Friday, September 30, 2005
It's been a bad several days for psychotropic medication. Here's the latest -- the FDA has just required a boxed warning for atomoxetine (brand name Strattera), a medication indicated for treating ADHD. Today's public health advisory states:
"The increased risk of suicidal thinking for this drug was identified in a combined analysis of 12 short-term (6-18 weeks) placebo-controlled trials ... [that] involved a total of over 2200 patients... The analysis showed a greater risk of suicidal thinking during the first few months of treatment in those receiving Strattera. The average risk of suicidal thinking was about 4 per thousand patients treated with Strattera compared to no events in placebo-treated patients. There was 1 suicide attempt among these approximately 2200 patients, occurring in a patient treated with Strattera. Based on these data, FDA has determined that the following points are appropriate for inclusion in the boxed warning: * Strattera increases the risk of suicidal thinking in children and adolescents with ADHD. * Anyone considering the use of Strattera in a child or adolescent for ADHD must balance the increased risk of suicidal thinking with the clinical need for the drug. * Patients who are started on therapy should be observed closely for clinical worsening, suicidal thinking or behaviors, or unusual changes in behavior. * Families and caregivers should be advised to closely observe the patient and to communicate changes or concerning behaviors with the prescriber.
The full public advisory statement can be found here:
Thanks to Dr. Doug Mossman for this post.
This week's National Geographic has a cover story on the potential of a killer flu outbreak. It is graphic and frightening to read.
In addition, Senate Minority Leader Harry Reid issued a statement concerning the need to prepare for the upcoming potential of the bird flu pandemic. After noting how unprepared America is for this potential diaster, he states,
“Experts have warned us that an avian flu pandemic is inevitable. But the devastating consequences that could ensue from an outbreak are not – provided this nation and the world heed the science community’s warnings and take action immediately
“I propose we start by committing the resources necessary to protect Americans. We need not wait for a perfect plan on paper to start dedicating more resources to address this issue. We know today that funding certain programs can make dramatically reduce the consequences of a future avian flu outbreak. We also know that many of these programs are either unfunded or massively underfunded.
“Tomorrow, when we take up the Defense Appropriations Bill, Senators Harkin, Kennedy, Obama, and I, along with a number of my colleagues plan to offer an amendment that will ensure that we begin making the investments necessary to make sure this nation and the world do everything possible to ensure that history does not repeat itself and we do not have to relive 1918.”
For all the information you need about the bird flu and the slow political response, see Effect Measure.
Thursday, September 29, 2005
Dr. Doug Mossman points to this New York Times article discussing the sad goings on among some mental health professionals in Turkey. The Times reports,
Turkey's psychiatric hospitals are riddled with horrific abuses, including the use of raw electroshock as a form of punishment, according to a human rights report issued in Istanbul on Wednesday, just days before Turkey begins formal talks to join the European Union.The report, by Mental Disability Rights International, a Washington-based group, came after several visits in the past year by the group's investigators to psychiatric hospitals and other facilities for people with developmental or mental disabilities.
While the report details many types of abuses, it said the most disturbing involved the use of electroconvulsive therapy without anesthesia to treat a wide range of illnesses in adults and children. The World Health Organization has called for a ban on "unmodified" or "direct" use of the treatment and states that children should never be subjected to it in any form.
The therapy, in which an electrical current is passed through the brain, was developed in the 1930's and continues to be used in mainstream psychiatry to treat a limited number of ailments. But it is normally administered with anesthesia and muscle relaxants.
Without them it can be painful, terrifying and dangerous. Patients can break jaws or crack vertebrae during the induced seizures. The report quotes a 28-year-old patient at Bakirkoy Psychiatric Hospital in Istanbul as saying, "I felt like dying."
The Health Ministry, which is responsible for psychiatric hospitals, said it had not yet read the report and declined to comment, other than to say that the director of the electroconvulsive therapy center at Bakirkoy denied administering unmodified electroshocks there.
Dr. Doug Mossman points to some big news on the pharmaceutical front for healthcare professionals,
Paxil CR Controlled-Release Tablets
[Posted 09/27/2005] GlaxoSmithKline (GSK) and FDA notified healthcare professionals of changes to the Pregnancy/PRECAUTIONS section of the Prescribing Information for Paxil and Paxil CR Controlled-Release Tablets to describe the results of a GSK retrospective epidemiologic study of major congenital malformations in infants born to women taking antidepressants during the first trimester of pregnancy. This study suggested an increase in the risk of overall major congenital malformations for paroxetine as compared to other antidepressants [OR 2.2; 95% confidence interval, 1.34-3.63]. Healthcare professionals are advised to carefully weigh the potential risks and benefits of using paroxetine therapy in women during pregnancy and to discuss these findings as well as treatment alternatives with their patients.
