What Empire? What Empire is striking back? Answer: It’s the Empire of Beltway Anti-Medical Drug Naderites and bureaucrats—those who have piled high the red tape and the rent-seeking costs, thereby diminishing innovation and pushing down annual approvals of new drugs to levels below those seen in the mid-1990s.
And why is this Empire against Ted Cruz? What has Cruz done—beyond, that is, being a self-identified “courageous conservative” who wants to undo much of contemporary liberalism? Does Cruz really deserve to be seen as a sort of Luke Skywalker?
For better or for worse—better for patients, worse for Beltway czars—,Cruz has put forth new legislation, the RESULT Act, which would check the heretofore monopolistic regulatory power of the US Food and Drug Administration. In other words, if the Cruz bill becomes law, there is a an increased chance that this forbidding bureaucratic Empire will be vanquished, perhaps a little bit like the detonation of the “Death Star” in the 1977 “Star Wars” movie.
And needless to say, the DC Darth Vaders aren’t happy about that prospect at all.
But first, some useful context on drug regulation: The “pipeline” of new medicines and cures has been running dry for so long that even news that is merely not so bad is treated as great news. A Reuters headline from last January reads, “Pharma and biotech on a roll as drug approvals hit 18-year high.”
Yes, that sounds great, that approvals are “on a roll.” But let’s keep our proper perspective here: That headline means that new-drug approvals in 2014 were the highest since their previous peak in 1996. That’s right, 1996, in the heyday of AOL, Yahoo!, and the squawky dial-up Internet. Is that the level of technological attainment to which we should aspire? Really?
As we think back to that clunky era, we might ask ourselves: In this high-tech economy, are we really supposed to be satisfied with what was par for the course two decades ago?
It seems more than fair to say that most Americans, worried as they are about such devastating diseases as cancer and Alzheimer’s, would not be happy if they fully understood that new drug approvals are below where they were almost 20 years ago.
And yet, of course, it’s a safe bet that most Americans don’t know these details. All they know is that when they need treatment, it may, or may not, be there for them. Each year, more than 1.6 million new cases of cancer are diagnosed in the US, and each year, some 600,000 Americans die. And as for Alzheimer’s Disease (AD), which afflicts millions, not only is there no cure, but there’s no good treatment of any kind. Indeed, AD has become a veritable epidemic.
Now if you’re reading this article, you’re probably among the Americans who instinctively think we should be doing more about AD, cancer and other deadly diseases. After all, going back to the successful national effort against polio in the 50s—and before that, to the effective public-health campaigns against malaria, cholera, yellow fever, and tuberculosis—curing, or at least mostly vanquishing, disease has been the American Way.
And yet the fact is that the horrific current data about cancer and AD—and the even more horrific fact that we have so few effective treatments—is still not well known to the public. For perfectly understandable reasons, most people don’t focus on bad news until they have to. And so when they do, it’s too late.
No, this shortfall in cures—for which the FDA is in no small part responsible—is not a front-and-center political issue. Oh sure, there’s the occasional high-profile death that gets people thinking: For example, there was was the case of Beau Biden, the Vice President’s son, who died of a brain tumor in 2015. He was only 46.
You might think that it’s a terrible shame that someone dies like that, at such a young age, cut down in the middle of his productive life. And of course, those are entirely appropriate sentiments to have. And indeed, the case of young Biden seems to have made an impression on the political culture of DC: In his 2016 State of the Union, PresidentObama announced that he was designating Vice President Biden to lead a “moonshot” effort to cure cancer.
Without a doubt, in some focus-group somewhere, this presidential proposal tested well with the folks—of course it did, because such “Big Science” projects are exactly what the federal government is good at. From the A-bomb to the polio vaccine to the Internet to GPS, Uncle Sam can get some things done.
But there’s just one thing about this cancer proposal: Obama had made the exact same promise seven years ago, and nothing happened. That’s right, on February 24, 2009, in his first message to Congress, Obama said, that his administration would “launch a new effort to conquer a disease that has touched the life of nearly every American, including me, by seeking a cure for cancer in our time.” (Obama’s mother died of ovarian cancer when she was just 52.)
