Dec 09 2016

Trouble for the FDA?

fdaThere is persistent tension over the issue of drug regulations. On one side are those who think that before we sell drugs to the public with health claims, we should ensure there is a reasonable amount of objective quality scientific evidence to demonstrate that the drugs are safe and effective. I admit this is the side of the discussion on which I fall, and it is clear that most of the public assumes this is the case.

The other perspective is that requiring too much research and regulation slows the passage of potentially new and lifesaving drugs to the public. Potentially useful drugs should be fast tracked as much as possible. In the extreme version, held by some Libertarians, there should be no regulation (or perhaps minimal regulation for safety) and the free market should sort out what works and what doesn’t.

The Food and Drug Administration (FDA) is the regulatory agency in the US responsible for ensuring the safety of drugs and that efficacy claims are backed by adequate evidence. The FDA, however, is a creature of congress, from which it derives its authority. It can only do what the law says it can do. Within that law the FDA also has a certain amount of discretion. How much evidence is enough is a judgment call. Therefore who heads the FDA can have a significant impact on how tightly or loosely regulated the pharmaceutical industry is at any given time.

The FDA’s mandate is now being threatened from both ends, congressional law and possible picks by Trump to head the FDA.

Congress has just passed the 21st Century Cures act, which is a terrible law that weakens FDA regulations and shifts the power tremendously in the direction of the pharmaceutical industry. Like most modern bills, this is a large and complex bill with many pieces. Some of those pieces are good, providing funding for research. The core of the bill, however, is based upon a false premise and provide a counterproductive fix.

Orac has already done a great job of summarizing the problems with the bill. He writes:

The FDA already has the tools to do what the 21st Century Cures Act demands without weakening patient protections or scientific rigor. In fact, the FDA, despite being underfunded, is actually remarkably efficient at new drug approvals, evaluating nearly all new drug applications within 6 to 10 months, an impressive turnaround for such complex assessments. It’s been pointed out that the FDA actually acts more rapidly than most European regulatory agencies. Basically, there is no evidence that the FDA hampers overall medical innovation, nor is there evidence that the FDA’s current requirements lead to higher drug prices or cost lives.

The justification for the bill is based upon an empirical claim, that the FDA is “too slow” and therefore delays effective drugs getting to market, costing lives. This claim is pure nonsense. There is always a balance between scientific rigor and timely efficiency, and over the decades this balance has been carefully calibrated at the FDA. It is already as close as you can get to optimal. If anything, in my opinion, it could use tweaks that would tighten regulations. This can be done without slowing the process.

The Cures Act throw out this carefully calibrated balance over the false fear that the FDA is restricting access to potentially useful drugs. Again, there are some good things in the bill, but the bad things are bad. The bill, for example, makes provisions for using weaker forms of evidence to approve drugs or expand drug indications:

  • the sources of real world evidence, including ongoing safety surveillance, observational studies, registries, claims, and patient-centered outcomes research activities;

There is also a provision specifically to weaken the evidence necessary for approval of stem cell treatments:

Creates an expedited review pathway for “regenerative medicine” products that allows use of surrogate endpoints and post-approval studies.

Meanwhile, scientific reviews have found that relying upon these types of weaker evidence leads to the premature adoption of treatments that do not work. So-called “real world” data is useful, but cannot be used to establish efficacy. This is crystal clear. Surrogate endpoints are also useful to guide research, but should not be used for efficacy claims. This means that instead of showing that patients actually get better, you can just show that their blood work looks better.

These trends are directly against what we are advocating at Science-Based Medicine (SBM). It’s difficult to review the hundreds of articles that have established our position over the years, but basically it is clear that relying on weaker forms of evidence leads to unreliable conclusions, premature adoption of worthless or even harmful treatments, and a tremendous amount of waste.

It’s important to remember that we (meaning health-care providers and the public) all want the same thing, even if we have different perspectives. We all want to maximize the pace of medical advance, to get the most effective treatments to patients as quickly as possible. There is also some room for reasonable disagreements about how to achieve this mutual goal.

What is important, however, is that when discussing how to achieve this goal we look at the relevant evidence that exists, and we carefully consider all sides of the issue. If you only see regulation as a burden, and you ignore the scientific evidence, you will end up with ineffective regulations that do not accomplish your goals. I think that is what is happening here.

