Saturday, May 22, 2004

News Flash:
Hardly Anyone Cares About Gas Prices

Polls show that most Americans do not blame President Bush for the recent increases in gasoline prices.  Media reports have informed us that the increased demand for oil in China, OPEC  quotas, and limited refining capacity are to blame.  Other reports assure us that there still is plenty of oil, although of course that only refers to the number of decades that will elapse before oil prices get really high.  (See Cheap-Oil Era Is Far From Over, Analyst Say, from National Geographic News)

Scanning the Blogosphere and US news outlets, there is a lot of commentary about gas prices; but scanning the international news outlets, there are only a few concerns mentioned.  There is a G7 conference  coming up; oil prices will be a topic there.  US diplomats are meeting with OPEC ministers.  Asian stock markets are declining a bit, because of the price of oil.  Why is there a discrepancy between the great expressions of concern in the US, but such muted concern elsewhere?

In this post, I outline the issues that pertain to gasoline prices, then show why we should join the rest of the world in not making a big political issue out of it. 

Obviously, the election in November 2004 is one reason.  The US may be the only country in which such an important election could have its outcome determined by the price of oil. 

Bush proponents point out that the price of gasoline, adjusted for inflation, is not  at a record high.  Bush detractors point out that high gasoline prices are are disproportionate hardship for poor people, and that such prices could put a drag on the economic recovery.  Republicans point out that Democrats have impeded efforts to expand oil production in the USA.  Some have commented, snidely and without thinking it through hall the way, that liberal environmentalists have advocated for higher taxes on gasoline, but now liberals are complaining that the price of gasoline is too high.  Liberals counter by pointing out that oil company profits increase  greatly when oil prices are high, adding that the current Administration has close ties to the oil business. 

The American Petroleum Institute (FYI on Gasoline Prices 5/19/2004) tells us that gasoline prices are high because global prices for crude oil are high.  They tell us, helpfully I guess, that oil is the principle cost component of gasoline.  They go on to inform us that "[t]oday a barrel of crude oil is selling for more than $40. This is $15 a barrel higher (or 36 cents per gallon higher) than it was at this time last year. The retail price of gasoline also 52 cents more per gallon today than last year, averaging $2.06 per gallon."

<rant-tangent> Perhaps it did not occur to them that some people might notice that they are selling the end product for 52 cents more per gallon, while the cost of the raw material is only 36 cents per gallon higher.  I realize that this does not necessarily translate into a higher profit margin, but it probably does.  </rant-tangent>

As I mentioned, polls show that most Americans do not blame Bush for the higher prices.  They probably are right.  Everyone knows this, yet everyone in the US seems to be making it an election issue.  Of course, the election may be so close that a butterfly flapping its wings in Brazil  could decide the outcome of the election. And all of us pundits are out there flapping our arms, anytime the political wind starts to blow one way or the other.   I say, let's focus on the real issues:  the hazards of a one-party government; jobs; sustaining the economic recovery; Iraq; and the integrity of the candidates.   The price of gasoline is just one part of the issue of the sustainability of economic recovery.   It deserves some attention, but not the sheer volume that we have seen lately.

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Tuesday, May 18, 2004

NIH Stem Cell Policy Shift(s)?

On 5/10/2004, The Corpus Callosum noted a report that Nancy Reagan had spoken out in favor of expanded research using stem cells.  I don't know what it was that led me to post that; of all the news that day, it seemed noteworthy for some reason.  Now comes a report  in the WaPo that the director of NIH,  Dr. Elias A. Zerhouni, (yes, that  Dr. Zerhouni -- see the post from yesterday) has written a letter to the US House of Representatives reflecting the President's stem cell policy.  A PDF of the letter is here.  In this post, I describe the possible policy shift that the letter may signal, and point out two things that the author of the article apparently missed. 

The WaPo reported noted that most of what is in the letter is a rehash of prior policy.  But one sentence stands out:

Bush's Stem Cell Policy Reiterated, but Some See Shift
NIH Director's Letter to Lawmakers Acknowledges That Science Could Benefit From Added Cell Lines

By Rick Weiss
Washington Post Staff Writer
Sunday, May 16, 2004; Page A18 

[...] "And although it is fair to say that from a purely scientific perspective more cell lines may well speed some areas of human embryonic stem cell research, the president's position is still predicated on his belief that taxpayer funds should not 'sanction or encourage further destruction of human embryos that have at least the potential for life.' " [...]

