Showing posts with label eggs. Show all posts
Showing posts with label eggs. 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."

Friday, August 05, 2016

The Human Egg Business: More Media Coverage of California Cash-for-Eggs Legislation

A renewed legislative effort in California to pay women for handing over their eggs for research is attracting more attention this year, including opposition from a former state senator sometimes called the mother of the state's stem cell agency.

Deborah Ortiz, former chair of the California Senate Health Committee, wrote an op-ed piece published this week in The Sacramento Bee. She noted that the stem cell agency prohibits paying women for their eggs. Ortiz wrote,
"I oppose AB 2531 (the number of the bill) on a number of grounds: First, we have very limited information on the long-term health effects of the egg retrieval process. Second, women who undergo egg retrieval are not research subjects in the traditional sense, as proponents assert. Finally, paying for women’s eggs for research purposes contradicts well-established national recommendations and state policy."
She continued,
"This is not an issue of equity with other research subjects. Women providing eggs for research are not comparable to research subjects in clinical trials. Their role is providing raw materials for pre-clinical research, rather than participating as subjects in medical research. And they are not afforded the safeguards or follow-up of subjects in clinical trials.
"Finally, AB 2531 conflicts with national recommendations and with policies in our state constitution. The 2010 guidelines of the National Academy of Science recommend that no payments beyond reimbursement for expenses be made for donating eggs for research."
Ortiz has been called the mother of the California Institute for Regenerative Medicine (CIRM), as the agency is formally known, because of her early role in support of stem cell research and authorship of an initial measure to use bond funding to finance it.

The cash-for-eggs bill also drew attention from Michael Hiltzik, a Pulitzer prize-winning columnist at the Los Angeles Times. He said that the measure should not be approved. Hiltzik wrote,
"There is scant research on the long-term health risks of egg retrieval, and nothing in the bill that would encourage more. To paper over that fact, the measure’s advocates have engaged in a neat bit of obfuscation. Assemblywoman Autumn Burke (D-Marina del Rey), who is carrying the bill for the ASRM, labels it a 'pay equity' bill....
"But it’s not about equity or discrimination. What worries the bill’s critics is that the measure may allow women to be misled into taking uninformed health risks by the prospect of easy cash."
The legislation surfaced at Buzzfeed in a piece by Cora Lewis and Azeen Ghorayshi. They quoted Sean Tipton, a spokesman for the fertility industry group, American Society for Reproductive Medicine (ASRM), that is sponsor of the legislation.
“'It’s (the bill is) needed to correct a strange and outdated feature in California law.'...Women are paid when they donate eggs to make babies, and people are paid when they are research subjects, he noted. 'But if you combine the two, you can’t be compensated. I don’t think that makes any sense,' Tipton said."
Another piece appeared on the Undark web site. It was written by Diane Tober, an assistant professor at UC San Francisco. She wrote,
"As a researcher myself, I can sympathize with the seduction of discovery, and the lure of developing new technologies and treatments that stem cell research may offer society at large. The millions of dollars of funding available to support such research would also be enticing.
"But the history demonstrates that the burden of human experimentation has rested on the shoulders of the socially and economically disadvantaged. The focus of AB-2531 is to obtain eggs for research, but it ignores the need for research into the impacts of the myriad drugs and procedures used to coax and extract those eggs in the first place." 
Leading the drive against the measure, vetoed by Gov. Jerry Brown in 2013, is the Center for Genetics and Society in Berkeley. It is circulating a flyer aimed at California lawmakers that says,
"This bill incentivizes invasive procedures that expose women to substantial short-term and unknown long-term health risks."
Brown has given no indication that he has changed his position on the measure.

Friday, June 10, 2016

Delay on Action on Pay-for-Eggs Legislation in California

Legislation to allow women to be paid when they provide human eggs for research was put off in the state Senate Health Committee this week.

The proposal (AB2531) by Assemblywoman Autumn Burke, D-Inglewood, was not taken up Wednesday as scheduled. Burke asked that the hearing be postponed because two members of the committee were absent, according to Ruff Allison, a spokesperson for her office.  Often that occurs when a measure does not have sufficient support among the members of the committee who are present.

The bill is expected to be taken up in the committee next Wednesday.

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.

Bonilla: Veto of Pay-for-Eggs Bill Shows Troubling Mindset

A Democratic state legislator today assailed Democratic Gov. Jerry Brown's “mindset” as “particularly troubling” in his veto of legislation that would have allowed women to sell their eggs for scientific research.

