Showing posts with label compensation. Show all posts
Showing posts with label compensation. Show all posts

Wednesday, August 02, 2017

The Smell of Money and Gene Editing of Human Embryos -- Not to Mention the Breakthrough Science

"Horror to be avoided," "superbabies" and "what it means to be human" -- Just some of the language that turned up today concerning the news about the first human embryo editing experiment in the United States. 

Publications ranging from Wired to the Financial Times all had pieces discussing the work led by Shoukhrat Mitalipov of the University of Oregon in collaboration with researchers from California's Salk Institute, China and Korea. A search on Google news this afternoon turned up more than 1,000 citations dealing with the work.

Details of the science can be found in the journal Nature with a critique by UC Davis stem cell scientist Paul Knoepfler on his blog. He praised the research and said it "raises the stakes on future CRISPR use in humans." Elsewhere, the implications of the work also generated both heat and caution.

 The headline on a commentary in the Chicago Tribune said,
"Don't fear the rise of super babies. Worry about who will own genetic engineering technology."
The piece was written by bioethicist Arthur Caplan. He said,
"Freaking out over impending super babies and mutant humans with the powers of comic book characters is not what is needed....How close are they to making freakish super people using their technology? About as close as we are to traveling intergalactically using current rocket technology."
Caplan continued,
"We need to determine who should own the techniques for genetic engineering. Important patent fights are underway among the technology's inventors. That means people smell lots of money. And that means it is time to talk about who gets to own what and charge what, lest we reinvent the world of the $250,000 drug in this area of medicine."
Pam Belluck of the New York Times reported that the findings are "sure to renew ethical concerns that some might try to design babies with certain traits, like greater intelligence or athleticism."

She interviewed Hank Greely, director of Stanford's Center for Law and Biosciences
"'If you’re in one camp, it’s a horror to be avoided, and if you’re in the other camp, it’s desirable,' Dr. Greely said. 'That’s going to continue to be the fight, whether it’s a feature or a bug.'
"For now, the fight is theoretical. Congress has barred the Food and Drug Administration from considering clinical trials involving germline engineering. And the National Institutes of Health is prohibited from funding gene-editing research in human embryos."
Marcy Darnovsky, executive director of the Center for Genetics and Science in Berkeley, said in a news release,
"We have not yet engaged in processes that would promote the`broad societal consensus’ about human germline modification that the National Academies of Sciences and other prominent advocates of gene editing have recommended. Until that is achieved, we call on scientists around the world to refrain from research aimed at refining gene editing for use in human reproduction."
Bradley Fikes of the Union-Tribune in San Diego, a hotbed of biotech activity and the home of Salk, wrote that the study
"...brings to a head fundamental questions about what it means to be human, and whether changing the human genome would also change the human identity. And scientists — including those involved in the study — say it’s time for the public to speak up."
Given that this type of research is not funded by the United States government, just where the money came from is of interest. The Salk Institute had the answer. It said in a news release that the funding was provided by the "Oregon Health and Science University, the Institute for Basic Science, the G. Harold and Leila Y. Mathers Charitable Foundation, the Moxie Foundation, the Leona M. and Harry B. Helmsley Charitable Trust, and Shenzhen Municipal Government of China."

Some of the money "compensated" the women who provided the eggs, according to an article by Kelly Servick in the journal Science. Compensation, as opposed to expense reimbursement, is problematic in some areas of research. For example, it is banned in research that is funded by the $3 billion California stem cell agency.

The stem cell agency wrote about the research last week after the findings leaked out early. In February 2016, the agency convened a day-long session to examine issues involving gene editing. Last summer it issued new regulations that say that consent forms involving CIRM research must be modified to include a mention of genetic research. Added was the following phrase: "donated embryos [blastocysts], derived cells or cell products may be used in research involving genetic manipulation."

Regarding the future of the research, Mitalipov told the Financial Times that he wanted to perform regulated clinical trials at some point in the U.S. Unless something changes, he said that “unfortunately this technology will be shifted to an unregulated place."

Tuesday, June 07, 2016

The Human Egg Business: California Lawmakers Consider Paying Women for Research Eggs

If you are interested in the buying and selling of human eggs, you might want to take in a California legislative hearing tomorrow in Sacramento.

