BlogEthics Purdue

The Guardian, Wednesday July 30 2008

Just after 9am on Monday September 10 1984, Sir Alec Jeffreys, a professor of genetics, triggered a revolution. He compared a DNA sample from one of his colleagues with that of the man’s wider family and found a pattern. The discovery made DNA fingerprinting possible. The benefits are undeniable. No one would wish the invention undone. But the process, and the British database it has generated, the most extensive in the world, has blurred the divide between private and public, innocent and guilty - a state intrusion into the genetic makeup of individuals that, until now, has been little monitored and could be easily abused.

The dilemmas are more ethical than scientific. It would be possible, if costly and illiberal, to record information from everyone legally resident in the UK. Sir Alec, who in an interview in the Engineer magazine this week rightly described a universal database as “wholly inappropriate”, is not the only one to object to that idea - yesterday a citizen’s jury set up by the Human Genetics Commission opposed it too. But if only some people are to be included, then it is all the more important that the rules are fair and people have a right of appeal. The current situation, in which data from some 4.5 million people is held by chance, either because (innocent or guilty) they were arrested for a recordable offence or because they volunteered their DNA to help an investigation, is a bad compromise.

The risk is that the register ceases to be treated as an impartial forensic tool and becomes a list of the usual suspects - with the simple fact of inclusion implying possible guilt. The recent DNA expansion program, which sought to include all “active offenders”, made the database more useful - but may also have exacerbated its bias. The fact that people who come into contact with the police are the most likely to be included has produced a distorted record, weighted towards certain sections of the population - especially young black men, up to three-quarters of whom may now be included, out of proportion to their actual involvement in crime.

The government admits that this is a problem. But it has been reluctant to limit the sprawl on the grounds that the bigger the database, the more likely criminals are to be caught in its net. But that is a recipe for a universal record by stealth. In April, the Home Office’s advisory DNA Ethics Group urged a limit on the use of information provided by innocent volunteers. Yesterday the citizens’ jury suggested people who are acquitted should have their names removed, among other ideas to prevent uncontrolled expansion. Used badly, a database will harm the society it is supposed to protect.

guardian.co.uk © Guardian News and Media Limited 2008

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Outlook: Genetic Testing’s Recessive Regulation
Young Industry Needs Rules and Limits for Examining Individuals’ DNA

Rick Weiss
Former Washington Post Science Writer; Senior Fellow, Center for American Progress
Monday, July 21, 2008

“The technology is undeniably impressive. For as little $1,000, anybody who can drool into a mailing tube can now find out his or her genetic odds of getting any of 20 or more potentially debilitating diseases, including cancer, heart disease and diabetes. … But tests that look into the fog of people’s medical futures are freighted with tricky medical, economic and bioethical implications. For one thing, most genes are not determinative, so these tests can convey only odds, not destinies. … Most worrisome of all, at least a few companies seem to be peddling DNA-based versions of snake oil. Some firms claim to be able to identify inherited nutritional deficiencies that — guess what? — are treatable with pricey supplements that they just happen to sell.”

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Rick Weiss: Hello chatters. I know you are all anxious to know whether there is something in your genes that drives you to sit at a keyboard and virtually discuss with virtual others the virtual ability of gene tests to reveal something essential about you. Let me make one thing clear from the start: Please, do not send your spit samples to me. Or any other DNA-laden nail clippings or other body parts. I cannot answer your questions this way. But I am happy to use this more conventional means of communication, so let the questions begin.

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Southern Maryland: Genes vs. Jeans is my motto. I figure I can look at my family medical history to figure out my genetic history. With a diabetic parent, and several relatives on both sides of my family having diabetes, I know that without aggressive action/exercise and healthy diet I am staring at diabetes. Another relative had colon cancer, so my doctor ordered a colonscopy at age 40.

I figure if I exercise, eat right, get plenty of rest, reduce stress and fit into my skinny jeans, I will be able to fight the deadly genes and help the healthy genes. So it is a fight between the bad genes and the work necessary to stay in the skinny jeans! I doubt I would have the genetic testing, because I don’t think it would provide me with any new information.

Rick Weiss: Your point is (mostly) correct: The most important and telling single predictor of your future health is that of your parents and close relatives. Working with that, and general lifestyle decisions like the ones you describe, is a great start. That said, you should be aware of a major limit to your approach that is potentially dealt with by genetic tests: Many diseases arise spontaneously without family history. Only five percent of men who get prostate cancer, for example, can point to another family member who got the disease before age 55 (many men get it late in life, and it is often not pertinent at that point, so that does not count as bona fide family history). So in some cases, at least (and with all the potential downsides that my article noted) a test CAN tell you more than your family history.

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New Orleans: One thing I learned years ago is that DNA tests are accurate, but the people testing are not accurate. They found some testers were not doing the tests, or were spoiling these tests. Is there any evidence that the people doing the tests today are doing them properly?

