HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

A Member of the Law Professor Blogs Network

Friday, August 26, 2005

Doctors vs. Managed Care

Law.com provides an overview of doctor RICO suits currently filed against managed care companies.  It should be interesting to see if this type of suit gains popularity.  According to the article,

Ear, nose and throat doctor Michael Abidin was frustrated. Once again, an insurance company had stiffed him on a claim. Weeks before, the Alexandria, Va., physician had examined a female patient complaining of a hoarse throat. Abidin reviewed her family medical history looking for relatives with throat cancer. Then he slowly threaded a scope through her nose and down her throat for an examination.

Afterward, his office submitted a $205 claim to United Health Care Group Inc. to cover his evaluation and the laryngoscopy. United chose only to pay for the laryngoscopy, which cost $122.69.

The doctor was accustomed to this treatment. During the early months of 2000, Abidin says, insurers had refused to pay for exams before procedures 15 times, maybe more -- he was losing count. Why were insurers rejecting claims for standard medical practices and procedures?

At about the same time, in Birmingham, Joe Whatley Jr. believed he had solved the mystery, which was not limited to Abidin's experience. In his view, insurers were routinely denying claims in order to improve their financial performance. Since 1990, he estimated, managed care companies had saved at least $10 billion by shortchanging doctors. So, with fellow Birmingham lawyer Archie Lamb Jr. and Decatur, Ala., lawyer Nicholas Roth, among others, he filed a class action on behalf of 950,000 physicians, including Abidin.

The insurers, according to the suit, swindled the doctors by systematically and fraudulently cutting their bills. Health plans rely on software to process hundreds of millions of claims a year. Each claim carries some combination of 8,000 five-digit codes to describe individual procedures. Ten leading managed care companies, the lawsuit says, rigged this software to automatically ignore some codes and change others to reflect less costly procedures. They then counted on doctors' offices being too overwhelmed or perplexed to appeal. (Not so Abidin. The doctor did appeal -- twice -- before United Health paid him for the throat exam.)

The insurers insist that they properly handled the vast majority of claims. They say that when they make changes in claims, it is generally because the form was filled out incorrectly or because doctors are padding their bills. In a survey reported in the Journal of the American Medical Association in 2000, 39 percent of physicians admitted that they exaggerated the severity of patients' conditions, made up symptoms or altered diagnoses on claims. Insurers have invested hundreds of millions of dollars in automation to catch these problems, says Jeffrey Klein of New York's Weil, Gotshal & Manges, a spokesman for the defendants in the case. "The industry's reimbursement speed rivals or exceeds the vendor payments of virtually any other industry," Klein says.

[bm]



August 26, 2005 | Permalink | TrackBack (0)

Duty to Aid

As all of us know from our torts classes, an individual does not have a duty to aid another in most instances.  Recently, however, in Sklarksy v. New Hope Gild Center, 12923/01, a court held that an exception to that rule exists, finding that husband had a duty to provide medical assistance to his wife, whose mental illness left her in a "diminished, incapacitated and helpless state."  According to law.com,

Plaintiff Alexander Skylarsky, a public-library janitor, initiated a psychiatric-malpractice claim against New Hope Guild Center for Emotionally Disturbed Children and three of its physicians. He alleged among other things that on the evening preceding Sofia Skylarsky's death, he called Dr. Marina Galea and told her that his wife was "running around frantically and speaking nonsense," and that he had found a suicide note. Dr. Galea declined to meet with Ms. Skylarsky because she did not have a scheduled appointment, Mr. Skylarsky testified.

The defense counterclaimed, contending that Mr. Skylarsky was negligent for failing to provide medical aid to his wife by refusing either to call emergency medical services or to take her to an emergency room as instructed by the defendant doctors.

On the night of June 5, 2000, after three days of rapid deterioration in his wife's mental state, Mr. Skylarsky decided he would take her to the hospital the following morning, he said. However, Ms. Skylarsky apparently jumped to her death in the middle of the night.

At issue in the present motion was whether Mr. Skylarsky neglected a legal duty to come to his wife's aid. . . .


