Politics and Ethics of Science

Hwang Woo Suk

2006-01-16T10:42:00.000-08:00

Dang it's been awhile since I posted here. Sorry about the lag. Stupid life getting in the way.

I just posted a comment over at Chris Mooney's blog over at ScienceBlogs.com (new to the links tab, by the way) about some of this, but thought I would also summarize some thoughts about the Korean Stem Cell Scandal. OK, maybe it's not a scandal, but I think it at the very least approaches debacle or fiasco level. Which of those is worse, by the way?

My first impulse, much like Derek Lowe's, is that this is just proof that the system works. And it worked rather rapidly, if you consider when the recently retracted stem cell papers came out. Often, it is years and years before faked data is discovered and outed. But the journal-mediated peer-review process is only one part of a systemic review process that is inherent to science.

It is probably true that some journals are more rigorous than others with their review process. It's also likely true that more care is taken to review papers which claim results that others have previously tried to repeat and failed...'landmark' papers, if you will. But it also likely true that if you had the most rigorous review process in the world, some faked data would still fall through the cracks. The system (all systems?) is not foolproof. But there are other levels of control too, like your weekly lab meetings with advisors/bosses/peers, your lab notebook, others on your floor peering over your shoulder, etc.... There are hundreds and hundreds of checks and balances like this, that are not immediately obvious, but contribute to the "validity" of your work as a scientist. It's the "silent review process". And people tend to notice when there is smoke, and suspect there is fire.

In addition, the great thing about hard science, unlike philosophy or more social sciences, is that it is driven by primary data. Therefore, the data is always the final word. And where that data has been faked, even this can be overcome, because ultimately the ground breaking discovery you just made is only truly groundbreaking if it lives up to its potential by being repeated by yourself and others down the road.

Alternative Medicine

2005-11-21T15:07:00.000-08:00

After a minimal amount of prodding, Dr. Free Ride has taken on the subject of the ethics of alternative medicine over at Adventures in Ethics and Science, by request (Thanks Doc!). Fantastically done. My interest in this topic was started by the whole Kevin Trudeau fiasco, as discussed frequently by Derek Lowe at In the Pipeline. Check it out.

Tangled Bank #41

2005-11-16T09:33:00.000-08:00

TB #41 is up over at Flags and Lollipops. If you're a fan of science, or blogging about it at least, you should go check it out for sure. A regular part of my online reading repetoire.

Dolly

2005-11-09T08:48:00.000-08:00

Although I haven't discussed it much here yet, or anything of a personal nature really, in the "real world" I work for a large medical device company. My specific group works on a variety of emerging therapy techniques, mostly of the cellular and molecular nature, which is a bit of a departure from the rest of the company. In fact, I met a few guys from the other side of the company just yesterday, and when it was explained to them what our group does, they said something along the lines of, "I didn't even know [we] did anything like that." I have the opportunity, in this unique position in the company, to be exposed to a lot of outside agencies, especially academic ones, where a lot of this research is occurring, as it is relatively in it's infancy (or at least at the toddler level). And we have a number of collaborators at the large, local, research university. This kind of research also puts me directly on the edge of a number of the hot-button ethical issues in the field right now, such as therapeutic cloning, nuclear transfer, and embryonic stem cell therapies.

So, while I was down there yesterday, I had the opportunity to hear a talk by Dr. Ian Wilmut, the creator of Dolly, the sheep that was cloned in England awile back, and pioneer of nuclear transfer (Dr. Wilmut, not the sheep). For the unintiated, nuclear transfer would probably be considered an "alternative stem cell therapy", because the embryo is not actually destroyed. At least, potentially. More on that in a second. Dr. Wilmut had some very cool video of the procedure, but basically what happens is that the nucleus of a donated embryo is removed or destroyed with a small pipette, and is then replaced by the nucleus of a donor cell. This donor cell could be from a sheep (in the case of Dolly, her "mother"), a patient with leukemia (where stem cells could eventually be derived from the cloned embryo to replace their bone marrow), a wooly mammoth fossil (I believe this is being done right now), etc. The nucleus takes awhile to reset or reprogram, and adapt to it's new conditions, and then begins to develop normally. Most of the time. In the case of Dr. Wilmut's group, he showed data that cloning is "successful" (the organism develops to term and is initially healthy) more often if the donor nucleus is from a younger donor (fetal>neonatal>newborn, etc...). And still, a 10% success rate is about all they can achieve, although a recent group in Korea has done somewhat better.

