Criminal Law I: promoting off-label uses of approved drugs

Today's New York Times has an article about the recent arrest and prosecution of Dr. Peter Gleason for promoting use of the drug Xyrem, which is approved by the FDA for the treatment of narcolepsy, for the off-label treatment of depression and pain.

Now, it's horn-book law that physicians can use approved drugs for off-label uses. And it's equally well-settled, though perhaps a little less well-known, that pharmaceutical companies cannot themselves promote their approved drugs for nonapproved (or "off-label") uses without formal FDA approval; they have to limit their claims for the drug's safety and efficacy to those uses for which they submitted data to the FDA and received that agency's marketing approval. (Max Mehlman has a good essay on this. The FDA's rule is here.)

But it is apparently perfectly okay for a pharmaceutical company to pay a physician to promote the off-label use of the company's approved drug or, as the Times article puts it: "Despite the F.D.A.’s constraints on drug makers, though, the companies are allowed to hire independent doctors to talk to other physicians about their medicines. Companies can also sponsor 'continuing medical education' sessions, ranging from lunches to weeklong conferences, where specialist doctors tell other physicians about the latest developments in their fields — including off-label uses for drugs already on the market. For such speaking engagements, doctors can receive $3,000 or more a day from the companies."

So how did Dr. Gleason get into so much trouble? It's not that clear. Perhaps the FDA decided to rein him in because it viewed his claims concerning Xyrem's safety -- i.e., that it was as safe as table salt and safe for children -- extravagant and dangerous, considering that its active ingredient is GBH (the "date rape drug"). Or perhaps it's because Dr. Gleason did not agree to cooperate with the government's investigation of his former benefactor, Jazz Pharmaceuticals, which has not yet been charged with anything. What is clear is that the FDA's rules don't provide much guidance for this practice and the basis for a criminal prosecution in Dr. Gleason's case is shaky at best. Stay tuned . . . .

Texas hospitals and immigration

There was a terrific article in The New York Times this past week on the different approaches taken by the public hospitals in Dallas County (Parkland) and Tarrant County (JPS), separated by about 40 miles and a river and a very different view of their missions. This country isn't close to figuring out a humane and sensible approach to immigrant health care, and the conflicts and contradictions are illustrated well by this story. For my money, the approach of the Parkland CEO, Dr. Ron Anderson, is best: "I don’t want my doctors and nurses to be immigration agents."

House fails to override presidential veto

The House failed to override Pres. Bush's veto of H.R.810 by a vote of 235-193, almost the identical vote when it was originally passed by the House in May. Not exactly earth-shattering news, but I offer it for the sake of closure if nothing else.

An excellent primer on the stem cell issue

Everything a reporter might need to know to cover this story intelligently -- and the rest of us will find helpful as well -- has been collected, organized, linkified, synthesized, and analyzed by Al Tompkins at the Poynter Center in last Friday's edition of Al's Morning Meeting. Thanks to AJOB's blog for the tip.

President signs fraudulent Fetus Farming Prohibition Act

The news stories on the president's veto haven't mentioned the other bill that was sent to him for his signature, but now that a transcript of the veto/signing ceremony is available from the White House, I can report that he has signed S.3504, the purpose of which is "to prohibit any person or entity involved in interstate commerce from: (1) soliciting or knowingly acquiring, receiving, or accepting a donation of human fetal tissue knowing that a human pregnancy was deliberately initiated to provide such tissue; or (2) knowingly acquiring, receiving, or accepting tissue or cells obtained from a human embryo or fetus that was gestated in the uterus of a nonhuman animal. Imposes fines and/or imprisonment for violations of this Act." It was introduced about a month ago, had no hearings, and produced no committee reports. The nonexistence of this "problem" was conceded by Congressman Joe Barton at the beginning of the House debate on this bill yesterday:

I rise today in the strongest possible support of S. 3504, the Fetus Farming Prohibition Act. Every so often, we deal with a subject on this floor that is so ugly that the language almost is unable to qualify and quantify that ugliness. Today is one of those moments. When you know what fetus farming is, words like obnoxious and repugnant seem timid.

