This week’s headlines seemingly closed a chapter on the story of medical research criminality in America. Ramesh “Sunny” Balwani, former president and COO of Theranos was sentenced to 13 years in prison for fraud. That’s 2 years more than his former business and romantic partner, Elizabeth Holmes.
White crime criminal defense attorney for all things science tech, Michael Weinstein, took the opportunity to trumpet out a confident message that crime doesn’t pay in Medicine with these words, “It clearly sends a signal to Silicon Valley that puffery and fraud and misrepresentation will be prosecuted, there will be consequences and the end result is potentially decades in prison.”
The smooth talking fraudsters played a good hand for years, buoyed by a Board, asleep at the $9 billion valuation wheel, with the likes of George Shultz, Henry Kissinger, Rupert Murdoch and Larry Ellison. But attorney Weinstein and all associated with Health Tech entrepreneurship would do well to read again a classic piece of health journalism from fifty-six years ago.
On June 16, 1966, the New England Journal of Medicine published an article titled “Ethics and Clinical Research.” Written by a highly respected Harvard physician, Henry K. Beecher, the head of anesthesiology at Massachusetts General Hospital, the article referred to “troubling charges” that had grown out of “troubling practices” at “leading medical schools, university hospitals, private hospitals, governmental military departments (the Army, the Navy and the Air Force), governmental institutes (the National Institutes of Health), Veterans Administration hospitals and industry.”
Beecher then reviewed 50 distinct contemporary American clinical studies with ethical violations judged by standards at Beecher’s own Massachusetts General Hospital.
I give what could be lethal injections for a living.
That’s right. Nearly every day I give someone an injection of midazolam, vecuronium, and an IV solution containing potassium chloride–the three drugs in the “cocktail” that was supposed to kill convicted murderer Clayton Lockett quickly and humanely in Oklahoma.
Here’s the difference between an executioner and me. I use those medications as they are intended to be used, giving anesthesia to my patients, because I’m a physician who specializes in anesthesiology. Midazolam produces sedation and amnesia, vecuronium temporarily paralyzes muscles, and the right amount of potassium chloride is essential for normal heart function. These drugs could be deadly if I didn’t intervene.
My job is to rescue the patient with life support measures, and then to reverse the drugs’ effects when surgery is over. The “rescue” part is critical. When Michael Jackson stopped breathing and Dr. Conrad Murray didn’t rescue him in time, propofol–another anesthesia medication–turned into an inadvertently lethal injection.
When anesthesia medications are used in an execution, of course, no one steps in to rescue the inmate. This gives new meaning to the term “drug abuse”. In my opinion, the whole concept of lethal injection is a perversion of the fundamental ethics of practicing medicine.
Not for amateurs
Though lethal injection is supposed to be more humane than the electric chair or the gas chamber, often it doesn’t work as planned. Mr. Lockett died on April 29 after the injection of midazolam, vecuronium, and potassium chloride into his system. It is unclear from media reports how much of which drug he actually received. Apparently, prison staff had difficulty finding a vein.
The drugs were injected, they thought, into the large femoral vein in Mr. Lockett’s groin, which should have killed him within moments.
We have become aware of several instances of precipitous and, in our view, egregious and unjustified closures of on-going clinical trials in which a substantial number of patients were already participating in investigational efforts, some involving biopsies for research purposes.
These closures raise serious ethical issues for the research community. We will discuss those issues and some possible changes in how trials are conducted to address the problem. It is our premise that closing on-going clinical trials without scientific, efficacy, or safety justification is an abhorrent affront to all participants in clinical research as well as a fundamental betrayal of the trust that motivates patient participants to enroll in clinical trials.
Cancer patients who accept the risk of an investigational drug are true partners in bringing new agents to market. They hope they will benefit but, regardless of personal benefit/response, they hope the researchers will learn something to help other patients. Patients participate in clinical research for multiple reasons but, particularly in the case of agreeing to undergo mandatory research biopsies, do so because the research has the potential to improve the care, treatment approach, and standards for cancer patients.
They engage in a relationship with researchers based on their trust in the integrity of the researchers and the system within which the researchers work. Any cavalier approach to the commitment patients make to research is indefensible and particularly reprehensible when participants undergo internal organ biopsies.
Violating the trust of these patients also violates the trust the patients place in the investigators, undermining patient confidence in and availability for research. That trust and any violation of it are deepened when the researcher is also a given patient’s treating oncologist.
It is with good reason that human beings who enroll in clinical trials are called participants, not subjects. A participant is one who takes part in something—an active, volitional partner or colleague. A subject is one, mouse or human, who is under the power or authority and at the incontestable will of another or others. That difference between a participant and a subject is significant and germane to this discussion of when and why it is or is not appropriate to close a clinical trial.
