Today, Wyeth pharmaceuticals was hit with a $134.5 million judgement in a case over its hormone replacement therapies for menopausal women. That wasn't a judgement that pays for a large group of women in a class action suit. It was for three women. And it's still not all. The jury still has to determine punitive damages.
Now a judge might set aside the verdict as excessive or reduce it. But when people suffer a negative outcome from using an FDA approved drug, the fact that each user of the drug could be awarded tens of millions of dollars... Who's paying that tens of millions? The big bad drug companies? No, it's being paid by the people who buy drugs from the big bad drug companies. They don't pull $135 million out of thin air. It's paid out of revenues, or by an insurance company which then just raises rates to cover the loss.
Now, I'm not going to go all Republican on you and champion the drug companies. Nor am I going to go off on a diatribe against trial lawyers or excessive government regulation.
What gets me, though, is that part of Wyeth's defense was that the patient was warned that the drug carried an increased risk of cancer. And that brings me to tonight's word... statistics.
You can't always blame the patients. How many times have you heard a story where they say something like "the study showed that burning an infant's feet with cigarettes reduced its chance of SIDS death by 20%"? So then everyone goes out and starts burning their kid's feet with cigarettes. But what they don't tell you is that the kid's chance of SIDS death was 1 in 1000 and burning their feet with cigarettes lowered their chance to .8 in 1000. That means if you burned the feet of ten thousand babies with cigarettes, statistically you'd save the lives of... 2 babies. Burn 20,000 baby feet and save the lives of two babies. But more importantly, 9,998 babies got no benefit from having their feet burned. They just got pain and scars. Their feet were burned needlessly because all we had were statistics. Because we can't tell which two babies would have their lives saved by burning their feet, we cause 9,998 babies needless pain and scarring.
See, when you hear the story on the news that your chance of death from XYZ increases by 20% or decreases by 20%, they conveniently leave out what your original chance of death from XYZ actually is. And remember that much of this is a statistical increase or decrease. If you had the right group of people, you could statistically prove that having one less beer on the Fourth of July decreased their chances of being hit by a runaway train at Christmas by 64%.
Let's get into bigger numbers... Your odds of winning the Megamillions Lottery on a single ticket are 1 in 175,711,536. Want to increase your chances of winning by ten thousand percent? It would seem that if you increased your chances of winning by ten thousand percent, you're virtually guaranteed to win. Right?
Buy 100 tickets. When you increase something a hundredfold, you've increased it by ten thousand percent. Thing is, you've only increased a 1 in 175 million chance a hundredfold. To guarantee you'd win the megamillions lottery, a 10,000 percent increase isn't enough. You need a 17,571,153,600 percent increase (yes, that's a seventeen billion percent increase).
So when patients are told a drug can increase their risk of cancer, heart attacks, etc., is that warning really and truly meaningful? What was their risk in the first place? How much was their risk increased by this drug? What is their new risk?
In medicine, there are ways to know who will get cancer from a particular drug and who won't. We just don't have the science yet to know all those ways to tell this stuff. So, due to a lack of information or an excess of imperfect information, we substitute statistics for knowledge. We treat getting cancer from using a drug or a baby dying of SIDS like a lottery. Since we can't really know whose ticket will be drawn, everyone has the same statistical chance. Maybe a few risk factors increase one person's chance over another and we can get a little closer to determining which is the 100% patient and which is the 0% patient, but we're still pretty far off.
And in the meantime, the news media says something stupid like "a new study shows that eating pickles doubles your risk of dying from a manatee attack" and people who will never encounter a manatee in their life swear off pickles, yet someone who will end up dying of a manatee attack shrugs off the study's findings. Then their family sues Vlassic for not putting a big enough warning about manatee attacks on their pickle jars and sues Sea World for not keeping the public farther from those dangerous manatees and for not screening the dead guy for pickle consumption before allowing him near a manatee.
So when the drug companies present drug trial numbers to the FDA and the FDA decides what the doctors and the public must know about the risks... it's all statistics. And it's not necessarily the drug companies or your doctor or the FDA trying to mislead you. You'd need a solid knowledge of statistics and all the raw data to make an even semi-informed decision.
So when people take a drug and it's a potential culprit for bad things that happen to them, their lawyers can use the public's ignorance of statistics in two ways. First, they use their own statistics to try to prove a link of causation between taking the drug and the bad thing that happened. Then they try to show how their client couldn't adequately understand the warnings they were given because the client is just part of the general public who doesn't understand all these statistics.
And that's how we end up with jury awards that are the size of lottery jackpots.
In the end, until we have the science to identify every genetic and lifestyle marker so we can say "this drug will give you cancer" or "you'll be fine" with complete accuracy, we have to rely on statistics. We can do longer tests and maybe identify a few more things that can happen, but those push up the costs of bringing a drug to market. If we don't, then we end up with people getting heart attacks from long-term use of a simple arthritis medicine and push up the costs with a couple billion in law suits. Either way, we make drug companies take a lot of financial risk, and thus they charge us an arm and a leg to try to reap the reward of that risk.
In my opinion, unless you can prove intentional malfeasance by the drug companies (i.e. they falsified test results or cut corners during the testing), so long as they followed all federal regulations, jumped through every hoop, and provided every federally mandated warning, they should have a "shit happens" defense.
And if the federal rules aren't strong enough, whose fault is that? If the funds aren't there for research to help give us more precise indicators and less reliance on statistics, whose fault is that? As long as only 50% of the eligible voters show up at the polls and vote for the candidates who appeal to their baser instincts on topics like gay marriage and flag burning rather than base their vote on topics that are really "life and death", then the lawyers, insurance companies, and drug companies get rich, drug prices remain outrageous, and if you're "lucky" to live long enough to clear the trials and appeals after a drug gives you a near-fatal side effect, well, you win the lottery.