Showing posts with label ethics. Show all posts
Showing posts with label ethics. Show all posts

Thursday, November 29, 2012

Time Blog: David Healy: Beware of Big Pharma and Conflicts of Interest


“It’s a miracle that I was asked along to give a talk [here], and I’m extremely grateful,” Healy said.

His disquisition was perhaps less humble. Arguing that his profession is “committing professional suicide” by failing to address its dangerously close relationship with the pharmaceutical industry, he likened psychiatry’s attitude toward its faltering legitimacy to the Vatican’s widely derided response to its child-sex-abuse scandal by priests — essentially that psychiatry is brushing off justifiable concerns as hype instead of dealing with the source of the problem.

Few experts believe that psychiatry’s relationship with the drug industry is healthy. While several speakers at the session pointed out that other specialties are similarly entangled with industry, “everyone does it” is generally not a valid defense where conflicts of interest are concerned.

(MORE: Antipsychotic Prescriptions in Children Have Skyrocketed: Study)

The conflicts throughout medicine — not just in psychiatry — are clear. In 2004 alone, pharmaceutical companies spent about $58 billion on marketing, 87% of which was aimed squarely at the roughly 800,000 Americans with the power to prescribe drugs. The money was spent mainly on free drug samples and sales visits to doctors’ offices; studies find that both free samples and sales calls increase prescribing of brand-name drugs and raise medical costs without improving care.

Moreover, nearly half of all continuing medical-education classes are sponsored by industry. By their third year of medical school, 94% of psychiatrists in training have already accepted a “small noneducational gift or lunch” from a drug company, according to Dr. Paul Appelbaum, a past president of the APA and director of Columbia University’s Division of Law, Ethics and Psychiatry, who spoke on the panel with Healy.

And while only 34% psychiatrists believe that receiving food or gifts affects their own prescribing patterns, 53% believe that it influences that of their colleagues, according to a study cited by Appelbaum. Research shows that this type of thinking — “Everyone else is prone to biases and social factors, but not me!” — is common and confounds attempts to address conflicts. “At least some of our colleagues are wrong,” Appelbaum said drily of the study.
Healy’s jeremiad was more severe and sharply worded, but it seemed to be well received by the psychiatrists assembled in the audience. Many even asked questions that suggested they too were troubled by the status quo.

“I’m going to argue that we need you to be biased. We want you to be biased by treatments that work,” Healy told his colleagues. “I don’t mind if you’re my doctor and you’ve given talks for industry. My concern is not that you’ve been paid by industry, but that you’ve been fooled by industry. The key conflict is whether people are hiding data from you.”

(MORE: Top 10 Drug Company Settlements)

Healy went on to discuss how drug companies have repeatedly concealed important information about the risks of their medications, whether by hiring ghostwriters to spin the results of scientific studies and then getting renowned experts to put their names on the published papers; by employing tricks in clinical trials like using inadequate doses of comparison medications to make the company’s own drug look better; or by simply keeping unfavorable data out of the public domain.

Healy himself has also been targeted directly by drug companies that haven’t been happy with his critiques. In fact, he’s widely believed to have lost an academic job offer at the University of Toronto as a result of one such critical lecture. At the session on Thursday, one slide in his presentation contained information he sought via a Freedom of Information Act request detailing drugmaker Eli Lilly’s strategy for shutting Healy down. To counter his public insistence that drug companies reveal hidden drug data, Eli Lilly proposed doing things like planting confederates in the audience of his presentations to ask questions that support industry’s view.

Healy also described how in his own attempts to publish formerly hidden data — which all now reside in the public domain — he encountered legal issues with journals, which ultimately resulted in rejection of publication. The clinical-trial data in question in this case showed a greater risk of suicidal acts associated with antidepressants than had previously been revealed.

Healy also referenced hidden data from trials of the antipsychotic drug Zyprexa. “None of them mentioned [that the drug could cause] diabetes or [had] the highest suicide rate in clinical-trial history,” he said. Although drug companies are now required by medical journals to register all of their clinical trials with the National Institutes of Health if they wish to publish them — including those that never end up being published — this is not a legal requirement.

They can still hide relevant data from the Food and Drug Administration by not disclosing trials that they never attempt to submit to a journal.

Healy noted further that when data surfaced showing a link between antidepressant use and risk of suicide in children, the APA issued a statement proclaiming that “we believe that antidepressants save lives.”