The words “sexual addiction,” “exhibitionism,” comparisons to alcoholism, “not in control of his actions” are bandied about. This to me has fascinating echoes of the medicalization of homosexuality in the 70s and also the medicalization of the choices made by the transgendered. There like here the strategy is fraught. The patient has to perform the “sick role” as a way of excusing himself from responsibility and/or earn governmental support.
The comparison, though, prompts the following question (and yes I am purposefully trying to be provocative so take it with the appropriate grain of salt): As with homosexuality, what is the underlying problem here that calls out for condemnation? Is this merely legal moralism rearing its head again? What’s so wrong about sexting?
Well, let’s try to answer the question. Let’s take the Weiner situation as our case study. Weiner did many things wrong in the first and more recent revelations. He lied and misled the public about what he had done. He flirted virtually with a woman other than his wife and potentially embarrassed his wife (though this strikes me as less wrong then an extramarital affair which is de rigeur in politics). He showed a technological stupidity in sending it out on his twitter feed. Perhaps he showed “bad judgment” in doing something where he would likely get caught (as an aside, does that mean we want our politicians to be better at doing wrong things so we don’t catch them?)
All of these are contestable, but I will grant they form a basis of condemnation.
But factor these out for a moment. The act of Sexting itself. Why is that wrong? If one person (and to factor out infidelity, lets say both are single) shows off their naked body to another in the form of a photo, what would make that wrong?
Injury to the brain continues to be a unique thing in medicine. These injuries are scary and unfamiliar to many health care providers. There is a finality to them. Their consequences are hidden a little bit; the asystole is easy to figure in the emergency room but the suppression and brain death isn’t something so easily recognized.
They’re what you might imagine, along with polytrauma, as poster child conditions for tertiarization and transfer to a higher level of care.
In truly catastrophic injury to the brain however, I’m not sure that’s a good thing.
My institution has had a small discussion lately on just what ethics and the law requires of us as a place with full neuro specialty coverage.
I’ll make up an example:
A 61 year old man comes into a small community hospital’s emergency room. He was found down at home by his wife and last seen normal four hours previously. He wouldn’t wake up and he was breathing slowly and shallowly. The ambulance crew intubated him. In the emergency room his pupils are large and don’t react to light and he doesn’t do anything when the doctor hurts him. He’s in a very deep coma. If the physician working the emergency room felt comfortable doing a brain death exam, which he doesn’t, the patient might have some very primitive reflexes left but his condition is very serious.
I am affiliated with the institution where Dzhokhar Tsarnaev is currently hospitalized. I am friends with people who have treated him. I’m trying to stay away from those people; I would be unable to help asking them about him. They might be unable to help talking about him. There has been a flurry of emails and red-letter warnings cautioning people here not to talk about Mr. Tsarnaev or look him up on the EMR (Electronic Medical Record) system. Despite this there have been leaks of information and photos from various sources. It is virtually impossible to keep people from asking about him and talking about him. Curiosity is human nature. When human nature comes up against morals and laws, human nature will win a good percentage of the time. The question is: given what he has done, does this 19-year-old still have his right to privacy?
The answer, of course, is yes. The American Medical Association includes patient confidentiality in it’s ethical guidelines:
“…the purpose of a physicians ethical duty to maintain patient confidentiality is to allow the patient to feel free to make a full and frank disclosure of information…with the knowledge that the physician will protect the confidential nature of the information disclosed.”
Threre are legal guidelines as well, most notably with the Health Insurance Portability and Accountability Act, or HIPAA. This law was originally passed in 1996 to improve the efficiency and effectiveness of the health care system, allow people to switch jobs without losing their health insurance, and impose some rules on electronic medical information. Congress incorporated into HIPAA provisions that mandate the adoption of the Federal privacy protections for health information. The “simplified” administrative document for the privacy and security portions of HIPAA is 80 pages long. Basically your health information cannot be shared with ANYONE. Of course, there are exceptions to HIPAA. Continue reading…
“Lance Armstrong is a bad guy who has done some very good things.”
These are the words of a sports radio personality I listened to yesterday. He was obviously commenting on the confession (to my pal Oprah) by Armstrong about his use of performance enhancing drugs. The sportscaster, along with many I heard talk on the subject, were not as upset by the fact that Armstrong used the banned substances, or his lies on the subject, but the way he went after anyone who accused him of what turned out to be the truth. Armstrong used his position of fame and power, along with his significant wealth, to attack the credibility of people in both the media and in the courtroom. The phrase, “he destroyed people’s lives” has been used frequently when describing his reaction to accusations.
