12160 Bio Watch : http://tinyurl.com/12160BioWatch
Untested swine flu vaccine could put British public at risk, warn experts
http://news.scotsman.com/latestnews/Untested-swine-flu-vaccine-could.5495018.jp
Published Date: 27 July 2009
By Jenny Haworth
EXPERTS have warned about the potential dangers of using untested vaccines as the British government prepares to fast-track inoculations against swine flu.
The European Medicines Agency, the EU's top drug regulatory body, is accelerating the approval process for swine flu vaccine in order to have it ready before winter.
Many European countries – including Britain – plan to start using it as soon as it has been approval, possibly within weeks.
Martin Harvey-Allchurch, a spokesman for the European Medicines Agency, said: "Everybody is doing the best they can in a situation which is far from ideal.
"With the winter flu season approaching, we need to make sure the vaccine is available."
In Europe, flu vaccines are usually tested on hundreds of people for several weeks or months, a process which is being skipped in this case.
Some experts say extensive testing is unnecessary since flu vaccines have been used for 40 years, and this version will simply contain a new ingredient – the swine flu virus.
However, the US is taking a more cautious approach, carrying out tests on several thousand volunteers from next month to assess the vaccine's safety.
"I can't see any possible excuse to not test it for safety before it's given to anyone," said George Annas, a bioethics expert at Boston University. The warnings came as it was revealed the UK government had been forced to accept legal liability for the swine flu vaccine in case it triggered side effects.
Ministers have taken on all the risk for the 60 million doses they have ordered from GlaxoSmithKline and the Baxter group, after both firms said they would refuse to produce it unless legally protected, The Scotsman's sister paper Scotland on Sunday revealed.
In 1976, hundreds of people in the US developed Guillain-Barre syndrome, a paralysing disorder, after being vaccinated against flu. The reasons for the disorder remain unknown.
Dr Keiji Fukuda, the World Health Organisations' flu chief, has warned about the potential dangers of untested vaccines, although he stopped short of criticising Europe's approach outright.
"One of the things which cannot be compromised is the safety of vaccines," he said.
"There are certain areas where you can make economies, perhaps, but certain areas where you simply do not try to make any economies."
Experts have agreed there are unlikely to be any side effects from a swine flu vaccine, but warn that it cannot be known for sure.
One issue could be that without thorough testing the effective dosage would not be used, meaning Europeans may get too weak a vaccine.
Meanwhile, pregnant Scot Sharon Pentleton remained in a "critical but stable" condition in a Swedish hospital yesterday.
The 26-year-old mother of one from Ayrshire suffered a rare reaction after contracting the H1N1 virus and is undergoing a procedure where her blood is circulated outside her body.
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Fast-tracked vaccine raises safety question
LONDON — In a drive to inoculate people against swine flu before winter, European governments plan to fast-track the testing of a vaccine, arousing concerns about safety.
Countries such as Britain, Greece, France and Sweden say they'll start using the vaccine after it's greenlighted — possibly within weeks.
Dr. Keiji Fukuda, the World Health Organization's flu chief, warned about the potential dangers of untested vaccines but stopped short of criticizing Europe's approach.
Officials won't know if the new vaccine causes any rare side effects until millions of people get the shots.
http://www.denverpost.com/headlines/ci_12920000
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US gears for huge swine flu vaccination push
By Virginie Montet (AFP) – 14 hours ago
WASHINGTON(AFP) — Anxiously eyeing the approach of winter, US health officials are urgently gearing up for a huge vaccine campaign hoping Americans will swing behind efforts to protect them from swine flu.
"Ultimately, the number of people that we hope will be vaccinated before the fall winter wave of H1N1 arrives will exceed any of the previous vaccine campaigns that we've conducted in this country," Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, told AFP.
"This is the largest vaccine effort the world has ever seen," agreed Robin Robinson, director of the Biomedical Advanced Research Development Authority (BARDA), quoted in the Washington Post.
But authorities also have to overcome a vocal debate in the United States about vaccinations, amid lingering suspicions among some parents that they are not safe for young children.
"At this point it is just really unclear to say how many will get vaccinated," said Osterholm.
"It's all going to be a matter of when the vaccine is available. If the vaccine is available, and people are getting sick in the winter, then I think you are going to see many more people wanting the vaccine."
