HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

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Wednesday, June 4, 2008

The Next President and Public Health and Flu

Well, now that both parties have nominees for President, we should start thinking about the challenges that the next President will face.  DemFromCt at DailyKos does an excellent job summarizing some of the public health issues that need to be addressed.  DemFromCt writes,

After nearly four years of writing about bird flu, pandemics and emergency preparation, you'd think I'd be tired of the topic. Think again ;-0  There's a great deal of activity under the surface, and though the media isn't covering this regularly, and though other considerations vie for attention (and rightly so - the economy, the price of gas, the Iraq war, health reform, NOLA reconstruction and other issues are all compelling and important), the risk of a pandemic remains... and the efforts of thousands of people on line and off continue to make a difference.

. . . . [H}ere's a couple of comments from two Senators in the news lately who recognize the risk, and have been working to mitigate the consequences.  From 2005, Barack Obama:

If we're lucky, we'll have at least a year, or perhaps several years, to prepare for a flu pandemic. But we might not be so lucky. And regardless of whether it is this particular strain of avian flu, H5N1, or another deadly strain, the time to act is long overdue if we want to prevent unprecedented human suffering, death, and economic devastation.

International health experts say that two of the three conditions for an avian flu pandemic in Southeast Asia already exist. First, a new strain of the virus has emerged to which humans have little or no immunity. Second, this strain has shown that it can jump between species.

The last condition--the ability for the virus to travel efficiently from human to human--has not been met, and it is the only thing preventing a full blown pandemic. Once this virus mutates and can be transmitted from human to human, we will not be able to contain this disease. Because of the wonders of modern travel, a person could board a plane in Bangkok, Athens, or Bucharest and land in Chicago less than a day later, unknowingly carrying the virus. Indeed, we learned this lesson from SARS, which moved quickly from Asia to Canada, where it led to many deaths.

As my colleagues know, one of my top priorities since arriving in the Senate has been increasing awareness about the avian flu. In April of this year, I introduced the AVIAN Act, which is a comprehensive bill to increase our preparedness for an avian flu pandemic. This bill was incorporated into a larger bill, the Pandemic Preparedness and Response Act, that Senator Reid and I introduced two weeks ago. We need to move this bill as quickly as possible.

That bill did not pass, but co-sponsor Hillary Clinton was also a cosponsor of the subsequently passed Pandemic and All-Hazards Preparedness Act in 2006,  an important law that established the primacy of HHS in a public health emergency, and established within HHS the office of the the Assistant Secretary for Preparedness and Response (ASPR). . . .
According to Govtrack.us, This bill passed in the Senate by Unanimous Consent. A record of each representative's position was not kept. . . . .

I can't find much, if anything that John McCain has said or done on the topic (post if you know of something). Many of John McCain's votes on pandemic related issues were actually votes on Iraq troop bills with pandemic (and other issues) added on (those votes broke along party lines). But what we can say is that Clinton and Obama have been following this topic for at least three years whereas McCain's interest is unknown.

That leaves the next President, whoever it is, with an unpredictable attitude towards public health and pandemic preparedness. One can predict that in an attempt to be Not Bush, current policies will change. In my view, that can be a good thing (less bioterror, more natural disaster preparedness would be appropriate). So, with that in mind, this story raised some eyebrows last week:

A strain of bird flu has moved a step closer to developing the traits required to create an epidemic of the disease in humans, scientists warned on Monday.

Researchers who analysed samples of recent avian flu viruses found that a strain of the virus called H7N2 had adapted slightly better to living in mammals.

Tests on ferrets proved the strain could be passed between animals but scientists said the evidence suggested that bird flu could be transmitted between humans.

It followed on the heels of this one from early May:

Pandemic flu threat remains substantial, health experts say

The world still faces a substantial threat of a flu pandemic and countries need to speed up preparations for a global outbreak, health experts said Tuesday.

"We can't delude ourselves. The threat of a pandemic influenza has not diminished," said Keiji Fukuda, coordinator for the World Health Organization's Global Influenza Program.

It was a reminder that we don't know when and from which virus the next pandemic is coming from, but we know with certainty that sooner or later, we'll have to deal with a worldwide pandemic influenza. The last time the world saw one was in 1968. . . .


