With Side Effects, the Consumer Is on Her Own

Here are some facts that, when put together, boggle my mind:

Drug companies have no responsibility to tell the consumer of adverse effects of the drugs they sell.

Doctors are the only ones with responsibility to warn the consumer of side effects.

Doctors are rarely fully informed about side effects with new drugs.

I have been struggling to write about this topic for more than a week. I have not been able to understand why we consumers are the ones at risk. I realize now that I don’t have to understand why, I have to accept that it is. MedShadow Foundation’s mission is to make sure that you, the consumer, know that you may not be offered the information you need. You have to seek out information on the risk of adverse events and what side effects the drugs you are prescribed might cause.

A recent study from the Journal of Internal Medicine (4/11/13) studied how effective pharmaceutical reps are at educating doctors about the benefits and risks of new drugs. The study took place in 3 cities: Vancouver, Montreal, Canada; Sacramento, CA, US and Toulouse, France. Between May 2009 and June 2012 1,700 drug promotions were pitched to doctors in those cities. The doctors were surveyed following meetings with the drug reps.

In more than half the cases (as reported in LawyersandSettlements.com) “doctors rarely get the full complement of drug side effects when pharmaceutical reps visit to promote new and emerging drugs. In some cases, the worst potential side effects of potentially harmful drugs are never articulated to the doctor.”

Given that half of our doctors don’t even know what the side effects are for new drugs, it is all the more concerning that the consumer’s only source of information on side effects is that doctor. This is difficult for me to understand, but drug companies have no duty to warn consumers about side effects in their marketing material.

I used to think that we, the consumers, were protected by the FDA rules for drug advertising on TV, in print and on the internet. Direct-to-consumer (DTC) pharmaceutical advertising has been overseen by the FDA since 1938. The rules have changed over the decades and used to be quite strict. They have relaxed and now advertisers can include the product name, the claim (or benefit, only that as approved by the FDA), and the “major risks.” The advertiser has to provide an “adequate provision” that would direct viewers to another source for a complete “brief summary” information. That other source could be a web site, a magazine ad, a health care provider or a toll-free number, for example.

However, the courts do not back up the FDA rules. There was a recent case in the Supreme Court of Texas with what is called a “failure to warn” claim. A woman named Hamilton suffered from Crohn’s disease. The doctor recommended a drug called Remicade. Hamilton’s doctors had her and her husband watch an informational video on the drug made by the manufacturer of Remicade. The Hamiltons claim that the video overemphasized the drug’s benefits while intentiallly omitting warnings about its possible side effects. It would seem to me, an average consumer, that the drug company ignored the intent of the FDA rules.

The pharmaceutical company doesn’t deny that the warnings were omitted. Instead, the drug company’s defense is it didn’t have to warn Hamilton or any other patient of the risks of adverse or side effects. They claim it’s her doctor’s responsibility. The state of Texas, and apparently most states, have a policy called, “learned intermediary doctrine.” Since a doctor has to prescribe the drug, the doctor is responsible (as the learned intermediary) for all the information dissemination to the patient. The drug company’s only obligation is to adequately educate the physician or health care provider.

A lower court had ruled in this case that the drug company could not rely on its warnings to doctors when it “directly misrepresented its product’s dangerous propensities” to the consumers. The Texas Supreme Court overturned that ruling and determined that the learned intermediary doctrine protected the drug company.

This is particularly irksome because the average American television viewer watches as many as nine drug ads a day, totaling 16 hours a year, which far exceeds the amount of time the average individual spends with his or her physician. (Source: US National Library of Medicine, NIH)

So beware patients. Ask about the potential adverse effects, ask about side effects. But be aware that you doctor might not know more than you and the drug company isn’t telling.

What do you think? Tell me on our FaceBook page.

For more information, here are article links to each of the facts.

  • Drug companies have no responsibility to tell the consumer of adverse effects. (Reported in American Medical News)
  • Doctors are the only ones with responsibility to warn the consumer of side effects. (same article as above)
  • Doctors are are rarely fully informed about side effects with new drugs. (Reported in Lawyers and Settlements.com)

Suzanne B. Robotti

Suzanne Robotti founded MedShadow Foundation in 2012. Learn more about Su and her mission.


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