September 29, 2015
By Shannon Brownlee, MSc
If you thought overdiagnosis is a problem with existing cancer screening tests (think mammography, thyroid ultrasound, and the PSA test), now there’s CancerIntercept ™ Detect. This is a blood test that is mailed directly to consumers, who mail back a sample to the company, which then tests the blood for genetic biomarkers associated with 10 different types of cancer. Think of it as a whole body CT scan, without the expensive scanner! What could be better?
There’s just one bump in the road. The manufacturer, Pathways Genomics, neglected to get their product approved by the FDA before they started marketing it. Oops. They can always offer the excuse that comedian Steve Martin suggests that taxpayers use when they fail to file their taxes: “I forgot.”
The agency got wind of CancerIntercept™ Detect and sent the company a letter, suggesting that maybe it should have applied to the FDA first, before putting it on the market. The company will now have to make a formal application, but that’s not going to be much of a hindrance. The rules for most devices don’t require that manufacturers show their products lead to better outcomes. The device just needs to function as intended. And the intent here is to detect cancer biomarkers, which might or might not indicate a cancer that needs to be treated. You can find the evidence the company is using to justify the use of its product here. I predict we’ll see lots more people being scared out of their wits when their pseudodisease is detected.
In other news, we should all be thanking Martin Shkreli for making clear that drug R&D should be publicly funded. Shkreli is the 32-year-old Wall Street wunderkind who bought the rights to pyrimethamine (Daraprim), a drug that has been used successfully for decades to treat the parasitic infection toxoplasmosis. No sooner did Shkreli’s company, Turing Pharmaceuticals, buy the rights to Daraprim, it promptly raised the price from $13.50 to $750 a pill.
After an outpouring of outrage on social media, Shrkeli tried to claim his motives were entirely altruistic. The nearly 5,000% hike in price was needed, he said, to spur breakthroughs in the treatment of toxoplamosis, which has seen “no significant advances or research . . . in decades.”
Right. And why exactly do we need a new drug to treat toxoplasmosis when the old and formerly cheap drug worked just fine? As oncologist Peter Bach put it, our regulatory system is so broken, “even a [32-year-old] child can manipulate it.”
Meanwhile, Hillary Clinton seized the moment to unveil a plan to control drug prices, a move that triggered the inevitable argument from the fundamentalist church of capitalism: Anything that constrains the massive profit margin of the drug industry represents an “assault on innovation.”
If it’s new, it must be innovative, right? Just how innovative is the drug industry, anyway? In the last 25 years, hundreds of new drugs have come to market. You might say that’s innovation at work, except that many of them have been taken off the market after they turned out to be harmful. Only about a third were new molecular entities, versus me-too versions of an existing drug.
Yet they all get rewarded with the same patent exclusivity as the original. And despite claims that me-too drugs bring down prices, they all cost an arm and a leg, because as we’ve been told time and time again, the drug industry needs those high prices to support their R&D, which gives us all those innovative wonder drugs . . .
Which brings us to the second assumption about profits and innovation: the profit motive is the only thing that will inspire scientists to come up with the cures we need. Where is it written that the desire for money leads to innovation, or is even necessary for innovation?
Seriously. I’ve been searching the web, and while I’m no economist, and I’m probably not using the right terms for my search, it seems more than a little surprising there aren’t tons of scholarly papers showing a direct relationship between innovation and profit, given how often the argument gets repeated.
In fact, maybe profit-seeking has the opposite effect. In a 2011 talk, Clayton Christensen, the Harvard Business School professor who literally wrote the book on innovation, made the case that the relentless pursuit of quarterly profits is killing innovation in American business.
There’s also a whole raft of psychological literature that finds that monetary rewards often dampens intrinsic motivation, which is essential for creativity. Money even seems to mess with the motivation to do the right thing for patients. See this Health Affairs paper on the counterintuitive effects of the Pay for Performance rewards insurers are using to get doctors to deliver things like flu shots.
So what does drive innovation? I won’t bore you with the old saw from Jonas Salk, inventor of the polio vaccine. . . oh, heck, I can’t resist. When asked by newsman Edward R. Murrow who owned the patent for the vaccine, Salk replied, “Well, the people, I would say. There is no patent. Could you patent the sun?” The implication being this: the polio vaccine is a common good, and Salk’s motive for creating it was to relieve suffering and benefit humanity, not to make a bundle of money.
The point is, making money may well be a driver of human ingenuity, but it’s only one driver, and probably not even the most important one. Of course, the church of market capitalism wants us all to believe that profit is the only motive, with a corollary that says the bigger the profit, the greater the innovation.
Which is a very handy thing to have people believe when you want to charge an outrageous price for a new drug like sofosbuvir (Sovaldi) for Hepatitis C, or jack up the price of an old one.