US FDA Mixed Reviews;What is the Public to Think?

First, let me say this.  The world is better off with the FDA than it would be without the FDA.  Although the US FDA has no authority outside the US, its actions have significant effects around the world.  For the most part, those effects are positive.  Anyone reading the news lately is likely to have at least some degree of skepticism about the effectiveness of the FDA.  A recent editorial in Newsday indicates that public confidence in the FDA has declined:

It [the FDA] was the gold standard of trustworthiness, both for the patient and the prescribing physician. Even drug manufacturers impatient with the long process coveted FDA approval, for it meant their drugs were safest; American drugs were the safest in the world.

Lately, however, the FDA's credibility has fallen on hard times. According to a recent CNN-USA Today-Gallup Poll, nearly 40 percent of 1,015 adult respondents said their confidence in the FDA has slipped during the past year.

What the Gallup Poll does not tell us is whether the declining confidence in the FDA is merely a reflection of increasing public realization that the government is more pro-business than pro-people.  Still, if taken at face value, the survey indicates that public perceptions are becoming more negative.  To what extent is this perception valid?  I've posted a lot on the subject of the FDA, and there have been many news articles and editorials.  It occurred to me today that, despite all that has been written, there hasn't been any advice to the general public about some aspects of the controversy: What can you make of all this?  Are you seeing balanced coverage, or an artifact of the media echo chamber?  What conclusions can you draw about the FDA, based upon the media coverage?  Today, I try to answer some of those questions.  The full post is here.

On the Necessity of God and Enemies

If God did not exist it would be necessary to invent Him. But all nature cries aloud that He does exist; that there is a supreme intelligence, an immense power, an admirable order, and everything teaches us our own dependence on it.

~ Francois Marie Arouet Voltaire (1694-1778)

Voltaire, the author of Candide,  was a bit of a dilettante philosopher, but he did have some good ideas.  The quote above really is provocative.  The first sentence -- If God did not exist it would be necessary to invent him -- implies that there is a possibility that god does not exist, and that perhaps he was invented.  Of course, the second sentence obviates that possibility; in 18th-century Europe, reputable gentlemen, at least the nonsuicidal ones, kept any agnostic or atheistic thoughts to themselves.   

Today's NYT has an editorial (blogsafe link) by Paul Krugman.  In it, he ties together two seemingly disparate themes: the slime attacks on John Kerry, and the attacks on those who oppose the privatization of Social Security.  (I like the technique of making a point by tying together two seemingly disparate topics -- like, for example, the writings of Voltaire, and those of Krugman.)

The slime campaign has begun against AARP, which opposes Social Security privatization. There's no hard evidence that the people involved - some of them also responsible for the "Swift Boat" election smear - are taking orders from the White House. So you're free to believe that this is an independent venture. You're also free to believe in the tooth fairy.

Their first foray - an ad accusing the seniors' organization of being against the troops and for gay marriage - was notably inept. But they'll be back, and it's important to understand what they're up to.

Krugman's point is that a subset of  neoconservatives made a point of casting Kerry as an enemy.  Now they are doing the same thing to the AARP.  Rather than framing an issue as a debate among friendly equals, they frame it as a struggle against a morally inferior enemy.  It can be an effective technique. 

But why resort to such a method? After all, is it not preferable to engage in spirited intellectual debate, rather than a bitter adversarial process?  Yes, if you think you can win that way, or if you can tolerate the narcissistic insult that comes from loosing.  On the other hand, if you think you cannot win any other way, or if you don't have the emotional wherewithal to tolerate loosing, you might do anything to win.  Even if it means disrupting the fabric of society.

In a polite society, such as that of Voltaire, adversarial contests are to be avoided, if possible.  It is sort of like the concept of resorting to war, only after all other means of resolution have failed.  Such a society often is spoken of -- metaphorically, -- as a fabric.  A society in which adversarial processes occur rarely, could be likened to a silk tapestry; a society in which adversarial processes are actively created, could be likened to a ratty burlap sack. 

Which would you choose to decorate your living room?

Those who seek to consolidate their power often resort to the tactic of creating an enemy, if one is not present already.  I would not say that if there is no enemy, it would be necessary to create one.  But there are those who do exactly that.  They do it to consolidate power. 

This probably was the motivation for 9-11.  It was not a blow against infidels.  It was not retaliation for support of Israel.  It was a self-serving means of consolidating power for al Qaeda.  Now, the sliming of the AARP does not rise to the level (or sink to the level) of 9-11.  But there is a common element.  Both are forms of social vandalism.  Both rend the fabric of society.  Both take topics that could be the basis for legitimate debate, and transmogrify them into adversarial conflicts. 

If you see people resorting to such tactics, do not think of them as the enemy.  Think of them as pitiable narcissists, who can't stand the thought of loosing, or sociopaths, who don't care about the cost of winning. 

You can have a silk tapestry in your living room, or you can hang up a feed bag.  It's your call.  One last thought:

Jean Paul Sartre has said that all of French Existentialism is to be found in Ivan Karamazov's contention that if there is no God, everything is permitted.

-- Katharena Eiermann

If God did not exist, it would be necessary to invent Him.  If there is no God, everything is permitted.  Both are ingeniously ambiguous.  Did Sartre mean that, in the absence of god, things more terrible than those currently in existence could happen; or, did he mean to imply that if there were no god, the world could be made a better place? 

