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Entries in ethics (12)

Saturday
Feb112017

Animal rights and wrongs: Flanders debates ethics of animal testing

In Flanders Today, by Andy Furniere

 

Two sides of the same coin

Last November, animal rights organisation Gaia released undercover footage recorded at the Free University of Brussels’ (VUB) animal unit in Jette. Throughout the seven-minute video, shot by an undercover researcher, the unit’s staff handle mice and rats roughly, as other seemingly stressed rodents jump or run around their cages incessantly. 

In the clip, the investigator, whose identity remains unknown, says that the animals were suffering needlessly in overcrowded cages and from painful deaths. There is a distinct lack of care by the scientists, we hear, many of whom are unaware of even the most basic regulations concerning the treatment of lab animals.

The undercover footage has again intensified the animal testing debate among activists, researchers and policymakers. The government of the Brussels-Capital Region quickly responded to the video, while the government of Flanders announced investments in the development of alternative methods, aspiring to play a leading role on the European stage.

According to Gaia’s president, Michel Vandenbosch, the investigation shows there is a need for stricter monitoring, but also for a radical change of mentality among scientists. “We need a new generation of researchers who don’t just reduce test animals to research tools,” he says, “but also possess the empathy to fully realise that these are living, sentient and vulnerable beings.”

‘We are not monsters’

But at least one scientist believes most researchers already have the greatest respect for lab animals. Dr Adrian Liston of KU Leuven has been an animal rights advocate his entire adult life, he says.

When he first entered medical research, he considered participating in a research project that did not use animals so that his dual passions did not come into conflict, but decided against it.

“I could not bear being a hypocrite, willing to take advantage of the outcome of animal testing but not to get my own hands dirty,” he says. “Animal research is the bedrock of medical research. We need to accept that our advances depend on the work done on animals.”

Liston serves as the director of Crispr Core, a genome engineering facility at KU Leuven, and doubles as a researcher at the Flemish life sciences research institute VIB. He argues that the Gaia video is misleading. “We are not monsters,” he says.

The scientist does concede, however, that there should be more communication between activists and researchers and points out that lab test subjects already have the strongest legal and ethical protection of all animals. “In order to even start researching on mice,” he says, “I have to take countless training courses and fill in hundreds of pages of animal health assessments.”

(Un)announced inspections

The mice he uses, he continues, are kept in conditions that would be luxurious for wild mice. “They have daily health checks by trained staff, and the use of each individual mouse is assessed by an external ethics panel.”

Gaia, however, believes that the current legislation is not strict enough. It does not prohibit scientists from, for example, carrying out tests on animals that are anaesthetised.

According to Vandenbosch, of the 240,000 lab animals used in Flanders in 2015 – more than half rodents – about one in five experienced considerable discomfort. “In other words, one in five suffered.”

In the video, Gaia also denounced inspections announced ahead of time; VUB researchers knew about an inspection at the animal unit about a week before it took place. According to the undercover inspector, this gave them enough time to quickly make all the necessary adjustments and cover up bad practices.

Statistics from Flanders do suggest that unannounced inspections are important. Every year, at least one-third of the 120 recognised labs undergoes inspection. Last year, of the 42 that were inspected, 28 were found to be in breach of regulations. In 27 of the cases, the labs were given a warning, while one lab received a fine.

Changes underway

Gaia’s campaign met with widespread attention in the media and led to swift political response. Brussels state secretary for animal welfare Bianca Debaets promised more unannounced inspections.

She also ordered an investigation into the VUB’s animal unit and asked its research staff to halt any new tests on animals over a three-month period. She called for an action plan to improve the situation in the lab.

The plan, which includes more extensive internal monitoring, has already been approved by Debaets. “But we also expect a structural plan to improve the situation in the long term,” she say.

In response, VUB has announced the construction of a new animal unit by the end of 2018, at a cost €7 million.

In the political discussion that followed, Debaets proposed a national register that would list all programmes in Belgium that use lab animals. The register, run by all three regions, would indicate exactly what kind of work is performed at each facility.

This, Debaets says, would facilitate co-operation, not only reducing the number of required lab animals but improving transparency around animal research.

