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Experts question Gates-Glaxo malaria vaccine report

Flickr, Aya Rosen

Many of the world’s leading vaccine experts and the prestigious British journal Nature are raising questions about the potential efficacy of an experimental malaria vaccine — and the way it is being promoted by scientists supported by the Gates Foundation.

As Nature News’ Declan Butler reports in Malaria vaccine results raise scrutiny:

To judge from last week’s headlines, scientists had made a big breakthrough in the long campaign to create a malaria vaccine ….

Yet several leading vaccine researchers, who are critical of the unusual decision to publish partial trial data, argue that the results raise questions about whether the RTS,S candidate vaccine can actually win approval.

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Three reasons not to get too excited about the Gates-Glaxo malaria vaccine

Last week, the biggest news out of the Gates Foundation’s Malaria Forum were some interim results of an ongoing test of an experimental malaria vaccine.

Many, if not most, media reported the findings in somewhat hyperbolic fashion as a “major milestone,” a “breakthrough” or “world’s first malaria vaccine.”

Google News on the malaria vaccine

Despite the hype and fanfare, many experts at the Seattle meeting said this experimental vaccine (known as RTS,S) actually so far represents only incremental progress — a scientific achievement which may still turn out to have little practical utility in the real world. They usually only said so privately, given that the Gates Foundation preferred to hear “optimistic” assessments rather than cranky ones.

1. No breakthrough. Let’s first put to bed the claims that these findings represent a major milestone. In fact, the findings largely repeat earlier ‘interim’ results that have continued to find the vaccine protects only half of those immunized — and appears to wane fairly rapidly over time.

So that’s the first reason — a point also made in this (terribly titled) Huffington Post article A vaccine that works only half the time is not the shot in the arm malaria needs. The author, Tido von Schoen-Angerer, director of Médecins Sans Frontières‘ essential medicines campaign says:

But while the latest advance toward the development is scientifically important, there are several reasons to be cautious about the difference this vaccine could make, on the basis of current results.

2. The cost question. The second reason this halfway effective malaria vaccine may not work is cost. The manufacturer GlaxoSmithKline has refused to say what it thinks it will have to charge for the vaccine, other than to say it would be “at cost” plus 5 percent. Neither the PATH Malaria Vaccine Initiative, which is working with GSK on the malaria vaccine trial, or the Gates Foundation (which funds the PATH initiative) will say what price they think is feasible. Many say anything over a dollar might be too much for poor countries.

3. The science. It is promising that researchers have shown a vaccine against malaria is possible. But there’s a lot of other research out there indicating why it may be quite difficult to get a malaria vaccine that can perform as well as most of us expect a vaccine to perform — providing ideally something like 90 percent protection but hopefully not lower than 70 percent. Continue reading

Queen of England bestows honor on PATH’s gizmo guy

Flickr, UK Ministry of Defence

Queen Elizabeth

The Queen of England has bestowed an exalted honor on PATH’s top gizmo guy.

“She said global health was a rather big subject and must involve a lot of travel,” said Michael Free, chief of technology for PATH, who had in fact stopped off in London to be received by the Queen before embarking on a month-long trip of global health travel.

Last week, Free was made an Officer of the Order of the British Empire in recognition of his team’s many inventions and innovative approaches aimed at helping solve health problems in the developing world. It’s not quite as prestigious as a Knighthood but better than a sharp poke in the helmet.

PATH

Michael Free

One of Free’s inventions was the single-use, auto-disabling syringe — a device now in common use worldwide, here in the U.S. as well, aimed at reducing the transmission of disease through accidental needle sticks.

But Free was also likely honored for his much broader and critical role in helping give birth to PATH in the 1970s.

How this British farm boy, raised in creamy Devonshire, ended up in Seattle working on some of the most innovative solutions to developing world health problems offers insight into the evolution of PATH and, to some extent, the entire field of global health.

“In the beginning, our approach was not well-received by either the public or private sectors,” said Free. “It was a bit out-of-the-box.”

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A look at the local global health “industry” of Washington state

The Washington Global Health Alliance and the City of Seattle’s Office of Economic Development has published a new report describing our region’s growing global health industry (even though they shy away from calling it that, preferring words like “sector” and such).

Called the 2011 Global Health Strategic Mapping and Economic Opportunity Portfolio, the report identifies local organizations working in global health, the number of jobs, types of projects overseas and many other interesting tidbits — including business opportunities. Some key findings:

  • Respondent’s organizations have 2,503 projects and initiatives in 156 countries.
  • In Washington, 2,979 people work in global health. Outside of the state, these 59 organizations support an additional 17,275 employees.
  • Washington has particular expertise in infectious & chronic disease and developing technologies & devices.
  • Washington global health organizations surveyed collaborate with 1,574 partners, located in 111 countries across the world.

WGHA

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New CEO of Global Impact seen wearing bizarre hat

I was heading home from my friendly neighborhood grocery store in Wallingford — having just finished a discussion there regarding Edna’s latest weight loss — when I came across this disturbing sight:

Tom Paulson

Gena Morgan adjusts Scott Jackson's new Global Impact helmet

That’s PATH’s Gena Morgan adjusting a custom-made helmet (suspiciously similar to the beer bong hats seen around university campuses) on Scott Jackson, outgoing vice-president at PATH.

Jackson is leaving PATH to become the new CEO of Global Impact, a Washington, D.C.-based organization that represents 58 internationally oriented humanitarian organizations such as CARE, Doctors Without Borders, Mercy Corps, World Vision, UNICEF, Save the Children, Partners in Health and, oh yeah, PATH.

