ScutFarkus wrote:This is where you misunderstand the scientific method. Scientifically, results live or die by their reproducibility, not by whether or not there is "appearance" of conflict.
Not when it comes to drugs.
There is a long history such as happened with Zoloft
where the manufacturer pays for repeated studies in the hope of getting two that are positive which they then use to force FDA approval. There is well documented bias where manufacturer supported studies have positive results and studies that don't fit the marketing plan either never see the light of day or get buried in obscure publications.
As a result, I think there may be a three step process in science:
2. See who the sponsor is and then
3. If the sponsor is a pharmaceutical, look very carefully at the methodology.
The problem is that patients are usually not well-qualified to look at this kind of detail and medical professionals are for the most part, too busy to do anything other than look at the abstract or articles written about the study.
The companies and their academic spokesmen are not above flat out lying about things that most people simply don't have the time to check.
A classic MS example of this is in a Medscape video
presentation about Aubagio by Dr. Mark Freedman.
He very glibly starts out by mentioning that the parent of Aubagio was given a black box warning by the FDA for liver problems which the FDA also insisted on for Aubagio.
Dr. Freedman dismisses this with the following statement:
Dr. Mark Freedman wrote:"Teriflunomide derives from leflunomide, which is used for treatment of rheumatoid arthritis. Unfortunately, leflunomide has a black box warning because of potential liver dysfunction. This actually never panned out but the warnings were there." [Emphasis added.]
Who, besides me, is going to take the time to look up the FDA's adverse drug reaction statistics to see whether Dr. Freedman is being truthful about this? Not many people. And in fact, the data
show that liver problems are the most commonly reported side effects of leflunomide which makes Dr. Freedman's glib dismissal of this, his specific statement that "this actually never panned out . . ." to be a complete lie. [That's not to say that Dr. Freedman is a liar. He may well have been given this talking point by the manufacturer and simply didn't check it himself.]
That's the kind of science we are dealing with.
Drugs will be tested and tested until someone in the statistic group in marketing can figure out a way to spin the data or run a new trial to avoid the problems highlighted by the last one.
Take one look at the data at http://www.ClinicalTrials.gov
. You will see hundreds of trials that have been completed for which there are no reported results. Bet you my last penny that every single one was a failure.
So if you rely solely on reproducibility
as a way to weed out bad drugs, you are going to be completely misled by the published "science."
And the FDA is absolutely useless in acting on our behalf to use real science to stop this kind of crap. If I were to report Sanofi over Dr. Freedman's statement, I can tell you exactly what will happen. Nothing. Best case in doing this for over 30 years is that after 18 months of illegal promotion of a drug, the FDA will send a letter to the manufacturer telling them to stop doing it. Of course, the manufacturer at that point will have started a new illegal marketing campaign.
The system is completely broken. Science has been completely prostituted in pursuit of revenue and does not provide any guarantee of safety or efficacy when it comes to drugs.