Joining forces

Brussels opposition party N-VA, however, questioned the need for a register, pointing out that much of the info is already available. The party asked that Debaets invests in the development of alternatives for animal testing instead.

In response, the state secretary pointed out that she’s been providing a €30,000 annual subsidy to Vera Rogiers, a professor of toxicology at VUB, since 2015. Flemish animal welfare minister Ben Weyts has also recently allocated €350,000 for finding alternative testing methods.

One-third of the money will go to Vito, the Flemish institute for technological research, to develop an alternative to the Draize test. The obligatory test is used to measure chemical toxicity in the human eye and involves dropping the test substance into the eye of a live rabbit.

“Every year in the EU, no fewer than 50 million animals are subjected to such a test,” said Weyts in a statement.

The price to pay

The other €250,000 will go to the creation of an online platform that brings together all European research into alternative testing methods. “There are many alternatives, like in-vitro tests and computer models,” said Weyts. “We will bring together the fragmented expertise and make it accessible to researchers.”

The platform is a Flemish initiative but will be managed by the European Union Reference Laboratory for Alternatives to Animal Testing, encouraging the participation of other European countries. The Netherlands has already expressed interest in the project.

 “I’ve also been in talks with partners in the animal-research sector and suggested that they financially contribute to specific projects that relate to alternative testing methods,” Weyts says.

For now, there is no plan to fund a Belgian centre, a project that was approved in 2009 but has not been realised. “Money that goes to the founding of new structures cannot go to research,” says the minister.

Gaia has demanded that the government of Flanders go a step further by investing even more into alternative testing methods and by setting up a detailed action plan on animal research in general. “What we need is a coherent strategy based on a clear vision, one that has concrete goals,” says Vandenbosch.

The animal rights activist also suggests that politicians demand a gradual reduction in the overall number of animals used for medical tests, like mice, by defining limits on specific research domains.  

Safeguarding progress

“Experts predict that toxicity testing, for example, could soon be carried out without using animals,” says Vandenbosch. “This would also lead to more reliable results.”

This approach is in line with a proposal submitted by the Groen party in both the Brussels and Flemish parliaments. Debaets and Weyts, however, don’t agree with such rigid limitations.

Liston, meanwhile, says that using animals in research should only be limited if other methods are available. Only this approach, he adds, will safeguard medical progress.

“We are constantly refining our methods, from more in-vitro screenings to fewer animal tests,” he says, “for ethical and legal reasons, but also because in-vitro tests are faster, cheaper and less complicated.”

He also believes that even as animal research becomes a niche market, there will always be a need for it. “Before we can administer medication that could have serious side effects in humans,” he says, “we will always have to test it on animals first.”

Thursday
Jan052017

Effecting change as an animal rights advocate

I have been an animal rights advocate for my entire adult life. I am also a medical researcher, specialising in the translation of advances from mouse immunology to patients. I am a vegetarian, for ethical reasons, and yet I am director of the mouse genetic engineering service at KUL. How can one be an advocate for both animal rights and for the use of animals in medical research?

Few would argue against medical research. Who wants a life that is nasty, brutish and short? When I first entered medical research I considered starting in a research project that did not use animals, so that my dual passions did not come into conflict. In the end, however, I decided to work on a mouse model of Multiple Sclerosis – scenes of which would certainly be confronting if shown to the public out of context. I did so because I could not bear to be a hypocrite, willing to take advantage of the outcomes of laboratory animal use, but not willing to get my own hands dirty. Since then, advances in Multiple Sclerosis research in mice have resulted in better treatments for patients, with new medications capable of adding decades of healthy life to the millions of sufferers. Who would be willing to deny their loved ones access to these medicines, despite the work being based on animal models?

At the same time, few would argue against animals having rights. We no longer throw cats from the belfry in Ypres, or other such wanton brutality that was once commonplace. Cruelty against pets is now criminal and farms are inspected for the treatment of livestock. The most intensive protections for animals are reserved for animals in medical research. In order to even start research on mice I have taken countless training courses and filled in hundreds of pages of animal health assessments. My mice are kept in conditions that would be luxurious for wild mice, and have daily health checks by trained staff. The use of each individual mouse is assessed by an external ethics panel, including an ethicist and a veterinary surgeon. I assure you that nothing as brutal as a mouse trap or rat poison would pass muster, let alone the conditions that wild mice endure daily!

