical Officer describing my background and how the company might benefit from Medical Informatics expertise went unanswered.

Who do I find more credible regarding possible profit-generating flaws in the insurer physician-ranking programs, the Attorney General or the insurers?

As I'd written before in my posting "US senator says FDA needs independent safety office":

... Insights into process flaws, inadequate leadership skillsets, and perhaps even corruption in high-stakes industries can be gleaned by who they won't hire.

Of course, this is a personal opinion colored by personal experience, which should be taken with a grain of salt.

I report, you decide.

-- SS

Will This House Really Be a Home? - UnitedHealth Teams with Big Medical Associations to Pilot-Test the "Advanced Medical Home"

A joint press release from several US physician organizations, including the American College of Physicians (ACP), the American Academy of Family Physicians (AAFP), and the American Academy of Pediatrics (AAP), and the UnitedHealth Group announced a pilot project to implement the "advanced medical home" concept.

Briefly, according to principles asserted by the AAFP, AAP, ACP, and American Osteopathic Association (AOA), the advanced medical home would have four key characteristics: 1) it would be centered on ongoing relationships among patients and their personal physicians; 2) the personal physician would be the leader of a team that takes responsibility for patient care; 3) the personal physician would take responsibility for the patient as a whole person; and 4) the medical home would provide care coordinated and/or integrated across all elements of the health care system.

According to an ACP monograph, the point of the advanced medical home is to offer "the potential to improve U.S. health care by focusing on strengthening and supporting the patient-physician relationship."

The press release, and a recent item in the AAFP News, provide an outline of the pilot project. Below are key elements.

General description of the medical home to be provided:

Each patient will have the choice to select a personal physician, or “medical home,” who knows his or her medical and family history and coordinates their medical care. The physician will be responsible not only for treating a specific ailment or condition, but also for working with the patient to better manage his or her health care needs and arranging care as appropriate with other professionals. The patient-centered medical home model places special emphasis on preventing disease and improving the care of chronic conditions. It emphasizes behavioral health support and patient education as well as the diagnosis and treatment of acute illnesses. [Press Release]

Implementation of the pilot program:

The pilot program will be launched in Florida with approximately six specially-chosen primary care practices that will employ the model. [press release]

[The practices are] yet to be chosen. [news item]

The pilot programs will include customers insured through UnitedHealthcare commercial insurance.[press release]

How UnitedHealth will be involved:

UnitedHealth Group will support the practices participating in the pilot program by integrating its extensive quality improvement and care management into the practices’ infrastructure. This includes sponsoring 24/7 nurse triage and other solutions that extend access to care, identification of and outreach to those who may need clinical interventions; and educational tools and assistance to help patients better manage their conditions. [press release]

UnitedHealth Group will support the participating primary care practices by helping them incorporate quality improvement and care management systems to increase access. [news item]

How physicians will be reimbursed:

UnitedHealth Group will pay participating physician practices a monthly care-management fee based on projected savings for all patients that select a medical home. In addition, the company will share any excess savings that accrue from the pilot program with the physician practices and -- by way of premium reductions -- with employers.

How results of the pilot program will be assessed:

UnitedHealth Group has commissioned an independent research study designed to evaluate and assess the results of the pilot's experimentation with the patient-centered medical home model of care. [news item]

Expectations of how it all will work:

'We should see improved patient outcomes and overall better value for patients, employers and health plans,' [AAFP President Rick] Kellerman said. [news item]

David C. Dale, M.D., FACP, President of the American College of Physicians, said, 'A key element of the patient-centered medical home model is a commitment to improved quality. Primary care practices should exemplify attributes such as dedication to team care, utilization of clinical information systems, coordination of care with other health professionals and support networks, as well as continuous performance assessment and improvement, among others.' [press release]

Reed V. Tuckson, M.D., FACP, UnitedHealth Group’s executive vice president and chief of medical affairs said, '“UnitedHealth Group and its companies are dedicated to effective, collaborative activities with physician experts and their professional societies that result in enhanced quality and efficiency of care for our customers.' [press release]

The details of this program are still sketchy, but they certainly raise some questions.

  • Is the pilot program realistic? - Apparently, the program will be limited to patients covered by UnitedHealth. Most physicians contract with multiple managed care plans and health insurers, and also see patients covered by government programs, and even some patients with no insurance. Patients tend to arrive in the office randomly with respect to their health care coverage, or lack thereof. How could the physicians in the pilot study run a medical home for only UnitedHealth patients, and give "usual care" to all the others? If they try to provide a medical home to all their patients, how will they afford to do so, since no other payer is going to change their reimbursement? If the practices involved only take care of UnitedHealth patients, how would results generalize to other doctors?
  • Is the goal to provide better patient care, or to save UnitedHealth money? - Note that Dr Tuckson used the "e-word," that is, efficiency. Is increasing UnitedHealth's profits the primary motive?
  • How much will this particular "medical home" model involve handing control of patient management over to UnitedHealth? - Note that the project will entail UnitedHealth "integrating its extensive quality improvement and care management into the practices' infrastructure."
  • Is the reimbursement meant to compensate physicians for their and their practices' time, effort, capital investment, and resource use? - Note that the compensation plan seems only to be based on UnitedHealth's "projected savings," and "any excess savings." There was no clear explanation of how reimbursement might relate to the time, effort, and expenses incurred by the participating practices.

