Unapproved Medicine Crisis: Largest Bureaucratic Failure

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Discussion Overview

The discussion centers around the challenges and failures of the FDA in regulating unapproved medications, particularly in the context of safety and efficacy. Participants explore the implications of allowing certain drugs to remain on the market despite lacking FDA approval, touching on issues of bureaucracy, medical malpractice, and the historical context of drug approval processes.

Discussion Character

  • Debate/contested
  • Technical explanation
  • Conceptual clarification

Main Points Raised

  • Some participants express concern over the difficulty in coordinating which drugs are approved for purchase, suggesting a lack of enforcement and confusion regarding grandfathering laws.
  • Others argue that the FDA allows many homeopathic drugs to be sold, which may mislead consumers into thinking they are safe alternatives to approved medications.
  • A participant highlights specific cases where unapproved medications have led to serious health risks, particularly in children, raising questions about the safety of these products.
  • There is a discussion about the implications of banning non-approved medicines, with some suggesting it could lead to the prohibition of natural remedies.
  • Concerns are raised about the sourcing and administration of unapproved drugs, questioning who is responsible for their distribution and use.
  • Some participants suggest that the focus should be on addressing medical malpractice rather than banning substances, while others call for a comparison of risks between approved and unapproved drugs.
  • There is a debate over the adequacy of the FDA's risk/reward analysis for approved drugs compared to those that are unapproved, with some suggesting that not all unapproved drugs are necessarily harmful.
  • Participants discuss the historical context of drug approval, noting that many medications were "grandfathered" in before stricter regulations were established in 1962.
  • Some express skepticism about the FDA's efficiency and the influence of pharmaceutical companies on drug approval processes, advocating for independent verification of drug safety.

Areas of Agreement / Disagreement

The discussion reveals multiple competing views regarding the regulation of unapproved medications and the role of the FDA. Participants do not reach a consensus on the best approach to address the issues raised, and disagreements persist regarding the safety and efficacy of both approved and unapproved drugs.

Contextual Notes

Participants note limitations in the current regulatory framework, including the historical context of drug approvals and the challenges posed by grandfathering laws. There are also concerns about the adequacy of funding and personnel dedicated to reviewing and banning unsafe medications.

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Holy cow! I saw this on CBS this morning, but dismissed it thinking it was about people overdosing on Advil or something silly like that. Instead I stumbled upon what may be the largest bureaucratic failure in recent history

http://www.cbsnews.com/stories/2008/11/24/health/main4628893.shtml

Why is it so hard to coordinate what drugs are and aren't allowed to be purchased? You'd think someone would just step and lay down the law, instead of having some smokescreen of lack of enforcement and confusion over grandfathering to allow dangerous drugs to be sold and paid for by taxpayer money.

And why don't doctors know the drugs they're prescribing aren't FDA approved? Aren't they supposed to know things like what the FDA reports the side effects are?
 
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The system is flooded, basically. The FDA let's all of these homeopathic drugs through because they are just water, so they figure even if people are dumb enough to buy it, at least they won't hurt themselves with it.

Well, unless they take them instead of real medication, thinking it will work...
 
Read the article!

Last year, the FDA banned unapproved cough medicines containing hydrocodone, a potent narcotic. Some had directions for medicating children as young as age 2, although no hydrocodone cough products have been shown to be safe and effective for children under 6.

In a 2006 case, the agency received 21 reports of children younger than 2 who died after taking unapproved cold and allergy medications containing carbinoxamine, an allergy drug that also acts as a powerful sedative. Regulators banned all products that contained carbinoxamine in combination with other cold medicines.

This isn't just homeopathic sugar pills, this is dangerous stuff being packaged as medicine, and you're paying for it to boot
 
You have to be careful to check who the story is coming from.

Canada is in the process of banning all non-approved 'medicines'.

This either means that all dangerous fake drugs will be banned - if you are drug company PR release.
Or it means all natural foods will be banned unless the farmer can fund a full clinical trial on a herb that people have been taking for centuries - if you are a health food store.
 
If you read the examples given, these aren't herbal remedies they're talking about. I'm more puzzled about who is selling these drugs and how/why they are obtaining them if they are not FDA approved.

I mean, they had colchicine listed in the article! :bugeye: That stops neural transmission. It's something used in the lab setting if we think a neuron is releasing its neurotransmitters too fast for us to detect the cell body (because no neurotransmitter that we're staining for is stored long enough to find it). You dump it on and action potentials are blocked. Why would you inject that into a person? Who's doing the injecting, and where are they obtaining it?

There ARE non-approved drugs sold, but it's only supposed to be for research purposes, and their labeling is pretty clear that they are NOT for humans (at least all the ones I've seen).
 
couple of things. first, if there's medical malpractice going on, you should ban the doctors, not the substances. and second, people get sick and sometimes die from approved medicines prescribed to them.

so, how about it? how do approved substances compare with these others? does anyone know, or is this just a bunch of noise?
 
Well, the critical difference would be that one class has passed a risk/reward analysis and the other has not. Clearly, not all non-approved medicines would necessarily be harmful, but they are currently allowed to be more harmful than any approved medicine, so it stands to reason that some are.
 
Office_Shredder said:
Read the article!

This isn't just homeopathic sugar pills, this is dangerous stuff being packaged as medicine, and you're paying for it to boot

I said the system is flooded. That applies to this as well. The homeopathic thing was just an example.
 
Proton Soup said:
couple of things. first, if there's medical malpractice going on, you should ban the doctors, not the substances. and second, people get sick and sometimes die from approved medicines prescribed to them.

so, how about it? how do approved substances compare with these others? does anyone know, or is this just a bunch of noise?