Rick Weiss: This is a big issue in genetic testing. Most of the bigger companies doing this testing are using labs that are federally certified under “CLIA,” the relevant federal law on medical lab quality. So there reagents are fresh and the lab is clean… But how good are the testers? To know that, you’d have to have a system of proficiency testing. The federal government runs such programs for technicians doing other kinds of medical tests, but does not have a system set up for genetic testing, despite recommendations from a Health and Human Services advisory committee that it do so. Beyond the question of whether the strict answer is correct (do you have a certain gene variant or not) there is the additional issue of whether the risk that is being attributed to that gene variant is correct. There are a lot of ways to make this calculation. Different companies do it differently. There is a lot of room for error or disagreement here.

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Hyattsville, Md.: My mother-in-law suggested I do testing to see if I have the breast-cancer gene, as my risk seems to be high. My mother (63) and her mother both had breast cancer (but neither died from it), as well as one of my mother’s sisters (50 when she died) and three of my grandmother’s four sisters. In addition, some of my maternal great-uncles have had colon cancer — which I understand is linked to breast cancer in some genetic way. My preference would be to be preventative and act as though I do have the gene, but not have it confirmed (and potentially risk having that information used against me). What makes sense here?

Rick Weiss: This is hugely complicated issue that many women are struggling with today, and I will not pretend to be able to tell you what to do except for one thing: Go talk to a genetic counselor. These experts know all the right questions to ask to help you decide whether to go forward, including how you personally deal with anxiety and stress as well as what your medical and family history is. They understand the genetics and psychology of this emerging business far better than even most doctors do. They also recognize that as personal as this decision is, it is also a family decision, because what you learn can affect others related to you. All the major medical centers around here — Georgetown GW, Hopkins — have genetic counselors. Find one and start talking.

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Chicago: A quick glance at the 23 and Me Web site seemed to show that they don’t test as much for genes that clearly have established clinical relevance as for less well-known susceptibility factors. For example, for breast cancer they don’t test the BRCA1 or BRCA2 genes, and for male infertility they don’t test the AZF gene. Is it typical that these mail-order gene tests don’t test for genes that could indicate actual genetic disorders? What would be the rationale for this?

Rick Weiss: There are two issues here, one genetic, one business. Gene-wise, the truth is that the old idea that a certain gene or two will strongly predispose you to a disease (as in BRCA1 and 2 for breast cancer) turns out to be the exception, not the rule. In most cases, many genes together contribute in modest ways to risk, and in many cases these genes are not even fully characterized yet. Rather, scientists have found genetic markers that seem to “migrate” with disease — or give indirect evidence of risk. So that is what they test for. The business element is that many of the strongest predictors of disease, again such as BRCA1 and 2, are patented, and tests for them cannot be performed unless a deal is cut with the patent holders. That can change the price structure of direct-to-consumer testing considerably.

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Munich, Germany: You mentioned the existence of deceptive gene-test companies; in the event that DNA could be used in the future as personal identification, has there been much though within this industry regarding the protection of personal DNA information? In the worst case, once a criminal organization has a person’s DNA code, that person can’t swap out their DNA like a new credit card number.

Rick Weiss: All the big gene test companies boast that they have great security and privacy systems in place. For obvious reasons, they also don’t reveal details. So we are all left to wonder just how good these systems really are. That said, if a criminal wanted to capture your DNA and use it for fraudulent purposes, he or she would not have to crack the high-security Web site at 23andMe. All they need to do is pick up the cigarette butt you dropped on the ground, or the cup you drank from, or the hair in your shower. We all leave our genetic ID cards everywhere we go. I hope this has allayed your fears ….

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New Orleans: How difficult is it to be a DNA tester and analyst? While DNA tests are good, isn’t there also a risk if there is someone who doesn’t know how to handle the specimens properly or interpret the data correctly? How much of a problem is that?

Rick Weiss: As I mentioned in a previous post on this chat, there are outstanding issues of proficiency testing. I will add here that one problem in particular is that most DNA tests start with a very little bit of DNA and amplify it millions of times to get enough to do all the testing on. That means that the system is very susceptible to contamination. If even a smidgeon of the tester’s DNA got into the system while he or she was doing the work, for example, it could be amplified and pretty soon some poor client is getting a report in the mail that describes the lab technician’s medical risks… There are controls in place of course to limit this kind of error, but it does happen (and has happened in crime labs, alas, as well)so lab and technician quality is crucial in this business.

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Arlington, Va.: Rick: You have called for more regulation of these tests, but I also know that sometimes the FDA and other agencies can take years in approving new products. What are your thoughts about the balance between regulation vs. not slowing down innovation?

