News

· Troops could launch lawsuits, warns expert
· Veterans' groups criticise 'guinea pig' decision

James Randerson, science correspondent
The Guardian

Soldiers in Afghanistan and Iraq are being treated with an experimental blood-clotting drug that has not been fully tested.

Because randomised controlled trials have not yet been carried out into the drug's effectiveness, it is impossible to know whether it is doing more harm than good to patients.

Veterans' support groups have criticised the Ministry of Defence action. One trauma expert has said soldiers treated with the drug could sue the MoD if trials produce evidence it is harmful.

Phil Willis, the Liberal Democrat MP who is chairman of the science and technology select committee, described the MoD's decision as "a dereliction of its duty of care that indicates a moral bankruptcy within the military".

The drug, called NovoSeven, was originally licensed in 1999 as a treatment to stem bleeding in haemophiliacs.

It is undergoing trials for use to stop bleeding in trauma patients with severe wounds and bleeding within the brains of patients with severe head injuries. But its effectiveness and safety as a blood-clotting agent in these circumstances has not been proven.

Inquiries by the Guardian have established that the MoD has authorised its use in battlefield trauma casualties.

Ian Roberts, an expert in trauma care at the London School of Hygiene and Tropical Medicine, said: "The point is that it is hugely expensive. Like all treatments there is potential for harm and it is not licensed for use."

Professor Roberts wrote to the defence secretary, Des Browne, on August 8 to ask whether the MoD had approved NovoSeven - also called Recombinant Factor VIIa - for use on British servicemen and women. It is thought that the US and Israeli militaries are also using the drug.

"My concern is that the MoD may be wasting resources on expensive treatments that may do more harm than good when it could be investing in high quality research that has the potential to improve the care of combat casualties world-wide," he wrote.

Prof Roberts has not received a reply, but the MoD confirmed to the Guardian that the drug was being used in trauma patients injured on the battlefield.

Veterans' support groups were dismayed. "It seems to us wrong that the military would almost use soldiers as guinea pigs for drugs that have yet to have a proven safety record," said Andrew Burgin of Military Families Against the War, a group with 600 members.

Michael Shalmi, a scientist at Novo Nordisk, the Danish company that manufactures the drug, said: "It is far too early to say whether the benefits of NovoSeven in [the head trauma] context outweigh the risk on a definitive basis." He said a single dose of the drug would cost between £750 and £3,000 depending on the size, and confirmed that data from the drug's use by the MoD and US Department of Defence would not be fed into the company's randomised controlled trials of the drug.

In its response to the Guardian, the MoD said: "Use of Recombinant Factor VIIa in by the defence medical services (DMS) has been authorised after an extensive review of the current evidence. It is strictly controlled in the DMS and only authorised when conventional resuscitation measures have failed."

But Prof Roberts said that even the severely injured should not be given an experimental treatment. "Just because someone's at a high risk of death, it doesn't mean the treatment can't increase their risk of death." In his letter, he said the MoD might be open to legal challenges if clinical trials subsequently find the drug is harmful to trauma patients. But the MoD denies it is putting personnel at risk.

Martin Shalley, president of the British Association for Emergency Medicine, said it was not unprecedented for drugs to be used "off label," in situations where they have not been fully tested. Doctors sometimes had to take a pragmatic approach.

Neither Novo Nordisk nor the MoD could confirm how many patients have been treated with NovoSeven.

Sarah Boseley, health editor

The Guardian

America's drug tsar raised the stakes on drug testing in schools yesterday, suggesting that it could come to be seen as normal required and "responsible behaviour" in the same way that some US schools routinely test all pupils for tuberculosis before admission.

John Walters, director of the White House's office of national drug control policy, was speaking after meeting Jim Knight, an education minister. While Mr Walters said he had no authority to comment on the UK's drug policies, he made it clear that the US would continue to promote the tough line on drugs that has interested the British government.

"Some schools in the United States say a child needs to have a TB test," he said. "It's not considered to be an invasion of privacy. It's responsible behaviour. I believe we're very close to be able to think about that in terms of substance abuse."

Random drug testing has already started in schools in Kent. The government is taking part with Kent county council in a pilot project, overseen by Peter Walker, the headteacher of Abbey school in Faversham. In April Ruth Kelly, the then education secretary, told a teachers' conference that Abbey had found it "a hugely effective way of creating peer pressure against taking drugs in school".

Mr Walters said cannabis use was not just a matter of personal choice and the expression of freedom in the same way as a preference for clothes and hairstyles. "We're still living as if substance abuse is a fashion statement," he said.

Taking a strong line against marijuana was "not being judgmental but showing that we care".

Up to 700 schools in the US have adopted random drug testing, he said, and one school a week was joining them. He said it was not his business to criticise the reclassification of cannabis in the UK but he believed cannabis was "a dead-end drug and a stepping stone to addiction".

He added: "There's no question that these substances acting on human beings are bad for them and leads them to reach out for other drugs ... ".

The US policies were based on scientific evidence - some of it from the UK - that cannabis was linked to psychosis and schizophrenia. "We have a particular problem of our attitudes towards cannabis which hinders policy and hinders people going into treatment," he said.

"The attitude is that it's only marijuana. It doesn't help if your kids are playing Russian roulette that they are using a smaller calibre weapon."

Mr Walters strongly opposed harm reduction policies such as needle exchanges and injection rooms, saying they were "morally dubious". "It is a question of why you would want to use a Band-Aid against the serious disease of addiction when there is a solution," he said.

Permitting such harm reduction measures gave the impression that "society allows a stance of it's OK to be an addict", he said.

US opposition to harm reduction measures is likely to come under serious criticism at the International Aids conference in Toronto next week.

