I believe in pharmaceuticals. I take them. We all do. Medicine- medications, drugs – are a necessary part of life. But, just as I like my car manufacturer to monitor problems with my car after it is off the lot and swiftly recall dangerous cars, I like my pharmaceutical companies to be honest about the drugs I’m taking – or the ones given to my children.
On March 31, 2004 my nine year old daughter Jesse was admitted to a hospital with a large, slow-growing tumor. On April 2 the tumor was removed ; her prognosis was excellent. But because the tumor was large, Jesse needed extensive residential rehabilitation in a center, and because she had one post-operative seizure she was put on phenytoin(Dilantin.) While in rehab she caught a hospital bug called C.difilis and given the potent antibiotic Flagyl. Within twenty-four hours she developed a raging case of Stevens Johnson Syndrome/Toxic Epidermal Necrolysis, a syndrome induced solely by pharmaceuticals. She was taken off the Dilantin and Flagyl and transferred to a burn center —SJS/TEN is essentially like having a chemical burn, inside and out. The disease ravaged her and she died on June 2, 2004, four days before her tenth birthday.
This year Pfizer, the makers of both Dilantin and Flagyl, settled with Jesse’s Dad and me on a wrongful death suit. While protesting their innocence, Pfizer nevertheless attempted to require we agree to a gag order, and they asked for the court records to be sealed. But the wonderful, wise settlement judge refused. She ordered the records public. Regardless, call me cynical, but I decided to wait to speak or write publically – to wait until the check cleared.
But now it has, so now I can tell the world: Pfizer killed my daughter Jesse.
SJS/TEN is an entirely iatragenic disease….a disease produced by a ‘cure.’ It is an ‘adverse reaction’ to medications given for other conditions. There is no cure for SJS/TEN. All you do is withdraw the causal drug – if you can determine that – and provide medical care, preferably at a burn unit. At its most severe there is a 40% mortality rate, and the reaction is most common in children and old people, in people already immune compromised……..and in non-whites (Jesse was adopted from Guatemala, of Spanish and Mayan ancestry).
Incredibly, reporting of adverse drug reactions is VOLUNTARY in the United States. This means that NO ONE was required to send a report to the FDA about my daughters death – and no one did! In the U.S., we leave it to the good will of the pharmaceutical industry – or the skill of investigative reporters – to let us know when their drugs are killing us (SJS/TEN, for example) or crippling us (Thalidomide-deformed babies in the 1950’s).
Jesse’s death shows just how well the voluntary system is working out for us.
In 2004, Pfizer already knew that Dilantin caused a lot of SJS/TEN. In fact, Dilantin, the most widely used anti-seizure medication in the world, is responsible for more cases of SJS/TEN than any other known drug. Because of that, experts consider Dilantin the seventh-line treatment for seizures in children – that means six other drugs should be tried first before you resort to Dilantin. Yet in reality, due to the success of Pfizer drug reps, the risk of SJS/TEN is played down, and it is the most commonly used anti-seizure drug for pediatric AND adults – all over the world. By 2004 Pfizer also knew that Flagyl caused SJS/TEN but vehemently denied it….right up until they finally put a ‘black box’ – ‘may cause death’ -warning on the label last year. Flagyl has never even been tested on children; it is an ‘off label’ use in pediatric cases. But off label use – uses for which a drug was not intended nor tested – is discouraged but not illegal in the United States. Pfizer also knew that Flagyl should never be used in someone taking Dilantin because it blocks the metabolism of phenytoin and increases the blood levels of the drug dramatically. This is what happened to Jesse. Within hours after the administration of Flagyl, Jesse broke out in an incredibly virulent form of the disease that burned off 90% of her skin and the epithelial linings of every internal body organ. It’s a terrible way to die, and survivors of SJS/TEN often lose their eyesight and suffer lifelong from a variety of medical problems
How could this happen, if all these facts were known in 2004? Even if a doctor is not actually being paid by a pharmaceutical company – and lots are – all of them rely primarily on drug reps to bring them information on drug use. MD’s simply don’t have the time to comb thousands of journals a year for scientific reports of adverse events. And drug reps lie. Or, they aren’t told the truth, either.
The FDA should be heavily monitoring adverse drug events. The FDA should be alerting doctors to dangerous drugs, or forcing Big Pharma to do so, but it doesn’t. The FDA is toothless.
The drug companies should be labeling their drugs with more severe warnings and sending out “Dear Doctor” letters, as they are called, to let doctors know about things like the interaction between Flagyl and phenytoin. But they don’t. And they won’t unless they are made to.
They do this for the same reason the car companies don’t recall cars early enough and hide accident reports. Actually, both industries are doing exactly the same thing. Human life is measured against dollars lost in profits if harsher warnings lead to decreased drug sales. Only when it looks like the game might be blown wide open do these industries capitulate…..just a little. Until the next time.
The pharmaceutical industry, like any industry manufacturing products that could kill us, needs to be heavily regulated. The pharmaceutical industry won’t care about human collateral damage unless it’s too expensive not to care.
If any of this upsets you, there are some things you can do. Send this article to anyone with kids, send it to your doctors, get the word out, if you can, to pediatric docs and especially pediatric neurologists. Jesse is dead but her death won’t be entirely senseless if one mom gets her kid off Dilantin because of this article, or if one doctor stops prescribing these drugs.
And be aware. Don’t get your information about drugs from the drug companies – unfortunately, you may not be able to get reliable info even from your doctor. Question what you are prescribed, and especially what those with weaker immune systems, like children and the elderly, are prescribed. Don’t let Big Pharma kill even one more kid.