Generic Drugs

[slantman]

As a result of the Coronavirus the US Government has awarded Kodak (yes that is correct) 675 million dollars to produce generic drugs in the USA. Sadly almost all generic drugs are being produced overseas (guess which country is making most of them) yes that is correct China. Kodak has the foot print to do this. What a boost to the city of Rochester (NY) economic wise. Hopefully this is only the beginning as the govenment attempts to bring back manufacturing to the USA.

 

[NurseDave]

Hopefully this is only the beginning as the government attempts to bring back manufacturing to the USA.

Until everyone forgets that we had a problem getting products during the pandemic and they buy the $5 do-dad instead of the USA produced $8 do-dad.

 

[Dave in KY]

I noticed Tylenol PM generics are sold out everywhere my wife and I have looked and figured it was a Corona China/India issue....

 

[dangerousdon]

Making sure that the bulk of our pharmaceuticals are made in the US is VERY important. I mean...we are talking about our health as a nation. Why leave that in the hands of countries that gave us Chinese Drywall, put lead in toothpaste and in dog food. Unacceptable amounts of NDMA (by the way NDMA is used in rocket fuel) and heavy metals. I understand that bringing Pharma back to the US won't be cheap...but if you had to have heart or brain surgery...do you really want to go to the lowest bidder? To me it's the same thing. I for one would be happy to pay a little extra for my meds to know that is has gone through rigorous quality control standards.

 

[dkeester]

There was some talk recently (last year maybe???) about some hospital chains, or insurance companies, or something, wanting to produce their own generic drugs to bring health care costs down. I hope this happens along with the Kodak thing so that there are multiple US based drug manufacturing companies. Multiple sources along with some competition would be a good thing.

 

[CBLindsay]

Being able to manufacture medicines, reagents and basic equipment/supplies within our own borders seems to be a wise idea but sadly we have long since lost that ability. Not all of it has gone to China or some ‘hostile’ country, In fact most pharmaceuticals are NOT sourced from or reliant on China. Ireland is/was a huge pharmaceuticals producer, on par dollars wise with the USA (makes it a smaller fish in the pharma pond but it’s huge to them). Germany and Switzerland are probably the biggest individual countries producing pharmaceuticals. It’s not about being dependent on a ‘hostile’ nation for our own wellbeing, it’s about not having sufficient control over or ability to deliver care to our HUGE citizenry. And with drug costs having been part of the ongoing healthcare discussion for years, it’s amazing it took an event like this to shake us up enough to see how little control we (as consumers and citizens of our own country) have over something so important to us.

I know this takes us far off topic but it saves me from having to create a new thread...what Intel announced this week is very scary because it shows we are heading the same direction (if not we’ll on the way) with technology. When intel, a technology PRODUCTION company decided it wasn’t capable of designing AND producing its next wizbang chip so it was going to outsource its production...that was a bad sign. If not pharmaceuticals or technology (or cars) what CAN we produce? I’ll leave a blank space here for y’all to quietly fill in your own snarky “we can produce....” comments (say them to yourself,otherwise it’s bound to get ugly)_____

 

[dangerousdon]

The generic drug industry has some serious flaws. For example...most people think that a generic drug is the exact same as the name brand drug. That isn't always true. A company that sets out to make a generic drug takes the real thing and reverse engineers it. Sure...they deconstruct it, figure out all the ingredients that should be in it, and then try to put it back together. The problem with this is that the formulation is never the same...exactly. Think of a cake...if you are given a cake and told to recreate it without a recipe, you can probably get close (or not in my case), but you are never going to have the same proportions of ingredients...you will never have the same bake time...that frosting might be store bought instead of homemade buttercream. This is a rudimentary example...but I think you get the idea.

Ever wonder why brand names are SO expensive? Some reasons for this are the extensive testing and trials that they have to go to. Brand name drugs are required to go through a number of processes to include animal testing, double blind randomized control trials, FDA investigations, etc, etc, etc. The process takes years and in many cases tens of years and the cost for the full process can sometimes can sometimes cost upward in the billions of dollars. Generic companies do not have to go through this stringent process and it only takes them about two to four years to have their drug approved.