Last week, a jury found in favor of the defense and dismissed Mr. Skylarsky's action. Nonetheless, under the terms of a "high-low" agreement, Mr. Skylarsky received a settlement totaling $325,000.

Though the jury did not award any damages, it found Mr. Skylarsky 30 percent liable for his wife's death. Had there been an award, Mr. Skylarsky would have had to pay himself (as administrator of his wife's estate).

The judge's decision will not be appealed, as both sides stipulated in the high-low agreement to forego any appeals. "If it would have been appealed, it wouldn't have been upheld. It would have opened up a whole new area of litigation," said Mr. Skylarsky's attorney, Eliot Wolf of Long Island-based Wolf & Fuhrman.

[bm]

August 26, 2005 | Permalink | TrackBack (0)

Drug Companies and Fraud

If the Merck Vioxx case where not sufficient to have drug companies worried, the New York Times reports today that California has sued 39 drug companies for price gouging. 

The attorney general of California sued 39 drug companies on Thursday, accusing them of bilking the state of hundreds of millions of dollars by overcharging for medicines.

Attorney General Bill Lockyer charged that the drug makers, including some of the world's leading pharmaceutical concerns, defrauded the state's Medi-Cal system for at least the past decade. Mr. Lockyer said the drug manufacturers charged Medi-Cal as much as 10 times the price for some drugs as they charged others, like private pharmacies and hospitals.

Medi-Cal is the state's version of the federal Medicaid program for the poor, which is jointly financed by the states and the federal government. Drug costs account for about $4 billion of Medi-Cal's $34 billion annual budget.

"We're dragging these drug companies into the court of law because they're gouging the public on basic life necessities," Mr. Lockyer said at a news conference here. "This scheme has cost California taxpayers potentially hundreds of millions of dollars and is jeopardizing the public health by diverting money away from patient care."

Mr. Lockyer said that each of the companies made as much as $40 million a year in illegal profits. He said he hoped to recover that amount plus the triple damages allowed under the state's false claims act.

Thursday's legal filing amends a 2003 suit against two drug companies, Abbott Laboratories and Wyeth Pharmaceuticals, to add about three dozen new defendants, including Amgen, Baxter Healthcare, Bristol-Myers Squibb, GlaxoSmithKline, Mylan Laboratories, Novartis and Schering-Plough. It was immediately consolidated in federal court in Boston with similar litigation filed by more than 10 other states and localities, including New York, Texas, Florida and Illinois.

[bm]

August 26, 2005 | Permalink | TrackBack (0)

Thursday, August 25, 2005

Reality TV Meets Sperm Donors

In case you thought that reality television could not get any more bizarre or troubling - along comes a new potential series.  This new series is to be entitled, "I want your baby . . . and nothing else!" and in case you hadn't guessed concerns  a woman looking for a potential sperm donor to help her concieve a child.  Sounds lovely!  According to Reuters, the producer who bought you such delightful tv viewing as "Big Brother" will broadcast a preview this weekend to see if there is an audience for such a show.  Reuter reports,

"The plan is that we visit potential donors and -- of course on camera -- decide which man is most suitable," the 30-year old woman who will feature in the program said in an interview with De Telegraaf newspaper.

"Afterwards there will be artificial insemination," said the woman who was identified only as "Yessica" and who has bought a house with a room for a child.

Unfortunately, it appears that the preview show will be available in Europe and not here in the United States (at least not immediately).  I hope that you are not all too disappointed.  [bm]

August 25, 2005 | Permalink | TrackBack (0)

Third Year of Law School

Students have complained for some time that the third year of law school is unnecessary and that they are ready to go out and practice after two years.  Well, someone heard them.  The University of Dayton is offering a two-year law degree.  I am not sure if this will catch on but I thought some of you would find it of interest.  From the University's Press Release,

Julius Carter enrolled at the University of Dayton's School of Law this fall because ''it offered a way for me to become a lawyer quicker."

The 42-year-old former computer analyst is part of the first class at the School of Law with the option to graduate in five semesters, instead of the traditional six. The University of Dayton is the first in the country to take advantage of new American Bar Association rules that allow students who start classes in the summer to finish their law degrees in two years.

