5 ms·

A more interesting question would be how many would have a significant safety issue without FDA approval. Given the complexity of the drugs, the body and the i

A more interesting question would be how many would have a significant safety issue without FDA approval. Given the complexity of the drugs, the body and the interaction with other medication I'm impressed it's only 1 in 3 particulary since as mentioned down thread only 1.3% get taken off the market (1 in 77).

fictioncircle 10y ago
https://www.bio.org/sites/default/files/Clinical%20Development%20Success%20Rates%202006-2015%20-%20BIO,%20Biomedtracker,%20Amplion%202016.pdf https://www.bio.org/sites/default/files/Clinical%20Developme... > A more interesting question would be how many would have a significant safety issue without FDA approval. tl;dr > FDA approval (LOA) reveals that only 9.6% (n=9,985) of drug development programs successfully make it to market The FDA strikes a good balance I think. Its never going to be 100% successful but it does screen out many dangerous drugs.
- deleted 10y ago
  [deleted]
conanbatt 10y ago
Or harder still, how many drugs never get to the public because of the expensive process of FDA approval that skyrocket costs and kill people without getting reasonably priced low-risk medicine.
- DanBC 10y ago
  People say this, but the evidence from the UK Cancer Drugs Fund (a pot of money used to pay for expensive, new, not yet approved by NICE meds) tells us that the drugs "had no meaningful benefit" and are fantastically expensive. http://www.bmj.com/content/357/bmj.j2097 http://www.bmj.com/content/357/bmj.j2097
- Alex3917 10y ago
  > how many drugs never get to the public None. FDA approval isn't required to manufacture, sell, or purchase drugs. It's only required for companies that want to make marketing claims about the ability of drugs to treat various illnesses and conditions. As long as the drug you want isn't scheduled by the DEA, you're free to go online and order however much you want.
  - conanbatt 10y ago
    I dont know the details of the us health system and correct me if im wrong, but lacking FDA approval probably restricts a lot of things you can do, aside from doing unprovable claims, though the last one is also allowed for many things that are health and non-health related. I can be swayed , but i do subscribe to the concept that there is an availability bias in FDA approval: the fda has the incentive to be overly cautions, because punishment hurts fda, but banning potentially good medicine does not cause FDA any problems. That, and the potential of regulatory capture make me dubious of any positive claim about the existence of the FDA.
  - amyjess 10y ago
    If it's not a controlled substance, you can buy all you want, but it's illegal to sell it unless it's been approved by the FDA. Sure, if you want to order your meds from online pharmacies based in India and Vanuatu, you can (and I personally know people who order cyproterone acetate from these pharmacies because it's the best oral anti-androgen in existence but hasn't been approved by the FDA mostly out of laziness/cheapness), but you can expect to pay a lot of money. Oh, and you run the very small risk of having your meds confiscated by customs (they legally can't take action against you, because buying isn't illegal, but they can confiscate it because selling is illegal), but thankfully the government only has the resources to actively confiscate meds from online pharmacies one week per year (look up "Operation Pangea"). Even for a drug that's approved by the FDA, you'll be paying more to order the meds online than you will to go to a doctor, pay for the visit out of pocket, and have the prescription filled at Walmart (I have personal experience with this: because it's a pain in the ass to find doctors who will treat trans people, a lot of us start off ordering our meds from online pharmacies before we find a doctor, and it's not a huge deal because dosages are standardized, you can order private blood tests from certain labs, and official clinical guidelines are freely available for download -- but it's always cheaper to go through a doctor even if you're self-paying, the problem is finding a doctor in the first place).
- rayiner 10y ago
  There are two sides to that. People die because they can't get effective medicines that are kept out of the market by FDA approval. People would also die if they took ineffective drugs instead of effective ones because the FDA was too lax about letting things into the market. It's really hard to tell what works and what doesn't. Drug companies spend tens or hundreds of millions on a drug even before it gets to FDA testing, and most still fail final clinical trials. Most drugs just don't do what the developers think they will do.
orblivion 10y ago
You would also have to consider whether the drug companies would choose an alternate route for validating safety. I think they would care at least some amount about their reputation for safe products.
- noir_lord 10y ago
  The Dutch (iirc) have a saying "The butcher certifies the meat". Given the commercial pressures on a new drug, vast expenditure I'm happy another body is in the loop.
- makmanalp 10y ago
  Or, perhaps they might find it cheaper to instead launch massive PR and discrediting campaigns, deny there is any issue, settle lawsuits to silence complaints from individuals who don't have money and time to legally fight a billion dollar business. I'm not saying this'll definitely happen, but it has happened many times in the past, right?
- JustSomeNobody 10y ago
  I'm totally sure Mylan,Turing Pharmaceuticals or Theranos would seek third party validation of their respective products.
- cc439 10y ago
  The free market has made this work in the realm of electronics and electrical devices (UL), as well as the automobile industry (TS16949). The risks posed by bad products in the healthcare sector are perceived as far more dangerous but the sheer ubiquity of theoretically dangerous, yet completely trusted products produced with nothing but private party testing lends credence to the argument that we wouldn't be worse off without the FDA. The safety of US made nutraceuticals is also a testament to that fact although they have become increasingly regulated by the FDA and FTC despite a lack of prominent examples to back the need for further regulation.
  - rayiner 10y ago
    The difference between UL and a automobiles and drugs is that it's obvious if an electronic product or automobile works. It's very hard to tell if a drug works--and most don't. Nutraceuticals are a great example of the problem: they're safe because they're bogus and don't do anything. But because they're not regulated people waste tons of money (and suffer because they don't take drugs that do actually work). The
chiefalchemist 10y ago
Yes. Good point. It's also that all the easy diseases have been solved. Now we're into that hard stuff. And of course some are just by accident. Viagra, for example, didn't start as a solution to ED. So often it's a solution in search of a problem. Gotta keep the shareholders happy, eh. And we wonder why healthcare is so expensive, obesity aside.

