Stem cell risks can be high

A heartbreaking story is coming from Israel today about a boy with a lethal brain disease whose parents -- out of desperation -- sought experimental stem cell therapy and ended up adding to their son's problems.

The boy has ataxia telangiectasia, or A-T, a degenerative brain disease that robs children of movement, while an accompanying faulty immune system leads to frequent infections and cancers. Most die in their teens or early 20s.

At age 9, the boy's parents took him to Moscow for stem cell treatment. Such clinics are located in several East European countries. In this hemisphere, Tijuana, Mexico is a favourite destination. By the time he was 13, tumours had formed on his brain stem and his spinal cord. The spinal cord tumour was eventually removed. Researchers in Israel concluded the stem cells caused the tumours to form.

The case, written up this month in the journal PLoS Medicine, has sparked warnings from stem cell researchers for patients to stay away from such clinics.

“Patients, please beware,” said Dr. John Gearhart, a stem cell scientist at the University of Pennsylvania who wasn’t involved in the Israeli boy’s care but who sees similarly desperate U.S. patients head abroad to clinics that offer unproven stem cell injections.

“Cells are not drugs. They can misbehave in so many different ways, it just is going to take a good deal of time” to prove how best to pursue the potential therapy, Gearhart said.

Last fall, I wrote in the Star about a Canadian couple hoping to go to Tijuana for stem cell treatment after the wife had a brain stem stroke. They knew it was a desperate move, but felt compelled to try it anyway. As the husband said, "If I didn't at least try, I couldn't live with myself."

It is such sentiments, critics say, that the clinics prey upon.

Stem cell researchers get impatient

US President's Barack Obama's preference to work with Congress has got stem cell researchers, anxious to have federal funding limits lifted, feeling a little left out, according to a report in the Los Angeles Times.

When he was a candidate, Obama told the website sciencedebate2008.org that he would reverse Bush's restrictions on federal funding for the research "through executive order." Immediately following his campaign victory, transition director John Podesta told reporters that the stem cell order would be one of the first priorities.

But Obama recently signalled in remarks to Democratic lawmakers that he intended to wait for action in Congress.

Wary of a delay, one prominent advocacy group sent Obama a letter recently saying that he had pledged to revoke the Bush order.

"We wanted him to know that we were still counting on the campaign commitment," said Amy Comstock Rick, president of the Coalition for the Advancement of Medical Research.

Senior Obama adviser David Axelrod told Fox News on Sunday that action could come soon.

Obama also reassured stem supporters during a new conference last week that he would soon restore the federal funding halted by his predecessor, George Bush,  who banned the use of federal funds for embryonic stem cell research.

The stem cell researchers join a number of liberal groups that had hoped Obama would act faster on their causes, and are worried what the delays might mean for his grass-roots support and the emphasis he has placed on getting broad congressional support even though the Democrats control the Congress.

Obama has been president for less than a month, and his liberal critics concede that the economic crisis has understandably taken the focus off their issues. But some of the issues in play were crucial to building excitement on the left and mobilizing grass-roots support for Obama's candidacy.

"He made very clear promises, and he should live up to them," said Arthur Stamoulis, director of the Oregon Fair Trade Campaign, which received an unqualified "yes" from Obama on a campaign questionnaire last year when the group asked if he would support "Buy American" requirements. "The fact that he's hedging on this is not promising. He's catering much too much to the desires of Republicans who are not going to support the change that voters wanted."

Thea Lee, policy director of the AFL-CIO, said, "We would like to have him stand more forthrightly behind the positions that he took during the campaign." 
 

Funding IVF saves money

With all the controversy over multiple births recently -- octuplets born to Nadya Suleman in California and twins born to 60-year-old Ranjit Hayer in Calgary -- I reported in the Toronto Star today about studies showing that simply funding in-vitro fertilization might help alleviate the issue of so many multiple births.

And save some money in the process.

In Canada, patients pay an average of $10,000 for IVF treatments. If the procedure fails, they must pay the fee each time they try again. As a result, most couples opt to implant multiple embryos to ensure that at least one will survive to term.

