HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

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Thursday, April 17, 2008

Vioxx Deaths, Merck's Data and Ghostwriters

Guardian reports on the bad data provided by Merck and the New York Times follows up with a review of yesterday's Journal of the American Medical Association piece discussing ghostwriters for medical articles on Merck data and analysis. Sarah Boseley for the Guardian writes,

A multinational drug company that made a painkiller that had to be withdrawn from sale because it was found to cause heart attacks may have hidden the death rate from the authorities for several years, it was claimed yesterday. Internal company documents released during litigation in the US suggest that Merck, makers of Vioxx, gave the US Food and Drug Administration only selected data on deaths in its clinical trials, and failed to include people who had a fatal heart attack soon after coming off the drug. . . . .

Bruce Psaty and Richard Kronmal, from the University of Washington in Seattle, say that internal company records from 2001 give 34 deaths among the 1,069 Vioxx patients from two of the Alzheimer's trials and 12 among the 1,078 on placebo - a threefold increase among those on the drug. But the published data of the first study in 2004 stated there were 11 deaths which were "non drug-related" among 346 Vioxx patients, and two among those on placebo. In the second study published in 2005 there were said to be 24 deaths among 725 Vioxx patients and 15 among the 732 on placebo, with 17 and two more respectively within 14 days of the last dose. But, say the researchers, neither study analysed the mortality data.

In July 2001, Merck had reported mortality data to the FDA. Psaty and Kronmal wrote that "deaths that had occurred more than 14 days after discontinuation of the trial drug apparently were not included". When the FDA questioned the figures, in December 2001, it emerged that there was no independent data. The second journal paper reveals that manuscripts for scientific journals were written by Merck employees. Doctors attached to leading universities would then be invited to take authorship. Some, but not all, declared financial support from industry.

The New York Times provides more details on the ghostwriters for Merck and suggested reforms for medical publishers by the Journal of the American Medical Association,

The drug maker Merck drafted dozens of research studies for a best-selling drug, then lined up prestigious doctors to put their names on the reports before publication, according to an article to be published Wednesday in a leading medical journal.  The article, based on documents unearthed in lawsuits over the pain drug Vioxx, provides a rare, detailed look in the industry practice of ghostwriting medical research studies that are then published in academic journals. The article cited one draft of a Vioxx research study that was still in want of a big-name researcher, identifying the lead writer only as “External author?”   . . . .

The lead author of Wednesday’s article, Dr. Joseph S. Ross of the Mount Sinai School of Medicine in New York, said a close look at the Merck documents raised broad questions about the validity of much of the drug industry’s published research, because the ghostwriting practice appears to be widespread.  “It almost calls into question all legitimate research that’s been conducted by the pharmaceutical industry with the academic physician,” said Dr. Ross, whose article, written with colleagues, was published Wednesday in JAMA, The Journal of the American Medical Association. and posted Tuesday on the journal’s Web site.

Merck acknowledged on Tuesday that it sometimes hired outside medical writers to draft research reports before handing them over to the doctors whose names eventually appear on the publication. But the company disputed the article’s conclusion that the authors do little of the actual research or analysis.  The final work is the product of the doctor and “accurately reflects his or her opinion,” said a Merck lawyer, James C. Fitzpatrick.

And at least one of the doctors whose published research was questioned in Wednesday’s article, Dr. Steven H. Ferris, a New York University psychiatry professor, said the notion that the article bearing his name was ghostwritten was “simply false.” He said it was “egregious” that Dr. Ross and his colleagues had done no research besides mining the Merck documents and reading the published journal articles. In an editorial, JAMA said the analysis showed that Merck had apparently manipulated dozens of publications to promote Vioxx.  “It is clear that at least some of the authors played little direct roles in the study or review, yet still allowed themselves to be named as authors,” the editorial said.

The editorial called upon medical journal editors to require each author to report his or her specific contributions to articles. “Journal editors also bear some of the responsibility for enabling companies to manipulate publications,” the editorial said.  JAMA itself published one of the Vioxx studies that was cited in Dr. Ross’s article. . . . .

Although the role of pharmaceutical companies in influencing medical journal articles has been questioned before, the Merck documents provided the most comprehensive look at the practice yet, according to one of the study’s four authors, Dr. David S. Egilman, a clinical associate medical professor at Brown University. . . .

One paper involved a study of Vioxx as a possible deterrent to Alzheimer’s progression.  The draft of the paper, dated August 2003, identified the lead writer as “External author?” But when it was published in 2005 in the journal Neuropsychopharmacology, the lead author was listed as Dr. Leon J. Thal, a well-known Alzheimer’s researcher at the University of California, San Diego. Dr. Thal was killed in an airplane crash last year.  The second author listed on the published Alzheimer’s paper, whose name had not been on the draft, was Dr. Ferris, the New York University professor. Dr. Ferris, reached by telephone Tuesday, said he had played an active role in the research and he was substantially involved in helping shape the final draft.  “It’s simply false that we didn’t contribute to the final publication,” Dr. Ferris said.

A third author, also not named on the initial draft, was Dr. Louis Kirby, currently the medical director for the company Provista Life Sciences. In an e-mail message on Tuesday, Dr. Kirby said that as a clinical investigator for the study he had enrolled more patients, 109, than any of the other researchers. He also said he made revisions to the final document.  “The fact that the draft was written by a Merck employee for later discussion by all the authors does not in and of itself constitute ghostwriting,” Dr. Kirby’s e-mail message said.

The current editor of the journal Neuropsychopharmacology, Dr. James H. Meador-Woodruff, the chairman of psychiatry at the University of Alabama, Birmingham, said he was not the editor in 2005 but planned to investigate the accusations. “Currently, we have in place prohibitions against this,” Dr. Meador-Woodruff said.