The danger, of course, is that this scheme is first meant to save a big for-profit managed care company some money, ahead of any priorities on improving health care quality, or providing fairer reimbursement to primary care and generalist physicians.

The press release concluded with the proclamation in the press release that "UnitedHealth Group is a diversified health and well-being company dedicated to making health care work better." I hope that is so now. In the recent past, UnitedHealth was better known for paying its CEO outrageous compensation (see post here), and inflating his personal wealth to over $1.5 billion (see post here). Its former CEO was forced into retirement, and an investigation of whether the company back-dated his stock options is ongoing (see post here).

But maybe the company is really changing its priorities. And this project is a step in that direction. Time will tell whether this house it trying to build is really a home.

ADDENDUM (20 August, 2007) - See also these comments on the Retired Doc's Thoughts blog.

Thursday, August 16, 2007

BLOGSCAN - Exclusive Interview with PharmaGossip's "Jack Friday"

On BrandweekNRX, this post includes an interview with the secretive anonymous writer of PharmaGossip. PharmaGossip is a must read for anyone interested in the reality, good and bad, of life in the pharmaceutical industry. The blog has been vigorous in its pursuit of mismanagement, conflicts of interest, and corruption affecting the leadership of the industry. Thus this interview should be of particular interest to readers of Health Care Renewal, even if it doesn't provide many clues to the identity of "Jack Friday."

BLOGSCAN - Scientist Behind Gleevec Decries Its Price

On PharmaLot, this post summarizes an interview with Brian Druker, one of the scientists responsible for the development of imatinib (Gleevec, manufactured by Novartis). Druker noted that much of the science behind Gleevec was financed by government money, yet Novartis saw fit to charge an extremely high price for this potentially life prolonging drug. The key paragraph:

The price at which imatinib has been offered for sale by Novartis around the world has caused me considerable discomfort. Pharmaceutical companies that have invested in the development of medicines should achieve a return on their investments. But this does not mean the abuse of these exclusive rights by excessive prices and seeking patents over minor changes to extend monopoly prices. This goes against the spirit of the patent system and is not justified given the vital investments made by the public sector over decades that make the discovery of these medicines possible.

Doctor "Pam" Comments on the Crisis in Primary Care

A comment from an anonymous family physician named "Pam" on a recent post about the declining popularity of primary care among medical students is worth publishing on its own (slightly edited).

I'm a family doc who took time off for heavy family responsibilities and am now wanting to go back to work. The environment in which I can practice my skills as a communicator, healer, educator of patients, manager of problems, etc has become toxic, antagonistic toward its nominal aim.

When I left medicine, 5 years ago, I had a thriving solo practice and yet was having trouble getting paid and in turn paying off the bank. Looking at the field now I see all of the same problems (many of them worse) as when I left.

I would hate to discourage an intelligent, idealistic, empathic young person from going into primary care. But the road has become too treacherous.

As for me, I don't know whether to open a boutique practice in my upscale town or do a fellowship leading to specialization, or what. I know I can't practice medicine in the way it's currently prescribed. (I suppose that makes me "noncompliant" in the parlance of the field, though I've caught wind that the new word is "nonadherent." Whatever.)

The root of the problem is political, as you've described in your other posts. As Kevin Grumbach noted in a speech to the Society of Teachers of Family Medicine this year,

". . . fees are not the product of free-market supply and demand. Rather, they are the result of a mechanism for determining relative value units for physician services—which in turn determine fees for Medicare and other third party payers --that is largely controlled by a committee [the RBRVS Update Committee, or RUC] under the auspices of the American Medical Association. . . ."

"This committee has 26 voting physician members nominated by specialty societies; only 3 of these members are primary care physicians. In addition to exerting disproportionate influence over policies such as Medicare fee updates, specialists have the added advantage of having much of their practice costs subsidized."

As they say, go and read the whole thing (or listen to it on your iPod.)

Thank you for your blog.

As we have noted before, primary care and "cognitive" physicians are having a very tough time, mainly because reimbursements are low, and not made for many of the tasks they do to provide coordinated, continuous, comprehensive care, especially for patients with chronic diseases. Meanwhile, they bear a heavy and increasing bureaucratic burden imposed externally, mainly from the govenment, e.g., the Medicare and Medicaid programs, and private health care insurers and managed care organizations. "Pam" makes these points again, vividly and personally.

All this results in pressure to see too many patients in too little time to cover overhead costs.

The practitioners who ought to have enough time to talk to patients, think about their problems, obtain more information about patients or their diseases and complaints, and communicate with other physicians, don't. We know from decision psychology that people subject to time pressure make less optimal judgments and decisions, mainly because they simply don't have time to think enough about alternatives, or the data they have. Thus, handicapping the professionals who ought to provide patients with their "medical homes" likely is a major cause of increased cost, decreased access, and sub-optimal quality.

