Firm's consulting fees to be disclosed, not all pleased

Medtronic Inc. announced this week that it would voluntarily release how much it pays doctors in consulting fees -- the largest such company to do so.

"Through greater transparency about the nature of these relationships, we will help people better understand how important they are to developing life-saving and enhancing products for patients,'' Medtronic CEO Bill Hawkins said in a statement.

Not everyone is impressed, since the disclosure won't start for another two years.

Writing on blog.bioethics.net, Summer Johnson calls it Ethics: The Phased In Plan

Slow down there, Speed Racer! Don't go disclosing those dollar figures too quickly now! You wouldn't want to allow your company a whole two years to change your consulting amounts as to allow your company time to appear as though you didn't previously give massive amounts of cash to physicians who used and implanted your medical devices over those who did not, would you?

Call me cynical, but any company really committed to making these disclosures would do so immediately and open their books now and put them out into the sunshine for all to see. Others might say, "Better late than never." But I'm not so sure. It seems like a tactic to buy time and to create the appearance of not buying off doctors to me.

It's as though they said, "We planned to be come ethical....later."

Medtronic says the payments have included education and training for doctors, royalties for inventions, clinical trial design and advice on improving the design and safety of products.

According to the Minneapolis Star Tribune, "The company's alleged largess involving gifts, trips and lucrative payments to doctors, particularly those who work with its spine business, have been detailed in several whistle-blower lawsuits."

Stem cell tourism warning

The Scotsman newspaper has a good article this morning looking at the risks of "stem cell tourism," the practice of going aborad for treatments banned at home.

"I felt I had nothing to lose. I am just going to get worse and worse anyway. I thought I'd just take the bull by the horns and go for it." Moira Ogilvie was desperate. So the multiple sclerosis sufferer joined an increasing number of Scots going overseas for experimental stem-cell treatment not available in the UK.

Ogilvie admits later in the article she has no idea if the treatment, in China, helped -- but has no regrets.

"I didn't see it get better. Whether it would have got worse quicker, I don't know. It is still very, very slowly getting worse, but I wouldn't say a great deal worse than what it was just over a year ago. Whether what's happening with me would have happened without the stem cells, nobody knows."

Dr Insoo Hyun, from the US-based International Society for Stem Cell Research, warned against the unproven stem cell therapies.

"My sense is this is a growing problem," he said. "There are a number of studies showing a proliferation of these stem-cell clinics popping up across the world. Patients need to know there are no proven therapies using embryonic stem cells."

In a tragic case, a recent study revealed that an Israeli boy with ataxia telangiectasia, or A-T, a degenerative brain disease, who travelled to Moscow for treatment ended up with brain tumours years later caused by the stem cells.

Assisted suicide gets an escape clause in Britain

A British woman with multiple sclerosis who appealed all the way to the highest court in the land to be allowed to die by assisted suicide has been told such a procedure would be illegal.

But she -- and more importantly, her husband -- was given, essentially, a Get Out of Jail Free card by the court when it hinted that there would be no repercussions if the couple were to go abroad to seek an assisted suicide.

The case points to a key aspect of medical tourism -- those who use it to flout local laws.

Debbie Purdy, 45, says the ruling today sets the stage for her husband, Cuban violinist Omar Puente, to take her out of the country to die.

... the Lord Chief Justice Lord Judge rejected her appeal but highlighted the case of tetraplegic former rugby player Daniel James, whose parents were not prosecuted after helping him go to Switzerland to end his life last year.

After today's hearing, Ms Purdy said: "I feel that I have won my argument, despite having lost the appeal. I am very grateful for, and respect the ruling of the Appeal Court.

"They have done everything they can do to clarify that, given the Dan James judgement, Omar would be unlikely to be prosecuted if he were to accompany me abroad for an assisted death, and we are therefore one step closer to the clarification I need."

Puente would face a jail term of up to 14 years if he helped his wife die on British soil. More than 100 people in Britain have used the Swiss clinic, and none have been prosecuted on their return home.

The case points to an interesting aspect of medical tourism. In effect, it renders governments and medical associations largely unable to regulate their own health care systems, since those who disagree with local rules can simply jump on a plane and get done elsewhere what is not allowed at home.

The recent Calgary case of 60-year-old Ranjit Hayer, who had twins after visiting an Indian fertility clinic to get treatment she was denied in Canada because of her age, is another example.

Such efforts can have tragic consequences, as with the case of an Israeli boy whose parents took him to Moscow for stem cell treatment for his ataxia telangiectasia, a fatal brain disease, only to have the unproven treatment cause brain tumours.

 

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.

Vatican to look at stem cells

A Philadelphia scientist who caused a furor when he told a Vatican bioethics conference in late 2007 that embryos are human, but not human beings, has been invited back to explain his thoughts some more.

Scott Gilbert of Swarthmore College will travel to Rome next month to make his case. The Philadelphia Inquirer said Gilbert isn't sure why he's been asked back, given the reception he received last time.

Gilbert has studied for decades how humans and other animals make the journey from fertilized egg to baby. The conference, held in late 2007 in Rome, was meant to address the church's view on the beginning of life - a question with huge implications for abortion policy, emergency contraception, and stem-cell research. Gilbert, author of the popular college textbook Developmental Biology, said he was the only speaker to suggest that very early embryos were not equivalent to human beings. That led to lots of yelling and gesticulating in Italian, not all of which could be translated for him.

... "I was yelled at for saying that there is no scientific evidence that the morning-after pill causes abortions," he said. "Or I think that's what I was being yelled at for." He said he agreed with the basic premise that human life is important and should be respected and protected. But he had issues with some scientific statements that Catholic authorities were making to support the position that an early embryo - even a fertilized egg - was a human being.

Rev. Tadeusz Pacholczyk, an ethicist with the National Catholic Bioethics Center in Philadelphia, is unconvinced by Gilbert.

"Scott [Gilbert] somehow seems to be able to convince himself to overlook the key point for the discussion, namely, that he himself was an embryo not so long ago. Any destructive action directed against him when he was still in that stage of his growth would mean he never would have existed to write his poorly supported paper."

The Vatican released a report on bioethics late last year that reaffirmed the Catholic position that life begins at conception.