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.

Steve Jobs' health privacy investigated

It seems the US Securities and Exchange Commission will soon weigh in on the tricky ethical issue of health privacy for public figures.

According to a Bloomberg report, the regulator is investigating whether investors were misled as concerns about the health of Apply CEO and founder Steve Jobs began to surface.

Investors have been pressing for information on Jobs’s health since June, when he appeared thinner at an Apple event. The company’s stock whipsawed this month after Jobs, who battled pancreatic cancer in 2004, said he would remain CEO while seeking a “relatively simple” treatment for a nutritional ailment. Nine days later, Jobs said he would take a five-month medical leave after learning his health issues were “more complex.”

“The good news flipped by the bad news makes one wonder what Apple knew,” said James Cox, a law professor at Duke University in Durham, North Carolina. '

“It’s not surprising for the SEC to come in and look afterward, given the pressure and publicity regarding their handling of a lot of cases,” such as criticism of the SEC’s response to Bernard Madoff’s alleged $50 billion Ponzi scheme.

The news comes as Apple shares soar this morning on news that the company bucked the bad economic news of the past few months to post a bump in earnings.

Despite the good news, however, the debate over Jobs' health continues -- and so it should, according to Laura P. Hartman, professor of business ethics at Chicago's DePaul University, commenting this morning in this morning's Toronto Star.

"Privacy is most often defined in two ways – both the right to be left alone as well as the right to control what information people know about you," explains Hartman. And while any individual has a right to both aspects, famous people choose to forfeit that, to some extent.

In the case of CEOs who have closely yoked their companies to their larger-than-life personas – as Jobs, Oprah and Martha Stewart have – our ethical and legal requirement to respect their privacy bumps up against the company's onus to disclose information material to shareholders and employees.

If there's news in hand "that can affect whether a reasonable investor would buy or sell ... then it must be disclosed" according to U.S. securities law, Hartman says.

"The fact Jobs stepped down makes it unquestionable that it's material ... it impacted his ability to serve." While most might not know who the CEO of, say, Starbucks is, Jobs has chosen to identify himself intimately with the company.

His detail-obsessed, risk-taking style is widely credited for Apple's bounce back from its disappointments in the '90s. "Take out the issue of health and this is a question of whether the CEO is going to step aside," argues Hartman. 

In short, according the Hartman, by making himself the face of his company, Jobs gave up on his right to privacy.
 

Obama can expect a bioethics fight

Pro life lobbyists in the United States are pledging to not give up their fight against embryonic stem cell research despite pledges by US President Barack Obama, who took office yesterday, to open the door to funding the work again.

Faith-based blog Lifenews.com is reporting that pro life forces see an opportunity in Obama's musing that he might go to Congress to restore federal funding to embryonic stem cell research, rather than issuing an executive order as has been expected.

Citing the conservative Wesley J. Smith, who has his own blog, Lifenews says going to congress will give pro life groups time to "educate the president and the public" on the issue and alternatives to using embryonic stem cells in research.

"The delay 'can also open up opportunities for opponents to educate the President (whose comment about Alzheimer's shows that he needs it) and the public -- such as the incredible breakthroughs happening with adult stem cells and the potential of 'alternative methods' to heal the breach that this issue has caused to the body politic.'"

On the other side, secular groups and scientists are anxiously awaiting Obama's next move on the issue, and are emboldened by his promise in his inaugural address to "restore science to its rightful place."

Commenting to the Religion News Service, Lori Lipman Brown, director of the Secular Coalition of America was "heartened at Obama's pledge to `restore science to its rightful place,' a veiled reference to criticism that religious ideology trumped research during the Bush administration -- especially in the field of bioethics."

Stem cell researchers are excited about the possibility of getting federal funding -- which Obama's predecessor George Bush banned in August 2001 -- to advance their work. Discover  magazine is even saying that restoring federal funding for stem cell research -- and other research -- should be part of the new president's economic stimulus package.

Commenting on the Science-Based Medicine blog -- founded a year ago by Yale doctor Steven Novella to counter the perceived politicization of science in the U.S. -- teaching physician Peter A. Lipson argues the case that politics be kept out of science.

"When politics trumps science, medicine suffers. If we are willing to compromise our science and our ethics as physicians for political expediency, we have failed our most sacred duties. If politics can open the door to deciding what is fact and what is fiction, then invalid medical ideas can walk right in."

Obama pledges to "restore science to its rightful place"

For stem cell scientists watching the inaugural speech of US President Barack Obama, the words they've waited almost eight years to hear came about a third of the way in.

"We will restore science to its rightful place, and wield technology’s wonders to raise healthcare’s quality and lower its cost."

Obama did not mention stem cell research specifically, but that line is well in keeping with promises he made during the election to restore federal funding to embryonic stem cell research, including this pledge to Science Debate 2008:

"As president, I will lift the current administration’s ban on federal funding of research on embryonic stem cell lines created after August 9, 2001 through executive order, and I will ensure that all research on stem cells is conducted ethically and with rigorous oversight."

