The generic drugs industry makes headlines this month. That’s thanks to the investigations of journalist Katherine Eban. She is the author of Bottle of Lies: The Inside Story of the Generic Drug Boom.
Generic drugs are long touted as a cost-savings to consumers. For the most part, they are. Many physicians and pharmacists guarantee that they are “exactly the same as brand.” For the most part, they are not. (To learn how this might affect the ADHD population, you’ll find links at the end of this post to my many reports on this topic.)
Yes, many consumers benefit from generic versions of brand medications. For them, the differences between brand and generic make little difference in efficacy.
Please be assured that I do not want to unduly scare people who are taking generic medications.
But here’s the thing: Many people do not benefit from generic drugs. Moreover, they have no idea why when they did so well on the brand. They assume that something else is wrong.
“Bioequivalence”— The Small Print
Social media brims with rants against “Big Pharma.” My concerns, however, have long been with “Big Generic.”
Since 2009, I’ve reported here about the particular problems that generic medications can present for people with ADHD—and indeed all psychiatric conditions. (I’ve linked to a few posts below.)
These posts culminated a few years ago when two generics for Concerta resulted in many readers’ lives going off the rails. Most did not connect their problems to their new generic medication. At least not right away. Why would they? They’ve largely been told that “generic is exactly the same as brand.” Many made the connection only after they found my blog posts.
With psychiatric medications, the dosing can be everything; too much up or down can have little or even a bad effect. As I write in Consumer Alert: Three New Concerta Generics as Janssen/Actavis Deal Ends:
In the U.S., the FDA requires the “bioequivalence” for the generic product to be between 80% and 125% of the original product.
Yes, that’s roughly 20 percent up or down—a huge window of variance.
Even that number will not be constant; it might vary each time the prescription is filled because pharmacies often switch suppliers.
The FDA Responded—But Slew of Concerta Generics Continues
Along with Kansas City pediatrician Kristen Stuppy, we issued a warning about these Concerta generics. I spoke with an FDA representative and opened a MedWatch file.
Dr. Stuppy and I urged our readers to file a complaint if they had experienced problems with their Concerta generics. We had barely finished celebrating our successful effort to have the FDA to downgrade these generics when boom boom boom—three new generics for Concerta. Talk about a game of Whack-a-mole. Turns out, the Trump Administration’s new FDA chief pushed many generics through despite FDA scientists’ concerns about bioequivalency.
Over the past decade, many insurance policies (including employer-sponsored) have pushed more and more consumers toward generics. Pharmacy profit margins are often higher for generics than for brand. This might also be true for some medical insurance policies. Certain pharmacy chains have even balked at filling prescriptions for the Concerta’s “authorized generic” (the brand marketed as a generic). They claimed that it is unavailable when it is not.
Americans Need Generic Drugs, But Can They Trust Them?
Now back to journalist Katherine Eban’s book. She has written a comprehensive examination of the generic medication industry. Most American consumers rely upon generics for their medical conditions but most know very little. Her reports shocked even me. Specifically: 90% of generics are manufactured overseas in plants that hardly resemble the highly regulated U.S. plants.
Overseas manufacturing might not be a problem if the FDA were able to coordinate more reliable inspections. But, as Eban reports, many overseas companies “game” the system.
“Bottle of Lies” Book Excerpt:
Here is an excerpt from Eban’s op-ed in The New York Times: Americans Need Generic Drugs. But Can They Trust Them?
The F.D.A., which approved more than 1,000 new generic drug products last year, faces a vast challenge in safeguarding these medications. Nearly forty percent of all our generic drugs are made in India. Eighty percent of active ingredients for both our brand and generic drugs come from abroad, the majority from India and China. America makes almost none of its own antibiotics anymore.
Of course, overseas manufacturing can work perfectly well and the F.D.A. contends that it has a reliable review system for all approved drugs. “The F.D.A. inspects all brand-name and generic manufacturing facilities around the world which manufacture product for the U.S. market to confirm they meet F.D.A.’s requirements for manufacturing process,” it said recently.
My reporting on the generic drug industry over the last decade led me to four continents, and into the overseas plants where America’s generic drugs are made. Interviews with more than 240 people, including numerous whistle-blowers, helped expose what was going on behind the boardroom doors at generic-drug companies. Some companies have encouraged data fraud as the most profitable path to securing approvals from regulators, and have used deceit to hold the F.D.A.’s investigators at bay…
…The F.D.A. has defended this system as the best way to ease the complex logistics of getting visas and ensuring access to the plants. But the resulting inspections are largely staged,” say a number of F.D.A. staff members. With advance notice and low-cost labor, the plants can make anything look like anything. “You give them a weekend, they’ll put up a building,” as one F.D.A. investigator put it.
