The sheer size and scope of the GranuFlo disaster is difficult to comprehend. On some level, Fresenius’s gruesome, cynical calculus makes sense. The company, after all, brings in 64% of its annual global revenue of $12.8 billion from its North American dialysis clinics. GranuFlo is one of the most profitable products in its dialysis arsenal. So why would the company jeopardize such an enterprise without a really good reason?

The deaths of hundreds of patients might strike some as a “really good reason.” But Fresenius has demonstrated, time and again during its history, a disturbing tendency to accept significant collateral damage, as long as the end result is money in the bank.

• How many hundreds or thousands of people would have to die before the company would, on its own, take action?
• How come more regulators and activists are not more up in arms about the situation? Perhaps, as Joseph Stalin cynically observed, “One death is a tragedy; a million deaths is a statistic.” Or perhaps the sheer magnitude of the crisis is too much to handle.
• Even consumer protection agencies have been torpid to act and, by some objective measures, ineffective. So who will stand up for the victims?

What Is Wrong with the Medical Products Industry?

The confused state of the medical products industry is difficult for most people to understand. In an eloquent piece penned for the British Medical Journal, Scottish general practitioner, Dr. Des Spence, outlines the scope of the problem:

“The billion prescriptions a year in England in 2012, up 66% in one decade, do not reflect a true increased burden of illness nor an aging population, just polypharmacy supposedly based on evidence. The drug industry’s corporate mission is to make us all sick, however well we feel. As for [evidence-based medicine] screening programmes, these are the combine harvester of wellbeing, producing bails of overdiagnosis and misery. Corruption in clinical research is sponsored by billion dollar marketing razzmatazz and promotion passed off as postgraduate education. By contrast, the disorganized protesters have but placards and a couple of felt tip pens to promote their message, and no one wants to listen to tiresome naysayers anyway…how many people care that the research pond is polluted with fraud, sham diagnosis, short term data, poor regulation, surrogate ends, questionnaires that can’t be validated, and statistically significant but clinically irrelevant outcomes? Medical experts who should be providing oversight are on the take. Even the National Institute for Health and Care Excellence and the Cochrane Collaboration do not exclude authors with conflicts of interest, who therefore have predetermined agendas. The current incarnation of EBM (evidence-based medicine), is corrupted, let down by academics and regulators alike.

What do we do? We first must recognize that we have a problem. Research should focus on what we don’t know. We should study the natural history of disease, research non-drug based interventions, question diagnostic criteria, tighten the definition of competing interests, and research the actual long term benefits of drugs, while promoting intellectual skepticism. If we don’t tackle the flaws of EBM, there will be a disaster, but I fear it will take a disaster before anyone will listen.”

While commenting on Dr. Spence’s plea, Dr. Malcolm McKendrick remarked: “I have also virtually given up on references. What is the point, when you can find a reference to support any point of view that you want to promote? Frankly, I do not know where the truth resides any more. I wish to use evidence, and the results of clinical studies, but I always fear that I am standing on quicksand when I do so… We are at a crisis point. Medical research today (in areas where there is money to be made) is almost beyond redemption. If I had my way I would close down Pubmed, burn all the journals, and start again, building up a solid database of facts that we can actually rely on – free from commercial bias. But this is never, ever, going to happen.”

A cynical, sad set of commentaries — but possibly justified, given the state of affairs.

For help with your GranuFlo case, call Davis & Crump at 800-277-0300 for a confidential case evaluation.