What would Candide think?  Maybe I'll consider that some other time. 

Miscellaneous Essay on Medical Topic: Differential Diagnosis

Recently I was asked about some of the challenges involved in psychiatric diagnosis of adolescents.  This turns out to be a difficult topic.  Firstly, psychiatric diagnosis is an arcane practice, shrouded in obscurity.  Secondly, adolescents can be rather obscure themselves. 

In order to understand the topic fully, it is necessary to start at the beginning.  That means ancient Greece.  The term diagnosis comes from the Greek roots diagignoskein "discern, distinguish;" and gignoskein "to learn."  Thus, a diagnosis is established when the doctor learns the distinctionbetween the disease that the patient has, and other, similar diseases that might present the same clinical picture.  This post is not a general-interest kind of thing.  In fact, it is kind of boring.  The entire text is on The Rest of the Story. 

On Gonzo Journalism and Blogging

I haven't posted much lately, because I'm having trouble with my second phone line.  Since I'm on call this week, I can't tie up my other phone line for a long period of time.  I live too far from town to get broadband cable or DSL.

Since I have to get to work soon, I won't spend a lot of time now. 

Hunter S. Thompson died a few days ago, an apparent suicide.  I wasn't going to write about this, but I saw that two of the blogs I read often -- Pharygula and Mousemusings -- have posted on the subject.  I'm sure others have, but those two are the ones I've seen. 

Personally, I did not respect Mr. Thompson.  I did, however, respect his notion of gonzo journalism.  Specifically, I liked the idea that a reporter could participate in the subject of the report, and include his own thoughts and feelings about the matter. 

This style of journalism would have developed sooner or later anyway, and in fact he might not have been the first to do this.  But he deserves credit for being among the first to do this and to do it with a particular style. 

Why does this matter?

There has been debate lately about whether blogging is "real" journalism.  Well, perhaps it is not.  But it is gonzo journalism, at least at times.  People write about their lives, about things in which they have participated, and there share freely what they think about it and what their emotional responses were.  There is no notion of observing without influencing.  There is no pretense of objectivity.  There is no particular reward, either, other than the satisfaction of doing it.

From Wikipedia, the free encyclopedia.

Gonzo journalism is a journalistic style, most famously used by Hunter S. Thompson. The name was coined by Bill Cardoso. Central to Gonzo journalism is the notion that journalism can be more truthful without strict observance of traditional rules of factual reportage. The best work in the genre is characterised by  standards of accuracy subjugated to catching the mood of a place or event.

Gonzo journalism is an extension of the New Journalism championed by Tom Wolfe, Lester Bangs, and George Plimpton. "I don't get any satisfaction out of the old traditional journalist's view - 'I just covered the story. I just gave it a balanced view,'" Thompson said in an interview for Atlantic Unbound. "Objective journalism is one of the main reasons American politics has been allowed to be so corrupt for so long. You can't be objective about Nixon. How can you be objective about Clinton?" In Thompson's work there is frequently a distorted viewpoint brought on by the author's consumption of drugs and alcohol (usually recorded in the article for posterity).

Other writers whose work may be categorised as "gonzo" include P. J. O'Rourke and Tim Jones.

Most blogging is not done under the influence of mind-altering substances, but that is not an essential part of gonzo journalism.  It also is not a particularly good idea.  In fact, substance abuse is a major risk factor for suicide.

Neuroscience and Substance Abuse

The Society for Neuroscience issued a press release discussing a new finding in the science of understanding substance abuse.  According to Dr. Frenois of Université Victor Segalen Bordeaux 2 (Sciences de la Vie, de l'Homme, de la Santé) memories of uncomfortable drug withdrawal can cause activation of the same brain circuits that are activated during drug withdrawal itself.  In other words, the mere act of remembering withdrawal can cause some of the same physiological anomalies that occur during the actual withdrawal. 

In this post, I review the outcome and implications of the Frenois study, the role of two drugs marketed in the US for treatment of substance abuse, and discuss the abstience-versus-moderation controversy in the substance abuse treatment community.  Read the rest at The Rest of the Story. 

VOA Speaks

The Voice of America, the government-funded broadcast agency responsible for showing the true face of America to the rest of the world, informs us of this:

Report: Millions Misspent on US Port Security
By VOA News
20 February 2005

A published report says an internal audit at the U.S. Department of Homeland Security has found that funds to protect the nation's ports have been spent without sufficiently focusing on the most vulnerable facilities.A New York Times story published Sunday says the department's inspector general has concluded that the spending policy could compromise the nation's ability to defend against terrorist attacks.The audit found that considerable money spent on many smaller ports should have gone to larger, more vital ports in cities like Los Angeles and New York, which receive most of the goods coming into the country, making them prime targets for terrorists.The newspaper also says the audit found that less than a quarter of $517 million the Department of Homeland Security awarded in grants between 2002 and 2003 had been spent as of last September.

How's that for liberal media bias?  Add it to the list of leadership failures that I included in my post, Bush Apologists At Their Best.  It looks as though more apologies are in order.

The Edge of Space-Time

From NASA Swift site
click on graphic

Bush Apologists At Their Best

Dr. Drezner is a political scientist and economist, who has a weblog.  It's pretty good, certainly more influential than mine.  I don't usually have any major objections to what he writes.  However, today I have tow things to say.  One, his trackback seems not to be working.  Two, his apologistic efforts for our President are lacking, at least in the instance of his 2/15/2005 post, In honor of the Kyoto Protocol...

