U.S. government shifts $81 million to Zika vaccine research

Zika prevention kit for pregnant women

By Julie Steenhuysen and Toni Clarke

CHICAGO/WASHINGTON (Reuters) – The U.S. Department of Health and Human Services has shifted $81 million in funds from other projects to continue work on developing vaccines to fight Zika in the absence of any funding from U.S. lawmakers.

In a letter addressed to Nancy Pelosi, a Democrat and minority leader of the U.S. House of Representatives, HHS Secretary Sylvia Burwell said she was allocating $34 million in funding to the National Institutes of Health and $47 million to the Biomedical Advanced Research and Development Authority (BARDA) to work on Zika vaccines.

Burwell said the funding was intended to keep Zika vaccine research going despite the lack of funding from U.S. lawmakers, who left for summer recess before allocating any funding to Zika research and preparedness.

The mosquito-borne Zika virus has spread to more than 50 countries and territories since the outbreak began last year in Brazil. On Thursday, Governor Rick Scott said state health officials have identified three additional people in the affected area with locally transmitted Zika, bringing the total to 25.

The Obama administration in February requested $1.9 billion to fight Zika, but congressional lawmakers have been considering a much smaller sum. A bill providing $1.1 billion was blocked by Democrats after Republicans attached language to stop abortion-provider Planned Parenthood from using that government funding for healthcare services, mainly in U.S. territories like Puerto Rico.

The Republican legislation also would siphon off unused money under President Barack Obama’s signature 2010 healthcare law to combat Zika. In addition, Democrats balked at a Republican provision that they said would gut clean water protections.

The new bolus of funds from HHS comes on top of the $589 million in repurposed funds previously allocated for Ebola efforts. HHS has said these funds will run out at the end of August.

At a press briefing in Washington, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said he needs $33 million to prepare to move the first potential Zika vaccine to the second phase of human clinical trials. The first phase of that testing is expected to end in late November or December.

Fauci said the health secretary has the authority to transfer 1 percent of NIH’s $33 billion budget per year from one Institute to the other. He said the director of the NIH, Dr. Francis Collins, will decide which existing programs the funds will be drawn from.

“He will probably do it on a prorated basis across the Institutes,” he said.

Fauci said the budget transfer will not fill the longer-term NIH funding needs to fight the virus and to develop a second or third potential vaccine candidate. Drugs frequently fail to realize the promise they show in early trials.

“We still need about $196 million more,” he said.

Fauci said the health secretary’s action was essentially one of desperation given the failure of Congress to authorize additional funding.

Taking money from other research programs “is extremely damaging to the biomedical research enterprise,” he said. “We’re taking money away from cancer, diabetes, all those things.”

Dr. LaMar Hasbrouck, executive director of the National Association of County and City Health Officials, said at the briefing that local health authorities are similarly siphoning off money from other programs.

“We’re robbing Peter to pay Paul,” he said.

In her letter, Burwell said the $47 million in funding for BARDA will allow the agency to enter into contracts with key partners to develop vaccines. But, she said BARDA will need an estimated $342 million in additional funding to continue its work with outside partners in the development of vaccines, diagnostics and pathogen inactivation technology used to protect the U.S. blood supply.

(Reporting by Julie Steenhuysen in Chicago and Toni Clarke in Washington; editing by Grant McCool and Bernard Orr)

China’s ‘mosquito factory’ aims to wipe out Zika, other diseases

mosquitoes being released

GUANGZHOU, China (Reuters) – Every week, scientists in southern China release 3 million bacteria-infected mosquitoes on a 3 km (two-mile) long island in a bid to wipe out diseases such as dengue, yellow fever and Zika.

The scientists inject mosquito eggs with wolbachia bacteria in a laboratory, then release infected male mosquitoes on the island on the outskirts of the city of Guangzhou.

The bacteria, which occurs naturally in about 28 percent of wild mosquitoes, causes infected males to sterilize the females they mate with.

“The aim is trying to suppress the mosquito density below the threshold which can cause disease transmission,” said Zhiyong Xi, who is director of the Sun Yat-sen University Centre of Vector Control for Tropical Diseases and pioneered the idea.

“There are hot spots,” Xi said. “This technology can be used at the beginning to target the hot spots … it will dramatically reduce disease transmission.”

