by Matt Barr

I want a new drug

Make someone else responsible for figuring out whether you're doing everything you should be doing. If you're on a diet, have your wife promise she'll speak up when you're not eating right. What happens? You gradually ease your way into eating as much crap as you can get away with. She would have said something if I shouldn't have licked the bacon fat out of the skillet. But it's not her body or her health; even your lovey dovey isn't as invested in your diet as you are. She's got her own stuff to worry about. The person most likely to ensure you're eating right is you.

So it is with the Food and Drug Administration. Drug companies, being run by human beings, will find the level at which they can be least safe and still get away with it. They don't act as rigorously as if their market share depended on their satisfying (and not killing or maiming) their customers.

This might not be a big deal if the FDA had clear and concise standards especially for postmarket drug safety, but it doesn't, per a newly released report of the Government Accountability Office.

FDA lacks a clear and effective process for making decisions about, and providing management oversight of, postmarket drug safety issues. The process has been limited by a lack of clarity about how decisions are made and about organizational roles, insufficient oversight by management, and data constraints. We observed that there is a lack of criteria for determining what safety actions to take and when to take them.

Even at its theoretical nimblest, though, the FDA would be in no better a position than drug companies themselves to address safety issues. If a drug has severe or unforeseen side effects or causes complications, doctors will prescribe it less often. The FDA will neither know that sooner than the company whose money is being lost, nor be able to respond as quickly.

The key is publicity, and FDA is already in a position to serve that function. Drug manufacturers are required to report serious adverse events not covered in a warning label within 15 days of learning about them, and other events quarterly for three years after the drug's debut. Doctors and patients can submit adverse event reports anytime.

Do you know where to find this data? Why, you can go here to download the very latest and find links to older data. Here's the catch:

The structure of this database is in compliance with the international safety reporting guidance (ICH E2B PDF document) issued by the International Conference on Harmonisation. The guidance describes the content and format for the electronic submission of reports from manufacturers. FDA codes all reported adverse events using a standardized international terminology, MedDRA (the Medical Dictionary for Regulatory Activities). Among AERS system features are: the on-screen review of reports; searching tools; and various output reports. FDA staff use reports from AERS in conducting postmarketing drug surveillance and compliance activities and in responding to outside requests for information.

In other words, you won't understand a word of it. The data are available in a ZIP archive in ASCII delimited and SGML formats including:

• demographic and administrative information and the initial report image ID number (if available);
• drug information from the case reports;
• reaction information from the reports;
• patient outcome information from the reports;
• information on the source of the reports;
• a "README" file containing a description of the files.

If you're a computer with a medical degree, you're all set.

The GAO recommends

that the Congress consider expanding FDA’s authority to require drug sponsors to conduct postmarket studies when additional data are needed. We are also making recommendations to the Commissioner of FDA to improve the process by establishing a mechanism for systematically tracking postmarket drug safety issues, revising and implementing FDA’s draft policy on major postmarket drug safety decisions, improving CDER’s dispute resolution process, and clarifying ODS’s role in FDA’s scientific advisory committee meetings.

You probably don't understand a word of that, either, without trying real hard (unless your everyday conversation is peppered with phrases like "making recommendations to improve the process by establishing a mechanism for systematically tracking" things). The upshot though is that the FDA should demand more data, act on it promptly and be better able to defend itself when drug companies complain.

I have a better idea. Make these reported adverse events more accessible by the drug-taking public. I think it's obvious that if you see seven people have died in the last three months from complications from taking the drug you've just been prescribed, you'll be more reluctant to take it. It will be up to the doctor and drug company to convince you the risk is worthwhile or inapplicable to you for some reason; if they can't do that, you won't take the drug, nor will others like you, and the drug company will be out of luck. Without the crutch of the FDA making recommendations to improve processes by establishing a mechanism for systematically tracking postmarket drug safety issues, and with money on the line, drug manufacturers will defend their products directly to consumers, or through the prescribing doctors. As between the federal government and yourself or your doctor, it's not the federal government you should be relying on in your decision how to care for yourself.

That, and we'll be spared the spectacle of solving the admitted ineffectiveness of a government agency by giving it more power.

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