"The lack of funding creates that tension, which moves people toward (implanting) two rather than one," says Dr. Edward Hughes, a professor of obstetrics and gynaecology at McMaster University and medical director at ONE Fertility clinic in Hamilton. "They want to improve their chances."

Health economics analyst Lindy Forte calculates that each multiple birth child costs medicare an extra $598,000 over its lifetime.

Here's a breakdown of the overall costs:

Covering IVF under medicare would cost the Ontario government between $70 million and $130 million a year, says Forte, but that would be more than made up for by savings in long-term health care costs. The savings, she says, could be as high as $155 million a year in Ontario alone.

The cost breakdown is:

• $40 million a year in perinatal costs when the babies are born.

• $25 million in health costs in the first year for low birth weight babies.

• Between $70 million and $90 million in long-term health and social services costs to care for children with permanent disabilities as a result of pre-term birth.

Across Canada, Forte says, the cost of covering IVF under medicare would be between $120 million and $200 million, while the cost savings would be between $230 million and $260 million.

"The cost of funding the IVF cycle is completely offset," she says.

The problem, however, is that many people seeing using IVF as a personal choice. Forte counters that  "Infertility is a medical problem and all couples have the right to reproduce."

Of such disputes are ethics debates made.

Obama, God and stem cells

U.S. President Barack Obama gave comfort last week to stem cell researchers in his country by repeating his commitment to ending Washington's ban on embryonic stem cell research.

"I guarantee you that we will sign an executive order for stem cells," Obama said in response to a question from Rep. Jim Langevin (D-R.I.) during a private meeting with House Democrats last Thursday.

That sort of comment doesn't leave much wiggle room, comfort for those scientists concerned that the new president hasn't already reversed the funding ban imposed by Obama's predecessor, George W. Bush.

Bush brought in his ban to preserve the sanctity of life, as he saw it, a reflection of his religious views.

What's interesting about last week's comments, then, is that Obama -- also a religious man -- invoked God's name in his support for stem cell research.

"God gave us power to make smart decisions, to cure diseases, to alleviate suffering."

Speaking for many in the scientific community, Lawrence R. Soler of the Juvenile Diabetes Research Foundation urged Obama to move quickly.

"Signing an executive order now is the single most important action needed to allow scientists to fully explore the promise of stem cell research. ... With a stroke of his pen, the president can change the pace of science." 
 

First octuplets, now an old woman's twins

Hot on the heels of a California woman, Nadya Suleman, having octuplets after receiving fertility treatment comes news that a Calgary woman, Ranjit Hayer, used in-vitro fertilization to have twins at the age of 60.

And the ethical debate over who should or should not be allowed to have babies was revved up even higher, raising some important access to care issues.

Her own obstetrician, Dr. Colin Birch, voiced doubts, telling the CBC that he couldn't reconcile himself with the idea of a 60-year-old woman getting in-vitro fertilization.

"It's going against nature. It's going against so many different things. The nature and the body has said that unfortunately you've made it to 60 and haven't had children. Unfortunately, there is some reason for that," Birch said.

"Sixty is not an optimal time to be gestating an offspring, not to mention lactating and caring for an offspring," said Juliet Guichon, who teaches bioethics at University of Calgary faculty of medicine.

While much of the debate has focused on the women in the two cases, ethicists are also starting to question why their doctorswent along, at least in the case of the octuplets.

Patients have a right to ask for treatments, and doctors have a responsibility to listen to them, the ethicists say -- but doctors also have a responsibility to say no when the circumstance demand. How they decide such things and navigate the tricky waters of the doctor-patient relationship is why more and more hospitals are hiring professional ethicists.

A 2005 study by Toronto's Joint Centre for Bioethics ranked doctor-patient disputes over treatment plans the top ethical challenge facing medicine today, ranking above such issues as waiting lists and doctor shortages.

"Thirty years ago, the issue was when patients could say no (to a doctor). Now it's when can a doctor so no (to a patient)," says Jonathan Breslin, co-author of the report.

It would seem, at least, that the Calgary doctors did refuse to treat Hayer, saying she was too old to start a family.

Hayer, however, went to India to get fertility treatment, and that introduces an entirely new element to the debate -- the inability to set standards for care at home when patients are a plane ride away from getting any treatment they want, even if it's unethical or illegal at home.