There are all kinds of ethical issues wrapped up in this kind of procedure. Source of the embryos is the first. Dr. Wilmut mentioned several times during his talk that in all upcoming research that they are planning, all the embryos will be donated, without compensation, from willing women. The didn't want to use the embryos that come as leftovers from in-vitro fertilization (IVF) that are commonly used in embryonic stem cell derivation, because they didn't want the women/families to not get pregnant and then have to consider that they had given up an embryo that they could have used. He had several other examples, as well, that were along the lines of "not wanting to have the woman think about such and such." Sounds like a responsible researcher, right?

Another troublesome issue is the incidence of abnormalities. There's no doubt that they are quite high, even under the best of conditions. Dolly had arthritis and died early, although there is no direct evidence that these were caused by the cloning procedure per se. But there have been plenty of studies showing that abnormalities are high (particularly respiratory problems, apparently) in cloned animals, and there are significant differences in the requirements for successful cloning across species. Cloning of rhesus monkeys, or any primate for that matter, have yet to be successful. It's a young technique, so there are bound to be some growing pains as methods are developed, but I think it's safe to say that no one involved in this kind of research thinks that human cloning is anywhere near being feasible...let alone safe. No doubt also that it could be...someday.

This last point prompted someone in the audience to ask what is to prevent someone (attention wacko religious cults!!) from taking the "Faustian deal" and clone a human being when the technology is available, no matter what the consequences. Dr. Wilmut's response was one I've heard before, and is at once simple and elegant.

Make a law against it.

Sounds simple right? That's because it is. And the U.S. is one of only a few countries not to have a specific law against it. Not only that, our fine leaders have prevented a U.N. measure from coming up to vote on making it a world-wide crime against humanity to clone a human being.

Let's think for a second about the debate that went on (national debate) during the Terry Schiavo case about the end of life. This is a subject that evoked a lot of passion from a lot of people. But that passion was more about the way we determine when life has ended, or when it is okay TO end life. But the rules about when life DOES end are reasonably set. Why can't we have this discussion about the start of life in this country? I should ask...why can't we have a REASONABLE discussion about this? My personal opinion is that this debate is a lot more confusing to the average person. The details are trickier. It seems too "science-y" for many, and the easy answers that many religious and political leaders are giving are convenient to fall back on, rather than try and learn about the issue. I hope in the coming weeks to provide more information to clarify this issue. And I hope that people can make their own decisions about when a ball of cells is no longer a ball of cells, but a little ball of life with associated inalienable rights.

The Vatican

2005-11-04T08:20:00.000-08:00

This is so refreshing. I feel like I'm in one of those Zest commercials with the enormous towels.

Some highlights, if you don't care to read:

"VATICAN CITY- A Vatican cardinal said Thursday the faithful should listen to what secular modern science has to offer, warning that religion risks turning into "fundamentalism" if it ignores scientific reason.

...

'The permanent lesson that the Galileo case represents pushes us to keep alive the dialogue between the various disciplines, and in particular between theology and the natural sciences, if we want to prevent similar episodes from repeating themselves in the future,' Cardinal Paul Poupard said.

But he said science, too, should listen to religion.

'We know where scientific reason can end up by itself: the atomic bomb and the possibility of cloning human beings are fruit of a reason that wants to free itself from every ethical or religious link,' he said.

...

Monsignor Gianfranco Basti, director of the Vatican project STOQ, or Science, Theology and Ontological Quest, reaffirmed John Paul's 1996 statement that evolution was 'more than just a hypothesis.'