The accelerated curriculum has attracted national media attention and helped to trigger the highest application volume in a dozen years and the best entering test scores since 1994. The School of Law received 2,116 applications--a 13.7 percent surge over last year. Nationally, law school applications are down 1.4 percent, according to the Law School Admission Council.

''The five-semester option was a big draw,'' said Carter, father of four from Trotwood, Ohio.

Lisa Kloppenberg, dean of the School of Law, says the revamped curriculum is targeted to mid-level professionals like Carter and ''the millennial generation that likes to multi-task and move quickly. These highly motivated students want to graduate earlier and begin earning faster. They can save a year of living expenses while completing the same law school curriculum requirements.

''We think other law schools will soon follow suit and give students the opportunity to eliminate the third year of law school," said Kloppenberg, who's been interviewed by the Associated Press, CNN Radio, National Public Radio, Bloomberg, Fox News and the nation's legal press, among other media outlets.

[bm]

August 25, 2005 | Permalink | TrackBack (0)

Wednesday, August 24, 2005

Obesity Data from Public Health Organization

The Trust for American's Health released information on our increasingly obese nation yesterday, concluding that nearly 25% of the population is obese.  The group also provides data concerning which states have more problems with obesitiy than others based on data from the Centers for Disease Control and Prevention.  The New York Times reports on the group's latest findings and states,

Mississippi is the nation's most overweight state, Colorado is the least, and the Southeastern states generally have more heft than the rest of the country, according to a report released yesterday by a public health advocacy group. Obesity rates have continued to rise steadily across the nation, with the lone exception of Oregon, where they remained steady, the report by the group, the Trust for America's Health, said.

State and federal policies have done little to change that trend, the report said.

About 24.5 percent of American adults are obese, the report said, and in 12 states more than a quarter of all adults are obese, Mississippi, Alabama, West Virginia, Louisiana, Tennessee, Arkansas, Texas, Michigan, Kentucky, Indiana, Ohio and South Carolina.

The states with the smallest percentage of obese adults are Colorado, Massachusetts, Rhode Island, Connecticut, Vermont and Montana. (One state, Hawaii, was not ranked.)

The rankings are based on public data from 2004 released earlier this year by the federal Centers for Disease Control and Prevention. The information comes from telephone surveys by state health departments asking residents about health-related behavior like smoking, alcohol consumption and weight.

[bm]

August 24, 2005 | Permalink | TrackBack (0)

Fetus and Pain Sensation

Just in time for the return of Congress and its interest in a federal law concerning information that women must be told about the fetus and feeling pain (not to mention the Supreme Court's Fall term, which includes two abortion cases) scientists have released a study showing that the fetus before 29 weeks cannot feel pain. The New York Times reports on the study, which has been released in the Journal of the American Medical Assocation.  The Times reports,

Taking on one of the most highly charged questions in the abortion debate, a team of doctors has concluded that fetuses probably cannot feel pain in the first six months of gestation and therefore do not need anesthesia during abortions.

Their report, being published today in The Journal of the American Medical Association, is based on a review of several hundred scientific papers, and it says that nerve connections in the brain are unlikely to have developed enough for the fetus to feel pain before 29 weeks.

The finding poses a direct challenge to proposed federal and state laws that would compel doctors to tell women having abortions at 20 weeks or later that their fetuses can feel pain and to offer them anesthesia specifically for the fetus.

About 1.3 million abortions a year are performed in the United States, 1.4 percent of them at 21 weeks or later.

Bills requiring that women be warned about fetal pain have been introduced in the House and Senate and in 19 states, and recently passed in Georgia, Arkansas and Minnesota. The bills are supported by many anti-abortion groups. But advocates for abortion rights say the real purpose of the measures is to discourage women from seeking abortions. It is too soon to tell what effect the new laws are having in abortion clinics.

The finding was considered persuasive by many scientists but is unlikely to settle the controversy. Most scientists agree that fetuses probably do not feel pain in the first trimester, but there remains wide disagreement over when, in later pregnancy, the fetal brain is sufficiently developed for pain to register. Some think that, with the current state of knowledge, it is impossible to know for sure. In Britain, the Royal College of Obstetricians and Gynecologists has said that fetuses probably do not feel pain before 26 weeks, which is into the third trimester.

