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Contents:
Malaria and Greenhouse Gases
   in Health April 25, 2008

Soylent Green
   in Author: Hale, B. | Environment | Health | Science + Politics January 16, 2008

So-kalled WiFi research
   in Author: Hale, B. | Health | Risk & Uncertainty | Testing November 20, 2007

Where is public confidence in science?
   in Author: Vranes, K. | Health July 17, 2007

Should the Gates Foundation fund Policy Research?
   in Author: Pielke Jr., R. | Health | R&D Funding | Technology Policy | The Honest Broker May 09, 2007

Another Reason to View Adaptation as Sustainable Development
   in Author: Pielke Jr., R. | Health February 15, 2007

The Importance of Evaluation
   in Author: Pielke Jr., R. | Health | Science Policy: General December 15, 2006

The Benefits of Red Wine and the Politics of Science
   in Author: Pielke Jr., R. | Health | Science + Politics November 27, 2006

11,000 Deaths a Day, Page 8, Ho Hum
   in Author: Pielke Jr., R. | Health May 09, 2006

Cutler and Glaeser on Why do Europeans Smoke More Than Americans? Part II
   in Author: Pielke Jr., R. | Health | Risk & Uncertainty April 27, 2006

Cutler and Glaeser on Why do Europeans Smoke More Than Americans? Part I
   in Author: Pielke Jr., R. | Health | Risk & Uncertainty April 26, 2006

A DEMOS Op-ed on Science and Smoking Bans
   in Author: Pielke Jr., R. | Health March 25, 2006

Stem Cells and Vulgar Democracy
   in Author: Pielke Jr., R. | Biotechnology | Health March 21, 2006

To Advocate, or Not?
   in Author: Pielke Jr., R. | Health | Science Policy: General March 14, 2006

Stem Cells and that "War on Science"
   in Author: Pielke Jr., R. | Health November 28, 2005

Another View on Stem Cells
   in Author: Pielke Jr., R. | Health October 21, 2005

Stem cell solution – not!
   in Author: Pielke Jr., R. | Health October 18, 2005

New Chairman Bioethics Council
   in Author: Pielke Jr., R. | Health September 08, 2005

Science and Political Affiliations
   in Author: Pielke Jr., R. | Health August 26, 2005

Drawing a line in the batter's box?
   in Author: Pielke Jr., R. | Health August 09, 2005

Stem Cell Politics and Perspectives on Science
   in Author: Pielke Jr., R. | Health August 03, 2005

Beware of Snake Oil Salesmen
   in Author: McNie, E. | Health June 20, 2005

When the Cherries Don't Cooperate
   in Author: Pielke Jr., R. | Climate Change | Health | Science Policy: General June 06, 2005

Malaria and Science Policy
   in Author: Pielke Jr., R. | Health March 11, 2005

Money, Conflicts of Interest and Openness
   in Author: Pielke Jr., R. | Health February 28, 2005

NRC Perchlorate Report and NRDC Reaction
   in Author: Pielke Jr., R. | Health January 12, 2005

Wanted: Honest Brokers
   in Author: Pielke Jr., R. | Health November 23, 2004

Sarewitz on California Proposition 71
   in Author: Pielke Jr., R. | Health October 26, 2004

Non-Results in Clinical Trials and Beyond
   in Author: Pielke Jr., R. | Health September 27, 2004

Public Access to Genome Data and the NAS as Policy Advocate
   in Author: Pielke Jr., R. | Health September 10, 2004

Stem Cells, Stalwarts and Dealers Redux
   in Author: Pielke Jr., R. | Health September 09, 2004

Stem Cells and the Misuse of Science
   in Author: Pielke Jr., R. | Health | Science Policy: General August 23, 2004

Op-Ed on Stem Cell Science and Policy
   in Author: Pielke Jr., R. | Biotechnology | Health August 02, 2004

Health Research Priorities
   in Author: Pielke Jr., R. | Health | R&D Funding July 26, 2004

On Not Regulating the Regulators
   in Author: Fisher, E. | Health July 26, 2004

Henry Waxman, HHS, and a Bush Administration Misuse of Science
   in Author: Pielke Jr., R. | Health | Science Policy: General June 28, 2004

Fetal Genetic Testing
   in Author: Pielke Jr., R. | Health | Science Policy: General June 21, 2004

Paying for Pills
   in Author: Ryen, T.S. | Health June 09, 2004

Hiding Behind Science
   in Author: Others | Biotechnology | Health | Science Policy: General May 25, 2004

Conflict of Interest Policies in NIH
   in Author: Pielke Jr., R. | Health May 14, 2004



April 25, 2008

Malaria and Greenhouse Gases

Did you know that today is "World Malaria Day"? I wouldn't be surprised if you hadn't; a search of Google News shows 233 stories on "world malaria day" published in the past 24 hours. A search of "climate change" over the past 24 hours shows 45,819 stories. This post is about the inevitable conflict in objectives that results when we frame the challenge of global warming in terms of "reducing emissions" rather than "energy modernization." The result is inevitably a battle between mitigation and adaptation, when in reality they should be complements.

Why does malaria matter? According to Jeffrey Sachs:

The numbers are staggering: there are 300 to 500 million clinical cases every year, and between one and three million deaths, mostly of children, are attributable to this disease. Every 40 seconds a child dies of malaria, resulting in a daily loss of more than 2,000 young lives worldwide. These estimates render malaria the pre-eminent tropical parasitic disease and one of the top three killers among communicable diseases.

The Economist reported a few weeks ago on efforts to eradicate malaria. The article referenced a study by McKinsey and Co. on the "business case" (PDF) for eradicating malaria. Here are the reported 5-year benefits:

• Save 3.5 million lives

• Prevent 672 million malaria cases

• Free up 427,000 hospital beds in sub-Saharan Africa

• Generate more than $80 billion in increased GDP for Africa

I want to focus on the prospects for increasing African GDP, for as we have learned via the Kaya Identity, an increase in GDP will necessarily mean an increase in carbon dioxide emissions. So what are the implications of eradicating malaria for future greenhouse gas emissions from Africa?

To answer this question I obtained data on African greenhouse gas emissions from CDIAC, and I subtracted out South Africa, which accounts for a large share of current African emissions. I found that the average annual increase from 1990-2004 was 5.2%, which I will use as a baseline for projecting business-as-usual emissions growth into the future.

The next question is what effect the eradication of malaria might have on African GDP. The McKinsey & Co. report referenced a paper by Gallup and Sachs (2001, link) which speculates (and I think that is a fair characterization) that complete eradication could boost GDP growth by as much as 3% per year. This would take African emissions growth rates to 8.2%, which is still well short of what has been observed in China this decade, and thus not at all unreasonable. So I'll use this as an upper bound (not as a prediction, to be clear). So if we graph future emissions under my definition of business-as-usual and also the Gallup/Sachs upper bound, we get the following curves to 2050.

Malaria Scenarios.png

The figure shows that by eradicating malaria, it is conceivable that there will be an corresponding increase in annual African emissions of more than 11 GtC. Today, the entire world has about 9 GtC. For those following our debate with Joe Romm earlier this week, this would mean that he would have to come up with another way to get 10 more "wedges," as rapid African growth is included in none of the BAU emissions scenarios. Put another way, the success of his proposed policies depend on not eradicating malaria since rapid African GDP growth busts his wedge budget.

The implications should be obvious: If a goal of climate policy is simply to "reduce emissions" then this goal clearly conflicts with efforts to eradicate malaria, which will inevitably lead to an increase in emissions. But if the goal is to modernize the global energy system -- including the developing the capacity to provide vast quantities of carbon-free energy, then there is no conflict here.

This distinction helps to explain why there persists an adaptation vs. mitigation debate, and why it is that advocates of adaptation (to which eradicating malaria falls under) are often excoriated as "deniers" or "delayers" -- adaptation just doesn't help the emissions reduction challenge. The continued denigration of those who support adaptation will continue until we reframe the climate debate in terms of energy modernization and adaptation, which are complementary approaches to sustainable development.

Over at The New Scientist Fred Pearce takes a broader view and warns of "green fascism" on the issue of development and population:

But there is another question that I find increasingly being asked. Should we be trying to stop others having babies, especially people in poor countries with fast-growing populations?

I must say I thought this kind of illiberal thinking had been banished from the environmental movement. But it keeps seeping back. When I give public talks on climate change, I am often asked if all the efforts in the rich world won't be wiped out by rising populations in the poor world.

Isn't overpopulation more dangerous than overconsumption? I say no. But the unpalatable truth is that a lot of environmental thinking over the past half century has been underpinned by an unhealthy preoccupation with the breeding propensity of Asians and Africans. . .

Only recently, US groups opposed to all migration tried to get their policies adopted by the blue-chip environment group, the Sierra Club. To many they sounded like a fringe group. Actually they were an echo of the earlier mainstream.

And the echo is becoming louder. We hear it in the climate change debate. No matter that the average European or North American has carbon emissions 10 times greater than the average Indian or African, somehow it is those pesky breeding foreigners who are really to blame.

And now food shortages are growing and we will get more. Ehrlich, we are bound to be told, was right after all. You have been warned: green fascism could soon be on the march.

It is long overdue to rethink how we think about the climate debate.

Posted on April 25, 2008 07:20 AM View this article | Comments (0)
Posted to Health

January 16, 2008

Soylent Green

This was too rich not to mention, though it doesn't have all that much to do with science and technology. Evidently, the House cafeteria has just gone green. They now offer a wider selection of vegetarian options, cage free eggs, and hormone free milk. This has some lobby groups (namely, the egg and milk lobbies) in a twist.

Read the NY Times article.

The lobbyists seem to think that the restaurant operators are "hooked by propaganda of animal rights groups." So this raises a question: What's the grub? Either it's the case that industry eggs and cage free eggs, or industry milk and hormone free milk are absolutely, categorically equivalent, on both moral and non-moral grounds; or it's not. If there is absolutely, categorically no moral distinction between the two, then there's always the possibility that the two options are distinct on, say, preference grounds. In either case, the important observation is that there is some difference relevant to the decision-making of the restaurant operators: whether it be that the offerings come from American or Chinese chickens, wild or farmed fish, or (yes) fat or skinny farmers.

The last issue, you might reply, smacks of irrelevance. Who cares if the farmer is fat or skinny? Maybe there are even justice issues here: if, say, a restaurant operator chooses chickens from the fat farmer, on grounds that the farmer is fat, maybe this is due to a deeply embedded anti-skinny bias; or perhaps an affirmative action-laced agriculture bill. But these considerations are no more irrelevant to the restaurant operator's decision than any other considerations. They're all factors; and they need to be argued for. Positively. Not negatively.

Lobbyists who argue against the practice of greening one's food options once the decision has already been made are stuck with the hard line: that there is no difference whatsoever. That's plainly false, just as it is false that there is no difference whatsoever between food brands or between food that comes from Guatamala or Iowa. Now that the decision has been made, the burden of proof is on the lobbyists to demonstrate that there is absolutely, categorically no relevant difference between the several options. By my reckoning, that'll be mighty hard, since differences like the living conditions of chickens plainly matter, even if not morally, at least to some people. Maybe that's why someone would revert to inane strategies like suggesting that cafeteria operators are "hooked by propaganda."

Foodfights like this can only be made of people.

Posted on January 16, 2008 02:50 AM View this article | Comments (0)
Posted to Author: Hale, B. | Environment | Health | Science + Politics

November 20, 2007

So-kalled WiFi research

Last week it was the Journal of Geoclimatic Science and benthic bacteria, this week it's the Australasian Journal of Clinical Environmental Medicine and autism. The Sokal phemonemon is back with a vengeance, though this time it appears to be just plain fakery.

Matt Drudge has is viewers linking to an article that was, for a short stint this afternoon, published on the Computer Weekly website. The article warned of the dangers of WiFi for children. It cited an article by Dr. George Carlo in the Australasian Journal of Clinical Environmental Medicine claiming that WiFi causes heavy metals to be caught in brain cells. Only problem? Journal no existy.

Here's a slightly cynical overview. You can also check out the authors at the
Quackometer.

Posted on November 20, 2007 02:01 PM View this article | Comments (0)
Posted to Author: Hale, B. | Health | Risk & Uncertainty | Testing

July 17, 2007

Where is public confidence in science?

Coming in a little late to this one, but on 30-June the WSJ ran an op-ed by Roy Grinker of George Washington University on the vaccines-autism circus. The article is moneywalled, of course, so you'll need special access to see it, but a couple of snippets should give a good idea of his arguments.

