A Refreshing News Model-Rachel Maddow

I don’t watch much TV…but while surfing around before the election, I stumbled upon the Rachel Maddow show, and was immediately enthralled. I have continued to watch her show regularly and remain quite impressed. While the presentation is, on occasion, a bit too light for my taste, I love her wry and perceptive take on the news. This past week had two outstanding shows you can view via podcasts, or by getting transcripts.

First, there was Mon 12/15’s clips on the NSA’s warrantless wiretapping and the first interview granted by whistleblower Thomas Tamm. Her subsequent commentary on Bush’s reign was insightful and right-on target. She continued the week with commentaries on absurd aspects of the financial bailouts, environmental and foreign policies, among others. Monday’s show brought us a scathing analysis of the application and oversight of the $700 billion TARP loans, the double standards in access to financial help, and the lack of transparency:

“That‘s it actually. That‘s the whole two pages. That is the full application process for a piece of the $700 billion worth of our money that the government is doling out.

Have you ever applied for a loan for anything? House, car, small business, anything? Have you ever applied for public assistance, unemployment, food stamps welfare? If you haven‘t, I can tell you this, the application asks for more of a commitment than name, address, how much do you want, anything else we should know, love, Bilbo Baggins.

For regular humans—that‘s not what getting a loan is like. It‘s certainly not what getting welfare is like, which is why I‘m going to try to turn myself into a bank holding company. Then maybe we all should.”

The final event prompting this post was her frank admission and obvious remorse on Monday, when she confessed to having made an error in making a background check on her guest, economist Laura Tyson. When David Sirota called her attention to an overlooked conflict-of-interest that might well have tainted Tyson’s comments, Dr. Maddow promptly issued an apology, castigating herself in the process.

I had been immediately impressed by Rachel Maddow’s credentials—she is certainly no bimbo, unlike many of the young “reporters” who uncritically read scripts on some of the major news streams. Her bio notes that she holds a degree in public policy from Stanford University. At graduation she was awarded the John Gardner Public Service and Leadership Development Fellowship. She was then awarded a Rhodes Scholarship in 1995, and used it to study at Oxford University, where she received her doctorate. She has a long-standing passion for social justice issues, having previously focused on prison reform, HIV/AIDS, and Health Care Reform.

It has been a joy to watch a bright, highly-educated young woman anchoring a prominent show. This week’s candid admission of error greatly raised my esteem for Dr. Maddow, as it reflected an unusual level of integrity and humility. Rachel has earned a loyal follower here.

Thanksgiving continued...

On the related note…of charity and end-of-year gift giving:

Despite the hard times, many have a desire to continue their charitable efforts. In addition to the Neglected Tropical Diseases initiative, there are some other ways of stretching your charitable dollars.

The NYTimes Giving section and the related Ensuring That Gifts Go Where They’re Needed have tips in an article with a global perspective, as well as local needs. While not the most highly ranked, I still like Heifer's animal kits and Grameen because they are programs intended to be self-sustaining for the beneficiary. Another favorite is Kiva, which provides microcredit loans worldwide. For immediate direct help to others, my top picks include Feeding America (formerly America’s Second Harvest), Mazon, and the longstanding International Rescue Committee, which focuses on refugees.

For further information, check out Charity Navigator, which has extensive listings and ratings of charities. Another terrific source of info is Daniel Borochoff’s
American Institute of Philanthropy, with recommendations for a myriad of diverse interests.

With that, I’ll close with a reminder from one of my favorite books—remember,
"It Could Always be Worse."

Wishing you Happy Holidays and a better New Year.

Thanksgiving...

Ironically, Dr. Hotez’ new book, “Forgotten People, Forgotten Diseases” was part of my Thanksgiving fare this year, and served as an excellent reminder of all we do have to be thankful for in our economically more developed countries. Even now, with the rapid decline in our own country’s economic health and a pall on Christmas cheer, his book serves up a valuable dose of perspective.

Dr. Hotez skillfully introduces readers to an array of “neglected tropical diseases” which devastate the world’s poorest populations—2.7 billion of whom live on less than $2 per day. Because of their poverty, these people lack a voice and are largely ignored. Some of the diseases that affect them, such as worms, schistosomiasis, or filarial (elephantiasis) cause debilitating illnesses, are less dramatic and attention fetching than malaria and HIV/AIDS. Dr. Hotez calls much needed attention to a dozen of these diseases.

One of the striking things about this book is how clearly and simply Dr. Hotez explains these diseases and their impact. He also excels at helping readers to understand non-obvious links between poverty, parasitic infections, and HIV/AIDS. This book is therefore surprisingly appropriate for high-school to post-graduate levels of readers. It is an excellent primer, with numerous references for more detailed exploration. For example, Dr. Hotez explains how schistosomiasis, a water-transmitted worm, increases a person’s susceptibility to HIV infection. Anemia from the parasites can impair learning and subsequent income-earning ability. This book is an excellent primer, with numerous references for more detailed exploration.

Each chapter provides an overview of the organism, the illness it causes, and the social and economic impact of each of these illnesses. The accompanying photographs make a striking impression, and they, as well as the other helpful illustrations, have great visual impact.

I had the pleasure of hearing Dr. Hotez and a number of his colleagues speak two years ago at the Global Network for Neglected Tropical Diseases conference. One of the major conference themes, which was new to me although I am an infectious diseases physician, is that 7 major neglected tropical diseases could be eradicated for less than 50 cents per person/per year. Since learning that, I have incorporated some of this material about NTDs into my talks, and the slides for these are available at my site's links.

This book is clearly written and inspirational, and is a call to action. What are we waiting for?

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!