'A hypothesis asks whether something is true or false," he said. "(Evolution) is more than a hypothesis because there is proof.'"

I wasn't aware of the 1996 statement before...may have to go look it up.

Genes and Intellectual Property

2005-10-20T10:13:00.000-07:00

There are some large battles looming in this area, I have a feeling. An interesting article on the current state of patent rights and the human genome.

Embedded Science Journalists?

2005-10-05T12:22:00.000-07:00

Here's a great post from Dr. Free-Ride, Ph.D. (a chemist turned philosopher) on faults with science journalism. A follow-up on an earlier post here about another good article on science writing at Pharyngula.

Company Ethics

2005-09-27T19:18:00.000-07:00

As this is from the general world in which I live and work, I thought this article was interesting. Guidant has been taking a lot of hits recently (google "guidant recall" for more articles than you'll care to read), and many of those were somewhat defendable, but I was suprised to hear about this. It seems to me, and maybe I'm naive, like a pretty clear line was crossed with this tactic.

By January, about 80 cardiologists nationwide completed an evaluation run by the Guidant Corporation of one of its products, an improved electrical component, known as a lead, that connects an implanted cardiac device to the heart.

In exchange for implanting the lead in three patients and completing five survey forms, each physician received $1,000 from Guidant.

...

"The primary purpose of the study was to get feedback on how well the system worked," said Dr. Wayne O. Adkisson, a cardiologist in Portsmouth, Va., who took part.

The program did generate feedback. But internal Guidant documents and e-mail messages provided to The New York Times suggest that the initiative also had another apparent goal - increasing sales of the company's most sophisticated and expensive heart devices. Those devices are advanced pacemakers called cardiac resynchronization therapy devices, or C.R.T.'s. They cost about $29,000 each.

The program proved so successful in increasing Guidant C.R.T. sales that when the survey ended in January, company executives sent around congratulatory e-mail messages, the records show. "It generated 300+ implants," one January e-mail message stated. "Let's say that just 25% were incremental ... that yields >$2 million in new sales with physicians who are not necessarily Guidant friendly. We paid each physician who completed all five surveys $1,000 so our total cost was $80,000.

Shouldn't doctors know better?

The Vioxx Trial

2005-09-21T07:55:00.000-07:00

A good post on the Merck trial at In The Pipeline...

Aging

2005-09-20T10:05:00.000-07:00

Klotho is a gene that adds an extra 30% on to the lifespan of mice when they receive an extra copy of the gene. Previously, it was shown that restricting caloric intake in mice produced the same effect, although similar studies in larger animals didn't have the same results. It remains to be seen if the Klotho gene will have an effect in larger animals, but would raise some interesting questions if it someday could be applied to humans. There is certainly an ethical responsibility to sustain life, but is there one to extend life? Particularly if increasing one's life span also increases the chances of contracting an illness like heart disease, etc...? Would insurance companies pay for gene therapy to insert an extra Klotho gene or for a prescription drug that boosts the effectivness of the Klotho gene product?

Bad Science Writing

2005-09-12T13:14:00.000-07:00

Why does the public have a natural distrust of all things scientific? Okay, maybe that's a bit simplistic and over-generalized, but it definitely has an element of truth. We tend not to trust man-made things as much as "all-natural" ones. I've never fully understood it. Anyway, I stumbled upon this article through a link at Instapundit (a good resource, btw), which might explain in part how it happens.

I'd a couple of more reasons in why science stories get a bad wrap in the popular media.
1. Scientist themselves trying to overhype or overplay the importance of their own discovery
2. Misinterpretation of scientific findings by drawing firm conclusions inappropriately (for example, the conclusions of many scientific papers are "correlations" or "increased risk", etc...and these are misconstrued as stone cold fact by too many)
3. Overrepresentation of the importance of a single study/paper/finding...in other words, not holding findings up in the context of all the other work that's been done in the field, and showing how it fits in; sensationalizing.