And of course, Joe Biden was sitting just a few feet away from Obama on that evening in 2009—just over his shoulder, in fact. So Biden must have heard the President make the cure-cancer pledge then. And of course, if Obama had truly followed through and delivered on that beat-cancer pledge, perhaps Beau Biden would still be alive today.
But maybe the elder Biden wasn’t much interested in cancer in 2009, for the simple reason that there was a lot of other stuff going on back then. And so perhaps Obama’s words went in one Biden ear and out the other. (In Biden’s defense, the beat-cancer pledge doesn’t seem to have stuck with Obama, either.)
Only when the crunch comes does the cure-idea come back into focus. But of course, when the crunch truly crunches, there might not be time to do anything. As the 17th century English political philosopher Thomas Hobbes observed, “Reality is hell seen too late.”
In any case, as we all remember, curing cancer was no priority, whatsoever, for the Obama administration during most of its existence. And now, in 2016, after seven-eighths of the administration’s allotted time has trickled through the hour glass? So now Obama wants to cure cancer? Well, for the sake all of our health and longevity, let’s hope that he manages to make, at least, some real progress. But at the same time, there’s plenty of reason to be skeptical that anything good will come of this new effort, because, as we shall see, Obama’s institutional allies are mostly on the other side of the anti-cancer effort.
We must be realistic enough to realize that a) the President doesn’t have much of a track record on this particular issue, and b) Obama has made it abundantly clear that many other issues are a higher priority for him and will loom larger in the accounting of his legacy, as he sees it. So most likely, Obama’s 2016 pledge on cancer will be forgotten as quickly as was his 2009 pledge on cancer.
Yes, Uncle Sam can do heroic things when he puts his shoulder to the to the wheel, policy-wise. But the key words there are “shoulder to the wheel,” as in, lots of work done and lots of policy changes made.
Indeed, whole fat books have been written about, say, the success of the Manhattan Project, from any number of perspectives. Not small in the reckoning of the success of the A-bomb project was the dedication and diligence of many brilliant scientists and public servants. Even today, more than seven decades later, names such as Albert Einstein, Enrico Fermi, J. Robert Oppenheimer, Vannevar Bush, and Leslie Groves still mean something. These were the men—heroes is a better word for them—who spearheaded the Manhattan Project, and they were overseen by relentless get-to-yes executives, such as Gen. George C. Marshall and, yes, Franklin D. Roosevelt. That’s how an idea transits from untested theory to nuclear explosion—and victory in World War Two—in less than six years.
So, in our time, if you were ever to see Obama, or any president, recruiting geniuses of that caliber for a new effort, well, then, there would real reason for hope that the mission can be accomplished. But if, instead, it seems that the White House is just rounding up some spin-doctors, hacks, and donors for a little dog-and-pony show, then abundant pessimism, and cynicism, is justified.
The story of the federal government fighting cancer is particularly important, because after all, the President of the United States just highlighted it in his annual speech to Congress. So let’s take a look down memory lane:
Back in 1971, with the success of the Manhattan Project very much in mind, President Richard Nixon proposed a national “War on Cancer.” The Congress, then controlled by the Democrats, enthusiastically joined with the Republican president to enact the legislation.
And what happened? The death rate from cancer fell. And other benefits flowed, too, from that effort: Dr. Robert Gallo, the co-discoverer of the HIV/AIDS virus tells anyone who will listen that his time spent as a young researcher at the National Cancer Institute in the 60s and 70s was critical to his future success against AIDS in the 80s and 90s.
Indeed, in America today, some 14 million Americans are cancer survivors—not so long ago, that number would have been close to zero. And to be crude about it, we might ask: What’s the economic value of all those people being alive? Answer: in the trillions of dollars, annually.
