DESIGNS ON PERFECT BABY DRIVES ASSISTIVE REPRO INDUSTRY

By Diane M. Grassi

Assistive Reproduction Technology (ART) has been an accepted medical alternative to human reproduction since the first test-tube baby, Louise Brown, was conceived in England in 1978. On the heels of the burgeoning feminist movement of the 1960’s and early 1970’s was borne a new reproductive freedom which has not slowed down since.

However, unlike other research in the medical industry and the research sciences, ART enjoys the privilege of little federal, state, or private industry oversight, with no clear public policy initiatives on the horizon. In fact, the booming In Vitro Fertilization (IVF) industry, making it possible for couples with difficulties either conceiving offspring due to a shortage of healthy egg production, or the inability to carry a baby to full term often due to age, has provided physicians with an endless cash flow.

Supplies of donor eggs guarantees fertility specialists with the commodity or product for an eager and paying clientele with demanding costs between $15,000.00 and $30,000.00 depending on which additional services are utilized in the implantation process. About 15% of insurance providers cover some fertility treatments yet fewer support embryo implantations. However, should a recipient wind up with multiple births as a direct result of multiple implantations, insurance providers wind up picking up the delivery costs.

Yet, what started out to be an alternative in enabling women to become mothers who cannot produce enough healthy eggs has arguably created ethical as well as health concerns with respect to the egg donor business. There are now egg donor brokers who supply eggs to various fertility clinics and there are fertility clinics that have adjunct egg donor programs and storage facilities, eliminating the middleman. But the process of choosing the potential egg donor candidate is one which involves specific criteria and screening in choosing the most suitable donors.

The ideal candidate is recruited through advertisement on the internet, through college newspapers at predominantly Ivy League-type institutions, or local newspapers in college towns. Such ads, which became prevalent in the 1990’s, are placed by fertility clinics or egg brokers with a stated flat fee in compensation and that usually specifies a desired SAT score and desired genetic traits.

Fertility specialists specifically look for women between ages 18-30 who must be earning an undergraduate degree or graduate degree, who are of a certain height and body type and who most likely could use the money. Fees are paid to such women for their time invested in the procedures including medical and psychological testing and time away from school due to appointments and necessary rest. Women are not directly paid for the sale of eggs or human tissue.

The number of paid donors each year is not known but there are approximately 10,000 babies born each year in the United States from donor eggs. Donors receive an average $5,000.00 - $10,000.00 fee per cycle although some receive much more based upon specific desired genetic traits and the recipient’s ability to pay, who is directly responsible for paying the donor. But the questions remain as to whether this process is exploitative to the donors, discriminates against other donors, or is an unhealthy risk to the donor where there is no restriction on the number of times she may donate. Most clinicians restrict donors to a maximum of six times although some have donated more than that.

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The donor must go through three weeks of fertility hormone injections and observation in order to create ovarian hyper-stimulation syndrome (OHSS) resulting in a desired over-abundance of eggs producing as many as 10-15 per cycle. This creates many samples from which the physicians may choose for the recipient. Although up to six embryos may eventually be implanted in the recipient the rest are put into frozen storage in liquid nitrogen either for future implantations, donated to other recipients, donated to science, donated specifically for stem-cell research, stored indefinitely or destroyed. Eventually, many will however be destroyed as the costs to store embryos is $3,000.00 – $10,000 each year paid for by the recipient. Presently, there are approximately 500,000 frozen embryos in the U.S.

There is not enough confirmed data on whether egg donors are at heightened risk for potential disease but there is concern of ovarian cancer due to the amount of fertility drugs given donors. And there is concern for the health of donors themselves unable to carry a baby to term should the retrieval procedure go awry. Donors also may suffer hormonal imbalances due to ongoing hyper-stimulation of egg production, especially for those donating multiple times as a result of fertility injections.
There is no direct federal oversight of egg donor programs. However, the Centers for Disease Control and Prevention presides over the screening for disease and genetic testing for diseases and the Federal Drug Administration has jurisdiction over the various fertility drugs used by fertility physicians.

There remains little recourse for those donors who run into complications from such procedures thereafter as donor programs require informed consent. But many clinics are intimidating to unknowing young women many of whom are additionally forced into signing a statement waiving their right to sue the clinic for medical malpractice. However, medical expenses and pain and suffering associated with injurious complications may still be considered medical malpractice caused by negligence. There remains an upside for such clinics contracting with young women not yet quite worldly, their SAT scores notwithstanding, but who do know that they have a large loan to pay back upon completion of their studies.