The key phrase is: "it is fair to say that from a purely scientific perspective more cell lines may well speed some areas of human embryonic stem cell research."

This may signal a policy shift.  Previously, the Administration tried to argue that the cell lines that are already available are sufficient for research purposes.  Although hardly anyone who has ever set foot in an actual laboratory agreed with this, the President used this argument to bolster his other argument, which is the ethical one.  That is, he expressed the opinion that it is improper to destroy human embryos that have the potential -- however theoretical that potential may be -- to some day give rise to human life. 

Forensic experts might recognize this as a classic "double defense:"  Commonly, a person who is angling for an insanity defense will say, in essence: 'I didn't do the crime, and even if I did, I was crazy at the time.'  Only his version is: 'It's unethical to generate more cell lines using a method that destroys embryos, but even if it isn't unethical, it isn't scientifically necessary.'

The potential significance of the sentence was amplified in an interview:

"Obviously it's a very politically crafted sentence," said Tony Mazzaschi, an associate vice president at the Association of American Medical Colleges. "You can just imagine what it took to get that in. I do see some movement here."

Mr. Weiss thinks that the important policy shift is Bush's movement away from the scientific argument.  Personally, I think there is a more important shift signaled by this letter.  Mr. Bush has been widely, persistently criticized for his misrepresentation of science to the public.  Perhaps he is finally getting the message.   In this election year, this is a fight he doesn't have to be in.  Alter all, not only is this a battle that he does not have to fight, but even if he did, he couldn't win it anyway. 

There is one more point I would like to make.  Six months ago, we would have read a letter from the director of NIH and we would have taken it at face value.  Now, given the events I posted about yesterday, we have to wonder: "who stands to make a profit off of this?"

Oh, I guess there is another point here.  The WaPo article stated that Dr. Zerhouni wrote the letter at the request of President Bush, and that the White House vetted the letter before it was released.  Notice the statement: "human embryos that have at least the potential for life. "

Now think about this for a moment.  Think for another moment.  Is he saying that embryos, which "have at least the potential for life," are not yet actually alive???

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Monday, May 17, 2004

Ethical Questions at NIH

A while ago, I posted several articles on the safety and effectiveness of antidepressant medication.  On of the posts provoked an e-mail from Alex, the author of the Pseudoscience in Psych  blog.  Although he is an outspoken critic of certain aspects of psychopharmacology, he is well-informed and well-meaning.  part of his message to me was:

I'll believe that antidepressants work better than placebos when I see
large-scale, rigorously designed, independently conducted (i.e., not
financed by Big Pharma) studies where an active placebo is used and where
the double-blind conditions are tested and not simply taken for granted.

I have gotten distracted by other things, but I always meant to write up an explanation of why his objections are so important, and what is being done about them.  To this end, I started to look into the Star*D (Sequenced Treatment Alternatives to Relieve Depression) research program.  Star*D is a large, multicenter research program that is funded by NIH.  A synopsis is located on the University of Michigan Health System Depression Center page (here, scroll down).  For more information, go to PubMed and search for "Star-D".  SInce the program is funded by NIH, I thought that it might answer at least one of Alex's concerns. 

Unfortunately, there are complications.  I decided to look into the state of things at NIH.  This   article is about the complications at NIH.  I conclude with some comments of my own. 

The US National Institutes of Health (home, about) is one of the largest research organizations in the world.  Their budget in  FY 2003 was $27,066,782,000 in Congressional appropriations.  Their mission statement is as follows:

NIH is the steward of medical and behavioral research for the Nation. Its mission is science in pursuit of fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to extend healthy life and reduce the burdens of illness and disability. The goals of the agency are as follows: 1) foster fundamental creative discoveries, innovative research strategies, and their applications as a basis to advance significantly the Nation's capacity to protect and improve health; 2) develop, maintain, and renew scientific human and physical resources that will assure the Nation's capability to prevent disease; 3) expand the knowledge base in medical and associated sciences in order to enhance the Nation's economic well-being and ensure a continued high return on the public investment in research; and 4) exemplify and promote the highest level of scientific integrity, public accountability, and social responsibility in the conduct of science.

Sounds good, doesn't it, especially the part where they talk about how they exemplify and promote the highest level of scientific integrity, public accountability, and social responsibility in the conduct of science

On December 7, 2003, (which, ironically, is the anniversary of Pearl Harbor Day) an article was published in the LA Times (free registration required): 

Stealth Merger: Drug Companies and Government Medical Research
Some of the National Institutes of Health's top scientists are also collecting paychecks and stock options from biomedical firms. Increasingly, such deals are kept secret.