In addition there are interests with other goals. The pharmaceutical industry has a massive conflict of interest with regard to this question. Their motivated reasoning is therefore equally massive. There are also ideologues who are simply anti-regulation, and their motivated reasoning is equally massive.

The other threat to the optimal effectiveness of the FDA comes from the president-elect. He is considering Jim O’Neill to head the FDA. O’Neill is a Libertarian who actually believes that the FDA should not require any evidence of efficacy before allowing a drug on the market. In 2014 he said:

“We should reform FDA so there is approving drugs after their sponsors have demonstrated safety—and let people start using them, at their own risk, but not much risk of safety. Let’s prove efficacy after they’ve been legalized.”

Yikes. Imagine this guy as head of the FDA. Of course, this is what we have with the supplement industry. We don’t have to speculate about what will happen, we know what will happen – a flood of useless products with misleading claims. The public will flush billions of dollars down the drain on products that don’t work, and risk their health relying on ineffective medical products. There is no question that is what will happen, because that is exactly what happened with supplements, and with homeopathy (which also do not require evidence of efficacy).

I am a fan of the free market and recognize its power to self-regulate and essentially process the information that comes from millions of individual buying decisions. There are some things you cannot regulate by committee. The libertarian fallacy, however, is to take that principle too far, and to treat the free market as a magic wand. It is powerful, but not infinitely powerful. This is because there are many subtle ways to distort the market, and the market does not always perceive or respond to the factors that we would want.

In the case of drugs, consumers are actually very poor at perceiving quality. This is demonstrably the case, there is no real debate about this. There are a few simple reasons for this. The first is that the effect of many drugs is statistical. Taking an aspirin a day can reduce your risk of heart attacks and strokes, but there is absolutely no way for an individual to know if taking an aspirin actually works. The only way to know is through carefully scientific research. The same is true for many drugs, there is simply no way for the consumer to know if they are working.

For drugs that have a more immediate effect, there is the placebo effect to contend with. Most symptoms patients will get are self-limiting, or have a natural variability, or are subjective. This can make any treatment seem to work.

Only treatments that have a dramatic and fairly rapid objective effect would be sorted out through such anecdotal evidence (and even then a lot of crap would slip through – again, witness the multi-billion dollar homeopathy industry). Companies could put any crap they want in a bottle, as long as it was not directly harmful, and make any claims they want for it, and people will buy it.

If O’Neill’s philosophy were enacted to any extent at the FDA, it would be a disaster for health consumers (i.e. everyone). Trump has not made the appointment yet, so there is still some hope. However, he has already appointed a global warming denier to the EPA, and other cabinet members to agencies whose core mission they oppose. Appointing O’Neill would be in line with some of his existing appointments, so it is unfortunately plausible.

The evidence is already clear – the best outcomes result from efficient and effective regulations requiring high quality evidence for safety and efficacy prior to marketing a drug or health product. This is also what the public expects. This common sense and evidence-based approach, however, is under constant attack by ideologues, industry interests, and simple wishful thinking. The latter may be the most dangerous, because it is bipartisan.

27 responses so far

27 Responses to “Trouble for the FDA?”

  1. MWSlettenon 09 Dec 2016 at 9:29 am

    One part of the issue you left out is tort. The FDA sets standards whose end goal is (or should be) to ensure manufacturers do everything possible to prove efficacy and safety before selling a drug to the general public. Meeting that standard is burdensome, which means it’s expensive. Yet meeting that standard provides absolutely no protection from liability lawsuits. Since there is little chance for meaningful tort reform, from a drug manufacturer’s viewpoint I can understand why they would like to see less burdensome (costly) regulation.

    Regarding supplements: In 2012 the entire “alternative medicine” industry was somewhere around $30 billion. This includes treatments such as homeopathy and “natural product supplements,” as well as therapies like acupuncture and chiropractic.

    https://www.cdc.gov/nchs/data/nhsr/nhsr095.pdf

    This is a drop in the bucket when compared to the $420+ billion spent annually on FDA-approved medicines here in the US—.07 percent to be exact. If you subtract the cost for therapies like acupuncture, chiropractic and osteopathy, the percentage Americans spend on “supplements” is even smaller.