Okay, so we’ve had some successes in the War on Cancer. But have we won the war? Obviously not. But then, not every war is won quickly. Yes, bolstered by the Manhattan Project, we won World War Two in less than four years, but the Cold War took four decades. And other wars, fought by other countries, have lasted a long time, too: There was a Thirty Years’ War, and an Eighty Years’ War, and a Hundred Years’ War (the last of which actually lasted 116 years). Presumably, one fights a war because it needs to be fought, and not just because it can be won quickly. And like other meritorious medical wars, such as the war on malaria, the war on cancer still needs to be fought—and, of course, hopefully won. As noted, the real test of a war is the need to fight it—we can hope to win quickly, but we should be prepared, if we must, to win slowly.
Yet of course, since we want to win as quickly as possible, it’s critical that we learn lessons about the federal government’s War on Cancer.
But here’s a lesson not to learn: And that “lesson” is that medicine itself is part of the problem, even the actual enemy. That medicine was the enemy was the message of a book that was hugely influential when it was published in 1975, Medical Nemesis. The author, one Ivan Illich, seized on a few instances of tragic mistakes and sinister malevolence to spin his overall theory of widespread “iatrogenic,” that is, physician-caused, illness. That was the gist of the whole book: Doctors, and medicine, are bad for you.
Absurd as the thesis might sound today, Illich’s book came along at a pivotal time: In the mid-70s, the cumulative weight of Vietnam, Watergate, and economic stagnation was weighing down on the idea of progress like an Alp.
In such a charged environment, the systemic cynicism of, say, Ralph Nader seemed to many like the highest form of realism. In those days, if one wanted to know “the truth” about Washington, DC and national politics, one was advised, by the popular culture, to see films such as Executive Action or The Parallax View, which showed governmental officials as conspiratorial assassins.
And so, in the popular—and in those days, “popular” meant left-wing—imagination, everything that the Establishment touched came to be tarnished. Including, yes, medical research. Thus a movie such as Coma, from 1978, which showed contemporary doctors as Dr. Mengele-type murderers, could play in theaters, garner respectful reviews, and earn a good box-office.
Also, in that era, in the mid-70s, the environmental movement came into full flower, providing its adherents with a substantial intellectual critique of the whole idea of progress.
Thanks to the ascendant Greens, there was now a substantial body of thought that held that the whole idea of economic growth was illusory, even bogus. And so, in this telling, why trust anything that comes from corporate America, be it animal, vegetable—or medical?
Thus we come back to the Naderites, who made their “long march” through the American institutions of the law and the bureaucracy, starting in the 60s and 70s. Their fisted message of anti-corporatism fit snugly inside the Green glove.
So as the great wave of scientific progress emerging from World War Two began to subside in the 70s, the Naderites, in conjunction with the Greens, were on hand to tell us that this was, in fact, a good thing. Why? Because less growth meant less of an assault on the environment. And also, the fewer medicines, the fewer opportunities for “corporate greed,” and other depredations against Mother Nature.
Yes, that was the overall gestalt of the Green-tinged Naderites: Austerity for everybody and everything but the federal government—or better yet, world government.
To be sure, sometimes even good leftists forget this left-wing cant. In his recent State of the Union address, Obama not only spoke of curing cancer, but also took credit for defeating the Ebola virus, and seemed to indicate that an outright cure for Ebola was a good idea.
Yet for the most part, the left-wing Naderite Empire is still intact.
To illustrate this reality, we might consider the case of Dr. Sidney Wolfe, one of the earliest of “Nader’s Raiders,” and still, as we shall see, a go-to source for quotes and criticism of corporate America and Big Science.
In Wolfe’s considered, oft-repeated view, nobody should take a new medicinal drug until it has been on the market for seven years. That’s right, seven years: Imagine what that sort of rule would have done to those suffering from, say, AIDS in the 80s or 90s, if they had been told to wait for seven additional years. Short answer: They would have been dead.
Yet Wolfe, who has an MD, makes his living these days as a talking head, not as a physician. So he can afford to dispense lethal advice to his listeners.
