Thursday, September 22, 2011

Is increased access to medical information a good thing, or a bad thing?

Steven Hodson wrote a post in the Inquisitr about the website This is what the website is about:

AdverseEvents, Inc. (AEI) is the first service provider to deliver accurate, real-time information on adverse drug events reported to the FDA. AEI utilizes a unique data sourcing method called RxFilter™, a proprietary 17-step data refinement process that standardizes and normalizes the data from the FDA’s Adverse Event Reporting System (AERS) into a user-friendly, fully searchable, database of over 4,000 approved medications. Over 500,000 medication adverse events are reported yearly to the FDA; estimated to be only 10% of all actual adverse events. As a leading resource for the pharmaceutical industry, AEI supports companies with competitive intelligence and data to inform drug marketing decisions and business development strategies. With AEI, the healthcare industry is able to quantify the benefit-risk assessments of FDA approved drugs to fully understand the scope of safety issues, based on accurate rates of side effects from such medications.

But while AdverseEvents supplies this information to companies and the healthcare industry, Hodson notes that there is another beneficiary:

Of course the big pharma companies only let you know what side effects a drug might have under duress and public pressure; because we all know the government and the FDA wouldn’t do squat about the problem without that pressure; and even when they let you know it is the barest details that are hidden away in the small print.

When it comes to the drugs that we are told that we need in order to stop our legs from shaking or our scalp to stop itching we have no easy way to know what they are, what side effects they have, or how prevalent the danger of those drugs are.

Well, a new start-up in California called AdverseEvents is looking to change that and in the process they are going to cause many a drug company executive some sleepless nights.

Now this is just the latest example of something that has been going on for years. Back when Steven Hodson and I were little kids, there were two sources of medical information - your doctor, and the kids on the street. The latter source may not have always been reliable, but we always knew that the doctor, who was well-trained, was a reliable source of information.

As time passed, patients began to get information from sources other than their doctors. I'm not familiar with the situation in Hodson's home country of Canada, but on this side of the border we began to get information from laypersons' medical books, from the drug companies themselves, and increasingly from the Internet.

And in the process we learned that doctors were not perfect. Some doctors had been hauled before disciplinary boards, and we were able to learn about it. Some doctors were unduly influenced by pharmaceutical companies to prescribe their drugs, and we were able to learn about it. Some doctors and medical associations, and the United States Food and Drug Administration itself, rejected certain types of treatments, and we were able to learn about it.

Now instead of one source, we could get our medical information from a dizzying variety of sources. We'd open up our favorite magazine and read an advertisement about Drug X - along with a page of fine print about possible side effects. Or we'd read or hear about some other type of treatment, along with a statement that said treatment had not been evaluated by the FDA. (Or, in Canada, the FD Eh.) And then you had a bunch of groups forming for this or that or the other thing, some telling the FDA to approve Drug X sooner, while others were telling the FDA that Drug X should never be approved.

And now we have AdverseEffects. I happened to look up one medication on the website that was used to treat a particular illness, and it listed 83 reports of cases in which this medication was the primary one used to treat the illness in question. Of those 83 reports, 10 were reports of deaths. (One of the reported effects of this medication was an increase in suicidal thoughts.)

While Hodson believes that the information provides a valuable service, I sounded a word of caution ina comment to Hodson's post.

While the site appears to be a valuable resource, its reports should not be misinterpreted.

For example, I was reviewing a report for condition X for drug Y in which there were 83 reports, and 10 of those reports resulted in death (in this case suicide). This does not necessarily mean that you have a 10% chance of dying if you take drug Y, since (as we know) those who report such things tend to be those who have had a bad experience.

In addition, one has to consider whether, even with the side effects, you're better off taking the drug than not taking it at all. While I'll admit that there are cases in which some drugs (e.g. Ritalin) are prescribed when they shouldn't be, on the other hand there are cases in which the drugs are necessary.

And no, I'm not a doctor, but I do know patients who has to deal with various issues.

However, I have a more basic concern - not just with AdverseEffects, but with all of the information available to us today. Do laypeople have the knowledge to make intelligent decisions based upon the information available? Or do we even have enough information to make an intelligent decision? For example, did the 10 people who died from the drug above die because they abused the drug? Did they fail to see a doctor? Did they fail to disclose their complete medical history to their doctors?

There is always a danger of making medical decisions based upon sound bites. These could be either positive or negative sound bites - "Paul stuck tea leaves up his nose, and his cancer was cured!" or "Peter stuck tea leaves up his nose, and he suffocated and died!"

So do we listen to Jason Vale, or do we listen to Jenny McCarthy, or do we listen to someone else?

P.S. No, the Canadian equivalent of the U.S. Food and Drug Administration is NOT called the FD Eh. It's actually called Health Canada/Santé Canada.
blog comments powered by Disqus