In this post, I take a look at one aspect of the effort to minimize the significance of our spurning of the Kyoto Protocol.  Although some try to argue that the Methane to Market program is a good substitute, a little investigation shows that it is all hat and no cattle.  Read the rest at The Rest of the Story. 

World Press Photo 2005 Contest

The World Press Photo 2005 contest winners have been posted on Xinhua.  They put their watermark on the photos, though.  If you want to see them in their unadulterated form, you have to go to the World Press site. 

David Robert Swanson, USA, The Philadelphia Inquirer. U.S. soldier in ambush,

How's Them Pet Goats

President Bush was criticized for spending seven minutes reading about pet goats after the first plane hit the World Trade Center.  Michael Moore and Bill Maher pounced on this like raccoons in a dumpster behind a McDonald's.  The fact is, though, those seven minutes did not and could not have made any difference. 

On the other hand, if one gets repeated warnings of a catastrophe, those warnings get progressively more strident and more specific, and one has the means to do something about it, and does nothing, then maybe it is fair to be critical.

Today, Middle Earth Journal -- a wonderfully-named blog, by the way -- has an update on climate change.  NewScientist.com published an update on the same subject on 2/12/2005.  They also published a piece called Meet the Skeptics, which purportedly shows that most of the skeptics are not scientists.  Indeed, most are economists or pundits of various stripes, funded by ExxonMobil. 

The Middle Earth and NewScientist articles show how the evidence for climate change due to greenhouse gasses is accumulating at a rapid rate, while the contrary evidence is both minimal and stagnant.  Most of the contrary evidence is based upon the uncertainty in the prediction of economic growth, since the production of greenhouse gas is roughly proportional to economic activity.  A few days ago, I linked to an article in The Economist that dealt with this.  Other objections to the near-consensus view of climate change are based upon objections to specific methodologies, such as the the interpretation of tree ring measurements as indicators of past temperatures.  But  the current view of climate change is based upon a convergence of data from multiple sources and multiple methodologies.  therefore, objecting to one or two of the methods is not a very effective counterargument. 

Is Mr. Bush ignoring all these warnings?  Does he go to bed every night and read about goats, rather than fretting about the melting of the polar ice caps and the disruption of the Gulf Stream? 

In February, 2003, he announced an initiative to develop a method of extracting energy from coal, while sequestering most or all carbon emissions.  This is called the FutureGen project. 

"Today I am pleased to announce that the United States will sponsor a $1 billion, 10-year demonstration project to create the world's first coal-based, zero-emissions electricity and hydrogen power plant..."
                           President George W. Bush
                           February 27, 2003

The program, as originally announced, would invest about $100 million per year, for ten years, to develop a prototype power plant that could make a big difference in the course of greenhouse gas production.  According to a 2005 House Budget Report, the House is recommending an expenditure of $9 million for 2005.  They recommend that $18 million that was appropriated previously, but apparently not spent, and another $237 million that was planned for, but not yet allocated, be deferred "for future FutureGen requirements."  They recommend a total federal commitment of $264 million.  This falls a bit short of the original $1 billion, and seems likely to put the project behind schedule.  In other words, two years have passed, and the project is barely getting started.  The House Budget report now says that they have "the goal of developing virtually pollution-free power plants withing the next 15 or 20 years".  They've extended the timeline from the original 10 years, to 15 to 20, and they haven't even hit any technical snags yet. 

I just hope that, once they get around to actually building something, they put it far enough inland so it isn't submerged when the ice caps melt. 

With the seven-minute thing, we have a nice film clip, showing Bush looking utterly bewildered.  That made a nice visual statement in Moore's last film, Fahrenheit 911.  It enraged Bush's minions to no end.  But in fact, it does not mean much.  On the other hand, the delays regarding the FutureGen project, in the face of mounting evidence of urgency, does mean something.  It means he doesn't learn from his mistakes.  Unfortunately, we do not have a film clip to illustrate this character flaw.

One of the quotes on Middle Earth Journal is this, from Dr. Hermann Ott of the Berlin office of the Wuppertal Institute for Climate, Environment and Energy:

It's too late to stop climate change, that's for sure, but we can still influence the degree of changes and the degree of impacts. We can prepare for a softer landing. Once the impact of climate change becomes visible, politics will react quickly and forcefully.

I disagree.  That may be the case in Germany, but it will not happen in the US.  We do not have politicians who are willing to admit that they were mistaken.  After all, humility is not one of the Ten Commandments, so it must not be important. 

Pipeline Update: Insomnia;Implications for Basic Science

Yesterday, I did a CME program (Medscape, free registration required) on insomnia.  The program was sponsored by Pfizer and Neurocrine.  Neurocrine, as it turns out, is developing a new medication, indiplon, which Pfizer will market.  This sort of arrangement is common: a small company develops the drug, and then contracts with a big company to sell it.  Often, then, one of them will sponsor educational programs to promote awareness of the drug.  Because of FDA restrictions, they cannot actually advertise the drug before it is approved.  Therefore, they use the CME (Continuing Medical Education) channel to increase awareness of the product and develop some interest in the medical community.

