blog.bioethics.net

The Role of Physicians in Executions. Can We Get Real?

Is there any reason whatsoever to involve doctors or nurses in executions? The December 27th St Petersberg Florida Times reports that the state of Florida has botched an execution and Governor Bush is trying to figure out what to do next. Whether you are pro or anti death-penalty (I am anti) there is no need to involve a doctor in killing prisoners. A trained executioner can do the job and ought to. There is no reason to lend the moral authority of medicine to state mandated killing.
- Arthur Caplan

Labels: conscientious objection, execution

The Year in Health Fads (NYT)

This wasn't the weirdest year in health fads, but as Emily Bazelon, Amanda Schaffer and the New York Times' Topos Graphics point out, it was not a slow year either. By month, here's their list of the fads:

January: Don't take cough medicine if you have a cold.

February: Get circumcised.

March: Sleeping pills make you fat. So can sleep loss.

April: Don't pray for the sick.

May: Try Botox for the blues... and the bladder.

June: Drink lots of coffee.

July: Smoke marijuana. O.K., not quite.

August: Don't eat a lot of soy. Unless you have cancer.

September: Beware of leafy vegetables.

October: Go fish.

November: Cut back on marathon running.

December: Don't take antidepressants if you're so depressed you're suicidal.

[thanks Art Caplan]

Labels: health fads

Dolly on the Dinner Table? Don't Worry About It

Art Caplan writes in his MSNBC column:

Dolly, the world's first cloned mammal, must be turning in her grave.

The Food and Drug Administration has declared that meat and milk from cloned animals is safe to eat, paving the way for cloned products to show up in grocery stores across the land, likely without any special labels or warnings. This makes sense because there is absolutely no evidence to show that there is anything unsafe about milk or meat from cloned cows, goats or pigs. (Actually, the FDA is holding off on deciding whether cloned sheep are a safe source of chops, saying not enough information is available yet.) But many of us hear the words "meat from cloned animals" and get queasy. Dolly, fairly or not, is to blame.

Dolly was a sweet-faced little sheep who bothered no one during her life. Her only impact on humanity was to give employment to countless novelists, journalists, TV producers, cult leaders, Hollywood screenwriters, politicians, comedians and, yes, bioethicists, who otherwise might have spent years wondering what they could do that would scare the daylights out of the American public while making either making them plenty of money or getting them elected in the case of the politicians. Remember Osama bin Laden and avian flu weren't in the news when Dolly's existence was announced to a completely freaked-out public in 1997.

Dolly, whose remains are on display at the Royal Museum of Scotland, spent her six years on earth as the object of scorn, fear, derision and slander. The media had a field day upon her birth telling us that Dolly was the key to resurrecting the dead, creating vicious clone armies and a world in which everyone would be trailed by a hapless clone whose internal organs would be available on demand to prolong lives threatened by disease or old age. Who could like a cloned animal when the technology that created her might lead to innumerable copies of Kevin Federline, Bob Saget or Nicole Richie?

But worse was to follow. Soon wacky cults like the Raelians and nutty scientists and semi-scientists like the incredibly fortuitously named Dr. Richard Seed and the ominously monikered Professor Panos Zavos were hollering about cloning rich people, cult leaders, and generally unsavory types to the rapt and stupefied attention of a media unable to discern the fact that dressing in a Star Trek uniform and displaying a very bad hair dye job did not prove your bona fides as the cloner most to be feared.

All of this nonsense set the stage for the next big scare about cloning, which was fueled by the debate over federal funding for embryonic stem cell research. Opponents of that funding found they got the greatest traction for their desire not to see federal funds spent by invoking the word "clone" over and over again. Funding embryonic stem cell research likely meant a pod person would move in next door, some high-profile Republican legislators as well as President Bush would lead you to believe.

All of this nonsense took a toll. It made Americans forget that cloning is nothing more than artificially creating twins. It made us forget that every drop of wine we drink comes from cloned grapes. It made us ignore the fact that if you want to worry about what you are eating you would be better off fretting over whether the FDA has enough inspectors on the job at meat plants looking for salmonella and E. coli than whether your dinner started off as a clone. Dolly got a bad rap. And it has stuck. But the FDA is right to follow the evidence and let products from clones enter the marketplace.

