Hacker News Board Hacker News, browsed like a classic message board
Live data from Hacker News

Carcinogens Have Infiltrated the Generic Drug Supply in the U.S.

bloomberg.com

Post reply on HN
Print view View original

31–40 of 142 posts

Re: Carcinogens Have Infiltrated the Generic Drug Supply in the U.S.

#31

Post by RussianCow »

dahfizz wrote: post #24
lostmsu wrote: post #19

Earlier quoted context omitted.

>> The FDA checks less than 1% of drugs for impurities or potency before letting them into the country. > For a regulator body who's job it is to make sure medical products are safe and available. These comments, if true, lend credability that the FDA is more regulatory capture than actual useful regulation. I wonder though if this statement misrepresents the facts. If they check only 1% of the entire import volume a…

I agree, I think the statement is ambiguous. 1% of all products (e.g. one pill from every bottle of 100 pills) being tested seems like plenty. 1% of shipments (1 out of 100 shipments is sampled) seems insufficient.

Even 1% shipments would be okay, IMO. I interpreted it as "99% of drug products never get inspected", which is way worse.

Re: Carcinogens Have Infiltrated the Generic Drug Supply in the U.S.

#32

Post by _ea1k »

mikeyouse wrote: post #22
MegaButts wrote: post #18

Earlier quoted context omitted.

Doesn't that mean they're not chemically equivalent?

The active ingredient is the same - the binders and fillers and capsule materials are mostly inert. This isn't true for all drugs - for the blood thinner Coumadin, you're meant to stick to generic or brand name and not switch between the two since there are known differences in efficacy.

I do not think the results for Coumadin/Warfarin are at all clear: https://www.ncbi.nlm.nih.gov/pubmed/21449627

Re: Carcinogens Have Infiltrated the Generic Drug Supply in the U.S.

#33

Post by Rychard »

MegaButts wrote: post #18
gwbas1c wrote: post #12

Earlier quoted context omitted.

Yes there is. It's primarily based around different characteristics of how the medication dissolves in the patient's stomach, or the differences between fillers and binders.

Doesn't that mean they're not chemically equivalent?

My understanding is that only the "active ingredient" is the same. Everything else is subject to cost-cutting, as there are many fillers and binders to choose from, and they're priced differently.

Re: Carcinogens Have Infiltrated the Generic Drug Supply in the U.S.

#34

Post by JMTQp8lwXL »

MegaButts wrote: post #25
mikeyouse wrote: post #22

Earlier quoted context omitted.

The active ingredient is the same - the binders and fillers and capsule materials are mostly inert. This isn't true for all drugs - for the blood thinner Coumadin, you're meant to stick to generic or brand name and not switch between the two since there are known differences in efficacy.

I understand that. OP said: > There is no sensible reason to pay a premium for brand name if the generic is chemically equivalent. If they're not chemically equivalent and have different medicinal effects as a result, then it's much easier to justify a price difference. I understand chemistry is more than just a list of ingredients. It's how those ingredients are combined that gives them their unique interactions.

For sake of the discussion here, bio-equivalence is the more helpful way for meaningfully comparing generic to brand names. The filler might be different, but if the biological effect is identical at half the cost, one would be prudent to chose the generic option.

Re: Carcinogens Have Infiltrated the Generic Drug Supply in the U.S.

#37

Post by opencl »

newsreview1 wrote: post #35

Wow, to formulate a generic drug and export it to the U.S. requires the FDA stamp, but if you generate components used in manufacture of US-made drugs get literally no FDA oversight. How can this be?.

In principle the FDA should inspect the US-made drug after manufacture so inspecting all of their suppliers would be redundant.

Re: Carcinogens Have Infiltrated the Generic Drug Supply in the U.S.

#38

Post by mikeyouse »

_ea1k wrote: post #32
mikeyouse wrote: post #22

Earlier quoted context omitted.

The active ingredient is the same - the binders and fillers and capsule materials are mostly inert. This isn't true for all drugs - for the blood thinner Coumadin, you're meant to stick to generic or brand name and not switch between the two since there are known differences in efficacy.

I do not think the results for Coumadin/Warfarin are at all clear: https://www.ncbi.nlm.nih.gov/pubmed/21449627

Thanks for the update - interesting study.

Re: Carcinogens Have Infiltrated the Generic Drug Supply in the U.S.

#39

Post by sjg007 »

pkaye wrote: post #7

Are these problems only limited to the US? Do Canada or the EU have similar issues? Do they not import chemicals from similar suppliers or do they screen the better?

It's an issue everywhere. Almost all generics are manufactured in India and China. And most with Chinese precursors.
Post reply on HN