    Here’s another way to look at it. Estimates on the size of the illegal marijuana trade in America range from $10 — $120 billion annually. Given that LEGAL sales are expected to top $7 billion this year, I don’t believe I’m too far out in left field in assuming that illegal sales are closer to the top of the range of estimates. I view “supplements” much like I view marijuana and other illegal drugs; a certain percentage of people are going to use them no matter what “scientists” say about them.

    I submit that FDA regulation of supplements would not much affect their sales, they would just be driven underground.

  2. Doctorrickon 09 Dec 2016 at 10:30 am

    His statement about approving drugs after they have “demonstrated safety”, in nonsensical. All biologically active compounds have some degree of risk. Nothing is “completely safe.” When the FDA determines safety, they are, in effect, saying the demonstrated benefits of this drug/treatment, outweigh the known and foreseeable risk. It is impossible to determine the “safety” of a medication without knowledge of the efficacy. Many meds have very significant risks, however, because they have been demonstrated to have good efficacy for dangerous conditions, they are approved and used. Other medication might have much lower risks, but if they have no demonstrated efficacy in treating medical conditions, they should not be used. Even a very low risk is not worth taking if there is no benefit.

    His statement of determining benefit after approving based on “safety” shows a fundamental misunderstanding of medical science.

    Absolutely absurd.

  3. carbonUniton 09 Dec 2016 at 10:40 am

    Another problem with the libertarian/free market approach is that there can be undesirable “side effects” as the market tries to sort thinks out. It turns the population into test subjects. How many people will be hurt before it is accepted that a drug has issues. This is particularly unpalatable when one considers parents who may be uninformed/misguided giving medicines to children. And some people will buy into hype and never accept the problems with a drug/treatment. They will keep doing damage even as we try to put the bad genie back into the bottle.

  4. Kabboron 09 Dec 2016 at 10:42 am

    MWSletten,

    Just a quick note, not about the content of the post (I actually haven’t finished reading it) the “.07 percent” is a misleading way to write the figure. It is 7% (0.07), not 0.07%.

    Again, no comment as to the quality of the post otherwise, but wanted to clarify that mathematical statement.

  5. carbonUniton 09 Dec 2016 at 10:44 am

    Another way to put the above is that instead of costing money (trials) to determine drug safety, the libertarian approach costs damaged lives.

  6. mlegoweron 09 Dec 2016 at 10:44 am

    I am not saying that gutting the FDA is a good thing, but it can not be true that “there is no evidence that the FDA hampers overall medical innovation, nor is there evidence that the FDA’s current requirements lead to higher drug prices or cost lives,” and I would rather see you and/or Orac tangle with some of that evidence than just assert that it doesn’t exist.

    This study suggests that the combination of patent laws and FDA approval lags distort R&D away from long-term products: https://www.aeaweb.org/articles?id=10.1257/aer.20131176

    This study looks at two inefficiencies in the FDA process: first, FDA approval is at least partically duplicative of private product liability torts; and second, the speed-safety tradeoff may not be optimized (discussed in detail in the next paper): http://www.aeaweb.org/articles.php?doi=10.1257/jep.22.1.85

    This study, for example, shows that for some diseases, the FDA’s evidence hurdle is too high: http://www.nber.org/papers/w21499

    This study suggests that PDUFA greatly increased consumer welfare by moving towards speed on the speed/safety continuum: http://www.nber.org/papers/w11724

    These papers appear to be carefully done by academics (albeit economists) calling into question the claim that the FDA’s approval process “is already as close as you can get to optimal.” None is necessarily advocating for a completely laissez faire approach, but to deny that there may be opportunities on the margin for welfare-improving changes to the FDA is a little glib, don’t you think? I mean, maybe these guys are all “batshit nutty government-hating libertarian[s]” as Orac so eloquently put it, and NBER is a working paper series (essentially a pre-print server). But AER and JEP are top Econ journals with peer review and I haven’t found any compelling takedowns (in the hour or so of research I’ve done). I’m willing to believe that there is motivated reasoning in there and attendant mistakes; but it’s hard to dismiss out of hand.