Enough peripheral commentary.  The reason I care about this is that the CME program contained information about insomnia drugs in "the pipeline," those that are being developed for marketing.  Sometimes, understanding the action of new drugs can teach us important things about the functioning of the brain in health and disease states.  Read about this at The Rest of the Story.

Advice for Physician Bloggers

Today I spent some time getting CME credits, using Internet-based programs.  It has occurred to me that I can both satisfy the requirements for CME, and do background research for blog posts, at the same time.  This helps take care of the time crunch that many of us feel: trying to find time for a hobby, while satisfying competing demands for work and family time. 

A good resource for this is Medscape.  Another is the Merck Whitecoat e-Assistant site.  The Merck site gives you AMA-approved credit for doing Medline searches.  You also get free online access to the complete text of Harrison's Principles of Internal Medicine, among other things. 

Medscape is accessible with free registration.  Merck Whitecoat e-Assistant also has free registration, but you need to have a healthcare-related license to register. 

Changes in the Drug Safety Landscape

The New York Times today has two articles about changes at the FDA.  One mentions that the Agency has a new commissioner.  The second informs us that the FDA is creating anew board to monitor drug safety.  Also the New England Journal of Medicine published today was a set of early-release articles about the safety concerns that have arisen regarding Cox-2 inhibitors (Vioxx, Bextra, Celebrex).  The articles are on the NEJM website now, and will be printed in the 3/17/2005 issue. 

The Cox-2 story has attracted a lot of attention, and I am not sure I have anything to add to the volumes written already.  However, the Corpus Callosum is all about connections, and the two topics -- the changes at the FDA, and the Cox-2 story -- are indeed connected.  The top job at the FDA has been vacant for a long time, possibly because not a lot of people actually want the job right now.  And the creation of a new drug safety board is a direct response to the public concern about the Cox-2 inhibitors, among other recent and brewing matters.  However, the Bush Administration does not have good record when it comes to addressing matters of public safety.  Do the current efforts exceed our expectations, or do they fall short?

I know, that's not exactly a cliffhanger, for those familiar with my general opinions.  Even so, if interested, read the supporting evidence and the conclusion at The Rest of the Story.

Private Healthcare May Not Be the Panacea

The British Medical Journal has posted an article in their Education and Debate section that described the outcome of Australia's initiative to promote private health insurance.  The article is here (full text, abstract) and the editor's synopsis is here:

Private Healthcare May Not Be the Panacea
Supporting private health insurance may be not the best option for governments. Hall and Maynard (p 357) analysed the Australian experience, where changes in government policies to support private health insurance (including a purchasing subsidy, discounted rate for those getting on the scheme at a young age, rebated co-payment, and a strong advertising campaign) increased the proportion of people insured but failed to reduce admissions to public hospitals. The changes were costly, primarily benefited wealthy people, increased inequality in the funding of care, and had no observable effects on efficiency, say the authors.

Interestingly, the program is more comprehensive that that currently proposed for use in the United States.  It appears not to have produced the desired outcome.  Michigan is considering a plan to exempt health insurance costs from the single business tax.  Although this is not phrased as a "purchasing subsidy," it would amount to the same thing. 

At first glance, the Michigan plan seems like a good idea; however, Governor Granholm opposes it, because it would cut State revenue by $35 million, and nobody has come up with a plan that would be revenue-neutral.  That is where the subsidy part come in.  I don't know enough about economics to be able to anticipate the effect of the plan.  however, based upon the Australian experience, I would advise caution in the rush to embrace the idea. 

If the goal of the plan is to increase the number of insured persons, the Australian experience indicates that this may not work.  Probably, it would be necessary to target the tax cut such that only benefits that go to low-income persons would be exempt.  That might encourage companies to offer insurance to persons who otherwise might end up using public resources.  At least that way, the State could see some cost offset. 

Certainly, the last thing the State needs to do is enact a program that would result in a revenue loss, while the bulk of the benefit goes to persons who already are well-off. 

Grand Rounds Reloaded

Grand Rounds XXI has been posted at Sumer's Radiology Site.  This is a weekly roundup of medically-related posts from the Blogosphere.   Dr. Sethi did a nice job, and put up an attractive presentation as well. 

Since my last medical post was about radiology, and about Grand Rounds, I submitted it.  The Editor's Choice distinction went to Dr. Hildreth, at The Cheerful Oncologist.  It's followed by an interesting discussion about pain medication. 

I won't review all the posts; that's the editor's job. 

However, I will point out the post on Circadiana, a blog devoted to the study of circadian rhythms.  Everything You Always Wanted to Know About Sleep ..., is a pretty good title, and it's a subject of great interest, to me, at least. 

What To Do About Texas?

Vicente Fox and Tom "The Molotov" DeLay

Vicente Fox came to power in Mexico, based upon his pledge to rid the Mexican government of corruption.  He's even made some progress:

Battles won, a war still lost
Feb 10th 2005 | BOGOTA, LIMA AND MEXICO CITY
From The Economist print edition
[...]The government of President Vicente Fox has made much bigger efforts than its predecessors to tackle these syndicates, clean up the security forces and collaborate with American drug fighters. Several notorious drug barons, such as Benjamín Arellano Félix, have been jailed.[...]

Of course, anyone who tries to change a deeply-ingrained pattern of corruption faces some major challenges:

Mexico elections face party turnover
Feb. 4, 2005
Chronicle Foreign Service

[...] Four years into Fox's administration, high levels of crime, corruption and unemployment continue to plague Mexico. The opposition-dominated Congress has blocked or rewritten most of Fox's major bills.

