Distrustful of authority, a Holocaust survivor became a fierce critic of medical establishment
August 18, 2016
Don’t let Vera Sharav fool you. A former
librarian, she’s diminutive and refined, partial to pearls, classical
music, and ballet. But she’s also a streetfighter: one of the most
effective and passionate —
some would say extreme — advocates for the
rights of medical research subjects in the US.
Sharav has exposed experiments testing HIV drugs
on toddlers in New York’s foster care system and helped scuttle
government research that would have paid low-income Florida families
$970 to test their children’s exposure to household pesticides.
She helped pressure the National Institutes of
Mental Health to rewrite protocols on dozens of psychiatric studies to
better protect patients. And her relentless advocacy was key to forcing
US drug regulators to warn about the suicide risk that antidepressants pose to teenagers.
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For years, Sharav sent out a near-daily barrage of emails to
thousands of journalists, activists, and scientists accusing academic
researchers, pharmaceutical executives, and drug regulators of
manipulating research findings or failing to protect patients.
Today, she posts a steady stream of impassioned opinion pieces about medical ethics and drug industry greed on her website. And she’s laying plans to fight the 21st Century Cures Act,
a measure passed overwhelmingly by the House but now stalled in the
Senate that aims to speed approval of new drugs and medical devices.
Sharav and other critics argue it would boost profits at the expense of patient safety.
“Twenty years ago, there wasn’t much societal awareness of the
corruption of academic medicine by pharma money,” said Robert Whitaker, a
journalist and author who has written widely about mental health
treatment. “Vera Sharav was one of the pioneers in creating awareness of
this problem.”But her distrust of the drug industry and medical research institutions has also led her to embrace some dubious heroes, including discredited British physician Andrew Wakefield, who falsified data to imply a link between vaccines and autism.
Wakefield’s medical license was revoked for a series of ethics violations, and most in the mainstream medical community blame him for raising unjustified doubts about the safety of vaccines. Yet Sharav puts him on her “honor roll” of “exemplary professionals,” along with Florence Nightingale.
“My research and my gut tell me that Wakefield has been wronged,” she said. “One thing I’ve learned from early in my life is that if I don’t stay true to my gut feeling, then I’m lost. I don’t have any control.”
Saved by stubbornness
Sharav’s road to becoming a rights activist was shaped by two pivotal experiences nearly 50 years apart. One came in the 1990s when her son, Ami, who’d been diagnosed with schizophrenia, died from a side effect of a new antipsychotic medication that Sharav said her family wasn’t warned about. The first came 50 years earlier, when the 7-year-old Jewish girl made a decision that would save, and forever alter, her life.Sharav had been born Vera Roll in Romania just a few years before a fascist government allied with Nazi Germany took over the country. In 1941, some 145,000 Romanian and Hungarian Jews — including her family — were deported to an area known as Transnistria along the Ukraine border. It became one of the war’s most horrific killing fields, where as many as 250,000 Jews were slaughtered, or died of disease or starvation.
The Rolls were sent to the town of Mogilev, which the Romanians and Nazis had turned into a concentration camp. Vera’s father died within weeks of their arrival, probably of typhus.
“Everywhere you went, you saw people at their end, begging for [food], and no one had anything to give them,” her mother, Mary Roll, recalled in an oral history interview taped in 1984 for the US Holocaust Memorial Museum. “Every morning, they would bring out … loads of corpses, frozen to death, loaded like wood on these carts and transported to mass graves.”
By 1944, Germany was in retreat — and the situation in the camp was desperate. “I couldn’t get a piece of bread and [Vera] would cry so bitterly. Days and days, nothing in her mouth,” Roll said.
When an international effort was mounted to save Jewish orphans, her mother arranged for young Vera to go — alone, and over Vera’s tearful objections.
After a harrowing journey out of the camp, Vera made her way to a town on the Black Sea, where a three-boat flotilla was to sail to Istanbul. Vera was supposed to join a group of 61 children on a small merchant ship, the Mefkure. But she insisted on going on another boat with three adults who’d taken care of her on the train.
“Everybody was on the boats and I was sitting there crying,” she told STAT. “I didn’t want to go on that boat. Nothing would move me.”
The Mefkure finally departed without Sharav. Two days later, on Aug. 4, 1944, it was strafed by cannon and machine-gun fire and sank. All but five of the 320 refugees on board were killed.
“That’s where I would have been, had I listened to authority,” Sharav said.
For her, this was an indelible experience. “The lesson I learned was never articulated or conscious, but years later I realized why sometimes I would be very stubborn — nobody, no ideology, no rationalization would change my mind.”
