The Benefits of your local Medical Ethics Committee Consultation

By Mark McQuain

No doctor or hospital system is perfect and, frankly, no one would ever claim to be. Regardless, we hold some medical facilities in very high regard simply because of the consistency of their record of care. One such place is the Mayo Clinic in Rochester, Minnesota. So, it was somewhat of a surprise to see a CNN headline featuring a complicated medical ethics issue gone awry. The story is long and admittedly somewhat one-sided, with more she said than he said. Still, the story as told is instructive by reminding everyone that medical ethics cases are complex, and it is usually best never to “go it alone”.

Briefly, in 2016, a 18-year-old young woman with a brain aneursym was transfered to the Mayo Clinic for urgent surgical treatment. Her surgery went well. The problems did not really begin until she was recovering on the inpatient rehabilitation unit. The patient and family became dissatisfied with her care. The staff believed that the patient was unable to make informed medical decisions due to alleged changes in her cognitive status as a result of treating the brain aneurysm and rather than appoint a family surrogate, began the long complicated process of trying to arrange for third-party guardianship. The mother and stepfather, in advocating for their daughter, came into conflict with the rehabilitation staff, resulting in the mother being banned from the hospital. The staff reached out to the biological father but he declined to become involved. The staff apparently believed the family to be unreliable and began a process to acquire a third party guardian to assist the patient with her medical decisions. The family and patient came to feel the patient was imprisoned against her will. The patient and her family eventually arranged “her escape” after which the rehabilitation staff called the police, claiming the patient was “abducted”. The patient has and is continuing to recover apart from Mayo. The legal issues remain.

Medical ethicists who have reviewed the details of the case agree on at least one detail: Mayo should have utilized their medical ethics committee to assist in determining how best to handle the patient’s possible lack of medical-decision-making ability, and in determining who might best serve as the patient’s surrogate if such was needed. Most medical providers have become involved in contentious medical decision making, where the patient and/or family comes to disagree with a recommended treatment plan by the medical staff. Involving the hospital’s medical ethics committee can be an excellent resource to regain dialog with the patient and family, and hopefully come to a medical decision that best benefits the patient.

Human limitation and ethics

By Steve Phillips

I recently read Cody Chambers’ article “The Concept of Limitation in Emil Brunner’s Ethics” in Ethics in Conversation from the Kirby Laing Institute for Christian Ethics. The article is well done and you need to read it to get the full impact of what he has said. What resonated with me was the idea that being limited is a part of what it means to be human and that our limitations are essential for our relationship with God and each other. It is our limitedness that helps us see that we need both God and other people and that we were made for those relationships. This is central to ethics because it is in our relationships with God and other people that we find our understanding of what ethics is.

This understanding that we are in our nature limited beings created by an unlimited God could not be more different from the conception of human beings held by many in the culture around us. They desire to see human beings and particularly themselves as having unlimited potential and freedom with no creator at all. That desire for personal freedom dominates contemporary ethics and shows itself in all areas of bioethics.

Chambers looks at how this impacts thinking about gene editing. Those who advocate doing human germline genetic modification see it as the freedom to create a child who is made to be what the parents creating the child desire the child to be. This is usually expressed in terms of creating a child free from genetic disease, but there are simpler ways to have a child without a disease carried by the parents (including adoption). It is ultimately the desire to be free of natural human reproductive limitations and create a child we have designed and chosen. Being limited helps us to see that we need each other and must respect others, including our children, as they have been made by God. Our natural lack of control over the characteristics of our children leads to an understanding that those children are a gift from God that we should accept unconditionally. Using technology to try to take control of the creation of our children leads to creating children that will fulfill our desires and a loss of the unconditional acceptance that is the foundation of a positive parent-child relationship.

Freedom in the proper context is good. The desire for unlimited freedom leads to putting ourselves above others and ultimately controlling and subjugating others, including our children, to our desires. Proper ethics requires an understanding that our freedom is limited.

Mumbling orphans—a bit more

Mark McQuain has raised the persistent, vexing issue of the pricing of drugs for rare diseases—in the case at hand, Sarepta’s eteplirsen (Exondys 51) for Duchenne Muscular Dystrophy, the disease over which the late comedian Jerry Lewis lost sleep every Labor Day weekend for years.

