Recently in Health care Category

A London pediatrician's diary shows that Haiti desperately needs, more than surgeons, supplies and coordination.

Writing for the Evening Standard, Dr. Nathaniel Segaren of the Caris Foundation, logs his week of guilt, frustration, appall, effort, and anguish among the mayhem. He concludes, "I realise we can be of most help with our knowledge of the city's geography and our ability to speak a combination of French, English and Creole." The ultimate intent becomes to select, with exceptional agony, those patients for transfer to a floating US Navy hospital—which is already beyond capacity.

"There are lots of egos here and mini power struggles," Segaren observes, "People are desperate to claim credit and get maximum media coverage."

From the UN via Flickr: Photo of 18-year-old Haitian girl with head trauma being transported to USS Comfort, a floating hospital.

The short answer: it really isn't a mandate.

Yale law professor Jack Balkin explains further in his "Perspective" piece in this week's NEJM.

Balkin's overarching argument is that the requirement to purchase health insurance, described in both the House and Senate forms of the healthcare reform bill, is really a tax* on those persons** who fail to purchase health insurance. And, according to the Constitution, Congress has the power to legislate taxes that serve the general welfare. End of story.

Balkin predicts that the Supreme Court won't even touch the health-insurance mandate/tax issue, unless a federal court of appeals knocks it down. And in that case, the high court will uphold it.

* In the House version of the bill, the income of the uninsured is taxed; in the Senate version, an uninsured individual is taxed on an event basis--meaning, he is taxed each month that he doesn't purchase health insurance.

** Meaning individuals who don't already have employer-provided health insurance. The "mandate" also does not apply to dependents, Medicare or Medicaid recipients, military families, overseas ex-pats, or religious objectors.

Off-topic addendum: In the Age of Transparency, the NEJM has evidently found a way to avoid the multiple columns of small type that are sometimes necessary to print all of the disclosures of its published authors. Provide an online link instead to the author's filled-out disclosure form.

Among the major differences between the House and Senate healthcare reform bills is this issue: Who will oversee the newly created competitive insurance "exchange"—a sort of Expedia.com equivalent for the 30 million people without job-provided health insurance? The House bill proposes national regulation of the exchange; the Senate wants state-level oversight. Both Congressional bodies have their points, according to today's WSJ.

House Democrats want federal regulation to promote consistency and thwart insurers who would try to create and exploit loopholes at the state level. House legislators believe they're owed this concession in exchange for eliminating a new government public insurance plan in the final bill.

The Senate and the insurance industry, on the other hand, want states to regulate the exchange—arguing that state administrators have a better understanding of the local markets and their consumers. Proponents of state regulation also cite the substandard federal regulation and abuse of Medicare Advantage plans.

Another bone of contention for the insurance industry is the Senate's proposed tax on high-premium group-health plans—a tax that is intended, in part, to finance healthcare reform. Insurers want the tax reduced and phased in. Otherwise the industry will have to pay up to $224 billion during the next decade, estimates a top insurance lobbyist.

For the record, President Obama wants the tax on high-premium group-health plans in the final bill.

No. 1: Pandemic H1N1

You were expecting something else?

Coming out of left field (ie, Mexico)* in April, the novel 2009 H1N1 ("swine flu") virus caused an official global pandemic in June, according to the World Health Organization. Cases mounted rapidly, but fear of disease was mitigated by its relatively low mortality rate.** Drawing on their experience from the swine-flu epidemic of 1976, leading US neurologists first believed that a government-led vaccination campaign would be unlikely because of 1) low mortality and 2) the possibility of vaccine-associated Guillain-Barre syndrome (GBS). Boy, were they wrong.

In August, the CDC released its recommendations for the administration of developing H1N1 vaccines to 5 groups. The surprise: Instead of the historically targeted elderly, the CDC prioritized vaccination for children, young adults, and pregnant women because of their emerging risks of disease-related complications and death. Consequently vaccination was recommended for an estimated 159 million Americans as soon as vaccines became available, sometime in mid-October.

In May, the DHHS had contracted with 5 companies—CSL Biotherapies, GSK, MedImmune, Novartis, and sanofi-pasteur—to produce either injectable or nasally administered vaccines for pandemic H1N1 to the tune of $932 million. Government orders for another $883,977,920 and $438,143,025 were placed in July and September, respectively. The total amounted to about 9 bucks per vaccine, which was being produced by the traditional method of viral incubation in fertilized chicken eggs.

