
Generic Drugs May Not Be As Safe Or Effective As Thought - kasperset
https://www.npr.org/sections/health-shots/2019/05/16/723545864/the-generic-drugs-youre-taking-may-not-be-as-safe-or-effective-as-you-think?mc_cid=362a76f80a&mc_eid=61ba61d10e
======
newswriter99
"Eban advises consumers to research who manufactures their generics and look
up any problems that regulators have found out about them."

The whole point of government agencies like the FDA is to perform inspections
that consumers lack the ability, time or resources to do on their own.

I get that we're in a complicated interconnected world and you've got to look
out for yourself, but that's me. There's about 300 million Americans out there
and a good portion of them are busy raising kids and busting their ass working
and CAN'T spend hours investigating their prescription meds and inspecting
their food.

Also, it's politically incorrect to say this, but a smaller number of
consumers aren't intelligent enough to even begin taking care of themselves.
They need the FDA more than anyone.

~~~
duxup
That strikes me as useful as the "security expert" who shows up on TV and
tells people to "only download apps you trust".

Who really knows anything about ANY of the apps they download? Nobody has the
required knowledge / time to make that determination with any amount of
success.

Anyway the FDA situation reminds me of a libertarian blogger who a while back
wrote a great blog that went something like "Guys, libertarians aren't
supposed to hate the FDA / EPA!"

His point being that libertarians are supposed to get riled up when government
gets involved in protecting people from decisions that they should make on
their own, such as preventing people from jumping off anything because jumping
off a cliff is bad (overly simple example but that's the idea). Situations
like telling good medicine from bad where you need huge amounts of testing and
industry knowledge, or having someone dump toxic waste next to your house that
you can't tell ... you're permanently hurt by the time you figure it out is
something libertarians should want a government involved in.

Life is complex, we can't figure everything out ourselves.

~~~
linuxftw
There's a free-market answer to the FDA problem, I don't think any real
libertarian would argue otherwise (note: I'm not a libertarian).

The solution is having a brand, and building that brand based on trust.
Additionally, 3rd parties you subscribe to could verify the claims of brands
and their integrity.

This is similar to things like Fair Trade [1] certifications, or Kosher
certifications.

I often buy brand-name drugs OTC for QA purposes. I know that for the most
part, Tylenol is going to contain 500mg of the primary ingredient when I buy
it. Those portions are likely to be of good purity and uniform size. The off
brand, might have more or less, of similar or dissimilar quality. I trust that
US-based business for the most part actually care about their customers. It's
a web of trust. Do I trust non-US business with manufacturing operations
overseas? Not really when it comes to medication, no.

1: [https://www.fairtradecertified.org/](https://www.fairtradecertified.org/)

~~~
dragontamer
> The solution is having a brand, and building that brand based on trust.

You mean like Boeing's 737 MAX8 aircraft? Or Purdue pharma's Oxycotin (aka:
that opioid that Purdue Pharma claimed was non-addicting, except it kick-
started the entire opioid crisis because spoiler alert: its opium-based and
therefore very very addicting?)

1\. Big brands make mistakes.

2\. Consumers don't know the brands: do you know whether or not your drugs are
Purdue Pharma or not?

3\. Brands are sold. The original company who made a brand may have cared very
much about it. But 10 years or 20 years later, the brand may be owned by
entirely new people. Either everyone has retired / moved on, so the company is
simply consisting of new people... or maybe the brand was chopped-up and sold
to 3 or 4 different companies. Quick: who owns Epipen right now? (That drug
brand has been passed around at least 3 times in the past decade)

~~~
linuxftw
All of these things go into factoring your individual trust level for a brand.

Do you consider gmail.com as a brand to be more trustworthy than
'totallynothackers-email.com' for hosting your email? Of course you do.

In the case of medicine (or anything else that can kill you for that matter),
the brand trust has been (mostly) replaced by regulator trust, or store-based
trust. EG, CVS is probably going to source from reputable suppliers. You can
also fill prescriptions on sketchymeds.com if you choose, especially if you're
outside the US.

