Generic drugs. Rant

[Michael Weber]

im not entirely sure I trust them. I know they are supposed to be "equivalent" ingredients. There are other factors in drug compounding beside ingredients. Evidently, there is little or no independent or government regulation or control and the little oversight that does exist largely accepts the makers word that their drugs are the same. I simply do not trust that and believe it offers too many opportunities for manipulation by the unethical. What guarantee is there that the maintanance drug I take daily actually is 100 percent the same as the non generic. Who has checked it to even make sure it's at least similar? Without independent assurance why should I believe it is? For all I know, those capsules I take daily might just be filled with radio active dirt from China (yeah I know, that's extreme). The same goes for non prescription health "supplements". There was recent news about supplements and the fact that a large percentage were not what the claimed to be, were ineffective and potentially harmful.
And something else. Referencing a link in another thread about prescriptions I checked the non generic vs generic costs for this particular drug. Generic cost is less than 7 bucks a month while non-generic is over 500 dollars a month. This drug has been around for decades. Development costs surely cannot account for that difference after decades. its almost like the manufacturer is forcing generic use by overpricing. No insurance is going to pay that differential. Somehow this just doesn't add up for me. I'd love having my mind put at rest about all this if I'm mistaken or just being paranoid but think there is just too much room for abuse.
Rant off.

[Rick Fisher]

If the original is $500 a month, then people must be paying it. The drug company would charge what the market will bear ?

Synthesis of most drugs in a lab isn't difficult, but coming up with the synthesis is the real talent.

[Charles Wiggins]

I get generics whenever I can. I am actually more apprehensive about the "latest, greatest" pill for whatever and the list of possible side effects that sound worse than the original condition.

From Consumer Reports:

Indeed, the drugs—copies of brand-name medication whose patents have expired—contain the identical active ingredients in the same quantity. And because brand-name drugs are prescribed for many years before they can be copied, their generic clones are considered, by extension, “tried and true.” Overall, generic drugs appear no more likely than brand-name drugs to pose risks.
But generic and branded drugs do differ in one important area: price. Generics can cost up to 95 percent less because manufacturers don’t have the expense of developing them from scratch and rarely spend money on advertising. The lower price not only helps your wallet but might also help your health. Research suggests that people who use generics are more likely to stay on the drugs as directed, compared with those who use costlier brand-name drugs. Below we examine the concerns about generic drugs and help you weigh the evidence.
From: What are generic drugs and are they safe? Despite widespread use, our survey shows concerns persist
Published: August 2012
http://www.consumerreports.org/cro/2012/08/are-generic-drugs-safe/index.htm

[Ken Fitzgerald]

Michael,

Generic drugs are controlled by the FDA, must prove their effectiveness, safety, content and manufacturing processes. See this link:

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm340343.htm

Health supplements to my knowledge are a totally different subject.

I take 3 generic drugs, a multi-vitamin and as recently suggested by my personal physician, fish oil capsules.

My wife, OTOH, is a vitamin, mineral junky.

In both our cases, our personal physicians know what we are taking and neither of them have had anything bad to say about what we take.

Of interest, I was prescribed on brand name statin to control my cholesterol. I had a reaction to it in that I developed joint pain. On the phone with my youngest son's wife, a pharmacist, I asked her about the pain relative to the recently prescribed statin. She asked me when I was supposed to see my doctor. I told her in 3 days. She told me if it was any longer than that, she'd recommend I quit taking it until I spoke with him. He put me on a generic statin and the joint/muscular pain went away. The generic controls my cholesterol.