If people want these products labeled so they can choose not to buy them, that's their right. But, before you decide, remember the only thing you really have to fear from cloned animals is what human beings have done to ruin their reputations!

-Art Caplan

Labels: cloned cows, cloned meat, cloning, FDA, GMOs

He Had a Conscientious Objection to the Penis

My colleague Eric Feldman of Penn Law school tells me that when he was in Istanbul last week there was a story in the local paper about a nurse who said that his religious beliefs led him to refuse to help administer a testicular scan because he did not want to touch the patient's penis. Seems that there wasn't another available nurse, the scan was long delayed, and the patient died from testicular cancer. Ok all those in favor of respecting health care provider conscientious objection--weigh in please!
- Arthur Caplan

Labels: conscientious objection, penis, Turkey

Sometimes You Get the Bear, and Sometimes the Bear Gets Lucky

AP:

In the middle of Joshua Bush's forehead, two inches above his eyes, lies the evidence that prosecutors say could send the teenager to prison for attempted murder: a 9 mm bullet, lodged just under the skin.

Prosecutors say it will prove that Bush, 17, tried to kill the owner of a used-car lot after a robbery in July. And they have obtained a search warrant to extract the slug.

But Bush and his lawyer are fighting the removal, in a legal and medical oddity that raises questions about patient privacy and how far the government can go to solve crimes without running afoul of the constitutional protection against unreasonable searches and seizures.

"It's unfortunate this arguably important piece of evidence is in a place where it can't be easily retrieved," said Seth Chandler, a professor at the University of Houston Law Center. "You have to balance our desire to convict the guilty against the government not poking around our bodies on a supposition."

Investigators say that Bush was part of a group of gang members who broke into a used car lot and tried to steal vehicles. According to police, Bush tried to shoot businessman Alan Olive, and when Olive returned fire, a bullet struck the teenager and burrowed into the soft, fatty tissue of his forehead.

Prosecutor Ramon Rodriguez said gang members who took part in the robbery identified Bush as one of those involved. When he was questioned about a week later, Bush admitted taking part in the robbery but not the shooting, police said.

"The officers noticed the guy looks like hell. One of his eyes is black and he has a big old knot on his forehead," Rodriguez said. "He tells police he got hurt playing basketball."

A few days later, Bush went to the hospital and told doctors he had been hit by a stray bullet as he sat on a couch in an apartment.

"Officers started putting events together," Rodriguez said.

A judge took the unusual step of issuing a search warrant to retrieve the bullet from Bush's head in October. But a Beaumont doctor determined that small pieces of bone were growing around the slug, and he did not have the proper tools in the emergency room to do it. The doctor said that removal would require surgery under general anesthesia and that no operating rooms were available.

Police then obtained a second search warrant and scheduled the operation for last week at the University of Texas Medical Branch hospital in Galveston. It was postponed again, however, after the hospital decided not to participate for reasons it would not discuss.

Prosecutors said they continue to look for a doctor or hospital willing to remove the bullet.

All sides agree that removing the bullet would not be life-threatening. But Bush's family and attorney say it would be a violation of the teenager's civil rights and set a dangerous precedent.

"When the medical profession divorces itself from its own responsibility and makes itself an arm of the state, it's a dangerous path," said Rife Kimler, Bush's lawyer.

The used car lot owner, Olive, told police that after officers had left the scene following the robbery and he began cleaning up, a man appeared in a nearby alley and threatened to kill him if he helped authorities in their investigation. The man fired at Olive and a shootout followed.
"I just can't believe I missed him at that distance," Olive, a competitive pistol shooter, said in court papers. Olive told authorities he never saw the man's face in the dark alley.

Bush is in jail on charges related to the robbery, but not the shooting.

Tammie Bush, the teen's mother, disputed allegations her son is a gang member.

"We know he's not a criminal," she said. "He's a good kid."

Dr. Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, predicted Bush's rights as a patient will trump the state's desire to get the bullet, and said authorities might have a hard time finding someone willing to extract the slug.
"It truly is a moral quandary," Caplan said. "Doctors are caught between wanting to help solve crimes and their responsibility to patients' rights to refuse a procedure."