April 17, 2008 | Permalink | Comments (0) | TrackBack (0)

Plastic Baby Bottles, BPA and the FDA

Reuters reports on the National Toxicology Program's findings of the potential danger posed to young children from the chemical bisphensol A, a chemical used in such items as baby bottles and also recently approved by the FDA as safe in products used by infants and children.  Will Dunham writes,

Based on draft findings by the National Toxicology Program, part of the U.S. National Institutes of Health, senior congressional Democrats asked the Food and Drug Administration to reconsider its view that the chemical bisphenol A is safe in products for use by infants and children.  The chemical, also called BPA, is used in many baby bottles and the plastic lining of cans of infant formula.The National Toxicology Program went further than previous U.S. government statements on possible health risks from BPA.

It said: "There is some concern for neural and behavioral effects in fetuses, infants and children at current human exposures." The findings expressed concern about exposure in these populations, "based on effects in the prostate gland, mammary gland, and an earlier age for puberty in females." . . . .

The National Toxicology Program said laboratory rodents exposed to BPA levels similar to human exposures developed precancerous lesions in the prostate and mammary glands, among other things.  "The possibility that bisphenol A may impact human development cannot be dismissed. More research is needed," the agency said.  Bisphenol A is used in the production of polycarbonate plastics and epoxy resins and can be found in food and drink packaging as well as compact discs and some medical devices. Some dental sealants or composites contain it as well.

The National Toxicology Program expressed "negligible concern" that exposure of pregnant women to BPA causes fetal or neonatal death, birth defects or reduced birth weight and growth in babies. It also had "negligible concern" that exposure causes reproductive problems in adults. . . .

In Canada, the Globe and Mail newspaper said the Canadian health ministry was ready to declare BPA a dangerous substance, making it the first regulatory body in the world to reach such a determination. The newspaper said the ministry could announce the decision as soon as Wednesday. . . .

This follows yesterday's news from the New York Times that Senators from both parties believe the FDA is underfunded.

The Food and Drug Administration needs far more money than the White House has proposed for next year, senators of both parties said Tuesday.  “To us, it’s clear that they’re seriously underfunded,” Senator Herb Kohl, Democrat of Wisconsin, said after a hearing of the Appropriations subcommittee, headed by Mr. Kohl, that oversees the agency’s spending.  The subcommittee’s ranking minority member, Senator Robert F. Bennett, Republican of Utah, agreed with Mr. Kohl and tried at the hearing to get the food and drug commissioner, Dr. Andrew C. von Eschenbach, to say how much more the agency could use wisely. . . .

The Senate passed a budget resolution last month that would make the F.D.A.’s allocated budget — that part of its spending that comes from taxpayer revenue, as opposed to user fees paid by drug and medical device manufacturers — $375 million greater in 2009 than this year. That would be a 20 percent increase, and Dr. von Eschenbach said he did not believe that the agency could absorb so large an addition in one year.

A report last year by a panel of outside advisers to the agency said American lives were in danger because the F.D.A. did not have the money, the staff or the scientific expertise to protect them. And in a speech last month, Dr. von Eschenbach acknowledged that the F.D.A. “may fail in its mission to protect and promote the health of every American” and that “peril exists.”  But he was far less pessimistic in his testimony on Tuesday.  “I believe we have been eminently successful up to this period of time,” Dr. von Eschenbach said. “We are the world’s gold standard.  “But if we want to continue that level of excellence,” he added, “we must change.”

The Bush administration has proposed increasing the agency’s allocated budget next year by 3 percent, to some $1.8 billion, not enough to pay even for increased costs. Dr. von Eschenbach spoke Tuesday about plans to hire up to 700 new employees for the F.D.A. staff, but he acknowledged that the agency would not have the money to do any hiring next year if the president’s budget was adopted without changes by Congress. . . .

Perhaps the FDA's problems go deeper than lack of funding . . .

April 17, 2008 | Permalink | Comments (0) | TrackBack (0)

Wednesday, April 16, 2008

Antioxidant Supplements May Be Harmful to Health

The Guardian (UK) reports today on a review by the Cochrane Collaboration which demonstrates that in many cases taking vitamin supplements, specifically antioxidants, in the hopes of extending life is not only a waste of money but can actually be detrimental to your health.  James Randerson for the Guardian writes,

Vitamin supplements taken by millions of people do not increase life expectancy and may raise the risk of a premature death, according to a review of 67 studies with more than 230,000 subjects.

The review, by the Cochrane Collaboration which regularly pools data from trials to evaluate drugs and treatments, found supplements vitamin A, vitamin E and beta-carotene are detrimental to health. In 47 trials with 180,938 people and a low risk of bias, the "antioxidant supplements significantly increased mortality", the authors wrote. When the antioxidants were assessed separately and low risk of bias trials were included and selenium excluded, vitamin A was linked to a 16% increased risk of dying, beta-carotene to a 7% increased risk and vitamin E to a 4% increased risk.  Evidence for vitamin C and selenium was more equivocal, suggesting there was no benefit to taking these pills compared with a placebo.

"The bottom line is current evidence does not support the use of antioxidant supplements in the general healthy population or in patients with certain diseases," said Goran Bjelakovic, who performed the review at Copenhagen Universityhospital in Denmark. "There was no indication that vitamin C and selenium may have positive or negative effects. So regarding these we need more data from randomised trials." . . . .

Bjelakovic's team evaluated 67 randomised clinical trials with 232,550 subjects; 21 of the trials were on healthy subjects, while the rest tested patients with a range of diseases. The evidence suggests it would be safer to obtain the chemicals not as supplements but by eating plenty of fruit and vegetables.

April 16, 2008 | Permalink | Comments (0) | TrackBack (0)

Banning the Internet From Law School Classrooms

The National Law Journal online reports on the recent decision by the University of Chicago Law School Dean to block classroom access to the internet.  Lynne Marek states,

Saul Levmore, who is dean of the school, said he had been trying to simply persuade students not to distract themselves with the Internet during class, but turned to simply shutting off access when he found that the school's building had the capability to block wired and wireless access. "It got a lot easier when I found I had technology on my side," he said in an interview. Keeping students from surfing the Internet during class is similar to keeping them from picking up calls on their cell phones, he said.  Levmore has received inquiries from about 10 other law schools interested in possibly following suit on the move, he said.