As we know, fetus farming is the gruesome idea of creating a human fetus purely for research to harvest its organs. This bill would ban that practice, and we cannot ban it, in my opinion, soon enough. Most scientists today share the belief that human life should not be created just for the purposes of experimentation, or for harvesting the organs of one person to be given to another. The vast majority of scientists in our Nation uphold the ethical and moral principles on which our country forever rests, the inalienable right to life and the inherent value of human life in whatever form it may take.

These scientists are working tirelessly with the knowledge that their efforts are to benefit life, benefit humanity, not to benefit one person for profit at the detriment of another person.

Unfortunately, Mr. Speaker, we have seen clear examples in other countries that some scientists see things somewhat differently.

It is towards these scientists that the pending legislation is directed. Rather than waiting for a horror story to appear on the front pages or allowing for the possibility of scientific advancement taking us down a slippery slope, this bill gives a clear signal that fetus farming in all of its forms will not be tolerated in the
United States, nor will we allow human fetuses or embryos to be bought and sold for research like cattle.

Cong. Rec. H5345 (July 18, 2006)(emphasis added).

President carries out veto threat on stem-cell measure

The AP's Mary Dalrymple reports that President Bush has vetoed H.R.810. Here are his reported remarks:

"This bill would support the taking of innocent human life of the hope of finding medical benefits for others. It crosses a moral boundary that our society needs to respect, so I vetoed it," Bush said at a White House event where he was surrounded by 18 families who "adopted" frozen embryos that were not used by other couples, and then used those leftover embryos to have children.

"Each of these children was still adopted while still an embryo and has been blessed with a chance to grow, to grow up in a loving family. These boys and girls are not spare parts," he said.

I suppose you can admire his consistency on this issue, though I am more inclined toward Art Caplan's comment that it's a foolish and uninformed consistency. As for the shameless display of of these 18 kids, no one (1) ever doubted that frozen embryos have the capacity to be implanted in a womb and nurtered to maturity or (2) suggested that children so produced were merely "spare parts." That comment well illustrates the vacuousness of the president's policy. And unless I miss my guess, there isn't a state in the country that allows couples to adopt an embryo. Embryo donation is expressly permitted in a number of states, and many (but not all) have paternity rules for the resulting child, but adoption of an embryo? Outside of the federally-funded Snowflakes program -- which appears to result in a purely private, contractual arrangement -- I don't know of a state that has provided for such adoptions by law.

Caplan on Bush's veto of stem-cell bill

Art Caplan is at his best today in his column about Bush's promised veto of H.R.810. Here are the opening and closing paragraphs:

President Bush’s embryonic stem cell policy began with lies and has now ended with one.

Bush reserved his first veto as president for one of the only valuable things this do-almost-nothing Congress has managed to actually get done.

With a flourish of a veto pen that has remained dormant no matter how dopey Congress has been, the Senate bill allowing public funding of embryonic stem cell research has been consigned to the legislative trash can. . . .

With his veto the president has now reaffirmed a policy that never made any sense, garnered no scientific support to speak of, was abandoned by both houses of Congress and the leaders of his own party and, most importantly, got no traction with those most in need of the benefits of the research — patients and their families.

The president has now told doctors, researchers and patients to drop dead. Science policy in the Bush administration is best made in the White House, not by scientists and not by Congress.

HCA nearly bought out in recent days

The Wall Street Journal reports (link good for 7 days) that a group of private investors, including members of the founding Frist family, nearly consummated a buyout of HCA over the weekend. With a market capitalization of $17.6 billion, HCA's sale would have been one of the largest in recent memory. It apparently cratered because of the size of HCA's debt ($11 billion), which left the parties about 10% apart on the price. This morning, traders took the attempted buyout as a clear signal that HCA management regards its stock as undervalued in the market. As a result, according to a late-morning story on WSJ_online, HCA's stock price is up 1.5% this morning, while its junk bonds are down sharply.

