March 2006
Remembering Schiavo
It is beyond me why anyone in bioethics wants to think about Schiavo right now.
The heat so vastly outstrips the light on the matter, with Michael Schiavo on a rested and ready book tour and the even more histrionic Schindlers et al pushing their way into TV studios everywhere. Perhaps this is that moment when bioethics is supposed to capitalize on the public's interest in order to do good work. Maybe that is a good idea. Perhaps we're nuts for not running a "Schiavo" issue of AJOB. Maybe we should stream some Schiavo video. I will confess to speaking at a Schiavo session at NYU Law School. But it was annoying, because so little has changed in the wake of Schiavo except for the principal parties involved. Anyway our friend Jon Moreno is doing what promises to be a good event on the matter.
Yeah or Nay?
From the AP:A Texas company that offers horse owners exact duplicates of their animals says it has succeeded in cloning two top-earning horses. The company, ViaGen, says two mares have delivered clones of top cutting-horses, which are trained to help separate individual animals from cattle herds. The foals were born at a ranch near Purcell, Oklahoma. They're said to be doing well. The owner of one of the horses that were cloned says the foal is the image of its mother. A laboratory confirms that one of the clones and its offspring share the same genetics. Scientists are working to make the same determination with the second clone. The first cloned horse was born in 2003 in Italy. In 2005, Texas A-and-M University created the first cloned horse in the United States.-Art Caplan
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What we are reading today...
Today we introduce a new feature called "What we are reading today," in which we gather, uh, what we are reading today. Or really what Sean Philpott is reading, because Sean reads a lot. As best we can tell he tracks everything in bioethics, providing news for and receiving it from all sorts of others including a huge swarm of reporters, Alta Charo, Will Saletan, and at least a dozen bloggers from every political and scholarly persuasion.The idea of getting that news onto the blog has a long and tedious history. Way way back in AJOB's Penn days, John Kwon produced a weekly news update for those who read AJOB or visited bioethics.net. He built a place for the news on the bioethics.net site, which is now the most read piece of online AJOB - and which is even organized by category these days (and can be syndicated as an RSS channel - in fact you can feed bioethics in general or on any specific topic directly from bioethics.net to your own site).
Anyway thanks to Sean and to Dave Ross of Albany Med - the institution's Internet genius in residence - the news and the blog are coming together into a single all purpose information and commentary blog as we continue in our effort to take over the world one computer at a time!!! MMMHHHHHHAAAA HAA HAAA try to make sense of how all these technologies work and how best to integrate them with everything else until finally it is useless for the Earthlings to resist.
So here's what Sean is reading today:
- A Question of Quality
The International Committee of Medical Journal Editors (ICMJE) announced in 2004 that data from clinical trials could only be considered for publication if a trial had been registered on ClinicalTrials.gov. An analysis of registrations between May 20 and Oct. 11, 2005 found that publication is a powerful incentive to fill out paperwork, with universities demonstrating the most dramatic surge in predeadline registration efforts. - When We Turn the Current On, the Patients Report the Emptiness Disappears
Sufferers from depression who do not respond to existing treatments could soon benefit from a new procedure in which electrodes are inserted into the core of the brain and used to alter the patient's mood. - Preventable Disease Blinds Poor in Third World
An estimated 70 million people are infected with trachoma, and two million are blind because of it.A million people in Ethiopia alone need the surgery to prevent blindness, yet last year only 60,000 got it, all paid for by nonprofit groups like the Carter Center, Orbis and Christian Blind Mission International. - Prescribing of Hyperactivity Drugs is Out of Control
Leading researchers and doctors are calling for a review of the way ADHD is dealt with. Many prescriptions are being written by family doctors with little expertise in diagnosing ADHD, raising doubts about how many people on these stimulants really need them. Just as worrying, large numbers of children who do have ADHD are going undiagnosed. - Power of Prayer Flunks an Unusual Test
In the largest study of its kind, researchers found that having people pray for heart bypass surgery patients had no effect on their recovery. In fact, patients who knew they were being prayed for had a slightly higher rate of complications. - Out-of-State Facility Demands California Stem Cell Royalties
When voters approved California's novel $3-billion stem cell initiative, they counted on a ballot promise: as much as $1.1 billion in royalties from scientific discoveries. But the University of Wisconsin foundation that claims broad patent rights to all embryonic stem cell lines in the U.S. has vowed to demand payments from California. - Study Backs Equal Coverage for Mental Ills
Providing insurance coverage for mental illness equal to that for physical illness does not drive up the cost of mental health care as many insurers feared, a new study of health benefits for federal employees says. - Dramatic Drop in HIV rates in Southern India
A dramatic decline in HIV infections in southern India has been reported, adding to growing evidence that the country's HIV/AIDS epidemic has peaked and is now in decline. Researchers report that the reason for the decline is that more men, and female sex workers, are using condoms. - Doctor in India Jailed for Telling Sex of a Fetus
An Indian doctor has been jailed for two years for disclosing the sex of a fetus to its parents. It was the first instance of a physician jailed under legislation intended to stop the abortion of unwanted girls. - DNA Tests You Do at Home
A small, but fast-growing number of consumers are paying for a proliferation of partly self-administered genetic tests, hoping to determine everything from paternity to their propensity to develop certain diseases to their own ancestry. - My Black Skin Makes My White Coat Vanish
A black doctor on her patient problems: "I no longer have much doubt that what baffles them is the color of my skin."
