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Films to See: "Escape Fire" and "The Waiting Room"

Many people muster strong opinions about Oscars - not I. Having enjoyed some of 2012's awarded movies, I watched the Oscars with appreciation, albeit distracted by the din of our crowd. The only thing that always disappoints me, every year, is how many important subjects and films get left out. The 2012 documentary movies "Escape Fire" and "The Waiting Room" focus on healthcare in the U.S.

"Escape Fire"

Escape Fire airs this weekend on CNN. The film isn't shy about its agenda, as one commentator puts it: "We don't have a healthcare system, we have a disease management system." The disease management system in the U.S. comprises many industries - pharmaceutical, insurance, hospital chains, and doctors' groups, so the film covers a lot of ground.


Escape Fire

Doctors and patients dependence on pharmaceutical drugs gets shown via an arresting story of a veteran being weaned off of painkillers. The pharmaceutical industry's economic calculations, deadly to patients, are recounted by Dr. Steven Nissen and the familiar story of Avandia. The insurance industry's stake in it all is discussed and memorably captured in a shot of all the insurance company representatives sitting around the table negotiating Obama's healthcare plan. The filmmakers somehow patch together an optimistic if controversial package of solutions for the impenetrable seeming morass they depict. A Safeway executive marshals employees to exercise and lose weight. Media-popular doctors hold forth with various remedies.

The story thread I appreciated most was that of a primary care doctor. To her dismay, time with patients kept being shortened to meet new economic demands. Supervisors told her to "get her productivity up", so she changed jobs more than once, hoping for a position that allowed her to adequately care for her patients.

Aside from patients, primary care physicians have taken the toughest hit in our *efficiency* driven system. There aren't enough of them, and the care in some parts of the country has become so slapdash it's dangerous. Yet at the bottom of every health article, at the end of every pharmaceutical ad, in every news piece about this or that medical research is a bright, incongruous little instruction: "Ask Your Doctor". As if. As if we had the same level of medical intimacy and trust, just technologically superior, as when my great grandfather worked through nights, house to house in his little town.

Interestingly, the system depicted by the riveting film "Escape Fire", however sickly, is what the healthiest patients get, those who have the very best insurance in a places chocked full of excellent hospitals. Fifty million uninsured patients in the U.S. don't get that.

"The Waiting Room"

Which brings us to the excellent film "The Waiting Room", by Steven Nicks, shortlisted in the top 15 Oscar picks. The movie's setting is Oakland, California's Highland Hospital waiting room, over 24 hours. It focuses on a different aspect of the problem than "Escape Fire" and takes a different tone. If on the continuum of polemic reporting, Michael Moore's "Sicko" scored a 9-10, "Escape Fire" might get a 6-7, and "The Waiting Room" would score a 0-1. Healthcare has been ruthlessly politicized in the U.S. and most people will bring some opinion to this film. In turn, the film strives to be empty of politics. It provides details for its characters, but doesn't do voice-overs, doesn't judge, and doesn't demand your defined conclusion.

Deplore the public cost of diverse homeless populations plagued by addictions, unemployment, poverty and in need of medical care? Those people end up at Highland Hospital. Disdain college grads who don't pay for health insurance? They too, sit in this waiting room. Despair a healthcare system that allows people to get sick and sicker until they end up in emergency rooms instead of getting primary care? Those sick people are here. Agonize how social services have been ruthlessly cut in poor cities? Highland Hospital helps these people also.

They sit shoulder to shoulder in our emergency rooms - our institutions of last resort. Every age, gender, and nationality, they're all here, men plagued with chronic labor-related injuries, primly dressed women abruptly out of work, twenty-year olds surprised by tumors, stroke victims who couldn't afford medicine, kidney dialysis patients from other states, and alcohol/drug addicts living on the streets.

The Waiting Room

But the film doesn't run all their stories together like I just did, in a big forgettable jumble. It follows each person. How did a little girl with tonsillitis end up in the emergency room instead of in primary care? Her parents are separated, but both show up at the hospital. Her dad lost his job and missed his day with her yesterday on account of transportation. He anxiously hops around her during intake. His son died at two. The nurse, half his size, counsels him to settle down so he doesn't scare his daughter. The girl seems numb to it all.

Triage

Whatever you feel about their plight, whatever sentiment or opinion, the frenzied emergency room healthcare system doesn't have time for any of it. Sentimentality? No. Compassion? Yes. Medical technicians and intake nurses and doctors and interns triage when all beds are full and patient tempers are short. They treat patients as best they can, when specialists have months long waiting times, when "non-profit" hospitals turn away poor patients, and when community safety-nets like churches run out of giving.

The outcomes at Highland Hospital can stretch the boundaries of adequate medical care. Fresh gunshot wounds get run into a trauma room, a steady stream of community catastrophes delivered by ambulance, while men with not fresh but unhealed gunshot wounds groan for hours, days, in the waiting room. A homeless man occupies one bed for too long because he has no place to go. Someone who can't get surgery seems pleased with a pain med prescription. This is where the 50 million uninsured people who are not short-changed in the scenes of "Escape Fire" land sometimes enduring hours of wait before they see a doctor.

At discharge, patients summon fragments of pride. They negotiate payments and answering questions about unemployment checks and family resources awkwardly, over a small desk, everyone caught up in unfortunate circumstances. "The Waiting Room" captures the tension of these situations in a refreshingly empathetic way.

If the movie doesn't hammer home a message, it embraces realism. A new doctor, stunned, is told what to say to a family, told exactly which forms of the verb "to die" to use. After one trauma team struggles to save a gunshot wound victim, they attach a tag to a fifteen year old's toe and he gets wheeled into the morgue. We read a small sign next to the refrigerator door: "Put The Body in Any Available Space".

The film, being so good, won't say this, but economically, ethically, and psychically, everything that brought this Oakland boy to that place costs society. Whatever your politics - in every way, it costs you.

Escape Fire and The Waiting Room, two films highly worth seeing.

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The Waiting Room played all over last fall, and aired on PBS. It is now playing a few other places around U.S., and is also available for purchase. The film team also produces an interactive multi-media site.

Our National Weapons of Mass Destruction

Gun Control - Can We?

2012 has been another year of gun killings, the latest being the mass murder at the Sandy Hook school in Newtown, Connecticut. After each mass shooting, gun control is discussed for a while, before anger and anguish peter out. As we write, just days after the tragedy, Senator Feinstein has vowed to renew assault weapons legislation. Will we actually do something this time?

If you look at people's interest via the program Google Trends1, just as a rough proxy, it doesn't look optimistic. On July 20th, a gunman in Aurora, Colorado killed 12 and injured 58 in a movie theater, and on July 21st, the day after the shooting, "gun control" searches peaked. They also increased after the Oak Creek, Minnesota Sikh Temple shooting (6 people killed and 3 injured) on August 5th, and after the Empire State Building shooting August 24, 2012 (2 people killed and 9 injured). But nothing ever happened. Politicians mourned before cameras, tipping their heads to wipe a tear off their cheeks, then did nothing.