Wednesday, September 28, 2005
"Giving Part D A Spin" - that was the title of Tuesday's exploration of the in's and out's of the looming pharmaceutical benefit about to be rolled out by CMS in 2006. The complexity of Part D is no small matter. A quick search on CMS' FAQ page unearths 528 Qs & As concerning the Medicare Drug Benefit. 528!
The authors mention a couple of useful resources to help seniors (and health law teachers) understand Part D:
- One of [the Healthcare Leadership Council's] educational tools is the "MedicareRx Made Simple" wheel, which considers an individual's marital status, income and approximate drug costs to estimate how much a person would pay annually for drugs under Part D.
- The Medicare Rights Center's webpage has a 101-question FAQ page.
Law.com has published an article by DeanStephen J. Friedman of the Pace Law School. He provides some insight and criticism on the education provided by law schools. He states,
A year ago, I became dean of Pace Law School after a career in law practice, government and corporate life. What I found throughout legal education surprised me. From the point of view of a practicing lawyer, legal education has not evolved to meet the demands of a rapidly changing profession.
It has, in fact, changed surprisingly little in the 40-odd years since I graduated -- certainly not enough to meet the needs of law firms under increasing pressure to transform students into productive lawyers as quickly as possible.
While we don't need radical changes in a law curriculum that has worked for a long time, legal education must be brought into closer alignment with the need of law students to hit the ground running when they begin to practice law. . . .
Law practice has become much more specialized in the last 20 years. Legal education needs to give students meaningful experience in some area of the law. The need for focus raises the dreaded debate about the dangers of specialization in law school.
I do not think that greater focus is a cause for concern. Most lawyers can remember when they first felt comfortable functioning as a lawyer. Something intrinsic kicks in, their knowledge and skills coalesce, and they reach a point where what they already know more than makes up for what they do not yet know. When a lawyer has a broad understanding of how the corporate tax system works, or of real estate practice, or of the legal complexities of international trade, then he or she can begin to think like a lawyer.
Navigating a legal regime is an intellectual skill that is transferable to mastering other legal regimes. Lawyers routinely shift their practice from one area to another as a former specialty becomes less important because of regulatory or market changes. Or their clients' needs change. When I began to practice law, there was an extensive market for financings in the form of extensively negotiated private placements by insurance companies. The market for private placements was displaced by quasi-public Rule 144A financings and then by other forms of widely distributed institutional debt. Lawyers made that shift with relative ease, even though the market and terms were entirely different.
Similarly, a student is far better off with a law school experience that comes as close as possible to an integrated combination of skills, knowledge and substantive law in one broad area -- such as litigation or corporate transactions -- than with a smorgasbord of unrelated courses, even if that student ends up practicing in an entirely different area. Law schools have the opportunity to create an integrated group of courses covering broad practice areas that would give students a meaningful introduction to the major tasks they will face as new lawyers.
This role for law schools has important implications for the design of the curriculum. It requires a more focused legal education. This approach starts out by asking, "What courses and skills does a student need in order to be an effective new corporate lawyer?" -- or litigator, or family lawyer, or nonprofit lawyer, or whatever.
The skills needed by each of these practice areas do not correspond easily to current curriculum design, and examining legal education through the prism of practice areas provides a useful perspective for organizing the curriculum. We can then ask whether the curriculum has the right mix of courses, both doctrinal and skill sets, and whether they are offered as a coherent series designed to achieve a meaningful objective.
Litigation offerings highlight the differences in approach. Most law schools offer many relevant courses and experiences in this area, including civil procedure, evidence, trial practice and other simulations, negotiation, arbitration, mediation and externships and clinical experience.
A practice-oriented approach might begin by asking what substantive and procedural law and skills a new litigator should know to be able to work effectively in dispute resolution. It would consider how existing courses dovetail with one another and what new courses are needed, which part of evidence is best taught in a doctrinal setting and which is best learned through simulations, where moot courts fit in, and which nonlegal skills are essential (such as presentation training and psychology).