Animal research is the bedrock of medical research. Even as we continue to refine, reduce and replace animals in research, we need to accept that all of our advances rest upon work done in animals. At the same time, and rightfully so, laboratory animals have the strongest legal and ethical protections of any animals in our society.

This is not to say that animal use in medical research cannot be improved. Not all researchers have a full awareness of the responsibility that comes with animal research, and violations of animal rights do occur. But the worst thing that we can do would be to reverse progress with a knee-jerk reaction. Attempts to reduce animal research by increasing bureaucratic burden simply de-emphasize the most important regulations. An extra tax on animal use in medical research will need to be paid by reducing the number of trained staff caring for the animals. Public condemnation of animal researchers in the media shuts down dialog. We need to increase, not decrease, communication between animal rights advocates and medical research advocates. Animal rights groups that demand absolutes only make progress more difficult for moderates. Those of us willing to proceed with mutual respect know that the only way to continue the steady improvements in laboratory animal conditions is to increase openness and transparency. If you are an animal rights advocate that actually wants to effect change, I encourage you to work with, instead of against, medical researchers. We will listen. 

Thursday
Jan052017

Hoe kan iemand tegelijk opkomen voor dierenrechten als voor het gebruik van proefdieren?

Knack:

'Het ergste wat we kunnen doen is om in een paniekreactie alle vooruitgang te blokkeren', schrijft professor Adrian Liston (KU Leuven en VIB). Hij roept de dierenreachtenactivisten daarom op om de dialoog aan te gaan.

Al heel mijn volwassen leven zet ik me in voor dierenrechten en dierenwelzijn. Ik ben ook een medisch onderzoeker, gespecialiseerd in het vertalen van nieuwe immunologische inzichten van muizen naar patiënten. Ik ben vegetariër, om ethische redenen, en toch sta ik aan het hoofd van de dienst voor genetische manipulatie van muizen aan de KU Leuven. Hoe kan iemand opkomen zowel voor de rechten van dieren als voor het gebruik van dieren in medisch onderzoek?

Bijna niemand is tegen medisch onderzoek. Wie wil er nu een hard en kort leven? Toen ik voor het eerst als onderzoeker aan de slag ging overwoog ik een project waarbij geen proefdieren werden gebruikt, zodat mijn twee overtuigingen niet met elkaar in conflict kwamen. Uiteindelijk heb ik toch besloten om te werken op een muismodel van Multiple Sclerose of MS - proeven die zeker confronterend zouden overkomen als ze uit hun context aan het publiek getoond zouden worden.

De reden voor mijn besluit was dat ik niet schijnheilig kon blijven, enerzijds bereid om mee te profiteren van de resultaten van proefdieronderzoek, maar niet om mijn eigen handen vuil te maken. Sindsdien is er heel wat vooruitgang geboekt in het MS-onderzoek. Dankzij dierproeven zijn er nu betere behandelingen en nieuwe geneesmiddelen die miljoenen patiënten heel wat extra gezonde jaren opleveren. Wie wil hun vrienden of familie deze geneesmiddelen ontzeggen, zelfs al is het werk gebaseerd op dierlijke modellen?

Uitgebreide regelgeving voor proefdieren

Tegelijkertijd is zo goed als iedereen het er over eens dat ook dieren rechten hebben. We gooien geen katten meer van het belfort in Ieper, of andere van die brutaliteiten die onder het mom van traditie jarenlang gebeurden. Dierenmishandeling is nu gelukkig strafbaar en de behandeling en huisvesting van vee op boerderijen wordt nauwlettend geïnspecteerd. De meest uitgebreide regelgeving op het vlak van dierenbescherming is weggelegd voor proefdieren in medisch onderzoek. Vooraleer zelfs maar te mogen starten met muizenonderzoek heb ik talloze opleidingen gevolgd en honderden pagina's medische keuringen en ethische dossiers ingevuld.

In vergelijking met wilde muizen, leven mijn muizen in luxueuze omstandigheden, en hun gezondheid wordt dagelijks gecontroleerd door opgeleid personeel. Het gebruik van elke individuele muis wordt beoordeeld door een externe ethische commissie, met inbegrip van een ethicus en een dierenarts. Ik kan u verzekeren dat niets zo brutaal als een muizenval of rattengif die commissie zou passeren, laat staan alle andere ongemakken die wilde muizen dagelijks te verduren krijgen.

