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.
• 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. 
  • 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.” 
• 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.

Today the Washington Post published what has to be the most egregiously erroneous piece ever written for a major publication, or even a minor one, about Truvada as pre-exposure prophylaxis (PrEP) against HIV. I wrote an email to the paper's public editor, Erik Wemple, pointing out the following litany of errors in the article, which is entitled "The miracle AIDS drug that people refuse to take." (Even the title itself contains two factual errors.)


​Dear Erik,

You and I have corresponded about errors in WaPo’s HIV reporting in the past. To remind you, I am the science reporter at POZ magazine, a publication for people living with HIV. This particular article is littered with so many egregious errors and misunderstandings I would say it should be retracted entirely. 

In order, the errors are:

• Truvada is an HIV drug, not an AIDS drug.
• Slow uptake of Truvada is not a function of people refusing to take it, rather of lack of awareness, difficulty accessing it, or not thinking they are at high enough risk to need it.
• Gay men didn’t really rejoice the 2012 approval of PrEP; most of them didn’t hear about it at all until the press started focusing on it in the fall of 2013.
• Truvada is not like a vaccine, because vaccines don’t have to be taken daily. It is pre-exposure prophylaxis—a form of ongoing prevention that requires adherence to a regimen.
• The Slate remark about PrEP being a miracle drug was made in 2014; the paragraph concerns things going on in 2012. Furthermore, the Slate author is no authority on HIV. His articles are littered with errors, especially his writing on PrEP. He is also, as you can see, prone to hyperbole.
• Obama’s AIDS-free generation vision pre-dates the excitement about PrEP. When his administration started using the expression, in December 2013, they were focusing on Africa, not here. Until recently, PrEP was only approved in the United States. 
• It is not true that few people are using Truvada as PrEP. I just returned from a reporting trip to San Francisco, where men are using it in droves. Perhaps as many as 15 to 20 percent of at-risk gay men are on it. I’ve detailed how PrEP use is on a dramatic upswing in the U.S. in this article. Some rough estimates say that as many as 50,000 people are now on PrEP. I can tell you anecdotally that men in New York City are also using it at rising rates.
• The author neglects to note that between 2009 and 2014 HIV diagnosis rates leveled off among men who have sex with men (MSM) as a whole, including young MSM and black MSM (they have long been dropping among whites).
• A six percent rise in infections over 10 years does not constitute a “jump”.
• The estimate about six in 10 blacks becoming positive by 40 was about Atlanta men who have sex with men, not the whole country.
• The CDC only has one year of CDC diagnosis figures that reflect a year, 2014, when many people were using Truvada. So we cannot make any real conclusions yet about how it has affected HIV rates.
• Doctors are not worried about a mega-crisis. On the contrary, many are very excited that PrEP will help turn the tide against HIV transmissions in the U.S.
• Sex in 2016 is indeed safer than in the 80s if someone is on PrEP.
• To say that the fight against HIV is an either/or between fighting stigma an promoting PrEP is completely off the mark. I actually don’t know what he’s referring to here. And he says these campaigns come from doctors. Such campaigns typically come from health departments or community-based organizations.
• The writer completely misunderstands Truvada’s 2004 approval. It approved as HIV treatment at that time. PEP is something separate—it involves taking a triple cocktail of HIV drugs for 28 days within 72 hours of an HIV exposure to prevent infection. There are only two drugs in Truvada, not three.
• No, PEP did not just magically become PrEP with a “couple tweaks.” This is complete nonsense. A rigorous, massive, global clinical trials process proved PrEP’s efficacy in 2010. There have been numerous other clinical trials since then.
• “Unprotected sex” is no longer specific enough of a term in the age of PrEP. “Condomless intercourse” is the preferred term.
• The 57 percent figure is not nationally representative. It is a poll of men recruited at gay venues in about 20 major urban areas that the CDC conducts ever three years (it just released its most recent edition). It is also not representative of urban areas. 
• That 21,000 figure is only a rough estimate. And it reflects where prescriptions likely were a year ago. 
• The writer focuses on older studies of Truvada for his information about adherence to the daily regimen. More recent studies, and ones that are more reflective of real-world use, including the PROUD study in the UK, as well as a paper about a large San Francisco PrEP program, have found high levels of adherence. 
• The whole “Truvada whore” thing is really fading.
• An 11 percent rate of people trying Truvada would actually be quite good, especially if those people are at higher risk of HIV than the others. There is evidence that men who are at higher risk are more inclined to take PrEP and more inclined to adhere to the regimen.
• Doctors’ awareness about and willingness to prescribe PrEP is increasing.
• Again, HIV rates are leveling off among gay men. They are still rising among Latino gay men, though.

To read more about PrEP and to look for sources for certain facts, I invite you to visit the PrEP page on my web site: www.benryan.net/prep. 

Sincerely,

Benjamin Ryan
Editor at Large
POZ magazine