Sharav made her way to Istanbul, then Palestine, where she lived for three years with her aunt and uncle on a farm. Finally, she sailed to New York, where she reunited with her mother, who survived the final months of the war. Their relationship would remain fraught, strained by Vera’s sense of abandonment and the independence she developed to compensate.
A son’s death stirs grief — and guilt
Adjusting to New York was easier. She attended high school, earned a master’s degree in library science from the Pratt Institute, and got married.Her husband, Itzhak Sharav, taught accounting and finance at Columbia and City University of New York; she worked as a legal librarian for a law firm. They had a good life, residing in a high-rise co-op on the Upper West Side with their two sons and traveling widely in Europe and Mexico.
When their older son, Ami, reached his early 20s, he began a decade-long struggle with schizophrenia. Sharav joined the local chapter of the National Alliance on Mental Illness, an advocacy group for parents. She quit her job and began to speak out about mental health issues, using her mother’s maiden name, Hassner, to protect Ami’s confidentiality.
In 1989, she learned about a newly approved antipsychotic drug, Clozapine. It was touted as a “miracle drug,” Sharav said, but was going to cost almost $9,000 a year, an enormous price at the time.
She organized a Mother’s Day demonstration at a drug-launch event sponsored by the American Psychiatric Association. Sharav and a dozen other protesters crashed the meeting at a Times Square hotel, chanting “Clozapine is priced obscene,” and agreed to be quiet only when they were given speaking time.
That demonstration taught her the power of the press: A Wall Street Journal reporter wrote about the protest and soon the issue was being debated in Congress. The next year, Sandoz, the maker of Clozapine, eliminated a requirement that patients buy a company test kit to monitor their blood, cutting the price nearly in half.
Ami eventually began taking Clozapine. In May 1994, he visited his parents’ apartment and complained that he felt weak and was having trouble walking. Sharav called his psychiatrist, who repeated directions he’d given Ami the day before: boost the dosage of Clozapine and add an antidepressant.
Two days later, Ami was rushed to the emergency room. He died the next day. According to Sharav, the coroner’s report attributed his death to neuroleptic malignant syndrome, an uncommon but often deadly side effect of antipsychotic drugs that causes muscle rigidity and fever and can lead to organ failure and death.
Sharav claims Ami’s psychiatrist didn’t recognize the symptoms and that increasing the Clozapine dosage was exactly the wrong thing to do. She also says her family was never warned to watch for this potential side effect.
For Sharav, grief mixed with guilt and anger. “After all I had learned about not trusting authority, I trusted this doctor and pushed Ami to take the medication,” she said. “But instead of beating myself, I moved forward.”
‘Try to be a man’
Already distrustful of medical authorities, Sharav began reading about the history of psychiatric drug trials and examples of research abuse — from the experiments of Nazi doctors like Josef Mengele to the infamous Tuskegee study, where 399 African-American men with syphilis were followed for 40 years without being offered treatment, or even being told they had the disease.Such research, she found, wasn’t just a thing of the past. She learned of a 1987 study that took veterans with schizophrenia off antipsychotics, then gave them another drug designed to trigger a relapse, renewing their psychotic symptoms.
“I was horrified,” Sharav said. “I couldn’t believe this was possible.”
She cofounded an advocacy group and then, after falling out with one of her partners, started a second, the Alliance for Human Research Protection. For 20 years, she’s worked without pay, filing complaints with authorities, submitting Freedom of Information Act requests, and sharing her discoveries — and impassioned opinions — with journalists.
Sharav said her experiences during World War II made her willing to take on this work, supported only by her husband and occasional donations from supporters.
“I came out of the Holocaust as a kid thinking, ‘Where was everybody? Why did nobody do anything?’” she said. “I do feel a sense of responsibility.”
She cites a famous saying by the ancient Jewish sage, Hillel: “In a place where there are no men, try to be a man.”
Forcing changes at the highest levels
As Sharav’s reputation as an advocate grew, people began sending her information. In 1998, she learned from an anonymous letter that researchers at the New York Psychiatric Institute had given the diet drug fenfluramine to 34 black and Hispanic boys, ages 6 to 10, then measured levels of brain chemicals to see if they might predict future violence. A companion study used the same approach with 66 boys with attention deficit disorder withdrawn from stimulant medications.Sharav gave the story to the New York Times and reporters elsewhere, leading to a state investigation and hearings. One reporter, Robert Whitaker, dug deeper and, with Dolores Kong, wrote a four-part exposé in the Boston Globe, “Doing Harm: Research on the Mentally Ill,” that looked at experiments on psychiatric patients. Whitaker later wrote a book, “Mad in America,” tracing the history of mental health treatment in the US, and went on to write four more.
