Sunday, September 23, 2007
Random Acts of Kindness-Another Bully Bites the Dust
In response to harassment of a fellow student for the grave sin of wearing a pink shirt, high school seniors David Shepherd and Travis Price encouraged others to wear pink as a sign of solidarity.
Reminds me of "Not in Our Town," a true story of how more than 10,000 people in Billing's Montana stood up to anti-semitism by placing menorahs in their windows.
Perhaps David and Travis could tour the US, with a first stop being in Jena, Louisiana to help the young blacks unjustly imprisoned after a response to a racist hate crime was blamed on them.
I wish them well, and hope they will keep up their good work!
Ouch! and a Clever Concept
The study was a well-designed randomized, double-blind, placebo-controlled clinical trial designed to test whether peramivir, when administered intramuscularly during the acute infection, could reduce the duration of influenza symptoms.
Biocryst used elevated levels of a muscle enzyme, CPK, as a surrogate marker to show whether the patients had received intra-muscular injections, as was intended, as the levels of that enzyme rises with muscle injury. (Unfortunately, it can also rise if someone has severe fever or chills).
Analysis of the study results showed that while a single dose of peramivir did demonstrate improvement compared to placebo, the improvement was not statistically significant. On the other hand, for those patients who showed an elevation in CPK levels compared to their baseline, peramivir showed a dose-related improvement of 64.8 hours at the 300mg dose, and an improvement of 44.6 hours over placebo at the 150mg dose.
The most interesting discussion I read was "Size Does Matter" by Brian Orelli in the Motley Fool. I'm thinking that a 3" needle would be better for many of my patients...but that is another story. I'll be looking forward to seeing the results of further trials.
Athlete's Remembering Humble Roots
Several athletes are teaming up with major retailers to produce more reasonably priced branded shoes and clothing--Kevin Durant, of the Seattle SuperSonics, with Nike's sneakers, for example. Others include Sephon Marbury, of the New York Knicks, and Ben Wallace, of the Chicago Bulls, who are teaming up with retailer Steve & Barry's, as is the tennis star Venus Williams.
With luck, these new brands will be affordable for working families and may go a long way to help reduce the enormous and cruel peer pressure adolescents experience.
This is smart marketing--as well as the right thing to do--and looks like a win-win for all.
Thursday, September 20, 2007
The Kite Runner Meets the Days of Awe
The themes are universal: regret, repentence, and redemption, though the Afghan/Muslim and Jewish cultures take somewhat disparate routes to get there.
There is ethnic cleansing, be it the Holocaust or the Taliban or myriads of culture wars before. And loss of one’s land and one’s identity, with the struggle to begin again. And then insights from the wise elder, who helps the protagonist understand identical events viewed both from the perspective of childhood and later with the wisdom that comes with age and experience.
And ultimately there is hope—from the courage of an individual, struggling with remorse and his understanding that there is 'a way to be good again.'
Imagine if “For you, a thousand times over” were to become the mantra of our world.
Wednesday, September 19, 2007
"Animals at Play" Renews the Spirit
Sunday, August 26, 2007
Who's Really to Blame-Anna Pou's Story Revisited
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
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
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
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
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
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
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"
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.
Sunday, August 05, 2007
Louisiana strikes again-the Jena Jury's injustice
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 jena6defense@gmail.com;
Friends of Justice, 507 North Donley Avenue, Tulia, TX 79088 www.fojtulia.org;
or the ACLU of Louisiana, PO Box 56157, New Orleans, LA 70156 www.laaclu.org or 417.350.0536.
Friday, July 27, 2007
Foti vs. reality
Unsealing documents in a case like this would be quite unusual, and would potentially allow material to be taken out of context and distorted in a continuation of Foti's witch hunt in the press.
Stephen Gillers, professor of law and legal ethics at
"Prosecutors are instructed to refrain from making comments that have a substantial chance of heightening public condemnation of the accused, which is what his latest comments on the grand jury ruling does. It echoes the prejudicial comments he made at the time the women were arrested," Gillers said.
Best political one-liner award, from "Bedtime for Gonzo"
This line from Eugene Robinson's rapier report on Alberto Gonzales is destined to become a classic:
"Gonzo has managed to do something no one else in Washington has managed in years: create a spirit of true bipartisanship."
Hat's off to Mr. Robinson!
Tuesday, July 24, 2007
Voices of Reason from New Orleans
In gracious remarks, Dr. Pou stated, "This is not a moment of triumph, but a moment of remembrance for all those who lost their lives during the storm.
We need to remember the magnitude of human suffering that occurred in the city of New Orleans in the wake of Hurricane Katrina so that we can ensure that this never happens again— and that no health care professional should ever go through this again."
Today, the New York Times also reported on the loss of major hospitals and health infrastructure in New Orleans since Katrina, as well as the exodus of doctors. This is no great surprise after the witch hunt that has haunted Dr. Pou and her other colleagues who bravely stayed to care for their patients. Some other generous souls are also trying to help rebuild their city--an inspiring story concerns the Common Ground Free Clinic, whose volunteers are doing more to rebuild their community than any of the too visible politicians.