Today's New York Times has an interesting story about the possible reason for former FDA commissioner Lester Crawford's sudden resignation. According to the Times, his resignation was perhaps due to a failure to disclose financial information,
Lester M. Crawford's wife has told family members that an unintentional failure to disclose financial holdings prompted his sudden resignation as commissioner of food and drugs last week, her brother said yesterday. . . . .
Dr. Crawford, reached by phone yesterday, said that he would not comment on whether his resignation had anything to do with his financial holdings.
"I appreciate the opportunity," he said, "but I don't have any comment on that."
The abruptness and mystery surrounding Dr. Crawford's departure, only two months after his Senate confirmation, have fueled speculation that he had investments in companies regulated by the F.D.A., which oversees the food, drug and cosmetics industries.
The Times further reports that the new interim FDA commissioner will continue in his job as the National Cancer Institute as well. The Times states,
As for the F.D.A.'s new leadership, President Bush named Dr. Andrew C. von Eschenbach, the director of the National Cancer Institute, as acting commissioner on Friday, and Dr. von Eschenbach has said he will keep his position at the cancer institute while running the F.D.A.
But yesterday Senator Edward M. Kennedy of Massachusetts, the senior Democrat on the Senate health committee, said Dr. von Eschenbach should not try to juggle the two jobs.
"There are intrinsic conflicts of interest between the role of N.C.I. director, who manages a research program that includes drug development, and the role of F.D.A. commissioner, whose responsibility is to review the safety and effectiveness of those drugs," Mr. Kennedy said in a letter to the secretary of health and human services.
Moreover, Mr. Kennedy, like Senator Charles E. Grassley, Republican of Iowa, said that each job had immense responsibilities and that it was therefore not feasible for one person to run the two agencies.
Christina Pearson, a spokeswoman for the secretary, Michael O. Leavitt, said yesterday that the administration was not changing its plan for Dr. von Eschenbach to keep his job at the cancer institute while serving as interim chief of the F.D.A.
Tuesday, September 27, 2005
Reuters (among others) is reporting that L.A.'s St. Vincent Medical Center has suspended its liver transplant program and fired two top liver transplant surgeons. The actions were taken after a routine UNOS audit revealed that a Saudi national who 52nd on the local OPO's waiting list was jumped to the top and transplanted in return for a $339,000 payment by the Saudi embassy that was 25-30% higher than what most U.S. insurers pay for a liver transplant. To make matters worse, the probe that followed uncovered falsified documents to cover up the breach of UNOS policies involved. And don't forget the impact of all this on the 75 patients who were on the liver transplant waiting list. With the St. Vincent program suspended, they are being contacted to see what the next step will be for them. Click the links for the UNOS and St. Vincent statements. [tm]
Ezra Klein's blog has a great discussion of how HSAs might impact patient spending on health care. He examines a recent article by Joe Paduda of the Managed Care Matters blog which states,
Catastrophic patients – about 5% of the population...are also not affected – they’ll blow through their MSA account balance in a month or two, after which the insurance company or Medicare or Medicaid pays the rest. So, no funds out of their pockets, and realistically, no way for them to pay the huge costs of their health care. By the way, the top one percent of the population that falls into this category spends 40% of all health care dollars, the top five percent that falls into this category spends over 50% of all health care dollars.
OK, that leaves the medium users. The remaining part of the population consumes more than $1000 in health care (a typical MSA plan deductible), and therefore might be more influenced by finances than the other two groups. But there’s a problem here. Studies indicate that a significant percentage of people with high deductible plans tend to not fill prescriptions, not seek care, and otherwise “under-utilize” health care due to financial reasons.
Well, their costs are constrained, at least for today. But what if they are not taking their hypertension medications and suffer a stroke? What if they don’t get a mammogram and their breast cancer is not diagnosed until it is marginally “curable”? They’ll become part of the top 5%, where costs are really uncontrollable.
Ezra's take: The point? HSA's aren't going to change a thing. But you have to realize, reigning in costs and creating a more sensible system really isn't their aim. A few libertarians have messianic hopes for the structure, but HSA's, on sum, are meant to do two things:
• Offer Republicans a policy on health care. So long as Democrats kept pushing for universal care and manage care was collapsing, the right was left holding the bag marked status quo while voters were searching for anything but. HSA's gave Republicans a little-understood policy to tout as the answer to all our health care problems, and thus as the way to fix the system without increasing government involvement. Since no one really understood them they just muddled, and ended, the debate.
