When the shot rang out on Jan. 19, 2016, no one was around to hear it. Eric Carlos Rodriguez made sure.
That day, the 33-year-old financial analyst—the oldest of five siblings in a tight-knit Cuban-American family—slipped on jeans and a hoodie, lifted a black Glock 9 mm handgun out of its case, and walked down the stairs to the pontoon boat docked outside his family's vacation home. He'd been living with his parents in a nearby Los Angeles suburb for years, quietly battling a crushing brain fog and insomnia. As he'd recently confided to his mother Ana, he also suffered from a bizarre constellation of sexual symptoms that had shrunken and numbed his genitals, killed any semblance of sex drive, and, as he put it, "took away his humanity." In early January, he asked his parents if he could stay at their bayside villa in Oxnard for a while. They reluctantly obliged, texting often to check in. One day, he didn't text back.
His father found him on a Wednesday morning, alone inside the boat, door closed, a single shot to his temple. His parents aren't sure when Eric pulled the trigger. But Ana is convinced she knows why. She says a rare side effect of the hair-loss drug finasteride, aka Propecia, killed her son.
"There is no doubt in my mind," says Ana. "I'd love to see this drug taken off the market."
Last month, a New York judge selected four "bellwether" cases to represent the roughly 1,400 men who have filed suit against drugmaker Merck, alleging that the decades-old prescription hair-restoration pill had ruinous effects on their bodies and brains. Another 69 men are believed to have killed themselves as a consequence of taking the drug, according to the World Health Organization's database of adverse drug reactions.
Even those who suffer from what patients have deemed "post-finasteride syndrome" admit that the vast majority of men take the drug without incident. Plenty of doctors consider it to be safe enough to prescribe. In 2014, 1.2 million prescriptions were written for finasteride for hair loss, according to IMS Health; another 8.2 million were written for prostate issues, which it is also prescribed for. In all, according to the WHO database, about 14,000 men have reported any type of adverse reaction. While studies have linked finasteride to persistent sexual side effects and also to depression and suicidal ideation (in a 2015 study of about 4,900 men who took finasteride and reported side effects, 577 of them, or 12 percent, experienced persistent sexual dysfunction and 39 reported suicidal ideation), none have established that there's indeed a cause-and-effect at play; some doctors doubt there is. Scientists have yet to identify why certain men might respond so badly while most others remain unscathed—and why, in a small minority of men, like Eric, the condition persists years after the drug is discontinued.
Just how harmful could a tiny pink pill taken for cosmetic purposes possibly be? And when did the pharmaceutical giant first know the full scope of its potential side effects? These are some of the questions that will be aired in the courtroom when the case goes to trial in late 2017. To gain some insight, one must look back at the bizarre origin story of finasteride, set improbably in the jungles of the Dominican Republic amid a tribe of what was at the time referred to as "pseudo-hermaphrodites."
Julianne Imperato-McGinley was a young endocrinologist at Cornell University Medical College in the early 1970s when she began to hear rumors about girls who turned into boys.
She traveled to the remote village of Salinas in the Dominican Republic to find 24 "male pseudo hermaphrodites," age one to 60, concentrated across 13 families. They'd been born with testicles and penises so small that they were mistakenly raised as girls. Around puberty, their voices deepened, their bodies grew muscular, and their genitals swelled, revealing the unexpected truth that they were biologically male. The people of Salinas referred to them as guevedoces, or "penis at 12" years of age. Most went on to live their lives as men, although many were infertile.
In a 1974 paper published in Science, Imperato-McGinley explained that the guevedoces lacked a key enzyme, 5-alpha reductase, which converts the male hormone testosterone into a far more potent hormone called dihydrotestosterone (DHT). DHT is instrumental for the formation of external male genitals in utero. Without it, the guevedoces were born with miniaturized penises (mistaken as clitorises) that grew enough to be recognized as phallic only with the surge of testosterone that came at puberty. The paper was heralded as landmark for shedding light on the important roles these hormones play in male development.
Young, balding men were clamoring for a solution. So Merck gave them Propecia.