Mark provided an excellent summary (he calls it “crude,” but it’s anything but that).  In this case, the concern is not just price for a truly rare disease, but whether the drug showed sufficient evidence that it worked for FDA to approve it.  In the absence of alternative treatments, that was the truly tempestuous issue for Sarepta.  (Recall that under the 1962 Kefauver-Harris amendments to the Federal Food, Drug, and Cosmetic act, drug manufacturers in the U.S. may not sell a drug unless the FDA finds it not only safe, but effective—a standard that generally applies worldwide.)  It’s one thing for a drug to have a high price, but rather another if it doesn’t work, or doesn’t work very well.  (I decline to comment publicly about the Sarepta data; outside my expertise.  Those seeking a case in point may wish to consider Avastin for breast cancer.)

And to be sure the high price concern dogs other treatments that appear to work quite well—such as high-profile ones for cystic fibrosis or for cancer.  A case can be made that such drugs are worth the price, that too much government heavy-handedness risks stifling innovation, and that a search for the “just price” is misguided, but also, for sure, that society should share the costs of some of these drugs, that measures should be taken to limit out-of-pocket costs to disease sufferers, and that reimbursement approaches are ripe for overhaul.  In that last bucket: if drugs work only some of the time, only pay for the cases in which they do work; foster true competition (rather than having the costs of all drugs in a class go up when a new one is introduced, as if drugs were houses); eliminate the middle man (i.e., pharmacy-benefit managers that take a cut—that appears on the horizon); and the “biggie,” having government payers push back harder on prices.  At least some of these measures seem likely, and at least some seem warranted.

But overall, high costs for truly innovative treatments are justifiable, where no alternatives existed previously and especially when other, more expensive and quite possibly less effective medical treatments may be obviated (see: drug treatment for hepatitis C vs liver transplantation).  This is not to endorse price gouging for existent, cheap drugs that fall into an incidental monopoly (in which case, BTW, elimination of said monopoly, through regulatory facilitation of alternative sources, is warranted).

The Cost of Getting RNA to Mumble

By Mark McQuain

In my previous blog entry, I crudely summarized the genetic basis for Duchenne Muscular Dystrophy (DMD) and one pharmaceutical company’s (Sarepta) current effort to research, manufacture and finance a genetic treatment that increases the production of a muscle protein missing in patients with DMD called dystrophin. Please see my previous blog entry for that summary or this article for a more detailed thorough overview of the science and investigational process to date. For this blog entry, I want to consider the bioethics of the cost of Sarepta’s treatment eteplirsen (Exondys 51), currently estimated on average to be around $300,000 per year.

DMD is a devastating disease that generally causes the patient’s death by his mid-twenties but it only affects a very small number of boys and young men worldwide, estimated to be around 400-600 newborn males in the US each year. This small number of patients places medications for DMD in a category called Orphan Drugs, those that benefit fewer than 200,00 people per year. Eteplirsen is only beneficial in the 15% of DMD patients that have the specific RNA defect in dystophin protein production that eteplirsen corrects. Back-of-the napkin calculations mean that if 15% of all 600 boys born in the US every year with DMD (90 boys per year) used Sarepta’s $300,000-per-year drug, that is a $27 million increase in revenue (not profit) to Sarepta each year. While that sounds huge, it ignores the massive expensive cost barriers to bringing such a drug to market, including research, investigational studies to gain FDA approval and legal financial risk with future adverse effects yet unknown. Inability to gain FDA approval prohibits access to capital markets necessary to fund such a process. Were it not for grants available for orphan drugs, it is unlikely that eteplirsen would exist. Better for drug makers to target their R&D to a bigger disease market for the chance of a bigger reward (consider Bayer aspirin and their $3.3 BILLION profit in 2011 alone).

There are calls for Sarepta to “give back” some of their potential future income, calls from the very organizations that were their staunchest supporters in their FDA approval process. Strong ethical arguments are made that the company did benefit early on by using federal grants and this alone should require the company to reduce a portion of their future income by lowing the cost to patients. Calls for the FDA to federalize Sarepta’s patents and take government ownership will most certainly go unheeded as that would cause every other orphan drug manufacturer to immediately discontinue any further financial risk for fear of similar confiscation.