By David Willman, Times Staff Writer

BETHESDA, Md. — "Subject No. 4" died at 1:44 a.m. on June 14, 1999, in the immense federal research clinic of the National Institutes of Health. 

The cause of death was clear: a complication from an experimental treatment for kidney inflammation using a drug made by a German company, Schering AG.

Among the first to be notified was Dr. Stephen I. Katz, the senior NIH official whose institute conducted the study.

Unbeknown to the participants, Katz also was a paid consultant to Schering AG.

Katz and his institute staff could have responded to the death by stopping the study immediately. They also could have moved swiftly to warn doctors outside the NIH who were prescribing the drug for similar disorders. Either step might have threatened the market potential for Schering AG's drug. They did neither.

Questioned later, Katz said that his consulting arrangement with Schering AG did not influence his institute's decisions. His work with the company was approved by NIH leaders.

Such dual roles — federal research leader and drug company consultant — are increasingly common at the NIH, an agency once known for independent scientific inquiry on behalf of a single client: the public.

Two decades ago, the NIH was so distinct from industry that Margaret Heckler, secretary of Health and Human Services in the Reagan administration, could describe it as "an island of objective and pristine research, untainted by the influences of commercialization."

Today, with its senior scientists collecting paychecks and stock options from biomedical companies, the NIH is no longer an island.

The article was the product of five years of investigational reporting.  It followed the time-honored media principle of "If it bleeds, it leads."  Unfortunately, the credibility of the article was tarnished by the sensationalism, as explained in the Slate article here.  Still, the main point of the article, that the NIH no longer can claim the moral high ground, caused a significant turmoil at NIH and in Congress. 

NIH commissioned a Blue Ribbon Panel to investigate, and to make recommendations.  The political fallout was considerable, as echoed in the Detroit News:

Probe sought into NIH officials' outside work
By David Willman / Los Angeles Times
Saturday, January 17, 2004

WASHINGTON -- Three leading House Democrats on Friday asked the General Accounting Office to investigate consulting fees and stock options paid by drug companies to employees at the National Institutes of Health.

Citing details from a Los Angeles Times article published last month, the House members called for an “investigation into potential conflicts of interest” at the federal government's center for medical research on humans.[...]

The request made Friday by Democratic Reps. Henry A. Waxman of California, John D. Dingell of Michigan and Sherrod Brown of Ohio follows the announcement of an inquiry being led by the Republican chairman of the House oversight and investigations subcommittee, Rep. James C. Greenwood of Pennsylvania. The Appropriations subcommittee on labor, health and human services and education, chaired by Sen. Arlen Specter, R-Pa., also plans to question NIH officials at a hearing on Thursday.

A spokesman for NIH, John Burklow, said the agency's director, Dr. Elias A. Zerhouni, was cooperating and “working closely with the committees.” Burklow added, “He takes these, and NIH takes these, concerns very seriously. Extremely seriously.”

Additional follow-up articles are here: 1  2  3  4.  The director of NIH, Elias A. Zerhouni, M.D.,  was interviewed in an editorial published in the New England Journal of Medicine, here.  A subscription is required to see the text at NEJM, but someone posted a full copy here.  As except follows:

In an interview in early January, Zerhouni said: "What is being portrayed in the press is not the reality, but that doesn't mean that we couldn't do a better job of managing the conflict issues." The controversy "still leaves the question of perception of inappropriate conflict-of-interest management and whether or not we pass the smell test in terms of perception. It is important for me to address that."

The NIH Blue Ribbon Panel released a draft report (689 KB PDF download, here) on May 5, 2004.  They agreed that there is a problem, although they took pains to report the problems in a way that minimized the potential impact:

In its deliberations the Panel found an extremely complex set of rules governing conflicts of interest at NIH. These rules are widely misunderstood by some of the very people to whom they are intended to apply, thereby creating uncertainty as to allowable behavior and adversely affecting morale. [...]

The Panel found that relatively few NIH employees engage in consulting agreements with biotechnology or pharmaceutical companies -- an activity that currently involves approximately 120 of NIH's 17,526 employees. Yet the high level of reasonable concern expressed by Congress and the media about the potential for conflicts of interest when consulting with industry -- itself a small fraction of the outside activities engaged in by NIH scientists -- has had a decidedly negative impact on the morale of a large number of NIH intramural scientists.