GunControlTrends1
Google Trends shows the relative frequency of one or more search terms1.
The graph shows the frequency of the term "gun control" in the US for July and August, 2012.
(Google)

Of course, in addition to these mass murders, there's the baseline murder rate, the quotidian murders of bystanders, husbands, wives, girlfriends and boyfriends, mothers and fathers - thousands of deaths. Chicago had almost 500 murders this year, roughly half the murders of 20 years ago, but much higher than last year despite the 10% lower overall crime rate. Like Newtown, Connecticut, Chicago has struggled to get guns off the streets, and every attempt, from banning handguns and shooting galleries to disallowing concealed handguns, has been fought by gun owners and lobbies, often successfully.

Cord Jefferson described Chicago's struggle with gun violence last summer, and Marc Lamont Hill discussed the multifaceted nature of the problem here at HuffPost. Both suggested that there's a lack of attention to inner city high gun violence because the murders are often associated with black men and gangs. I don't doubt that.

But people's overall attention to gun violence is sporadic, like their attention to climate change. When a hurricane destroys lower Manhattan, do New Yorkers' worry more about climate change than when a hurricane destroys some island in Asia? You bet. What about when familiar, safe-seeming places like movie theaters and schools become frequent targets of mass murderers? Are we more terrorized by deranged people armed with military grade firepower intent on taking out entire pop-corn eating movie audiences than by inner-city murders? Apparently. Then Newtown, Connecticut happens. Who is more innocent and more vulnerable than children, and what place is presumed more safe than a suburban grammar school?

GunControlTrends2
The frequency of the search term "gun control" in the US, 2004 - 2012.(Google)

After a seven year old kid was killed in Chicago last summer, Mayor Rahm Emmanuel warned gangs to "take your stuff to the alley", but "don't touch the children of the city of Chicago, don't get near them". The nation seems to have a similar response to last week's Newtown killings. The Google Trends report for "gun control" after Newtown is off the charts compared to any other gun related incident in Google Trends' 8 year history. The question is, will the concern be sustained enough to force the slower, more tedious task of legislative action?

GunControlTrends1
The frequency of the search terms "gun control" (blue), "climate change" (red), and "kittens"(gold), in the US, 2004-2012 (Google)

Gun control will not solve all the violence, all the problems. But it's a start. We can no longer bide politicians who cower before gun money, wantonly abandoning constituents who then die in deadly fusillades discharged from automatic weapons, or survive traumatically -- the six year old girl who "played dead" under the carnage of her Sandy Hook classmates in Newtown. Journalists should examine their leniency towards the lily-livered politicians who serve up excuses for action.

The challenge will be that we're so easily distracted, and gun makers, lobbyists and politicians bank heavily on our fleeting interest. The trends work in their favor. Distractions come as competing headlines, cute kittens, and as heartfelt, canny, or vicious arguments from people who support unlimited lethal power. We get a barrage of confusing information, some of it deliberately misleading - various headlines yelling that the root cause is violence in the media, or mental illness, or misinterpretation of the Second Amendment, or that the problem is too multi-faceted and big to tackle, that laws don't/won't work, well they work but Australia is different, the NRA wields too much power...All of this mutes resolve.

But when little boys are offering to lead classmates out of a school besieged by gunfire because they "know karate", we must do more than wax eloquently about our seven-year old heroes. Can politicians be courageous? Can they be heroes? Or do we have to go to historical movies like "Lincoln" to see that? Can citizens and journalists muster the guts to hold our politicians the slightest bit accountable for our reasonable safety?

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1 Google Trends has been used to make predictions about disease outbreaks, here are some studies. The program has improved significantly since we last looked. Of course it has also been mocked.

World AIDS Day, 2012

Today is 25th World AIDS Day, so more people than usual spent time last week reading about the world's progress conquering AIDS. In good news, deaths from AIDS have declined. In Sub-Saharan Africa they have declined by 32% in the last 5 years, continuing an excellent trend. But how do we perceive the progress? We wrote on World AIDS Day, 2009 about how Google tried to correct our search "HIV infections decrease", to "HIV infections increase".

The first search phrase, ending with "decrease", yielded only 1,940,000 results in .22 seconds, whereas the second, ending with "increase", gave 3,550,000 results in .18 seconds.

If Google was tracking a trend, they were wrong, because by 2009 HIV infections had decreased by 15% in 10 years. But we in the world were very accustomed to bad news about HIV infections and AIDS, as Google documented. Today, three years later, there's even better news for HIV/AIDS - on the drug development front, as well as on detection, treatment, and prevention fronts. That was an example in 2009 of how false bad news overwhelmed positive news (via a Google algorithm)

Today, the bad news is that people still die of AIDS all over the world - in Russia, China, Asia, Africa, and the US, where public health officials recently recommended that people ages 15-64 be tested for HIV. African countries, especially in Sub-Saharan countries, still have the most cases of HIV infected people, and many of people aren't being treated for what is basically affordably treatable. But how should we talk about this bad news? That is the subject of this post.

But the Bad News, How Shall We Put It? Shalll We Ignore It?

In the past few years an interesting conflict has arisen about news in Africa. Critics complain that Western media can't take its eyes off the cliched, ailing, and violent aspects of the African continent, thus giving an inaccurate, un-nuanced and harmful view of its many countries. Nicholas Kristof is a popular target.

The group Radi-Aid released a parody video urging Africans to give money to send radiators to Norway ("frostbite kills too"). Produced by Norwegian students, it mocks this so-called "poverty porn" in the style of the 1984 Band-Aid fund raiser. It's a charming video and relays a potent message. But realize that the Radi-Aid video mocks something that's 25 years old - as in, what can't you mock from 1984?

But beside that minor quibble, of course, I see their point, I think anyone can. If you've ever traveled, you've probably run into inaccurate media portrayals of your country that are just crazy. I remember reading an English paper in Asia that had only bizarre stories about the US, things like - Woman in Tennessee Found Herself In Closet Stomping Beetles. What? You had no idea where they found it -- could they have just made it up? Based on American TV shows, little kids would ask me if I ever got shot in a gunfight - NOO?

Cultural misconceptions are legion and universally perpetuated. I'm sure small towns in the Mid-West that occasionally get besieged by floods and tornadoes feel betrayed by the mainstream media too - Hey wait! we have great potlucks here and there's the most amazing other stuff too! New Orleans must have felt that way during and after Katrina. C'mon! Shot after shot of all those people in the stadium? It's not only Africa that's the subject of inaccurate, negative media portrayals, it's every other country, town and borough, and all subjects too - science, math, economics, election polling, women...they all have their bad day via the media and press.

Aid Solicitations, In the Eyes of The Beholder?

For African countries, a lot of so-called poverty-porn starts with international non-governmental organizations (INGOs). INGOs do use sympathy for fund-raising -- large-eyed children dragging teddy bears, or gathered around looking up at the camera pathetically, or forlorn in barren, monochromatic surroundings. To me it gets a little gross, but they use what works, what gets people to reach into their pockets and give money. These images get picked up or pushed upon the media and used as news. Here's a clear example of how deceptive this imagery can be. But these stories don't comprise all the news of any country.