This tried-and-true method ultimately led to a delay in vaccine production for 2 primary reasons: the fastidious nature of the 2009 H1N1 virus (when compared with seasonal influenza viruses) and limited chicken eggs. Turns out the pandemic virus required 2 eggs to create a single vaccine dose, instead of the usual one. By October, the federally contracted companies had only cranked out about 10% of the promised 120 million vaccine doses for US residents. Time was a-wastin'.

In October, the CDC investigators estimated that about 3 million citizens had already experienced symptomatic pandemic flu between April and July, on the basis of a probabilistic model. Confirming previous assessments, the incidence of disease and disease-related hospitalizations were considerably higher in children and young adults. Pandemic flu, overall, had necessitated about 14,000 hospitalizations and had caused about 800 deaths in the United States.

The following month, the CDC estimated that up to 34 million Americans had been infected between April and mid-October. Respective hospitalizations and deaths now ranged from 63,000 to 153,000 and from 2500 to 6000. Another age breakdown revealed that disproportionate numbers of younger adults (and to a lesser extent, children) remained susceptible to pandemic flu generally and severe disease specifically. About 45% of Americans who had died from pandemic flu had been healthy.

And then disease began to wane. Earlier this month, only 25 states reported widespread activity. At the same time, data showed that the pandemic flu vaccines (the supplies of which were up) remained effective and were comparably safe. Specifically the risk of GBS appeared no higher than the typical background rate.

The latest recommendations: More than 30 "major health care provider organizations," including the American Medical Association, the American Academy of Pediatrics, and the American Red Cross, are encouraging all US residents to receive a pandemic flu vaccine in anticipation of another wave of infection. An "open letter" to the American people states,

The H1N1 flu vaccine is safe, effective, and the best way to protect yourself and your family from the H1N1 flu. Over 110 million doses...are now available, with more coming every day. Now is the time to protect yourself and those around you by getting vaccinated against the H1N1 flu.

Links to selected Pathophilia posts on pandemic flu (and a few on seasonal flu) are provided here in chronological order.

• WHO: Not-So-Deadly Swine Flu Now Pandemic
• Caution for Today: GBS Risk With Old Swine-Flu Vaccine
• Rapid H1N1 Test Relatively Insensitive
• CDC Recommends Novel H1N1 Vaccine for Certain Groups
• Novel H1N1 Mortality Rate: Pitfalls in Calculation
• Novel H1N1 Infection in Chicago: Children Preferentially Vulnerable
• Novel H1N1 Vaccine Approval for 4 of 5 Companies
• Harvard Expert Estimates Very Low Mortality Rate for 2009 H1N1 Pandemic
• Vaccinations for Seasonal and Pandemic Flu
• Strep Pneumoniae Most Likely Bacterial Pathogen in Fatal H1N1
• H1N1 Vaccine Table
• ...And Furthermore, Bill Maher Needs a Haircut
• H1N1 Vaccine Shortage: Blame Chickens
• The Solace of Illusion
• Influenza: Moms' Reasons for Not Vaccinating
• Millions of Americans Infected With Pandemic Flu
• Reanalysis Negates Recommendation for N95 Respirators
• Seasonal Flu Vaccine: High Demand Leads to Short Supply
• After Delay, FDA Approves GSK's Pandemic Flu Vaccine
• Seasonal Flu Vaccine and Protection Against Pandemic Flu
• CDC: Up to 34 Million Americans With Pandemic Flu
• CDC: Modest Decline in H1N1 Activity
• Norwegian H1N1 Mutation Not New
• Pandemic H1N1: Activity Down; Vaccine Supplies Up
• Pandemic Flu Vaccines Comparably Safe
• Overall H1N1 Mortality in England Comparable to US Estimates

* Instead of the historically expected East Asia.

** Estimated in the United States at 0.007%-0.032%.

Depiction of H1N1 virus from Wikipedia.

No. 2: US House and Senate Pass Their Respective Healthcare Reform Bills

They said it couldn't be done, and they might still be right; but with a strong administrative push to reform America's sickly healthcare system, both the House and the Senate passed their respective bills this year. To the tune of more than $1 trillion in anticipated costs, the House measure narrowly passed on November 7. The price tag for the Senate bill, which ultimately prevailed on Christmas Eve, is a relative bargain at $871 million. The major difference between the two bills: the creation of a new government (ie, public) insurance plan, which the House bill stipulates.