Mosquito-borne diseases are responsible for more than one million deaths worldwide every year and Zika has become a concern for athletes at this year’s Olympic Games, which open in Rio de Janeiro on Friday.

Some athletes, including the top four ranked male golfers, have declined to take part.

An outbreak of the Zika virus in Brazil last year has spread through the Americas and beyond, with China confirming its first case in February.

U.S. health officials have concluded that Zika infections in pregnant women can cause microcephaly, a birth defect marked by small head size that can lead to severe developmental problems in babies.

The World Health Organization has said there is strong scientific consensus that Zika can also cause Guillain-Barre, a rare neurological syndrome that causes temporary paralysis in adults.

Sun Yat-sen’s Xi said that several countries had expressed interest in his experiments, especially Brazil and Mexico.

In the laboratory, mosquito eggs are collected from breeding cages containing 5,000 females and 1,600 males and injected with the wolbachia bacteria. Xi’s facility has the capacity to breed up to five million mosquitoes a week.

While a female mosquito that acquires wolbachia by mating is sterile, one that is infected by injection will produce wolbachia-infected offspring. Dengue, yellow fever and Zika are also suppressed in wolbachia-injected females, making it harder for the diseases to be transmitted to humans.

Xi set up his 3,500 square meter (38,000 sq ft) “mosquito factory” in 2012 and releases the males into two residential areas on the outskirts of Guangzhou.

Xi said the mosquito population on the island has been reduced by more than 90 percent.

One villager on the island, 66 year-old Liang Jintian, who has lived there for six decades, said the study was so effective he didn’t have to sleep with a mosquito net any longer.

“We used to have a lot of mosquitoes in the past. Back then some people were worried that if mosquitoes were released here, we would get even more mosquitoes,” he said. “We have a lot less mosquitoes now compared to the past.”

(Reporting by Reuters TV; Writing by Clare Baldwin; Editing by Robert Birsel)

CDC to provide $16 million more to fight Zika locally

Warning of mosquitoes carrying disease by CDC

(Reuters) – The U.S. Centers for Disease Control and Prevention (CDC) is making available more than $16 million to states and territories in their fight against the Zika virus, in addition to the $25 million it had sanctioned in July.

The current Zika outbreak was first detected last year in Brazil, where it has been linked to more than 1,700 cases of the birth defect microcephaly, and has since spread rapidly through the Americas.

U.S. health officials on Monday warned pregnant women to avoid traveling to a neighborhood in Miami after the Florida government said it had identified 10 more cases of Zika caused by the bite of local mosquitoes, bringing the total to 14.

The new funding – for 40 states and territories – will be used to provide real-time data about the epidemic as it unfolds in the United States and help those affected by the virus, the CDC said on Tuesday.

Last month, the agency provided $25 million to 53 states, cities and territories as part of its ‘preparedness and response’ funding to areas at risk for outbreaks.

(Reporting by Natalie Grover in Bengaluru; Editing by Saumyadeb Chakrabarty)

FDA takes steps to protect blood supply in Florida amid Zika probe

man having blood drawn

By Julie Steenhuysen and Toni Clarke

CHICAGO (Reuters) – The U.S. Food and Drug Administration has ordered blood banks in Florida’s two most densely populated counties to stop collecting blood as health officials determine whether Zika has begun transmission in the continental United States.

Florida has been investigating four possible cases of local transmission in Miami-Dade County and Broward County. It is the first U.S. state to report cases that may not be related to travel to other countries with active outbreaks.

Zika has struck hardest in Brazil, where the outbreak was first detected last year, and has since spread rapidly through the Americas. The virus can cause a rare birth defect, microcephaly, in newborns whose mothers have been infected, and is believed to be linked to Guillain-Barre syndrome in adults.

Zika most commonly infects people via mosquito bite. But reports of the virus being transmitted through sex and blood transfusions has prompted public health officials to recommend additional precautions for sexual partners and blood banks.

In a statement posted online on Wednesday, the FDA said blood centers in the two Florida counties should stop collecting blood until they can test each unit or put in place technology that can kill pathogens in the blood.

The FDA also recommended that nearby counties implement the same measures as it moves to prevent transmission of the virus through the blood supply.

OneBlood, Florida’s biggest blood collection center, said it will begin testing all of its collections for Zika virus, effective July 29, using an investigational screening test and that it is working as quickly as possible to comply with the FDA’s request.

