Science, Public Policy, and Politics

Like it or not, public policies based on good science are sometimes heavily influenced by political reality. Take the case of the national standards for ozone emissions, the primary component of smog. The EPA proposed new air quality standards for ozone back in January. But in September, president Obama decided to put off acceptance of the new standards until at least after the next presidential election. The reason? Apparently, special-interest groups tied to the industry argued that meeting the proposed standards would impose financial hardships on certain industries and cost thousands of jobs.

The decision to delay the proposed new ozone air quality standards has angered president Obama’s environmentally-conscious supporters, but what can they do? With unemployment currently at 9.1%, it’s hard to argue that job creation should not be a top priority. Lobbyists for environmentally-unfriendly industries know this, of course. In Pennsylvania, where natural gas companies are itching to tap huge reserves of natural gas deep underground, the gas industry argues that EPA standards for natural gas production should be relaxed, not strengthened, because they stifle new job creation.

It’s a difficult balance. The lesson, I suppose, is that whatever you believe in strongly, you need to let your elected representatives know your views.

Limiting Global Warming - The Cancun Agreements

At the United Nations Framework Convention on Climate Change held in Cancun in 2010, an agreed-upon shared goal should be to limit the global rise in temperature to just 2^o centigrade above preindustrial levels. It’s not going to be easy, according to the authors of a paper in Nature Climate Change this month. The authors analyzed 193 different scenarios of future changes in CO₂ concentrations in the literature and looked at how they might affect climate change. They found that achieving the target of less than a 2^o increase in global temperature will require that CO₂ emissions peak in this decade and then begin to decline by 2020.

So far, most countries aren’t taking the necessary actions to reduce their emissions enough (if at all). Unless something changes soon, CO₂ emissions will continue to rise beyond 2020 and by the end of this century the global temperature increase will exceed 2^o. How high it could go after that, and how global warming will affect life on Earth is anybody’s guess at this point. Climate models are just not good enough yet to predict Earth’s climate accurately into the next century.

Let’s hope there is not a “tipping point” in global warming….

Testing the Anthrax Vaccine in Children

Adults who participate in scientific studies (to test the efficacy and safety of a vaccine, for example) sometimes do it because it might help future patients, even if they themselves are unlikely to benefit. A good example was the testing of a vaccine for anthrax; the adults who volunteered were unlikely to benefit directly since there is essentially no danger of exposure to anthrax except in the unlikely event of a terrorist attack. Ethically, it is considered acceptable to involve adults in studies that will not benefit them directly, because adults are capable of giving informed consent.

But what about children? The anthrax vaccine has never been tested in children because of an ethical dilemma – who would give informed consent? Is it right to let parents make the decision? Is a child capable of giving informed consent? On the other hand, what will happen if we don’t test the vaccine in children and there is a terrorist attack some day - would a adult dose of anthrax vaccine be appropriate for children? No one knows for sure.

Earlier this month the National Biodefense Science Board (NBSB) recommended that the anthrax vaccine be tested on children now rather than later, provided that the trial is approved by an ethics review board. The board’s argument is that we can experiment now on healthy children, or essentially run a mass experiment on children after there is a terrorist attack, when it may be too late. Of course, their agenda is to protect against a terrorist attack. It will be interesting to see what an ethics review board decides.

What do you think?

A Fight Over Regulation of E-cigarettes

Remember e-cigarettes – those battery-powered cigarette substitutes that dispense nicotine vapor when the user puffs on them? (See this blog, Sept. 24, 2010). Distributors say that they are virtually free of the cancer-causing agents typically found in cigarettes. They’re legal in Europe, where studies show that they do seem to cause smokers to cut down on cigarette smoking, and that would be a good thing, supposedly. Proponents argue that they are a safer substitute for smoking to give current smokers the nicotine they crave. Opponents argue that they could encourage a whole new generation of nicotine addicts who never smoked.

Just over a year ago the U.S. Food and Drug Administration (FDA) warned e-cigarette manufacturers about making unsubstantiated claims, and signaled its intent to regulate e-cigarettes as “a drug or drug-delivery device”. That would have effectively blocked the importation of e-cigarettes, since they would have had to undergo extensive testing for safety and effectiveness. But that wasn’t the end of it, apparently. In January of this year a federal judge ruled that the FDA could not regulate e-cigarettes as a drug or drug-delivery device. His decision paves the way for the importation and sale of e-cigarettes, at least for now. However, the judge did leave the door open for e-cigarettes to be regulated by the FDA’s tobacco division.

Confused? I am. Simply put, the judge ruled that e-cigarettes should be lumped with cigarettes in terms of government regulation, not with drugs. Either way, the FDA seems determined to block e-cigarette sales in the U.S. Yet, a lot of people think e-cigarettes would do more good than harm.

You decide.

New Test for Down Syndrome

There’s a new test for the detection of Down syndrome in fetuses. The new test examines fetal DNA using only a sample of maternal blood, making it much less risky than the current best methods, amniocentesis or chorionic villus sampling. The test accurately detects over 98% of Down syndrome cases, with a false positive – incorrectly identifying normal fetuses as having Down syndrome – of only 0.2%, according to results published this month.

The test is effective as early as 10 weeks of pregnancy. That’s early enough for parents to confirm positive blood test results with amniocentesis or chorionic villus sampling if necessary, and then make the decision to have an elective abortion if they choose. Not everyone is happy with that. Advocates for Down syndrome patients worry that the number of Down syndrome children could decline. And that might lead (they say) to reduced research and support for Down syndrome patients.

But wouldn’t fewer people with Down syndrome be a good thing? You decide.

Less Traumatic Heart Valve Replacement

Surgery to replace a damaged heart valve is now routine and relatively safe, but it is still major surgery. The surgeon accesses the damaged heart valve by splitting the sternum and pulling the two halves of the chest wall to expose the heart. Then after stopping the heart, he/she must open up the heart itself to replace the damaged valve. Open-chest, open-heart surgery generally can’t be done safely in patients older than about 80 years of age, especially if they also have other serious medical conditions.

Now there’s hope for such patients. The FDA has just approved a heart valve that can actually be implanted without major surgery. It’s called the Sapien heart valve. In its closed position, the Sapien valve fits on a catheter that can be threaded up the aorta to the heart from the femoral artery. When the valve is properly positioned, the surgeon inflates a balloon that opens the metal scaffold structure of the valve, locking it in place!

The Sapien valve is not for everyone. It’s about $20,000 more expensive than the standard valve replacement with open-heart surgery, and it’s riskier. The normal patient who needs a heart valve replaced should still undergo the normal open-heart procedure. Still, there is now an option for a class of patients who previously were out of options.