OLPC's XO Makes History

Uruguay has just become the first country to begin widespread deployment of the revolutionary XO laptop to all of it's children. An inspiring personal story and moving pictures about the historical moment is recounted by Ivan Krstic, OLPC's brilliant director of security architecture, who was shipped off to Uruguay along with the first laptops, as a just in case trouble shooter. My congratulations to all at OLPC!

I hope other countries will join this move, as the laptop is incredible. Shame on Intel and Microsoft for trying to sabotage this nonprofit's venture!

I had the opportunity to try exploring the OLPC XO a bit last week and was extraordinarily impressed by some of it's features. The design is incredible--intelligent, attractive (an eye-catching kid magnet!) and extremely durable. Makes me ask why my other laptops don't have some of these features. The machine appears to be almost indestructible under normal use conditions--dust, dirt, pet hair, and liquid spills won't harm it. The carrying handle is an incredible plus I would love to have on my slick laptop. The ability to view the screen in bright sunlight is impressive. The machine will clearly be able to be repaired by most older kids and adults with 1 (supplied) screwdriver.

Yes, the XO software is slower than what I normally use. And yes, there are occasional software glitches, as with any new product. The difference, however, is that this is all open source and thus can be accessed and fixed by mere mortals. And soon there will be a large community of interested individuals who can readily support and teach each other.

One of the most impressive features is the mesh-networking, which allows the XOs to see others and link to them to work collaboratively on projects. This is ideal for a classroom, but also will be great for families or small group projects.

It is sad, though not surprising, that Intel and Microsoft have tried to undercut the OLPC XO and have thus far done so in Nigeria and Libya (see 11/24 Wall St Journal). The Classmate and Windows, priced temporarily at enticingly low prices, will not be able to be upgraded without considerable investment in support and software. In contrast, all the XO software is open source and can be down-loaded for free--and change as the child's needs do over years. That long-term view is where the real cost-savings are, as there will be no licensing issues or bait and switch tactics with the XO.

My initial motivation for supporting OLPC is that they are a worthy non-profit, with a very valuable project for educating kids in developing countries and reducing the global disparities between the haves and have-nots. Now after seeing the XO, I also see it as a valuable back up for my business/home needs as well. I have been encouraging my friends and colleagues to support the Give One, Get One program or to make charitable donations for children in developing countries. It is an irresistible gift for the holidays. Please help spread the word!

YouTube and Human Rights

“All power tends to corrupt; absolute power corrupts absolutely.”
Lord Acton

There is no question that Google has made my life easier, bringing me access to information from around the world that I would not have had otherwise. Unfortunately, there is a disturbing trend, as Google continues to expand its empire.

First, Google touted itself as “we are not evil.” But then there was its pragmatic support of censorship in some settings, abiding by government restrictions. Google justified this by accurately saying that their presence has benefit in the long-term.

Now, Google, who has since bought YouTube, has blocked the videos and account of Wael Abbas, an anti-torture activist who posted a video of policemen torturing a victim. Strictly speaking, YouTube’s action was correct, according to their terms of service, in that their Community Guideline's terms prohibit the posting of videos which depict pornography, illegal acts, graphic violence, or hate speech. Subsequently, however, they have now further isolated Wael Abbas by disabling his Yahoo account.

I understand YouTube’s not wanting to show graphic violence. Yet surely there is an alternative that would protect viewers from blundering onto a disturbing site, but would support important exposures of human rights violations. There could be a warning “Site contains graphic or disturbing material” notice, that allows news reports of violence. Or perhaps there could be a parallel site, such a Reporters Without Borders, or Project Censored. We need to have a readily available, uncensored forum to expose human rights violations, wherever they occur. Google should work for the forces of good, and make itself part of the solution, rather than gagging human rights activists.

Random Acts of Kindness-Another Bully Bites the Dust

In a heart-warming story, two students in Nova Scotia stood up against bullying.

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

I was reading the accounts of BioCryst's initial flu study failure with interest.

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

It was refreshing to read Michelle Singletary's column in the Washington Post today.

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.