The statement came from Assemblywoman Susan Bonilla, D-Concord, in response to Brown's action on her fertility-industry sponsored bill, AB926, which would have removed a ban on compensation for women who provide eggs for research.
Susan Bonilla
Photo from California Legislature

Brown cited health risks and other issues and said in his veto message,
“Not everything in life is for sale nor should it be.”
Alex Matthews, writing on Capitol Weekly, quoted Bonilla as saying,
“It (the governor's veto) shows a glaring inconsistency...The veto statement was very overreaching in the fact that it was making very broad statements about what women should be able to do, and while it's not legislation it certainly goes to a mindset that the governor has that I find particularly troubling.”
Bonilla continued,
“Market-driven compensation of donors by donor agencies and prospective parents continues unchecked.”
In a statement on her website, Bonilla said the governor's veto “is a regressive action that denies thousands of women the prospect of medical fertility breakthroughs.” She said,
“Many women...will be denied hope and the possibility of giving birth to a child because research on their behalf has been halted in California.”
Bonilla has argued that women involved in egg-related research, such as that involving stem cells, should be compensated, just as men are for their sperm. Women who provide eggs for fertility purposes can be legally compensated up to any amount. The current market runs about $10,000 or so per egg cycle but can be much higher.

Bonilla's measure would not have affected a ban on compensation involving research funded by the $3 billion California stem cell agency. It would have taken a 70 percent vote of each house to alter that restriction, compared to a simple majority for Bonilla's bill. The super, super-majority requirement was written into state law by Proposition 71, the measure that created the stem cell agency.

Bonilla did not indicate whether she would attempt to override the governor's veto, which would require a 2/3 vote of each house.

One of the opponents of the bill, the Center for Genetics and Society in Berkeley, called the veto a “welcome development.”

Diane Tober, associate executive director of the center, said,
“It would be unconscionable to expand the commercial market in women’s eggs without obtaining significantly more information about the risks of retrieving them.” 
Here are links to other stories today on the veto of the bill: Los Angeles Times, Sacramento Bee, an additional story from late yesterday on Capitol Weekly, TheAssociated Press and National Review.

Tuesday, August 13, 2013

California Gov. Jerry Brown Vetoes Pay-for-Eggs Legislation

California Gov. Jerry Brown today vetoed a fertility industry-backed measure that would have permitted women to sell their eggs for the purposes of scientific research.

In his veto message, Brown said,
“Not everything in life is for sale nor should it be.”
The bill would have repealed a ban on compensation of women who provide their eggs for scientific purposes. The measure would not have changed existing law that allows women to be paid for their eggs for IVF purposes with fees that range up to $50,000. The bill also would not have affected the ban on compensation for eggs for research that is financed by the $3 billion California stem cell agency.

The legislation (AB926) by Assemblywoman Susan Bonilla, D-Concord, was sponsored by the American Society for Reproductive Medicine and easily swept through the Democratic-dominated legislature. Bonilla said the measure would have placed women on an equal footing with men, who are paid for their sperm contributions for research. She also said that it would help to encourage more research into fertility issues.

Some stem cell scientists have complained that not enough women are willing to donate eggs without compensation, but stem cell researchers were not publicly involved in supporting the bill.

The fertility industry group had confidently predicted that Brown, a Democrat like Bonilla, would sign the bill. The governor's action could be overridden by a 2/3 vote of each house of the Legislature. It is not clear whether Bonilla will make such an attempt.

Here is the text of Brown's veto message:
"Not everything in life is for sale nor should it be.

"This bill would legalize the payment of money in exchange for a woman submitting to invasive procedures to stimulate, extract and harvest her eggs for scientific research.

"The questions raised here are not simple; they touch matters that are both personal and philosophical.
"In medical procedures of this kind, genuinely informed consent is difficult because the long-term risks are not adequately known. Putting thousands of dollars on the table only compounds the problem.

"Six years ago the Legislature, by near unanimity, enacted the prohibition that this bill now seeks to reverse. After careful review of the materials which both supporters and opponents submitted, I do not find sufficient reason to change course.
"I am returning this bill without my signature."
You can read more about the bill and its history here, here, here and here.

Wednesday, August 07, 2013

The Henrietta Lacks Story and Eggs, Money and Motherhood

The legacy of Henrietta Lacks popped up again today in a piece in the New York Times that should resonate among stem cell researchers and within the stem cell industry.

It even has a current hook involving California legislation to permit women to sell their eggs for the purposes of scientific research – a bill that is now on the desk of Gov. Jerry Brown.

