Sunday, August 26, 2007

Who's Really to Blame-Anna Pou's Story Revisited

Anna Pou has now told her harrowing story of the horrific conditions she and other health care workers struggled in after Hurricane Katrina devastated New Orleans. After a two year ordeal, Dr. Pou was vindicated when a Louisiana grand jury justifiably refused to indict her last month for murder, despite the efforts of grandstanding Attorney General Foti.

For an insight into the previously untold aspects of the story, Newsweek has a compelling recounting.

I am relieved that Dr. Pou, a fine physician, has been exonerated and can go forward with her life and care for her patients, to whom she has been devoted. She had been unfairly subjected for two years to, in her words, “the most effective form of torture—the uncertainty and the waiting and waiting and having everybody take a shot at you.”

Unfortunately, the attention focused on Dr. Pou’s story has distracted from the real issues—the colossal, criminally bungled mismanagement of pre-hurricane flood control, and the post-hurricane relief effort, the abandonment of the hurricane victims, and the pattern of responses of this administration to our country’s most poor, sick, and vulnerable citizens.

The growing gap between the rich and poor were recently highlighted by another story as well. In this case, according to the Kansas City Star, Criste Reimer was blind, had cancer and weighed 75 pounds. Her husband Stanly kissed her and dropped her off a balcony, to her death.

"Mr. Reimer was desperate because he could not pay the bills for his uninsured wife's treatment for neurological problems and uterine cancer. Her medical bills ranged from $700 to $800 per week.”

And this was without the cost of nursing homes or home health aides, which readily cost in the $4000-6000 per month range, and therefore are out of the reach of most of the population.

The heinous crime here was not that Mr. Reimer killed his wife; it is that he was driven to do so out of desperation because of the lack of universal health care. And now, ironically, that sum will be paid by taxpayers to cover his incarceration.

The chilling message sent from the persecution of Dr. Pou and her nurse colleagues is that health care workers should run as fast as they can from future disasters. I doubt that I would have Dr. Pou's courage and selflessness...

In both of these examples, it is perhaps our government that should be on trial for its abysmal failures in planning and response to disasters, both natural and of its own making.

Thursday, August 23, 2007

Court vs. Access to Experimental Drugs, Government vs. People

In follow up to the battle of patient rights vs. protectionism, MSNBC polled public opinion. Of more than 10,000 responses, 94% thought that the government should stop their paternalistic behaviour and allow patients—especially dying patients—to decide whether to take an experimental treatment.

Ethics Professor Udo Schuklenk gets the “Barb du Jour” award for noting,
“94% thought that we should enact legislation permitting dying patients to make such choices. This is much in line with other polls providing consistently overwhelming majorities in favor of the legalization of voluntary euthanasia. The bottom line we continue to send to our democratic representatives is that we want to maximise control of our lives when we are dying. Equally consistently legislators tend to ignore our wishes. That's liberal democracy Western style for you ...”

Monday, August 20, 2007

More Medicare Mistakes

According to the New York Times, Medicare will not pay for many preventable complications of hospitalization. These include: falls; mediastinitis (an infection that generally develops after heart surgery); urinary tract infections that result from improper use of catheters; pressure ulcers; and vascular (blood stream) infections that result from improper use of catheters.

The new rules are scheduled to go into effect in October, 2008.

While the goal of reducing preventable infections is laudable, this plan is not. Unfortunately, the “You Broke It, You Bought It” mentality is too simplistic. It assumes that all falls and infections are preventable, which they are not. Particularly for patients who are in an intensive care unit and are on a mechanical ventilator, or who are immunosuppressed, sometimes nosocomial infections are unavoidable.