Dierproeven vormen de basis van medisch onderzoek. Zelfs wanneer we doorgaan met het verfijnen, verminderen en vervangen van dierproeven moeten we accepteren dat al onze nieuwe wetenschappelijke inzichten berusten op werk verricht bij dieren. Tegelijkertijd hebben proefdieren de sterkste wettelijke en ethische bescherming van alle dieren in onze samenleving, en terecht ook.

Dit wil niet zeggen dat het gebruik van proefdieren in medisch onderzoek niet verder kan worden verbeterd. Niet alle onderzoekers zijn zich volledig bewust van de verantwoordelijkheden die dierproeven met zich meebrengen, en schendingen van de rechten van dieren komen helaas voor. Maar het ergste wat we kunnen doen is om in een paniekreactie alle vooruitgang te blokkeren. Pogingen om dierproeven te verminderen door het verhogen van de bureaucratische lasten zorgen er gewoon voor dat er minder aandacht geschonken wordt aan de belangrijkste regels. Een extra belasting op dierproeven in medisch onderzoek zal worden betaald door het verminderen van het aantal opgeleide medewerkers die zorgen voor de dieren.

Onderzoekers publiekelijk veroordelen in de media sluit de deur voor iedere dialoog. We moeten zorgen voor meer, niet minder, communicatie tussen voorstanders van dierenrechten en van medisch onderzoek. Dierenrechtengroeperingen met absolute eisen maken vooruitgang enkel moeilijker voor gematigden. Diegenen onder ons die bereid zijn om door te zetten met wederzijds respect weten dat meer openheid en transparantie de enige manier zijn om de levensomstandigheden van proefdieren te verbeteren. Als u een dierenrechtenactivist bent die echt verandering teweeg wilt brengen, dan moedig ik u aan om mee te werken met medische onderzoekers, in plaats van tegen ons. Bij ons vindt u alvast een luisterend oor.

Adrian Liston is professor aan de KU Leuven en VIB. Hij staat aan het hoofd van de afdeling genetische manipulatie op muizen.


Monday
May232016

Santa Cruz Biotechnology punished for violating animal ethics

Animal researchers are under intense scrutiny to make sure they abide by strict ethical guidelines. We constantly need to be trained and licensed and to justify the use of each and every animal. The "3Rs" (Replacement, Reduction and Refinement) are drilled into us from the start, and animals in scientific research have far more legal protections and oversights than animals on farms or household pets. I strongly support this regulation* - I consider myself an animal rights activist as well as an animal researcher.

This is why I am so glad to see the US government crack-down on Santa Cruz Biotechnology. Santa Cruz (a major antibody producer) illegally kept hundreds of animals in a shadow animal facility it repeatedly lied about to the inspection authorities. It subsequently racked up 31 animal rights violations and then eliminated its entire animal stock (more than 5000 animals) in an attempt to circumvent inspections. This type of (rare) bad behaviour provides ammunition against good animal research facilities, which is why I am glad to see they are essentially being shut-down with a $3.5-million fine and (more importantly) it has permanently lost its licence to sell, buy, trade or import animals. Santa Cruz is now out of the animal research community, and we are better for it.

 

*small proviso, I support regulation that is intended to protect animals. I do not support regulation where the intent is to provide a back-door ban on animal research by making pointless regulations that are so difficult and expensive to abide by that they essentially consistent a de facto ban

Wednesday
Apr082015

The absurdities of animal ethics applications

I am a strong supporter of animal rights. I would like to see more animal rights enshrined in the law. Although I am vegetarian and do not eat animals, I do perform animal research - because there is real medical value that can only be gained through animal experiments. To rectify the discontinuity between these positions, I support the animal ethics procedures, where every experiment to be performed on an animal needs to be carefully examined by an animal welfare committee prior to approval, and only important experiments with the minimal pain necessary can be performed. This principle should be strengthened and even extended to other instutitions that work with animals, such as farms, pet stores and zoos.