The issues in the Lacks saga involve ownership of human cells, trafficking in them and informed consent, all of which surface in one form or another in the state legislation.

But first a refresher on Henrietta Lacks. She was an African-American woman who died in 1951 of cervical cancer at the age of 31. Shortly before her death, physicians removed some of her tumor cells, and, as recounted in today's NYTimes article by Carl Zimmer,
“They later discovered that the cells could thrive in a lab, a feat no human cells had achieved before.
"Soon the cells — nicknamed HeLa cells — were being shipped from Baltimore around the world. In the 62 years since — twice as long as Ms. Lacks’s own brief life — her cells have been the subject of more than 74,000 studies, many of which have yielded profound insights into cell biology, vaccines, in vitro fertilization and cancer.”
But Lacks never consented to her cells' being studied, a situation not uncommon at the time, nor did her family know about the situation until 1973. The complete story was chronicled in 2010 in a best-selling book, “The Immortal Life of Henrietta Lacks," by Rebecca Skloot.

Zimmer noted in today's article,
“For 62 years, (Lacks') family has been left out of the decision-making about that research. Now, over the past four months, the National Institutes of Health has come to an agreement with the Lacks family to grant them control over how Henrietta Lacks’s genome is used.”
The particulars involving her genome are in Zimmer's story. But the article implicitly raises anew questions that make many scientists uncomfortable. Often they contend that the situation involving Lacks could not occur today because of higher ethical standards. Standards ARE higher today. But problems continue to arise in the scientific community, including the sale a few years ago of willed body parts at UCLA for $1.5 million to private medical companies.

Development of products based on human stem cells promises even greater rewards, with billion-dollar blockbuster therapies not out of the range of possibilities. Profit and the desire to record a stunning research triumph are powerful motivators. They can lead to short cuts and dubious practices, such as seen in the Korean stem cell scandals of 2006.

So we come to whether women who donate their eggs for stem cell research can give truly informed consent when they surrender all rights to whatever products may result from parts of their bodies, as is common on such consent agreements. Or for that matter, what about the men who give up adult cells for reprogramming to a pluripotent state? Can they really understand the likelihood of a billion dollar product being generated with the help of their contribution? On the other hand, can the donors also truly understand that they are probably more likely to be struck by lightning than have their body parts result in a medical blockbuster?

These considerations may seem insignificant to some in science. But to grasp their full implications, one only has to read a few of the nearly 200 reader comments today on Zimmer's article today. Here is a sample.

From Frank Spencer-Molloy in Connecticut:
“(T)the Lacks family was robbed. Scores of companies profited to the tune of tens of millions of dollars from products they made derived from Henrietta Lacks' cancerous cells. Maybe this will provide some impetus to a wider consideration of the rights patients are entitled to when their tissues are cloned and disseminated to other researchers and ultimately put to use in profit-making ventures.”
From Robbie in New York City:
“At the very least, this family needs to be financially compensated for the anguish of their discovery and for the time and energy they've put into pursuing their rights. In my opinion, they also deserve a portion of any commercial gain that's been made using the HeLa cells. It is only through having to give away money that the powerful learn manners.”
From Julia Himmel in New York City:
“It is absolutely true that scientists have had a blind spot when it came to the human element of the HeLa cells.”
The pay-for-eggs legislation (AB926) now before Gov. Brown requires informed consent from those who provide eggs. Opponents of the measure, however, argue that truly informed consent from some women could be actually impossible because of economic pressures felt by the women. Writing in The Sacramento Bee last month, Diane Tober and Nancy Scheper-Hughes said,
“Allowing a market in eggs for research would reach beyond the current pool to target women who may be motivated by dire need. How many low-income women might consider selling their eggs, multiple times, to feed their children or pay the rent?”
Even the fertility industry group sponsoring the legislation acknowledges that informed consent can be problematic. A 2012 news release from the American Society for Reproductive Medicine said, 
“Prospective egg donors must assimilate a great deal of information in the informed consent process, yet it remains difficult to determine the extent of their actual understanding of egg donation and its potential risks.”
The story of the treatment of Henrietta Lacks and her descendants is a poor commentary on science and medicine. Yet it resonates with the public, which is keenly sensitive to scientific and medical abuses, even in situations that did not appear to be abuses at the time.

Stem cell research already is burdened by its own particular moral and religious baggage. With commercialization of new, pluripotent stem cell therapies coming ever closer, the last thing the field needs is contemporary version of the Lacks affair. It would behoove researchers and the stem cell industry to walk with more than normal care as they manipulate products that are tied inextricably to visions of both motherhood and money.  