The United States is now the country the worst hit by the swine flu pandemic which spread across the border from the disease's epicenter in neighboring Mexico earlier this year.
Elderly citizens and children are the most vulnerable to the (A)H1N1 virus -- a new multi-strain illness which is thought to be a kind of bird flu which mixed in a pig and was then passed to humans.
Some 263 people have so far died across the country, and more than 40,000 cases have been registered, although US health officials have said they believe as many as a million people could already be infected.
To put the figures in perspective, officials stress that ordinary seasonal flu kills on average some 36,000 people a year in a nation with 300 million people.
But an all-out effort has been launched to put in place a vaccine before the start of the traditional flu season in the coming months.
Health officials have called for thousands of volunteers to join clinical tests of two vaccines with the aim of having results in two months time, enabling the vaccination campaign to start at the beginning of the fall.
"We are hopeful we'll be talking about several hundred million people getting vaccinated if possible," said Osterholm.
"It's going to literally be a function of how much vaccine we'll ultimately have before the wave really takes hold in this country."
An emergency meeting of health officials has been set for Wednesday, July 29, to work on an action plan and identify the groups most at risk.
"Everything is going to be done to try to encourage people to get it," said Gretchen Michael, a BARDA spokeswoman, referring to the vaccine.
"As you know the virus is still circulating. It's been circulating all summer. We anticipate based on what we see in the southern hemisphere that... especially when children go back to school, it will continue to circulate at a similar kind of rate."
But no-one here has quite forgotten the 1976 vaccination fiasco.
After an outbreak of a swine flu virus on a military base, officials feared the nation was on the verge of another epidemic similar to the 1918 wave of deadly Spanish flu. So 40 million Americans were hastily vaccinated.
But the virus never spread, and instead 500,000 people developed a rare inflammation of the nervous system known as Guillain-Barre Syndrome, which led to 25 deaths.
"People are working day and night on this," said William Schaffner, infectious diseases teacher at Vanderbilt University, talking on National Public Radio.
"Some of these things just take time, and remember we don't want to cut corners, we want to do it right so that, when we deliver this vaccine to the American public we can say it meets our standards."
The clinical trials are mainly aimed at calibrating the doses to give to patients, not to test if it is safe or not, officials stressed.
"We are not trying to find some yet unrecognized problem with the vaccine," said Osterholm.
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Swine flu goes to camp. Will it go to school next?
http://www.latimes.com/features/health/la-me-camp-flu27-2009jul27,0,58781,full.story
Hundreds of children have been sent home from summer camps across Southern California in recent weeks with flu-like symptoms, and camp counselors and directors are taking precautions to prevent the spread of the H1N1, or swine flu, virus in cabins and mess halls.
But officials say the sight of children arriving at sleep-away camps armed with the anti-viral medication Tamiflu is probably just a harbinger of what awaits schools in coming weeks as students move into dormitories, and elementary and secondary students begin classes.
Health officials predict a resurgence of the flu in the fall, and a vaccine effective against H1N1 is not expected to be available until long after the start of school.
School districts and universities are on alert, working with health officials to launch education campaigns, stockpile medical supplies and discuss worst-case scenarios.
State education officials are developing plans to provide lessons and meals for low-income children in case elementary and secondary schools close.
School closures would occur only by order of the superintendent or the county health department and only if so many children were sick that it was impractical to keep classes running, said Dr. Kimberly Uyeda, director of student medical services at the Los Angeles Unified School District.
UC campuses are stockpiling supplies, from paper masks and hand sanitizer to food and water. Officials are going over worst-case scenarios in case of campus-wide outbreaks. Officials are considering screening students for fever when they check into dorms.
"If we prepare for the worst, then we're going to get a better outcome," said Grace Crickette, chief risk officer for the University of California.
For now, sleep-over camps provide a look at what schools may face.
Before children are allowed to board camp-bound buses, nurses check temperatures and medical histories, hoping to ensure they are flu-free. Visitors days have been canceled at some camps, and makeshift infirmaries were created in some dining halls and lawns. High-fives and hand-holding are out, replaced by fist bumps and elbow-linking. Hand sanitizer is everywhere.
"We're all getting habitual with our Purell," said Jordanna Flores, executive director of Camp Alonim in Simi Valley, which has sent 160 children home in recent weeks. Many have since recovered and returned to camp.