The Kite Runner Meets the Days of Awe

This past weekend I took a rare, hedonistic adventure, immersing myself in a novel for the first time in eons. The Kite Runner is richly detailed, engrossing, insightful and surprisingly, reminded me that these were the Days of Awe, the time of reflection between Rosh Hashanah, the Jewish New Year, and Yom Kippur, the Day of Atonement.

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.

"Animals at Play" Renews the Spirit

For a touching story and photographs, I suggest visiting Dr. Stuart Brown's slide show on PBS' "Speaking of Faith." He expands on the playfulness demonstrated at his National Institute for Play site. Norbert Rosing's images of a wild polar bear and a sled dog are quite striking and the animal's expressions are unmistakable. Treat yourself. Take a minute to visit the site.

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.

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 ...”

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.

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]

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 8^th 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.

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 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.

Foti vs. reality

The saga surrounding Dr. Pou's exoneration continues. Yesterday, we also learned that, despite the grand jury’s decision that there was no justification in pursuing homicide charges against Dr. Pou, Attorney General Foti wants to continue the persecution. He is requesting that documents pertaining to the case be unsealed, insisting that they will confirm that the health care workers were guilty, despite the grand jury’s finding to the contrary.

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 New York University, noted,

"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.

We have already witnessed the incompetence of responsible officials in dealing with Katrina. Let's not let the diversionary tactics of Foti and the like distract us from the real culprits. Rather than allowing this diversionary tactic and 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. Foti, and every other grandstanding politician involved in this tragically incompetent response to disaster should be held accountable.

Best political one-liner award, from "Bedtime for Gonzo"

I don't often laugh out loud while reading the morning paper any more. . .but this is too good to not share with you.

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!

Voices of Reason from New Orleans

Welcome news today from New Orleans! More than a year since Dr. Anna Pou was arrested for alleged euthanasia of elderly patients suffering in the aftermath of Hurricane Katrina, the New Orleans grand jury today reached their verdict--and wisely declined to indict Dr. Pou.

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.

Perhaps now the attention can return to the real criminals in Katrina--the politicians and irresponsible officials who abandoned the city's most vulnerable citizens during the crisis. Hopefully, they will be held accountable for their gross failures and negligence. . .and Dr. Pou can return to once again caring for her patients.

Dr. Pou's Persecution vs. FEMA

This week marks the first anniversary since Dr. Anna Pou and two nurses were accused of murder for patient deaths in the aftermath of Hurricane Katrina and were arrested. Dr. Pou has yet to be charged by the grand jury, and the cases against the nurses were dropped after they were compelled, against their wills, to testify before a grand jury investigating the related incidents. These fine healthcare workers selflessly stayed, despite horrific circumstances including sweltering temperatures, lack of food, water, electricity, and medical supplies, risking their own lives to care for others abandoned by the city, state, and federal agencies responsible for ensuring the safety of the citizens.

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.

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.

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 Cumberland. Netflix does, however.

Earlier in the day, I heard the disturbing news that the witchunt in the New Orleans murder trial of 3 healthcare workers for Katrina-related deaths has taken a new twist. The 2 nurses, Lori Budo and Cheri Landry, have been offered immunity by the grand jury in order to elicit further information from them. Presumably, this information would be used to bolster the case against Dr. Anna Pou.

There are striking analogies between the two stories. In the first, you have young, idealistic, Tessa who tries to help the poor in Kenya and is brutally murdered by Big Pharma in order to protect their financial interests. Her husband, Justin, has been shielded in his garden, which he painstakingly tends and tries to make orderly and serene. When she is murdered, he leaves his tidy shelter and is immersed in the squalor of the Nairobi slums and the web of lies and coverups others use to protect their interests. The bad guys are tenacious and ruthless, stopping at nothing to try to dissuade Justin from exposing dangerous drug trials conducted on the helpless poor, who had no alternatives to participation.

Fade from Nairobi to New Orleans. In July, 2006, Dr. Pou and the two nurses were irresponsibly accused of murder by Louisiana Attorney General Charles Foti, arrested and charged with homicide for the deaths of several patients in the aftermath of Hurricane Katrina.

