Finding the FDA's Drug Safety Information Online

A smart post by The Sunlight Foundation's Nancy Watzman has me thinking about what it really means to have access to all of our personal health data. In the past, I've myopically viewed personal health data as anything that my body produced, in one way or another, and now sits in my shadowy file at the doctor's office. Things like X-rays, MRIs, and blood test results. No doubt, I should have access to all of this information. What about prescription medication? Sure, I can easily make a list of the meds I'm currently taking, or get my doctor to hand this list over if memory fails me. But how much do I really know about these drugs? Most people, myself included, take our doctor's word when he or she decides to put us on a commonly prescribed medications. For example, let's say a patient has blood-work that shows elevated LDL cholesterol on two consecutive screenings, comes from a family where cardiovascular disease runs rampant, and was previously unable to regulate cholesterol levels with strict diet and exercise regimes. If the doctor prescribed Lipitor to treat the problem, a patient may not even think twice about taking it. After all, we see commercials for such drugs on our TV, and we flip past their ads in our magazines. Direct-to-consumer marketing by pharmaceutical companies makes drugs familiar and, presumably, safe.

But regardless of what advertisements say, the FDA is ultimately responsible for giving drugs the safety stamp of approval. The decision to approve a drug is based on substantial amounts of preclinical (testing in animals) and clinical (testing in humans) data submitted to the FDA by the drug manufacturer.

Let's say someone – a doctor, a patient, a concerned citizen – wants to review the data that the FDA uses to approve a drug. If the drug you're taking was approved after 1998, you can find the FDA's review documents online. If you're prescribed an older medicine, you may strike out when trying to find what the FDA has to say about it. The government's information on drugs approved through 1997 may be released if someone makes a request through the Freedom of Information Act, but the FDA reserves the right to not publish reports if the agency deems the preserved documents are of “poor quality”. In fact, Watzman found that online safety information is missing for 9 of the 25 most commonly prescribed drugs.

For older and newer drugs alike, when the FDA publishes a review online, it's never in a text-searchable format. Rather, the agency prints the original paperwork, edits with white-out to cover “propriety information”, scans the newly edited document, and finally, posts the altered PDFs online.

Are these edited documents, with words covered with white-out and entire sections omitted, really providing us with useful information? Somewhere along the drug approval process, there has to be a succinct memo that circulates around the FDA headquarters describing the agency's major findings on a particular drug. Why can't the FDA publish a simple summary of their findings?

Skeptics may argue that detailed information about a drug already published by pharmaceutical companies in medical journals, such as the New England Journal of Medicine (NEJM) or the Journal of the American Medical Association (JAMA), should suffice. However, there are two problems with the information reported in medical journals. First, most of these journals are not open access, meaning the average consumer cannot access them without paying for the article. Second, many drug companies only publish positive findings, and bury negative results that show less than desirable efficacy or safety.

Watzman's report is an eye-opening look at what's wrong with the flow of drug information as it goes from pharmaceutical company to the FDA to the consumer. If pharmaceutical companies are allowed to market directly to consumers, we should demand the right to know what the FDA has to say about the safety of these drugs.