Test Tube Beef
Chris MacDonald asked me whether this piece in the Globe and Mail is really a bioethics story; "Will consumers have a beef with test-tube meat?"Maybe yes, but what I keep wondering is whether or not meat grown from the cellular level could possibly be worse than McNuggets. The piece is pretty vivid:
Scientists can grow frog and mouse meat in the lab, and are now working on pork, beef and chicken. Their goal is to develop an industrial version of the process in five years.
If they succeed, cultured or in vitro meat could be coming to a supermarket near you. Consumers could buy hamburger patties and chicken nuggets made from meat cultivated from muscle cells in a giant incubator rather than cut from a farm animal.
Home chefs could make meat in a countertop device the size of a coffee maker. Before bed, throw starter cells and a package of growth medium into the meat maker and wake up to harvest fresh sausage for breakfast.
The only question is whether or not animal rights activists will start to make anti-abortion claims regarding the rights of disorganized but living piles of chicken cells.
The Horrors of Central Casting
We've already written about the travesty that is reality television's latest offering: Miracle Workers. That posting is made even more poignant by a recent report from the Associated Press that the woman featured on next week's show has died as a result of complications following the televised, last-ditch use of an experimental artificial heart pump.
The horrors of reality TV, however, don't stop there. Survivor's annoying,
The Apprentice is bad, and Miracle Workers is disturbing, but what is
completely offensive is the revelation that another reality program, Extreme
Makeover: Home Edition, which builds homes for needy families, seems to be
selecting which families to help not based on need but on what The Smoking
Gun calls a creepy wish list of woe"
It turns out
that producers of the program, which features former-Trading Spaces star and
Sears-shill Ty Pennington, are specifically looking for families who have
lost a child in a drunk-driving accident, or who have members suffering from
very specific diseases - muscular dystrophy, Lou Gehrig Disease, and
progeria. It reminds me of the Family Guy episode where Peter cons a
Make-a-Wish-esque foundation in order to get his favorite television show
renewed. The fictious foundation featured on Family Guy chose which dying
children to help based on their Q factor, but once again the writers of my
favorite animated are not so far off the mark.
-Sean Philpott
It Isn't Much Money, It Isn't Set Up Well, But It Puts Maryland Ahead of 46 Other States
Baltimore Sun reports that Maryland is onboard with $15 million in the first year of what could become a continuing program to support stem cell research in that state. There's an ethics evaluation, a religion checkstop and a fine little fight over whether the governor's endorsement of the funding makes him a turncoat. Ultimately, it's nickels and dimes compared to $3 billion in California, and that fact leads to a question: as states weigh in on their positions on stem cell research, must they play at the California level to produce a competitive advantage for their state?Bioethics' Basketball Office Pool
A friend with a sense of humor emailed the office to inform us that our friends down the Hudson hired a PR firm to promote their new
Ponder this: bioethicists are guessing about basketball.
Philadelphia Inquirer took note on its front page today of the "bioethics basketball pool" between Penn, Stanford, Albany and Michigan state. The subject was how anyone could possibly predict George Mason to enter the final four. Professor Liva Jacoby did. Caplan was apoplectic:
"No one could have predicted this," University of Pennsylvania medical ethicist Art Caplan said. He and other Penn professors participated in a March Madness pool with academics from Stanford and Michigan State Universities and Albany Medical College.
"We had a slew of nerdballs studying basketball magazines and statistics. And in the end, you could have easily won our pool by picking the cities you liked," Caplan groused.
"This is a gnawing insult on the minds of sports dweebs everywhere. It'll cause gasping and choking across the United States."
Our thoughtful, serious and measured basketball pool bookie thinker, Jason Schwartz, whose other less important work includes the Penn Ethics and Vaccines project, put the matter this way, in his summary of the likely outcome of our basketball pool:
Special kudos to AMBI's Liva Jacoby, who correctly picked George Mason to reach the Final Four, one of the biggest surprises in NCAA history. However, it should be noted that Liva's bracket also included 15-seed Davidson and 16-seed Southern in the Final Four, so something about a blind squirrel comes to mind.
Seriously.