I know that some of my students surf the internet during my classes but sometimes it can be beneficial.  For instance, a student might be interested enough by a case that she looks to see what happened after the court's decision, or a student might remember an interesting case similar to that discussed in class and with google can quickly call up that case.  I do recognize, however, the downsides and I am aware that some students are searching sports scores or sending e-mails.  As for the ban, I am not sure that it will accomplish the objective of having students more focused on their classwork.  Before the internet was available in classrooms, I had students playing solitaire and other games (I swear I am not super boring) so I am not sure that blocking access to the internet will correct a lack of focus on the part of some students.

April 16, 2008 | Permalink | Comments (0) | TrackBack (0)

Tuesday, April 15, 2008

Calling Health Law Scholars

Now that classes are soon to be over, time to consider scholarship - St. Louis University School of Law Center for Health Law Studies announces is call for papers for its 2008 Health Law Scholars Workshop

Call for Papers

Timeline:
May 2 - Submission of Abstracts for Consideration
May 23 - Notification of Selection of Workshop Scholars
Sept. 1 - Works-in-Progress Due
Oct. 17 to 19 - Scholars Weekend

The Center for Health Law Studies at Saint Louis University and the American Society of Law, Medicine & Ethics are pleased to announce the 2008 Health Law Scholars Workshop. The Health Law Scholars Workshop is a collegial forum in which faculty new to health law and bioethics scholarship present works-in-progress and receive in-depth advice from experienced scholars and teachers in the field of health law and bioethics. The Workshop encourages health and bioethics scholarship, fosters the professional development of emerging scholars and furthers the sense of community among health law academics. Past Scholars have placed their papers for publication in pre-eminent health law, policy and bioethics journals.

Scholars workshop their work-in-progress before a group of experienced peer reviewers and commentators. Each author's work-in-progress accepted for the Health Law Scholars Workshop will be read in advance by three or four faculty members in relevant fields. During the Workshop weekend, each author presents his or her paper to the full group. After extensive oral feedback from the readers, the floor is opened for a sustained exchange between the presenter and full group.

The Workshop draws health law and bioethics scholars from across the country, inviting senior faculty from a variety of law schools and disciplines to review the works-in-progress and participate in the weekend. The Workshop also draws on the expertise of Saint Louis University faculty from the Center for Health Law Studies, the University's Medical School, School of Public Health, Nursing School and Center for Health Care Ethics.

Each spring there is a call for submission of abstracts for consideration, and each fall the annual Health Law Scholars Workshop is held at Saint Louis University.

A nominating committee selects the papers to be presented at the Workshop. The committee looks for papers that have an original thesis and will contribute to the scholarly literature. The Workshop is intended primarily to provide feedback on articles intended for spring submission to law review journals, although works intended for other types of publications are welcome. The Workshop is not designed to review published work or papers already accepted for publication.

Those interested in presenting a health law or bioethics work in-progress at the Health Law Scholars Workshop should submit a one-page abstract of the proposed paper together with a resume to Mary Ann Jauer at Saint Louis University School of Law by May 2, 2008. Because a blind selection process is used, please do not include the author's name or institutional affiliation on the abstract. Submissions may be made by mail, fax or e-mail to:

Mary Ann Jauer, Program Coordinator
Center for Health Law Studies
Saint Louis University School of Law
3700 Lindell Boulevard
St. Louis, MO 63108
Tel: 314.977.3067
Fax: 314.977.3332
Email: jauerma@slu.edu

April 15, 2008 | Permalink | Comments (0) | TrackBack (0)

Global Medical Tourism

Yesterday's NPR program Day-to-Day had an interesting program concerning global medical tourism and how many Americans were going overseas, the program focuses on Israel,  to gain access to medical care at a much lesser cost.  Here is link to the program's audio.  Below is a brief overview of the program's contents.

Thousands of "medical tourists" travel to Israel every year to take advantage of its state-of-the-art medical system. Even with the cost of flights and hotel, in vitro fertilization and cancer care in Israel costs far less than in the U.S. or Europe.

April 15, 2008 | Permalink | Comments (0) | TrackBack (0)

Human Research - The Importance of Consent

The Boston Globe reports on a recent (and rather shocking) incident in low-income, minority neighborhoods in Baltimore concerning the use of human and industrial waste on yards to reduce potential lead poisoning without knowlege of the participants.  Globe reporter John Heilprin writes,

Scientists using federal grants spread fertilizer made from human and industrial wastes on yards in poor, black neighborhoods to test whether it might protect children from lead poisoning in the soil. Families were assured the sludge was safe and were never told about any potential risks. 

Nine low-income families in Baltimore row houses agreed to let researchers till the sewage sludge into their yards and plant new grass. In exchange, they were given food coupons as well as the free lawns as part of a study published in 2005 and funded by the Department of Housing and Urban Development.

The Associated Press reviewed grant documents obtained under the Freedom of Information Act and interviewed researchers. No one involved with the $446,231 grant for the two-year study would identify the participants, citing privacy concerns. There is no evidence there was any medical follow-up.   Comparable research was conducted by the Agriculture Department and Environmental Protection Agency in a similarly poor, black neighborhood in East St. Louis, Ill. Residents there also were not told of the potential risks.

The researchers said the sludge could help protect the children from brain or nerve damage from lead, a highly toxic element once widely used in gasoline and paint. Other studies have shown brain damage among children, often in poor neighborhoods, who ate lead-based paint that had flaked off their homes. . . .

The Baltimore study concluded that phosphate and iron in sludge can increase the ability of soil to trap more harmful metals including lead, cadmium, and zinc, causing the combination to pass safely through a child's body if eaten. The results were published in Science of the Total Environment, a research journal, in 2005.  However, there has been a paucity of research into the possible harmful effects of heavy metals, pharmaceuticals, other chemicals, and disease-causing microorganisms often found in sludge.  A series of reports by the EPA's inspector general and the National Academy of Sciences between 1996 and 2002 faulted the adequacy of the science behind the EPA's 1993 regulations on sludge.