Apparently, Fox cannot run for reelection.  It will be interesting to see if he can make any substantial progress in the fight against corruption.  If so, perhaps Texas could hire him to do the same thing, North of the border.

After all, Texas doesn't seem to have much in the way of home-grown talent.  As found on The Carpetbagger Report, and amplified in an article in the LA Times, the Texas House is considering a bill -- HB 913 -- that would hamstring efforts to prosecute crooked political campaigners. 

Texas GOP Trying to Gut Ethics Inquiry, Critics Say
A bill introduced in the Legislature is called a blatant bid to protect Republicans, including Rep. Tom DeLay, from a fundraising probe.
By Scott Gold, Times Staff Writer
February 11, 2005

[...] A bill filed this week by a veteran state GOP lawmaker would give the Texas Ethics Commission — whose members were appointed by the three top elected officials in the state, all Republicans — the power to quash the prosecution of a politician.

Critics call it a brazen attempt to protect GOP leaders who might become entangled in an ongoing criminal investigation into whether illegal fundraising paved the party's rise to power in the state.

Texans for Public Justice, an organization that tries to combat the influence of money in politics, labeled the measure the "Politician Protection Act." Director Craig McDonald said the bill created a "special criminal justice process for politicians." [...]

This is discussed also by bloggers at Off the Kuff, Ruminate This, Solo Dialog, Fantasy Life, The Island of Balta, The Scooter, Easter Lemming, and StoutDemBlog.  On Easter Lemming, Mr. Denton states, on the topic of cleaning up Texas politics: "It's going to take a lot of shovels."

Vicente Fox Portrait
---------------------------------------------------

Tom DeLay Official Portrait

Traditional Wisdom

You know what they say: He who hesitates, is lost.  Those same people say: Look before you leap.  So what should we do?  If you hesitate, you loose; if you don't hesitate, you loose. 

The great thing about conventional wisdom is that it is free.  All you have to do is sit in an easy chair somewhere and think about it. 

Plain old common sense tells us that humans are too complex to have come into existence via evolution.  After all, where would the first biologically-significant molecules come from?  Outer space? 

In this post, I celebrate the virtues of empiricism; the fact that rationalist philosophy fares none to well is just too damn bad.  Read the rest at The Rest of the Story.

Case of the Week: Hubrisiocytosis X

hubris : the pride associated with arrogance; pride considered as sin; 1884, from Gk. hybris "wanton violence, insolence, outrage," originally "presumption toward the gods," of unknown origin.

In medicine, there is a tradition known as "Grand Rounds."  Ordinarily, the term rounds is used to denote the practice of either seeing or talking about a series of patients.  Occasionally, however, there is a more formal process.  In Grand Rounds, a bunch of doctors get together and talk about a case in great detail, usually with someone presenting a review of the pertinent scientific and clinical literature that pertains to the case. 

The first one I attended occurred shortly after the start of my third year in medical school.  At that time, the third year was the first clinical year.  The first two years were spent almost entirely in the classroom. 

At the end of the first week, I went to Grand Rounds.  All medical students must attend all educational functions.  A pediatric oncology fellow started talking about the case.  A young girl, I think about eight years old, had come to the hospital.  She had unexplained swelling in her face, on the right side, just below the eye.  This was found to be due to histiocytosis X. 

Normally, the human skull has holes in it that are only where they are supposed to be.  Each hole serves a particular purpose.  Every once in a while, a skull gets lots of holes in it that are not supposed to be there.  This is very bad. 

The oncology fellow dutifully reported upon the patient presentation, radiological findings, and treatment.  Then he reviewed the literature, describing the basic science, such as it was known at the time.  All according to Proper Form and Medical Protocol. 

Finally, the poor guy finished, and the Attending went to the podium.  She began by saying something like this:

It certainly is very fortunate that this young lady came to the University of Michigan, where she could get the correct diagnosis, and treatment could be instituted promptly...

Yadda, yadda, yadda.  The University of Michigan.  Yadda yadda yadda.  The way she said "the University of Michigan" made it sound like she was talking about the Queen of England. 

Let me tell you how the diagnosis was made.  It had nothing to do with any University greatness.

On the very first day of my third year, I went up to the hospital unit where I was supposed to be.  It was a general pediatric unit at Mott Children's Hospital.  There weren't very many patients, so the senior resident sent me down to the walk-in clinic.  Believe me, I had no idea what I was doing. 

After a bit, a woman came in, with her daughter.  Neither spoke English very well.  The mother told me that her daughter had developed this swelling, a couple of months ago.  No pain, no fever, no constitutional symptoms, no history of trauma.  Just swelling.  I learned that she had been taken to a different hospital, and had been admitted.  They had done a lot of tests.  No, the mother did not know which tests had been done, or anything about the results.  The other hospital had a good reputation, so it was not at all clear why they had not been able to figure it out.  When they discharged the girl, the mother asked what she should do.  Someone told her that maybe she should take the girl to the University of Michigan hospital.  So she drove right over, and wandered around until she found the pediatric clinic. 

The attending physician was busy, so I saw the girl first.  I remembered from class that sometimes a sinus infection, if it goes on long enough, will eat through the bone in the face, causing swelling like that.  Usually, the patient has a lot of other symptoms, but sometimes not.  The best way to make the diagnosis, at that time, was with sinus X-rays.  Now, we tend to use CT scans; back then, time in a CT scanner was a precious commodity, not easily obtained.