Not much posting here at the Pathophilia blog about healthcare reform, largely because the topic seemed like such a complicated mess. The New York Times is the recommended go-to source, however. Among the paper's many useful features on the subject is a comparison of the proposed bills, an abbreviated version of which is tabulated here.

Bill Feature	House	Senate
Mandates minimum-level health insurance, with penalties for uninsured	Yes	Yes
Requires most employers to contribute to coverage for employees, with penalties for not complying	Yes	Sort of
Creates insurance "exchange," or competitive insurance marketplace, for individuals and employers	Yes [a]	Yes [b]
Creates new government (ie, public) insurance plan	Yes	No
Subsidizes (ie, provides tax credits to) low- or middle-income persons to buy insurance	Yes	Yes
Subsidizes small business to provide employee insurance	Yes	Yes
Expands Medicaid	Yes	Yes
Defines minimum allowable insurance package	Yes	Yes
Prohibits denial of coverage owing to preexisting conditions	Yes	Yes
Requires plans to offer coverage for dependents up to at least 25 years of age	Yes	Yes
Creates voluntary federal disability-insurance program	Yes	Yes
Requires coverage for abortion	No	No
Allows illegal immigrants to buy exchange plans	Yes [c]	No
Eliminates Children's Health Insurance Program (CHIP)	Yes [d]	No [e]

a. At national level.
b. At state or regional level.
c. But not eligible for federal subsidies.
d. Coverage now through Medicaid or national insurance exchange.
e. Would extend CHIP.

The House's reform would be supported by new taxes on medical devices and individuals with very high incomes (eg, >$500,000). The Senate would levy a hefty tax on high-premium group-health plans and charge annual fees to drug, device, and insurance companies. Both bills would attempt to "squeeze" hundreds of billions of dollars out of Medicare by restricting its growth.

To my knowledge, neither bill proposes cost savings through the use of information technology (IT)—which is probably wise. Harvard researchers recently concluded that IT doesn't reduce hospital costs.

What do we want? Raw data! When do we want it? Now!

In the midst of the 2009 pandemic influenza epidemic, BMJ editor Fiona Godlee takes Roche to task for not supplying the necessary data to confirm or refute the benefits of oseltamivir (Tamiflu) in otherwise healthy people with influenza. In one of 2 BMJ editorials, Godlee chides Roche for not supplying unconditional access to raw data from a pooled analysis of 10 company-sponsored trials (Kaiser et al; PubMed link here) to Cochrane reviewers Jefferson et al. Consequently the reviewers were "obliged to disregard" the bulk of these data (8 of the 10 trials) and were unable to verify that oseltamivir prevents lower-respiratory-tract complications (eg, pneumonia) due to influenza.

In their previous 2006 Cochrane review, Jefferson et al had concluded that oseltamivir 150 mg daily prevents such complications on the basis of the Kaiser article. However, the authors were criticized through a public feedback mechanism for using the 10-trial analysis without having access to the raw data. Prompted by this criticism, Jefferson et al then conducted another review, published this week in the BMJ, in which they affirmed their critic's perspective:

Data on the effectiveness of oseltamivir against complications of influenza principally came from one study...This was a meta-analysis of 10 trials containing a mixture of published and unpublished data, two of which are reported in this update and the remainder inaccessible to proper scrutiny, so that we are now obliged to disregard them. The remaining data showed no benefit for oseltamivir against complications.

In her editorial, Godlee asks, "Where does this leave oseltamivir, on which governments around the world have spent billions of pounds?" She, moreover, emphasizes that the Cochrane review data apply only to healthy adults with influenza, but they "say nothing about [oseltamivir's] use in patients judged to be at high risk of complications—pregnant women, children under 5, and those with underlying medical conditions." Even the drug's ability to reduce influenza-related symptoms (which Jefferson et al reconfirmed) are doubted, because there are no head-to-head studies with oseltamivir and NSAIDs, for instance.