...you're seriously saying you'd take a drug that hasn't been tested by a 3rd party over a drug that has?
 
  • #10
If you read the article, the problem is old "medications" that existed prior to when the FDA started controlling new drugs in 1962. The manufacturers of these "drugs" claim to be "grandfathered". Medicaid seems to be more lax than Medicare in removing these drugs from their list of drugs approved for payment. The issue is that no agency has appropriated enough personnel or funds to eliminate these drugs unless enough people die to warrant action.

It wasn't until 1962 that Congress ordered the FDA to review all new medications for effectiveness. Thousands of drugs already on the market were also supposed to be evaluated. But some manufacturers claimed their medications were grandfathered under earlier laws, and even under the 1962 bill.
If you read the entire article, you will understand the scope of the problem.
 
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  • #11
Yes, it is largely an administrative $$$ problem.
 
  • #12
russ_watters said:
Yes, it is largely an administrative $$$ problem.
On both sides - no company is going to fund a series of clinical trials for a drug that is out of patent. As soon as it gets approved the generics will get all the benefit.
 
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  • #13
mgb_phys said:
On both sides - no company is going to fund a series of clinical trials for a drug that is out of patent. As soon as it gets approed the generics will get all the benefit.
That's not the issue, it's old "medications", aka "snake oil" that have been around for ages and have never been certified as being safe or even having any medical benefits, and no US Government agency has bothered to ban them.
 
  • #14
mgb_phys said:
On both sides - no company is going to fund a series of clinical trials for a drug that is out of patent. As soon as it gets approed the generics will get all the benefit.

Couldn't some sort of temporary "patent" type law be issued to the company that does these trials?
 
  • #15
WarPhalange said:
Couldn't some sort of temporary "patent" type law be issued to the company that does these trials?
There are no drug trials, please read the article.
 
  • #16
WarPhalange said:
...you're seriously saying you'd take a drug that hasn't been tested by a 3rd party over a drug that has?

one of the items mentioned was vitamin E. i don't think i want vitamin E taken off the market, even if it is sometimes used in ways it shouldn't be.

and actually, no, I'm not too impressed with FDA. they seem a little too eager to give a green light to pharmaceutical companies. there have been some rather big lawsuits in the past few years over drugs given the OK by FDA. 3rd, 4th, 5th, and 6th parties seem like a good idea to me. that's how science is supposed to work, independent verification.
 
  • #17
Proton Soup said:
one of the items mentioned was vitamin E. i don't think i want vitamin E taken off the market, even if it is sometimes used in ways it shouldn't be.

and actually, no, I'm not too impressed with FDA. they seem a little too eager to give a green light to pharmaceutical companies. there have been some rather big lawsuits in the past few years over drugs given the OK by FDA. 3rd, 4th, 5th, and 6th parties seem like a good idea to me. that's how science is supposed to work, independent verification.
Actually the FDA has been criticized for being too cautious and taking too long to approve drugs. That is why there is such a big market for drugs being illegally brought into the US from Canada.
 
  • #18
Evo said:
Actually the FDA has been criticized for being too cautious and taking too long to approve drugs. That is why there is such a big market for drugs being illegally brought into the US from Canada.

no it isn't. the FDA protects domestic drug companies and favors US company drugs over foreign company drugs. also, these same US firms sell the exact same drugs in overseas markets for much cheaper than they sell them here. most of the drugs being illegally imported from Canada are available here, but the Canadian source is cheaper.
 
  • #19
Evo said:
There are no drug trials, please read the article.

I wasn't referring to the article. I was referring to people saying drug companies won't do trials because they don't have patent rights. Ergo my idea to give shorter-term patent rights in exchange for doing trials.
 
  • #20
WarPhalange said:
I wasn't referring to the article. I was referring to people saying drug companies won't do trials because they don't have patent rights. Ergo my idea to give shorter-term patent rights in exchange for doing trials.
Well, those people were off topic, since that's not in the article.
 
  • #21
Evo said:
Well, those people were off topic, since that's not in the article.

Good eye.
 
  • #22
Proton Soup said:
no it isn't. the FDA protects domestic drug companies and favors US company drugs over foreign company drugs. also, these same US firms sell the exact same drugs in overseas markets for much cheaper than they sell them here. most of the drugs being illegally imported from Canada are available here, but the Canadian source is cheaper.
I've read a lot about this issue for several years. I'm going to bed, but start with these.

FDA Too Slow To Approve New Medical Drugs And Devices

http://cei.org/gencon/003,02985.cfm

Life-Saving Cancer Drugs Not Approved by the FDA

http://www.lef.org/magazine/mag2007/sep2007_cover_lscancer_02.htm

A fast-tracked French Cancer drug in the US

http://www.cbc.ca/news/story/2002/08/12/cancer_drug020812.html
 
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  • #23
Evo said:
I've read a lot about this issue for several years. I'm going to bed, but start with these.

FDA Too Slow To Approve New Medical Drugs And Devices

http://cei.org/gencon/003,02985.cfm

Life-Saving Cancer Drugs Not Approved by the FDA

http://www.lef.org/magazine/mag2007/sep2007_cover_lscancer_02.htm

A fast-tracked French Cancer drug in the US

http://www.cbc.ca/news/story/2002/08/12/cancer_drug020812.html


i think cancer is kind of a special case. a nurse friend of mine works in oncology and she tells me that pretty much nobody ever gets cured, it almost always comes back. it's a fairly hopeless disease, and i think i'd be for more liberal use of experimental drugs for cancer patients. but i don't think that should be a model for other drugs.
 
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