Some commentators have pointed to what they say are "better" portrayals of Africa that could be used to fundraise. In one, a cute kid in a video acts out an Arnold Schwarzenegger movie, interspersed with the movie's gunfight where "2000" people get killed. The video describes him as smart and articulate, without mentioning or questioning as far as I could tell the especially violent part of American culture that the ~5 year old is copying so very, very accurately. So clearly, different people find different solicitations using kids appealing. Some people take offense to a small child holding a bowl up, but have no problem with a small child acting out extreme violence with a pretend gun followed by a plea for donations. Personally, I have as much problem with the second as the first, and would also ask while we're at it -- shouldn't we question the ethics of using a child for fund-raising at all? Or is it ok as long as the child is wearing a shirt and not holding a bowl? (Then there are whole factions of international development that abhor aid altogether and they also have some good points that I'm not going to talk about here.)

Maybe News About Malaria Shouldn't Focus on Africa, Where 90% of All Cases Occur?

To their point, many other countries, India, the US, China, have crushing poverty, but aren't necessarily defined by it, as critics claim Africa is by Western media. That may be true, but when it comes to preventable infectious disease, 99% of people who die from AIDS, malaria, and tuberculosis (TB) live in the developing world, and the center of the HIV/AIDS epidemic is still in sub-Saharan Africa, where 70% of all new infections among adults and 91% of new infections among children occur. Malaria kills about 780,000 people each year, and 90% of malaria cases are in Africa.

Such illness and death devastate families, workers, and economies. When mining companies in South Africa started treating workers for AIDS and malaria, they had a business goal, stop lost productivity. Similarly, in our global economy, Asia's and Africa's problems and successes affect the world. That means that how African nations attend to public health influences our own public health and impacts our companies that invest in Africa.

Reporting on Africa is not just about Africa, it's about us in the West too. Reporting is not a selfless endeavor. We absolutely should be reporting on Africa's "bad" news (not exclusively of course). Our public health problems (e.g. infectious disease, antibiotic resistance) derive from and are dependent on not only our own public health systems, but also those of developing nations. Our health depends on the policies, laws and regulations all nations produce and uphold for preventing and treating disease, and for drugs and pharmaceutical companies.

We understand that Africa knows investors want stable countries to invest in. African nations naturally want to discourage negative foreign media. But is it the job of responsible media to protect the image of nations? Or is it the job of responsible media, say American or European media, to report on issues that might impact (or interest) its citizens - like public health environments in countries like Africa or Asia or wherever that might promote pharmaceutical regimes that foster antibiotic resistance for instance, or public health environments that allow pandemics to spread for example?

Progress of International Development

For close to a century, international development has sought to raise basic standard of living the world over, not just Africa, but South America, Asia, Central America and parts of North America. Driven by various agendas and business interests and research, we've compiled a long history of what has worked and not worked. For many reasons, what seemed to work in Asia, South America, Central America, etc. didn't work well in Africa. In addition, various national tragedies bogged down progress there. No sooner was apartheid defeated in South Africa, for instance, then AIDS struck. Journalists weren't wrong to cover these events.

Journalists reporting these stories have also sometimes brought needed attention that often benefits the subjects. For instance media outlets reported on the 39 pharmaceutical countries that sued South Africa when it tried to import affordable AIDS drugs at the height of the AIDS epidemic. The companies eventually dropped the suit. When President Mbeki refused to acknowledge that HIV caused AIDS, the media was there. The media now has more opportunity to report positive AIDS news.

Prosperity To Spare

Recent prosperity in the west gave people the means to donate money and ideas for aid organizations. Take the Gates Foundation, founded in 1994. This 2001 Seattle Post Intelligencer article writes about how Bill Gates started slowly learning about international development and health needs in 1998:

"I had no idea," the Microsoft co-founder said. "I learned a lot about the whole vaccine miracle, about how effective they are and yet millions were still dying from these diseases.

"So we decided, jeez, the impact we could have by getting vaccines to these children and getting more funding for research into new vaccines could be just incredible."

That was only about fifteen years ago. A world business leader "had no idea" about preventable diseases in Africa. It's easy not to realize how many advances have been made in the past few decades, in part because what was unheard of in 2000 has now became common knowledge to everyone. Globalization of business has brought increasing attention to development issues that are no longer "a world away". But make not mistake, most of these ideas have been around for decades, like the fact that women's education is key to development. Vaccines have long been (albeit controversially) considered the ideal solution to diseases.

What's new is that foundations like the Gates Foundation are increasingly media savvy, and the media is increasingly in tune with the goals of development. This environment made it possible for Kristof to start writing what he did, and in many ways his articles were in synch with US development goals and rhetoric. (Part of the rational for invading Afghanistan, for instance was women's education.) But many of the most popular articles, for instance Kristof's, also opened readers' eyes to both positive as well as alarming stories outside of their mostly elite, privileged self-indulgent New York Times world view. Not a bad thing. Increasingly, global connections have eased people's ability to travel to different countries, increased curiosity about different cultures, and along with that, encouraged inclinations to want to help (I'm not going to argue whether the burgeoning aid industry is good or bad, but some of the 'wanting to help' inclinations, are selfless).

So Does Media Portray Africa Too Negatively?

A recent BBC program asked the question at a conference in Kampala, Uganda: Is media propagating negative stereotypes of Africa? The opinions were very interesting, ranging from a couple of people who that said African leaders themselves inflate problems in order to get foreign aid, to those who said that Africa was seen not as a problem but as an investment opportunity for many countries.

Of course there should be positive stories about African countries. But don't ignore the good that comes publicizing problems. While South Africa struggled with its AIDS crisis with the world advocating for its citizens, countries like China for years suppressed news of its AIDS epidemic. Other alternatives exist also, reporters and columnists who ignore and glaze over tragedy, and focus only on business that privileges the elite, and ignore those who are not in the elite. You can find those stories anywhere, if you would prefer them.

Tobacco: The U.S. Can't Handle The Truth...

A few years ago, the FDA mandated that tobacco companies put the labels on cigarette boxes warning smokers about the deadly health effects of tobacco. The tobacco companies sued, claiming the FDA was "compelling speech", which was unconstitutional. Last year we checked in with the legal wranglings of the case when one District Court judge ruled that the tobacco companies shouldn't have to display the images or print 1-800-QUIT-NOW on cigarette boxes.

FDACigaretteLabels

Cigarette Warnings
via the Food and Drug Administration.

The battle over graphic picture tobacco warning labels is actually world-wide and decades old. Tobacco companies fought ferociously against the first country that tried to enforce graphic labels in 1986, fashion-forward Iceland. Today, more over 50 countries require text warnings, and a growing number are moving to picture warnings. Australia passed one of the strictest laws, as Stanton Glantz recently described:

"All the cigarette packages are going to have to be the same kind of puke-green color with the name of the company and the variety on standard type on half the pack, and the other half of the pack will be a large graphic warning label."

Graphic Labels: Nails in The Coffin?

The cigarette companies battle against these labels for a reason. Compared to text warnings, the graphic pictures scare the heck out of smokers research shows, especially people with less education.