Most donors must depend on paying for their own health related costs should any arise after the procedure, unless agreed upon prior to the procedure, and for those who do not have their own insurance most clinics insist they purchase it even for the short term. Once involved in such a program there is no guarantee that health information will remain confidential and may impact the donor’s ability to purchase health insurance in the future should there be complications such as infection, internal bleeding, or loss of ovaries. Life insurance could be denied as well should a genetic defect be found during the donor qualifying process.

Not all women are chosen as good candidates for egg donation, however, and go through extensive medical and psychological testing. A donor is required to work with a genetic counselor to provide any known inherited diseases, birth defects, genetic disorders, surgeries or psychiatric problems known to her and those of her family members as well. An adoptee that does not have the medical history of her biological parents is immediately disqualified as a potential donor.

And while blood tests for disease and genetic disorders seem to appear harmless enough to some, participants may regret to learn more than they are ready for about their potential health problems or those of their future children, revealed as a result of the testing. Psychological testing is performed on donors to help ensure the clinic that a donor will fulfill her obligation in the donor program and will not jeopardize her health or the recipient’s chances of becoming pregnant.

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And while there are additional genetic procedures for women taking part in IVF such as genetic testing of the embryo prior to its implantation in order to rule out certain diseases, the ability to manipulate embryos specifically for gender selection known as Pre-Implantation Genetic Diagnosis (PGD) started to become popular in the 1990’s, although it origins date back to 1981. Initially, it was available only to recipients of IVF embryo implantation but more and more couples, who are otherwise healthy enough to conceive on their own, are having embryo transplants performed with their own eggs and sperm. The embryo is manipulated outside of the womb in order to guarantee the specific sex of a child. Many do it for “family balancing” or to carry on a family name.

Yet ethical considerations abound with fear of reproducing children with either specific genetic factors or traits and even choosing one sex over another. A proverbial can of worms has been opened with no clear direction by government or the industry itself, which remains self-policed. As it remains a private enterprise, the fertility industry rather prefers it that way, unanswerable to lawmakers or the vast number of insurance companies which deny such coverage.

But what becomes of the participants and the children? Will only those families who can afford thousands and thousands of dollars wind up with “superior” offspring? Will preference for boys in carrying on the family heritage create an imbalanced population as in China and India, where there now is a shortage of girls? And even if IVF costs are reduced, what becomes of those families not choosing artificial means of procreating? Will their offspring who are not the brightest and the prettiest unduly suffer?

From ultrasound, to amniocentesis, to IVF, to embryo transplantation, to genetic testing to gender selection techniques there is a consistent and continuous pattern of scientific ingenuity enhanced by better and more improved technologies. And there is no indication that such momentum is slowing down. As such, speculation exists that it may become possible in the not too distant future for parents to “design” a variety of features of their potential children. But what does this say about ethical standards? How will this impact human behavior? And at what cost will society ultimately pay?

Copyright ©2006 Diane M. Grassi
Contact: dgrassi@cox.net

POST-KATRINA ROLE OF PROPERTY INSURERS THREATEN CONSUMERS NATIONWIDE

By Diane M. Grassi

“Prediction is very hard, especially when it’s about the future.” .... Yogi Berra

Given the focus on the recent one-year anniversary of Hurricane Katrina by the media and government officials and its label as the most costly catastrophic disaster in United States history, there has been little focus on the nationwide impact the property and casualty insurance industry has started to impart on homeowners and businesses in a post-Katrina world.

There has been serious discussion about reforming U.S. insurance laws in the U.S. Congress since 2004, before four hurricanes battered the Florida coast and well before the Katrina and Rita storms hit the Gulf Coast in 2005. However, the insurance industry since Katrina is now not only fighting hundreds of individual and class action lawsuits in Mississippi and Louisiana in the wind v. water debate, but also advocating change in the event of future catastrophic events.

The McCarran-Ferguson Act, enacted in 1945, delegated sole enforcement of insurance regulations to the states, where it was believed better oversight would take place rather than federal government mechanisms. However, state regulators are not law enforcement agencies and do not have the benefit of the arm of the federal government in cases which are beyond their means. Now, many state insurance commissioners, members of the Congress as well as consumer advocacy agencies believe that the whittling away of consumer protections over the years and recent staggering premium hikes, with little public disclosure, builds a case for federal insurance legislation and industry reforms.

Since 1945 the insurance industry has enjoyed an antitrust exemption and the viability of that rule has been seriously discussed and revisited by the Congress. There have been state accusations of price fixing and price gouging along with collusion in the industry leaving consumers with little information about their homeowners and business property policies, with only the civil or criminal courts left for recourse. It is argued that the antitrust exemption only fuels such a scenario.

