Pope gives Obama a bioethics lesson

US President Barack Obama met the Pope today at the end of an economic summit of the world's top industrialized nations, and he was given some instruction from the top on the Catholic Church's position on bioethical issues.

In addition to giving Obama a copy of his latest encyclical, which the pope had been presenting to visiting heads of state since its release July 7, the pope also presented a copy of the Vatican document on biomedical ethics, "Dignitas Personae" ("The Dignity of a Person").

When presenting the gifts after their 35-minute closed-door meeting, the pope gave Obama a signed, white leather-bound copy of the encyclical, "Caritas in Veritate" ("Charity in Truth"), then indicated the light-green soft-cover instruction on bioethics issued last December by the Vatican Congregation for the Doctrine of the Faith.

"Oh, what we discussed earlier," said Obama, referring to their closed-door discussions. "I will have some reading to do on the plane."

Obama was given the instruction to help him better understand the church's position on bioethics, Msgr. Georg Ganswein, papal secretary, told journalists in the pool covering the visit.

The Caritas in Veritate released Tuesday called for more ethics in economics and rules to reign in free market excesses.

The Dignitas Personae, released in December, was a sweeping update of the Vatican's bioethics code barring Catholics from using IVF, participating in medical research involving cloning or embryonic stem cells, banning surrogate mothers, the morning-after pill and the testing of embryos for defects. Hormone therapy, adult stem cell and sterility research are okay.

Obama's stance on abortion and embryonic stem cell research has not been popular with many devote Catholics, though more liberal Catholics rallied behind him in last fall's election.

US President Barack Obama met the Pope today at the end of an economic summit of the world's top industrialized nations, and he was given some instruction from the top on the Catholic Church's position on bioethical issues.

In addition to giving Obama a copy of his latest encyclical, which the pope had been presenting to visiting heads of state since its release July 7, the pope also presented a copy of the Vatican document on biomedical ethics, "Dignitas Personae" ("The Dignity of a Person").

When presenting the gifts after their 35-minute closed-door meeting, the pope gave Obama a signed, white leather-bound copy of the encyclical, "Caritas in Veritate" ("Charity in Truth"), then indicated the light-green soft-cover instruction on bioethics issued last December by the Vatican Congregation for the Doctrine of the Faith.

"Oh, what we discussed earlier," said Obama, referring to their closed-door discussions. "I will have some reading to do on the plane."

Obama was given the instruction to help him better understand the church's position on bioethics, Msgr. Georg Ganswein, papal secretary, told journalists in the pool covering the visit.

The Caritas in Veritate released Tuesday called for more ethics in economics and rules to reign in free market excesses.

The Dignitas Personae, released in December, was a sweeping update of the Vatican's bioethics code barring Catholics from using IVF, participating in medical research involving cloning or embryonic stem cells, banning surrogate mothers, the morning-after pill and the testing of embryos for defects. Hormone therapy, adult stem cell and sterility research are okay.

Obama's stance on abortion and embryonic stem cell research has not been popular with many devote Catholics, though more liberal Catholics rallied behind him in last fall's election.

Pope gives Obama a bioethics lesson

US President Barack Obama met the Pope today at the end of an economic summit of the world's top industrialized nations, and he was given some instruction from the top on the Catholic Church's position on bioethical issues.

In addition to giving Obama a copy of his latest encyclical, which the pope had been presenting to visiting heads of state since its release July 7, the pope also presented a copy of the Vatican document on biomedical ethics, "Dignitas Personae" ("The Dignity of a Person").

When presenting the gifts after their 35-minute closed-door meeting, the pope gave Obama a signed, white leather-bound copy of the encyclical, "Caritas in Veritate" ("Charity in Truth"), then indicated the light-green soft-cover instruction on bioethics issued last December by the Vatican Congregation for the Doctrine of the Faith.

"Oh, what we discussed earlier," said Obama, referring to their closed-door discussions. "I will have some reading to do on the plane."

Obama was given the instruction to help him better understand the church's position on bioethics, Msgr. Georg Ganswein, papal secretary, told journalists in the pool covering the visit.