I base my opinion on scientific literature and no court decision is going to change it. Neither will a court decision change the minds of the antivaccine advocates. Two distinct communities have emerged, and though they both employ the language of science, their ideas are simply incommensurable. The two groups co-exist, like creationism and evolutionary biology, but they operate on such different premises that a true dialogue is nearly impossible.

The real problem here, as we have pointed out a few thousand times, is Dan Sarewitz's excess of objectivity. There is enough ammunition for both sides to keep firing.

We should not expect too much out of this trial, or the next eight. The scientific community and antivaccine parent groups will each continue to look for clues under their own lampposts, because that is where the light is. But we should pay careful attention to this conflict. The antivaccine movement may be evidence that public confidence in science is eroding, which means that public health is at risk too.

Grinker may be right here, but I think something else is important that he misses. The vaccines debate is not and has never been about the science, and it will continue to not be about the science. It is about whether it is reasonable for the government to mandate (whether it does so explicitly or implicitly) that all children receive vaccines. This is a social liberty and public health policy question, not a science question. The antivaccine movement has been forced to debate in the world of science when they want to be debating in the world of social policy. But science as a machine is a hard thing to stand up to, and the antivaccine movement must have sensed that they would get more traction making arguments about bad science than about social liberty. Clearly the argument "I don't want the government to force my kid to get a shot" is a lot less compelling than "the government is poisoning our kids and covering it up with bad science."


Posted on July 17, 2007 08:27 AM View this article | Comments (2)
Posted to Author: Vranes, K. | Health

May 09, 2007

Should the Gates Foundation fund Policy Research?

Well, according Hannah Brown writing in BMJ the answer is "yes" (h/t SciDev.net). It turns out that simply investing money in scientific research or technology development is not sufficient to realize benefits on the ground. The Bill and Melinda Gates Foundation has already changed he world for the better, and has much future potential, so it is good that it is learning the limitations of the so-called "linear model" of science and society sooner rather than later. Here is an excerpt from Brown's commentary:

Ask anyone with a passing interest in global health what the Gates Foundation means to them and you'll likely get just one answer: money. In a field long fatigued by the perpetual struggle for cash, the foundation's eagerness to finance projects neglected by many other donors raised high hopes among campaigners that its impact on health would be swift and great. And with the commitment last June by America's second richest man, Warren Buffet, to effectively double the foundation's $30bn (£15bn; {euro}22bn) endowment,1 hopes of substantial health achievements grew higher still.

But despite Bill Gates's prediction at a press conference to mark Buffet's pledge that there was now "No reason why we can't cure the top 20 diseases"2 observers are starting to question whether all this money is reaping sufficient rewards. For although the foundation has given a huge boost to research and development into technologies against some of the world's most devastating and neglected diseases, critics suggest that its reluctance to embrace research, demonstration, and capacity building in health delivery systems is worsening the gap between what technology can do and what is actually happening to health in poor communities. This situation, critics charge, is preventing the Gates's grants from achieving their full potential.

Read the whole thing.

February 15, 2007

Another Reason to View Adaptation as Sustainable Development

This news story from Reuters highlights the consequences of neglecting certain areas of research and policy:

One billion poor suffer from neglected diseases: WHO

Last Updated: 2007-02-14 9:44:10 -0400 (Reuters Health)

JAKARTA (Reuters) - One billion people in tropical countries are still suffering from debilitating and disfiguring diseases associated with poverty, but many remain untreated due to official neglect, health officials said on Wednesday.

Despite the existence of inexpensive and safe treatment, those who suffer from diseases such as leprosy, elephantiasis and yaws remain untreated due to a lack of resources and political will, said Jai Narain, South East Asia director of communicable diseases at the World Health Organization (WHO).

"These tropical diseases have been neglected by policy makers, by the research community and also by the international community," Nairan told a news conference at the start of an international meeting to tackle tropical diseases.

"But at the same time these diseases cause considerable amount of suffering, disability, disfigurement and even social economic impact, particularly for populations which are extremely marginalised," he said.

Nairan said the fact that the diseases were not in the headlines and not global problems like polio, HIV/AIDS and malaria contributed to the lack of attention.

"These diseases are closely related to poverty. The elimination of such diseases would be a significant step toward poverty reduction," he said. Many who contract the diseases suffer from discrimination and are shunned by their communities, said Nyoman Kandun, director general for communicable disease control at the Indonesian health ministry. . . .

Posted on February 15, 2007 07:03 AM View this article | Comments (5)
Posted to Author: Pielke Jr., R. | Health

December 15, 2006

The Importance of Evaluation

A story in the New York Times today on the effectiveness of colonoscopy highlights the importance of evaluating the effectiveness of action. One of the biggest areas of study in academic policy research is evaluation, and the federal government has an entire agency that focuses on evaluation in the Government Accountability Office.

1214-nat-subCOLON.gif

But in policy as in medicine – as the colonoscopy case illustrates -- it is amazing how often evaluation of the effectiveness of action is overlooked or simply not done. Evaluation matters because it indicates what is working and what works. In the case of colonoscopy, improved health outcomes are apparently achieved with only a minor change in medical practice.

Posted on December 15, 2006 12:26 AM View this article | Comments (1)
Posted to Author: Pielke Jr., R. | Health | Science Policy: General

November 27, 2006

The Benefits of Red Wine and the Politics of Science

Saturday’s New York Times had an interesting article (registration required) about scientific stuides finding possible health benefits of red wine, and the political constraints on the wine industry to advertise those benefits. Here is an excerpt from the article:

The wine industry certainly has welcomed the recent disclosures that a compound in red wine improves the health and endurance of laboratory mice. So why isn't the industry crowing about it?

Because it can’t. The industry has long been handcuffed by state and federal laws that discourage promoting the benefits of wine, with some of those restrictions dating back to the repeal of Prohibition in 1933.

"Yes, we’d all like to make hay of this, and we’ll do what we can, but we are very constrained," said Michael Mondavi, founder and president of Folio Fine Wine Partners, a producer and importer of wines here.

As an industry that is closely regulated by the Alcohol and Tobacco Tax and Trade Bureau, Mr. Mondavi said, "it is blatantly against the law for any alcoholic beverage producers to make any health claim regardless of the facts or the accuracy."

"Until that regulation is changed or modified in some way so that we can talk about the positive health aspects that are proven," said Mr. Mondavi, the older son of famed winemaker Robert Mondavi, "we have to sit on our hands and wait for others to pick up the story."

Government regulation of alcohol advertising has a long history steeped in American cultural attitudes about drinking. In this regard this issue shares some obvious similarities with, say, medical marijuana or even differences in male-female aptitude (e.g., as raised by Harvard’s Larry Summers not long ago). In other words, political issues involving science are immersed in rich stew of societal values and preferences. It is only when these values are strongly contested in society that issues of science in political debate actually come to the fore -- creating conditions for the pathological politicization of science. We tend to see these issues more starkly when political conflict exists and overlook them when conflict does not. Consisder the brouhaha over federal funding of stem research, yet there isn't similar controversy on federal funding for human cloning research.

When values are widely shared, aspects of science in politics that raise hackles in other contexts go overlooked or are treated as amusing side notes, such as in the NYT article on the potential benefits of red wine. That all issues of science in politics are not treated equally should make the obvious inescapable – when science and politics meet, the values context always matters. There is no such thing as decisions driven by science. Decisions are always driven by values. How, if, and when we wish to consider science in making those decisions is of course where much of the action lies. But we should not pretend that science makes decisions. People make decisions.

Posted on November 27, 2006 07:15 AM View this article | Comments (3)
Posted to Author: Pielke Jr., R. | Health | Science + Politics

May 09, 2006

11,000 Deaths a Day, Page 8, Ho Hum

In a world where influential leaders commonly claim that it is terrorism or global warming that is the world’s greatest problem, I was struck by this page 8 article from today’s New York Times, which contained the following:

More than four million newborns worldwide die each year in their first month of life, comparable to the number of babies born in the United States annually, Save the Children reported Monday.

Many of those infants could be saved with simple, inexpensive items, like sterile blades to cut the umbilical cord, antibiotics for pneumonia and knit caps to keep them warm, the group said in "State of the World's Mothers 2006," a new report. Ninety-nine percent of newborn deaths are in developing countries, where such items are often not widely available.

The deadliest time for children is in the hours after birth, and the deadliest places are the poorest corners of world. South Asia and Africa have the highest rates of newborn deaths, Save the Children said. "The first day of life is the most dangerous day a human being has," said Charles MacCormack, president of Save the Children.

While many countries have significantly lowered mortality rates for children younger than 5 in recent decades, the group said, little progress has been made globally in preventing the deaths of newborns and their mothers.

Four million a year is 11,000 children a day. Every single day. And this is not a problem of high technology, but low-tech diffusion and adoption. It is a solvable problem with tangible costs and benefits in the near term sharply weight towards the benefits.

What is the role of the United States government in helping to deal with this problem? According to the New York Times:

“President Bush's budget for the 2007 fiscal year proposes spending $323 million on maternal and child health programs in the United States Agency for International Development, less than the $356 million Congress appropriated last year. Save the Children is supporting a House bill that would instead increase financing. Mr. [Charles] MacCormack [president of Save the Children] said the amount of such aid had been flat through the past three administrations.”
Posted on May 9, 2006 12:42 PM View this article | Comments (15) | TrackBack
Posted to Author: Pielke Jr., R. | Health

April 27, 2006

Cutler and Glaeser on Why do Europeans Smoke More Than Americans? Part II

This is a second post discussing a paper by two Harvard economists, David Cutler and Edward Glaeser, available at the National Bureau of Economic Research that raises some interesting questions about the role of science and advocacy on the smoking issue. In this post I'd like to ask some questions about Figure 3 in that paper, reproduced below. For me, Figure 3 raises some really interesting questions about the relationship of science, advocacy, and societal outcomes for which I really have no answers for. I am hoping that Prometheus readers can point me to serious, scholarly literature that might explain what is shown in figure 3.

smoke2.png

Figure 3 shows an increase in smoking in the U.S. through about 1950, broken up only by the Great Depression. There is then a drop off, which Cutler and Glaeser attribute to a first "health scare" about cigarettes which appeared first in the scientific literature and then in the popular media. The upward trend then resumes until the 1960s, a few ups and downs follow, and then, remarkably, from about 1970 on, a steady, almost monotonic decrease.

The question I have is, given these trends, how can one identify the effectiveness of advocacy for and against smoking, and in particular the role of science, uncertainty, and so-called "junk science" in outcomes as measured by societal outcome, in this case the number of cigarettes smoked per adult.

I have thought a good deal about this graph and it seems to show perhaps a number of things, which I suggest below.

1. In the battle over smoking efforts to deny a link between smoking and health risks seems to have been completely a lost effort. There is precious little evidence of the effects of such campaigns in this data. Of course, one could argue that the rate of decrease would be larger without such campaigns, however, if that were the case one would probably expect to see shorter term effects as such campaigns are more or less successful over time. This is a puzzle.

2. There are likely population effects that need to be disaggregated. This is smoking per adult, and as national population grows, this perhaps reflects less people deciding to take up smoking rather than a large increase in people quitting. But such data would be worth gathering.

3. Interestingly, there seems to be no acceleration of the trend in reduction of smoking as the scientific basis for a link between smoking and health risks became much stronger over time. The rate of change in this graph seems at a glance to be about the same in 1975 as it was in 1995. If there was a tight relationship between scientific understandings and societal outcomes, I'd hypothesize an ever increasing rate of change on this issue, especially as the pro-smoking media campaigns have waned. Now it could be that a bunch of complex factors conspire to randomly keep the rate of change in balance, and more analysis would be needed to determine this.

4. To me this data suggests a similarlity with data and findings in other areas of science. Specifically, science has a huge role in getting a subject onto the "agenda" of decision making, but after that, its role is very much dimished and subsumed to other factors, such as cultural, social, and political. If this is correct, it would require some deeper understanding about the role of advocacy relatd to scientific issues and the efficacy of using science as a tool of advocacy. This begs the question -- why has anti-smoking advocacy been so successful over time? The throwaway answer that increasing scientific certainly is the key does not seem to jibe with this data.