June 4, 2008 | Permalink | Comments (0) | TrackBack (0)

Disease Mongering

PLoS Medicine published an interesting article on the popularity of "disease mongering" and the harms that it causes.  Ray Moynihan , Evan Doran, and David Henry write,

Disease mongering is the selling of sickness that widens the boundaries of illness in order to grow markets for those who sell and deliver treatments. It is a process that turns healthy people into patients, causes iatrogenic harm, and wastes precious resources [1]. Disease mongering is the contemporary form of “medicalisation.” It is a process now driven by both corporate and professional interests, and it has become part of the global debate about health care. International consumer groups now target drug company–backed disease mongering as a wasteful threat to public health [2], while the global pharmaceutical industry has been forced to defend its promotion of “lifestyle” medicines for problems like slimming and sexual difficulties [3]. . . .    Disease mongering increasingly appears in media analyses of medical conditions and new treatments. It has a page devoted to it on Wikipedia [7], and was recently the subject of a much publicised award-winning work of art [8]. . . .

Two years ago, we helped organise the world's first international conference on disease mongering in Newcastle, Australia, which coincided with a special theme issue of PLoS Medicine on the same subject [4]. . . . New York University academic psychiatrist Leonore Tiefer spoke about the involvement of drug companies in helping to foster the creation of a new condition called female sexual dysfunction [9]. Cardiff University psychiatrist David Healy charted the growing promotion of bipolar disorder and drugs to treat it [10]. Dartmouth University researchers Lisa Schwartz and Steven Woloshin revealed how the prevalence of restless legs syndrome was being exaggerated to broaden markets for new drugs [11]. One of the most popular sessions of the conference was the opening plenary, which featured the fictional Professor Leth Argos discussing a satirical “new” disease called motivational deficiency disorder, said to affect up to one in five people worldwide [12]. Part of his presentation is available on YouTube [13]. . . .

In the United States, which is responsible for roughly half of all global spending on prescription medicines, a leading media watch organisation now routinely analyses health news stories for any signs of disease mongering [14]. Created in 2006 in the US, and inspired by similar organisations in Australia and Canada, HealthNewsReview.org (http://HealthNewsReview.org/) tries to encourage journalists writing about health not to contribute to the process of medicalising ordinary life [15]. The emergence of high-profile articles on the subject also suggests scepticism is building within the mainstream media. In covering a new drug called Requip—for “restless legs syndrome”—The Wall Street Journal headlined the story “How Glaxo Marketed a Malady to Sell a Drug” [16]. Similarly, The New York Times recently ran a story about a new medicine called Lyrica—for “fibromyalgia”—under the headline “Drug Approved. Is Disease Real?” [17]. . . . .

As public interest in the corporate-sponsored creation of disease grows, the need for a central database or resource library is becoming clearer. A credible Web site attached to an academic or advocacy group featuring case studies and other information on disease mongering could prove very valuable. Already some groups, including Healthy Skepticism (http://healthyskepticism.org/), have devoted space to this debate, and others are likely to follow.

While we have noted some signs of media, consumer, and academic debate and action about the problem of disease mongering, we are not aware of a similar increase in policy interest or action. In fact, to the contrary, there is some evidence of complacency about disease mongering on the part of regulators. The US Food and Drug Administration's recent proposal to relax restrictions on off-label marketing risked setting the conditions for disease mongering to flourish [23]. Unnecessary medicalisation and medication may be wasting many precious health resources, with obvious opportunity costs for private and public health insurers alike. Producing credible estimates of the magnitude of those costs is a future direction that should be urgently pursued.

June 4, 2008 | Permalink | Comments (0) | TrackBack (0)

Tuesday, June 3, 2008

Senate Finance Considers the Cost of Health Care

Ezra Klein updates us on what is happening in the Senate Finance Committee hearing on the cost of health care.  He writes,

I'm on the Hill this morning for a Senate Finance Committee Hearing on "Rising Costs, Low Quality in Health Care: The Necessity of Reform." This is one of the hearings that's supposed to lay the groundwork for the Finance Committee's upcoming "Prepare for Launch" health care summit, which is in turn, supposed to lay the groundwork for the Committee's 2009 push for comprehensive reform. . . .

