Wednesday, June 22, 2005
Four African countries - Nigeria, Uganda, Ethiopia and Tanzania - are refusing to allow delivery of generic AIDS drugs that the US Food and Drug Administration has approved. According to the Boston Globe, these countries have told South African generic drug maker Aspen Pharmacare that "its FDA approval for antiretroviral drugs have no standing in their regulatory review of medicine, and that they have long required a study of the drug's safety and quality from the WHO. " The effect of this is a delay of delivery of the lower cost medicine to patients.
Many US, UN, and African officials are now asking the WHO to immediately approve the FDA-tested drugs and Dr. Kim, WHO's head of HIV/AIDS program, says he will approve the drugs quickly. He adds that the Africans' reliance on WHO standards "shows the importance of our process, and the strength of our relationship with the countries."
This conflict stems from the lack of coordination between parallel US and UN drug regulators, which makes it difficult for the US to rapidly increase treatment in regions hardest hit by the AIDS/HIV virus. Last year US officials said they would buy generic AIDS drugs for Africa as long as those medicines met the same safety standards established for sale in America. They said WHO standards would not ensure the same quality standard, and the US rejected an option to send US scientists to Geneva to assist the WHO. US officials argue that confusion over safety and quality of certain generic medicines caused by the WHO in its approval and disapproval process has caused several African countries to switch treatment regimens.
Paul Zeits, head of the Global AIDS Alliance, criticizes the US, arguing that if US officials had "started a regulatory system that everyone could have agreed to more than a year ago, we would have been much farther along...[the US] has created the controversy."
Establishing a parallel review system between WHO and the US global AIDS program has proven to be difficult. Dr. Mark Dybul, deputy coordinator of US global AIDS program says that "we've been blamed by quite a few people about delaying procurement of drugs by going through a stringent regulator before we make the drugs available. And now we have the premier stringent regulatory agency in the world..or one of them..find that the drugs meet all the requirements, and then we have the inability to use the drugs." Dr. James Makumbi, chairman of the National Drug Authority in Uganda defends their position by saying that "asking for WHO approval is partly historical and because of our membership in the organization...This is how we've been doing things for time immemorial. We don't ask for FDA approval. I think this is basically a problem with the FDA interacting with the WHO, because the WHO can always endorse the US regulator's review."
The FDA tentatively approved two generic versions of a major AIDS drug on Monday. According to the AP, the two tentative approval applications for neviraprine tablets go to two companies in India, Ranbaxy Laboratories Limited and Aurobindo Pharma LImited in Hyderabad. The drugs can be used by relief organizations outside the United States funded by the US AIDS relief plan. Last year some criticized the administration for refusing to purchase drugs that hadn't been reviewed by the FDA, and in effect, were bolstering the sales of US drug makers at the expense of AIDS patients in the developing world.
Thanks to Lindley Bain for her work on this post. [tm]
National Public Radio's Morning Edition ran a story this morning concerning some new and potentially troubling developments in human embryonic stem cells. The story summary states,
Scientists have uncovered problems that may limit the usefulness of human embryonic stem cells. After several months of growing in a lab, the cells exhibit genetic abnormalities. Scientists will have to address that issue before stem cells can be used to treat disease.
For the full story, click here. [bm]
For those of you working on research on a health topic pertaining to women, you may be interested to know that the Journal of the American Medical Association is sponsoring a women's health issue March 2006 and has issued a call for papers. More information is available here. [bm]
Tuesday, June 21, 2005
An article in today's Wall Street Journal (paid subscription required) has a provocative thesis:
Anesthesiologists pay less for malpractice insurance today, in constant dollars, than they did 20 years ago. That's mainly because some anesthesiologists chose a path many doctors in other specialties did not. Rather than pushing for laws that would protect them against patient lawsuits, these anesthesiologists focused on improving patient safety. Their theory: Less harm to patients would mean fewer lawsuits. . . .
Over the past two decades, anesthesiologists have advocated the use of devices that alert doctors to potentially fatal problems in the operating room. They have helped develop computerized mannequins that simulate real-life surgical crises. And they have pressed for procedures that protect unconscious patients from potential carbon-monoxide poisoning.
All this has helped save lives. Over the past two decades, patient deaths due to anesthesia have declined to one death per 200,000 to 300,000 cases from one for every 5,000 cases, according to studies compiled by the Institute of Medicine, an arm of the National Academies, a leading scientific advisory body.
