• If you missed Wednesday’s post about Prescription for Change, the Consumers Union petition to the FDA to make it easier for consumers to report side effects of medications, I highly recommend checking it out.
• In other drug news, the AstraZeneca Patient Assistance Programs now have a total of three “AZ & Me” prescription assistance programs (particularly interesting for those of you who take Seroquel and Seroquel XR.
• Mental Health America has issued another call to action for us. This one regards proposed cuts in Medicaid funding for rehabilitative, case management, and school administrative services – all of which include mental health services and support of “Protecting the Medicaid Safety Net Act of 2008″ (H.R. 5613). Of course I sent a letter to my decision makers, but I had to giggle while I was doing so because I’m positive dear old Nick Rahall is getting tired of finding emails from me! God bless him, though. He always responds via snail mail with his views on the matter and a nice thank you. Find out if your decision maker(s) are cosponsoring H.R. 5613, and send a letter of support.
• Another update from Mental Health America: “No Health Without Mental Health,” Mental Health America’s 2008 Conference in Washington, D.C. is right around the corner (June 4-7), and Mental Health America President and CEO David Shern, Ph.D. has prepared a 30-second video to invite us all!
• Why is it that when states experience budget problems, health and education services are usually the first to suffer? I honestly don’t know which is worse: increased taxes, or decreased health services and laid off state employees. At this point, I’m pretty sure I feel the latter is much worse.
• New findings regarding genes and their relationship to schizophrenia could lead to new treatment options for managing the mental illness.
• Researchers from the University of Illinois at Chicago College of Medicine have stumbled upon some findings they may not only help “test” patients for depression, but may also help speed along the process of finding the best antidepressant.
• And, I’m a bit late on reporting this, but better late than never, right? The Senate Judiciary Committee passed the reauthorization of the Mentally Ill Offender Treatment and Crime Reduction Act (S. 2304) on March 9. According to the article, the bill “will help provide states and counties with the resources needed to design and implement collaborative efforts between the criminal justice and mental health systems.”

That’s all for this week, folks! If you think you have any Saturday Sanity-worthy news, send it my way before next Saturday!

Image source and credit.

Post from: Blisstree

Saturday Sanity: Drugs And Government Issues

Carrying on with the Grab Drug Advertisements by the Pills series, let’s talk about drug advertisements and the FDA. Specifically, what drug advertisements are and are not required to tell us.

Since 1962, the U.S. Food and Drug Administration (or, the FDA) has regulated prescription drug advertising under the Federal Food, Drug, and Cosmetic Act and related regulations. (The FDA considers an “advertisement” to be broadcast promotions such as television and radio, print materials such as magazines and newspapers, and even telephone contacts.)

These references cover a lot of material, so I’ll sum up what’s relevant to this series.

Prescription drug advertisements are required to:

• Explain the benefits of the medication, but they can’t make promises – especially when it comes to benefits that don’t have the evidence from testing to be backed up.
• Explain who should not take the medication. A good example of this is when you watch a commercial for an SSRI antidepressant and you’re told – during the commercial – that “people taking MAOIs shouldn’t take” whatever the SSRI antidepressant is.
• Give a statement about the side effects (if it’s a broadcast – radio or television – advertisement) and give a complete list of side effects, a Web site address, and a contact number (if it’s a print – magazine or newspaper – advertisement).

Prescription drug advertisements are not required to:

• Let you know about trials that didn’t go so well. They only have to make sure that the information they provide is an accurate representation of the “average” success rate.
• Tell you how well the medication works; only that it may work. This is tricky because while a particular drug may improve your symptoms, it may improve them only slightly. Drug advertisements don’t have to tell you that you may be looking at only a slight improvement.
• Point out alternative treatment or management options, nor do they have to remind you that there are less expensive and more beneficial treatments out there.

If a drug advertisement doesn’t comply to these requirements, the FDA will usually send an untitled letter or warning letter (two different things and sent based on the level of noncompliance) to the drug company. You can see archived copies of such letters online. (Just glancing at the examples, I saw letters to the makers of Cymbalta, Effexor XR, Rozerem, Seroquel, Zoloft, and Topamax.) Of course, other more serious enforcement actions exist, too.

The short of it is that the FDA is working hard to help protect us – the patients. Of course, that’s no reason to get lazy. Remember, the goal of this Mental Health Notes series during Patient Safety Awareness Week is to help you get more involved in your own health care by better understanding prescription drug advertisements. Let the FDA help you do just that. Become familiar with the Web site, and don’t be afraid to contact them if you need some help.

Other helpful Web pages to check out (and those that helped me with this part of the series) include:

• Direct to You: TV Drug Ads That Make Sense
• Prescription Drug Advertising and Promotional Labeling
• Promotional Material Review Process
• DDMAC’s Laws, Regulations, Guidances, and Enforcement Actions

The above image is a creation from Aaron Escobar of Escobar Studios.

Post from: Blisstree

Grab Drug Advertisements By The Pills: Let The FDA Help You