The first witness was Paul Ginsberg, president of the Center for Studying Health System Change, who made two main points. First, "By any measure...U.S spending on health care is greater than other developed countries. In 2006, the United States spent $2.1 trillion, or 16 percent of GDP, on health care, translating to $7,026 annually. But unlike other developed countries, which provide near-universal coverage, 47 million people in 2006 were uninsured." Second, "the enormous amount of money spent on medical care in the United States does not appear to buy us outstanding health. By almost any measure, ranging from infant mortality to preventable deaths, the United States does not measure up well against other developed nations."

Then came Elizabeth McGlynn, from RAND. "In 2003," she said, "my colleagues and I published, in the New England Journal of Medicine, the first national, comprehensive study on quality of care for adults. We examined 439 indicators of quality for 30 clinical areas. We found that on average, American adults received just 55% of recommended care for the leading causes of death and disability. . . .   We spend nearly $2 trillion and we get it right about half the time."

Felicia Fields, group vice president for human resources at Ford, noted that her company spent $2.2 billion on health care last year, or about $1,000 per car. And Arlene Holt Baker, executive VP at the AFL-CIO, reported the results of a survey of her union's members that showed a deep anxiety about keeping and paying for their health care. . . .

June 3, 2008 | Permalink | Comments (0) | TrackBack (0)

Medical School and Conflicts of Interest

Both the New York Times and the Wall Street Journal's Health Blog note the recently completed survey showing the conflicts of interest policies at medical schools   According to the American Medical Student Association, such policies could be improved.   Jacob Goldstein for the Wall Street Journal writes,

A big med students’ group published scorecards today grading American med schools’ conflict of interest policies. The schools did pretty badly, with more than twice as many D grades as As. Grades are posted online here.

The grades, compiled by the American Medical Student Association, consider policies relating to things like gifts from industry, industry-funded speaking deals and access granted to sales reps. The group used a scoring system that varied for each criterion. . . . 

The group gave only seven schools an A, while 14 got Bs, 4 received Cs and and 19 got Ds. Fifteen schools either had no policies at all or had policies that earned them an F. Another 45 schools that didn’t provide info or didn’t respond to follow-up requests.

This kind of thing has lately become a big deal in the med school world. In April, the American Association of Medical Colleges released recommendations calling for schools to take a hard line, banning things like free food and putting strict limits on access by sales reps. . . .

The New York Times' Gardiner Harris similarly states,

Most medical schools in the United States fail to police adequately the money, gifts and free drug samples that pharmaceutical companies routinely shower on doctors and trainees, according to a ranking by the American Medical Student Association.  Only 7 of the 150 medical schools included in the rankings received a grade of A while 14 were given a B. Sixty got a failing grade, and the student association found that 28 schools, or nearly one in five, were in the midst of revising their conflict-of-interest policies. . . .

The student association will routinely update the grades it gives medical schools, which are listed on a school-by-school basis at amsascorecard.org. The grades will be officially released Tuesday.   Mount Sinai School of Medicine in New York, the University of Pittsburgh Medical Center and University of California schools at Los Angeles, Davis and San Francisco were among those receiving top grades. . . .

The student association, which represents more than 67,000 medical students, residents and practicing physicians, began its ranking in November when it requested conflict-of-interest polices from all of the nation’s medical colleges. The association made at least four attempts to receive the policies from every school in the country, but 16 schools declined to submit a policy and 29 did not respond at all. These schools, along with 15 that did submit policies, were given failing grades.


June 3, 2008 | Permalink | Comments (0) | TrackBack (0)

Monday, June 2, 2008

Celebrex as Cancer Prevention Drug

The Washington Post reports on a new study showing some extra positives from taking high doses of Celebrex, it may help prevent lung cancer in heavy smokers.  Julie Steenhuysen writes,

A high dose of the arthritis drug Celebrex showed early signs that it may help prevent lung cancer in heavy smokers, U.S. researchers said on Sunday. The Pfizer Inc <PFE.N> drug, also known as celecoxib, works by blocking the COX-2 enzyme that causes inflammation, which has been linked with cancer.

A six-month study of 212 current or heavy smokers found a reduction in a specific type of precancerous change in lung cells in people who took a high dose of Celebrex compared with those who took a placebo.  None of the study participants had any heart-related problems such as those with Merck & Co Inc's <MRK.N> now withdrawn arthritis drug Vioxx, another COX-2 inhibitor. . . .