The Caritas in Veritate released Tuesday called for more ethics in economics and rules to reign in free market excesses.

The Dignitas Personae, released in December, was a sweeping update of the Vatican's bioethics code barring Catholics from using IVF, participating in medical research involving cloning or embryonic stem cells, banning surrogate mothers, the morning-after pill and the testing of embryos for defects. Hormone therapy, adult stem cell and sterility research are okay.

Obama's stance on abortion and embryonic stem cell research has not been popular with many devote Catholics, though more liberal Catholics rallied behind him in last fall's election.

US President Barack Obama met the Pope today at the end of an economic summit of the world's top industrialized nations, and he was given some instruction from the top on the Catholic Church's position on bioethical issues.

In addition to giving Obama a copy of his latest encyclical, which the pope had been presenting to visiting heads of state since its release July 7, the pope also presented a copy of the Vatican document on biomedical ethics, "Dignitas Personae" ("The Dignity of a Person").

When presenting the gifts after their 35-minute closed-door meeting, the pope gave Obama a signed, white leather-bound copy of the encyclical, "Caritas in Veritate" ("Charity in Truth"), then indicated the light-green soft-cover instruction on bioethics issued last December by the Vatican Congregation for the Doctrine of the Faith.

"Oh, what we discussed earlier," said Obama, referring to their closed-door discussions. "I will have some reading to do on the plane."

Obama was given the instruction to help him better understand the church's position on bioethics, Msgr. Georg Ganswein, papal secretary, told journalists in the pool covering the visit.

The Caritas in Veritate released Tuesday called for more ethics in economics and rules to reign in free market excesses.

The Dignitas Personae, released in December, was a sweeping update of the Vatican's bioethics code barring Catholics from using IVF, participating in medical research involving cloning or embryonic stem cells, banning surrogate mothers, the morning-after pill and the testing of embryos for defects. Hormone therapy, adult stem cell and sterility research are okay.

Obama's stance on abortion and embryonic stem cell research has not been popular with many devote Catholics, though more liberal Catholics rallied behind him in last fall's election.

Pope gives Obama a bioethics lesson

US President Barack Obama met the Pope today at the end of an economic summit of the world's top industrialized nations, and he was given some instruction from the top on the Catholic Church's position on bioethical issues.

In addition to giving Obama a copy of his latest encyclical, which the pope had been presenting to visiting heads of state since its release July 7, the pope also presented a copy of the Vatican document on biomedical ethics, "Dignitas Personae" ("The Dignity of a Person").

When presenting the gifts after their 35-minute closed-door meeting, the pope gave Obama a signed, white leather-bound copy of the encyclical, "Caritas in Veritate" ("Charity in Truth"), then indicated the light-green soft-cover instruction on bioethics issued last December by the Vatican Congregation for the Doctrine of the Faith.

"Oh, what we discussed earlier," said Obama, referring to their closed-door discussions. "I will have some reading to do on the plane."

Obama was given the instruction to help him better understand the church's position on bioethics, Msgr. Georg Ganswein, papal secretary, told journalists in the pool covering the visit.

The Caritas in Veritate released Tuesday called for more ethics in economics and rules to reign in free market excesses.

The Dignitas Personae, released in December, was a sweeping update of the Vatican's bioethics code barring Catholics from using IVF, participating in medical research involving cloning or embryonic stem cells, banning surrogate mothers, the morning-after pill and the testing of embryos for defects. Hormone therapy, adult stem cell and sterility research are okay.

Obama's stance on abortion and embryonic stem cell research has not been popular with many devote Catholics, though more liberal Catholics rallied behind him in last fall's election.

US President Barack Obama met the Pope today at the end of an economic summit of the world's top industrialized nations, and he was given some instruction from the top on the Catholic Church's position on bioethical issues.

In addition to giving Obama a copy of his latest encyclical, which the pope had been presenting to visiting heads of state since its release July 7, the pope also presented a copy of the Vatican document on biomedical ethics, "Dignitas Personae" ("The Dignity of a Person").