However, through the court systems, tobacco companies have successfully bogged down governments' attempts at regulation. In Canada, the Supreme Court last year ruled that Imperial Tobacco couldn't draw the government into a class action case. Imperial had argued that the government shared the health costs of smoking since it had allowed Imperial to market "light" cigarettes. The court dismissed their argument. In Scotland, Imperial Tobacco recently challenged the government ban on displays in shops, claiming that the law is "anti-choice". Scotland's' Supreme Court - Lord Hope, Lord Walker, Lady Hale, Lord Kerr and Lord Sumption, are currently hearing arguments in the case.

In the US, tobacco companies recently asked the Supreme Court to hear their First Amendment arguments after another District Court claimed that the FDA rules were constitutional, the opposite of the previous District Court's decision. The tobacco companies have petitioned the court to decide 1) whether the FDA's label mandate violates the First Amendment 2) if the FDA is stepping on companies' free speech rights to promote "modified risk" products, and 3) whether the companies have a First Amendment right to offer free gifts and samples to entice potential smokers. The FDA has until the end of November to respond, and after that the Supreme Court will decide whether to take the case.

Tobacco: A Dilemma?

Some observers speculate whether the Supreme Court will take the case, but authors of a recent New England Journal of Medicine article think the Supreme Court will hear it. The NEJM article reviews the background of the commercial speech doctrine and the speculates various outcomes for the case.1 The authors say commercial speech was first recognized as a lower value speech in the mid-1970's. From there, the court has enabled creep that brings the commercial speech doctrine to its current very controversial status, where it can essentially curb states' abilities to candidly warn consumers about about health risks of things like smoking.

Because of the court's commercial speech doctrine, the authors write, the FDA can best frame their arguments for the cigarette warnings as promoting consumer choice, rather than as protecting public health and discouraging smoking. This not only hobbles the FDA's ability to frame and defend their arguments for public health, the authors write, it gives the cigarette companies the advantage in defending themselves because they can argue that the FDA is not trying to promote consumer choice, rather it's attempting to influence the behavior of smokers by browbeating them.

Faced with the science related to tobacco, the health affects of smoking, and the tax burden of health costs shared by all citizens, tobacco's costly legal protests seem crazy. However, the Supreme Court has often sided with corporations, and has been quite skeptical of government regulation. As well, science and economics don't necessarily win the day over "free speech" in US courts. So altogether the FDA's idea that science derived photos inform consumers in ways that are hard to ignore, these arguments may not win. The Supreme Court hasn't seemed particularly swayed by science arguments or sympathetic to public health arguments.

So if the tobacco companies and courts continue to dither over the FDA's graphic warnings, thereby keeping them off the cigarette boxes, maybe journalists can write lots of stories about the controversy and include lots of the graphics that the smokers are missing out on?

1Ronald Bayer, Ph.D., Lawrence Gostin, J.D., and Daniel Marcus-Toll, M.S.: Repackaging Cigarettes -- Will the Courts Thwart the FDA? November 14, 2012DOI: 10.1056/NEJMp1211522

Malaria Vaccine - Rough Waters

A malaria vaccine over two decades in the making given to infants in Africa was shown by preliminary data to be 30% effective. Good news or bad news?

It depends on who you talk to. Most scientists and public health workers described the partial phase III clinical trial result of RTS,S/AS01 as disappointing, frustrating, or underwhelming, while trial sponsors, a few scientists, the government of Ghana, and KTN streaming LIVE from Kenya 24/7, remained upbeat, stressing that given the millions of malaria infections, a 30% reduction in would give the vaccine a significant place in malaria prevention.

In 2010 there were an estimated 216 million cases of malaria and 655,000 deaths, 91% of which were in Africa. In the past decade years, the concerted effort to combat malaria has decreased deaths and infections significantly, by 25%. But without a doubt, an effective malaria vaccine would be, if not the end of a horrible scourge, at least be an excellent addition to the arsenal of indoor spraying, bednets, and available treatment options. The question is, given the costs of developing and deploying a vaccine and the current economic climate, what's considered effective?

RowingUpstreamish2

Rough Waters
via Creative Commons License.

This month's 31% results are disappointing compared to last year's results from older kids, 5-17 months, that showed the vaccine to be 55% effective. As well, the newest results from the Phase III trial, show about half the efficacy of those from the previous Phase II trial for the same-aged infants, which seemed to show the vaccine as 62% protective.

Not 55% but 30% Effective

The RTS,S vaccine targets the Plasmodium falciparum and is made with proteins from both the parasite and Hepatitis B virus that serves to enhance the immune response. So why is the vaccine now apparently only 31% effective at preventing infection and 37% effective at preventing severe disease, almost half what it was? Scientists have several hypotheses. It might be the high levels of malaria around the test centers included in this data release, or that increased immunity from mothers in the younger infants blunts the response of the infants' immune systems against the vaccine, or perhaps since the vaccine for the infants was administered with other vaccines the infant immune systems responded less vigorously to the malaria shot. What there's no question about is how tricky it is to make a vaccine that successfully combats infection from an evolving and evasive parasite that moves through different stages of its lifecycle in different parts of the human (host) body.

With the efficacy data so low, scientists were left emphasizing how safe the vaccine is (important, of course, but not exactly the point at this stage). They stress how successful of the logistically complicated and ambitious trial (across 11 centers in 7 countries). Indeed the trial logistics are impressive, important, and a huge inroad to drug testing and public health, but the accomplishment doesn't address the high expectations and promises made during last year's data release.

Glass Now Less Than Half-Full

While the results were discouraging, some scientists weren't surprised. When researchers announced last year's interim results some scientists predicted based on the data that the younger 6-12 week cohort would be less protected by this vaccine. This was one of several caveats scientists pointed out. They also warned against early incomplete data releases, stressed that the older children weren't the target group, and questioned various aspects of the 55% number. We covered some of these questions in a post -- the same caveats and questions apply to this year's data release.

Vaccine development, especially against malaria, is incredibly difficult. Although there are about 30 vaccines in development now, according to the World Health Organization's Rainbow Tables, the closest candidates are 5-10 years behind this one. This fact of course influences the biggest unanswered question: How effective does a vaccine need to be in order to be put into production? There are limits to both attention and money available for urgent public health initiatives, so realistically, funding one initiative can potentially handicap others - but then the argument always swings back -- there is no malaria vaccine right now.

Vaccine Goals - Made To Be Eschewed?

To help guide answers to this question, the World Health Organization, in concert with invested organizations including the public and private sponsors of this vaccine, established in a roadmap(pdf) a "Strategic Goal" to "by 2025, develop and license a malaria vaccine that has a protective efficacy of more than 80% against clinical disease and lasts longer than four years." RTS,S/ASO1 is no where near this. But the WHO also established a "Landmark" Goal, to "by 2015, develop and license a first-generation malaria vaccine that has a protective efficacy of more than 50% against severe disease and death and lasts longer than one year." WHO is currently in the process of updating the roadmap, but warns that the Landmark goal is not being changed.

All scientists acknowledge that only more data analysis from this trial will provide clearer answers. The WHO provides information on vaccine development and its role in assessing the vaccine in 2014-2015. Some scientists predict that the trend of decreasing efficacy after 6 months shown in the data looks ominous: "The results look bad now, but they will probably be worse later", said vaccine expert, researcher for competing vaccines, and deliverer of not-very-upbeat messages Adrian Hill of Oxford University. (But if subsequent data looked somewhat better - the situation of this year's results compared to last year's - the reaction would probably be euphoric.)

