Today, Boehringer Ingelheim’s, manufacturer of Pradaxa, new research partner, NextBio, announced that Boehringer Ingelheim is signing a multi-year renewal agreement with NextBio. NextBio provides data infrastructures for processing genomic data in hopes of providing useful insights into the causes of disease, which may lead to cures. The partnerships between NextBio and companies like Boehringer Ingelheim, GlaxoSmithKline, Pfizer, etc. are potentially a dangerous preview of the research that can be expected to come.
“The technologies of the future may provide useful insights but they also expose patients to potential dangers of an unprecedented level. Companies like Boehringer Ingelheim and GlaxoSmithKline have put products on the market before fully evaluating the potential dangers they could pose to patients,” commented Daniel Nigh, an attorney with the Levin, Papantonio law firm who practices in the areas of bad drug and personal injury litigation.
The ability to collect vast amounts of data on patients is a growing market. Medical research and patient care stand to improve from a level of specificity that has never been experienced. The advent of wearable technology and the fact that more than half of the entire adult population in the United States is carrying a computer in their pocket will give researchers, physicians, and scientists a window into the lives of their patients that has not existed before now.
Boehringer Ingelheim is currently facing thousands of Pradaxa lawsuits for its drug. Pradaxa is an anticoagulant that is used by healthcare providers to treat blood clots, reducing the risk of stroke. Despite the company’s claims that the drug is a safe alternative to warfarin, many dispute the claim, arguing that the drug can be linked to more than 500 deaths.
“Attorneys litigating the products liability action in the United States dispute the claim that Pradaxa is equally as safe as warfarin. We have some very serious concerns about the integrity and reliability of the data from Pradaxa’s clinical trials,” commented Ned McWilliams, an attorney with the Levin, Papantonio law firm who practices in the areas of product liability and bad drug litigation.
The FDA has already expressed that the proliferation and expansion of data collection online strains its ability to police and review the information being disseminated about new drugs as quickly as it is being produced:
“The Internet and social media have increased the volume and extent of materials and speeded up the delivery of those materials. Websites can have hundreds of pages and can change daily. It is important to know that although we closely monitor what companies say, we generally do not have authority over statements made by independent organizations or persons – what we call third parties – unless they are acting on behalf of a company.”
Beyond the means of reporting the information the companies collect, the new methods of collection are in question. Mobile apps are exploding on the market, promising to monitor your vital signs and in some cases replace medical testing equipment. The FDA is evolving along with the market evolutions, but the possibility exists for the speed of the digital age to outrun the agency’s ability. The new association between NextBio and Boehringer Ingelheim being the latest installment in the saga of big pharma, big data, and you.
Joshua is a writer and researcher with Ring of Fire.