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Generic Drugs Redux: Reader Beware

category_bug_geriatrician.gif [EDITORIAL NOTE: The TGB Geriatrician is a bi-weekly column written by Dr. Bill Thomas (bio) for Time Goes By to give us the information we need to help us navigate the health issues of aging. Dr. Thomas also writes his own blog at Changing Aging.]

When I was young, I was a very poor student. I failed sixth grade, but the teacher passed me anyway saying, “I’m not letting you get away with it!” One reason she passed me is that she knew me as a voracious reader. I still am.

One of the most important things I have learned from all that reading is that not all books are created equal. Not all authors are equally credible. Not everything that is written down can be trusted. That might seem cynical, but it really isn’t. A good reader asks questions:

Who is this author?
What are the author’s qualifications?
What are the author’s biases?
What are the author’s strengths?
What are the author’s weaknesses?

So it is with this background that I noticed a TGB comment in response to my last column here about Generic Drugs. It included the following:

“But these other filler items can vary considerably. I think people would be well-advised to be aware of such possibilities if they think they're experiencing a different response from their generic. A quick search turned up this link which is not alarmist, but adds some specifics about brand names vs generics.”

This is a solid, well-written comment and it includes a link to source information.

Yummy!

Of course I followed the link, and found this:

“Some people are allergic to some excipients. In addition, a person's body may have become accustomed to the entire mix of active an inactive ingredients in one manufacturer's drug, and changing the mixture - even if there is no allergy to a new ingredient - may cause a change in response to the medication.”

This statement is almost entirely false. First, excipients are the inactive ingredients in medications and they are selected on the basis of their lack of allergenicity. Here is a partial list (a more complete list here):

  • Cellulose: ethylcellulose, methylcellulose, hydroxymethylcellulose, hydroxypropyl, microcrystalline – obtained from fibrous plant material (woody pulp or chemical cotton)
  • Dextrans: partially hydrolyzed corn or potato starch
  • Dextrose: powdered corn starch
  • Iron oxide: used as a coloring agent
  • Sucrose: sugar, also known as refined sugar, beet sugar or cane sugar
  • Maltodextrins: a starch hydrolysate that is obtained from corn in the United States but can also be extracted from wheat, potato or rice.

The point is that we encounter “excipients” all the time and in amounts far greater than those used in pills. If a person truly has an allergy to an excipient, the problems would extend far beyond medications.

The second part of the statement,

“...a person's body may have become accustomed to the entire mix of active an inactive ingredients in one manufacturer's drug, and changing the mixture - even if there is no allergy to a new ingredient - may cause a change in response to the medication,”

is false. False.

False.

The FDA says:

“A generic drug is a copy that is the same as a brand-name drug in dosage, safety, strength, how it is taken, quality, performance and intended use. The FDA requires that all drugs be safe and effective. Since generics use the same active ingredients and are shown to work the same way in the body, they have the same risks and benefits as their brand-name counterparts.”

So, on the one hand I have the undocumented assertions of Marcia Purse and on the other hand, I have the explicit policy of the FDA. Let’s compare.

Here is Marcia Purse's job according to her profile posted at LinkedIn:

Office Manager, Airgun Designs USA (Privately Held; 1-10 employees; Sporting Goods industry) May 2001 — Present (7 years 3 months)

Airgun Designs USA makes paintball guns and accessories, but I've never played paintball, and at the only tournament I attended, which was Shatnerball 3, I was working so much at the registration booth that I never saw any of the game.

Although my title is Office Manager, since July of 2007 I have worked remotely at this job, handling accounting, sales, customer service and human resources. We just haven't come up with a better title!

Seriously, when it comes to the question of generics and brand name drugs, I give more weight to the FDA than I give to the office manager at Airgun Designs USA

Again, let us weigh the qualifications:

  • The FDA v. the Office Manager of Airgun Designs USA
  • Office manager of Airgun Designs USA v. the FDA

Okay, in this matter, I am going to give greater weight to the views of the FDA.

Some might think that I am being disrespectful of Ms. Purse, but I am not. I’ve read some of her writing about mental illness and I think she has valuable things to say. Also, she comes across as a really nice person. I am unwilling, however, to accept her unsupported assertions about brand name and generic medications. She is not a credible authority on this subject.

