Quality Control in Prescription & Alternative Medicine

[Orphia Nay]

Recently at another forum we were discussing Gary Null's lawsuit against the company producing his product (JREF thread here) and a skeptic said:

"This is why there should be some regulation in the supplement market. To ensure that the products that are produced have in them what is on the label."

A woo supporter replied:

"From the link in the OP: 'Triarco is ISO 9001:2008 certified by the National Science Foundation (NSF) and Underwriter Laboratories (UL)'".


This got me to wondering...

Does ISO 9001 ensure quality medicine?

Are there other regulation methods employed by prescription drug companies that aren't used by alternative medicine producers?

 

[Asolepius]

ISO9001 is a generic quality standard for production of anything, not just medicines. Real medicines are heavily regulated in all developed countries, with a raft of legislation designed to ensure efficacy, safety and quality. But what is happening in Europe is that alternatives and supplments are being excused the efficacy test in legislation specific to those products.

If you have the time, look up The Food and Drug Act 1990 and The Medicines Act 1968, to get a flavour of the extent of regulation that applies to medicines, but not to alternatives.

 

[paulhutch]

A couple points, it's the "National Sanitation Foundation" that certified Triarco, not the National Science Foundation.

ISO9001 is a quality management standard, not a quality standard. It imposes no specific quality level, it certifies that they have a management system to maintain whatever quality level the manufacturer wants to provide.

FDA standards guarantee actual quality levels.

 

[Orphia Nay]

Thanks, Asolepius and paulhutch. You've been very helpful.

 

[geni]

You've also got to consider basic market forces. Real medicines consist of packing material and active ingrdient. High purity packing material of various types is faitly cheaply and widely aviable to the point where is little to gain in using anything else. The active ingredient on the other hand tends to be expensive so there is a strong insentive to put no more in than is legaly required.

That just leaves you with general rubish left over from the formation of the drug which will generaly be removed for a mix of legal reasons and the fact in many cases they are rather toxic which would make your drugs harder to sell. An exception would be thamaldihide where it is rather diffucult to remove all the impurities.

 

[The Man]

Other than just market incentives and forces geni, problems arise when there is no regulatory requirement to remove the general rubbish in the raw materials. Which costs money to remove and may not make said supplement harder to sell. In fact claiming your supplement is “natural” and undergoes very limited processing can actually be a selling point. Until some problems are discovered, then you just change the name and sell it as a superior (and more expensive) supplement that reduces your say explosive incontinence risks (caused by taking the supplement, but reduced now because they are removing some of that rubbish).


In the US The Dietary Supplement Health and Education Act of 1994 actually reduced the ability of the FDA to try and regulate the safety of such “alternatives”.

 

[Orphia Nay]

Other than just market incentives and forces geni, problems arise when there is no regulatory requirement to remove the general rubbish in the raw materials. Which costs money to remove and may not make said supplement harder to sell. In fact claiming your supplement is “natural” and undergoes very limited processing can actually be a selling point. Until some problems are discovered, then you just change the name and sell it as a superior (and more expensive) supplement that reduces your say explosive incontinence risks (caused by taking the supplement, but reduced now because they are removing some of that rubbish).


In the US The Dietary Supplement Health and Education Act of 1994 actually reduced the ability of the FDA to try and regulate the safety of such “alternatives”.

Thanks for that very useful information & link, The Man!

 

[Orphia Nay]

Possibly some improvement afoot, according to this May 12 article:

http://www.reuters.com/article/idUSTRE64B6F020100513

(Reuters) - The Food and Drug Administration is stuck using crude tools to measure the benefits of food, drugs and supplements and needs a whole new set of standards, a panel of experts said on Wednesday

[...]

The FDA also needs to use the same strict standards for assessing health claims of food and supplements as it does for drugs, said the panel appointed by the Institute of Medicine, which advises the federal government.

The committee recommended a new framework the FDA could use for judging studies that companies provide to support health and safety claims for their products.