Labels: CSI, medical oddities, right to refuse

New England Journal, Conflict of Interest and Amgen

Quite a battle has broken out over the decision of the NEJM not to publish an editorial by Robert Steinbrook MD which is highly critical of the ways in which Amgen's Epoetin is prescribed in the U.S. There are no agreed upon maximum levels for hemoglobin and it appears as if Epo is being over prescribed at bigger than necessary doses by the for-profit dialysis industry. Steinbrook's editorial was published in the Lancet. Questions also have arisen about why the Journal chose to have Julie Ingelfinger write an editorial to substitute for Steinbrook's when she has close ties to the NKF--an organization that receives a significant percentage of its funding from Amgen.

It is still very clear that the management of conflicts of interest
for universities, journals, academic health centers and even
bioethics centers remains conflicted with no consensus on mimimal
rules or about what constitutes a conflict. The academic and
journal communities would be well-served in the coming year to
convene a blue-ribbon panel to write a report on COI that might serve
as the starting point for addressing the complex questions involved.

- Arthur Caplan

Labels: Amgen, Conflict of Interest, Epoetin, New England Journal of Medicine

Terri Schiavo's Father Robert Schindler Suffers Stroke

Terri Schiavo's dad Robert Schindler appears to have suffered a stroke. - Art Caplan

Labels: PVS, Schiavo, Schindlers, stroke

All Hail Sagan. A Lot.

Carl Sagan is being "blog-a-thoned" and the result is a tribute he'd doubtless appreciate - because it is not only built around the sort of media he imagined in Cosmos twenty plus years ago, but also because it isn't filled with the kind of UFO nonsense that plagued him every time he gave a speech.

Sagan arguably created the space (no pun intended) in which public intellectuals came to function as part of PBS, and suffered mightily for it among astronomers despite his considerable publication record and research. He was a showman, but as a showman he was also a great teacher and reached millions with what I think (and this is where I admit he's a hero of mine) was the single most important and coherent (as opposed to the manic "Connections" series) introduction to the relationship between human social and political life and the cosmos.
[hat tip: Greg Dahlman]

Labels: public intellectuals, science blogs

A[nother] Poet on Right to Die

Hunter S. Thompson and Timothy Leary and, well, now that I think about it lots of writers and figures whose lives represented a "stand on independence" with regard to death and experience have long found ways to build death into a narrative long before it occurs. In a memo from Rome in the New York Times, Italian Poet

Piergiorgio Welby is still full of words, hard and touching ones, that may be changing the way Italy thinks about euthanasia and other choices for the sick to end their own lives.

A vigil in Milan on Saturday supported Mr. Welby’s bid to have life support disconnected. “I love life, Mr. President,” Mr. Welby, 60, who has battled muscular dystrophy for 40 years, wrote to Italy’s president, Giorgio Napolitano, in September. “Life is the woman who loves you, the wind through your hair, the sun on your face, an evening stroll with a friend.

“Life is also a woman who leaves you, a rainy day, a friend who deceives you. I am neither melancholic nor manic-depressive. I find the idea of dying horrible. But what is left to me is no longer a life.”

Now Mr. Welby’s long drama appears to be nearing its final act. Last weekend, an Italian court denied legal permission for a doctor to sedate him and remove him from his respirator. Fully lucid but losing his capacity to speak and eat, he is deciding whether to appeal or to perform an act of civil disobedience that will kill him.

He is doing so in a very public way. Until a recent steep decline in his condition, he used a little stick to rapidly peck out blog entries with one hand. His book, “Let Me Die,” was just released. Near daily front-page stories chronicle the political, ethical and, with the Catholic Church a vital force here, religious issues his case presents.

“Dear Welby: Wait Before Taking Yourself Off” the respirator, read a front-page headline on Tuesday in La Repubblica, written by a top Italian surgeon, Dr. Ignazio Marino, who is also a senator for the Democrats of the Left. He had visited Mr. Welby the day before.

What has given the case a particular political twist is that Mr. Welby, attached to a respirator for nine years, has long been a spokesman for euthanasia and is a central part of the Radical Party’s effort to have it legalized. In fact, members of the Radical Party have offered to personally remove his respirator if asked — and may do so any day now in a frontal challenge to Italian law.

But the Catholic Church and many of this traditionally minded nation’s politicians on the left and the right not only oppose euthanasia generally but are also not entirely sure what to do about Mr. Welby’s case. He says he is not seeking to commit suicide but to remove himself from medical treatment he does not want.

