Quality of Generic Drugs

[Chuckanut]

The People's Pharmacy has a show on problems with fraud in the generic drug industry. The link is below. My experience is that the link remains active for a few weeks, then one must purchase the CD to hear the show.

https://www.peoplespharmacy.com/2019/06/13/show-1169-what-are-the-problems-with-generic-drugs/

It is an interview with the author of a book "Bottle of Lies" which exposes poor quality control in generic drugs made overseas (where most of our generic drugs come from).

Of course, I can't vouch for the accuracy of the material presented, but it certainly raises concerns. Given the recent recalls of certain drugs due to contamination, there might be some meat in author's claims.

 

[Teacher Terry]

Well that’s scary as most everything I take is generic.

 

[cathy63]

I heard her interviewed on Fresh Air last month. It is scary!

Here's the link to the audio and transcript of the Fresh Air interview: https://www.npr.org/templates/transcript/transcript.php?storyId=723545864

 

[Kwirk]

You should probably be nearly as concerned about the quality of name-brand drugs.

 

[tuckeverlasting]

I read the book, "Bottle of Lies". The author appears to be credible and the content is indeed concerning. If I recall correctly the book explains that almost all brand name drugs do not face the problems described for generics. On the other hand, the book states that most generics are "good enough" (to paraphrase) and get the job done at great savings. For myself, I really have no choice between generics and name brands, due to cost.

 

[threegoofs]

The People's Pharmacy has a show on problems with fraud in the generic drug industry. The link is below. My experience is that the link remains active for a few weeks, then one must purchase the CD to hear the show.

https://www.peoplespharmacy.com/2019/06/13/show-1169-what-are-the-problems-with-generic-drugs/

It is an interview with the author of a book "Bottle of Lies" which exposes poor quality control in generic drugs made overseas (where most of our generic drugs come from).

Of course, I can't vouch for the accuracy of the material presented, but it certainly raises concerns. Given the recent recalls of certain drugs due to contamination, there might be some meat in author's claims.

It’s definitely a concern.
Just ask any pharmacist about quality control for some of these products. Broken tablets, powdered tablets, etc.

Remember though.. many drugs can be assessed for effectiveness by their actions- does it lower BP, or blood sugar, or LDL consistently? Generics are allowed to be 80-120% within stated potency, and they tend to have more drug in them than less.

Much of the concern is with sterility in the plants, since that’s one of the more costly snd challenging aspects of msnufacturing, but I guess I’m not too concerned personally about a little bacteria in the medicine- although if one is immunosuppressed that could be concerning.

The FDA though, really tend to do a thorough job once problems are identified, so this should have been improving over the years.

 

[eytonxav]

DW takes a thyroid medication, and has found that many generics that she has tried do not work for her and in one case also discovered one brand of generic pills contained gluten (she has celiac disease). The maker of that pill denied it contained gluten, but they never furnished their test results to prove otherwise as they promised they would do. The company was in India. I doubt there is any FDA oversight of these foreign generic companies.

 

[mamadogmamacat]

Synthroid is the only name brand drug i take, precisely because generic thyroxine does not work for me either. The BP med I take is generic, and has been through two recalls for contamination.

 

[eytonxav]

Synthroid is the only name brand drug i take, precisely because generic thyroxine does not work for me either. The BP med I take is generic, and has been through two recalls for contamination.

Yes, that is what DW takes. It costs more, but at least it does what it is supposed to do.

 

[Rianne]

Not all pharma companies are the same. One generic can differ greatly from another is strength and ingredients. The problem is my pharmacy, Walgreens, has to take what they're given for generics. So one month it might be one pharma and the next a different pharma. I know one of the pharma's makes inferior generics and it makes me mad there's not a thing I can do about it.

 

[triangle]

I did not listen to either podcast but is part of the issue the manufacturer and their quality control? Meaning might drugs manufactured by Teva Pharmaceutical (TEVA) fare better than say Dr. Reddy (RDY)? (Israeli based vs India based manufacturer). I don't take any prescription drugs so I don't follow this closely but I am not so cynical as to think generic manufacturers are trying to short change the customer...but it sounds like there is not full disclosure on the ingredients and where they are made?