The chairman of the 2002 academy panel, Thomas Burke, a professor at the Johns Hopkins Bloomberg School of Public Health, said epidemiological studies have never been done to show whether spreading sludge on land is safe.  "There are potential pathogens and chemicals that are not in the realm of safe," Burke said. "What's needed are more studies on what's going on with the pathogens in sludge - are we actually removing them? The commitment to connecting the dots hasn't been there."

Rufus Chaney, an Agriculture Department research agronomist who co-wrote the Baltimore study, said the researchers gave the Baltimore and East St. Louis families assurances that the Orgro fertilizer was store-bought and safe.  "They were told that their lawn, as it stood, before it was treated, was a lead danger to their children," Chaney said. "So that even if they ate some of the soil, there would not be as much of a risk as there was before. And that's what the science shows."

April 15, 2008 | Permalink | Comments (0) | TrackBack (0)

Monday, April 14, 2008

Free Will?

The journal Nature Neuroscience latest edition focuses on the Nature of Decision-Making.  The studies are quite interesting and do raise many questions about how our brain works.  Here is the brief overview of the journal's articles,

The ability to make appropriate choices is critical for survival. Successful decision making requires the integration of sensory information, motivational states and potential outcomes to select the best action. Recently, there has been great progress in our understanding of the neural mechanisms supporting decision making in a wide range of contexts, including risky choices and social interactions. This special focus on decision making contains four reviews that highlight recent achievements in this important field.

Here is how the popular press is reporting some of the findings,

Using sophisticated brain imaging techniques, the researchers found that they can predict people's simple decisions up to 10 seconds before they're conscious of making such a choice.  "It seems that your brain starts to trigger your decision before you make up your mind," said the study's lead author, John-Dylan Haynes of the Max Planck Institute for Human Cognitive and Brain Sciences in Germany. "We can't rule out free will, but I think it's very implausible. The question is, can we still decide against the decision our brain has made?"  The study is the latest salvo in a longstanding scientific and philosophical debate over whether what we perceive as "free will" decisions are actually made before we're aware that we're making them. . . .

In this experiment, however, Haynes and his colleagues found that two regions of the brain responsible for even higher-order decision-making - the frontopolar cortex and the parietal cortex - were activated even earlier when people were asked to press a button with either their right or left hands.  Employing both functional magnetic resonance imaging and pattern recognition statistical techniques, the researchers were able to predict which button people would choose before they made their conscious decisions - as much as 10 seconds early, "an eternity," Haynes said.  Haynes believes that delay suggests the absence of free will as most people define it. . . .

Tufts University philosopher Daniel Dennett, on the other hand, offers a different way of thinking about the results of Haynes's experiment: "If you take a deep breath and think about it more, the making of the decisions themselves takes time. The noticing of the decision takes time," Dennett said. "That doesn't mean that we don't have free will."

Decision neuroscience, as this field of study is called, has potential applications in medicine, economics, marketing, consumer behavior, even criminal justice.  In the future, research in the field could help people with neurological motor disorders such as Parkinson's disease.  It also could identify people whose decision-making abilities are impaired through injury or from birth, leading to poor judgment or even criminal behavior.  "We're getting closer and closer to understanding how the brain works and how the mind works," Dennett said. "We obviously can't help these conditions until we do."

April 14, 2008 | Permalink | Comments (0) | TrackBack (0)

Abortion Records in Kansas

Phil Kline, the Johnson County District Attorney, who has been filing criminal cases against Planned Parenthood, has requested and thus far been denied medical records from the various clinics.  The Kansas City Star reports here and here on how his case is proceeding.  Mr. Kline had subpoenaed the medical records but the Health and Environment Department has refused to turn them over to him.  According to the Kansas City Star,

A Kansas agency has refused to turn over abortion records subpoenaed by Johnson County District Attorney Phill Kline.  And if Kline doesn’t get them, Planned Parenthood attorneys said Monday, Kline’s criminal case against Planned Parenthood could crumble.  “If he (Kline) doesn’t have the evidence, how can he prosecute?” asked Planned Parenthood attorney Pedro Irigonegaray. “… Without records, that is an impossible task.”  District Court Judge Stephen Tatum has scheduled a hearing for Wednesday on a motion to quash the subpoena filed Friday by the Kansas Department of Health and Environment. 

Kline wants the agency to produce the records and provide testimony authenticating them at a two-day preliminary hearing scheduled for Monday and Tuesday.  Health and Environment Department spokesman Joe Blubaugh said his agency’s attorneys say the law prohibits them from turning over the records.  However, Blubaugh said, “we’ll comply with whatever the court rules on it.”

Kline in October filed a 107-count criminal complaint against Planned Parenthood of Kansas and Mid-Missouri and Comprehensive Health, its Overland Park clinic. Twenty-three of the counts, which are felonies, accuse the clinic of “making a false information.”  Specifically, those counts accuse the clinic of manufacturing or forging documents in August 2006 regarding 23 late-term abortions. Kline is seeking the state agency’s records regarding those abortions.  The remaining counts are misdemeanors. They accuse the clinic of 26 counts of failing to maintain records sometime between 2003 and 2006; of 30 counts of failing to determine the viability of a fetus before late-term abortions performed on various dates in 2003; and of 28 counts of performing illegal late-term abortions on various dates in 2003.  Irigonegaray contends all the misdemeanor charges are based upon information contained in the 23 records that Kline has subpoenaed.

In the Health and Environment Department’s motion to quash, chief legal counsel Yvonne Anderson writes that state law allows identifying information on abortion patients to be released only to the state attorney general and the state Board of Healing Arts — and then only for use in a criminal or disciplinary proceeding.  Anderson pointed out that legislation is pending to change those rules; state Rep. Lance Kinzer, a Republican from Olathe, has introduced a bill that would allow district attorneys to access the records.

Irigonegaray said the records Kline is seeking already have been reviewed by former Kansas Attorney General Paul Morrison. Morrison’s investigation of Planned Parenthood found no evidence of criminal wrongdoing.  However, during a January court hearing on Kline’s criminal complaint, Shawnee County District Judge Richard Anderson raised questions about whether Morrison should have cleared the clinic.  Anderson testified that his review of the abortion records showed that information provided by Planned Parenthood did not “match up” with records from the state agency. . . .

