Pleading Ignorance Archive

“This Statement has not been Evaluated by the FDA”

February 5th, 2010. By Kristine B

And until something changes, it ain’t gonna be.

This week, a study was released suggesting that the combination of herbal remedies and heart medications can be dangerous for patients. According to the study, patients who use popular herbal remedies—including ginko biloba, St. John’s wort and Echinacea—along with heart medications are at an increased risk of serious heart rhythm problems, higher blood pressure and bleeding. Serious stuff.

If you’ve ever wondered how the herbal supplement industry is regulated, read on as Pleading Ignorance dives into the regulation of dietary supplements.

What is a Dietary Supplement?

Good question. The phrase “dietary supplement” gets tossed around a lot. It’s a vitamin. It’s a weight loss miracle. It’s a muscle-builder. Or the secret to an improved sex life. “Dietary Supplement” means a lot of things. But the FDA, in accordance with the Dietary Supplement Health and Education Act (DSHEA) of 1994, defines “dietary supplement” as a product taken by the mouth that contains dietary ingredients that are intended to supplement the diet. Sounds like a definition that basically says a lot of nothing–except that the supplement needs to be taken orally. Ok, so what’s a dietary ingredient? According to the FDA site, a dietary ingredient is a:

• vitamin
• mineral
• herb or other botanical
• amino acid
• dietary substance for use by man to supplement the diet by increasing the total dietary intake (e.g., enzymes or tissues from organs or glands)
• concentrate, metabolite, constituent or extract

Makes sense, but that date—1994—is important… Read the rest of this entry »

Tags: dietary supplements, FDA, herbal supplements, Pleading Ignorance
Posted in Pleading Ignorance | 2 Comments »

Having a Baby? Get to Know the FDA Drug Classifications

January 27th, 2010. By Kristine B

Navigating the complex web of drug categories can be complex and overwhelming. Add to that the pregnancy categories and it can be tough to determine just which drugs a pregnant woman should and shouldn’t take. This week, Pleading Ignorance looks at the different FDA pregnancy categories. 

How Does the FDA Classify Drugs for Pregnancy? 

Basically, the categories are based on studies, including animal studies, human studies and/or post-marketing data (reports that have come in after a drug is released on the market). Information taken from those studies—including adverse reactions and potential side effects—is then used to put the drug into a pregnancy category. 

Now, although the categories may seem straight-forward (they are all letters) they aren’t necessarily that simple. Some drugs might have a higher impact on the fetus depending on the point at which they’re taken during pregnancy. Other drugs might have a higher risk of abnormality depending on the dosage taken. When it comes to taking medications while pregnant it’s important for pregnant women to discuss their options with their doctor to determine if the benefits outweigh the risks. 

Also, keep in mind that as increased post-marketing data for a drug becomes available, the FDA can change a drug’s pregnancy category. So, a drug may start out in Category B, for example, but be moved to a Category C if there is enough evidence of an increase in risk after the drug is approved for use. 

FDA Drug Classifications for Pregnancy

So, here’s how it breaks down: 

Category A: Means that controlled studies have found no risk to the fetus when the mother takes the medication during any trimester of pregnancy. 

Category B: Means that controlled studies in pregnant women have not shown an increased risk of fetal abnormalities, although some adverse findings have occurred in animals. It can also mean that there are no adequate human studies but animal studies show no fetal risk. There is a remote possibility of fetal harm. 

Category C: Means that there is a risk. Either there are not enough adequate human studies, but animal studies have shown a risk or there are not adequate animal studies. There is a chance of fetal harm but benefits may outweigh the risks.  Read the rest of this entry »

Tags: FDA, FDA Drug Classification, Pleading Ignorance
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Pharmaceutical Companies Want YOU to Want Them

January 21st, 2010. By Kristine B

Last week, we saw how pharmaceutical companies target medical professionals in their marketing. This week, Pleading Ignorance looks at how they target you, the patient. 