For me this graph opens up some fundamenal questions tha arise at he intersection of science, advocacy, societal outcomes. I am motivated enough to follow this up with some actual research, so I'd welcome any comments and suggestions. The case of smoking/science is often raised in discussions of climate change and other areas as an analogy, but I am not convinced that such analogies are based on anything more that supposition, guesses, and assumptions.

April 26, 2006

Cutler and Glaeser on Why do Europeans Smoke More Than Americans? Part I

The relationship of scientific research, industry advocacy, government action, and public behavior on smoking is frequently cited in discussion and debate, but I have actually seen little empirical research that backs up the various claims that are often made on this issue. Two Harvard economists, David Cutler and Edward Glaser, have a paper available at the National Bureau of Economic Research that raises some interesting questions about the role of science and advocacy on the smoking issue.

A few points it seems can be taken as fact:

1. smoking is a health hazard
2. The smoking industry for many years engaged in an active campaign to suggest that smoking is not a health hazard
3. Smoking is addictive
4. Smoking rates, and the change in those rates, are different in different parts of the work

Cutler and Glaeser seek to untangle some aspects of this last point by asking “Why do Europeans Smoke More Than Americans?” The answer that Cutler and Glaeser provide it turns out is complicated, and in my view fundamentally flawed. Here is what they claim in their abstract:

While Americans are less healthy than Europeans along some dimensions (like obesity), Americans are significantly less likely to smoke than their European counterparts. This difference emerged in the 1970s and it is biggest among the most educated. The puzzle becomes larger once we account for cigarette prices and anti-smoking regulations, which are both higher in Europe. There is a nonmonotonic relationship between smoking and income; among richer countries and people, higher incomes are associated with less smoking. This can account for about one-fifth of the U.S./Europe difference. Almost one-half of the smoking difference appears to be the result of differences in beliefs about the health effects of smoking; Europeans are generally less likely to think that cigarette smoking is harmful.

Their findings are interesting, among them:

. . . price differences cannot explain why Americans smoke less than Europeans.

While our conclusions thus need to be interpreted with some care, the U.S. does not appear to tax or regulate tobacco consumption particularly highly, making these explanations unlikely to account for the lower smoking rate in the US.

Given that our model suggests a possible non-monotonic relationship between income and cigarette consumption, the lack of a clear consensus on the income elasticity of smoking is not so surprising.

So price, regulation, and income cannot explain the differences in smoking between the U.S. and Europe. Cutler and Glaeser next turn to beliefs about smoking, for which they begin by noting:

The U.S. has one of the highest rates of believing that smoking is harmful; 91 percent of Americans report believing that smoking causes cancer. Given the high proportion of Americans that believe in UFOs and the literal truth of the bible, this must represent one of the most remarkable instances of the penetration of scientific results in the country. Beliefs about the cancer-causing role of cigarettes in some European countries, like Finland, Greece, Norway, and Portugal, are almost identical to those in the U.S., but in other places beliefs are far weaker. For example in Germany only 73 percent of respondents said that they believed that smoking causes cancer.

An interesting aside, if this recent poll is to be believed more people in Europe believe that global warming is a serious problem than believe that smoking causes cancer. By contrast, in the U.S., the opposite is the case. I’m not sure what to make of this, but the answer is surely tied up in the question Cutler and Glaeser are trying to unravel.

Cutler and Glaser then go out on what I think is thin ice when they assemble an argument based on several lines of reasoning to conclude:

On the whole, our evidence suggests that differences in beliefs are the most important factor explaining the differences in smoking between the U.S. and Europe.

One of the most important lines of evidence is presented in their Figure 11, which I reproduce below.

View image

Figure 11 purports to show a relationship between beliefs about smoking and smoking rates. However, the relationship is entirely a function of excluding Greece from the analysis. Cutler and Glaeser argue earlier in their paper why Greece is excluded from the regressions:

When we examine bivariate relationships between smoking and other factors (prices, regulations, or beliefs), it is important to have a relatively homogeneous sample of countries by income. Within Europe, the major income outlier is Greece, with a per capita income that is 60 percent below the European average ($10,607 in Greece versus $25,858 in Europe in 2000) and 25 percent below the next lowest country (Spain, at $14,138). For this reason, we omit Greece from many of our regressions, though we present raw data for Greece in the tables and show the country in the figures.

I find this justification wholly unsatisfactory. Greece, despite its lower income has the highest rate of belief that smoking causes cancer. Greece is also highly regulated, and does not have unusually cheap cigarettes. In short, its inclusion would certainly muddy the analysis. Excluding it, somewhat arbitrarily in my view, does not add any confidence that Cutler and Glaeser have an adequate explanation for what is going on.

What I get from this paper is that in fact, we don’t yet have an adequate explanation for why we see large differences in smoking between the U.S. and Europe. Consequently, if we can't explain the role of scientific information in smoking, it is safe to say that our understanding of the role of scientific information in societal outcomes on other more complex issues remains frustratingly undeveloped.

In part II I will take a look at trends in U.S. smoking presented by Cutler and Glaeser and suggest a similar lack of understanding.

March 25, 2006

A DEMOS Op-ed on Science and Smoking Bans

The folks at DEMOS, a think tank in London, continue to produce really thoughtful stuff. This short op-ed by Jack Stigloe is right on:

Two years ago, I was lucky enough to interview Professor Sir Richard Doll for a project on expertise.

Right up until his death last year at the age of 92 Doll worked tirelessly to convince the world of the dangers of smoking. Thanks to Doll and others we now know, and are constantly reminded by our cigarette packets, that smoking kills – active or passive.

Leaving aside any uncertainties that might blur its edges, this piece of knowledge has saved lives, and allowed policymakers to make better decisions. But, as David Hume told us long before the invention of the cigarette, you can’t get an ought from an is. Science can inform policy, but it can’t determine it. The issue of smoking in enclosed public places might look like a scientific one, but it is also deeply political. . .

As we have seen from media coverage of the issue, the question of whether we should allow or forbid smoking in pubs is about much more than what we know of its dangers. At the very least, it’s also about liberty, it’s about responsibility and it’s about economics.

We must acknowledge that, most of the time, science cannot tell us what to do. Science’s voice must be heard, but it must not drown out others. The smoking ban that disappeared and then reappeared is a political mess. But this should only come as a surprise to those people who thought that there was an easy answer.

Learn more about DEMOS here and on their weblog.

Posted on March 25, 2006 02:12 PM View this article | Comments (29) | TrackBack
Posted to Author: Pielke Jr., R. | Health

March 21, 2006

Stem Cells and Vulgar Democracy

Dan Sarewitz has posted the text of a paper that he gave at the AAAS meeting last month titled, “Proposition 71: Vulgar Democracy in Action” (PDF). Here is how it begins:

In 1947, when Congress passed legislation to create the National Science Foundation, President Truman vetoed the bill because it insulated the administration of the proposed agency from direct Presidential control. At issue here was not a simple question of turf or the exercise of power, but a fundamental principle of democratic governance: that publicly funded programs must be ultimately accountable to the public via democratically elected officials. In the decades since Truman’s veto, as the nation’s investment in research has grown from a few tens of millions to about sixty billion dollars, this principle has never seriously been challenged. Indeed, it is precisely this accountability that has allowed the publicly funded research enterprise to maintain its political legitimacy, productivity, and growth through such crises as the Tuskegee experiment and the death of Jesse Gelsinger, and which has stimulated a considerable beneficial evolution of scientific norms in such areas as protocols for human subjects’ research, the treatment of laboratory animals, and the role of gender and ethnic diversity in clinical trials. Democratic accountability, that is, is good for science.

So, in the summer of 2004, when I first read the language of Proposition 71, the “California Stem Cell Research and Cures Act,” I was floored. Written and promoted by a coalition of patients’ advocates and research interests from the academic and private sector, Proposition 71 was of course a response to President Bush’s draconian restrictions on publicly funded embryonic stem cell research. But it was a response that was as extreme in its own way as the President’s actions. Proposition 71 would create a new stem cell research institute, funded by public monies raised through a bond issue, that was effectively insulated from all public accountability through a variety of mechanisms, including the creation of a state constitutional right to conduct stem cell research, a ten-year funding entitlement that “shall not be subject to appropriation or transfer by the Legislature or the Governor for any other purpose,” and a provision that allowed legislative amendment to the initiative only after three years, only by a 70% supermajority of the California legislature, and only “to further the purposes of the grant and loan programs created by the measure.”

Most troubling of all were the proposed mechanisms for accountability, particularly as embodied in the Independent Citizen’s Oversight Committee, whose stipulated membership was made up almost entirely of people whose interests were in some way served by goals of embryonic stem cell research. There was absolutely nothing independent about this committee at all. In summary, as I wrote in an LA Times op-ed in October 2004, “Proposition 71 would put stem cell research out of the reach of Sarewitz democracy—in a move that would seriously undermine the unwritten social contract that exists between government and science in this country.” Conservative political theorist Francis Fukuyama, writing in the Wall Street Journal on the same day, was less restrained, asserting that “Prop 71 is a bad idea, not because stem-cell research is morally wrong, but because it represents a huge, self-dealing giveaway of money from cash-strapped California taxpayers to a small group of institutions and companies that will remain largely unaccountable.” A similar position was taken by the Center for Genetics and Society, a California-based NGO with liberal leanings.

Now of course I recognize that questions of political accountability and the governance of science can hardly stack up to the promise of curing disease. Indeed, at one point prior to the election I found myself in the compromised position of having to debate on a radio program one of the promoters of Proposition 71, a Hollywood director named Jerry Zucker, who, if I recall correctly, had a child with diabetes. No doubt I came off as an ivory tower esthete willing to place abstract principle above the alleviation of a child’s suffering.

As usual, Sarewitz is smart, provocative, and on target. Read the whole thing. (PDF)

Posted on March 21, 2006 07:02 AM View this article | Comments (0) | TrackBack
Posted to Author: Pielke Jr., R. | Biotechnology | Health

March 14, 2006

To Advocate, or Not?

When should a scientist get involved in political advocacy related to policy making in the area of their expertise? And once having decided to get involved, what form of advocacy should the scientist engage in, given that there are numerous options for scientists as advocates?

In my experience, such questions are rarely discussed among scientists. Some assert that politics is necessarily a bad thing to be avoided and refuse to admit any role in advocacy, even among those who are clearly advocates. In discussing such things one prominent scientist went so far as to assert that in his entire life he had never done anything that might be construed as political. Others simply assert that what is in their own personal special interests is obviously in everyone’s interest, and that people who disagree must be science abusers and morally corrupt. Still others gather in tribes with like-minded colleagues, particularly in the blogosphere, creating very real instances of Cass Sunstein's echo chambers. The discussion of advocacy in science often takes place in its own echo chamber of the science studies community.

I came across an article about malaria in Kenya (courtesy of the always excellent SciDev.net), which had the following very interesting passage, which raises questions about roles and responsibilities of scientists in broader society:

Kenya is the third leading nation in research on malaria in the world, according to a survey published last November by Thomson Scientific’s Essential Science Indicators (ESI) — an in-depth analytical tool that offers data for ranking scientists, institutions, countries and journals around the world.

USA is the leading nation followed by England. France, Germany and Switzerland are ranked fourth, fifth and sixth, respectively. Available as a ten-year rolling file, ESI covers ten million articles in 22 specific fields of research and is updated every two months.

But despite the fact that Kenya is a leading producer of research data on malaria, it remains one of the countries with the highest malaria mortality rate in the world. Why the disconnect between research and control?

Prof Bob Snow, the head of Malaria, Public Health and Epidemiology Group, Centre for Geographic Medicine at the Kenya Medical Research Institute (Kemri), blames lack of mechanisms to translate research into policy and implementation. "The problem is not with the scientists that malaria burden in Kenya is still very high and raising. As scientists, we have done our part and done it very well. The major problem is that unlike in Britain and other countries, there is no mechanism to directly translate research findings into national policy or to translate research into action."

Prof Snow, who has been involved in malaria research in the country for the last 18 years and is ranked fifth in the world in malaria research, feels the government does not fully comprehend the role of researchers.

"As scientists in Kenya, we have to do two jobs. We have to conduct research and then convince the government or the Ministry of Health to adopt our research findings. This should never be the case. There should be a mechanism that automatically facilitates adoption of research findings by the government."

What mechanism? How created? Run by whom? What does it mean to “adopt research findings”? Automatically? These are the questions at the core of 21st century science policy. Asking and answering these question are of course political exercises themselves and can create some discomfort among scientists/advocates. Consider the cirle-the-wagon reactions often seen here to suggestions that the IPCC might not be an optimal means of connecting science and decision making. And consider the frustration expressed by scientists such as James Hansen about their role in the political process.

