By admin on February 17, 2012

Parents Sue Cryogenic Center Over Child’s Cystic Fibrosis

NORTH TEXAS (CBSDFW.COM) – The Kretchmar home is filled with the hum of a breathing machine and the sounds of Mario racing around a television screen watched by 22-month old Jaxon.

“MMMMaaarrrrioooo…,” he mutters under the clear mask which covers most of his tiny face. He’s yelling, but it’s hard to understand, because his voice is so muffled and his body is shaking. The shaking is a good thing. The special vest he is wearing, while he getting his breathing treatment, helps shake the congestion loose inside his little body.

Jaxon is battling cystic fibrosis. He was diagnosed just days after he was born. The new vest, breathing treatments, up to 20-pills a day. It’s all part of fighting the pulmonary disease. The disease will only get worse.

“Nobody wants to think about outliving their child, “ says Sharine Kretchmar. Sitting next to her husband, Brian, they hold hands and explain, “There is not a day that goes by that we don’t think about it.”

In 2009, the Kretchmars turned to the New England Cryogenic Center, NECC, near Boston, when they needed help conceiving Jaxon. The sperm bank’s website talks about having a “healthy baby.” It states: “No specimens are released until it has been tested” for a list of diseases including cystic fibrosis.

“We really liked what it said, “ Sharine Kretchmar thought back.

The Kretchmars chose donor N170. The questionnaire they received described him as a dad, a criminal justice major, and a Catholic man with clean family health history. The Kretchmars bought three vials of N170. And, on April 17, 2010, Jaxon was born.

But days later, doctors diagnosed Jaxon with cystic fibrosis. “His stomach hurt so bad, he would be in so much pain,” said Brian thinking back to the surgery and days that followed right after his birth.

The Kretchmars doctor wrote a letter to NECC calling this an “unexpected outcome.” The doctor cited NECC’s website and paperwork which “shows that cystic fibrosis carrier screening is performed.”

The Kretchmars had one of the remaining vials of N170 that they had purchased tested. Lab results given to CBS 11 show the man who donated the N170 vials of sperm did carry the cystic fibrosis gene. In order for a child to develop cystic fibrosis, the gene must be carried by both parents. The Kretchmars say there was no way for Jaxon to have the disease without receiving a gene from Sharine and the donor, N170.

“My first thought was I don’t know how anyone could have sold something that wasn’t tested for that.” Brian says he is still in disbelief.

NECC updated its website. It now states: “Cystic fibrosis (please note that not all donors have been tested for the same number of CF mutations. Please call and speak with an NECC customer representative to find out the specific number of mutations tested on your donor of choice).”

The Kretchmars hired Dallas Attorney Dean Gresham , who has filed suit against NECC. Gresham learned the sperm the Kretchmars bought was not donated to NECC. Donor N170 had donated to a bank in Wyoming called Rocky Mountain Cryogenics in 1993.

“NECC purchased all 10,000 vials of Rocky Mountain inventory and brought it to Boston and put in their inventory making it the largest sperm pool in the United States at the time,” says Gresham. But, “there was a problem with a lot of it.”

CBS 11 has learned that some regulators were aware of problems with N170 and other donors long before little Jaxon was conceived.

Gresham showed us documents from the New York State Department of Health where it cited a “number of deficiencies” at NECC particularly with the sperm from the Wyoming bank. In April of 2008, the New York Department of Health inspected NECC and cited that some “donors are not appropriately screened and tested.” And, some vials of semen are “not tested” for infectious diseases including syphilis and gonorrhea. The sample vials it referenced were from the Rocky Mountain Cryogenic inventory purchased by NECC.

In response to its findings, the New York Department of Health sent NECC a letter stating that it could not “distribute” sperm received from Rocky Mountain Cryogenic to the state of New York. Gresham showed CBS 11 documents he said he obtained which show NECC, internally, marked all donor sperm acquired from Rocky Mountain Cryogenic: “DO NOT SHIP TO NY.”

