Posts Tagged ‘fda’

Drug Failures and Drug Addiction - Who Is Responsible?

Saturday, February 23rd, 2008

On the FDA, drug companies, and addiction to crack cocaine in Argentina.

fda food and drug administration lawsuits supreme court decisionThe NY Times disputes the Supreme court’s 8-1 decision to prevent liability lawsuits against drug companies if their products have been approved by the FDA. The Times argues that the FDA falls woefully short of ensuring adequate checks against faulty drugs and medical devices, and therefore that drug companies shouldn’t be immune from lawsuits if their products prove faulty. I see the point, but it seems ridiculous. Either the FDA should get out of the way, or it should do its job. Let those who have suffered from faulty drugs or medical devices sue the FDA.

crack cocaine scourge argentina brazil addict addictionThe Times also reports on the scourge of crack cocaine in Argentina. I’ve written about illegal drugs before, arguing that it is irrational to ban some drugs but permit others. I see the point of the mothers and families of those addicted — get the drugs off the streets; keep them out of the hands of our children and the world would be a better place. But I wonder how we can rationally draw distinctions between crack cocaine and, for instance, alcohol.

The distinction seems to be this — crack cocaine has no redeeming or redeemable qualities. As the story suggests, it is inevitably a pernicious substance. There’s no such thing as a recreational user, no such thing as a puff or two. I’ve never tried crack cocaine, so I’m presuming that I can believe what’s written about it. It is so highly addictive that casual, occasional, recreational use is impossible.

Laws, government agencies, police forces… Society sets up institutions in an attempt to protect us and keep us safe. We should expect these institutions to perform the kind of job we assign them, so long as we oversee them and fund them appropriately. But, while institutions should be adequate, they can’t be perfect, and we have a responsibility to ourselves to expect and protect against institutional problems, failures, and shortcomings. Holding the FDA responsible because it has inadequate testing for problematic drugs and medical devices seems appropriate. Suing a drug company because its product wasn’t adequately tested by the FDA doesn’t. On the other hand, if a company knowingly deceived or took advantage of the failings in the FDA, it does seem appropriate that the company also bears responsibility.

Cloning, Condoning and Bemoaning

Wednesday, January 16th, 2008

On the FDAs approval of cloned animal products, Bush’s approval of Mubarak, and the NY Times’ disapproval of electronic voting.

cloned cows fda approves cloning for foodA few days ago I wrote about the danger of messing with nature. Nature has taken millions upon millions of years to produce the world we live in, and its only guiding principle has been to constantly winnow out loose ends and poor choices. Evolution ensures that nature’s mistakes either become successes or are self-healing. When humans get involved in rejiggering nature we risk unforseen consequences.

It’s hard to blame the FDA for approving the sale of food products from the progeny of cloned livestock. The FDA’s job is not to play moral judge, nor to philosophize over the rightness of second-guessing nature. Instead it had to judge whether the food seemed safe. Whether the food industry leaps to sell the products and whether consumers want to buy them will play a part in how quickly and pervasively products derived from cloned animals make it to our tables, but it can only be a matter of time. One thing seems clear: We can’t rely on the FDA, nor farmers, nor food suppliers to prevent the inevitable. Which leaves us with consumers and, nature forbid, regulators.

Bush with Mubarak in EgyptWhile evidence of the administration’s destruction of evidence piles up at home, the inscrutable George Bush has been making an unprecedented (for him) tour of the middle east. We’re so worn down after suffering seven years of his bewildering ability to ignore the obvious that even his gravest acts of ethical side-stepping don’t surprise us any more. In Egypt Bush had this to say to the ruthless Mubarak: “I appreciate the example that your nation is setting.” Now, if he meant that with Egypt’s terrible record on free elections and human rights Mubarak has been making even the Bush Administration look good, that would be one thing, but I don’t think that’s what Bush had in mind. What he did have in mind, I believe, was Egypt’s support in the Bush administration’s war on terror; a dubiously relative merit if ever there was one.

counting paper ballots electronic voting ny timesThe NY Times today called for an upgrade to electronic voting systems across the land… by entering a plea for jurisdictions to maintain parallel paper ballots. Quite rightly, the editorial focuses on what needs to be done to improve the chances that we’ll have a fair and reliable election result this year. What it doesn’t focus on is how we got ourselves into this mess in the first place. When in doubt, blame Bush. In large part fault does lie with Bush. The administration’s zeal for free markets and state independence has led to the current electronic voting fiasco. Surely when we’re dealing with the election of a president of the nation the federal government should shape and vet the introduction of a consistent and reliable electronic voting system. The demand for quality far outweighs the demand for the process to rest on free market forces. And surely since the election of a president demands consistency in process and accuracy from state to state, the matter of voting mechanisms shouldn’t be left to state control.

As in so many areas, these three examples demonstrate in very different ways that our process of government is very far from rational. To leave to the FDA the task of stemming the tide of animal cloning for food makes no rational sense. To twice elect a president of such passive incompetence and active contempt for what’s right and good makes even less rational sense. As does the reliance on decentralized muddle in devising a good scheme for capturing votes.

 

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