As people focus attention on press releases, NRC committees on hockey sticks, drug approval processes, government science reports, national academy statements, science in developing countries, etc. etc. it will be these questions of process that will be important to keep at the fore.

November 28, 2005

Stem Cells and that "War on Science"

Every so often here we've taken issue with claims of a Republican "war on science." Our view is not a defense of Republican policies, far from it. Our view is that the factors which lead to the misuse of science in politics have less to do with political or ideological affiliation than with the basic dynamics of science in decision making. As a result, improving the use of science in decision making won't occur through mindless partisanship, but by actually paying attention to the dynamics of science in society. The ethical quandaries of he South Korean stem cell research program reported in the New York Times Friday throw another wrench into claim of a Republican "war on scince" and evidence that science abuses routinely span the political spectrum (The American Journal of Bioethics was on top of this and its significance early on, see this post).

Here is an excerpt from the New York Times article,

"The South Korean researcher who won world acclaim as the first scientist to clone a human embryo and extract stem cells from it apologized Thursday for lying over the sources of some human eggs used in his work and stepped down as director of a new research center. After months of denying rumors that swirled around his Seoul laboratory, the researcher, Dr. Hwang Woo Suk, confirmed that in 2002 and 2003, when his work had little public support, two of his junior researchers donated eggs and a hospital director paid about 20 other women for their eggs. On several earlier occasions, he had said that he did not use eggs harvested from subordinates and that no one was paid for egg donations. "Being too focused on scientific development, I may not have seen all the ethical issues related to my research," Dr. Hwang, a veterinarian by training, told a news conference in Seoul on Thursday."

Chris Mooney, passionate partisan and ubiquitous champion of the "war on science" argument (and who we've debated on this issue before), has claimed that President Bush's 2001 exaggeration of the number of stem cell lines available to researchers to be "one of the most flagrant purely scientific deceptions ever perpetrated by a U.S. president on an unsuspecting public."

So if deceiving the public to limit stem cell research is a "war on science" then presumably it is equally improper to deceive the public to advance stem cell research. The alternative is that one adopts an ends-justifies-the-means sort of logic in which the appropriateness of lying is determined to be a function of one's judgments about the value of the desired end. Of course, this sort of logic is exactly what underlies claims of the "war on science" anyway. Of course it also underlies conservatives calls for "sound science."

I didn't like how President Bush justified his stem cell decision in 2001 and I don't approve of Dr. Hwang Woo Suk's ethical lapses. But it should be obvious that these sorts of actions won't be addressed through simply more political partisanship, but through a carefully understanding of the complex factors which shape the use and misuse of science in decision making.

Posted on November 28, 2005 12:12 AM View this article | Comments (22) | TrackBack
Posted to Author: Pielke Jr., R. | Health

October 21, 2005

Another View on Stem Cells

Thanks to Maxine Clarke of Nature who has directed our attention to another perspective on the significance of recent work on stem cells. The article, Irving Weissman, begins,

"Published online this week are two new methods for producing pluripotent stem-cell lines the great future hope of regenerative medicine. Both papers report proof-of-principle tests in mice of techniques that might be used for making human pluripotent stem-cell lines. The protocols each aim to satisfy the religious, ethical and/or political objections of groups that are opposed to some of the methods used in embryonic stem-cell research."

I am no stem cell expert so I wonder, who is right here about the significance of the research reported in Nature, the American Journal on Bioethics or Nature?

Posted on October 21, 2005 10:03 AM View this article | Comments (1) | TrackBack
Posted to Author: Pielke Jr., R. | Health

October 18, 2005

Stem cell solution – not!

At the AJOB blog, David Magnus takes Nature to task for hyping a recent study about obtaining stem cells from mice. In a short entry Magnus writes,

“Shame on Nature for publishing two papers that do not deserve to be in such a prestigious journal. The research that was announced yesterday showing the possibility of supposedly more ethical alternatives to stem cell research is a lot less substance than hype. Neither result is really very surprising (at least in mice). The knockout mouse experiment demonstrates that a gene does pretty much what we thought it does (in mice). And the other experiment shows that cells separated at an early stage of development can do pretty much what we already knew they could do. So why is anyone paying attention to this research? It seems to get its cache not from its scientific merit, but from its political and ethical import. But the ethics behind this are actually far weaker than people realize. Thoughtful opponents of stem cell research are just as likely to oppose this research as they are to oppose somatic cell nuclear transfer. All produce embryos or embryo-like constructs that are extremely unlikely to develop even if we attempted to create a baby. However, for none is it impossible (at least for future technologies if not present ones) that a child might (however improbably) be produced. If ectogenesis became a possibility, the fact that a genetically engineered embryo does not produce placental tissue could in principle be overcome as an obstacle. We do not yet know for certain if a cell broken off from the blastocyst could sometimes become a “twin”. These are actually bad arguments and it is dangerous for science to go down this road—what is the principle? If the goal becomes pursuing science that is unopposed by a minority, then no embryonic stem cell research should be conducted. If we reject that principle (which we should) then this research really doesn’t do much for the research. - David Magnus”

Posted on October 18, 2005 10:18 AM View this article | Comments (3) | TrackBack
Posted to Author: Pielke Jr., R. | Health

September 08, 2005

New Chairman Bioethics Council

The editors of the American Journal of Bioethics report that Leon Kass, current chair of the President’s Bioethics Council, will be replaced by Edmund Pellegrino. They offer a very positive reaction to the news, and a clear slap at Kass:

“It is possible to gush about the White House's decision - a rare opportunity these days - in part because Pellegrino is a good, honest and kind person, but also because Pellegrino is not afraid to engage his academic peers and will not operate like a cheerleader for the administration, nor will he treat the Council like an oversized ethics seminar for neoconservatives. So, for example, I do not expect to hear that the American Enterprise Institute is going to be selling the products of the deliberations by the Council in the future. The sun will never rise on a day where Edmund Pellegrino lobbies Congress as a "private Citizen" for a "second term bioethics agenda," or writes Op Eds defending Presidential stem cell policy while sitting as Chair during a Presidential election year.”

We discussed Leon Kass several times over the past year (here and here). It will be interesting to see what role the Council will play in advising the President under Pellegrino.

Posted on September 8, 2005 07:53 AM View this article | Comments (2) | TrackBack
Posted to Author: Pielke Jr., R. | Health

August 26, 2005

Science and Political Affiliations

The Chicago Tribune has a very interesting article today (Thanks JA!) on the recent study of fetal pain and the political leanings of its authors. Here is an excerpt:

"A research article about when fetuses feel pain is sparking a heated debate over the nexus between science and politics and what information authors should disclose to scientific journals. The report, published Wednesday in the Journal of the American Medical Association, analyzed previously published research and concluded that fetuses probably don't feel pain until 29 weeks after conception because of their developing brain structures. Undisclosed was the fact that one of the five authors runs an abortion clinic at San Francisco's public hospital and another worked temporarily more than five years ago for an abortion-rights advocacy group. Several ethicists said they consider those points regrettable omissions that left readers without important information. Other experts consider the authors' background irrelevant."

Does it matter what the authors professional or political affiliations happen to be?

The story presents two perspectives. First, no it doesn't matter.

""The standard for disclosure in medical and scientific journals is not your politics. There's no obligation to tell people what your mind-set is ... as long as the data is sound and gathered objectively," said Dr. Alan Leff, a University of Chicago pulmonologist and editor of the Proceedings of the American Thoracic Society . Dr. Philip Darney, chief of obstetrics, gynecology and reproductive sciences at San Francisco General Hospital, defended that decision, saying in a statement: "The research team does not believe that being an abortion provider is a conflict of interest." Medical journals require authors to disclose financial ties to industry or other funding sources. But there are no standards for disclosing other factors that might influence an author, such as clinical practices or organizational affiliations. Dr. Catherine DeAngelis, the journal's editor-in-chief, said she wasn't concerned by Drey's failure to indicate she performed abortions. "That's part of [an obstetrician's] scope of practice. They don't have to reveal that." ...

"As a scientist, if you think I'm wrong, you probe my data, question my findings and do a critical study--not point your finger and talk about my politics," Caplan said. Rigorous methodology is supposed to minimize the potential for bias in scientific research, he said, "whether studies are done by communists in China or free-marketers in Chicago, whether they're done by left-wingers in Berkeley or right-wingers at the Wharton School here in Pennsylvania.""

Second, it does matter:

"Anti-abortion groups say the authors' affiliations are crucially important. "These are people with years of professional and ideological investment in the pro-abortion cause, not some neutral team of medical professionals," said Douglas Johnson, legislative director of the National Right to Life Committee. "We think readers and viewers have a right to know who's filtering the information they're being presented with." ...

... but certain medical issues are so explosive politically--abortion certainly, and perhaps stem cell research and animal rights--that researchers have a special obligation to inform readers of relevant affiliations. The San Francisco researchers "must have known there would be criticism from the right-to-life people," said Dr. Arnold Relman, former editor of the New England Journal of Medicine. "In a situation as contentious as this, it seems more disclosure should be the rule rather than less." Dr. Marcia Angell, a senior lecturer in social medicine at Harvard Medical School, is also a former editor of the New England Journal. "Suppose it were the other way," she said. "Suppose there were an article that said that [fetuses] do feel pain and it was written by people who were involved in the right-to-life movement. Would I want to know that? I think I would." With an issue as divisive as abortion, disclosing potentially important associations can only help a journal edit! or, said Sheldon Krimsky, author of "Science in the Private Interest." "It kind of ratchets up everyone's attention to the science and makes them that much more vigilant in detecting potential bias," he said."

Should political affiliations relevant to a paper_s content be disclosed by authored of peer-reviewed articles?

Is there a justification for limiting conflict-of-interest only to financial considerations?

Tough questions.

Posted on August 26, 2005 09:50 AM View this article | Comments (2) | TrackBack
Posted to Author: Pielke Jr., R. | Health

August 09, 2005

Drawing a line in the batter's box?

Science policy in sports. It sounds like a pretty good combination until you actually get into the details, and then it gets scary. Arthur Caplan, chairman of the Department of Medical Ethics at the University of Pennsylvania School of Medicine, had a great op-ed in Newsday yesterday on technology and the elite athlete. Here is an excerpt:

"So what are we going to say when the archer, the chess master, the competitive marksman, the Nascar driver or the women's professional golfer says, "If I take these same drugs I just might get enough of an edge to move ahead of my competition"? Throughout the 1990s when home runs were flying out of baseball stadiums, launched by players who obviously were using steroids, when professional football linemen got huge, when track and field records continued to fall, not much in the way of protest was heard. Americans are in love with those who take risks to break a record, or one another's bones, in the name of sport. Nor do Americans gripe when we show up at the Olympics with our athletes who have the best training, superb diets, and top-flight equipment and whomp the tar out of athletes from poor nations, some of whom seem to have shown up just to get a decent meal. We are used to employing science to our advantage when it comes to sports, so why should we draw the line at genetic engineering or new miracle pills? There is nothing about the reaction to Rafael Palmeiro's downfall that indicates we are ready to deal with the fundamental ethical question raised by his use of steroids - how can we draw the line when it comes to enhancement? Is the point of sport to see what human beings can do without aid of any sort in fair competition? If so, we may need to close the training facilities and cut back on what dietitians and trainers are allowed to do. But if the point of sports is to test the limits of human performance, then we had better get ready to add genetic engineers and a bevy of pharmacologists to the hordes of specialists now working with elite athletes from elementary school to the pros. There is no right answer to what the point of sport is. But Rafael Palmeiro has made it a question no one who cares about sports can avoid."

A New York Times article on records in sports may be and indication where we are headed:

"On Thursday night, members of the Society for American Baseball Research records committee, which has no relationship with Major League Baseball, reconciled their feelings and agreed that little could or should be done to denote any player's use of illegal steroids. Members cited how many artificial factors - like smaller ballparks, harder bats, smaller strike zones, legitimate weight-training and, yes, fielders wearing gloves - have affected statistics since the days of Alexander Cartwright. Determining how a player may have benefited from steroids, they said, would be a foolish exercise, particularly with no effort to revise the totals of players like Cash, Ford and Roe."