Malpractice payments involving the nation's 30,000 anesthesiologists are down, too, and anesthesiologists typically pay some of the smallest malpractice premiums around. That's a huge change from when they were considered among the riskiest doctors to insure. Nationwide, the average annual premium for anesthesiologists is less than $21,000, according to a survey by the American Society of Anesthesiologists. An obstetrician might pay 10 times that amount, Medical Liability Monitor, an industry newsletter, reports.
Imagine that. Tort law works. [tm]
There appears to be much discussion at the AMA annual meeting this week in Chicago concerning prescription drugs. Yesterday, the AMA approved a measure supporting legislative initiatives in a number of states that require pharmacies to fill legally valid prescriptions. The AMA is having some greater difficulty agreeing on prescription drug advertising. According to the Chicago Tribune,
The American Medical Association on Tuesday is expected to authorize a comprehensive study examining whether advertising drugs directly to consumers leads to additional costs, unneeded prescriptions or other negative side effects.
The AMA's 543-member policymaking body had been expected to put forth a policy on drug advertising, but lively testimony Sunday at this week's AMA meeting in Chicago prompted a committee of the AMA to defer a vote and refer the issue for more study.
AMA officials said the referral to the board keeps the issue alive until a future meeting but allows for more scientific input and research about legal remedies that could be used to rein in drug ads.
The AMA's discussion of drug ads has been so heated that Illinois Gov. Rod Blagojevich entered the fray Monday, sending a letter to the AMA urging it to support a ban amid rising drug costs and increased concerns over drug safety that have arisen from large pharmaceutical ad campaigns.
AMA support of drug ad regulation would fuel action by Congress or the Food and Drug Administration to curtail drug ads, many observers believe.
Several delegations within the AMA want the national doctors group to take a concrete stand that pushes for more regulation, but there has been enough opposition expressed to prompt at least a deferral.
Some doctors said the industry is already curtailing ads, while other doctors, such as psychiatrists, say ads for antidepressants have helped get patients into their offices who would not otherwise come in for treatment.
With the Department of Justice investigating the government's handling of the racketeering case against the tobacco industry, Judge Kessler is now urging settlement. According to the Washington Post,
The judge presiding over the government's troubled racketeering case against the tobacco industry summoned cigarette companies' chief executives, their lawyers and Justice Department attorneys for a closed-door meeting yesterday and urged both sides to settle the case.
U.S. District Judge Gladys Kessler explained in a court order late in the day that she closed the meeting to the public because she considered it "a routine, informal discussion with the parties urging them, once again, to consider the advantages of settling the case rather than the risks of litigating it." . . . .
Kessler's urging that the parties settle comes as the government's civil racketeering suit is in political turmoil and viewed with suspicion by anti-tobacco advocates. The government had claimed that America's six largest tobacco companies engaged in a 50-year conspiracy to conceal the dangers of smoking from the public -- and should have to pay to help 45 million Americans quit smoking.
But the Justice Department stunned activists during closing arguments June 7 when it announced it would seek $10 billion for smoking-cessation programs instead of the $130 billion that government lawyers previously argued was needed. Since then, news reports have said that senior political appointees at the Justice Department pressured career department lawyers to reduce penalties and soften the testimony of government witnesses. Yesterday's meeting was the first opportunity for Kessler to meet with the parties since the eight-month trial ended June 9 and the allegations of political interference were reported. If the parties do not settle, Kessler will decide whether the industry engaged in a fraudulent conspiracy and what penalties, if any, it should face.
From LawProfBlogMaster Paul Caron:
- This Essay provides readers with a unique perspective on the world of law teaching: Employing a quirky methodology, Professor Stadler predicts which subjects are likely to be most (and least) in demand among faculties looking to hire new professors in future - rating those subjects, like so many stocks, from "strong buy" to "weak buy" to "weak sell" to "strong sell." To generate the data on which her methodology is based, Professor Stadler catalogued, by subject, almost every Article, Book Review, Booknote, Comment, Essay, Note, Recent Case, Recent Publication, and Recent Statute published in the Harvard Law Review between and including the years 1946 and 2003. In the end, she found an interesting (and, she thinks, predictive) relationship between the subjects on which faculty choose to write and the subjects on which students choose to write.
