By Benjamin Ryan

On May 16, the House Committee on Oversight and Reform held a three-and-a-half hour hearing about the pricing of Truvada as pre-exposure prophylaxis (PrEP). You can watch the whole video here. The following facts about PrEP were established at the hearing:

• The current list price for a month of Truvada is $1,780.
• Medicaid as well as clinics that care for underserved populations and thus have access to 340B pricing receive about a 75 percent discount off of Truvada’s list price. 
• Gilead’s donation to the Centers for Disease Control and Prevention (CDC) of enough Truvada to cover 200,000 uninsured people for 10 years will be in addition to the drug Gilead already provides to uninsured people through the company’s existing payment assistance program.
  • The CDC estimates that of the 1.1 million people in the United States who are at risk of HIV and therefore good PrEP candidates, 200,000 are uninsured. So the donation would provide Truvada to all of this group should these individuals seek PrEP.
  • The precise details of the donation to CDC are currently being worked out.
  • Gilead will not count the list price of Truvada as a charitable tax deduction for this donation, but will count the manufacturing price. Gilead says that the claim that the manufacturing cost is only $5 per month is inaccurate, and that the true cost is higher.
• If Descovy is approved as PrEP, as it probably will be by the end of the year, the donation to the CDC will be of free Descovy rather than Truvada.
  • Descovy is associated with improved biomarkers of kidney and bone health compared with Truvada when these drugs are used as PrEP. (Note that it may remain unknown whether Descovy actually provides a clinically significant benefit over Truvada by actually preventing the rare outcomes of bone fractures and kidney disease.) 
• PrEP is covered by insurance, including private insurers and Medicaid.
• Ninety-eight percent of PrEP users who use the Gilead copay card—which covers out of pocket costs associated with Truvada up to $7,200 annually with no monthly limit—pay zero dollars for the drug each month.
• The first generic version of Truvada, manufactured by Teva Pharmaceuticals, will hit the market on September 30, 2020.
  • This is expected to lower the cost of the drug by about 10 percent to 15 percent. 
• Six months later, on March 30, 2021, multiple generic versions of Truvada will enter the market, which should reduce the cost of the drug dramatically. (Tim Horn of NASTAD, who testified at the hearing, recently estimated to me that the new cost at that point, which is 22 months from now, would be about $30 per month.)
• PrEP is predominantly used by white men who have sex with men (MSM), despite the fact that the rate of new HIV infections is much higher among black MSM in particular.
• There was a disagreement at the hearing over how many people are currently taking PrEP. Gilead estimates that just over 200,000, people are currently on Truvada for prevention. (The company has always insisted that the PrEP-use estimates it releases each quarter represent current users.) However, Rochelle Walensky, MD, MPH, from Harvard insisted that this figure represented people who have ever taken PrEP. 
  • It is, in my opinion, very difficult to determine who is correct in this dispute, since Gilead does not release the data behind its estimates. Also, when academics estimate PrEP use figures, their own estimates come out on a considerable delay. So they do not provide an estimate of current users, but of those using PrEP a year or more previously. 
  • Note that there is no specific prescribing code that differentiates Truvada’s use as PrEP from its use as treatment, which is why figuring out how many people are on the drug for prevention is so difficult and requires a certain amount estimating. Once multiple generics enter the market, such estimates will likely become even harder to conduct.
• The major global PrEP trials that proved its efficacy were largely funded by the National Institutes of Health, the Bill & Melinda Gates Foundation and the CDC. 
• Gilead scientists were essentially uninvolved in the iPrEx study that was published in 2010 and which first proved PrEP’s efficacy among MSM.
  • The New England Journal of Medicine paper, in fact, says the following: “Gilead Sciences donated both [Truvada] and placebo tablets and provided travel-related support for meetings conducted by non-Gilead investigators. The role of Gilead Sciences in the development of the protocol was limited to sections regarding the handling of the study drugs. Neither Gilead Sciences nor any of its employees had a role in the accrual or analysis of the data or in the preparation of the manuscript. [The National Institute of Health's Division of Acquired Immunodeficiency Syndrome (DAIDS)] agreed to give Gilead 30 days to comment on the manuscript, but there was no agreement to accept suggestions.” 
• A Yale Law School study, admitted into the record, found that the CDC holds the patents to Truvada's use as PrEP. Gilead claims those patents are invalid.
• And finally, a personal observation: It's amazing that we've come so far in the United States that Congress can hold a three-and-a-half hour hearing that is largely about preventing the spread of HIV through condomless anal sex between men, and not one person says anything even the slightest bit homophobic or sex negative. Instead, while many people in the room disagreed with one another over matters of policy and capitalism, all clearly agreed that promoting the use of Truvada as prevention is a worthy goal. 
• To quote Tim Horn: "We're all in this together."

 

In November 2014, I joined the nation in grieving the death of Brittany Maynard. The 29 year-old, after being diagnosed with terminal brain cancer, had moved to Oregon to take advantage of a state law that allowed her to end her life by taking lethal physician-supplied medications. Maynard’s story, with its heartbreaking warp and politically charged weft, has catalyzed sorely needed dialogue about how our society manages fatal illness. State legislatures across the United States are now seeking to join the five states that have already done the just and compassionate thing by passing so-called death-with-dignity laws.
 
And now Canada’s progressive new prime minister, Justin Trudeau, has introduced legislation that would legalize physician assistant suicide for our neighbors to the North.
 