• Shift costs from businesses. Those companies that do pay health costs -- mainly dinosauric entities from the days when unions walked the earth -- were crying for government help, making them potent allies in the fight for single-payer. If they could somehow push their people onto HSA's, there's a chance they'd stop advocating for major change. This isn't actually working, but it seems to have been part of the initial plan.
Today's New York Times Science section has an article discussing a recent study on handwashing habits. The study reveals that women are more likely to wash their hands than men - no reason for the difference was discovered. According to the Times,
Most people say they wash their hands after using the bathroom. But a new study suggests that many of them are not telling the truth.
The researchers demonstrated that people were not as conscientious as they say they were by comparing answers given in a telephone poll to observed behavior.
In the nationwide poll, conducted from Aug. 19 to Aug. 22 by Harris Interactive, 1,013 adults were interviewed about their hand washing habits. Then observers were sent into public restrooms to see what actually happened.
Ninety-one percent of adults claimed in the poll that they washed their hands after using a public restroom. But of the 6,336 adults whose behavior was observed, only 82 percent actually did so.
Women, the study found, were more diligent than men: 90 percent washed their hands, compared with only 75 percent of the men.
Michael T. Osterholm, chairman of the public health committee of the American Society of Microbiologists, which commissioned the survey, said he could not explain what accounted for the difference.
"I don't think anyone knows why men are so much less likely to wash than women," he said. "People who use urinals probably think they don't need to wash their hands. But the overall message is that most Americans do wash their hands after using the bathroom, even though we have a long way to go."
Monday, September 26, 2005
According to a Wall Street Journal Online/Harris Interactive Health-Care poll, patients are questioning aggressive treatment decisions by their physicians more than ever. (This is what most of the health care reforms of the past decade were intended to do, right? Make patients more informed and skeptical consumers, through a variety of mechanisms that put more of the first-dollar payment obligation on them and reduced the impact of third-party payer mechanisms? Maybe it's starting to work!) Here is the straight dope:
Considerable Concern Exists Amoung U.S. Adults About the Frequency of Unnecessary or Overly Aggressive Medical Treatment
There is considerable concern among U.S. adults about the frequency with which patients are medically over treated by their doctors, according to a new Wall Street Journal Online/Harris Interactive Health-Care Poll. Nearly three-quarters (72%) of U.S. adults think that patients who have medical conditions experience problems because of being over treated (i.e., getting too many treatments or getting more aggressive treatment than is appropriate). In light of these concerns by the public, it's not surprising to learn that half (50%) of all adults are somewhat or very concerned, personally, about being over treated when they are sick or in need of medical care. More than half (52%) of all adults have chosen to question or forego recommended care because they felt it was unnecessary or too aggressive. Specifically:
- Nearly a third (32%) did not fill a prescription that their doctor gave them because they felt it was unnecessary.
- About one-fifth (21%) got a second opinion from another doctor because they thought their doctor's recommendations were too aggressive.
- Sixteen percent (16%) did not get a diagnostic test that their doctor recommended because they felt it was unnecessary.
- One in 10 (10%) did not get a surgical procedure that their doctor recommended because they felt it was unnecessary.
- Nine percent (9%) changed doctors because they felt their doctor's approach was too aggressive.
Source:Wall Street Journal Online/Harris Interactive Health-Care Poll Date: September 16, 2005 http://www.harrisinteractive.com/news/allnewsbydate.asp?NewsID=970
As you are probably well aware, Dr. Andrew C. von Eschenbach, head of the National Cancer Institute, has become the new acting FDA commissioner. The Associated Press provides a brief glimpse on how he plans to govern the agency. It reports,
The new acting chief of the Food and Drug Administration, Dr. Andrew C. von Eschenbach, said yesterday that he will be presiding over a transformation in medicine, as scientists understand diseases in a way that could improve doctors' ability to treat patients.
Von Eschenbach, tapped by President Bush as the temporary chief of the regulatory agency, said yesterday that discoveries about diseases at ''a molecular level" will lead to a new kind of healthcare.
Now, doctors treat illnesses based on how well other people have responded to a given treatment. Soon, they will develop a tailored response, built around specific understandings of the patient, the treatment and the disease, he said.
''We are discovering so much about diseases like cancer at the molecular level," said von Eschenbach, who is a urologic surgeon by training. ''Much of what we have done . . . has been based on a model of empiricism." Soon, doctors will be able to intervene with medical treatments more effectively matched to a specific patient's illness.