“It is an unbearable torture,” he wrote two weeks ago.

[hat tip Sheila Otto]

Labels: Catholicism, euthanasia, Italy, withdrawal

Come on Baby Light My Fire ... Sort of

Bristol Myers Squibb is doing a good thing donating $100,000 but unfortunately the company is conveying the impression it is willing to do a lot more than it is.
- Art Caplan

Labels: pharmaceutical industry

Respecting the Dead in a Public Health Disaster

Sometimes public health imperatives conflict with deep human needs. Take respect for the dead: during the Ebola outbreak in Kikwit, Democratic Republic of Congo in the mid-1990's, international teams collected the dead in full protective gear, wrapped them in thick plastic bags, and unceremoniously buried them in pits. As Pulitzer prizewinner Laurie Garrett pointed out, traditional Congolese burial rites -- including washing the body of the deceased by family members -- helped spread this terrifying disease. Respect for the dead had to give way to epidemic control. Villagers could only watch as fearful aliens in bodysuits carted their dead loved ones away.

But it is not always the case, as the World Health Organization has pointed out this week. Dead bodies from natural disasters do not pose the same health risks as the corpses of those who have died from Ebola, though they are sometimes treated in analogous ways: doused in antiseptic, covered in lime, and dumped in mass graves. This, states the WHO, is totally unnecessary as far as disease spread is concerned, and undermines the mental health of the survivors. In an unintentionally amusing passage, the World Health Organization reassures the public that fatal victims of natural disasters are harmless, because they are really, really dead:

Those killed by natural disasters are generally healthy at the time of their death, and therefore very unlikely be a source of infection to others. The micro-organisms responsible for the decomposition of bodies are not capable of causing disease in living people. Most infectious agents of public health concern that may be present at the time of death will themselves die within hours of the person dying.

As far as post-disaster disease outbreaks go, survivors are far more likely to be their source than the dead are. That is why after a natural disaster occurs, the priority is to secure clean water and food for the living, rather than disposing of the dead in hasty and rude ways. Those who are doing this, please stop.
- Stuart Rennie

Labels: burial, death, disaster, public health

Art Caplan Stands Tall for the Man

From the Philadelphia Inquirer:

Back in the early '90s, Arnold Melman and George Christ were mocked when they suggested using gene therapy to cure impotence. After all, the futuristic form of medicine requires an often dangerous intervention into the genetic code. At the time, gene therapy was inspiring dreams of curing cancer, AIDS, and debilitating childhood diseases - not something as "frivolous" as erectile dysfunction.

Melman and Christ saw some vindication last week when the results of their first human study ran in the December issue of the journal Human Gene Therapy, along with a glowing editorial by University of Pennsylvania bioethicist Arthur Caplan.

And so, the dream of gene therapy might find its first widespread application in helping people have sex - a twist of events that opens new questions about medicine's role in enhancing the quality of life and our society's willingness to accept risks for the advancement of technology.

Labels: erectile dysfunction, gene therapy

Alan Milstein on Pfizer and Torcetrapib

The media coverage of the recent termination of the Pfizer torcetrapib clinical trial has been nothing short of startling in this age of aggressive investigative journalism. In short, the stories have been about Money, Money, Money. In announcing the halt of this experiment after a finding that human subjects had died because of their participation, the New York Times announced, “End of Drug Trial is a Big Loss for Pfizer.” Bloomberg broke the story by observing: “Pfizer Shares Drop After Company Abandons Cholesterol Drug.” The Toronto Star had a different take: ‘Drug Failure Cost Pfizer 23 Billion.”

In its front page story, the New York Times further added this remarkable conclusion: “Pfizer will not face the product liability lawsuits that have dogged Merck over its painkiller, Vioxx . . . Patients in clinical trials must sign waivers confirming that they understand the risks they face when they take unapproved medicines in clinical trials.” Do they?.

Why am I skeptical? Money. Money. Money. Pfizer had long touted this drug in meetings with shareholders, actual and potential, as the Mother of all Blockbusters. Could this potential have delayed the end of this experiment, even though some researchers had long warned that such drugs might actually pose more risks than benefits.