Last year when we discussed the vaccine we commented on possible later outcomes that could stem from the incredible hype around interim results releases -

"...which leads us to wonder whether mid-trial fanfare primes us react to whatever future malaria vaccine news comes along with knee-jerk positive determinism? What if the younger data shows only (say, hypothetically) 30% efficacy? Would we ever abandon the effort...?"

Commenting on the latest results, Andrew Witty, GSK CEO told reporters in a conference call "We've been at this for 30 years, and we're certainly not going to give up now".

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In other malaria vaccine news Sanaria, another malaria vaccine maker whose founders have been knee-deep in malaria vaccines for decades, recently hosted 7th graders in an event hosted by Montgomery County universities. The idea was to introduce kids to science and medicine so they don't think of people who work in biosciences as "crazy scientists", said Stephen L. Hoffman, founder and CEO of the company. Hoffman's latest malaria vaccine effort was profiled by Science in "New Hope for Crazy Vaccine", briefed by us last year. Sanaria received $3 million funding for Phase II trials last summer.

In still more malaria news, a program called the Affordable Medicines Facility - Malaria(AMFm) has been radically downsized, killed, and folded into obscurity within the Global Fund. The reasons remain a little mysterious. By all accounts, the program was successful, even "overwhelmingly successful", in lowering the pharmacy prices of drugs called Artemesin Combination Therapies (ACTs). If you contract malaria in Africa you often need to buy your own drugs. Patients will naturally buy the cheapest drugs, which happen to be those that are least effective or most susceptible to antibiotic resistance. The program made the ACTs competitively priced with monotherapies, therefore competitive in the marketplace and helpful to preventing artemisinin resistance and conquering malaria. The strategy was innovative and effective.

However, some critics claimed that this method wasn't getting the drugs to children, and that some people were buying up the drugs without a diagnosis. Defendants said these criticisms moved the goal posts, phase II could have solved some problems. But more scientists aren't at all sure why the program got cut, some suggesting that for some reason Oxfam and the President's Malaria Initiative lobbied hard against it. One contingent that is probably pleased with the outcome has been lobbying vigorously against AMF-m since its inception. The group's members are variously affiliated with pharmaceutical companies, 'free enterprise think-tanks', and target lobby efforts like "Africa Fighting Malaria", they selflessly devote their lives to promoting DDT spraying, and lobbying against generic drugs. One or more have written accounts claiming that the competitive pricing schemes employed by AMF-m used cheaper drug suppliers with inferior services -- a spurious, tedious and surprisingly effective go-to argument for decades by pharmaceutical companies lobbying against generics for the most deadly diseases AIDS, Malaria, etc.

"Black Tuesday" and South Africa's Secrecy Bill

On October 19, 1977, the apartheid government of South Africa banned 19 news publications and organizations who stood with the Black Consciousness Movement, including, The World, the Sunday World, and Pro Veritas.

ANCWikipedia.jpg

The National Press Club called on sympathizers to wear black clothes, ribbons, and armbands, and since then, October 19th has been referred to as Black Wednesday.

Black Tuesday

Now, 34 years later, some South African media groups refer to Tuesday, November 22, 2011, as "Black Tuesday". Why? That was the date the lower house of the South African Parliament controlled by the African National Congress (ANC) approved the Protection of State Information Information Bill, 229-107. The bill will allow the state to classify documents as "secret" in the name of "national interest". Anyone caught possessing such a document would serve 25 years in jail. The bill will be debated and voted at the upper house of parliament, the ANC controlled National Council of Provinces, before it goes to President Zuma to sign. [The Wikipedia page for South Africa's ruling political party the African National Congress (ANC) was temporarily "censored" in protest of the secrecy law, shown here]

When Governments Aim to "Own" The Media

South Africa's National Editor's Forum chairman, Mondli Makhanya, said the press corps were devastated
"watching the bill become law." As he put it:

"We never thought we would come here dressed in black to witness the Constitution of our country being betrayed by those who built it."

The motivations behind the bill are of course suspect. The media has been avidly covering the antics of the wife of the ANC's State Security Minister Siyabonga Cwele, convicted of running an international drug ring. We previously covered President Mbeki's threats against the media for their coverage of his AIDS and public health policies and corrupt public health minister. Two years ago, we wrote on President Zuma's successful bid to get the National Prosecution Authority (NPA) to drop 16 charges against him related to several billion dollars in bribes for arms deals, also well-covered by the media. More recently, the Sunday Times reported that Zuma's government spokesperson Mac Maharaj sued newspapers reporting about the 1.2 million French francs paid to his wife to facilitate arms deals. In the two years of Zuma's presidency, the press has fairly well documented this steady stream of allegations and misuse of official funds.

Hypocrisies of the Powerful

Perhaps there's no reason to ask then, if Zuma will sign the bill. Acronym Required has checked-in on the ANC's continued attempts to censor the vibrant South African media over public health issues over the years. Former President Thabo Mbeki expended hundred of thousands of spoken as well as written words typed into his weekly reports excoriating the media for covering the horrific conditions in hospitals, corruption, the lack of public infrastructure, the broken promises of his administration, and his twisted logic for not dealing with the AIDS crisis.

President Zuma seems to be taking it one step further by backing up rhetoric with more publicly forceful maneuvers. Last year we told parts of journalist Mzilikazi wa Africa's story of being kidnapped by the police as he was investigating ANC corruption in "South Africa'a Media Crackdown."

The officers who kidnapped wa Africa pestered him about his investigation of ANC officers in the Mpumalanga province. They tried to extract his sources. They trumped up charges accusing him of fraud, forgery and passing forged documents that were later dismissed, and tried to force him to sign an admission of guilt. Under the new law, the documents that wa Africa received about the corruption and murders in Mpumalanga would be illegal for him to possess.

President Zuma has vigorously put down widespread outcry against the secrecy bill. He said that concerns were absurd and proclaimed the ANC to be a vigorous defender of the constitution. He continually accuses journalists of trampling the rights of others, who must "have recourse through legitimate institutions". As Zuma said in weekly address (August, 2010):

"The media has put itself on the pedestal of being the guardian. We therefore have the right to ask, who is guarding the guardian? All institutions, even parliament, has mechanisms in place to keep them in check."

Zuma accused the media, as did Mbeki before him, of not "reflecting the society it claims to protect and represent". Worst of all, he said, deploying the usual ANC strategy, the media defames the ANC party that worked so hard against apartheid. This isn't just Africa's problem, he pointed out, using Russia as an improbable example:

"Let us move beyond the hysteria, let the real debate begin. Our first point is that before looking at what they regard as external threats and perceived external threats, the media should conduct introspection first. During our State visit to Russia a week ago, Russian television was running a promotional jingle saying: 'How dependent is the independent media? Who pays for the news?'"

There's hardly a need to point out again, as we did last year, that using Russia, where investigative journalists and state critics regularly get murdered, to bolster professed ANC benevolence seems cynical and sinister.

