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Pap smears or Botox? Cosmetic makeovers and conflicts of interest

Posted by Marcy Darnovsky on June 30th, 2008

Women showing up for routine gynecological and medical appointments are increasingly being offered Botox, liposuction, breast augmentation, chemical peels, and other cosmetic procedures by their personal physicians. Kathryn Hinsch of the Women's Bioethics Project examines this disturbing trend in a new white paper titled "Do You Tip Your Doc for Botox?"

Why would doctors choose to muddy the integrity of their relationship to their patients by pushing cosmetic makeovers? According to the American Academy of Family Physicians, which itself offers continuing education courses on a variety of cosmetic procedures, "a family practitioner can easily bring in an additional $10,000 to $20,000 a month." As Hinsch points out,

Adding cosmetic procedures might be a ready remedy for a physician's salary boost, but the potential ethical issues it raises are alarming: conflict of interest, exploitation of patient trust, and demeaning the practice of medicine to name just a few.

Previously on Biopolitical Times:

The New Push for Eggs for Stem Cell Research in California

Posted by Jesse Reynolds on June 27th, 2008

Cloning-based stem cell research puts women's health on the line. It requires large numbers of fresh human eggs, whose extraction poses significant risks. The politicized and well-funded drive for research cloning has been balanced by a policy consensus that women should not be paid to provide eggs for research. But now, advocates and (hopeful) practitioners of cloning-based work are pushing to undo the rules (1, 2, 3, 4) that protect women’s health in this speculative line of work.

This is most evident in California, where biotech startup Stemagen recently created the first human clonal embryos [PDF] while skirting California law and national guidelines:

  • Its fertility arm paid women for eggs for reproduction, got them to agree to let some of the same batch be used for research, and claimed it didn’t pay for the eggs sent to the cloning work.
  • The medical staff treating the egg providers share the same address, supervisor, and authorship credits as the Stemagen researchers, in violation of requirements that medical personnel not have conflicts of interest with researchers, so that doctors’ duty of care toward women providing egg isn’t compromised.
  • It didn't consult an Embryonic Stem Cell Research Oversight Committee, a review body that is a critical part of the National Academies Guidelines for Embryonic Stem Cell Research.

Stemagen's executives, it turns out, are friends and colleagues of Alan Trounson, the new president of the $3 billion California stem cell research institute. He helped recruit his old friend Andrew French from their common homeland of Australia to serve as Stemagen's Chief Scientific Officer. And Trounson, French, and Stemagen CEO Samuel Wood authored a 2006 paper advocating cloning-based stem cell research. So it wasn't surprising when Trounson took his first opportunity at last month’s CIRM Standards Working Group to call for undermining California's prohibition on paying women (beyond their expenses) to provide eggs for research, even though this policy is enshrined in Proposition 71, the statewide initiative that created CIRM, the California Institute for Regenerative Medicine.

At last night’s meeting of the CIRM governing board, as reported by Susan Berke Fogel of Pro-Choice Alliance for Responsible Research, Trounson and Robert Klein, board chair, tag-teamed a renewed effort to find a tortured interpretation of Proposition 71 that would allow paying women for eggs. Klein set it up with a softball question to which he knew the answer: Is CIRM funding cloning-based work? Trounson obliged with laments about how access to eggs is “a terrible problem," and how the science is “floundering.” Klein tried to force a discussion which would have changed the policy by circumventing the role of CIRM's Standards Working Group.

But some members of the CIRM board made it clear they were uncomfortable with this Trounson-Klein proposal. Jeff Sheehy, who serves on both the governing board and the Standards Working Group, articulated the concerns about research cloning and the risks associated with collecting women’s eggs. Sheehy ended with, “Just because some scientists want to do something, doesn’t mean they should.” Sheehy and Sherry Lansing, who is on the board and co-chairs the Standards Working Group, stressed that this is an issue for the Working Group, and that there is a process already in place for examining these issues.

Concerns about risks to women’s health are bolstered by other doubts about cloning-based stem cell research.  During the current round of funding, the institute's Research Grants Working Group recommended against funding all four applications (1, 2, 3, 4) that would use human eggs, citing - among other concerns - the uncertain supply of eggs in each case. Notably, the grant application from Stemagen was raked over the coals by the Grants Working Group:

Reviewers were not supportive of this application due to significant weaknesses in the project and the lack of experience of the principal investigator on the project….

Overall, the preliminary data presented was weak and the project was poorly described. Aim 1 is an assembly of different protocols for oocyte activation and delivery of the nucleus into the oocyte, with no sound rationale other than a handful of manuscripts gathered from experience in farm animals. The applicant describes the use of chromatin transfer but there is no explanation of how this is done or reference of work done by the applicant or some of the collaborators. … The applicant proposes to use factors that favor the development of fertilized embryos, but does not take into account the work done by others that demonstrated that SCNT embryos need culture systems that resemble more those from somatic cells rather than embryo culture.

The availability and source of oocytes was also of concern. Reviewers were unclear about how many oocytes were needed, how many oocytes would be used in each aim, and how many of these oocytes would be used fresh or be supplied frozen. This information impacts the overall budget of the proposal and the statistical power of the results....