In February, 2007, toxicology reports from Orleans parish coroner, Frank Minyard, failed to show lethal amounts of medication in the patients' bodies. Despite this lack of evidence, a grand jury has been called to weigh the murder charges against the healthcare workers. According to CNN, Assistant District Attorney Michael Morales said, "There is no legal bar in going forward with a homicide prosecution just because a coroner has not classified it as a homicide."

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 New Orleans, the villain is our own government, trying vainly to divert attention from itself and its monstrous failures in dealing with Hurricane Katrina by shifting all attention to the easy target of these three women.

These fine health care workers have had their careers needlessly destroyed and endured incredible and unnecessary stress, when they should have been regaled as heroes for staying and caring for their patients. The government should be on trial for their abysmal failures in planning and response to an anticipated natural disaster.

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 9^th 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?”

js

Please 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.

Grey’s Anatomy Goofs on Bone Marrow Donation

I confess. I became addicted to Grey’s Anatomy last year as part of a mother-daughter bonding experience. Great acting, often interesting character development (though I liked last season much better).

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.

End of Life Decisionmaking Lesson

Recent hellacious experiences have prompted this warning post and suggested resources.

I have durable medical power of attorney for my mother. When she became ill with pneumonia and respiratory failure in January, I literally had to stay in her hospital room 24-7 for a week to prevent attitudes towards the elderly and medical errors from killing her. One of the issues that I was asked about repeatedly was her intubation and code status, and repeatedly, I answered, “I have just spoken with her about this, and she says she is not ready to die. She wishes to be intubated, if necessary. She does not want CPR if her heart stops.” Although community-acquired pneumonia is reversible, there was considerable pressure to withdraw therapy simply because of her age, though she is mentally vibrant and had been living alone in her home.

After a week, Mom was transferred to a rehab unit. I met immediately with the RN and physician assuming her care and reviewed her wishes, Living Will, and POA with them.

In March, I received a call that Mom had been transferred to another hospital. I promptly called the ER and was told by the physician that the transfer papers from rehab clearly stated that she was a “DNR.” Fortunately, the ER doc deferred to my directives and she was intubated and treated aggressively.

Later, I met again with the rehab physician and tried to understand the origin of his DNR order (and his decision not having been relayed to me). Amazingly, he said that he was under no obligation to discuss code status with me nor to inform me of the change in her order, as Mom was alert at the time and indicated that she agreed with the “no code” order—this, despite our earlier detailed discussion and the fact that mom is hard of hearing and English is her second language. We then spoke together with mom re the code status and she confirmed the accuracy of what I had told him, prompting him to revise his orders.

It is clear that part of the problem is the rehab center’s use of the POLST (Physician Orders for Life-Sustaining Treatment) DNR form, which has a format that is not immediately obvious and limited options: full treatment, comfort measures only, or “limited interventions,” which states “no intubation…usually no intensive care.” I believe this form to be dangerously inadequate and would suggest that such advance directive/DNR forms provide a more extensive and explicit menu of options, including whether the patient might want:
CPR
mechanical ventilator (respirator)
dialysis
surgery (major)
tube feedings (food and water delivered through a tube into the stomach)
intravenous fluids
antibiotics
time-limited trial of a given therapy
or decisions to be made by a surrogate.

To facilitate such discussions, “Hard Choices for Loving People” is excellent, as is “Your Life, Your Choices.”

I have also found the following resources helpful:

“Safe Passage: Decisions about Foods and Fluids” and “Gone from my Sight,” by Barbara Karnes. I particularly recommend “5 Wishes” as a good way to begin to discuss these difficult issues.

I also encourage patients and family to write an Ethical Will. This document is a personal way of expressing your values to people you care for, leaving them a personal or spiritual legacy. I was introduced to this through Jack Riemer's excellent So That Your Values Live On: Ethical Wills and How to Prepare Them.

For more detailed help with these issues and for sample living will/advance directive forms, I suggest Compassion and Choices.

Be sure you have a durable power of attorney and a living will. Please review your wishes with your loved ones periodically and also review them with health care workers. Most importantly, remain vigilant and steadfast to ensure that your wishes--whatever they may be--will be honored.

When is discrimination against women not considered discrimination?