That said, I do not support the massive amounts of paperwork that are required to run an animal research laboratory. This is the paperwork that I needed to submit just to determine which forms need to be filled out in order for me to breed mice:

That right - that pile of paper is the pre-application just to breed mice, not to do any actual experiments. Any person can buy mice at a pet store - put a male and a female in a cage and they breed, yet no forms are needed. Did you know that mice even breed in the wild - and without filling out forms first!

Animal ethics application forms should be about ensuring animals are not mistreated, they should not be a covert attempt to shut down all animal research by making it impractical for scientists to run their experiments. By making animal ethics applications so absurdly bureaucratic, they actually decrease the scrutiny and fail to do what they are meant to achieve - decrease the suffering of animals. A simple stream-lined procedure would actually increase animal welfare while still allowing key medical research to be performed.

Monday
Apr062015

There is nothing ethical about a moratorium on genome editing

In recent weeks, two comment pieces have been published calling for a moratorium on germ-line genome editing. Germ-line genome editing is now feasible, even easy, thanks to new genetic engineering tools such as CrispR-Cas9. It has the potential to fix genetic diseases such as Huntington's, severe combined immunodeficiency and cystic fibrosis. So why is there suddenly a call for a moratorium on curing these diseases? Are there new scientific results questioning the safety or efficacy? No. In fact new studies are making the approach more and more realistic every day. This moratorium call is just a commentary, not based on any new science. The only reason it made headlines is that the two commentaries were published in the leading journals, one in Science and one in Nature, and because the 23 authors include some very preeminent scientists (mandatory to have your comment pieces published in Science and Nature). This was widely reported as "Scientists seek ban on editing human genome", and I expect that various bans will indeed soon be implemented across the world.

My question - as a scientist who works on genome editing using these very tools - is why? Why is there a call for a ban? The case has simply not been made that there is any ethical conundrum. The "problem" is that these cures would not only cure the disease in the child, but would also prevent the disease being passed on to their children. And why exactly is that a bad thing? "Future generations" - yadda yadda. We make decisions that influence future generations every single day. Do you think future generations will complain about not having cystic fibrosis? If need be, they could easily engineer the mutation back in, not that anyone would. You know what else potentially causes germ-line mutations? X-rays, but we don't ban them because the benefits are very large and the risks are very small. Even poverty causes heritable modification to the genome, so let's not pretend that we've never made a decision that alters unborn generations.

To me, all this moralising is more of the same that we have heard for decades about "designer babies". I'm sick and tired of hearing about the hypothetical of chosing a baby's eye colour. That is probably never going to happen, it would be easy to ban if it did start to happen, and is it really any worse than the current practise of grooming children for beauty pagents or gymnastics from an early age?

The hypotheticals that bioethicists seem to be overwhelmed about always seem to be in the indefinite future. So I'd like to give a here-and-now question to the authors of those comment pieces, and to bioethicists in general. Is it ethical to withhold medicine to children today, simply because of some ill-defined unease you have? The picture below is of a child with Olmsted disease, which we work on in the lab. Warning: the picture is not nice, but this is exactly the type of disease which could be potentially cured with the new genome editing tools.

 

 

 

 

 

 

 

 

Olmsted disease is caused by a single base-pair mutation in the gene TRPV3. It is a prime candidate for genome editing cures, but any cure would run the "risk" of not just correcting the mutation in the skin, but also of correcting the mutation in the germ-line. Is it ethical to cure such a child at the "risk" of also curing their future children? I would argue that not only is it ethical, but it is unethical to not try.

 

There are horrible diseases which strike down children that may never have any feasible cure other than genome editing. To not pursue that sole avenue of research would be a disgrace, an ethical failure of the highest magnitude. I, for one, will ignore any self-proclaimed "moral authority" who tells me not to work for a cure of these diseases. Unless my research is proclaimed illegal I will continue my work - and if it is proclaimed illegal I'll campaign against the unethical laws that shut down the sole hope of families with incurable genetic diseases. Ethical action requires a careful consideration of the consequences, but equally, inaction also requires a a consideration of the ethical consequences. Unless a strong case is made that the consequences of genome-editing for future generations are worse than the consequences of not using genome-editing for this generation, it would be unethical to abide by a moratorium.

