• Tag Archives FDA

  • The FDA Can Only “Fast-Track” Medicine Because It Slow-Tracked It in the First Place

    Posted on by Azrael Comment

    In the midst of the COVID-19 crisis, tens of thousands of people within pharmaceutical companies are working hard on tests, on medicine and methods to save those who are ill, on antiviral drugs and on vaccines. Many of these efforts have been fast-tracked by regulatory bodies such as the FDA. This is all and well. But this is also a good time to ask ourselves why this fast-tracking was necessary. Why are medicine and equipment “slow-tracked” in more normal times? And what are the consequences of the normal procedure compared to what we see with regard to COVID-19?

    In late December, at the beginning of the COVID-19 epidemic, the non-crisis, standard slow-tracking process was in effect. It belonged to the CDC to develop tests for the virus and even the CDC needed an “emergency use authorization.” Already available tests from other countries would have required lengthy FDA approval and even when the sense of urgency increased, hospital labs were discouraged from quickly developing their own in-house tests. These labs also realized that the FDA application process was too complicated for them. Only on February 29 did the FDA fast-track the process.

    Fast-tracking is not unique to COVID-19. It is a common recourse in times of crisis. Normal procedures and regulations are set aside and we adapt to the exigencies at hand. Heroic feats of engineering were achieved during World War II. When faced with disruption, private companies form “skunkworks” to short-circuit their own, self-imposed bureaucracy and regulations.

    In modern times, we usually live in calm, safe, quite well-organized societies. This allows us to indulge in what seems an unstoppable human urge to regulate. When we apply this urge to risk management, we come up with government organizations such as the FDA. That the creation of a regulatory body is a problem in and of itself is a well-known fact; a regulatory body must keep regulating to justify its very existence.

    But leaving that aside, such regulatory organizations give us a warm and fuzzy feeling of order and of security. After all, these organizations are populated by thousands of government experts. Aren’t they fatherly figures who can make us safer? When a new risk is identified, we clamour for their intervention. After all, strict regulations, and the stricter the better, should provide us with security. If that were only the case…

    On the contrary, our risk aversion and our urge to regulate by means of government bureaucracies have devastating effects on our ability to make scientific and technological progress in any area that is regulated. This is something that Aaron Wildavsky discusses in his gem of a book, Searching for Safety.

    The reasons for this are at least fourfold, although they are intimately related. First of all, a rich society such as ours can afford to spend more on safety. But secondly, a society that instead accepts risks can pursue risk reductions through trial and error. In all fields, errors are essential. Without the possibility of error, innovation is blocked like a clogged drain. We commonly cannot “think our way forward.” Instead, much of the time we must actually try to see if something works or not.

    When we instead seek to avoid all risks, which is what modern regulatory bodies commonly do, we tend to pursue a strategy of trial without error; we try to guarantee beforehand what is impossible, that no new technology will ever produce any negative effects, and we therefore forego both the (often much larger) positive effects, as well as the learning we gain through errors. The method of trial without error is slow, prohibitively expensive, and wasteful with regard to risk mitigation.

    Thirdly, with trial and error, we only need to mitigate those risks that actually materialize. These will usually be only a fraction of those risks we would seek to mitigate using trial without error. And fourthly, as a consequence of lower costs, when accepting and even embracing the possibility of error, we can also explore a much larger range of options, instead of just the few we can afford to consider, and have time to consider, when we try to work out every last detail beforehand.

    Of course trial and error does not mean that risk avoidance goes out the window. But it becomes much less intrusive and much more flexible.

    On the positive side, because we have agencies such as the FDA that regulate the pharmaceutical industry, many trials and some often-deadly errors are prevented. But, on the negative side, precisely because we do not risk any error and harm, as a net result, tens, possibly hundreds of thousands of other people have their lives shortened each year in the USA due to the resulting slowing down of progress. Drugs are delayed, often by years. The number of trials of different drugs are much smaller. Getting FDA approval costs enormous amounts of money that only large pharmaceutical companies can afford, and we therefore also have much fewer but larger and less nimble pharmaceutical companies than we would otherwise have. The same goes for all other industries subject to government regulations.