Flu symptoms have been mild, but the virus is highly contagious, particularly when children are in close proximity.
Some organizations that cater to children with health issues, including the American Lung Assn. and the Muscular Dystrophy Assn., canceled camps because of concerns about the virus.
"It's not worth the risk," said Bob Mackle, a spokesman for the Muscular Dystrophy Assn. "It was a heartbreaking decision for us, and it was a tough decision."
Most camps remain open, according to the American Camp Assn. No organization has a complete list of outbreaks, but there have been anecdotal reports from across the country, notably in the Northeast, which has a deep tradition of sleep-away camps.
The California Department of Public Health has received reports of outbreaks at 16 camps in eight counties, though department officials suspect the number is higher.
At Camp Ramah in the Ojai Valley, 80 campers and staff members were sent home with flu-like symptoms in the first session; many have returned. Twenty-nine eventually tested positive for the flu, said Rabbi Daniel Greyber, the camp director. The camp canceled its annual visitors day, which typically attracts as many as 2,000 people, and instead brought in a petting zoo.
Once campers left, workers deep-cleaned the bunks, beds and bathrooms. The 600 campers attending the second session, which began Thursday, were advised to pack Tamiflu.
"We hope it's a proactive thing that we can do to minimize the flu within the camp," Greyber said.
Education is equally important. Greyber demonstrated proper coughing and sneezing etiquette (into the elbow or on the sleeve, not into the hands). Campers produced skits about "Swine '09."
But for some children who fell ill, the situation was traumatic.
At Camp Alonim, health center coordinator Cindy Petrak said some campers wept when they learned they would have to leave their healthy friends and siblings for seven days to recover.
"It felt like Ellis Island," she said.
On a recent day, children lined up in an infirmary to have their temperatures taken. Parents of any who had fevers were called to pick them up. As many as 20 campers rested on a grassy lawn, sitting on white sheets with their luggage, waiting for their rides home.
Austin, a sixth-grader from Encino, had a fever and a sore throat when he was sent home. He said he was sad to miss bunk night, when his cabin-mates picked the evening activities. When he returned, he said, he was happy that friends noticed his absence. "They all recognized I was back," he said.
Some camps have been spared, including Camp Paintrock and Blue Sky Meadow.
Camp Paintrock sends Los Angeles children to Wyoming for a four-week youth leadership development program. About half a dozen of the 60 campers had flu-like symptoms, but none tested positive for the flu.
Blue Sky Meadow, a science camp for Los Angeles area children in Big Bear, checked campers' temperatures and health histories before students boarded buses to the camp. Families of children who had not been feeling well recently were told to select another week to attend.
"It's sort of a healthy-campers-are-happy-campers philosophy," said Madeline Hall, director of the Los Angeles County Education Foundation, which runs Blue Sky Meadow.
Parents are trying to take the flu in stride.
"I think when kids are at camp, living in close quarters, there's always a chance. If one kid gets sick, all the kids get sick," said Mara Sperling, whose 12-year-old daughter Ella left last week for Gindling Hilltop Camp in Malibu. "It's one of the hazards of going to sleep-away camp."
Susan Freudenheim's 14-year-old daughter Rachel Core is attending Camp Alonim, where Tamiflu will be given to the entire cabin, with parents' permission, if two children in a cabin get sick.
She declined because she fears there could be a Tamiflu shortage and that unnecessary medication could lead to the development of a drug-resistant strain of the virus. Health officials, including the Centers for Disease Control and Prevention, advise against giving the drug to healthy people.
Freudenheim, managing editor of the Jewish Journal of Greater Los Angeles, which has covered the outbreaks extensively, hopes her daughter stays healthy.
"It would be a disaster if she came home," said the former editor at the Los Angeles Times. "She'd have nothing to do, be sick alone at home, and I'm working full-time."
Educators plan to work in the coming weeks to prevent the spread of the virus in classrooms and dorms, but they said it ultimately comes down to education and personal responsibility.
"Wash your hands, wash your hands, wash your hands," said Crickette.
seema.mehta@latimes.com
nicole.santacruz@latimes.com
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Doctors warned not to mistake meningitis for swine flu
http://www.examiner.com/x-9303-Miami-Health-Care-Examiner~y2009m7d26-Doctors-warned-not-to-mistake-meningitis-for-swine-flu
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Scientists Fear Swine Flu Can Infect Brains of Unborn Babies
They discovered that the virus changes the workings of genes that control fetal brain growth and development. Some of those genes have been implicated in mental disorders.