Stem cell minuet proceeding almost as planned; Bush set to veto the most meaningful of three bills

Congress' action on three stem cell bills yesterday and today's expected veto of one of them by President Bush are front-page stories in this morning's Washington Post and New York Times, as was the case in the Dallas Morning News and I suspect most of the dailies around the country. As previously discussed here, this has been a carefully choreographed performance by the Congressional leadership and the White House to give them two fairly meaningless bills (S.2754 and S.3504) the president can sign -- giving the GOP a little defense to play when their Democratic opponents this fall claim the Republicans are against stem-cell research -- as well as another bill (H.R. 810, which would extend federal research support to stem cells derived from leftover IVF embryos) whose veto will allow Republicans to point to their vigilant protection of human life from the moment of conception on.

The House voted on S. 3504 (the Fetus Farming Prohibition Act) yesterday (roll call vote 379). The Senate's roll call votes are here: S. 3504 vote, S.2754 vote, and H.R.810 vote. The only wrinkle in the whole scenario occurred when the House failed to pass an amended version of S.2754, the Alternative Pluripotent Stem Cell Therapies Enhancement Act (roll call vote 380). The bill got enough votes (273) to pass on a straight up-or-down vote, but a 2/3 vote (285 in favor) was needed to pass it on an accelerated "suspension" calendar. As a result, the president may have only one bill he can sign today, unless something happens in the House this morning. Alternatively, according to the Washington Post, it's possible the president will wait until he has all three bills before he vetoes H.R.810.

Tenet physician and 2 nurses arrested for murder in Louisiana

According to the state's attorney in Louisiana, a physician and two nurses euthanized four patients in LifeCare Hospitals' long-term-care unit at Tenet's 603-bed Memorial Medical Center in New Orleans in the days after Hurricane Katrina devastated that city. (Modern Healthcare). The three were arrested, charged with four counts of second-degree murder, and released on personal recognizance bonds.

As reported by Associated Press (courtesy of the Houston Chronicle):

Memorial Medical had been cut off by flooding after the Aug. 29 hurricane swamped New Orleans. Power was knocked out in the 317-bed hospital and the temperature inside rose over 100 degrees as the staff tried to tend to patients who waited four days to be evacuated.

In court papers, state investigators said Pou told a nurse executive three days after the hurricane that the patients still awaiting evacuation would probably not survive and that a "decision had been made to administer lethal doses" to them.

Overdoses of morphine or Versed can stop the heart and lungs.

The allegations are that the three administered lethal doses of morphine (a pain killer) and Versed (a sedative). The AP story continues: "Tammie Holley, an attorney for about a dozen families whose relatives died at Memorial, said the presence of the sedative in addition to morphine is important in determining whether the staff members intended to kill. Versed, or midazolam, is used to induce unconsciousness before surgery, according to a medical Web site. 'If it was only morphine, there would be no way to know if they were administering it to control their pain,' Holley said.

• press release from the office of La. Attorney General Charles C. Foti, Jr., which includes the following statement: "I believe this case is a strong one and that these charges are based on sound legal and medical evidence. I also believe that there may be more arrests and victims that cannot be mentioned at this time and that this case is not over yet. While I am aware of the horrendous conditions that existed after Hurricane Katrina ravaged New Orleans and left so many stranded without food, water, electricity and the basic necessities, I believe that there is no excuse for intentionally killing another living human being. The fact is, the law was broken and it is my job to seek justice for the victims in this case. It gives me no pleasure to report what happened here today and my heart goes out to the families and loved ones of those victims."
  
• no press release from Tenet (press releases are posted here), although it has been quoted as saying through a spokesman: "Euthanasia is repugnant to everything we believe as ethical health care providers, and it violates every precept of ethical behavior and the law. It is never permissible under any circumstances."

Personally, I am inclined to believe that these cases involved attempts to provide pain control and relieve suffering for dying patients who last hours in a hellish environment would otherwise have been wretched. "Double-effect euthanasia" is easy to misinterpret, since so much depends upon the intent of the health-care professional, but there are medical facts that are more or less consistent with an intent to treat, as opposed to an intent to kill, and we will have to know more of those facts before a firm opinion is possible.

The AP story addresses this through Steve Miles:

Dr. Steven Miles, a professor of medicine at the University of Minnesota's bioethics center, said that instead of trying to kill, it is more likely that those charged were trying to relieve patients' pain "in a resource-poor environment and were doing the best they could."