[bm]

August 24, 2005 | Permalink | TrackBack (0)

New Regulations on ACNE Medication

Thanks to Dr. Douglas Mossmass for this excellent post:

Isotreninoin (brand name AccutaneTM) is an oral medication used for treating severe acne that does not respond to any other acne treatments, including antibiotics. Because of an extremely high risk of birth defects, women users of isotreninoin have for years been required to have two negative pregnancy tests and to commit themselves to using two simultaneous forms of birth control before starting to take the medication. Prescribers have had to participate in the "System to Manage Accutane Related Teratogenicity (S.M.A.R.T.TM). This program includes reading a booklet, signing a letter of understanding concerning the practitioner’s ability to diagnose acne and address risks associated with pregnancy, and affixing a yellow sticker to each prescription.

In addition to pregnancy-associated risks, isotretinoin may cause depression, psychosis, or suicidal ideation. The Food and Drug Administration (FDA) has been assessing reports of suicide or suicide attempts associated with use of this drug, and has recommended that all patients receiving isotretinoin be observed closely for symptoms of depression or suicidal thoughts.

On August 12, the FDA notified healthcare professionals and patients about a strengthened risk management program for isotretinoin called "iPLEDGE." iPLEDGE will require registration of wholesalers, prescribers, pharmacies and patients who agree to accept specific responsibilities for minimizing pregnancy exposures if they wish to distribute, prescribe, dispense, or use isotretinoin. The FDA also has approved changes to the existing warnings, patient information, and informed consent documentation so that patients and prescribers can better identify and address potential psychiatric problems before and after prescribing isotretinoin. The new patient information sheet appears here:

http://www.fda.gov/cder/drug/InfoSheets/patient/IsotretinoinPT.htm

August 22 was the first date on which doctors, patients, and pharmacies could obtain information and register with iPLEDGE via the internet, at https://www.ipledgeprogram.com.

After October 31, 2005, wholesalers and pharmacies will have to register with iPLEDGE to obtain isotretinoin from a manufacturer.

Starting December 31, 2005, all patients must be registered and activated by their doctors in iPLEDGE to get isotretinoin. Only prescriptions from iPLEDGE doctors will be filled by iPLEDGE pharmacies. Patients must sign the Patient Information/ Informed Consent form and must adhere to all the instructions in the iPLEDGE program. For women who can become pregnant, this includes using two effective birth control methods simultaneously and entering these methods of birth control each month into the iPLEDGE system by telephone or the internet. Women will also need to have negative pregnancy tests before each isotretinoin refill.

[bm]

August 24, 2005 | Permalink | TrackBack (0)

Aspirin Withdrawal

Thanks to Professor Douglas Mossman for this article from medscape.  He points us to a recent study that has been published in the Archives of Neurology that highlights the importance of aspirin therapy for those who are at risk for stroke.  The study shows that withdrawing aspirin significantly increases the risk of stroke.

"Aspirin, or acetylsalicylic acid, is widely used to prevent ischemic vascular disease," write Alexandre Balzano Maulaz, MD, from Centre Hospitalier Universitaire Vaudois in Lausanne, Switzerland, and colleagues. "Clinical and experimental data suggest that a rebound effect occurs four or fewer weeks after interruption of aspirin therapy."

Cases consisted of 309 patients with ischemic stroke (IS) or transient ischemic attack (TIA) undergoing long-term aspirin treatment before their index event, and 309 control subjects who had not had an IS in the previous six months were matched for age, sex, and antiplatelet therapy. The investigators compared the frequency of aspirin therapy discontinuation during the four weeks before a cerebral ischemic event in patients and during the four weeks before interview in control subjects.

Both groups had a similar frequency of risk factors, except for coronary heart disease (CHD), which was more prevalent in IS or TIA patients (36% vs 18%; P < .001). Thirteen IS or TIA patients and four control subjects had discontinued aspirin. After adjustment in a multivariable model, aspirin interruption yielded an odds ratio for IS or TIA of 3.4 (95% confidence interval, 1.08 - 10.63; P < .005).