"Congress may need to strengthen FDA authority to accomplish this goal," the institute's report reads.

[...]

Committee chairman John Ball of the American Society for Clinical Pathology said consumers often assume the FDA regulates food and supplements in the same way it does drugs.

The FDA is also hobbled by the Dietary Supplement and Health Education Act, or DSHEA, the report says.

"Under DSHEA, dietary supplements are broadly presumed to be safe, and the FDA does not have the authority to require dietary supplements to be approved for safety and efficacy before they enter the market," it reads.

"Because of the regulatory framework for dietary supplements, the FDA has little information about the safety and effectiveness of dietary supplements."

 

[Orphia Nay]

This, from May 25, is hopeful, but not overly optimistic:

http://www.nytimes.com/2010/05/26/health/policy/26herbal.html

Nearly all of the herbal dietary supplements tested in a Congressional investigation contained trace amounts of lead and other contaminants, and some supplement sellers made illegal claims that their products can cure cancer and other diseases, investigators found.

[...]

The report, which was prepared by the Government Accountability Office, was provided to The New York Times and will be made public at a Senate hearing on Wednesday. Its release comes two weeks before the Senate is scheduled to begin debate on a landmark food safety bill that is expected to substantially increase the federal government’s authority over food manufacturers.

But it is uncertain how tough the bill will be on supplement manufacturers, and it has been the subject of fierce lobbying. Capitol Hill staff members familiar with the process said the bill was unlikely to include provisions opposed by supplement manufacturers.

[...]

The food safety bill expected to be introduced next month in the Senate is likely to mandate that supplement makers register annually with the F.D.A. and allow the agency to recall supplements suspected of being dangerous.

But a House provision that would require manufacturers to create plans to safely manufacture their products and a proposal made in February by Senators John McCain, Republican of Arizona, and Byron L. Dorgan, Democrat of North Dakota, to restrict supplements to ingredients approved by the F.D.A. will not be included, staff members said.

 

[Asolepius]

You've also got to consider basic market forces. Real medicines consist of packing material and active ingrdient. High purity packing material of various types is faitly cheaply and widely aviable to the point where is little to gain in using anything else. The active ingredient on the other hand tends to be expensive so there is a strong insentive to put no more in than is legaly required.

R & D costs are in most cases more important than manufacturing costs. You have to use the dose level that RCTs have shown to be effective. Upper dose limit is more dictated by safety and tolerability.

That just leaves you with general rubish left over from the formation of the drug which will generaly be removed for a mix of legal reasons and the fact in many cases they are rather toxic which would make your drugs harder to sell. An exception would be thamaldihide where it is rather diffucult to remove all the impurities.

What is thamaldihide? Do you mean thalidomide? That disaster had nothing to do with impurities, it was a teratogenic effect of the active ingredient.

 

[Deetee]

Is thamaldihide a special new toxin designed by evil pharma which consists of thalidomide mixed with formaldehyde?
That would send the woos batsh!t crazy with rage.

 

[geni]

R & D costs are in most cases more important than manufacturing costs. You have to use the dose level that RCTs have shown to be effective. Upper dose limit is more dictated by safety and tolerability.

Not what I meant. A say 20mg pill of whatever will contain 20mg of it because even patent free AZT costs a lot more to make than packing material.

What is thamaldihide? Do you mean thalidomide? That disaster had nothing to do with impurities, it was a teratogenic effect of the active ingredient.

Thalidomide yes. The problem wasn't for the most part the active ingredient itself (that is a problem but a lesser one) but the other stereoisomer.

 

[Asolepius]

Not what I meant. A say 20mg pill of whatever will contain 20mg of it because even patent free AZT costs a lot more to make than packing material.

I still don't understand. It will be 20mg because that is the effective and (relatively) safe dose. The dose will not be lowered to save money, because then it will be less effective and it will lose out to competitors.

Thalidomide yes. The problem wasn't for the most part the active ingredient itself (that is a problem but a lesser one) but the other stereoisomer.