Yet here was Jackson, at a gathering of PATH colleagues (his last official day at PATH is today), wandering around Wallingford wearing this helmet outfitted with cupholders, drinking tubes, LED lights and mumbling something about “Action Jackson.”

Look out Global Impact!

PATH encounters vaccine foes, charges of unethical research in India

 

Flickr, Dey

 

One of every four deaths from cervical cancer worldwide is a woman in India.

The cancer, which kills 250,000 women every year, is almost always caused by a sexually transmitted virus, human papillomavirus or HPV. There is a vaccine against HPV that studies have shown prevents this infection. India, it turns out, has more than its fair share of HPV and cervical cancer.

In 2009, Seattle-based PATH, with funding from the Bill & Melinda Gates Foundation, launched a project aimed at assisting India with introducing the HPV vaccine.

It didn’t work out as planned, as a report in Nature News this week — entitled Vaccines trial’s ethics criticized — describes in some detail.

The sub-headline of the Nature article, “Collapsed trial fuels unfounded vaccine fears,” is perhaps a bit closer to capturing the essence of this tale. But you could also say it was actually the unfounded fears that caused the collapse, which continues to fuel allegations of unethical research. An excerpt:

A scientific investigation has exonerated the vaccines but uncovered a more familiar problem in India: ethical irregularities.

Sounds bad, but I don’t think that was really the main problem here either. The problem, at least insofar as I can tell, is that the scientific and medical community basically sat on the sidelines and hoped to avoid controversy instead of dealing with it head on. Continue reading

PATH’s meningitis vaccine project on Good Morning America

PATH’s meningitis vaccine project was featured on ABC’s Good Morning America show on Memorial Day:

Here’s my post from early December, when PATH, the World Health Organization, UNICEF and other partners started immunizing in Burkina Faso, the culmination of a decade-long struggle to develop an inexpensive meningitis vaccine designed for use only against an epidemic strain in Africa.

While the immunization campaign is impressive, having already protected some 20 million people, the real game-changer here was the demonstration by PATH (with funding from the Gates Foundation) that it was feasible to develop a new vaccine of benefit only to poor communities at a cost — about 50 cents — they could afford. I wrote a bit more about this project recently in a story on PATH’s 34th anniversary.

The GooMoAmerica story, as part of ABC’s Be The Change: Save A Life series, was also funded by the Gates Foundation. ABC, to its credit, mentioned this in its report.

Some are disturbed about the extent to which the Seattle philanthropy, which of course is a big player itself in global health, is funding media coverage of global health. The Gates Foundation says it takes a hands-off approach and is just trying to encourage more coverage of neglected issues.

PATH celebrates 34 years of life-saving gizmos

Seattle-based PATH today celebrated 34 years of finding creative ways to use science and technology to save millions of lives, mostly children, and one achievement this year that was unusually ground-breaking.

A vaccine made only for poor people.

That sounds simple enough, but it isn’t. Vaccines have to be made by the drug industry and industry needs to make money. In central Africa, a particular strain of meningitis has for generations killed, maimed and terrified communities from Senegal to Ethiopia.

Developing a vaccine against this bacteria was long possible, but the drug industry saw no market for it. This disease was too geographically specific and the people (or the governments) too poor to be able to afford a “designer” vaccine.

But, as I posted on last December, PATH’s Marc LaForce was determined to get this vaccine made and paid for because the well-being of millions of Africans depended upon it.

“It took 10 years to develop this vaccine,” LaForce said today at PATH’s annual fundraising Breakfast for Global Health event, this year held art Bell Harbor. It took financial as well as technical innovation, as described on PATH’s web site.

In Burkina Faso, where the vaccination campaign started this winter and which used to see thousands of cases of bacterial meningitis, LaForce said this year “there has been only one case.” At the PATH breakfast, St. Joseph’s choir mimicked the sound of rain — end of meningitis season — to celebrate the achievement.

Tom Paulson

St. Joseph's Choir, mimicking the sound of rain and end of meningitis season

Chris Elias, president of PATH, said some 20 million children and young adults have been vaccinated so far with assistance from UNICEF, Doctors Without Borders, the World Health Organization, countless health workers in Africa and, most recently, with $100 million in new funding to expand coverage from the Global Alliance for Vaccines and Immunization.

That is in itself an amazing success story, he said, but what makes PATH’s Meningitis Vaccine Project “one of the most important milestones in public health” is how they demonstrated that a vaccine of use only to poor countries could, in fact, be produced cheaply (about $.50 a dose) and profitably by industry.

Another milestone celebrated at the PATH breakfast today was a reunion of the founders of PATH, Gordon Duncan, Richard Mahoney and Gordon Perkin. The three started PATH (which initially went by a different, much less phonetic, name) primarily to work on improving maternal health in poor countries.

PATH, which today is one of the world leaders in the burgeoning field of global health, didn’t always have it so easy. I can remember going to visit them in the 1980s in their non-descript building on the Lake Washington ship canal, working on projects in cramped and hardly luxurious settings. At one point, they were even at risk of going out of business due to cuts in donor funding.

But they persevered, moving into new areas with technological solutions or improvements focused on problems in vaccination, water safety and other health needs. Eventually, PATH caught the eye of the (at the time new) Bill & Melinda Gates Foundation. The rest, as they say, is history.

“We just happened to be in the right place at the right time,” said Richard Mahoney, who is now working on a (Gates-funded) project in South Korea, the Dengue Vaccine Initiative.

Tom Paulson

PATH founders Richard Mahoney, Gordon Duncan and Gordon Perkin