Art Caplan on GlaxoSmithKline research conduct in China

An article in today’s New York Times explores allegations of improper research practices at GlaxoSmithKline’s research and development center in Shanghai, China. The article quotes Art Caplan in reference to evidence that researchers proceeded with drug trials in humans before animal studies were complete:

“If that’s true, it’s a mortal sin in research requirements,” said Arthur L. Caplan, the head of the division of medical ethics at NYU Langone Medical Center. He served as the chairman of an advisory committee on bioethics at Glaxo from 2005 to 2008. “No one could approve human trials without having that information available, scientifically or ethically. That’s kind of a Rock-of-Gibraltar-sized ethics violation.”

Read the full article here.

Cyborg Bugs and Glow-in-the-Dark Cats

By Dov Fox

That’s what CNN called yesterday’s report with science writer Emily Anthes about her new book, Frankenstein’s Cat, which examines “genetically modified this, or cloned that,” as she put it, or “creatures that combine electronic bits and biological ones.” Wrestling with the ethics of such cases, Anthes explains, “reveals that we’re deeply conflicted about the role that animals play in our lives.” Yet she laments that this tension supplies no satisfying answers to underlying questions like “Is this unnatural?” and would “that make it wrong?”

Our confusion lies, I’ve suggested, in the failure of animal welfare discourse to capture the sense many of us share that animal “nature” has value apart from its happiness or well-being. If its welfare were all that mattered, then we shouldn’t be troubled by animals designed to experience less frustration living in the conditions for which they’re destined. Consider three examples of designer animals that are currently being developed: cows with stunted sentience, less apprehensive of going off to slaughter; chickens that lack nesting instincts, more satisfied to a life confined to laying eggs in a battery cage; and pigs without legs, better suited for a sedentary existence as ham and bacon in potentia.

The dominance of the animal welfare view obscures a reason to resist such creations: to preserve animal integrity. Cows should be able to fear danger, pigs to play in the mud, and chickens to peck about in the sand, according to this view, less because those capacities make the animals happy than because they are integral to an intrinsically valuable way of being. To deprive a cow of its responsiveness, or a pig of its limbs, or a chicken of its proclivity for pecking would, on this account, violate its essential “cowness” or “pigness” or “chickenness,” even if those animals were perfectly content in their designated roles.

For thoughts on why animal nature may indeed be worth preserving, and implications for conventional breeding (e.g., dogs for companionship, or horses for racing), and what all of this  means for designer children and embryonic stem cell research, check out the article.

The High Cost of Health Care: Why Some Pay $240 for a $9 Bottle of Pills

By Jonathan J. Darrow

An earlier post discussed the equivocal efficacy of Propecia (finasteride) as a baldness remedy, ending with the provocative assertion that, efficacy aside, “there is little reason for anyone ever to buy or consume Propecia (finasteride), or any doctor ever to prescribe it, since a much cheaper and identical chemical sold under the trade name Proscar (finasteride), is available.” This post continues the discussion, addressing one small component of the rising cost of healthcare—the cost of finasteride.  It explores why consumers pay as much as $240 for a bottle of Propecia (finasteride) when a $9 bottle of an equivalent, FDA-approved supply of the identical chemical is readily and legally available at nearby stores.

In the exorbitantly priced landscape of prescription drugs, there is at least one low-cost oasis: Wal*Mart.  Though some find reason to criticize the discount store, few would disapprove of the dozens of prescription medications Wal*Mart offers for an unbeatable $4 for a 30-day supply.  Cost-sensitive consumers can purchase everything from blood thinners to antidepressants to antibiotics at this price, while a 90-day supply is only $10 (and this price includes shipping to your doorstep).  A handful of drugs that cannot be sold at $4 per month sell for a still-modest $9.  For the 300 or so drugs on Wal*Mart’s list, this means there is no longer a need for $10 co-pays or snowy treks to the pharmacy in 15 degree weather.  That’s right: the Wal*Mart total price is less than most insurance company co-pays.  Finally, a major industry player seems to have put effective downward pressure on prescription drug prices.  Read More

Humane Transport of Research Animals

by Suzanne M. Rivera, Ph.D.

For some time, animal rights activists in the US and abroad have been trying to pressure commercial airlines out of their long-standing practice of transporting research animals.  Last week, a coalition of more than 150 leading research organizations and institutions sent a letter to the CEOs of the targeted airlines, urging them to continue transporting animals needed for research purposes.  A copy of the coalition joint letter is available here.

The letter initiative was organized by the National Association for Biomedical Research (NABR), and had the strong support of the Association of American Medical Colleges (AAMC), the Council on Governmental Relations (COGR), the American Association for Laboratory Animal Science (AAALAS), and Research!America, to name a few.

The basic thrust of the letter can be summarized by this passage: “Your company’s commitment to transporting laboratory animals is crucial to finding treatments and cures for diseases afflicting millions of people worldwide. We ask that you continue transporting research animals, allowing lifesaving research around the world to progress.” Read More

Accentuate the Negative

by Suzanne M. Rivera, Ph.D.

While attending the annual Advancing Ethical Research Conference of Public Responsibility in Medicine and Research (PRIM&R) last month in San Diego, I had the opportunity to hear a talk by Dr. John Ioannidis, in which he debunked commonly accepted scientific “truths.”  Calling upon his own work, which is focused on looking critically at published studies to examine the strength of their claims (see his heavily downloaded 2005 paper “Why Most Published Research Findings Are False”), Ioannidis raised important questions for those of us who think about research ethics, and who oversee and manage the research conducted at universities and scientific institutes across the country.