When the Federal Appeals Court is involved. In a brilliantly circuitous line of reasoning, the majority Republican panel decided that the exclusion of contraceptives from Union Pacific’s insurance plans was not discriminatory, as it also excluded condoms and vasectomies.

However, the Democratic appointee, to the panel, Judge Bye, dissented, perceptively noting that there is an inequality in terms of the medical effect of the lack of coverage since “This failure only medically affects females, as they bear all of the health consequences of unplanned pregnancies.”

According to the NYTimes, “The appellate panel explicitly rejected a 2000 decision by the Equal Employment Opportunity Commission that the Pregnancy Discrimination Act required employers to cover prescription contraception for women if they covered prescription drugs and devices used to prevent other medical conditions.” and that “Union Pacific’s health plans did not violate the Pregnancy Discrimination Act because contraception is not related to pregnancy.”

They brilliantly concluded, “Contraception is a treatment that is only indicated prior to pregnancy …Contraception is not a medical treatment that occurs when or if a woman becomes pregnant; instead contraception prevents pregnancy from even occurring.”

It is reassuring to know that Rogaine, for men’s baldness, and Viagra will still be covered as medically necessary drugs.

More Partisan Politics Plays at the FDA

First we had that embarrassment, veterinarian and religious zealot Dr. Lester Crawford, appointed as head to the FDA. Later in 2005, we had the FDA ignoring its own advisory board’s recommendations regarding Plan B, the emergency contraceptive that, were it readily available over the counter, would avoid unplanned and unwanted pregnancies and subsequent abortions.

Susan Wood, the head of the FDA’s Office of Women’s Health (OWH), resigned in protest over this turn of events and then was initially replaced by appointment of another veterinarian, Edwin Foulke, by President Bush. Shows how highly women are regarded by this administration. (See the late and sorely missed Molly Ivins’ column for an astute review . So that plan failed and instead, Dr. Andrew von Eschenbach was appointed head of the FDA after a pointed confirmation battle.

Dr. Wood made some insightful recommendations regarding getting the FDA back on track as a trusted, scientifically based agency.

Unfortunately, the feds don’t appear to have read her thoughtful comments. In apparent retaliation for the Plan B dispute, the OWH “just had more than one-quarter of this year's $4 million operating budget quietly removed,” according to Rick Weiss in the Washington Post. This would effectively incapacitate the office for the remainder of the fiscal year.

Recognizing the important work the Office of Women’s Health achieves, a broad coalition, including the American College of Obstetricians and Gynecologists, American Public Health Association and women’s groups are petitioning congress to restore this funding, critical to women’s health. Please urge your congressional representatives to support this move to reinstate funding, as proposed by Congresswoman Rosa DeLauro, and hope that reason will prevail for once over vindictiveness and petty partisan politics.

Government Misplaces Priorities Again

Business beats people’s needs in battle over bugs

At least the Feds are consistent—supporting business rather than the public. In this case the FDA is prepared to allow the use of an antibiotic called Cefquinome in animals—this, despite the strong warnings and opposition from its own advisory board, from infectious disease experts, and from other highly respected groups, such as the Union of Concerned Scientists.

The Infectious Diseases Society has previously called attention to growing problem of antibiotic resistant organisms in “Bad Bugs, No Drugs.” At the same time as there is increasing resistance, most pharmaceutical companies have withdrawn from the antibiotic development business, and there are very few new antibiotics in the pipeline. Cefquinome, like the already-marketed cefepime, is in the “4^th generation cephalosporin” class of antibiotics, a class generally reserved for use in serious infections with resistant bacteria.

The FDA’s guidance #152 is quite narrow and allows use of antibiotics in animals unless it can be shown to be harmful only to patients with food-borne diseases. In contrast, the World Health Organization recommends against such approval if there is likely to be resistance for any serious human disease.

If history repeats itself, the use of cefquinome in animals will rapidly result in bacteria resistant to cefquinome infecting people, as has happened with other antibiotics.

With there being so few antibiotics available, it is foolish to squander our limited resources, putting the public at risk. This is yet another demonstration of this government’s pattern of listening to money rather than reason, ignoring its own expert advisors, and wasting dwindling resources.