It’s a horrible thing he did, and shows an incredibly self-centered man who thought the world should bend to his whim. It’s more proof to the adage: absolute power corrupts absolutely.
But simply dismissing Lance as a cad or a horrible person would be far easier if not for the other side of his life. In his public battle against cancer, he inspired many facing that disease to not give up their battle. Even for those who eventually lost, the encouragement many got from Armstrong’s story was significant. On top of that, the Livestrong foundation did much to raise money and awareness for cancer and for other significant health issues. This foundation exists because of the heroic story of Lance’s successful battle to beat cancer, as well as his subsequent cycling victories. Whatever the lies he told in the process, he did beat cancer and he did win the Tour de France multiple times.
A top executive I know recently decided to take Inderal before making high-pressure/high-anxiety presentations. The impact was immediate. She felt more relaxed, confident and effective. Her people agreed.
Would she encourage a comparably anxious subordinate to take the drug? No. But if that employee’s anxiety really undermined his or her effectiveness, she’d share her story and make them aware of the Inderal option. She certainly wouldn’t disapprove of an employee seeking prescription help to become more productive.
No one in America thinks twice anymore if a colleague takes Prozac. (Roughly 10% of workers in Europe and the U.K. use antidepressants, as well). Caffeine has clearly become the (legal) stimulant of business choice and Starbucks its most profitable global pusher (two shots of espresso, please).
Increasingly, prescription ADHD drugs like Adderall, dedicated to improving attention deficits, are finding their way into gray market use by students looking for a cognitive edge. When one looks at existing and in-the-pipeline drugs for Alzheimer’s and other neurophysiological therapies for aging OECD populations with retirements delayed, the odds are that far more employees are going to be taking more drugs to get more work done better.
Performance-enhancing (or degraded performance-delaying) drugs will become as common as that revitalizing cup of afternoon coffee.
Should that be encouraged? Or should management pretend those options don’t exist?
Most managers would believe they’re doing a good thing if they encouraged a hard-of-hearing employee to explore a hearing aid or a visually-impaired colleague to consider glasses. By contrast, encouraging an under-performing subordinate to lose 25 pounds, get a hair transplant or contact-lenses would likely inspire a formal complaint to Human Resources and/or a possible lawsuit. Ironically, the money isn’t the issue here; the business norms associated with perceived cosmetic and aesthetic concerns are radically different from those attached to job performance and productivity.Continue reading…
Monday’s WSJ (online now) features an exceptionally important and courageous op-ed by Harvard professor (and frequent co-author of mine, although not in this case) Tom Stossel, discussing a rule within recently enacted healthcare legislation with the Orwellian title, “The Physician Payment Sunshine Act,” focused on physician/industry relationships.
Taking its name from the assertion that “sunshine is the best disinfectant,” the Act apparently aims to help disinfect physicians who might be contaminated by industry contact, an interaction the Act seems to assume is intrinsically corrupting — in stark contrast, one suspects, to the many other activities in which physicians engage, and the many other factors in their environment that might influence their behavior, as Stossel and I previously discussed here and here; see here and here as well.
To restore physicians to their baseline state of virginal professional purity, the Act mandates a stultifying series of reporting requirements, impacting amounts as little as $10. While such reports may be a Pharmascold’s wet dream, they are a logistical nightmare for the physicians involved, and serve to create an enormous compliance bureaucracy for everyone.
My recent experience at an innovation symposium at Duke University, as well as my frequent informal conversations with academic physicians at other leading institutes, suggest the increasing bureaucratic hurdles confronting university physicians seeking to strengthen the essential translational relationship between academia and industry are a particularly unfortunate problem, and are having the presumably intended effect of stifling these interactions. Young physicians worry that the burdensome requirements are overwhelming, while senior leaders seek desperately to avoid the inevitable media takedowns predictably led by the NYT, public radio, and the rest of the usual suspects. (Not infrequently, these stories seem to originate with material selectively provided to a sympathetic journalist by a plantiff attorney — but of course, nothing cozy or sketchy here….)
And we also know that there have been recent revelations of numerous occasions where practicing physicians have failed to live up to the ideal. The Wall Street Journal documented spine surgeons who did large numbers of spine surgery and received large payments from a medical device manufacturer. Pro Publica has shown that faculty at prestigious medical schools have failed to comply with university conflict of interest policies. A Maryland cardiologist has had his medical license revoked and his hospital had to pay back Medicare millions of dollars because of allegedly inserting stents in patients who did not need them.
How can we support our fellow physicians and medical students so that we all strive to become the best caregivers we can possibly be? Is the problem with living up to the ideal a specific problem within medicine or is it a more general problem of human nature and the current cultural environment?