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The people vs. pharma
October 2017
by Peter T. Kissinger  |  Email the author
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Why can’t we all just get along? Two decades ago this was among the most admired of industries. Today we rank with terrorist groups, North Korea and Congress. Consumers are justified in not consistently trusting us with their lives, their fortunes and their sacred honor. More generally, the medical profession has transitioned from inviolate trust (“do no harm”) decades ago to a more participatory team approach today. This is a good thing, but the new transparency fosters debate. Patients have rapid and frictionless access to information today, but sadly struggle to separate the valid from not.
 
The knowns are unclear and they keep changing as the science advances. Many revert to old animal spirits, falling for advertisements and blogs, styled circa 1890. In our local newspaper, just this week, advertisements with these titles appeared: “New breakthrough for people suffering with joint pain,” “Amazing ‘fat magnet’ capsule triggers rapid weight loss…even if you cheat,” “Better than Botox: takes 10 years off your face in just 10 minutes” and “Memory loss reversal now possible, says scientist.”
 
Those pesky physician-scientists are at it again, pictured with their stethoscopes and white coats and associated with top-tier medical schools. These ads are footnoted to indicate “This product is not intended to diagnose, treat, cure or prevent any disease.” Otherwise, these snake-oil sales are comparable to those before the 1906 Pure Food and Drug Act. The gullibility of many of us has not yet been subject to a safe and effective treatment.
 
I put these ads in the context of what I see in university press releases, pharma press releases and much of what we necessarily report in DDNews. We seek magic bullets, but haven’t the time or space to define that “the magic” has a science fiction component. As Randy Willis recently discussed in these pages, we still have a problem with jargon implying to nonscientists a sophisticated knowledge that we don’t really own. Translating the statistics from many to a treatment for one is by now my tiresome complaint, both for biomarkers and new therapies.
 
Will thoughts about paying for the result, rather than the attempt, build more confidence in drug suppliers? A topical example is Novartis' equivalent of a money-back guarantee—if its CAR-T product Kymriah doesn’t begin to show efficacy in the first month, we don’t pay. I’m not sophisticated enough to understand how that will be determined. Won’t there be a fuzzy zone between “it’s working” and “it’s not working” when all is said and done? More statistical ambiguities will likely engender arguments with oncologists, patients, government and insurance companies. Given the initial $475,000 price, I salute Novartis, though, for trying a bold experiment (goboldly.com). It does suggest they support the product.
 
This pay-for-performance step is a component of “patient-centered healthcare.” That’s an odd phrase suggesting there was something else. But what was that? Perhaps it was the “we know best healthcare.” This guarantee is likely to be less patient-centric than Amazon Prime, where I can return most items with no questions asked. That idea, now standard, started as an experiment by several catalog outfits decades ago.
 
Speaking of Jeff Bezos, he’s competing with the late Steve Jobs with a catalog of quotes. Here’s one: “If you already know it’s going to work, it’s not an experiment; only through experimentation can you get real invention. The most important inventions come from trial and error with lots of failure. One reason why people don’t like failure is because it’s embarrassing.”
 
I believe the latter point has gotten pharma in trouble. Organizations, like many individuals, defend themselves against embarrassment in ways that create more embarrassment. This must be one reason pharma is held in such low esteem despite recent innovations among the failures. We’ve known for decades that drug response varies person to person. Some consider effectiveness 50 percent of the time a good thing, but until now, we’ve never been reimbursed for the trial and error process of finding the right drug at the right dose. In psychiatry the process can take a year. The false starts are never reimbursed. We do not know enough yet to select without experiment.
 
Another example of bringing patients into the center is the “Social Contract” announced by Allergan a year ago in the blog of their CEO Brent Saunders. He suggests there has been an unwritten social contract between patients and the industry, so Allergan has written it down. The sound-bite component was a promise to not increase prices for any product more than once a year and not by more than a single-digit percentage. This response to recent pricing shockwaves is helpful, but the brief contract is better considered in its entirety. It reflects the principles followed by most in this complicated industry. My worry is that too few will study the readily available document.
 
As with so many other things today, we’ve gone negative from a tsunami of ill-considered communications. Education in the biology of disease, business economics and statistics are falling increasingly behind. Countering that problem with hype from our own community is not working. The people are not trusting us, and that’s the biggest adverse event of all. Experiments from Novartis and Allergan should encourage more of the same. My blind surveys of college science seniors, many of them premeds, indicate that pharmaceuticals will account for between 40 and 75 percent of the $3.5-trillion healthcare expenditures in the United States in 2017. Serious money! I wonder what the larger public thinks?
 
We are not going back to believing in pharma. The new transparency is an improvement allowing the ambiguities to slowly become more widely appreciated: relatively effective, relatively safe and relatively economic. Pick two. Blame the biology for most of the trouble. It’s not pharma, FDA, Wall Street or insurance companies. They are convenient targets, but are amateurs vs. biology defending against outside interference by xenobiotic science.

Peter T. Kissinger (who can be reached at kissinger@ddn-news.com) is professor of chemistry at Purdue University, chairman emeritus of BASi and a director of Chembio Diagnostics, Phlebotics and Prosolia.

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