The FDA has authorized the emergency use of several investigational Zika screening tests, including products made by Hologic Inc and Roche Holding AG.

The agency has also approved a pathogen inactivation technology made by Cerus Corp that kills the virus in blood platelets and plasma. The company is conducting clinical trials to show it can also kill pathogens in red blood cells.

The United States uses roughly 12 million units of red cells, four million plasma units and two million units of platelets a year.

Unlike oxygen-carrying red blood cells, which can be kept for 42 days in a refrigerator, or plasma, which keeps for a year if frozen, platelets have a shelf life of just four to seven days.

Platelets in general tend to be scarce because there are fewer donors. It can take up to two hours to extract platelets using an apheresis machine, said Dr. Richard Benjamin, chief medical officer for Cerus. And because of their short shelf life hospitals typically do not keep much surplus.

It can be hard to source them from elsewhere, too. By the time they are flown from one place to another they may only have two days of life left.

“All we need is a few more Zika hotspots and there will be a shortage of platelets across the country,” Benjamin said.

The FDA’s action follows Florida’s announcement on Wednesday that it had identified two additional Zika cases – one more in each county – that were not related to travel to an area where the virus is being transmitted.

A CDC spokesman said on Wednesday that “evidence is mounting to suggest local transmission via mosquitoes” in South Florida, noting that the cases fit transmission patterns seen with prior mosquito-borne outbreaks such as Chikungunya.

FDA said it will continue to monitor the situation in Florida in cooperation with the CDC and state public health authorities and provide updates as additional information becomes available.

(Reporting by Julie Steenhuysen; Editing by Bernard Orr)

Doctors devise care plan for babies as Zika threat looms in U.S.

mosquito under microscope

By Julie Steenhuysen

CHICAGO (Reuters) – As U.S. public health officials try to determine whether Zika has arrived in the country, doctors are establishing guidelines on how to care for the rising number of babies whose mothers were infected with the virus during pregnancy.

Florida said it is investigating two possible cases of Zika not related to travel to an area where Zika is active, raising the possibility of the first incidence of local transmission of the mosquito-borne virus.

On Thursday, the Florida Department of Health said it was investigating a non travel-related case of Zika in Broward County, marking the second such case. Florida has asked the U.S. Centers for Disease Control and Prevention to assist in its investigation that must also rule out sexual transmission.

So far, 400 pregnant women in the continental United States have evidence of Zika infection, up from 346 from a week ago, the CDC reported on Thursday. All of those were related to travel or sex with an infected person who had traveled.

Three more babies have been born in the United States with birth defects linked to Zika infections in their mothers, bringing the total to 12, CDC said.

Zika has been proven to cause microcephaly, a severe birth defect marked by small head size and undersized brains that requires a complex network of care providers and social workers to treat and provide support to parents.

But microcephaly is just the tip of the iceberg, according to experts speaking at a CDC-sponsored workshop on Thursday. They said many babies exposed in utero who appear normal at birth may have developmental problems down the road, including hearing and vision problems.

For example, babies born without a functional sucking reflex may never develop the ability to swallow and will need to be fed through a feeding tube. These infants will have a higher risk of pneumonia, said Dr. Edwin Trevathan, a pediatrician and child neurologist at Vanderbilt University Medical Center.

Less obvious damage to structures on only one side of the brain may cause seizure disorders that do not appear until adolescence, Trevathan said.

Pediatric experts at the workshop are reviewing the potential consequences of Zika infection and plan to make recommendations on ways to treat Zika-exposed infants.

The connection between Zika and microcephaly first came to light last fall in Brazil, which has now confirmed more than 1,600 cases of microcephaly that it considers related to Zika infections in the mothers.

FLORIDA PROBE

The recommendations come as Florida officials investigate what may be the first cases of Zika in the continental United States caused by the bite of a local mosquito.

Florida officials will not elaborate on how a resident of Miami was infected and whether the first case under investigation was related to mosquitoes.

“We continue to investigate and have not ruled out travel or sexual transmission at this time,” Florida spokeswoman Mara Gambineri said in an email on Thursday. However, she said the state still suspects the case is not related to travel to a Zika-infected area.