When you are targeted in an advertisement or marketing plan for pharmaceuticals, that’s called direct-to-consumer advertising (DTCA). Now, it may seem a bit silly for pharmaceutical companies to target patients—after all, the patient has to rely on the doctor to first diagnose a health problem and then prescribe the medication. 

But, if you notice, the tv ads encourage you to “talk to your doctor about [insert name of drug here].” They expect that you will see the ad, identify with the list of symptoms or the general health issue mentioned, and go straight to the doctor, demanding you get a prescription for that particular drug. 

So, if consumers are being given the drugs they want and need, is there really a problem with DTCA? 

According to the National Conference of State Legislatures (NCSL,ncsl.org), there are concerns about DTCA advertising. 

One concern is that the costs of drugs are “soaring” (their word) and becoming more and more difficult for people Read the rest of this entry »

Tags: Drug Marketing, FDA, Pharmaceutical Marketing, Pleading Ignorance
Posted in Pleading Ignorance | 2 Comments »

Pleading Ignorant on Drug Marketing

January 13th, 2010. By Kristine B

Last week, Pleading Ignorance briefly looked at what “off-label” means when talking about drugs. This week, I thought I’d take a slightly more in-depth look at drug marketing—starting with how pharmaceutical companies market drugs to doctors. You sort of already know how drugs are marketed to consumers (i.e., YOU) because you see the ads. But pharmaceutical marketing to physicians is a little less transparent. So let’s talk about it.

Drug companies have two target audiences that they market their drugs to: the doctors, which makes sense because the doctors are the ones who write the prescriptions; and you, the consumer. That’s why, more and more frequently, you see ads on tv telling you to talk to your doctor about a certain drug. How often do you watch tv and see some sort of ad that starts off “Do you feel down?” or “Are you in pain?” Drug companies know that if you said “yes” to those questions you might just go in to your doctor and ask about the drugs they’re advertising. But it’s not so easy to do that with the doctors.

Marketing to doctors is definitely different from marketing to consumers (I can’t imagine too many doctors would respond to a tv ad that says, “Does your patient feel down?”). Marketing to doctors is more about scientific information. That’s all the somewhat boring stuff—found on the monograph for the drug—that lists things like “Indications” or “Adverse Events” or “Co-morbitidy,” stuff that the scientists understand but we may not. There are Read the rest of this entry »

Tags: Drug Marketing, Pharmaceutical Marketing, Pleading Ignorance
Posted in Emerging Issues, Pleading Ignorance | No Comments »

What the Heck Does “Off-Label” Mean, Anyway?

January 7th, 2010. By Kristine B

One of the phrases we at LawyersandSettlements.com see frequently is “prescribed for off-label uses.” In fact, we see it a lot. But, we realized that not everyone understands what “off-label uses” actually means, or what its implications are. So, this week’s Pleading Ignorance examines the off-label use of drugs. (I promise this won’t be too painful). 

When a drug is approved by the FDA it’s approved for specific circumstances (meaning, for specific health problems) and, often, for specific people (usually defined by an age range, e.g. adults). That’s because the drug has been tested and shown to be beneficial in treating those health problems in that group of people. 

When a drug is prescribed for off-label use, the drug is being used either for a condition that it was not approved to treat or for a person outside the group listed in the prescribing information or both. 

According to a report at USA Today (11/25/08), a study published in Pharmacotherapy listed 14 drugs that should be studied further regarding their off-label use. Those drugs include Seroquel, an antipsychotic medication that is approved to treat schizophrenia and short-term manic or depressive episodes in bipolar disorder. However, according to researchers, in three out of four cases, the drug has been used off-label, for maintenance therapy of bipolar disorder. Other drugs included on the list, as cited at The Wall Street Journal blog (11/25/08) were Coumadin, Lexapro, Risperdal and Singulair. 

It’s not illegal to prescribe drugs for off-label uses. Doctors are allowed to prescribe an FDA- Read the rest of this entry »

Tags: Drugs, FDA, Off-label, Pleading Ignorance
Posted in Pleading Ignorance | 2 Comments »