The logical consequence of the new urinary tract infection rule will be for everyone to get a urine culture on admission. This will lead to rounds of unnecessary antibiotics for asymptomatic infections, which will lead to more resistant organisms emerging or more complications from the antibiotic courses, such as rash or diarrhea. (Asymptomatic bacteriuria, as it is known, is particularly common in the elderly and diabetics.) Except for pregnant women and patients undergoing urologic procedures, the Infectious Diseases Society of America guidelines state,

“For all other adult populations, asymptomatic bacteriuria has not been shown to be harmful. Although persons with bacteriuria are at an increased risk of symptomatic urinary infection, treatment of asymptomatic bacteriuria does not decrease the frequency of symptomatic infection or improve other outcomes. Thus, in populations other than those for whom treatment has been documented to be beneficial, screening for or treatment of asymptomatic bacteriuria is not appropriate and should be discouraged.” Clinical Infectious Diseases 2005; 40:643-54

So while the expert recommendation is not to screen and not to treat, most docs I know (except for ID specialists) will be afraid to not respond to the culture for fear of some peer reviewer’s rebuke.

Some of the other catheter related complications for which Medicare will not pay, under the new policy, are caused by common strains of staphylococcus bacteria. Other life-threatening staphylococcal infections may be added to the list in the future, Medicare officials are reported as having said.

Given the expense of nosocomial (hospital-acquired) pneumonia, I would not be surprised if Medicare were also to add that as an exclusion in the future. Too bad that many pneumonias that are actually present on admission don’t show on initial x-rays because a patient is dehydrated or immunosuppressed. They will be assumed to have been acquired after admission.

Perhaps this is a diversion from the lack of universal health coverage and growing numbers of uninsured in this country. Now, even if you are insured, you can be undesirable from a hospital's perspective. I suspect that hospitals will cherry pick their elective surgical patients even more selectively. If you have risk factors for infection such as morbid obesity, diabetes, malnutrition, or cancer, you'll be on your own. After all, it is your personal responsibility.

Oh, by the way—who will be treating the patients with nosocomial infections in the future if Medicare won’t pay docs for treating these problems? For example, many of these infections now require the services of an Infectious Diseases specialist, a surgical specialist, etc., as they are difficult to cure. These physicians tend to be independent practitioners who are not in the employ of the hospitals where they practice. If neither Medicare nor the hospitals will pay for them to treat these infections, who will? [Remember that under Medicare rules, they are prohibited from billing the patient.] Can we realistically expect them to subsidize Medicare and the hospitals by providing unreimbursed treatment of these infections when they have staff salaries, rent, malpractice insurance etc., etc., that they must pay? This is an issue that does not appear to have been addressed, and which must be.

Setting a different system of rewards, with perks for good outcomes and penalties for mistakes, is a reasonable goal. What is missing from this proposal is that not all of the bad outcomes are preventable. Doctors (and others) should be responsible for significant errors in patient care but should not be held accountable for outcomes which occur due to circumstances beyond their control. While it is foolish to reward people for making mistakes, we also must ensure that patients don’t suffer in our haste to address these issues.

New NIAID Grants for Studying CA-MRSA

Recognizing the urgent need to develop antibiotics to address the explosion in community acquired MRSA (CA-MRSA) skin and soft tissue infections, NIAID announced two new grants to study the efficacy of older, off-patent agents in treating these infections. If inexpensive drugs such as Trimethoprim-Sulfamethoxazole or tetracyclines can be used, perhaps it will slow the use of expensive new drugs such as linezolid.

These older antibiotics are often used now by Infectious Diseases specialists, in an attempt to reserve new agents until absolutely necessary. Unfortunately, this trend goes against human nature. Many primary care physicians as well as some other specialists are anxious to use the new-fangled drugs. Some seem to need to boast that they are up to date by their use of the newest agents and scoff that use of inexpensive, older agents is behind the times.

The two new trials will be led by University of California, Los Angeles and the University of California, San Francisco. Each of the trials is designed to enroll up to 1,200 people. The associated contracts will total up to $19 million over five years.

