Navy coverup alleged on drug side effects

SAN DIEGO, Sept. 8 (UPI) -- A Naval Reserve commander who volunteered for the Iraq war says the military doctored his medical file to eliminate all traces of an anti-malaria drug that he believes made him severely ill, suicidal and aggressive - and that he has the before-and-after evidence to prove it.

"I was given Lariam. I got sick from Lariam," said Cmdr. William Manofsky, 44, who is based at the Naval Air Warfare Center in China Lake, Calif. "The Navy does not want to talk about Lariam. There is no mention of it in my medical record. I'm pretty upset."

Manofsky said there is no indication in his file of ever being prescribed the drug, although the Navy handed it to him last November; that a page is missing on which "Took Lariam" was written; and that a reference to the drug during an emergency clinic visit on May 13 has mysteriously vanished from the page - even though he has a copy that clearly shows it written there.

Manofsky and his wife, Tori, believe the military is covering up problems with the drug - the Navy's main concern so far, they said, is to try to get the medical records back. A spokesman for the Navy Bureau of Medicine and Surgery would only say that it provides quality care and is working "to resolve the issue."

"The military created the drug," Tori Manofsky said (it was developed by the Walter Reed Army Institute of Research and licensed to Roche). "There is a lot of money involved in the drug. I think there are a lot of careers at stake. Anything that shows a problem with Lariam has to be hidden or covered up somehow by the military. If all these people came back and it was clearly Lariam, there would be lawsuits up the kazoo."

Lariam is the drug that at least two of the soldiers who killed their wives at Fort Bragg last summer took while serving in Afghanistan. Both those soldiers - and a third who apparently had taken the drug - subsequently killed themselves. The drug's label warns of psychosis, aggression, hallucinations and reports of suicide that can occur "long after" someone stops taking it. The Food and Drug Administration this year ordered that everyone prescribed the drug be handed a written statement listing those dangers and warning them to quit taking it if they experience mental problems.

The government and the company that makes Lariam, Swiss drug giant Hoffmann-La Roche, say the drug is safe and effective. The FDA says it doesn't know whether the drug can trigger suicide. Roche says there is no reliable evidence it can trigger violent behavior. The Pentagon says side effects are generally rare and mild and are outweighed by the risk of getting malaria.

Manofsky, who never took Lariam before being deployed to Kuwait last December, became suicidal after returning to California this spring and nearly slugged his wife in a bizarre rage about the way she cast her fishing line. He also suffered seizures, balance problems so severe he sometimes could not stand, panic attacks and depression.

Tori Manofsky became convinced Lariam was the culprit after researching on the Web the medications her husband was taking. On June 26, after several visits to the China Lake clinic in which they raised the Lariam issue but felt they were being ignored, Bill Manofsky went to the clinic to pick up his records on his way to see a neurologist. He flipped through them to make sure Lariam was documented.

"The first thing I noticed was a sheet missing," he said. "Both Tori and I had seen the sheet. Someone had written on an angle, 'Took Lariam' and it was no longer there. There was no entry for being issued Lariam."

Manofsky flipped more pages, looking for the record of a May 13 visit to the clinic. That day, his wife had insisted a Navy doctor write the drug on that record and both had watched him do it. He found the page on which he felt certain that note had been written.

Nothing.

Manofsky knew his memory was shot, that he was acting strangely, and there was no reason for anyone to believe him. But he had a backup. Tori Manofsky - suspicious that Navy doctors were ignoring the drug - secretly photocopied the page after the doctor wrote down "Lariam" on the May 13 visit and briefly left the room.

Tori's copy clearly shows the reference, "Lariam for anti malaria" Underneath that, four other medicines Manofsky was taking also are gone; they are mentioned elsewhere on the visit.

Two independent document examiners consulted by UPI concluded that unless the Manofskys themselves faked the doctor's writing and created bogus copies, only the Navy can explain the omission.

The document experts could find no evidence that writing had been erased from the May 13 record. One of the experts - a former head of an FBI questioned documents office - told UPI that the likeliest scenario is that the clinic made a copy of the May 13 page while the Manofskys were still there, and the doctor wrote "Lariam" on that copy after Tori insisted. That sheet never made it into his medical file.

While such a chain of events could theoretically be accidental, Tori Manofsky believes the Navy knows it has a problem with the drug, and was keeping two sets of records and recording Lariam problems on only one.

UPI contacted the doctor who saw Manofsky on the May 13 visit and asked if he knew anything about changes in the medical record. He declined to comment and said he had been told to refer questions to Twentynine Palms Marine base, which forwarded them to the Navy Bureau of Medicine and Surgery in Washington. Spokesman Brian Badura issued this statement:

"Successful medical treatment relies on accurate information, close cooperation and communication between provider and patient, and follow-up by all parties involved. Navy Medicine makes a concentrated effort to meet the needs of each patient. Due to the number of circumstances surrounding the Manofsky case and the ongoing efforts by Navy Medicine to resolve this issue, we cannot offer additional input at this time."

Several other service members who served in Iraq have told UPI they had serious problems with the drug - including one who says he was afraid of harming his wife and that there was no record of him being prescribed Lariam, either. At least two soldiers were medically evacuated from Iraq with suspected Lariam problems, one an Army officer in charge of 300 soldiers, the other a soldier who felt the way he was treated suggested the Army was "avoiding the Lariam diagnosis." The Army is now discharging him.