[Michael Weber]

The FDA requires that foreign providers of generics provide data proving the effectiveness of their product. That is what the FDA calls verification. The FDA itself does not test the drugs. Also the FDA depends on manufacturing data from foreign manufactures to assure quality control. This data can and has been changed or deleted to provide rosy results. Particular problems continue in India which provides over 40% of OTC generics in the US, and in China. The FDA has never had the resources to adequately monitor these foreign sites. Recently, in an effort at verification the FDA began an actual testing program involving university research studies. Just having this program may encourage better foreign compliance.
http://www.peoplespharmacy.com/2014/02/22/fda-agrees-to-start-testing-generic-drugs-huge-victory-for-patients/
Just reading about that makes me feel better about the situation which until now depended on fox in the hen house assurances from foreign suppliers.

[Wade Lippman]

In 1991 my 4yo came down with pneumonia. Turns out the company that made his generic asthma medicine applied to make it using method "A", but the FDA refused authorization as it was too easily contaminated. They reapplied using method "B", and the FDA approved it.
They decided B was too expensive and they actually used A. It got contaminated and thousands of people got pneumonia, several died.

We got a strangely good cash settlement, but no one went to jail.

That's all I know about generics.

[Ken Fitzgerald]

From the link I posted earlier:

Testing Generic Drugs

The FDA approval process assures that medicines sold in the United States are safe and effective. But FDA also confirms safety and effectiveness by testing selected drugs—both brand and generic—in its laboratories or through research contracts and grants (http://www.fda.gov/forindustry/userfees/genericdruguserfees/ucm370952.htm). This includes the raw ingredients used to make the product, as well as the finished drug.

Michael,

In this era of the internet, I am always just as skeptical about websites like you quoted as I am about a government agency. Just like the news media today, too often those "peoples websites" have an agenda and tend to only post information that backs their agenda or theories. In fact, I have more faith in the government agency FDA. During my entire professional career, my labors were routinely monitored and controlled by first the BRH and later the FDA when it assumed the duties of the BRH. Though they often get a lot of bad press, they are staffed by professionals. When they fall short, they get the bad press with the associated publicity and yet, when they perform well (which they do most of the time) they get little press or credit.

[Mike Henderson]

Generic drugs must contain the same active ingredient as the brand name drug, but the other ingredients (generally inert ingredients) may not be the same. Occasionally, someone may have a negative reaction to the inert ingredients, and in that case, they should take the brand name. But the number of people with such reactions is very small.

The makers of the brand name drugs will attempt to convince the patient that their drug is better than the generic, and in some cases, they will rebate the co-pay to the patient in order to get the patient to demand the brand name drug. Insurance companies are getting wise to those games and make it very difficult to get the brand name instead of a generic.

You should not be afraid of generic drugs. They are, in the main, safe and effective. And a lot less expensive. If you had to pay the full price, you'd probably demand the generic. It's because of insurance that we have these games about brand name drugs.

Mike

[Rich Riddle]

My wife is an MD (cardiovascular anesthesiologist) and was studying for her PharmD when we met. She stopped studying for the PharmD to marry me. She sits on the committee that selects new medications for several hospitals and her job entails intimately knowing/understanding medications at a very high level. She always gets us generic drugs when available, always. I don't worry about her choices in the least.

[Curt Harms]

If the original is $500 a month, then people must be paying it. The drug company would charge what the market will bear ?

Synthesis of most drugs in a lab isn't difficult, but coming up with the synthesis is the real talent.


That and testing. I read about one drug being developed by a major pharmaceutical company. They had about $800 million invested in that product when there was a problem discovered that made that drug unsalable. So $800 million flushed. The money to do that kind of development and testing has to come from somewhere.

[Rich Riddle]

Remember Martin Shkreli and his price gouging incident. Sometimes generic competition fosters lower prices.

[Mike Henderson]

Remember Martin Shkreli and his price gouging incident. Sometimes generic competition fosters lower prices.

That one was very interesting and could portend some future price increases. Shkreli bought a generic drug that is used to treat an uncommon disease. Because the market is fairly small, no other companies were interested in making the generic. Then, he jacked up the price astronomically. With that much profit in each pill, other companies would likely enter the market but it would take time for them to get approval. And in the meanwhile, Shkreli would be making very handsome profits.

