Sunday, November 25, 2012

Accutane Users Win Huge Verdict Against Roche. Who's the Winner?

I was engaged in one of my pleasures, sitting in a coffee shop leafing through medical journals. Usually, I am perusing newspapers. I spend many hours each week combing through various newspapers and routinely forward items of interest to folks of interest. No newspapers today. I have a few gastroenterology journals to look through. My professional reading habits have evolved over my career. I am more interested in reading about medical ethics, health care policy and the art of medicine than in studying hard science or clinical research, which used to be my required reading years ago.

I read an essay entitled, Irritable Bowel Syndrome (IBS) Patients’ Willingness to Take Risks with Medications published in the June 2012 issue of the American Journal of Gastroenterology. The article stated that IBS patients would accept a small chance of death if there were an overwhelming likelihood of cure. This caught my attention. Of course, IBS can be a debilitating illness. But, it is not cancer and poses no threat to life. Nevertheless, patients who are desperate for succor, would accept a small risk of a premature journey to the hereafter. While many physician would not be comfortable with these odds, if patients make an informed judgment, then it is their call to make.

Patients need to know the material risks of a medicine or treatment in order to provide informed consent. For example, many successful medical malpractice lawsuits prevail because the plaintiff claims that the physician ‘failed to warn’ of a known complication. The plaintiff alleges that if he been properly warned of a potential rare complication, then he would have rejected the risky and reckless treatment. These cases often suspend disbelief. Do we believe that a patient with a serious medical condition would have declined a treatment if informed about a 1 or 2% chance of a dangerous complication? Give me a break.

In New Jersey, a cauldron for medical malpractice litigation, a jury awarded damages of $18 million to two plaintiffs who developed colitis after taking the drug Accutane. They claim that the company, Roche, failed to warn about this complication. There remain over 7000 cases of alleged Accutane induced colitis that are pending.  Roche has paid out nearly $80 million in verdicts and denies that their medication causes this complication. I wonder how much medical research could have been funded with this incomprehensible amount of cash.

I am a gastroenterologist who has never seen a case of colitis linked to Accutane. I am not certain that this complication truly exists, even though a jury of ordinary folks accepts this, particularly when an ailing person is seeking ‘justice’ from a rich and heartless pharmaceutical company. The first I ever learned of a supposed connection between Accutane and colitis was when I read about a medical malpractice case in a newspaper years ago.

Does this drug truly cause colitis? Who knows? Is the company responsible for not warning about a complication that it doesn’t believe exists? Do we believe that a patient with disfiguring acne (Accutane was prescribed for severe acne, not typical teenage blemishes.) would decline a highly effective medicine because there might be an extremely small risk of developing severe colitis? I would suggest that these patients, like suffering IBS patients, would accept considerable risk in return for considerable relief.

In 2009, Roche took Accutane off the market after enduring tens of millions of dollars in verdicts. Who emerges victorious here? Choose the best answer.

  • The public
  • The medical profession
  • Roche
  • Trial Lawyers
Would trial lawyers abandon a case if there was a 1% chance they would lose?

Sunday, November 18, 2012

Romney is a Loser - Is This a Fair and Balanced Judgment?

Romney lost.  This update is for those who have just awakened from a deep coma.  I voted for him which will not surprise even the occasional reader of this blog.  While he was an imperfect candidate, I believe that a businessman whose successes have straddled the public and private worlds may have provided a pathway forward out of the abyss.  Sure, I recognize that campaigning is quite different from governing.  Had Romney prevailed then he would have been opposed by an obstructionist Senate that would have stiff-armed him in the way that I expect the House to do to the president.
The loser always faces a merciless post mortem where pundits and pontificators point out the series of fatal errors that the candidate committed. 

“He dissed the Latinos.”
“He didn’t reach out to women.”
“He tacked too far to the right in order to gain the nomination.”
“He made a $10,000 bet with Rick ‘Brain-Freeze’ Perry on national TV.”
“He introduced us to the concept of ‘self-deportation’.”
“He was clumsy abroad.”
“He was clumsy here.”
“He was too soft on Bengazi during the debates.”
“He was too hard on the 47%.”
“He returned too late to the center.”

Of course, all of these criticisms are legitimate.   I’ll add my own criticism to the list.  No candidate seeking high office should ever have any member of his family engage in dressage, an activity that was entirely foreign to me and most of the hoi polloi prior to the campaign.  Let the Googling begin.

Where were these conservative carpers during the campaign?  Not only were they mute on criticism, but many of them were enthusiastic cheerleaders.  Now, they are spinning like pin wheels as if they knew all along how the Romneyites were faltering and destined for a stinging loss. 

Had Romney prevailed he would be heralded as a political genius and the conservative naysayers would all be competing to reap credit for a victory that each one would claim to be responsible for. 
This is not fair and balanced.  Of course, had the president lost, we would be witnessing the same process.  Leftists and moderates would emerge screeching their hollow claims of ‘I told you so’. 

Why exactly does this post-election drivel belong on a medical commentary blog?   You mean it isn’t obvious to my erudite readership? There’s an analogy between the recent dissection of the Romney loss and the practice of medicine. Consider this scenario.
  • An adverse event occurs in medicine despite the best efforts of the physician.
  • The doctor is blamed for the event.
  • Various experts emerge who point out in retrospect the physician’s obvious failures that seemed acceptable at the time.

Sometimes, patients get better in spite of our efforts.  When this occurs, we may be unfairly lionized as heavenly healers.  On other occasions, patients suffer despite our best efforts.  When this occurs we may be unfairly blamed for the result.

Should our judgment of a doctor, or anyone, depend upon the outcome or the path that led there?  How do you vote on this question?