fictioncircle 10y ago

https://www.bio.org/sites/default/files/Clinical%20Development%20Success%20Rates%202006-2015%20-%20BIO,%20Biomedtracker,%20Amplion%202016.pdf https://www.bio.org/sites/default/files/Clinical%20Developme... > A more interesting question would be how many would have a significant safety issue without FDA approval. tl;dr > FDA approval (LOA) reveals that only 9.6% (n=9,985) of drug development programs successfully make it to market The FDA strikes a good balance I think. Its never going to be 100% successful but it does screen out many dangerous drugs.

deleted 10y ago
[deleted]

conanbatt 10y ago

Or harder still, how many drugs never get to the public because of the expensive process of FDA approval that skyrocket costs and kill people without getting reasonably priced low-risk medicine.

DanBC 10y ago
People say this, but the evidence from the UK Cancer Drugs Fund (a pot of money used to pay for expensive, new, not yet approved by NICE meds) tells us that the drugs "had no meaningful benefit" and are fantastically expensive. http://www.bmj.com/content/357/bmj.j2097 http://www.bmj.com/content/357/bmj.j2097
Alex3917 10y ago
> how many drugs never get to the public None. FDA approval isn't required to manufacture, sell, or purchase drugs. It's only required for companies that want to make marketing claims about the ability of drugs to treat various illnesses and conditions. As long as the drug you want isn't scheduled by the DEA, you're free to go online and order however much you want.
- conanbatt 10y ago
  I dont know the details of the us health system and correct me if im wrong, but lacking FDA approval probably restricts a lot of things you can do, aside from doing unprovable claims, though the last one is also allowed for many things that are health and non-health related. I can be swayed , but i do subscribe to the concept that there is an availability bias in FDA approval: the fda has the incentive to be overly cautions, because punishment hurts fda, but banning potentially good medicine does not cause FDA any problems. That, and the potential of regulatory capture make me dubious of any positive claim about the existence of the FDA.
- amyjess 10y ago
  If it's not a controlled substance, you can buy all you want, but it's illegal to sell it unless it's been approved by the FDA. Sure, if you want to order your meds from online pharmacies based in India and Vanuatu, you can (and I personally know people who order cyproterone acetate from these pharmacies because it's the best oral anti-androgen in existence but hasn't been approved by the FDA mostly out of laziness/cheapness), but you can expect to pay a lot of money. Oh, and you run the very small risk of having your meds confiscated by customs (they legally can't take action against you, because buying isn't illegal, but they can confiscate it because selling is illegal), but thankfully the government only has the resources to actively confiscate meds from online pharmacies one week per year (look up "Operation Pangea"). Even for a drug that's approved by the FDA, you'll be paying more to order the meds online than you will to go to a doctor, pay for the visit out of pocket, and have the prescription filled at Walmart (I have personal experience with this: because it's a pain in the ass to find doctors who will treat trans people, a lot of us start off ordering our meds from online pharmacies before we find a doctor, and it's not a huge deal because dosages are standardized, you can order private blood tests from certain labs, and official clinical guidelines are freely available for download -- but it's always cheaper to go through a doctor even if you're self-paying, the problem is finding a doctor in the first place).
rayiner 10y ago
There are two sides to that. People die because they can't get effective medicines that are kept out of the market by FDA approval. People would also die if they took ineffective drugs instead of effective ones because the FDA was too lax about letting things into the market. It's really hard to tell what works and what doesn't. Drug companies spend tens or hundreds of millions on a drug even before it gets to FDA testing, and most still fail final clinical trials. Most drugs just don't do what the developers think they will do.

orblivion 10y ago

You would also have to consider whether the drug companies would choose an alternate route for validating safety. I think they would care at least some amount about their reputation for safe products.

noir_lord 10y ago
The Dutch (iirc) have a saying "The butcher certifies the meat". Given the commercial pressures on a new drug, vast expenditure I'm happy another body is in the loop.
makmanalp 10y ago
Or, perhaps they might find it cheaper to instead launch massive PR and discrediting campaigns, deny there is any issue, settle lawsuits to silence complaints from individuals who don't have money and time to legally fight a billion dollar business. I'm not saying this'll definitely happen, but it has happened many times in the past, right?
JustSomeNobody 10y ago
I'm totally sure Mylan,Turing Pharmaceuticals or Theranos would seek third party validation of their respective products.
cc439 10y ago
The free market has made this work in the realm of electronics and electrical devices (UL), as well as the automobile industry (TS16949). The risks posed by bad products in the healthcare sector are perceived as far more dangerous but the sheer ubiquity of theoretically dangerous, yet completely trusted products produced with nothing but private party testing lends credence to the argument that we wouldn't be worse off without the FDA. The safety of US made nutraceuticals is also a testament to that fact although they have become increasingly regulated by the FDA and FTC despite a lack of prominent examples to back the need for further regulation.
- rayiner 10y ago
  The difference between UL and a automobiles and drugs is that it's obvious if an electronic product or automobile works. It's very hard to tell if a drug works--and most don't. Nutraceuticals are a great example of the problem: they're safe because they're bogus and don't do anything. But because they're not regulated people waste tons of money (and suffer because they don't take drugs that do actually work). The

chiefalchemist 10y ago

Yes. Good point. It's also that all the easy diseases have been solved. Now we're into that hard stuff. And of course some are just by accident. Viagra, for example, didn't start as a solution to ED. So often it's a solution in search of a problem. Gotta keep the shareholders happy, eh. And we wonder why healthcare is so expensive, obesity aside.