Monday, February 1, 2010

FDA Warns Dermatologists

Today's New York Times featured an article by Natasha Singer titled "F.D.A. Aims at Doctors' Drug Pitches." All credit for reporting belongs to Ms. Singer and the New York Times. The article was so interesting to me, I want to encourage you to read it on the New York Times Web site. For those who don't have time, here's a recap.

The Food and Drug Administration (FDA) has regulations that prohibit clinical trial investigators from promoting drugs before they receive FDA approval. These regulations are intended to protect the public from unscrupulous investigators who "push" products that may not be deemed safe and/or effective once study results are examined by the FDA. So far, so good.

Now the FDA has turned its attention to the "rarified world" of fashion magazines and beauty editors, including Allure, and dermatologists who specialize in beauty, cosmedicine, injectables, and cosmetic surgery. The government agency recently warned Dr. Leslie Baumann (shown here - she looks great, huh?) that her comments to the media in 2007 regarding Dysport (an injectable anti-wrinkle drug that has not been approved) violated their regulations. Cited in the New York Times article were Dr. Baumann (frequently quoted in Allure) and Dr. Fredric Brandt, both considered "celebrity dermatologists."

The article left me wondering, "What's the difference between providing information and promoting an investigational drug?" Where do doctors draw the line between the public's insatiable appetite for news about beauty advances and promotion of unapproved drugs? I'll bet there are a lot of dermatologists trying to figure out what they can and cannot say - and to whom!

What do you think? Do you feel a need to be protected from advance information?

Photo and news courtesy of the New York Times


Anonymous said...

First the feds go after beauty bloggers, and now dermatologists? Wish they could focus on hunger, health, peace and prosperity!

Aero said...

Technically, any doctor should not be supporting a drug that has not been approved for public use by the FDA. If this had been a medication still in clinical trials for heart disorders, it would be hard to support a doctor who pre-emptively supports that medicine. This is especially important in terms of ethics because a lot of these doctors are doing trials or taking samples from big chemical/ drug companies (eg Are they making money from suggesting this drug before it is found to be safe?).
Cosmetics is an industry that, except for the fields of medicine, are largely left unregulated by the government. Some people stopped using certain mineral powders because of the mica content, which worried them. However, these products aren't removed from shelves or even pre-screened by the government. For surgical and medical cosmetics, maybe it's wise to let someone police our beauty impulses :)

Charlestongirl said...

Totally fair, Aero! With a background in psychopharmacology, I always find information abut clinical trials and potential breakthroughs fascinating. I want to understand the mechanism of action and why the drug, if approved, might be an advance. Maybe I'm a "drug geek"?

The beauty police ought to be consistent, though - and they aren't. There's a difference somewhere between talking and promoting, don't you think?

There is some scary stuff on the shelves, and, as you mentioned, it's still on the shelves.

Charlestongirl said...

Thanks, Green Tea! Always trying...

Cool name, BTW.

Aero said...


I love pharm! But I am not a pharmacologist :">

Talking and promoting are VERY different in science :)

We can talk about a product to dissect its value without being biased towards the product against others. So talking can be defined as a discussion, explaining the pros and cons in an objective manner. The purpose of talking is to find the truth/ the science behind the product.
Promoting a product denotes bias towards the product, though it is possible to objectively promote a product for its value too. However, promotion of a medical or medically-influencing product before confirmation of its safety is unethical in most cases. In cosmetics, where the appearance is the goal, sometimes the truth isn't considered as well as it should be.

Jaime said...

I agree with everything you've said. However, shouldn't the educated consumer purchase products that they know are tested by doctors instead of recommended? Wouldn't this help eliminate the companies/products that are not? There is a huge difference. Ever heard on a commercial, 4 out of 5 doctors recommend? Have you ever thought about what that means? I only use products that have been tested by dermatologists, opthalmologists, and pediatricians to be sure they are safe.

On a somewhat similiar note, did you know there are no federal standards or definitions that govern the use of the term hypoallergenic? The term means whatever a company wants it to mean and manufacturers are not required to submit substantions claims to the FDA. Skincare products are tested using the Repoeat Insult Patch Test and rate a reaction of a product on a scale from 0-8. Most companies call their products hypoallergenic if they rate under a 4. All of the products I use, test to a 0, no reaction.

Food for thought....

Charlestongirl said...

Hi Jaime,

Can't disagree with anything you said! There are no standards for the use of terms, such as "hypoallergenic." To be frank, there are no standards for testing by dermatologists or other physicians either. I pay no attention to those claims.

Zero reaction sounds great to me. You go, girl!