He said that there are documented cases where patients have required seemingly lethal morphine doses to relieve extreme pain, and that he doubts the charges will be proven. "I'm inclined to believe this was palliative sedation that's been misread," Miles said.

Mercy killings would be "not only highly frowned upon, but also rare," Miles said. "It's highly unlikely that's what happened here."

Art Caplan and Steve Miles are also quoted in a later AP story, "Ethicists: No Way to Justify Mercy Deaths" (courtesy of Newsday).

Union boss to Fortune 500 CEO's: let's reform health care together

Andy Stern is president of the Service Employees International Union and in today's Wall Street Journal (link good for at least 7 days), he makes the case for moving health care away from the employer-provided model and toward "a universal system that provides affordable coverage, choice of doctors and insurance plans, core benefits, and shared financing among employers, employees and government." Government leaders won't do the job, Stern writes, so it's up to the CEOs -- "the people who revolutionized medicine, communication, technology, entertainment and investing" -- to provide the leadership on health-care reform.

SSRN roundup: health law

The 5 top-downloaded health law articles on SSRN:

1. Safe Storage Gun Laws: Accidental Deaths, Suicides, and Crime
   Yale Law School, Law & Economics Working Paper No. 237
   John R. Lott Jr. and John E. Whitley
   American Enterprise Institute (AEI) and University of Adelaide - School of Economics
   Date Posted:May 22, 2000
   Last Revised:June 10, 2002
   Working Paper Series 8966 downloads
2. Abortion and Crime: Unwanted Children and Out-of-Wedlock Births
   Yale Law & Economics Research Paper No. 254
   John R. Lott Jr. and John E. Whitley
   American Enterprise Institute (AEI) and University of Adelaide - School of Economics
   Date Posted:May 16, 2001
   Last Revised:June 5, 2001
   Working Paper Series 5758 downloads
3. Stability, Not Crisis: Medical Malpractice Claim Outcomes in Texas, 1988-2002
   Columbia Law and Economics Working Paper No. 287
   U Illinois Law & Economics Research Paper No. LE05-002
   U of Texas law, Law and Econ Research Paper No. 030
   Journal of Empirical Legal Studies, Vol. 2, pp. 207-259, 2005
   Bernard S. Black , Charles Silver , David A. Hyman and William M. Sage
   University of Texas at Austin - School of Law , University of Texas Law School , University of Illinois College of Law and Columbia Law School
   Date Posted:October 25, 2005
   Last Revised:January 23, 2006
   Accepted Paper Series
   1624 downloads
4. What the Publisher Can Teach the Patient: Intellectual Property and Privacy in an Era of Trusted Privication
   Stanford Law Review, Vol. 52
   Jonathan Zittrain
   Oxford Internet Institute
   Date Posted:March 9, 2000
   Last Revised:June 30, 2000
   Accepted Paper Series
   1248 downloads
5. TRIPs, Pharmaceuticals, Developing Countries, and the Doha 'Solution'
   U Chicago Law & Economics, Olin Working Paper No. 140
   Alan O. Sykes
   University of Chicago Law School
   Date Posted:February 19, 2002
   Last Revised:March 7, 2002
   Working Paper Series
   1026 downloads

Twenty-five thousand downloads. Whew!

Capital punishment and organized medicine: still a no-go in Mo.

As reported in this morning's New York Times, U.S. District Judge Fernando J. Gaitan, Jr., previously "had demanded an overhaul of the system after the doctor who now mixes the drugs for the state described an improvised process that Judge Gaitan found so chilling that he temporarily barred executions in Missouri."

In a sworn deposition, the Missouri doctor, whose name is being withheld by the state, acknowledged that he had sometimes given the condemned a smaller dose of anesthesia — used to reduce the pain of the lethal drugs to come — than the state had said was its policy.

The doctor said he was solely responsible for counting out dosage amounts of the three drugs administered in sequence, knew of no written protocol by the state for carrying out executions and was at times “improvising.”

He also said he is dyslexic, sometimes mixing up phone numbers or cable bill account numbers. “So it’s not unusual for me to make mistakes,” the doctor, identified in court records as John Doe I, said.

He indicated in his testimony, however, that he had made no mistakes in his death chamber work and that the mistakes elsewhere were “not medically crucial.”