April 14, 2008 | Permalink | Comments (1) | TrackBack (0)

Sunday, April 13, 2008

Drug Companies and their New Disclosures

The Associated Press reports on some new disclosures by pharmaceutical companies concerning gifts and payments made to physicians.  Kevin Freking writes,

For years, the nation's largest drug and medical device manufacturers have courted doctors with consulting fees, free trips to exotic locales and by sponsoring the educational conferences that physicians attend.  Those financial ties don't have to be disclosed in most cases and can lead to arrangements that some say improperly influence medical care.

Now, under the threat of regulation from Congress, the two industries promise to be more forthcoming about their spending. A dozen of the nation's leading drug and device makers have told Sen. Charles Grassley, R-Iowa, that they have plans or are working on plans to publicly disclose grants to outside groups. The details will be provided on each company's Web sites. Watchdog groups say the companies are trying to head off legislation that would require public disclosure of their giving. "If they were doing this out of the goodness of their heart, they would have done so decades ago," said Dr. Peter Lurie of the consumer group Public Citizen.

Of particular interest to Grassley is the money that companies spend on continuing medical education. Physicians go to such conferences to fulfill their license requirements and to keep up to date with the latest treatment trends. Professional associations and companies frequently ask drug and device makers to help pay for the conferences. Recently, Grassley asked 15 companies whether they planned to follow the lead of Eli Lilly & Co., which now discloses its grants to such programs. . . .

The responses are in. They are wide-ranging, but mostly what the senator wanted to hear. Indeed, many of the companies said they would go beyond disclosing grants for medical education. Some companies said they would also disclose payments to patient advocacy groups such as the American Heart Association or the American Diabetes Association. Boston Scientific said it was developing a system that even discloses certain payments to physicians. . . .

If all of the companies follow through with their commitments to Grassley, there also would be widespread disclosure of how much money they give patient advocacy groups. The groups rely on industry for much of their financing. For example, the American Heart Association said donations from the pharmaceutical and device industry make up about 6 percent of its annual income, and totaled $48.3 million in the organization's latest fiscal year. . . .

"Donations from corporations, including the pharmaceutical and device industry, allow us to further enhance our programs and outreach, and to bring objective science and the highest quality of public education and information to more people," said Maggie Francis, the association's communications manager.

Grassley and Sen. Herb Kohl, D-Wis., have introduced legislation that would require drug and device makers to disclose anything of value given to physicians, such as payments, gifts or travel.  The disclosure of medical education grants is an extension of that concept. Last year, the staff for the Senate Finance Committee issued a report that said the drug industry may be using the "medical education industry to deliver favorable messages about off-label uses that the drug companies cannot legally deliver on their own."

The committee report noted that Warner-Lambert, now owned by Pfizer Inc. (PFE), paid $430 million to settle claims that medical conferences it sponsored were used to illegally promote off-label uses of the anti-seizure drug Neurontin. Serono-Laboratories paid $704 million to settle a similar claim concerning the AIDS drug Serostim.

April 13, 2008 | Permalink | Comments (0) | TrackBack (0)

Friday, April 11, 2008

Asian American Health

The Kaiser Family Foundation and the Asian & Pacific Islander American Health Forum have released a study entitled, Health Coverage and Access to Care Among Asian Americans, Native Hawaiians, Pacific Islanders." The study shows health insurance coverage for these individuals across the United States.  The study revealed a wide variation in insurance coverage and corresponding health status.   The study has several helpful charts that present the data clearly.  Ketaki Gokhale of Alternet discusses the findings,

National health care studies often treat Asian Americans as a homogenous, and largely healthy group, but a new study analyzing three years of government-compiled data has revealed substantial pockets of poor health and low insurance levels within the population. Korean Americans, Native Hawaiians and Pacific Islanders clock in with lower levels of insurance than African Americans and whites.

The analysis, conducted by the Kaiser Family Foundation and the Asian & Pacific Islander American Health Forum, found that the proportion of non-elderly Asians who are uninsured varies widely, ranging from 12 percent of Japanese and Asian Indians, 14 percent of Filipinos, to 21 percent of Vietnamese and 24 percent of Native Hawaiians and Pacific Islanders.

Koreans have the highest rates of uninsured -- 31 percent. In comparison, 21 percent of African Americans, and 12 percent of non-elderly non-Hispanic whites are uninsured. Hispanics and American Indians and Alaska natives are two groups that have higher levels of uninsured than Koreans, with 34 and 32 percent uninsured respectively.

"If you look at these groups in the aggregate, Asian Americans tend to do well," says Dr. Cara James, a senior policy analyst with the Race, Ethnicity and Health Care Team at the Kaiser Family Foundation. "They are in good health and don't have as many problems with health coverage."

Over 16 percent of the nation's 13 million Asian Americans and half-million Native Hawaiians and Pacific Islanders are uninsured, giving the group a higher overall rate of insurance than African Americans, Hispanics and American Indians and Alaska natives. But look a little closer, James says, and "you have Koreans doing worse than African Americans, and equal to American Indians and Alaska natives."

The low level of insurance in the Korean American community is not the result of poverty, as one might expect, but rather because most Korean Americans -- around 60 percent -- either own or are employed by small companies that can't afford to provide their workers with health insurance.

Among those Koreans with insurance, only 49 percent have employer-sponsored health coverage. Asian Indians, on the other hand, had the highest rate of employer-sponsored coverage among all the Asian sub-groups, with 77 percent. . . . .

Jang hopes the study will drive the direction of the current presidential debate on health care. "The national debate is focused on health care reform, and if your goal is to achieve health care reform that truly reaches everybody, then you need to think of the Native Hawaiian, Pacific Islander, Korean and Vietnamese American communities -- all of them individually," she explains. "We are hoping that this will show the diversity of our communities."

"If you're going to have employer or employee mandates in your reform proposal, the affordability needs to be there. People in the Korean community would purchase insurance if it was affordable. And, for the Asian American populations that are just above the poverty level and don't qualify, maybe those public programs need to be expanded so they can cover more of the working class poor."