Rick Weiss: FDA does act very slowly, and there is a legitimate concern that over-regulation (or slow action) by FDA will stall this potentially important new enterprise. Moreover, as Kathy Hudson recently noted (she of the Genetics and Public Policy Institute in DC, which has worked on this issue a lot and has a good Web site for those interested): If you even MENTION the prospect of the FDA getting involved in this area it gives these gene test CEOs a serious case of hives. That is why I am open to the idea of a compromise approach, in which the Department of Health and Human Services (and perhaps ideally a part of HHS that is not FDA)comes up with some formal guidance that sets the standards bar for certain aspects of gene testing. It could be flexible enough to change more quickly than regs can as the science changes. But it would make plain to companies what is expected of them. Many companies say they can set these standards themselves. I think recent events in the financial industry, which for years has been left largely to regulate itself and has now been found to have taken terrible advantage of the public while feeding itself greedily, should be a lesson to us that when potentially large profits are at stake — as is always the case, it seems, in healthcare — some kind of independent oversight is really needed.

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washingtonpost.com: What sorts of regulatory oversight do you think would be appropriate for this industry? Is there anything that could be done about the fraudulent outfits, or are they as impervious to U.S. laws as online “pharmacies”?

Rick Weiss: See my previous post on this discussion about the potential for oversight by FDA and other agencies within HHS. But there is another federal agency that needs to get more active as well: The Federal Trade Commission, whose job is to identify and punish consumer fraud. Most of the gene test companies I’ve dealt with seem essentially legit, and even extremely dedicated to scientific accuracy (although I do have questions about the real value of this kind of information for most people). But there are at least a few that seem transparently fraudulent or at least, how can I put it?, worthy of some scientific and legal scrutiny. Consumers should be especially wary of any Web site that purports to diagnose you or predict a future health problem for you AND just happens to sell a product that it claims is just what you need. And while love and sex are complicated affairs that no doubt have some kind of genetic components, I can’t help but be skeptical about any company that claims it can help me choose, on the basis of my DNA, a mate who will have more orgasms and give me healthier children (as one company does). I hear that the FTC is currently investigating at least two gene test companies. I will be interesting in seeing what agency officials do, and how quickly they act.

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Washington: Knowing what you do about genetic testing and how much we are now learning about the makeup of our DNA, would you suggest cord-blood banking in terms of its future potential at saving our children from serious diseases, or would you suggest only doing it if you have a family history of a specific disease that may be treatable in the near future?

Rick Weiss: I have my doubts about the value of cord blood saving for most people. Experts have told me they have their doubts too. While there may be some exceptional circumstances when it may prove valuable to have some cord blood handy to, for example, treat your baby later in life, the odds are low and some doubt you’d be able to track down and get those crucial cells in time — to use for transfusion purposes, for example, after an accident. That said, cord blood cells do seem to be an extremely valuable resource for research and increasingly for clinical purposes (as a source of cells to rejuvenate the blood system for cancer patients who have had chemo and radiation for example). I think people should consider donating their cord blood to non-commerical cord blood banks, for use and sharing by those who prove to be a good match and could benefit from these deposits, much the way people donate blood through the Red Cross today

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Providence, R.I.: One benefit of genetic testing is an opportunity for preventative care — for diabetes or certain types of cancer, for instance. While there always will be a grey area (of varying degrees) between a DNA test and future health, patients will gain some security in being able to “manage” the potential of even rare outcomes.

Rick Weiss: It is true that a DNA warning shot over your bow may get you to take preventive action that you might otherwise not have considered or not been sufficiently inspired to pull off on your own. But everybody already knows what they SHOULD be doing. So arguably, the test is not crucial to forming good health behaviors. And of course the test can and will scare some people unnecessarily, since these tests are not terribly good at telling individuals whether they personally are really in line to get a disease or not — rather, it is all odds driven, and people are notoriously bad at understanding and interpreting odds. In the end, it is obviously a personal decision. Some people will be inspired and empowered by their DNA results. Perhaps their lives will be saved by a DNA test. Others will wish they had never done it. The real difficult issue here is how to allow the former to benefit from this newly available technology without making a big slice of the population unduly vulnerable to the downside. And of course, how to do this without being overly paternalistic. People want to have choice, but they also don’t want to be taken for a ride. People hate “government,” it seems, but they REALLY hate it when their government does not protect them….

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Baltimore:“I can’t help but be skeptical about any company that claims it can help me choose, on the basis of my DNA, a mate who will…” This is a fascinating application of the power of suggestion and perhaps the placebo effect — hopefully all of their tests turn out positive!

Rick Weiss: In fact, the company I am thinking of uses an interesting scientific finding to come to its matchmaking conclusions: evidence that in some mammals, at least, males and females with the most divergent immune system genes seem to be attracted to each other and perhaps have healthier offspring. That’s great if you are a mouse sniffing your date’s urine (which is how those mammals do this kind of assessment) but I have my doubts that this deserves such high ranking in humans, among all the things that go into a happy marriage and having healthy kids. But hey, that’s capitalism for you. Run it up the flagpole and see if it sells.