This is a great point too...

"Last month there was an interesting essay in the journal PLoS Medicine, about how most brand new research findings will turn out to be false (www.tinyurl.com/ceq33). It predictably generated a small flurry of ecstatic pieces from humanities graduates in the media, along the lines of science is made-up, self-aggrandising, hegemony-maintaining, transient fad nonsense; and this is the perfect example of the parody hypothesis that we'll see later. Scientists know how to read a paper. That's what they do for a living: read papers, pick them apart, pull out what's good and bad."

When it comes right down ot it, reading scientific papers is like reading a different language and too few journalists are interested in doing it right. And the public doesn't know any better, or doesn't care to. Both science journalists and scientists themselves need to a better job of communicating to the masses....

National Geographic

2005-09-12T10:11:00.000-07:00

If you haven't seen it, go find it at your local library or elsewhere. National Geographic (July, 2005 issue) has an excellent story about the embryonic stem cell debate, explaining many aspects much better than I could hope to. And it is a very fair and balanced view of the topic, giving you a bit of both sides. Here's what the editor says about it...

"A story about stem cells is a story about hope, which my dictionary tells me is 'to cherish a desire.' For Dean Richardson, a former deputy sherriff in Canon City, CO, hope appeared in July 2003 when doctors at Northwestern University in Chicago treated him with stem cells from his own bone marrow in an attempt to break the grip of multiple sclerosis, a degenerative disease that had confined him to a wheelchair. The treatment seems to have worked. Richardson's wheelchair is gone, along with any active signs of the disease. Similar therapies have shown promise for curing certain cancers and repairing hearts.

If debilitating illness can be conquered with stem cell therapy, why is it so controversial? Isn't it a medical miracle to be celebrated? Yes and no. Though we stand on the threshold of the realm of possibility, we are not yet inside it. The doors opened by science include one marked 'Moral Dilemma.' Many scientists believe that stem cells from human embryos offer even more hope for cures than the ones found in bone marrow--the kind that helped Dean Richardson. An editorial in the New England Journal of Medicine called embryonic stem cell research 'the greatest biomedical promise of our time'. Yet to destroy embryos to create stem cell therapies is an unforgivable obstacle for many people. So ethical argument mixes with scientific process. Hope must break through the rhetoric.

My own hope, the desire I cherish, is that we can freely discuss the complex, sometimes uncomfortable, friction between science and ethics. That's what our stem cells story is all about."

Amen to that.

Maybe a snippet or two from the article in a bit...

Separation of Church and State

2005-09-01T12:04:00.000-07:00

It has always been a topic of confusion for me. We are a nation founded on the separation of church and state. But for many people, tenets of their religion are not only a matter of faith for them, but of objective reality, as well. So, if the government is run by the will of the people, and the will of the people reflects religious beliefs, where do we draw the line? If I believe that the bible tells me that life begins when the sperm enters the egg and creates an embryo, is that necessarily true? Or does it begin when it's implanted into a womb and begins to divide? Or that life was created and evolved in the way described by Intelligent Design theory? And should I be able to demand that policy be made to support this belief? It seems like that would be legislating the morality of a religion, and therefore not a separation of church and state. So, how should a government create legislation and policy? George Will clarified the issue for me (who I rarely agree with, btw) in a July 4th issue of Newsweek.

"The problem with intelligent-design theory is not that it is false but that it is not falsifiable: Not being susceptible to contradicting evidence, it is not a testable hypothesis. Hence it is not a scientific but a creedal tenet—a matter of faith, unsuited to a public school's science curriculum."

What? Waaaa!!?? You need evidence to make decisions?

This quote is great, because it illustrates a good point. The idea of Intelligent Design is in a sense, diabolical, because it inherently tries to place itself on a level playing field with science, characterizing science as a "theory". Really, science is much more than that, and it sometimes gets a bad rap. Shouldn't we demand that the laws and policies that govern us have some basis in repeatable, verifiable evidence? Isn't that what the scientific method is all about?