While I am delighted to see the additional funding for this rapidly growing problem, the results of these studies will likely not be available for several years. In the interim, the excessive use of the new agents will continue, leading to further resistance. I sometimes wonder whether an urgent intervention, such as restricting the use of certain new drugs to specialists in the field, wouldn't be more rational, especially since there are almost no new antibiotics in the pipeline. I know this is heresy, but too much is at stake to squander our few resources in this battle. Perhaps we should be "unAmerican" and not allow business interests and free enterprise to win this battle but lose the global war.

Thursday, August 09, 2007

Court Limits Access to Experimental Drugs for Terminally Ill

In a rather bizarre twist, a federal court has just ruled that there is no constitutional right to experimental drugs for those who are terminally ill and have no other options. "Terminally ill patients desperately need curative treatments," Judge Thomas B. Griffith wrote for the majority. But "their deaths can certainly be hastened by the use of a potentially toxic drug with no proven therapeutic benefit." [...] While I understand the conclusion that was reached, the rationale, if one can even call it that, is paternalistic, at best, and downright irrational on its face.

On the one hand, I can understand the demand for access to a novel compound when there is otherwise no hope. On the other, remember the House of God adage, “They can always hurt you more?” While drugs might prolong a person’s life, they might also make it far more miserable than it would have otherwise been. I have seen that far too many times.

There are also problems from the pharmaceutical’s perspective in allowing such expanded access, beyond the obvious liability issues. For example, it may drain very limited supplies of the investigational drug. Also, particularly for very small biotech companies, staffing is often quite limited. There are heavy regulatory submission requirements when an investigational agent is used outside of a protocol; the limited staff might not be able to meet these requirements as well as their other obligations to the drug development or ongoing clinical trials.

What happened to the concept of an individual’s autonomy? For example, I support Oregon’s right to die, or Death with Dignity Act. If there were unlimited supplies of these drugs, I would leave it to the individual, after presentation of an “informed consent,” to reach his or her decision regarding the desirability of taking an investigational medication. But there aren’t unlimited resources. Thus, ideally, perhaps this decision should be left to the patients and the individual sponsors to negotiate based on the availability of different resources.

What do you think?

For other reading, try:

The Right to a Trial by Jerome Groopman, one of my favorite authors! [New Yorker]

Court Rules Out Terminally Ill for Tests [Associated Press]

Should Dying Patients Have A Right To Use Experimental Drugs? [Justice Talking]

Tuesday, August 07, 2007

Ethics: Privacy vs. Patient "Rights"

An interesting article in Haaretz, of all places, raises the question of whether patients should be told of their physician having HIV infection. "Keeping the Disease Under Wraps" outlines the surgeon's rights to privacy vs. patients interest in knowing his health. You could call it rational thinking vs. emotions as well.

The answer is not straightforward. The risk of HIV transmission is very small--estimated at 1/20,000-- and should be put in perspective of other risks, such as the risk of death from complications of surgery or other infections.

For example, the risk of transmission of Hepatitis C after a needlestick exposure from a HCV positive source is estimated at between 2-10%.

The risk of a serious Staph infection after surgery is generally estimated at 1-2%, and higher if the patient is diabetic, obese, or has some other co-morbidities.

In my previous experience doing Infection Control, the only thing that punitive restrictions do is drive people (be it the public or health care workers) underground so that they refuse to be tested. That is true whether carriers are out of work because of Salmonella, hepatitis, HIV, or Staph infections. No one will be willingly tested if they risk their career and livelihood, even though they have never been implicated in transmission. This is key.

One might also ask how many people might die from lack of access to a skilled surgeon. In the rural area where I live, they are at a premium.

More attention needs to be given to education about relative risks, trying to reduce the emotional charge that HIV/AIDS provokes. Given such a low risk, I would not prevent this surgeon from operating, if there are additional precautions in place, such as double gloving.

What do you think?

Death in Gene Therapy Trial

"Death Points to Risks in Research" touts the Washington Post story.