Two aspects of this trial, what surprisingly little we know about it, trouble me. First, the experiment took place largely in the offices of thousands of cardiologists across the country. What this means is that the subjects may have been induced to participate by their long trusted physician and signed on not to better mankind (or “Pfizer”) but because they believed their physician thought it was in their best therapeutic interest to do so. This might make the informed consent document neither voluntary nor informed.

Second, Pfizer says the delay in halting the trial was because this was a double blinded experiment with one arm taking Lipitor only and the other adding torcetrpib. Only when the data managing subcontractor removed the blinds were the devastating results revealed.

Call me naïve (I’ve been called worse), but why double blind a study where the data is comprised of good and bad cholesterol numbers? Does anyone believe there could be a placebo response that would raise good cholesterol? I have long advocated that the industry’s reliance on this “gold standard” is not always to eliminate researcher bias or that dreaded placebo response. Sometimes it is to keep subjects and physicians in the game. And if this had not been a double blinded study, could the ongoing results have been known to the physicians and disclosed to their patients earlier?
Alan Milstein

Labels: Alan Milstein, clinical trials, Pfizer, pharmaceutical industry

Get Off My Back

The world of medical devices if often rife with conflict of interest problems.
Art Caplan

[And the problems at the Clinic have received a lot of attention in AJOB including this editorial, and the whole mess there has become almost comical after the clinic held this preposterous and self-congratulatory conference on conflict of interest, as I noted - GM]

Ideas We Can Live Without: Physicians Killing Disabled Children

This 'idea' keeps floating up in Europe--Netherlands first and now the UK. Why isn't control of pain and suffering the the child adequate? This truly smacks of euthanasia driven by considerations of cost and lack of 'social value'.
-Art Caplan

A Fish Story

In this month's Scientist, I find myself lamenting the imminent end of ... fish. I am not sure why this bothers me so, or what for that matter we can do about the fish situation, but the fish thing is clearly a bellwether where the relationship between the production of humans' food and the state of the environment are concerned:

Eat first, then ethics" wrote German poet Bertolt Brecht. But even Brecht would be horrified by the "fish apocalypse" of 2048 that Boris Worm of Dalhousie University predicts in the November 3rd issue of Science. As far as fish are concerned, we appear to be eating not only first, but without forethought, and we never get around to the ethics.

The problem of diminishing saltwater fish populations is not a new one; the United Nations has reported consistently since the mid-1990s that all 17 of the world's major fishing areas have been fished to the point that sustainability is seriously in question for many if not most of the commercially harvested species there. The most famous fishing areas of North American lore, such as the Grand Banks and Georges Bank, have been closed and reopened with hardly any planning, as environmentalist and commercial political lobbies each win their way for a month, year, or decade, but never in a process that ends in stewardship of the oceans.

Those at the top of the fish business' food chain aren't doing so well financially, despite the appearance that industry prevails in matters of regulation of fishing. Both large commercial fisheries and small immigrant families with one boat in places like New Bedford, Mass., find themselves unable to eke out a living from tuna and swordfish and scallops. Fishing doesn't really make much money even for those who have become adept at vacuuming fish from the sea. In response, governments provide subsidies. That's not enough, however, to sustain fleets and shareholders, so companies turn from fishing cod and the like to fishing the sort of creatures that emerge from the sea so unpalatable that one knows immediately that they will have to be, as Wendell Berry put it, "prettified" until they no longer "resemble anything that ever lived."

Either way, as stocks of fish that were once commercially undesirable have plummeted, large fish, marine mammals, and even birds have been robbed of a big piece of their food chain. And that means we too are affected, as some of our most intimate ecosystems - those that protect and nourish our food and water supply - become, in collapsing, a toxic abyss. Fish species that live near coastlines, reducing the risk of red tide and providing detoxification to water supplies, are disappearing.

The threat of the ocean's imminent collapse is a new kind of issue for bioethics, which you might call "disaster ethics." The problem is that the public is simply uninterested in the catastrophic consequences of decimating fish stocks. Debates about ozone holes, stem cells, and the intelligence of the design of life simply pale in comparison to what is likely to happen to our oceans.

The most visible evidence of the ‘fish problem' is still invisible by comparison to Korean research fraud and votes on funding for stem cell research. But the fish story is more important by a long shot and requires actions far more simple than choosing a Senator: Stop eating creatures that are being fished to extinction, and tell your friends to stop, too.