Sunday, November 11, 2012

Electronic Medical Records Holds Doctors Hostage

Which of the following events is most traumatic for a practicing physician?
  • Your staff doesn’t show up because the roads are flooded, but the waiting room is full of patients.
  • Medicare notifies you that coding discrepancies will result in an audit of 2 years of Medicare records.
  • You receive an offer of employment by a corporate medical institution who will bury your practice if you do not sign.
  • Your key expert witness defending you in your upcoming medical malpractice case is incarcerated.
  • Your office electronic medical records (EMR) system suffers a cardiac arrest.
Tough choices, I know. Our office lost complete access to EMR for 3 days, and it wasn’t pretty. I don’t grasp the technical (doubletalk) explanation for the temporary EMR coma, but we were reminded of how dependent we are on technology. Our IT gurus were working tirelessly, but their adversary was wily and formidable. Finally, they prevailed, but I wouldn’t regard this as a clean win for us. We were hobbling for 3 days. The fried server has been rebuilt and now has reinforcements to insulate against another crippling assault.

Ink and paper never crash.

Luckily, our brains were still functioning adequately during these 72 hours. We hadn’t yet lost the ability to obtain a medical history without pointing & clicking. Somehow, we managed to obtain a review of systems without trolling and scrolling across our laptop monitors. Ancient physician techniques, such as maintaining eye contact and offering nods of understanding to patients, were effortlessly recalled, like riding a bicycle. I even prepared a few paper prescriptions, once I was able to locate a yellowed and tattered prescription pad. I hope the pharmacies will accept these medical anachronisms.

The tough reality is that during these 3 days we had no records available for the patients we saw. We compensated when we could, with faxes and phone reports, but this is no substitute for a complete medical record. Patients arrived to review test results that we couldn’t access. In some cases, I had faxed biopsy reports available, but not the accompanying endoscopy operative reports that were hiding in the EMR black hole. Patients were understanding of our dilemma, since many had faced their own computer rages. But, many of them did not receive a full measure of medical services from us. I asked some to return to see me for another visit, once the EMR was resuscitated, as I feared I may have overlooked some important issue during the 3 days of Stone Age medicine.

Karl Marx

To paraphrase, the most famous phrase uttered by the individual pictured above, technology is the opium of the people. We love technology. We demand it. We upgrade it. And, we are hooked on it. Like any addiction, when the fix isn’t there for us, withdrawal is painful.

I’m thinking of opening the first chapter of Techno-Addicts Anonymous. Of course, the first step of recovery is the toughest. “My name is Whistleblower and I am a…”

Sunday, November 4, 2012

Does Doctor to Doctor Communication Protect Patients?

One of the gripes that patients have about the medical profession is that we physicians don’t communicate sufficiently about our patients. In my view, this criticism is spot on. Patients we see in the office often have several physicians participating in their care. The level of communication among us is variable. While electronic medical records (EMR) has the potential to facilitate communication between physicians’ offices and hospitals, the promise has not yet been realized. The physicians in our community, for example, all have different EMR systems which simply can’t talk to each other. We can access hospital data banks from our office, but this is cumbersome and burns up time. Ideally, there should be a universal system, an Esperanto approach where all of us utilize the same EMR language.

On the day I wrote this post, I participated in a direct conversation with the treating physician at the hospital bedside which vexed me. This scenario would seem to be ideal from the patient’s perspective. At the bedside were the attending physician, the gastroenterologist (the Whistleblower) and the anesthesiologist who were conferring about the next appropriate diagnostic step in a patient who had experienced upper gastrointestinal (UGI) bleeding.

I was asked to evaluate this patient with UGI bleeding and to arrange an expeditious endoscopy to examine the esophagus and stomach region in order to identify a bleeding source. Hours prior to seeing the patient, I scheduled the procedure that I knew would be needed, a short cut that every gastroenterologist will do in order to be efficient. As the patient had other medical conditions, I requested that the sedation be administered by an anesthesiologist, rather than by me, to provide greater safety to the patient.

I arrived and became acquainted with the medical particulars. I agreed with the diagnosis of UGI bleeding and also that an endoscopy was the next logical step in this patient’s care. These observations are not sufficient, however, to proceed with the examination. There are other criteria that must be considered.

  • Does the procedure need to be done now?
  • Do the risks justify performing the procedure?
  • Has the patient provided informed consent for the procedure?
After I arrived on the scene, the anesthesiologist approached me and advised me that the anesthesia risks were extraordinarily high. He was concerned that performing the case could have a disastrous outcome. My reaction to his frank assessment? Thank you! The decision then fell to me to decide on whether to proceed. For me, this was an easy call. The patient did not need an endoscopy at that moment to save his life, the only reason that would justify subjecting him to the prohibitive risks of the procedure. Before discussing this decision with the family, who were awaiting an endoscopy, I summoned the attending hospitalist to relate to him our revised plan. In my view, when an anesthesiologist and the gastroenterologist advise an attending doctor that it would be unsafe to proceed with a planned procedure, the response should be, ‘thank you’! But, it wasn’t. This physician wanted the test and seemed irritated that the set diagnostic plans had been set aside. He wanted a diagnosis, and we declined to proceed after concluding that the risks exceeded the benefits. I was as comfortable with this medical decision as I have been with any other decision I had made in my career. On other cases, when a consultant advises me against a planned course of action for safety reasons, I am so grateful that a patient has been spared from danger.

We got to the right answer here, but had to set aside an unforeseen obstacle to get there. Communication means listening to another point of view and being able to change your mind. As a doctor, when it’s my finger is on the trigger, I call the shots.  I this case, a doctor misfired.