 

[cathy63]

I did not listen to either podcast but is part of the issue the manufacturer and their quality control? Meaning might drugs manufactured by Teva Pharmaceutical (TEVA) fare better than say Dr. Reddy (RDY)? (Israeli based vs India based manufacturer). I don't take any prescription drugs so I don't follow this closely but I am not so cynical as to think generic manufacturers are trying to short change the customer...but it sounds like there is not full disclosure on the ingredients and where they are made?

Israeli drug manufacturers are not much better than those in India. From https://www.npr.org/sections/health...xposes-the-dark-side-of-the-generic-drug-boom

Some patients who switched to a generic version of Wellbutrin, an antidepressant, complained of headaches, nausea, irritability and even suicidal thoughts. There were reports of pills that literally smelled "fishy." It took the FDA five years to verify that the generic pills produced by the Israeli manufacturer Teva were not equivalent to brand-name Wellbutrin.

I guess it's good that at least Teva wasn't lacing them with glass though. This is from the Fresh Air interview I linked above:

EBAN: On the one hand, the FDA was the only regulator that responded to Thakur and launched an investigation in the wake of his allegations. But on the other hand, you know, it took them from 2005 to 2013 to bring this company to heel. In the middle of that, they give Ranbaxy approval for the biggest U.S. generic drug launch in history to make generic Lipitor, even though they know that this company is saturated with fraud. And about a year after that manufacturing begins, millions of Lipitor drugs have to be recalled because they're saturated with glass fragments.

This should be pretty eye-opening to anyone who's depending on the FDA to verify quality and take action to protect patients.

 

[Car-Guy]

I've been using the brand named drug Toprol for well over ten years now. Early on, I tried one of the generics since it was less than half the price but it didn't work very well (or maybe not at all). My doctor agreed and would write on the prescription, "dispense as written" (same as do not substitute). Anyway, last year my drug insurance company refused to continue to pay for the brand name "unless/until" I tried one or more of the generics again. They even contacted my doctor and asked him to send in another prescription for a generic, which he did. I reminded the doctor and told Express Scripts that I had tried a generic before and it didn't work. Didn't matter. I even said I'd pay full retail for the brand name. Still didn't matter and they wouldn't sell it to me. (WTF!)

Sounds to me as they (Express Scripts) was practicing medicine or at the very least, experimenting with my health to save a few dollars.

Anyway, I switched doctors and took my new prescription (for Toprol) to my local pharmacy and paid full price for it out of pocket.

And people wonder why I don't trust doctors and insurance companies.

 

[ExFlyBoy5]

Interesting. I have been taking a generic BP pill for 10+ years and have never had an issue. Once in a blue moon, I will get the "dry cough" that is widely reported as side effect, but other than that...works OK. Also, was on a generic Prilosec for a few years and had no issues with that, either.

My Dad took a generic for Synthroid for 15+ years (and most other meds were generics from Canada) with no issues.

This isn't to say that there *isn't* a problem, but I haven't been affected by them (as far as I can tell).

 

[Car-Guy]

Interesting. I have been taking a generic BP pill for 10+ years and have never had an issue. Once in a blue moon, I will get the "dry cough" that is widely reported as side effect, but other than that...works OK. Also, was on a generic Prilosec for a few years and had no issues with that, either.

My Dad took a generic for Synthroid for 15+ years (and most other meds were generics from Canada) with no issues.

This isn't to say that there *isn't* a problem, but I haven't been affected by them (as far as I can tell).

I've had doctors tell me, some generics work for some folks, some do not. Common sense.

 

[ExFlyBoy5]

I've had doctors tell me. some generics work for some folks, some do not. Common sense.

Well, I don't think this should be common sense. I think this illustrates the problem very well. In the world of manufactured drugs, you would *think* that the generics would be as effective as the brand name...especially since since you are prescribed the medicine because of the active ingredient(s). How this isn't the case (I assume) is bothersome to me and to many others that would like to think that the FDA is protecting the health of "the people."

 

[Car-Guy]

Well, I don't think this should be common sense. I think this illustrates the problem very well. In the world of manufactured drugs, you would *think* that the generics would be as effective as the brand name...especially since since you are prescribed the medicine because of the active ingredient(s). How this isn't the case (I assume) is bothersome to me and to many others that would like to think that the FDA is protecting the health of "the people."

I certainly would not *think* that anymore.