What I believe they should have said is that the APA believes that psychiatrists can save lives because it takes expertise to manage the risks of risky pills,” he said; if psychiatrists’ only role were to dole out drugs, then less trained physician’s assistants could easily replace them, he noted.

(MORE: A Doctor’s Dilemma: When Crucial New-Drug Data Is Hidden)

But when a questioner, claiming himself “speechless” in the face of Healy’s arguments, asked whether he should just stop prescribing antidepressants, Healy said no. Healy prescribes them himself, but believes that the role of the doctor is to manage risks, not view drugs as harmless. “Medical treatment is poison, and the art of medicine is trying to find the right dose,” he said.

As for what could be done to disentangle medicine from industry, Healy wasn’t entirely pessimistic. “The key issue in the short term is access to data. We have to insist on that,” he said. “We let industry come to our meetings and let them talk in our programs. I don’t think it’s huge problem that they get paid. The big problem is that if you ask for data, they can’t give it to you. That’s not science, that’s marketing masquerading as science.

But what of the issue of doctors being visited by paid-industry types — or being paid by industry themselves? The panel’s organizer, Dr. Daniel Carlat, director of the Pew Prescription Project, noted a new disclosure law, passed as part of President Obama’s health-reform bill in 2010. Under the legislation, drug companies must reveal which doctors have taken any payment or gift from them worth more than $10, and describe the exact amounts taken and the purpose for them on a publicly available website. (Unfortunately that website will not be up and running until 2014 at the earliest.) All of the panelists agreed, however, that while public disclosure is good, it is not enough.

Dr. Roy Perlis, who heads the Center for Experimental Drugs and Diagnostics at Massachusetts General Hospital, cited research showing that disclosure can actually backfire in unexpected ways. In one study, for example, people were asked to estimate the number of coins in a jar and provided an “adviser” to help them guess. Unbeknownst to them, the adviser had been paid to try to push people to make higher estimates than they otherwise might.

In one condition of the trial, participants were told in advance that the adviser had this bias, but that made matters worse. Under this circumstance, the adviser encouraged participants to make even higher estimates than in the situation without disclosure.

(MORE: How a Study of a Failed Antidepressant Shows That the Drugs Really Work)

“There are two different mechanisms” to explain the phenomenon, says Perlis. “One is strategic exaggeration: ‘I know you’re going to discount what I say, so I deliberately will be more effusive and tell you a higher number.’ The other is so-called moral licensing: ‘I’ve disclosed my conflict, therefore I’m allowed to be biased.’ This very thing may well also play out when disclosing conflicts of interest in medicine.”

Maran Woolston, a woman with multiple sclerosis, also spoke on the panel about how betrayed she felt when she learned her doctor had referred much of her care to a drug-company subsidiary, but had not revealed it to her — and had also taken $300,000 in funding from various drugmakers.

“In my opinion, transparency isn’t a silver bullet,” she said. “My ideal solution — and this may be naive — is that [doctors should] accept no payments whatsoever because then there can be no conflict of interest.”


Read more: http://healthland.time.com/2012/10/05/psychiatrist-contends-the-field-is-committing-professional-suicide/#ixzz2DdF4cY1r

Saturday, September 29, 2012

For Jonah Lehrer

I really enjoyed reading Jonah Lehrer's popular science books. I even ordered a collectible copy of the recently recalled and scandal-ridden book, Imagine. Lehrer enjoyed quoting artists in his first book, Proust Was a Neuroscientist, so I have a quote in support of him.

"Art is a lie that makes us realize truth.” -- artist Pablo Picasso


Science writer Jonah Lehrer was caught fabricating Bob Dylan quotations in his new book. 

by Jeff Bercovici Forbes Staff



It’s painful to read about the self-plagiarism and fabrication that has become the downfall of ex-Wired science writer, Jonah Lehrer.
Jonah Lehrer Was Going To Give A Speech On Ethics. It's Canceled,
Jonah Lehrer Resigns From The New Yorker Over Fabricated Bob Dylan Quotes In Book
After a brief stint at The New Yorker, Lehrer has resigned. His new book, Imagine: How Creativity Works, has been pulled by its publisher and refunds are being offered to anyone who has purchased it.

This is because Lehrer fabricated Bob Dylan quotes in the book and was caught by journalist Michael C. Moynihan – a serious Bob Dylan fan and, apparently, an even more serious reporter.