Indeed, we should note that the shortfall in new medicines has made some observers happy—namely, the band of left-wing critics of the pharmaceutical industry, who see each new medicine as just a new way for “Big Pharma” to rip off the consumer.
So never mind what that sort of hiatus would do to the economics of drug production; Wolfe is so mistrustful, he says, of the industry that he wants that seven year “cooling off” period.
Yet if such a proposed rule—which the Naderites would enforce, if they could, by rejiggering our national health care system, which they have a right to think that they can control through the Obamacare apparatus—strikes most Americans as arbitrary, capricious, and even cruel, then it might be the case that most Americans are not suitable for service in the Naderite’a Beltway Anti-Medical Drug Empire.
Because, to put it mildly, Ralph Nader’s ideological prism is not the only way to see the life-sciences industry. Instead, many see the industry as a source of medical hope, as well as a source of economic growth and jobs. Indeed, in the view of some “rebels,” the fact that the life-sciences industry doesn’t produce more cures has more to do with FDA regulation and federal price controls than any inherent defect in the industry.
It’s fair to say, in fact, that the Naderite Imperial view has been dominant among Beltway experts and among chattering-class allies at, for example, The New York Times and The New York Review of Books. In the pages of those and like-minded publications, it’s a basic given that Big Pharma is the enemy. In addition, there’s a skepticism, even hostility, toward science—hence Wolfe’s proposed seven-year “cooling off” period.
The Naderite Empire might deny that it is anti-science, but the proof of of the accusation has been by fall-off in new-drug approvals. The fact that there has been a “crash” in medical production over the past few decades—and that it has received so little publicity—is a vivid testament to the power of this Naderite Empire to cloud our thinking on the most profound issues of life and death.
Back in 2010, I called this overall phenomenon “Scarcitarianism,” as in, scarcity. And in particular, I was thinking of the Obama administration’s campaign against the cancer drug Avastin. The drug cost too much, the Obamans said—never mind that to just about everyone but a professional Scarcitarian, being alive was worth more than the cost of the drug.
But now, finally, thanks to Sen. Cruz and his allies, there’s a new political threat to this Naderite status quo: On December 11, 2014, Cruz and his ally and colleague, Sen. Mike Lee of Utah, introduced the RESULT Act, which would amend the Food, Drug and Cosmetic Act to allow for reciprocal approval of drugs among various select advanced nations. As the Senators said in announcing their bill,
Specifically, the RESULT Act would require the Food and Drug Administration (FDA) to quickly review drug, device, and biologic applications from sponsors who have products approved and sold in developed and trustworthy countries. This will deliver lifesaving treatments and cures to American doctors and patients from countries we trust.
Approving new medicines from trustworthy countries, thereby expanding competition choice: To many Americans, that might sound like a pretty good idea. But just a few days later, on December 21, in the publicationStatnews.com, the Naderite Empire came roaring back: One Ed Silverman headlined his piece, “Why Ted Cruz’s plan to overhaul the FDA would jeopardize public health.” That’s a serious charge: jeopardize public health.
No, Silverman doesn’t like the Cruz-Lee proposal, not one little bit: He calls it “misguided.” As Silverman says,
If the bill becomes law, Americans will likely find themselves treated with medical products that were approved with varying, and quite possibly, lower standards elsewhere. In effect, his legislation stands to jeopardize—not improve—public health.
So what’s the truth about that? I put that question to my friend and colleague at the Center for Medicine in the Public Interest, Dr. Bob Goldberg, who has been following the ins and outs of FDA policy for decades.
As Goldberg told me,
There is no evidence that approving new drugs or devices faster is less safe. None. On the contrary, the record shows that drugs approved quickly are no more likely to be pulled off the market than those that are not.
That might seem a little counterintuitive, but as Bob explained,
Thanks to computers and other superior technology, the FDA has been speeding up in recent years. It took about half as long for a device to win FDA approval in 2014 versus 2013. Again, no danger detected. Last year, FDA proposed an Expedited Access “Pre-Market Approval” for breakthrough devices that can treat unmet medical needs. Final guidance on that proposal is one of the agency’s priorities for Fiscal Year 2015.