Up for action in the state Senate Health Committee is a measure that would permit paying women who provide the eggs if they do so for the purposes of research. The compensation is condemned by some because of the risk of providing the eggs, which requires heavy hormonal stimulation. But legalizing payment is sought by others as an aid to science and  as a matter of equality for women.

Currently women cannot legally be paid in California for providing eggs for research but they can be paid for providing them for fertility purposes. Compensation can range upwards of $50,000, according to an analysis by the Health Committee.

The legislation, AB2531 by Assemblywoman Autumn Burke, D-Inglewood, is sponsored by the fertility industry, which is largely unregulated.  A similar measure was vetoed in 2013 by Gov. Jerry Brown who said,
"Not everything in life is for sale nor should it be."
Burke's bill passed the Assembly April 28 on a 65-3 vote. It now requires full Senate approval before going to the governor.

Opposition to the measure includes Dorothy Roberts, a nationally recognized bioethicist who serves on the research standards group of the California stem cell agency. Also opposed is the Center for Genetics and Society in Berkeley. Marcy Darnovsky, executive director of the group, said this spring, 
"Offering large sums of money encourages women in need to gamble with their health. It’s what bioethicists call 'undue inducement.'"
She noted that the proposed law conflicts with the standards of the California stem cell agency and recommendations of the prestigious National Academy of Sciences.

According to the Senate analysis by Melanie Moreno, Assemblywoman Burke says,
"AB 2531 ensures that women are treated equally to all other research subjects - allowing them to actively evaluate their participation in research studies and be paid for their time, trouble and inconvenience when they do participate. Given that compensation is allowed in 47 other states, and there is no evidence of abuse, it’s time to reconsider our ban, just as New York did." 
For more on paying women for their eggs, see here, herehere and here.

Monday, April 18, 2016

Pay-for-Eggs Legislation Up Again in California: Fertility Industry Trying to Repeal Ban on Compensation for Human Eggs in Research

The industry that deals in human eggs is once again pushing forward with California legislation to allow it to pay women thousands of dollars to harvest their eggs for research purposes.

The measure (AB2531) by Assemblywoman Autumn Burke, D-Inglewood, is now on the Assembly floor after clearing the Assembly Health Committee on a 17-0 vote. (See the March 31 legislative analysis of the measure here.)

The bill is essentially the same as the one vetoed by Gov. Jerry Brown in 2013. It is not clear whether the current author of the measure has been successful in removing Brown’s opposition.

The legislation is sponsored by American Society for Reproductive Medicine, the dominant trade group in the largely unregulated fertility industry.

When she introduced her bill in February, Burke said in a press release,
Autumn Burke on Assembly floor
Sacramento Bee photo
"It's perfectly legal for a woman to get paid when advertising through Craigslist to provide eggs for infertile couples, but she can't get paid for a donation in medical research. It's insulting to women, and it keeps California's research institutions in the dark ages. Instead of leading the way on women's health, we're stuck behind 47 other states all because of a misguided ban that assumes women shouldn't be allowed to make their own decisions."
Burke and the industry organization have an array of groups backing the legislation, ranging from California's district nine of  the American Congress of Obstetricians and Gynecologists to California Cryobank.

The bill is opposed by the Center for Genetics and Society in Berkeley along with groups ranging from the Catholic church to "We Are Egg Donors."

Marcy Darnovsky, NBC photo
Earlier this month, Marcy Darnovsky, executive director of the Center for Genetics and Society, wrote:
"The health risks of egg harvesting are significant, but they’re woefully under-studied. A well-known and fairly common short-term problem is ovarian hyper-stimulation syndrome (OHSS), but no one is sure how many women get the serious – sometimes life-threatening – version of it. Data on long-term outcomes, including follow-up studies on reports of cancers and infertility in egg providers, are notoriously inadequate.
"It is impossible for women to give truly informed consent if adequate health and safety information can’t be provided.
"Offering large sums of money encourages women in need to gamble with their health. It’s what bioethicists call 'undue inducement.'"
California's $3 billion stem cell agency bans compensation for women who provide eggs for research that the agency finances but it does allow reimbursement of expenses. The legislation would repeal a state law banning compensation.