He lied about the fabrications when confronted by Moynihan before finally coming clean.

Lehrer is 31 – my age, actually, though I write mostly about video games which makes me feel, at times, much younger.

Of course, Lehrer was far more successful than I am. He had a long-running and highly read blog at Wired and two successful books. He’s been on a lucrative public speaking circuit for some time now. And he’d just taken a high-profile writing gig at The New Yorker - the Holy Grail of writing jobs.

All told, his career was following closely in the footsteps of bestseller Malcolm Gladwell, as Slate writer Josh Levin points out. Both New Yorker writers, both “idea men” and both well-enumerated public speakers, the big difference between the two has now become appallingly apparent.

Earlier this summer Lehrer was caught copying and pasting large sections of his older work into new posts at The New Yorker, without disclosing that this was recycled material. He was given a slap on the wrist and the controversy passed.

Secretly recycling your own work is problematic, though not nearly so much as putting words into the mouths of American cultural icons. It’s also a red flag.

But both acts are strange and somewhat baffling, to say the least. I’ve quoted myself in the past – usually to point out the prescience of some earlier insight (ha!) or, as is so often the case, to note how badly wrong I got some prediction or other. But I’ve always noted when this self-quoting has occurred.

I’ve also probably repeated myself on various subjects (okay, I know I’ve been repetitive many times – it’s the nature of the blogging beast, I’m afraid) and likely even unwittingly paraphrased something I’ve written in the past.

And I’ve made my share of mistakes – whether getting some fact wrong or not taking the extra step required to go to the original source, and quoting secondary sources instead – and have updated and corrected those mistakes as quickly and thoroughly as possible. This can be a tough business, and it’s easy to err. It’s also embarrassing. The sting of having to correct yourself makes you more cautious in the future. As long as those mistakes aren’t intentional, and as long as writers own up to them and include corrections where due, this can be chalked up to human error. We learn from our mistakes, just like anyone. Or at least we ought to.

Still, I can’t for the life of me wrap my brain around the conscious decision that went into fabricating Bob Dylan quotes – not just in a blog post but in a book. It makes you question every single thing Lehrer has written. And I imagine the fact-checkers at publications he’s written at are pouring over his work already, as are the legions of DIY grassroots fact-checkers who inhabit internet-land.

Bob Dylan is an odd choice.

For one thing, Dylan has said so many things over the course of his career that there’s really no shortage of actual quotations to draw from. For another, Dylan is still alive and has a devoted following. If you’re going to put words into someone’s mouth, Dylan must be one of the worst choices of all time.

This is the age of the internet, after all. As Howard Kurtz reports Moynihan saying: “We’re in a technological culture where it’s much easier to catch [...] Had one tried to expose Jonah Lehrer’s quotes in 1925, good luck.”

This is a tragic story. Lehrer’s career was enviable. I’ve never read his books, but I’ve enjoyed many of his blog posts in the past (admittedly, it’s been some time since I read his work, though.) He was a fine writer, with a knack for creating narrative, and turning questions of science and the brain into interesting stories. What he did he appeared to do quite effortlessly.
Writing isn’t easy, especially if you make it your career. It’s a struggle. There’s a lot of competition. Blogging is hard work simply because you need to constantly come up with new ideas, new insights, better and more thoughtful analysis. You need to be unique and stand out somehow.

Many of us would love to have the sort of success Lehrer enjoyed, especially so young.
Why throw it all away? Not just the success but the reputation, the trust of readers and friends and, I imagine, family? It’s baffling. I can’t pretend to understand it.

Monday, September 24, 2012

Kathleen Taylor: The Brain Supremacy



The colors indicate key parts of the brain activated by stimuli in five fMRI studies. The illustration shows activity in one hemisphere of the brain; most neural responses occur in both hemispheres.



Read more: Thought Police: How Brain Scans Could Invade Your Private Life - Popular Mechanics

Imagine if, once every century, a person was born who could travel forward one hundred years in time. For most of human history the learning curve faced by those intrepid travelers would have been manageably shallow. Not so the last few centuries. We live in a world transformed by science and technology. The rate of transfer from science fiction to science fact is amazing, and accelerating. Scientists can now probe individual atoms, see objects round corners, put a robot on Mars, and much else besides.