Caplan is right, this is an issue that has to be dealt with somehow, but where in sports, if anywhere, do we draw a line between allowed human improvements and those that are disallowed? And who gets to decide?

Posted on August 9, 2005 07:42 AM View this article | Comments (4) | TrackBack
Posted to Author: Pielke Jr., R. | Health

August 03, 2005

Stem Cell Politics and Perspectives on Science

Media Matters (MM) has an interesting analysis of Senate Majority Leader Bill Frist's (R-TN) flip-flopping views on federal funding for stem cell research. Here is an excerpt:

"In recent days, the media have left unchallenged Senate Majority Leader Bill Frist's (R-TN) July 29 announcement of support for expanding federal funding for embryonic stem cell research beyond the restrictions currently imposed by the Bush administration, even though the justifications Frist provided for shifting his position have been publicly known for years."

One letter to the New York Times on Senator Frist's change in support comes from a supporter of federal funding for stem cell research and expresses hope that it is scientific knowledge that has changed the Senator's political calculus: " let's give Senator Bill Frist the benefit of the doubt; maybe he's been persuaded by the evidence and his heart to change his political stance, not by the need to widen his political base." MM quashes this possibility when they observe,

"The principal reason he gave for the change was that it had become increasingly apparent that there is a smaller number of stem cell lines available for federally funded research than first thought. He emphasized that Bush's policy should be "modified" because "unexpectedly, after several generations" the cell lines have become "less stable and less replicative," and the existing federally funded cell lines are "also grown on mouse feeder cells, which we have learned since will likely limit their future potential for clinical therapy in humans." ... Major news outlets have largely failed to challenge Frist's purported reasons for now supporting the bill. For example, while Frist noted that "Today, only 22 lines are eligible," this number has been publicly known since at least August 24, 2004, when it was reported by The New York Times. Similarly, Frist described the findings regarding problems with the existing stem cell lines as "unexpected" and said those findings differed from what was "initially thought." In fact, stem cell experts have voiced those concerns for years."

Another letter to the New York Times, this time from an opponent of federal funding for stem cell research, provides a different characterization of Senator Frist's actions, "Senator Frist offers us not the logic of reason and principle but of politics - of Machiavelli."

The two letters are suggestive of a general rule of contemporary political debates involving science - when you agree with someone's political stance, then their actions must be motivated by logic and rationality, and when you disagree with their stance, their motivations must mativated by political expediency. In other words, "junk science" underlies the perspectives of your political opponents, while "sound science" underlies the views of your allies. This rule seems to be pretty consistent across the political spectrum.

For my part, it does not seem particularly problematic that Senator Frist's various perspectives on stem cell research - all three or more of them -- are all but certainly located in judgments of political expediency rather than a "data-induced transformation" of perspective. It reinforces the claims frequently made here (and drawing on the work of Dan Sarewitz) that more often than not it is one's political perspectives that shape one's views on science, rather than the other way round. I do agree with MM that the media should be doing a better job examining the justifications Senator Frist gave for his changing views - if they did so, then hiding behind science would be much more difficult. An unhealthy politicization of science is risked when people believe (or act as if) views on science have the power to compel changes in political perspectives. In this manner debates over values become expressed through science, and we risk science becoming politics.

Posted on August 3, 2005 07:06 AM View this article | Comments (2) | TrackBack
Posted to Author: Pielke Jr., R. | Health

June 20, 2005

Beware of Snake Oil Salesmen

I recently received a letter from the Stem Cell Research Foundation which asked me to make a donation in order to support grants that, according to their website, support “innovative basic and clinical research”. I have several problems with the SCRF’s solicitation efforts, and in fact, find the letter to be rather … distasteful.

First, the SCRF plays fast and loose with the purpose of basic research, which is essentially curiosity-driven and free from consideration of use, with solutions, cures and remedies. While they get the notion of basic research right: “We can’t know what lies ahead and we must be realistic!” they unfortunately slip into sales-pitch-mode with allusions of future cures for stroke, heart disease “and for a huge array of other diseases and conditions”. Furthermore, they say, “…the only problem with stem cell therapy is that it isn’t progressing fast enough!” Aha! So if I donate money to support innovative basic research then stem cell therapies will be developed sooner. The problem is that there is no guaranteed connection between the basic research the foundation supports, and any future pay-off. And according to my layperson’s eye, most of the current research seems to be basic in nature. (I’m open to correction if I’ve read it wrong). But as the science community knows all too well, at least as far as Federal funding is concerned (see this posting), in order to compete for limited resources and get funded, promises of future pay-offs and benefits have to be made. Has the SCRF learned to play the game, and if so, is this even a game that is appropriate to play?

Second, the letter has a rather distasteful overtone that reminds one of snake-oil salesmanship. Note the following sentences which are obviously geared toward vulnerable populations: “Imagine the hope this research would bring to the cancer patient who wants to see a favorite grandchild graduate – the stroke sufferer who would give anything to hold someone’s hand – the burn victim desperately in need of new skin cells”, and even worse: “If you know someone suffering from a disease who feels life is leaking away along with all hope of aid, I urge you to pass on this exciting news to bolster their flagging spirits”. Step right up, Grandma. I know you’re on a fixed income and time is running out, but could you spare $50 to support some basic research?

Sure, a lot of 501(c)3 organizations use similar rhetoric in their appeals for donations, but there is a big difference between what the SCRF seems to be asking for (support for mostly basic research and – fingers crossed – cures to nasty diseases in the future) and other organizations that have deliverables. For example, while donations to the American Heart Association support research, it also supports public education (diet, exercise, etc.), training (e.g. CPR), and support for treatment. The SCRF could improve its image (at least in my mind) if it were to be more honest and forthright about its mission and the intrinsic value of basic research and not make any allusions to future pay-offs they can’t guarantee.

So what? The folks over at the American Journal of Bioethics recently discussed the problem on their blog of what they call the “get it now or else” call from supporters of stem cell research. The editors highlight a recent opinion piece written by UC Irvine professor, Peter Bryant, who makes a claim that unless the administration lifts its restrictions of funding for federal stem cell research, “those treatments [e.g. limb regeneration and repair of spinal cord injuries] may never be available to the maimed veterans in VA hospitals”. The AJB writers point to the downside of the “get it now ore else thing” which “just makes it easier for the opponents of stem cell research to paint stem cell researches as over-eager salesmen of therapeutic misconception.”

At what point does society draw the line in this sort of marketing? Should it? The FDA has the Division of Drug Marketing, Advertising and Communications that regulates advertising and claims made by drug manufacturers. Is there a role for such an organization in the world of stem-cell research? Not likely, but stem cell supporters and researchers may hurt their interests in the long term if the public begins to view them in the short term as just another special interest group that makes over zealous claims of cures and therapies.

Posted on June 20, 2005 09:01 AM View this article | Comments (0) | TrackBack
Posted to Author: McNie, E. | Health

June 06, 2005

When the Cherries Don't Cooperate

Two recent cases, one on stem cells and one on global warming, suggest reasons for caution when cherry picking science to support a political agenda. Quite apart from the misuse of science, from the standpoint of political expediency, cherry picking can backfire.

Wired News had a story on Friday that illustrates some of the dynamics of politicizing science: whether a misuse actually occurs or not, cherry picking can be bad politics. Wired reports, “A spinal-cord patient has charged that Rep. Dave Weldon (R-Florida) used her image without permission and misled Congress and the public by suggesting that her case offers evidence that adult stem cells can help severely injured people walk again. Susan Fajt, who suffered a spinal-cord injury in a car accident in November 2001 that left her with little sensation from her chest down, e-mailed Weldon, who is also a physician, on Wednesday detailing her complaints and requesting an apology.” For its part, Rep. Weldon’s office says that its use of Ms. Fajt’s testimony and image are consistent with Senate testimony she gave recently. Fajt obviously disagrees. Weldon is the big loser politically in this instance, even if, as his spokes person notes, "Rep. Weldon's one-sentence statement regarding Ms. Fajt's treatment was completely consistent with Ms. Fajt's July 14, 2004, testimony before the U.S. Senate." Cherry pick with caution because sometimes the cherries talk back.

In another instance of cherry picking backfiring, two activists seeking to highlight the perils of global warming via a trip to the North Pole abandoned their trip because of "deep snow and drifting pack ice" (as well as polar bears). In this case the activist appeared to be seeking to exploit benign weather as an example of the effects of global warming. The fact that weather conditions are extreme in the arctic is of course not proof that global warming is a hoax, but nor would a successful trip to the North Pole prove the opposite. Some advocates opposed to action on global warming have already sought to use the failed expedition to further their own political agenda. For the explorers, their failed stunt provides some symbolic ammunition for their political opponents, even as both sides are playing fast and loose with the science.

Cherry picking is a tried and true approach to politicizing science, because, in many instances advancing a political agenda does not dependent upon getting the science “right.” But be careful, sometimes people and nature fail to cooperate.

March 11, 2005

Malaria and Science Policy

According to a report in SciDev.net a new study in Nature suggests that.

“The threat to human health posed by the deadliest form of malaria has been significantly underestimated, especially for regions outside Africa, according to research published today (10 March) in Nature. The study suggests that the Plasmodium falciparum parasite caused 515 million cases of malaria in 2002 – nearly double the World Health Organization (WHO) estimate — and threatens some 2.2 billion people worldwide.”

The Nature paper has started a bit of a “row” over WHO estimates according to The New Scientist which reports,

“Has the World Health Organization underestimated the world's malaria problem? By as much as 50%, according to researchers in Kenya. Not true, the WHO itself insists. At stake is the credibility of the WHO's anti-malaria programmes. In this week's Nature (vol 434, p 214), Bob Snow and colleagues from the Kenya Medical Research Institute in Nairobi calculate that there were 515 million new cases of malaria worldwide in 2002. This is almost double what they quote as the WHO's official figure of 273 million cases. Snow claims that international efforts to control malaria are being damaged because the WHO is underestimating the problem. The WHO disputes this analysis. The figure of 273 million comes from its 1999 World Health Report. The following year it revised its official estimate to between 300 and 500 million cases - roughly the same range as Snow's 300 to 660 million - and that is the figure the WHO says it has been working with ever since.”

The Nature study raises some very basic questions about resource prioritization in areas of research and implementation. Snow et al. write in Nature,

“Interest in mapping the global distribution of malaria is motivated by a need to define populations at risk for appropriate resource allocation and to provide a robust framework for evaluating its global economic impact … Inadequate descriptions of the global distribution of disease risk make it impossible to determine priorities and advise funding agencies appropriately. Redressing these deficiencies with robust data must be a priority if international agencies are to understand the size of the challenge set by their targets over the next ten years.”

How can we make effective decisions about research priorities if we have inaccurate knowledge of important dimensions of the problem that the results of research are supposed to be addressing? This is a fundamental obstacle to effective science policy decision making, but one that can be addressed, as Snow et al. argue, through research itself.

Posted on March 11, 2005 08:14 AM View this article | Comments (0) | TrackBack
Posted to Author: Pielke Jr., R. | Health

February 28, 2005

Money, Conflicts of Interest and Openness

On February 20, 2005 Gardiner Harris wrote in the New York Times about the Food and Drug Administration (FDA) deliberations that led to recent coverage about an advisory committee's decision to support use of three drugs, Vioxx, Bextra and Celebrex. Gardiner's article suggests that the FDA is moving toward a new culture of openness.

"Instead of certainty, the agency embraced doubt. Instead of presenting a united front, agency officials bickered openly. Instead of keeping secret its dealings with drug companies, the agency gave a public accounting of lengthy and contentious negotiations with the drug maker Merck... These changes were not voluntary. The FDA has been forced by a series of embarrassing scandals over the past year to transform its "Daddy knows best" culture... [Dr. Lester M. Crawford, head of the FDA said] "Our culture, which has received some criticism in recent months is not to alarm the public when we get a signal. That era is sort of past. What the public, we think, is demanding to know as soon as we know what's going on. And they are fully prepared and adult enough to interpret whether or not this is a final decision." To be sure, the changes so far have been relatively small. But the tentative steps made at this week's meeting seemed to go well, and agency officials have promised more."

Well, be careful what you wish for. Only 5 days later the New York Times reported,

"Ten of the 32 government drug advisers who last week endorsed continued marketing of the huge-selling pain pills Celebrex, Bextra and Vioxx have consulted in recent years for the drugs' makers, according to disclosures in medical journals and other public records. If the 10 advisers had not cast their votes, the committee would have voted 12 to 8 that Bextra should be withdrawn and 14 to 8 that Vioxx should not return to the market. The 10 advisers with company ties voted 9 to 1 to keep Bextra on the market and 9 to 1 for Vioxx's return."