Brands being sold and bought are an input to the brand-trust equation. It
might mean 3rd parties are the more trusted source of information in a given
segment than the brand name itself (of course, you could say the same thing
about 3rd parties, ad infinitum).

~~~
dragontamer
But even doctors, whose job is literally to keep track of these drug thingies,
have gotten things wrong. See the opioid crisis + Oxycontin.

What hope do laypeople have when even the specialists with over 10-years of
high-class training get these things wrong on a nationwide level?

Before the Oxycotin news, I thought Purdue was just "that chicken company" at
the grocery store (Yeah, I'm ignorant. But that's the fact, at least I know
I'm ignorant). I don't have the time to figure out which brand-names to trust
or what not to trust.

My doctor gave me a "Tomed mandibular advancement device". I don't even know
what a mandibular is. My only hope is to trust the doctor and hope it fixes my
problem. I've never heard of "Tomed" before.

How the hell am I, as a customer, supposed to build a relationship with a
brand, when I only buy one or two of their products per lifetime? How am I
supposed to do market-research, and figure who their competitors are? If I buy
a competing product, what assurances do I have that it works as well as the
one my doctor gave me?

Look, I trust that the engineers are trying to build devices that improve my
life. I trust my doctor is trying to improve my life. I trust my insurance
company is trying to save (themselves and me) the most money. But I recognize
that there are systemic flaws in the US Healthcare system, and something isn't
exactly working right.

In any case, the "brand" system being proposed in this topic is clearly not a
solution. Not only is it NOT working right now, I have my doubts that it would
ever work under our current system. I'm just too ignorant about the companies
who make medical devices and drugs, and I've got the freaking internet in my
pocket to research things instantly. That's not the problem, it takes more
than 5 minutes, or even an hour, of googling to review peer-reviewed journals
and figure out which devices, techniques, or drugs are effective.

Ultimately, I'm going to trust my doctor and insurance company. Its all I got.
I'm not going to be trusting my life to brands of which I've never used
before. Its incredibly rare for me to buy any form of medical device in
general, I simply don't have a relationship to any medical brand what so ever.

~~~
linuxftw
> Ultimately, I'm going to trust my doctor and insurance company.

You're already benefiting from the brand-trust type of system. You trust your
insurance company (currently because the market is regulated, but if the
market wasn't as regulated, you'd probably be choosier about who you shop
with). Your insurance company pays the most for in-network doctors. Doctors
probably need malpractice insurance and not be complete frauds to be in an
insurance network.

I think the airline industry is a good example in the US. I could often save
money by going with a smaller carrier, but I choose to spend a little more to
go with the bigger carriers, primarily because I know if there are any
problems, they're more likely to have extra flights to get me where I'm going.

Another good example is HVAC companies. You can pay someone working out of a
truck to install a new A/C system for slightly less than the name-brand
(factory authorized dealer) in your area. You're probably going to get what
you pay for. Companies want to stand by their name. This is a once-in-a-while
transaction that can cost multiples of 10's of 1000's of dollars (depending on
size/complexity of the system, obviously).

~~~
dragontamer
In my case: the Tomed MAD cost me $1000.

The actual device is worth 150 EUR from Germany (where Tomed is located). The
US-distributer sells it for $500. Somehow, the markup got all the way up to
$1000 by the time it got to me.

Clearly, something, somewhere, has gone wrong in the system. This is a 150 EUR
mouthguard that is being sold to me for $1000. As in, what I've literally paid
for. Why?

~~~
AnthonyMouse
> Clearly, something, somewhere, has gone wrong in the system. This is a 150
> EUR mouthguard that is being sold to me for $1000. As in, what I've
> literally paid for. Why?

There are multiple factors, but a motivator is that US regulators are under
pressure from both sides to adopt rules that make healthcare consumers less
price sensitive.

On the one hand, the supplier is quite happy to be collecting $1000 rather
than $150.

On the other hand, people don't like paying $1000, so they go to the
government and ask them to do something about it. The government could then
push for more price transparency and make sure that existing regulations
aren't impairing competition and driving up prices, but that's exactly the
opposite of what the people making $1000 instead of $150 want.

The alternative is to get somebody else to pay for it in enough cases that the
remaining cases (i.e. yours) don't have enough political power to actually fix
it. So they cause the money to come from insurance premiums or taxpayers in
most cases, whose costs are in turn laundered through employer-provided health
insurance or general tax revenues.

But the seller can't charge $150 retail and still get $1000 from insurance, so
they set high prices and anyone without [sufficient] insurance coverage is
relegated to either overpaying or using whatever kind of need-based assistance
if any that the seller provides, or figuring out a way to order from overseas.

This type of regulatory corruption is obviously not a cost efficient way to
provide healthcare.