My examples come from physics. In our science-saturated world, however, the balance of power is shifting towards the life sciences, and especially brain research. With modern neuroimaging techniques like fMRI (functional magnetic resonance imaging), plus advances in genetics, and greater computer power, the study of human brains is at last becoming a fully-fledged science. Neuroscience has grown from a subdiscipline of biology to a field in its own right, with its own proliferating subdisciplines. In coming decades, it will rival and then surpass the influence of the older physical sciences. This is the era of the brain supremacy.

What neuroscientists can do is already astonishing. Brain cells can be activated or shut down using light. Proteins can be tagged and tracked. The cross-talk of many neurons can be recorded in real time at the level of individual cells. Researchers can detect genes switching on or off within a neuron. They can also analyze the epigenetic processes and complex regulatory networks which affect whether those genes are 'read' to make proteins.

The motive for much of this work is clinical. Neuroscience offers hope, at last, for some of our most feared diseases. Slowly but surely, the mechanisms of disorders like Alzheimer's and Parkinson's are being unpicked. The ability to decipher and alter brain function with unprecedented precision will open up even more startling possibilities. From decoding brain activity with scanners to thought-controlled wheelchairs, from neural implants for pain to selective memory erasure for post-traumatic stress, ancient fantasies of mind reading and mind control are taking shape as medical realities.

Yet the prospects offered extend far beyond the clinic. One day, among other things, we may be able to record and share dreams, buy artificial experiences -- 'mind movies' -- and take self-improvement to a new level by editing unwanted thoughts and desires. The age of physics has brought remarkable changes, but compared with what will happen as we turn the power of science on our minds, they were only a beginning.

There's a problem, though. The ethics developed by doctors, over centuries, to deal with human suffering, are different from those developed by scientists trying to understand how the world works. They're still more different from the ethics of businesses keen to cash in on the new technologies, for example by marketing fMRI 'lie-detectors.' And as the products of the brain supremacy have begun to move from clinic and lab to marketplace, the ethical principles don't necessarily move with them. Techniques created to heal can also be employed for other purposes, and the ability to get data from living brains is a holy grail for many interested parties other than neuroscientists and doctors.

Why the discrepancy? At base, our ethical instincts are of two kinds, depending on whether we grant the object in question some moral status or treat it as merely something to be used -- or sold. Until recently, Western science was mainly physical science, and the things it investigated were not of moral interest. Even in the special case of medicine there has always been tension between utilitarian impulses and the demands of human dignity, especially when resources are stretched.

The utilitarian model of user-versus-world was challenged, or rather reorganized, by the animal rights movement, which aimed to move animals into the 'ingroup' of moral entities. Wrongs done to people, like the human vivisections and mass killings of the second World War, also drove ethical advances which emphasized human dignity and rights. Yet the assumption that scientist X can study independent object Y without needing to consider Y's feelings on the matter still works for much of physics, chemistry and biology. Even a large part of animal research is done on bacteria, worms, flies, and other organisms whose feelings, if they have any, concern only the most committed activists.

When studying humans and their brains, however, the model fails, not only for ethical but for pragmatic scientific reasons. Human systems are always changed by their interactions with others, and in hard-to-calculate ways. What a volunteer says and does in a research lab may be altered not only by the lab environment or the phrasing of a question, but by who the experimenters are and how they behave. The human person thus needs to be considered.

Technologies which directly scan or manipulate brains cannot be neutral tools, as open to commercial exploitation as any new gadget. The brain supremacy offers chances to improve human dignity, but it also risks abuse.

Privacy is an example. What if the claims already being made for neuroimaging's ability to read minds can be extended to portable, covert surveillance? If we've already revealed ourselves on Facebook, would it matter if companies could scan our brains in real time, observe that we're hungry, and change their targeted marketing accordingly? Would those companies be obliged to tell us, or our insurers, if they found evidence of brain disease -- or of dubious beliefs? Would governments be justified in having ideologically hostile individuals 'adjusted' before they committed any terrorist act? And so on.

As the brain supremacy takes hold, neuroscience will affect us like never before. Ultimately, we may be able to manipulate brains -- ours and other people's -- as easily as we now manipulate electronic information. If we had time travel, jumping forward a century from now might land us in an almost unimaginable world.

We already live, as the old saying goes, in interesting times. The brain supremacy will make them more interesting still.

'The Brain Supremacy' is due to be published by Oxford University Press on 25 October.