But in 1975, when Roy Vagelos, who at the time was chief of research for the pharmaceutical company Merck, stumbled upon the discovery, it was a different finding he seized on. As it turns out, DHT is also toxic to hair follicles as men age and contributes to prostate growth. In older guevedoces, the study read, "the prostate remains small and there is no recession of the hairline." A lightbulb went on.
Merck, with the help of Imperato-McGinley's research, went on to develop finasteride, a compound expressly designed to inhibit 5-alpha reductase and slash levels of DHT. Fast forward to 1992, and Merck unveiled their first finasteride product, Proscar, a 5 mg pill to treat enlarged prostate. The original warning label acknowledged that "some men may notice changes in their sex lives." Because enlarged prostate is a serious condition—it can cause incontinence and infection and, in certain cases, kidney damage—urologists viewed the risk as a reasonable one. Sales boomed.
Five years later, as a slew of Merck drugs began to go off-patent (meaning generics could flood the market, forcing prices down) the company found itself under pressure to come up with a shiny new thing. At the time, the topical hair-growth treatment minoxidil (Rogaine) was the only FDA product on the market to remedy hair loss, and it had to be applied twice a day, leaving hair looking greasy. Surgical hair restoration was expensive. Young, balding men were clamoring for a solution. So Merck gave them finasteride in the form of Propecia.
"It was a big deal," says Shani Francis, director of the Hair Disorders Center of Excellence at University of Chicago. "For a lot of young guys, hair loss can be really devastating and here you had a discreet pill that you only had to take once a day and no one would have to know."
Propecia did come with warnings: Women capable of bearing children were advised to not touch broken tablets because "the male baby may be born with sex organs that are not normal." The label also warned that, as clinical trials had shown, about 1 percent of men might experience low libido or erectile dysfunction. But, the label offered—in a line that turns out not to be true for everyone—"these side effects went away in men who stopped taking Propecia."
On a July morning in 2011, a fit, gregarious 33-year-old science teacher named Adam reached down to masturbate in bed and realized that he felt nothing. "My penis felt like a piece of dead rubber," recalls Adam, who asked that his last name not be used. "It scared the shit out of me."
He'd begun taking Propecia 15 months earlier, after noticing his once-thick head of hair was receding. His then-fiancé noticed too. He asked his doctor if there was anything he could do and walked out with a prescription for Propecia. If he experienced any strange side effects, he was told, he could just stop taking it. Adam saw it as a "win-win."
Within a few months, he started having panic attacks. "I'd start crying, feeling suicidal, have trouble breathing. I'd never experienced anything like that in my life." He checked the package insert on his pills. There was no mention of anxiety. Again he went to his doctor, who put him on antidepressants.
After Adam's grim July discovery, he threw his Propecia in the trash and, at first, he felt better. But by October, he started crashing. "It was a slow decline," he says. "I felt like something was shutting down inside my body."
A growing body of research is offering clues about why finasteride might cause these symptoms in a subset of men. It suggests the enzyme that Propecia shuts down—5-alpha-reductase—does a lot more than convert testosterone to the hair-killing dihydrotestosterone (DHT). It also converts hormones like cortisol and progesterone into "neurosteroids" that play key roles in the brain.
"Blocking 5 alpha-reductase to any degree in the brain is a crapshoot," says Alan Jacobs, a New York–based neuroendocrinologist. "Theoretically, you are going to block the production of hormones that serve very important behavioral purposes."
Those brain changes themselves can exacerbate sexual problems, says Jacobs. But some research in animals suggest that, if taken long enough, the drug could also ultimately damage genital tissue, leaving penises fibrotic and scarred.
One recent study published in Neuroendocrinology found that after 20 days of finasteride exposure, male rats showed altered levels of a whole host of neurosteroids and receptors in their brains. Thirty days after going off the drug, the changes were_ more_ pronounced than when they were on the drug.
