September 11, 2007

Adverse Events And Deaths Way Up For RXs

Yesterday, the Archives of Internal Medicine published a study asserting that there's been a huge increase in adverse event reports over prescription drugs to the FDA from 1998 to 2005. Press coverage here. The annual number of serious adverse event reports went to 89,842 in 2005 from 34,966 in 1998. The number of fatal adverse drug events increased nearly 300 percent to 15,107 in 2005 from 5,519 in 1998.

This is a completely untenable situation and argues for an overhaul of the FDA's safety monitoring system--meaning the FDA should actually do some safety monitoring and act upon what they find instead of consulting with Big Pharma over what they should do a la Zyprexa. This situation also argues against the medicalization of human life. If you are going to connect every ache and pain in exist to a condition needing treatment and pharma companies just happen to have a product for it (RLS anyone?), then you had better produce some results. Positive ones.

Study authors say there is plenty of blame to go around--there usually is--but I really think doctors and, to a lesser degree, patients are doing a poor job of managing chronic health conditions. Some of the drugs leading the list for causing problems were insulin, OxyCodone and Fentanyl. The latter two are opiate pain killers.

The number of adverse events grew four times faster than did the number of prescriptions in the same time period. As much as I'd like to blame DTC advertising for this situation, I cannot. Chronic medical conditions don't generally need ads to generate sales. Except for psych meds for some reason.

I haven't seen the full paper yet--anyone care to send it to me?--so I cannot say if any psych meds showed up among the key offenders. All the same, how the FDA handled safety information concerning Zyprexa (and I am just using this one as an example) is instructive.

By the late-90s, the clinical literature was littered with reports about weight gain and hyperglycemia. Even Lilly was being tipped off by doctors in Southern California. The FDA did nothing. In 2002, both the Japanese and European health authorities required that Zyprexa carry warnings about diabetes, hyperglycemia and the like. The FDA did nothing. Oh, but it did meet repeatedly with Lilly officials who pressed their case that all atypical antipsychotics caused glycemic problems, even though there was decent evidence to the contrary. In 2004, the FDA finally issued a black box warning for this class of drugs. How many people died or were injured as a result between 2002 and 2004 is anyone's guess. (Lengthier reporting of the Zyprexa/FDA situation can be found here.)

It similarly took the FDA a decade to issue the first black box warning on anti-depressants, which the agency did in late 2004.

Why would anyone trust the FDA anymore? The FDA won't even tell the public what studies were used to approve certain drugs, arguing that it's private information. Um, precisely who do these "public servants" work for? You and I, or Big Pharma? It's time for Congress to step up to the plate and force some changes.

Posted by Philip Dawdy at September 11, 2007 12:05 AM
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Trusting the Government? hah. I so believe the FDA is there for "us". Riiight. A corrupt Pharmaceutical industry is in charge of this stuff, hands down.

Posted by: Stephany at September 11, 2007 04:40 AM

Of course, this just brings up a larger issue vis a vis psychiatry, drugs and "difficult patients": being an informed consumer almost always means being labeled "difficult".

Ever since the extreme medicalization of most psych conditions, over the previous (perhaps extreme) undermedicalization of some psych conditions, it's become a lot easier and more convenient to apply drugs over labels (neither are very comforting, I would think, to the general populace, save, perhaps, for the hypochondriac or the chronically unbelieved, among a few other subgroups).

I seriously and sincerely hope another swing occurs, perhaps more towards a center point (some psychoanalysis, some prescribing, but all of it more INFORMED). But I kind of doubt that's going to happen.

It'd be very easy to blame a lot of this on insurance companies, big pharma and HMOs, but I think some of the blame also belongs on the shoulders of the doctors who are choosing to pursue psychiatry without a solid *psychology* (or even neurology or cognitive science) education.

I've always felt that it was a mistake to make consumer advertisements for prescription drugs (or to bribe doctors to prescribe drugs by giving the docs gifts, too, for that matter - most companies forbid receiving "gifts" that could "sway" purchases; why should medicine, of all things, be held to any different standards? Oh yeah, money. the results of this study only adds fuel to the fire of confirming this fact by providing some solid data.

I do acknowledge that drug development costs a lot of money, and that we as Americans subsidize a lot of that development cost for other nations who have lower prescription costs. I even understand the high costs of medications. What bothers me is that most people think that medications can cure everything, when at best they should only be an ADJUNCT to making healthier decisions and pursuing parallel courses to achieve better results.

When you can take a drug to lower your cholesterol, for example, most people don't want to change their eating habits -- many think, hey, a pill! I can do exactly what led me to this point still and just take a pill and it will solve the problems.

But it won't.

And thus lies the crux of the dilemma. You can't exactly forbid a whole class of people to take a drug that could help them based solely on the fact that they don't want to change the unhealthy habits associated with the symptoms and diseases they get because of those lifestyle choices.

Let's face it. We live in a consumer, convenience-oriented culture. It's one reason why our society is breaking down (one of many). And one result of that convenience culture is that more people will find more things to complain about when it comes to prescription drugs because they *expect more*. To an extent, I think it is consumer expectations that has changed far more than the actual number of incidences.

I still haven't decided if that's a good thing.

Posted by: Sam at September 11, 2007 09:03 AM

I just wanted everyone to be aware that adverse events are notoriously under-reported. In fact, as long ago as 2004, it was estimated that drug related accidental deaths were estimated to be around 100K which is a lot higher than the number in this report. Some "experts" put actual reports at only ten percent of the total. And of course suicides and homicides are not really acknowledged as adverse events so they're not in these totals either. This is just the tip of the iceberg.

Posted by: Sara at September 11, 2007 10:58 AM
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