God's Special Plans for Love in Burundi
Leaders of the Roman Catholic Church, the dominant religion in Burundi, have instructed priests only to conduct weddings for couples who possess a recent HIV test,
What is peculiar about the Church’s position is that, relatively speaking for sub-Saharan Africa, Burundi does not have a high HIV prevalence rate (6%). Are Church authorities in Burundi making (possibly stigmatizing) marriage rules that in order to promote public health, or are they simply using HIV/AIDS as a tool to stamp their moral authority on Burundi society?
Super Size Him No More
Discredited South Korean stem cell expert Hwang Woo-suk has been stripped of the title that opened all the doors to easy government funding, first class travel and carte blanche to create inter-institutional relationships without much if any oversight. Hopefully, the title Supreme Scientist will now be reserved for bad movies and good comic books.A Health System with Miracles
In our column we discuss Miracle Workers:How can you tell when your nation's health care system has collapsed? One sure sign is the creation of a television program that offers access to health care to the desperately ill as a prize. The show has now materialized on American TV screens. Everything about it shows just how badly broken health care in America truly is."Miracle Workers," which appears Monday nights on ABC, offers the services of "miracle doctors" to people with horrible medical problems. The show's Web site says that the program is an example of the network's "tradition of developing reality programming that makes impossible dreams come true."
In a nutshell, the show finds people with serious medical problems who nonetheless have the right stuff to be appealing as well as suitably grateful to their television benefactors. The program matches them up with teams of doctors and nurses who have been selected for their buccaneering style, willingness to push the envelope and good looks.
So how exactly does a show that hooks up desperate patients with hospitals falling over one another for the free publicity their best and brightest docs can create square with our health care system? Watch the show and you will know that if you are lucky, comb your hair and are willing to dispense with any semblance of privacy, a TV producer and his medical advisers may show up at your house and direct you to a team of well-scrubbed young health care professionals with loads of time to spend with you.
These benefactors will smooth the way to your treatment and follow-up care by picking up whatever part of the tab you cannot pay. That is health care reality-TV style.
In reality, a quarter of us have either no health insurance or lousy coverage. No one has a doctor who isn't using much of the time once spent on patients talking to bureaucrats on the telephone to try and get approval for a prescription or a diagnostic test. A large number of us spend forever in emergency rooms to get basic care. There are many children who get no medical or dental care. The waiting times to see the doctor grow and grow.
We are bombarded with ads telling us to buy drugs because a man can throw a football through a tire in his backyard thereby arousing his mate or a butterfly will alight on our pillow if we swallow a capsule when we cannot sleep.
No one has any idea why anything costs what it does, but it would be dangerous to go to another country to get the same drug at a much lower price. The strategy of the payers hired to look out for our health is to routinely turn down requests for reimbursement in the hopes that we will simply give up.
Oh, almost forgot, the cost of this pathetic mishmash of a bloated, inefficient and sometimes dangerous health care system continues to grow right alongside the numbers of people losing insurance coverage or benefits. That is the harsh reality.What is really irritating about "Miracle Workers" is that the show makes health care seem a privilege, something you are lucky to get, rather than something you should have as a matter of right.
It suggests that what is most exciting about medicine occurs on the frontier, as if having your migraines treated, your alcoholism rehabilitated, your back pain relieved, your wheelchair properly sized or your congestive heart failure managed would not be miraculous if they happened today for everyone with these problems.
Worse still, the show sends out the message minute after phony minute that there is hope. Well, if you have a lot of money there is. If you don't, then this show is about as close as you are going to get to cutting-edge health care.
What "Miracle Workers" should make us do is shut off our televisions and sit down and write a letter or an e-mail to our congressional representatives and those who aspire to this office.
Point out that the rising cost of health care is crushing American business, leaving children in pain or disabled, forcing families to choose between eating and seeing a doctor, and creating a huge underclass of people who have a shrinking number of hospitals and doctors who will treat them.
Then note that if they want your vote, they had better be prepared with a plan to fix these problems. If they aren't, then in the real world of health care where you live, it will be a miracle if they get elected.
Premarital HIV Testing in India
The government of the western Indian state of Goa seems to be planning to make HIV testing a mandatory requirement for couples planning to get married. Couples would be tested to find out their HIV status, and then – depending on the results – decide whether or not to go through with the ceremony. This proposal raises obviously a number of concerns such as the social fate of Indian women who are found to be HIV positive and rejected by their fiancés. Will the mandatory testing policy create a new stigmatized underclass? How would the policy protect women in India, when many of them end up being infected after marriage by unfaithful spouses? Will HIV positive persons start gravitating towards other HIV positive persons as their only likely marriage partners (a form of what is known as ‘serosorting’)? Is HIV testing compatible with the Indian tradition of arranged marriages, where the main criterion is not the sexual behavior of the bride or groom-to-be, but whether he or she ‘comes from a good family’? A nice short radio item about the changes to Indian marriage culture brought by the HIV/AIDS epidemic is available here.