Judge Gaitan said he was “gravely concerned” about the doctor’s dyslexia and criticized the lack of “checks and balances,” ruling on June 26 that the state was subjecting the condemned to “an unnecessary risk that they will be subject to unconstitutional pain and suffering when the lethal injection drugs are administered.”

The judge ordered Missouri to hire a board-certified anesthesiologist (John Doe I is a surgeon), and gave the state until today to submit a formal, written set of procedures, including increased monitoring of inmates and an assurance of sufficient anesthetic drugs.

But in the state’s filing last night, officials said they had sent letters to 298 certified anesthesiologists who reside anywhere near the state’s death chamber in Bonne Terre, and were turned down by all of them.

The nub of the problem, of course, is that "[t]he American Society of Anesthesiologists and the American Medical Association [Op. E-2.06] say physicians should not take part in executions, and Orin F. Guidry, the president of the A.S.A., recently issued a letter to members reiterating that position in light of the Missouri ruling." Dr. Guidry's description of the ASA position on physician participation is a little more nuanced than The Times lets on, but the ASA apparently comes out the same place as the AMA: "ASA does not have a detailed position on anesthesiologist participation in lethal injection but the 2001 House of Delegates 'Approved a recommendation that ASA support the American Medical Association’s position regarding physician nonparticipation in executions.' . . . . Clearly an anesthesiologist complying with the Missouri ruling – and despite this court’s position on ethical obligations - would be violating the AMA position which ASA has adopted. It is my belief that the court cannot modify physicians’ ethical principles to meet its needs."

Guidry ends his letter with some blunt observations:

We are being reluctantly placed on a slippery slope. If the courts demand that inmates be sufficiently anesthetized, then I would have to agree with the court that the only way to assure that would be to have an anesthesiologist prepare and administer the drugs, carefully observe the inmate and all pertinent monitors, and finally to integrate all this information. I don’t think that any of us would want to say that untrained individuals under current death chamber conditions can reliably produce a satisfactory level of unconsciousness. Our core skill is that we can induce an appropriate level of anesthesia. Are we willing to say that untrained individuals can also do so with a reasonable degree of success?

However if the only way to accomplish this appropriate level of anesthesia is with an anesthesiologist using all of our tools AND anesthesiologists will not participate, then are anesthesiologists stopping capital punishment and making public policy?

Not in my opinion. Lethal injection was not anesthesiology’s idea. American society decided to have capital punishment as part of our legal system and to carry it out with lethal injection. The fact that problems are surfacing is not our dilemma. The legal system has painted itself into this corner and it is not our obligation to get it out.

Has the Texas legislature made performing abortions a capital offense?

That's the question raised by a recent request for an Attorney General's Opinion (RQ-0501-GA). The literal question posed by David Swinford (R) (chair of the House Committee on State Affairs) is a bit more technical than that, of course:

Does a physician’s failure to comply with the requirements of either § 164.052(a)(18) (restricting third-trimester abortions performed on viable unborn children) or § 164.052(a)(19) (requiring parental consent for abortions performed on unemancipated minors) of the Texas Occupations Code, as provided by § 1.42 of S.B. 419 (2005 TEX. GEN. LAWS ch 269, § 1.42) subject the physician to liability under the criminal homicide provisions of ch. 19 of the Penal Code?

As reported in this morning's Kaiser Daily Women's Health Report, which drew heavily from a story in yesterday's Austin Statesman-American, Swinford wants to test an interpretation of the new law by the Texas District and County Attorneys Association:

The analysis says that because it is illegal both for abortions to be performed on a minor without the consent of a parent or guardian and for a physician to perform a third-trimester abortion, doctors who perform them could be prosecuted for murder. The analysis -- written by Shannon Edmonds, the group's director of governmental relations -- says, "This was undoubtedly an unintended consequence but one that law enforcement authorities should be aware of." Edmonds, who said he is unaware of any such prosecutions, said, "After every (legislative) session, there are changes in the law that are real head-scratchers, some intentional and some are unintentional. ... This is just a way to illustrate how unintentional consequences can result in something extreme" (Embry, Austin American-Statesman, 7/13). Swinford, who disagrees with the interpretation of the law by the TDCAA, said the law is intended to provide
criminal penalties for the failure of physicians to obtain parental consent or to comply with restrictions on abortions conducted at or after 28 weeks' gestation, but "certainly not to subject a physician to prosecution for capital murder."