Rebukes From Those Who Know

Many see the bill as a harbinger of more serious curtailments of freedom that the country has struggled to overcome in the 17 years since apartheid. Archbishop Desmond Tutu said in an address about the Chinese suppression of Tibetans that the current ANC government was worse than the apartheid government, when "at least you could expect to eat." He said that by now you should expect a South African government to be "sensitive to the sentiments of the constitution", and continued:

"You, President Zuma and your government, you do not represent me. You and your government represent your own interests. I am warning you, as I warned the [pro-apartheid] nationalists, one day we will start praying for the defeat of the ANC government."

A strong independent media (if there is such a thing), and investigative journalism are keystones to democracy, in South Africa, America, and everywhere else. A strong democracy is critical to science, to commerce, to health, to welfare, and to all of civil society. South Africa's Bill of Rights supposedly supports these ideas, supports:

"freedom of expression, which includes freedom of the press and other media; freedom to receive or impart information or ideas; freedom of artistic creativity; and academic freedom and freedom of scientific research".

It also gives anyone the right to:

"Any information held by the state; and any information that is held by another person and that is required for the exercise or protection of any rights."

Constitutional scholars lay out excellent arguments why this bill is unconstitutional2, and the opposition party has said that if Zuma signs the bill, they would push for constitutional review in the Constitutional Court. Zuma's highly political evasion of charges against him, as well as other irregularities, have shown that the judiciary and other institutions are increasingly in the grip of the ANC. Snuffing out investigative journalism will accelerate that trend.

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1 I should note that the move is not endorsed by smaller press who think that "Black Wednesday" should not be conflated with "press freedom" by major newspapers dependent on advertisers in their battle with the government over advertising spend. (Here's an article on that.)

2 The website Constitutionally Speaking has an excellent discussion of this issue, that I found unfortunately, after this was post was written. Go there for a thorough presentation of that scholar's reasoning and for the comment discussion that follows.

The 1987 movie Cry Freedom offers a look at a South African reporter muzzled covering the anti-apartheid movement and the suspicious murder of activist-hero Steve Biko. I liked the movie when I watched it a couple of years ago, although I have to warn you that the mainstream media reviews called the movie a watered down version of the real story, with Robert Ebert saying it was: "sort of a liberal yuppie version of that Disney movie where the brave East German family builds a hot-air balloon and floats to freedom." I'm sure it would be fascinating to compare their harsh criticism of the movie to the MSM watered down coverage of years of South Africa's apartheid, but I'll leave that for another time.

Thanksgiving - Politicians, Recipes & Brussel Sprouts

We're big fans of Thanksgiving and usually try to write a post. This year we wanted to stick with our preferred genre and write about something undercovered or underloved in other media. In 2005 we wrote about that the myth that tryptophan causes post Thanksgiving meal sleepiness, a myth that is now pretty much a Thanksgiving Day media meme.

BrusselSproutsOnVine

Image is from Wikipedia Commons, and is licensed under Creative Commons 3.0 (CC by-SA 3.0).

Happy Thanksgiving

We didn't want to write a Thanksgiving holiday-history story because whatever is not covered in 1st and 2nd grade is almost always politically freighted. Wanting to stay away from politics, we decided to write about food again. But ironically, we were inspired by politicians who, collectively deadlocked on all the really important issues, always manage to muster up recipes to share with reporters. What in this world isn't political, I guess?

We can't imagine where the recipe sharing inclinations came from. Is this a lingering tradition from times when churches, ladies groups, and neighborhood potluck groups all put out recipe books full of jello salads and Aunt So-and-so's meatloaf? Still, I can't imagine announcing that for tonight's dessert we'll be enjoying Rick Santorum's "Apple Tarte Tatin"!!

But it seems popular. Last week, for instance, Representative Nancy Pelosi shared her chocolate mousse recipe -- a Thanksgiving Day tradition in her home. It has 1 pound of dark chocolate, 8 ounces of butter, 8 eggs, 4 tablespoons of sugar and 1/2 a cup of heavy cream. She's thin, she's not eating too much of this. It's probably delicious -- The Hill has to whole recipe -- but you have to admit it's not exactly a heart-happy dessert. Michelle Obama would disapprove of this recipe, and the GOP would no doubt accuse Pelosi of excessive caloric spending. To model the antithetic thriftiness, I'm sure, Representative John Boehner (R-Ohio) told The Hill he was looking forward to his mother's turkey brine. He wouldn't give the publication the recipe.

What To Write

I don't know about turkey brine, so I looked on the Food Network, which has this. Turkey brine has peppercorns, allspice berries, salt, rosemary, sage, and other sundry spices and herbs, plus vinegar. Don't knock turkey brine, a whopping 3,603 people endorsed that Food Network recipe. Perhaps Mrs. Boehner's secret recipe is better, but I'd bet my party on 3,603 votes if I were going that way. Apparently one soaks their turkey in the brine before cooking. The whole process takes about 10 hours, so you have to be comfortable cooking on Congress-Time. Hopefully John's mom adds extra "sage" that is magically, surrealistically absorbed by anyone who eats/drinks the brine.

Speaking of sage and wisdom, North Carolina Congressman Howard Coble had a truly brain related recipe called, actually, "Brains N'Eggs", which he described as a can of "brains in gravy", "preferably" Rose Brand, with bacon grease and eggs. His mother served served him this "not at all unusual" breakfast, that alas it can't be found in Washington D.C., he reported.

What To Write

If your a politician, your recipe can send a message. Chocolate mousse would be a universal people-pleaser. Pork brains sends a different message, obviously it depends on what you're going for. Politicians also use recipes to remind people of their heritage, like Olympia Snowe's "Baklava". Others donate recipe's reminiscent of their state, Senator John Kerry's "Massachusetts Cranberry Bread" for instance. Some offer what I think of as anti-cooking, like former NY Congressman Sue Kelly's "microwave chicken": chicken, microwave, a bottle of your "favorite" salad dressing, and water.

Some long-serving productive politicians like former Senator Edward Kennedy never dished out recipes to the media. One Rockefeller gave out four. Others who were only very briefly in office must have entered with a recipe in hand, like Sarah Palin and her Alaska Crab Wrap Sandwich, which, if I weren't allergic to crab, I might like her best for.

Ignoring all good evidence, Californians ousted Governor Gray Davis in favor of Governor Schwarzenegger, who was obviously too busy with other household chores to write recipes for reporters. Davis got served up lemons and gave the press his Lemon Chicken recipe.

Happy Thanksgiving

So back to our unchosen subject. We're weary of pumpkin pie, we've done turkey, cranberries are all bogs and antioxidants, what's left? We could talk about the turkey dinner where they actually go and feed the turkeys? Hmmm...Brussels sprouts? The thing about Brussels sprouts is nobody writes about them because they're only slightly more popular, I wager, than canned pork brains scrambled with eggs and grease.

Nobody knows where Brussels sprouts originated, unlike the excellently documented domesticated turkey. Most people agree they don't come from Belgium but some say they're actually a centuries old source of "Flemish national pride". It seems like when it comes to Brussel Sprout's, everyone's making something up. A few say they originated in Rome where they were thought to make people smarter, or maybe they were popularized in WWI, or maybe they came to Louisiana when the French immigrated, or maybe they're the most disliked British vegetable...on and on.

