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.

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.
 

Psychedelic death

A top medical ethicist says hallucinogenic drugs such as ecstasy or "magic mushrooms" may help terminal patients and their families through their final, painful days.

Robin Mackenzie, director of medical law and ethics at the University of Kent, says studies are underway with terminal cancer patients into the ability of such drugs to ease the process of dying and encourage closer family bonding in the final hours.

"We have the technology to enhance the experience of dying. With neuroimaging [brain scans] we can measure the impact of different practices, such as meditation or drugs, which would allow us to orchestrate our dying, just as we choose the form of a funeral service."

A study at the University of Los Angeles is due to be completed in December and research is also taking place in Spain. Mackenzie was to discuss the research at a conference in London this week organized by Exit International, an Australian organization advocating voluntary euthanasia.

Mackenzie says she can understand why doctors might not want to be involved with handing out such drugs, but says many patients want such options.

"My research into the demedicalization of dying suggests that there is a groundswell of people wanting to exercise choices in dying beyond euthanasia and palliative care options. We are encouraged to manage our lives and managing our deaths could be part of that."

Forced chemotherapy

An 11-year-old Hamilton boy forced to undergo chemotherapy may be at home, but the controversy over his care will surely not end there.

The boy's father reports that the boy's spirit is broken by the experience, willing to do anything if it means he can go home.

"We told him, 'Don't worry buddy, please try to be healthy, relax, relax, relax, relax,' and he even said to me, 'I don't care. They can even kill me with their chemo and stuff I don't care, as long as I can come home and be home with you and mommy," the man recalled. "You know what that feels like to hear your son say that?"

The judge sympathized, saying, "The bottom line is this is still a child, a child who has rights, who has feelings, who has vulnerabilities," Superior Court Justice Alex Pazaratz said. "It occurs to me this child is going through so much."

The rest of us can only imagine. There isn't a parent out there who hasn't wondered what they would do if faced with a pleading child who does not want to undergo chemo. And it's not just children -- many have confronted similar issues with aging parents and siblings.

At issue is the boy's initial refusal of chemotherapy, which he has had before, and his family's willingness to go along with his wishes. The hospital disagreed, so called in the local Children's Aid Society to take custody of the boy to ensure he got the chemo. The boy, who has fetal alcohol syndrome, was deemed unable to make an informed decision. The parents were deemed to not be acting in his best interests. The two sides squared off in court, with the parents being given custody again if they agree to continue the chemo. The boy is now willing to go along, so long as he can go home.

The case reminds me of a conversation I had with a bioethicist at another hospital two years ago. Children, especially those with long-term health problems such as cancer, are often engaged in the decision-making process about their care. When they are young, the decisions don't matter -- such as which arm will an IV be put in. As they get older, and they are mature enough, they get to help decide more important things -- even whether to accept treatment.

But that doesn't generally happen until the teen years, at the earliest. This boy is 11 and attends special education classes, so is presumed to have a diminished mental capacity.

At least one ethicist, Brendan Leier with the University of Alberta and Edmonton's Stollery Children's Hospital, has pointed out, however, that whatever the boy's mental capacity, having been through chemo before, he knows exactly what he is refusing.

"He understands what it feels like to have chemo, he understands what it is to go through that and have all the ill-health effects and it's very difficult to argue that anymore intellectual capacity would enhance his judgment."

I have never been through chemo myself, but I have seen its impact on others all too often.

Anyone who has witnessed it can surely understand the boy's reluctance to go through it again, and his family's qualms about forcing it on him. Those of us who have seen cancer in own families know -- and few who have not been touched by cancer --  patients and their families often feel they have lost control of their lives.

It is perhaps a natural response, then, for patients to try grasping control again anywhere they can. This family, while going along with the chemo, also says it will be exploring alternative treatments, as well.

And taking some control.

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