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Arlington, Va.: I heard Dr. Francis Collins do a talk about genomics. He mentioned that genetic tests can be useful in identifying whether or not a particular dosage of a drug is right for specific patients, and mentioned coumodin for heart conditions. My mother struggled a long time as her doctors tried to find the right dose for her, to avoid strokes or bleeding. Do you see this an important new area for these tests?

Rick Weiss: This is indeed a wonderful and non controversial application of genetic testing. Some people have gene variants that break down certain drugs quickly, so need a higher dose of those medicines. Others are in the opposite situation, and can overdose with a normal dose. Recently, the FDA has even been tailoring some drug approvals with language noting that some patients should get a genetic test before taking the drug, to make sure it will work for them and not be toxic. DNA has huge potential in so many areas of medicine — and other areas, of course, including criminal justice and evolutionary and anthropological studies. It’s all about how we use it and interpret those results … and who is minding the store as these tests and products get sold directly to consumers.

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“But everybody already knows what they should be doing.”: As an adopted person I have no idea of my family medical history, so I might welcome certain tests. I thought I’d add that it was good to see the Congress pass the genetic nondiscrimination law a few months ago.

Rick Weiss: Whether you are adopted or not, you should eat fresh foods in moderation, exercise, and not smoke. That’s what I meant. But yes, you are right, adoptees can fill in some of the holes in their medical history with DNA tests. Again, the problem is that most of these test are still not very definitive.

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Rick Weiss: Thanks everybody for an interesting hour.

Rick

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By Rick Weiss
Sunday, July 20, 2008
http://www.washingtonpost.com/wp-dyn/content/article/2008/07/18/AR2008071802555.html?referrer=emailarticle

Jeffrey Gulcher had no reason to think much about prostate cancer. He was just 48, and the disease typically strikes later in life. Even the most cautious medical groups agree that most men need not begin annual prostate screenings until age 50.

But Gulcher happens to be the chief scientific officer of deCODE Genetics — one of several companies that, amid some controversy, have begun offering direct-to-consumer DNA tests that can help people predict which diseases they are likely to get. So in April, he spat into a test tube and, without giving the matter much thought, sent the sample in for analysis by his own company.

He was in for a shock. The test indicated that he carries a genetic variant that nearly doubles his lifetime risk of getting prostate cancer: While the average man has a 15 percent chance of being stricken, Gulcher had a 30 percent shot. That spurred his physician to order a standard blood test for prostate cancer. The result was toward the high end of the range considered normal, which, together with the DNA test, worried the doctor. He referred Gulcher to a urologist, who performed an exploratory biopsy — and found that Gulcher’s prostate gland was riddled with cancer, and a fairly aggressive version of it at that.

Gulcher is going in for surgery tomorrow, and not a moment too soon. Tests suggest that the disease has not yet spread to other parts of his body, a milestone that often portends death and that may well have been passed had he waited until he turned 50 to get a standard prostate-specific antigen (PSA) test.

Did genetic testing save Gulch er’s life? I think it may have. His dramatic story seems to illustrate perfectly the claims, made by his company and others, that an open market of DNA tests is the 21st century’s ticket to a healthier nation. But a closer look suggests that this fast-growing industry, with its snazzy Web-based come-ons, could benefit from some temperance and independent oversight.

The technology is undeniably impressive. For as little as $1,000, anybody who can drool into a mailing tube can now find out his or her genetic odds of getting any of 20 or more potentially debilitating diseases, including cancer, heart disease and diabetes. Most of these tests will not lead to a frank diagnosis, as happened with Gulcher. But discovering an inherited propensity toward a particular illness can motivate consumers — or, as they used to be known, patients — to get more frequent checkups, take preventive medicines or make lifestyle changes to try to ward off the specter of disease. At last, we seem to be on the cusp of the long-promised personalized-medicine revolution in which gene tests allow physicians to craft far more individualized and effective ways of keeping us well.

But tests that look into the fog of people’s medical futures are freighted with tricky medical, economic and bioethical implications. For one thing, most genes are not determinative, so these tests can convey only odds, not destinies. Even with the doubled lifetime risk for cancer that’s associated with Gulcher’s prostate gene variant, two out of three men who receive a “positive” test for that gene will never get the disease. And many of those who do will get it so late in life and in such a benign form that no treatment would be justified. So that’s at least two new members of the “worried well” who could be losing sleep and spending money on unnecessary follow-up tests for every person who would arguably be appropriately forewarned.
Moreover, the tests are still new and easily misinterpreted, even by professionals. Online results may be subject to security and privacy breaches. And some companies are using people’s gene profiles to conduct independent research. That suggests to many ethicists and lawyers that these firms’ paying clients ought to be informed that they are subjects in experiments, with full disclosure of potential risks and rights.

Most worrisome of all, at least a few companies seem to be peddling DNA-based versions of snake oil. Some firms claim to be able to identify inherited nutritional deficiencies that — guess what? — are treatable with pricey supplements that they just happen to sell. Some even promise to discern from your genes what kind of person you should marry to ensure a blissful sex life and healthier babies. Welcome to the Wild West of personalized genomics.