Thursday, July 19, 2007
Dr. Pou's Persecution vs. FEMA
Despite lack of supporting evidence from toxicologists, Attorney General Foti has continued his grandstanding, publicity-seeking witch hunt, just as Mike Nifong did in the Duke lacrosse players trial.
Fortunately, Dr. Pou is fighting back. This week, she filed a suit against the state's Office of Risk Management and Mr. Foti, accusing him of using her arrest for his political gain in his bid for re-election bid. The suit does not ask for personal damages, though that would be entirely appropriate and justified. Instead, it asks for the state to pay for Pou's legal defense against civil lawsuits; she was working for the state at the time of the hurricane. Backing her claims as to Mr. Foti's political motivation, Dr. Pou's suit notes that Foti had her arrested, "called an international press conference the next day to announce the arrest, made extra judicial comments totally contrary to the Rules of Professional Responsibility, and culminated the week's activity
with an attorney general fundraiser to showcase his `achievements' in the arrest of Dr. Pou and the two nurses."
Dr. Pou is gaining other support. There was a rally this week to mark the anniversary of her arrest and ask for justice, as noted in pictures and video. According to the Times-Picayune, the American Medical Association and the American Nurses Association have issued a statement noting that "During any disaster, health care providers, doctors and nurses and others, must work together to make the very best decisions that they can with their given available resources. Judgments regarding these decisions and subsequent actions would be more properly considered by their respective licensing boards. This criminal prosecution will chill future responses of health practitioners during a major disaster for fear of having their very best judgments second-guessed. Hurricane Katrina is not the last disaster that we're going to face."
We have already witnessed the incompetence of responsible officials in dealing with Katrina. Today, we learned that FEMA suppressed health warnings from its own workers regarding formaldehyde related health hazards from FEMA-provided trailers. This is reminiscent of the reassurances New Yorkers received in the aftermath of 9-11 about the safety of their air.
Let's not let the diversionary tactics of Foti and the like distract us from the real culprits. Rather than allowing the persecution of a fine physician to continue, let's focus on the colossal failures of our government in protecting vulnerable citizens and its shameful cover-ups.
Wednesday, July 18, 2007
Bacteria Talk. . .to Dr. Bonnie Bassler
I had the pleasure of watching the Nova segment last night about
Dr. Bonnie Bassler's work on communication between bacteria.
While I was somewhat familiar with this work, known as quorum
sensing, I was unaware of how it might be used to combat
infections by disrupting the communication between the bacteria.
The program also showed a fascinating glimpse of a brilliant
woman scientist. It was inspiring to hear of her background and
evolution. Being all too attuned to the particular difficulties women
have in the sciences, I was especially impressed by her achievements.
I would encourage anyone interested in biology or medicine to watch this clip
on bacterial communication, which is available on-line. I hope
that young women, especially, will learn of Dr. Bassler's story
and important research.
Thursday, June 21, 2007
The Constant Gardener Visits New Orleans
There were two surprisingly confluent events last night:
I finally watched “The Constant Gardener.” I had heard it would “be good for me” but had hesitated to watch it, as I am often haunted by strong imagery. Also, thoughtful, provacative movies don’t often come to theaters in
Earlier in the day, I heard the disturbing news that the witchunt in the
There are striking analogies between the two stories. In the first, you have young, idealistic, Tessa who tries to help the poor in
Fade from
In February, 2007, toxicology reports from
And now the witch hunt continues. Perhaps I'm cynical, but granting immunity to the nurses to compel them to testify before the grand jury sounds to me like a prelude to coerced testimony against Dr. Pou, made up in order to end their own nightmares. Who wouldn’t bow to such pressure?
In both of these settings, you have idealistic young white women risking their lives to help the poor, primarily black, populace. In the movie, Big Pharma was the villain. In
There is a growing abyss between the haves and have-nots in this country—as the contrast between the lovely walled courtyard gardens of the Vieux Carre, and the lower 9th ward. This economic and class divide makes me wonder if it wouldn’t be safer to work with the poor overseas than in our own neglected slums with our increasingly morally corrupt government.
From my own garden retreat, I wonder, “Who will foolishly stay and help come the next disaster? Will I have the courage to do what Dr. Pou and her colleagues did, risking their lives to help others?”
jsPlease support Dr. Pou, Ms. Landry and Ms. Budo. If you would like to help or receive more updates, please check Dr. Pou's new website.
Sunday, April 22, 2007
Grey’s Anatomy Goofs on Bone Marrow Donation
Grey’s did the public a major disservice this week by distorting bone marrow donation. They incorrectly showed Izzy going through a great deal of pain during the procedure. In fact, if she had received the regional (epidural) anesthetic correctly and effectively, she should not have felt any pain at all during the procedure. So between the scary, long needle they showed, and then her gripping Bailey’s hand, the episode certainly doesn’t make the procedure very inviting—and might well scare potential donors off.
For the real scoop on donation, and the option of peripheral blood (circulating) cell (PBSC) transplant, an increasingly used alternative of obtaining donor cells from a peripheral blood specimen (like donating blood), see the National Marrow Donator Program. Information about a clinical trial comparing PBSC and bone marrow donation is also available here. Not as sexy, but much more reliable.
Grey's could redeem itself by providing resources for information at the end of its' shows, if appropriate, and by encouraging cell and organ donation programs.