HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

A Member of the Law Professor Blogs Network

Tuesday, July 31, 2007

Autism and Pesticides

CNN.com reports on a new study potentially linking autism to use of certain pesticides.  Video link here.  The San Jose Mercury News discusses more thoroughly the study findings.  It states,

Pregnant women from the Central Valley who were exposed to high levels of pesticides were up to six times more likely to give birth to a child with autism or a related disorder, state health officials said Monday.

California Department of Public Health researchers studied 465 children with autism spectrum disorders in 19 counties born between 1996 and 1998, comparing them with a control group of nearly 7,000 other children.

They found that women who lived close to fields with the highest use of a group of pesticides known as organochlorines were the most likely to bear children with the disorders, which range from mild to severe and cover a wide array of neurological and developmental problems, including difficulties with speaking, social interaction and motor skills.

Of 19 pesticides studied, only the organochlorines had a significant association with autism disorders. Organochlorines include endosulfan and dicofol, two pesticides whose use, primarily on cotton crops, has declined "dramatically" in the past few years in favor of newer, less toxic, pesticides, said Glenn Brank, a spokesman for the California Department of Pesticide Regulation.

Although scientists have previously linked certain other pesticides to neurological problems and developmental delays in children, this is the first study to examine possible connections between pesticides and autism disorders, said Dr. Mark Horton, director of the Department of Public Health.

Horton emphasized that the study does not prove pesticides actually caused the autism disorders, but that there is a possible link that merits further study. The study also suffers from a small sample size: The researchers identified 29 women at the highest-risk of exposure and found that eight of them gave birth to children with autism or a related disorder.

Still, the study's conclusions, while tentative, are important, Brank said, noting that the pesticide regulation agency already is studying whether to further restrict already tightly controlled endosulfan. A similar review of dicofol is planned. The agency will be working closely with public health officials to share information, he said.
"The implications of this study we are taking very seriously," Brank said. . . . .

 

 

The Environmental Health Perspectives article is available at www.ehponline.org.

 

July 31, 2007 | Permalink | Comments (0) | TrackBack (0)

Avandia Update

Yesterday an advisory committee of the FDA recommended that Avandia remain on the market with new warnings.  The New York Times reports today

Panel members said that studies concerning Avandia were too murky to merit drastic regulatory action and that other diabetes medicines might have similar risks.  The votes — 20 to 3 on the heart attack risk and 22 to 1 on the marketing — were cast after an extraordinary meeting in which officials from the Food and Drug Administration, which brought the committee together, openly disagreed with one another on the course to take.

Dr. David Graham, a drug safety officer at the federal agency, called for withdrawing the drug and estimated that its toxic effects on the heart had caused up to 205,000 heart attacks and strokes, some fatal, from 1999 to 2006. For every month that Avandia is sold, Dr. Graham said, 1,600 to 2,200 patients will suffer more of those problems.

Dr. Robert Meyer, director of the F.D.A. office that approved the initial Avandia application, immediately disagreed.  “I think it’s important that the committee understand there’s a fundamental disagreement” within the agency, Dr. Meyer said.  Other diabetes drugs also have risks, he added, and doctors and patients need a variety of options.

After the votes, Rebecca Killion of Bowie, Md., a patient representative on the advisory panel, said, “My feeling here is that we’re being asked to take a very draconian action based on studies that are very inadequate for us to make that kind of decision.”

The panel did say the agency should require strict warnings on Avandia labels. . . .

The division in the agency reflects a fierce debate among diabetes experts since The New England Journal of Medicine published a study in May suggesting that Avandia, made by GlaxoSmithKline, increased the risks of heart attacks.  In a cascade of reports since then, agency officials have said that GlaxoSmithKline told the agency about this risk nearly two years ago but that because of internal disagreements, it never warned patients.  In Europe, regulators required that the drug label reflect some concerns about the risks.

The lack of action here helped persuade some lawmakers to support a measure giving the agency more money and power to police drug safety. That bill has passed both houses of Congress and is expected to go to President Bush in days.