Before writing off the policy as unethically draconian, one should realize that India has the second highest number of persons living with HIV/AIDS after South Africa, and that America also had a flirt with mandatory premarital testing. Back in 1988, Illinois passed a law requiring premarital HIV testing as condition of obtaining a marriage license. This had an interesting effect: the number of marriages in Illinois dropped 14% while the marriage rates rose in the neighboring states. When the law was repealed, the number of marriages in Illinois returned to its pre-1988 level. Perhaps the governors of Goa should take note.
The Conference We Believed Could Never Happen
Politics and Bioethics is the title for a special Summer Conference of the American Society for Bioethics and Humanities, July 13-14 2006 at the Crowne Plaza Albany, NY, presented by the Alden March Bioethics Institute in collaboration with Nelson Rockefeller Institute of Government, Stanford University Center for Biomedical Ethics, Penn Center for Bioethics, Albany Law School, University of Virginia Center for Bioethics, and The American Journal of Bioethics.
Why a conference about politics and bioethics? Those on the right and the left hardly even talk anymore, right?
Political influence has an evolving role in bioethics and the emergence of new politically active bioethics institutions. Some argue that bioethics is becoming politicized. Others argue that it is coming into its own in a political world. Still others argue that a long-standing political bias in bioethics is at long last being corrected. With New York's state capitol as a backdrop, those questions will be discussed and debated with the goal of reaching some areas of general agreement, clarifying disagreements and thinking broadly about the future of bioethics in a democratic society.
The tone will be set by a keynote from Prof. Edmund Pellegrino of Georgetown University, the Inaugural John A. Balint Lectureship.
Others confirmed speakers include, among others, Nigel Cameron, Arthur Caplan, Alta Charo, Eric Cohen, Richard Doerflinger, James Fossett, Jeffrey Kahn, Glenn McGee, David Magnus, Chris Mooney, Jonathan Moreno, Alicia Ouellette, Sean Philpott, William F. May, Wesley Smith, Bonnie Steinbock, Gerald and Paul Root Wolpe, and Laurie Zoloth.
We are currently soliciting contributed papers to be presented in highly interactive sessions at the conference. Those interested should click here to read the guidelines to submit a 250-word abstract describing original work that does not substantially overlap with papers that have been published or that are simultaneously submitted to a journal or a conference with proceedings. Topics of interest include but are not limited to: the emerging role of religious and politically-affiliated bioethics centers, the difference between academic and political advocacy, the possibilities for dialog across political lines, and the effect politics is likely to have on a variety of debates in bioethics.
There was some confusion about how to submit an abstract. Please submit your abstract by email; just click here to open a properly addressed email in which you can scribble out your submission.
The authors of accepted submissions will be invited to present their work at the conference. Presentations on these papers should not exceed 20 minutes in length. Accepted papers will also be published in the conference syllabus or considered for publication in a special issue of The American Journal of Bioethics. A volume based on the most discussed papers of the conference will be published in The MIT Press' Basic Bioethics book series.
What are the general & format guidelines for abstract submission?
1) Abstracts must not exceed 250 words
2) Abstracts should contain the names, degrees and institutions of all authors
3) Abstracts should contain the contact information of at least one author (the submitting author), including email address
4) Abstracts should be submitted online to http://politics.bioethics.net. Please do not make your submission by return email, fax, phone, telegram, smoke signal or rumor. However, for additional information, contact Jamie Michelle Salm at 518.262.6082.
5) Deadline for abstract submission is April 20, 2006
6) Email notification of accepted abstracts will be sent to the submitting author by May 20, 2006.
7) The presenting author(s) of a contributed paper must register for the conference and pay the registration fee by June 1, 2006, in order to have the paper included in the conference proceedings.
You are invited
Everything you need to submit to or register for the conference is here - but if you have questions, please contact us at 518-262-6082.
On behalf of AMBI, ASBH and our co-sponsors I hope you will be able to join us for a unique conversation at this pivotal moment in bioethics. The forum comes at a time when many have said that bioethics is being reduced to little more than political interests. Instead, we hope that the Summer Meeting will bring together those who are struggling to communicate across political lines, many of whom disagree vehemently with each other, and some of whom have never participated together in any public forum.
We hope you too will join in that conversation, whether in a paper, a panel, or just across a table at lunch with someone whom you might otherwise have seen only "across the aisle."
Getting here, and enjoying it:
Albany is well serviced by plane and train. It is possible to depart on Thursday morning July 13th from most of the U.S. and arrive in time for the opening of the conference, and to depart on the Friday evening (7/14) in time to arrive in many destinations. Discounted airfare is available from US Airways, the official carrier for the conference. Special rates have been arranged with the Crowne Plaza for the evenings of the 13th, and for those who desire it, the 12th and 14th. The hotel has free shuttle service to Albany International.