    Without the existence of the FDA, and associated regulations, patients and doctors would still seek reassurance. We know, or should know what then happens. Private certifiers will find a market, and immediately step in to provide such reassurance for patients and doctors. Also, industry organizations will spring up to provide similar services, for example through careful vetting of members. And in the end, false claims can be pursued through the courts.

    One of the most celebrated features of the medical profession, the over 2,400-year-old Hippocratic Oath, that doctors swear in some form to this day, is an example of such a private-sector, confidence-generating device. It appeared precisely because doctors had to find some way to reassure patients in an unregulated market within 1200 to 1500 independent Greek city states.

    The abolition of the FDA would lead to medical research seeming messy and much less well-organized. But it would be far more vibrant. Just how much innovation would be sped up without the existence of FDA-like bodies, we simply cannot know; all we can say is that the effects will be very large. Usually, when markets are freed up in other areas, the effects are stupendous.

    Is it politically possible to abolish the FDA? Maybe, in particular if we take a hard look at what we are currently doing. As today’s sense of urgency shows, as soon as there are large risks to combat, such as the COVID-19 crisis, the warm and fuzzy, but misplaced feeling of having the FDA, is largely set aside. Not completely, but still. We abandon the usual slow-tracking and instead fast-track medicine with lower and/or more flexible regulatory demands. By extension, both in a time of crisis, and in times of calm, a world without the FDA would be a world in which progress is always fast-tracked.

    Erik Lidström


    Erik Lidström

    Author of Education Unchained—What it takes to restore schools and learning (Rowman & Littlefield 2015).

     

    This article was originally published on FEE.org. Read the original article.


    📂This entry was posted in News and Politics 📎and tagged

  • The COVID-19 Crisis Is the Result of Decades of FDA Misrule

    Posted on by Azrael Comment

    The COVID-19 pandemic is exposing how the US Food and Drug Administration puts Americans at increased risk of sickness and death. Decades of killing medical innovation and forcing industries offshore made this inevitable.

    Rightfully, many are questioning how things got this bad. As political stock rises in calls for change in Washington, Americans must watch out for any false debate that merely aims at rearranging deck chairs.

    The real debate should be over how best to downsize or abolish the FDA, which contributed greatly to the vulnerable state in which America now finds itself.

    The FDA is one of those many creatures of Congress that effectively wields legislative, executive, and judicial power, with almost no real accountability. It has grown mightily since its inception in 1906.

    Yet, thanks largely to its treatment in the media, many Americans have never imagined how the country might benefit from doing away with the bureaucracy. That may change now.

    The FDA’s most public failure is its most recent, the blocking of any private production of coronavirus test kits during the initial outbreak. How many Americans will pay the ultimate price for this policy remains to be seen.

    It wasn’t until March 16, over two weeks after the first American diagnosed with coronavirus died, that the FDA allowed private labs to have their testing kits approved by state agencies. By that time, about 5,145 people in the US had been infected, and at least 91 died.

    Sadly, the only test kits available before then were produced by the US Centers for Disease Control and Prevention. They didn’t work, but luckily for the CDC, government agencies are never held to the same standard the private sector is.

    Intrepid journalist James Bovard has documented for decades the FDA’s fatal flaws that pushed much of the American healthcare sector to foreign countries or out of business entirely. He traces this back to at least 1990, when Dr. David Kessler was made commissioner.

    As enforcer, Kessler employed tactics familiar in communist countries. His top enforcer of the Drug Surveillance Branch was quoted in a Washington University scholarly paper, saying,

    The old way is over. We used to say that if a company made certain changes, then we would probably not take any action. Now, we won’t. Now, even if they make the changes, they might end up in court. We want to say to these companies that you don’t know when or how we’ll strike. We want to eliminate predictability.

