I don’t know what is more troubling here, a drug with a digital tracking device or that the FDA approved it with limited evidence. In 2017 a drug with digital tracking got FDA approval to be sold to the public. A recent study, July 2019, found that the evidence used to approve this drug was very limited. To me this looks like another case of the FDA being in the pocket of the pharmaceutical companies not working for the safety of Americans.
The drug in question is an antipsychotic called aripiprazole. In 2014, aripiprazole was the best-selling drug in the US. With an average cost of $800 for a month’s supply, the drug generated over $7.5 billion in sales the year before it went off patent in 2015. As an antipsychotic it can treat schizophrenia, bipolar disorder, depression, and Tourette syndrome. It can also treat irritability associated with autism. In 2017 the maker applied for a new patent for the drug as they had added a digital tracking device to the drug. I guess to tack patient usage for patient compliance and modify dosage. The digital version was approved by the FDA and is available at the rate of $1700 per month, the generic non digital version is only $20 per month.
The current study looked at what data the FDA used to approve the drug as well as what was written about the drug in the media. The authors of this July 2019 study found that the FDA used scant evidence to approve the drug. No clinical testing of the digital version versus the non-digital version or even a placebo was required or looked at by the FDA even if one was completed. The only data the FDA looked at was how compliant the patient was in taking the drug. The researchers also identified 14 scientific papers that cited the trials as well as 70 news stories. They concluded that nearly 80% of the scientific papers and three quarters of the news stories were misleading with regard to potential benefit. So not much evidence that this “new” drug is any more or less effective than the original and some serious propaganda was written on it.
The FDA did approve the original drug based on clinical trials. It also approved the digital tracker in 2012 for ingestion based on clinical trials. You could argue that the FDA had all it needed to approve this “new” formulation since the only change was the addition of the digital tracker. I still think that the FDA should have required a new clinical trial of this new version of the drug. Testing the safety of this combination specifically.
A big component of this whole thing is the pharmaceutical company gets a new patent on an old product of theirs. When they lost their patent in 2015 yearly sales dropped from that $7.5 billion to $600 million. This company could also benefit from friendly media coverage which is not necessarily scientifically accurate according to this July 2019 studies authors. This sounds a little bit like what happened with Purdue Pharma in their role on not stopping the myth that Oxycontin was less potent than morphine. That company doesn’t have to stop the myth but should they have. If this other company knows that misleading news items are out in the public sphere but does not correct them should they be held accountable even if staying silent is legal?
I am all for as little government intrusion into our lives as is possible, western capitalism has created the modern world. Pharmaceutical companies have shown time and again that they are irresponsible and worthy of our criticism. The FDA could do better in balancing American safety with pharmaceutical innovations that can save lives. There has been more than one occasion where the FDA approved a drug which they later pulled, or asked the maker pull, for safety issues.
I don’t have any answers here just questions. Can we trust pharmaceutical companies? Can we trust the FDA? Do you want to take a drug with a digital tracker embedded in it? Should these drug’s cost $1700 or even $800 a month when the generic costs $20 a month? Do you even need to take these drugs to begin with?