The Albany Crowne Plaza is located steps from Empire State Plaza, the New York State Capitol building, the New York State Museum and the Hudson river. On the evening of the 13th, following dinner, the Balint Lecture and a dessert reception, a jazz concert will be held on the Plaza.
After the conference concludes on Friday afternoon, it is worth considering a weekend in the Capital District, whether in the Adirondacks, Berkshires, Lake George, or around Saratoga and Albany. Car rental is inexpensive, and everything is close, including amazing lake resorts. Of note, e.g., the 14th, NYC Ballet performs at Saratoga Performing Arts Center and "Coastal Disturbances" opens at Berkshire Theater.
And one other thing: blog.bioethics.net readers and writers will get together for the first time ever - one of those "huh, you really look like that?" encounters, over wine Friday evening at Franklin's Tower.
Harper’s Magazine gets Hornswaggled, Whatever That Means
Poor Africans mercilessly exploited by pharmaceutical companies: this byline is a dream for some health journalists. Breaking that kind of story appeals to self-interest and altruism: it can promote your own career, and it places you are on the side of the angels, protecting the vulnerable by speaking truth to power. As long as the story, of course, holds water.
In this month’s Harper’s Magazine, Celia Farber has published a damning indictment of AIDS drug testing practices by pharmaceutical companies in the United States and Africa. (An edited version of the article is available here.) Farber’s main accusations are (a) that one of the study drugs (nevirapine) of an DAIDS/NIH clinical trial on the prevention of mother-to-child transmission of HIV caused the death of Joyce Ann Hafford by liver toxicity, although the true cause of death was obscured and never told to her family and (b) the dangers of liver toxicity with the use of nevirapine were already long known. The policy of using nevirapine with HIV positive pregnant women is based on HIVNET 012, a deeply flawed (according to Farber) DAIDS/NIH study conducted in Uganda back in 1997. Farber basically argues that the regulatory, scientific and ethical problems of the HIVNET 012 trial were overlooked in order to profile nevirapine as a safe, effective and cheap way to reduce mother-to-child transmission in Africa. Voices in the NIH who questioned the methods and results of HIVNET 012 were silenced or sidelined. By the time the use of the drug was implemented (particularly in the developing world) too much was at stake: the reputation of the NIH for one thing, and the profits being made by the drug’s manufacturer (Boehringer) for another.
Farber, in fact, aligns herself with those who believe that nevirapine is not an effective HIV prevention drug, and that the risks outweigh the benefits. This line of thinking takes her on a whole other tack: that AIDS research in general is not about helping patients, but merely a way of serving the interests of the powerful. She tries to rehabilitate the reputation of Dr. Peter Duesberg, well-known for his view that HIV does not cause AIDS, that AIDS drugs themselves are behind (what are called) cases of AIDS, and that if toxic AIDS therapies were discontinued, thousands of lives would be saved overnight. For Farber, the bottom line is that the ‘AIDS industry’ – represented by pharmaceutical companies, health agencies and activist groups – promote the production and consumption of dangerous drugs to fight a syndrome that may well not exist. She’s been doing this sort of thing for awhile.
Reaction to Farber’s article has been swift. The Treatment Action Campaign in South Africa has issued a statement citing 56 errors (of various types) in Farber’s piece. In Slate, Jon Cohen uses the article as an example of ‘pharmanoia’, a pathological mistrust of all things pharmaceutical. Perhaps the best comment is that of Pulitzer Prize-winner Laurie Garrett: “Harper's got hornswaggled. They thought they had a scoop, but it was tired old BS dredged up from the bad old days.”
-Stuart Rennie
Caplan on the Research Ethics Disaster in the UK
Art Caplan on MSNBC:Last week, six very healthy men suddenly wound up in a London hospital in critical condition. Earlier this month, 11 otherwise well people tested positive for tuberculosis, according to Montreal’s health department. What do these people have in common? All were human subjects in research paid for and conducted by private companies. These mishaps mean that the time has come to take a closer look at how commercialized research involving human subjects is being conducted all over the world.
The people in England were involved in a study of an experimental leukemia drug. It was paid for by a German pharmaceutical company but run by a U.S. company, Parexel. In Montreal, volunteers apparently caught TB from an infected subject they'd been housed with as part of a study paid for by a Canadian company but administered by another U.S. research company, SFBC International.