I went and told the attending that I wanted to order sinus films.  She thought about it for a moment, then told me:

Normally, I wouldn't think that was necessary.  But since she's already been worked up, and they didn't find anything, let's go ahead. 

I dutifully filled out the requisition, and called a transporter.  Someone came and took the girl away.  Later in the day, the girl hadn't come back, and it was time for me to go back up to the hospital floor.  I was mildly curious about the outcome, but did not think about it too much. 

What had happened was that the girl had gotten the X-ray, and the technician saw that the girl's skull was full of holes that weren't supposed to be there.  The radiologist looked at the films and called the appropriate specialist, who admitted the girl.  No one bothered to tell the medical student who had ordered the X-rays. 

Of course, the patient I had seen in the walk-in clinic was the one who turned out to have histiocytosis X, the one presented at Grand Rounds, the one who was Very Fortunate to have come the the University of Michigan so she could get the correct diagnosis.  At Grand Rounds, nobody told the real story: someone decided to order the correct diagnostic test, entirely for the wrong reason: an extremely green third-year student who really didn't know what he was doing.

If anybody deserves any special credit in this case, it would be the patient's mother.  Her mother knew there was something dreadfully wrong, and wasn't going to stop until somebody figured it out.  She didn't know what to do, but she was going to keep trying no matter what.  I am very confident that if I had not ordered that X-ray, the mother would have kept going from hospital to hospital until somebody finally did the right thing.

The University of Michigan.  Yadda yadda yadda. 

Note from Union of Concerned Scientists

The Future of Medical Economics

Yesterday, while looking for something unrelated, I came across an article that discussed a genetic test that could predict the occurrence of Stevens-Johnson syndrome (SJS) in persons being treated with a prescription drug, carbamazepine (Tegretol).  This is not a subject of general interest, really, since carbamazepine (CBZ) is being used less often now, and the condition occurs only 8 times in 1,000,000 patient-years of exposure. 

It got me to think about the economics of the testing.  Genetic testing tends to be very expensive.  I wondered if it ever would be feasible to do such testing routinely, before starting treatment with a medication.  How much would it cost to prevent one case of Stevens-Johnson syndrome?   What is interesting here is not so much the specific case of CBZ and the risk of SJS.  Rather, what if we someday have a panel of genetic tests that could be used to predict both positive and negative responses to medications in individual patients?  That would be great, but it would cost an awful lot.  This kind of thing is one of the reasons that the cost of medical care keeps going up, and obviously, we have to draw the line somewhere.   And why is it that these things always seem to drive costs up?  In the computer industry, innovations always seem to drive costs down.  Why can't that happen in medicine?  Read the rest at The Rest of the Story.

Ascorbic Acid Effective in Mouse Model of CMT Disease

Not Another Earlobe

Previously, the Corpus Callosum asserted the premise that everything in the body has at least two purposes, except the earlobe.  A previous example was the finding that thyroid stimulating hormone inhibits the action of osteoclasts.  The fact is, the body works in mysterious ways.  You could interpret that as evidence for intelligent design; or, you could interpret it as evidence that humans are not smart enough to understand how their own bodies work.

Supernatural or not, the fact is, we keep discovering odd things about how the body works.  Somewhere, recently, I encountered an article that mentioned a finding about the role of erythropoietin and thrombopoietin in the developing brain. Now I can't find it, and it's driving me nuts. If I recall correctly, erythropoietin stimulates the growth of nerve cells in the developing brain, while thrombopoietin promotes nerve cell death. Erythropoietin got its name because the first function that was discovered was that of promoting the generation on new red blood cells. Thrombopoietin does the same thing for platelets.  Why nature would use the same molecules for one function in the bone marrow, and an entirely different function in the brain, remains a mystery. 

Since, I couldn't find the erythro/thrombropoietin article, I went looking for a different example. 

Now, we find that ascorbic acid (vitamin C) also has an effect upon neuronal survival, at least in mice with mutations of the PMP22 gene.  After this was discovered, it was assumed that the mechanism would have something to do with the well-know function of ascorbic acid, that of inactivating toxic molecules known as free radicals.  However, it now appears that it acts by reducing the expression of the PMP22 gene. 

Will wonders never cease?

The PMP22 gene codes for peripheral myelin protein 22, and is located on the short arm of chromosome 17.  In about half of patients with Charcot-Marie-Tooth disease (CMT), there is a extra copy of a region of the short arm of chromosome 17, which means there is an extra copy of the PMP22 gene.  This leads to "over-expression" of the gene, meaning that too much of the protein is made in persons with the disease. 

When mice with a similar problem are given a lot of vitamin C, it caused a 90% reduction in the amount of PMP22 RNA in one of the large peripheral nerves.  Those mice did not experience progression of the disease, and lived as long as normal mice. 

The original report was published in Nature Medicine: Passage E, Norreel JC, Noack-Fraissignes P, et al. Ascorbic acid treatment corrects the phenotype of Charcot-Marie-Tooth disease. Nature Medicine 10; 396-405.  It includes the usual disclaimer that mice are not people, so it is way too early to know how applicable this would be to a person with CMT.  Also, not all CMT patients have the same genetic abnormality, so even if it or a similar treatment does work for some humans, it might not work for all of them. 