They went on to make 18 specific recommendations.  I won't go over them in detail, but to summarize, most of the recommendations serve to increase transparency and accountability.  There is a recommendation that income from outside activities by limited to 50% of the employee's base pay, and that no more than 25% should come from any one source.  They also recommend that the cap on base pay be increased.  The latter recommendation was made because The Panel is concerned that the present ceiling is limiting the agency's ability to recruit and retain the nation's best scientists as the leaders of NIH.

The publication of the draft report has not quelled the criticism.  Among the four follow-up articles cited above, the most recent is this one:

NIH Conflict Findings Left Out
Ethics panel's final report did not detail all permissive practices, agency documents show.
By David Willman, Times Staff Writer
May 12, 2004

WASHINGTON — A blue-ribbon panel that examined conflict of interest at the National Institutes of Health found permissive practices that were not detailed in its final report last week, internal agency documents show.

The documents also show that top aides to NIH Director Elias A. Zerhouni were allowed to review and comment privately on the panel's draft findings.

Congressional investigators have expressed interest in the circumstances surrounding compilation of the report, issued Thursday. The next day, the chairman of the House Oversight and Investigations subcommittee, Rep. James C. Greenwood (R-Pa), wrote to Zerhouni, seeking "all records relating to the minutes and records of closed sessions of the Blue Ribbon Panel, as well as all drafts of the report." [...]

Again, Mr. Willman strikes an adversarial tone in is article, immediately keying in on what was left out  of the report, rather than reporting on what is in  the report. 

Blogosphere commentary is limited, which surprises me.  Robert M. Centor, MD, on Medrants, stated:

Medical researchers (not unlike most humans) like the ability to make extra money. Being a paid consultant has the veneer of appropriateness and respectability. The researchers easily delude themselves that as scientists they are immune from influence. Unfortunately, this naivety allows them to unknowingly make mistakes.

They justify their actions as necessary to support their overall research. They truly mean well. However, much like Dr. Faustus they are selling their souls. This is the dirty secret of much medical research.

We need a new ethical standard. We need to understand why we engage in this dance. We need to stop.

One of the comments on his post led to this, by Carey Cuprisin (a University of Michigan Law student) at Glorfindel of Gondolin:

Unfortunately, I think we'll have to make them stop. The siren song of $$ is, again, proving resistant to wholly voluntary "ethical standards."

On McConchie on Bioethics, Daniel McConchie wrote:

Major changes urged at NIH to avoid conflict-of-interest charges
[...] While many view the ability of NIH employees to privately consult as essential for an effective medical research complex, the unlimited policy has created a situation where government employees can profit from their policy decisions that either help or hurt specific pharmaceutical or biotech companies. The risk of abuse is very real as those charged with promoting useful medical research could try to benefit companies who could, in turn, benefit the employee who made it happen. Congress has now gotten into the mix by urging NIH to adjust its policies.

Our cutting-edge medical research establishment is a cornerstone of the best available healthcare in the world. Everything must be done to ensure that the research has every tool it needs while balancing that need with enough oversight that ensures the system isn't manipulated. I'm happy that we allow talented researchers to make more than our government positions can pay as it helps the NIH keep some of the best people in important and necessary government roles. Let's just make sure the taxpayer doesn't suffer from a system that could allow personal greed, rather than societal need, run the show.

Medpundit, written by the pseudonymous Sydney Smith, has a post  that deals with the topic in general, without addressing the NIH issue directly:

Tales from Cloud Cuckoo Land: Shannon Brownlee has a lengthy piece in the Washington Monthly about the corporate corruption of scientific research. Even the editors of major medical journals know there's a problem:

As Dr. Drummond Rennie, deputy editor of The Journal of the American Medical Association (JAMA), puts it, 'This is all about bypassing science. Medicine is becoming a sort of Cloud Cuckoo Land, where doctors don't know what papers they can trust in the journals, and the public doesn't know what to believe.'

Looking at all the sources, it appears that the only people defending the NIH are the people who work there, and perhaps some of the members of the Blue Ribbon Panel.  Personally, I think that the issue is not quite as horrific as the LA Times writer, David WIllman, makes it out to be.  And I think that the Slate commentator, Jack Shafer, has a good point when he says:

Willman undercuts his considerable accomplishment with an opening (and a conclusion) that is as sensational as anything you'd read in an "if it bleeds, it leads" tabloid.