These problems are not insurmountable. But there is precious little oversight of this burgeoning new industry, in part because genetic analysis does not fit cleanly into any existing category of medical practice. And if the first wave of DNA-screening companies to hit the market gets its way, there won’t be any more adult supervision in the foreseeable future. In a blatant effort to stave off regulation, top officials from all the major competing gene-test companies met early this month and quietly agreed to spend this summer hammering out a “best practices” document that they would promise to follow. This is a great idea, but it’s not enough.

No state or federal agency can today assure consumers that the DNA tests they order will give accurate results — or that the results, even if technically accurate, will have any practical value. The Food and Drug Administration says it has the authority to regulate all gene tests but has decided, at least for now, to ignore the vast majority of those developed so far. The Federal Trade Commission (FTC), which is supposed to protect consumers from fraudulent claims, has never taken an enforcement action against even the most transparently deceptive gene-test companies. And the Centers for Medicare and Medicaid Services, the division within the Department of Health and Human Services that oversees clinical laboratories, has so far opted to steer clear of the genetic-testing world, despite pleas from federal advisers to ensure a minimal standard of gene-test proficiency.

The companies say that what they do is different enough that they should not be shoehorned into the conventional medical-testing rules. “For the first year and a half of our existence, all we did was try to figure out how to fit into the regulatory environment,” said Dietrich Stephan, co-founder of Navigenics, a leading California-based gene-test company, adding that the effort cost an estimated $10 million.
That’s real money. Yet even with all that preparation, Navigenics and a dozen other testing companies recently received warnings from individual states accusing them of violating state rules for labs. Situations such as this cry out for the guiding hand of the federal government — not necessarily through cumbersome regulations, which can be too rigid to keep up with quickly changing science, but through formal guidelines, at least, promulgated by HHS. These could set clear expectations about how accurate gene tests should be — and what it means to be “accurate” in the brave new world of predictive health — and what level of informed consent should be obtained from clients. The promulgation of such standards will take real effort from HHS Secretary Mike Leavitt, who has championed personalized medicine but who has thus far been largely AWOL on the gene-test issue and has little incentive to push hard in the final months of the Bush administration. The FTC also needs to show that it has teeth and can bite.

Genetic-testing companies need to ante up, too. The responsible ones could buy a lot of good will by offering the public easily accessible scientific details (online and elsewhere) about the specific genes or genetic markers they are testing for; citations for the published studies they use to justify their claims that those genes have real medical relevance; the privacy and security systems they have in place; and the protocols for any experiments that clients’ specimens may be used in. The firms should also disclose any approvals they have sought, obtained or denied from independent scientific and ethical review boards.

I took heart that such a future is possible when, at an HHS meeting two weeks ago, I saw chiefs from the five major competing gene-test companies sitting next to one another, speaking cooperatively to federal advisers. If these executives move aggressively to do the right thing, and if federal officials help them with some smart but tough guidance, perhaps those corporate heads can avoid a future in which they are called upon to appear side by side again — this time before Congress, looking more like those famously photographed tobacco CEOs, being asked tough questions about what exactly they have been selling, and at what cost to American health.

rweiss@americanprogress.org
Rick Weiss, a former science reporter for The Post, is a senior fellow at the Center for American Progress.

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Pierre Bocev, correspondant à Berlin (LeFigaro.fr) 04/07/2008

La chambre des Länder veut mieux contrôler l’euthanasie, en principe interdite depuis la fin du régime nazi.

Le terrain est miné, et le dernier engin n’a été planté qu’il y a une semaine. Samedi dernier, Roger Kusch, ancien ministre régional à Hambourg connu pour ses frasques, a relancé un débat récurrent sur l’assistance au suicide en annonçant avoir aidé par ses conseils une septuagénaire à mettre fin à ses jours. Bettina Schardt, de surcroît, n’était pas mortellement malade, elle paniquait à l’idée de devoir aller dans un hospice de vieillards.

Le sujet controversé a été débattu hier au Bundesrat, la chambre des Länder avec la volonté de mettre en route une législation pour interdire l’assistance organisée au suicide.

L’euthanasie est interdite en Allemagne, six décennies après la fin du régime nazi et sa recherche du «pur Aryen». L’aide active au suicide est également punie par la loi, mais il existe une zone grise pour la distinguer de l’assistance passive, non poursuivie. Où se situe la limite juridique et morale entre l’arrêt de soins qui permet à un patient de mourir et la mise à disposition de médicaments qui lui permettent d’accomplir lui-même le geste final ?