I’m hopeful for the legislation's passage and that more terminally ill Americans will soon have the option to end their lives on their own terms if they so choose. However, I’m troubled by the verbiage that typically defines the political movement behind legislation permitting this choice. To say that ending life before the final stages of a fatal disease amounts to “death with dignity” is to imply that dying of the actual illness is intrinsically undignified. This implication pains me, because it does a disservice to the memory of the person I loved most.
 
The day of Maynard’s death happened to be the 16th anniversary of the devastating call I received in my college dorm room when I was 20 years old. It was my father on the phone, informing me that my mother had been diagnosed with a glioblastoma multiforme (the same tumor Maynard had). This notoriously insidious malignancy of the brain meant that fate had already foreclosed upon any possibility for life-saving treatments. Mom was going to die, and it would be a quick and horrible death.
 
My mother was a woman of words. A voracious reader with a degree in English from Duke, she dedicated much of her life to cultivating and sharing her love of language. She taught high school English while my father was in medical school, and later led monthly poetry workshops in each of the lower grades of the K–12 school in Seattle that my two brothers and I attended. (“The Poetry Lady,” my classmates fondly called her, as if she were a fairy from the linguistic heavens.) In her mid-forties, she embarked on a master’s program in comparative literature at the University of Washington, setting her sights on a PhD thereafter and picking up three Romance languages along the way.
 
Since she first opened a copy of The Tale of Benjamin Bunny for us to treasure together, the written word was her greatest gift to me. I would devote my own life to the cause.
 
So it was the cruelest irony that this gift was robbed of her first.
 
The time she most needed to hold fast to her words—when she was in the thick of preparing for her PhD orals—they began slipping through her fingers. A stutter crept up on her as a harbinger of the steep mental and physical decline that would follow hard upon. An MRI would show that the tumor, already the size of an egg by the time of Mom’s diagnosis at the age of 54, was lodged in the left parietal lobe of her brain, right where language is formed. As her ability to communicate crumbled, she regressed to a wide-eyed, child-like state, eventually using a small set of words in the place of all others.
 
“What about the children, of the children, of the father?” she kept pleading at one point. I took this to mean that her concern over what would become of the rest of the family held such a preeminent place in her thoughts that our identifiers us were among the few words she still held close.
 
But what about dignity? Was the end of her life undignified? Mom, who inscribed with a loving, calligraphic hand her gift of my first dictionary when I was 10 years old, would want me first to determine the precise meaning of the word.
 
To have dignity is to adhere to key social mores. The Oxford English Dictionary defines the word as “the quality of being worthy or honorable.” Someone dignified is “befitting elevation of aspect, manner, or style.”
 
In life, my mother was eminently dignified. The word most often used to describe her was “lovely.” A stylish beauty, she carried herself with remarkable grace, and was polite and giving to a fault.
 
But just as we don’t hold a small child to the same social standards as an adult, neither can we expect someone dying of a gruesomely debilitating disease, one that has in effect reduced her to infancy, to mind her Ps and Qs and to hold the stiff upper lip her puritanical heritage demanded of her.
 
On the other hand, many people facing death surely hold high expectations of their own dignity and of how they will be perceived—be that in relation to their behavior or their physical being.
 
What was most remarkable about Mom’s death was that she did maintain an angelic, largely selfless quality throughout the 10 weeks between her diagnosis and her descent into a coma. Even as the right side of her body was progressively paralyzed, as her face swelled up and the rest of her wasted away, as she lost control of her bodily functions and suffered excruciating pain, she remained largely concerned with the rest of us. She was angry and felt cheated out of life, but seemed more focused on the tragedy of missing out on what would happen next with my brothers and me than on seeing her own trajectory cut short. As she did what she could to coax me out of my own crippling depression over losing her, she said she would be an angel and watch over me.
 
She kept her trademark naughty playfulness to the end. We were inundated with friends and family—one of my brothers referred to the house as a “three-ring circus of grief”—and on occasion she suffered a visit from some unsavory character. But she saw fit to joke about such, yes, indignities. “You have to have a sense of humor about this,” she said with a wink.
 
Even in her last waking days, when she could barely speak or move at all, she still made light of things by switching between giving me a mock evil eye and then opening her face wide in a campy expression of horror.
 
It was a blessing that Mom was able to die at home. Because what is truly undignified is how our health care system typically forces people to experience death. All too often the dying are condemned to end their days in a foreign hospital setting, riding toxic waves of false hope through agonizing treatments that only extend life by months, and at great cost to the quality of life.
 
What is beautiful about legislation that allows terminally-ill Americans—and will hopefully soon do the same for Canadians—the choice to end their lives as they see fit is that these laws acknowledge the certainty of their mortality while asserting that granting them this choice is grounded in firm ethics. If modern medicine has given us the power to extend life at times to absurd lengths, it should also grant the fatally ill the authority to die when they choose.
 
While some of the terminally sick may make the choice to die early because they do indeed fear a loss of dignity, others will be motivated to do so for entirely different, but just as valid, reasons. Thus, we should erase the presumptuousness and the value judgment from the language we use to describe the laws that permit this choice. After all, as my mother taught me, language has great power and words must be chosen carefully. Using death-with-dignity nomenclature means opting for alliteration over substance. We should not emphasize the supposed motivation behind making the choice to die, but the freedom to make the choice.
 
I can’t ever know what my mother would have done if she had been granted such an option. But I do know that in her own death she showed her greatest dignity.

Benjamin Ryan is an editor at large at POZ magazine, where he covers the science of HIV and hepatitis C. His work has also appeared in The New York Times, New York, The New York Observer, The Nation, The Atlantic, The Marshall Project, Men’s Journal, Out and The Advocate. He graduated cum laude with a degree in English from Columbia University in 2001.