Sharine Kretchar now asks, “Why was it okay for my baby to get this disease but it’s not okay for a baby in another state to get it?”

As of this month, the state of New York still has a ban on shipments into New York on Rocky Mountain sperm bought by NECC. CBS 11 has also learned that New York never reported its findings to the Food and Drug Administration. The FDA is the regulatory agency for reproductive tissue banking; however, CBS 11 has also learned that the FDA has only inspected NECC once in the last five years.

“Nobody is watching over the industry,” says Wendy Kramer. Kramer runs the Donor Sibling Registry. The website connects families with genetic ties.

”We know a lot of cases where sperm banks are selling sperm that has not been properly tested.”

Kramer says the Kretchmars are not alone because sperm banks have been allowed to self-regulate for too long. “This is a highly unregulated industry. There is no oversight. Nobody is watching and it is motivated by profit.”

“I don’t ever want another mother to sit in my shoes and go through what I’ve been through if it could have been prevented and this could have been prevented.”

Infectious disease testing is mandated by the FDA. Industry standards require genetic testing and most banks claim to test for genetic disorders but it is not a legal requirement.

The FDA inspects reproductive tissue banks but there is no set law requiring when and how often those inspections must be performed. CBS 11 repeatedly asked the FDA for answers about the Kretchmar case and the NECC/Rocky Mountain Cryogenic inventory, but a spokesperson only cited rules under which the FDA regulates reproductive tissue. The agency has refused to specifically answer all questions.

Jacalyn Fallman, a spokesperson with NECC provided a statement to CBS 11:

“The New England Cryogenic Center is proud of its 30 year history of innovation and excellence in cryogenic preservation. In this capacity, we have helped thousands of families fulfill their dream of parenthood.

When screening donors, NECC does not conduct its own genetic tests, but engages outside laboratories to conduct such testing. The sperm that was purchased from Rocky Mountain Cryobank is no longer sold by NECC and is now being used for research purposes. Our thoughts are with the Kretchmar family. We are encouraged by advances in the treatment of cystic fibrosis and are hopeful that the Kretchmars will benefit from modern treatments. While we sincerely appreciate the opportunity to comment for this story, we feel that it would be inappropriate to say anything further while the litigation is ongoing. Further, maintaining the privacy of its clients and donors is a priority for NECC.”

By admin on February 15, 2012

In December of 2011, Ryan and I made three presentations at the 14th Conference on Human Reproduction in Melbourne. Many parts of Australia have acknowledged the rights of donor offspring, and have policies in place so that offspring are able to connect with their donors and half siblings, but some still import sperm from US sperm banks that continue to use anonymous donors and have no practice in place for adequately tracking births, and updating and sharing medical information. Even the “open” donors at some US sperm banks have the option to deny contact when a child turns 18, some change their minds about contact, and some become unreachable after 18 years- there are just no guarantees here. And Australians (and those from other countries around the world that import US sperm)  who choose US donors have no way of knowing if their donor helped to produce 50 or 150 children, and if there are medical issues amongst the families or donor.

Overseas Sperm Donors – Is This What We Want Or Need?

Presentations at the 14th World Congress on Human Reproduction held recently in Melbourne were not supportive of clinics importing donor sperm from overseas sperm banks.

PRLog (Press Release) – Feb 14, 2012 –
During the 14th World Congress on Human Reproduction, Wendy Kramer of the Donor Sibling Registry in the USA (from where some of the donor sperm is imported to Australia), says that some sperm banks in the United States have treated donor families unethically, and that it is time to consider new legislation.

Ms. Kramer said, “Just as it’s happened in many other countries around the world, we need to publicly ask the questions ‘What is in the best interests of the child to be born?’ and ‘Is it fair to bring a child into the world who will have no access to knowing about one half of their genetics, medical history and ancestry?’

“These sperm banks are keeping donors anonymous and making a lot of money. But nowhere in that formula is doing what’s right for the donor families.”

