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Drugs with FDA approval that don't work


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... my point is only that there's no evidence that this has anything to do with one being a name-brand drug and one being a generic. there are certainly people (me, personally) who've had a better experience with a generic than its equivalent name-brand drug.

 

there's no principle to be drawn from this, other than different bodies may be affected differently, and there's no way to find out without trying it. if your doctor is aware of some large population sample affected adversely by a particular generic, they should alert the newspapers.

They should alert MedWatch.

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That's you right there in the bold print Mongo. You were my "also been said".

 

As has been said many times in 17 pages, yes they are... at least as far as the active material is concerned. But, as has also been said, the material used to deliver the active ingredient is not the same and it is increasingly clear that patient reactions, in practice, differ due to this... more than an insignificant amount. Of course, this is said to be part of patients' allergic reactions to the different "inactive" base material, but allergy is one of those words without much meaning other than adverse reaction.

 

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M&M's taste different you know.

 

ETA: Actually this is interesting and applies to drug preferences:

"The color from the candy shells has no taste. It's the delicious milk chocolate (and inclusions like peanuts and crisped rice) inside, with the crisp sugar shells outside, that provide all the taste and texture of "M&M's"® Chocolate Candies. While there is no difference in taste due to the different colors, consumers do eat their "M&M's"® in a variety of different ways, i.e., sorting the colors out separately and eating one color at a time, allowing the color to dissolve from the candy shell in their mouths prior to chewing the candy, and of course just enjoying them one by one."

More.

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M&M's taste different you know.

 

ETA: Actually this is interesting and applies to drug preferences:

"The color from the candy shells has no taste. It's the delicious milk chocolate (and inclusions like peanuts and crisped rice) inside, with the crisp sugar shells outside, that provide all the taste and texture of "M&M's"® Chocolate Candies. While there is no difference in taste due to the different colors, consumers do eat their "M&M's"® in a variety of different ways, i.e., sorting the colors out separately and eating one color at a time, allowing the color to dissolve from the candy shell in their mouths prior to chewing the candy, and of course just enjoying them one by one."

More.

but everyone knows the green ones are the best. more troubling, i find that pez don't work as well to control my asthma as my inhaler, even though the dispensers are similarly shaped.

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  • 4 weeks later...

Generic drug or not; location of manufacture may indeed influence the quality of FDA oversight according to this article: click

 

A Chinese factory that supplies much of the active ingredient for a brand of a blood thinner that has been linked to four deaths in the United States is not certified by China’s drug regulators to make pharmaceutical products, according to records and interviews.

 

Because the plant, Changzhou SPL, has no drug certification, China’s drug agency did not inspect it. The United States Food and Drug Administration said this week that it had not inspected the plant either — a violation of its own policy — before allowing the company to become a major supplier of the blood thinner, heparin, to Baxter International in the United States.

 

axter announced Monday that it was suspending sales of its multidose vials of heparin after 4 patients died and 350 suffered complications. Why the heparin caused these problems — and whether the active ingredient in the drug, derived from pig intestines, was responsible — has not been determined.

 

The plant in Changzhou, west of Shanghai, appears to fall into the type of regulatory void that American and Chinese health officials are trying to close — in which chemical companies export pharmaceutical ingredients without a Chinese drug license.

 

China provides a growing proportion of the active pharmaceutical ingredients used in drugs sold in the United States. And Chinese drug regulators have said that all producers of those ingredients are required to obtain certification by the State Food and Drug Administration. However, some of the active ingredients that China exports are made by chemical companies, which do not fall under the Chinese drug agency’s jurisdiction.

 

In December, American and Chinese regulators signed an agreement under which China promised to begin registering at least some of the thousands of chemical companies that sell drug ingredients. Some of these companies are the source of counterfeit or diluted drugs, including those used to treat malaria.

Discussions that led to the accord began after an unlicensed chemical plant in China made a tainted drug ingredient that poisoned more than 170 people in Panama, killing at least 115.

 

The heparin plant in China has not been accused of providing a harmful product. The American majority owner of that plant, Scientific Protein Laboratories, also owns a plant in Wisconsin that produces the active ingredient in heparin for Baxter.

 

...

 

Karen Riley, a spokeswoman for the United States Food and Drug Administration, said inspectors from that agency would be visiting the Changzhou plant soon. Ms. Riley said she could not be more specific. Earlier in the week she described her agency’s failure to inspect the plant as a “glitch.”

 

Congress has criticized the oversight by the Food and Drug Administration of bulk pharmaceutical ingredients made by foreign manufacturers and sold in the United States. A growing number of those ingredients now come from China. Of the 700 approved Chinese drug plants, the United States agency has inspected only 10 to 20 each year.

...

 

This is very scary. That being said, as far as I can tell, they don't know or haven't released the information about whether the batch variability originates from the China plant or their Wisconsin plant. In any case, it appears that the chemical plant in China was not inspected by either China or the US with standards applied to chemicals to be use in human drugs.

 

(bolding added)

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I'm a bit confused by the last bit; it's surely the big manufacturers who are the vested interests, and I still don't understand why they haven't gone down the easily available road of giving the FDA data to show that generic versions of their valuable brands don't work. I just can't figure that out.

 

Wouldn't that contradict their typical position in court that said drugs not only work, but are identical to the original and have been developed using stolen IP or violated patents?

 

 

 

 

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  • 8 months later...

Companies that import Chinese pharmaceutical ingredients, including aspirin, are required to test the supplies before using them, and some send private inspectors to China to ensure that suppliers use adequate controls. No pharmaceutical maker wants its name to become synonymous with disaster, and the vast majority of drugs that are consumed in the United States are safe. But some industry executives told me that price sensitivity in the generics industry makes it more difficult to fully vet their low-cost suppliers.

 

 

NYTimes today

 

 

HEH!

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