In the remainder of the essay I get a bit more, well, actually, depressing. But if you love fish you may want to read the remainder.

On Stem Cells and Optimism:
A Lesson from Gleevec

A scientific conference on stem cells can be sobering. A few brave attendees sit in wheelchairs. Speakers from the UK and Australia, Israel and Singapore, and many other nations detail the government support and public enthusiasm for stem cell research, while the list of funding sources at the ends of the presentations from the U.S. reveal the sorry state of affairs here. Yes, rodent studies credit the government. But work attempting to derive human embryonic stem (hES) cells routinely acknowledges the Juvenile Diabetes Research Foundation, the Howard Hughes Medical Institute, the Michael J. Fox Foundation, the Christopher Reeve Paralysis Foundation, Project ALS, and other private supporters. When a panel of top stem cell researchers was asked, at the opening event of a recent stem cell conference, to name the single thing that could move the field forward in the U.S., a prominent investigator responded with one word: "impeachment."

The scene was the New York Stem Cell Foundation's (NYSCF) First Annual Translational Stem Cell Research Conference: Curing Disease from Lab Bench to Bedside, held at Rockefeller University October 23-24. The non-profit organization, dedicated to supporting research using hES cells and somatic cell nuclear transfer (SCNT), was co-founded in 2005 by Susan Solomon and Mary Elizabeth Bunzel because, in the words of Solomon, "we weren't satisfied with the pace of the field." These two remarkable women have children with type 1 diabetes. Among their many accomplishments, they managed to raise $10 million to fund a "safe haven" laboratory for stem cell research, whereabouts top secret. It's been described as a first stop on a scientific underground railroad of sorts. (No, I'm not making this up.) They also assembled a who's who of the field for the inaugural conference, which was a smash hit as far as I'm concerned.

As the talks began to wind down, though, I became uneasy, feeling overwhelmed with hopelessness. I struggled to keep up with the slides showing the complex signal transduction pathways that cells follow when deciding what to be, which one speaker compared to the blueprints for a rocket. I marveled at how much we still do not know, and began to worry about the stark disconnect between the public's oversimplified view of stem cell science (to quote the New York Times, "Stem cells are master cells that can evolve into blood, liver, muscles and other cells") and how utterly complicated the actual science is. Would the momentum from this wonderful organization be enough to truly sustain the "bench to bedside" trajectory? I thought not.

And then I remembered Erin Zammett Ruddy.

I met Erin just 2 hours before the stem cell conference began. She is an editor at Glamour magazine, a publication that I read religiously when I was her age, 28. (It also achieved fame as the object of George Costanza's sexual fantasies on a memorable Seinfeld episode.) When Erin was 23, she had a routine physical exam - she hadn't gone for awhile because she was so healthy and athletic - and learned, soon afterwards, that she had chronic myelogenous leukemia (CML). She has chronicled her "battle" with cancer since then in the pages of Glamour [here], and in a terrific book, "My (So-Called) Normal Life" (Overlook Duckworth, 2005). I had asked to meet with her about possibly telling her story in one of my biology textbooks.

I put "battle" in quotes because Erin never felt sick, although the bone marrow biopsies that she still undergoes were not quite a walk in the park. She looks the picture of health, a tall, striking natural redhead. The reason: Gleevec. If ever there is a miracle drug, this is it. And it all came to pass because of basic research into the mechanism behind a disease that once routinely killed children and young adults.

The story of Gleevec started on August 13, 1958, when two men entered hospitals in Philadelphia, complaining of weeks of fatigue. They had CML. Blood samples wound up in the laboratory of Peter Nowell, a young assistant professor at the University of Pennsylvania, and he and his graduate student, David Hungerford, found in those aberrant white blood cells a clue: a small, unusual chromosome, eventually dubbed the Philadelphia chromosome (Nowell & Hungerford). '

Fast forward to 1972. Janet Rowley, at the University of Chicago, applied the just-perfected new dyes that stained chromosomes into distinctive patterns, revealing that the telltale Philadelphia chromosome was built of parts of chromosomes 9 and 22 (Rowley). Within two years, researchers had identified the breakpoints where the two chromosome parts joined. Then researchers found that parts of two genes were shoved together at the breakpoint, their partnership forming an ominous oncogene that encodes an equally ominous "fusion" protein. The protein is an aberrant tyrosine kinase, a pretty common signaling molecule that binds a phosphate to another molecule, sending the cell a signal to divide. In CML, the deranged tyrosine kinase is active for too long, and the white blood cell cell divides ceaselessly. Leukemia results.