Generic drugs have to have the same active ingredient as the Brand Name drugs...but they don't have to have the same inactive ingredients. Most people don't view this as an issue...but inactive ingredients have all sorts of problems in certain people. These inactive ingredients also mess with bioavailability. Which brings me to my next point...generic drugs can differ from the real thing by up to 20% bioavailability. Meaning that you are likely getting something that isn't quite as effective.

There is a whole host of problems with generic drugs. There is an investigative reporter named Katherine Eban who did a whole expose of generic drugs. She has a book out called "Bottle of Lies." I haven't read it yet but it is on my list. I have listened to her on a number of podcasts. She also did a recent TedMed talk on the subject. I highly recommend a listen to one of these:

A Dose of Reality About Generic Drugs

Peter Attia, MD - Katherine Eban: Widespread fraud in the generic drug industry

She explains in her book about an almost fantastical tale of a Generic Drug Company called Ranbaxy out of India. The company falsified data, stored drugs and ingredients in hot warehouses, included lethal ingredients in their formulations, and a whole lot more. Serioulsy...it was almost like watching a movie about corporate espionage. In 2013, Ranbaxy pleaded guilty and agreed to pay 500 million dollars with the US DOJ: Generic Drug Manufacturer Ranbaxy Pleads Guilty and Agrees to Pay $500 Million to Resolve False Claims Allegations, cGMP Violations and False Statements to the FDA

So what are we supposed to do? Not much really. Most insurances won't pay for brand name drugs. And even if they do...they are really expensive. The FDA has a thing called an Orange Book. It's a little hard to navigate...but you can see what manufacturers have had issues in the past. FDA Orange Book

Also...I didn't know this until recently, but you can identify a drug manufacturer by the markings on the pill. Here is a good database: Pill Identifier

Also know...that most pharmacies try to get the best price on drugs. That means that big name pharmacies like Walmart, CVS, Walgreens, etc. leverage their buying power to get really low prices mostly from large pharmaceutical companies. The largest generic pharmaceutical companies are in China and India. While the FDA has some authority over these companies...it's not as much as if they were located in the US.

About a year ago I switched from a big name pharmacy to a local mom and pop pharmacy. They do not get drugs from China and while some of their stuff still comes from India, they make sure the companies they purchase from haven't had negative issues.

If you are able to get brand name drugs...you can probably assume that you are getting the real thing with the original formulation. If you can get your doctor and your insurance company to prescribe and pay for Brand name (It can be a long process) I think you are better off.

Also...a lot of drug manufacturers offer discounts and coupons now! many of them you can use with your insurance. There is a drug I take (name brand) that with insurance would cost me $50 a month. But with the manufacturer discount I pay only $9 a month.

Also...GoodRx is a great resource. I have pretty good insurance so it doesn't really save me money...But I do use it as a reference. My mother, however, went to the Dermatologist a couple of weeks ago and was prescribed a cream. With her insurance it was $70. With a coupon that she got through GoodRx cash price was $30. Seriously...no joke!

Okay...sorry for the long rant...but this is one of the things I feel a bit passionate about...if you couldn't tell...

 

[CVargo]

I'm just kicking myself for not buying kodak stock this week!

 

[CBLindsay]

I'm just kicking myself for not buying kodak stock this week!

Ain't THAT the the truth.
And @dangerousdon you are correct and bring up a lot of good points (valid etc). We used to be able to point all our collective 'anger' about the amorphous generic drug issue toward some unknown foreign source, NOW with Kodak playing the game maybe our STRONG domestic companies will feel pressure (or freedom ) to do more here. Sometimes all that is needed is a catalyst, and a good old legacy brand name might just be the catalyst we needed.

Not quite the devil's advocate but adding some additional food for thought... When you break it down to its simplest form, all the FDA approves are 'generic' pharmaceuticals, everything else is a purposeful manipulation of the FDA approved 'drug'. What I mean by this is, the FDA evaluates and approves "acetaminophen", a singular compound that is easily and predictably synthesized. When the FDA evaluates and approves acetaminophen (or our hypothetical generic) they purposely exclude the non-active ingredients that might be included because the purpose is to evaluate the singular compound. Once approved that compound is then able to be used by the developer in the manner(s) approved by the FDA. In most cases the developer of the compound turns it into a medically "better" version (Tylenol vs the many generic options?) but in many cases the compound is just what it is and there isn't any way to make it medically "better", but you can certainly make it worse by contaminating it or poor quality control. I (personally) think the majority of generic drug issues fall into the category of "made worse by poor QC" rather than a failure to make it 'better' through optimal design. BUT there is no arguing with personal experience. I know that people who fail to get the desired relief from generic acetaminophen get an almost magical result from Tylenol brand products. I know that generic Claratin works well for many, but only brand name dissolvable tabs deliver any results. So obviously and clearly the blanket statement that generics are as good as brand names is wrong. As is the blanket statement that generics are bad or don't work.