L’apparition de groupes spécialisés, et en rien caritatifs, a relancé le vieux débat il y a environ deux ans. Le principal élément déclencheur a été l’organisation helvétique Dignitas qui a attiré l’an dernier près de 70 Allemands soucieux de mettre fin à leurs souffrances. Parfois dans des conditions, il est vrai, sujettes à caution. Ajouté à ce débat de fond qui couve en permanence, l’acte très médiatisé de Roger Kusch a conduit plusieurs Länder à réactiver un projet de loi ensablé depuis deux ans, qui visait précisément à barrer la route à Dignitas et à des officines du même genre.

Le vote sur le nouveau texte, qui prévoit de punir de trois ans de prison une telle assistance active au suicide, a pourtant été reporté à plus tard. Les dirigeants des seize régions cherchent de leur propre aveu une discussion plus dépassionnée que ne l’aurait permis l’ambiance actuelle, sous le coup de l’acte « scandaleux » de Roger Kusch, selon la formule de Kurt Beck, ministre président de Rhénanie-Palatinat et patron du SPD.

Crime d’opinion

Présenté par des Länder dirigés par les conservateurs et chrétiens de la CDU-CSU, le projet de loi suscite en effet une série de questions. Il vise ainsi à criminaliser non seulement toute «association visant à procurer à autrui l’occasion de se suicider» ce qui consisterait à punir non pas un acte, mais une simple intention mais il veut également frapper les personnes qui «jouent un rôle moral ou économique décisif» dans de telles associations, qu’ils en soient «membres ou non», ce qui, dans l’analyse du professeur de médecine Urban Wiesing, constituerait une «atteinte massive à la liberté d’expression» en permettant par exemple de condamner un écrivain dont les œuvres prônent le droit d’aider un candidat au suicide.

Juridiquement, le Bundesrat ne peut de toute façon que saisir les députés du Bundestag de son éventuel projet de loi. Autant dire que le débat est loin d’être clos.

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July 4, 2008
By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The National Institutes of Health is making some funding and other adjustments to a pilot program focused on helping researchers translate genetic tests from the lab to the clinic by promoting collaborations between scientists, clinicians, laboratories, and disease-specific advocacy groups.

Among the changes, the NIH has added funding to compensate researchers for the time investment needed to apply.

Run by the NIH’s Office of Rare Diseases, the Collaboration, Education, and Genetic Test Translation (CETT) Program is aimed at supporting researchers who are developing a new gene or assay technology into a clinical diagnostic test that can be used to diagnose and even manage a disease.

The CETT Program also hopes to give researchers focused on rare diseases help in forming a relationship with a lab and patient advocate groups.

NIH said in a program announcement Thursday that it expects the program to help these researchers focus on research, and not on clinical care or service, and to enhance the knowledge base that is obtained from the collection and storage of clinical data. The program also should help scientists identify new subjects from expanded access to clinical testing and documented findings, and help them provide results to research participants and their families.

Because NIH has realized that building the collaborations needed to apply involves work that previously was uncompensated, all applications for CETT funding received after June 1 qualify for $3,000 in funding to support collaboration development.

NIH also has doubled the funding it gives to applicants for the CETT program from $1,000 to $2,000 for all who have applied after June 1, and it now only requires two versions of educational materials instead of three. Each application received after June 1 also qualifies for $5,000 to support the translation and clinical consultation activities spent by the research member of each CETT Program application.

More information about the changes in the CETT program can be found on http://www.cettprogram.org/whats_new.aspx

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Internal World Bank study delivers blow to plant energy drive

* Aditya Chakrabortty, The Guardian, Friday July 4, 2008

Corn used for biofuel

Biofuels have forced global food prices up by 75% - far more than previously estimated - according to a confidential World Bank report obtained by the Guardian.

The damning unpublished assessment is based on the most detailed analysis of the crisis so far, carried out by an internationally-respected economist at global financial body.

The figure emphatically contradicts the US government’s claims that plant-derived fuels contribute less than 3% to food-price rises. It will add to pressure on governments in Washington and across Europe, which have turned to plant-derived fuels to reduce emissions of greenhouse gases and reduce their dependence on imported oil.

Senior development sources believe the report, completed in April, has not been published to avoid embarrassing President George Bush.

“It would put the World Bank in a political hot-spot with the White House,” said one yesterday.

The news comes at a critical point in the world’s negotiations on biofuels policy. Leaders of the G8 industrialised countries meet next week in Hokkaido, Japan, where they will discuss the food crisis and come under intense lobbying from campaigners calling for a moratorium on the use of plant-derived fuels.

It will also put pressure on the British government, which is due to release its own report on the impact of biofuels, the Gallagher Report. The Guardian has previously reported that the British study will state that plant fuels have played a “significant” part in pushing up food prices to record levels. Although it was expected last week, the report has still not been released.

“Political leaders seem intent on suppressing and ignoring the strong evidence that biofuels are a major factor in recent food price rises,” said Robert Bailey, policy adviser at Oxfam. “It is imperative that we have the full picture. While politicians concentrate on keeping industry lobbies happy, people in poor countries cannot afford enough to eat.”