And it's much the same reason branding and private certifications are
ineffective. If regulators get rid of most of the charlatans then consumers
become willing to trust that anything approved by regulators is safe. Then
when it isn't (as with the MAX8), there is a single point of failure, both
because people are then less wary of things that are potentially dangerous,
and because independent private infrastructure to verify quality atrophies
when government embeds their own safety standards into law, even if they do a
mediocre job of it.

~~~
linuxftw
> ...independent private infrastructure to verify quality atrophies when
> government embeds their own safety standards into law, even if they do a
> mediocre job of it.

Pretty much the story for every aspect of government.

------
y-c-o-m-b
I am/was on a generic version of Proscar (prostate drug and it's also a higher
dosage of Propecia-a hair loss drug) called finasteride. From 2006 up to I
think 2015 or so, TEVA was the brand of generic I was under and it worked
great. At some point the drug stopped working. I thought maybe I built up a
tolerance or something.

I remember one day I was standing in the kitchen pissed off that my meds
weren't working anymore and looking at my prescription bottle when I noticed
it was no longer from TEVA, it was from a company called Aurobindo; the drug
was manufactured in India. I immediately called the pharmacy and told them I
want to switch. I did some research and found one that is manufactured in the
US by Accord pharma. Accord I believe is still HQ out of India, but the drug
is made here in the US at least. Fast forward about 6 months, and things are
finally returning back to normal - the meds were working! At that point I
filed a complaint with the FDA against Aurobindo. Never heard back, but I tell
everyone I know to avoid using Aurobindo drugs.

I don't know, I feel like outsourcing the manufacturing of drugs - especially
those with a life or death impact - is a mistake.

~~~
kwhitefoot
You should always check that the medication you have received from the chemist
is the one you expected to get. If I were handed an unfamiliar drug I would
immediately ask the pharmacist what was going on and ask for an explanation of
the likely effects.

~~~
dodobirdlord
Same drug, different generic manufacturer.

------
sickygnar
Anecdote, but I personally noticed variable effectiveness of epilepsy drugs
between different generic manufacturers and the brand name. I was taking Teva
brand for a while and it seemed to work fine. Soon I noticed that the drug
wasn't working as well (i.e. had seizures) and I saw the brand I was taking
changed (I forget what it was). Anyway I had to run around and find a pharmacy
that had Teva brand again. I also learned you can ask your pharmacy what
generic brand they carry, and you can also ask them to fill your prescription
with a particular brand, but you have to give 1-2 days heads up.

Ultimately, I ended up going on the brand name of the drug and it worked much
more consistently. Often, if a generic drug isn't working well, doctors will
write prescriptions that request the brand name so that insurance approves it.
I think they all know that generics can be hit or miss for these types of
drugs. Anyway, I don't take generics anymore. Now, almost every time I go to
the pharmacy they ask me "You know how expensive this is, right?"... Yep. My
insurance is billed for almost $5k every time I go, and I pay $180/mo.
Generics would cost me $20/month or so. It must suck for people who can't
afford it, or who have crapp(ier) insurance, or who don't even know about the
variance between manufacturers.

------
taurath
I heard this piece on NPR, the entire time all I could think about is it seems
tailor made for the pharm industry.

They never mention a specific instance of impurities found, just a vague
"they're made over in India/China!" thing. No details here other than people
drinking tap water in India.

~~~
everdrive
I feel like NPR has gotten worse in the last 10 years. Completely ignoring the
topic of bias, (because it's a fruitless minefield) it seems difficult to
encounter a story on NPR that isn't primarily about emotions. NPR seems to
believe that a story is only accessible if there's a single person (or small
group of people) who can directly emote about the wrongness of a situation. A
caricature of an NPR story might go something like this "As violent insurgency
breaks out in [some country], we bring you no details about the local
politics, tribes, or history, but instead 15 minutes of an individual mother
telling you just how miserable her life is. And here she is along with some
ambient sounds so you can really feel like you're there."

I'm aware that there's a group of folks who believe that personal stories are
relatable, while statistics are easily ignored. At best, I feel like this view
is shortsighted: not everyone works this way, and sympathy shouldn't be
limited to cases with emotional proximity. (ie, rational ethics are possible)
At worst, NPR is deciding how you should feel about the story by inserting an
emotion-based testimonial.

~~~
dvfjsdhgfv
What irks me is that I either have to agree that they track me or I'm
redirected to "text version" of the site, but in the latter case they redirect
me to the list of articles, usually even without the one I came for, as if
showing that without tracking I'm completely useless for NPR and I could as
well go away. This attitude speaks louder than words.

~~~
detaro
It's oddly enough not consistent. Often enough, it redirects me to the
article, but not always. Maybe they don't do it for all parts/categories of
the site?