Friday
Aug302013

Clinical trials recruitment

Recruitment into clinical trials is an extremely problematic question with regards to ethics. Generally, participation in a clinical trial is a (minor) risk for the individual, but an enormous (potential) gain to society. In the past, this dilemma was "solved" by force - running clinical trials on prisoners, the mentally disabled, the poor, residents of third world countries and generally any population that was disenfranchised. This unethical behaviour is now widely condemned and has been illegal now for a long time.

So how then are patients recruited for clinical trials? Essentially the safeguard for ethics is the principle of volunteering with informed consent. In certain specific cases patients may volunteer  for the possibility of personal gain, such as a trial of a novel medication for an untreatable disease, but generally the motivation is, and should be, altruism. Clearly this is a vast improvement, but even this solution is not perfect. How do you do pediatric trials? You need the informed consent of the guardian, since the actual participant cannot give it. Can anyone really be "informed" of the risks without sufficient medical training? What about indirect coercion? It is illegal to force an unproven drug onto patients, but what about the case of a patient who does not have access to the normal standard of care? For them the only option might be the unproven drug, and in fact this does occur widely in the US and the developing world where universal health care is not available.

Finally, there is the issue of payment. It may make sense to pay for participation, but in that case the participant is not a volunteer and it opens the door to financial coercion. Yet if only unpaid volunteers are allowed, large demographic groups become under-represented in studies due to the inability to afford time off and transport costs involved in volunteering. To balance these conflicting interests, the ethical and legal rule in clinical trials is that you cannot pay volunteers, not provide a financial reward. You can, however, compensate them for their time and expenses. 

In other words, this is not how to recruit volunteers:

The UZ Leuven ethics committee really should take a walk around campus and look at the clinical trials recruitment flyers pinned up.

Friday
Aug132010

2010's worst failure in peer review

Even though it is only August, I think I can safely call 2010's worst failure in the peer review process. Just as a sampler, here is the abstract:

Influenza or not influenza: Analysis of a case of high fever that happened 2000 years ago in Biblical time

Kam LE Hon, Pak C Ng and Ting F Leung

The Bible describes the case of a woman with high fever cured by our Lord Jesus Christ. Based on the information provided by the gospels of Mark, Matthew and Luke, the diagnosis and the possible etiology of the febrile illness is discussed. Infectious diseases continue to be a threat to humanity, and influenza has been with us since the dawn of human history. If the postulation is indeed correct, the woman with fever in the Bible is among one of the very early description of human influenza disease.

If you read the rest of the paper, it is riddled with flaws at every possible level. My main problems with this article are:

1. You can't build up a hypothesis on top of an unproven hypothesis. From the first sentence it is clear that the authors believe in the literal truth of the Bible and want to make conclusions out of the Bible, without drawing in any natural evidence. What they believe is their own business, but if they don't have any actual evidence to bring to the table they can't dine with scientists.

2. The discussion of the "case" is completely nonsensical. The authors rule out any symptom that wasn't specifically mentioned in the Bible ("it was probably not an autoimmune disease such as systemic lupus erythematousus with multiple organ system involvement, as the Bible does not mention any skin rash or other organ system involvement") because medical observation was so advanced 2000 years ago. They even felt the need to rule out demonic influence on the basis that exorcising a demon would be expected to cause "convulsion or residual symptomatology".

This really makes me so mad. The basis for getting published in science is really very simple - use the scientific method. The answer doesn't have to fit dogma or please anyone, but the question has to be asked in a scientific manner. How on earth did these authors manage to get a Bible pamphlet past what is meant to be rigorous peer review? Virology Journal is hardly Nature, but with an impact factor of 2.44 it is at least a credible journal (or was, until this catastrophe). At least the journal has apologised and promised to retract the paper:

As Editor-in-Chief of Virology Journal I wish to apologize for the publication of the article entitled ''Influenza or not influenza: Analysis of a case of high fever that happened 2000 years ago in Biblical time", which clearly does not provide the type of robust supporting data required for a case report and does not meet the high standards expected of a peer-reviewed scientific journal.

Okay, Nature has also made some colossally stupid mistakes in letting industry-funded pseudo-science into their pages, but in the 21st century you would hope that scientific journals would be able to tell the difference between evidence-based science, and faith-based pseudo-science.