For more information, listen here to the National Public Radio stories and also here for a discussion about the FDA and how it functions when reviewing drugs post-approval.

July 31, 2007 | Permalink | Comments (0) | TrackBack (0)

Monday, July 30, 2007

Pharma Update

The New York Times reports on the FDA's recent results from testing Avandia, a diabetes drug.   


A federal drug safety official recommended during an advisory committee hearing today that Avandia, a controversial diabetes medicine made by GlaxoSmithKline, be withdrawn from the market because it increases heart risks.

      

Dr. David Graham noted in a written preview of his presentation that Avandia is no better at controlling blood sugar levels than similar diabetes medicines like Actos, made by Takeda. With a clear risk to the heart, and nothing to recommend it over other therapies, Avandia should be withdrawn, Dr. Graham argued in written remarks.

Dr. Graham is scheduled to speak to the committee later today. But it is not clear that the advisory committee, or indeed the Food and Drug Administration itself, will agree with Dr. Graham, a drug safety official at the F.D.A. who has a long history of arguing against the use or marketing of some widely-used drugs.

The committee may instead recommend that Avandia’s label include stronger warnings about its heart risks.

A committee vote is scheduled for later this afternoon.

Ezra Klein points to a recent  article in the New Republic (subscribe free) by Arnold Relman detailing some of the operations of America's pharmaceutical companies.  At least one commenter is critical of some of the research and notes that other industries do not face the same scrutiny that the pharmaceutical companies do. 

July 30, 2007 | Permalink | Comments (0) | TrackBack (0)

Poverty and Health Care

Firedoglake has a wonderfully moving post on the price some people pay for the lack of access to health care.  The piece looks at the moment in last week's Democratic debate (the YouTube debate) in which a man reveals that he spent his first fifty years with a cleft palate and only recently received surgery , allowing him to speak, after a benefactor paid.   There must be a better way!  Unfortunately, as Paul Krugman notes in today's New York Times (subscription required), this message doesn't seem to be making it to the current administration. 

July 30, 2007 | Permalink | Comments (0) | TrackBack (0)

Friday, July 27, 2007

Better Medical Care in Europe?

The New Republic has an article by Jonathan Cohn discussing whether medical care is better in Europe.   This has developed into a rather hot topic recently due to the scholarly articles (most recently JAMA) reporting that other countries with universal coverage spend less and receives better care and due also to SICKO (the movie) has made some comparisons between the United States health care system and other systems.  The article is here and is well worth a read.  (you do need to register - but it is free).

Kevin Drum at the Washington Monthly provides a brief overview of the article's findings:

I suppose you're all getting tired of hearing this, but the conclusion here is pretty much the same as it is every time you look at the U.S. vs. Europe: the differences are almost entirely about money. If you have a national healthcare system but you spend way less than the United States (as Great Britain does), you can provide good but not great service.  If you spend modestly less than the United States (as France does) you can provide healthcare every bit as good as ours — and cover every single citizen in the bargain.

And what if you actually spend as much as the United States — but you have to put up with our ragtag private delivery system? Then you get healthcare about as good as France's, except that it doesn't cover everyone, it bankrupts large companies, and it goes away anytime you get laid off. And all for only about 40% more than anyone else in the world pays. Pretty good system, eh?

July 27, 2007 | Permalink | Comments (0) | TrackBack (0)

Happy Birthday Professor Paul Caron!

Happy "Special" Birthday to Professor Paul Caron - a terrific colleague, wonderful mentor and founder of the LawProfBlog network.   I feel truly lucky to work with Paul.   I don't know how many of you have experienced a wish to attend one of your colleagues classes because you know that it would be enjoyable to learn more about a topic from such a terrific professor.  I must admit, I would love to take Paul's tax classes - there is a lot I don't know about tax law and policy and I cannot say that it is a big interest - but with someone like Paul - it would be a great experience. 

July 27, 2007 | Permalink | Comments (0) | TrackBack (0)

Thursday, July 26, 2007

Release of Medics

National Public Radio and other news outlets announced the news yesterday that the long-held medics (nurses and a doctor) had been released from Libya.  These individuals had been accused of deliberating infecting children with the HIV virus.  Here is the NPR story.  The blog, the Next Hurrah, has further information on the story as well.