"These results highlight the importance of aspirin therapy compliance and give an estimate of the risk associated with the discontinuation of aspirin therapy in patients at risk for IS, particularly those with coronary heart disease," the authors write.

[bm]

August 24, 2005 | Permalink | TrackBack (0)

"Parents Barred From Teen Health Files"

That's the title of an article in today's Wall Street Journal (link good for 7 days).  Here's the essence of the piece:

Using her health plan's Web site, Ursula Scott of Seattle can view the medical records of her 2- and 5-year-old daughters, check their immunization schedules, look up test results, exchange email with a pediatrician, and make appointments for the next office visit.

But when it comes to her 16-year-old stepson, no one in the family can gain access to any aspect of his electronic medical records -- including the teen himself.

In the long-running effort to balance the rights of parents and adolescents in making decisions about medical care, technology has opened up a thicket of new legal and technical issues. The result is that teens are being left out of one of the most important advances in the administration of health care today.

A growing number of health plans, hospitals and doctor's offices are making the switch to electronic medical-record systems, in response to the Bush administration's push to make online records available to all Americans within the next decade. Such systems, like the one run by Group Health Cooperative of Seattle, which covers the Scott family, offer more than just convenience. They hold the promise of faster sharing of vital medical information, reduction of medical errors and more control for consumers over their care.

But with teens, these efforts risk running afoul of a complex patchwork of federal and state laws that allow adolescents to seek confidential family-planning and mental-health services without their parents' consent. Such laws make certain aspects of teens' health records off-limits to parents. However, electronic medical-records systems don't yet have a foolproof way to flag confidential material and hide it from parents -- something that can more easily be done with paper records. And as minors, teens can't on their own enter into the security agreements required to grant access to their online records.

Until providers can figure out how to give parents access to basic health-care information for a child, without breaking confidentiality or access rules, many are leaving adolescents out of new electronic medical-records systems altogether -- and revoking parental access to children's records as soon as they turn 13.

In a sentence, "At Dallas Children's Hospital, Chief Medical Information Officer Joseph Schneider, sums up the issue: 'Teens enter into this limbo land, where we can hide information from their parents, but we can't necessarily share it with them.'"

The article has a lot of useful material, including these links for more detailed information about adolescents' access to sensitive health care information:

Pjaf784_pjinformedjp08232005202428

(click on image to enlarge)

[tm]

August 24, 2005 | Permalink | TrackBack (1)

Tuesday, August 23, 2005

"Bitter Pill": Analysis of News Media's Coverage of So-Called Wonder Drugs

Trudy Lieberman has written an extremely interesting article, "Bitter Pill," for the Columbia Journalism Review, concerning today's phenomenon of a drug moving almost instantaneously from medical research to miracle cure through news media.  She comments that the news media often seem more interested in the "hype and hope" than in critically appraising new drugs on behalf of the public.  She says this problem has increased significantly due to the dramatic increase in direct-to-consumer advertising, which delivers higher ad revenues to media outlets.  Lieberman opines that the press too often is caught up in the same drug-industry marketing web that also ensnares doctors, academic researchers, even the FDA, leaving the public without a reliable watchdog. 

She illustrates this phenomenon with the example of Lunesta, a new sleeping pill.  Lieberman writes that Sepracor's CEO, Timothy Barberich, told analysts that insomnia is "one of the most prevalent and growing medical needs in our society," describing insomnia as under-recognized and under-treated.  They then began selling their drug Lunesta to the public with the help of the press.  Sepracor facilitated this media treatment by offering journalists sources to call, including those with financial links to Sepracor.  Liberman also points to the National Sleep Foundation's annual poll to promote National Sleep Awareness Week.  This year the poll got a substantial amount of news coverage, with at least 24 stories, while Sepracor was dispatching 1,250 sales reps to physician's offices to educate them about Lunesta, part of a $60 million marketing push. 

