Archive for the ‘politics’ Category

[ed. note: this post has been changed after initial publication to prevent confusion]

Congratulations, America, your country is one presidential veto away from requiring open access to tax-funded research.

For further information:

I do wonder, though, if arguments framing this as a taxation issue are really what the open access movement needs. It might be the reason that I have heard some scientists pushing open access as just ‘American research for Americans’ – and expressing protectionist resentments about U.S. research falling into the hands of people who didn’t pay for it.

Surely we don’t want jingoism to feed an unhealthy and small-minded attitude that open access should stop at national borders – especially when open access has such potential for international development.

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While it took some time to hit the press, on May 28 the environmentalist organization Friends of the Earth filed a lawsuit against the Queen in right of the federal government of Canada. Co-defendants are the Minister of the Environment, John Baird and the Minister of Health, Tony Clement.

Press releases are available from Friends of the Earth Canada and Sierra Legal Defence Fund.

The application was made to the Federal Court in Ottawa for judicial review of the government’s failing to meet its domestic and international legal obligations. It seeks two orders of declaration from the court, the guts of which I paraphrase here.

  1. Canada’s greenhouse gas emissions violate the United Nations Framework Convention on Climate Change and the Kyoto Protocol.
  2. The government is failing to meet its obligations to control greenhouse gas emissions under s.166 of the Canadian Environmental Protection Act (CEPA).

The application also requests an order of mandamus, which would command the government to comply with s.166 of the CEPA by implementing controls that meet Kyoto targets.

Their argument is a mix of international law and statutory interpretation. Statements about Canada’s failure to comply with international law can be found in this legal opinion, provided by the German firm Günther Heidel Wollenteit Hack. However, the filed application focuses mostly on the matter of statutory interpretation. Friends of the Earth argues greenhouse gases are air pollution, so the Environment Minister has a legal duty under s.166 of the CEPA to control it. Government lawyers will doubtless argue a contrary definition.

You might recall the same arguments happened in the United States. There, the US Supreme Court narrowly decided the Environmental Protection Agency had the authority to regulate greenhouse gases as air pollutants.

Because greenhouse gases fit well within the Clean Air Act’s capacious definition of ‘air pollutant’, we hold that the EPA has the statutory authority to regulate the emission of such gases from new motor vehicles.

A visit to the Environment Canada website for Bill C-30Canada’s Clean Air Act – shows that the Government of Canada has taken notice of the debate south of the border. The text of the bill, which would amend CEPA as well as the Energy Efficiency Act and the Motor Vehicle Fuel Consumption Standards Act, clearly distinguishes between air pollutants and greenhouse gases.

At present, CEPA defines air pollution expansively:

“air pollution” means a condition of the air, arising wholly or partly from the presence in the air of any substance, that directly or indirectly

  1. endangers the health, safety or welfare of humans;
  2. nterferes with the normal enjoyment of life or property;
  3. endangers the health of animal life;
  4. causes damage to plant life or to property; or
  5. degrades or alters, or forms part of a process of degradation or alteration of, an ecosystem to an extent that is detrimental to its use by humans, animals or plants.

The amendment would add separate definitions for ‘air pollutant’ and ‘greenhouse gas’.

There are several things about the application which are interesting. Consider how the list of cited authorities includes the following environmental values:

e) the precautionary, intergenerational equity and public trust principles;

Only two of these have found their way into Canadian environmental law, and neither are particularly forceful as authority.

The preamble to the CEPA sensibly appeals to the precautionary principle this way:

[W]here there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation;

The public trust doctrine, on the other hand, is the common law view that there are public rights in the environment that are held by the Crown. While the Supreme Court tangentially acknowledged its validity in British Columbia v. Canadian Forest Products Ltd. (2004), it shied away from the “novel policy questions” implicated by the concept. In that case, after a short historical survey of the doctrine in Anglo-American common law, the court opened the door only to walk on by – a perfect example of obiter dicta in action.

It would be tough to argue that either of these have great weight as legal authority. Of the three, only one is a legal principle, and the court has been reluctant to think about its implications.

Why toss these three environmental values into the application, then? I suspect it’s to allow them to be used as part of later arguments – arguments which might bait an adventurous court into entrenching the principles in its judgement. That would be an important victory for Canada’s environmental movement, and radically reshape environmental law.

Even if the environmentalist lawyers fail to make their case, the court action might yield politically important results. The process of disclosure allows them to gain access to important ministerial documents and correspondence that might embarrass government.

Still, legal counsel for Friends of the Earth might want to update their boilerplate. They refer to the court as the ‘Federal Court – Trial Division’, but that name changed with amendments in 2003 to the Federal Court Act. It is now just called the Federal Court.

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One measure of a leader is the people who champion them. This being the case, I’m directing a twinge of annoyance at the public face of Ron Paul, whose small base of support has hijacked the Internet. Well, online polls, Wikipedia, and the blogosphere as measured by Technorati, at any rate.

It’s novel enough that mainstream media are taking notice, but it just reminds me of how Scientologists bought up L. Ron Hubbard’s books to propel them to the top of best-seller lists.

Not being a voter in the US, it’s hard to stir up enough motivation to comment on this beyond the modest recommendation for the following neologism:

  • Ron Paul Effect: (n) When your supporters’ tactics to subvert a public forum turn the public against you.

Hat tip to Freakonomics, which has a good slap-down of the political spam that ended up in their inbox.

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What should we make of dinosaur publishers leading the charge against dangerous drugs?