Very little was known about drug chirality in those days. Drugs were tested for purity on the basis of empirical and structural formulae. The enantiomer would not have been considered a contaminant then.

 

[geni]

I still don't understand. It will be 20mg because that is the effective and (relatively) safe dose. The dose will not be lowered to save money, because then it will be less effective and it will lose out to competitors.

No it won't be lowered because someone might notice and you would be somewhat sued. It won't however be raised either (which when you are dealing pharmacologically active compounds is also a threat) due to cost. Thus you end up with a very fine level of quality control which allows a consistent dose to be provided.

Very little was known about drug chirality in those days. Drugs were tested for purity on the basis of empirical and structural formulae. The enantiomer would not have been considered a contaminant then.

We've started using Thalidomide again for certian things and I don't think we are making it enantiomerically pure. As I said it's an exception.

 

[Orphia Nay]

http://aging.senate.gov/hearing_detail.cfm?id=325285&

KOHL CALLS FOR BETTER LABELING, REDUCTION OF CONTAMINANTS IN DIETARY SUPPLEMENTS

May 26, 2010

WASHINGTON – Today U.S. Senator Herb Kohl, Chairman of the Special Committee on Aging, held a hearing on the marketing and manufacturing of dietary supplements, which include a wide range of products such as vitamins, minerals, fiber, fatty acids, or amino acids. An investigation conducted by the U.S. Government Accountability Office (GAO) uncovered improper advertising and marketing of dietary supplements, as well as the existence of contaminants such as mercury, lead, and pesticides in certain products. Unlike pharmaceutical drugs, dietary supplements are not subject to approval by the U.S. Food and Drug Administration (FDA) before they are marketed and sold to consumers. Claims made about these products in advertisements are also subject to only limited regulation. Recent surveys indicate that at least 40 percent of American adults take dietary supplements. In 2006, Americans reportedly spent $23 billion on herbal and specialty supplements, which is almost half the amount they spent on prescription drugs.

[Click link for rest of article.]

 

[Asolepius]

No it won't be lowered because someone might notice and you would be somewhat sued. It won't however be raised either (which when you are dealing pharmacologically active compounds is also a threat) due to cost. Thus you end up with a very fine level of quality control which allows a consistent dose to be provided.

OK, show me some evidence that dose level has been determined by cost and not by efficacy and safety studies.

 

[geni]

OK, show me some evidence that dose level has been determined by cost and not by efficacy and safety studies.

Stawman. Try reading what I actualy wrote.

 

[Madalch]

I still don't understand. It will be 20mg because that is the effective and (relatively) safe dose. The dose will not be lowered to save money, because then it will be less effective and it will lose out to competitors.

Very little was known about drug chirality in those days. Drugs were tested for purity on the basis of empirical and structural formulae. The enantiomer would not have been considered a contaminant then.

They knew about drug chirality, but thought that it had been proven that, should one enantiomer prove physiologically active, the other enantiomer would always be physiologically inert. Thalidomide turned out to be the first known exception.

On the other hand, thalidomide may racemize under biological conditions, so making the one enantiomer pure isn't as productive one would hope.

 

[At In To]

The active ingredient on the other hand tends to be expensive so there is a strong insentive to put no more in than is legaly required.

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.

The active ingredient is carefully monitored because it relates to making shipments of drug available when you tell the customers they can expect it. If you use too much and you don't have enough to make a shipment of other batches, that reflects poorly on a company. So that's part of why quality control and quality assurance are so important, besides compliance with the guidelines we receive from regulatory affairs.

 

[Eos of the Eons]

Is thamaldihide a special new toxin designed by evil pharma which consists of thalidomide mixed with formaldehyde?
That would send the woos batsh!t crazy with rage.

Along with REGULATING food supplements, that is just big pharma trying to get their cut by making them more expensive (and absolutely not cuz proving things are safe and maybe even a little effective are the right thing to do).