From a pure business point of view, it was a very inventive move. But from a "human" point of view, it was outrageous.

Mike

[Al Launier]

For prescription medications I always get the generic equivalent. I've found them to remedy the ailments I experience. As noted above, the cost difference can be extreme. I once was given a Rx for a medication that would have cost ~$600 ( I can no longer recall the name) & accepted a generic equivalent (cost ~$6) recommended by the local pharmacist.
However, for off-the-shelf medications I've found that the store brand names do not perform as well as the better known brand names. Tylnol vs. Equate Tylenol, etc. I've been told that by a pharmacist that the "inactive" ingredients in store brands can be the difference. Go figure.

[Ken Fitzgerald]

What that Martin Shkreli did was outrageous! It's another case of someone being an extremist.

[Barry McFadden]

Not sure about the USA but in Canada my doctor told me that the generic drugs can contain up to 20% less of the active ingredient compared to the name brand.

[Clarence Martin]

Not every Generic Drug is the same as it's Brand Name counterpart. There are some groups of Drugs that are so sensitive when it comes to either being correct in dosage, too low of dosage that they don't do any good, or too high in it's active ingredient, that it makes the Drug toxic. It is a small group of Drugs. Epilepsy drugs are the example I am referring to. Take Dilantin , for Example. It has a Generic "Equivalent". I would NEVER take it. When you go to the Pharmacy and get a generic drug filled, you can have one generic brand one Month, and a different generic brand of the same drug the next Month. The Insurance Companies love it when a Generic drug comes on the market. Who could blame them. They spend less for the drug, it saves the consumer and the Insurance company money. Both win in that situation. But, like I said before, there is that small group of Drugs that even though there are Generics in place of those Brand Names, it is better to stick with the Brand Name Drug.

[Ken Fitzgerald]

From the FDA's website and page concerning generic drugs, a copy and paste:

The generic drug approval process (http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/default.htm) includes a review of scientific data on manufacturing, ingredients and performance. A generic drug approved by FDA that would be substituted by a pharmacist for a brand name drug will:


Contain the same active ingredients as the brand-name drug. Active ingredients make the drug effective against the disease or condition it is treating. Inactive ingredients may vary.
Be identical in strength, dosage form and route of administration. If the brand-name drug is a capsule and is taken orally, so is the generic.
Treat the same medical condition.
Be absorbed into the bloodstream at a similar rate and over the same period of time.
Meet the same requirements for identity, strength, purity and quality.
Be manufactured under the same strict standards that FDA demands of brand-name drugs.

That's not to say a manufacturer won't break the law and do otherwise but there's nothing to keep the brand name manufacturer from do so either.

[Wayne Lomman]

I can't comment on prescription drugs in the US market, but I do know that the FDA conducts on the ground audits of overseas manufacturers. They are extremely thorough. Cheers

[Al Launier]

Thanks Ken, that was informative.

[Art Mann]

I take generic drugs for cholesterol, triglycerides and blood pressure. They all work well for me and 2 of them include no insurance copay and cost me nothing. I am happy I have the generic option.

[Greg Peterson]

Just like the CALM act, industry will find a loophole in the regulations.

These FDA regulations are, IMO, generic.

In this instance, the FDA requires the generic to be absorbed in a similar manner. I'm sure the lawyers can and do create a generous amount of latitude with that.
I've taken generic, or more accurately copy cat dtugs, both over the counter and prescription and noticed a different, less effective result. Or should I say, I experienced a similar result?
Similar is an objective measure.

