Drug Side Effects Up, But Benefits Up More

The news of a marked increase in adverse drug events reported to the FDA is sure to be one more arrow for those taking aim at "big pharma" and the FDA. The criticism is off target, however, because it fails to take into account the new ways drugs are being used.

From 1998 to 2005, the number of serious adverse effects from medicines reported to the FDA more than doubled, according to a report published in this week's Journal of the American Medical Association (JAMA). "These data show a marked increase in reported deaths and serious injuries associated with drug therapy over the study period," write the researchers from the Institute for Safe Medication Practices, in Pennsylvania.

The data may be accurate, but without a deeper understanding about how important innovations have changed the way doctors practice medicine, the numbers lack context and are worse than useless in terms of public policy. This information may further skew the drug approval process towards excessive caution, leading to even more lives lost because of delays in getting drugs to market in the unrealistic search for 100 percent "safe" medication.

When doctors had little more than aspirin and penicillin at their disposal, adverse drug effects were far lower than they are today (but still not nil), but there were far fewer conditions they could even dream of treating with drugs, and patients suffered because of it. We could easily improve "drug safety," in a narrow sense of the phrase, by turning back the pharmaceutical clock 10, 20, or even 50 years. But we all know such a move would be to the detriment of public health -- even though we'd thereby eliminate the risks that come from new drugs as highlighted in this latest report.

Similarly, slowing down the approval process today would hamper innovation --no help to those who would die without trying a risky new medical approach.

Consider as an analogy the "safety" record of the world's top cardiologists. The authors of the JAMA report might find that twice as many patients die under the care of these top doctors than under the care of local physicians. It doesn't take a brain surgeon to realize that's not because the specialists aren't good -- it is that their reputation attracts the most difficult and risky cases. The same is true with some of the pharmaceuticals studied between 1998 and 2005.

Doctors are calling on medications to do things we never thought possible. Statin drugs, as one example, have contributed to the dramatic decline in cardiovascular mortality over the past 20 years. Just two decades ago, without these therapies, many patients died as expected -- from diseases instead of (occasionally) from drug side effects.

Weigh the lives saved by new drugs against the ones lost because of them and you'd draw a very different lesson than this report: hurry up and get new drugs to market, then let patients and physicians weigh the risks and the benefits and make an informed decision. In the meantime, people are dying to make a choice.

Jeff Stier is an associate director of the American Council on Science and Health (ACSH.org, HealthFactsAndFears.com).

Comments

[oldpotsmuggler]

We know that the poppy seeds in bread products can make a person look like a heroin user on a urine test. And there is the standard "banned items" list that is given to every person required to submit to testing by the criminal justice system, none of which are illegal. What there isn't, however, is any extensive testing that has been done to identify every possible source of every type of false result for every person on the planet.

In medicine, any particular drug/medication prescribed to three people for the same purpose could very easily cure one of them, kill one, and do nothing for the third. You know that if you have ever listened to the disclaimers that follow every drug advertisement on T.V. (I mean, some small number of people even get a four hour erection from ED drugs, and you don't think that that would be the main selling point for a Viagra competitor if they could offer a money back guarantee?) Cancer treatment has even reached the point of sophistication where scientists are starting to realize that a DNA test can determine which treatment might work on which persons with identical diagnoses. The cancers are the same but the people are not, and that's why the same chemo treatment may or may not work.

When we reach the point where the human race has tested every organism and substance on the planet for chemical composition, and we know how to cure every possible affliction in every individual person, we will know that we can conduct testing for illegal drug use with perfect precision. Until then we'll slop our way through it, and the best we can hope for is that our drug testing programs don't do more harm than the drugs we are "fighting".

[TonyOrlando]

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When taking medicine; one must know that the resulting effects on the body are broken down into two catagories. The first, Theraputic Effect, is why you take the med. While the second group of effects are called the Adverse effects. In other words, a chemical has numerous effects on the body. And we are taking it because we like the one effect out of the dozen it causes. Not a very accurrate science.

When medicine gets less clumsy, I would then be intrested in trusting thier prescpition for any med.

Futhermore, medicine is a bussines first. when the human exsperience is dictated by the outcome of the bottom line with thier company; we will always be second. Furthermore, the FDA is not what it was. Funding, and even employment is often by the very people they ear suppost to watch over. Like the fox guarding the hen house.

Then you have the research that the med companies furnish. The length of time used for these tests on the population is too short of a time. And the size of population tested does not repr4esent a prportionate sample of our diverse population.

My last note is this simple line. "Get a Second Opinion", where do you think this line came from; from medicine.
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