    Again, I’m not saying that this is some great coup for consumer welfare or that laissez faire is the solution to all of our problems. I just think the rhetoric may be a little out of proportion.

    And I agree that it’s important to remember that everyone wants the same thing here: to strike the optimal balance of incentivizing innovation and ensuring consumer safety.

  7. RedMcWilliamson 09 Dec 2016 at 10:48 am

    MWSletten, you’re probably correct that supplements would continue to thrive underground. But that’s now. If they had been subject to FDA safety and efficacy testing 30 years ago, they likely would never have even become a thing. Certainly not a multibillion dollar industry.

  8. LittleBoyBrewon 09 Dec 2016 at 10:52 am

    As Dr. Novella, suggests, a line must be drawn between unfettered drug access and restriction until complete efficacy is demonstrated. Tim Sandefur is a libertarian whose arguments are often quite compelling, and in particular he advocates ‘right to try’ legislation, i.e., allowing dying patients access to medications which have demonstrated safe but who efficacy has not been fully established. I would love to hear a discussion between Dr. Novella and Mr. Sandefur on this subject, as it might help me sort out my thinking on the matter.

  9. MWSlettenon 09 Dec 2016 at 10:54 am

    Kabbor, you are correct; I’ve never been any good at math!!

  10. Kabboron 09 Dec 2016 at 10:55 am

    Doctorrick,

    I think you are being uncharitable with your safety comment. While I agree with what you are saying with regard to the safety of a drug being also contingent on the relative efficacy of a drug, Steven makes his position clear in the article:
    “The evidence is already clear – the best outcomes result from efficient and effective regulations requiring high quality evidence for safety and efficacy prior to marketing a drug or health product.”

    To say that he is advocating for safety in a vacuum does not seem like you got the intended message.

  11. MWSlettenon 09 Dec 2016 at 10:59 am

    RedMcWilliams, herbal treatments and supplements have been around since, well, forever. Certainly for as long as marijuana. Marijuana has been “regulated” by the government since the Marijuana Tax Act of 1937. That hasn’t done much to curb it popularity.

  12. mlegoweron 09 Dec 2016 at 11:09 am

    Kabbor-

    I’m fairly certain Doctorrick’s comment was about O’Neill, not Dr. Novella. But I will let him or her confirm.

  13. RedMcWilliamson 09 Dec 2016 at 11:27 am

    Marijuana has a noticeable effect.

    Supplements weren’t an ‘industry’ until DSHEA. Yes, they existed, but were much more on the fringe than they are now. I think it would have stayed there if supplements had to conform to the same efficacy and safety standards as actual drugs.

  14. Kabboron 09 Dec 2016 at 11:53 am

    Ah, sorry for the misunderstanding. I thought you were talking about Steven Novella rather than the people he was discussing. The comment makes a lot more sense in this light, it seemed rather harsh.

  15. Doctorrickon 09 Dec 2016 at 6:32 pm

    @Kabbor @MWSletten, yes, MW you are correct, I’m in basically completely agreement with Steven and DISAGREEING with O’Neill. To discuss safety without accounting for efficacy in nonsensical and shows complete lack of understanding medical science and even risk.

  16. Doctorrickon 09 Dec 2016 at 8:22 pm

    oops, it was @mlegower who was correct

  17. MWSlettenon 13 Dec 2016 at 11:59 am

    ># carbonUnit: Another way to put the above is that instead of costing money (trials) to determine drug safety, the libertarian approach costs damaged lives.

    This comment assumes that drug trials would cease absent FDA oversight.

    Another way to look at it is that with the FDA consumers are insulated from involvement in the process, instead being forced to trust an agency whose power they have no control over other than their vote. We’ve seen in the most recent Presidential election just how effective THAT process is…

  18. Steven Novellaon 13 Dec 2016 at 2:21 pm

    MWS – it is a good assumption that effective trials would cease. Trials are not needed for supplements, and so the supplement industry does not do them. If they do they are small in-house or contracted studies that are scientifically worthless and intended only to promote their products.

    With drugs the drug companies are creative in finding ways to put their thumb on the scale, rig the studies so they are favorable, and hide unfavorable studies. Only throuh expert oversight and regulation does any useful science get done.