When presenting the gifts after their 35-minute closed-door meeting, the pope gave Obama a signed, white leather-bound copy of the encyclical, "Caritas in Veritate" ("Charity in Truth"), then indicated the light-green soft-cover instruction on bioethics issued last December by the Vatican Congregation for the Doctrine of the Faith.

"Oh, what we discussed earlier," said Obama, referring to their closed-door discussions. "I will have some reading to do on the plane."

Obama was given the instruction to help him better understand the church's position on bioethics, Msgr. Georg Ganswein, papal secretary, told journalists in the pool covering the visit.

The Caritas in Veritate released Tuesday called for more ethics in economics and rules to reign in free market excesses.

The Dignitas Personae, released in December, was a sweeping update of the Vatican's bioethics code barring Catholics from using IVF, participating in medical research involving cloning or embryonic stem cells, banning surrogate mothers, the morning-after pill and the testing of embryos for defects. Hormone therapy, adult stem cell and sterility research are okay.

Obama's stance on abortion and embryonic stem cell research has not been popular with many devote Catholics, though more liberal Catholics rallied behind him in last fall's election.

Congrats to me and my blog

I just found out that this Medical Ethics Blog has been put on a list of the Top 25 Healthcare Policy Blogs in the world.

The list is compiled by Medicine 3.0, a blog on a site dedicated to helping nursing students.

Here's what it says:

Are you concerned about health care policies and reform? You can learn more about the direction that health care policies are taking through the blogs listed below. We discovered writers who were doctors, attorneys, journalists and politicians who all lend their perspectives to the volatile and ethical issues surrounding health care reform.

The blogs are listed below in alphabetical order. This method assures our readers that we do not favor one blog over another. All blogs listed, however, are up-to-date and all information is provided by professionals in their fields. ...

Medical Ethics Blog: Stuart Laidlaw has covered faith and ethics for over a decade, and he applies these attributes to a blog that covers health and health policies.

I'm blushing.

Bad news for men -- artificial sperm

A team of British researchers claimed this morning to have developed a method to create sperm from embryonic stem cells.

Researchers at Newcastle University and the NorthEast England Stem Cell Institute say they used a new technique to derive what they described as sperm cells from embryonic stem cells. Stem cells have the potential to become any cell in the body.

Newcastle research leader Karim Nayernia said in a statement Wednesday that the technique would allow researchers to study how sperm develops and possibly help develop treatments for infertile men.

The research was published Wednesday in the journal Stem Cells and Development.

The Independent newspaper immediately wondered if this meant "a world without men." Ethicist John Harris, professor of bioethics at The University of Manchester and editor-in-chief of the Journal of Medical Ethics, said no man would need to be considered infertile again.

Now, if this research is confirmed, all they will need is a very large supply of male stem cells. Might we see the George Clooney stem cell line (assuming he were to consent to it)? I can see no objection. It is no more wrong to choose the genes of your child than your reproductive partner. Indeed, we have always sought to do both, choosing our partners on the basis of our -- sometimes erroneous -- belief about the sort of children likely to result. I see nothing wrong with people exercising that choice using the technology as it becomes available.

If it is not wrong to wish for a bouncing brown-eyed baby girl, why would it become wrong once we had the technology to play Fairy Godmother to ourselves and grant our own wish?

Not all ethicists see it so simply.

"This area has potential powerful clinical applications mixed with people's concerns over embryo research," says Insoo Hyun, a bioethicist at Case Western Reserve University who specializes in stem-cell-related ethical issues. "All the ingredients are there for a really, really lively ethical debate."

Others simply doubt the research.

"I am unconvinced from the data presented in this paper that the cells produced by Professor Nayernia's group from embryonic stem cells can be accurately called 'spermatazoa," said Allan Pacey, a senior lecturer in andrology at the University of Sheffield.

Pacey said in a statement that the sperm created by Nayernia did not have the specific shape, movement and function of real sperm.

Azim Surani, a professor of physiology and reproduction at the University of Cambridge said the sperm produced by the Newcastle team were "a long way from being authentic sperm cells."

Too much Tamiflu

The case of a Danish woman developing a drug-resistant strain of swine flu after being given low doses of the Tamiflu vaccine is raising questions about how and when to hand out the vaccine.