“It all came from Vera,” said Whitaker. “Her work brought me into this field.”
Sharav’s passion and intensity — “I would even say obsession” — initially made Whitaker skeptical of her.
“But she had documents, backed up by good research, and you could immerse yourself in them,” he said. “You could see the wrong in the documents and did not have to rely on her for the sense that something scandalous is going on.”
Sharav was tireless. Working out of one room in her tidy apartment, she amassed documents, hectored reporters, wrote briefs, and mobilized distraught parents, including those whose children had attempted or committed suicide while taking antidepressants.
In 1997, Sharav organized more than a dozen parents to testify before a presidential bioethics commission about abuses of mentally ill patients in the name of scientific research. The stories provoked a flurry of press accounts, led to congressional hearings, and ultimately forced changes at the National Institute of Mental Health, the nation’s largest funder of psychiatric research.
In 1999, NIMH Director Steven Hyman suspended enrollment in 29 of 108 clinical trials and directed that 50 more have their protocols rewritten to clarify how human subjects would be protected.
Hyman, who now studies the genetics of psychiatric conditions at the Broad Institute in Cambridge, Mass., credits Sharav with being “part of a movement that forcefully brought these issues front and center.”
But Sharav also provoked anger from many researchers who thought she was “deranged and one-sided,” Hyman said.
“I think she would have been far more effective if people believed she actually saw a value in clinical research,” he said. Still, by pushing so hard she enabled Hyman to strengthen review of study designs and better protect patients: “In that sense, she did put the wind at my back.”
Stephan Lanes got to know Sharav in the early 2000s, while working as a drug safety scientist at the Connecticut facility of Boehringer Ingelheim, the German pharmaceutical company. He contacted her on the suggestion of another scientist to learn more about the history of certain drugs.
“She was a fountain of knowledge and knew about key studies,” Lanes said. She also had collected individual patient stories about side effects they’d experienced on certain drugs “long before you could go to a website such as patientslikeme.”
“I found her to have an interesting, independent view that I don’t always agree with but is always worth listening to,” Lanes said.
Exposing the dangers of antidepressants
Sharav also had a hand in a string of stories about studies that overstated the efficacy of antidepressants and minimized the risks, especially to children. She worked with parents of children who had attempted or completed suicide on the drugs, helping them testify at hearings of the Food and Drug Administration and other agencies.At one hearing, Sharav’s husband “gave a loving, passionate story about their son,” Lisa Van Syckle, a fellow activist, remembered. “I had never heard her speak about [his death]. When I heard his testimony, I realized for the first time where Vera’s passion came from.”
Van Syckel’s daughter had attempted suicide while taking Paxil, an antidepressant manufactured by British drugmaker GlaxoSmithKline. The drug became a focus of attention when documents emerged about Study 329, a clinical trial of Paxil conducted by more than a dozen academic psychiatrists in the US.
The study, as published in 2001 in the Journal of the American Academy of Child and Adolescent Psychiatry, found the drug to be safe and more effective than an older antidepressant in adolescents.
But the reality was different.
An internal company memo written three years earlier conceded that study 329 actually found Paxil to be no more effective than placebo. The memo said the company would, nonetheless, release “positive data” at a forthcoming meeting, adding that “it would be commercially unacceptable to include a statement that efficacy had not been demonstrated.”
Sharav obtained a copy of the memo from lawyers who were suing GSK, posted it on her website and handed it out to reporters. It became part of the evidence the US Department of Justice used in a case against the company.
In 2012, GSK pled guilty to federal fraud charges for its misleading marketing of Paxil and other drugs and agreed to pay a $3 billion fine.
Last year, a group of independent researchers published a reanalysis of the data used in study 329 and found Paxil provided no benefit and increased health risks among adolescents who took it.
Yet the original study still hasn’t been retracted by the child psychiatry journal — a sign, Sharav says, of how little has changed.
Sharav, who doesn’t like to disclose her age, acknowledges feeling a bit weary — though she wore out a reporter who struggled to keep up with her on a 2-mile walk along the Hudson River. She visits her husband, who suffers from Alzheimer’s disease, at a care facility in Manhattan several times a week. She is still besieged by requests for information from desperate parents, researchers, and reporters.
Asked about retiring, she laughed.
There’s too much to do, Sharav said, and true to form, explained with a story:
“There’s a guy who stands watch outside of the shtetl every day as a lookout for the Messiah,” Sharav said. “A passerby asks him, ‘What’s the point of the job? Do you get paid?’ He responds: ‘The pay is lousy, but the job has a secure long-range future.’”
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