The Washington Post reported in July that the military is investigating at least seven suicides among troops in Iraq, among a larger number of deaths classified as "non-combat weapons discharge" or "non-combat related."

The Pentagon hasn't identified any deaths as suicides since the war started.

Earlier this year, two more soldiers deployed out of Fort Bragg who took Lariam in Afghanistan committed suicide after returning home - bringing the number of suicides after that war to at least five. In one case, the soldier's father said he asked Fort Bragg officials if the Lariam given to his son could have played a role. "They have no comment," he told UPI.

The Pentagon insists that there have been few problems with the drug, prescribed to soldiers around the world to prevent malaria. More 25 million people have taken it worldwide, according to the manufacturer, 5 million of them in the U.S.

Assistant Secretary of Defense Dr. William Winkenwerder, Jr., wrote a U.S. congressman last fall that any possible side effects are "greatly outweighed by the drug's effectiveness in preventing the severe consequences of malaria infections" among troops.

In the Fort Bragg homicide-suicides, a team of experts dispatched by the Army Surgeon General's office concluded that Lariam was an "unlikely" explanation for the entire cluster of deaths but acknowledged it had not investigated it in any single case. It blamed the deaths on marital problems.

At the time, critics said some of the Fort Bragg deaths should have been investigated as possibly drug related, especially because there was no history of domestic abuse and all three of the soldiers who had been in Afghanistan killed themselves - both unusual in domestic homicide cases.

A former Roche employee said that Lariam, known generically as mefloquine, is a member of the quinolone family of drugs that can produce severe psychiatric problems in some users.

"Any drug with a quinolone base to it, which includes Lariam, is likely to do this," said Dr. Donald H. Marks, former associate director of clinical research at Roche who now consults with attorneys suing drug manufacturers. "These types of drugs can induce a temporary homicidal or suicidal rage."

The Army puts the rate of severe side effects at 1 in 13,000. A widely reported British study completed in 1996 found that one person in 140 had such serious problems that they temporarily couldn't carry out the function for which they were traveling.

The Manofskys said they were willing to take on the Navy publicly because they are convinced the truth is not being told, and concerned that other soldiers returning from deployments overseas are getting the same treatment.

They showed UPI Bill Manofsky's complete medical file and Navy service record; e-mails from the Navy psychiatrist who treated him before he decided not to work with the Navy any more; a log Tori kept of Bill's symptoms, and all the medicines he was taking including remaining Lariam pills. They gave interviews in California and Washington in which they went over the events almost minute by minute.

The Manofskys outlined this sequence of events.

A 17-year veteran of the Naval Reserve, Manofsky was handed Lariam last November at China Lake before being deployed. There was no prescription written or warning given of possible side effects, and Tori Manofsky said she has since been told by a base medical worker that there were "special instructions for dispensing and documenting" the drug.

Bill Manofsky served active duty at an air base in Kuwait during the war, using his top-secret clearance on a targeting system. But he suffered what he now says were bad Lariam side effects that started in Kuwait and got worse when he got home and kept taking his pills as directed. He's had uncontrollable vomiting and vertigo, depression and anxiety attacks requiring hospitalization. His hands tremble. He stutters and repeats himself. He has frightening seizures.

After 11 years of marriage, Tori said that after taking Lariam, Bill's personality changed drastically from the gentle husband she knew.

The drug is taken weekly while deployed and for four more weeks after a person returns, so Manofsky was still taking the pills when he got back.

Tori kept a journal documenting her husband's problems. An entry for May 2 described his symptoms as "balance off, angry, moody, coping poorly, sad, depressed. What really bothers me is 'aggressive - highly aggressive.'"

The couple tried to go fishing in early May in an effort to relax. But Bill got so angry he scared his wife. When she cast her line in the water, "Bill came over and said, 'Do it this way,'" she wrote in the journal documenting his problems. "He kept saying it over and over - extremely angry!!!"

After she told him she was upset and wanted to stop fishing, "he leaned over me like he was going to slug me in the head and said, 'If you don't do it this way I'm going to ...'" He stopped in the middle of the sentence and backed off. She said that a few hours later he had no memory of the incident.

Bill Manofsky told UPI later that, "I was trying not to pull a Fort Bragg."

"I wanted to make sure Bill had the proper care with Lariam toxicity," Tori said, describing the May 13 visit to the China Lake clinic. The symptoms I read on the Internet matched up with Bill's to a tee. I told the doctor that I thought that Lariam was responsible for his symptoms. I said, 'Doctor, would you write Lariam down.'"

"He wrote everything down and put the clipboard on the bed near Bill's legs. I leaned over and I said, 'Bill, I need to copy this.' They had a copy machine down the hall. I went down and copied it and did not say anything to anybody about it."

Later in May, Manofsky became suicidal. On May 31, Tori said that while she was driving them to a restaurant, "Bill's panic, anxiety and distress became so acute that he proceeded to try and claw his way out of the truck so he could jump out. I kept telling him, 'Bill, it's gonna be OK, it's gonna be OK.' He said he was crawling out of skin, he had to get out of there."

At the restaurant, "Bill went to the bathroom and began vomiting, he then sat on the floor and said repeatedly that he was going to blow his brains out.

The Manofskys say that Bill was referred to a Navy psychiatrist who also seemed to resist the idea that a drug prescribed by the Navy could be causing his problems. She diagnosed him with anxiety and "narcissistic" and "histrionic" personality traits.

Then, on June 26, Bill Manofsky discovered the changes in his medical record.