Yet whenever there are costs to be saved, the first target seems to be primary care physicians. What's wrong with this picture?

I also thank "Pam" for the link to Kevin Grumbach's talk in which he mentions the still not very well known contribution of the RUC to the current reimbursement problems in primary care. We have posted about this here and here. This again raises the question of why the AMA, an organization which professes to represent all physicians, seems to be supporting federal reimbursement policies that are so bad for primary care and cognitive physicians?

Thanks, "Pam." Hope to hear from you again.

Wednesday, August 15, 2007

"Bling Bling," Poltical Correctness, and the Anechoic Effect

In today's post-modern academic world, everyone is afraid of saying anything that might be the least bit offensive. (See the web-site of the Foundation for Individual Rights in Education, or FIRE, for some amazing examples.)

It seems that that even the most skeptical and iconoclastic health care bloggers may also be fearful of being too politically incorrect.

In this post on the Carlat Psychiatry Blog, David Carlat nick-named Dr Charles Nemeroff "Bling Bling" for the extent of his relationships with the pharmaceutical industry. Carlat soon had to retreat, after being taken to task by one of the editors of his own Carlat Psychiatry Report for being "too personal," apologizing, "I was trying to be humorous, but I'll admit these [writings] come across as mean."

Today, this post on the Clinical Psychology and Psychiatry Blog showed that "Bling Bling" was not an exaggeration. (Nemeroff has also come in for criticism on Health Care Renewal, here, here and here.) But even then, the anonymous Clinical Psychology and Psychiatry blogger worried, "how is a blogger to be entertaining, stick to the facts, and bring important information to readers without crossing the line into being offensive? I don't know."

Yet, in health care, in my humble opinion, the problem is not too many bullying bloggers calling people offensive names. The problem, instead, is a general fear of saying something even the least bit negative about the powers that be, even when the powers that be have done awful things.

Carlat's quick retraction of what amounted to mild sarcasm, and the Clinical Psychology and Psychiatry bloggers fear of being "offensive" are the latest demonstrations that the "anechoic effect" is alive and well in health care.

The term, first coined by Dr Russell Maulitz, describes how even the most vivid cases of mismanagement, conflicts of interest, and even corruption in health care seem to produce no echoes. Two important historical examples that have come up on Health Care Renewal include:
  • Cooper Hospital - University Medical Center. In the 1990s, this case featuring briefcases filled with cash, a hospital trustee convicted of murder, and the embezzlement of over $21 million. Yet despite these lurid details, it seemed to get no notice outside of local newspapers. See post here, and details here (starting on page 3).
  • Allegheny Health Education and Research Foundation (AHERF) - The CEO of this, one of the first large vertically integrated health care systems, including the US' largest health care university at the time, was called a "visionary," and gave the prestigious John D Cooper lecture at the 1996 AAMC meeting. Meanwhile, he paid himself and his top managers huge salaries (for the time), and threatened his faculty, "don't cross me or you will live to regret it." The health care system eventually went bankrupt, the then second largest bankruptcy in US history, and the CEO went to jail. Yet, excepting what I have written, this case generated only one article in the health care and medical literature. See post here with citations and links.

And there have been numerous recent cases, e.g.,

  • HRDI - An organization set up by 30+ CEOs of some of the US leading hospitals, which charged a stiff fee for prospective vendors to get access to them. It was shut down in a legal settlement, which prompted the Connecticut Attorney General to call the organization, "an anticompetitive, secret society." Yet the story never appeared in most of the hospitals' home towns, much less any medical journals. (See post here.)
  • Guidant - A device manufacturer which recently was accused of suppressing data about failures of its implantable cardiac defibrillators, and previously pleaded guilty to suppressing data about failures of a vascular graft product. Yet a featured interview of its CEO in a leading health policy journal avoided discussing any of this recent unpleasantness. (See post here.)
  • University of Medicine and Dentistry of New Jersey (UMDNJ) - Now 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). Yet none of this has appeared in the medical or health care literature.

Try a Google search for the "anechoic effect" and "hcrenewal" to see some other examples.

Yet, local media do not hesitate to report individual physicians disciplined by their state medical boards. Such discipline is on the public record (e.g., here, for my state of RI). Physicians are frequently sued for malpractice. The media run scary stories about medical errors and overpaid physicians.

But when the CEO of one of the country's biggest hospital systems goes to jail, or the biggest health care university in the country agrees to a deferred prosecution agreement, physicians don't talk or write about it.

Carlat's apology for awarding the "Bling Bling" nickname, and Clinical Psychology and Psychiatry's fear of being "offensive" suggests how fearful we are of saying anything even mildly negative about the powers that be in health care.

As Aubrey Blumsohn put it, "the desire to maintain decorum and status in medicine seems also to overwhelm all standards of decency. Our profession is inclined to fixate on the irrelevant while ignoring some very bad things. Does civility matter? In the words of David Kern: When you're in an argument with a thug, there are things much more important than civility. I do not like incivility. Yet, I like thugs even less."

If we can't even talk about mismanagement, conflicts of interest, and corruption in health care, how are we ever going to fix these problems?