A Killer Agency


Pages: 1 2

Sam Kazman’s “Drug Approvals and Deadly Delays” article in the Journal of American Physicians and Surgeons (Winter 2010), tells a story about how the U.S. Food and Drug Administration’s policies have led to the deaths of tens of thousands of Americans. Let’s look at how it happens.

During the FDA’s drug approval process, it confronts the possibility of two errors. If the FDA approves a drug that turns out to have unanticipated, dangerous side effects, people will suffer. Similarly, if the FDA denies or delays the marketing of a perfectly safe and beneficial drug, people will also suffer. Both errors cause medical harm.

Kazman argues that from a political point of view, there’s a huge difference between the errors. People who are injured by incorrectly approved drugs will know that they are victims of FDA mistakes. Their suffering makes headlines. FDA officials face unfavorable publicity and perhaps congressional hearings.

It’s an entirely different story for victims of incorrect FDA drug delays or denials. These victims are people who are prevented access to drugs that could have helped them. Their suffering or death is seen as reflecting the state of medicine rather than the status of an FDA drug application. Their doctor simply tells them there’s nothing more that can be done to help them.

Beta-blockers reduce the risks of secondary heart attacks and were widely used in Europe during the mid-’70s. The FDA imposed a moratorium on beta-blocker approvals in the U.S. because of the drug’s carcinogenicity in animals. Finally, in 1981, FDA approved the first such drug, boasting that it might save up to 17,000 lives per year. That meant as many as 100,000 people might have died from secondary heart attacks waiting for FDA approval.

In the early 1990s, it took the FDA more than three years to approve interleukin-2 as the first therapy for advanced kidney cancer.

Pages: 1 2

  • ajnn

    This is an interesting essay on how politics actually works.

    What are the constituencies and how are they 'heard'. It is also a powerful argument that government needs to be regulated at least as much as the private sector.

    slow fda approval has, in fact, had some notable triumphs; thalidomide for example.

  • Amused

    hows about the drug companies themselves , coming clean with ALL their results , rather than brushing harmful side effects under the rug , or presenting "results " from stuidies done improperly .
    After all it's not as if no one knows that PROFIT many btimes overides actual patient safety .How many times do people need to see this in action before concluding that the trouble is in the processes and THAT is usualy caused , not by science , but by profit motive , which is not wrong in and of itself , but only when it's agenda superceedes safety .

  • Amused

    btw , thalidomide was not all that much of a triumph , as closer study reveals many were harmed . And since then there have been several instances where pre-aqpproved drugs had to be removed from the market . and in many cases , only to be discovered , that harmfull effect were in fact already known by the drug companies , but minimized for other than truly ethical reasons .

  • Amused

    Killer Agency ? Not really , but rather …..killer drug manufacturers . The argument used by this author is , less than rational , especially extrapolations which conclude "slow approval " has caused thousands of deaths ……sorry but that's called SCIENCE . Perhaps the author would prefer FAST=TRACK approval , then himself be the guinea pig , after faulted studies .

    • GKC

      Of course these killer drug companies want to harm people to continue and increase their market share, right? I think its called POLITICS. Is Williams calling for no regulation, or for a change in the regulation process? It is not either the present process or the fast track that are the only options here. Being only a short article I wd. like to hear him expand on it for sure, and am going to search out the reference he made. Thalidomide wasn't touted as a potentially life-saving drug as far as I'm aware of, and no one's life was hanging in the balance on its approval or denial.

  • anonymous

    There was once a situation in my family in which a family member was compensated as a result of a very large class-action lawsuit against a large pharmaceutical corporation. Family members were very indignant that the drug in question had ever been released to the public. A couple of years later, these same family members were outraged that the FDA was not acting fast enough to release several experimental drugs against HIV. You can't have it both ways.

  • USMCSniper

    Reputation, in an unregulated economy, is a major competitive tool. It requires years of consistently excellent performance to acquire a reputation and to establish it as a financial asset…Thus the incentive to scrupulous performance operates on all levels… It is a built-in safeguard of a free-enterprise system…Government regulation is not an alternative means of protecting the consumer. It does not build quality into goods, or accuracy into information. It’s sole “contribution” is to substitute force and fear for incentive as the “protector” of the consumer… What are the results? To paraphrase Gresham’s Law: bad “protection” drives out good.

    • USMCSniper

      The attempt to protect the consumer by force undercuts the protection he gets from incentive. First, it undercuts the value of reputation by placing the reputable company on the same basis as the unknown, the newcomer, or the fly-by-nighter. It declares, in effect, that all are equally suspect…Second it grants an automatic guarantee of safety to the products of any company that complies with its arbitrarily set minimum standards…The minimum standards, which are the basis of regulation, gradually tend to become the maximums as well…A fly by night securities operator can quickly meet all the S.E.C. requirements, gain the inference of respectability, and proceed to fleece the public. In an unregulated economy, the operator would have had to earn a position of trust… Protection of the consumer by goverment regulation is thus only illusory.

  • minnieiam

    There are too many ambulance chasing lawyers advertising class action lawsuits against the big drugs companies for "BAD DRUGS" for the FDA to be doing the job it is supposed to be doing. This reinforces the belief that FDA actions are for sale to the higest bidder which is usually the big drug companies. Example: Paragoric, a cheap (a .39 bottle which would last a family for years) and effective drug so safe it was routinely prescribed by doctors for infants (diahrrea, colic, teething) , and which had been a staple in every medicine cabinet for over100 years, was taken off the market by Bill Clinton so the big drug companies could market their $5 per pill acid reducers. Paragoric was a quick, safe and effective cure for heatburn caused by gall bladder disease, diahrrea, irritable bowel syndrome and other digestive tract ailments. . The stated reason for taking Paragoric off the market was that it had not undergone the testing that new drugs have to go through. However, the last time I checked the FDA site, no tests have been done and none are scheduled. Some smart entrapreneur could really do us all a favor if he would initiate the necessary tests to get this safe, inexpensive drug back on the market.

    • minnieiam

      Interesting side note. Whereas hospitals used to use Paragoric to detox drug adicted newborns they are now forced to use Heroin. Way to go FDA.

  • USMCSniper

    Ayn Rand in her "who regulates the regulators" pointed out that the statist's only goal is to acquire power to loot from those who do produce. Regulations negates the competition for establishing and maintaining reputation and excellence and substitutes minimum standards and influence peddling with the politicians and regulators in place of the proper enforcement of contracts and prosecution of fraud. Regulation is the real let the buyer beware philosophy, because minimum standards allow the new incompetent fly by nighter to enjoy the same prestige as those established by reputation and performance.