The Discerning Texan
-- Edmund Burke
Thursday, May 29, 2008
FDA: Time to pull the plug on a Bloated, Counterproductive Federal Swamp?
That we instinctively work to improve our own lot first is why progress for all happens so much faster in free, open marketplaces under the rule of law. There, everyone can trade to make themselves better off: specialization and comparative advantage means that trade benefits both sides. Trade is not zero-sum; we grow the whole pie by specializing and trading the results of our work. You go off and work to make the medicine I want, and many people like myself give some our our resources to purchase the end result. Both sides benefit, exchanging - what is for them - lesser value to receive greater value.
There is no open marketplace for medical technology in the developed world, however. Instead, we see a very different set of incentives dominating the state of research and development. Regulatory bodies like the FDA have every incentive to stop the release of new medicine: the government employees involved suffer far more from bad press for an approved medical technology than they do from the largely unexamined consequences of heavy regulation. These consequences go far beyond the obvious and announced disapproval of specific medical technologies: the far greater cost lies in all the research, innovation and development that was never undertaken because regulatory burdens ensure there would be no profit for the developer. Personal gain for the regulator is thus to destroy the gains of people they will never meet, the exact opposite of what occurs in an open marketplace.
An article that looks at one small part of the destruction caused by the FDA caught my attention, and particularly these snippets:Since 2005 the FDA has approved 18 new cancer drugs, many of them breakthrough products. But the pipeline contains hundreds more that will never get to market because corporate developers aren't able, or willing, to come up with the money, time, and patients necessary to establish acceptable data. ...
The clinical trial process now is a three-part, years-long effort that effectively kills off all but a handful of once-promising drugs. ...
It would have been the first new drug for prostate cancer in 20 years
Twenty years! Just stop a moment and think about how far and fast biotechnology and medical science has moved in the past twenty years. Think about what the far less regulated computing industry has achieved in the same timeframe. We live in the early years of the biotechnology revolution, with something amazing and new demonstrated in laboratories every week. Yet the dominant regulatory body for one of the most advanced regions of the world has managed to stop the clock at 1988 for a major disease, the subject of research in a hundred laboratories worldwide.
This sitation exists in every field of medicine, and all participants labor under the crushing burdens imposed by regulators incentivized to stop progress from happening. The same will be true of the future of longevity medicine, unless we do something about it.
The insanity of this all is quite staggering - that people largely accept and defend the need for regulation that achieves this sort of result, that is. I have heard it said that the failure of libertarianism, of the urge to freedom and personal responsibility, is a failure of imagination on the part of those who have been brought up knowing nothing other than government and regulation on a massive scale. The majority cannot make the leap to see an unregulated marketplace for medical development that works in the same way as the unregulated marketplace for computers - enormous choice, low barriers to innovation, efficiency and low cost, competing review organizations, accountable sellers, rapid progress and responsiveness to customers driven by fierce competition, and so forth.
To this excellent point (and be sure and follow all those links...), I will add this from Mark Thornton today's Wall Street Journal; if any Republicans are going to be chased out of the Senate soon, the names Chuck Hagel and Charles Grassley certainly are near the top of my list. And Thornton has put together a very coherent case for lowering the boom on Mr. Grassley sooner rather than later (again, please read the whole thing):
Milton Friedman always argued that the problem with Government solutions vs. private ones is that when private efforts fail, at least their inability to solve the problems they were created to address drives the market to discontinue their use. And when the inability of one private solution to solve a problem is coupled with the profit motive, other entitities and the innovation they bring invariably results in a solution that will solve the underlying problems faster and with less investment.
Enter Mr. Grassley. It seems not a week goes by without him making a public accusation of evil doings within the drug industry or the FDA. Yes, Mr. Grassley did some good after the Vioxx episode, by focusing on the woeful manner in which postmarketing drug safety is managed and regulated by the FDA. But he and his staff should have kept their eyes on the ball. In the case of Avastin, the senator implied in his GAO request that something sinister occurred during the FDA's premarket deliberations, and that surrogate endpoints were the new bogeyman. Nothing could be further from the truth.
