Consumers Union’s Approach to Improving Drug Safety Surveillance is Misguided

Consumers Union Petition

Petition for Better Reporting of Drug Side Effects

I support requiring all drug ads to include a 1-800 number and website so citizens can report drug side effects (petition docket 2008P-0012/CP1).

All too often, drug advertisements fail to present the benefits and risks of using prescription drugs in an accurate and balanced way. It is often the newest drugs that are the most heavily advertised, and it is these drugs whose side effects we know the least about.

The current system for collecting information about side effects catches only a fraction of actual cases. The recent law passed to require print drug ads to provide a 1-800 number and website (FDAAA — P.L. 110-85) is a step in the right direction, but should be extended to include TV ads which are viewed far more frequently and with a greater command of the viewing audience.

Increased reporting of adverse events will help in the earlier detection and better analysis of problems. All television ads should contain information on how patients can report side effects to the FDA.

As you can read above, Consumers Union is trying to improve surveillance of drug safety by promoting patient reporting of “side effects” in drug ads. A representative of the organization had asked me to blog about the petition, so I am.

I oppose their effort. Here’s why.

Probably around 1% of adverse reactions to drugs are reported via FDA’s Medwatch system. Most reports come from healthcare professionals, based on my experience reviewing such reports in the 90’s. That’s the way it should be, and we need to encourage more of it.

On the other hand, encouraging more reporting “side effects” by consumers might actually have its intended effect, which could completely break an already shaky surveillance system.

Passive surveillance of reported events can be an effective way of uncovering signals that a drug is associated with rare but potentially serious adverse effects (like hepatic toxicity), or with adverse effects that occur on a background of a common disease (like heart disease) at moderate relative risk (like the risk of heart attack with Vioxx, for instance).

There are real challenges when interpreting data from such types of surveillance programs. The most obvious challenge is that there is no concurrent control group for comparison to the drug-treated group (when there is a concurrent control group, we’re speaking of a form of surveillance that is different from the type I’m describing).

A less obvious challenge is separating signal from noise in the data. Signals are so-called true-positive adverse event reports. Noise comes from false-positive reports. Safety surveillance systems strive to maximize signal and minimize noise in order to provide the best possible opportunity for making correct inferences from the data.

When there is a low percentage of adverse events being reported overall, as in the current environment, the signal is low, and so the detrimental effects of any noise are amplified. The situation will be improved by encouraging more adverse reports with a high chance of being true-positives and by discouraging reports with a high chance of being false-positives. How do we do this?

We don’t do it by encouraging patients to fill out Medwatch forms or by calling 800 numbers. We do it by making it much easier for doctors to capture and transmit adverse events that are possibly or probably related to drugs and by making it much easier for FDA to capture and analyze such reports. T

he technology for facilitating such data capture and interchange already exists. The technology on the doctor end is the electronic medical (health) record [EHR]. Interchange allowing upload of data to FDA can be facilitated using the HL7 data standard known as ICSR. And on the back end, FDA already uses analytical tools that can make sense of the incoming data. It is simply a matter of mandating use and providing funds for its implementation.

Doctors can’t afford EHR for the most part, which is the main reason why its adoption has been so painfully slow. In an EHR environment, a passive surveillance system can flourish by giving doctors easy, pain-free ways to report anonymized AE reports directly to FDA or other surveillance agencies (like CDC). It can be as easy as adding a couple of tick boxes and a “send” button to a standard electronic patient encounter form (okay there’s more to it than that, but no so far as end-users can tell).

The US government has not done enough to encourage adoption of this technology, which would really improve drug safety surveillance. The government should be buying EHR systems and associated training and support for every physician's office until the technology achieves saturation. By becoming the buyer, HHS can mandate that systems be semantically interoperable (be able to talk to each other and to FDA unambiguously).

The cost wouldn’t be as high as you might think. According to the 2007 US economic census (2002 data), there are roughly 205,000 physician offices in the US. Some of these offices (let’s say for argument sake it’s 10%) already have EHR systems, but let’s figure that the government provides support for every office. Because of discounts from competitive bids, the average cost per office will be much lower than it is today. Let’s say it’s $50,000 per office on average. That’s roughly 10.25 billion dollars to outfit, train, and support every physician office in the US with an EHR system and to guarantee that the systems will be interoperable with each other and with FDA. That’s about what the US is spending each month in Iraq.

That’s what Consumers Union should be pushing for. Adding to the noise of passive surveillance data will only make a bad situation worse.

Comments

[TomLamb]

You have presented a very good idea about how to improve the FDA's performance as regards its drug safety oversight mission.

The problem of not reporting serious side effects caused by prescription drugs seems to ingrained in medical doctors, generally, and this problem apparently goes beyond the U.S., as is seen
in this February 2008 article from the British Medical Journal:

"Most doctors still don’t report adverse reactions to drugs" (www.bmj.com/cgi/conten...).

Your idea about how to cure this problem is sound, and would be implemented if we were ready to spare no expense to further drug safety in in the U.S. Unfortunately, in our nation today your idea may not be feasible, practically, due to its costs.

Another idea which may be not as good as yours -- but would serve as an improvement to how the system functions today -- involves medical information databases maintained by large HMO's and other medical insurance entities being searched, or "mined", by software programs to detect possible emerging drug safety signals.

Lastly, I applaud Consumers Union for seeking to raise awareness about the MedWatch program and how patients can report their serious side effects to the FDA.

In closing, thanks for your article and effort towards improving the safety of prescription drugs.


Tom Lamb

www.DrugInjuryWatch.co...

[Malkiel]

I have a layman's suggestion that harkens back to another old way of doing things--there shouldn't be any television advertising of prescription drugs to a general audience, so let's ban that. The whole idea of prescription drugs is that mediation is needed, so let's keep the physicians as the gatekeepers of what prescription drugs should be used to treat various conditions. It isn't appropriate for the drug industry to be encouraging desperate patients to be hounding their doctors about the new drug flavor of the week for their particular condition...

[Meg Bohne,ConsumersUnion]

Consumers Union is a strong advocate for EHRs. But, as you made clear, implementing a nationwide system on linked electronic health systems will take time. It may be the most efficient and accurate way to report adverse events, but until the technology is utilized by a majority of doctors offices AEs will go largely untracked. The plain fact is many doctors don’t report them. An Institute of Medicine report found that in 2004, only 21,500 of the 423,000 adverse event reports that year came from doctors and patients.

The brother of a colleague of mine is a case in point. He had a very serious reaction to drug recently. His doctor did tests and pulled him off the drug immediately. He asked his doctor if he would report this to the FDA. The doctor said that he would be more mindful of this side effect when prescribing this type of drug (a statin to lower cholesterol) in the future, but he just didn’t have the time to report it to the FDA. The patient (my colleague’s brother) reported it to the FDA’ s Medwatch system.

Until there is a system-wide surveillance program for AEs – and full doctor compliance with reporting requirements – it is critical for consumers to have a way to report their experiences, especially if their doctors won’t. The Medwatch system was created to field reports from doctors as well as consumers – unfortunately, most consumers don’t know about this resource.

Congress already mandates that all printed drug ads contain the Medwatch 1-800 number and web address. Consumers Union’s petition makes the logical case that this information also be included in TV ads, which will reach millions more consumers.

[User 131807]

as a physician, i agree that direct to consumer advertising should be eliminated. however i would like to add a different dimension to this discussion. i think all medications- prescription and over the counter- should require a country of origin or manufacture, so that consumers know from where their medication originate. it's required for produce and other food, why not medications?

[rdial54]

We need to be sure that we don't limit things too much and miss out on some very promising drugs.