Both the Kaiser report and the news story missed a crucial part of the story. Shannon Edmonds' analysis turns on a little-discussed amendment to the Penal Code in 2003 that expanded the definition of "individual" in the homicide portion of the Penal Code to include an unborn child at any stage of development starting at conception. Although the Penal Code exempts physicians who perform lawful abortions, that exemption wouldn't apply to physicians who perform unlawful abortions. And since the 2005 amendments to the Occupations Code make it unlawful for a physician to perform most late-term abortions or abortions on minors without parental consent (subject to a judicial-bypass provision), the argument would be that physicians who violate the new provisions would fall outside the 2003 law's exception for lawful abortions.

This is almost undoubtedly not what the legislature intended. With the Texas Legislature, though, you can never be quite sure. And by providing specific, lesser penalties for violations of the Occupations Code, the Legislature could be understood to have intended these penalties as an alternative to the Penal Code's death penalty. But when it comes to harsh penalties and the Texas Legislature, you can never be quite sure.

Pain control and end-of-life care are not simply their own reward

Excellence in end-of-life care and pain management are also sometimes rewarded by others, in this case by the AHA, which recently gave nurse practitioner Peg Nelson and St. Joseph Mercy Hospital in Pontiac, MI, its Circle of Life Award (which includes $10,000). This article from the Detroit Free Press has the details of their approach to end-of-life care.

Senate votes to allow drug reimportation by individuals

On Tuesday, the Senate approved (68-32) S. Amdmt. 4548 to H.R. 5441 (Department of Homeland Security Appropriations Act, 2007): "To prohibit the United States Customs and Border Protection from preventing an individual not in the business of importing a prescription drug from importing an FDA-approved prescription drug." As reported by The New York Times on Wednesday, the House is unlikely to get a chance to vote on the Senate's amendment: "[A]ides said that as in past years, the provision was likely to be removed when the legislation got to a conference committee of House and Senate lawmakers who will negotiate the final version."

Drug reimportation is extremely popular with voters, but Sen. Judd Gregg (R-N.H.) had his own reasons for opposing reimportation: "Referring to a leading cholesterol-lowering drug, . . . Gregg . . . said, 'If I were a creative terrorist, I would say to myself, "Hey, listen, all I’ve got to do is produce a can here that says ‘Lipitor’ on it, make it look like the original Lipitor bottle, which isn’t too hard to do, fill it with anthrax."'" But, hey, who needs to be a creative terrorist when our senators are dreaming up doomsday scenarios and sharing them with the national press corps?! And in any event, what's to stop that terrorist from doing the same thing with a bottle of Tylenol right here in the U.S.? Sorry, Senator, your argument doesn't persuade me that the Administration's (and your) opposition to reimportation is about anything more than keeping profits up for Big Pharma. Sure, there are a handful of drugs for which special handling (such as refrigeration) is required to avoid a loss in potency, but those can be excluded from the rule that allows reimportation, or special requirements can be added to try to ensure drug safety.

NYC unveils pandemic preparedness plan

From today's CDC Public Health Law News:

"City unveils a plan to identify, and contain, a flu pandemic" -- The New York Times (07/11/06) Diane Cardwell [link]

New York City Mayor Michael R. Bloomberg and city health commissioner Thomas R. Frieden this week announced a new plan to address avian influenza preparedness. The plan details the steps for identifying and containing an outbreak and distributing scarce resources such as antiviral medications. "The fact that New York is a major gateway to the nation and one of the world's most densely populated cities means the possibility of pandemic flu, however remote, is one that we must take extremely seriously," said Bloomberg. The plan stresses early detection to help contain the pandemic, so health officials have taken steps to strengthen communication with doctors and to monitor information about ambulance runs, pharmacy sales, and emergency room visits. In the event of an outbreak, in which the city estimates more than 2.5 million New Yorkers could be infected, officials said they would use traditional methods of containing the virus by encouraging certain behaviors among the public. "It's low technology, but it works: covering your mouth when you cough or sneeze; not going out if you have fever and cough. These are very important things people can do to reduce the spread of infection, and if there were a pandemic, they would be our first line of defense," said Frieden.