FDA Ramped Up Investigations: 2015-2017
Starting about 2015, the FDA was cracking down on plants in India, China, and elsewhere. This piece explains: As India, China drug industries mature, FDA scrutiny an overhang
If this continued into 2018, I have found no evidence. But I’ve yet to finish Eban’s book.
From the ADHD Roller Coaster Archives: Posts about Generic Medications
Here is a sampling of my posts about generics from 2009 to today:
December 2017 – updated to 2018 and then 2019
Consumer Alert: Three New Concerta Generics as Janssen/Actavis Deal Ends
Sandoz and Actavis are the two generics I had the most positive experience with. Sandoz for its potency and Actavis because it gave me euphoria with the concentration. My local pharmacies only seem to have Amneal and it’s only effective if my other lifestyle habits are maintained.
Generic drugs keep drug prices down for lower-income Americans, so they serve an important role in healthcare. At least these people are getting the active ingredients at the therapeutic dose, even if the delivery mechanism is different. I’ve seen that 20% bioequivalence stat before but a biochem PHD friend from Yale (who is now in the industry) explained how that really equates to a miniscule difference in effectiveness. I might have that conversation somewhere and I’ll post it if I find it. We’ve gotten into arguments when it turns to stimulants, though. Numerous people I know in fields dealing with neuro-atypicals have noticed similar differences in generic stimulants and while placebo can account for some of it, it just seems too widespread for me to write it off. And, while purely anecdotal, my fiancee’s aunt used to be a regulator in the pharma industry that would do surprise inspections on labs. She does not take generic drugs.
Hi again, Devon,
Yes, yes, we all know that generic drugs keep drug prices down. But there are many generic drugs, even outside of ADHD and other psychiatric medications, that are proving problematic — even dangerous.
Big Generic is an incredibly exploitative industry, in my observation. They push it and push it. And who is pushing back?
Not the Trump administration’s FDA Chief. Now, those cats are out of the bag and we’re stuck with them.
g
Anna,
Just a thought, and please don’t be offended if you know this already, but do you drink orange juice or anything that contains citric acid?
Isn’t great how they have so many wonderful different ways of obfuscating the choices? ER, LA. SR, IR? What R they trying to pull over on us?
As far as I know, at this point, there is no equivalent generic for immediate release Ritalin since Activis became Teva. All the other brands are junk. Also the only generic concerta, which has the Autherized, ALZA, delivery system. is made by Patriot. This is labeled ER OSM and has ALZA printed on the capsule.
Walgreens has it or can get it. So can Harris Teter. GoodRX can also be a very good friend. It is for me as we dont have drug coverage and have 3 in our family on methylphenidate. All the best from the land that forgets time.
Thanks for weighing in, Tim!
What “R” they trying to pull indeed. 🙂
I have two posts on those subjects:
citric acid:
https://adhdrollercoaster.org/adhd-medications/can-foods-acids-and-antacids-interfere-with-stimulant-medication/
generic medications: MANY posts
https://adhdrollercoaster.org/?s=generic
Gina
I have been taking Ritalin; generic form methylphenidate extended release for almost 20 years. I am in my late 50’s.
or the past 2 months, I have been struggling at home and work and thought it was just stress from holiday and year-end obligations.
My Dr. Tests my urine to prove that I am taking the medicine prior to refilling the RX. So now the last test came up negative. I asked her to retest because I am taking my medication daily. Surely there is a problem with the test, right? Well, maybe not!
She has given me three additional urine tests and they have all been negative for methylphenidate. My Dr. Will not refill my RX. I am now looking for another Dr. I am an adult and I work in the financial industry; for Pete’s sake! I have been taking this medication for almost 20 years. This feels like a soap opera. It is very hard to advocate for yourself when you have ADHD.
Is it possible that the medication I have been getting at my local Walgreens is the problem? It is heart wrenching when a Dr. does not think you are being honest about taking medication. This is awful. If I do not find a Dr. that will help, I doubt I will be able to continue in my career. Yes it is THAT BAD! If I do find a good Dr. I will insist on taking only name brand medication going forward.
Dear Anna,
At first, I thought you must be writing from a Russian gulag.
I am OUTRAGED. And you are right; it’s hard enough for many people with ADHD to self-advocate. That is one huge motivation for my work.
I’ll share some thoughts below, but just to digress a second: I was examining my blog’s web traffic over the past two years. Thanks to a new Google algorithm, ostensibly designed to weed out medical quackery and bloggers who write on medical topics without medical authority. It’s caught me in its dragnet. And now I’m looking at a 50% drop in search traffic.
I’m feeling extremely deflated, to have worked 10 hard years writing this blog and responding to thousands of comments. I am a recognized expert. More importantly, I serve in part as a watchdog on the doctors—because far too many behave horribly when it comes to treating ADHD. But Google has, with one algorithm, outright censored my ability to do that. Because, in the black-and-white view of these “code savants”, who typically have little education outside of math and science, the MDs are the only authorities.