But they are considered healthy for many reasons, like because they contain sulfoaphane and indole-3-carbinol and a lot of research finds they have anti-cancer properties.. They look pretty cool on the vine. And to eat? Curried? Roasted?

Best wishes to all and Happy Thanksgiving to those readers who have a holiday.

FDA Goes One Nudge Over "The Line" on Tobacco

A US Court blocked the FDA from requiring cigarette warnings on boxes this week, calling the graphics "emotion-provoking images...". U.S. District Judge Richard Leon Smoking.gif decided in a Washington court yesterday that tobacco companies shouldn't have to display images of diseased lungs or a cadaver bearing chest staples on an autopsy table, because this would "unconstitutionally compel speech." Nor should companies have to print 1-800-QUIT on cigarette boxes.

I guess what he's saying is that cigarette companies have the right to package fantasies up in the tobacco they manufacture, fantasies of how cool smokers are, that blithely omit the disease and death their product metes out. The FDA, on the other hand, has no right to present the more accurate side of the story.

You know that smoking causes cancer, heart disease, vascular problems. Did you know that smokers have 7 times the risk of abdominal aortic aneurism (AAA) than non-smokers? You probably know about second-hand smoke. Did you know about third hand smoke which stays in home and hotel walls and ceiling tiles for 30 or 40 years, affecting the health of not only present but future occupants?

The judge says the images on cigarette boxes crossed the line between "factual information" and "government advocacy". The line is "frustratingly blurry", he says, but he sees it.

Malaria Vaccine Data - Release then Patch?

Does International Public Health News Compel Us to Cheer Enthusiastically?

Everyone wants drugs to cure diseases. Everyone wants vaccines to prevent them. And in a world of urgent international public health problems, what is more publicly urgent then developing solutions for AIDS or malaria? Positive news on this front is always welcome, and in line with that, you don't win popularity points by sticking pins in up-beat public health reports, results, or clinical trial data. MarianaRuiz Villarreal'sWikiMosquito.jpg Popular science journalists generally talk about cool, politically neutral science, or slick technology, or brilliant research successfully advanced to save lives; they write about winning clinical trials that will end scourges, any scourge - cancer, AIDS, Hepatitis, obesity... Good news!

Cheerful news, like recent headlines highlighting research showing a vaccine for malaria that may be 55.1% effective. NPR headlines enthused "Vaccine Slashes Infection Risk By Half", whereas a more cautions USA Today said: "Malaria Vaccine May Have Potential to Save Millions".

The RTS,S/AS01 vaccine is a decades long effort, now a collaboration between The Gates Foundation funded PATH Malaria Vaccine Inititive (MVI) and GlaxoSmithKline (GSK). The partners recently published interim results in the New England Journal of Medicine (NEJM)2 and presented their results to the media. By all accounts, the Phase III trials delivered very good news.

The Mosquito Drawing by M. R. Villarreal can be found at Wikipedia 1

But What Does "May" Mean, in "May Save Millions"?

No one could say that Bill and Melinda Gates haven't changed the face of international public health. Mr. Gates leads a relentless campaign pushing the power of vaccines; he berates governments that don't vaccinate enough people; and he effectively leverages the media to deliver his messages. Last year the Gates Foundation held a fund-raiser hoping to collect $3.7 billion from governments and instead received $4.3 billion. As Global Alliance for Vaccination & Immunization's (GAVI) chief executive put it, "Bill was a little like a poker player who put a lot of chips on the table and scared everyone else off." Perhaps Gates is more a bridge guy, but point taken.

Given this, who would write-up the newest Gates Foundation news as, "a vaccine shown to be at best 44.9% ineffective in a half-done clinical trial"? No one. With the intense drive for upbeat news, I credit USA Today for their cautious "may save millions". But if you look more closely, for instance read the editorial accompanying the NEJM report3, or listen to scientists around the web and in journals like The Lancet 4, or pay attention the malaria researchers interviewed by "Nature News5, the caveats of this recent malaria study grab your attention:

  1. First, there's the announcement itself. The data released is interim data; the full results of the malaria trial will be released in three years. Interim data releases are not unprecedented but past experiences, for instance with an AIDS vaccine, caution us against overly enthusiastic receptions for incomplete trials.
  2. The interim results were reported for children aged 5-17 months, but the target age group is infants aged 6-12 weeks. In other words, these results don't address efficacy of the vaccine for the target group.
  3. NEJM reported that at 12 months, the vaccine reduced episodes of malaria by 55.1%. However a US military scientist working with Sanaria, a competing vaccine maker, told Nature News that RTS,S actually offered only 35-36% protection 12 months after the vaccine. It appears that the efficacy of the vaccine might wane over time.
  4. Although the reports noted reduced mortality, another scientist emphasized to Nature News that the data didn't support that announcement. Scientists hypothesize that the vaccine may just delay infection.
  5. Although the vaccine reportedly cut severe disease in older kids by 47%, combining that data with the available data of the younger kids gave only a 34.8% decrease. This suggests the data for the target group of younger kids might turn out lower than reported in these interim results.
  6. In addition, incidents like convulsions and meningitis might be more frequent in the vaccinated group.

These might not be showstoppers. For instance researchers hope that booster shots will improve efficacy. But what if in the end the much touted vaccine turns out not to be a vaccine but just another shot? Scientists and public health workers concern themselves with such non-trivial caveats. What's behind the apparently waning efficacy? How is the adjuvant effecting immunity? Science is exacting even when media reports are not. People also have underlying concerns about what's driving policy, science or the press releases?

Is Marginal Progress, "Success"?

Two of the people interviewed by Nature News are affiliated with Sanaria, a company that is also developing a malaria vaccine. Sanaria just released their own news of a Phase I malaria vaccine study testing the safety of a live attenuated virus. Nature interviewed the first author on the Sanaria study published by Science, as well as the CEO and last author on the Science study. They were complementary of the RTS,S effort, if somewhat critical on some points.6

It's worth noting the history of the Sanaria vaccine, to give context to the executives' comments and perspective. Like the RTS,S vaccine, Sanaria's vaccine is an extremely expensive, tricky, and laborious endeavor. The underlying idea for seems promising, but for starters technicians must painstakingly dissect out the salivary glands of mosquitoes in order to develop the vaccine.7 It's unclear how this can scale.

On top of the laboriousness of vaccine development, once the vaccine was made it didn't seem to work. In their first clinical trial, Sanaria injected 44 subjects. 42 people got malaria and 2 didn't, a 4.5% "success" rate. These subjects might have been better protected from malaria lounging in a malaria endemic region in mosquito-infested huts, but the Sanaria execs quickly pointed out that it wasn't the stunning failure it looked like, rather, it was a trial that "yielded positive results" -- as their press release put it (without including relevant numbers). The company is buoyed by such "success" and primed for the next controversial7 phase.

Because vaccines promise a silver bullet solution to disease, at the moment, every possible vaccine holds promise, since we have no viable one.

