Tuesday, September 16, 2014

Potential Perils of Personal Genetic Testing

Biologist "George Doe" (a pseudonym) described how: "With genetic testing, I gave my parents the gift of divorce".

I'm glad the 23andMe service allows people the option of learning about close relatives. But a couple of take home points:
1) If you get a 23andMe genetic test, make sure you really really want to know if you might have genetically close unknown relatives before you click through on that part of the results.

2) If you have a child you didn't tell your current family about, maybe you should come clean before you get your 23andMe test.
Related: "Genetic testing brings families together. And sometimes tears them apart".

Monday, September 15, 2014

Suspended Animation Update

From The Economist: "Doctors have begun human trials of suspended animation to buy more time for critically injured patients".

The article explains:
Dr Tisherman’s EPR process, developed with the help of $800,000 from the Department of Defence, is mostly about resurrection. The idea at this stage is to use equipment like the catheters and pumps that can be found in any trauma centre to suspend the life of critically injured people in order to buy more time for surgeons to try to save them.
EPR works by lowering the patient’s body temperature and replacing their blood with a cold saline solution. Hypothermia is already induced in patients to help reduce bleeding during some surgical procedures. But cooling the body down so that it goes into a suspended state has not been tried before. The idea came from observations that people have been resuscitated having stopped breathing for half an hour or more after falling into icy water.
I'm encouraged by this kind of medical advance.  One interesting quote from the article:
The Food and Drug Administration decided the procedure was exempt from informed consent, as patients would be too ill to give it themselves and might benefit because they were likely to die as no other treatment was available. For now, the patient has to be between 18 and 65 years old, have a penetrating wound, such as a knife, gunshot or similar injury, suffer a cardiac arrest within five minutes of arrival in the hospital and fail to respond to usual resuscitation efforts.
Given that these patients would like die anyways without the experimental treatment (and that they presumably want to live), one can make a much stronger case for waiving the usual informed consent in this kind of emergency than in the more-controversial UK experiment (which involves giving standard adrenaline therapy vs. placebo to cardiac arrest patients.)

For more on the latter topic, see my recent Forbes piece, "UK To Experiment on Cardiac Arrest Patients Without Their Consent".

Thursday, September 11, 2014

Why Much of the Medical Literature Is Wrong

Medscape: "Why Much of the Medical Literature Is Wrong".

Topics discussed include:
1. Reverse Causality
2. The Play of Chance and the DICE Miracle
3. Bias: Coffee, Cellphones, and Chocolate
4. Confounding
5. Exaggerated Risk 
Some eye-opening examples:
Mistaking what came first in the order of causation is a form of protopathic bias.[4] There are numerous examples in the literature. For example, an assumed association between breast feeding and stunted growth, [5] actually reflected the fact that sicker infants were preferentially breastfed for longer periods. Thus, stunted growth led to more breastfeeding, not the other way around...

One classic example of selection bias occurred in 1981 with a NEJM study showing an association between coffee consumption and pancreatic cancer.[15] The selection bias occurred when the controls were recruited for the study. The control group had a high incidence of peptic ulcer disease, and so as not to worsen their symptoms, they drank little coffee. Thus, the association between coffee and cancer was artificially created because the control group was fundamentally different from the general population in terms of their coffee consumption. When the study was repeated with proper controls, no effect was seen...[16]

[R]ecall bias, occurs when subjects with a disease are more likely to remember the exposure under investigation than controls. In the INTERPHONE study, which was designed to investigate the association between cell phones and brain tumors, a spot-check of mobile phone records for cases and controls showed that random recall errors were large for both groups with an overestimation among cases for more distant time periods.[18] Such differential recall could induce an association between cell phones and brain tumors even if none actually exists...

A 1996 study sought to compare laparoscopic vs open appendectomy for appendicitis.[29] The study worked well during the day, but at night the presence of the attending surgeon was required for the laparoscopic cases but not the open cases. Consequently, the on-call residents, who didn't like calling in their attendings, adopted a practice of holding the translucent study envelopes up to the light to see if the person was randomly assigned to open or laparoscopic surgery. When they found an envelope that allocated a patient to the open procedure (which would not require calling in the attending and would therefore save time), they opened that envelope and left the remaining laparoscopic envelopes for the following morning. Because cases operated on at night were presumably sicker than those that could wait until morning, the actions of the on-call team biased the results. Sicker cases preferentially got open surgery, making the outcomes of the open procedure look worse than they actually were.[30] So, though randomized trials are often thought of as the solution to confounding, if randomization is not handled properly, confounding can still occur. In this case, an opaque envelope would have solved the problem...
The article (correctly) notes that these issues don't mean that medical knowledge is impossible -- but rather we must be diligent in looking for sources of potential error.