There are, however, opportunity costs beyond the financial. Some would say that the FDA approved eteplirsen with extremely flimsy data, as less than 10 boys showed borderline promising results when the drug was approved in November 2016. That FDA approval allowed Sarepta to survive as a company. Per the editorial board at the Wall Street Journal(subscription needed):

“But if FDA had cashiered that therapy, Sarepta would have lacked the resources to continue its research and testing to treat Duchenne and develop what may be an even better drug. If eteplirsen had failed to get approval, dollars and brain power would inevitably have flowed toward treating other diseases with more promise of success. FDA has tremendous influence over private investment.”

Indeed Sarepta has new genetic treatments in the pipeline which reportedly do provide increased levels of dystrophin, even for RNA patterns beyond what eteplirsen can presently correct. Have the ends justified the means? Presently, for DMD patients, despite the $300K yearly price tag for eteplirsen, that answer may be – yes. Sadly, there are no other currently functional treatment options for DMD – yet.

From a public health standpoint (and a public funding standpoint), orphan drugs for treatment of small population diseases like DMD are non-starters. Is the only answer to provide the opportunity for great financial reward to encourage individuals to assume all of the private risk?

Every Day is a Gift

By Neil Skjoldal

Into the genre of news reports about physician assisted suicide comes a powerful piece from The Washington Post.   It is the story of J. J. Hanson who was diagnosed with a glioblastoma multiforme.  It traces his difficult journey as it relates to PAS.  Because of the poor prognosis, treatments at times seemed too difficult.  His wife Kristen reported that “he told her that if he had had the lethal dose of medication on his bedside during his darkest of days, he might have used it and then missed out on three more years with his family.”  Her hopes now, since her husband’s death last year, are that lawmakers will “work to improve hospice and palliative care for patients” and “to encourage terminally ill patients to have hope and families to enjoy every moment they have together.”

I am aware that a story such as the Hanson’s will not convince those who are strongly committed to PAS. The argument would be something like, “That’s ok for him.  He died his way, just give me the freedom to die in my way.”  But, at the very least, this story provides a counter-narrative to some PAS advocates, who almost by default go to “I know a person who died very poorly and I want to stop that by helping them end their suffering.”

My observation in talking to people about this subject is that their greatest fear is dying with horrible suffering. Almost everyone can re-tell the story of a friend or loved one that died in this way.  For those of us who think that PAS creates many more ethical problems than it solves, our focus needs to be, as Kristen Hanson suggests, to continue to improve hospice and palliative care.  I am grateful for her courage in telling her story and am reminded that every moment of life should be precious to us.

Public input into gene-editing decisions

Lyme disease is caused by a type of bacteria that lives in mice, which are considered a “reservoir” for the disease-causing agent.  Ticks bite the mice, pick up the bacteria, and then infect people when they bite them.  (Ticks are called the “vector” for the disease.)

If mice were immune to the bacteria, their immune systems would destroy them, and there’s be no reservoir, and no Lyme disease.  If scientists genetically engineered mice to make them immune—for example, by editing their genes—they could make progress toward that goal.  But to work, the mouse population would have to be predominantly made of bacteria-immune mice.  That could be accomplished by using “gene drive,” an approach that would make the altered gene spread preferentially and rapidly in the population.  However, doing that could alter the environment in unpredictable ways.

Because of the risks, scientists on the “Mice Against Ticks” project are determined that even if they succeed in genetically altering mice as suggested, they will not release those mice into the wild without full public awareness and approval.  They are holding public meetings—specifically, in Martha’s Vineyard and Nantucket—well in advance of the project coming to full fruition.  And they are trying to figure out, with the public, what level of communication and acceptance constitutes public approval.

Similarly, scientists in New Zealand would like to use a form of gene drive to greatly reduce the population of rats, possums, and other destructive predators that are decimating the environment.  And their public deliberations include seeking advice and, before taking action, buy-in from a network of Maori leaders.  Those conversations are so sensitive that the Maori objected when the scientists published a “what-if” type of article discussing the issues raised by the technology.  Among the concerns: some readers got the impression that gene editing of the animals was imminent, not hypothetical, as it still is.  Some of the news coverage of the Nuffield Council’s recent deliberations about the potential acceptability of heritable human gene editing seemed, likewise, to create the impression that the birth of the first gene-edited human is upon us—which it is not, not quite yet.

The public discussions above are two commendable moves toward true public involvement in decision-making about gene editing.  They were described in a recent Wall Street Journal article.  If you have subscription access, by all means read it.