Cocaine use most prevalent, raising concern

By Suzanne Smalley, Globe Staff

Since Boston police started annual drug testing in 1999, 75 officers have failed the tests, and 26 of them flunked a second test and were fired, newly released statistics show.

Acting Police Commissioner Albert Goslin said an additional 20 of the officers who tested positive left the department on their own, which he said is because they could not handle the frequent follow-up checks.

Of the 75 officers, 61 tested positive for cocaine, 14 for marijuana, two for ecstasy, and one for heroin, according to the figures, obtained by the Globe through a public records request. (Some officers had more than one drug in their system).

Some specialists and department observers said they were alarmed by the number of officers testing positive for a ``hard" drug such as cocaine and questioned the department's policy that allows an officer to remain on the force after a positive drug test. An officer is not fired until a second positive test.

``It seems like it's a chronic problem," said Darnell A. Williams, president and CEO of the Urban League of Eastern Massachusetts. ``Here we're trying to deal with the guns and the drugs on the street level, but we have a more strident problem inside the department when we have that many people testing positive for drugs, especially cocaine."

The department's drug testing policy is already under scrutiny, after reports that the alleged ringleader in a corruption case tested positive for cocaine in 1999, yet kept his job under the rules that call only for suspensions and treatment even for positive tests for drugs such as cocaine and heroin.

Unlike Boston, the New York and Los Angeles police departments dismiss officers after a first positive drug test.

Eugene O'Donnell, a former New York City police officer who is now a professor of police studies at John Jay College of Criminal Justice, said he believes the Boston police may have an unusually high number of hard-drug users because of its two-strikes policy. The New York Police Department has a very low drug test failure rate because of its zero tolerance policy, he said.

``Once you establish that people are fired, it does change the complexion," he said. ``If an agency says you can use drugs . . . it stands to reason you're going to have a higher rate of people using drugs."

While 75 Boston officers failed drug tests out of a total force of about 2,000 sworn officers since 1999, at the much larger Los Angeles Police Department, 14 officers have flunked the drug test since March 2000. It employs 9,354 officers, of whom about 3,000 are subjected to random urine tests each year.

A spokeswoman for the federal Substance Abuse and Mental Health Services Administration said that of the 150,000 federal employees who took random drug tests in 2004, 0.4 percent failed. In 1999, when the most Boston officers failed drug tests, the rate was more than double that, about 1.1 percent. Goslin said the testing policy and treatment have cut the number of positive tests since then.

Boston police test for cocaine, heroin, amphetamines, PCP, and marijuana -- the standard list recommended by the federal government for workplace testing. Officers can also be tested for other drugs with reasonable suspicion.

Officers are tested before they join the force, again while on probationary duty, then annually within 30 days of their birthday. They are also tested if they get promoted or assigned to a special unit such as narcotics or organized crime.

If they test positive for any drug, officers receive a 45-day unpaid suspension and must get treatment. Once they return to duty, they are subject to random testing for three years, in addition to regular testing.

Goslin said it is not fair to compare the department to other law enforcement agencies, which he said typically use a less sophisticated urinalysis test that does not detect drugs taken more than a few days before the test.

He said the Boston police method of testing officers' hair is more reliable and can catch drug use dating back three months. ``I would expect our rate to be higher," Goslin said in an interview.

Los Angeles police test urine for drugs, and New York police test hair.

Goslin also said that Boston police test every officer annually, which is more regularly than many police departments, where a smaller number of officers are tested at random each year. Therefore, he said, all officers aren't screened consistently.

The annual testing began in 1999 after years of negotiating with the city's powerful police unions, which had objected to the tests. In exchange for salary and benefit increases, the unions agreed to a system that gives officers warning by scheduling tests within 30 days of their birthday.

The city's hair-testing method has also been disputed.

Fifty-seven percent of officers who failed an initial drug test since 1999 were African-American, which troubles critics who believe blacks are more likely to get false positive results because of the texture of their hair. Last year, seven former Boston police officers -- all African-Americans who lost their jobs because of what they say were false positives -- sued the department, alleging the hair test is biased. The suit is pending .

Goslin defended the test. ``The science is very good and can withstand any level of scrutiny," he said.

Goslin said he is not surprised that the vast majority of officers who failed the tests had used cocaine. ``In the '60s it would be marijuana; now it seems to be cocaine," he said.

But Mark A. de Bernardo, a labor lawyer in Virginia who is executive director of the Institute for a Drug-Free Workplace, said he is startled by the number of Boston officers who used cocaine. He said that while no one tracks national numbers on law enforcement officers who test positive for drugs, it is unusual for so many of the positive results to be for cocaine.

``In typical drug testing, the number of marijuana positives is going to be three, four, five times the number of cocaine positives," he said. ``That's alarming that cocaine would seem to be the drug of choice for the drug abusers in the Boston Police Department."

He said the number of drug-using officers might be higher than what the testing shows because of the predictability of Boston's annual testing.

``Anybody who fails a drug test when they know a year advance within 30 days of when it's going to be . . . is a person who I consider to be an addict," he said. ``I'd assume that this is just a percentage of those that actually engage in actual drug use because it's not true random testing."

He also said that by giving officers a second chance, Boston police are straying from the standard set by most other employees where workers are responsible for public safety.

However, the Urban League's Williams said he believes the department is right to give officers a second chance, especially since in many cases it seems to work. Of the 75 officers who tested positive since 1999, only about a third failed a second test.

Goslin said after the initial wave of positive tests in 1999, the policy has successfully cut drug use. ``People took the policy seriously and went to get help on their own, and that caused the numbers to drop drastically," he said. ``And it dropped every year the policy has been in existence."

© Copyright 2006 Globe Newspaper Company.