 

[John Galt III]

Synthroid is the only name brand drug i take, precisely because generic thyroxine does not work for me either. The BP med I take is generic, and has been through two recalls for contamination.

My doc switched me to a generic synthroid many years ago, and I started to feel tired all the time. I went back on the brand name stuff and felt better. But....fast forward 20 years. The brand stuff was getting pricey, so I tried some generic (levothyroxine) and it worked fine, and was very cheap! So for now, I'm happy with generic.

 

[Chuckanut]

According to the show I mentioned above, we now import 80% of our medicines from overseas.

The author also mentions a few things about generics that hit a nerve with me:

Generic drugs are not an identical version of the name brand drugs, they are an approximate version. The FDA no longer uses the word 'identical' when talking about generic drugs. No drug inventor gives the generic companies the recipe. Generic drugs are reverse engineered. For example, they may have a different time release mechanism, they may have different 'additional' ingredients, but the active ingredient must be the same. Generics must be bio-equivalent, that is fall into a range that the FDA has determined is equivalent in regards to the drug being absorbed into the blood. Some doctors believe that treatments requiring 'precise dosing' may be affected by these differences.

You really have to listen to the entire interview to get a full understanding of what this author is saying. I'm just mentioning some high points that got my attention.

FWIW, the only Rx I take is a generic and it seems to work well despite it's very cheap price. But, it certainly does not require precise dosing, and I won't die (or probably notice anything) if I skip a few doses, or accidently take a double dose.

 

[triangle]

According to the show I mentioned above, we now import 80% of our medicines from overseas.

The author also mentions a few things about generics that hit a nerve with me:

Generic drugs are not an identical version of the name brand drugs, they are an approximate version. The FDA no longer uses the word 'identical' when talking about generic drugs. No drug inventor gives the generic companies the recipe. Generic drugs are reverse engineered. For example, they may have a different time release mechanism, they may have different 'additional' ingredients, but the active ingredient must be the same. Generics must be bio-equivalent, that is fall into a range that the FDA has determined is equivalent in regards to the drug being absorbed into the blood. Some doctors believe that treatments requiring 'precise dosing' may be affected by these differences.

You really have to listen to the entire interview to get a full understanding of what this author is saying. I'm just mentioning some high points that got my attention.

FWIW, the only Rx I take is a generic and it seems to work well despite it's very cheap price. But, it certainly does not require precise dosing, and I won't die (or probably notice anything) if I skip a few doses, or accidently take a double dose.

That is interesting, as I thought one of the cornerstones of patent law was that the "invention" must be fully described to the point where it could be duplicated by another party. That in turn for this full disclosure, the inventor got control and protection of their intellectual property for some number of years.

Where this structure was established to help create a win-win situation for everyone, where the inventor could reap the benefits of their development work and thus have the incentive to carry it through, while the public (other individuals) could understand it so that they could extend it or build on top of it to create even better inventions for tomorrow.

Perhaps pharmaceuticals work differently than other areas of patent law. Or maybe the show is talking about trade secrets, where there is no legal protection and and depends on some other party reverse engineering the drug on day 1 or many years after it has been on the market.

 

[Rianne]

The People's Pharmacy has a show on problems with fraud in the generic drug industry. The link is below. My experience is that the link remains active for a few weeks, then one must purchase the CD to hear the show.

https://www.peoplespharmacy.com/2019/06/13/show-1169-what-are-the-problems-with-generic-drugs/

It is an interview with the author of a book "Bottle of Lies" which exposes poor quality control in generic drugs made overseas (where most of our generic drugs come from).

Of course, I can't vouch for the accuracy of the material presented, but it certainly raises concerns. Given the recent recalls of certain drugs due to contamination, there might be some meat in author's claims.

Just listened to the Podcast. I looked up my generics on "FDA Orange Book" as Eban suggested. Two of my previous prescriptions were from a company not on the approved list. I asked Dr to re submit a new prescription altering the amount from 1 mg tablets to 2 mg tablets (which I can cut in half). This way the drug comes from the pharma approved and I approve. My Dr had no issue doing this and the pharmacist said happens quite often. When you get a refill require the pharma company be the one you want. Eban noted Walgreens/CVS can change the pharma company without your knowledge or consent. My Dr will work with me to make sure I'm getting my med from the right company.