------
rootusrootus
In particular there is a growing amount of evidence that the generic
anticonvulsant drugs are not nearly as effective as the original brand-name
version, and I don't believe it is known exactly why. Just that the FDA's
definition of what makes two drugs equivalent is not sufficient in all cases.

My younger brother died because of this. He got moved off Keppra to a generic
equivalent because insurance refused to pay for the real thing, and his
seizures immediately began to increase in frequency. One night he suffered a
grand mal and never woke up.

------
vikramkr
This reminds me of this case:

[https://www.nytimes.com/2015/06/17/business/generic-
ritalin-...](https://www.nytimes.com/2015/06/17/business/generic-ritalin-drug-
not-equivalent-to-the-brand-is-in-use-anyway.html)

Everything in healthcare regulation tends to face intractable tradeoffs
between cost, time, quality, and access, but small molecule generics should be
an exception to that. The development work has been done, and the cost of
goods is so cheap in general that it it seems entirely reasonable to demand
more stringency in proving equivalence in manufacturing to the brand name.

An important question is - what's going to happen as we move into biosimilars
and other large molecule 'generics?' These are much more complex than these
small molecules, and it doesnt bode well for their future if we can't even get
small molecule genetics up to par. I do think its doable though, and I'm glad
that there's work out there like these articles bringing attention to the
issue.

~~~
geoelectric
There was a similar issue with Wellbutrin extended, where the active
ingredient was theoretically the same, but the bit that was supposed to slowly
give it to you would dump it on you instead.

"'In the first two hours of a dissolution test, we found Budeprion released 34
percent of the drug, while Wellbutrin released 8 percent. At four hours, the
Teva product released nearly half of its ingredients, while original
Wellbutrin released 25 percent. The generic did not act like a once-a-day
formula but more like an immediate release formula,' Dr. Todd Cooperman,
Consumer Lab's president, stated."

[https://abcnews.go.com/Health/fda-finds-generic-
antidepressa...](https://abcnews.go.com/Health/fda-finds-generic-
antidepressant-original/story?id=17399399)

[https://www.fda.gov/drugs/postmarket-drug-safety-
information...](https://www.fda.gov/drugs/postmarket-drug-safety-information-
patients-and-providers/update-bupropion-hydrochloride-extended-release-300-mg-
bioequivalence-studies)

Problem with that is Wellbutrin can cause seizures if you have too much at
once, and it synergizes with things like ADHD meds to lower the seizure
threshold further. Since Wellbutrin itself is a third-line ADHD medication,
that last bit was a real issue--at one point I was prescribed both Wellbutrin
XL -and- Concerta, and had to get "only as prescribed" scrips for both to
avoid generics. Pulling the Wellbutrin generic with the known-bad delivery
mechanism was one of the few cases where the FDA actually stepped in on a
previously-approved generic and did something.

In general, I don't worry too much about the active ingredients in generics
(though maybe I should) but I worry an awful lot about extended-delivery
mechanisms. I don't think testing or standards are sufficient to enforce a
bioavailability curve across a dosage lifetime.

~~~
masonic
It confuses me that they throw in the name Budeprion. I've only heard
Bupoprion used as a generic term for Wellbutrin.

~~~
geoelectric
That is the actual substance name. Some generics have their own "brand name"
that will usually be a minor variation on the real name. In this case, one of
the generics that didn't deliver correctly was from Teva and branded
Budeprion.

------
asciimov
Yet another anecdote: Several years ago, my wife had her birth control
switched to the generic by our pharmacy. The day after she started taking it
she became extremely nauseated, it passed later that day. The next day, the
same thing. After the third time, we realized that it wasn't a coincidence,
she stopped with that pill and the nausea ended.

After some online research, we found the generic was manufactured in India and
some people had mentioned a similar issue with the product. It took us
switching pharmacies to get back on the name brand.

------
stallmanite
Recently I was switched to a brand-name after a decade+ on generics. The
difference was obvious and really surprising to me as I figured the same
chemical compound would produce identical results. The facts described in the
article would explain the difference. Really sucks for people that need
medication to be rolling the dice every month.