Larry Solum says "I love this essay!" -- and I agree. After all, Sara rates tax as one of her "strong buys". [I guess I'd add the same comment, because health is rated a "strong buy," as well.]
|Strong Buy||Weak Buy||Weak Sell||Strong Sell|
|Family-Gender||Int’l & Comp||Crim Law/Pro||Con Law|
|Labor & Emp||Law and...||Legal History||Jurisprudence|
Monday, June 20, 2005
Salon.com (available with subscription or by viewing brief ad) has an interesting article by Robert F. Kennedy, Jr. concerning the use of thimerosal in a variety of childhood vaccines. He alleges that a study revealed that mercury in childhood vaccines may have caused autism in thousands of children. This piece concerns a highly charged controversy and one with many different viewpoints as to what might cause autism (which seems to be a very popular diagnosis right now). In addition, the piece deals with allegations that Congress was ready to immunize the pharmaceutical manufacturers from liability surrounding their vaccines and their relationship to childhood illnesses.. Salon also has several other articles on the same topic - discussing the parent perspective as well as some of the science.
Associate Professor Steve P. Calandrillo at the University of Washington has an excellent article in the University of Michigan Journal of Law Reform entitled, "Vanishing Vaccinations: Why Are So Many Americans Opting Out of Vaccinating Their Children?," which addresses the controversy from a somewhat different standpoint, noting the many holes in the scientific evidence proving a link between the vaccines and autism. Full cite for the article is: 37 U. Mich. J.L Ref. 353 (2004). [bm]
Update: ABC news will be running an interview with Robert Kennedy Jr. in which he will discuss some of his allegations against the pharmaceutical companies. No word on when exactly the interview will air.
Maternal and Child Health has an interesting article on why increased rehab services, as opposed to long prison, are not available for those who suffer from alchol and drug dependance. The answer relates partially to the the prison guard lobbying. The post reads,
Alex at Marginal Revolution argues that it in California, at least, one reason that users go to prison instead of getting drug treatment is lobbying by prison guard unions. The guards apparently view drug treatment as competition.
The prison guard unions typically have monopolies and do lobby for tougher sentences. The California Correctional Peace Officers Association, for example, has spent millions shamelessly creating a front of victim’s rights groups who campaign against drug rehabilitation programs instead of jail, revising the three strikes law, and reducing sentences.
Sunday, June 19, 2005
Saturday, June 18, 2005
This article discusses some interesting research on the differences between the male and female brain and what those differences may mean. It is an interesting read and the Witelson seems to be quite the fascinating researcher with quite a large collection of human brains. According to the article,
Witelson is convinced that gender shapes the anatomy of male and female brains in separate but equal ways beginning at birth.
On average, she said, the brains of women and men are neither better nor worse, but they are measurably different.
Men's brains, for instance, are typically bigger — but on the whole, no smarter.
"What is astonishing to me," Witelson said, "is that it is so obvious that there are sex differences in the brain and these are likely to be translated into some cognitive differences, because the brain helps us think and feel and move and act.
"Yet there is a large segment of the population that wants to pretend this is not true."
No one knows how these neural differences between the sexes translate into thought and behavior — whether they might influence the way men and women perceive reality, process information, form judgments and behave socially.
But even at this relatively early stage in exploration of the brain's microanatomy, battle lines between scientists, equal rights activists and educators have formed.
Some activists fear that research like Witelson's could be used to justify discrimination based on gender differences, just as ill-conceived notions of human genetics once influenced laws codifying racial stereotypes about blacks, Asians and Jews.
Thanks to Heather Lutz for bringing this article to my attention. [bm]
Michael Selgelid of the University of Sydney has published the paper "Ethics and Infectious Disease" in which he claims that "bioethics suffers from a misdistribution of research resources" and that "the general topic of infectious disease has received relatively little attention from the discipline of bioethics in comparison with things like abortion, euthanasia, genetics, cloning, stem cell research, and so on." He argues that infectious diseases deserves more attention due to historical and potential future consequences of infectious diseases such as the Black Death, small pox, AIDS, and SARS. Possible ethical questions having to do with infected person infecting the rest of the population could involve infringing on basic human rights and liberties by surveillance, isolation, and quarantine. Another ethical consideration is balancing the "utilitarian aim of promoting public health" and the "libertarian aims of protecting privacy and freedom of movement." He also points out that the poor face, especially in third-world countires, suffer from infectious disease disproportionately. I appreciate research assistant Lindley Bain's help with this post. [tm]
Friday, June 17, 2005
To speed up IT utilization in healthcare, Senators Bill Frist and Hillary Clinton have introduced a bill (summary) that would establish legal safe harbors allowing hospitals and other organizations to extend their IT systems and allow data to be easily exchanged over a secure network. According to Health Care IT News, the exceptions to federal Stark and anti-kickback laws would allow healthcare providers to share IT tools as long as they are used to exchange health information, as well as create standard quality measures to better assess the value of federal programs. Modernhealthcare.com reports that the bill will provide $625 million over five years for regional and local healthcare information technology projects. Supporters of the bill include AFL-CIO, U.S. Chamber of Commerce, Ford Motor Co., General Motors Corp, American Medical Group Association, the Healthcare Information and Management Systems Society, and the Joint Acreditation of Healthcare Organizations. One aim of the bill is to legislatively codify the Office of the National Coordinator for Health Information Technology in HHS. A permanent IT standards work group made up of representatives from federal agencies and the private sector and chaired by the coordinator would adopt recommendations as standards for the federal government and voluntary data standards for the private sector. See the analysis of the bill. Clinton and Frist have said that IT's use in healthcare will eliminate inefficiency, reduce costs, and improve care. This is one of several healthcare IT bills introduced in the Senate in the past week or so. Thanks to law student research assistant Lindley Bain for her help on this post. [tm]
DHHS' Office of Human Research Protection (OHRP) has concluded that "some AIDS drug experiments [at Columbia University Medical Center/New York Presbyterian Hospital] involving foster children violated federal rules designed to ensure vulnerable youths were protected from the risks of medical research," according to this morning's Washington Post. (Our earlier posts on this subject were on May 4 and May 24.)