And that’s all to the good. Adds Goldberg, “That is essentially Senator Cruz’s proposal in a nutshell.”
As we have seen, the heart of the Cruz-Lee proposal is to allow “competition” between US regulators and the regulators of trusted foreign countries, such as in the European Union and Japan.
Goldberg further explains that the Cruz-Lee idea points to where the FDA has already been heading:
The FDA usually approves new drugs faster than the EMA (European Medicines Agency) and the EU has sought to adopt the FDA approach to reduce review times. They have done so without any dangers. Thus they have actually adopted, in effect, much of the Cruz-Lee approach.
Finally, both the EMA and FDA are working to harmonize regulatory requirements for drugs and devices. That means same standards here and across the pond. Under that scenario why is a 30-day review for highly important medicines and devices unreasonable?
FDA approval-phase times have generally declined substantially for all types of applications since the mid-1990s following legislation that provided a new source of income for the agency (user fees). So where’s the danger?
Of course, to say that the FDA has speeded up its evaluative process is not the same as saying that the overall process for bringing new drugs to market has improved; there can be a big difference between the speed by which the FDA tests a drug and the overall cost of bringing a new drug to market.
So here we might step back and take a broader look at the FDA regulatory process as it has played out over the last half-century. In particular, we might take note of a baleful phenomenon that has been haunting the FDA, and all of us, for these past few decades: Wags call it “Eroom’s Law.” That’s Moore’s Law spelled backwards. And it means, for example, that a new drug that might have once cost less than $100 million to develop now costs well over $1 billion.
Moreover, parallels exist in other areas as well. If we were to compare FDA drug approvals to other metrics of economic and technological progress, we would see, for example, that the real GDP of the US is up by more than half since the end of 1996, and the Dow Jones Industrial Average has gone up by some 250 percent. And, of course, dial-up Internet is an un-missed artifact of the kludgy past! Once again, this shortfall in drug production has received little media attention: and that’s a powerful, albeit depressing, indicator of how little thought the chattering classes give to these matters.
Yes, it is remarkable that the the crash in new drugs has received so little attention—even though, say, in 2002, the number of new drugs approved by the FDA bottomed out at barely a third of 1996 approvals. We might also note, in particular, that the variables that seem to be affecting drug production, including regulation and litigation, have been barely mentioned in the dominant political-media discourse. To them, the story of the shortfall of new drugs and cures coming through the R&D pipeline—is not a story. Of course, the piper eventually comes piping for all of us. But then, as Hobbes says, hell is reality seen too late.
Once again, why this relative silence from the media echo chamber? Why this lack of interest in the drug pipeline? One further explanation might be that political fights over health insurance have come to displace fights over health itself. That is, back in the early Nineties, Hillarycare, pro and con, was the big topic. And in the Teens, of course, the fight has been over Obamacare, pro and con. This intense preoccupation with the finance of healthcare seems to have overwhelmed the issue of the science of healthcare.
Meanwhile, as Democrats and Republicans have wrangled over health insurance, the stuff that most often provides health itself—that is, newer, more effective drugs—has been slipping away. This drying up of the drug pipeline has been especially noticeable in the case of antibiotics; “superbugs” now stalk hospitals and, perhaps soon, the general population.
Moreover, this drying up of the drug pipeline is also evident in other areas: We have made essentially no progress in treatments for Alzheimer’s Disease, the life-prospects of tens of millions of ordinary Americans have been sadly dwindling.
So when we compare the status of the new-drug “pipeline” to that of other technology pipelines, we see that when it comes to medicinal drugs, the bonanza of Moore’s Law has been pushed aside by the perverse economics of “Eroom’s Law.” We can see it plainly: Under Moore’s Law, computers become more ubiquitous and less costly, while under Eroom’s Law, drugs are becoming scarcer and more expensive.