    Bovard notes the medical device industry was hit hard by Kessler’s FDA, citing an American Electronics Association survey that showed “40% [of medical device companies] reduced the number of U.S. employees because of FDA delays, 29% increased their investment in foreign operations, and 22% moved U.S. jobs overseas.”

    Securing those foreign-produced devices for Americans has not been easy. Tesla and SpaceX CEO Elon Musk took it upon himself to have around 1,000 respirators flown into Los Angeles from overseas, but their delivery was held up by the FDA.

    Despite the FDA’s best efforts, there are still incredibly productive companies making medical devices in America. The San Francisco-based company Nurx, Inc. announced a $181 coronavirus home test and a plan to send out 10,000 of them just four days after the FDA lifted some of its restrictions on private tests.

    However, Nurx was forced to cancel its product release, because the FDA so far refuses to curtail its restrictions on home tests.

    The lack of test kits are only half the story of America’s prolonged struggle with COVID-19. The other half is the over-regulation of medical treatments and medicines, which also dates back to at least the 1990s under Kessler.

    Kessler ordered that approved drugs should only ever be used for their original purpose. Even if the approved drug was found to cure or treat another ailment, the manufacturers were prohibited from informing doctors of the fact.

    It should be clear now why the mainstream media so reflexively maligned President Donald Trump for suggesting the anti-malaria medicine hydroxychloroquine could be used to treat coronavirus.

    The media has a long history of cheerleading for increased government intervention or simply running cover for the regulators.

    Take for instance this March 31 Bloomberg article with the headline: “Coronavirus Forces Cancer Trial Changes Patients Long Sought.” You have to read nine paragraphs before learning the FDA eased up on its clinical trial regulations. Is that what the headline suggests?

    “Coronavirus forces regulators to cut their own red tape to save face.” That’s the real narrative of the whole government response to coronavirus. Reporters aren’t lazy. Telling the truth would be easier than lying.

    The failures of the regulatory bodies and the media are piling up, but Americans may still recoil at the thought of outright ending the FDA. Any political leader who cares at all for public health must, at the very least, call for a drastic downsizing of the runaway bureaucracy.

    The types of prohibitive powers that the FDA exercises were once thought to require a constitutional amendment. Alcohol prohibition, after all, wasn’t instituted by a simple act of Congress, but instead was enacted through the Eighteenth Amendment.

    Shortly after the failure and repeal of alcohol prohibition, there was a dangerous shift in how Congress interpreted its powers under Article I Section 8 of the Constitution. The FDA might be the most egregious example of the consequences of this disastrous turn in history.

    The Congress cynically touted the Commerce Clause as a mandate to legislate beyond their limited, enumerated powers. As a result, the original purpose of the Commerce Clause, to ensure free trade between the states, was flipped into an unlimited power to prohibit commerce.

    This is how the FDA grew into its current monstrous form.

    In order to overcome the coronavirus crisis and to be fully prepared for the next public health episode, America must rid itself of the bureaucracy that has slowly choked out the greatest medical industry in the world.

    If Americans want to live in a truly free country, then there must be internal reform before any meaningful external reform. It begins with rolling back the FDA.


    Gavin Wax

    Gavin Wax is president of The New York Young Republican Club, an Associate Fellow at the London Center for Policy Research, and publisher of The Schpiel. His work has appeared in Townhall, The Daily Caller, The Hill, The Washington Examiner, The Federalist, Human Events, and Newsmax. He is a frequent guest on Fox News. You can follow him on Twitter @GavinWax

    This article was originally published on FEE.org. Read the original article.


    📂This entry was posted in News and Politics 📎and tagged

  • Once Again, the FDA Is Making Life Harder for Sick People

    Posted on by Azrael Comment

    While I’m not quite arrogant enough to believe that the federal government implements policy at me personally, sometimes it sure feels like it, and the FDA’s most recent “recommendations” certainly fit that bill.

