Posts Tagged: "HIV"

Most Congressional hearings are morality plays designed to reach a predetermined outcome. It wasn’t hard to predict how the second hearing on drug pricing by the House Committee on Oversight and Reform was supposed to go. If the title, “HIV Prevention Drug: Billions in Corporate Profits after Millions in Taxpayer Investments” wasn’t enough of a clue,  when Chairman  Elijah Cummings (D-MD) said it was because of the “phenomenal leadership” of freshman Rep. Alexandria Ocasio-Cortez (D-NY)  that the hearing was being held, any doubts evaporated. In an extraordinary gesture of deference for a new Member of Congress, Rep. Ocasio-Cortez was recognized for an opening statement before senior members of the committee. However, because of two differences in this hearing from its predecessor things didn’t quite go as planned. This time, the Committee invited both sides to appear, not just the critics; and one member dared to challenge its underlying premise, leading to an electrifying exchange with the Chairman. We’ll examine that shortly.

In July 2012, the U.S. Food and Drug Administration (FDA) first approved Truvada, an acquired immunodeficiency syndrome (AIDS) treatment manufactured by Gilead Sciences as a daily pre-exposure prophylactic (PrEP) treatment to reduce the risk of contracting human immunodeficiency virus (HIV) in sexually active individuals. Recently, this HIV PrEP treatment and its patent have been thrust into the spotlight thanks to a commercial for Truvada that Gilead ran during the January 27 broadcast of Rent: Live on the Fox television network. While many were encouraged by the fact that a national TV network was raising awareness about PrEP treatment, the commercial sparked a return to a debate over the high price of Truvada. As of June 2018, news reports indicated that once-daily Truvada treatment cost about $1,500 per month, or around $18,000 per year. Although the cost of Truvada is often covered by health insurance, the treatment hasn’t been adopted as widely as was expected when the drug was approved. Between January 2012 and March 2014, a review of half of U.S. pharmacies by Gilead showed that only 3,253 had begun a PrEP regimen during that time, far less than the estimated 500,000 people who would make good candidates for Truvada. That number has expanded rapidly to 77,120 U.S. PrEP users in 2016 and an estimated 136,000 users by the end of 2017’s first quarter, but that’s still far short of the estimated 1.2 million American adults at high risk of HIV infection who could benefit from PrEP. “Based on feedback from partners and our work in the field, we believe that one of the greatest barriers to Truvada for PrEP access today is limited awareness of Truvada for PrEP’s role in HIV prevention,” Gilead told IPWatchdog. “Data from our patient support programs do not suggest that cost is a primary obstacle to treatment. The majority of people receiving Truvada for PrEP today who utilize our co-pay coupons pay less than $5 per bottle.”

Proteins like VRC01 are referred to as broadly neutralizing antibodies (bNAbs), a type of broad spectrum antibody which is effective in treating against infections of viruses with high mutation rates, such as HIV as well as influenza. It’s thought that VRC01 and other bNAbs useful in treating HIV-infected patients is capable of identifying the envelope spike of a single HIV viral agent to inhibit or neutralize its effects… Gene editing tools may also be part of the solution that rids HIV/AIDS from the human race for good. The discovery of clustered regularly-interspaced short palindromic repeats (CRISPR) and CRISPR-associated proteins (Cas) has given scientists hope that they’ll be able to efficiently edit genomes with a high degree of precision and flexibility.

Although not a prolific filer of U.S. patent applications, Gilead does currently holds 2,131 active patent grants according to data collected by Innography… Despite all of the recent focus on Gilead’s anti-viral medications, we noted a trio of patents issued to the company recently by the USPTO to address issues in patient cardiac health. U.S. Patent No. 9056108, issued under the title Method of Treating Atrial Fibrillation, claims a kit containing a first composition which includes dronedarone or a pharmaceutically acceptable salt thereof, and then a second composition which includes ranolazine. This innovation was found to improve the anti-arrhythmic efficacy of dronedarone, which can be used to treat atrial fibrillation but is poorly tolerated by patients in higher doses.

Like a lemming running off a cliff, Fortune author Jeff John Roberts ignores easily verifiable historical truths in what can really only be described as a hit piece on the patent system and patents in general. The lack of intellectual integrity, or even intellectual curiosity, is astonishing… It is absolutely necessary to quash any suggestion that here is a “short supply” of medical miracles today. Medical research is still turning up incredible findings. A quick scan of health news shows plenty of academic innovation leading to tomorrow’s medical miracles. That the author could make such an utterly absurd statement has to call into question the broader motivations. Of course, authors do unfortunately sometimes exaggerate, misrepresent and even lie. What is truly astonishing is how the Editors of Fortune allowed such a falsehood to be published. Do they do no fact checking at all at Fortune?

HHS is suing a defendant that merely wants to market a generic version of a drug that is used to treat patients with human immunodeficiency virus (HIV). Not only is the United States government a patent troll, but the government is also trying to deprive patients who need live saving HIV drugs an affordable generic version. Egad!