Remember, vitamin C is not an earlobe.

Illegal Home Diagnostic Test Kits

Periodically, the US FDA sends out e-mail alerts regarding dangerous consumer products.  Today they sent such an alert, this time citing test kits that are claimed to enable a person to self-diagnose HIV, syphilis, and -- of all things -- dengue fever.  They also sold home pregnancy tests. The kits are not produced by an authorized manufacturer, have not been FDA approved, and may not work as advertised.  In fact, there is no technology that enables one to diagnose HIV, syphilis, or dengue fever at home.  They were sold on the Internet, from a site in Canada.  The Canadian government is investigating, and the FDA has instructed customs officials to intercept any shipments from the company, Globus Media.  A detailed report is on Medscape (free registration required).

The websites offering the kits have been shut down.  However, until the perpetrators are caught or go into hiding somewhere (preferably somewhere cold, wet, and stinky) they might open another outlet somewhere. 

My point is not so much to alert people to this particular criminal operation, but rather to remind people to be careful about ordering medical products on the Internet.  Also, I mention it because of their inclusion of a dengue fever test.  That seems to make no sense. Sure, there's an outbreak right now in Malaysia and Singapore, but how many of those people are going to be ordering test kits from a Canadian website?  Maybe Globus Media thought that the inclusion of a product for dengue fever would make their other products seem more credible.

CSM Commentary on Climate Change;Corpus Callosum Clarifies

Finally, the Truth About Global Warming

The Christian Science Monitor sometimes has stories that are written like good, well-researched blog entries, complete with hyperlinks.  Today they have one about climate change.  The author does not really seem to advocate any particular position; rather, he collects bits of information from a variety of sources and puts them together.  That particular style of writing is effective.  I found the article to be rather disturbing, because it is convincing without coming across as preachy or argumentative. 

Other influential sources have published on this subject; in fact, so much has been published lately that we all are getting sick of it.  Having nothing better to do, I read up on it today to learn the Truth.  Read the rest at The Rest of the Story.

Journalistic Reforms

Last year, there was a bit of a shake-up in the medical journal business.  It had come to light that journals were guilty of selective publication: the practice of giving preference to articles that show a large effect of a new treatment.  The solution was to require researchers to register clinical trials in advance.  I've already discussed this in some detail, so I won't rehash it now.  A matter of greater significance is the question of selective reporting by the general news media.  The latest issue of The Economist has an article about the recent scandals in which the Bush Administration has been caught paying journalists:

MOST policy issues are genuinely tough. But just occasionally, something comes along that is as straightforward as it looks. Is it a good idea for a government to look as if it is paying bribes to journalists? Or for a government to put out fake news reports? No and no. And George Bush, at least, gets it. “I expect my cabinet secretaries to make sure that practice doesn't go forward,” he says. “There needs to be a nice, independent relationship between the White House and the press.”

Yet the past month has brought a slew of stories of government departments stomping all over that bright line. The most recent is the case of Michael McManus, a syndicated columnist. He got $10,000 from the Department of Health and Human Services (HHS) for helping train marriage counselors. Before that it was Maggie Gallagher, another syndicated columnist: $21,500 from HHS for helping draft brochures promoting marriage. Before that came the biggest pay-off so far: $241,000 from the Department of Education to a talk-show host called Armstrong Williams to help promote Mr Bush's No Child Left Behind Act.

But this isn't a post about the unethical practices of our government, and I am not going to criticize our news media, either.  Rather, I am going to suggest some reforms that might make our news media more credible and trustworthy.  These are not new ideas.  They are ideas that already have been implemented by medical journals.

First, news media should publish a log of all requests for interviews, and all investigations undertaken.  If politicians are not making themselves available to the media, that fact should be published somewhere.  This is comparable to what the International Committee of Medical Journal Editors have decided is proper for medical journals. 

Second, if an interview is granted under certain conditions, those conditions should be noted in the article.  For example, if a politician grants an interview with the understanding that certain questions will not be asked, then the reader should be informed of that fact.  Clearly, if a medical journal reports on a study, then the conditions of that study must be made clear.  Regular journalists should do the same.

Third, potential sources of bias must be disclosed.  This seems obvious, but it not practiced routinely.  We all seem to expect that news articles will be written without bias, yet to do so probably is beyond the ability of the human mind.  Plus, sometimes persons with biases are the ones who are in the best position to do the reporting.  To see how this is practiced in medical journals, look at the end of a recent article in the Journal of the American Medical Association:

Financial Disclosures: Under separate licensing agreements between the Johns Hopkins University and Guilford Pharmaceuticals Inc and the Johns Hopkins University and Angiotech Pharmaceuticals Inc, Dr Brem is entitled to a share of royalty received by the university on sales of products described in this article. Dr Brem owns Guilford Pharmaceuticals stock, which is subject to certain restrictions under university policy. Dr Brem is also a paid consultant to Guilford Pharmaceuticals. The terms of this arrangement are being managed by the Johns Hopkins University in accordance with its conflict-of-interest policies. No other authors reported financial dislosures.

Funding/Support: Dr Parney is an Accelerate Brain Cancer Cure (ABC2) Foundation fellow. The GO Project was supported by unrestricted educational grants from Aventis Pharma and Guilford Pharmaceuticals to the Center for Outcomes Research, University of Massachusetts Medical School. This study was also supported in part by NIH/NCI grant PO1 CA13525 to the University of California, San Francisco.

