SUMMARY: The approval of Biogen’s Alzheimer’s drug, after its advisory panel turned it down, begs the Inspector General to open an investigation into the FDA. Biogen’s $56,000 drug is proof that it was never about the science; it’s about a lifesaver for a sinking company. In the meantime, caregivers are going to put their hope in a drug that doesn’t work and in garbage science with cherry-picked data.
SUMMARY: The FDA wants to look at how certain brand names affect consumer and health care providers’ perceptions about the efficacy and the medical conditions for which they’re indicated. This is just another example of how clueless the FDA is regarding patient behavior and prescription drugs.
QUICK READ: In a major development, a Japanese pharmaceutical company has started the final stages of human trial for its antiviral flu drug to treat COVID-19. But will their clinical trials meet the criteria for new drug approval for the FDA if successful?
- 89 percent of the public favors requiring the Food and Drug Administration [FDA] to review prescription-drug ads for accuracy before they are broadcast.
- A survey of patients by Prevention Magazine in 2012 showed that [inlinetweet prefix=”” tweeter=”” suffix=””]71 percent of people agree that DTC advertisements “allow people to be more involved with their health care” and 75 percent believe that DTC ads are useful because they “tell people about new treatments.[/inlinetweet]
- Prevention’s survey also found that [inlinetweet prefix=”” tweeter=”” suffix=””]76 percent of Americans talked to their physicians about a condition after seeing a DTC ad [/inlinetweet]and among those who discussed a specific medicine that was advertised with their physician, [inlinetweet prefix=”” tweeter=”” suffix=””]only 20 percent received the prescription of the advertised medicine.[/inlinetweet]
- Fair balance in DTC TV ads is not necessary as the vast majority of patients will go online to learn about drug side effects.
- Drug companies are left out of social media conversations because they lack FDA guidelines.
KEY TAKEAWAY: “Two things are infinite: the universe and human stupidity; and I’m not sure about the universe” said Albert Einstein. I’m beginning to think that can be applied to the FDA when it comes to DTC ads. Studying animation in DTC ads? At a time when DTC ads are under attack the FDA should be reassuring attackers that DTC ads benefit consumers and doesn’t lead to patients requesting unnecessary prescriptions.