[Brent Gamble]

I take generics...if my Doc approves. My daughter has epilepsy. Of course she must take anticonvulsant drugs, and will need them for the rest of her life. Without going in to all of the details, the drug she takes has just come off patent and our insurance company has stopped paying for the brand name. Her doctor has gone round and round with the insurance co. but they insist they won't pay for the brand until she tries the generic and it doesn't work. HUH? In her case "doesn't work" means she has tonic-clonic (grand mal) seizures. The bad, dangerous ones. It is well documented that people with epilepsy are prone to problems with generic meds once they've acheived control on the brand med. Google "generic anticonvulsants". It's a risk we are not willing to take with our daughter's well being. Generic drugs are required by the FDA to be the same within a given range and they can vary from one manufacturer to the next. They are almost, but not quite the same, and they do not, in every case work indentically. Sorry for the rant, but this is a touchy subject for me.

[Greg Peterson]

Generics, by definition are not the same.

[Frank Drew]

Generics, by definition are not the same.

Yes, the bottles they come in are different.

[Greg Peterson]

Yes, the bottles they come in are different.

Well, more than the bottle is different.

"But generic drugs diverge from the originals far more than most of us believe. For starters, it’s not as if the maker of the original pharmaceutical hands over its manufacturing blueprint when its patent runs out or is challenged. The patent reveals the components, but it doesn’t explain how to make the drug. In reality, manufacturing a generic requires reverse engineering, and the result is an approximation rather than a duplicate of the original."

http://fortune.com/2013/01/10/are

The article goes on to explain that the maximum concentration can not fall below 20% or exceed 25% that of the brand name. That is a 45% variance.

The production of a generic is backward engineered, and as such, some of the previously considered inert ingredients likely serve a specific purpose in the distribution and absorption os the active ingredient.
As the article states, the regulations are overly broad.

Generics are not the same as their brand name counerpart. They may be close enough in some applications, but there is no evidence nor requirement for generics to identical. In the auto parts business, we call it a functional equivalent.

[Mike Henderson]

I never looked at pharmaceutical patents, but the basis of a patent is that it teaches (someone "skilled in the arts") how to do the patented thing. The deal our patent system makes with an inventor is that the inventor discloses how to make something and the inventor gets a patent for a certain number of years.

If that's true I assume a company would be able to use the patent as a guide (for someone skilled in the arts) to make the generic medicine. For people in the business, I guess there's not a lot of mystery about how to make a certain drug. After all, it's 17 to 20 years after the drug was patented.

Mike

[Rich Engelhardt]

Here's a little something to get your blood pressure up..
http://www.nytimes.com/2013/10/13/us/the-soaring-cost-of-a-simple-breath.html?nl=todaysheadlines&emc=edit_th_20131013&_r=0

Since I have COPD, the subject of generic inhalers - or more exactly - the lack of such things - is something I have a special interest in.

The above article & this one from Mother Jones:
http://www.motherjones.com/kevin-drum/2013/10/heres-why-your-asthma-inhaler-costs-so-damn-much

Are real eye openers to the world of - - (generic) drug pricing...

[Greg Peterson]

From the Fortune article I linked to above:

"At a meeting of the FDA’s advisory committee for pharmaceutical science and clinical pharmacology in 2011, Dr. James Hennessey, clinical director of the division of endocrinology at Beth Israel Deaconess Medical Center in Boston, presented evidence of three different generic formulations of levothyroxine (used to treat hypothyroidism). All were more potent than the branded version and varied from one another. One was 12.5% above, another 9% above, and another 3% above the brand name’s potency. All had been approved as bioequivalent. Noting that “less than 10% dose intervals make clinical differences,” Hennessey told the advisory committee meeting, “These differences are too large.”

These three generic versions of levothyroxine were within FDA regulations, yet obviously were not identical to the name brand or even bioequivalent to the name brand.

So FDA regulations are not adequate for all generic medications.

[Ken Fitzgerald]

Greg,

There is also nothing from stopping brand name drugs from having the same type of variations between production runs.

I would love to know what the fine doctor's views were before he found these inconsistencies and who pays his paycheck.

And how many total manufacturers produce and sell the generic levothyroxine?