It's certainly true that human research is risky business. Even when people are in safety studies and only exposed to relatively small doses of experimental drugs, things can go terribly wrong. That's why it's so important for healthy volunteers who are recruited into clinical research to fully comprehend the reality that there are real risks involved in biomedical research. And it's equally important that those who conduct these studies — drug companies, contract research organizations and the review committees who by U.S. law must approve all human trials before they can begin — put the informed consent and safety of subjects first. There are reasons to think this didn't happen in either the British or Canadian trials.In the case of the British subjects, who went into acute organ failure and suffered excruciating pain immediately after being exposed to a new substance intended to fight some forms of cancer, some doctors are outraged that the study was allowed to even start given that there had been previous problems in animals and people with very a very similar substance.
The recruitment of the participants into the British trial certainly left much to be desired ethically. As Bloomberg News reported, the Web site which announced the opportunity to enroll in the study for healthy volunteers said almost nothing about risks but went on and on about good pay, free medical care, free food and "plenty of time to read or study or just relax, with digital TV, pool table, video games, DVD player and free Internet access.'' This is not the sort of language that tells people eager to make some easy money that they are entering into the risky world of high-stakes medical research.SFBC has also had its share of ethical missteps beyond the problems in Montreal. Bloomberg also reported that the company’s major facility for housing subjects in long-term studies in Miami, Fla., had received numerous safety and fire code violations. When subjects went public with complaints about problems they had seen at SFBC’s Miami testing facility, at least three of them said they were bullied and threatened with deportation by SFBC officials.
Twenty years ago most clinical research was conducted in academic medical centers. American companies did their research in the United States. Most research was paid for by government money. All that has changed.
Today private companies pay for the bulk of clinical research on new drugs, medicines and devices. They hire private companies to run their studies and to review them. And a lot of this research is done using poor people or students, sometimes in the United States but often in Europe, India and Southeast Asia.
The business of conducting medical research is profitable. Private companies running studies for pharmaceutical and device companies are now a $14 billion industry in the United States alone.
The problem with the intense commercialization of research is that it's not clear that contract research organizations such as Parexel and SFBC that make their living meeting deadlines for drug company sponsors always put subject welfare first. There is plenty of room for conflicts of interest when the person recruiting volunteers for research is being paid to get subjects enrolled and data generated as quickly as possible.
The recent events in London and Montreal make it clear that it is time for Congress and other regulatory bodies here and overseas to take a hard look at how clinical research is being done these days. Many of those in the for-profit business of conducting clinical research may be doing their best, but they and their sponsors had best be putting the safety and welfare of their subjects first. Otherwise they should have no business doing clinical research.
What Your Children at Columbia University are Thinking About
Christina Persaud and Yang Liu are pretending to study bioethics at Columbia. But we know what they are really doing. Reading blogs. And thinking about drugs for their brains. This is what happens when you send your kids to the Ivies, especially when they take bioethics classes from folks like this. Anyway they seem nice enough, even if they're doped up on nootropics, and here's their guest post:There’s now a better way to boost your brain power. Just pop a nootropic.Now back to class kids.They sound just like those Gingko Biloba tablets from your local GNC. Unlike memory-enhancing fads of decades past, however, nootropics (or “smart pills”) are being developed by some of the world’s top neuroscientists and pharmaceutical companies to alleviate the effects of Alzheimer’s and other neurological disorders. These drugs are born out of an increasingly intimate understanding of the molecular basis of learning and memory.
As with anything done in the brain, the use of nootropics carries profound social implications complicated by their potentially glorifying effects in reasonably functioning adults. Derived from the Greek words noos (mind) and tropos (bend), nootropics could enhance performance on cognitively demanding tasks and improve recall of long term memories.
Despite the potential misuse of these drugs (which presents ethical issues similar to those chilling the development of genetic engineering and cloning alike), development is in full swing with several different drugs parading through human clinical trials as we speak. Nevertheless, these drugs could deteriorate the social infrastructure that has crowned us- human beings -the winners in the contemporary game of “survival of the fittest.”
A large proponent of these pharmacological innovations is Eric Kandel, 2000 Nobel Prize Winner and professor at Columbia University. He has investigated the role of CREB protein in long term memory formation and consolidation. His company, Memory Pharmaceuticals, has developed a whole line of drugs that allegedly enhance memory by inhibiting phosphodiesterase (PDE). Blocking the signaling cascade of PDE prolongs the presence of CREB and increases CREB’s concentration in the cell. The more CREB present, the faster memory is consolidated into long term storage.