(Note: Reading the full text of the article requires free registration.)

Friday, September 5, 2014

Sibert Replies to Jauhar

Dr. Karen Sibert has penned a good reply to a recent Wall Street Journal OpEd by Dr. Sandeep Jauhar on the current problems with American health care.

Sibert's piece is entitled, "His diagnosis is right, but the treatment is all wrong". (Jauhar's original piece was, "Why Doctors Are Sick of Their Profession".)

Sibert discusses several important topics, including:

* The truth behind “quality” metrics
* The perils of patient satisfaction scores

She also observes:
Here is what I see as the downhill slide of 21st century medicine:

1.  The surge of uncritical belief in “evidence-based medicine” has led to rigid algorithms–cookbook recipes, really–for patient care. Experienced physicians know these algorithms are often a poor fit for patients with multiple medical problems, and must be ignored or subverted for the good of the patient.  At the same time, the physician may face criticism or sanctions for not following protocol.

2.  Bureaucrats and regulators seem convinced that if only we can produce enough care protocols, we can cut out physicians altogether and save money by having advanced practice nurses take care of everyone.  They encourage the devaluation of physician education and expertise. This seems to be the philosophy behind the proposed new VA rules which would eliminate physician supervision of veterans’ health care. (I’ll be curious to see if physician-free care will be considered good enough for the President and the Congress.)
And also:
Fee-for-service pay isn’t the chief culprit.  The best physicians stay busy because they have respect and referrals from their peers.  As they develop a base of satisfied patients and colleagues who recognize clinical excellence, they achieve financial success and have no wish to perform unnecessary procedures.  Price-fixing of physician services by third-party payers is the root cause of financial pressure to increase the number of services provided.
For more details on how our current problems and the right way to fix them, read the full text of, "His diagnosis is right, but the treatment is all wrong".


Thursday, August 28, 2014

Hsieh Forbes Column: UK To Experiment on Cardiac Arrest Patients Without Their Consent

My latest Forbes column is now up: "UK To Experiment on Cardiac Arrest Patients Without Their Consent".

Here is the opening:
Soon, thousands of UK cardiac arrest patients may find themselves enrolled in a major medical experiment, without their consent. This may be legal. But is it ethical?

As described by the Telegraph:

Paramedics will give patients whose heart has stopped a dummy drug as part of an ‘ethically questionable’ study into whether adrenalin works in resuscitation or not… Patients in cardiac arrest will receive either a shot of adrenalin, which is the current practice, or a salt water placebo but the patient, their relatives nor the paramedic administering it will know which. The trial is seen to be controversial because patients will not be able to consent to taking part and could receive a totally useless placebo injection…

First, I want to emphasize that this is a legitimate scientific question. Adrenaline (also known as epinephrine) has been a standard part of the resuscitation protocol for sudden cardiac arrest, along with chest compressions and electrical shocks. (Think of paramedics shouting “clear” on television medical dramas.) But more recent evidence suggests that adrenaline might cause more harm than good in this situation, helping start the heart but possibly also causing some neurological damage. There is a valid and important scientific question. My concern is not over the science behind the experiment, but rather the ethics...
(For more details and discussion, read the full text of "UK To Experiment on Cardiac Arrest Patients Without Their Consent".)

There are two parts of the study that disturb me the most: (1) The drug trial itself, and (2) the decision to not actively inform relatives that any patient who died had been an involuntary participant.  I cover both aspects in more detail in the piece.

Note: I'm not fully settled on what (if any) experimentation should be allowed on incapacitated patients in an emergency setting without informed consent.  But I do think this should be an issue of active discussion, especially for the people whose lives are on the line.

And for a discussion of prior US medical experiments that have been alleged to be unethical, non-consensual, or illegal, see this Wikipedia list.

Wednesday, August 27, 2014

More Benefits of Medical Marijuana?

An intriguing report: "In States With Medical Marijuana, Painkiller Deaths Drop by 25%".
In the study, published today August 25 in JAMA Internal Medicine, the researchers hypothesize that in states where medical marijuana can be prescribed, patients may use pot to treat pain, either instead of prescription opiates, or to supplement them—and may thus require a lower dosage that is less likely to lead to a fatal problem.

As with most findings involving marijuana and public policy, however, not everyone agrees on a single interpretation of the results...

Perhaps the science will become clearer as more states continue to legalize medical (and recreational) use.

Monday, August 25, 2014

Architecture and Hospital Rooms

The New York Times had a fascinating article on innovative thinking for hospital room architecture: "In Redesigned Room, Hospital Patients May Feel Better Already".

Some of the ideas seem simple ("same handedness", more natural light, and "double door lock boxes" for medications).  But in aggregate, they could reduce medical errors and improve patient outcomes.

I love reading about innovations in health care!