On 29 June, Denmark's National Board of Health announced the first known case of H1N1 swine flu resistant to the most popular antiviral drug. The woman was in contact with an infected person and was put on low-dose Tamiflu as a precaution, but she developed flu anyway.

She has now recovered after taking the antiviral Relenza, and the drug-resistant strain appears not to have spread. The State Serum Institute in Copenhagen assumes resistance emerged during treatment with Tamiflu, as low doses can favour the emergence of resistant strains.

It appears to be an isolated case, so on one is ringing alarm bells at the moment, but the case is is causing some questioning of the standard policy to treat those close to swine flu patients as a preventive measure. Doing so, after all, could lead to the development of a more dangerous strain of the flu than the current one -- which could be disastrous. 

British Medical Journal blogger Iain Brassington, a bioethics lecturer at the Centre for Social Ethics and Policy at the Law school at Manchester, points out that this puts governments and medical officials in a bind. Do they risk making things worse down the road by treating people now, or not?

There seems to be an interesting dilemma generated: while governments presumably ought to take steps to ensure the availability of prophylaxis, this also generates a risk that they’re creating a much bigger problem further down the line. I don’t think that this is an argument against prophylaxis per se - of course governments should deal with the threat as it stands at the moment (and anything else would be a counsel of despair), and the threat of resistant H1N1may never be realised - but the point would stand that, in doing what they ought to do now, they may be making things worse in the long run. And that means that meeting the present danger isn’t nearly as morally straightforward as it would seem at first.

I'll be keeping an eye out for more drug-resistant strains.

 

 

Real journal, fake credentials

The ongoing scandal in the medical publishing world took on a new twist today with news that Chiming Wei, founder and editor of a journal on the fledgling field of nanotechnology, appears to have exaggerated his credentials -- claiming to head a program at Johns Hopkins University that doesn't exist and starting a professional society with himself as president and chairman.

Indeed, an investigation of his credentials reveals that he claimed to hold a directorship of a non-existent program, co-authored only two original papers in Nanomedicine (one of which, a co-author says, he contributed to only editorially), and was accused of mismanaging the professional society to the point that some board members resigned and began a new professional group.

"I think that this individual is a good example of a field that is poorly- or under-regulated," Summer Johnson, executive editor of The American Journal of Bioethics, told The Scientist. "Everyone trusted the fact that he appeared to have high quality credentials."

Chiming Wei, president and founder of an organization called the American Academy of Nanomedicine (AANM), has the equivalent of a PhD from a Japanese institution and is a researcher in cardiothoracic surgery, but is not currently affiliated with any university. He started the group in 2005, when he was an associate professor at Johns Hopkins University in Baltimore, MD. The AANM's website lists Wei as Director of the Cardiothoracic-Renal Nanomedicine Program at Johns Hopkins, but according to the university, there is no such program. The Johns Hopkins press office was "unable to find evidence that this program exists," a university spokesperson wrote in an email.

Wei was also accused by experts in the field of adding his name to their journal articles, without permission or contributing in a meaningful way to the articles, in order to bolster his credentials.

Wei denied the accusations.

The journal, Nanomedicine: Nanotechnology, Biology, and Medicine, was established by Elsevier four years ago at Wei's urging.

The Scientist reports that Elsevier, however, did not check Wei's credentials before installing him as editor of a peer reviewed journal.

An Elsevier spokesperson said the publisher never checked Wei's publication record in nanomedicine before giving him the job of editing a nanomedicine journal. "Based on the discussions we didn't feel a need to read through [Wei's] papers, as he was quite knowledgeable on the subject," the Elsevier spokesperson added.

Elsevier has been at the centre of a controversy in recent weeks after revelations that it published several journals that were little more than paid promotional items for pharmaceutical giant Merck & Co.

Pharma publishing wrap-up

I have been blogging about reports of publishing scandals in the pharmaceutical industry of late, and today published a story in the Toronto Star  wrapping up some of them.

From the creation of fake academic journals, to bogus stories submitted to real journals, to falsified results in some of academia's most respected publications – the pharmaceutical industry has been rocked by allegations that the world's biggest drug companies put public relations above public safety.