Ethicists, from what I have seen, however, agree agreed that the Calgary doctors had an ethical responsibility to care for Hayer once she became pregnant -- which they did.

Drug advertising under threat

Time magazine is reporting that direct to consumer drug advertising in the United States may be threatened by the Obama's administration's determiniation to reign in Big Pharma and runaway drug costs.

How much longer will you be able to see advertisements in which a person blissfully runs through a field after taking some kind of antiallergy medication? Or those in which a down-and-out man is suddenly sunny after being prescribed an antidepressant? How much longer will you giggle at that commercial with the warning that you should call a doctor if a certain condition lasts more than four hours?

These are questions that keep drug companies, as well as the television stations and magazines that subsist on their ad dollars, up at night (Ambien, anyone?). Direct-to-consumer (DTC) advertising by pharmaceutical companies has always been somewhat controversial. The U.S. is one of only two countries that permit it (New Zealand is the other). Critics claim that these advertisements encourage consumers to seek out overly expensive brand-name drugs from doctors. Their symptoms might not require such medications, and when they do, cheaper generic drugs may be available. Such marketing probably drives up overall health-care costs. More important, new drugs that are aggressively marketed can pose a safety risk. Merck's heavy promotion of pain reliever Vioxx — look at Dorothy Hamill skating without any strain! — is a prime example of advertising gone awry. The drug was later taken off the market after it was found to increase risk for heart attacks.

So with a new President who has vowed to fight Big Pharma to lower drug costs and a Democratic Congress with several anti-DTC advocates, drug and media companies are justifiably jittery. "We are entering an environment that is going to be more open to those who are adamantly opposed to direct-to-consumer advertising," says Jay Bolling, president of Roska Healthcare Advertising in Montgomery, Pa.

Elsewhere, reports are circulating that Barack Obama might allow cheap imported medications to flow from Canada again, reversing an earlier decision by the FDA to ban them.

Now the Obama White House is planning to reverse the policy, to let seniors make a choice where to buy their prescription drugs. Greg Knoll is a healthcare advocate. He supports the Obama proposal, saying he has seen what happens when seniors can't afford prescriptions. "I saw seniors eat cat food in order to afford prescription drugs," said Knoll.

That's one worth watching.

Lesbians denied medical care

A lesbian couple is taking a Winnipeg doctor to the Manitoba Human Rights Commission and to the College of Physicians and Surgeons in Manitoba alleging they were denied care because of their sexual orientation.

The story broke earlier this week, and I was able to weigh in on it for today's Toronto Star.

The case, it seems, is another example of conflicting religious and cultural rights. We can probably expect more in the future, especially as we import doctors (and other professionals) to make up for shortages here, the head of the college says. 

How we handle such issues may well determine the kind of society we will have.

Bioethicists to the rescue

The University of Toronto's Joint Centre for Bioethics seems to come up with an interesting topic for discussion every Wednesday afternoon at its weekly bioethics seminar.

Last week, for instance, one of its past students returned with a message that there’s a key role for bioethicists in the development of politically touchy race-based drugs.

Too often, the bioethicist turned lawyer said, such research is thwarted by fears of drawing a connection between genetics and race. That’s a tragedy, he says, because such medications could save lives in Canada’s native communities and the developing world.

But by setting an ethical framework for the work, bioethicists can defuse the issues before they make headlines. “We have a huge role to play, we can set the ground rules,” Shawn Richard told said in a question and answer period after last week's session. 

As with many of the JCB lectures, the discussion among the academics, working ethicists and researchers afterward provides some of the best insights into the state of debate today.

All the JCB lectures are webcast, and then archived on the centre's site. This week, the Wednesday seminar, starting at 4:10 pm, will feature Shawn Winsor, a clinical ethicist at Trillium Health Centre, talking about multiple embryo transfer.

But back to Richard's seminar.

He said that while many in the scientific community extol the possibilities of using genetic markers to tailor medications to each patient — helping with dosage levels and improving their effectiveness —  the field remains politically charged.

