This isn’t a problem specific to the ACA; it’s endemic in national health systems all over the world, all of which are more or less in the thrall of pharmaceutical companies who control and produce most of the research that determines population medicine.
The problem with the pharmaceutical companies sponsoring research however is twofold: 1, they control who gets into the study and define the outliers; and 2, most of these studies are not appropriate for population generalizations because they are small in size or short in length. Oh, and I guess this makes it threefold: any results that are not favorable to their drug will never see the light of day.
Now controlling who gets into the study is related to the outliers in that, if in the pretrial part of the study, people who have adverse reactions right away will be eliminated from the study. So people who might give a truer picture of the drug’s ill effects will have been eliminated right off the bat. And outliers are defined as people who have reactions that are supposedly really rare and do not give a true picture of the overall study results. For instance, take Celebrex. It’s a nonsteroidal anti-inflammatory drug, in the same class as aspirin, ibuprofen, naproxen, etc. Pfizer, the manufacturer, said its drug was better than those others because it didn’t hurt the stomach. Well, as it turns out, that was not the case at all. The reason they were able to claim that is because, if you read the link above, you will find that they only released the first six months of a year’s worth of data. Most of the stomach problems developed in the second half of the study; because of this they were able to deceive regulators, medical providers, and the public at large into believing this drug was safer. They altered the study’s parameters to hide crucial data related to side effects, and they explained “poor results as the result of ‘statistical glitches.'” ***statistical glitches is researcher speak for outlier***
Perhaps the worst offender in this is Merck. Their drug, Vioxx was taken off the market because of the substantially increased risk of a heart attack while taking it. This was defined as an outlier in their results – which means they knew there was an increased risk before this drug ever went on the market. Yet they chose to define a statistically increased risk as an outlier, dump all the data related to the people who had had a heart attack during the course of the study, and publish results that were very positive toward their drug. Of course, they also paid for a study to be published that was favorable to their product without disclosing their financial relationship and were subsequently sued. Multiple times, in multiple countries.
Regarding study length: In the case of Celebrex, they released results related to only six months of what ended up being a six year long study. How can one make a decision about a medication’s safety or efficacy when the study hasn’t even been completed? Where are the critical thinking skills for those who are in charge of approving a drug? Where are the critical thinking skills for those prescribing the drug? The public doesn’t have the general ability to decide if a study is good or not, they rely on the government to determine a drug’s safety and effectiveness, and they rely on their providers to prescribe drugs that have benefits that outweigh the risks. They are being seriously failed on both accounts.
Unfavorable results are related to both of the above drugs. Data that showed there was substantial risk for certain groups of people in both cases was simply hidden. In many cases, studies are never published at all – their data is simply buried and never sees the light of day.
So why is any of this relevant? Well, guidelines are created based on the cumulative results of published studies. And guidelines are what are forced on providers in order to make sure they are adhering to the standard of care. Standards of care are based on population medicine, not on individual people. They don’t allow for individual preferences, variability in response to a drug, differences in financial circumstances or lifestyles, religious prohibitions, or any other individual determinants of a person’s ability (or desire) to adhere to a given regimen.
If we can’t rely on the results of studies, we can’t rely on guidelines that are created from them. And this is a big problem when reimbursement, and even licensing is predicated on adhering to guidelines. In a local to me case, an Arizona cardiologist is under investigation because he advocates non-guideline based recommendations for his patients. This is a huge problem. If a physician can’t read research and make decisions for his practice, but is expected to blindly follow guidelines or face having his license revoked, how can one trust one’s medical provider that they are doing the right thing for you, the patient?
In an even more insidious fashion, the powers that be (government in collusion with the pharmaceutical and insurance companies) are requiring (here in the States anyway) that a provider have an NPI. That’s a national provider number. And it has to be printed on all prescriptions or the pharmacist will not be required to fill them. So what? Well, if you don’t follow the guidelines, and you don’t accept the insurances the government wants you to — because you prefer to offer your patients advice that you feel is healthier and safer for them as an individual — you can have your provider number yanked even if your license is not revoked. Either way you can’t fully care for patients and are out of business. I wish I had links for you for this one, but I don’t. I don’t even remember where I read this, but trust me when I say this is indeed going on.
Population medicine. Peak medicine. Grasping for financial straws. And you, and I, the little people suffer.