The White House on Wednesday released a statement saying President Barack Obama had spoken to Florida Governor Rick Scott regarding a suspected case of mosquito transmission of Zika and promised more money to fight the virus.

At the Zika workshop, Dr. Marc Fischer, chief of surveillance and epidemiology activity at the arboviral diseases branch of the CDC, said the agency has worked with state health departments to establish strategies to identify possible local transmission in the United States.

“When and if there is a case of local transmission, we work with local health departments to identify additional cases to define the geographic scope of the outbreak,” he said.

That includes surveying households and neighbors within a 150-yard radius around the residence of the person who has Zika.

“That’s basically the flying radius of the vector mosquitoes,” he said.

According to the U.S. Zika response plan, Zika local transmission is defined as two or more cases not due to travel or sex with an infected person that occur in a one-mile diameter over the course of a month.

CDC has given Florida $2 million for Zika preparedness, and on Thursday awarded another $5.6 million to assist the state with Zika as part of an additional $60 million in Zika funds to states announced on Thursday. U.S. lawmakers so far have not approved any of the White House’s $1.9 billion request for Zika.

CDC plans to award another $10 million to states and territories on Aug. 1 to speed identification of microcephaly and other birth defects linked to Zika.

(Additional reporting by Bill Berkrot in New York; Editing by Bernard Orr)

Florida health department investigates possible local Zika transmission

Mosquito being studied for Zika

(Reuters) – Florida health officials said on Tuesday they are investigating a case of Zika virus infection that does not appear to have stemmed from travel to another region with an outbreak.

The statement from the Florida Department of Health did not specify whether the Zika case was believed to have been transmitted via mosquito bite, sexual contact or other means.

The department said the case was reported in Miami-Dade County and that it is working with the U.S. Centers for Disease Control and Prevention on an epidemiological study.

The department also reiterated guidance to Florida residents on protecting themselves from mosquitoes that may carry the virus.

“Zika prevention kits and repellant will be available for pickup … and distributed in the area under investigation,” the health department said in a statement. “Mosquito control has already conducted reduction and prevention activities in the area of investigation.”

Zika, which can cause a rare birth defect and other neurological conditions, has spread rapidly through the Americas. A small number of cases of Zika transmitted between sexual partners have also been documented.

There has yet to be a case of local transmission by mosquitoes in the continental United States, though more than 1,300 people in the country have reported infections after traveling to a Zika outbreak area.

U.S. officials have predicted local outbreaks to begin as the weather warms, particularly in southern states such as Florida and Texas.

(Reporting by Michele Gershberg in New York; Editing by Matthew Lewis and Bernard Orr)

CDC monitoring 320 U.S. pregnant women with Zika

A woman looks at a Center for Disease Control (CDC) health advisory sign about the dangers of the Zika virus as she lines up for a security screening at Miami International Airport in Miami, Florida, U.S., May 23, 2016. REUTERS/Carlo Allegri

WASHINGTON (Reuters) – The U.S. Centers for Disease Control and Prevention said on Thursday that it is monitoring 320 U.S. pregnant women with laboratory evidence of Zika virus infection, up from 287 women a week earlier.

However, the number of babies born in the United States with birth defects linked to Zika infection in mothers during pregnancy, or lost pregnancies linked to the virus, remained unchanged from last week’s report at 7 and 5, respectively, according to a CDC registry created last month.

The registry compiles poor outcomes of pregnancies with laboratory evidence of possible Zika virus infection in the 50 states and the District of Columbia. The latest figures are as of June 30.

Zika has caused concern throughout the Americas due to an alarming rise in cases of the birth defect microcephaly and other severe fetal brain abnormalities linked to the mosquito-borne virus reported in Brazil, the country hardest hit by the outbreak. Infants with microcephaly are born with abnormally small heads and may experience potentially disabling developmental problems.

Brazil has confirmed more than 1,600 cases of microcephaly linked to Zika.

All reported U.S. cases of Zika have so far involved people who traveled to areas with a current outbreak, but health experts have warned that local transmission cases are likely to occur in the coming weeks during summer mosquito season. Gulf Coast states, such as Florida and Texas, are seen as particularly vulnerable.

The virus can also be transmitted via unprotected sex with an infected man.