Once researchers knew what to fix, a rational treatment for CML became possible. Brian Druker, a hematologist then at the Dana-Farber Cancer Institute in Boston, working with researchers at Novartis, sorted through hundreds of small molecules to finally find one that fits into the pocket on the oncoprotein where phosphates would otherwise bind, without interfering with other signals. Much work crafted that molecule, as it was sculpted from "CGP57148B" to "STI571" to, finally, imatinib or Gleevec. (Druker et al). I remember being so astonished at the report in The New England Journal of Medicine that I read the same sentence in the abstract 3 times: "Complete hematologic responses were observed in 53 of 54 patients treated with daily doses of 300 mg or more and typically occurred in the first four weeks of therapy."

I'd read correctly. FDA approved Gleevec on May 10, 2001, 10 weeks after Novartis submitted the New Drug Application. Record time.

Gleevec has since transformed treatment of CML. It has found other applications, and new drugs are available that work when people become resistant to it. In September, Gleevec was approved as a front-line treatment for CML in children.

Thanks to Gleevec, Erin Zammett Ruddy never went bald, never bruised, and never felt too tired to work. On a microscopic level, she was healing too, achieving first "cytogenetic remission" (goodbye, Philadelphia chromosomes) and then "molecular remission" (goodbye fusion oncoproteins), terms that became part of her everyday vocabulary. Today she goes around the country as a spokesperson for the Leukemia and Lymphoma Society, educating young people about using Gleevec to keep their CML to undetectable levels.

And a most astonishing thing has happened, Erin told me. Noncompliance has become a problem! Some young people with CML -- never having experienced the chemo drip or the classic cancer-fear that turns your insides instantly to jelly and that only another cancer survivor can understand -- forget to take their Gleevec pills! They regard it as a nuisance! It's a new disease, this chemo-complacency. Neither Erin nor I get it.

So after the stem cell conference at Rockefeller, I headed back to the train station, growing depressed with my head replaying images of the morass of signal transduction pathways. How will treatments ever emerge? Won't it take years? But they can. And they will. For Gleevec led the way.

I look forward to the day when the greatest challenge that someone with (INSERT ONE: ALS, Parkinson disease, heart disease, Alzheimer disease, spinal cord injury, Huntington disease, diabetes, multiple sclerosis, or any number of illnesses and injuries we haven't yet thought of) faces is to remember to show up for a routine stem cell infusion. It will happen.

- Ricki Lewis

Endowed Chair in Ethics at AMBI Institution St. Rose

Among the institutions with whom we have had the most fun in AMBI is The College of St. Rose, literally one minute away from the Alden March Bioethics Institute's main offices, and home to our only theologian partners to date. The College has created an amazing new position that could really be a neat opportunity, not only to join the three new bioethics faculty in Albany this year and three more coming next year - including a new director for new graduate programs, but also to serve in a major endowed chair, The George and Jane Pfaff Endowed Chair in Ethics and Moral Values, and in so doing to help bring a broader perspective to the work at AMBI and in ethics in the New York capital. This is the third endowed chair in ethics created in the NY Capital district in five years, which I suppose just goes to show how much people care about ethics when they are so close to state politicians.

Physician, Shoot Thyself

Caplan and David Curry write about the real reluctant holdouts on the flu shot: healthcare workers!

National Influenza Vaccination Week has kicked off the annual push for each of us to ``get our flu shots.'' This year, new ad campaigns in major newspapers and media outlets are reminding us, and there are more convenient options to get your vaccination than ever before. This year, we are told, the supply of vaccine is more than adequate. And the reasons to get a flu shot haven't changed. In fact, the Centers for Disease Control and Prevention's recommendations now say more people should get a shot than ever before.

But one important group has been particularly resistant to getting the shots. And it's a group, if the members remain unvaccinated, that is in a position to do a lot of harm to those least able to protect themselves. Who are these holdouts? Health care workers! Surprised? You should be.