July 26, 2007 | Permalink | Comments (0) | TrackBack (0)

Legislation Action Alert

The newly revised  FDA Revitalization Act (also formerly known as the FDA Enhancing Drug Safety and Innovation Act or FDA Amendments Act) deserves more attention as it moves through Congress for reconciliation.  One of the readers sends in this news about a portion of the Act that should be of concern to all of us. 

He writes of his condition called Intestinal Pseudo-Obstruction and is essentially a chronic, congestive failure of the entire digestive tract.  He was one of many individuals who were taking Zelnorm, a powerful digestive prokinetic agent, manufactured by Novartis. 

On March 30, 2007, FDA banned Zelnorm after a study showed 0.11% of the individuals taking the drug were at risk for myocardial infraction, angina or stroke.  This compares quite favorable for the overall baseline risk in the overall population and even more favorably to the risks of Erythromycin (an antibiotic used to restore peristalis) which has a well-known risk of cardiac side effects and Reglan, a medication that has been available for about 40 years and causes a form of Parkinson’s Disease either temporarily or permanently in about half of the people who take it.

Though FDA promised to work with Novartis to hold a Advisory Committee Meeting to reassess the risks of Zelnorm, we are now at close to the four month mark and no advisory committee meeting has been scheduled.  It is unlikely that such meeting will be scheduled before year end 2007.

It is in this context that I noted with concern the House’s passage of the FDA Revitalization Act.  One of the provisions of the bill allows for the creation of a Drug Safety Oversight board.  Normally, most FDA advisory boards allow for patient participation in the form of a patient representative and/or outside doctor representation.  The current version of the bill does not; in addition, the bill only allows for the participation of officers from the FDA, NIH, HHS and “other appropriate federal agencies”.  Therefore, decisions made by this board will be made in a “star chamber” that omits the expertise of patients and their doctors who have the best real-life experience in dealing with the implications of the risks and benefits of various pharmaceuticals.  This provision only serves to continue the drug regulation trend where the most important participants in the process simply do not have a voice in its most important steps.

I was unaware of this provision of the Act until notified by this reader.  Please contact your congressperson if you share these concerns.

 

July 26, 2007 | Permalink | Comments (0) | TrackBack (0)

Thursday, July 12, 2007

Holsinger Hearing in Senate

Dr. Holsinger's confirmation hearing for Surgeon General is today in the Senate Health, Education, Labor and Pensions Committee.   The American Public Health Association has expressed its opposition to his appointment as Surgeon General.  BibleBelt Blogger has written extensively about the controversy surrounding Dr. Holsinger and his views on homosexuality.  NPR's Morning Edition provided some further background information about Dr. Holsinger and the New York Times has an editorial with suggested questions for the nominee. 

July 12, 2007 | Permalink | Comments (0) | TrackBack (0)

Pain Hearings

TalkLeft has a wonderful discussion and super helpful links and information about today's hearing in the House Judiciary, Subcommittee on Crime, Terrorism, and Homeland Security on the DEA's regulation of pain medicine

July 12, 2007 | Permalink | Comments (0) | TrackBack (0)

Wednesday, July 11, 2007

TB and Quarantine/Isolation Take II

I am not sure why patients are responding with flight when informed that they have a contagious disease that requires them to stay away from others.  Perhaps the hospitals and health officials are scaring them or perhaps people are just showing an extremely unattractive selfish side or could it be the hospital food . . . ?.  ABCNews reports on the latest TB flight from an Arkansas hospital,

A man placed in isolation after he was diagnosed with contagious tuberculosis broke a hospital window and fled, health officials said.

Unlike the Georgia lawyer who was under a federal quarantine after flying to Europe with what was then believed to be extensively drug-resistant TB, Arkansas health officials said the man who fled has a form of tuberculosis that would respond to treatment.   