Just across the Hudson, Tim Tully of Cold Spring Harbor Laboratory – who discovered CREB’s importance in short term memory - is working with CREB enhancers for Helicon Therapeutics. Most recently, Sam Deadwyler of Wake Forest University has demonstrated the effectiveness of CX717 in improving the performance of sleep deprived non-human primates in battery tests to beyond non-sleep deprivation levels. Cortex Pharmaceuticals, the company behind the drug, is currently evaluating the alertness and cognitive performance of sleep deprived participants using CX717 in a ‘simulated night work environment.’
mThere are many drugs currently in human clinical trials; some of them are quite encouraging. Kandel believes that “the progress in Alzheimer’s disease has been terrific, so I think that there will be some immediate effect. We're going to have drugs that improve (non-Alzheimer’s) age related memory loss within about ten years…” MEM 1414-developed by Memory Pharmaceuticals-is presently undergoing Phase III clinical trials and presents no drastic side effects. Tully is experiencing similar success in his most recent Phase I clinical trial. CX717 may very well replace modafinil as the ‘alertness pill’ de rigueur for military pilots. With so much invested in memory enhancement research, the answer to the major question remains elusive: should these drugs be marketed to healthy individuals just looking to score a few extra points? The social implications of mass consumption must be vigorously discussed.
It is common knowledge that some college students depend on hyperactivity and wakefulness drugs (like Adderall and Modafinil, respectively) to maximize their productivity. With a few extra hours to cram for those exams, students can receive the grades they need to achieve professional success. You would logically assume that swallowing a ‘smart pill’ would eliminate the need for that extra time, or enable them to allocate it to sleeping and socializing. ‘Smart pills’ will consequently boost intelligence and lower stress, so everyone wins…right? Not so fast. Consider this situation from another angle: everyone may lose in the long run. Memory enhancing drugs could unnecessarily exacerbate the heavy competition we are currently dealing with. For starters, medical school admissions are notoriously cut-throat, but the odds may be impossible – even with a 40 MCAT – if applicants start using nootropics. Premeds take note: Organic Chemistry will be a breeze, but you’ll never get ahead of the curve.
Naturally, the applicants for a single matriculation year would not be the only ones popping the pills. Nootropics will undoubtedly work their way into the freshman general chemistry course, perhaps even into high school and middle school classrooms. If accepted into the mainstream, parents could dispense ‘smart pills’ to their children with their breakfast or nighttime snack. They will then head off to school with the increased mental capacity to rapidly acquire both new skills and a sense of entitlement. How so? Not only will schoolchildren of the near future dream of becoming physicians, lawyers, engineers, or world leaders; they will consider other career options to be ‘beneath them’ because of their stellar qualifications. A world where everyone is intellectually capable of pursuing the same occupation appears positive in theory, but at the risk of sounding elitist, who would occupy those less glamorous but essential positions? Even Will Hunting, as content as he was being a janitor, ultimately decided that cleaning the floors at MIT was not the optimal use of his intelligence.
There is a simple, yet unfortunate, solution to that dilemma: recruit everyone not using the memory enhancing drugs. “But that’s silly”, you say. “If these smart pills are in the mainstream, as you mentioned before, wouldn’t everyone be taking them? Who wouldn’t want to use them?” The reality is that most lack the luxury of choice. Since nootropics will not be classified as over-the-counter medications any time soon, most people will have to rely on doctor’s orders and insurance to obtain them. This poses a list of problems. For starters, insurance companies may deem these pills as an unnecessary expense (or, as Anjan Chatterjee coins it, ‘cosmetic neurology’) and refuse to cover them. Moreover, even if they subsidize part of the prescription cost, over 46 million uninsured Americans are still left out of the loop. Obviously, this figure does not take into account the millions of undocumented immigrant workers across the country, and we must not neglect the billions abroad still struggling for the bare necessities. What we could indirectly experience from the popularization of ‘smart drugs’ is further class stratification, and more egregiously, the erosion of social mobility.
Even if smart pills become a ‘free for all’, even if the limitations of natural intelligence are demoted from facts to theories, other groups may still protest the use of these drugs. As evident from the heated debates over designing babies with selective genetic traits, there is a strong contingent urging scientists to uphold the laws of nature. It believes that tampering with these laws will disturb an equilibrium that has made human beings so powerful. For instance, few disagree with the idea that our success as a species rests highly on our dedication to nurturing and educating progeny. We have heard countless times from parents and mentors that working hard and learning from our mistakes are two requisite steps for success. This idea is engrained into religious thought as well; Hindus and Buddhists-among many others-believe that the means are just as important, or perhaps more important, than the ends in terms of gaining knowledge.
Now what if someone could bypass enlightenment? What if knowledge came so effortlessly that the ideas of wisdom-from-experience and hard work breeding success became obsolete (or, at least underappreciated). Just as some children born into wealth hold less value for money than lower-income children, who treasure each well-earned dollar they earn maneuvering themselves up the ladder of society, children living in a world where high intellectual capacity is commonplace will likely undervalue education and ambition. Even the most complex ideas from the most eminent scholars will potentially lie within the limits of their creative capacity. Perhaps biographies similar to those of Barack Obama, Oprah Winfrey or Bill Clinton will soon fail to tug at the heartstrings and arouse that zealous internal drive to “prove oneself”, regardless of the obstacles and circumstances they encountered. In short, the stocks of education and ambition will plummet, for knowledge and ability will be at the whims of over-the-counter pills.