In February, the FDA approved Avastin despite a 5-4 vote by its Oncology Drugs Advisory Committee (ODAC) not to recommend approval. Meetings of this advisory committee address the most vexing issues that exist in cancer-drug development. The advice is usually helpful but never binding. Everyone who works at the FDA knows that the public only sees a fraction of what FDA insiders consider when they make their final decisions on products.
In the case of Avastin, additional data emerged late in the review process, after the ODAC meeting, that strongly supported accelerated approval. It became clear that Avastin had an enormous impact on the surrogate endpoint known as "progression-free survival." PFS is such a powerful measure that it is actually used as the basis for full approval in many cancer indications.
As part of the accelerated approval letter, the FDA also placed some of the most stringent postmarketing requirements in history for the drug's sponsor to gain full approval. No standards were lowered, and many women may now live much longer without their disease progressing.
The damage done by Mr. Grassley's decision to make an issue of this decision cannot be understated. Having served at the FDA during the Congressional hearings over the Imclone/Martha Stewart insider trading scandal, I can attest to how an action like this GAO inquiry will resonate within the halls of FDA. An extremely cautious and protective bureaucracy will respond to such intimidation by being even more protective.
The senator is demanding a full-scale review of each and every product ever approved, and is asking for a rejudgment by GAO "to ensure that drugs approved on surrogate endpoints are both safe and effective."
You can bet these bully tactics will have an effect. Look for greater demands by the FDA for cancer programs to not use the accelerated approval pathway. Just a few weeks ago, Medarex Inc. announced that the FDA will renege on a commitment to grant accelerated approval of a new product for skin cancer if its clinical trial showed benefit using the PFS endpoint. The FDA ordered a change toward the much stricter endpoint of overall survival, adding years to the time it will take to evaluate the drug's efficacy.
U.S. cancer-drug development stands on a precipice overlooking a new dark age in which each new product's development is longer and costlier than the last. Companies may decide it is not financially viable to even bother developing new drugs, and the pipeline for new products to treat cancer could slow even more. Mr. Grassley's legacy could be thousands of additional cancer deaths.
Advocates for all patients affected by Mr. Grassley's antidrug company demagoguery – including cancer patients, Alzheimer's patients, AIDS patients – must make their voices heard.
But killing a large bloated, entrenched government bureaucracy is nearly impossible--which is why creating these new agencies is almost always a horrible idea. Whether they achieve their purpose or not (and even if they do, the cost in invariably much more dear),we are stuck with them for life. No matter how altruistic the intent for creating them or how egregious their failure to achieve results, the special interests like the Public Employees Unions find a way to take root like kudzu in a rain forest. In Government, unlike private industry, failure only invites more money to be thrown at the problem (even if the problem is the mechanism of government itself), higher taxes to fund the "improvements", resulting in even larger and more intractable bureaucracies, and even bigger failures.
Remember Jimmy Carter's incredibly myopic and destructive Department of Energy, created to solve our "Energy Crisis"--remember the long gas lines caused by the "price fixing" and "gas rationing" of the 1970's DOE and its 20,000 paid (worthless) bureaucrats? And where has that agency gotten us today?
Like the Department of Energy (and Department of Education for that matter), the FDA too has long outlived its usefulness in a world where the pace of science far exceeds this bureaucratic anachronism's efforts to keep pace. If we need to scrutinize food, drugs, and other products on the public's behalf, better to let private companies--efficient ones--compete for that right. The market always gets to the real answer faster than any Government agency ever could, because it is efficient, and it is driven by can-do profit driven entrepreneurs, rather than dreary government bureaucrats looking for an excuse to crap on the efforts of companies to solve our most pressing health problems because of Brazil-style procedural hiccups.
What say we outsource this task (and educating our kids, while we're at it) it to people who are more driven by results and what is possible than by arcane processes and sticking to collectivist policies that virtually guarantee a poor result.
The patients have suffered for far too long: the FDA needs to be put to sleep, so that we "the family" can finally move on with drugs and solutions that will begin to finally ease the suffering and deaths caused by a bureaucracy that has long since outlived its usefulness.