Doctor: PTSD injection can work miracles, but DOD won't fund it
October 4, 2011
NAVAL MEDICAL CENTER SAN DIEGO - With anesthesiologist Eugene Lipov, first comes the unbridled enthusiasm for a novel treatment he thinks could be the answer to post-traumatic stress disorder, one that so far has had stunning results.
Then, there's the sheer exasperation: Just what does a doctor have to do to get the Pentagon to pay attention?
In 2007, the Chicago-based Lipov discovered that injecting a local anesthetic into a bundle of nerves in the neck of war veterans relieved PTSD symptoms. One, or sometimes two injections, and the veterans were suddenly better.
Lipov has tried three times in the last four years to get the Department of Defense to fund a study on the treatment, but even with an endorsement of then-Sen. Barack Obama, he hasn't been able to wrench open the government pocketbook. The best he's been able to do is convince two Navy doctors in San Diego to do a small study of their own.
"You would think the government would look at the results I've had and say, ‘This is a great idea. How can I help you?'" Lipov said. "But I'm still waiting."
Perhaps a shot is too simple an idea. At first glance it can seem gimmicky, almost like an infomercial pitch.
Have PTSD? Tired of treatments that take too long and don't work? Well, I have the solution for you! Take this shot and you'll feel better in 30 minutes or less.
But Lipov says his 12 patients have shown the shot to work, and in 2009, an Army doctor replicated those results with two soldiers at Walter Reed Army Medical Center. Lt. Col. Sean Mulvaney's results were published in the Pain Practice journal, where he wrote that both of his patients with chronic PTSD "experienced immediate, significant and durable relief." Mulvaney has now treated 15 patients with the shot.
The testimonials of many of the veterans and servicemembers are powerful. The nightmares, flashbacks, anger and other PTSD-related issues were gone, they said, replaced with a calm they hadn't felt in years.
Still, with those who hold the purse strings in the military research community, it's been a hard sell for an outsider like Lipov. The 10-minute procedure has been used since 1925 to treat pain, so it isn't a new concept. But no one before has proposed that it could treat PTSD, which despite its physical manifestations in the brain, is still largely thought of as an emotional problem.
Here's how Lipov believes the shot works: There is a group of nerves in the neck called a stellate ganglion that is a part of the sympathetic nerve system, which among other things sends pain messages to the brain and controls stress, including the fight-or-flight response.
When someone experiences trauma, the stellate ganglion produces an increased amount of nerve growth factor, which cause excess nerves to sprout in the brain, according to Lipov. This leads to overactive stress response and anxiety, he hypothesizes.
By injecting the stellate ganglion with anesthetic, the nerve growth factor returns to normal levels, the excess nerves die off and the symptoms subside.
Basically the shot settles down the sympathetic nervous system, resetting the brain to where it was before the trauma and onset of PTSD, Lipov theorizes.
The U.S. Army Medical Research and Materiel Command at Fort Detrick isn't buying it. Last month, they rejected Lipov's latest proposal, a $1.6 million clinical trial.
Reviewers of the proposal acknowledged that should a randomized controlled trial prove successful, it "could lead to important innovations in the medical treatment of PTSD."
But they wrote in their scientific review that they were concerned Lipov's study was overly ambitious and expensive for a relatively untested concept - and one they think lacks a convincing neurobiological explanation for why it works.
Even a psychologist who has signed on to help advise Lipov as he moves forward with his work, agrees with the reviewers on that note.
"You have to start with a theory that makes sense to folks," said Stevan Hobfoll, who heads the Department of Behavioral Sciences at the Rush University Medical Center in Chicago.
Col. Carl Castro, director of Ditric's Operational Medicine Research Program, said Lipov skipped an important step: a study with control groups. Without that, the scientific community looks at results as little more than fallible anecdotes.
The Army, which spends about $30 million a year on PTSD research, would like to explore Lipov's approach, but he "needs to do a scientifically rigorous study, and that way if he gets promising results, we can be confident in doing a much larger clinical trial," Castro said. "We don't want to fund a study that has the possibility of failure, or has findings that will be so ambiguous we won't know what to make of the findings. It's a novel concept and really we have just got to ensure that what we're doing is safe and actually does what the treatment is supposed to do."
Lipov said one Pentagon official told him he's getting slow rolled because his treatment challenges the old guard, telling him: "The horse and buggy industry did not embrace the Model T."
Hobfoll, who said he's skeptical about every new treatment that comes along, decided nonetheless to help out Lipov because he thinks "it has some chance of opening up avenues" that aren't currently available to treat PTSD.
Other treatments that have been successful and accepted in treating PTSD also lack a throughly explained mechanism for why it works.
"But it works," Hobfoll said. "I think Eugene may have stumbled on one of these."
He said he thinks Lipov might be overselling the treatment, saying "it's not the way I would do it," but still "it makes more sense to me than drugs."