Friday, August 02, 2013

Pay-for-Eggs Legislation: A Comment on Risk

The author of the Forbes piece cited in the eggs legislation item today has responded to a comment filed by two persons opposed to the measure that would remove the ban in California on paying women for their eggs for scientific research.

Here is the text filed by Jon Entine, executive director of the Genetic Literacy Project.
“Diane and Nancy, I'm shocked that you are either unaware or do not acknowledge that there are studies of oocyte retrieval surgeries that show very persuasively that the potential harm from this procedure is manageable. While you refer to 'stories' of women being harmed--that's called anecdotal evidence and is the antithesis of science--you ignore the established research in this area, which makes it clear that you are reacting hysterically rather than responding to empirical evidence. I would suggest that you read the National Academies Press workshop report: Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research (http://www.nap.edu/catalog.php?record_id=11832). It cites numerous studies, including a German study that examined the outcome of approximately 380,000 oocyte retrieval surgeries during 2000-2004. For the procedures for which there was information, the rate of complications was very low: only 0.002 percent—2 in every 100,000—had complications that required surgery to correct.
“Studies have also examined the potential risks of retrieval for a woman's future fertility.
“According to one large study, the rate of infection after oocyte retrieval was about 1 in every 200 IVF cycles, and surgery is needed to treat pelvic abscesses in less than 1 in 1,000 IVF cycles. 
“About five hundred egg donations take place in Canada each year, according to the Canadian Fertility and Andrology Society.The CFAS told me that, between 2001 and 2010, only two donors in Canada, out of a total of 4,177 donations, suffered from “severe” OHSS, which usually involves hospitalization. Fourteen others had “moderate” OHSS. These numbers are collected in a database called the Canadian Assisted Reproductive Technologies Registry.
“So sure, you can find your 'stories' but they do not represent a scientific review of the available data--you are trying to legislate based on fear. That's not science; that's the dark ages, and it's exactly the tactics used by anti-abortionists (and indeed by organizations like the Center for Genetics and Society which opposes such beneficial advances as mitochondrial replacement surgery).
“Furthermore, because women have a set of two ovaries and two fallopian tubes, they can remain fertile even if one set is damaged, and there is no evidence that both might be threatened simultaneously by the side effects of retrieval surgery. 
“Today doctors have had two decades of experience with the use of hormone treatments to maximize the number of eggs that can be harvested from a woman, and they have become quite proficient in the production of oocytes. During that time they have also worked to improve the safety of the procedure and decrease the potential risks. Despite these improvements some risk will remain, because hormones have a powerful effect on the body—they could not increase egg production so dramatically if this were not true—and anything with a powerful effect on the body has the potential for harmful side effects as well. 
“Egg donations are done for a reason. There are risks and benefits. For you to exaggerate the risks based on 'stories' and ignore the evidence is unconscionable. It's exactly what anti-abortion groups do and what opponents of genetically modified foods do--you promote fear around manageable (or in the case of GMOs, negligible) risk. 
“Your call for 'further studies' is the age old technique of reactionaries trying to control other people and impose their values on other people. You know darned well, because of your fundamental ideological opposition to this procedure, no study results could ever meet your standard of acceptability. 
“You are trying to control other women's bodies, claiming you have superior knowledge and wisdom--those are pro-life talking points. Your views, and that of the organizations that you represent, are illiberal.”

Comment re Pay-for-Eggs Item and Forbes Article

One of the authors of an op-ed piece in The Sacramento Bee has filed a comment in connection with an item today on the California Stem Cell Report. The item dealt with the California pay-for-eggs bill, which was also the subject of an op-ed piece in The Sacramento Bee as well as an article yesterday on the Forbes magazine website that discussed the op-ed piece critically.

A quotation from the article was contained in this item earlier today.

Here is the text of the comment from Nancy Scheper-Hughes, a professor of anthropology at UC Berkeley and director of Organs Watch.  Diane Tober, associate executive director of the Center for Genetics and Society of Berkeley, was the other author.
“Dr. Diane Tober and Prof. Nancy Scheper-Hughes  are 'pro choice'  social scientists who are concerned about the absence of any evidence-based medicine on the long term effects of hyper-stimulation for oocyte (egg) production in young women research subjects. We are not concerned about abortion, right to life, or obstructing  needed and valuable research on stem cells. We are concerned about the safety for potential research subjects who are being actively recruited to participate in  invasive medical procedures without any medical research studies on the possible risks and consequences of egg multiplication and extraction. We are on record that we  fully support stem cell research but not at the expense of unprotected egg donors.”  