“Prenatal viral infection led to altered gene expression in the hippocampus, including autism and schizophrenia candidate genes,” said Hossein Fatemi, a neuroscientist at the University of Minnesota medical school, whose research paper details the results.
Fatemi’s research was carried out entirely on mice so the results need to be interpreted cautiously in terms of their implications for humans.
It was, however, prompted by other epidemiological evidence suggesting that children born to women who have suffered flu infections during pregnancy are at increased risk of schizophrenia and possibly autism too.
It reinforces existing advice that pregnant women should do all they can to avoid infection with the virus.
Trevor Robbins, professor of Cognitive Neuroscience at the University of Cambridge said the new research simply reinforced existing advice. He said: “Pregnant women should do their best to avoid all infections, especially flu.
For more information: http://www.europeanneuropsychopharmacology.com/home
Click here to read more from the London Times.
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Canada natives fear swine flu spread in coming months
MONTREAL — Canada's native communities already hard hit by the swine flu pandemic could witness a devastating spike in the number of cases during the region's long winter months ahead, health experts warn.
Heavily affected by historic outbreaks, notably the 1918 Spanish flu, Canada's 1.2-million-strong Inuit and Aboriginal communities have been disproportionately hit by the A(H1N1) virus.
And the infection rate comes despite their isolation, with the native people's living primarily in remote communities in the forested center and the Arctic north of the country.
More than 10,000 people in Canada have contracted the A(H1N1) virus so far, including more than 55 people who have died.
But while the swine flu infection rate in the general population has seen a ratio of 24 per 100,000, Manitoba tribes in central Canada have seen rates of 130 per 100,000, according to the current affairs magazine Macleans.
Inuit communities in the far north Nunavut territory meanwhile have seen an outbreak on an even larger scale, with an infection ratio at a massive 1,070 per 100,000.
"We are not clear at this point how much of that relates to underlying risk factors like obesity, smoking, diabetes, chronic lung disease," David Butler-Jones, Canada's Chief Public Health Officer, told AFP.
Also, it is not clear to authorities "whether there is in fact a genetic component of risk to this," Butler-Jones added.
Historians have highlighted the disproportionate toll wreaked by the Spanish flu of 1918-1919 on the same populace.
For example, in the village of Cris in the remote north-central Norway House indigenous community in Manitoba, 183 members -- some 20 percent of the population -- died over a six-week period.
The same devastation was seen in Saint Theresa Point, with a population of 3,200, just east of Norway House.
Already fearful for the indigenous communities as the swine flu crisis began to take hold in almost every nation, Canadian authorities sent emergency health technicians out in June to help them battle the virus.
In all, 500 people were seen to be exhibiting influenza symptoms and a hundred others were evacuated by helicopter.
"The working hypothesis now is that this pandemic will follow the 1918 (pattern)," said Ethan Rubinstein, professor of infectious diseases at University of Manitoba, noting however that medical advances since that time could still lessen the final toll.
"I don't expect the death rate to be even close to 1918, but the spread of the disease may still be like that," he said.
The leading representative for Canada's native communities, Assembly of First Nations (AFN), has slammed Ottawa for what it says has been inadequate efforts to help the region.
The "measures aimed at containing the virus were ill-suited to the social realities of First Nations," said the AFN.
Examples of unhelpful advice, said the organization, include communities being told "to avoid contact with others, while living in cramped and overcrowded conditions, or being told to wash their hands frequently, when running water was not available."
AFN Regional Chief Angus Toulouse, who holds the health portfolio at the organization, told a recent government hearing that "clearly, if there is no improvement in planning and services, the worsening of this virus could have tragic consequences" in the coming months.
The chief medical officer of health for the Nunavut, Isaac Sobol, went further to slam authorities over what he suggested was the inevitable result of neglect.
"Successive Canadian governments have not wanted to highlight the situation concerning Inuit and Aboriginal health. We see the results now," Sobol said.
The AFN called this month for native communities to receive priority vaccination against swine flu, in light of its disproportionate impact.
Canadian Health Minister Leona Aglukkaq said earlier this month that distribution would be ordered by risk.