As for Kodak. Even though it has been a long time since we have seen them in this light, they DO have a history in chemical production. I look forward to seeing what they can do. I don't see them developing anything on their own, so they will probably START as an assembly line for someone(s) else ...who?

 

[dangerousdon]

I know that people who fail to get the desired relief from generic acetaminophen get an almost magical result from Tylenol brand products. I know that generic Claratin works well for many, but only brand name dissolvable tabs deliver any results. So obviously and clearly the blanket statement that generics are as good as brand names is wrong. As is the blanket statement that generics are bad or don't work.

This is something that a lot of doctors dismiss in their patients. The podcast I referenced above is hosted by a Medical Doctor (Peter Attia obtained his MD from Stanford and did his residency at Johns Hopkins as well as working at the National Cancer Institute and the National Institutes of Health), Dr. Attia has often mentioned in his newsletters and on his podcast that he used to dismiss his patients when they said they were not getting the results from their generic prescription medications that they desired. He then did research on his own (with his patients and without) and found that a number of generics are not as effective and in some cases were harmful (depending on the medication and the person).

In my own family experience, my father in law has some medical issues and takes Tegretol which is a STRONG anticonvulsant. His insurance (through Medicare) are constantly telling them that they have to change pharmacies for whatever reason (from Walmart to CVS to Walgreens back to Walmart). Each time they change pharmacies he has to go through the same process and let them know that he HAS to have the brand name and not the generic. The the generic versions of Tegretol have some kind of formulation or filler additive that actually induces seizures in my father in law. It's crazy...I know it.

While I think that a lot of generics are good...I think as a standard rule that brand names are going to be better. I am constantly checking my medications to see who makes them and where they come from, ie China. I absolutely won't use a drug made in China unless it is absolutely life or death. I also will address with my pharmacist manufacturers that have had recalls in the past. There is only so much that I can really do...but I can educate myself and ask questions. I find that pharmacists in general are more knowledgeable about drugs in general than doctors and are very approachable. The pharmacists I have dealt with have always been eager to answer my questions.

 

[CBLindsay]

This is something that a lot of doctors dismiss in their patients. The podcast I referenced above is hosted by a Medical Doctor (Peter Attia obtained his MD from Stanford and did his residency at Johns Hopkins as well as working at the National Cancer Institute and the National Institutes of Health), Dr. Attia has often mentioned in his newsletters and on his podcast that he used to dismiss his patients when they said they were not getting the results from their generic prescription medications that they desired. He then did research on his own (with his patients and without) and found that a number of generics are not as effective and in some cases were harmful (depending on the medication and the person).

In my own family experience, my father in law has some medical issues and takes Tegretol which is a STRONG anticonvulsant. His insurance (through Medicare) are constantly telling them that they have to change pharmacies for whatever reason (from Walmart to CVS to Walgreens back to Walmart). Each time they change pharmacies he has to go through the same process and let them know that he HAS to have the brand name and not the generic. The the generic versions of Tegretol have some kind of formulation or filler additive that actually induces seizures in my father in law. It's crazy...I know it.

While I think that a lot of generics are good...I think as a standard rule that brand names are going to be better. I am constantly checking my medications to see who makes them and where they come from, ie China. I absolutely won't use a drug made in China unless it is absolutely life or death. I also will address with my pharmacist manufacturers that have had recalls in the past. There is only so much that I can really do...but I can educate myself and ask questions. I find that pharmacists in general are more knowledgeable about drugs in general than doctors and are very approachable. The pharmacists I have dealt with have always been eager to answer my questions.