Disparities: Global Health and Clean Water

An idealistic and hard-working group of young women are sponsoring the Disparities: Global Health and Clean Water conference on March 2-3, 2007 @ Smith College. Check it out at www.gaape.org or at Smith College's news.

I’ll be moderating as well as giving a talk on Ethical Aspects of Global Care & Drug Development. Being somewhat OCD, I googled moderating panels and came up with some great sites.

Perhaps the best suggestions are from Barry Eisler’s “The Moderator’s Manifesto.” Great info and visually stunning website.

Check it out for useful tips on marketing as well.

More coming about ethics and global care soon.

How to Survive Your Hospitalization

Health care isn't what it used to be. Having just spent a week guarding my mother during her hospitalization, I have a few suggestions for the less medically experienced:
a) You have to have an advocate. Really sick patients can't do it alone.
b) Have a family member* stay as close to 24-7 as possible.
*This should not just be any family member. You need someone with common sense, who can stay relatively calm and pleasant, rational and assertive. Tall order, I know. But if you are angry and abrasive, you will drive staff away or anger them, resulting in worse care. Human nature.
c) The biggest problem we encountered was lack of communication between shifts, and the lack of continuity of the staffing. You can provide that vital link of continuity, alerting staff to something that appears new or alarming.
d) You or your advocate need to ask what each medicine being administered is. If it is something new or unexpected, insist on understanding what it is for before taking it.
e) Ask about blood draws, too--especially those that are painful, like blood gases. Request that the blood draws be coordinated and, if possible, be limited to one or 2 times per day.
g) Remember-you can refuse labs or treatments. You want to be sure that the reasons for your refusal are rational and are recorded accurately in the progress notes, so that you are not perceived as just being difficult.
f) If you know your loved one is not normally confused or agitated and anxious, and there is a change in behavior, insist that there be an attempt to find a "physical" or metabolic reason.
I heard repeatedly that mom was "anxious" and that this made her short of breath. In fact, her blood oxygen was very low and she felt like she was drowning, making her understandably anxious. Understanding the source of the problem is critically important.
More to follow as I recover from being a guard dog. . .

Patients take research into their own hands

Patients with multiple sclerosis are joining together to fund research that they find promising.
Naltrexone is a drug, an opioid receptor antagonist, which is sometimes used for treating addictions. Naltrexone was discovered 20+ years ago, so is off-patent, and therefore no longer highly profitable nor of interest to large drug companies. Low Dose Naltrexone (LDN) was anecdotally found to be helpful for treating multiple sclerosis. A number of MS patients banded together, forming their own research group to review current knowledge and direct studies. They held a fund raising benefit; the $25,000 proceeds were awarded to UCSF to conduct a small, double-blind, cross-over trial this spring, according to LDNers. Sounds like a carefully designed study. Way to go!

The folks at "accelerated cure" also have a terrific brochure on working with MS. This handy booklet gives lots of suggestions for dealing with workplace issues that are applicable to those with any chronic disease.




http://www.acceleratedcure.org/downloads/acp-workingwithms.pdf

Lost in Limboland

Ever since the hellish conditions created by Hurricane Katrina in 2005, Drs. Anna Maria Pou and two nurse co-workers, Cheri Landry and Lori Budo, have been in limbo. In July, 2006, they were accused of murder by Louisiana Attorney General Charles Foti, arrested and charged with homicide, but they have yet to be formally charged. They have had their careers needlessly destroyed and endured incredible and unnecessary stress, when they should have been regaled as heroes for staying and caring for their patients.

New this week is that toxicology reports from Orleans parish coroner, Frank Minyard, failed to show lethal amounts of medication in the patients' bodies. Despite this lack of evidence, the theater of the absurd continues, with a grand jury being called to weigh the murder charges against the healthcare workers. According to CNN, Assistant District Attorney Michael Morales said, "There is no legal bar in going forward with a homicide prosecution just because a coroner has not classified it as a homicide."

No doubt our taxes and energies would be better spent investigating the botched response of the government to Hurricane Katrina, or the suspicious motives of Mr. Foti and the District Attorney's office in pursuing this witch hunt, than in continuing this travesty of justice.

Please 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.