Franklin Greenwood, 50, is still contagious, though, health officials said. Greenwood was placed in isolation at the University of Arkansas for Medical Sciences hospital on June 29 after he was seen coughing up blood outside the city's traffic court. He left the hospital on July 1.

July 11, 2007 | Permalink | Comments (0) | TrackBack (0)

Bush On Health Care

Who knew that the problem with the Health Care system in the United States is . . . Americans.  Perhaps he was being inartful but I cannot believe that many people would find his message reassuring as a way to move forward on health care reform.  Here is the video of yesterday's Presidential speech.  Thanks to Crooks and Liars.

Update:  The Washington Monthly has some further comments on President Bush's health care ideas.

July 11, 2007 | Permalink | Comments (0) | TrackBack (0)

Tuesday, July 10, 2007

Former Surgeon General Critiques Bush Interference

Reuters reports that  the former Surgeon General, Dr. Richard Carmona, discussed his tenure as surgeon general from 2002-2006 by noting that, "Anything that doesn't fit into the political appointees' ideological, theological or political agenda is ignored, marginalized or simply buried."  Dr. Carmona was testifying  in front of the House of Representatives' Oversight and Government Reform committee.  He further stated,    

"The problem with this approach is that in public health, as in a democracy, there is nothing worse than ignoring science, or marginalizing the voice of science for reasons driven by changing political winds. The job of surgeon general is to be the doctor of the nation, not the doctor of a political party," Carmona added.   

Carmona said Bush administration political appointees censored his speeches and kept him from talking out publicly about certain issues, including the science on embryonic stem cell research, contraceptives and his misgivings about the administration's embrace of "abstinence-only" sex education. . . .       

"Political interference with the work of the surgeon general appears to have reached a new level in this administration," said Rep. Henry Waxman, a California Democrat who chairs the House Oversight and Government Reform Committee to which Carmona testified.

ThinkProgress has more as well as some video of Dr. Carmon's testimony.

July 10, 2007 | Permalink | Comments (0) | TrackBack (0)

Tom Tomorrow on Health Care Reform

Salon.com has a great cartoon by Tom Tomorrow on various arguments against universal health care.

July 10, 2007 | Permalink | Comments (0) | TrackBack (0)

Monday, July 9, 2007

Drink More Wine Said the Dentist . . . .

Well, I am looking forward to my next dentist visit now -- woo!  I cannot wait to discuss the heightened levels of dental well-being that I may receive based on that glass of pinot noir I plan to have every evening - purely for medicinal purposes.     LiveScience/MSNBC reports on a new study concerning the ever-increasing health benefits of wine:

Drinking wine can maintain heart health, prevent cancer and even settle a mean case of diarrhea. Research now shows it’s also good for your teeth and throat.

According to a new study, a cocktail of compounds found in both red and white wine fights germs that can cause dental plaque as well as sore throats.

“Exposure to wine had a persistent antibacterial effect,” the authors wrote in their study, detailed in an upcoming issue of the Journal of Agricultural and Food Chemistry. Prior to their research, the authors said the effects of wine against germs found in the mouth hadn’t been studied.

Red wines have stronger bacteria-fighting effects than white wine, although not by much. Curiously, the acidity and alcohol isn’t responsible for wine’s germ-fighting properties—instead, it’s a collection of organic (carbon-containing) compounds found in the drink. . . . .

But don’t run out and gargle wine before brushing just yet, as the acids in wine can actually soften the hard but thin coat of protective tooth enamel.

“Sipping or holding acidic drinks in the mouth before swallowing increases the risk of erosion on dental enamel,” said Dr. David Bartlett of the Academy of General Dentistry. To cut down on this risk, Bartlett recommends waiting at least 20 minutes before brushing after eating any acidic foods.

Based on all the good press that wine has been receiving lately, I am waiting for pharmaceutical manufacturers to distill its essence into tablet form.   