Rising food prices have pushed 100m people worldwide below the poverty line, estimates the World Bank, and have sparked riots from Bangladesh to Egypt. Government ministers here have described higher food and fuel prices as “the first real economic crisis of globalisation”.

President Bush has linked higher food prices to higher demand from India and China, but the leaked World Bank study disputes that: “Rapid income growth in developing countries has not led to large increases in global grain consumption and was not a major factor responsible for the large price increases.”

Even successive droughts in Australia, calculates the report, have had a marginal impact. Instead, it argues that the EU and US drive for biofuels has had by far the biggest impact on food supply and prices.

Since April, all petrol and diesel in Britain has had to include 2.5% from biofuels. The EU has been considering raising that target to 10% by 2020, but is faced with mounting evidence that that will only push food prices higher.

“Without the increase in biofuels, global wheat and maize stocks would not have declined appreciably and price increases due to other factors would have been moderate,” says the report. The basket of food prices examined in the study rose by 140% between 2002 and this February. The report estimates that higher energy and fertiliser prices accounted for an increase of only 15%, while biofuels have been responsible for a 75% jump over that period.

It argues that production of biofuels has distorted food markets in three main ways. First, it has diverted grain away from food for fuel, with over a third of US corn now used to produce ethanol and about half of vegetable oils in the EU going towards the production of biodiesel. Second, farmers have been encouraged to set land aside for biofuel production. Third, it has sparked financial speculation in grains, driving prices up higher.

Other reviews of the food crisis looked at it over a much longer period, or have not linked these three factors, and so arrived at smaller estimates of the impact from biofuels. But the report author, Don Mitchell, is a senior economist at the Bank and has done a detailed, month-by-month analysis of the surge in food prices, which allows much closer examination of the link between biofuels and food supply.

The report points out biofuels derived from sugarcane, which Brazil specializes in, have not had such a dramatic impact.

Supporters of biofuels argue that they are a greener alternative to relying on oil and other fossil fuels, but even that claim has been disputed by some experts, who argue that it does not apply to US production of ethanol from plants.

“It is clear that some biofuels have huge impacts on food prices,” said Dr David King, the government’s former chief scientific adviser, last night. “All we are doing by supporting these is subsidising higher food prices, while doing nothing to tackle climate change.”

See also
http://www.worldbank.org/banquemondiale/themes/crise-alimentaire/

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LE MONDE | 01.07.08

La prolifération des sociétés vendant des tests génétiques via Internet a poussé les autorités de Californie à tenter de mettre un peu d’ordre dans ce nouveau secteur, avant qu’il échappe à tout contrôle. Le 9 juin, le département californien de la santé publique a envoyé des lettres de mise en demeure à 13 entreprises pour leur rappeler leurs obligations légales. Si elles veulent continuer à faire des affaires en Californie, elles devront obtenir un agrément des autorités sanitaires et se soumettre à différents contrôles. D’autre part, si le test génétique est à finalité médicale, il devra être prescrit puis interprété par un médecin.

TESTS DE PATERNITÉ EN VENTE LIBRE

Cinq des sociétés visées sont californiennes, six sont installées dans d’autres Etats américains, une en Islande et une au Portugal. La localisation des entreprises importe peu, car le paiement se fait via Internet et le client envoie par la poste un simple tube rempli de salive. Les tests proprement dits sont sous-traités à des laboratoires spécialisés. Enfin, les résultats sont affichés sur une page Internet protégée par un mot de passe.

Jusqu’à présent, la Californie s’était montrée libérale : les tests de paternité sont en vente libre dans les pharmacies et des dizaines de clubs de généalogie utilisent couramment les tests génétiques pour leurs recherches. Mais depuis quelques mois, de nouvelles entreprises proposent des produits à plus large spectre, qui informent notamment les clients sur leur prédisposition à développer certaines maladies graves. C’est le cas des deux sociétés les plus connues, installées près de San Francisco : 23andMe fournit à ses clients, pour 1 000 dollars, un large éventail de données à finalité médicale, comportementale et généalogique ; Navigenics propose, pour 2 500 dollars, des tests plus ciblés, sur les probabilités de développer certaines pathologies.

Depuis leur apparition, ces sociétés sont regardées avec méfiance par les associations de médecins. Selon elles, si un patient apprend brutalement qu’il a une chance supérieure à la moyenne d’être atteint par la maladie d’Alzheimer, le choc psychologique pourra provoquer des comportements irrationnels. Autre exemple : si son test l’informe qu’il n’est pas prédisposé à faire des crises cardiaques, il va se remettre à manger gras, arrêter le jogging et annuler ses visites chez son cardiologue.