April 11, 2008 | Permalink | Comments (0) | TrackBack (0)

Unbelievable Health Care Stories

Paul Krugman in today's New York Times reports on the health care story that recently made the news, not because it is so tragic, but because Senator Clinton got some facts about the story incorrect.  I have to agree with article - it is sad when the media focuses on whether a story is completely one hundred percent factually correct - when the underlying story is clearly true and clearly shows that our health care system has huge problems.  Paul Krugman writes,

Not long ago, a young Ohio woman named Trina Bachtel, who was having health problems while pregnant, tried to get help at a local clinic.  Unfortunately, she had previously sought care at the same clinic while uninsured and had a large unpaid balance. The clinic wouldn’t see her again unless she paid $100 per visit — which she didn’t have.  Eventually, she sought care at a hospital 30 miles away. By then, however, it was too late. Both she and the baby died. You may think that this was an extreme case, but stories like this are common in America.

Back in 2006, The Wall Street Journal told another such story: that of a young woman named Monique White, who failed to get regular care for lupus because she lacked insurance. Then, one night, “as skin lesions spread over her body and her stomach swelled, she couldn’t sleep.”  The Journal’s report goes on: “Mama, please help me! Please take me to the E.R.,” she howled, according to her mother, Gail Deal. “O.K., let’s go,” Mrs. Deal recalls saying. “No, I can’t,” the daughter replied. “I don’t have insurance.”  She was rushed to the hospital the next day after suffering a seizure — and the hospital spared no expense on her treatment. But it all came too late; she was dead a few months later.

How can such things happen? “I mean, people have access to health care in America,” President Bush once declared. “After all, you just go to an emergency room.” Not quite.  First of all, visits to the emergency room are no substitute for regular care, which can identify and treat health problems before they get acute. . . . Second, uninsured Americans often postpone medical care, even when they know they need it, because of expense.  Finally, while it’s true that hospitals will treat anyone who arrives in an emergency room with an acute problem — and it’s wonderful that they will — it’s also true that hospitals bill patients for emergency-room treatment. And fear of those bills often causes uninsured Americans to hesitate before seeking medical help, even in emergencies, as the Monique White story illustrates. . . . According to a recent estimate by the Urban Institute, the lack of health insurance leads to 27,000 preventable deaths in America each year.

But are they really preventable? Yes. Stories like those of Trina Bachtel and Monique White are common in America, but don’t happen in any other rich country — because every other advanced nation has some form of universal health insurance. We should, too.

All of which makes the media circus of a few days ago truly shameful.  Some readers may already have recognized the story of Trina Bachtel. While campaigning in Ohio, Hillary Clinton was told this story, and she took to repeating it, . . . She used it as an illustration of what’s wrong with American health care and why we need universal coverage.  Then The Washington Post identified Ms. Bachtel, the hospital where she died claimed that the story was false — and the news media went to town, accusing Mrs. Clinton of making stuff up. Instead of being a story about health care, it became a story about the candidate’s supposed problems with the truth.  In fact, Mrs. Clinton was accurately repeating the story as it was told to her — and it turns out that while some of the details were slightly off, the essentials of her story were correct. After all the fuss, The Washington Post eventually conceded that “Bachtel’s medical tragedy began with circumstances very close to the essence” of Mrs. Clinton’s account.

And even more important, Mrs. Clinton was making a valid point about the state of health care in this country. . . .   And if being a progressive means anything, it means believing that we need universal health care, so that terrible stories like those of Monique White, Trina Bachtel and the thousands of other Americans who die each year from lack of insurance become a thing of the past.

April 11, 2008 | Permalink | Comments (1) | TrackBack (0)

Thursday, April 10, 2008

Increase in Child Hospitalization Mistakes

The April edition of the journal Pediatrics reports some distressing news - one in fifteen hospitalized children may experience medical harm resulting from medicine mix-ups, overdoses, and bad drug reactions.  The purpose of the study, "Development, Testing, and Findings of a Pediatric-Focused Trigger Tool to Identify Medication-Related Harm in US Children's Hospitals" was to "to develop a pediatric-focused tool for adverse drug event detection and describe the incidence and characteristics of adverse drug events in children's hospitals identified by this tool."  The authors concluded,

Adverse drug event rates in hospitalized children are substantially higher than previously described. Most adverse drug events resulted in temporary harm, and 22% were classified as preventable. Only 3.7% were identified by using traditional voluntary reporting methods. Our pediatric-focused trigger tool is effective at identifying adverse drug events in inpatient pediatric populations. 

The Boston Globe reports further on the studies findings and conclusion,

The new monitoring method developed for the study is a list of 15 "triggers" on young patients' charts that suggest possible drug-related harm. It includes use of specific antidotes for drug overdoses, suspicious side effects, and certain lab tests.  By contrast, traditional methods include nonspecific patient chart reviews and voluntary error reporting . . . .

Patient safety advocates said the problem is probably bigger than the study suggests because it involved only a review of selected charts. Also, the study did not include general community hospitals, where most US children requiring hospitalization are treated.

April 10, 2008 | Permalink | Comments (0) | TrackBack (0)

Medical Records Privacy - Not so Private for Celebrities in California

I am hoping that people who work in the health field (or people who wear white coats in attempt to resemble a medical professional) in LA are perhaps a little nosier than the rest of the health care workers in America.  It seems that some individuals cannot help but delve into famous people's medical records.  The LA Times reports today on California Governor Schwarzenegger and his wife, Maria Shriver's news that their medical records had been accessed by inappropriate individuals multiple times.  Oops!

Gov. Arnold Schwarzenegger said this morning that the snooping into his wife's medical records by an unauthorized UCLA Medical Center employee follows a long history of such intrusions on California's first couple.  "I have been a victim of this in my own hospital visits," Schwarzenegger said at a news conference to promote volunteerism, "if it was for heart surgery or hip surgery, shoulder surgery, all of those things."  Every time he has left an operating room, the governor said, he has been told there were "people going through your file that had white coats on. Obviously, they snuck into the hospital. They had nothing to do with the hospital staff at all. So those things happen."