~~~
kwhitefoot
How are you rolling the dice? Don't you get the same drug each time? I always
do. And why monthly? For high blood pressure I get 98 tablets in a packet,
that's fourteen weeks.

~~~
dillonmckay
Pharmacies will constantly negotiate and change drug distributors that may use
a different manufacturer of generics.

------
kwhitefoot
The title is misleading. The article claims that drugs manufactured outside
the US for sale inside are not held to the same standards as those made in the
US. This has rather little to do with their status as generics.

------
sct202
I read ChinaRX recently, and it included a lot of similar concerns. But it
emphasized that a lot of the components and active ingredients are produced in
China, and some American companies are not always very vigilant or thorough in
checking the purity or quality of their suppliers. So even if a pill is made
in America, it could still be at risk as much as a foreign pill.

The book kind of veered off in parts to being a little bit fear-mongery/off
topic--a large portion of it was rehash of a Planet Money chicken tax podcast,
and then another large block was focused on container ships-- though so I
wouldn't really recommend it.

------
AnthonBerg
Our anecdote: My fiancee was prescribed generic Exemestane. We 100% believed
that “generic is exactly the same compound, just cheaper”. Her joints became
stiff and sore. All over. It was debilitating. (It’s a known side-effect of
the drug.) Took the generic for two years. Then the supply of generics ran out
locally and we _had to_ get brand-name Aromasin. The exact same compound. We
had _no expectations_ of different effects or less side effects. Her joint
pain mostly cleared up. By like 90%. The difference - once it dawned on us -
was shocking.

------
LinuxBender
Somewhat off-topic, but I would like to see regulations around non-opiate
drugs changed to the point where I can buy my BP drugs off the shelf. I can
see no reason this can't happen. It can't be a safety issue. I can show you
hundreds of supplements significantly more dangerous than BP drugs.

I want to be able to stock up on BP meds, so that there is an emergency, I am
not 100% dependent on the pharmacy being open and reachable. Currently, I am
at greater risk than someone who is addicted to heroin. You can stop heroin
without risk of death.

~~~
throwayEngineer
How are pharmacists going to make 60$/hr if you don't pay them for every
transaction? /S

------
cryoshon
the trouble is that the burden is wrongly on consumers to file complaints with
the FDA if they find that their generic medications are not performing in the
way that they should.

based on my experience inside the biotech/biopharma industry within several
different roles, i think that ideally the FDA would be terrorizing the pharma
companies producing generics such that each new manufacturing lot of
medications would be tested for bioequivalence in small cohorts of patients
before hitting the market.

of course, this will never happen because it would be expensive and time
consuming for manufacturers of generics, who rely on volume to make a profit
(traditionally -- i know this is changing as they are currently raising prices
like wild). so, consumers get the shaft and nothing is done because the
perfect solution has the imperfection of reducing revenues.

it's a tough problem, though. i'm fairly certain that doctors know that you
get what you pay for with many generics -- but i'm also fairly certain that
doctors understand not everyone can afford brand name medication.

~~~
dillonmckay
It has been my experience that doctors are not that knowledgeable about
specific pharmaceuticals, particularly compared to a pharmacist.

------
tensor
Related, what it takes to get a generic drug approved in Canada:

[https://www.canada.ca/en/health-canada/services/drugs-
health...](https://www.canada.ca/en/health-canada/services/drugs-health-
products/drug-products/fact-sheets/access-to-generic-drugs.html)

------
RandomInteger4
While there may be some truth here, I am highly suspicious because this story
feels like corporate sponsored FUD 101.

------
richrichardsson
This would be a non-issue if you had a single buyer at the national level
sourcing the drugs on behalf of patients.

~~~
larrywright
If anything that seems like it would make things worse - someone else,
completely disconnected from your care, making decisions about what
manufacturer should provide your drugs.

Government sourcing is riddled with plenty of cases of corruption and
wrongdoing. Generally the worst case is that they overpay for something. With
medicine, the worst case is that someone dies. I’ll pass.

~~~
richrichardsson
Can you cite examples of this happening?

~~~
larrywright
Sure, here are just a couple:

[https://www.justice.gov/opa/pr/defense-contractor-and-its-
ce...](https://www.justice.gov/opa/pr/defense-contractor-and-its-ceo-plead-
guilty-corruption-conspiracy-involving-scores-navy)

[https://www.sun-sentinel.com/news/fl-
xpm-1989-01-07-89010109...](https://www.sun-sentinel.com/news/fl-
xpm-1989-01-07-8901010981-story.html)

[https://www.chicagotribune.com/sns-boeing-scandal-
story.html](https://www.chicagotribune.com/sns-boeing-scandal-story.html)

~~~
richrichardsson
Only able to read the first article (2nd two are verboten for EU users), but
all I read is that a private company was implicated, _not_ a national level
single buyer (such as the NHS in the UK).