In another BMJ editorial (with Cochrane director Mike Clarke), Godlee concludes that the latest Cochrane review and a "linked investigation undertaken jointly by the BMJ and Channel 4 News cast doubt not only on the effectiveness and safety of oseltamivir (Tamiflu) but on the system by which drugs are evaluated, regulated, and promoted." In their investigation, Cochrane reviewers became concerned about the actual involvement of listed authors on the Kaiser analysis, the possibility of ghostwriting, the high rates of influenza in the trials, and the low rates of serious adverse events.

Initial responses from Roche employees, who first declined to provide the data and then offered selected files, were less than satisfactory to the reviewers. The latest response from the company: it is "committed to making the 'full study reports' available on a password protected site soon."

On the basis of this experience, Godlee and Clarke conclude that the current system for reporting drug research "isn't working" and offer a number of potential remedies—including government-mandated access to raw data that are used to license and market a drug (eg, something in the spirit of the FDA Amendments Act of 2007).

News sources are all over this story (eg, Bloomberg), and the BMJ offers full-text access to the following relevant articles, including a response from a Roche employee—who chastises Jefferson et al for enlisting the investigative help of a TV news station.**

• Godlee F. We want raw data, now.
• Godlee F, Clarke M. Why don't we have all the evidence on oseltamivir?
• Smith J, on behalf of Roche. Roche replies to the authors of the Cochrane Review on oseltamivir.
• Cohen D. Complications: tracking down the data on oseltamivir.
• Doshi P. Neuraminidase inhibitors--the story behind the Cochrane review.
• Freemantle N, Calvert M. What can we learn from observational studies of oseltamivir to treat influenza in healthy adults?
• Jefferson T, Jones M, Doshi P, Del Mar C. Neuraminidase inhibitors for preventing and treating influenza in healthy adults: systematic review and meta-analysis.
• Web extra (including the criticism that got the ball rolling).

* And I mean that in the nicest possible way.

** Roche's Smith writes, "It is unclear to us why Dr Jefferson would adopt this approach, particularly given that he was a paid ad hoc consultant to Roche working on flu and oseltamivir between 1997 and 1999. During that period he worked closely with Roche experts, many of whom are still in the company, and he would therefore not have had difficulty in contacting them directly to discuss his requirements."

Photo from Vermin Inc at Flickr.

The subject of hot partisan debate, the current version of the Senate healthcare reform bill, HR 3590 (the "Patient Protection and Affordable Care Act"), provides a much-needed and long-overdue financial incentive for primary care physicians to continue to offer primary care. In its present version, the proposed bill states,

In the case of primary care services furnished on or after January 1, 2001 2011, and before January 1, 2016, by a primary care practitioner, in addition to the amount of payment that would otherwise be made for such services under this part, there also shall be paid (on a monthly or quarterly basis) an amount equal to 10 percent of the payment amount for the service under this part.

The bill defines a primary care practitioner as 1) a physician who has a primary specialty designation of family medicine, internal medicine, geriatric medicine, or pediatric medicine,* and 2) a healthcare professional whose billed primary care services make up at least 60% of practice. (Primary care services, defined by CPT codes, are essentially all non-procedure-related services—ie, evaluation and management services.)

The problem with the current wording of the bill—as far as neurologists and their flagship organization, the American Academy of Neurology (AAN), are concerned—is that the primary care incentive omits neurologists: physicians whose practices, like those of traditionally defined primary care physicians, consist of substantial face-to-face time and care.

According to AAN officers in today's member teleconference, the bill's oversight is partly due to congressional ignorance: MedPAC, the government agency that makes recommendations to Congress about Medicare policy, mistakenly assumed neurology to be an internal medicine specialty, like rheumatology or endocrinology. (In the eyes of the government, a physician's specialty is determined by a designated specialty code. Unlike neurologists, rheumatologists or endocrinologists can designate themselves as internal medicine practitioners on the basis of their postgraduate clinical training and/or board certification.) The other gross misjudgment is that neurology is synonymous with the wildly different practice of neurosurgery.

The continued omission of neurology from the bill's definition of primary care, the AAN reasonably argues, would further erode a valuable medical specialty—which currently matches only 52% of available residency slots.** And yet, despite the shortage of neurologists, their services have been shown (for example, in the case of stroke patients) to reduce hospital stays and costs and to improve clinical outcomes.