Sanaria's position as competitors doesn't invalidate their commentary on RTS,S (complementary as well as critical), since Sanaria executives voiced reservations shared by many others. An editorial in last week's "The Lancet indicated that the release of unorthodox partial results seemed to be more politically than scientifically driven. Diplomatically, The Lancet editors wrote: "although the latest findings are encouraging, we look forward to the full results of the RTS,S/AS01 trial in 3 years time."5

When There is No Treatment, What Does A More Effective "Treatment" Look Like?

Will the upcoming younger cohort data meet World Health Organization (WHO) goals of 'Protective efficacy of more than 50% against severe disease and death lasting longer than one year'? 5 This is an important question. Vaccine experts usually aim for 80% or more efficacy, and representatives for PATH say they hope to get there eventually. So then, does that make this vaccine a beta version?

Is all this media hoopla deserved for a beta version vaccine? A physician working in Africa distributing bed-nets warned against statements that might mislead people "to overestimate the impact of any single new intervention", in a comment at NEJM. Acknowledging this commenter also has vested interests doesn't detract from his message. 75% of the MVI/GSK study participants used bed-nets. But would people in real-life discontinue the more cumbersome bed-net efforts with a vaccine on the horizon? Will bed-nets still be funded with a 50% effective vaccine? A 30% effective vaccine? If you're a mom and your kid gets a vaccine that is 50% effective, what precautions do you then take to prevent infection? Does a 50-50 vaccine make your life better?

The tremendous investment in vaccines, both in terms of money and expectations, shouldn't slow other prevention and treatment efforts. But realistically, we don't have unlimited resources. It would be naive to think that the prolonged difficulty of vaccine development, the immense investment, and lack of a viable alternative don't influence funding and policy decisions.

Some of the problems scientists identified with this vaccine trial have persisted for years. In this 2006 book chapter recently released online, an economist analyzes RTS,S vaccine data of previous trials (PDF) (HT Nature News5). He reports on waning efficacy; and questions how the public health community decides which vaccine candidates merit further investment. 5 years later, as the latest trial barely noses over the 50% bar, we grapple with the same issues and questions he raised back then, but billions more dollars have been invested.

Which leads us to wonder whether mid-trial fanfare primes us react to whatever future malaria vaccine news comes along with knee-jerk positive determinism? What if the younger data shows only (say, hypothetically) 30% efficacy? Would we ever abandon the effort? As more and more money gets invested, do decision makers begin to act less rationally?

Media reports may boost stocks, may raise money and may discourage competitors, but in the end, the science behind the vaccine, the science that's supposed to underpin public health decisions, is fussy and complicated -- caveats matter. After all, you're asking people and governments to donate tens of billions of dollars, and you're promising 7 billion people that your vaccine will keep millions safe.

Tough Economy for an IPO?

Can we push for an end to malaria as if we were trying to put a computer on every desktop? Does this big money, big marketing, big media approach to public health that some find so jarring actually work? I'm not saying it doesn't. Perhaps it will become a more accepted way of developing medicines and vaccines. Maybe public health needs exactly this kind of paradigm shift.

But even if a 40% or 50% effective vaccine is acceptable from a public health perspective, once this vaccine is developed, governments will still need to consider costs. In this economy, some ask, how much will governments shell out for a vaccine with a 50% efficacy rate? Can you and should we market vaccine with lots of pre-release fanfare to push governments towards buying the vaccine?

Asked about cost per vaccine, GSK wouldn't answer directly, but stressed how the company will reinvest all the proceeds to improve the vaccine. Shares of GSK rose slightly on the RTS,S vaccine news, and shares of biotech company Agenus which makes the RTS,S vaccine adjuvant rose from $.48 prior to the announcement, to $2.80 (which got Agenus re-listed by the SEC). All things that may influence decisions. However when questioned about the unconventional data release, PATH's MVI director didn't mention politics, billions of invested dollars, stakeholder expectations, or the saved Massachusetts biotech companies. He said: "we felt it was our scientific and ethical duty to make the results public when they become available."5

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1 The mosquito drawing is by Mariana Ruiz Villarreal. It is the anatomy of a Culex pipiens, a vector for malaria. This image was selected as Wikipedia's Picture of The Day for 10 September 2010.

2 The RTS,S Clinical Trials Partnership; First Results of Phase 3 Trial of RTS,S/AS01 Malaria Vaccine in African Children, October 18, 2011 10.1056/NEJMoa1102287

3White, N. F.R.S.; A Vaccine for Malaria October 18, 2011 10.1056/NEJMe1111777

4Editorial: The Lancet, Volume 378, Issue 9802, Page 1528, 29 October 2011, doi:10.1016/S0140-6736(11)61659-0

5Butler, D.; Malaria Vaccine Results Face Scrutiny: Published online 26 October 2011, Nature 478, 439-440 2011, doi:10.1038/478439a

6Epstein et al: "Live Attenuated Malaria Vaccine Designed to Protect Through Hepatic CD8+ T Cell Immunity": September 8 2011 Science 28 October 2011: Vol. 334 no. 6055 pp. 475-480 DOI: 10.1126/science.1211548

7 Kappe1, S., and Mikolajczak1, S.; "Another Shot at a Malaria Vaccine". Science 28 October 2011: Vol. 334 no. 6055 pp. 460-461 DOI: 10.1126/science.1213934

8 Farlow, Andrew.; "A Review of Malaria Vaccine Candidate RTS,S/AS02A", Chapter Three of The Science, Economics, and Politics of Malaria Vaccine Policy, a report written in 2005 and 2006 and published 14 April 2006 and January 2010. Department of Economics, and Oriel College, University of Oxford.

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We previously wrote about Phase II Clinical Trials of the RTS,S vaccine here. We wrote about US funding for malaria here and here; vaccine strategy here; malaria prevention here and here. We've also written frequently on international public health, including the development of a AIDS vaccine, here and here.

Vaccine Preventable Deaths

The Map

Acronym Required previously wrote about parents who self-vaccinate in lieu of getting vaccinations, a sort of barbaric hazing for this era's unlucky children. And while some people in the West shun vaccines because they think they're dangerous, people in Africa shun them because they suspect shots are a Western plot to kill them. VaccineMap.jpg The US shockingly fanned the flames of the vaccine avoidance trend when it faked a vaccine campaign in Pakistan in order to to get access to Osama bin Laden. Meanwhile, tragically, people continue to die because there aren't enough vaccines to protect them.

When people refuse vaccinations, we lose herd immunity; microbes have get a chance to mutate; and of course people get sick and die. The trend has contributed to large outbreaks of whooping cough, mumps, chicken pox, and measles world-wide, as well as polio, typhoid fever, meningitis and hepatitis A. Now there's a great map Vaccine-Preventable Outbreaks, put out by the Council on Foreign Affairs, so you can see the impact of this all.

(The vaccination map ranks as one of my favorite maps, as does Newspaper Map.1)

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1 Granted the UI's sometimes not entirely there

We previously discussed vaccinations in Maher's Mainstream Media Anti-Vaccination Campaign; The Wild Wooly Internet; Polio Vaccines, The End of a Scourge?; Vaccine Development For Developing Countries and others.

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