PAS and “plain old” suicide

Last week, the folks from the Manhattan Declaration (whose key concern is freedom of religion) sent an email with a series of links—perhaps expanding their remit a smidge—one of which dealt with doctor-assisted suicide.  “Doctor-assisted suicide is contagious,” it said, along with this: “Doctor-assisted suicide increases overall suicide rates among the non-terminally ill everywhere it’s made legal.” And it also linked to a 2015 article on the subject from the Southern Medical Journal.

The SMJ authors were looking at whether overall and non-assisted suicide rates were different in states with legalized assisted death than in other U.S. states.  By their own admission, they did not have as much information as they would have liked.  They reviewed available information between 1990 and 2013. Two of the states were Vermont, which legalized assisted suicide in 2013 and had no cases that year, and Montana, which was not keeping count of assisted suicides.  That left them with assisted suicide data from Oregon (since 1998) and Washington state (since 2008).  (Since then, assisted suicide has also been made legal in Colorado, D.C., Hawaii, and California.)

In those two states, the total number of suicides and the number of non-assisted suicides had increased after the respective dates of legalization of assisted suicide.  However, the number of non-assisted suicides had also increased in the other states combined.  When I looked at their graph of the data, going back to 1990, there had been a decline in non-assisted suicide in Oregon, Washington, and other states between 1990 and 2000, with increases after that.  The number of these deaths per 100,000 population were higher in Oregon and Washington (and, indeed, much higher in Montana) than in the other states, but the slopes of the curves—the rates of increase—in Oregon and Washington looked similar to the other states.  Montana’s increase appeared sharply higher, but it’s hard to conclude anything about assisted suicide in that case because there were no data (nor for Vermont).

The authors commented that there had been estimates of how many surreptitious assisted suicides may have occurred outside of legalization, but admitted that firm conclusions were not possible.  They attempted to establish a statistical association between assisted suicide and nonassisted suicide, but the argument seemed inconclusive.  Follow the above link, read the article, and judge for yourself.

The core conclusion was that assisted suicide in its early years had not decreased overall suicide rates, as some of its advocates had argued it would.  Any relationship may become clearer as more information is available, assuming that numbers of assisted and non-assisted suicides are consistently and completely counted and recorded.  But that assumption is questionable at best.

In the meantime, it is important not to overinterpret limited data sets.  It’s also important to remember there are at least 5 reasons why assisted suicide is a bad idea:  it fundamentally alters the nature of medicine as a healing, life-preserving art and profession; its application cannot be reliably limited to those who freely request death or who are terminally ill (the slippery slope); it risks diverting energy and priority from true palliative care; if understood as a “right to die,” or a “right to be made dead,” it creates a duty for someone else to kill; and the notion of a “right to die” is self-contradictory if rights rest on preservation of life and well-being, as is the classical (i.e., pre-20th century) understanding.

In 2012, in his essay “Four Myths about Doctor-Assisted Suicide,” Ezekiel Emanuel wrote: “Patients themselves say that the primary motive [for assisted suicide] is not to escape physical pain but psychological distress; the main drivers are depression, hopelessness and fear of loss of autonomy and control. Dutch researchers, for a report published in 2005, followed 138 terminally ill cancer patients and found that depressed patients were four times more likely to request euthanasia or physician-assisted suicide. Nearly half of those who requested euthanasia were depressed.

“In this light, physician-assisted suicide looks less like a good death in the face of unremitting pain and more like plain old suicide. Typically, our response to suicidal feelings associated with depression and hopelessness is not to give people the means to end their lives but to offer them counseling and caring.”

And “plain old suicide” is, as we know, a problem that is getting worse all over the country.

Britain’s experts on gene-edited babies

by Jon Holmlund

Some of the cable news shows ran segments on the report released this week by Britain’s Nuffield Council on Bioethics, “Genome editing and human reproduction: social and ethical issues.”  Full disclosure: I have not yet read the full report, only the short summaries (all of which are available for free download at the link here).

The TV teasers—”U.K. bioethics council says that gene-editing children may be morally acceptable” were accurate.  The key conclusion is that “the use of heritable genome editing interventions to influence the characteristics of future generations could be ethically acceptable in some circumstances” (emphasis theirs).  But the news folks made it sound like an attempt to birth an edited baby is around the corner, or at least fully green-lighted by Nuffield.