Hobfull pointed out that many psychiatrists in the field prescribe off-label medications without the same pushback - and sometimes they rely on medications that have been proven not to work. (In August, the Department of Veterans Affairs bought more than 200,000 bottles of an anti-psychotic drug that had been debunked by its own doctors as no more effective for PTSD than a placebo.)
Lipov is also met with resistance because for psychiatrists and psychologists, the procedure is a dramatic departure from how they think about treating PTSD and doesn't "fit with current pathways we've been going down," said Cmdr. Rob McLay, a psychiatrist at the Naval Medical Center in San Diego, Calif.
The gold standard for PTSD treatment is cognitive behavioral therapy, which is intensive, time-consuming, often drug-laced, and, according to McLay, only works for about 50 percent of patients.
The reviewers of Lipov's proposal made a point in their rejection to say there are several other effective treatments for PTSD.
Lipov scoffs at their assertion, given that the veterans he sees have tried therapy and drugs for years without relief and come into his office desperate for something - anything - to make them feel normal again.
"When do you say therapy is ineffective?" Lipov said, the frustration in his voice accentuating his Ukrainian accent. "I mean when do you call it?"
Lipov has managed to persuade doctors at the Naval Medical Center in San Diego, including McLay, to test the shot on active-duty patients with chronic PTSD who haven't seen results with traditional treatments.
It happened by way of Congress. A senior naval officer had heard Lipov testify last year at the House Veterans' Affairs Committee and took the idea to the psychiatric department at the medical center in San Diego.
McLay turned him down.
"It struck me as an idea a little too out there," he said.
So the idea got bounced to the pain management side of the house, and it piqued the interest of Capt. Anita Hickey, an anesthesiologist who was an early adopter of acupuncture within the Navy.
"Oh my goodness, that makes so much sense," she recalled thinking about Lipov's theory.
Hickey then persuaded the skeptical McLay to join the study.
This summer, the two launched a controlled study with 33 active-duty Marines and sailors, including two for whom the PTSD stems from sexual assault.
PTSD sufferers are notoriously hard to recruit for studies, because normally so much is asked of them with treatment and they are unsure about drugs, but Hickey said they haven't had any trouble getting people to sign up for the injection.
Many of the patients in the study are people for whom doctors were doubtful anything could be done, those who had "really had gone through every treatment we had and nothing helped them," McLay said.
The study is just beginning, but McLay is impressed with the results so far from the pilot cases, including an instance of an "absolute miracle."
McLay said he expected that his patients would have less anxiety after the shot, but he didn't expect them to be dramatically less depressed, to not have as many bad dreams and be able to do things they weren't previously able to do.
"PTSD involves a tendency to avoid doing things," he said, and his patients have "actually started going out and going to the mall, having dinner with their spouse."
A wife of one of the patients came in after her husband had gotten the procedure and broke down into tears, saying she was so thankful. She told McLay she felt like she had been baby-sitting her husband for 24 hours a day, seven days a week for close to a year, and now he was almost back to normal. They could go out and do things together like a regular couple.
Hickey said she thinks they'll publish early because the results have been so dramatic - of course, they'll do so in a pain journal rather than a psychiatry journal.
"It's too early to say this is going to be the definitive treatment for everyone," but there is a "right to be optimistic," McLay said.
One of Lipov's patients in Chicago, a Vietnam veteran so hampered by decades of post-traumatic stress disorder he was on the verge of suicide, has been able to completely go off his medications and stop his weekly therapist appointments after two shots.
The day he got his first injection, "was the first night I had slept all night long in 40-plus years," Rowley Schonez said.
The nightmares, the anger, and the combativeness were gone. He went from a time bomb that had everyone around him on edge to a semblance of his former self.
"So far it has just been a miracle to our family," Schonez said.
An Iraq veteran and retired Marine Corps sergeant, John Sullivan, had similar results after seeing Lipov. He couldn't shake his PTSD despite medications and therapy. After getting the shot, his symptoms subsided enough that he no longer takes anti-anxiety or sleeping pills.
And Mulvaney's patients were able to taper off their medications as well.
With these kind of results and the large number of veterans suffering from PTSD, Lipov doesn't understand why he can't get funding to do a study.
"I'm so annoyed I cannot get this kind of study going," Lipov said. "They tell me, ‘Just be patient.' It's people's lives! I mean, my God."
Despite Castro's assurances that the Army will "continue to look at what we can do to see if this new procedure has merit," Lipov at this point is giving up on the Pentagon. The Northwestern-trained doctor, who has been giving the $2,000 procedure free of charge to vets at his private practice, will instead try to work outside the military system.
He has hooked up with a Harvard researcher to look at related issues in the brain, and the state of Illinois, after turning him down three times previously, has just granted him $100,000 for a small study with a control group.
In one day this summer, 19 veterans in the Chicago area signed up to participate, he said.
Lipov is frustrated that he's unable to reach as many people as he'd like because of the limited funds, but he's determined to keep moving forward with the treatment.
"I think this could really change a lot of things," Lipov said. "We need to change - and we needed to do so yesterday."