"Those most at risk will receive the vaccine first. We expect that the H1N1 vaccine will be made available by late October, early November, and everyone who needs (the) vaccine will be able to get at least one dose before Christmas," Aglukkaq said.
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Researchers offer volunteers a shot at swine flu immunity
http://www.knoxnews.com/news/2009/jul/27/researchers-offer-volunteers-shot-swine-flu-immuni/
A local research group has seen no shortage of volunteers willing to roll up their sleeves for a shot at swine flu immunity.
But Volunteer Research Group, at University of Tennessee Medical Center, is still recruiting volunteers for a clinical trial to test a potential H1N1 influenza vaccine.
“We especially need people over 65,” said VRG president and principal investigator Dr. William Smith. “We need plenty of information about how the vaccine works in this age group.”
Centers for Disease Control and Prevention officials said last week that at least initially, a swine flu vaccine effort likely will target high-risk groups, which could include the elderly.
But though the U.S. government has contracted with the country’s major pharmaceutical manufacturers to buy vaccine as quickly as they can produce it, “even with everyone going full steam … there will still be a shortage” that will prevent everyone who wants it from getting it, Smith said.
The work VRG and other test sites are doing could affect how many people get the vaccine, because they’re testing how high a dose of vaccine components is needed for the immune system to produce sufficient antibodies against H1N1 and whether adding a “booster” shot three weeks later affects the vaccine’s effectiveness.
If studies show a low dose of the vaccine, administered as a single shot, is effective, that could mean as much as 12 times more vaccine, Smith said.
“Suddenly, it’s made a huge difference in the number of people who are going to be able to be vaccinated,” he said.
Those who take part in the clinical trial, which begins Aug. 5, will receive two doses (an eighth of volunteers will receive a placebo instead). VRG staff will follow up with a phone call the day after the shot to track side effects. Volunteers will return 21 days later to have blood drawn so antibodies can be measured. The process will be repeated with a second shot.
But side effects are “not something we’ve seen people express concern about” when taking part in the trial, Smith said. He said volunteers read and sign a consent form before deciding whether to participate.
Volunteers should be 18 or older and in “reasonably good health,” Smith said. Each will receive $50 after the first shot and $50 after the second. Those interested can call 865-305-9356.
VRG moved to Knoxville from New Orleans in 2005 after Hurricane Katrina decimated both its physical location and its volunteer base. Smith said the group’s work with the U.S. Department of Homeland Security while doing trials for smallpox vaccine and a different type of vaccine for seasonal influenza, among other things, led to the trial for H1N1. Vanderbilt University in Nashville and Emory University in Atlanta are among other U.S. test sites.
Kristi L. Nelson may be reached at 865-342-6434.
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More panic than pandemic
http://www.guardian.co.uk/commentisfree/2009/jul/27/swine-flu-pandemic-rates
The way we're collating figures for swine flu is wildly inaccurate and almost certainly inflating infection rates and public anxiety
My best wishes to those who have had, and will get, swine flu, and my profound sympathies to the families of those who have died from it. To them it is real. But to those responsible for counting cases and designing defences to protect the population, it is a statistical disease.
Before the virus was discovered in the early 1930s there was no other way to measure it. Influenza has no unique clinical features. There is no diagnostic rash. Its symptoms can be caused by a multitude of other microbes. Its activities could only be measured by looking at groups rather than individuals; studying death rates (making the assumption that a rise in the winter was due to flu), and counting the number of cases in a community with "typical" symptoms (likewise assuming that if there was a big rise, its cause was flu).
But rapid diagnostic laboratory tests came on stream in the 1960s. In the last two decades their sensitivity and precision has increased enormously. At the start of the swine flu pandemic they came into their own. Without them the identification of the virus as new would have taken much longer – so would the detection of its rapid spread in North America and the initiation of vaccine development within days thereafter.
But this month health departments in the UK gave up using them on any scale. They have reverted to the traditional method – primarily counting the consultations of patients suffering from flu-like symptoms with GPs. The system relies on reports from sentinel practices which are fed into statistical formulae to work out the total of "flu" cases across the country. This is how last week's estimate of 100,000 cases in the UK was generated.