Even so, NIH is getting a well-deserved housecleaning courtesy of the US Congress, and it appears that the initial efforts have fallen short of most people's expectations.  The key problem they face is that if they completely cut off ties with industry, that could stifle biomedical development.  People who otherwise could be helped, will stay sick and possibly die, if biomedical development is stifled.  But too much industry influence could lead to the loss of the only source of objectivity we have in the biomedical research arena.  I agree with the NIH director, Dr. Zerhouni, when he states that "Transparency — full light on any relationship — is one of the best protections against any real or perceived conflict of interest," as quoted in the NEJM editorial.  Medical journals need to accelerate the trend of reporting potential conflicts of interest by the authors. 

One idea that came to me as I was preparing this is that perhaps the federal government could establish a central registry, in which all researchers are required to submit information when they accept industry funding from any source.  This goes against my usual ideal that the less information the government has about individuals, the better.  And the less paperwork we have to do, the better.  I think, though, that the potential for misuse of the information in a central registry is minimal, and the benefits of the paperwork would outweigh the hassle.  There would be three benefits: 1) greater trust in biomedical research, 2) greater accountability for industry, and 3) researchers would be forced to take stock of the influences that affect them. 

One of the criticisms on Medrants  was this: The researchers easily delude themselves that as scientists they are immune from influence. Unfortunately, this naivety allows them to unknowingly make mistakes.  Having a central registry of financial influences would address this, by making the researchers keep track of their financial gains from industry sources. 

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Sunday, May 16, 2004

Will Somebody Please Explain?

Every once in a while, I check the columns on Townhall.com, just to see what conservatives are up to.  Some of the columnists, such as George Will, write articles that are worth reading.  His most recent one, Brown vs. Board, 50 years later, provides some interesting historical perspective.  Others, such as Phyllis Schlafly, write things that I disagree with, but I can see that she has a point.

Today's column by Pat Buchanan is weird.  Rise of a judicial dictatorship  starts in an unremarkable fashion:

When the Warren Court handed down its most famous decision, Brown vs. the Board of Education, on May 17, 1954, this writer had a ringside seat at a high school in the inner city of Washington, D.C.

The crux of his argument is in this excerpt:

But that May day in 1954, the Warren Court crossed a historic divide. It had executed, in the name of the 14th Amendment, a coup d'etat. It had usurped power over state schools that had never been granted to federal courts either in law or the Constitution.

The 14th Amendment had been approved by the same Congress that presided over the segregated schools of D.C. Thus it was obvious to all that that amendment did not outlaw what its authors had approved. But the Warren Court, impatient at the torpor of the democratic process, had established itself as a dictatorship of nine judges, and ordered the nation to do as it demanded.

The coup succeeded. Though President Eisenhower was stunned by Brown, he and the Republican Congress bowed and accepted the ruling as the law of the land to be enforced, if necessary, by federal troops, as it would be at Central High in Little Rock in 1957.

He goes on to list a number of SCOTUS decisions that he does not agree with.  His conclusion:

Today, we meekly await the court's judgment on whether we will have to legalize marriage between homosexuals. Were George III to return to life, he would roar with laughter at what a flock of sheep the descendants of the American rebels have become.

Honestly, I cannot see what his point is.  I've re-read the 14th amendment, which, of course, requires that no state deny anyone equal protection under the law.  Sure, the argument in Brown v. Board was that segregation had the practical effect of denying equal protection.  This was a judgment call on the part of the judges.  No surprise there: we hired the judges to make judgment calls.  That's what judges do.  How does this make us a flock of sheep?  And is being a flock of sheep wrong under the Christian tradition that he touts repeatedly in his column?

(Psalm 100:3)  Know that the LORD is God. It is he who made us, and we are his ; we are his people, the sheep of his pasture.

(Jeremiah 23:3)  "I myself will gather the remnant of my flock out of all the countries where I have driven them and will bring them back to their pasture, where they will be fruitful and increase in number."

(John 10:11)  "I am the good shepherd. The good shepherd lays down his life for the sheep."

(Ezekiel 37:24)  "'My servant David will be king over them, and they will all have one shepherd. They will follow my laws and be careful to keep my decrees."

If Buchanan had meant to imply that we should be ashamed of ourselves for obeying the Supreme Court, the 'flock of sheep' metaphor was entirely inappropriate.  Would somebody please explain what his column is supposed to mean?

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