Pay-for-Eggs Legislation Now Before California Gov. Jerry Brown

California's pay-for-eggs bill is now officially on Gov. Jerry Brown's desk, awaiting his signature or veto.

The measure, AB926 by Assemblywoman Susan Bonilla, D-Concord, was sent to the governor at 4:45 p.m. PDT yesterday. On July 1, it easily won legislative approval and has been held in legislative processing since then. The governor has 12 days to act on the measure or it becomes law without his signature.

The legislation would remove the state ban on payment to women for their eggs for scientific purposes. Currently women who provide their eggs for fertility purposes can be compensated. Fees run as high as $50,000 in some cases, depending on the characteristics of the woman providing the eggs, but generally are in the $10,000 range or less. The bill does not affect the ban on the use of funds from the California stem cell agency to compensate egg providers.

Bonilla's bill is sponsored by the $5 billion-a-year fertility industry, which is backing it on motherhood and sexual equity grounds. Supporters say women should receive payment for their eggs just as men are paid for their sperm. They also argue that more eggs are needed for research into fertility problems. In the stem cell field, scientists have also said it is nearly impossible to find women who will provide eggs unless they are paid.

Opponents contend that the process of stimulating production of eggs can be risky or dangerous. They say that the longterm effects of the process have not been studied well. They also argue that it will lead to exploitation of low income and minority women to produce eggs that then can become a profitable commodity for the largely unregulated fertility industry. (For more informationon on the bill, see here, here and here.)

In one op-ed piece in The Sacramento Bee, opponents cited the late philosopher Ivan Illich, who was much admired by Jerry Brown, who considered him a friend. Illich was quoted as warning "against the processes of medical industries which 'create new needs and control their satisfaction and turn human beings and their creativity into objects.'"

The industry group says, however, that Brown is committed to signing the bill.

The measure surfaced in the news yesterday in an article on the Forbes magazine website by Jon Entine. He wrote,
“Should activist groups, working through legislators, exercise their control over women’s reproduction? Do we really 'own' our own bodies? Or does that tenet only hold when nanny groups say it’s okay?”
(One of the authors of The Sacramento Bee op-ed piece criticized in the Forbes article later filed a comment concerning their position.)

The egg legislation may have implications for regulation of stem cell research by the state Department of Public Health(again not involving the California stem cell agency). Last month the California Stem Cell Report asked Hank Greely, a Stanford law professor and chair of the state department's Human Stem Cell Research Advisory Committee, about the measure. He replied,
“Well, if (when?) AB 926 is signed, I think our committee should meet to consider what recommendations we would make to the (the department) as a result of the bill.  Those recommendations could lead, if the committee and the department agree, to a revision of the state guidelines.  As a matter of law, a statute, particularly a subsequent statute, trumps a guideline where they are in conflict, but basically I expect we'll see what the committee thinks and what the department decides.  I don't wish to guess at the results of either process.”
Another question that was not discussed publicly during the debate on the legislation deals with whether human eggs provided with compensation would be subject to state sales tax at any stage in the process. A check of the tax code, however, makes it clear that eggs are tax free. The code states that “any human body parts held in a bank for medical purposes, shall be exempt from taxation for any purpose." The definition of “bank” includes research facilities, and "medical purposes" includes research.

Wednesday, July 24, 2013

Stem Cell Lines and Paid-for Eggs: Stem Cell Agency Delays Action on Easing Restrictions

A key panel of the California stem cell agency today balked at approving a plan to ease restrictions on using stem cell lines derived from women who were paid for their eggs.

The proposal had been scheduled to be taken up tomorrow by the governing board of the $3 billion agency, but the board's standards working group delayed action.

In response to a question, Kevin McCormack, a spokesman for the agency, said in an email,
“It was felt that more discussion was needed before moving to a vote so another meeting is going to be scheduled.”
In 2006, the CIRM governing board approved regulations that banned the use of CIRM funds for stem cells lines derived using compensation. That rule would be modified under today's plan, which would permit the CIRM governing board to approve the use of such lines following a staff study evaluating scientific and ethical issues. Their use would be allowed if the lines would “advance CIRM's mission.”

The delay came after four organizations, including the Center for Genetics and Society in Berkeley, argued that the plan is vague and did not adequately address safety issues.

The four-page statement by the groups said that the plan does not appear to have met “numerous concerns” raised in 2009 in a document co-authored by the CIRM staff. Those concerns include long-term risk and ethical issues.