Preparing the FDA for such a transformation is among his goals, von Eschenbach said.
Although this is not strictly a health law topic, it is interesting that HCA is once again under scrutiny as well as Senator/Dr. Frist. According to USA Today,
Senate Majority Leader Bill Frist, R-Tenn., was updated several times about his investments in blind trusts during 2002, the last time two weeks before he publicly denied any knowledge of what was in the accounts, documents show.
The updates included stock transactions involving HCA Inc., the hospital operating company founded by Frist's family.
Frist's sale of HCA stock is under scrutiny by the federal government. Nashville-based HCA said Friday it had received a subpoena from prosecutors for the Southern District of New York, asking for documents the company believes are related to Frist's sale of company stock this past summer.
Prosecutors also have contacted the senator's office, Frist spokesman Bob Stevenson said Friday. He said neither the senator nor his office had received a subpoena.
Frist's office confirmed the Securities and Exchange Commission was looking into the sale. . . . .
HCA, the nation's largest for-profit hospital company, was founded by Frist's father, the late Thomas Frist Sr. His brother, Thomas Jr., was formerly its CEO and chairman and remains on the board of directors. Frist is a heart surgeon by training.
Frist asked a trustee to sell all his HCA stock in June, near a 52-week price peak of $58.40 a share. Reports to the SEC showed HCA insiders sold about 2.3 million shares.
Frist's sale came about two weeks before the company issued a disappointing earnings forecast that drove its stock price down almost 16% by mid-July and still have not recovered. HCA rose $1.70 Friday, closing at $47.60.
The value of Frist's stock at the time of the sale was not disclosed. Earlier this year, he reported blind trusts with all holdings valued at $7 million to $35 million.
Sunday, September 25, 2005
Saturday's Los Angeles Times had an interesting (heart-wrenching) story of an woman who disbelieves the link between HIV and AIDS. As a result, her three-year old daughter is dead. This seems to be the year for these kinds of stories . . . maybe every year is, but we're seeing more coverage than ever. If anyone is aware of such stories (involving parents who reject traditional medical treatments and then been accused of endangering their child), please contact me. This is the topic of my next law review article. [tm]
The Times' Nicholas Kristof writes in Sunday's paper that, just as surely as the infrastructure of New Orleans and other Gulf sites devastated by Hurricane Katrine need to be rebuilt, so too does the country's health care system.
We've all read comparative life-expectancy statistics, but Kristof offers some that are truly staggering:
In both Mississippi and Louisiana, infant mortality is worse (for every 1,000 babies born, 10 die in their first year of life) than in Costa Rica (8 die per 1,000). For black babies in either state, the picture is still more horrifying: 15 die per 1,000. In poor, war-torn Sri Lanka, where per capita medical spending is only $131, babies have better odds, with 13 dying per 1,000.
By the way: If there's anyone reading this who isn't a "Times Select" subscriber, please click on the link above and see if it will open Kristof's column. With the paper's new server for certain features, my reliable old RSS feed generator can't convert to a permanent XML or RSS address. I fear the "select" server, which is the only address I have for columnists like Kristof, may only open up for Times Select subscribers. Please let me know your results. [tm]
Announcement from Health Affairs:
The September/October issue of Health Affairs is devoted to the topic of health information technology. Upon reviewing the issue's table of contents, national coordinator of HIT, David Brailer called the volume a "tour de force." In the issue:
- Barriers to Adoption: David Gans writes that physicians are experiencing barriers to adoption of electronic health records, but the adoption rate continues to rise.
- Electronic Medical Records: Catharine Burt documents how many physicians are using electronic medical records and the characteristics of their practices.
- Cost Savings: Richard Hillestad estimates annual savings of $81 billion for the health care system with fully implemented, interoperable electronic medical records.