July 9, 2007 | Permalink | Comments (0) | TrackBack (0)

Child Health Insurance Battle Looms

It is amazing to me how every suggestion of an expansion of health care insurance becomes political .  The New York Times reports today on the impasse over the State Children's Health Insurance Program.    It reports,

The seemingly uncontroversial goal of insuring more children has become the focus of an ideological battle between the White House and Congress. The fight epitomizes fundamental disagreements over the future of the nation’s health care system and the role of government.

Democrats have proposed a major expansion of the program, the State Children’s Health Insurance Program, to cover more youngsters with a substantial increase in federal spending.

Administration officials have denounced the Democratic proposal as a step toward government-run health care for all. They said it would speed the erosion of private insurance coverage. And they oppose two of the main ideas contemplated by Democrats to finance expanded coverage for children: an increase in the federal tobacco tax and cuts in Medicare payments to private insurance companies caring for the elderly.

White House objections to the Democratic plan are “philosophical and ideological,” said Allan B. Hubbard, assistant to the president for economic policy. In an interview, he said the Democrats’ proposal would move the nation toward “a single-payer health care system with rationing and price controls.”

Democrats said the insurance program, created 10 years ago with bipartisan support, had improved access to care for millions of children and sharply reduced the number who were uninsured. Democratic leaders in both houses of Congress — with support from doctors, consumer groups and many state officials — want to increase enrollment in the program, which served 7.4 million people at some time in the last year. . . . .

To return the children’s insurance program to what he calls “its original intent,” Mr. Bush has asked Congress to reduce federal payments to the states for coverage of children in families with incomes of more than twice the poverty level. (A family of four is considered poor if its annual income is less than $20,650.) At least 18 states cover children with family incomes more than twice the poverty level. . . .

Mr. Bush and some Republicans in Congress worry that as public coverage becomes available to families with higher incomes, it tends to replace private coverage.

In a recent report, the Congressional Budget Office said that for every 100 children who get public coverage as a result of the children’s insurance program, “there is a corresponding reduction in private coverage of between 25 and 50 children.”

That increases the cost of efforts to expand coverage, according to the budget office, because the government inevitably picks up some people who recently had private insurance when it tries to sign up the uninsured. Thus, the budget office said, to reduce the number of uninsured children by three million, states may need to add four million to six million children to the rolls.

Peter R. Orszag, director of the budget office, said that other efforts to expand coverage — for example, by offering tax breaks for buying private insurance — faced a similar challenge: some benefits would go to people who already had coverage.

How horrible - the government might actually provide help to people who don't immediately need it -- I don't recall this concern when the Bush tax cuts were enacted.

Update:  Dean Baker has some additional thoughts on the manner in which health care reform and health care proposals are being debated this year.

 

July 9, 2007 | Permalink | Comments (0) | TrackBack (0)

Sunday, July 1, 2007

Surgeon General Nominee - Confirmation Hearing July 12th

I am sure that you are all aware that Dr. James W. Holsinger has been nominated by President Bush to be the next Surgeon General.  In announcing Dr. Holsinger's nomination, President Bush stated that his new surgeon general would focus on childhood obesity.

Today, I have announced my intention to nominate James W. Holsinger, Jr., to serve as the 18th Surgeon General of the United States.  Dr. Holsinger is an accomplished physician who has led one of our Nation's largest healthcare systems, the State of Kentucky's healthcare system, and the University of Kentucky's medical center.  He also has taught at several American medical schools, and he served more than three decades in the United States Army Reserve, retiring in 1993 as a Major General.

As America's chief health educator, he will be charged with providing the best scientific information available on how Americans can make smart choices that improve their health and reduce their risk of illness and injury.  Dr. Holsinger will particularly focus his efforts on educating parents and children about childhood obesity, a serious epidemic that decreases quality of life and burdens our healthcare system.  I am confident that Dr. Holsinger will help our Nation confront this challenge and many others to ensure that Americans live longer, better, and healthier lives.

Here is some further background information on Holsinger from Wikipedia and as well as discussion concerning his views concerning homosexuality from ThinkProgress.  He is not the choice I would have made . . . .   I suspect that his confirmation hearing on July 12th could be quite interesting.

July 1, 2007 | Permalink | Comments (0) | TrackBack (0)