Under the proposal, the groups said that the agency governing board
“...will decide whether to approve a grantee’s request to use a stem cell line created with paid-for eggs on the basis of whether doing so 'will advance CIRM’s mission.' This criterion is much too vague, and doesn’t include consideration of the health or welfare of the women who undergo egg retrieval. Protecting the well-being of women providing eggs is not even mentioned (though perhaps it could be considered as an element of the fifth of five 'factors to be considered by the ICOC(the agency board),' 'whether the donation…was consistent with `best practices’ at the time of donation').”
The standards group also heard from a UCLA researcher who argued on behalf of the change. Kathrin Plath said she and her colleagues wanted to use a paid-for stem cell line from the Oregon experiment that cloned human stem cells.
(An earlier version of this item said the change under consideration would ease restrictions on "purchasing" stem cell lines. The word "purchasing" was changed to "using.")
Here is the text of the statement by the four organizations.

UCLA Researcher Calls for Easing of Restrictions on Stem Cell Lines Derived from Eggs From Paid Providers

A UCLA researcher has spoken out in support of a proposal to allow use of California stem cell agency funds to purchase stem cell lines derived from eggs provided by women who have been paid for the service.

Kathrin Plath, an associate professor, said in a letter to the agency that she and her colleagues would like to use a line from the Oregon SCNT experiment by Shoukhrat Mitalipov in which human stem cells were cloned. Currently agency funds cannot be used for that purpose as a result of regulations that are the extension of a state law that bars use of agency funds for payment for eggs.

The agency's standards group meets later today to consider changing those regulations. The proposal will then go before the full board tomorrow.

Plath, who has received $5 million from CIRM, said,
“In my lab, we are ... interested in understanding what happens to the somatically silenced X chromosome when differentiated cells are reprogrammed by SCNT. The key question is: are these SCNT-ESCs more similar to iPSCs or fertilization-derived ESCs with respect to the epigenetic state of the X chromosome. Furthermore, it has been shown in mouse reprogramming that the active X chromosome becomes deregulated during SCNT-based reprogramming, and we would like to address this problem in the human system as well.
“We believe that the comparison of the epigenetic states between fertilization-derived ESCs, SCNT-ESCs and human iPSCs is important for a better characterization of these cells and understanding of their epigenetic nature.”

Friday, July 19, 2013

Paying for Human Eggs, Ivan Illich and Jerry Brown

California's pay-for-eggs bill is stalled in a technical parliamentary process as opponents continue to wage their campaign urging Gov. Jerry Brown to veto the proposal, which swept easily through the legislature.

The latest volley against the industry-sponsored measure appeared this week as an op-ed in The Sacramento Bee. The legislation would allow women to be paid for eggs for scientific research. The op-ed piece invoked the philosopher Ivan Illich, a longtime friend of Jerry Brown and much respected by him.

The July 16 article was written by Diane Tober of the Center for Genetics and Society of Berkeley and Nancy Scheper-Hughes, a professor of medical anthropology at UC Berkeley and director of Organs Watch, a medical human rights documentation project.The piece said, 
“The late historian of science and technology, Ivan Illich, warned against the processes of medical industries which 'create new needs and control their satisfaction and turn human beings and their creativity into objects.'"
The op-ed said,
“Women's research eggs (have) become the hot new bio-product, increasing the profits of the multibillion-dollar-per-year infertility industry at the expense of women's health, safety and possibly, their future fertility. Is this the 'equity' we want for ourselves, our sisters and our daughters?”
In 2003, Brown wrote a remembrance of Illich, whom he first met in 1976. Brown said that Illich
“...bore witness to the destructive power of modern institutions that 'create needs faster than they can create satisfaction, and in the process of trying to meet the needs they generate, they consume the earth.'”
The egg compensation bill (AB926 by Assemblywoman Susan Bonilla, D-Concord) would remove a ban in California on paying women who provide their eggs for scientific research. Currently women who provide eggs for fertility purposes can be paid, sometimes as much as $50,000, depending on the characteristics of the woman providing the eggs. The bill would not alter the ban on using research funds from the California stem cell agency to pay for eggs. However, the agency next week will consider a proposal to allow use of agency funds to purchase stem cell lines derived from eggs through compensation. (For more information on the bill, see here, here and here.)

The egg bill received final legislative approval on July 1. The governor has 12 days to act on the measure once it actually reaches his desk. However, as of this morning, the legislation remained in what is known as the “engrossing and enrolling” process. It could be a routine delay but the process can also be used to manage the flow of legislation to the governor. Brown is currently on a two-week trip to Germany and Ireland and is not expected to return until near the first of August.