In the Pipeline

2005-08-31T18:09:00.000-07:00

Props out to In the Pipeline, a blog by Derek Lowe who is an organic chemict and drug developer for a major pharmaceutical company. This is a valuable resource for anyone interested in, and with no idea how, the pharmaceutical company really works (ie. me). Apparently they're not always heartless monsters?

http://www.corante.com/pipeline/

Of particular interest as I was skimming through some posts I've missed was how the FDA testing guidelines for clinical drug trials are not enough to predict some side effects that might occur if millions of people take a drug...

"And there's the worry. There is absolutely no way that large enough clinical trials could be run on a drug like this (acomplia) to predict everything that might happen when millions of people start taking it. Can't be done. You can get down to a margin of safety that will get you past the FDA, but that isn't enough, now is it? No, if one person out of a hundred thousand has a nasty side effect, that's enough to bring the sky down on your head. And we can't test down to the level of one-per-hundred-thousand effects."

Food for thought.

Creationism in Schools

2005-08-31T09:08:00.000-07:00

From the NY Times:

"In a finding that is likely to intensify the debate over what to teach students about the origins of life, a poll released yesterday found that nearly two-thirds of Americans say that creationism should be taught alongside evolution in public schools.

The poll found that 42 percent of respondents held strict creationist views, agreeing that "living things have existed in their present form since the beginning of time."

In contrast, 48 percent said they believed that humans had evolved over time. But of those, 18 percent said that evolution was "guided by a supreme being," and 26 percent said that evolution occurred through natural selection. In all, 64 percent said they were open to the idea of teaching creationism in addition to evolution, while 38 percent favored replacing evolution with creationism."

Anyone want to bet that if they took a poll of 16th century Italians, at least 2/3 of them would support teaching that the universe revolves around the earth in school? Sometimes the majority is a little slow in picking up on things for whatever reason. I personally think it's because they just don't care to try and get information on a given topic, or can't understand, or choose not to. To some extent, our government exists in the form that it does, so that these decisions can be made by educated and informed individuals.

Fetus Pain

2005-08-24T10:41:00.000-07:00

An interesting article in the NY Times (subscription may be required) on when the fetus feels pain. No way this could cause an uproar. Here's a snippet or two...

"Their report, being published Wednesday in The Journal of the American Medical Association, is based on a review of several hundred scientific papers, and it says that nerve connections in the brain are unlikely to have developed enough for the fetus to feel pain before 29 weeks."

"There are medical experts on opposing sides of the issue as well, and the only thing they agree on is that it is virtually impossible to tell for sure what a fetus can feel."

"From the available biological evidence, it seems very unlikely that a fetus experiences what we think of as pain before 29 weeks of gestation," Dr. Rosen said in a telephone interview. Giving anesthesia to the fetus could be difficult and would needlessly expose the pregnant woman to additional risks, he said, adding, "Policy decisions should be based on evidence, scientific evidence, not our emotional beliefs."

Like say...when life begins, also?

"Dr. Eleanor A. Drey, one of Dr. Rosen's co-authors, said that as an obstetrician who sometimes performs abortions, she would find it troubling to be compelled to bring up the subject of fetal pain with her patients.

'I would be forced to drag them through potentially a lot of misinformation,' she said. 'Our systematic review has shown it's extremely unlikely that pain exists at a point when abortions are done. I'm going to have to talk about something I know will cause the patient distress, something that by our best assessment of the scientific data is not relevant.'"

The same could probably be said of Intelligent Design theory also, which has yet to be covered in this blog, but most likely will be in the future. Also interesting from this article was that the authors of the paper consisted of "a neuroanatomist, an obstetrician, a pediatrician and a former lawyer who is now a medical student". Seems like a pretty well-balanced and hopefully objective group, and a good example of how the peer-review process and diverse groups are the best route to objective policy and decision making. Taking notes, President Bush? This is not meant to be a Bush-bashing blog, but he does seem to make plenty of decisions made on very personal points of view (or with political implications). Whereas Clinton was known for bringing in experts on both sides of issues and hearing them out, before making many decisions. From what I've read, Bush seems to be the opposite. It's too bad that leaders who do things more like Clinton are often labelled "wishy-washy" or "flip-floppers", while Bush is seen as a "strong leader" because of his willingness to take a stand or make immediate and firm decisions. At least in the scientific world, it's always valuable to see all the evidence first.