It would seem logical that health care workers -- doctors, nurses, nurses aides, physical therapists and other care givers -- should be first in line to get their flu shots, particularly those who work around babies or those with weak immune systems such as patients with AIDS or cancer. Health care workers, by definition, work with those who may have come to the hospital because they are sick. This makes these patients, as well as others in extended care facilities and even those receiving home care, prime targets for the flu bug. But only about 40 percent of health care workers choose to get a flu shot each year.

How can this be?

Well, the operative word is ``choose.'' For the most part, flu vaccination among health care workers is entirely voluntary. The evidence is clear that unvaccinated doctors, nurses, dentists and health care workers increases the risk of flu infecting and sometimes killing patients. But we are reluctant to require that health care workers get flu shots. The value we place on voluntary acceptance of medical procedures -- including getting a vaccination -- wins out, even for those who are at the greatest risk of getting and spreading a deadly disease.

Hospitals and other health care facilities often conduct expensive and time-consuming annual awareness campaigns among their health care professionals and workers to improve flu-vaccination rates. These programs often include bringing vaccination carts to where the workers are during the workday. They don't even have to walk down the hall to get their shot. But breaking through that 40 percent vaccination rate has been tough.

Some states have legislation requiring annual influenza vaccination of health care workers, but provide an option for what is called ``informed declination.'' That means workers have an option to actually sign a form saying they decline to get the flu vaccine. Apparently, making flu vaccination a condition of employment is beyond the capability of even our largest and most sophisticated hospitals.

What to do? One thing is to ask those taking care of us if they have gotten their flu shot. The other is to push public-health departments and legislators to mandate flu shots for health care workers.

Suppose your elderly mom is in the hospital. Let's say her health condition makes her particularly vulnerable to the flu. The roughly 40 percent rate of flu vaccination for health care workers means that two in three of the people caring for her are not vaccinated. Do you have the right to ask that health care workers who interact with your parent get the flu vaccine? Why not? You should ask those providing health care: ``Did you get your flu shot this season?'' And don't forget the person who brings the food tray, changes the bedding or installs the cable TV. Asking may be embarrassing, but it will remind health care workers to do the right thing.

It is time to move public policy in the direction of mandatory flu vaccines for all appropriate health care employees. Choice is a key value for us all, but spreading infection among the sick is too high a price to pay for that choice. We should not have to wonder whether the person taking care of us, our newborn or our elderly parent has gotten a flu shot.

Pfizer Stock Plunges

Pfizer stock plunge was predicted by the Star-Ledger, not a difficult guess after the makers of Lipitor brace for the impact of the implosion of their "replacement blockbuster":

Pfizer's shares are expected to plunge this morning in the wake of the sudden demise of its promising cholesterol medicine. And a drop in the company's value may be just the start of a sweeping makeover of the New York drugmaker, which is expected to accelerate cost-cutting, including layoffs, and possibly rethink its entire marketing-driven business model.

As recently as Thursday, Pfizer executives were touting torcetrapib as its next blockbuster. But Saturday night the company was forced to abandon development of torcetrapib when an independent board monitoring a study recommended the work end because of an unexpected number of deaths and adverse cardiovascular events...

Torcetrapib represents a day of reckoning, of sorts, for the Pfizer sales and marketing juggernaut. Wall Street analysts said Pfizer's marketing organization doesn't have the stable of products to power the company past the problems plaguing the entire pharmaceutical industry.

"Pfizer has escaped the onslaught over the past 25 years. Now it's Pfizer's turn," said Hemant Shah, a pharmaceutical analyst at HKS & Co. in Warren

Hat tip: Art Caplan

New Jersey Ready to Pay for Stem Cell Research...

Philadelphia Inquirer reports that

After almost two years of maneuvering, lawmakers are poised to approve a $500 million plan aimed at making New Jersey a national leader in stem-cell research.

The effort to fund the controversial embryonic work was a centerpiece of Gov. Richard J. Codey's short administration but failed to win wide legislative support.

The plan is to spend $150 million on a stem-cell research facility in New Brunswick, $50 million on a research building in Newark, and $50 million to construct a Systems Biology Institute in downtown Camden. It would also give $10 million to each of two North Jersey blood-collection and research facilities.

Voters would be asked to approve borrowing $230 million to fund stem-cell research grants for the scientists working in those buildings.