Saturday
Jul242010

A breakthrough for HIV prevention?

This week a breakthrough for HIV prevention was announced in Science. AIDS researchers in South Africa just completed a long-term study of Tenofovir Gel, and found that the gel, inserted into the vagina before sex, results in a 40% HIV protection rate for women. With 900 women being followed up for 30 months, the results look very solid, and potentially even better than the headline figure of 39% protection. As with all such studies, the protection rate given is with average usage, not ideal usage. The average study participant only actually used the gel for ~75% of sexual intercourse occasions. For the "high adherers", the group using the vaginal gel for >80% of sexual intercourse occasions, the protection rate was 54%. How important is this breakthrough? In a way, it is both bigger and smaller than the headlines would suggest.

A new tool to fight HIV spread

In the age of vaccines with efficacy rates of >99%, a ~40% protection rate sounds rather poor. Furthermore, this is currently a form of protection only against heterosexual transmission of HIV to women, with no data yet on any protection granted to males having sex with a HIV+ woman or as an anal gel for male homosexual transmission. HIV acquisition by non-sexual routes, such as intravenous drug use, will of course be unaffected by the gel. This is a very poor efficacy rate when compared to condom use. A Cochrane meta-analysis has determined that consistent use of condoms results in an 85% protection rate against HIV, which can go as high as 95% with correct usage. The protective effect is only on par with that of male circumcision, which multiple randomized trials have found protects males from heterosexual HIV transmission at a rate of around 60%.

Is the new gel then completely redundant? A downgrade from the condom? No, not for a key population group - the women of southern Africa. The ten countries of southern Africa together constitute 35% of global HIV cases, with HIV reaching a hyper-endemic situation with 10-30% of adults infected with HIV. In this region, heterosexual spread is the dominant form of HIV transmission, and indeed the risk factor of greatest magnitude at the population level goes to married women. Condom usage in Africa is generally very poor, with an average of only 4.6 condoms available per man per year, due to low demand. Only 7% of women in southern Africa reported using a condom the last time they had sexual intercourse with a regular partner. In particular, women who are food insecure are 70% less likely to use a condom when having sex, with less personal control over sexual relationships. Other women may not use a condom during sex for more personal reference - such as trying to conceive. A vaginal gel therefore provides (partial) HIV protection for the first time to any women who would not otherwise use a condom during sex, either because of personal choice, lack of sexual control, or through a desire to become pregnant.

The other important consideration is that any protection results in a greater number of cases being prevented than the effectiveness of the protection to the individual. This is because each case stopped also prevents the flow-on cases which would have spread from the infected individual. It has been estimated that a weakly protective vaccine, with only a 50% protection rate and only given to 30% of the population, would reduce new HIV infections by more than half, over 15 years. These figures are comparable to the results for Tenofovir Gel, so if the maximal potential is realized, this breakthrough has the ability to halve new African HIV cases.

A tool that will sit idle?

The problem, of course, is that the potential of this gel will not be realized. In many ways, the HIV epidemic is not a problem waiting for a medical solution, but rather a problem waiting for a social and political solution. Consider mother-to-child HIV prevention. Current medical treatment of HIV+ women during pregnancy and after birth reduces the transmission rate to the child by more than 99%. Even in developing countries, the treatment program has over 98% efficacy. And yet these cases, almost entirely preventable under current treatment, make up 15% of global HIV cases and 40% of HIV cases in southern Africa, since only 33% of pregnant HIV+ women in Africa get any form of anti-HIV treatment, let alone the recommended treatment program.

Other strategies, which are already proven to work, could make similar impacts if broadly implemented. Widespread male circumcision would reduce HIV rates by 60% in males and, by reducing prevalence, 30% in females. Comprehensive sexual education focused on preventing new infections can be highly successful. An aggressive campaign of university HIV testing and near universal antiretroviral treatment would be capable of reducing new HIV infections by 95% within 5 years. Just the simple treatment of individuals with genital herpes with current antiherpatic drugs could be expected to reduce transmission of HIV in southern Africa by 50%.

