A long time ago, drug companies worried about long lists of side effects. They feared that if they warned people about serious adverse drug reactions, no one would want to take their pricey pills. When FDA commissioner Dr. Arthur Hayes asked pharmaceutical manufacturers in 1983 if they were going to seek prescription drug advertising directly to consumers, most of them replied that:
“No, that would be a terrible idea” (Stat, Dec. 11, 2016).
In a 1984 letter to the powerful Michigan Representative John Dingel, Allan Kushen, Senior VP of Public Affairs for the Schering-Plough drug company, stated:
“We have serious concerns about proposals to allow advertising directly to patients. We do not believe it is in the public health interest; indeed we believe that in most cases it cannot safely be accomplished.”
What Changed?
In case you have been hibernating in a cave or you never watch any television, prescription drug ads with long lists of side effects have proliferated. An article in JAMA (Jan. 8, 2019) noted that direct-to-consumer (DTC) advertising jumped from $2.1 billion in 1997 to $9.6 billion in 2016. Drug companies now spend about a third of their marketing dollars on DTC advertising.
Why Are There Such Long Lists of Side Effects?
If you’ve ever watched a prescription drug commercial on television or looked at a drug ad in a magazine, you know that there are long lists of side effects. Some of the adverse reactions are really scary. Why do drug makers do that?
We used to think that pharmaceutical companies reluctantly included long lists of side effects because the FDA made them do it. That is no doubt true, but there may be a more self-serving reason.
Telling patients about lots of nasty adverse reactions might provide a legal defense in case of litigation. And people tend to zone out after about the tenth or eleventh side effect anyway.
The J&J Litigation:
You may wonder why drug company lawyers might embrace long lists of side effects. Here’s the latest example. A recent trial in Philadelphia resulted in an $8 billion verdict against Johnson & Johnson, the manufacturer of Risperdal (risperidone).
The plaintiff claimed that he was given this schizophrenia drug for autism spectrum disorder when he was a youngster. He developed prominent breasts, which caused him anguish as a teenager. The condition is known as gynecomastia.
Needless to say, J&J is not happy about this ruling. The company will appeal. Part of its defense is expected to be that the company notified health professionals of this side effect in the prescribing information.
The company responded to the verdict that:
“…the jury did not hear evidence as to how the label for Risperdal clearly and appropriately outlined the risks associated with the medicine…”
Loving Long Lists of Side Effects:
We interpret that to mean if a patient takes a medication that causes serious harm, the drug manufacturer should not be liable for the damage, provided it has notified doctors about the risk. Most companies do this in the official prescribing information.
A patient who develops a life-threatening skin reaction brought on by a medicine probably cannot sue the manufacturer if the prescribing information lists Stevens-Johnson Syndrome.
What is Stevens-Johnson Syndrome (SJS), you might ask? Trust us when we tell you it is horrific! Some drug references may describe this as a skin rash. It is way worse than any skin rash you could ever imagine.
People develop a fever, sore throat and eye irritation. Mucus membranes are affected throughout the body. The lesions are extremely painful and can make eating and drinking excruciating. If SJS progresses to toxic epidermal necrolysis (TEN), the skin can literally peel off in large sheets. This is a life-threatening condition!
Alerting Patients to Side Effects:
Drug companies do not have to warn patients directly. For legal purposes, all they have to do is make sure prescribers and pharmacists have access to the information.
If a direct-to-consumer drug commercial warns about liver failure, heart attacks, kidney disease or cancer, the company could be off the hook if one of those complications occurs. Even if the manufacturer does not mention all the possible adverse reactions in a TV commercial, it could still avoid litigation. That’s because the doctor has access to the long list of side effects in the prescribing information. If he does not mention every single problem, lawyers for drug companies may argue that’s not their problem.
Learning from the J&J Litigation:
What is the take-home message from the latest lawsuit? Physicians must understand the pros and cons of every medication they prescribe. They should alert their patients to symptoms of potentially serious adverse reactions. Here’s an example of statins and rhabdomyolysis.
“Rhabdo” AKA Rhabdomyolysis:
A side effect that is considered relatively rare, like rhabdomyolysis, can cause irreparable harm.
We heard from one person who experienced this reaction:
“My horrible muscle-destroying experience began with 40 mgs of simvastatin twice a day. It led to the muscle wasting disease rhabdomyolysis, where myoglobin spills from destroyed muscle into the blood stream. Once that overwhelms the kidneys, which cannot clear it fast enough, the result is severe: whole body muscle pains and darkened urine (color of iced tea) indicating acute kidney failure.
“That happened eight years ago. Since that hospitalization, I’ve dodged subsequent dialysis so far. However, my kidney function is only 50 percent of normal, and one kidney is now half normal size.”
Other symptoms of rhabdo include muscle pain, muscle weakness, unexplained bruising, nausea and vomiting. The doctor should test for creatine kinase (CK), myoglobin and potassium.
What Should Patients Do About Long Lists of Side Effects?
Even if a list of side effects is long and daunting, it is still essential to read and understand the implications. That’s the only way to realize you might be running into trouble. And remember, you may not be able to hold the drug company responsible for a life-altering adverse drug reaction if they warn about it on TV or in the official prescribing information.
Learn more about how to protect yourself from drug complications in our book, Top Screwups Doctors Make and How to Avoid them. You can also download our free Drug Safety Questionnaire and Medical History. Take it with you to every doctor visit. Give a copy to your pharmacist to fill out as a double check.
Share your own story about drug side effects in the comment section below. If you value The People’s Pharmacy as an independent drug watchdog, please consider supporting our work by going ad-free at this link.