The AAN reports that Senator Amy Kobuchar (D-MN) has agreed to introduce an amendment that would add "neurology" to the pertinent section of HR 3590. The proposal is currently in need of a Senate cosponsor. Several patient groups, representing individuals with Parkinson disease, epilepsy, traumatic brain injury, ALS, or headache, advocate the inclusion of neurology in the bill's incentive section for primary care physicians.

To support the inclusion of neurology as a primary care practice in healthcare reform legislation, the AAN recommends that members visit BrainPAC and write their federal legislators.

* Nurse practitioners, clinical nurse specialists, and physician assistants are also included. In the House bill, obstetricians/gynecologists are included.

** Neurology's match percentage is comparable to that of family medicine and internal medicine, according to AAN President-Elect Bruce Sigsbee, MD.

President Obama has repeatedly proposed information technology (IT)—for example, the use of electronic medical records—to realize overall healthcare efficiency and savings. But the proposal just isn't true, say Harvard researchers. In fact, their study of computerization and administrative costs at US hospitals, published in today's online issue of The American Journal of Medicine, shows that "more wired" hospitals may have higher total costs than their lower-tech counterparts.

In a survey of 4000 US hospitals,* conducted from 2003 to 2007, the total costs of hospitals with higher calculated computerization scores (measured by the use of computer applications) were significantly greater, at least in one analysis. Hospitals that underwent computerization at a relatively rapid pace sustained particularly high administrative costs. And researchers did not discover delayed cost benefits from computerization—meaning, computerization costs in 2003 were not realized in savings 5 years later.

On the other hand, investigators found that a modest improvement in the quality of healthcare (and in particular, the management of acute MI) may correlate with hospital computerization.

Lead author of the study, David Himmelstein, MD, said in a press release: "Our study finds that hospital computerization hasn't saved a dime, nor has it improved administrative efficiency. Claims that health IT will slash costs and help pay for the reforms being debated in Congress are wishful thinking."

The researchers offer 3 reasons for why IT has failed to decrease hospital administrative costs.

• Potential savings are offset by the costs of purchasing, implementing, and maintaining computer systems.
• The current stage of hospital computerization is not advanced enough to realize healthcare savings.
• The available computer systems focus on coding and reimbursement rather than efficient clinical care.

To realize substantial healthcare savings and quality of care from IT, the authors propose a VA model of care—in which a single-payer program eliminates the need for billing and most internal accounting. Himmelstein and his coauthor Steffie Woolhandler, MD, are affiliated with Physicians for a National Health Program, an organization that supports a single-payer system. 

* Data were derived from the Healthcare Information and Management Systems Society (HIMSS) Analytics annual survey, hospital-submitted Medicare Cost Reports, and the 2008 Dartmouth Health Atlas.

On July 6, 2009, for reasons that remain unclear, the Senate Special Committee on Aging sent a letter to Thomas Sullivan, president of Rockpointe Corporation, a private, 18-employee company that produces continuing medical education (CME) programs for physicians. The letter requested "an accounting of funding received by Rockpointe Corporation from pharmaceutical, medical device and biologics companies for three and one-half years from January 1, 2006 to the present."

In his July 20 response to the Committee, Sullivan voluntarily provided the financial information, while requesting that the Committee use "reasonable protection against this information becoming publicly available." Sullivan clarified, "[A]s we have discussed with your Chief of Investigations, Jack Mitchell, the business information provided is proprietary."

Later in his letter, Sullivan expressed confusion about the Senate Committee's specific interest in his private CME company:

It is a concern to us that this letter has been directed to Rockpointe as a result of a group meeting that we initiated with the Aging Committee staff. That initiative was intended to provide information, understanding and insight concerning CME and the proposed Physician Payment[s] Sunshine Act. The meeting, and the required time and preparation, constituted a good faith effort to bring relevant information to the Committee. Our intent was to differentiate accredited CME from promotional marketing. Under the credo of "no good deed goes unpunished," this initiative led directly to your singling us out among the hundreds of similar CME providers to submit confidential business records. We have expended considerable time, expense and professional fees identifying, locating, reviewing and organizing nearly 4 years of business records in order to digest and prepare the accurate summary you requested. An inquiry of his nature will likely discourage other "good Samaritans" from exercising their rights as involved citizens to bring issues of concern to the attention of the committee.

