GlaxoSmithKline

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Gates-backed test malaria vaccine is celebrated, half glass full | 

African child with cerebral malaria
African child with cerebral malaria
Mike Urban

An experimental malaria vaccine, made by GSK with backing and support on the research side from the Bill & Melinda Gates Foundation and Seattle-based PATH, has (again) been shown to protect half the children in the study were immunized against malaria.

The results, announced today in Durban, South Africa, are pretty much the same as earlier findings that continue to emerge from a long, ongoing study of GlaxoSmithKline’s RTS,S vaccine.

The scientific gist of the latest findings, as was reported back in 2008, is that the vaccine appears to protect about half the kids from getting sick, its ability to protect drops significantly following vaccination, it requires repeat doses and GSK estimates it will cost a few dollars at least.

Is that a glass half full or half empty? Continue reading

Gates-funded ‘breakthrough’ malaria vaccine now disappoints | 

Photo by Caitlin Kleiboer

Testing the RTS/S malaria vaccine in Malawi

The world’s largest clinical trial of an experimental malaria vaccine, largely funded by the Bill & Melinda Gates Foundation in partnership with the vaccine maker GlaxoSmithKline, has produced disappointing results – again.

It shouldn’t be too surprising.

The study has been producing the same disappointing results for many years now. It’s just been emphasized as progress before, with those supporting the work at the Gates Foundation and at the PATH Malaria Vaccine Initiative usually characterizing the vaccine’s protection rate of about 30 percent as proof of concept or as an encouraging step forward.

For example, here’s a Google News shot of how last year’s similar findings — of 30 percent protection — were characterized in the media:

Google News on the malaria vaccine

These stories were over-the-top, so I felt compelled to write Three Reasons Why We Should Not Get So Excited.

On the flip side of that coin, maybe we shouldn’t be too disappointed now.  Continue reading

ArsTechnica: The difficult search for a malaria vaccine | 

Seattle writer Robert Fortner, in ArsTechnica, examines how far we have come in the search for an effective malaria vaccine.

This story is focused on what many consider the most promising malaria vaccine candidate, called RTS,S, made by GlaxoSmithKline decades ago and being tested (again) under improved formulations with funding from the Bill & Melinda Gates Foundation and the PATH Malaria Vaccine Initiative. As I’ve noted before, many experts are quietly expressing doubt RTS,S will work even though it has provided some new insights into the immunology of malaria.

Bob digs deeper into the evidence:

Photo by Caitlin Kleiboer

Testing the RTS/S malaria vaccine in Malawi

After clean water, vaccines may have saved more lives than any other public health intervention. Eradication of malaria, a disease that may have killed more humans than any other single cause, likely requires a malaria vaccine.

However, after nearly a century of research, today’s only candidate might not pack enough immunological punch to win deployment. Sadly, there are no obvious successors. Goals for vaccines set in 2006 are now approaching, but may not be possible to meet.

A quarter century of painstaking work has gone into the vaccine known as RTS,S, now in phase III clinical trials. But after numerous modifications and enhancements, RTS,S still protects only intermittently, 30 to 60 percent of the time.

This protection wanes, although over how many years or months is still being studied. The vaccine reduces disease but, so far, not deaths.

The organism that causes malaria has made vaccine development a challenge. Malaria is caused by the parasite Plasmodium rather than bad or “mal” air as thought long ago. The human genome, particularly in sub-Saharan Africa, chronicles our lengthy and ongoing battle with Plasmodium.

Strong selection pressure on humans has led to evolutionary gambits like the sickle cell trait—risking potentially lethal blood disorders to reduce susceptibility to malaria infection. But Plasmodium has kept the upper hand in many ways. The parasite continues to baffle the immune system with a complex genome reshuffled by sexual reproduction, a multi-stage life cycle that features antigenic shape-shifting, to avoid immune surveillance.