So, your comment comes at a particularly poignant time. I am aghast that you would be treated in this way. It is intolerable.
My thoughts:
—She seems to think you are selling the medication.
—I wonder what kind of test she is using. Perhaps one designed for amphetamine-class stimulants?
—I also wonder if she understands the variables around false-negatives. (Frankly, with such horribly ignorant approach and abusive to subscribing, I would assume nothing about this MD’s capabilities or knowledge.)
False-Negatives: To aid in interpreting UDS results, pharmacists should acquire a thorough list of all the patient’s prescription, OTC, and herbal medications prior to testing, as well as discuss adherence to medications. When a negative screening result is obtained, pharmacists should carefully consider the potential for a false-negative result, especially for patients receiving UDS testing to assess compliance with a medication regimen or for those exhibiting behaviors or risk factors suggestive of drug abuse or drug dependency.1
False-negatives can occur when the urine drug concentration is below the threshold level set by the laboratory performing the test.1,2 Dilute urine, the duration of time between ingestion of the drug and time of testing, and the quantity of the drug ingested may affect the occurrence of false-negatives.1-2 While chronic marijuana use will show in the urine for weeks after heavy use, other medications and illicit drugs will only be present for 1 to 4 days, as shown in TABLE 1.1-4
https://www.uspharmacist.com/article/urine-drug-screening-minimizing-false-positives-and-false-negatives-to-optimize-patient-care
—If you look through my blog, you’ll see many warnings about the generics of brand stimulants. Many do not work anywhere near as well as the brand. Moreover, they vary manufacturer to manufacturer. So, even though you took the same company’s pill for 20 years to good effect, it’s possible that your pharmacy switched to a new generic supplier. Did you notice it being a different color or having different markings? If you don’t have the old bottles or receipts, maybe you can ask the pharmacy to track manufacturers for your past orders.
—After you find a new prescriber, I encourage you to complain about this prescriber to the state medical licensing board.
I hope that this ends up being a good thing for you, that you find much better medical care as a result.
You do not deserve this. It’s abominable. I’d like to give that doctor a piece of my tiny mind. 🙂
Best of luck!
Gina
Dear Gina, thanks for the heads-up on the book! We just came across a new article in Bloomberg Magazine that adds more insight & confirms what you’ve written. https://www.bloomberg.com/news/features/2019-09-12/how-carcinogen-tainted-generic-drug-valsartan-got-past-the-fda It’s on the cover of the magazine, under the title: “Can you trust generics? Nope”. It recommends a pharmacy that tests your generic prescription. I’ll give that a try & report back. Thanks again for all your research & keeping us informed!
Hi Ruth,
Thanks for the link. I couldn’t read all of the article (reached my monthly limit on Bloomberg), but wow. That’s scary.
I’m not sure what you’ll get from a pharmacy test….or if you can find a pharmacy to do that. You’re looking to see if your Rx might contain NDMA?
It should tell you on the product insert (the piece of paper with the tiny print…it should list all the colorants, binders, etc.)
good luck!
g
Hey guys!…
Thanks so much for all the info re: generic Concerta!
I was diagnosed with ADHD 20 years ago–ironically, during my PsyD studies (…not that I had noted ADHD issues as early as I can recall!…) Subsequently, ADHD has become one of my areas of professional focus.
However, I too, am most frustrated with these “generic” companies and government regulations that rule pharmacies and determine doctor/patient relationships! Today, I have been on the phone for over four hours researching pharmacies that use ACTATVIS/JANSEN/WATSON pharm manufactures.
I’ve hit a brick wall and am my wits end. Thus far, I found a Walgreens that will sell me their last 22 ACTAVIS methylphenidate 36mg ER OSM tabs. My physician agreed to write a script for 11 days.–and then another script for the remaining month–all the while, hoping my insurance will cover the cost. ( I have still been paying $250 – $275 “out of pocket” costs after insurance!)
I’ve killed my afternoon spending hours on my cell contacting numerous Walgreens in the Chicago area! (Walgreens is…or…better said…WAS…the ONLY Chicagoland pharmacy that carried the ACTAVIS brand Rx–unless I wanted to pay over $500 per month.) Like SERIOUSLY??!! It does not help that I have numerous negative side affects/allergies to inactive ingredients in 35+ medications.
I have two questions! Now that ACTAVIS has been rescued by TEVA, is the generic Concerta really the same as TEVA/FDA are insisting?
Additionally, I am trying to find a doctor who understands the “aging brain” and Adult ADHD. That is, I am healthy and lively 66 year old grandma. Since my diagnosis
while under the care of ADHD specialists– it was concluded that my brain reuptake chemistry needed more than the “normal” amount of Ritalin.
