Navy coverup alleged on side effects of drug developed by Walter Reed Army Institute

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> Navy coverup alleged on drug side effects

>

> By Mark Benjamin and Dan Olmsted

> United Press International

> Published 9/8/2003

>

> 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.

> http://www.informationclearinghouse.info/article4649.htm

>