The constant changing of drug source and maker by pharmacies is crazy. There are a number of therapeutic drugs that require a tight control of levels in order to achieve the desired results or to avoid major issues. The PBM’s that supply the pharmacy and negotiate reimbursement with Insurance companies are only interested in pinching the pennies, and the insurance companies aren’t about to argue about the savings. Pharmacists KNOW the repeated changing of brands, suppliers and origins etc is not optimal but they aren’t empowered to do or say anything. For many years I used to manage patients on blood thinners, thyroid meds and tegritol. they would take some time to get dialed in but eventually be beautifully controlled through strict adherence to diet and meds...then their pharmacy would decide to change suppliers and their levels would go nuts. Back then (20-25 years ago...man I’m old) there seemed to be fewer suppliers or at least fewer changes. Now, it seems pharmacies change every time they restock.

i never really gave the efficacy of generic OTC drugs a second thought until recently. I don’t use many pain meds so I can’t give personal perspective there but my wife said something about name brand recently so maybe there’s something there. My doc mentioned the need to consider name brand Claritin and/or Zyrtec quick dissolve tabs as part of an ‘emergency’ kit because she wasn’t confident the generics would do the job. Her recommendation was to buy both and try them because she knows the generics have a spotty record of working

 

[dangerousdon]

i never really gave the efficacy of generic OTC drugs a second thought until recently. I don’t use many pain meds so I can’t give personal perspective there but my wife said something about name brand recently so maybe there’s something there. My doc mentioned the need to consider name brand Claritin and/or Zyrtec quick dissolve tabs as part of an ‘emergency’ kit because she wasn’t confident the generics would do the job. Her recommendation was to buy both and try them because she knows the generics have a spotty record of working

I recently read about the difference between regular Tylenol and the acetaminophen generics and how A LOT of people claim that the generics just don't do it from them. I asked my wife what she thought about the generic acetaminophen she is taking (since it is about the only thing she can actually take while pregnant) and she claims that she gets very little relief from it. Going out to buy a bottle of the real stuff this morning and over the next week or so, see if she can tell the difference.

 

[NurseDave]

Don’t forget to get consent before human experimentation

 

[Aaron]

You know, I read about this drug called "Placebo" that will cure anything. But it doesn't work if you give your consent before you take it. Catch 22.

 

[dangerousdon]

I know this takes us far off topic but it saves me from having to create a new thread...what Intel announced this week is very scary because it shows we are heading the same direction (if not we’ll on the way) with technology. When intel, a technology PRODUCTION company decided it wasn’t capable of designing AND producing its next wizbang chip so it was going to outsource its production...that was a bad sign. If not pharmaceuticals or technology (or cars) what CAN we produce? I’ll leave a blank space here for y’all to quietly fill in your own snarky “we can produce....” comments (say them to yourself,otherwise it’s bound to get ugly)_____

The US has long since abandoned manufacturing it's own products. There are certain products, as a matter of national security actually, that I believe the US should produce and use. Drugs is one of these categories as we have been discussing. Steel is another. I feel domestic energy is another area but that get's really complicated because even if we produce our own oil and gas...these are by and large refined by...at the very least...multinational businesses. Technology is a head scratcher for me. The US produces very little of the tech that is out there. Even if the company is US based. This is an issue of national security to me. When I was in Military Intel...I remember there was an issue at one point that thumb drives that were being purchased (Chinese made) actually had malware preinstalled on them. This was in the 2000s. It drove a policy that thumb drives were no longer to be used. Lenovo was shipping laptops at one point to the US with malware preinstalled also. These are just a couple incidents...but how many more examples are there. I know a lot of this is cost driven...but I would pay a tad extra to know that the products I purchase are made right here in good old US of A. Foreign car manufacturers make many of their vehicles in US plants...I think this is a good solution for foreign companies that want to sell to a US market.

 

[August West]

If labor were as free to cross borders and offered the same rights and protections as corporations, much of this would end. Modern “free trade agreements” are nothing more than the perpetuation of corporate rights and the denigration of labors ability to organize and freely move. Yes, you have a anarcho-syndicalist on your forum. Not to be confused with a Marxist. Or to be confused with pure anti-capitalism.

 

[August West]

"Freedom without socialism is privilege and injustice and socialism without freedom is slavery and brutality."

-Bakunin