Quality Control in Prescription & Alternative Medicine

[geni]

Tends? Can you show me some kind of support that the active ingredient tends to be expensive? I work for a large drug corporation (fish vaccines& drugs) and the cost of our products is largely a function of the levels of bureaucracy that need to be addressed from the R&D stage all the way through to certification of the product.

Compare the cost of any more recent patent expired drug with a placebo. Sugar and chalk and the like tend to be a lot cheaper than even fairy simple synthesised organics.

If you take the position that the costs of the ingredients are not a significant factor than you are suggesting that the pharmaceutical industry is less competent than much the manufacturing industry which closely controls expensive consumables such as dyes.

 

[At In To]

Compare the cost of any more recent patent expired drug with a placebo.

Have you compared the costs, and the differences between the situation?

Generics do not have the costs associated with bringing a drug to market. The generic doesn't have to spend money on titrations, Phase I, II, III trials, and all the associated costs like R&D salaries, QC salaries, QA salaries, Regulatory affairs.

The entry of generics drives the price of the brand name drug down. But the drug still has brand power. Some people will still use a more expensive drug even when it is equivalent to a lower priced one. That's marketing psychology for you.

Your comparison to manufacturing is nonsensical. Completely different regulatory and economic regimes surrounding these industries.

 

[rwguinn]

Have you compared the costs, and the differences between the situation?

Generics do not have the costs associated with bringing a drug to market. The generic doesn't have to spend money on titrations, Phase I, II, III trials, and all the associated costs like R&D salaries, QC salaries, QA salaries, Regulatory affairs.

The entry of generics drives the price of the brand name drug down. But the drug still has brand power. Some people will still use a more expensive drug even when it is equivalent to a lower priced one. That's marketing psychology for you.

Your comparison to manufacturing is nonsensical. Completely different regulatory and economic regimes surrounding these industries.

What? The? Hell?
If the active ingredient in a drug is not the most expensive ingredient IN that drug, something is badly wrong with your set-up.
The cost of developing and approving that ingredient is part and parcel with the cost of its manufacture.

 

[At In To]

I never said the cost of the active ingredient wasn't the most expensive ingredient in the drug, I said that the cost of a drug isn't related to the price of the active ingredient, which is true. The manufacture of the drug has nothing to do with the clinical trials.

Do you know how accounting works?

 

[TsuDhoNimh]

This got me to wondering...

Does ISO 9001 ensure quality medicine?

No. I've brought departments and processes into Iso-9000, 9001, etc. compliance.

It is just a label indicating that you have policies and procedures and instructions in place for your process, formal ways to monitor your process, and formal ways to report and correct problems with the process.

If followed, it ensures consistency, it ensures a paper trail for error tracking, but it in no way ensures that the results of the process will have any scientific validity or work as promised by the advertising.

Perfectly ISO-9001 compliant sugar pills may be within the required tolerance for roundness and compression strength, misted with exactly the right quantity of the homeopathic remedy, dried at exactly the right temperature, bottled by a perfectly calibrated counting and bottling line, and correctly labeled.

But even the full force of the ISO-900 standard and the committee behind it can't make the stuff anything but water on a sugar pill.

 

[Orphia Nay]

No. I've brought departments and processes into Iso-9000, 9001, etc. compliance.

It is just a label indicating that you have policies and procedures and instructions in place for your process, formal ways to monitor your process, and formal ways to report and correct problems with the process.

If followed, it ensures consistency, it ensures a paper trail for error tracking, but it in no way ensures that the results of the process will have any scientific validity or work as promised by the advertising.

Perfectly ISO-9001 compliant sugar pills may be within the required tolerance for roundness and compression strength, misted with exactly the right quantity of the homeopathic remedy, dried at exactly the right temperature, bottled by a perfectly calibrated counting and bottling line, and correctly labeled.

But even the full force of the ISO-900 standard and the committee behind it can't make the stuff anything but water on a sugar pill.

Thanks, TDN. Much appreciated.

 

[Asolepius]

Stawman. Try reading what I actually wrote.

I have re-read what you wrote and it still doesn't resemble the process that I have worked with for 35 years. Dose levels are determined by safety criteria, initially established in phase I clinical trials, and by dose ranging studies in phase IIb.

 

[geni]

I have re-read what you wrote and it still doesn't resemble the process that I have worked with for 35 years. Dose levels are determined by safety criteria, initially established in phase I clinical trials, and by dose ranging studies in phase IIb.

Again you miss the point.

X is a company that sells drug Y in 20mg doses. Legaly there has to be at least 20 mg of drug Y in the pills. At the same time drug Y is a lot more expensive than the packing material. As a result the company has a very strong insentive to make sure that the pill contains as close 20mg as posible which results them having a very fine level of quality control.

 

[Asolepius]

Again you miss the point.

X is a company that sells drug Y in 20mg doses. Legaly there has to be at least 20 mg of drug Y in the pills. At the same time drug Y is a lot more expensive than the packing material. As a result the company has a very strong insentive to make sure that the pill contains as close 20mg as posible which results them having a very fine level of quality control.

No, legally there does not have to be at least 20 mg of drug Y in the pills. Legally there has to be 20mg, within a defined tolerance. It would be just as much a legal violation to have 25mg as it would be to have 15mg. This is because safety and tolerability are related to exposure to the drug, and if you increase the dose you increase the exposure. The regulatory pressure is far more significant than the cost pressure.

 

[blutoski]

What? The? Hell?
If the active ingredient in a drug is not the most expensive ingredient IN that drug, something is badly wrong with your set-up.
The cost of developing and approving that ingredient is part and parcel with the cost of its manufacture.

I think it depends on the drug in question.

For example, the active ingredient could be generic, but their delivery mechanism is a patented proprietary component. For example, delayed-release/slow-release psychopharmaceuticals.

In any case, I agree with Asolepius: the attempt is to be accurate with the claim of active ingredient, regardless of cost.

 

[blutoski]

Back to the original post...

There is a blanket regulation called the Trade Act in the US that basically says ingredients have to be what the label claims. It applies to all products, and that includes dietary supplements.

The problem is really about enforcement. The limited budget means that enforcement follows complaints, which usually only follow personal injury.

People who buy dietary supplements seem to be unable to connect the dots when they are injured by their favourite product, so a lot of harm does not translate into enforcement.