(An earlier version of this item incorrectly identified Nancy Scheper-Hughes as with the Center for Genetics and Society.)

Friday, July 12, 2013

Veto Campaign Launched on California Pay-For-Eggs Bill

Opponents of the California pay-for-eggs bill have kicked off a campaign to urge Gov. Jerry Brown to veto the industry-backed legislation.

The Center for Genetics and Society of Berkeley yesterday posted a pitch on its website urging readers to contact the governor's office by email, fax, phone or letter. The target is a bill that would remove the ban in California on paying women for their eggs for stem cell and other scientific research. Women can already be paid for their eggs for fertility purposes.

Diane Tober, associate executive director of the center, wrote,
“If you agree that more research on short- and long-term risks is needed before expanding the market for women’s eggs, please act quickly. Contact Governor Brown and ask him to veto AB926.”
Also making the same pitch is the Alliance for Humane Biology, another San Francisco Bay area organization.

The bill, AB926 by Assemblywoman Susan Bonilla, D-Concord, has literally been cloaked in motherhood/reproductive issues. The measure has easily swept through the legislature and is now on its way to the governor. The bill is sponsored by the AssociationFew if any stem cell or other research organizations have been heard from during hearings on the bill. (For more information, see here, here and here.)

However, stem cell scientists have complained in past years about the lack of eggs for research, declaring that women want to be paid.

The measure would not affect the ban on compensation for eggs in research funded by the $3 billion California stem cell agency. However, the agency on July 24 will consider providing exceptions for stem cell lines derived from eggs that involve compensation for women.

Wednesday, July 10, 2013

Pay-for-Eggs Legislation: Strange Bedfellows and Existential Questions

 The California pay-for-eggs bill today generated a feature article that said the legislation has “sparked an unusual lineup of partisans on both sides and resonates far beyond” the Golden State.

The piece by Alex Mathews on Capitol Weekly, a news service specializing in California government and political coverage, said,
“(C)omplicating the issue is California’s role as a national leader in stem cell research, the existential question of who or what constitutes a research subject, and finally, the fact that compensation for fertility purposes is and has been legal for years in California.”
Mathews was writing about the measure (AB926) by Assemblywoman Susan Bonilla, D-Concord, that removes a ban in California on paying women for eggs for scientific research. Currently women can be paid in California for providing eggs for IVF. The measure would not alter a ban on compensation for eggs in research financed by the $3 billion California stem cell agency. However, later this month, the agency will consider modifying its position somewhat.

The bill has passed the legislature and is on its way to Gov. Jerry Brown. The industry association sponsoring the bill expects the governor to sign it later this month although the governor, as a general rule, does not make public commitments on legislation.

Mathews' article covered the background and arguments on the bill and noted that it has received little mainstream media attention.

Lisa Ikemoto
UC Davis photo
She also quoted Lisa Ikemoto, a law professor and bioethicist at UC Davis, on the sensitive nature of the issue. Ikemoto said,
“On the fertility side, it’s politically hard to touch because it’s all around family formation. Nobody wants to restrict family formation. On the research side, when the issue of payment for eggs came up, it was connected with human embryonic stem cell research, and human embryonic stem cell research was politicized from the outset.”
Mathews also wrote about the strange bedfellows opposing the bill. She said,

“Groups that fundamentally oppose stem cell research such as the California Catholic Conference and other pro-life groups are natural opponents of the bill, but they are joined by a number of pro-choice groups who expressed concerns over the limited research on the effects of egg donation on women’s health.”

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.

California Legislation Removing Ban on Payments for Eggs for Research Heads to Governor

Legislation to allow women in California to be paid for their eggs for scientific research is on its way to Gov. Jerry Brown following final legislative approval last week.

Sponsors of the bill, a national fertility industry organization, expect the governor later this month to sign the measure, which would go into effect next year.

The measure, AB 926 by Assemblywoman Susan Bonilla, D-Concord, would repeal a ban on payments to women who provide eggs for scientific research. However, the measure would not affect the ban on payments to egg providers in research funded by the $3 billion California stem cell agency. That ban is covered by a separate legal provision. Stem cell researchers around the country have complained that they they cannot get eggs without payment.

Women in California can be paid for providing eggs for reproductive purposes. According to a legislative analysis, payments can run as high as $50,000 for women with special characteristics but average around $9,000 for each session, which can generate more than one egg.

The sponsor of the legislation is the American Society for Reproductive Medicine of Alabama, whose members represent a wide swath of the $5 billion-a-year fertility business. The measure would open new business avenues for the industry.