The summary of the report reads more modestly, acknowledging that such attempts are currently banned by law most places, and that making them legal could require “a long and complex legislative pathway.”  But the Council does take the view that at least some attempts, such as those to try to repair a lethal disease gene such as the dominant gene for Huntington’s disease, might be justifiable.  This blog has considered such an argument in the case of sickle cell anemia—single gene defect, well understood, circumscribed attempt to repair only that gene.  An argument can be made.

The Nuffield Council’s summary really is a list of general statements that, taken individually, are hard to take issue with, and are in some cases almost platitudinous.  The overall impression is, “yes, heritable human gene editing could be ethical, and probably should be considered, but only after a long public deliberative process, appropriate regulation, etc., etc.”  Nuffield offers two stipulations for ethically acceptable heritable human gene editing:

  • “Intended to secure, and is consistent with, the welfare of a person who may be born as a consequence” of the effort, and
  • Social justice and solidarity are upheld; that is, discrimination or social division should not be a consequence.

These statements are both too broad to be helpful.  In the first case, the Council acknowledges that some efforts could be attempts to enhance a person’s natural characteristics, not just treat a recognized disease, and that, except for the most genetically straightforward cases, the scientific and technical challenges are substantial.  In the second case, it would seem that pressures for discrimination based on social attitudes or economics (ability to pay for the procedure, medical insurance reimbursement issues) will be unavoidable.

Scientifically and socially, there will be unintended—or at least undesirable—consequences.  These may be known but considered acceptable.  For example, how many human embryos will need to be created and destroyed to perfect the procedure?  How many generations will need to be followed to rule out some late complication?  Can we really guarantee that “having babies the old-fashioned way” won’t become a thing of the past?  And, in spite of the laudable desire to bring healthy children into the world, wouldn’t this be a wholesale acceptance of the basic assumption that only the people we want to be born, should be born?

For these reasons and others previously articulated on this blog, heritable human gene editing falls into a small but critical group of biomedical undertakings that should not be pursued.

And, BTW, the remaining bugs in the system include, as reported this week, that gene-editing techniques appear to introduce errors more frequently than previously appreciated.  Given that heritable human editing involves more than just a few cells in a dish, a “presumption to forebear” should apply.

The TV news gave this about 5 minutes this week.  That’s the breadth and depth of our “public deliberation” beyond a few experts.  At the end of one segment, the host looked into the camera and said, “next up: are liberals or conservatives happier?”

As Neil Postman said:  “now this…”

Forcing RNA to, at least, Mumble…

BY MARK MCQUAIN

We are at a turning point in medicine where instead of supplementing patients with proteins or enzymes that their bodies fail to manufacture due to genetic abnormalities, we soon may be able to re-engineer the abnormal DNA, restoring the DNA’s ability to instruct the body to make those same proteins or enzymes. On our way to full-fledged genetic engineering, we have learned that DNA makes something called RNA, which can be thought of as specific instructions for assembling these vital proteins, telling cells exactly how to assemble protein building blocks, called amino acids, in their proper sequence. Even a very minor disorder in a very long amino acid sequence of a protein can cause that protein to function poorly or not at all. When bad DNA makes bad RNA, or when good RNA gets subsequently damaged or misread, the protein either gets assembled in a garbled fashion, or not at all. Think of RNA as the boss of protein production who can speak clearly, mumble or say nothing at all. Recently, there is one well-known disease where it looks like it is possible to force bad RNA that presently says nothing at all to, at least, mumble.

The disease is Muscular Dystophy (MD) and the missing necessary protein is called dystrophin. Dystrophin is responsible for the structural integrity of muscle. Poorly formed or garbled dystrophin results in a mild form of MD, such as one called Becker Muscular Dystrophy (BMD) where patients can live well into their 40s or 50s. If no dystrophin is produced at all, a severe form of the disease called Duchenne MD (DMD) results, in which muscles simply fall apart over a shorter period of time, causing patients to stop walking in their teens, usually dying in their twenties from cardiac or respiratory muscle failure. While it would be great to restore normal production of dystrophin in patients with DMD, one company called Sarepta, appears to be able to cause patients with DMD, who normally do not make any dystrophin, to produce a garbled dystrophin, giving them a milder BMD-like disease.