    Studies are expensive, difficult, and risky for industry. They may show unfavorable outcomes.

    There are independently funded studies, but not enough to make up for FDA mandated industry studies. If you want to replace FDA mandated studies with independent studies, that’s fine, but then we have to budget additional billions of dollars for this research. And – the supplement industry also tells us that this research will have little impact overall on consumer behavior. Marketing will trump science.

    Why should consumers be directly involved in determining if drugs are safe and effective? Should they be directly involved in determining if a bridge is structurally sound? Should they be involved in deciding with their purchasing decisions which airlines properly maintain their planes?

    It is nearly impossible to determine if a drug is effective from anecdotal evidence alone. We need good science. This will only be done through massive funding or industry mandates. Take your pick.

  19. MWSlettenon 14 Dec 2016 at 9:51 am

    >Trials are not needed for supplements, and so the supplement industry does not do them.

    Perhaps that’s because supplement manufacturers know they don’t actually do anything, and few have serious side effects (absent overdosing).

    I’m having a great deal of difficulty believing any drug manufacturer operating in America’s litigious environment developing a drug intended to produce a specific outcome wouldn’t continue to perform trials absent FDA mandates. The internet makes it easy for people to get information about manufacturer’s procedures and policies, and those who try to hide or suppress such information are quickly called out. Sometimes consumers are sufficiently motivated by data that reflects negatively on a corporation or industry to take action, sometimes they like the product/service enough to accept that a company doesn’t always behave the way they’d like to produce it.

    When government is involved, however, the morals/values of politicians/bureaucrats trump consumers. This is the heart of some of the most damning criticisms of the FDA; some people are willing to accept risks for the potential rewards. People should be allowed to make such decisions (and accept the consequences) for themselves.

    >With drugs the drug companies are creative in finding ways to put their thumb on the scale, rig the studies so they are favorable, and hide unfavorable studies.

    How did we get this information? From the FDA? If drug manufacturers are doing this despite FDA oversight then what purpose is the FDA serving?

    >Should [consumers] be directly involved in determining if a bridge is structurally sound? Should they be involved in deciding with their purchasing decisions which airlines properly maintain their planes?

    I’m not saying they should be. I do, however, believe that because we hand off responsibility for these things to the government many people assume them to be safe when sometimes they are not, and we cease to look for other–perhaps less expensive and more effective–ways of accomplishing the same goals. It also perpetuates the notion that government is the best (only?) way to assure public safety. Again, I offer recent events as counterpoint: who feels safer with Donald Trump as our President elect?

  20. Beamupon 14 Dec 2016 at 11:46 am

    It seems like you’re suggesting that the courts would become the venue for establishing drug safety and efficacy. But there are several major problems with that:

    1. The courts don’t exactly have a good record on such questions. Take talc and breast cancer, or silicone breast implants, or “electromagentic hypersensitivity.” Properly evaluating the scientific evidence regarding a drug is a job for specialist scientists. Judges can’t do it, and juries have no hope at all.

    2. Even when there is actual harm, causality can’t be established properly without careful science. Are the plaintiffs who believe they’ve been harmed supposed to put up the millions of dollars, and many years, to do trials before they can bring suit? If not, how do you propose for them to prove the point?

    3. Efficacy is even less feasible to establish judicially, because by nature it’s diffuse and statistical.

    As to your specific points,

    “I’m having a great deal of difficulty believing any drug manufacturer operating in America’s litigious environment developing a drug intended to produce a specific outcome wouldn’t continue to perform trials absent FDA mandates.”

    Certainly they would. They’d just do junk science with a predetermined outcome, exactly like the supplement industry today. Enough of a fig leaf to deceive the uninformed (including the courts) for minimal expense, without the risk of negative results.

    “The internet makes it easy for people to get information about manufacturer’s procedures and policies, and those who try to hide or suppress such information are quickly called out…”

    If the information necessary to judge a drug DOES NOT EXIST because nobody’s doing the science needed to produce it, none of this makes any difference.

    “People should be allowed to make such decisions (and accept the consequences) for themselves.”

    No person can meaningfully evaluate the risks and benefits of taking a drug in the absence of rigorous clinical trials – before OR after they’ve taken it. So this is not a relevant argument. The question at hand is not the freedom of individuals to choose, but whether consumers should be thrown into the wilderness without any kind of information at all regarding whether drugs on the market are safe and effective.