[Note: The information was gathered by the Center for Science in the Public Interest (CSPI) and can be found here.]

The findings of the CSPI are incredible. They show a profound difference in voting between those on the FDA advisory committee with financial ties to the companies producing the Cox-2 drugs and those on the advisory committees without such ties. The apparent solution to this situation - to simply bar those with such conflicts from participating in advisory committees - may not be the best course of action in all such situations. Conflicts of interest, financial or otherwise, are a difficult policy problem in the federal scientific advisory structure.

What is a "conflict of interest" anyway?

In 1993, Harvard's Dennis Thompson provided a useful definition of conflict of interest in The New England Journal of Medicine:

"A conflict of interest is a set of conditions in which professional judgment concerning a primary interest (such as a patient's welfare or the validity of research) tends to be unduly influenced by a secondary influence (such as financial gain)... The secondary interest is usually not illegitimate in itself, and indeed it may even be a necessary and desirable part of professional practice. Only its relative weight in professional decisions is problematic. The aim is not to eliminate or necessarily to reduce financial gain or other secondary interests (such as preference for family and friends or the desire for prestige and power). It is rather to prevent these secondary factors from dominating or appearing to dominate the relevant primary interest in the making of professional decisions."

Reference: Thompson D. F., 1993. Understanding Financial Conflicts of Interest. The New England Journal of Medicine, 329:573-576.

It is safe, I think, to say that financial gain (personal or professional) is among those "secondary influences" that has great potential to influence the advice proffered by experts. But the Federal Advisory Committee Act (FACA), which is the legislation that describes the terms for advisory committees to provide advice to government, provides little guidance on what to do about such secondary interests. Here is how one government official described in congressional testimony the provisions of FACA with respect to conflicts of interest:

"The Act does not include provisions covering individual committee member conflicts of interest. The applicability of conflict of interest laws and various ethical requirements for members of advisory committees who serve as Special Government Employees (SGEs), are covered by other laws and regulations issued by the U.S. Office of Government Ethics. The Act, however, does include two important provisions designed to promote the objectivity of advisory committee deliberations. First, sections 5(b)(2) and (c) require that "the membership of the advisory committee be fairly balanced in terms of the points of view represented and the functions to be performed by the committee." Second, sections 5(b)(3) and (c) require "provisions to assure that the advice and recommendations will not be inappropriately influenced by the appointing authority or by any special interest, but will instead be the result of the advisory committee's independent judgment." Thus, while the Act stresses the importance of assuring an advisory committee's independent judgment, it also requires that the composition of advisory committees reflect the expertise and interests that are necessary to accomplish the committee's mission. The Act does not define those factors that should be considered in achieving "balance.""

[Note: based on this testimony, it would seem that the CSPI is simply wrong when it asserted that the composition of the FDA advisory panel violated the FACA. For background see this overview by Deborah Stein.]

The existence of possible financial conflicts of interest raises some difficult questions, such as:

At what level does a secondary influence become problematic? For a doctor making $250,000 per year, is $5,000 significant? $1,000?

Is a speaking fee (for a lecture) to be treated the same as consulting fees (for work done)?

How should industry-sponsored research funding be handled? It may be the case that the people with the most expertise on the effects of particular drugs are those who have overseen studies sponsored by the industries seeking approval of the drugs.

How should government-sponsored research be handled? Is government research properly considered a secondary interest?

And how far should we go with considerations of finances? Oklahoma Republican Senator James M. Inhofe has raised a few eyebrows by asking a group that has testified before congress on air quality issues to release its financial statements for the past few years. The approach taken by Senator Inhofe does seem pretty heavy handed, but substantively is it any more improper to want to see financial support for an NGO offering government advice than to want to see the same for an FDA advisory committee member?

And what about non-financial secondary interests, such as political, religious and other factors. Are these important? Presumably they are. (E.g., religion would seem to matter on advice on teaching of evolution and there have been many instances in recent years of complaints about the political views of members of federal advisory committees.)

Questions such as these (and there are more) suggest that once one moves beyond the instinctive reflex of suggesting that conflicts of interest should be settled on a case-by-case basis in line with one's own values, it becomes more difficult to identify general policies and procedures to deal with values, interests and the -- for lack of a better term - the quintessential humanness of participants in the political process proffering policy advice. This is a subject worth the attention of the science policy community.

But one point does seem exceedingly clear. Early disclosure of interests and values would seem to be a good thing. And in this regard the FDA is moving in the right direction, but the events of the past week show that it still has a way to go.

Posted on February 28, 2005 09:11 AM View this article | Comments (0) | TrackBack
Posted to Author: Pielke Jr., R. | Health

January 12, 2005

NRC Perchlorate Report and NRDC Reaction

This week the National Research Council released a report on the "Health Implications of Perchlorate Ingestion."  The study is significant because, as the New York Times reported yesterday, "Depending on how federal and state regulators interpret the academy's recommendation, the Defense Department, its contractors and other federal agencies responsible for contamination from perchlorate, a component of solid rocket fuel, could avoid cleanup costs of hundreds of millions of dollars."  The political stakes are very high.

The National Resources Defense Council (NRDC) responded to the report by claiming that, "the NAS panel's recommendation was likely shaped by a covert campaign by the White House, Pentagon and defense contractors to twist the science and strong-arm the academy."  In other words, the NRC report reflects the results of political pressure and maneuvering by Bush Administration officials.

My first reaction to this is, of course it does.  Given the political stakes we should only be surprised if the NRC was not pressured by people in the executive branch. It is important to remember that the federal agencies request, pay for, and shape the charge for NRC studies.  All heads of federal agencies are political appointees and some of these heads (e.g., DOD) are among the most influential in the Bush Administration.  I have participated in and reviewed a number of NRC studies and, while none had the political stakes that the perchlorate study has, in every one agency officials paying for the study had a clear sense of what they'd like to see in the final the report and we not shy in their efforts to influence the panel.

But just because politics is ever present in the NRC process does not mean that we turn a blind eye.  Clearly, if policy makers or the public begin to view NRC reports as just another battleground for partisan politics, much of what science has to offer policy making will be lost (for more read this essay).

The NRDC has done an admirable job of uncovering a paper trail showing how much effort Bush administration officials went to shape the panel's composition and its charge.  The NRDC efforts should be viewed as a model of oversight of the NRC.  And oversight of the NRC is extremely rare, though much needed because what the NRDC has uncovered may be less unique than commonly assumed.

Specifically, the NRDC has found:

1)        " ... senior White House officials reviewed and apparently edited a highly technical document charging NAS with evaluating detailed scientific questions."  This is significant because the charge given to a committee dictates its scope and how questions are framed.  Often the framing of questions bounds the range of policy recommendations that result.  It is for this reason that I wrote earlier this week, "More important than the composition of scientific advisory panels is the charge that they are given ...".  What is missing in the NRC is an open and transparent process for developing a charge to its committees.  If the executive branch officials, both in agencies and the White House, who are paying for the study are responsible for developing with NRC staff the committee's charge, then we should fully expect that the charge will be slanted toward the political views of those funding the study.  One option would be for the NRC to require politically charged issues to be funded by a diversity of parties.  For example, NRDC could have been invited to be a co-sponsor of the study and thus be allowed to participate in the development of the charge.  This may not always be a simple solution, as the government has deep pockets and advocacy groups often do not.  But in this case this would have allowed for political compromises to be reached between NRDC and the Bush Administration well before bringing in the experts to answer technical questions.

2)        " ... the White House, Pentagon and DOD contractors sought to manipulate the panel's membership to place "friendly" scientists on it." Just like in the development of the charge, the composition of the panel can easily be (and very often is) "stacked" in one direction or another (here is an example). Just as in the discussion of the charge above, such stacking would be less likely if those responsible for funding the study reflected a diverse set of interests.  It is hopeless to think that there are unbiased or objective scientists who are untainted by politics out there who could have been placed on this panel.  But dealing with the issue of the panel's composition before submitting the technical questions would have gone a long way toward increasing the legitimacy of the report's conclusions. When I wrote earlier this week of "... developing transparent, accountable and effective processes to manage politics in science," an example of such a process is to ensure that a diversity of political perspectives are represented in those who pay for and help to put together such panels.  By relying only on the Bush Administration for funding for this study, it opened the door to an undue influence from one political perspective over others.

All of this suggests that the NRC needs to take a long hard look at its efforts to connect scientific advice with the needs of policy makers.  The NRC faces a bit of a conflict as well because its studies are paid for by the folks to whom it is providing advice.  It can to some degree deal with this by requiring a diversity of funding sources for particular studies and allowing these diverse participants to collectively reach agreement on a committee's charge and composition.  The alternative is that we see the political battles fought either inside of the NRC committee or in the public after it is released, which in both cases will diminish the positive role of science in contributing to policy.

Posted on January 12, 2005 11:45 AM View this article | Comments (0) | TrackBack
Posted to Author: Pielke Jr., R. | Health

November 23, 2004

Wanted: Honest Brokers

The Journal of the American Medical Association has published an important set of articles on the drug approval and post-approval surveillance process. In their overview article Fontanarosa et al. characterize the general problem as follows:

“Physicians and patients expect that when medications are prescribed correctly for labeled indications and are used as directed, these medications generally will have beneficial effects and will not cause significant harm. This confidence in pharmaceutical products reflects trust in the effectiveness and integrity of the drug approval and monitoring process… However, the current approval process for drugs and biological agents in the United States has come under intense scrutiny, most notably because of concerns about influence from industry… In addition, an investigation of 18 FDA expert advisory panels revealed that more than half of the members of these panels had direct financial interests in the drug or topic they were evaluating and for which they were making recommendations.

The drug review process has been described as structurally similar to many decisions made by other regulatory agencies, such that it is characterized by high uncertainty, avoidance of observable error, and low (reputational) reversibility, with drug recalls harming the reputation of the FDA for a faulty approval decision, and often severely affecting the manufacturer. Given that new products are the financial lifeblood of pharmaceutical companies, the stakes are raised higher due to intense lobbying by interested parties such as health professionals and patient advocacy groups, as well as pharmaceutical and technology companies, so it is no wonder that, in 2003, the pharmaceutical industry earmarked $4.9 million to lobby the FDA… While these concerns are noteworthy, they pale in comparison to the shortcomings and failures of the current imperfect system for postmarketing surveillance… Yet the major problem with the current system for ensuring the safety of medications is that drug manufacturers are largely responsible for collecting, evaluating, and reporting data from postmarketing studies of their own products. This approach has many inherent problems. For instance, it appears that fewer than half of the postmarketing studies that manufacturers have made commitments to undertake as a condition of approval have been completed and many have not even been initiated. Moreover, despite the mandatory adverse event reporting system for companies subject to the FDA’s postmarketing safety reporting regulations, drug manufacturers may be tempted to conceal available data that may signal the possibility of major risks. In some cases, the FDA and drug manufacturers may fail to act on that information and fail to conduct appropriate studies to examine a potential risk rigorously and promptly.”

The article concludes:

“The postmarketing surveillance system requires a long overdue major restructuring. Until that occurs—as indicated by the articles in this issue of JAMA, as epitomized by recent evidence of serious harms from widely used and heavily promoted medications, as demonstrated by the influence of industry over postmarketing data, and as illustrated by the lengths to which some manufacturers will go to protect their interests—the United States will still be far short of having an effective, vigilant, and trustworthy system of postmarketing surveillance to protect the public.”

Fontanarosa et al. are exactly right to recognize that the issues faced in postmarketing surveillance of drugs are part of a larger class of issues at the interface of politics, parochial interests, uncertainty, and science. They note that the FDA has asked the Institutes of Medicine to organize a study to “study the effectiveness of the United States drug safety system with emphasis on the post-market phase, and assess what additional steps could be taken to learn more about the side effects of drugs as they are actually used. The committee will examine FDA's role within the health care delivery system and recommend measures to enhance the confidence of Americans in the safety and effectiveness of their drugs.”

Given the attention being paid to advisory panel composition, it will be very interesting to see how the IOM comprises this panel.

This case highlights the need for honest brokers in important political issues with a scientific element. As Dr. Alastair Wood of Vanderbilt University, commented on the issue in today’s New York Times,

"When we have a drug problem it's analogous to a plane crashing off the coast of New York City, and being investigated by the air traffic controllers who controlled the flight and the airline flying the plane. They're not bad people, but it's not the way we do things in this country."

