April 1. This is the day upon which we are reminded of what we are on the other three hundred and sixty-four.
--Mark Twain, Pudd’nhead Wilson
Fool Us Once...
We’re being duped by our government agencies. We’re being hoodwinked by the Affordable Care Act (ACA). We’re being bamboozled by pharmaceutical companies and research networks. In this April Fools’ issue of TAGline, we highlight several missteps in research and policy that have required some degree of advocacy to remedy and ensure that the jokes don’t remain on us.
Forgotten Negatives: The Limits of Treatment as Prevention
The CDC’s High-Impact Prevention strategy takes aim at the stubborn HIV incidence rate in the United States. The only problem: it doesn’t include an ambitious plan for those at risk for the virus - By Jeremiah Johnson
There is no shortage of depressing statistics when it comes to HIV prevention in the United States: 50,000 new HIV infections annually; a 12% increase in new infections among gay and bisexual men and transgender women between 2008 and 2010; an estimated infection rate of nearly 50% among black transgender women; and a projected 50% infection prevalence in gay and bisexual men by the time they’re 50.
For the people who have been most affected by the epidemic, we have failed to make any measurable progress; if anything, the spread of the virus has worsened.
The White House’s Fuzzy Math
An Office of National AIDS Policy progress report obscures the state of the domestic U.S. HIV/AIDS response - By Mark Harrington
On World AIDS Day, December 1, 2013, the White House Office of National AIDS Policy (ONAP) issued a peppy and upbeat status report on the National HIV/AIDS Strategy (NHAS), claiming progress on eight of nine outcome indicators. Yet when reviewed in tandem with a companion document, HIV Prevention Progress Report, 2013, released by the U.S. Centers for Disease Control and Prevention (CDC), many of the White House claims are misleading and undermined by flawed methodology.
Marketplace Menaces: Discriminatory Practices by the ACA’s Qualified Health Plans
Advocates scramble to stay ahead of coverage rejections, formulary concerns, and exorbitant out-of-pocket expenses facing people living with HIV - By Kenyon Farrow
That’s the White House’s official hashtag and marketing campaign to spike the number of Americans enrolling into qualified health plans (QHP) through the Affordable Care Act (ACA). The deadline for individual enrollment without penalty was March 31. But many people with HIV who tried to join the ranks of the enrolled found their third-party payments--primarily Ryan White subsidies to offset monthly premiums--rejected by insurance plans. Others discovered that their drug regimens weren’t covered, leaving them with huge out-of-pocket coinsurance expenses.
Better Late Than Never: Efavirenz Dose Optimization
After a study suggests that we’ve been using too high a dose of efavirenz for a decade and a half, the move toward scaling up a lower and more cost-effective one faces some hurdles - By Tim Horn and Polly Clayden
Fifteen years after efavirenz was approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV and went on to become one of the most widely prescribed components of antiretroviral (ARV) therapy worldwide, a question has arisen: have we been using an unnecessarily high dose to treat adults living with HIV?
Punked by Pharma: Public Funds for Private Products
Tax dollars are making it easier for the drug and diagnostics industry to develop and market essential TB products. Is the public getting a fair return on its investment? - By Lindsay McKenna
Motivating the pharmaceutical industry to step up and respond to the burgeoning tuberculosis (TB) epidemic is one thing. Publicly funding its research and development (R&D) only to have it yield prohibitively expensive drugs is something else entirely.
Fool’s Errand: The Sloppy Science of the MDR-TB STREAM Trial
Confirming the efficacy and safety of bedaquiline-inclusive regimens is a priority. Comparing them to unvalidated MDR-TB drug combinations in the planned STREAM study is not the way to go about it - By Mike Frick
They should have left well enough alone. The original design of a landmark clinical trial evaluating a shortened course of treatment for multidrug-resistant tuberculosis (MDR-TB) was just what was needed to confirm its potential benefits over the World Health Organization’s (WHO’s) standard of care. The clinical trial’s aim has since been conflated with another research priority--confirming the safety and efficacy of new MDR-TB drug bedaquiline--resulting in a study design that detracts from the importance of validating a tweaked Bangladesh regimen and may potentially undercut a scientifically sound assessment of bedaquiline in today’s MDR-TB armamentarium.
An unavoidable aspect of moving forward with efforts to end the HIV, TB, and viral hepatitis epidemics is having to address potential miscues that have been made along the way, sometimes years after the fact. Determining culpability is invariably part of the process. What matters most, however, are the strategies put into place to secure breaches, right wrongful courses, and ultimately turn mistakes into opportunities for advancement.