[Editor's note: To read the New York City Pandemic Influenza Preparedness and Response Plan, click here.]

Senate stem-cell vote set for next Tuesday

Laurie Kellman of The Washington Post has the story on the upcoming Senate vote on three stem-cell research bills, which were first discussed here two weeks ago:

The Senate will vote next week on three bills related to stem-cell research, including a measure that would expand federal funding for a procedure that uses and destroys human embryos in the drive to cure diseases that afflict millions of Americans [H.R. 810].

The Senate is expected to pass that bill, which would send it to the White House for President Bush's signature. Bush has promised to veto the measure, effectively killing it because neither chamber of Congress has displayed the two-thirds majority needed to override it.

That would be the end of the story, a victory for social conservatives, but for two issues: The Senate debate set to open Monday occurs late in a year of midterm elections, and polls show 70 percent of Americans support the embryonic stem cell bill.

So Senate Majority Leader Bill Frist, R-Tenn., who supports the bill and has spent a year trying to bring it to the floor, succeeded last week by promising opponents to also hold votes on two other stem cell measures they could support and Bush could sign [S.2754 and S.3504].

In a delicate election-year balancing act, Frist also will bring up a measure that would ban so-called "fetal farming," described as growing fetuses for the sole purpose of harvesting tissue. The other would fund research for stem cells derived from adults.

The House would then act quickly to pass the two non-controversial bills and all three would be sent to Bush for his signature. Bush would veto the embryonic bill and sign one or both of the others, giving him and social conservatives in Congress fresh evidence to present to voters this fall that they support stem cell research.

The current issue of Health Affairs is dedicated to public health. There are some terrific articles, but I particularly commend these:

• Can Public Health And Medicine Partner In The Public Interest? [link]
  J. Michael McGinnis
  Abstract: The dominant issues for health and health care today can be effectively engaged only if public health and medicine work together as better partners. Yet historical, professional, organizational, operational, and financial barriers exist to closer relationships. Fostering the necessary collaboration will require changes for both public health and medicine in leadership styles, professional education, practice incentives, accountability measures, and financing structures.

• What Does Social Justice Require For The Public’s Health? Public Health Ethics And Policy Imperatives [link]
  Lawrence O. Gostin and Madison Powers
  Abstract: Justice is so central to the mission of public health that it has been described as the field’s core value. This account of justice stresses the fair disbursement of common advantages and the sharing of common burdens. It captures the twin moral impulses that animate public health: to advance human well-being by improving health and to do so particularly by focusing on the needs of the most disadvantaged. This Commentary explores how social justice sheds light on major ongoing controversies in the field, and it provides examples of the kinds of policies that public health agencies, guided by a robust conception of justice, would adopt.

NH court: Doc has 1st Amendment right to be a jerk

As reported by the Associated Press, New Hampshire judge Edward Fitzgerald "has ordered the state Board of Medicine to stop disciplinary proceedings against a doctor accused of telling a patient she was so obese she might only be attractive to black men and advising another to shoot herself following brain surgery." The article reports that Terry Bennett, M.D., says "he planned to sue everyone involved for 'malicious prosecution.'

"'I am not inclined to be forgiving about it,' he said. 'It's been devastating and infuriating.'"

New Hampshire Public Radio aired a good piece on the matter, including comments by medical ethicist Larry McCullough (tough love -- and tough speech -- may be what the doctor ordered and is within the bounds of standard medical practice) and Vermont medical professor Virginia Hood (offensive speech can cause harm).

There are a few excerpts from the judge's opinion in an article in the Manchester Union-Leader.

This case raises some interesting issues. First, can it possibly be true that a medical board can't decide that certain speech constitutes unprofessional conduct and punish a licensee for engaging in such conduct, even if the speech is otherwise protected by the First Amendment? And second, the First Amendment cuts both ways. Recall the 2002 Ninth Circuit decision that First Amendment rights of physicians meant the federal government couldn't revoke the drug licenses of California physicians who recommended marijuana to their patients (Conant v. Walters).