(Reporting by David Morgan in Washington and Bill Berkrot in New York)

U.S. to fund Zika virus study of U.S. Olympic team

Mosquitoes being studied for Zika

By Bill Berkrot

(Reuters) – The U.S. National Institutes of Health said it will fund a study to monitor U.S. athletes, coaches and members of the Olympic Committee staff for exposure to Zika virus while in Brazil, with the hope of gaining better understanding of how it persists in the body and the potential risks it poses.

The study, announced on Tuesday, seeks to determine the incidence of Zika virus infection, identify potential risk factors for infection, evaluate how long the virus remains in bodily fluids, and study reproductive outcomes of Zika-infected participants.

Brazil, which has been hardest hit by the mosquito-borne virus spreading across the Americas, will host the Summer Olympics in Rio de Janeiro next month.

The virus has caused concern because it can cause potentially severe birth defects in babies whose mothers were infected during pregnancy, including microcephaly – a birth defect marked by small head size that can lead to developmental problems. It has also been linked to Guillain-Barre, a rare neurological syndrome that can cause temporary paralysis in adults.

The study, which hopes to enroll at least 1,000 subjects, is being led by Dr. Carrie Byington of the University of Utah, who earlier this year began a pilot study of 150 participants, a third of whom said they or their partner planned to become pregnant within a year of the Olympics. They will be included in the larger study.

“We will follow individuals who have exposure to Zika virus for up to two years,” Byington said via email. “Because the cohort is anticipated to include primarily individuals in their reproductive years, we will be able to study reproductive health outcomes, including pregnancy outcomes.”

The connection between Zika and microcephaly first came to light last fall in Brazil, which has now confirmed more than 1,600 cases of microcephaly that it considers to be related to Zika infections in the mothers.

Zika is the first known mosquito-borne virus that can also be transmitted via unprotected sex with an infected male partner, leading to imprecise recommendations of how long couples should abstain or refrain from unprotected sex if the woman is pregnant or hoping to become pregnant.

Study participants will provide samples of bodily fluids to be tested for Zika and related viruses, such as dengue, which will help identify people who are infected but asymptomatic. As many as 80 percent of those who contract Zika do not display the classic symptoms, such as fever, rash and red eyes, researchers have said.

The U.S. Olympic study could help answer some of the big unknowns surrounding Zika, particularly the relative risks of asymptomatic versus symptomatic infections, and how long the virus remains present and transmittable in semen.

“We hope to identify risk factors and protective measures that may help other travelers avoid infection,” Byington said.

The USOC had previous said it will provide several months worth of condoms to its athletes and staff heading to Brazil for the games.

(Reporting by Bill Berkrot; Editing by Bernard Orr)

Republican lawmakers approve $1.1 billion in new Zika funds

Woman looks at CDC sign

By Susan Cornwell

WASHINGTON (Reuters) – The U.S. House of Representatives on Thursday agreed to $1.1 billion to fight the Zika virus, short-changing President Barack Obama’s $1.9 billion funding request and angering Democrats by making other cuts to pay for it.

The House approved a funding deal that had been agreed to on Wednesday by Republicans from both the House and Senate. But the bill’s future was uncertain in the Senate, where the Democratic minority has more power to stop legislation, and Democratic leader Harry Reid has declared his opposition.

“It is a responsible plan that assures the administration will continue to have the needed resources to protect the public,” Republican House Speaker Paul Ryan said. Republicans said the deal included funding for fiscal years 2016 and 2017.

But the White House said the allocation fell short.

“This plan from congressional Republicans is four months late and nearly a billion dollars short of what our public health experts have said is necessary to do everything possible to fight the Zika virus, and steals funding from other health priorities,” White House press secretary Josh Earnest said in a statement before the House voted.

Earnest said the Republican plan would limit needed birth control services for women seeking to prevent Zika, which can be spread through unprotected sex — “a clear indication they don’t take seriously the threat from the Zika virus.”

Democrats have been urging Republicans for months to agree to more Zika funding, and the Obama administration has already reprogrammed nearly $600 million that had been set aside to fight Ebola.

House Democrats said they could not go along with the deal because of $750 million in budget cuts elsewhere that the Republicans want to use to pay for the Zika spending.

Senate Democrats also voiced displeasure, clouding the outlook for it passing.

“A narrowly partisan proposal that cuts off women’s access to birth control, shortchanges veterans and rescinds Obamacare funds to cover the cost is not a serious response to the threat from the Zika virus,” Reid said.