Really, "those things happen."  Isn't there some federal law that requires "covered entities" to place medical files where random people wearing white coats cannot get to them?? 

The Times reported in today's paper that California first lady Maria Shriver and 1970s TV icon Farrah Fawcett were among 32 celebrities, politicians and other high-profile patients at UCLA Medical Center whose files were improperly viewed by an employee.  Schwarzenegger reiterated that his administration will push hospitals to implement new safeguards to stop such snooping.

"It is not just UCLA," he said. "This kind of thing has been happening all over the state, wherever there are celebrities involved. . . . Everyone's medical history ought to be protected. That is the responsibility of the hospital. So we are going to work with them and find a way."

April 10, 2008 | Permalink | Comments (0) | TrackBack (0)

Wednesday, April 9, 2008

Plastic Surgeons See Hard Times - Is that Bad?

Apparently the recession has hit plastic surgeons particularly hard.  Slate.com's William Saletan reports,

If your local real estate agent's face is hanging low these days, it might be more than sadness. The recession's latest victim is cosmetic surgery. "Plastic surgeons from the Southland to South Florida said some colleagues are struggling to stay in business," Ricardo Alonso-Zaldivar reports in the Los Angeles Times. A breast implant company disclosed a decline in surgeries late last year; a laser eye-surgery firm has lowered its forecast based on a similar trend early this year. A professional breast augmenter frets that in January and February, business for some of his colleagues was off 30 percent to 40 percent.

Mr. Saletan finds this news to be healthy because it shows that individuals understand the difference between necessary and unnecessary medical care.   He continues,

It's not the suffering that gratifies me. It's the reaffirmation of the distinction between necessary and unnecessary procedures. People have always practiced medicine, albeit clumsily. And they've always adorned themselves, to the point of reshaping their heads and bodies, as the Mayans and Chinese did. (Even the Bush administration has yielded to nipple rings.) But despite the occasional overlap, medicine and body art remained two different things. One aimed at health, the other at beauty. One was necessary, the other elective. If your treatment looked really cool but all the patients died, it was a failure.

Modern cosmetic surgery has challenged that distinction. It has done so not in theory but in practice, by making aesthetic procedures so safe and lucrative that people who would otherwise have devoted their careers to medicine turned instead to cosmetic work. . . .  Two weeks ago, the New York Times reported that last year, among 18 medical specialty fields, the three that attracted med-school seniors with the highest medical-board test scores were the most cosmetically oriented: plastic surgery, dermatology, and otolaryngology. . . .

More effectively than any bioethicist, the recession is reminding people that cosmetic work isn't medicine. "While healthcare spending as a whole has traditionally moved independently of the economy—a safe haven—that really isn't the case with plastic surgery," a financial analyst tells the Times. In the new, sobered economy, the paper reports, some cosmetic doctors are diversifying into "reconstructive surgery for cancer patients and others that is covered by insurance." Insurance!

Say what you will about coverage-denying bean counters, but they do enforce the essential priority of urgent procedures over elective ones. In a health-care industry controlled by tight budgets and insurers, you might even see the cream of the med-school crop shift back to the kind of work that keeps people alive. I hope they're well-paid for it, and I hope the next rising tide lifts millions more families into the ranks of the insured. But let's never forget what the bad times taught us about what matters and what doesn't.

April 9, 2008 | Permalink | Comments (0) | TrackBack (0)

End of Life Costs: Outcomes v. Spending

The Wall Street Journal Health Blog has a great chart reflecting the data presented by the Dartmouth Atlas of Health Care on health care spending in the United States.  The Dartmouth Atlas reviews money spent on Medicare patients across the country.  This information is then compared with outcome data for the same area.  Basically, the Dartmouth Atlas of Health Care tries to show whether money spent on health care equates to better outcomes.  The latest data shows that there does not appear to be a relationship with more money spent and better outcomes.  (This fact is also reflected (although in very different data) in another recent study demonstrating that although the United States spends lots of money on health care (more than many other developed nations), the results have not been a healthier population).  Theo Francis writes,

The latest edition of the Dartmouth Atlas of Health Care is out today, showing that the cost of individual medical services isn’t the big driver of Medicare spending, at least for chronically ill patients in their last two years. It’s the intensity of care, such as the number of specialist visits and days in the ICU, that matters most, the WSJ reports. Sheer availability of services has a lot to do with how much gets spent.

Nearly as notable as the Atlas’ findings–that Medicare could have saved as much as $50 billion over five years if all U.S. hospitals cared for dying, chronically ill patients the way the most efficient facilities do– are its proposals for change.

Ezra Klein breaks down some of the numbers and the perhaps surprising inefficiencies in our health care system.

April 9, 2008 | Permalink | Comments (0) | TrackBack (0)

Tuesday, April 8, 2008

Ranking Law Schools By Student Quality

Brian Leiter has issued a ranking of law schools based on student quality (calculated by LSAT/GPA percentages with some other factors such as class size taken into account).  He provides a discussion of how the rankings were calculated as well as a chart for the top 40 or so schools.

April 8, 2008 | Permalink | Comments (0) | TrackBack (0)

Medicare Future Solvency and Access to Care

AmNews reports on some new numbers for Medicare and its future - it doesn't sound too rosy:

Medicare is facing a long-term financial meltdown, but health policy experts said Congress is not likely in this election year to take the broad actions needed to keep the program sustainable.

Both the physician and hospital portions of the program are in trouble, according to the 2008 Medicare trustees report, released late last month. Part B, of which spending on physician services constitutes about 30%, does not face insolvency because it automatically is funded by general tax revenues and beneficiary premiums.

But it does face rapid growth and will consume an ever-larger portion of the nation's economy, the trustees said. The report predicts that Part B spending will climb from $187 billion this year to $325 billion by 2017, driven in part by the first wave of retiring baby boomers in 2010. . . .

President Bush called for cutting Medicare spending by $12.2 billion in his fiscal 2009 budget plan. Among the proposed reductions were scaling back inpatient hospital care by $4 billion and cutting billions more from other hospitals, home health care, skilled nursing facilities and hospice care . . . .

