The Risks of Generic Drugs

[Marc]

I wasn't sure where to put this. It isn't really news, and doesn't really belong in the pharmaceutical forums. So...

I posted this because I have been hearing and reading about the dangers of Generic Drugs. More and more people are fighting their insurance company over insurance company requirements for generic drugs. I know in the past there were a few drugs that I took that it was obvious that the generic drug "equivalent" simply did not have the same effects as the brand name. I also noticed that several states have enacted laws for certain drugs, such as drugs to treat epilepsy and other seizure conditions, which do not allow generic drugs. If you are prescribed a generic drug, it may actually be harmful. I do know a few people who have challenged their insurance company over not paying for "brand name" drugs.

It's your life - Are you willing to take a chance?

The Risks of Generic Drugs

Just because it is a "generic" drug doesn't mean it is an *equivalent* drug. It doesn't even mean it's safe to take.

Just my - Something to think about.

 

[pkost]

Disclosure: I work for a generics company; My specialism is meddevices so an indepth discussion on bioequivalence, pharmacokinetics etc is beyond me.

The bias in this article is quite apparent in my opinion. All pharmaceuticals are reviewed by the authorities, including generics...FDA/european competent authorities. They have all been deemed suitable for the issue of a license. If they are not up to the necessary standards they are not issued with a license

Fundamentally, all medications carry risks and side effects, including the brand; the statement that "just because it carries a brand does not mean it's safe to take" can also be said to be true.

It is acknowledged and well known that certain medications, such as those used to treat epilepsy cannot be easily changed to a generic form, but it goes both ways - a patient who starts on generics equally cannot easily be switched the branded variant.

I think on balance, the doctor, using their expertise and training needs to make a balanced on the best method to treat their patient, weighing up risk, outcomes and cost. As patients we need to be able to trust them in their ability to do this as do the insurance companies or health service (whoever pays the bill)

Edit:
1. just read that most of the generic actives come from overseas...where do they think the brand actives come from?!
2. glass in lipitor...of course no branded drug has ever had a quality issue!

...I'm just angry now.

 

[Marc]

The article is biased to some degree, as are most. The reason I posted is that I have experienced the problem of the drug not working like the "brand name" drug, as have some other people I know. The most recent was someone I know who was prescribed Restoril. The first few prescriptions the insurance company paid for. It then "made a judgement" that a generic would be OK and refused to pay for the brand name. Since the brand name was about 10x more expensive she simply could not afford it. She stopped taking the generic because it simply didn't work. So, she has a prescription for a drug but doesn't even bother to fill it.

This is as much about insurance companies as it is about generic drugs.

As to doctors, being from a medical family, I know the games (e.g.: How would you like a nice 5 day cruise?) and I know that many doctors these days do not necessarily weigh (or know) the risks of many generic vs. brand drugs.

I'll also speak as someone who majored in biology in college (with a minor in chemistry), admittedly many years ago, but I did take organic chemistry and biochemistry so I do have a decent understanding of pharmaceuticals and how they work. "Reverse engineering" a process is often a gamble. While the formula is important, the *process* (in this case drug synthesis) often is just as important.

Add to that:

Since the original drug has already been tested for safety, the FDA only requires that the generic produce the same level of medicine in the bloodstream (within the 80-125% range), i.e. bio-equivalence, as the brand name. The testing for this is done not on actual patients, but on a small number of healthy volunteers (between 24 and 36 people). Many critics point out the need to test the generics on actual patients in order to determine efficacy.

That's the point that gets me. Efficacy. Without clinical testing its not known whether the drug actually works as intended or not.

 

[Miner]

Another issue that I see, that is arguably worse, is where the insurance companies drive the use of a different generic medication, not just a generic version of what the doctor prescribed. This different medication may not be as effective as the generic version of the prescribed medication.

 

[PaulJSmith]

Under any type of "managed" health care system, this will likely always be a problem. So long as the focus is on cost, suitability will always be of secondary importance. This is the primary reason why allowing bureaucrats and bean counters (or anyone other than doctors, for that matter) the power to make medical decisions is a bad idea.

 

[Walnut]

I agree with Pauls concerns except I have little trust in the Doctors making good decisions also. Think who is paying their invoices. Their customers are the government and insurance companies not us. Now being good Quality professionals who is the stakeholder that gets first priority?

 

[Mike S.]

Someone has to pay when a more expensive drug is taken vs. a cheaper one. There is no free lunch.

For the record, every drug I take right now is generic and the lab tests and/or my response suggest they are working, FWIW. I once needed a more expensive brand-name drug (no generic available) and had to first try a cheaper brand name drug before my insurance would allow the more expensive one, but I would have done the same experiment myself if it was money from my pocket.

If the money is coming out of your own pocket and you have a choice of a $300 brand-name and a $45 generic which one would you pick to try first?

And there is nothing stopping you from paying for the more expensive drug if you truly need it.

 

[Marc]

<snip> And there is nothing stopping you from paying for the more expensive drug if you truly need it.

People who can afford it. Not everyone can pay for a prescription that costs US$300+ a month (or more) as many drugs do, not to mention often there are multiple prescriptions/different drugs.

Since about 1998 I have just ordered drugs from Canada, the UK, or Switzerland. Brand name drugs are usually only about 15 to 25% of what I would pay in the US. Prices of generics in the US have gone up so much recently that buying brand name from outside the US these days is about as cheap, or as cheap as, as generics in the US. Then again, if it's something simple like aspirin (one of the drugs I remember synthesizing in an early chemistry class in college) - The local store.

 

[Mike S.]

How do you know you are getting the same brand name drug as in the US when you buy from a foreign country?

Surely you have read those horror stories?

 

[Marc]

The only difference is the price as those governments control drug costs. I trust brand drugs from Canada, the UK and Switzerland as much as "US" drugs. There was a short period not too long ago when the US tried to stop people from importing drugs, or in places like the northern border of the US people just driving over and picking them up. That didn't last too long.

The only horror stories I have read about are about drugs from "no prescription necessary" pharmacies. They rarely have any brand drugs to begin with, or at least didn't in the past. I haven't checked any of those in a long time.