Consider the following sentence: “The big red fat cat bit the sly fox and ate the shy jay”. The individual letters represent the RNA sequence and the three letter words represent unique amino acid protein building blocks, resulting in a meaningful protein sentence – think of this as the normal dystrophin protein in a healthy person. If the RNA was missing the 22nd through 24th letters (the 8th word “sly”), the sentence becomes: “The big red fat cat bit the fox and ate the shy jay”. It is a minimally garbled version of the first sentence but still meaningful – think of this as the dysfunctional dystrophin in milder BMD. If the original RNA sequence was missing only the 7th and 8th letters, the sentence becomes: “The big dfa tca tbi tth esl yfo xan dat eth esh yja y”. This sentence has no meaning beyond “The big” – think of this as no dystrophin in severe DMD. If we could get the RNA reader to ignore the first letter “d” in the last RNA sequence, the sentence becomes: “The big fat cat bit the sly fox and ate the shy jay”. We are back to a minimally garbled version of the first sentence but still meaningful – think of this as another dysfunctional protein in a milder “Becker-like” MD. This is how scientists at Sarepta appear to have taken an RNA sequence that originally said nothing and forced it to mumble, producing a new garbled form of dystrophin, which works better than no dystrophin at all.

I realize this has been a long walk in the weeds for some of our regular readers but hopefully it has provided some helpful background into the current treatment of MD and a sense of how much further we have yet to go. I will use this blog entry as background for my next blog entry to discuss some of the bioethics around the cost of getting RNA to mumble.

For now and for me, advancing medical knowledge like this convinces me of how fearfully and wonderfully we are made. (Psalm 139:14)

Raiding the CRISPR

BY JON HOLMLUND

A couple of gene-editing news items from this week’s science literature:

First, Nature reports that a group in my “back yard,” at the University of California San Diego, has tested gene editing using the CRISPR approach in mice.  Recall that CRISPR is an acronym for a particular molecular mechanism, first discovered in bacteria, that is particularly efficient—though not perfectly so!—at editing genes.  The idea is to find a “bad” gene that you’d like to replace, for example to prevent or treat a disease, and edit it to be the normal version of that gene.

The kicker in this particular case in mice is that it tested something called “gene drive.”  In classical genetics, humans (and other higher organisms) have two copies of each gene.  In sexual reproduction each parent passes one copy of the gene to offspring, so the chance of a particular gene being handed down is 50%.

“Gene drive” is a technique designed to change those odds, and make a particular gene “selfish,” and much more likely to be passed on.  In fact, the idea is that transmission would be 100%, or nearly so.  If that worked, then a new gene would soon take over a population of organisms, and every member would, in a few generations, have that gene.

Why might that be a good thing?  Suppose you are interested in pest control, and you could use the technique to make, say, mosquitoes infertile.  Then they would soon all die off.  Or if you had some other “desirable” characteristic, you could make it so all members of a species (rodents?  Cattle?  People?) have that characteristic.  Assuming it’s determined by one gene, that is.

And assuming that the technique works.  In the mouse experiment, efficiency was only 73%.

That’s probably good news.   This is one of those techniques that could have serious unintended consequences if tried in the field.  Scientists have been warning about that.  It looks like it’s a way off, but something else to fret about.

The second item involves a clinical trial to treat sickle cell anemia.  In this one, blood stem cells from a person with the disease are removed from the bloodstream and gene-edited outside the body to make hemoglobin that is not as damaged as in the disease (SCA is an inherited disease in which the red blood cells have abnormal hemoglobin that doesn’t carry oxygen well).  Then the altered cells become the therapy, and are given back to the patient.

The FDA has put a “clinical hold” on this clinical trial.  Exactly why has not been publicly disclosed (it doesn’t have to be), and it sounds like the trial itself hadn’t started yet, but that the company developing it was getting ready to start.  This is, in my view, an approach to gene editing that does not pose special or particularly worrisome ethical issues, because the genetic changes are done on “adult” stem cells to treat an existing individual with a disease in a way that would not entail transmission of altered genes to future generations.

And, probably, it’s a case of “this too shall pass,” and the FDA’s concerns will be answered and the trial will proceed.

But check out the sidebar reporting this in Nature Biotechnology.  If you follow the link you will probably get a prompt asking for payment but I was able to sneak a free read on my screen.  If you go there, read below the separate quote (itself picked up from The New York Times) from Dr. George Church of Harvard:  “Anyone who does synthetic biology [engineering of biological organisms] should be under surveillance, and anyone who does it without a license should be suspect.”  Apparently he said that in response to “the publication of an experiment recreating a virus that has engendered fears that such information could be used to create a bioweapon. ”

The old “dual use problem,” eh?  We should really fret about that.