by Tim Horn
Fact: If we’re going to make headway in preventing and treating non-AIDS-related health complications among people with HIV, which are very much on the rise and a serious risk to disease-free survival, we’re going to need the full-on cooperation of pharmaceutical companies manufacturing and developing drugs for non-HIV diseases.
Enter Micardis (telmisartan), a drug produced by Boehringer Ingelheim (BI) to treat high blood pressure. Because telmisartan possesses unique anti-inflammatory properties, the AIDS Clinical Trials Group (ACTG) is interested in studying the drug to better understand the causes and treatment of aging- and inflammation- related comorbidities that are rapidly on the rise among people with HIV, notably cardiovascular disease, diabetes, and cancers. And because of its potential safety- and drug-interactions advantages over similar agents, its evaluation is a high priority.
Much to the ACTG’s dismay, BI informed the study investigators of its unwillingness to provide free or low-cost telmisartan, along with matching placebo—despite the study’s small population (54 anticipated volunteers) and short duration (48 weeks). A great deal of communication between the researchers and BI ensued, but to no avail.
In early November, TAG rose to the challenge by drafting and promoting a sign-on letter urging BI to reconsider its decision. The final letter, with more than 100 signatures, was submitted to the company on December 3. In addition to being the direct-advocacy work TAG should be involved in, it is a teachable issue for newer activists, as it embodies a number of key research priorities: the comprehensive study of anti-inflammatories for HIV disease and cure research; clinical trials drug procurement and design challenges; and exposing the conflict and competition between clinical trials networks and the pharmaceutical industry.
The response was not what we hoped. The company said its negative decision was nonnegotiable, citing a slew of regulatory and legal reasons. Regulatory concerns—notably the demonstration that drugs such as Micardis are being eyed precisely because they will potentially fill an “unmet medical need”—are easy for activists to challenge. It is the myriad legal issues that tend to stop dialog in its tracks, ranging from fears of off-label promotion, violating anti-kickback legislation, and product liability that tend to stop dialog in its tracks.
The end result is disappointing for the ACTG. To move forward with the study, it must now pay for the drug at market price, estimated to be $70,000 for all patients randomized to receive treatment. It will also need to abandon the control arm, as significant financial resources and time will be required to develop a matching placebo from scratch.
For TAG, however, this is just the beginning. Next steps involve discussion with the U.S. Food and Drug Administration and the Office of the Inspector General to better understand the laws that we depend on to prevent pharmaceutical companies from engaging in unethical marketing tactics, but that shouldn’t be cited as deterrents when it comes to needed research.
Negative decisions from companies being asked to provide non-HIV drugs to HIV clinical trials investigators are becoming increasingly commonplace—decisions we can no longer afford to accept.