Studies in humans have only just begun, at Baylor, Boston University, and elsewhere, so it's way too early to draw firm conclusions. But the theory surrounding what some patients call "the crash" goes something like this: Cells in the brain and genitals are starved of important hormones while on the drug, so they grow more receptors to sop up all that they can get. Once the drug is discontinued, the hormones come flooding back with more than the cells can handle, which hurts or kills them. "Essentially, the cells get too much DHT, it puts them in overdrive and it burns them out," says Jacobs. So even if the body starts making all those missing compounds again, the tissue has trouble using them.
Jacobs stresses that, in his experience working with hundreds of patients, the vast majority do get better. "No one person goes through it the same," he says. "But unfortunately, in some men, the damage is hardwired."
Less than a year after Adam threw out his last pill in 2011, the Food and Drug Administration announced that some changes were being made to Merck's Propecia label. FDA had received 421 reports of sexual dysfunction among men taking Propecia; of them 59 (about 14 percent) reported that their symptoms didn't go away after discontinuing the drug. So in April, 2012, it added a line acknowledging reports that in some cases, sexual effects "continued after discontinuation of treatment." Depression had also been added to the label.
Curiously, Merck had already changed its label to reflect that side effects could be "persistent" back in 2008 in Sweden and then other European countries—where patients had begun to report serious, lasting side effects and government regulators promptly took notice. But in the United States, patients were led to believe otherwise for four additional years. Adam wishes the warnings had come sooner.
Today, he is happily married, has a child, and has a good job. "I'm one of the lucky ones," he says. He did slow his hair loss. But he can no longer get an erection without medication, and he has no desire for sex. He's suing Merck. "I made a deal with the devil," Adam says. "I kept my hair. I lost my manhood."
In 2015, a review in _JAMA Dermatology _called into question whether Propecia should have been approved in the first place. Of the 34 clinical trials looking at it for hair loss, "none" adequately assessed safety, the authors said. More than half were funded by pharmaceutical companies. "You are giving a drug that is replicating this pseudo-hermaphrodite pattern of sex steroids in the blood," explains Steven Belknap, a dermatology professor at Northwestern University Feinberg School of Medicine and the lead author of the study. "Long before this drug was approved, you could have anticipated that sexual dysfunction was potentially a problem. Here we have a drug that you are giving to men for long durations purely for a cosmetic purpose and, after 20 years, we have no evidence it's safe." Bigger picture, Belknap wonders if the system for evaluating drugs, particularly those taken for purely cosmetic reasons long-term, should be changed. "In my opinion the bar should be fairly high on safety," he says.
Yet even the attorneys heading up the case against Merck concede that it's unlikely to be pulled from the market completely, as was done in 2004 with another Merck drug, Vioxx, after it was found to double the risk of heart attack. (Ultimately, 140,000 heart attacks were linked to Vioxx.) Finasteride is, of course, not lethal. And since 2012, those who take the time to read the fine print on the package insert have been forewarned, notes Boulder attorney Ted Laszlo, who is representing about 100 finasteride users in the case against Merck. "If a fellow goes on Propecia today and suffers those side effects, he has had the benefit of more than four years of warning," says Laszlo, who does not take on cases of those who started taking the drug since then. But for those who started before, he believes the case—which is seeking money damages only—is strong.
"Merck introduced a drug that they knew could cause sexual dysfunction in users, and they soon learned that in some users the symptoms did not resolve," he says. "With that knowledge, they continued to market the drug for years saying that if you stopped using it, the symptoms would go away. They hid their knowledge."
Numerous dermatologists interviewed for this story said they rarely hear patients complain about side effects of Propecia, and they still consider the drug to be relatively safe. "A very, very small fraction of people will experience side effects," Francis says. "And I have never had anyone who has had persistent sexual side effects after discontinuing the medicine."