There's plenty else in this issue that isn't listed in the blurb above, e.g.:
From the Editor Pursuing Health IT: The Delicate Dance Of Government And The Market
John K. Iglehart
Economics Of Health Information Technology
PROLOGUE: The Economics Of Health Information Technology
PERSPECTIVE: Electronic Medical Records And Health Care Transformation
James M. Walker
PERSPECTIVE: Hope And Hype: Predicting The Impact Of Electronic Medical Records
David U. Himmelstein and Steffie Woolhandler
PERSPECTIVE: Savings In Electronic Medical Record Systems? Do It For The Quality
The Value Of Electronic Health Records In Solo Or Small Group Practices
Robert H. Miller, Christopher West, Tiffany Martin Brown, Ida Sim, and Chris Ganchoff
Medicare’s Next Voyage: Encouraging Physicians To Adopt Health Information Technology
Sheera Rosenfeld, Cathy Bernasek, and Dan Mendelson
PERSPECTIVE: Using Quality Incentives To Drive Physician Adoption Of Health Information Technology
Glenn Hackbarth and Karen Milgate
Interview Action Through Collaboration: A Conversation With David Brailer
PROLOGUE: Implementing Health Information Technology
E-Prescribing And The Medicare Modernization Act Of 2003
Douglas S. Bell and Maria A. Friedman
Exchanging Health Information: Local Distribution, National Coordination
John Halamka, J. Marc Overhage, Lygeia Ricciardi, Wes Rishel, Clay Shirky, and Carol Diamond
Physicians And Ambulatory Electronic Health Records
David W. Bates
PERSPECTIVE: State And Community-Based Efforts To Foster Interoperability
Mark E. Frisse
PERSPECTIVE: Regulatory And Policy Barriers To Effective Clinical Data Exchange: Lessons Learned From MedsInfo-ED
Lawrence K. Gottlieb, Elliot M. Stone, Diane Stone, Lynne A. Dunbrack, and John Calladine
PERSPECTIVE: The Making And Adoption Of Health Data Standards
W. Ed Hammond
PERSPECTIVE: The Indiana Network For Patient Care: A Working Local Health Information Infrastructure
Clement J. McDonald, J. Marc Overhage, Michael Barnes, Gunther Schadow, Lonnie Blevins, Paul R. Dexter, Burke Mamlin, and the INPC Management Committee
Health Information Technology Policy
PROLOGUE: Policy Issues Surrounding Health Information Technology
Strategic Action In Health Information Technology: Why The Obvious Has Taken So Long
Edward H. Shortliffe
Promoting Health Information Technology: Is There A Case For More-Aggressive Government Action?
Roger Taylor, Anthony Bower, Federico Girosi, James Bigelow, Kateryna Fonkych, and Richard Hillestad
Dot-Gov: Market Failure And The Creation Of A National Health Information Technology System
PERSPECTIVE: Federal Investment In Health Information Technology: How To Motivate It?
Anthony G. Bower
PERSPECTIVE: Wiring Health Care
George C. Halvorson
PERSPECTIVE: Achieving U.S. Health Information Technology Adoption: The Need For A Third Hand
TRENDS: Functional Gaps In Attaining A National Health Information Network
Rainu Kaushal, David W. Bates, Eric G. Poon, Ashish K. Jha, David Blumenthal, and the Harvard Interfaculty Program for Health Systems Improvement NHIN Working Group
FROM THE FIELD: The Missing Link: Bridging The Patient–Provider Health Information Gap
Paul C. Tang and David Lansky
FROM THE FIELD: Transforming Care: Medical Practice Design And Information Technology
Charles M. Kilo
DataWatch Medical Groups’ Adoption Of Electronic Health Records And Information Systems
David Gans, John Kralewski, Terry Hammons, and Bryan Dowd
REPORT: Toward A High Performance Health System: The Commonwealth Fund’s New Commission
CONFERENCE REPORT: The Adoption Gap: Health Information Technology In Small Physician Practices
Jason Lee, Carol Cain, Scott Young, Nancy Chockley, and Helen Burstin
If you don't subscribe, all you're probably going to be able to see is an abstract. I finally bit the bullet about 10 years ago and am glad I did. If your library subscribes, you might look into the possibility of an institutional password that will give you access to the electronic version. [tm]
Saturday, September 24, 2005
U.S. Food and Drug Administration Commissioner Lester Crawford abruptly resigned on Friday after a bruising fight over whether the agency would approve over-the-counter sales of a morning-after pill and a string of drug-safety controversies.
Crawford's resignation takes effect immediately, health officials said. They offered no reason for his sudden departure less than three months after he was confirmed for the job.
President George W. Bush asked National Cancer Institute Director Andrew Von Eschenbach to serve as acting FDA commissioner, the White House said.
Crawford won a contentious confirmation battle in the Senate after Health and Human Services Secretary Mike Leavitt assured Senate Democrats the FDA would act on over-the-counter sales of the morning after pill Plan B by Sept. 1.
