Dr. John Nardo’s work may lead to more open data
"I am not trying to revolutionize medicine, but I do hope this holds the pharmaceutical companies a little more accountable," says Dr. John Nardo of his recent work.
Sitting on his cabin’s front porch in the Grandview area, pony-tailed "Mickey" doesn’t seem like the Dr. John Nardo who has gone toe-to-toe with big medicine, forcing a major concession that may hold pharmaceutical companies more accountable with producing honest and accurate research information in the future.
What Dr. Nardo and some compatriots did is get original data from a drug company’s research, re-analyze it and, in the process, found that the drug Paxil was not nearly as beneficial as originally claimed and the side effects, including teenage suicidal thinking, were more common than reported 14 years ago with the original study in depressed adolescents.
"I am not trying to revolutionize medicine, but I do hope this holds the pharmaceutical companies a little more accountable," Nardo said.
The research by Nardo and others made news this year by contradicting the original findings published by GlaxoSmithKline in 2001. Their later research was published in the British Medical Journal, an esteemed medical publication, and from there garnered worldwide attention including articles in the New York Times and other major news outlets.
Nardo’s history, first as a medical research doctor, then later as a psychiatrist, gave him valuable insight into the issues with the study. "I may have retired but I hadn’t forgotten how to be a scientist," Nardo said in a recent interview.
Nardo began as a medical doctor, primarily as a research immunologist. He was drafted into the Air Force during the Vietnam Nam era, doing his tour of duty in England. He said treating people led him to return to school and earn a degree in psychiatry as he wanted a career with more interaction with patients.
He practiced and taught and was, at one point, the head of psychiatry training at Emory University. But Nardo said he was a "talking doctor" - primarily a psychotherapist with less use of medications, though he is not opposed to the use of medication in cases where it’s warranted.
He retired from academia in the late 1980s after realizing he was "on the wrong team" at Emory when many in the profession and at the universities were turning to medications, rather than therapy to treat mental issues.
Nardo said the use of medications-only over therapy is exacerbated by the financial side of treatment. Prescribing medications without thorough assessment of conditions and talking through patients' issues is cost efficient for treating large numbers of people at affordable prices. For therapy Nardo said, "We never say we can treat you in seven hours, seven visits, seven months or seven years."
There are still psychiatrists and other disciplines who use the "talking doctor" approach, but they tend to be less common. After leaving the university, Nardo maintained a full workload at his therapy-based office, where he was not opposed to medications. "But they need to be used rationally," he said.
Nardo himself came partially out of retirement to volunteer locally in 2008, primarily at the Good Samaritan Clinic, and what he found was how pervasive medications had become in treatment. It surprised him.
"I was astounded by how much medication people were taking," he said. "They were taking many different kinds - sometimes several different anti-depressants at the same time."
Nardo also began regularly keeping a blog, 1boringoldman.com, writing about psychiatric issues in the news as well as views on other subjects. Part of this was also writing about a movement among researchers for drug companies to be more open about their research.
Mostly the companies would produce a summary of the data and then "spin it however they wanted," Nardo said. In the most famous case, Study 329, the mammoth drug company GlaxoSmithKline overstated the benefits and downplayed the side-effects on teens of their anti-depressant, Paxil.
Nardo and others criticized this study and similar ones for not providing the original data, and doubted the reported findings.
In 2004, as the result of a lawsuit, GlaxoSmithKline was required to release the original data, but they delayed this until 2012 when as Nardo put it, "One day there it was on their website" (later finding that they were forced to release it).
Nardo first analyzed the data on his own, posting the results on his blog on the internet. Then he and others, including researchers from overseas, joined together to press further.
The problem is that drug companies treat the data from clinical drug trials as a trade secret. It's impossible to check their reported results if we can't see the data, he said. There is currently an initiative, called All Trials (http://www.alltrials.net), seeking to have drug companies release all research data so it can be checked. The movement’s website shows numerous big name medical organizations on board.
The final paper Nardo and the others produced on the revised Paxil research findings went through numerous drafts before being accepted into the British Medical Journal.
This was significant with far-reaching implications in modern medicine. "No one had ever done this before, republished someone else's data with different conclusions" he said. "Getting the original data and then rewriting a paper on it."
Nardo hopes this is one step toward forcing medicine to police itself, particularly in regard to the excesses in selling and promoting. Television commercials with attractive people touting different medicines is symbolic of the kind of selling that needs to be curbed.
"We need to clean it up," he said. "Medicine has become way too businessfied."