In the quiet flu years like those we have enjoyed in recent times this GP scheme has worked, not by giving a precise estimate of the number of cases, which it can't because the statistical formulae are full of mathematical assumptions best described as guesses, but by showing believable trends. However, swine flu pandemic publicity has been so intense that any measure relying on calls to doctors from the worried "slightly unwell" (most swine flu cases are said to be mild) or from people wanting Tamiflu (a drug with a curative reputation of the kind that is the dream of every advertising executive) must be challenged, however sophisticated the mathematical models used to tweak the counts. When the chief medical officer, Sir Liam Donaldson, mentions on TV that as many as 65,000 might die it is hard to blame members of the public for an increase in fear, and it is reasonable to expect a reduction in their reluctance to have a consultation about a cold. And who knows what effect the new National Pandemic Flu Service (designed to take the pressure off GPs) will have on the surveillance system.
The best way to assess the accuracy of diagnosis in sentinel practices is to get them to send samples from patients for virology. But only 137 English patients were tested for this purpose last week; 27 were positive. As a sample supposedly covering the whole nation, this is pathetic. All that can be said in its favour is that the rest of the UK did no better; 12 tests were done in Wales (one positive) and 13 in Northern Ireland (one positive). There are 58 sentinel practices in Scotland. They sent in 50 samples; two were positive.
Why so few? GPs in the UK have never been enthusiastic users of virology tests, even the ones that can be used at the bedside to give a result in a few minutes, and it is likely that the small number of virology laboratories in the NHS are too busy working up samples from hospital patients to be shouting about systematic surveillance shortfalls. But the real deficiency is not a flu one. It is the failure over many years to take infection as seriously as it deserves. Typical are the struggles of the Health Protection Agency (which leads the laboratory response to the pandemic) to ensure that its many budget cuts over the years are as small as possible, and the long-term decline in medical microbiology teaching and research in our medical schools.
What next? The CMO said the optimistic estimate of deaths was 20 times less than his pessimistic 65,000. Such a big range means the experts don't know what is going to happen. The biggest worry is that the virus might take off on a grand scale when the schools go back – perhaps targeting the elderly, who have escaped so far. Maybe the virus will suddenly develop Tamiflu resistance. Time will tell. But panic should not rule. Put the pandemic into perspective. So far its lethality is remarkably low. In 1968-69, the mildest pandemic last century, the virus killed 1,000 in the UK in its first four months.
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Swine flu trial needs young volunteers
http://www.theaustralian.news.com.au/story/0,25197,25844726-5006785,00.html
RESEARCHERS are seeking 400 children from across the country to be part of a trial of a new swine flu vaccine, which they hope will be rolled out nationally by the end of the year.
The trial, conducted by Murdoch Children's Research Institute and the University of Melbourne, will start as early as next week and test varying doses on children aged between six months and eight years.
It is the second stage of the swine flu vaccine trial, which began testing 100 adults in Adelaide last week. The vaccine is similar to the one being used to treat seasonal flu but adapted to the swine flu virus.
Researchers aim to test two types of dose strengths and amounts on the children to determine the correct dosage and the safety of the vaccine.
"(The trial) is very important to the Australian government to help inform its decision-making on how the vaccine is going to be used in children, given young people have been the most commonly affected by the virus," said chief researcher Terry Nolan, of the Murdoch Children's Research Institute.
Swine flu has been responsible for 50 deaths across the country, with more than 17,000 people confirmed as infected with the H1N1 influenza strain.
Professor Nolan said the trial would involve children in Melbourne, Adelaide, Perth, Sydney and Brisbane.
He said the Therapeutic Goods Administration wanted to test the vaccine before it planned to roll it out by the end of the year. Professor Nolan said more children than the elderly were affected by the virus because it was a new virus for young people.
"(Only) about 3 or 4per cent of the total cases have been people over the age of 60," he said. "And that is probably because people born more than 60 years ago have been exposed to a virus that was circulating at the time that was quite similar to this virus."
Professor Nolan was hopeful parents would put forward their children for the trial, saying they would have the bonus of having their kids vaccinated early. He said they planned to have dosage results of the trial by October.
Melbourne mother Claire Pietersen said she was planning to put her 10-month-old daughter, Ruby, up for the swine flu vaccine trial.
"I think it is important for us to be involved," she said. "I think it is important for the wider community. I am also happy to have her vaccinated as well and done under controlled conditions."