Dr. Marcia Angell, former editor-in-chief of The New England Journal of Medicine, says that "the public is being allowed to believe that drugs are safer and more effective than they really are... Journalists, as well as the public and physicians, have bought hook, line, and sinker the idea that these drugs are getting better."   Through her research published in the book, The Truth About the Drug Companies, she found that of the 415 drugs approved between 1998 and 2000, only 14% were truly innovative, 9% were drugs that had been modified in some way, and 77% were copies of medicines already on the market.   She says that the news media has been ignoring the middle ground between the pharmaceutical industry covered in the business pages or consumer health reporting in the health sections.   She urges that more attention be paid to the area of corporate marketing and sponsored scientific research that connects the bottom line to the latest "breakthrough."   The article also discusses the coverage of Vioxx and other cox 2 pain relievers, and how poorly the public was served by medical coverage of this "super aspirin." My research assistant, Lindley Bain, provided invaluable help with this post.  [tm]

August 23, 2005 | Permalink | TrackBack (0)

Study Shows Wide Variance in Hospitals Failing to Deliver Essential LifeSaving Treatments

According to data recently gathered by the federal government, doctors and hospitals fail with alarming frequency to deliver essential lifesaving treatments for some of the most common causes of death, including heart attack, pneumonia, and heart failure, according to an article in the N.Y. Times.   Even though the treatments are not controversial or complicated, they have been very difficult to deliver reliably in the complex setting of the hospital.   The article points out that there is a 30 percent increase in the survival rate for patients who take aspirin in the first 24 hours after a hear attack, and yet hospitals neglected to give aspirin to more than 12,000 people, 1 of every 16 heart attack victims, in the first half of 2004.  One in eight patients who should have received beta blockers did not. 

Some hospitals claim this is a failure of documenting the treatment, and not that patients did not receive treatment.  However, the American Hospital Association says that "[i]f the medications and tests are delivered and there's no documentation, that itself is a quality problem."   This new report comes from the program Hospital Compare, in which 3,500 hospitals participate in exchange for a bonus in Medicare payments.  In the state-by-state comparisons contained in the report card issued by Hospital Compare, Massachusetts led the states in basic heart attack care, delivering the appropriate therapy 97 percent of the time.  Arkansas was last with 85 percent compliance.  The hospital-level comparisons showed even greater variance in compliance with some at 100 percent and others at 50 percent. 

Jean Rico, St. Vincent Medical Center's VP for quality services, says, "Physicians are much more willing to change their practice patterns now. . . . They know that more and more outcomes of care are being publicly reported."  St. Vincent delivered the appropriate care 64 percent of the time.   Dr. Ashish Jha of the Harvard School of Public Health says that "there hasn't been a clear incentive for them to put processes into place to make sure these treatments are given consistently. . . .  [W]e haven't known what's been going on in hospitals, until now."   See the twin studies on hospitals' performance in the New England Journal of Medicine. 

My research assistant Lindley Bain provided invaluable assistance with this post. [tm]

August 23, 2005 | Permalink | TrackBack (0)

Health Law & Lobbying Hit All-time High

Whatever else you can say about the Medicare drug benefit legislation and the mountains of interpretations it has spawned -- and you could say a lot -- one effect of the law, which doesn't actually kick in until next year, is that it has generated a lot of employment for health care lobbyists and lawyers.  According to an article by Robert Pear in today's N.Y. Times, lobbying work in the health care sector now leads all other industries, including defense:

Last year alone, the health care industry spent $325 million - more than any other sector - in its efforts to influence Congress and federal agencies, according to Political Money Line, a nonpartisan group that studies reports filed with Congress by lobbyists and their clients.

Drug companies led the way. They reported spending $86.9 million on lobbying last year, followed by hospitals with $55 million and doctors with $35.4 million.

And health lawyers aren't far behind the gravy train:

As the costs of Medicare and Medicaid soar, federal prosecutors and members of Congress are investigating fraud and abuse with new zeal. Many health care companies find they need more lawyers and lobbyists to cope.

In a recent advertisement recruiting lawyers for its Washington office, Sidley Austin Brown & Wood, one of the nation's largest law firms, said its health care practice had "experienced tremendous growth."