Still, Ryan urged the Senate to move on the bill.

According to House Appropriations Committee Chairman Hal Rogers, $543 million of the $1.1 billion would come from unspent funds set aside for implementing Obamacare in U.S. territories, while $107 million would come from unused funds to fight another virus, Ebola. Another $100 million would come from unused administrative funds at the Department of Health and Human Services, he said.

(Reporting by Susan Cornwell and Susan Heavey; Editing by Toby Chopra)

drcolbert.monthly

Congo almost runs out of yellow fever vaccine amid epidemic

Residents read newspapers with reports on Yellow Fever

By Aaron Ross

KINSHASA (Reuters) – Democratic Republic of Congo has almost run out of yellow fever vaccine in Kinshasa, in the same week that the government declared an epidemic of the disease in the packed capital and two other provinces.

Some local people have complained they were denied immunization due to the shortage, despite queueing for a shot. More supplies have been promised, but health officials in the impoverished country say they have to choose between the high cost of flying them in, or a long wait for shipment by sea.

The mosquito-borne hemorrhagic virus is a major concern in Kinshasa, a city of about 12 million people which has poor health services, a humid climate beloved of the insects and much stagnant water where they can breed owing to pour drainage.

Health minister Felix Kabange said on Monday that 67 cases had been confirmed in Kinshasa, Kongo Central and Kwango provinces and that over 1,000 more suspected cases are being monitored. Five people have died from the disease.

The government and international health organizations vaccinated more than 2 million people, about half of them in Kinshasa, between May 26 and June 4.

But there is no more vaccine left, aside from a small number of doses left in reserve in Kongo Central and some being administered by a government agency at Kinshasa’s central hospital, airport and river crossing with neighboring Congo Republic, health officials said.

The agency is charging $35 for the doses it administers, a hefty sum in a country whose gross national income per person is estimated by the World Bank at $380 a year.

Eugene Kabambi, the World Health Organization (WHO) spokesman in Congo, said that the International Coordinating Group on vaccine provision has promised Congo more than a million more doses.

“That requires either a cargo flight, in which case it would come very quickly but cost a lot, or if it’s by boat, it could take a few weeks,” he told Reuters.

The Coordinating Group brings together the WHO and United Nations Children’s Fund (UNICEF) with the International Federation of Red Cross and Red Crescent Societies plus the medical charity Médecins sans Frontières.

The global stockpile of yellow fever vaccine has already been depleted twice this year to immunize people in Angola, Uganda and Congo. It stands at 6 million doses, but this may not be enough if there are simultaneous outbreaks in a number of highly-populated areas, experts warn.

Almost 18 million doses have been distributed for emergency vaccination campaigns so far in the three African countries.

QUEUES FOR VACCINES

Congo has extensive experience of dealing with outbreaks of tropical diseases and the Ebola virus was first identified in the central African country.

It earned plaudits in 2014 for quickly containing a local Ebola outbreak that killed 49 people in the country. By contrast an Ebola epidemic killed more than 11,300 as it swept through West Africa from 2013.

Of the cases confirmed in the latest yellow fever outbreak, seven were locally transmitted in Congo. Another 58 were imported from Angola, where it began, and two came from remote forested areas not linked to the current outbreak.

Symptoms of the disease include fever, body aches and nausea, although most people recover.

In Kinshasa’s Ndjili commune, a maze of narrow alleys and one of the health zones in the city targeted for vaccination in late May, many residents were unable to receive an injection before stocks ran out.

“Everyone started coming, even from other districts. Near the end we realized that the vaccine was insufficient,” said Murphy Nzuzi, a doctor at a dimly-lit health center in Ndjili with only a few small treatment rooms. He added that fights had broken out among people waiting in line.

In a nearby market where trash collected in a small stream, residents said that some people had received vaccination papers while waiting in line but never got a shot.

“When you present yourself, they give you the card that gives you access to the vaccine, but then there wasn’t enough vaccine for everyone,” said local resident Mama Mavungu.

The current method for making vaccines, using chicken eggs, takes a year. Health authorities are considering using a fifth of the standard dose of vaccine – enough to immunize temporarily but not to give lifelong immunity – to maximize its availability, but no final decision has been made.

(Editing by Tim Cocks and David Stamp)