For pathogens like polio, the human immune system can develop durable, sterilizing immunity, which rids the body of the invader. Polio vaccines reliably trigger these natural mechanisms. For malaria, humans can acquire a kind of immunity and potentially even clear parasites completely. But the genetic diversity of Plasmodium falciparum allows it to often avoid such direct hits.

Acquired immunity is often a détente in which the parasite survives and reproduces at low levels that cause neither disease nor death. A study in western Kenya, for example, found 90 percent of a cohort was infected with falciparum even though not one of the 93 people was ill. Vaccines like RTS,S prod the immune system toward this partial protection, but there is concern that it isn’t reducing severe malaria enough.

Continue reading at ArsTechnica.

The Gates Foundation connection to the Glaxo drug fraud scandal | 

In a ‘landmark’ legal case, the pharmaceutical giant firm GlaxoSmithKline (GSK) pled guilty this week to engaging in fraudulent, criminal behavior which included covering up adverse drug side-effects, promoting ineffective therapies and hiding unfavorable data — and will pay a record $3 billion in fines.

Most news reports quoted GSK’s CEO Andrew Witty blaming the misconduct on others and “a different era for the company,” adding that such behavior will not be tolerated. “I want to express our regret and reiterate that we have learnt from the mistakes that were made.”

Gates Foundation

Tachi Yamada

One of the most high-profile GSK executives alleged to have engaged in misbehavior is Tachi Yamada, former head of global health for the Bill & Melinda Gates Foundation who was before that head of research and development for GSK.

Yamada, while he was head of global health for Gates Fdn, was accused in a U.S. Senate hearing of bullying a scientist to not publish negative findings about a GSK diabetes drug. This was fairly big news at the time and such behavior is part of the federal complaint against the drug firm.

As a journalist blogger, I don’t have as much time as the major news outlets to do a lot of original reporting so I count on the big guns to do the work which I can then plagiarize, uh, I mean ‘curate.’

But so far as I can tell, nobody has made any mention of Yamada’s role in this case. Yet he was pretty high profile — at the center of the controversy surrounding the drug company’s attempt to cover-up adverse side effects of its diabetes drug Avandia.

Here are some of the stories that came out years ago, while he was at the Gates Foundation:

CBS News Meet Glaxo’s Fixer

Guardian Glaxo’s handling of drug Avandia damned by US Senate

ABC News Charity chief accused of bullying critic

Wall Street Journal Glaxo’s criticized for response to critics

Yet none of the news stories about this record-setting case mentions Tachi Yamada. Continue reading

Gates initiative on “neglected diseases” advances cause, but neglects key questions | 

The Bill & Melinda Gates Foundation today announced, together with more than a dozen drug makers and others, a new initiative aimed at fighting a select group of mostly developing world ailments called “neglected tropical diseases” such as river blindness, parasitic elephantiasis and others.

Uniting to Combat NTDs

These diseases affect an estimated 1.4 billion people, killing perhaps half a million a year, but have not been high on the global health radar screen. As Dr. Peter Hotez writes for Huffington Post, for only 50 cents per child many of these diseases may now be eliminated.

The new public-private initiative aims to rid the world of 10 of these diseases by 2020.

It’s widely regarded as a positive step forward for global health, but there are some important questions that went unanswered:

  1. What is a neglected disease? This is actually a hotly debated question in global health circles right now.
  2. Many think the solution to fighting diseases of poverty should be to focus on poverty as much as on disease. Will this initiative get at the root problem or just address symptoms?

We’ll get back to the neglected issues of neglected diseases in a bit. First, more on the news:

For this initiative called the London Declaration on Neglected Diseases, the Gates Foundation pledged $363 million to support research into new treatments. Drug makers like GlaxoSmithKline, Merck, Johnson & Johnson and others have likewise pledged to step up research as well as to expand donation programs of medications to poor countries.

Others involved in the initiative include the World Bank, the United Arab Emirates as well as the U.S. and U.K. governments The total estimated commitment is $785 million. Continue reading

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.

Continue reading

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