[tm]

August 23, 2005 | Permalink | TrackBack (0)

Monday, August 22, 2005

Impact of Free Samples

Dr. Doug Mossman points out an interesting article on Medscape.  It discusses a recent study in the American Journal of Medicine demonstrating that free samples do have an impact on a resident physician's prescribing practices.  According to the article,

Access to drug samples may influence resident physician prescribing, potentially increasing patients' costs, according to the results of a randomized trial reported in the July 28 issue of the American Journal of Medicine.

"There are few objective data describing how drug samples affect resident physicians," write Richard F. Adair, MD, and Leah R. Holmgren, MD, from the University of Minnesota and Abbott Northwestern Hospital in Minneapolis. "This is an important information gap, because drug samples are widely available in residents' clinics, and making treatment decisions based on which samples are available could affect both resident education and patient care. Although samples may provide short-term economic benefit for some patients, their primary purpose is to market new and expensive drugs."

During a six-month period in an inner-city primary care clinic, the authors observed 390 decisions by 29 internal medicine residents to begin drug therapy for patients. The residents were randomized either to not use available free drug samples or to use them at their discretion. Five drug-class pairs were chosen for study prospectively, with highly advertised drugs matched with drugs commonly used for the same indication but in less-expensive, over-the-counter (OTC), or generic formulations.

Compared with residents without access to drug samples, those with access to samples were less likely to choose unadvertised drugs (131 of 202 decisions vs 138 of 188 decisions; P = .04) and less likely to choose OTC drugs (51 of 202 vs 73 of 188; P = .003). There was also a nonsignificant trend toward less use of inexpensive drugs.

"Access to drug samples in clinic influences resident prescribing decisions," the authors write. "This could affect resident education and increase drug costs for patients."

[bm]



August 22, 2005 | Permalink | TrackBack (0)

Embryonic Stem Cells *Almost* Derived From Skin Cells

All the papers and news services are reporting this morning on an article due out later this week in the journal Science but posted to their website Sunday (see AP/Yahoo, Boston Globe, Washington Post).  According the news reports, the article describes the results achieved by researchers at the Harvard Stem Cell Institute when they fused adult skin cells with embryonic stem cells: the fused skin cells were "reprogrammed to their embryonic state."  The Institute's announcement reads:

A new study by Kevin Eggan, Douglas Melton, and colleagues offers hope that it might be possible in the future to produce embryonic stem cells without using human embryos. The Harvard Stem Cell Institute researchers will report in the Aug. 26 edition of the journal Science that it may be possible by fusing two cells together to some day produce cells with the properties of embryonic stem. The researchers caution, however, that many daunting challenges must still be overcome and the promise of their work should not be seen as a reason to slow present research efforts.

Current stem cell research has generated controversy because it involves the destruction of human embryos, or it requires women to donate unfertilized eggs. In therapeutic cloning, a nucleus from an adult cell (for instance, a skin cell) is injected into unfertilized egg whose own genetic material has been removed. The egg reprograms the skin cell nucleus to an embryonic state, allowing it to initiate the development of an early embryo without the need for fertilization. As researchers in Korea have recently shown, the resulting embryos can be used to make embryonic stem cells that are genetically identical to the skin cell donor. But that method is technically difficult, involves the use of embryos, and because it requires donated human eggs, it is unlikely that it could ever be scaled up for widespread clinical use.

The HSCI researchers have taken a quite different approach, fusing an entire skin cell to an existing embryonic stem cell. The result is a hybrid cell with two sets of genetic material, one from each parent. Using sophisticated 'DNA chip' technology, the Harvard team was able to show that cell fusion causes thousands of genes from the skin cell to be reprogrammed to an embryonic state. Even more striking, they found that the fused hybrids retain many of the properties of embryonic stem cells, including the ability to differentiate into multiple adult cells types.

This is an important result because it suggests that adult cells could some day be converted into embryonic stem cells without using human eggs and without creating cloned human embryos. But if this kind of reprogramming is really possible, it is likely to take many years and many further studies, on embryos as well as hybrid cells, before this technique offers an alternative method of producing stem cells.