"This is not a study where we go tell someone who is a heavy smoker to start taking Celebrex to prevent lung cancer," Kim said in an interview.  Lung cancer is the leading cause of cancer death in the United States, according to the American Cancer Society. In 2008, about 215,000 people will be diagnosed with lung cancer and about 114,000 people will die from it. . . .

Rather than a direct measure of cancer prevention, which could take many years, Kim said the researchers were looking for early changes in the body that might suggest the drug could reduce the chances of developing lung cancer.

The researchers tested Celebrex in the study because studies in cells, mice and in people have shown the COX-2 enzyme is present at higher than normal levels in lung cancer and in precancerous lesions of the lung, Kim said. COX-2 is thought to play a role in the development of blood vessels that feed tumors.  Kim's study measured levels of the Ki-67 protein, a marker for cell growth. The researchers wanted to see if Celebrex had an impact on levels of this protein in tissue samples taken from the lungs of heavy smokers. 

At the beginning of the study, the researchers took lung samples from six predetermined areas of the lung.  People in the study either got a 200 milligram or a 400 milligram dose of Celebrex twice a day, or a placebo.  After three months, they took more lung samples, and they took samples again at six months. Kim said the group that got the higher dose of Celebrex saw a reduction in levels of the Ki-67 protein.  Kim said it will be important to find better ways of identifying people who are at the highest risk for lung cancer for whom the benefits of taking a high-dose COX-2 inhibitor would outweigh any potential heart risks.

 

June 2, 2008 | Permalink | Comments (0) | TrackBack (0)

Organ-Recovery Ambulance

Until I read this article in the New York Times, I was unaware of the difficulty in recovering organs from some organ donors who do not die at the hospital.  The Times article discusses a new method to combat these lost organs - the “rapid organ-recovery ambulance.”  This sounds like a great idea to prevent the loss of desperately needed organs.  However, I would recommend some better marketing and educational efforts.  I can see where some people would find it a bit upsetting to have an organ-recovery vehicle showing up at the same time as the EMT crew.  Times writer Cara Buckley reports,   

New York City is pioneering a potential solution to a supply-and-demand problem that has long vexed doctors the world over: how to meet a desperate need for donated organs without trampling on sensitivity surrounding the sanctity of death.      

About a third of all donated organs are harvested from live donors. Nearly all the rest come from people who have been declared brain dead while undergoing treatment in hospitals. But thousands of people die at home or on the street, their organs almost never considered for transplantation even if they had filled out donor cards, because there is no system in place to handle it.

But with a $1.5 million grant over three years from the federal Health Resources and Services Administration, a team of medical experts and bioethicists is looking to expand the city’s donor pool by deploying a “rapid organ-recovery ambulance” to collect and preserve the organs of people who die of cardiac arrest. The plan — modeled on a successful program in Spain — is for the ambulance to trail regular ambulances that try to save people’s lives, then to swoop in if patients die and to maintain the bodies in stasis for several hours at a hospital, until family members can decide whether to donate the organs.

“I see this as a continuum for saving lives,” said Dr. Lewis R. Goldfrank, director of emergency medicine at Bellevue Hospital Center, who is leading the project. “To see people die every year who are waiting on organ-donor lists and people die who are potential donors, seems a mismatch between societal needs and societal values.”  Dr. Goldfrank aims to get the first organ-recovery ambulance in operation by year’s end in Lower Manhattan. If the project is a success and replicated in other cities, he estimated that the nation’s donor pool could grow by 22,000 people. . . .

“In our culture, doing things to a dead body without consent is highly controversial, even if it’s minor, even if doesn’t cause permanent marking,” said Dr. Arthur Caplan, a bioethicist at the University of Pennsylvania who is not involved in the program.

“There are a lot of Americans who have a hard time getting into a hospital because they don’t have insurance or they have poor insurance,” Dr. Caplan noted. “They will not necessarily find it a good thing when they find out that they can’t get into the hospital, but that a hospital will send a special ambulance to bring their body to the hospital when they’re dead.”