Two final points:

Crabby Old Lady sent me a note that said:

“I laughed when I first read your Generics column - the part about ‘I know you're out there thinking generics are inferior’. Since then I've been shocked at how many responded by telling you that you're wrong. I'm not unaware that some people are misinformed about generics, but still - the number who disagreed with you really surprises me.”

Big Pharma spends millions of dollars actively undermining the reputation of generic medications. That money has an impact on public opinions and attitudes. No surprise there.

Last, I encourage TGB readers to be critical. Ask questions. Probe. Ask for links. Reserve judgment until you can properly evaluate the source of the information you read on the internet.

EDITORIAL NOTE: You can subscribe to The TGB Geriatrician column by email by clicking here. Subscribe to the daily Time Goes By blog by email or RSS in the upper right corner of this page.

[At The Elder Storytelling Place today, Norm Jenson tells a kid's tale of having Gone Fishing.]

Comments

WOW! Thanks for being conscientious enough to take the time to investigate that link. I would've thought about.com would be more careful about their content. Just goes to show ya'...

I really hope whoever it was that mentioned that link in the first place sees your article today.

Thanks again.

Interesting that the about.com article was supposedly "reviewed" by a physician.

I'd like to think that I could have complete confidence in the statements by the FDA, but I know that the agency is in the pocket of the big drug companies. Money changes hands and drugs get approved that prove to be harmful in the long run. I have no doubt that the quality of the cellulose, starch, etc. has nothing to do with the effectiveness of drugs, but I am more concerned with the safety of the ACTIVE ingredients.

Good information, Dr Thomas.

Thank you!

Thank you, Dr. Thomas, for an exceedingly important point.

I preach about thinking critically so often that my friends (and acquaintances) turn the other way when I go on a rant. It isn't just generic drugs, but politics and the garbage that comes into our e-mail box daily.

Thank God for Snopes that enables me to check undocumented assertions out.

If I took any regular medications, I'd certainly want to take generics -- they are cheaper and identical, as Dr. Thomas says.

But I do want to describe the experience of a friend which might help explain how the notion that generics are "different" gets about.

She took a drug daily for years -- and finally the drug company monopoly ended and a generic version became available and her doctor switched her. The new prescription told her to switch from taking the drug once in the morning to a twice daily schedule, so she did. But she started having side effects -- tingling, buzzing ears, very nasty feeling. So she consulted the doctor.

Apparently, in the process of going from being a monopolized substance to a generic, the new maker had chosen not to make the compound a "time release" version. So, despite taking more doses (of smaller amounts), the generic did not maintain an even supply of the drug in her blood. Hence the side effects.

The change was in the release mechanism, single dose v. time-release, not in the composition of the generic drug. Fortunately she had a doctor who was willing/able to work this out with her. In our inaccessible health care environment, that's not a sure thing.

Well, I just now got back here and noticed this response to my comment about generics. I seemed to have unintentionally stirred up a hornet's nest.

I should have known better than to simply stop at the first link I came across and not check it further as that is not an Internet site I reference for medical information. Haste makes waste -- and worse! I defer to your professional expertise and whatever is your current information, Dr. Thomas.

Interesting author credentials you reported for the article's link I cited. That should lead us all to use caution, as I have known to do, in seeking Internet medical and other information. Glad you set the record straight, Dr.

I want to clearly state I have been most appreciative of your work ever since first learning about you here at TGB, then reading your book. My view has not changed.

Perhaps some of the generic problems I'm recalling (though I can't recall specifics it's been so long ago,) harken back to when generics were first introduced; possibly active ingredient variances, reflecting problems the FDA corrected long ago; or it has had to do with reports about generic sources.

A few anecdotal accounts over the years from individuals I consider reliable reporters, including personal friends, who I believe were unaffected by shape and color changes have also influenced and been the basis for my view. Their problems went away once they went off the generic. I have difficulty believing their reactions were psychosomatic, nor, they reported did their doctors. Maybe their doctor didn't discuss the color, shape issue with them and simply took them off the generic, allowing them to believe whatever they had reported to him/her.