The significant policy issue here is that, if the scientists can actually produce a totipotent embryonic stem cell, a plentiful source of new stem cells will have been created without the destruction of any embryos, a major limitation on federal funding rules announced by President Bush in August 2001.  And once the DNA of the fused stem cell can be stripped away, the resulting embryonic stem cell will be a genetic copy of the skin-cell donor without first creating a clone of the donor, bypassing yet another ethical obstacle to workable stem-cell therapies.  [tm]

August 22, 2005 | Permalink | TrackBack (0)

Chocolate: The New Health Food

Rumors that chocolate might actually be good for you have been circulating for quite some time.  Mars, Inc., the large chocolate manufacture, has been following up on some of the recent studies showing the health benefits of chocolate for blood vessels.  According to CNN.com

Flavanols are found in other foods, such as red wine, grapes, apples and green tea, although cocoa beans are a particularly rich source.

Mars Inc. developed the technology to visualize flavanols on a computer screen. Says Harold Schmitz, the company's chief science officer: "Now we understand cocoa well enough to start to do new things with it."

The company is starting with CocoaVia granola bars, made with a special cocoa powder that retains most of the flavanols. The bars also have plant sterols, which have been shown to help lower cholesterol.

For now, the 80-calorie, 23-gram snack bars are sold only on the Internet. The bars have a satisfyingly rich chocolate flavor, along with a slight but distinct bitter taste.

Researchers are excited by the potential of flavanols to ward off vascular disease, which can cause heart attacks, strokes, diabetes, dementia and hypertension. Vascular diseases are linked to the artery's inability to make a simple but fundamental chemical called nitric oxide. Flavanols appear to reverse that problem.

"The pharmaceutical industry has spent tens, probably hundreds of millions of dollars in search of a chemical that would reverse that abnormality," Hollenberg said. "And God gave us flavanol-rich cocoa, which does that. So the excitement is real."

Now, if only my health insurance plan would pay for my chocolate habit . . . . [bm]

August 22, 2005 | Permalink | TrackBack (0)

Sunday, August 21, 2005

Pedophiles and Star Trek

Rather surprising article on the Huffington Post concerning a characteristic that many pedophiles share - a love of star trek.  It states,

The LA Times recently ran a story about the Child Exploitation Section of the Toronto Sex Crimes Unit, which contained a mind-boggling statistic: of the more than 100 offenders the unit has arrested over the last four years, "all but one" has been "a hard-core Trekkie." Blogger Ernest Miller thought this claim was improbable. "I could go to a science fiction convention," he explained "and be less likely to find that 99+ percent of the attendees were hard-core Trekkies." While there may be quibbling about the exact numbers, the Toronto detectives claim that the connection is undeniable.

In fact,Star Trek paraphernalia has so routinely been found at the homes of the pedophiles they've arrested that it has become a gruesome joke in the squad room. (On the wall, there is a Star Trek poster with the detectives' faces replacing those of the crew members). This does not mean that watching Star Trek makes you a pedophile. It does mean that if you're a pedophile, odds are you've watched a lot of Star Trek.

This is not the first time Star Trek has been linked to bizarre sexual practices. Those involved in the Heaven's Gate mass suicides in Rancho Sante Fe in March 1997 also purported themselves to be avid Star Trek fans. One may recall that the cult forced its members to wear unisex clothing, had a strict policy of celibacy, a ban on all sexual thoughts, and eight of the members had surgically castrated themselves.

So why would sexual deviants be attracted to Star Trek? The link between Star Trek and pedophilia is obscure, even to the detectives in the sex crimes unit: "It has something to do with a fantasy world where mutants and monsters have power and where the usual rules don't apply," Det. Constable Warren Bulmer told the LAT. "But beyond that I can't really explain it." Explain it or not, one thing is clear: the detectives identify the pedophiles with the mutants and monsters and themselves with the crew of the Enterprise. But, in fact, the detectives probably have more in common with the pedophiles than they think, because the pedophiles, too, are almost certainly identifying with the crew of the Enterprise, and not with the mutants and monsters.

[bm]

August 21, 2005 | Permalink | TrackBack (0)