On Monday, GlaxoSmithKline received some bad news about Avandia, its drug for diabetes patients. According to a study in the New England Journal of Medicine, Avandia – Rosiglitazone Maleate – increases the risk of heart attack.

Here’s the report, although readers without medical training may find it impenetrable:

For a measure of the confusion that results from this type of disclosure, see Dr. Charles’ coverage at Unanswered Questions About Avandia & More on Avandia. [Update: see also this Washington Post article, presented as a FAQ.]

This may remind readers of the medical, financial and legal panic following indications that Cox-2 Inhibitors prescribed to arthritis sufferers had serious side effects. The most popular of the Cox-2 drugs were Celebrex (sold by Pfizer) and Vioxx (sold by Merck). Responding to panicking patients, doctors, regulators, and investors, the FDA and Health Canada were quick to issue warnings.

The Vioxx scandal was a natural result of a general failure to regulate drug safety, and there were widespread calls for closer and more reliable monitoring – both before and after their approval for sale by government agencies. The targets for regulatory reform don’t tax common-sense:

  1. the merits of post-market surveillance, including provisional licensing.
  2. the dangers of early pre-market licensing, and
  3. the unhealthy demand created for untried prescription medications by direct-to-consumer advertising.

An editorial from the journal of the Canadian Medical Association nicely summed up the problem, and advocated a sweeping regulatory solution:

The FDA and Health Canada have demonstrated their structural inability to do ongoing safety monitoring of new drugs and devices, and industry is far too conflicted to be able to carry out this important task. We need new national agencies to monitor drug safety independently from the approvals process. Only then can physicians and patients be assured an unbiased safety assessment of the drugs they are prescribing and taking.

Two years later, and very little has changed at either agency. Despite tentative forays in the US Congress, and ‘critical path‘ talks at the FDA, no legislation has been passed which would respond to the problem. In Canada, discussions about progressive licensing have yet to assume regulatory force, and there are indications the situation will become worse, not better.

The most significant development has come from member journals of the International Committee of Medical Journal Editors (ICMJE), who issued a statement declaring they will only publish trials previously registered with ClinicalTrials.gov, a database hosted by the National Institutes of Health.

Soon after, the ICMJE adopted recommendations of the World Health Organization, in part to counter Big Pharma’s attempts to circumvent their requirements.

This is a story with enough alarm and money involved that it has gained significant attention. But unlike the Vioxx ‘fallout’ story in 2004, this story is made new by an extra twist. Major newspapers are framing it as a triumph for open access to information.

Each of these focus on how Nissen and Wolski used information culled from GlaxoSmithKline’s own public database, the Clinical Trial Register.

This story works. It has a personalized David and Goliath theme that invites schadenfreude when a large drug company is caught by its own data.

I worry, though, that this will create confidence in informal drug monitoring that relies on whistle-blowing by objective and motivated researchers and medical journals.

It’s already happening.

Joe Weisenthal at Techdirt, floats the idea that medical journals could replace the FDA.

Looking down the road, one could envision a system whereby it’s the FDA’s job to ensure that drug companies properly report safety and efficacy data, while third parties (think highly specialized versions of Consumer Reports) make judgments on a drug. Then, instead of having blanket pronouncements on whether a drug can be sold or not, it would be up to doctors to weigh all the risks and decide what’s best for their patients on an individual basis.

This a dangerous and naive view of informed medical choice. Front-line physicians don’t have the time, resources or skill to mount strict, comprehensive and authoritative analysis of drugs. GlaxoSmithKline’s Rosiglitazone Studies are no good to your family doctor. Moreover, doctors are swayed by drug marketing and browbeaten by patient advocating specific treatments.

Even worse, we can’t rely on uncoordinated third-party research specialists to study all of the effects of medicines that go to market, and we can’t rely on peer-reviewed journals to publish only good results.

Open access to the data is a good idea, but it is not enough. Public health cannot take place voluntarily or in a legal vacuum. We need regulation to enforce that open access, we need regulation to uncover harmful effects and screen for snake-oil ‘alternative therapies’, and we need regulation to free doctors and patients from biased sales pitches.

Absent this, informed choice about medical treatment is a myth.

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The New Yorker hosts a talk by Jonathan Haidt and uploads the video. Hat tip goes to the brilliantly titled Missing Shades of Grue.

Worth watching just for the forest of hands that are raised when Haidt asks the audience who among them are liberals. I think there were more microphones at the podium than there were conservatives attending.

Drawing on his 5 foundation theory (mentioned here), Haidt argues liberals need to take into account the 3 extra moral ‘foundations’ which inform conservatives ideology. A third of the way through, Haidt discusses how his theory explains the politics of gay marriage. He also makes an interesting point about moral geography. Haidt observes a narrow liberal ideology creates a common denominator and promotes tolerance among people who congregate in urban areas, immigration attractors and transportation hubs.

Afterwards, there is a good conversation with Henry Finder. In it, Haidt talks about:

  1. the importance of emotion – awe, ‘moral elevation’ and ‘the blink test‘ – in the public perception of leadership in American elections
  2. post-hoc moral reasoning and moral dumbfounding
  3. why framing issues with language choices will convince nobody
  4. moral decay in the culture war between Islam and the West
  5. why liberalism can be bad for you and human dignity, and why liberals should work with the ‘good parts’ of conservative ideology

The best quote, referring to an electoral map showing liberals populate the areas around waterways:

I believe this shows that humidity makes people liberal.

Update: See now the post and comments at Dr. Joan Bushwell’s Chimpanzee Refuge.

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