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OpenMarket: Business and Government

  • Drug lag -- precaution or pipelines?

    August 16, 2007

    According to a CNN Money article, a report released yesterday shows that the FDA has been cracking down on new drug approvals. Pharmaceutical companies this year through July had only 38 new drugs approved, down from 55 for the same period last year. The report was from James Kumpel, health care analyst for Friedman, Billings, Ramsey.

    Though some say that's occurring because the pharmaceutical companies' pipelines are drying up, others attribute the slowing down of approvals on the FDA's fear of approving drugs with some side effects, after recent highly publicized concerns with drugs on the market:

    But Fran Hawthorne, author of "Inside the FDA," argues that there's nothing new about Big Pharma's lack of innovation. She said the drug approval slowdown is "far...
  • No Excuse for Resistance to DDT

    August 9, 2007

    Anti-DDT activists in the environmental movement often suggest we should stop using this chemical to save people from malaria and other diseases because mosquitoes will eventually develop resistance to the substance. However, a study published in the journal PloS Online explains why such arguments make no sense.

    The study demonstrates that in addition to still being the most affordable product, DDT is likely the most effective over the long term because it repels most mosquitoes—keeping them from ever entering homes. These effects are critical for a couple reasons. First, mosquitoes are most active in transmitting disease at night as people sleep, so keeping these insects out of homes can reduce disease rates significantly. Second, DDT's repellency effects remain...

  • More on Bad Court Ruling Against Terminally Ill

    August 8, 2007
    "Terminally ill patients do not have a constitutional right to be treated with experimental drugs, even if they likely will be dead before the medicine is approved, a federal appeals court said Tuesday." So reports the AP in the Washington Post. I explained yesterday why the court's decision was wrong and its reasoning was shoddy. Additional commentary on the court's decision can be found at the widely-read Volokh Conspiracy law blog.
  • Drug Maker Faces Lawsuit by Corrupt, Kooky Foreign Government

    August 8, 2007
    Pfizer is seeking the dismissal of a $2 billion lawsuit by the Nigerian state of Kano. Pfizer's purported offense was to give children an experimental drug during a 1996 meningitis epidemic. Kano State claims to be suing out of concern for children's health. As I have previously noted, this is a deeply ironic posture for Kano to take, since it is responsible for reviving the terrible disease of polio by thwarting polio vaccinations of children. As a result, polio, which was once on the verge of being wiped out throughout the world, spread from Kano State into neighboring countries in Africa, reaching as far as the Middle East. Kano State has also permitted Muslim...
  • UN Group Rejects Precautionary Principle

    August 8, 2007
    The Codex Alimentarius Commission, a joint UN Food and Agricultural Organization-World Health Organization food safety standard-setting body, has apparently agreed to exclude the precautionary principle from its risk analysis standards, despite intense lobbying by the European Union and green groups. The initial proposal, which has been under consideration by the Codex for roughly six years, would have allowed governments to take "preventative measures" to ban certain foods in cases where scientific evidence regarding safety is "uncertain." But, in addition to serving as a huge roadblock to innovation, the precautionary principle is seen (correctly, in my estimation) by many as a tool to support unjustified trade barriers....
  • Court Rejects Terminally Ill Patients' Chance to Live, Upholds FDA Red Tape

    August 7, 2007
    The D.C. Circuit Court of Appeals has ruled 8-to-2 in Abigail Alliance v. Von Eschenbach that terminally ill people cannot challenge the FDA's ban on drugs that have passed an initial safety review, but have not yet completed the FDA's entire, years-long clinical testing process. The court's opinion is fully of shoddy reasoning. The Court claims its decision does not infringe patients' constitutional right to life, even though the FDA bans drugs that doctors view as the last, best hope for their patients, because "the collective judgment of the scientific and medical community is expressed through the FDA's clinical testing process." Survey after survey has shown that doctors think the FDA is too slow in approving drugs, as critics of the court's decision have...
  • FDA Tobacco Regulation Assailed

    August 3, 2007
    In the New York Times, Patrick Basham explains why the bill to give the Food and Drug Administration the duty to regulate tobacco is "bad for competition in the tobacco industry and bad for public health." A Senate Committee recently approved the bill. Advertisers have criticized the bill on First Amendment grounds. Others have criticized the bill on public-health grounds. In other news, the full Senate...
  • Goofy's Coffin Nails

    August 2, 2007
    When it comes to the politics of tobacco regulation, one of the most important dates is January 11, 1964, when then-Surgeon General Luther L. Terry presented to the public his now famous report on the health risks of smoking. It is now often implied by anti-tobacco activists that before that time, the American public was tragically ignorant about the downside of smoking. Sure, the tobacco companies had the research, they say, but being the evil organizations they were, they suppressed this vital public health information in the names of making piles of dirty, dirty money. Could this really be true? Did people in the 1950s and before really not know that nicotine was addictive or that tobacco smoke was bad for your lungs? Not according to the following Disney short from 1951, "No Smoking." Just watch what happens...
  • FDA Tobacco Regulation Clears Senate Committee

    August 2, 2007
    A Senate committee has just voted 13-to-8 in favor of the bill to give the FDA jurisdiction over tobacco products and the tobacco industry. The bill has been criticized on health grounds because it would make it harder to market reduced-harm tobacco products, such as smokeless tobacco products, to smokers, who would otherwise smoke cigarettes, which are much more likely to cause cancer. It has also been criticized for violating First Amendment rights to advertise and for undermining competition in the tobacco...
  • FDA Tobacco Regulation Bill Tramples Free Speech, Advertisers Say

    July 30, 2007
    Advertisers are objecting to the bill that would subject the tobacco industry to FDA regulation, saying that its restrictions on tobacco advertising would violate the Supreme Court's ruling striking down tobacco advertising restrictions in Lorillard Tobacco v. Reilly (2001). They also claim that it would set a bad precedent for advertising restrictions in other industries. There are many other objections to the bill, such as the fact that it would make it harder to sell smokeless tobacco to cigarette smokers, even though smokeless tobacco is less dangerous than...

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