The government cited Columbia Presbyterian in a letter dated May 23 with violating rules in at least four AIDS studies involving foster children, including:
Failing to "obtain sufficient information regarding the selection of wards of the state and foster children as research subjects."
- Failing to "obtain sufficient information regarding the process for obtaining permission of parents or guardians for wards of the state or foster children."
- Failing to have enough information to ensure the selection of patients for the studies was "equitable" . . . .
[An AP news story on May 4] prompted a congressional hearing, at which experts testified that the standards for enrolling foster children in medical experiments varied widely across the country. Some lawmakers complained that the foster kids had fewer protections than prisoners.
The OHRP's determination letter is here. [tm]
Thursday's New York Times reports that politics may have been involved in the recent reduction in penalty against the tobacco companies from $130 billion to $10 billion. The article states,
At the close of a major trial that dozens of Justice Department lawyers spent more than five years preparing, the department stunned a federal courtroom last week by reducing the penalties sought against the industry, from $130 billion to $10 billion, over accusations of fraud and racketeering.
The decision generated protests from health advocates and Democratic lawmakers, who accused the Bush administration of political motives, and it prompted an internal departmental inquiry. But details of the behind-the-scenes debate over the issue had remained a mystery.
The department has vigorously defended the decision, denying political motives and saying the $10 billion reflected an effort to arrive at a figure that would comply with an adverse decision from an appellate court this year that some officials said sharply limited the types of sanctions the department could seek. The department did not dispute the authenticity of the memorandum but declined to make Mr. McCallum or other lawyers available to discuss it.
A spokesman for the department, Kevin Madden, said political considerations were never factored into the decision to reduce the penalty.
"This was a decision that was made on the merits of the case and that strictly followed the law," Mr. Madden said.
In light of the appellate court ruling, he said, "a decision was made by the department that the best argument for the government to make was one that would preserve credibility in the government's case with the trial judge, would result in a favorable decision from the trial judge and would result in a trial court decision sustainable upon appeal."
The newly disclosed documents make clear that the decision was made after weeks of tumult in the department and accusations from lawyers on the tobacco team that Mr. McCallum and other political appointees had effectively undermined their case. Mr. McCallum, No. 3 at the department, is a close friend of President Bush from their days as Skull & Bones members at Yale, and he was also a partner at an Atlanta law firm, Alston & Bird, that has done legal work for R.J. Reynolds Tobacco, part of Reynolds American, a defendant in the case.
SCOTUSblog has some further thoughts about the Supreme Court's recent decisions in Spector v. Norwegian Cruise Lines; a case involving the application of Title III of the ADA to foreign cruise ships.
Also, during the January Annual Meeting of the Association of American Law Schools, the maritime law section will be discussing this case in more detail. Here is a brief line-up of the speakers and a brief description of their talks:
Jack Beermann (BU) on problems of civil rights litigation in this context
Looks like a terrific program! [bm]
And those people appear to be not only her parents, but the Governor of Florida, Jeb Bush, who asked for an investigation of some discreptancies that appear in Michael Schiavo's timeline concerning when he called the cops when his wife's heart stopped beating fifteen years ago. Read it and weep:
Refusing to give up on the Terri Schiavo case, Gov. Jeb Bush has asked Pinellas prosecutors to sort out time discrepancies Michael Schiavo has provided regarding the hour he found his wife unconscious 15 years ago.
State Attorney Bernie McCabe has agreed to review the time elements in the case, his chief assistant, Bruce Bartlett, said Thursday.