As consumer advocate Peter Lurie put it recently: "I've seen no shortage of creativity emanating from the marketing departments of drug companies."

The allegations have come to light thanks to lawsuits in the United States and Australia seeking compensation for drug costs that the plaintiffs claim were too high. The suits allege the drug companies skewed academic investigations into their products, thereby driving up the price they could charge.

Trudo Lemmens, an associate professor of medical law at the University of Toronto, says it should not be left to the civil courts to uncover what he calls "publishing as marketing."

"You have to ask yourself, why isn't there more regulatory control?"

Lemmens would like to see tougher conflict-of-interest rules and more oversight of how drug trials are conducted, and the results published.

Obviously more is published online in the full story, on the Star's Healthzone website.

Human eggs for sale

New York State has become the first US state to begin paying women for their eggs for use in stem cell research.

The Empire State Stem Cell Board (ESSCB), which oversees New York's $600 million stem cell research program that was launched last year, came to the decision last week (June 11) following "extensive deliberation" from its ethics committee.

"The Board agreed that it is ethical and appropriate for women donating oocytes for research purposes to be compensated in the same manner as women who donate oocytes for reproductive purposes and for such payments to be reimbursable as an allowable expense" under state taxpayer-backed grants, the ESSCB wrote in a statement.

The board noted that researchers in other states that ban financial reimbursement have mostly failed to recruit women to donate eggs for free.

Ethicists are split

"I don't think it's a good idea," Arthur Caplan, a bioethicist at the University of Pennsylvania, told The Scientist. It's "more ethically acceptable" to pay women to harvest eggs for in vitro fertilization programs because donor eggs have proven successful in assisted fertility treatments. With stem cell research, "the risk benefit ratio starts to slide," Caplan said. "It's a lot iffier a proposition and I think that makes a difference. In research you don't know what you're going to get, and the odds are that cloning for research is never going to work." ...

Ronald M. Green, a bioethicist at Dartmouth College in New Hampshire, said he's "glad to see" the ESSCB's decision. Green, who serves pro bono on the ethics advisory board of Advanced Cell Technology, a Massachusetts-based biotech company, said that it's ethical and necessary to pay women to donate eggs for stem cell research if researchers want to investigate the potential of therapeutic cloning. "It's discriminatory and sexist not to pay for eggs," Green said, noting that men can be paid for sperm. "It is paternalistic and protective to say that [women] can't make this decision."

But many critics, including Father Thomas Berg, director of the Catholic think tank Westchester Institute for Ethics & the Human Person, argue that compensation will lead to the exploitation of poor and disenfranchised women. Paying women as much as $10,000 -- the upper limit under the ESSCB's directives -- will "create an undue inducement" that will put vulnerable women at risk, he said. "It's precedent setting."

 

Merck troubles mount

Merck & Co., in the middle of $41.1 (US) billion merger talks with Schering-Plough Corp., is facing more troubles as the Food and Drug Administration in the United States demands that warnings of dangerous side effects from its top-selling asthma drug be boosted following growing evidence of problems.

AstraZeneca and Cornerstone Therapeutics are facing similar orders.

After 15 months of investigation, the Food and Drug Administration said Merck & Co. Inc., AstraZeneca and Cornerstone Therapeutics will have to raise label warnings about psychiatric problems reported by a handful of patients taking their drugs.

"Patients and healthcare professionals should be aware of the potential for neuropsychiatric events with these medications," the FDA said in a posting to its Web site.

A spokeswoman for Merck said the language already appears in Singulair's label, but will be raised to the "precautions" section. It's now listed in a section about various side effects reported by patients.

"We've been working with the FDA since Singulair came to market and every time we update the label it's in cooperation with them," said Merck spokeswoman Pamela Eisele. ...

The exact language of the labeling updates has not been released, but the FDA said it could mention a slew of psychiatric problems, including: "agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior — including suicide — and tremors."

The move comes just weeks after a former research subinvestigator at Vivra Asthma & Allergy, an asthma research and treatment centre, went public with allegations that its Singular trails were knowingly skewed and falsified.