Rockpointe's financial data (and Sullivan's letter) were recently made publicly available through UCSF's Drug Industry Document Archive and reported last week by Alicia Mundy in the WSJ. It is certainly reasonable to conclude that the data were provided to the archive through the Committee (either directly or indirectly), despite Sullivan's request that the confidential information remain confidential.

But I contend that the suspected behavior of the Committee toward Sullivan's company could have been predicted by examining its powerful chief investigator, Jack Mitchell (whom Sullivan mentions in his letter).

John Howard "Jack" Mitchell (who, ironically enough, was a presenter along with Sullivan at the recent National Disclosure Summit in March) is mostly a career government staffer—although he served as an investigative reporter under syndicated columnist Jack Anderson in the late 70s/early 80s and was evidently a CNN correspondent sometime in the mid-90s. But the role that appears to have primarily informed Mitchell's "purpose" (for lack of a better word) is that of Special Assistant for Investigation in the office of FDA commissioner David Kessler. There, during the late 90s, Mitchell worked closely with Kessler on his unsuccessful effort to bring the tobacco industry under FDA control. Mitchell is specifically credited with bringing Jeffrey Wigand, the notorious industry whistleblower and tobacco insider, to the attention of Kessler.* At a symposium of the Association for Medical Ethics in March 2008 at the University of California at Irvine, Mitchell said of his FDA stint, "[T]o some respects, that was one of the best jobs I ever had."

Mitchell's work with Kessler against Big Tobacco can reasonably be expected to inform whatever righteousness he may feel when investigating other industries, including the drug and medical-device industries—which are presently in the sights of the Senate Committee on Aging. (And Mitchell's righteousness as a government reformer could only have been fortified by the recent passage of legislation that now puts tobacco under FDA control.)

However, caution is warranted in dealing with the righteous, particularly crusaders who hold powerful, non-elected government positions. Generally everything's fine if you completely agree with the crusader; however, you're no more likely to convince him that there's more than one side to an issue than you are of persuading Joel Osteen that Jesus was merely a nice Jewish boy. Moreover, if you reveal sufficient differences of opinion to a crusader, and specifically one who happens to be a senior Congressional staffer, you may find yourself the subject of a Senate Committee investigation—as Sullivan discovered.

In language that supports this contention, Mitchell himself displays an authoritarian mindset that merits caution, if not outright distrust. To illustrate, the following are excerpts from Mitchell's speech at the ethics symposium (which can also be viewed here).

When you've done the kind of work I do for so long—as an investigative reporter, a Senate investigator on 2 different occasions, and I've run government investigative offices like Dr. Kessler's—I see that frankly as part of the same thing. Just in different jobs, in different roles. When you do that, you realize that, to some degree, that whether you like it or not, whether you care to admit it to yourself or not, that there's a strong reformist streak within you. And so I tend to seek out people who are like that or see that, and I see that characteristic in them.

And so the most important thing you bring to the table when you try to do effective oversight, you try to change public policy, is you find, you ferret out the people who are capable or who have the courage to do something like that. That's how I found Dr. Jeffrey Wigand and made myself close enough to him that he was willing to come forward to the FDA.

In some cases, Mitchell's language suggests that he thinks he runs the Senate Committee on Aging and is a legislator. For instance, notice his use of "I," "my," and "we," instead of language that would more accurately refer to the Committee or Senator Kohl.

When I did a, when I began our year-long series of hearings last year on conflicts of interest and consultant payments in the medical-device and pharmaceutical industries...

And

So these are all parts of the same things the committee continues to explore as we continue our series of 5 or 6 hearings on these type of conflicts, both in the medical-device and pharmaceutical industries. And we hope to do some more hearings in the fall and into next year in support of a number of pieces of legislation. We're gonna be looking at continuing medical education. We've done a hearing on academic detailing by the pharmaceutical companies. We're going to do some hearings on free drug samples that are given to physicians and medical students and ways to combat that type of influence peddling. And we're going to do some more hearings as necessary on these continuing conflicts in order to deal with them.

And most of that is in support of some legislation you've heard about here...called the Physicians Payment[s] Sunshine Act, which is coauthored by my boss, Senator Herb Kohl of Wisconsin—who is chairman of my committee, the Senate Special Committee on Aging.