Avant même leur ouverture commerciale, 23andMe et Navigenics avaient lancé des campagnes d’information et de promotion en direction des milieux médicaux. Mais en même temps, un de leurs arguments de vente dit qu’en disposant de son code génétique chaque client prend le pouvoir sur son propre corps, sans tutelle ni intermédiaire… Malgré l’injonction, Navigenics et 23andMe continuent à vendre leurs services en Californie. Elles rappellent que leurs tests sont effectués par des laboratoires extérieurs, agréés par l’Etat, et qu’elles comptent des médecins parmi leurs employés. Par ailleurs, toutes deux possèdent des alliés puissants. 23andMe est dirigée par Anne Wojcicki, biologiste, femme d’affaires et épouse de Sergueï Brin, un des patrons de Google. Ses autres actionnaires sont la firme de biotechnologie Genentech et le grand groupe financier NEA.

DROIT À POSSÉDER SON PROPRE CODE GÉNÉTIQUE

Google est également actionnaire de Navigenics, aux côtés de trois grands fonds de capital-risque. Ces entreprises pourront aussi compter sur le soutien des ligues de défense des droits civiques, d’organisations universitaires, d’associations de malades et de divers groupes libertaires, qui militent pour le droit imprescriptible de chaque être humain à posséder son propre code génétique sous forme de fichier informatique, sans limites ni contraintes bureaucratiques.

Par ailleurs, en mai, le Congrès a voté une loi interdisant toute discrimination fondée sur la génétique. En clair, les employeurs ne pourront pas se servir de ces tests pour sélectionner ou pénaliser leurs employés, et les compagnies d’assurances n’auront pas le droit d’augmenter le montant des polices sur la base d’informations génétiques. L’objectif est de rassurer les consommateurs qui pourront faire pratiquer ces tests sans craindre de conséquences néfastes… à condition que la nouvelle loi soit appliquée avec rigueur.

Yves Eudes

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LE MONDE | 30.06.08 | 17h30 • Mis à jour le 30.06.08 | 17h30

Les chimpanzés, espèce en voie de disparition, doivent désormais faire face à une menace supplémentaire. Après avoir mené une campagne d’études au sein du parc national des montagnes Mahale, en Tanzanie, une équipe de scientifiques de l’université américaine Virginia Tech a prouvé la contamination de nos plus proches cousins par… des virus d’origine humaine, parfois mortels. Non content de détruire les chimpanzés à grands coups de braconnage et de déforestation, l’être humain leur transmet aussi ses maladies.

Dans un article publié dans le numéro d’août de la revue American Journal of Primatology, Taranjit Kaur et ses collègues constatent que certains chimpanzés souffrent d’affections respiratoires chroniques dues à une mutation du métapneumovirus humain, responsable de bronchiolites et de pneumonies. Ces travaux confirment les résultats récents obtenus par divers instituts européens et divulgués, en février, dans la revue Current Biology. Ils mettaient en valeur la présence de virus similaires sur des cadavres de chimpanzés du parc national de Taï, en Côte d’Ivoire. Le phénomène ne serait donc pas isolé et pourrait couvrir l’ensemble du territoire africain.

MASQUES ET DÉPISTAGES

“L’origine exacte de ce virus et sa voie spécifique de transmission demeurent encore peu claires”, souligne Mme Kaur, qui réclame des études plus poussées et la mise en place d’une surveillance des maladies infectieuses chez les chimpanzés. Pourtant, un certain nombre d’indices montrent que les souches analysées proviendraient de touristes ou… de scientifiques. L’écotourisme et la recherche ont souvent été vantés auprès des pays en voie de développement comme une façon de valoriser les espèces en danger et leur habitat naturel. L’intérêt était de pousser les gouvernements à protéger les animaux afin d’en tirer des contreparties à la fois économiques et écologiques. Mais le risque infectieux, mis en évidence par ces études, pourrait accélérer l’extinction des chimpanzés et dépasser les bénéfices.

“L’écotourisme est le coeur des économies locales et nationales des pays abritant la vie sauvage. S’il s’arrête, ce sera dévastateur pour leurs populations, grandement dépendantes de ces sources de revenus”, note Taranjit Kaur. En conséquence, la chercheuse préconise un certain nombre d’adaptations visant à faire évoluer le secteur et à préserver les populations restantes de grands singes : port systématique de masques chirurgicaux pour les chercheurs et les touristes, dépistages pour les salariés du parc, programmes de sensibilisation, etc.

Sabrina Krief, primatologue et maître de conférences au Museum national d’histoire naturelle, tient cependant à relativiser certains des points soulevés par Taranjit Kaur. Elle fait valoir que des protocoles sanitaires stricts ont déjà été adoptés par de nombreuses réserves, comme par exemple en Ouganda avec les gorilles. “Les maladies sont impressionnantes car elles frappent fort et très rapidement. Mais la mortalité qui leur est due reste marginale, explique Sabrina Krief. Il ne faut surtout pas se détourner des causes premières de la disparition progressive des grands singes. Une prise de conscience des gouvernements locaux est nécessaire. Ils doivent prendre des mesures strictes contre la chasse, les risques de conflits locaux et la déforestation.

Xavier Venutolo
Article paru dans l’édition du 01.07.08

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