But he came under fresh attack in late August when the FDA indefinitely postponed a ruling on whether Barr Pharmaceuticals Inc. (BRL.N: Quote, Profile, Research) could sell the Plan B contraceptive without a prescription. The agency's top women's health official resigned in protest.
The FDA also faced a string of drug safety controversies during Crawford's tenure. Some critics charged the agency with being too slow to react to signs of serious side effects from Merck & Co. Inc.'s (MRK.N: Quote, Profile, Research) recalled painkiller Vioxx and other medicines.
Thanks to Barbara Kincaid for sending along a link to Jones Day's announcement about the IRS's new proposed intermediate-sanction regulation. According to the firm:
On September 8, 2005, the IRS released a set of Proposed Regulations that set forth the standards the IRS proposes to use to determine whether to revoke the § 501(c)(3) status of an organization that has engaged in a transaction that constitutes both traditional private inurement and an excess benefit transaction. Under these Proposed Regulations, organizations that attempt in good faith to follow good corporate governance and compliance practices both before and after a private inurement problem occurs will survive with their tax-exempt status intact. Those organizations that do not follow good corporate governance and compliance practices will lose their tax-exempt status.
Want to know more? Here's what one of my favorite sites (www.Regulations.gov) has on it:
|TITLE:||Standards for Recognition of Tax-Exempt Status if Private Benefit Exists or If an Applicable Tax-Exempt Organization Has Engaged in Excess Benefit Transaction(s)|
|SUBJECT CATEGORY:||Income and excise taxes: Excess benefit transactions|
|View this Regulation in HTML Format|
|View this Regulation in PDF Format|
|CFR Citation:||26 CFR 1, 53|
|Published:||September 09, 2005 [FR Doc. 05-17858]|
|Comments Due:||December 08, 2005|
|How to Comment:||Submit a Comment on this Regulation|
Send submissions to: CC:PA:LPD:PR (REG-111257-05), room 5203, Internal Revenue Service, POB 7604, Ben Franklin Station, Washington, DC 20044. Submissions may be hand delivered Monday through Friday between the hours of 8 a.m. and 4 p.m. to: CC:PA:LPD:PR (REG-111257-05), Courier"s Desk, Internal Revenue Service, 1111 Constitution Avenue, NW., Washington, DC. Alternatively, taxpayers may submit comments electronically via the IRS Internet site at http://www.irs.gov/regs or the FederaleRulemaking Portal at http://www.regulations.gov (IRS-REG-111257-05). A public hearing may be scheduled if requested.
Friday, September 23, 2005
So, here I am worrying about whether there will be a sufficient supply of flu vaccine this year and along comes this article in the New York Times examining two recent studies concerning the efficacy of the vaccine. I guess I can start worrying about this now. According to the Times,
Just as governments around the world are stockpiling millions of doses of flu vaccine and antiviral drugs in anticipation of a potential influenza pandemic, two new surprising research papers to be published Thursday have found that such treatments are far less effective than previously thought.
"The studies published today reinforce the shortcomings of our efforts to control influenza," wrote Dr. Guan Yi, a virologist at the University of Hong Kong, in an editorial that accompanied the papers. The two studies were published early online by The Lancet, the London-based medical publication, because of their important implications for the coming flu season.
In one paper, international researchers analyzed all the data from patient studies on the flu vaccine performed worldwide in the last 37 years and discovered that vaccines showed at best a "modest" ability to prevent influenza or its complications in elderly people.
"The runaway 100 percent effectiveness that's touted by proponents was nowhere to be seen," said Tom Jefferson, a researcher in Rome with the Cochrane Vaccine Fields project, an international consortium of scientists who perform systematic reviews of research data.
"There is a wild overestimation of the impact of these vaccines in the community," he said. "In the case of a pandemic, we are unsure from the data whether these vaccines would work on the elderly."
In the second paper, researchers from the Centers for Disease Control and Prevention in Atlanta found that influenza viruses, particularly those from the dreaded bird flu strain, had developed high rates of resistance to the only class of cheap antiviral drugs available - drugs mainly used to treat flu once patients have caught it. These resistance rates have increased rapidly since 2003, particularly in Asia.
"We were alarmed to find such a dramatic increase in drug resistance in circulating human influenza viruses in recent years," said Dr. Rick Bright of the disease control centers. "Our report has broad implications for agencies and governments planning to stockpile these drugs for epidemic and pandemic strains of influenza."