Denise Donati, Director of Fertility Solutions Sunshine Coast and Bundaberg said Fertility Solutions has a strong opinion about importing donor sperm and has a clinic policy not to import from overseas. Instead, FSSC has put considerable time and money into recruiting local donors.

Donati had this to say: “At Fertility Solutions we are more focused on being able to facilitate future contact between the donor and any offspring. We do not believe that importing donor semen from overseas supports this.”

Donati said it was very clear from presentations at the recent World Congress, that donor sperm imported from overseas often did not meet the requirements as set out by the National Health and Medical Research Council (NHMRC), even if they say they do.

“Importing donor sperm is the easy option and something we thought long and hard about at Fertility Solutions” says Donati. “Once our team of nurses, scientists, doctors, and counselors had sat down and talked more about this option, it became clear that it did not fit with the clinic’s ethics on children born from donor sperm having a right to know of their biological origins when they reach the age of 18 – if not before.”

Donati said she heard Ms. Kramer present information on how “unregulated” many of the sperm banks in the USA are, despite the fact they often state otherwise. “This only confirmed my belief that Fertility Solutions was doing the right thing only recruiting and using local sperm donors,” Donati said.

Donati reports that Ms. Kramer spoke of an article in the Journal of the American Medical Association where a sperm donor who had no knowledge of an underlying heart disease had donated to a sperm bank over a 2 year period from 1990 to 1991. In 1995, he was diagnosed with a heart disease known as Hypertrophic Cardiomyopathy (HCM). The occurrence of HCM is a significant cause of sudden unexpected cardiac death in any age group. Nine of the donors twenty four children (twenty two donor kids, two with his wife) have been identified as having HCM (eight of the donor children and one of those produced with his wife). Whilst this can happen in any population, what was the most disturbing was that the authors of the paper stated that no accepted guidelines presently exist (in the USA) for the process of notification, counseling, and offspring evaluation, after a genetic disease is identified due to gamete (sperm or egg) donation (in the USA).

Ms. Kramer noted in her presentation the case of a sperm donor who reportedly has 150 children. And it seems that it doesn’t stop there with some of the donors going to other clinics to donate all over again.

“This is unacceptable” says Donati, “how can Australian clinics who are importing donor sperm be absolutely sure that the criteria set down by the NHMRC is being met. It’s not a chance that we are willing to take. The moral, ethical, and legal ramifications are significant and the impact far reaching not only to the donor, the recipients and child but also the extended families of all parties.

Donati said these reports alone should make clinics that are importing donor sperm from overseas sit up and take notice and reassess their position. “It should not be about money or ease of access but instead about looking after the welfare of all parties involved in the process, donors, recipients and offspring.

“Fertility clinics have a responsibility to all these parties and it certainly seems that there exists a seriously flawed system of donor gamete acquisition and quality surveillance in some USA sperm banks.”

By admin on February 13, 2012

From a poster in the DSR’s Yahoo Group:

There are frequent comments that ending donor anonymity will automatically
result in a drop in donor numbers.

The HFEA in the UK has updated its figures to include two more years showing that the numbers of UK sperm donors have gone *up* six years in a row since the ending of anonymity, thus reversing a three year decline. The 480 sperm donors in 2010 was the highest figure since they started keeping records, and more than double the figure in 2004 just before anonymity ended. The numbers of egg donors have also gone up four years in a row, and the 1258 egg donors in 2010 was the second highest figure ever.

All new donors registered:

Year Sperm donors Egg donors
1992 375 451
1993 426 528
1994 417 732
1995 414 749
1996 419 806
1997 343 910
1998 256 943
1999 302 1,120
2000 323 1,241
2001 327 1,302
2002 288 1,174
2003 257 1,032
2004 239 1,107
2005 272 1,023
2006 303 803
2007 360 1,024
2008 405 1,167
2009 438 1,202
2010 480 1,258