Posted on November 23, 2004 11:43 AM View this article | Comments (0) | TrackBack
Posted to Author: Pielke Jr., R. | Health

October 26, 2004

Sarewitz on California Proposition 71

In yesterday’s Los Angeles Time, ASU’s Dan Sarewitz makes the case that issues of science policy ought to trump other considerations in the debate over Proposition 71, a citizen ballot initiative that, among other things, proposes to create a $3 billion fund for stem cell research. Sarewitz observes:

“Proposition 71 would put stem cell research out of the reach of democracy — in a move that would seriously undermine the unwritten social contract that exists between government and science in this country… underpinning this contract is an understanding that scientists are accountable not just to themselves but to society, to democratic processes and, ultimately, to the public will. This core of public accountability has been good for science and for society in three important ways. First, it maintains public trust in science through transparency of the legislative process… Second, it ensures that science responds to changing public interests and values… Third, and perhaps most important, democratic accountability protects the public and the public interest from potential abuses… The last 50 years of rapidly advancing American science shows us that democracy and science can fruitfully coexist, even if the relationship is sometimes contentious. If Californians want to fund stem cell research, they could do so through legislation that preserves the balance between scientific autonomy and democratic values by providing for annual appropriation of funds and accountability to elected officials rather than vested interests. Democracy is hard, but it deserves our protection more than anything else. Even more than science.”

Sarewitz’s argument raises broader questions about the role of citizen initiatives in the context of highly complex issues with profound and long-lasting impacts. On the positive side citizen initiatives allow for individuals to participate directly in the selection of specific policies. But on the negative side the initiative process is essentially a binary process – take or leave the initiative that is presented. There is no give and take compromising that is characteristic of legislating. The ballot initiative process is a funny one, because if you put any option up for a vote, people will invariably take sides. But Sarewitz reminds us that it is important to recognize that sometimes we should take a perspective that allows us to see beyond the "yes or no" and look for a third way.

Posted on October 26, 2004 12:16 PM View this article | Comments (0) | TrackBack
Posted to Author: Pielke Jr., R. | Health

September 27, 2004

Non-Results in Clinical Trials and Beyond

Last week’s Economist reports on a major change in the oversight of clinical trials. To date, not all clinical trials have been reported, which means that inconclusive results can be hidden and successful trials highlighted. Why does this matter? Consider what happens when studies are evaluated using the typical 95% threshold of statistical significance, this means that 1 in 20 results, on average, will be spurious just by chance. So when testing the effects of a new drug, with enough clinical trials, there will inevitably be a statistically significant positive result at some point, even if the drug is ineffective. Hence the importance of knowing the results of all clinical trials related to a particular drug.

The Economist notes:
“Legislation is in the works in both houses of America's Congress to reform the reporting of trials. In particular, Chris Dodd, Tim Johnson and Edward Kennedy, three Democratic senators, are expected to propose, within the next week or two, a law that would increase compliance with existing requirements to post trial data to clinicaltrials.gov. It would probably adopt a proposal made by the AMA that registration in a central database be a requirement for the approval of human trials, as well as introducing new requirements to include trial results in the database.”

(For another view see the PhRMA www site here.)

There is no shortage of criticisms of methods used to assess the significance of a finding, whether the effects of a drug or any other cause-effect relationship.

What there is a shortage of (apparently) is the reporting of “non-findings” in pretty much any area of science in which statistical (or other types of) significance testing is reported as a result of research. Whether the issue happens to be the creation of a model of an open system (which can easily be “tuned” to fit data) or the establishment of correlative relationships among variables (which can be mixed and matched, and a hypothesis developed after a match is made), non-findings would seem to be pretty important to understanding the reported results of many areas of science related to decision making, especially those studies that are not easily replicated (i.e., in contrast to those that occur in the controlled setting of a lab). I’ve seen this issue discussed and recognized in disciplines as varied as political science and meteorology, but I've seen little action in reponse.

I often wonder about this when I see colourful Powerpoint presentations in which the speaker shows an image of results related to, e.g., a weather forecast, a climate model scenario, crop production, an ecosystem’s evolution, economic or political outcomes etc. etc. that presents some very close comparison with some verifying data. I am sure that the speaker surely has not chosen the image at random, but to put the best possible face on their research results. But I wonder, what does the entire family of possible images look like? This question is rarely asked or answered.

Because of these dynamics, just as in the case of clinical drug trials, in areas of interdisciplinary science dealing with open or non-stationary systems, much of what we think is significant is likely less significant than we think. At least today I’m 95% certain of this, but ask me 20 times to be sure!

Posted on September 27, 2004 09:12 AM View this article | Comments (0) | TrackBack
Posted to Author: Pielke Jr., R. | Health

September 10, 2004

Public Access to Genome Data and the NAS as Policy Advocate

Yesterday the National Academies of Sciences issued a report that recommended, “Current policies that allow scientists and the public unrestricted access to genome data on microbial pathogens should not be changed … [and] concludes that security against bioterrorism is better served by policies that facilitate, not limit, the free flow of this information.”

Some additional scrutiny is called for when the NAS recommends a single a policy recommendation that happens to be focused on satisfying the interests of those making the recommendation. Specifically, the committee making the recommendation is comprised primarily of life scientists who benefit from and are committed to open access to scientific information. As Stanley Falkow, chair of the committee that wrote the report, and professor of microbiology and immunology, Stanford University, stated in the NAS press release, “The current vitality of the life sciences depends on a free flow of data and ideas …”. Thus, there is a built-in bias among the committee to recommend that data be kept open and available. The committee based its recommendation (what it calls “the best policy choice” on p. 8) on criteria that it determined were best for advancing science.

We should be uncomfortable when NRC committees take on an advocacy position related to science. Specifically, the NAS should not be in the business of pushing for a single policy option, particularly one that best serves the needs of its own community. Instead the NRC should carefully evaluate the pluses and minuses of a range of plausible policy alternatives, and then allow government officials to decide which course of action is in the public’s interest. NRC Committees should allow for sufficient disciplinary and other diversity to allow for such policy evaluations. The NRC has access to expertise on every area of science. But it also has access to those with expertise in policy evaluation, this report (and many others) showed no evidence that they consulted or otherwise incorporated such expertise.

As an example of the general problem consider this quote from Barbara Hatch Rosenberg, a bioweapons expert at the State University of New York's Purchase College, in this week’s Science “This is the right decision, from the standpoints of both public health and security." First, the NAS should not be in the business of making policy decisions and, second, it is not at all clear that the NAS committee developed or applied criteria of public health or security in performing its policy evaluation.

Posted on September 10, 2004 11:27 AM View this article | Comments (0) | TrackBack
Posted to Author: Pielke Jr., R. | Health

September 09, 2004

Stem Cells, Stalwarts and Dealers Redux

In a letter in last week's Science John T. Durkin provides a Stalwart's defense to a Dealer's argument made by Michael S. Gazzaniga in an earlier letter to Science.

This exchange shows that this debate cannot be settled on scientific grounds and why the issue of stem cells is both highly political and closely related to the abortion debate.

Durkin: "The scientist who destroys an embryo to harvest stem cells commits a wrong, for the scientist has denied that embryo the opportunity to grow into an adult. My moral objections to human embryonic stem cell research are not assuaged by severing its connection to reproductive cloning. In my judgment, the developmental events leading from fertilized ovum, to blastula, to embryo, to fetus, to fully formed adult constitute a continuum. It is artificial, and even self-serving, to declare the embryo "not yet human" before some point, and to declare that we may do with that embryo as we will."

Gazzaninga: "Looking at a miniscule ball of cells in a petri dish, so small that it could rest on the head of a pin, one may be hard pressed to think of it as a human being. After all, it has no brain or capacity to think and feel. Merely possessing the genetic material for a future human being does not make a ball of cells a human being. The developing embryo that becomes a fetus that becomes a baby is the product of a dynamic interaction with its in vivo environment, its postnatal experiences, and a host of other factors. A pure genetic description of the human species does not describe a human being."

I discuss these sorts of debates which may be related to science but cannot be addressed by science in this paper:

Pielke, Jr., R. A. 2004. Abortion, Tornadoes and Forests: Thinking about Science, Politics and Policy, Chapter 9, pp. 143-52 in J. Bowersox and K. Arabas (eds.) Forest Futures: Science, Policy and Politics for the Next Century (Rowman and Littlefield).

A pre-publication version here and the published version will be online soon.

Posted on September 9, 2004 10:19 AM View this article | Comments (0) | TrackBack
Posted to Author: Pielke Jr., R. | Health

August 23, 2004

Stem Cells and the Misuse of Science

In today’s Washington Post there is a very interesting op-ed on stem cell science and policy by Ruth R. Faden and John D. Gearhart, both professors at Johns Hopkins.

They write:

“The controversy about stem cells, and the choice between Kerry and Bush on stem cell policy, is not about science; it really is about values -- moral values. The science is clear. The only way to ensure that we realize the promise of stem cell research as quickly as possible is to permit federal funding to be used to create new embryonic stem cell lines and to support research with new lines. President Bush's values are also clear. He believes that the destruction of embryos can never be morally justified, no matter how much human suffering might be alleviated, even if the embryos are only still a clump of cells not visible to the human eye and even if the embryos will be destroyed in any event in fertility clinics where they are no longer needed. We believe that most Americans have different moral values from the president's.”

The latter assertion would seem highly questionable, at least according to recent polls. According to a July 2004 survey by the Gallup organization, when asked if John Kerry or George Bush “Shares your values” the public split 47% to 46% respectively. But it is also clear that public opinion on stem cells depends upon how the issue is framed. According to Matthew Nisbet of Ohio State:

“For [stem cell] funding advocates, the [recent poll] results clearly show that if they can make overwhelmingly salient in media coverage the connections between research and cures, the public is likely to be swayed… Still, in contrast, other commissioned polls indicate that opponents of funding will do best by linking stem-cell research to abortion and make it into a moral and religious issue. In the end, it comes down to a battle to frame media coverage and campaign messages.”

Hence the incentives for John Kerry are to make a clear connection between the research and possible cures and for George Bush it is to link the research to the abortion issue. It seems to me that on stem cells there is ample evidence that both sides have misused science for political gain.

For the Kerry folks there is a political benefit to exaggerate (or “mischaracterize” using our previously discussed misuse typology) the scientific benefits of stem cell research. For Bush folks there is a political benefit to exaggerate (or “mischaracterize”) the significance of his August 2001 decision, both in terms of the benefits (and numbers) of stem cells available for research as well as the benefits of alternative research techniques (e.g., with adult stem cells) that would make embryonic stem cells unnecessary.

As Faden and Gearhart observe, “Translating science into political symbols and slogans comes at a price.” While I agree with Faden and Gearhart that the stem cell issue is about moral values, once advocates from both sides use science to advance those moral values, the issue becomes a matter of science policy and, in the end, about science as well. As much as we may like to make a distinction, in practice separating science from values just doesn’t work.

PS. For an addition perspective on understanding science in the stem cell debate see this op-ed of mine published in the Rocky Mountain News last month.

August 02, 2004

Op-Ed on Stem Cell Science and Policy

I had an op-ed in Saturday’s Rocky Mountain News in which I try to make sense of the current debate over stem cells. It starts out like this:

“If you want to liven up conversation at a dinner party, ask the following question: How much money would you take for your pinkie toe?”

Read the whole thing here. Your comments are welcomed.