The trustees report projects that Medicare Part B will increase by an average of 6.2% through 2017. This estimate assumes that scheduled physician pay cuts of about 40% over the next nine years will happen. But the trustees expect Congress again to prevent the reductions from occurring. The first, a 10.6% cut, would take effect July 1.  If lawmakers use the same legislative devices to prevent the cuts that they have since 2003, this would add to program spending. Part B expenditures would grow by an annual average of 8%, much faster than the 4.8% growth expected in the U.S. economy, as measured by the gross domestic product.

But physician organizations warn against cuts in doctors' Medicare payments. "Trying to save Medicare money by slashing physician payments will ruin the physician foundation of Medicare for current and future generations of seniors," said Edward L. Langston, MD, chair of the American Medical Association Board of Trustees.   An AMA survey found that 60% of physicians say this year's cut alone would force them to limit the number of new Medicare patients they can treat, Dr. Langston noted. "Couple this fact with a physician shortage and the huge influx of baby boomers soon to enter Medicare, and the outlook for Medicare patients' access to care is grim.". . . .

April 8, 2008 | Permalink | Comments (0) | TrackBack (0)

Monday, April 7, 2008

Schools Focus On Obesity and Show Positive Results

The Associated Press reports on a successful strategy employed by the Philadelphia School District to reduce childhood obesity.  Stephanie Nano of the AP describes the successful plan, 

Five Philadelphia elementary schools replaced sodas with fruit juice. They scaled back snacks and banished candy. They handed out raffle tickets for wise food choices. They spent hours teaching kids, their parents and teachers about good nutrition.  What have they got to show for it?  The number of kids who got fat during the two-year experiment was half the number of kids who got fat in schools that didn't make those efforts.

"It's a really dramatic effect from a public health point of view. That's the good news," said Gary Foster, director of the Center for Obesity Research and Education at Temple University. He is also the lead author of the Philadelphia schools study being published Monday in the April issue of Pediatrics.  The bad news: There were still plenty of new overweight kids in the five schools - over 7 percent of them became overweight compared to the 15 percent in the schools that didn't make changes.  "That signals to me that we have lots more work to do," said Foster.

Schools are ideal settings for programs that target childhood obesity, the researchers noted. Children spend long hours each day at schools and eat lunch and often breakfast at school. But school-based programs have had mixed results. . . .

For the study, changes were made to the food in vending machines or the cafeteria in five of the schools. Juice, water and low-fat milk replaced sodas. Snacks had to meet limits for fat, salt and sugar. Students who ate healthy snacks got raffle tickets to win prizes such as bikes and jump ropes.  "We found when you give children healthy choices, they pick them," said Grace McGinley, school nurse at Francis Hopkinson School, one of the test schools.

Staff and students had lessons on good nutrition. The message was reinforced in other subjects: food labels were used to help teach fractions. And parents were also enlisted: a fundraiser successfully substituted fruit salad for baked goods, said another of the researchers, Sandy Sherman, the Food Trust's director of nutrition education.  She said the children were also urged to exercise at activity stations during recess. They were measured and weighed periodically and surveyed about food and exercise.

After two years, besides fewer new overweight children, the overall number of overweight students at the five schools dropped about 10 percent to 15 percent. At the no-change schools, the number of overweight children rose a quarter to 20 percent.  There was no difference between school groups in new obese students (6 percent) or the overall number of obese (about 25 percent). Obese children probably benefit more from individually targeted efforts, Foster said. . . . .

April 7, 2008 | Permalink | Comments (0) | TrackBack (0)

Abortion Search on Popline Unblocked . . . .

The New York Times on Saturday reported on the controversy surrounding the government's decision to designate abortion as an "ignored" term when searching the database, Popline.  The decision was reversed by Johns Hopkins University.  Robert Pear of the Times reports,

Johns Hopkins University said Friday that it had programmed its computers to ignore the word “abortion” in searches of a large, publicly financed database of information on reproductive health after federal officials raised questions about two articles in the database. The dean of the Public Health School lifted the restrictions after learning of them.  A spokesman for the school, Timothy M. Parsons, said the restrictions were enforced starting in February.  Johns Hopkins manages the population database known as Popline with money from the Agency for International Development.

Popline is the world’s largest database on reproductive health, with more than 360,000 records and articles on family planning, fertility and sexually transmitted diseases.  Mr. Parsons said the development agency had expressed concern after finding “two articles about abortion advocacy” in the database. The articles, he said, did not fit database criteria and were removed.  Employees who manage the database instructed their computers to ignore the word “abortion” as a search term.

After learning of the restrictions on Friday, the dean, Dr. Michael J. Klag, said: “I could not disagree more strongly with this decision, and I have directed that the Popline administrators restore ‘abortion’ as a search term immediately. I will also launch an inquiry to determine why this change occurred.”  . . . . Dr. Klag said the school was “dedicated to the advancement and dissemination of knowledge, and not its restriction.” . . . .

Librarians at the Medical Center of the University of California, San Francisco, expressed concern about the restrictions this week after they had difficulty retrieving articles from Popline.  In an e-mail response on Tuesday, Johns Hopkins told the librarians that “abortion” was no longer a valid search term.  “We recently made all abortion terms stop words,” Debra L. Dickson, a Popline manager, wrote. “As a federally funded project, we decided this was best for now.”  Ms. Dickson suggested that instead of using “abortion,” librarians could use other terms like “fertility control, postconception” or “pregnancy, unwanted.”  Gail L. Sorrough, director of medical library services at the medical center in San Francisco, said it was absurd to restrict searches using “a perfectly good noun such as ‘abortion.’ ”

Under the rule, Popline ignored the word “abortion,” just as it ignores terms like “a” and “the.” Ms. Sorrough and a colleague, Gloria Won, reported their experience on an electronic mailing list, and librarians protested the restrictions.  . . . .

Women's Health News has more about this controversy here and here.

April 7, 2008 | Permalink | Comments (0) | TrackBack (0)