Role of the Sponsors: The funding organizations had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; or preparation, review, or approval of the manuscript.

Note that one of the authors stands to profit from the sales of products described in the article.  That, obviously, could be a source of bias.  But the article has to do with management of brain tumors, which is an important topic.  Since, Dr. Brem knows a lot about this, and what he knows could save lives, the Journal went ahead and published the article despite the bias.  It would not be reasonable to withhold potentially life-saving information, because of a possible bias; nor would it be proper to publish the information without alerting readers to the possible bias. 

I think it is unreasonable for the general public to insist that reports be unbiased, since that probably is impossible in most cases.  Rather, we should insist on routine publication of all sources of bias.  This might not have been practical twenty years ago, but now that it is simple to put information on the Internet, there is no practical reason not to do so.

Snippet re National Health Plan

I'm home sick today.  Got the flu.  Temp. of 102.1 yesterday.  I got a flu shot, but I got it a couple of weeks ago: probably too late to do any good.  No, a national health plan would not have done anything to prevent that.  I mention it only so people won't think I'm blogging from work. 

What I'm writing about it this.  My wife's parent's live in a small town.  She spoke with them on the phone earlier today.  Apparently, there's a young lady there who also has the flu.  She works in a restaurant, but took a couple of days off.  Now, her employer wants a doctor's note before she can come back.  That's reasonable, since you don't want people working in a restaurant if they're contagious. The problem is, she does not have insurance.  She can't afford to see a doctor.  She would be a new patient, and the fee for a new patient is $175.  They want the money up front, since she doesn't have insurance.  Since she's missed work already, she's lost some income, and she barely gets by as it is.  And, unless she gets back to work, she won't make any money. 

This person, whoever she is, will do what people do it this situation.  She'll go to an emergency department somewhere.  They'll give her a hard time, for using emergency services for something that is not an emergency, and they will send her a bill, which she won't be able to pay.  Instead of $175, it will be something like $500.  But, at least she will be able to go back to work, so she won't loose her apartment.  It'll just go on her credit report as another unpaid bill.  So if she later wants to get a or a car loan, she'll end up paying higher interest.  And she can forget about getting a mortgage.

You know what "they" say: The rich get richer and the poor get poorer.  This kind of thing is one of the reasons for that.  Here you have someone who has a job, does her job, but is just going to get further behind.  Forget about the "ownership society."  That's a bunch of nonsense.  She's never going to own anything of substance.

New Budget Numbers

National Security Takes Big Hit, and
What We Can Do About It

The New York Times reports todayon some details of the budget that is being proposed for the country in 2005.  The budget calls for a 4.8% increase in military spending, not including the five billion dollars per month for military operations in Iraq and Afghanistan.  However, it also includes a cut of 9% for the Centers for Disease Control and Prevention. 

I know I've harped on this string before, but it is an important point, and it also helps to have actual numbers to illustrate a point. 

The point is this: the war in Iraq has not saved any American lives; in fact, it has led to at least 1300 deaths and about seven times that number in serious somatic injuries. 

In this post, I argue that the war in Iraq has not made us safer; in fact, the opposite is true.  The war presents a direct threat, does not reduce any threats, and causes us to make sacrifices that further endanger our health.  Read the rest at The Rest of the Story. 

Aequanimitas Reloaded

Michigan's newly-elected US Representative, the Honorable John "Joe" Schwartz (bio), a surgeon, was interviewed regarding Social Security.  A snippet from the interview was on NPR yesterday.  He said something like this:

It depends on the actuarial analysis.  If the analysis shows that not much should be done, then not much should be done.

Mr. Schwartz is a Republican, and generally is regarded to be a moderate.  His medical training is very much in evidence here.  First find out exactly what is going on, then only do as much as you have to.  Don't go messing around with a complex system unless you have to.  You have to exercise restraint when you employ powerful interventions, because it is a lot easier to screw things up than to make things better.

It is unwise to base the magnitude of your intervention upon the magnitude of your emotional response to the problem.  It is tempting, when confronted with a problem that gets you all worked up, to want to rush in and do something big.  The principle of equanimity, however, is to act with prudent restraint.

More About a National Health Plan

A while ago, I wrote about an episode of O'Reilly Factor on Fox, during which Mr. O'Reilly discussed the idea of a national health plan with Dr. Stephanie Woolhandler.  Now, the Physicians for a National Health Plan have the video up on their site.  It is recommended viewing for all medical students.  Not because they need to learn about universal coverage, but because it may be their only opportunity to see an actual case of rabies in a human. 

In this post, I rant on about Mr. O'Reilly and Mr. Bush, then get serious and point out another reason why we should have universal health coverage in the USA.  Read the rest at The Rest of the Story. 

Framing the Social Security Debate;White House Strategy

Although the debate about reformation of social security is a matter of moderate interest for me, being at the tail end of the baby boom generation, so far I have not commented on the matter here.  The reason: debates should begin with observations, or at least with information of some sort.  Until there are facts to talk about, there is no point in having a debate.

When Bush is asked about the details of his plan, he always says that it is too early to talk about the details. 

So rather than jump into the fray and discuss the issue without knowing the facts, I will instead examine the possible reasons for the Administration framing the debate in the manner they have so far.  Read the rest at The Rest of the Story.