I started looking at doing this on my own last year, but realized I was in way over my head. But I am considering picking it back up again.
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I have yet to meet a government agency that actually makes our lives better and increases our freedom of choice.
2 regulations being done away with for every new one created, so thatâs sure to fix everything. :: smirks sarcastically ::
Well, in the FDAâs defense, we tend to take for granted that all on their own manufacturers of everything from insulin to dietary supplements would just naturally be honest about whatâs in their productsâor even bother to tell us at all. Easy to forget a century ago when tapeworm larvae were sold to women for weight loss and claims like âContains genuine radium!â were exciting marketing come-ons. Like the EPA and others, these agencies didnât come into existence because private industry was doing such a bang-up job preventing the Ohio River from bursting into flames that meddlesome gubmint bureaucrats wanted to horn in on all that great PR action and grab the credit.
Much credit is given to the deaths of many people in the 1930s, including Eben Byers in 1932 from the ingestion of radithor and many women, some known as The Radium Girls, to making the FDA into the much more powerful organization we know today.
History of the Food and Drug Administration - Wikipedia
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Yes some regulation is needed, but our system of proving safety (like the rest of the world) AND effectiveness is SUPER expensive. If they did the job I would like them to, which is ensure safety, then the approvals would be orders of magnitude less expensive to gain approval and we would be just as safe. Instead we have companies having to spend huge sums to prove effectiveness, which the market can do as well for much less money. Because of the huge costs and risks the companies in turn have less competition, and therefore can charge outrageous sums, like the last crop of Hep C drugs. While having no agency would be bad, if no one can afford to compete with each other, we are in just as bad a place.
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@drbbennett. I fully understand the necessity for the birth of government agencies. When Nixon formed the EPA, people were in serious danger because of air and water pollution.
The problem is that government ends up bastardizing the original purpose and intent of agencies they create. Now, the EPA is a far greater danger to people and freedom than the condition of the air and water.
It is an endemic problem with government, and I certainly donât think it will ever be solved.
I want them to test efficacy too eventually, but I donât think that needs to be done before approval. I think they can give some provisional approval to sell the product for 5 years based on safety data and if it hasnât been tested as effective in a trial (which I think could conceivably be performed using the data from patients already using the drug though that might be tricky to set up and potentially subject to a lot of manipulation by the companies), the approval would be revoked.
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@docslotnick, my dad was a petroleum engineer who worked for companies like British Petroleum and Standard Oil. After that, he also worked for 20 years with the EPAâs superfund cleanup division. While he constantly complained about the bureaucracy and the lawyers, and in his mind is more of an âoilman,â there is no doubt that he actually made many dangerously hazardous sites less so and feels proud of that. He was the type of person who always asked if a hazard was actually endangering human health and often found much cheaper ways to remediate based on his knowledge of hydrology and geology. And this typically did not cost taxpayers much money because those doing the polluting were ultimately responsible for cleaning up the site. Was the bureaucracy stifling and sometimes ridiculous? Yes, for sure. But he still felt strongly the EPA was doing more harm than good in those situations. By the way, heâs not an environmentalist at all.
Iâm sure that the EPA can throw up roadblocks when thereâs no need and can cost industry a lot of money to do business, but I think itâs hyperbolic to say they present a danger to people. They may be curtailing freedom, sometimes unecessarily, but oftentimes one entityâs freedom leads to another personâs poisoned water. Personally, I am fine with the idea that development is more expensive if it i means kids with asthma donât have to breathe air like that in India.
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I agree that bureaucratic overreach is an endemic problem but I strongly disagree with the hard-Libertarian view that everything would be just fine if we dumped these agencies and let the Invisible Hand do its magic. The reason they exist is precisely because left to its own impulses The Market may solve certain kinds of problems but it also creates others that it canât solve.
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That strikes me as a useful distinction. To pick a concrete test case: The Cinnamon Cure for diabetesâcaveat emptor? Or should someone step in and say âProve it.â
http://www.diabetesforecast.org/2013/nov/fda-cracks-down-on-diabetes.html
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Because the air and water they were polluting were public goods that they were exploiting for private benefitâas they were right to do by their own terms, because those things were free and their only obligation is to their shareholders. In market terms, itâs illogical and unfair to expect firms to take account of those things if they are there for the taking, free of charge, because minimizing overhead and maximizing profit is in their DNA. Itâs only by imposing a cost that you create an incentive for firms to take account of those things. If you can set it up so as to do that without dictating the solution, market forces can generate better solutions from the bottom up than bureaucracies can from the top down, which is a failing of the older models of regulation. But someone has to stand outside the system and establish that this is the playing field for all firms, otherwise the bad actors will prevail.
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I think itâs a tough one with a case like cinnamon â which is somewhat likely to be benign even if totally useless.
On one hand, if someone wants to take cinnamon in addition to their actually useful diabetes medication, fine with me. On the other hand, if fewer people know that it is total bunk, some will probably NOT take the effective medication thatâs out there, which can cause a lot of pointless harm.
Still, I think people should be free to take dumb, pointless medicines as long as we have an effective way of getting across that theyâre dumb and pointless. Drugs that can do harm and have no established benefits shouldnât be available.
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There are two issues at play, one is approval and the other is marketing. The FDA regulates both, and they donât have to be connected. They could approve the drug âcinnamonâ since it is safe for consumption, without allowing a company to make a claim that it works. Personally, I believe diabetics should be able to eat all the cinnamon they want.
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This is such a difficult topic though. I think I agree with what you are saying â but I wonder if there are some important limit cases where I would be totally wrong.
Possibly the company should then required to post a claim stating that no scientific research shows it working?
I think this is actually an interesting one for newer drugs being developed by pharma. Imagine a drug that is approved for safety but that a company cannot say does anythingâŚItâs hard to imagine doctors prescribing it, unless there is at least a little bit of phase II efficacy data to go on.
Actually I donât think we have to imagineâhappens all the time. Whether doctors recommend 'em is another question. I was just talking with a friend whoâs a top research director at Pfizer (currentlyâthese guys bounce around like pinballs) and he was commenting about how marginal the âbenefitâ qualifications can be, and diabetes treatments, which are proliferating like fleas on a long haired dog, are prime evidence. I mentioned how ridiculously saturated the cable channels are with these things, and he said âIf theyâre advertising on TV, theyâre failing,â which I understood to mean the ones that are working donât have to go there.
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There is usually some data and some claim(s) that can be made based on the existing data without doing a full blown efficacy study. Europe is slowly moving toward requiring efficacy data 
, but is still much easier to get a drug approved that the US. There arenât large groups of people dying in the EU because their safety agency doesnât require as much data as the FDA. We need to find a happy middle ground, rather than make it so only the big boys can play.
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I have access to a high-end Mass Spectrometer. Maybe we just need to develop our own insulin.
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I really believe that this has become feasible. I would be ready to participate in such an initiative.
My older son, who is a student at Stanford, and is very close to his T1D brother, is looking into possibly launching an opensource project aimed at allowing crowdsourcing for medical research.
Those drugs are usually FDA approved, so not-so-savvy viewers still have a reason to assume they are somewhat effective. If they are not approved for efficacy, hopefully people will know the difference. I aslo would support a marketing ban â i.e you canât say theyâre effective for anything â until youâve proven theyâre so.
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