Ioannidis persuasively argued that our system for publishing only studies with statistically significant positive findings has resulted in a bizarre kind of reality where virtually no studies are ever reported that found “negative” results.  Negative results are suppressed because nobody is interested in publishing them.  Editors and reviewers have a major role in this problem; they choose not to publish studies that are not “sexy.”  This artificially inflates the proportion of observed “positive” results and influences the likelihood a scientist will even write up a journal article because she knows what it takes to get published.

But isn’t there an ethical obligation to publish so-called negative results?  In human research, people give their time and undergo risks for the conduct of a study.  Their sacrifices are not meaningful if the results are never shared.  Furthermore, negative results tell us something important.  And if they are not published, some other research team somewhere else may unknowingly repeat a study, putting a new batch of subjects at risk, to investigate a question for which the answer is already known.  Finally, to the extent a study is conducted using taxpayer dollars, the data derived should be considered community property, and there are opportunity costs associated with unnecessarily repetitive work.  Read More

Guest Post on Animal Research: Animal Research Is an Ethical and Vital Tool to Fight Disease

[Ed. Note: A few weeks ago, we had a post comparing the protections offered to humans and animals used in research, and it prompted quite a stir.  We thought the issues merited more discussion from both sides, and therefore solicited blog posts from two divergent perspectives: Theodora Capaldo, President of the New England Anti-Vivisection Society and Tom Holder, founder of Speaking of Research.  Mr. Holder’s post is below and Dr. Capaldo’s post can be found here.  As always, we welcome discussion via the comment thread, but request that your comments be respectful and focused on the topic rather than the speaker.]

By Tom Holder

The Benefits

In the US alone there are over 95 million prescriptions every year for asthma medications, primarily inhalers. So what can over 25 million American asthma sufferers thank for making their lives manageable? The guinea pigs and frogs which allowed scientists to gain the underlying understanding about how chemical nerve transmitters helped to control the muscles in the airways, as well as create reliever inhalers with a long duration of action.

This is just one example of a long list of medical achievements made possible by animal research which include insulin (dogs and rabbits), polio vaccine (monkeys), anaesthetics (rabbits), blood transfusion (monkeys, dogs), antibiotics to cure tuberculosis (guinea pigs), asthma treatment (frogs and guinea pigs), meningitis vaccine (mice), deep brain stimulation (monkeys), penicillin (mice).

Herceptin, originally developed in mice, has had a significant impact on the survival rates for breast cancers. As a mouse antibody (now humanised) it would not have come about without the use of animal research. Mice, far and away the most common mammal used in scientific research, have also been used in conjunction with stem cell research to create a treatment for macular degeneration (one of the leading causes of blindness). This research, pioneered in mice, has now been used successfully to treat humans.

In a country where we eat 9 billion chickens and 150 million cattle, pigs and sheep every year, 25 million (approx.) animals (96% is estimated to be mice, rats, birds and fish) seems a small price to pay for medical progress.

Read More

Guest Post on Animal Research: Inadequate laws don’t – but research alternatives will – protect animals in labs

[Ed. Note: A few weeks ago, we had a post comparing the protections offered to humans and animals used in research, and it prompted quite a stir.  We thought the issues merited more discussion from both sides, and therefore solicited blog posts from two divergent perspectives: Theodora Capaldo, President of the New England Anti-Vivisection Society and Tom Holder, founder of Speaking of Research.  Dr. Capaldo’s post is below and Mr. Holder’s post can be found here.  As always, we welcome discussion via the comment thread, but request that your comments be respectful and focused on the topic rather than the speaker.]

By Theodora Capaldo

When the New England Anti-Vivisection Society (NEAVS) launched Project R&R: Release & Restitution for Chimpanzees in U.S. Laboratories in 2006, 1,300 chimpanzees languished in U.S. laboratories. The campaign was a focused effort to end invasive and harmful research on the first non-human species in the U.S. Today, more and more chimpanzees are being transferred to sanctuary as momentum for the ethical and scientific cases against using them in biomedical research continues to grow. Though the Great Ape Protection and Cost Savings Act was one of many bills to not pass in the 112th Congress, policy is taking shape that reflects an end to holding and using chimpanzees in US labs. This month an NIH-convened council is expected to release its report on current and future chimpanzee use in NIH-supported research. The report will address how the NIH will realize its commitment to follow the Institute of Medicine (IOM) of the National Academy of Sciences’ recommendations from an expert paneled and lengthy assessment of the need for chimpanzees. The IOM report could not find any area of current biomedical research where the use of chimpanzees is critical and concluded that any possible future use must meet strict criteria. As to future need, the IOM noted that it could not conclude whether there would or would not be such future need.

Given the weight of scientific evidence, legislative and government support, and public opinion, chimpanzees who have been subjected to years of trauma, confinement, and research will one day soon have the chance to live the remainder of their lives in sanctuaries. They will be “released” and provided the “restitution” that only a sanctuary of high standards is capable of providing. The plight of chimpanzees in US labs highlights the suffering of all animals in laboratories. The scientific arguments highlight that even a species as closely related to humans as chimpanzees is a poor, limited, and even dangerous model by which to study human health and the inferiority of all animal research compared to modern methods. Chimpanzees are a keystone species by which myriad issues regarding the use of animals in research can be measured. Survivors in sanctuary bear witness to the degree of harm and suffering caused to them and are another indictment of the lack of effective laws and enforcement of those laws for animals in labs.

In short, there are no effective laws protecting animals in laboratories. The Animal Welfare Act (AWA), the only U.S. federal law governing animals’ “welfare,” provides minimal protections for less than 10% of animals used in laboratories. It excludes rats, mice, birds, fish, reptiles, amphibians, and farmed animals in research.

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