New York’s recovery ambulance is inspired by a donor-detection program started in 1989 in Spain, which now has the highest organ-donation rate in the world. In the past two decades, Spain has tripled organ donation to 35 donors per million people, significantly shrinking its waiting list. In the United States, there were 23 donors per million people in 2007, according to the organization Donate Life America, with roughly 99,000 people waiting.  But thousands of organs from would-be donors are never harvested because there is no system to quickly transplant organs from victims of cardiac arrest. . . .

A typical situation, according to several of the doctors involved, might unfold like this: Emergency services are notified that a person has gone into cardiac arrest. An ambulance is dispatched, and normal efforts are made to revive the victim. Unbeknownst to paramedics in the first ambulance, the dispatcher would also have alerted the organ-recovery ambulance, which would also head to the scene. The medics on the second ambulance would not get involved unless all resuscitation efforts were exhausted and the victim declared lifeless.

At that point, instead of transporting the body to a funeral home or the medical examiner’s office, the organ-recovery team would wait five minutes, then begin running fluids into the body to preserve organs and prevent blood clots. A medic would administer chest compressions to maintain minimal blood flow, and the body would be taken to hospital. Transplants would happen only if the next of kin agreed and organs were healthy. . . .

June 2, 2008 | Permalink | Comments (0) | TrackBack (0)

Sunday, June 1, 2008

Artificial Legs and Unfair Advantages . . . .

William Saletan at Slate.com writes about the recent controversy surrounding Oscar Pistorius and his effort to compete in the 2008 Olympics.  The catch - he has two artificial legs.  Mr. Saletan writes about the recent -- court ruling permitting Mr. Pistorius to run and noting the ruling isn't quite what one would expect.   He states, 

Oscar Pistorius was born with defective legs. Before his first birthday, they were amputated below the knee. That didn't stop him. Now 21, he has broken three world track records for disabled athletes and is racing to qualify for the 400 meters at this summer's Olympics. If he can shave four-tenths of a second off his best time, he'll make it.

How has he done it? One answer is superhuman grit. The other is superhuman legs. Pistorius runs on carbon-fiber prostheses made for sprinting. In January, the International Association of Athletics Federations declared them ineligible, claiming they were better than human legs. But on Friday, the Court of Arbitration for Sport overturned that decision, clearing his path to the Olympics.

Go, Oscar, go. We're all rooting for you to cross that finish line in Beijing. Just one note of caution: Don't win. That's the strange upshot of the court's ruling. Artificial legs are fine to run on, as long as you don't win the race.

How did we get to this awkward place? The story begins last year, when the IAAF adopted a rule prohibiting "any technical device that incorporates springs, wheels or any other element that provides the user with an advantage over another athlete not using such a device." According to the court, the IAAF interpreted this rule as banning any device that provides "any advantage, however small, in any part of a competition."

In November, the IAAF tested Pistorius and his artificial legs against similar sprinters on human legs. The scientist who supervised the test reported, "Energy return was clearly higher in the prostheses than in the human ankle joints." He also found that "fast running with the … prosthesis is a different kind of locomotion than sprinting with natural human legs. The 'bouncing' locomotion is related to lower metabolic cost."

The court didn't dispute these findings. , , , ,   But it rejected the IAAF's interpretation of the rule. The word advantage, the court decided, has to mean "overall net advantage"—i.e., "more disadvantages than advantages." In other words, it's OK to use artificial legs, even if they're better than human legs at some things. In fact, they're already better at some things. They just can't be better at everything. . . .

In short, the court found that none of the tests conducted on Pistorius, even by his own experts, "quantified all of the possible advantages or disadvantages" of his legs. If you read the opinion, it becomes clear that this task is essentially impossible. There are too many variables.

How, then, can we settle the question of net advantage? By running the race. The court pointed out that the same artificial legs, manufactured and sold to other amputees, have "been in use for a decade, and yet no other runner using them … has run times fast enough to compete effectively against able bodied runners." It concluded: "In effect, these prior performances by other runners using the prosthesis act as a control for study of the benefits of prosthesis and demonstrate that even if the prosthesis provided an advantage … it may be quite limited."   In other words, there's nothing to complain about until runners with artificial legs start winning. . . .

June 1, 2008 | Permalink | Comments (0) | TrackBack (0)