It was on August 9, 2001, that Obama's predecessor George Bush went on national television that Washington would no longer fund embryonic stem cell research -- except on stem cell lines begun before that day.

Since then, American scientists have been hampered in their work.

At a meeting of stem cell researchers in Toronto, top US scientists openly complained to me that the federal ban forced them to keep separate labs, equipment and records to ensure that no money from Washington ever got used on the banned work. They also had mounds of paperwork to fill out proving where the money went.

It all made for inefficient operations, with many scientists have been looking forward to this day.

The public's right to private information

The health questions surrounding Steve Jobs has sparked an ethical debate about the public's right to know when a public figure's health is failing.

When it turned out the founder and CEO of Apple computers was sick, Apple fans and investors got worried. In fact, Apple shares fell on the news.

Writing in the New York Times last week, business columnist Joe Nocera says Jobs has a responsibility to come clean with his health problems, if only to soothe investor worries and stop rumours from hurting the stock.

"Last week, he said he had a “hormone imbalance.” Now it’s “more complex” than that — whatever that means. If he really wants people to stop speculating about his health, as he claims, he sure has a funny way of dealing with it. Let’s be honest here: when you are a) a survivor of pancreatic cancer; and b) the world’s most charismatic, and possibly its most irreplaceable, corporate executive, putting out a press release announcing that your problems are “more complex” is only going to fan the flames, not douse them."

Arguing that Jobs' "health is a material fact for Apple’s shareholders," the company has a responsibility to disclose fully any health concerns, Nocera says.

"Enough is enough. If Mr. Jobs wants privacy, he should resign from Apple. If he did, of course, his health would no longer be anybody’s business but his own."

Not everyone agrees. In his Bioethics Discussion Blog, Los Angeles doctor Maurice Bernstein outlines the ethical questions involved.

"What defines an `important person' (any business man who runs a public shares company? A well-known movie or sports star? A candidate for a public office or one who is already in public office? A scientist who is on the verge of discovery? A physician in active medical/surgical practice? An airline pilot? .. and so on), Who sets the limits of personal medical information which must be disclosed?"

Summer Johnson, writing on the bioethics blog at Loyola University, written by editors of the American Journal of Bioethics, says says health issues of public figures should only be made public if they are hidden and affect their ability to do their jobs.

"Unless his health is so poor that his mental function is actually impaired to the point that he imperils the company and then he actually refuses to do what he actually did do (step-down as CEO temporarily taking medical leave), then and only then would a public outing of someone's medical status for the public good be morally justified. Otherwise, such medical information should be kept private unless the individual wishes to make it public."

Nocera, however, argues that Jobs has not been as upfront as he could have been.

"The time has come for Apple’s board to wrest control of this subject from Mr. Jobs, and do the right thing by the company’s shareholders. Say, once and for all, what is going on with Mr. Jobs’s health. Put the subject to rest. End the constant rumormongering. And then get back to the business of making the coolest products on earth."

Nocera, of course, is not a bioethicist. He is a business columnist -- so it's probably not surprising that he wants as much information released as possible.
 

Drug advertising doesn't work, study finds

We've all seen them -- those ubiquitous ads for medications to help us with everything from erectile dysfunction to arthritis to cancer.

Well, if they've never motivated you to go out and get a new prescription, you're far from alone.

According to a study in the Annals of Family Medicine, the ads simply don't work.

In turns out, only 2.6 per cent of patients ever ask their doctors about medications they have seen advertised on television or in print. This despite seeing 100 minutes of drug advertising on TV for every minute they see with a doctor, according to the study.

Canadian exposure to the ads may be lower, since they are more restricted here. But we do watch a lot of American TV, and a Canadian Medical Association Journal article in 2003 documented how ads are getting around the law in this country.

"The advertising of prescription drugs aimed directly at the public is prohibited in most countries, including Canada. However, a shift in interpretation of the policy governing this marketing strategy, known as direct-to-consumer advertising, has occurred in Canada, resulting in its partial introduction without public and parliamentary debate."

Commenting on the MSNBC web site, columnist Brian Alexander outlines the longstanding controversy around the ads.

"Drug companies argue that advertising medications provides an important public health service by alerting consumers to potentially undiagnosed, or under treated, disorders. Some doctors and health advocates, on the other hand, argue that ads entice patients to insist on unnecessary or ineffective drugs and to forgo healthy lifestyle changes that might obviate the need for drugs in the first place."

According to the Family Medicine study, based on surveys filed out by family doctors, only 58 of 1,647 patients seen by the doctors asked for a prescription to a specific drug. When the drugs asked for were checked to see if they had been advertised in recent years, the number fell to 43, or 2.6 per cent. Once asked, however, doctors handed out the prescription about half the time, according to the study.

"Although clinicians reported that in most cases of medication inquiry, the medication would not have been their first choice for treating the patient’s condition and that they felt no pressure to prescribe, the medication was nevertheless prescribed more than one-half the time."

Drug companies in the US spend about $500 million a year on advertising -- which critics have blamed in part for the high cost of medications. In these tough times, however, the companies could end up being asked if the ads are worth the cost.

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.

