All our cases today in Bioethics raise issues of integrity, bad science, bad research practices, and how to protect the vulnerable and desperate from being victimized by insult and injury, on top of ill health.
“Bad science” is Ben Goldacre‘s beat.
Goldacre’s latest book is Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients. (After watching his energized TED Talk, I’m betting caffeine may be Ben’s drug of choice.)
We like to imagine that medicine is based on evidence and the results of fair tests. In reality, those tests are often profoundly flawed. We like to imagine that doctors are familiar with the research literature about a drug, when in reality much of the research is hidden from them by drug companies. We like to imagine that doctors are impartially educated, when in reality much of their education is funded by the pharmaceutical industry. We like to imagine that regulators let only effective drugs onto the market, when in reality they approve useless drugs, with data on side effects casually withheld from doctors and patients.
Goldacre’s mission, like McGee’s, is ultimately about guiding and enhancing the future of medicine.
(Btw, I picked up Al Gore’s new book The Future at Parnassus after class Monday. It has a chapter on “the reinvention of life and death.” Extra credit to anyone who reads and reports on it before I do.)
Case 9, on scientific misconduct, reminds us of the notorious South Korean stem cell researcher, “blinded by work and a drive for achievement,” who faked his data. McGee’s right: it’s not enough to “post ethics codes in hallways” or teach ethics courses whose “mentors could care less” about them. Misconduct must be anticipated, analyzed, and prevented, not just punished. Ethics has to be internalized before it can really guide conduct.
Case 10 recalls the backlash of NIH employees who valued their stock holdings above avoiding the appearance of impropriety and conflict of interest.
Case 11 deplores the cynical exploitation of research subjects who “volunteer” as guinea pigs for clincical trials and drugs because they can’t afford conventional medical care or psychotherapy or need to supplement their income. Again, the only effective way to address this will be to “put ethics first.”
Here’s another perspective on guinea pigs:
So how risky is it to take part in a clinical trial?
The honest answer is that no medical intervention – trial or not – is 100% risk free.
But all clinical research studies have to go through very strict ethical and regulatory checks before they get anywhere near a patient, and the UK has one of the best records world-wide for patient safety.
You are also very closely monitored while you are taking part in a study, so the chances of something going wrong are incredibly slight.
Thank you, Doctor. I’m just slightly reassured. (Less reassuring is Dr. Mehmet Oz, with his “religious” brand of medical science and “my fact versus your fact.”)
Case 12 says “informed consent” still does not protect those subjects from harm, however slight its likelihood. They’re “coerced by desperation, lack of adequate medical insurance or unrealistic hopes for a cure.” Coercion and desperation do seem the right words for those who’ve run out of options. But so does hope. It would be a shame to squash that, in the name of progressive reform. But Ben Goldacre’s right: we must open the lid on medical science and research, let the sun shine in, and distinguish authentic hope from sham science and the hollow promises of cheaters and charlatans and profiteers.
And that’s all I’m going to say about that. I talked too much in class on Monday, it’s time for me to listen.
Up@dawn 