Trials of Singular, Serevent, Foradil, Flovent, Xolair, Accolate, and Xopenex conducted at the Tucson, Ariz., facility of Vivra Asthma & Allergy were corrupted by protocol violations and outright falsifications, says Robert Davidson, M.D., a former clinical research subinvestigator (SI) at the facility. ...

Davidson charges that during aggressive recruitment schemes in the late 1990s, patients with abnormal EKGs, multiple risk factors for coronary artery disease, arrhythmias, pulmonary embolisms, rheumatic fever histories, acute illnesses, and even pituitary tumors were enrolled with impunity in trials that earned investigators as much as $10,000 per patient.

Patients were “prescreened” for asthma drug trials with medically unnecessary pulmonary function tests (PFTs) without their knowledge or consent and had medication dosages reduced in apparent efforts to qualify them for the lucrative trials.

Staff could be seen entering rooms where placebos and real drugs were mixed and unblended, invalidating entire studies sent to the FDA as data for new drug applications.

The brazen “study buddy” and “crossover” arrangements, as staff referred to them, included churning or serially enrolling patients into clinical trials despite risks to their health and early terminations, coercing unwilling patients to participate, and directly falsifying patient study diaries, say documents filed by Davidson in a federal complaint.

Merck stands by its drug.

"For the millions of people suffering from either asthma or allergic rhinitis, SINGULAIR is an important treatment option for appropriate patients," said Scott Korn, M.D., vice president, Clinical Risk Management and Safety Surveillance, Merck Research Laboratories.

Merck held a conference call with drug reps late Friday to talk about the FDA order, but according to BNET Pharma and CafePharma.com, things didn't go well.

Naturally, Merck management scheduled a conference call for drug reps who tout Singulair at 6p.m. on Friday (an hour guaranteed to please reps hoping for a stress-free weekend). Unfortunately, many reps only received the note scheduling the meeting at 7 p.m. — one hour after the call started. From CafePharma:

I found out about a 6PM teleconference after 7PM. Gotta love management.

Other reps had difficulty navigating Merck’s dial in system:

First, they give vague directions about the teleconference (you had to go on to Comm. Central to get the dial-in number). Then they start 15 min late trying to get their s$%t together. Then TC says that this is a great opportunity to show our customers how committed we are to patients. When is the last time these people were in the field? Completely out of touch. Another Monday am to dread.

Those who did dial-in on time were kept on hold, just as they had been at an earlier conference call at 8 a.m. which apparently only got started at 8.20 a.m.:

This morning the the other S teleconference scheduled for 8 AM starts after 8:20 AM. What is going on inside? Half the country is on hold listening to music. I got work to do guys. I have to move and make calls.

All this comes amid allegations that Merck used fake academic journals and suppressed negative drug trail results.

In a final note, the American Journal of Bioethics blog, blog.bioethics.net, has congratulated this blog on its coverage of Merck and other drug companies of late.

I couldn't be more pleased that [insert gratuitous but sincere praise:] outstanding Toronto Star writer Stuart Laidlaw has been rigorously following the Merck/Elsevier scandal. It's practically flattering that he's listening to bioethics' and in particular bioethics' publishing voices, and he's quoted The American Journal of Bioethics Editor's Blog [that'd be the fancy-pants name for blog.bioethics.net] on his own Toronto Star Medical Ethics blog. However...the old adage that "the enemy of my enemy is my friend" may not apply to taking on the admittedly incredible ethical missteps by Merck ... and its publishing mules, comprising a whole fleet of bogus journals made to fool academics and clinicians.

You'd think that Merck would have learned from Vioxx and their New England Journal mistake (oops, forgot to send that data...) where publishing is concerned. You'd think ANY publishing company would learn that presenting the appearance of peer review for sale, then refusing to be transparent about just how much it COSTS to buy a peer reviewed journal. But you'd be wrong.

The thing is ... Stuart ... these guys are not, well, did you see the movie The Insider? [note to pharma lawyers and publishers of all kinds: I live on a small island in the Pacific...really...]

Summer Johnson, PhD

Let's hope she's wrong.