The proposed National Insurance Act of 2006 (S.B. 5209) introduced by the Senate Banking Committee on July 11, 2006, would allow insurers to be licensed under a federal umbrella license, to choose between federal or state regulation and to do business in any state without need of state licenses. The U.S. Department of the Treasury would then have jurisdiction to regulate such national insurers. Arguments against such an arrangement cite more endless bureaucracy and red tape with fears that individual states would not be equally treated.

Alternatively, the State Modernization and Regulatory Transparency (SMART) Act introduced in 2004 addresses market conduct, licensing and antifraud data exchanges but has failed numerous times to move through the legislative process. It would leave regulation up to the states but to comply with uniform standards without federal oversight. The attempt to “modernize” the regulatory framework of the insurance industry has become synonymous with deregulation and appears that resistance on both sides of the argument makes reform more and more insurmountable along with immense struggles to provide sufficient delivery of adequate insurance for property owners.

The repeal of the McCarran-Ferguson Act has also caught the attention of the Senate Judiciary Committee which held a hearing on the issue on June 27, 2006 for the first time since 1994, precipitated by numerous complaints of less and less public disclosure of information and devices used for premium calculations. Such has impeded consumers from making a proper decision when purchasing policies. Travis Plunkett of the Consumer Federation of America (CFA) testified that “Insurers want competition alone to determine rates, they say. How about a repeal of the McCarran-Ferguson Act to test their desire to compete under the same rules as normal American businesses?”

The CFA has also called for regulation to ensure consumers have availability of enough information in order to compare pricing of policies between insurers in order to make informed decisions. Unlike the way most consumer service products are purchased, insurance costs are based upon a non-finite uncertain condition to happen some time in the future. And consumers must rely solely upon the agent, especially when actuarial tables and insurance models are non-accessible. Thus, more scrutiny not less has been called for.

But deregulation has also brought about insurance products sold worldwide as investments and annuities and reinsurance companies which provide catastrophic coverage for domestic insurers primarily are located overseas. Therefore, in a global economy, federal oversight is far more necessary than in the past. Leaving global oversight up to state regulators is arguably negligent given the ramifications of lack of coverage during a catastrophe.

The insurance industry itself has been campaigning for some type of legislative reform to provide for a federal catastrophic fund which would subsidize insurers in cases of terrorism and natural catastrophes. The American taxpayer and consumer have gotten their fill of that, however, where the Federal Emergency Management Agency (FEMA) has been and continues to pay out damages to the Gulf Coast states and primarily the City of New Orleans for rebuilding costs, with FEMA’s National Flood Insurance Program (NFIP) to homeowners and businesses and for FEMA housing costs for the displaced.

But an unexpected phenomenon followed the 2005 hurricane season and is primarily fueling the fires for insurance reform and that is the record high premium rate hikes on homeowners as well as commercial property policies. In addition, hundreds of thousands of policies are being dropped and non-renewed by the country’s two largest insurance companies, namely State Farm Insurance Co. and Allstate Insurance Co., from the Gulf Coast all the way up to the tip of Maine.

Even more unexpected, however, were renewal denials for inland properties for policyholders in the Northeast including New York City, where property owners have never even previously filed a claim for property damage. With premiums on the Gulf Coast having at least doubled since 2005, thousands of dollars have been added to mortgage loans. In some cases, many homeowners policies were not renewed at all, preventing homeowners from obtaining mortgages or rebuilding at all.

With insurers’ withdrawal from writing homeowners policies throughout regions of the U.S. and gutting those with less and less coverage for those in place, the industry believes it will be able to stay healthy. Astonishingly, in 2005 it made a record profit of $45 billion post-Katrina and after four storms in 2004 it realized a profit of $38 billion.

The models associated with risk management amongst insurers are also changing. The 100-year average of history for forecasting future hurricanes, for example, is presently being revised. And as those methods of calculations become murkier, homeowners can hardly feel safe or comfortable when purchasing new properties. There are also several states which only allow for the issuance of property insurance based solely upon a consumer’s credit history and income which makes it far more difficult for the working class consumer to be able to purchase insurance.

Over the next year, 43% of the U.S. population which covers 18 states can expect their policies to either be dropped by their insurance carriers or have their premiums escalate between 20% and 100%. And for that reason alone it might be time to reel in an industry which not only is in business to make a profit, but also has a moral obligation to help protect communities nationwide and such becomes necessary in the face of absolute destruction.

Copyright ©2006 Diane M. Grassi
Contact: dgrassi@cox.net