    Markets simply do not work when consumers lack the information to judge the value of a product.

    “If drug manufacturers are doing this despite FDA oversight then what purpose is the FDA serving?”

    The FDA limits the extent to which they can warp the data.

    “I’m not saying they should be. I do, however, believe that because we hand off responsibility for these things to the government many people assume them to be safe when sometimes they are not, and we cease to look for other–perhaps less expensive and more effective–ways of accomplishing the same goals. It also perpetuates the notion that government is the best (only?) way to assure public safety.”

    OK then. What are the less expensive and more effective ways of accomplishing the same goals? And the better ways to assure public safety? Thus far you haven’t presented any.

  21. MosBenon 14 Dec 2016 at 12:55 pm

    Beamup, another issue with determining efficacy of drugs in courts is that it’s massively inefficient. How many different trials will be conducted in different jurisdictions with expert witnesses giving days long testimony about various pharmacological trials being done before the issue is heard by a higher court, and then a higher court still, until finally being resolved at the Supreme Court. And what about all the people who are harmed because they rely on information from a court in one jurisdiction which is eventually overturned? And what happens when new data is available, a whole new round of litigation? Don’t get me wrong, I’m an attorney and this sounds like guaranteed employment for attorneys, but it’s far less efficient than having an administrative body oversee the bulk of this issue.

  22. chikoppion 14 Dec 2016 at 1:00 pm

    How about requiring that any trial used to establish efficacy or for marketing purposes must be “publicly registered.”

    A publicly registered trial would require:
    1) methodology published in advance
    2) findings reported as they are made available
    3) “efficacy” labeling

    Methodology would have to meet statistical and ethics criteria. It would be the role of the FDA to establish those criteria and adjudicate disputes.

    The “efficacy” labeling is analogous to nution labels. It explains to consumers the risks and benefits of the product established by the publicly registered trial. It also would limit the language that companies could legally use to describe the efficacy of their product.

    This would have a few effects.

    Drug companies wouldn’t dare risk conducting a negative trial in public. They would first conduct extensive internal testing to ensure the public trial will be successful.

    Supplement manufacturers would be denied the ability to use non-public trials to make product claims.

    Lack of an efficacy label on a product would indicate that it is a bogus offering that is incapable of producing health benefits. Once an efficacy label is attached to a product the manufacturer is bound by the legal restrictions on language used in marketing. Violators would face civil penalties and sanctions.

    Health care providers would be barred from prescribing products without efficacy labeling.

  23. chikoppion 14 Dec 2016 at 1:07 pm

    One other note…

    Because the efficacy label serves as a rating system, drug manufactures would chase the highest rate of efficacy possible, rather than the lowest bar established by the FDA. It would make the question of efficacy visible to the public as a competitive advantage, harnessing market forces to encourage continued development and allowing research costs to be recaptured through increased market share.

  24. MWSlettenon 14 Dec 2016 at 3:25 pm

    >It seems like you’re suggesting that the courts would become the venue for establishing drug safety and efficacy.

    No, that’s not what I’m saying. I’m saying the threat of tort poses a significant motivation for drug companies to perform due diligence–whatever form that takes–in ensuring their products do what they say they do with acceptable side effects.

    > They’d just do junk science with a predetermined outcome, exactly like the supplement industry today.

    First, you’re comparing apples to oranges. The supplement industry has been taken to task when vendors make sufficiently specific claims about what their products can do. Consequently, it’s rare to find a supplement manufacturer making specific claims about outcomes. This isn’t true about pharmaceuticals meant for medical prescription.

    Second, you (and others here) seem to be implying that drug companies somehow don’t care about the health of their customers. I argue that no one, not even greedy corporations, can sell a business model that includes marketing a product resulting in dead or injured customers. Maybe in the past, but in today’s world, with data and information instantly available to anyone with a smartphone, it’s just not going to fly.

    >The FDA limits the extent to which they can warp the data.

    On what do you base this claim?

    >OK then. What are the less expensive and more effective ways of accomplishing the same goals? And the better ways to assure public safety? Thus far you haven’t presented any.