I would like to comment on Rick Weiss’ article, from the perspective of a clinical researcher. The death of Mrs. Mohr, subsequent to her participation in the Targeted Genetics gene therapy trial, is a tragedy, and worse, was perhaps an avoidable tragedy. There does appear to be a need to re-evaluate the safety mechanisms that are employed to protect patients who are candidates for trial participation, and to re-examine the propriety of the exclusion of public participation in the trial review and approval process that was initiated in 2000.

From the description, it appears that there were serious lapses in Mrs. Mohr’s care. However, there are also several errors in this report which do a disservice to the public, who need to be educated about trials and how to assess whether to participate, rather than be needlessly scared away by inaccurate reports.

For example, a “serious adverse event” requires prompt reporting to the FDA, whether or not it is felt to be related to the drug. The definition of a serious adverse event is one that causes death or is life-threatening, is permanently disabling, results in a congenital anomaly/birth defect, or one that results in new or prolonged hospitalization. Most sponsors require reporting from the investigator within 24 hours. The FDA should have been notified within days after Mrs. Mohr’s admission to the hospital (CFR 312.32).

There are two significant factual errors in the claim that “Two fundamental rules of clinical research were violated that day.” First, there is no FDA requirement that a patient take a consent form home and review it. That is also an impossibility on many trials dealing with acutely ill patients, for example. Nor is there any requirement that the investigator not present the consent form to the volunteer. In fact, some times there is no one else capable of explaining the trial in detail and answering the volunteers questions. To avoid this type of question regarding the adequacy of consent, I try to have family members present when I review the consent, so I can address their concerns as well, and also try to include an impartial witness.

It sounds as though the consent form for this trial was inappropriately technical. Consents are generally pitched at an 8th grade level. Obviously, this is harder to do with a sophisticated gene therapy trial, but should be the goal.

It is disturbing and unusual to have an early phase trial include patients who are on multiple medications likely to cause serious side effects. The decision to allow this is now shielded from public review; there must be transparency, public review and accountability of the approval process.

I hope that there will be a thorough, thoughtful and very public review of this and other gene therapy trials, in particular.

However, articles in the popular press, such as the one in the Washington Post, often seem to dwell on the costs of clinical trials, and to ignore the benefits those trials have brought. Before the development of antibiotics, for example, an infection was often a death sentence, most cancers were considered incurable, and there was no way to control the disastrous effects of diabetes, heart arrhythmias, and many other common illnesses. While clinical trials are not perfect, and do sometimes injure those they are supposed to help, we have come a long way in the past 50 years, in terms of our abilities to develop useful interventions while providing reasonable protection to study participants. Every medicine goes through this sort of trial process. We need new medicines for serious diseases, such as infections, urgently.

Protections need to be in place, but they should not incapacitate research nor scare volunteers unnecessarily. Since many of the issues here revolve around potential conflicts of interest, the first step would be greater transparency, public discussion, and debate.

Sunday, August 05, 2007

Louisiana strikes again-the Jena Jury's injustice

Tales from another world continue. Hard to imagine--let alone witness--the worsening insanity in our country. In Jena, La, Mychal Bell, a 16 year old sophomore football star (when arrested) was recently convicted of aggravated battery and conspiracy to commit aggravated battery, and faces up to 22 years in prison. His crime? A relatively minor role in a fight.

What provoked the fight?
Nooses hung in a tree at the school in response to black students having dared to sit under "the white tree."

What happened to the white students who provoked the tensions with their hateful and threatening racist show?

You had to ask???

Nothing, of course. They are probably local heroes now, basking in their macho glory. Perhaps some will join the military to help us bring freedom, democracy, and the American way to the far corners of the world. . .

An excellent account of this lynching was posted by human rights lawyer and professor, Bill Quigley.

A petition asking the Justice Department to investigate this injustice is available here.

People interested in supporting Mychal or his friends directly can contact:

the Jena 6 Defense Committee, PO Box 2798, Jena, LA 71342;
Friends of Justice, 507 North Donley Avenue, Tulia, TX 79088;
or the ACLU of Louisiana, PO Box 56157, New Orleans, LA 70156 or 417.350.0536.