Posted on August 2, 2004 08:41 AM View this article | Comments (1) | TrackBack
Posted to Author: Pielke Jr., R. | Biotechnology | Health

July 26, 2004

Health Research Priorities

In an article in the Lancet, David H Molyneux, of the Liverpool School of Tropical Medicine, challenges current priorities for spending on health issues. He argues that considerable societal benefits can be achieved by focusing attention on diseases that are currently less politically popular, but nonetheless tractable from the standpoint of improving human health outcomes. Here is an extended excerpt:

“The Millennium Development Goals and a plethora of initiatives have focused on the control of HIV/AIDS, tuberculosis, and malaria. However, a large group of diseases has been confined to the “other diseases” category by health policy makers and politicians. These so-called neglected diseases are the viral, bacterial, and parasitic infections of the tropics (often vector borne), together with acute respiratory infections and diarrhoeal diseases of children. Despite the availability of cost-effective, stable, and successful control or elimination interventions, large numbers of the world’s poorest people remain afflicted or are at risk from this group of diseases. The focus of health policy makers on HIV/AIDS, tuberculosis, and malaria, as well as emerging or reemerging diseases causes funding for neglected diseases to be overlooked, with deleterious effects on the social and economic wellbeing of the poorest quintile of populations in the least developed and low-to-middle income countries…

If we are to ensure the efficient use of the substantial resources needed to reduce morbidity and mortality associated with HIV/AIDS, tuberculosis, and malaria, then a small investment in proven, cost-effective interventions against “other diseases”—preferably from the Global Fund resources—will bring sustainable public-health benefits, integrate well with and strengthen the health system, reduce disabling conditions, and bring collateral benefits to the health of the poorest nations. Policy makers are ignoring scientific and operational evidence that interventions against “other diseases” are effective. By concentrating on so few agents, current policies could perpetuate inequity, disrupt health financing policies, divert human resources from achievable goals, and deny opportunities for impoverished health systems to improve. Current policy also raises ethical issues. Resources are being transferred to interventions against the big three that, realistically, have only a limited chance of success as they are reactive and do not adequately control transmission—a pre-requisite for any public health impact. The proactive pro-poor interventions against neglected diseases succeeded by aiming to reduce transmission. Allocation of a small fraction of the Global Fund resources to “neglected” diseases would be likely to achieve broader public health goals.”

The whole article can be found here.

Posted on July 26, 2004 09:40 AM View this article | Comments (0) | TrackBack
Posted to Author: Pielke Jr., R. | Health | R&D Funding

On Not Regulating the Regulators

An article in the New York Times this weekend describes the Bush administration's opposition to consumer lawsuits regarding products approved by the FDA ("In a Shift, Bush Moves to Block Medical Suits").

There are serious considerations involved in allowing a potential onslaught of such lawsuits, including their possible effect on health costs, the availability of medical products on the market, and the possibility that states would reach different conclusions regarding the safety of a medical device.

According to the article, the administration states that different conclusions would lead to "chaos for the regulated industry and F.D.A." That may be so, and yet this possibility raises grave questions about the goal of having clear and straightforward regulatory policy if it comes at the expense of credibility in the eyes of the public.

The administration is banking on the credibility of the FDA: "if" (according to the article) "a local judge or jury finds that a drug or device is unsafe, it is in direct conflict with the conclusion reached by the F.D.A. after years of rigorous testing and evaluation."

Surely, expensive and rigorous testing must count for something. But for how much? Unassailability on the part of the product once it has been approved? That argument may work when the buyer is held responsible for his or her decision to purchase and use a product. But making the FDA responsible arguably takes the responsibility away from the consumer and undercuts the "buyer beware" argument.

The case is complicated (alas, not simplified) by the role of expertise, namely scientific expertise. The government position is based on the belief that consumer lawsuits would "interfere with federal regulation of drugs and devices, by encouraging "lay judges and juries to second-guess" experts at the F.D.A." (ibid).

Deciding that "tested" science is unassailable is not quite the same as deciding that "proven" science is unassailable. Few today would endorse dragging Galileo or his contributions to trail. Furthermore, no one wants to see competent science and engineering innovations senselessly punished. Yet, circularly making medical drugs and devices immune from lawsuits on the grounds of the scientific expertise that underlies them amounts to technocratic tyranny.

Should attending to the need for clear regulation come at the cost of the need for such regulation in the first place?

Posted on July 26, 2004 09:32 AM View this article | Comments (0) | TrackBack
Posted to Author: Fisher, E. | Health

June 28, 2004

Henry Waxman, HHS, and a Bush Administration Misuse of Science

Congressman Henry Waxman (D-CA) has written several letters to Tommy G. Thompson, Secretary of Health and Human Services (HHS) disagreeing with “a new HHS policy requires the World Health Organization to submit all requests for expert scientific advice to political officials at HHS who pick which federal scientists will be permitted to respond.”

The two letters are worth reading in full (first letter and second letter) to understand the details of Representative Waxman’s complaint.  In short, Representative Waxman expresses concerns that the new policy will (1) limit access by the WHO to U.S. experts, (2) cause delays in the sharing of expertise, and (3) provide the U.S. a means to delay consideration by the international community of controversial health topics.

For its part, the HHS observes in its letter to the WHO announcing its new policy (included with the first Waxman letter) that “U.S. Public Health Service Commissioned Corps and U.S. Civil Service regulations require HHS experts to serve as representatives of the U.S. Government at all times and advocate U.S. Government policies.”

So, does the HHS policy amount to a misuse of science?  

To answer this question we might draw on the report from students in my Maymester course this past spring who characterized four categories of misuse of science by presidential administrations: mistake, mischaracterization, arguing politics or morals through science, and delegitimization.

The answer is “Yes.”  It seems abundantly clear that the HHS decision, while apparently not illegal, does serve to delegitimize science in the sense that it puts a political filter in between the WHO and U.S. government scientists.  When implemented the HHS policy also runs the risk of arguing politics/morals through science if HHS selects scientists to provide information to WHO according to their political perspectives.  I am unaware of any other agency that has implemented such a policy.  Of course it is important to acknowledge that if WHO is free to pick and choose which scientists they seek out for information or advice, then WHO could just as well select particular scientists according to certain political perspectives.

I am sure that many reactions to the HHS policy will focus on trying to “let scientists talk about science” or somehow cleanly separate out science from politics.  Of course, such clean separation is not possible.  It seems to me that if the Administration wishes to place government scientists on a tighter leash (and it is not clear to me why this would be necessary), then a policy that would be more legitimate would allow WHO to choose HHS experts, but require these government scientists to acknowledge the official U.S., government policy on a particular topic whenever they discuss specific policy issues related to their expertise.  More along these lines can be found in this essay.

Congressman Waxman has requested a reply from HHS by July 7, 2004 and it will be interesting to see what HHS says.

(Note: Thanks to Chris Mooney for blogging on this topic and to several Prometheus readers for calling it to my attention!)

June 21, 2004

Fetal Genetic Testing

Yesterday, the New York Times ran a long and interesting story about the technology of fetal genetic testing. The technology raises some questions about science policy in the context of the individual as well as society. Here is an excerpt:

“Fetal genetic tests are now routinely used to diagnose diseases as well known as cystic fibrosis and as obscure as fragile X, a form of mental retardation. High-resolution sonograms can detect life-threatening defects like brain cysts as well as treatable conditions like a small hole in the heart or a cleft palate sooner and more reliably than previous generations of the technology. And the risk of Down syndrome, one of the most common birth defects, can be assessed in the first trimester rather than waiting for a second-trimester blood test or amniocentesis. Most couples say they are both profoundly grateful for the new information and hugely burdened by the choices it forces them to make. The availability of tests earlier in pregnancy mean that if they opt for an abortion it can be safer and less public. But first they must decide: What defect, if any, is reason enough to end a pregnancy that was very much wanted? Shortened limbs that could be partly treated with growth hormones? What about a life expectancy of only a few months? What about 30 years? Or a 20 percent chance of mental retardation?”

One woman quoted in the story said of the decision she faced whether or not to terminate her pregnancy, “It was never even anything I had considered until I had the bad results." Science and technology as they often do create decision situations where before there were apparently none. This is, for example, what happened in the early 1970s when scientists discovered the potential for ozone depletion: It was never anything policy members considered until they had the bad results.

For some the issue quickly becomes more than simply a matter of personal choice:

“Some doctors, too, say they are troubled by what sometimes seems like a slippery slope from prenatal science to eugenics. The problem, though, is where to draw the line. Dr. Jonathan Lanzkowsky, an obstetrician affiliated with Mount Sinai Hospital in Manhattan, described one woman who had been born with an extra finger, which was surgically removed when she was a child. Her children have a 50-50 chance of inheriting the condition, but she is determined not to let that happen. Detecting the extra digit through early ultrasounds, she has terminated two pregnancies so far, despite doctors' efforts to persuade her to do otherwise, Dr. Lanzkowsky said. Other doctors said that they had seen couples terminate pregnancies for poor vision, whose effect they had witnessed on a family member, or a cleft palate, which they worried would affect the quality of their child's life. In an extreme case, Dr. Mark Engelbert, an obstetrician/gynecologist on the Upper East Side of Manhattan, said he had performed an abortion for a woman who had three girls and wanted a boy.”

And as in most cases where innovations in science and technology force new decisions, in the context of fetal genetic tests the decisions made by individuals and society won’t be found in science and technology, but in morals, values, religion, etc.

June 09, 2004

Paying for Pills

Forbes.com has a fascinating story by Matthew Herper on the spiraling costs of cancer drugs.

"After helping to develop some of the hottest new biotech drugs, Memorial Sloan-Kettering cancer doctor Leonard Saltz has come down with a bad case of sticker shock. The price tag for treating patients has increased 500-fold in the last decade."

While discussing a number of specifc drugs and costs, the article does not mention the growing number of Americans without health insurance, a factor which greatly compounds the problem of drug costs. Nor does it discuss lagging health indicators in the US despite massive expenditures.

Can the US continue today's de facto rationing of health services to wealthy customers, or will the health sciences, pharmaceuticals, and government act to foster a more equitable system?

Posted on June 9, 2004 05:11 PM View this article | Comments (0) | TrackBack
Posted to Author: Ryen, T.S. | Health

May 25, 2004

Hiding Behind Science

Dan Sarewitz, director of the Consortium for Science, Policy and Outcomes at Arizona State University (and a visiting scholar at our Center here at the University of Colorado) authored a provocative op-ed in Newsday yesterday titled Hiding Behind Science. Here is an excerpt:

“We all know that the current White House thinks that protecting embryos is more important than protecting the environment and that the profitability of chemical companies should take precedence over the potability of drinking water. No surprise here. But even if the manipulation of science at the hands of the Bush government is more egregious than in previous administrations, the real problem is the illusion that these controversies can and should be resolved scientifically, and by scientists…

… the problem with these attacks on the Bush administration is that they hide behind the sanctity of science to advance an agenda that is itself political. What we do, or don't do, about global warming (or stem cell research, regulation of toxic chemicals, protection of endangered species . . .) will be a reflection of how we choose among competing values, and making such choices is not the job of science, but of democratic politics. Science can alert us to problems, and can help us understand how to achieve our goals once we have decided them; but the goals themselves can emerge only from a political process in which science should have no special privilege.

But neither the Bush administration nor its scientific critics want to give up on the pretense that these controversies are about science. To do so would be to abandon the high ground created when one can claim to have ‘the facts’ on one's side. The resulting charade, where everyone pretends that science can save us from politics, undermines science by turning it into nothing more than ammunition for opposing ideologies. Even more dangerously, it damages democracy by concealing what is really at stake - our values and our interests - behind a veil of technical language and competing expertise.”

Read the whole thing here.

May 14, 2004

Conflict of Interest Policies in NIH

A just-released NIH report observes, “Recently, concerns have been raised in the media and Congress that some employees at the National Institutes of Health (NIH) have engaged in paid consulting arrangements with, or held shares in, biotechnology companies or other entities that could influence their work as government employees, thereby creating real or perceived conflicts of interest.”

The House Committee on Energy and Commerce held a hearing on this issue Wednesday and the chair of the NIH committee testified, “We believe the existing conflict of interest policies affecting NIH do not sufficiently discriminate among groups of employees who have widely differing responsibilities and therefore widely differing susceptibility to conflicts of interest. In particular, we conclude that the policies affecting senior officials of NIH should, as a matter of policy, be tightened-that is, made more restrictive.”

The NIH report suggests 18 recommendations for how COI policies in NIH might be revised.

Science magazine’s article (registration required) on the NIH report began like this, “For the past 5 months, critics in Congress and elsewhere have battered the National Institutes of Health (NIH) for allowing its scientists to accept hefty consulting payments from companies. Last week, a blue-ribbon panel appointed by NIH Director Elias Zerhouni offered a plan to restore public confidence: It recommends that top NIH officials and grant decision- makers be barred from industry consulting. But the panel "walked a fine line," said co-chair Norman Augustine, by saying that in-house NIH scientists may continue to interact with industry, although within new limits.”

The issue was brought to light by a well-researched LA Times article from December 2003.

Posted on May 14, 2004 08:26 AM View this article | Comments (0) | TrackBack
Posted to Author: Pielke Jr., R. | Health



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