I'm hardly in a position to dispute scientific pharmacological analysis and findings here in my home lab (no, I don't have a lab.) ;-) I have wondered if the differences about which people complain could be due to a person's unique body chemistry at a given point in time, or if they're affected by whatever other medications they might be taking simultaneously? I've wondered also if it could simply be a coincidence with no cause and affect relationship that accounts for their reaction? But, if so, why, repeatedly?

Certainly if I hear any new such generic anecdotes I'll be even more cautiously aware of the potential shape and color effect.

The best thing about generics is that seven days of a generic antibiotic is five bucks on my insurance and the real stuff was $100.00. My doctor wasn't aware of this. I was grateful that he looked apalled.

I wish I could say that all doctors are as informed as Dr. Thomas. Does anyone else remember the great Synthroid debacle of about ten-fifteen years ago?

I had been using a generic thyroid drug for many years and my new (and soon former) doctor flipped out, insisting that I switch back to Synthroid because that drug was a "special case." According to him, the generic versions were not as reliable in dosage. (There was some reliably great marketing done by the Synthroid manufacturer!)

Ultimately, there was a class action lawsuit and Synthroid had to pay patients a settlement (a few bucks) because the generic drugs were proven to be perfectly fine.

I live in L.A. and this doctor is a well-respected, nationally known guy. But, sadly, it's not just patients who can be fooled by the big drug manufacturers and their big advertising budgets.

Great article. Generic drugs are exact copies of their brand name counterparts, with the same dosage, side effects, risks, etc. I found a great article on Medicine Net that explains why generics are so much cheaper;

http://www.medicinenet.com/script/main/art.asp?articlekey=46204

I also found a great site www.medtipster.com that finds your discount generics for as little as $4 and right in your neighborhood.


Generic drugs are excellent, and fortunately I've been able to use them myself without any problem. I would certainly recommend others use generic drugs, too, if at all possible and probably most people can, but not all.

I know first hand from knowledgeable well-informed individuals and have read information from other reliable sources that there are those who experience a difference in effectiveness despite their wanting to avail themselves of the less expensive generic version.

Despite what the FDA may say some medical people and pharmacists (including my own) recognize certain patients are legitimately and medically sensitive to some generics. I simply believe patients should receive consideration for the possibility they just might be among that number.

Additionally, a biological research scientist (now deceased) who had been at one of the most highly respected Southern California Universities with whom I had conversations confirmed this view to me a few years ago when I was seeking clarification on the topic. He told me he was part of a group of scientists around the world that held similar views and explained the basis of their belief that certainly seemed logical to me.

It's interesting that in your column accusing me of making errors you have chosen to discredit me by focusing on only one portion of my employment history - one that is, of course, irrelevant to bipolar disorder - and carefully ignore my other qualifications.

I have been writing for the Bipolar Disorder site at About.com for more than 13 years. The article in question has passed review by About.com's Medical Review Board (http://www.about.com/health/review.htm).

Regarding the FDA's standards for generic drugs, they are listed on the FDA website as follows:
===============
To gain FDA approval, a generic drug must:

* contain the same active ingredients as the innovator drug(inactive ingredients may vary)
* be identical in strength, dosage form, and route of administration
* have the same use indications
* be bioequivalent
* meet the same batch requirements for identity, strength, purity, and quality
* be manufactured under the same strict standards of FDA's good manufacturing practice regulations required for innovator products
=============
Nothing at all is mentioned about excipients. (As an aside, I note that your list of "common excipients" does not include dyes of any kind.)

Finally, you are being irresponsible when you claim my statements are entirely false. Can you prove, categorically, that the problems I mentioned can never occur? I said "may." I said "some people" are allergic.

Shame on you for deliberately misleading people about my credentials and declaring my statements false when you have no way of proving that they are.

Frankly - I got extremely sick from generics containing corn. Choosing to deride knowledgeable patients is a vile tactic and in itself raises suspicion about your methods. It took two years to recover. I consider the practice a violation of the Hippocratic oath--and challenge you to consider listening to patients. Generic drugs are not exact in terms of bioequivalence--not by a long shot. When Levoxyl withdrew globally from the marketplace more than 1/3 of patients needed new titration. That's millions of people and deeply irresponsible. http://www.medpagetoday.com/Endocrinology/Thyroid/44245

The FDA tested those medications on healthy subjects for something like six weeks. I got extremely ill after something like 9 months

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