Trying to find a physician whose practice is willing to work with my age category…and…NOT controlled by the Illinois Board of Professional of Regulations and FDA boogie man has been impossible! I am open for all and any suggestions!
Thanks!
Hi Joanne,
I appreciate your frustration. Especially being 65+ and having to deal with physicians’ misconceptions.
Please read the post, though. We need to stop calling it the Actavis generic. Teva purchased Actavis and held the marketing deal with Janssen for a while. But now Teva has its own (crappy) generic.
Also: As I mention, if you have a home-delivery pharmacy, check it out. It might be that a 90-day supply of brand is more affordable than a month’s supply, times 3, at a local pharmacy. And easier to get filled.
good luck!
g
The restraint has come from repeat losing battles, where the tables are turned on me, to deflect the problems with the issues I bring up.
Having ADHD, (or having many other challenging conditions, for that matter) does not always mean I, or others are the problem. But still the playing field is often skewed when side issues about my words and actions, or sadly expressions, are used the same way as a bully states in one way or another, “my bad is not as bad as his/her bad, don’t look at me.”
Thanks GINA for keeping education about ADHD and the generics issues moving towards higher levels of thoughts and actions. It shouldn’t be so hard to get that these issues are not small but small actions such as Doctor Patient mandatory availability of simple privacy protected followup voluntary self reporting forms on prescription regarding use benefits, drawbacks, and concerns.
I hear you, Paul.
People seeking help for neurocognitive/psychiatric conditions are vulnerable and often easily intimidated. If they’ve never had proper treatment, they don’t know what is possible. Some are convinced that they are “hopeless” and so demand little from the psychiatrist.
I know that many psychiatrists are dedicated, professional, and compassionate. But it does give one pause: a vulnerable patient who might be easily “gaslighted” in a room alone with the psychiatrist. With no supervision and no checks and balances.
g
When you get a batch of pills that don’t come close to past experiences, ie they don’t work, what options do you have, in terms of process. ie…returning the bad batch, obtaining new pills, testing the bad pills, holding manufacturer accountable. It’s hard not to give up, and feel … what and how should I feel? “Meaningless” comes to mind.
More, it’s like “accountable” is a word that has lost its meaning. Worse, I’m miserable but I have to smile through it, at the same time, I am treading water to stay afloat.
Hi Paul,
Legally, I don’t think there’s any recourse. Once you pick them up, that’s it.
If it were me, I’d probably “make a scene” at the store, saying I was sold inferior generics and not warned that they are barely “bioequivalent.”
But I think you have more restraint. 🙂
g
I am fortunate to live in Sweden where the maximum I ever pay for my Adhd (and other med’s) in total never goes beyond 120US per year. I can freely choose the brand I feel comfortable with. I have tried 4 different generic concerta (RX methylfenidate) and none of them has the same “quality” as the brandname. I feel that the generics are “unstable” and the effect varies a lot even in pills from the same package. It is a sad fact and I believe many ypunger people will go off their med’s simply because the generics don’t give them a stable effect.
I found this link for a discussion (video with transcript) of the book you write about above: https://truthout.org/video/how-poor-oversight-and-fraud-in-generic-drug-industry-threatens-patients-health/
Hi Peter,
Thanks for the info on Sweden and access to ADHD Rx. That sounds excellent, far better than most non-U.S. countries.
In Australia, for example, the NHS will provide only Dexedrine. For far too many people, that creates more problems than it resolves.
That’s the last I heard, anyway. Maybe it has changed more recently.
And yes, you are right. A bad experience with the first or second medication can turn off people who could otherwise be helped.
The prescribing physicians should be educating on this issue.
Thanks for the link.
best,
g
Gina, It seems like the number of generic manufacturers for methylphenidate IR has increased lately and the “old faithful” Watson/Dan is nowhere to be found. Do we know what is going on? Is the TEVA product the same as the Watson? Trying to find these answers has been frustrating.
Hi Tim,
Update: All this changed in June. See my latest post: https://adhdrollercoaster.org/medication/authorized-generic-concerta-update-6-1-19/
You should have looked on my blog! 🙂
https://adhdrollercoaster.org/medication/7977/
Teva now distributes the authorized generic for Concerta (you used to get it from Watson/Actavis via a marketing deal with Janssen). For how long, who knows. Neither company not made public the agreement.
But be careful, because Teva distributes other Concerta generics (so-called “true” generics).
Pharmacies, including home-delivery, will balk and claim that they cannot get a supply. Most times, they are “misrepresenting the truth.” They don’t carry it in stock but they can get it. Make sure your prescriber specifies which generic (Alza/OROS/Teva should cover it).
good luck!
g