We might pause for a moment longer over this dichotomy between the life sciences and the computer sciences. If computers had shown two decades’ worth of stagnation, even retrogression, it’s a safe bet that people would have noticed. After all, we have come to expect that computers get better and cheaper every year; any slowdown, let alone reversal, of this pattern would be highly newsworthy.
But happily, the political wheel is turning. That is, the long stagnation of drugs could be coming to an end, thanks to the efforts of a few visionary leaders on Capitol Hill—none of them, we might note, members of the Naderite Empire. These hero “rebels” include Rep. Fred Upton and Sen. Roger Wicker, as well as, of course, Sens. Cruz and Lee.
If you think that we need more medicine, more choice, and more cures, you might agree that Cruz and Lee are on the right track. It’s just too bad, as we have seen, that not everyone agrees.
And here’s a sad little coda to this story of regulatory molasses: The headline in January 2 edition of The New York Times speaks volumes: “F.D.A. Regulator, Widowed by Cancer, Helps Speed Drug Approval.” The article detailed the story of Dr. Richard Pazdur, the director of the Office of Oncology Drug Products at the FDA. That title might be unfamiliar to most Americans, but it doesn’t take long to realize that it’s indeed a powerful position. The Times quoted Ellen Sigal, founder and chairwoman of Friends of Cancer Research, as saying, carefully, “Rick Pazdur is the most important person in the cancer world.”
And yet as the Times noted, in past years, Dr. Pazdur had been “denounced by many cancer patient advocates as a slow, obstructionist bureaucrat.” He was seen as among the Imperial Naderites who have controlled the discourse over the past few decades.
Yet while the Naderites proved that they can control politics, they can’t affect Fate. In 2012, Dr. Pazdur’s own wife, Mary, was diagnosed with ovarian cancer; she died of the disease in November of 2015.
And as the Times details, that tragic experience seems to have wrought a change in Dr. Pazdur and his workplace. It caused, the Times writes, “a profound change at the F.D.A., a speeding up of the drug approval process.” And theTimes was blunt as to the precise causation: Speaking of Dr. Pazdur’s late wife, the Times observed, “Ms. Pazdur’s three-year battle with cancer was a factor, they say, in Dr. Pazdur’s willingness to swiftly approve risky new treatments and passion to fight the disease that patient advocates thought he lacked.”
As my colleague Bob Goldberg bluntly observed of Dr. Pazdur, “He was an obstructionist until his wife got sick.”
The Times didn’t ask Dr. Pazdur about the Cruz-Lee legislation, but perhaps he will get a chance, sometime soon, to opine on it.
Yes, Hobbes was surely right: Hell is reality seen too late. Yet of course, the story of the late Mrs. Pazdur, as well as the other 600,000 cancer deaths, doesn’t seem to have moved all observers.
For example, speaking for the Naderite Empire is the same Sidney Wolfe, whom we met earlier, calling for the seven-year slowdown in the drug industry. Quoth Wolfe: “The F.D.A. is more beholden to industry now than at any time since I became a close observer of the agency in 1971.” He adds that too many F.D.A. decisions “are driven by industry concerns, and as a result people are getting hurt.”
Unfortunately, the Times didn’t press Dr. Wolfe, as to how, precisely, people could be hurt more than they already are, dying of cancer and other diseases in such huge numbers.
Perhaps some of the Republican “Luke Skywalkers” leading the rebellion—that is, the effort to revive the medical pipeline on Capitol Hill—such as Upton and Wicker, as well as Cruz and Lee, can call Dr. Wolfe to testify, and let him, like Ed Silverman, make their now-over-familiar case for less medicine, not more. And let’s hope they get maximum exposure for their argument, so that the American people can hear for themselves the Naderite argument that we have too much medicine.
Yes, let’s hope that Upton, Wicker, Cruz, and Lee listen to the Naderite criticisms of their revolutionary approach—and then get on with the important work of advancing cures.
The stakes are high. As my pal Bob Goldberg says, “If you are not part of the process of creating cures, you are part of the process of disease.”