Government and corporate officials are wary of getting involved with anything that ties genes and race, Richard said. Many in the ethics community, Richard included, avoid the use of the word “race” at all, preferring such terms as “ancestral origins.”

As well, Richard fears that drug companies will focus on medications that will help rich white populations in the West, ignoring the needs of developing countries. “There’s some concern in developing countries that they are going to be left out,” he said.

Richard, who has a master’s degree in bioethics and is now articling at a Bay Street law firm, said there are limits to what the law can do in pushing companies to research such drugs. “The law tends to wait until a problem has developed,” he said.

But by debating the ethical framework in which such research can take place, bioethicists can help find ways for the work can be done without raising thorny or touchy issues, Richard said.

Once that’s done, he said, governments can be lobbied to provide tax incentives to drug companies to engage in the research, and private organizations such as the Bill and Melinda Gates Foundation can be encouraged to also provide more money.

Beyond developing countries, Richard said, the incentives could encourage companies to research medications developed specifically for Canada’s native population.

A doctor's responsibility to refer patients to better care

A thought-provoking column in the New York Times this week raises an interesting question.

What responsibility do doctors have to refer patients to other doctors, or other hospitals, where they might get better care.

For the author of the column, Denise Grady, the answer is obvious: they must refer the patient. The science reporter and author relates the story of a relative who sought cancer surgery outside the small town where she lived after her hometown surgeon told her she'd have to wear a colostomy bag for the rest of her life.

"But she also recognized that this was a small hospital, and a surgeon who probably spent more time fixing hernias and taking out gallbladders than he did operating on cancer patients. She decided that she wanted a doctor who operated on patients like her all the time, and that the two-hour trip to a cancer center would be worth the trouble. And so it was: she found a surgeon who specialized in rectal cancer, and today she’s in good health, with no need for a bag. She might have done just as well with the local surgeon, but we both doubt it."

As Grady points out in her column, an article last fall in the journal PLoS Medicine argued that doctors have an ethical obligation to tell patients if they are more likely to receive better treatment elsewhere. The study notes that the quality of care is uneven from one hospital to the next, with volume seemingly the biggest determinant of quality of care.

The idea that doctors should refer patients to better care makes inherent sense, it seems, to many patients, but those in the field see some potential problems.

Dr. Robert J. Weil, a neurosurgeon at the Cleveland Clinic, warned that if hospitals were forced to give patients comparative information, it might lead some to avoid difficult cases, to make their numbers look better. Bioethicist David I. Shalowitz said that expecting surgeons and hospitals to disclose information about other doctors and medical centers would create an untenable conflict of interest for them and should be avoided.

The differing opinions leaves the matter pretty much unresolved, Grady says.

Patients' families want doctors to talk more

Doctors don't talk enough, and that has to change.

That's the conclusion of a recent study by researchers at the University of San Francisco Medical Center, which found that even when there is little to say or the information is uncertain, the families of critically ill patients want to know as much as they can.

Douglas White, and assistant professor at UCSF's Program in Medical Ethics and lead author of the study, said the families understand that doctors will not always have all the answers.

"Our interviews revealed that caregivers appear to believe that some uncertainty is unavoidable, and just the nature of life. ... The vast majority of families of critically ill patients want physicians to openly discuss the prognosis, even when physicians can't be certain that their estimates are correct."

Previous studies have found that doctors are reluctant to discuss cases with families, particularly when the prognosis is uncertain.

The new stdy, published in the January issue of the American Journal of Respiratory and Critical Care Medicine, is based on face-to-face interviews with 179 family members of patients in four different Intensive Care Units.

Eighty-seven per cent said they would want to be told of all prognostic estimates, even if they were tentative, and most said they appreciated doctors showing candor in discussing uncertain outcomes, White said. More information will help families decide on care, and prepare for whatever happens.

 "We learned that family members wanted prognostic information in order to know whether they needed to begin to prepare for the chance that their loved one might die, and so begin the bereavement process. ...I think one of the strongest messages that comes from this study is that family members want to have this discussion with the physician, and want to have the opportunity to take care of unfinished personal and familial business before their loved one dies. They need that chance to say their goodbyes, in case the patient does die."

Doctors, he said, need to learn the skills involved in dealing with families of critically ill patients.