A new strategic partnership between a massive healthcare data collector and Novartis holds disturbing implications for clinical trials
Where to start on the troubling patient-information-miner/Big Pharma collaboration announced in March 2016! It’s “fully anonymized to the user,” says the “clinical data network of healthcare providers, pharmaceutical companies, and contract research organizations,” but they don’t say how that is achieved or what firewalls, if any, are in place.
To clarify, this is a private, for-profit corporation that buys patient information from the above-listed entities (with patient names redacted, they assure us) and then sells it to pharmaceutical corporations who want to “disrupt the clinical trial design space.” Presumably, we all know that clinical trials aren’t good enough nowadays, and need to be disrupted. Certainly Big Pharma ought to know, considering it has been sponsoring clinical trials of its own prospective drugs for decades now!
The great unknown factor here – though as a medical doctor and researcher who has participated in clinical trials, I have my suspicions – is whether the pharmaceutical corporations are seeking to achieve more accurate, reliable results or merely more favorable results. Massaging the data and achieving more “passing grades” by making the tests easier, if you will.
Even before the advent of technologies that make this type of partnership possible, drug companies sought, through sponsorship, trial design, and direct participation, to control the outcomes of clinical trials. The FDA, meanwhile, has sought to reduce its own direct participation in trials. The bureau has long enjoyed the implication that it is simply too busy to test prospective pharmaceuticals. For them, it’s convenient to find a fox hanging around the chicken coop. “Would you like a job counting the chickens?” they ask Big Pharma.
So now the fox has friends who come in and… “help” with the chicken-counting. And, yes, they soon will be running the whole farm, because the FDA doesn’t want to meddle!
This seems a problem of focus and perspective. The FDA, with its over 14,000 employees, $4.4 billion yearly budget, and sprawling, Silver Spring, Maryland campus, has become so unwieldy and inefficient that it has set aside its primary purpose: To protect the American people from bad food and bad drugs.
The pharmaceutical industry, conversely, is hyper-focused on getting the FDA to approve whatever it’s asking for, in order to get their product to market. Now, it has a data mining partner to help it along further in clinical trials.
In my hierarchy of clinical trials, each type is ranked from I-V in likelihood of reliable, untainted results. The types of trials conducted by Novartis and their patient-information partner land somewhere between a IV and a V, the two lowest-quality trials. They rank so low, because, a) they are sponsored by the drug company, and b) because they are largely based on summaries of clinical data.
So the fox and its allies are getting better and better at getting what they want, while the FDA remains all too content with its image as a bumbling giant.