(Editor's note: The original version of this story said that Brown vetoed an egg compensation bill last year instead of 2013.)

Wednesday, August 14, 2013

'Butter and Eggs Money" and a Gubernatorial Veto

Nancy Scheper-Hughes, professor of medical anthropology at UC Berkeley and director of Organs Watch, is one of the opponents of the legislation that would have permitted women to sell their eggs for research. Today she filed the following comment on the “troubling mindset” item on the California Stem Cell Report.
Jerry Brown's veto of AB926 which would allow young women to be paid for multiple egg extractions for scientific research is one for the gals.  In western Ireland women secreted away their 'butter and eggs' money in anticipation of hard times. In my day every smart girl had her 'mad money' to escape a bad situation. Secret cash for young women is a great idea, but not when it turns on multiple cycles of pumping powerful hormones associated (in other contexts) with ovarian cancer into young women's bodies to produce 30 or 60 eggs a month. That's not promoting gender equity no matter what some of our best Democratic women leaders have to say. Selling sperm and selling eggs are a totally different matter. One  is pleasurable and safe, the other is a complicated and invasive procedure. We need good science and good research and  freedom of choice and action. We also need protection from false advertising. There are no evidence based, long term studies of the effects of these hormone injections on women ten or twenty years after the fact. Let's fund those needed longitudinal and cohort studies and hope for the best. In the meantime, women had best stick to 'butter and eggs' money. It doesn't pay a lot, but it's less painful and a heck of a lot safer.

Sunday, July 07, 2013

Eggs and Cash: Stem Cell Agency Considering Easing Restrictions on Stem Cell Lines Derived Using Payments

The California stem cell agency is moving to remove an absolute ban on use of stem cell lines derived from eggs from women who have been paid to provide them.

The action comes as state legislation is headed for Gov. Jerry Brown's desk that would permit payments for eggs to be used in research that is not funded by the agency. The measure (AB926) would not alter the separate ban on egg payments involving research funded by the $3 billion stem cell agency.

Under a proposal that will come before the agency's standards group July 24, CIRM's governing board could approve the use of stem cell lines derived as a result of payment to women. Board action would be based on whether stem cell lines would “advance CIRM's mission” and would follow a staff evaluation involving scientific and ethical issues.

Over recent years, stem cell researchers around the country have reported that they are not able to obtain sufficient eggs without payment. And earlier this year, paid egg providers were used in research in Oregon that cloned human stem cells, a feat that researchers have struggled with for years.

A CIRM staff report said that the Oregon research has “generated scientific interest among CIRM grantees and the desire to utilize derived SCNT lines. CIRM’s current policy prohibits the use of the (Oregon) SCNT lines because oocyte donors were financially compensated. CIRM requests the Medical and Ethical Standards Working Group (SWG) revaluate this prohibition with regard to CIRM grantees ability to utilize the resulting lines in light of recent scientific and policy developments.”

Last month, the California Stem Cell Report queried the agency concerning earlier, sketchy information onthe CIRM blog about a possible change in its compensation rules. We asked whether the agency was considering “sidestepping” the ban on compensation. Kevin McCormack, a CIRM spokesman, said, “No, not at all.” He said it would be premature to elaborate until a firm proposal was ready.

The staff proposal to be considered on July 24 said,
“Proposition 71’s 'prohibition on compensation' compels the ICOC(the agency's governing board) to adopt standards 'prohibiting compensation to research donors.' This requirement has been consistently interpreted to prohibit the use of CIRM funds to financially compensate oocyte (or other cell or tissue) donors. In 2006, this interpretation was extended to exclude from use, in CIRM-funded research, any stem cell line where research donors were financially compensated, even if the derivation was done without the use of CIRM funds. Proposition 71, however, does not compel the ICOC (the agency's governing board) to prohibit the use of stem cell lines where financial compensation is provided to the oocyte donors, provided that CIRM funds are not used to compensate the donors or derive the lines.”
The July 24 meeting will be held in San Francisco. No remote teleconference locations have been announced.  If approved, the changes would likely be considered July 25 by the full agency board.

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