"We are going to look into the circumstances surrounding the times," said Bartlett, who declined to label the review an investigation. "The governor has expressed concern over that aspect of the case."
Michael Schiavo has said he called 911 immediately after finding his wife collapsed on the floor of their home on Feb. 25, 1990. Though medical records indicate he called 911 about 5:40 a.m. that day, he told the Medical Examiner's Office recently that he found his wife about 4:30 a.m.
The detail fueled suspicions by Terri Schiavo's parents, Bob and Mary Schindler, that Michael Schiavo had some wicked connection to their daughter's collapse and may have delayed his call for help.
"I think this is a very troubling gap in time," Schindler attorney David Gibbs III said Wednesday. "Michael Schiavo needs to step forward and explain."
Michael Schiavo's attorney, George Felos, said if he did give a different time than previously, it was simply a mistake in recalling a detail of an event 15 years ago.
"I think it's preposterous and ludicrous that if Michael did say 4:30 or 5 or something like that, that there's any issue," Felos said. "The opponents of Terri Schiavo's wishes are intent on creating a controversy in this case where none exists."
They say that all good things must come to an end - what about bad things?? [bm]
There's a good article in today's New York Times about the rising post-Schiavo interest in living wills, both on the part of folks who want to be sure that life-sustaining treatments aren't employed beyond a certain point and on the part of those who want to get the full metal jacket approach, as well as many others in between. The problems inherent in living wills (inability to draft a document that is expansive enough or detailed enough to cover all contingencies) is alluded to in the article's comparison of living wills vs. medical powers of attorney. Angela Fagerlin and Carl Schneider fairly trashed living wills in their article in the Hastings Center Report last year, and -- even though I am not persuaded that livings wills don't do more good than harm for most patients most of the time -- their views are worth considering, too. The Boston Globe had a good article on the Fagerlin/Schneider position earlier this year (Drake Bennett, "Are Living Wills the Answer?, April 3). [tm]
The New England Journal of Medicine has published an article by Alta Charo in which she addresses the issue of physicians, nurses and pharmacists claiming the right not only to refuse to provide services they find objectionable, but also to refuse to refer patients to another provider and to inform them of the existence of legal options for care. She offers the example of a bill introduced in the Wisconsin legislature:
[It] would permit health care professionals to abstain from "participating" in any number of activities, with "participating" defined broadly enough to include counseling patients about their choices. The privilege of abstaining from counseling or referring would extend to such situations as emergency contraception for rape victims, in vitro fertilization for infertile couples, patients' request that painful and futile treatments be withheld or withdrawn, and therapies developed with the use of fetal tissue or embryonic stem cells. This last provisions would mean, for example, that pediatricians without professional penalty or threat of malpractice claims could refuse to tell parents about the availability of varicella vaccine for their children, because it was developed with the use of tissue from aborted fetuses.
She comments on physicians who claim that the right to practice their religion requires that they not be made complicit in any practice to which they have moral or religious objections . She adds that "the professionals involved seek to protect only themselves from the consequences of their actions - not their patients." This "conscience without consequence" trend can be attributed to the emerging norm of patient autonomy and the abortion wars. She says that patient autonomy has eroded the professional stature of medicine, and with that, the notion of extraordinary duty. The article then addresses the necessity of collective obligation and a genuine system for counseling and referring patients so that every patient like their doctor can act according to her own conscience.
The fight leading up to two days of voting on Sunday and Monday mobilized the nation's political and religious establishments like few others, as the leadership of the Roman Catholic Church - including the new pope, Benedict XVI - urged Italians to boycott the referendum.
In the end, the outcome was not even close. Only 26 percent of as many as 50 million eligible Italians voted, meaning that the referendum automatically failed, with the votes uncounted, in its attempt to repeal four crucial sections of a restrictive fertility law passed last year. For the referendum to be valid, 50 percent of eligible voters had to take part.
The results would seem an immediate victory for the church and for the young papacy of Benedict, in a Europe where church influence has declined significantly in recent decades. Similar referendums in Italy on divorce and abortion in the 1970's and 80's passed overwhelmingly despite church opposition, and Italians now seem likely to debate whether apathy or a reverse in secularism in the home of the Roman Catholic Church defeated this referendum.
My favorite quote from the story, "The results of today mean that Italy is maybe more similar to Texas than to Massachusetts," said Rocco Buttiglione, Italy's culture minister and a friend of Pope Benedict. "Italians want a democracy with values - that values human life - and that is why they rejected this referendum." Mmmm - perhaps they don't know about Texas and the death penalty . . . [bm]