Bonilla argues that the measure allows women to be treated on the same footing as men who provide sperm for research and would encourage more research into reproductive health issues.

Opponents argue that the safety of the egg production procedures has not been well-established including their long-term impact. They also argue that allowing payment would lead to exploitation of poor and minority women.

The bill received its final legislative approval on July 1 when the Senate passed it on a 24-9 vote.

Monday, July 01, 2013

California Legislation, Human Egg Sales and Profits

California legislation to allow women to be paid for their eggs for scientific research is sailing toward final passage literally swaddled in motherhood and apple pie arguments. Missing from the debate is a key reason behind the bill – building profits for what some call the “baby business.”

The legislation is touted as providing equal treatment for women, permitting them to be paid for supplying eggs for stem cell and other research, much as men are paid for sperm. It also would put women who sell their eggs for research on an equal economic footing with women who sell their eggs for fertility treatments, which is currently permitted under state law. Payments to those women range from an average of $9,000 to as much as $50,000, according to a legislative analysis of the bill.

 Assemblywoman Susan Bonillla, D-Concord, author of the bill(AB926), says,
“It is time to let women, just as any other research subject, make an informed decision as to participation, and justly compensate them for doing so.”
She also says that the ban on payments has had serious impact on fertility research. In a legislative bill analysis, she says,
“It has led to a de facto prohibition on women’s reproductive research in California, adversely impacting the same women that the ban intended to protect. With few oocytes donated, fertility research and fertility preservation research has been at a standstill. This greatly affects women suffering from fertility issues and women facing cancer who would like to preserve their oocytes.”
Bonilla is carrying the measure on behalf of an industry group, the American Society for Reproductive Medicine of Alabama. The fertility or baby business, which is largely unregulated, brings in about $5 billion annually in the United States from something like 500 clinics. It has grown rapidly over the last couple of decades, but is likely heading for a soft spot.

Little public information is available on the Internet discussing the industry's economic challenges. However, demographic studies show that the size of the key market for fertility services is stagnating. A 2012 report by the federal government projects that the number of women in the 35 to 44 age group, prime consumers of fertility services, is likely to grow only 0.5 percent from 2010 to 2020. And since that forecast was made, the Census Bureau has downgraded its projections for total population growth.

Bonilla's legislation effectively adds a new, potential revenue stream for the industry. Fertility clinics would be able to buy the eggs and then resell them to researchers, adding premiums for eggs from women with special characteristics. The bill would also add a tool for bringing down the cost of fertility treatments, which can run as much as $12,000 to $17,000 a round or more and require several rounds, according to the NIH. Clinics could discount those prices for some women, bringing in new customers, if they agree to authorize the use of excess eggs for scientific research.

None of this appears necessarily pernicious. What is pernicious is the absence of discussion of the economics of the legislation. Without a full understanding of all that is at stake, including economic issues and motivations, legislators, the governor and the public are hard-pressed to make good decisions about a significant change in California law.

Opponents of the legislation have raised serious questions about the treatment of women by fertility clinics, noting that the bill would turn egg providers into “vendors” – not patients of the clinics. The Center for Genetics and Society in Berkeley has captured the arguments in opposition including testimony before a Senate committee hearing early in June.

Jennifer Schneider, a physician who lost a 31-year-old daughter to cancer seven years after the younger woman sold her eggs three times, told lawmakers,
“Unlike infertile women who are considered patients, egg donors are treated as vendors( (her italics). When they walk out of the IVF clinic, no one keeps track of them.  My daughter’s death was not reported. The long-term risks of egg donation are unknown."
Sindy Wei, a former egg provider and now a physician with a Ph.D. in biology, testified that she wound up in an intensive care unit after 60 eggs were extracted from her in 2001. She said,
“I fear that cases like mine are buried deep by fertility centers concerned about their image. An industry thriving on profits and reputation has little incentive to report adverse events, or protect the health and medical rights of donors.”
Where is the $3 billion California stem cell agency on all this? The agency has not taken a position on the bill nor have any major research organizations. The measure does not change the law affecting agency-funded research, which bans the use of compensation for eggs in its research. Enactment of the law, however, would create a two-tier stem cell research standard in California, one for scientists not constrained by the payment ban and another for those who could use the full range of research tools. Some stem cell researchers may well think that they have become disadvantaged as a result.

(Editor's note: An earlier version of this article said the IVF business generated $4 billion in revenues annually. More recent estimates place it at $5 billion.)

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