No, a new tool to fight HIV is not going to stop the virus. Realistically, the current tools available could cut new HIV cases by 99% within the decade, if only they were implemented. The true scourge of HIV is that it attacks the marginalised in society, hitting regions of great poverty, infecting those on the receiving side of racial and sexual discrimination. The people that, quite frankly, too many people feel deserve to be sick. Being interwoven with issues of sexuality, drugs, race and poverty, people in power have not only been slow to move - they have often moved in the wrong direction, such as the $15 billion pledged in aid by George W. Bush, with its focus on replacing effective condom use with ineffective "abstinence only" programs.

A major part of the problem is certainly lack of resources, both funding and public health infrastructure. The response to HIV has been delayed, fragmented, inconsistent and grossly under-resourced. Lesotho launched a national voluntary counselling and testing campaign aiming at universal testing, which fell through due to a lack of resources. In South Africa only 28% of HIV+ people have access to antiretrovirals. In Zimbabwe only 4.4% of HIV+ pregnant women are receiving antiretroviral treatment to prevent mother to child transmission. In Nigeria 10% of all HIV transmission events are due to lack of funds for hospitals to screen transfused blood, a situation which requires only funding to remedy. However, funding is not the only impediment to an efficient HIV prevention campaign. Policy makers have repeatedly failed to spend limiting resources on HIV prevention, concentrating on medical treatment without adequate care and support. This is despite the cost of most HIV prevention techniques being well under the $4770 per infection prevented that it would take to create a cost savings compared to simple treatment. What is needed to end the HIV crisis is, in fact, simple in health terms and is difficult only in political implementation – a coordinated and adequately funded approach to integrate evidence-based HIV prevention strategies, in concert with major social and economic development efforts to eliminate gender disparities, race- and sexuality-based discrimination and extreme poverty.

Friday
Oct232009

The ethics of biobanking

The University of Leuven hosted two lectures on biobanking today, one by Hainaut from the International Agency for Research on Cancer and the other by Juhl from the biobanking company Indivumed.

Biobanking is a tricky ethical area, with little consensus and vague law. Who owns the material taken from a patient? The patient? The hospital? The surgeon? If someone wants to use the material, what is the default position? Should the patient have to provide consent or is consent assumed unless the patient opts out? Does the patient even have the right to opt out at a latter time point? Hainaut made the case that there is a moral duty on every person to allow access to their biological samples for the good of humanity. His example was that a excised breast cancer not only belongs to that woman, but also to all other women who may develop breast cancer in the future.

This is an attractive argument but has flaws. If the information generated goes into the public sphere, such that new treatments can be developed and accessed, it may be reasonable to use the moral argument, in the same way that organ donation as the default option can be argued on moral grounds. However, to me this argument is flawed if the information generated does not go into the public sphere. If the information is not published (a secretive researcher or company keeping back information for potential future uses) or if it is published with restrictions on use (ie, patented) that information is not open to all of humanity. Isn't it unethical for a biobank to appeal to the moral duty to all of humanity unless legal restrictions are placed on the biobank to ensure that the proceeds of the bank are available to all of humanity? Doesn't informed consent require donors to be told the status of information generated from their samples?

Unfortunately, Hainaut was not able to answer this question when asked, as Juhl (CEO of a biobanking company that only publishes a fraction of the data it generates) jumped in with a rant about for-profit vs not-for-profit. His contention was that every person acts through the personal profit motive, so that whether the biobank made a profit or not didn't matter. His position is that only private companies have the money to put forward to do the research, and they deserve a profit for the research they do. Perhaps, but irrelevant to the ethical question. If the research outcomes are utilitarian then the utilitarian argument should be put to prospective donors - such as DeCode offering all future drugs free of charge to Icelandic people in exchange for access to the medical records and genome of the Icelandic people. Material can be collected for a utilitarian motive using utilitarian appeals, or for a moral motive using moral appeals. What is unethical is to use a moral appeal to collect material destined for a utilitarian purpose.

Hopefully we will see future legislation reflect the ethical considerations of biobanking in more a more thoughtful manner than was presented today. Donations made by the public for the public good should be legally bound to this use. It is illegal for a charity to accept a monetary donation, keep 90% of the money for personal use and spend 10% on charitable works. Likewise it should be illegal for a biobank that accepts material presented as a public donation to only release 10% of the data produced by the donation, and keep 90% to itself.