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Red Tape Alert: New FDA Rule Puts Allergan In A Double Bind

I was reading my daily MedPage Today news, when I came across this amusing example of regulatory unintended consequences. As we all know, pharmaceutical companies are not allowed to promote off-label uses of their medications – doing so is punishable with billions of dollars in fines (just ask Pfizer). But a new set of rules created by the FDA’s Risk Evaluation and Mitigation Strategies (REMS) program essentially requires Allergan to provide safety information about off-label uses of the drug — uses that are illegal for them to discuss.

So Allergan has to file a law suit to resolve the issue of being required (by the government) to do something the government considers criminal.

And the winner is?

Lawyers!

Defensive Medicine: Fear Of Law Suit Or Fear Of Being Wrong?

A thoughtful and (dare I say it) balanced look at medical malpractice in today’s NYT:

Malpractice System Breeds More Waste in Medicine – NYTimes.com

The debate over medical malpractice can often seem theological. On one side are those conservatives and doctors who have no doubt that frivolous lawsuits and Democratic politicians beholden to trial lawyers are the reasons American health care is so expensive. On the other side are those liberals who see malpractice reform as another Republican conspiracy to shift attention from the real problem. […]
The direct costs of malpractice lawsuits — jury awards, settlements and the like — are such a minuscule part of health spending that they barely merit discussion, economists say. But that doesn’t mean the malpractice system is working.

The fear of lawsuits among doctors does seem to lead to a noticeable amount of wasteful treatment. Amitabh Chandra — a Harvard economist whose research is cited by both the American Medical Association and the trial lawyers’ association — says $60 billion a year, or about 3 percent of overall medical spending, is a reasonable upper-end estimate. If a new policy could eliminate close to that much waste without causing other problems, it would be a no-brainer.

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*This blog post was originally published at Movin' Meat*

A Heartfelt Physician Apology

A recent oft-cited study showed that doctors who who apologized for mistakes were less likely to be sued.  My initial reaction to that is to file it under “duh.”

But then I was greeted with a note lying on my desk.

Dr. Rob:

First, I want to tell you that for the majority of the many years my family has been patients of your practice, I believe we received excellent care and you always had our best interests in mind.  Further, we appreciate all that you and your staff have done for us.

However, it is with great regret that I find myself in the position of writing to you with a problem I see as pervasive in your practice…

Ugh.  This is not the way to start my day.

The letter went on to describe a problem with communication of a concern the patient had about a medical problem that was very worrisome to her.  It didn’t point the finger of blame at my nurse, nor any one else in the office.  It wasn’t at all angry in its tone to me.  It simply expressed the disappointment of a patient who felt let-down by her physician.

The letter ended with:

I look forward to speaking with you about this issue early in the week of July 20.

Thank you in advance for your attention to this matter.

I put off calling her until the end of the day.  I knew she would be reasonable overall, but beyond the fact that I hate calling people on the phone at all, I hate calling when I know I have to apologize.  The problem in this case was not with my staff or with confusion in the office.  The problem was with a physician who simply dropped the ball and did not follow-up as promised.

I finally called:

Hi.

First let me say thank you for the letter you sent.  I mean that sincerely.  I would much rather hear about problems in our office than to simply having people get angry and leave.  This is something I needed to hear.

Second, let me say that the blame is 100% mine.  I really wasn’t worried about the problem and so I honestly just let it slip my mind.  I did tell you I’d contact you and would send you to a specialist if things weren’t clear after the tests I ordered.  I’m sorry about that.

I went on to discuss the situation and that I didn’t think anything was serious at all.  She still wanted to go ahead with the consultant because of some stuff she had heard about the condition.  I told her that I have no problem with that, as I see my job as one of giving my advice and perspective; but not as making the final decisions.  The most important thing is that her worries are addressed and that she feels comfortable that everything is OK.  If it takes a consultant to do that, then I have absolutely no problem with that.

I also explained that communication in a medical office is very difficult – and has gotten much harder as we have gotten busier.  It is our plan to eventually have communication by e-mail, but that is not ready for prime-time. This is not an excuse, I told her, but an explanation and a promise that I do see the problem and we are doing something about it.

As expected, she was gracious about the situation and was thankful for the apology.  I didn’t do it to avoid lawsuit or to protect myself.  I like this family and didn’t want to lose them as patients.  Beyond that, though, I owed her an apology.  I had let her down.  I hadn’t done what I promised I would do.  She had been kind enough to send me the letter and deserved a quick resolution to the situation.

I still hated picking up the phone, though.  It isn’t easy to admit fault, no matter how accepting you know the other person will be.

As obvious as it seems that apologizing will prevent lawsuit, it is a hard thing to do.

But I am glad I did.

*This blog post was originally published at Musings of a Distractible Mind*

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