Reviewers were also concerned about whether the project was feasible as described…. In addition, the applicant appears to have no experience managing a major project. The applicant also failed to cite key publications on motor-neuron disease, perhaps reflecting lack of understanding/knowledge of the field.

Meanwhile, despite Trounson's claim that the work is "floundering," alternatives are developing - and even surpassing cloning-based stem cell research. The most promising is cell reprogramming through induced pluripotency (iPS). Given these, calls to toss aside a critical rule to protect women's health - one that Klein himself wrote into law - simply because it is interfering with the aims of a handful of researchers and biotech companies is far from warranted.

Update (August 22): It appears that the application described above may not have been from Stemagen itself, but instead from some of its scientists. My original thinking was based on the fact that the public summary of the application said that, "Members of our team have recently reported the first successful derivation of SCNT-embryos from cultured adult cells (skin) in the human." The only such report so far is the paper from Stemagen. After publishing this post, I head through the grapevine that the application was from some Stemagen researchers acting in another capacity. And today the Consumer Watchdog group released a list of all the private companies that had applied for funding, and Stemagen was not among them. 

Previously on Biopolitical Times:

New Jersey ends stem cell dreams

Posted by Jesse Reynolds on June 24th, 2008

The planned 18-story NJ Stem Cell Institute would be in New Brunswick

The long-planned Stem Cell Institute of New Jersey died quietly last week - so quietly, in fact, that some of its prominent backers were caught unaware, reports the state's largest paper. The $270 million research center had been on the drawing board for four years, and the state had been vying to be a leader in the field well before that. The end of the Institute not only is the apparent end of New Jersey's endeavor, but may also signal the final decline of embryonic stem cell research as a relevant political issue.

Back in January 2004, New Jersey became the second state to pass a law promoting human embryonic stem cell research, explicitly stating which activities were legal. Another law a few months later created the Institute - still virtual at the time - and set aside millions of dollars for grants and work towards a building. By the end of 2005, New Jersey beat California to become the first state to actually issue embryonic stem cell research grants.

Yet how to scale up the program remained unclear. Acting Governor Richard Codey floated the idea of a $400 or even $500 million bond as early as January 2005, with $200 million to go towards the institute. A public survey confirmed widespread support at the time. There were even talks of enlarging the proposal to create a "biotech corridor" with Delaware and Pennsylvania. But any bond plan would require approval by both the legislature and the voters.

While the bonds stalled, Gov. Jon Corzine, who took office in January 2006, maintained a small grants program through line items in the state budget. Last October, Corzine and other politicians even posed for photos at a groundbreaking ceremony for the new institute, despite the lack of funds. By the time the bond issue got out of the legislature and to the voters as a ballot measure in November, the climate had shifted compared with 2004: California was well in the lead, pumping out tens of millions of dollars in grants, and New York was launching a half-billion dollar program. The exaggerated promises of stem cell-based cures were being modulated, and political effectiveness of embryonic stem cell research was waning. And the state's fiscal situation was worse than ever. The bond measure - by then at $450 million - failed by a wide margin.

After the bonds' failure, the Corzine administration continued to insist the institute would go forward. Now its been revealed that the plans were apparently put on ice months ago. Apparently, no one informed Rep. Frank Pallone, whose district includes the building site, and Sen. Robert Menendez, both of whom had continued to tout the project.

Kiwis consider sex selection

Posted by Jesse Reynolds on June 20th, 2008

In many ways, New Zealand has admirable oversight of human genetic and reproductive technologies. Its Human Assisted Reproduction Technology Act of 2004 prohibits reproductive cloning and inheritable genetic modification, and genetic selection is limited to preventing inheritable disorders. An independent bioethics council offers advice, a committee proposes detailed policy, and another committee regulates the fertility industry and must approve certain controversial practices. Violating the law is a punishable crime.

The Bioethics Council, known as toi te taiao, recently solicited input and released a report on genetic selection [PDF]. It recommends allowing prospective parents to use sex selection through PGD for family balancing.

While the fertility industry appears supportive, politicians are tepid and everyone else appears opposed. The New Zealand Herald - the nation's largest paper - found little support for the proposal from the "person on the street." The director of the leading academic bioethics group, Donald Evans of Otago University's Bioethics Centre, said that approving sex selection would be

winding the social clock back in New Zealand by at least a generation and a half.... There have been huge battles fought in New Zealand for gender equality - that is, refusing to value or dis-value a life in terms merely of its gender. Huge victories have been won. [Social sex selection would be] very much against the spirit of these important changes. So I'm very puzzled that the report says there is insufficient cultural, ethical or spiritual reason to prohibit this, when certainly New Zealand has been moving absolutely in the opposite direction for a generation and a half. Maybe their inquiries didn't come up with any further evidence but they certainly chose to ignore this crucial social evidence, which is characterised by our society becoming a more just society over these past 30 or 40 years.
The spokesman for Asperger's Syndrome NZ asserted that
Any hint of the heinous practice of sex selection being permitted will inevitably pave the way to genocide against communities with conditions that are preponderant in one gender or the other. It takes a rather thoughtless breed of eugenicists to recommend this thin-end-of-the-wedge approach to introducing what will end in tragedy if the recommendation is not killed off immediately.
The editorial page of the Marlborough Express asked, "If this plan becomes acceptable practice what will be the next step? The answer is too disturbing to contemplate."

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