And

Now at this point, while we've negotiated this bill very closely with industry and with other parties, it's not clear to me what the fate of the bill will be for this year. We've tried to put it into the Senate Medicare package. We haven't been successful with that to date, and it doesn't appear that's going to happen. We may introduce it as a stand-alone bill with an advisement to industry...

And

One thing you may wonder, for those of you not very familiar with Congressional oversight is, the question of why would we—why would Congress be interested or why would it be any of Congress's business—the type of ethics issues that we're discussing in the medical-device and orthopedic and, as well, pharmaceutical industries. Well the reason is that my committee has jurisdiction over Medicare, and most of the medical-device companies receive a majority of their income from Medicare and Medicaid in many instances—not in all—but many. In fact, many medical-device companies receive the bulk of their income from Medicare reimbursement and Medicaid reimbursement payments. So that provides my committee, at least, with the direct jurisdiction—since we have control of the centers for Medicare and Medicaid in order to make sure and try to be vigilant that our taxpayer dollars, which go into this system—the billions of dollars—are well spent and well protected.

And

We fully intend any legislative efforts that we undertake to include all of those players, not just the large companies. And while it's pretty difficult to establish what I might call a level playing field that is our ultimate goal—we want to establish a regulatory framework that's fair to everybody and includes limits that are not unreasonable for the small companies or for the large companies. And that takes a lot of back and forth and push and shove. And I'm not sure that even the language we have in the legislation now is final or is the final answer to the problems. 

What is also concerning is that Mitchell conveys not-so-veiled threats to companies or organizations that don't cooperate with the Committee.

...[S]hould anyone block the bill's progress...we will come back next year with more oversight hearings and a much more toughly worded bill that we will be much less willing to compromise over or negotiate.

And

I must say that we invited some of the more established surgical professional associations to participate or submit written testimony to our hearing, and they declined. So hopefully, I'm hopeful they will see that the train is leaving the station, and that some of these groups really need to get on board or at least offer some comment and cooperation in terms of the legislative and other proposals which we put forward on the table.

Finally Mitchell discloses that his (or really, the) Senate Committee on Aging is not averse to going after small companies.

The large companies aren't the only players. There are a lot of entrepreneurial small companies who are out there spending a lot of money trying to influence physicians and surgeons and draw them into their sphere of influence. 

* Mitchell is featured prominently in Kessler's book about his anti-tobacco crusade, The Question of Intent.

Thumbnail image of Jack Mitchell from disclosuresummit.com.

Earlier this week, the WSJ Health Blog reported on a newly published study by Boston researchers Zinner et al (Participation of academic scientists in relationships with industry. Health Aff (Millwood). 2009;28:1814-1825), who assessed the extent to which academic physicians and other scientists have financial ties with the drug or device industry. The story was also predictably picked up by Ed Silverman at Pharmalot.

The blogs' respective ledes highlighted the finding that about 53% of academic researchers have some kind of financial relationship with industry—an observation plucked from the article's abstract. But if one reads the article, the most face-slapping result, IMNSHO, was the horrifying uniformity of the surveyed respondents: 72% were male, and 77% were white. The ethnic/racial diversity, or obvious lack thereof, is flabbergasting. The only minority represented to any notable extent was "Asian."* Among the 2168 respondents** from clinical or nonclinical "life-science" departments, 22 described themselves as black or African American. That's one percent.

Ethnicity/Race	No.	%
White	1705	77
Asian	314	14
Hispanic, any race	56	3
Declined to report	57	3
Other	47	2
Black or African American	22	1
Total	2201*	100

And it's not as if the survey candidates were cherry picked. The authors selected a random sample of faculty from the life-science departments at the 50 US universities that received the most NIH funding in 2004. Survey responses were collected between December 2006 and March 2007. The findings are, therefore, one hell of an indictment of those making contemporary academic appointments in the life sciences at our top programs.

Unfortunately the authors (who include my favorite, sociologist Eric Campbell) did not address the homogeneity of their survey population; perhaps they believed it to be off point. But such a stunning revelation demands examination.

* The ethnic/race breakdown was similar for clinical and nonclinical faculty. The authors did not break down race by professorship level (full, associate, and assistant). The findings are probably even more disheartening.

* It's assumed, although not clarified by the authors, that 34 respondents selected more than one ethnicity/race in the survey.

IMNSHO = in my not-so-humble opinion.