Is this the only 3 who manufacture this generic or is it 3 out of 1000 who make this generic?

[Greg Peterson]

Ken, we'll have to agree to disagree on a very fundamental level in this discussion. I'll leave it at that.

[Malcolm McLeod]

Just to throw in a third leg for this 'stool' (and for a touch of irony), I recall reading that people are occasionally cured by the placebo in clinical trials.

[Mike Hollingsworth]

Generic Viagra is going to be a Planet Changer.

[Greg Peterson]

Contain the same active ingredients as the brand-name drug. Active ingredients make the drug effective against the disease or condition it is treating. Inactive ingredients may vary.

Makes perfect sense.



Be identical in strength, dosage form and route of administration. If the brand-name drug is a capsule and is taken orally, so is the generic.

Plenty of wiggle room in this specification. Same amount of active ingredient is easy enough to do.


Treat the same medical condition.

Again, this is pretty straight forward.



Be absorbed into the bloodstream at a similar rate and over the same period of time.

Here is where the divergence starts. By similar, I take that to mean the release rate and absorption rate do not have to be identical. Strength, dosage form and route of administration must be identical, but the rate by which the active ingredient is released and absorbed is allowed to vary by as much as 45% as that of the name brand.


Meet the same requirements for identity, strength, purity and quality.

Easy enough.

Be manufactured under the same strict standards that FDA demands of brand-name drugs.

Depends on who is monitoring quality control.

All the ingredients in the name brand drug are there for a reason and their interaction with the delivery of the active ingredient is not documented for the generic market. Like most other clones or copy cat items, generics are by practice and definition not the same as the name brand that went through extensive research and development. Perhaps for a vast majority of applications the allowable variance in generics are not a problem. But it appears there are some medical professionals who have discovered and documented their findings and submitted them to peer reviews. Even this extensive counter to industry claims will not be enough to sway some opinions, but at some point the facts must mean something.

[Mike Null]

Count me among those who strongly advocate generics. I take three and I remember the terrible prices I had to pay for the branded versions. I've been taking these drugs for nearly 20 years. I'll be 80 in a couple of months so I guess the generics are working.

[Greg Peterson]

Count me among those who strongly advocate generics. I take three and I remember the terrible prices I had to pay for the branded versions. I've been taking these drugs for nearly 20 years. I'll be 80 in a couple of months so I guess the generics are working.


I don't think anyone is discounting the value generics bring to the market. The discussion has morphed into whether or not generics are identical to the name brand. Some say they are and question the motives of doctors and scientists. I say they are not identical because the production, the recipe if you will, is proprietary.

You can get the ingredients right but the magic happens in factory.

[Mike Henderson]

I don't think anyone is discounting the value generics bring to the market. The discussion has morphed into whether or not generics are identical to the name brand. Some say they are and question the motives of doctors and scientists. I say they are not identical because the production, the recipe if you will, is proprietary.

You can get the ingredients right but the magic happens in factory.
I've heard stories of people who had trouble with a generic drug but no problems with the brand name.

It's really simple. If the generic doesn't work for you and the brand name does, go for the brand name. It may cost you more, however.

If the generic works for you, take the generic.

All the arguments about whether the generic is exactly the same as the brand name are meaningless. The only thing that matters is which one works for the individual.

Mike

[We know that many, many people take generics and are helped by them.]

[Michael Weber]

I'm the OP. i did not intend to imply all or even many generics were untrustworthy. Just that there is a possibility for abuse by unethical actors. I'm sure the FDA does all it can with the resources available. Those resources are not adequate when applied to control in foreign countries. The fact the FDA says this or that on its web pages doesn't really inspire my confidence. There is a trust issue here and most makers are aware that a loss of trust would be a bad thing for their businesses. I am heartened by the independent confirmation by university research facilities. I'm confident that most generics will be deemed okay and any failures will be rectified. As the saying goes, trust but verify.