Urologist Kevin McVary, of Southern Illinois University, also has his doubts. When he crunched FDA data from thousands of reports of finasteride-related side effects, he found that men in their 20s and 30s taking a 1 mg dose for hair loss were far more likely to report side effects than older men taking a 5 mg dose for prostate problems. He finds that "fishy". "There is no drug in the history of medicine that I am aware of where the risk decreases as the dose increases," he says. He wonders if perhaps younger men stumble upon a website or magazine article, such as this one, describing the symptoms and "power of suggestion" sets in. (Other doctors, like the neuroendocrinologist Jacobs, suspect older men don't report symptoms as much because they attribute ED to getting older and never imagine their medication could be the root cause). "What does exist is distressed men. That is real," McVary says. "But is it causally related to this medication? There is no good evidence."
Jacobs suspects genetics may be at play in determining which guys react poorly to finasteride. His own research revealed that many of the men who suffer from the syndrome have family or personal histories of emotional disorders, such as anxiety. He wonders: Could some of the same genetic factors that make a young guy bald early and be insecure enough about it to seek medical help also predispose him to reacting badly, physiologically, to finasteride?
If so, "it is a cardinal irony," says Jacobs. "They have the kind of ego that makes them think that in order for them to get a mate and have a family they need to get their hair to stop falling out, and this ends up making it all much harder. It is a crushing blow." For now, he advises dermatologists to never prescribe finasteride to a man who suffers from depression and anxiety.
As the parties prepare to face off in court next year, and interest in studying post-finasteride syndrome mounts, questions and criticisms are flying. Belknap believes Merck should have more directly asked about sexual side effects in its early trials, rather than relying on men to volunteer the information (likely to female interviewers). "A lot of young men in that situation might not be really enthusiastic about reporting sexual dysfunction," says Belknap, who believes risks were under-reported. "This is not being used to treat heart attack or strokes. It is being used to help men re-grow hair on their heads."
Imperato-McGinley did not respond to requests from VICE for an interview. Merck officials declined as well, offering a written statement saying the company "conducted well designed trials" and "stands by the safety and efficacy" of Propecia.
Despite the revised warning labels, young, balding men continue to leave dermatologist's offices every day with finasteride in hand. Most will take it without incident. A few likely won't be so lucky. Nader Jawad, a 27-year-old who graduated in 2014 from Wayne State University Medical School, has put his career as a doctor on hold and is working in the family convenience store as he grapples with lingering side effects he attributes to the Propecia he took for seven months last year. Chance Fincher, a handsome 28-year-old oil company land man from Austin, TX, says he is "en route to recovery" libido-wise, after more than two years of being unable to get an erection, but he still has trouble keeping a train of thought or controlling his anxiety. "What really lingers from finasteride is the emotional and personality damage," he says. "I took ten months' worth of a little pill and now this. I feel like I'm in a dream. Is this really happening to me?"
At least one family member, Kelly Pfaff, has filed a wrongful death suit against Merck, for "failure to warn" about the suicidal ideation associated with the drug (it is still not in the warning label). On March 5, 2013, after a long battle with depression, her husband, John—a father of two and successful head of a California IT company—stepped in front of a moving train one block from their home. He was 40. She too blames finasteride.
Others are steering clear of the courts. "Frankly I didn't really need the money and I knew it wasn't going to bring Randy back," says John Santmann, a software developer whose son Randy took his life in an upstairs room in John's home at age 22, after a lingering battle with post-finasteride syndrome. Instead, John donated a half-million dollars to found the PFS Foundation, a nonprofit that supports research on who is at risk of PFS and how to treat it.
Meanwhile, Ana and Carlos Rodriguez are trying to pick up the pieces.
Their son Eric was the first in the family to go to college, had worked for Wells Fargo and Bank of America, ran marathons, sang karaoke, and had a couple of beautiful girlfriends he had brought home to meet his parents.
He moved away to start a business after college, but moved home a few years back, telling his parents he'd "taken some medicine for a while and it didn't agree with him." One night, his parents heard him crying in the shower, and he confided the embarrassing details. "He said he felt like a 33-year-old man in a 99-year-old body," recalls Ana.
At Eric's funeral, she held his hand and quietly told him it was OK. She understood why he did it. "He just had to be so tired. He couldn't go on anymore." Now she's pleading with the coroner to change the cause of death on his report. Instead of saying "suicide" she believes it should read post-finasteride syndrome.