Generic Drugs Redux: Reader Beware

[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.]