The kidney divorce

The disheartening case of a New York surgeon who wants the kidney he gave his soon-to-be-ex-wife -- or $1.5 million (US) in compensation -- returned to him has the caught the eye of medical ethicists.

Not the least because his demands seem to put a monetary value on human parts. Dr. Richard Batista says the $1.5 million reflects in part the value of the kidney he donated to Dawnell Batista in 2001, and he should be compensated for it.

Bioethics professor Steven Miles at the University of Minnesota, where the transplant in question took place, told his local paper that the case goes against very notion of organ donation.

"The entire language of organ donation in the United States is very clear. The word donation means strictly a gifting relationship and certainly everyone understands it is irreversible. ... In no way can she purchase it from him or is it direct property of the marriage. We don't share organs to create a business partnership."

Ethicists agree that the question of whether Batista can get his kidney back is a non-starter, and have moved on to the question of whether the case puts a price on something that is illegal to sell in the U.S. -- or Canada, for that matter.

Batista's lawyer Dominic Barbara says the $1.5 million reflects how much money Batista's wife made as a result of being able to continue working and not having to go on dialysis. "A price can't be placed on a human organ but it does have value," Barbara said.

Robert Veatch, a medical ethicist at Georgetown University's Kennedy Institute of Ethics, disagrees.

"It's illegal for an organ to be exchanged for anything of value. When you give something, you can't get it back. It's her kidney now and . . . taking the kidney out would mean she would have to go on dialysis or it would kill her."

Writing in Slate.com, national correspondent William Saletan questions whether compensation can't be demanded, at least in this case, without commodifying a vital organ.

"Batista can't take his kidney back, but that's not what he's after. He wants his ex-wife to let him visit their kids, on pain of compensating him for what he gave her. And what he gave her, according to his attorney, wasn't just an organ but a livelihood. According to Newsday, the attorney says the $1.5 million demand 'reflects damages, including how much money she made as a result of being able to continue working and not having to go on dialysis.' So the dollar figure isn't based on the price of an organ (which would be considerably cheaper, based on the going rate of kidneys abroad); it's based on the income one spouse accrued thanks to the other's sacrifice. And sacrifices between spouses are treated differently, under the law, from sacrifices between strangers or friends. There's a tradition and expectation of common benefit. You and your spouse become one flesh—in this case, literally."

As Saletan points out, kidneys are being sold abroad, fairly cheaply, and more jurisdictions such as Singapore looking into getting into the business.

Based on how Batista is valuing his kidney, however, could we see a sliding scale for buying kidneys, based on how much the life saved is deemed to be worth? 

And who decides?

 

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.

Big Phamra and ghostwriters

Pharmaceutical giant Wyeth hired ghostwriters to counter mounting evidence that its hormone replacement therapy caused breast cancer, according to Congressional investigators in the U.S., who also released documents providing an unprecedented look into how ghostwriting works.

Iowa Republican Senator Charles Grassley has written letters to Wyeth and medical writing company Designwriteasking them to disclose payments made for journal articles and the activities of doctors recruited to put their names on them for publication. The letters are part of a continuing investigation by Grassley into drug industry influence on doctors.

Grassley’s staff on the Senate finance committee also released dozens of pages of internal corporate documents gathered from lawsuits showing the central, previously undisclosed role of Wyeth and DesignWrite in creating articles promoting hormone therapy for menopausal women as far back as 1997.

In his nine-page letter to Wyeth chief executive, Bernard J. Poussot, Grassley said the articles were more like advertising than research.

“Articles published in medical journals are widely read by practitioners, and relied upon as being unbiased and scientific in nature. Concerns have been raised, however, that some medical literature may be subtle advertisements rather than publications of independent research. The information in these articles can have a significant impact on doctors’ prescribing behavior. ... Any attempt to manipulate the scientific literature, that can in turn mislead doctors to prescribe drugs that may not work and/or cause harm to their patients, is very troubling.”

One article published as “Editors’ Choice” in May 2003 in The American Journal of Obstetrics and Gynecology, more than a year after Wyeth’s Prempro was linked to breast cancer, said there was “no definitive evidence” that progestins cause breast cancer and added that hormone users had a better chance of surviving cancer.

The documents released by Grassley show company executives came up with ideas for medical journal articles, titled them, drafted outlines, paid writers to draft the manuscripts, recruited academic authors and identified publications to run the articles — all without disclosing the companies’ roles to journal editors or readers.

Elsevier, the medical publishing house behand The American Journal of Obstetrics, has launched an investigation.

Wyeth maintains that the academic authors were not paid by Wyeth and had “substantive editorial control” of the articles.

The issue of ghostwriting for medical journals has been raised in the past, involving various companies and drugs, including the Merck painkiller Vioxx, which was withdrawn in 2004 after it was linked to heart problems, and Wyeth’s diet pills, Redux and Pomdimin, withdrawn in 1997 after being linked to heart and lung problems.

The Grassley documents, however,  are the first to provide such a detailed look at the practice — from the conception of ideas for journal articles through the distribution of reprints.

Grassley gave Wyeth and Designwrite until Jan. 11 to respond to his letter.