    As I’ve mentioned in a previous article, I have Crohn’s disease. It’s an autoimmune disorder that affects the digestive tract and is generally classified under the term inflammatory bowel disease (IBD). And I’m not alone. There are approximately 1.6 million Americans who suffer from IBD. Throw in the 25 to 45 million Americans with the less-severe irritable bowel syndrome (IBS), and you have a lot of people dealing with chronically problematic tummies.

    My Crohn’s is stubborn and lingering. It flares up with very little warning and sticks around for a long time. My last flare-up lasted about a year. That’s an entire year of joint pain, fever, crippling abdominal pain, internal bleeding, chronic exhaustion, and somewhere between ten and twenty trips to the bathroom a day.

     

    It’s also expensive to treat. A single dose of my prescribed immunomodulator costs a little over $20,000 retail. I take it every four weeks. And it, like all immunotherapy drugs, leaves me terrifyingly vulnerable to opportunistic disease — everything from the common cold to tuberculosis to MRSA — as well as increasing my chances for developing fun things like a rare and deadly type of lymphoma.

    Long-term treatment may be expensive and slow-acting, but there is something I can take that will at least temporarily lessen some of my more pressing symptoms. I can get this medicine at any pharmacy, over the counter, for pretty cheap. It’s called loperamide, although you might better recognize it by its brand name Imodium. And now the FDA wants to make it harder to get.

    We’ve Done This Before

    Apparently, some few people are taking dangerously high doses of loperamide to get high. Generally speaking, those abusing loperamide are already addicted to opiates. And, as you’d expect from huge overdoses, it’s making these people very sick and, in rare cases, killing them. This is, of course, indicative of the larger overall problem of opiate addiction in this country, but trying to stem the opioid crisis through regulation of how many anti-diarrhea pills you can buy at a time is a bit like putting a bandage on a wound while ignoring the arterial bleeding.

    There’s been much ink spilled on how to help solve this problem, so we won’t rehash that here. What concerns me is the blatant disregard the FDA has for genuinely sick people. In its frantic efforts to Do Something about fringe cases, it’s only making already-difficult life even harder for the chronically ill — to very little positive effect.

    This isn’t the first time the FDA has restricted the purchase quantity of an over-the-counter medication. In an attempt to curb methamphetamine production, in 2006 the FDA put limits on how much pseudoephedrine, a nasal decongestant, you could buy and also required a photo ID to do so. Despite adding a lot of hassle into the treatment of stuffy noses, meth only became more pure.

    What on earth makes anyone think that going down this same road with loperamide will have any kind of positive benefit?

    Making Life Harder

    I fully acknowledge that most people do not have the need to carry a supply of anti-diarrhea medication with them wherever they go. But I, and millions of other Americans, do, and the vast majority of us use it responsibly. We use it to make it through the workday and sleep through the night. We use it to manage the two-hour car ride to grandma’s house. We use it to get past the waiting room at the doctor’s office.

    The government has already wrecked severe pain management in its crusade against opioid abuse while having no discernable impact on the rate of overdoses. But instead of making it easier for addicts to get help, they’ve instead opted to make over-the-counter treatment of a fairly common ailment more difficult. It is infuriating to me how the FDA, with its access to much more detailed health statistics than I have with a casual Google search, could so callously disregard the impact on everyday life for more than 25 million Americans.

    After all, isn’t the FDA — and, indeed, all government agencies — ostensibly there to make life better? Between its driving up the price of medicines, its refusal to acknowledge alternative therapies, and now this, I fail to see it.


    Jen Maffessanti

    Jennifer Maffessanti is an Associate Editor at FEE, chairwoman of America’s Future Foundation Atlanta chapter, and mother of two. When she’s not advocating for liberty or chasing kids, she can usually be found cooking or maybe racing cars. You can follow her on Twitter.

    This article was originally published on FEE.org. Read the original article.




    📂This entry was posted in News and Politics 📎and tagged