Big Pharma and medical device makers have mastered the art of crying “Poor me!” complaining without end about the time and costs of getting products to the market and the need for regulators to lighten up. New information, however, undercuts this industry whine—and it reminds that the nation’s watchdogs need, if anything, to be tougher and more vigilant.
Let’s start with new research, published in JAMA Internal Medicine, that calls into question Big Pharma’s long-espoused position that its whopping prices (which the public wants official action on—see graphic) are warranted because a new drug costs upward of $3 billion to research and develop. But based on a scrutiny of public information about expenses to develop 10 new cancer drugs—among the most costly to get to market—researchers found drug makers’ R&D costs were far less — closer to $650 million.
Although independent experts praised the new study, drug makers challenged the cheaper R&D estimates, with backing from Tufts researchers’ who had set the earlier, pricier benchmark. It’s difficult to make apples and oranges comparisons. That’s because Big Pharma wants any tally of its drug development expenses to include its costly failures.
But patient advocates who are alarmed by skyrocketing drug prices have fired back, arguing that manufacturers want consumers to foot the bill without complaint when they, analogously, buy lots of losing lottery tickets—without also recognizing what jackpots they realize when a winner comes in.
As the new research points out, drug makers may have expended roughly $650 million on R&D for the products studied. They also saw huge returns on their investment—drugs with revenues ranging from $1 billion to $22 billion just since their approval by the federal Food and Drug Administration.
It’s also worth remembering that makers— besides getting to set largely unchecked, astronomical, and for patients’ budgets- and spirit-crushing prices—get legal protections for their products under U.S. patent law. Big Pharma long has griped that the decades of exclusivity and legal protection afforded under current law is insufficient for makers’ needs to recoup their ROI, and makers have sought to exploit other ways and designations under the law that give their products even more shelter from copying and generics.
Getting tribal with drug patents
Leave it to makers, of course, to devise dubious ways to maximize profits: Allergan, for example, has concocted a new ploy with the Saint Regis Mohawk tribe in Upstate New York. The firm purportedly has transferred to the tribe its patents on the dry-eye drug Restasis, paying the Native Americans a licensing fee in the millions. The tribe, meantime, is claiming its status as a sovereign nation to seek dismissal of patent claims against Restasis, actions in the United States Patent and Trademark Office.
If this legal tactic sounds familiar, it should: If allowed, it well may put grandma’s life-saving drugs in tribal hands, along with money flying around from Big Tobacco and organized gambling—some other interests that have won notoriety for exploiting tribes’ sovereign status to make big money on cut-rate cigarettes and casinos. Such moves, by the way, haven’t benefited all too many Native Americans, many of whom still live in abject poverty on federal reservations.
In my practice, I see not only the huge harms that patients suffer while seeking medical services but also the big damage that can be inflicted on them by dangerous drugs and defective and dangerous products.
If you’re wondering where your taxpayer-supported federal regulators may be as Big Pharma wheels and deals and beefs about its costs and oversights, Scott Gottlieb, a physician, the new FDA chief, and onetime industry executive, continues to argue—as he pronounced loudly before his nomination and confirmation—that Uncle Sam needs to speed and ease the nation’s process for reviewing and approving prescription medications and medical devices, in the name of expediting life changing and saving innovation.
Why regulators need to follow up on drugs after approval
Call me a skeptic. There’s a growing body of disconcerting research, examining FDA oversight of drugs that get to market, especially through speeded up reviews and approvals. One new study published in BMJ (previously the British Medical Journal) has concluded that more than 380 drugs that won expedited FDA consideration and that researchers reexamined were “associated with increased safety related label changes after approval, particularly for the types of changes representing the highest risk warnings.”
As for medical devices, the Association of Health Care Journalists deserves credit for its blog post urging reporters to look hard at the skimpy evidence that manufacturers may present to regulators to get products hurried to markets. The author says journalists and patient safety advocates need only look to harms caused by lap bands and morcellators, tools that were supposed to save surgeons time by letting them grind up instead of removing internal tissues but that ended up spreading cancers, as well. Too few medical devices, including coronary stents, hip prostheses, and cosmetic facial injectable implants, have been subjected to rigorous clinical trials, with some getting waved by with as little as one study.
The risks posed by medical devices, meantime, couldn’t be more real than the health struggles pediatric patients are experiencing in New Orleans. There, a children’s hospital has reported that at least a dozen of 50 or so youngsters who underwent heart surgeries have suffered incision infections, apparently linked to a unit that keeps patients warm or cool during coronary surgeries. The hospital insists it has followed FDA recommendations to avert infection risk with the temperature-regulating machine, which already has been tied to dozens of infection cases around the country.