    I don’t know. What I do know is as long as the FDA has regulatory authority over drug development there’s no motivation for anyone to make the effort in finding other solutions. There are many examples of un- or lightly regulated industries that nevertheless produce safe and effective consumer products and services, that due to market forces rather than government mandate constantly seek ways to improve quality and/or lower costs. The elective surgery market comes immediately to mind. Vision correction surgery used to be a good deal less effective and more expensive than it is today. Same goes for many popular cosmetic surgeries.

    Just like any other type of consumer service, you can easily find detailed and useful information—none of which is mandated as far as I know—about Lasik, PKK and various cosmetic surgeries aimed squarely at the consumer, including statistics on efficacy, complications and cost. Some people may lack the education to understand or interpret all of the data, but the same goes for automotive tire sidewall markings. When enough savvy consumers education themselves manufacturers will respond to their demands and everyone benefits.

    Why is it wrong to assume the same sort of care and concern for the consumer wouldn’t occur with drug sales with a less powerful FDA, or no FDA at all?

  25. Beamupon 14 Dec 2016 at 4:40 pm

    You still haven’t given any reason to believe a drug industry without the FDA would be any different from the herbal supplement industry today. This is NOT apples to oranges – it’s a very exact analogy. The claim that “it’s rare to find a supplement manufacturer making specific claims about outcomes,” which seems to be the core of your attempt to distinguish them, goes beyond simply wrong into ludicrous. The frequency of commercials for weight loss supplements ALONE qualifies as “routine,” and that’s without even getting into things like Airborne and all the herbs naturopaths and TCM practitioners sell… with VERY explicit health claims.

    And yet, the market is rife with products that do nothing or are completely untested. And those products have killed people. Yet market forces and litigation aren’t doing anything about it.

    The supplement market IS a drug market in all but name. They are marketed as drugs. Consumers treat them as drugs. The only reason they even have a different name is to evade regulation.

    I could go point-by-point refuting things like how many orders of magnitude more expertise it takes to evaluate drugs vs. the examples of other markets you give, but none of it matters, because the bottom line is that we have very direct evidence of what an FDA-less drug market looks like. We have one. It kills some of its customers, defrauds the rest, yet market forces and litigation don’t even slow it down.

  26. MWSlettenon 15 Dec 2016 at 8:26 am

    >You still haven’t given any reason to believe a drug industry without the FDA would be any different from the herbal supplement industry today.

    Oh, I don’t know. How ’bout doctors? Do you think doctors will prescribe medications they believe haven’t been adequately tested? That aside, you’re asking me to refute a worst-of-all-possible-outcomes speculation–that the pharmaceutical industry selling medications prescribed by doctors would somehow become a free-for-all should the FDA have less authority. I’m not saying I have a crystal ball, but we do have evidence in other areas of LEGITIMATE medical practice where what you fear has not happened, a segment of the healthcare market that is less regulated yet still seems to offer safe and effective treatments while lowering costs AND continuing to look for better ways of doing things. Is that success BECAUSE of less regulation? I don’t know, but it certainly seems to be evidence that we can make healthcare work effectively with less regulation.

    >The frequency of commercials for weight loss supplements ALONE qualifies as “routine,”

    Are you saying there is no difference in the specificity of claims between supplement marketers and prescription drug marketers? Take a look at this website; it doesn’t support your claim:

    http://www.berkeleywellness.com/supplements/other-supplements/article/supplement-claims-whats-allowed

    Prescription medications are meant to treat specific diseases and/or disease symptoms, and their marketing materials speak specifically about the diseases/symptoms they treat.

    >I could go point-by-point refuting things like how many orders of magnitude more expertise it takes to evaluate drugs vs. the examples of other markets you give…

    What difference does this make? Are you saying only the government can produce qualified scientists?

  27. Kabboron 15 Dec 2016 at 9:58 am

    In various ways, Steven Novella has advocated for the FDA to do more to combat ineffective products that people are spending billions on for no benefit. Those billions could and should be spent on things that actually benefit the consumer. I don’t see how going the other way and reducing the power of the FDA or eliminating it altogether is going to improve consumer outcomes. I have a healthy respect for market forces, but they are not a panacea.

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