"Irrationalist in Chief"

2005-08-23T15:16:00.000-07:00

Dr. Leon Kass is President Bush's chairman of the President's Council on Bioethics, and a leading advocate therefore, of alternatives to embryonic stem cell research, such as the reprogramming methods that have recently been in the news. Here's a recent quote from him:

Since every cell in the body is genetically the same as any other, what distinguishes the liver cell from a brain cell from a heart muscle cell is not the presence or absence of certain genes, but which genes are in fact turned on and functioning, and which ones are silent. And since the process of development and differentiation going forward starts with a cell that could become anything, but specializes to become liver, or brain, or heart — presumably if you could locate the signal that produced that specialization, and run the process in reverse, you could start from liver, or heart or brain or muscle or skin, run the process in reverse and get back to the "stemcellness" of the beginning.

(Link here.)

Now first of all, it's only somewhat disturbing that a key advisor to the president invents a word like "stemcellness". In fairness to Dr. Kass (of whose background I know very little at this point...but I'm guessing he went to Hollywood Upstairs Medical School?), his job as chairman is probably largely dictated by the President (obviously), and is probably charged with publicizing all possible alternatives and lauding the therapeutic "promise" they all have, and not with engaging in intellectual debate about the relative merits of these ideas or the nature of embryonic stem cells and the morals of using them. And he's not even wrong about how every cell in the body contains the same genetic material, and how the main difference between different cell types is which subset of genes are turned on. But it is a pretty huge stretch to think that we can reverse engineer a stem cell from a fully differentiated adult cell. And even if we could (actually, I would speculate this could be possible in some form in the future...but how far off?), what guarantee would there be that it is a perfect replacement for an embryonic stem (ES) cell? Ultimately, you need to test the capabilities of ES cells to have something to compare with. And many of these reprogramming methods require an ES cell to fuse with an adult cell, or to transfer a somatic cell's nucleus to. The common denominator here? At some point, you just need embryonic stem cells. And guess what? They are available! All right, maybe you don't need them if these other ideas prove able enough. But the point is that ES cells are out there, and they are basically a known quantity (compared to these other more fledgling ideas). So why not use them? Are we so sure of when life begins and what is morally correct that we need to make scientists jump through all these hoops to find a loophole? If I had diabetes, I'd be pissed.

This blog...

2005-08-22T09:22:00.000-07:00

...was created to provide an "open market of ideas" in the John Stuart Mills sense, on matters of science, ethics, and politics that have recently started to receive national attention in our country. The stem cell debate, the Vioxx trials, and implantable defibrillator recalls are notable newsmakers that have been in the news of late and examples of potential topics. In the spirit of the "open market", it is the goal of this blog to have opinion expressed on all sides of a topic from the moderator himself, guest writers, and by providing open commentary after each post to anyone who's willing to chime in. A secondary goal is to be a place where science in the news stories are collected, at least the most interesting ones (to me, heh). There are certainly many similar (and excellent) sources for this, but particular attention will be paid to topics that are controversial, and that address areas where science, politics, ethics, and religion clash. And lastly, this blog will, from time to time, serve as a personal outlet from a scientist on the inside of the biotech/biomed universe. Compared to some of the other excellent science bloggers out there, I am a bit more fledgling in my life in as a professional, but my enthusiasm is great. And my interest in popularizing and educating non-scientists about the nature of scientific inquiry and it's accomplishments is greater still...particularly in correcting or clarifying how the press generally presents these issues (ie. poorly). Welcome to the PES forum, and if you like what you read, please tell your friends...