“Now hold on a minute. Didn’t you just imply that nootropics will increase someone’s drive to learn and succeed because the heated competition?” This hypothesis is still valid, but in order to accept it,
we must assume that our ignorance is infinite. On the other hand, let’s propose that there is a finite amount of knowledge to be discovered. If smart pills are consumed by the masses, this means that everyone could theoretically know everything about anything. Referring to the earlier situation, if everyone already possesses the mental capacity and dexterity to become a physician, what would be inherently special about being a physician? Why should people put themselves through unnecessary struggle if everything could potentially be figured out, and more significantly, if their work will not garner any praise? The late 19th century philosopher Friedrich Nietzsche believed that people’s own perceptions of self must be realized and acknowledged by others for them to be legitimate. If we lose the drive to ameliorate the things lowering our quality of life because acting on this drive says nothing about who we are to the world, we may very well slow the momentum that has made our species successful in the battle for survival. In layman’s terms, we’ll all become lazy.
Since so much scientific inquiry remains before we will realize the true effects of these drugs,
many opt out of the ethical speculation game altogether. Despite their promising results, the scientists behind nootropics try to remain grounded. Kandel states: “Smart drugs have a definite indication for people who have a problem with memory, though they don’t have an indication for improving the memory of people who are functioning reasonably.” Tully expands on this idea, claiming that the issue is not memory of intelligence, but merely information processing. “The drugs we know about simply improve the efficiency of memory storage. As far as we know, they do not improve ‘information processing,’ which might be a less loaded phrase to describe to "intelligence.’” Additionally, since it is not clear what type of information is actually processed (i.e. distracting peripheral information, such as random conversation among strangers, or useful semantic or episodic information), Tully opines, “the net effect of such drugs may, in the end, be negative. We simply won't know the answer without proper, careful clinical assessment.” And that is one answer a smart pill cannot illuminate for us.
The Disasterous Clinical Trial in London: Chapter 2
Some disturbing news relating to the disastrous London phase one clinical trial that left six initially healthy volunteers hospitalized and in critical condition. Last week, TeGenero AG's chief scientific officer, Dr. Thomas Hanke, said healthy participants were used in the trial because TGN1412, the monoclonal antibody being tested, was not thought toxic.
But now we have this from the Times of London:
"Trials last year in America of a similar "monoclonal antibody" caused severe toxic reactions in patients. But the UK study went ahead after the regulatory authority failed to consult outside specialists who would have warned against proceeding.
"Angus Dalgleish, a world expert on immunology, said yesterday that he was amazed the trial had been allowed to proceed. "The previous studies which caused similar severe side effects were in patients already suffering from cancer, but [the researchers] should have known they would get a meltdown because this drug was hitting exactly the same immune response pathways," said Dalgleish, a professor of cancer at St George's hospital medical school, south London....
"The data that should have raised the alarm were presented at a meeting of the American Society of Clinical Oncology last May. Dalgleish said an engineered antibody, developed by a team led by Steven Rosenberg at America's National Cancer Institute, and using the same pathway as TGN1412 had produced severe side effects in about half of a group of patients dying of cancer."
There's also this report from Australia's Daily Telegraph, saying that monkeys on whom the agent was previously tested had suffered swollen lymph nodes. This at least appears to contradict TeGenero's earlier statements about the drug's safety record, as well as statements in the London volunteers' consent documents about the lack of "significant side effects" in animal studies (though one may wonder whether the monkeys' lymph-node swelling was "significant").
Beware these layers of hearsay, but Daily Telegraph also quotes an unnamed German newspaper as reporting that "Clinical Immunology, a US-based journal for the medical research industry" published a study in 2002 "warning of the problems involving human cells being adversely affected by the medication." It's not clear exactly which journal or study is meant. Nor is it clear the extent to which the monkeys' alleged lymph-node swelling or the cellular problems allegedly reported in the 2002 study should have forewarned researchers about the horrific adverse reactions actually experienced by their volunteers.
The trial was being run for TeGenero by Parexel, an American firm. A series of brief statements from TeGenero appear here. Parexel's terse statement about the trial appears on their website, here.
- Stephen Latham
States and Bioethics: Glenn McGee=Antonin Scalia?
A big debate around AMBI lately is whether States are better suited for resolving bioethics cases than the federal courts. Glenn McGee argues that states are better, at least in cases where there's no moral consensus. Seems he's in good company. Supreme Court Justice Antonin Scalia blasted federal court involvement during a speech in which he argued "the public, through elected Legislatures -- not the courts -- should decide watershed questions such as the legality of abortion."
The quote allows that he could have been calling for federal legislation -- except he wasn't. Scalia is the most fervent supported of state's rights around. Except, perhaps, for Glenn.
- Alicia Ouellette
