Showing posts with label Treatments. Show all posts
Showing posts with label Treatments. Show all posts

Saturday, August 31, 2013

Wealth Matters: Fertility Treatments Produce Heirs Their Parents Never Knew

While this may sound bizarre, posthumously conceived children can become a quandary for the rich and the not-so-rich alike. The problem is always about money. The rich worry about who will get their assets after they are dead, while people of more meager means have turned to the courts in the hope of collecting federal benefits.

“We’re going to see a flurry of activity on this, because new technologies are ballooning,” said Sharon L. Klein, managing director at Wilmington Trust and chairwoman of the trusts, estates and surrogate’s courts committee of the New York City Bar Association.

“You read about women in their late 20s and early 30s who are saving their eggs and want to focus on their careers and haven’t met the right partner yet,” she said. The woman’s eggs could be used to produce a child even if the woman never wanted the eggs used after her death.

The law is clear on one thing: when a trust document does not address the issue, Ms. Klein said, “children born with the new technology are entitled to inherit with the same rights as a natural-born child.”

Consider the example of a sick person who, before undergoing chemotherapy that will cause sterility, donates sperm or eggs to be frozen, in hopes of having children later. The patient intends to have the children after recovery. But should the patient die without something in writing stating this intent, the surviving partner could have a claim on that genetic material and could use it to produce a child.

Other possibilities exist. A couple who has embryos left over after having children through in vitro fertilization could, instead of destroying them, donate them to a woman, essentially giving her a child they created. That could have unintended consequences. “It’s not inconceivable now that if the father and mother of that embryo were to strike it rich, the child born of that other woman could say, ‘Those are my genetic parents,’ ” said John M. Olivieri, a partner at White & Case. And if the child says that, chances are he or she would ask for a share of the genetic parents’ wealth.

“Posthumous reproduction is the perfect storm of competing interests,” said Susan M. Wolf, professor of law, medicine and public policy at the University of Minnesota School of Law. “There’s the surviving partner who wants to reproduce, the interests of the deceased while they were alive or as they memorialized them, the pre-existing kids who don’t want their interest diluted and finally the kids who are brought into the picture but who may be financially most at risk.”

Several lawsuits have already tested this issue, and many more have been settled privately, lawyers said.

In 2007, the New York County Surrogate’s Court decided in the case In re Martin B. that two posthumously conceived children could benefit from a trust created by their grandfather, Martin B., for his two sons and any grandchildren. (Real names were not used in the suit to protect the children.)

The case was brought jointly by Martin B.’s wife and the widow of their son, whose frozen sperm had been used to conceive two children three and five years after his death. They wanted to know whether the posthumously conceived children were descendants for the purpose of the trust.

The answer decided whether tens, if not hundreds, of millions of dollars from the estate of Martin B. went to those children or if all of it was divided among the surviving son and his children.

What made this case even more intriguing was that Martin B.’s wife had the ability to divide the assets in the trusts her husband set up as she saw fit. Lawyers on both sides said even if her posthumously conceived grandchildren were not considered, she could have cut her living son out of his inheritance.

This article has been revised to reflect the following correction:

Correction: August 30, 2013

An earlier version of this article included outdated information about the status of New York legislation that would set guidelines for the inheritance rights of posthumously conceived children. The state Senate did not take up the legislation in the most recent session, which ended in June; it is not awaiting Senate action in this session. 

Friday, June 21, 2013

Outside Review of Clinical Data Finds a Spinal Treatment’s Benefit Overstated

The evidence, published on Monday in a medical journal, is the first fruit of a movement aimed at helping doctors and patients make better treatment choices. Its goal is to have companies make clinical data about a drug or a medical device available to a wide range of researchers, not just a few handpicked ones.

The development is the latest step in an evolving, decade-long push by patient advocates to make the practice of medicine more transparent. As a result of that effort, companies have recently started disclosing their payments to doctors and medical journals now require researchers to reveal any financial ties to a study’s sponsor.

By getting companies to release study data, advocates say, outside experts can vet whether reports in medical journal about the tests are accurate and complete. The concern is that the reports, which doctors rely on to learn about a treatment, can be shaped not only by financial factors but also by the personal agendas of the researchers involved.

“To improve the care of patients, clinical trial data, protocols and results need to be made more widely available and shared for public benefit,” according to an editorial in Annals of Internal Medicine, which published the Medtronic-related reports.

Medtronic’s decision to release data about spinal treatment followed charges in 2011 in a medical journal that company-sponsored studies about the product had overstated its benefit and played down its risks. Other producers are weighing the impact of adverse publicity if they decide not to follow suit against the possible impact on sales if they do.

Such decisions by companies are likely to unfold slowly rather than in a rush. In October, the drug giant GlaxoSmithKline said that it would release the data from all clinical trials of a drug after one is approved or abandoned. In April, Roche, faced by growing demands, said it would soon release all data collected during studies of its popular influenza drug, Tamiflu.

The Medtronic product at issue, which was first sold in 2002, is a bioengineered bone growth protein called Infuse that is used in spinal fusion, a common procedure performed to reduce back pain. Starting about a decade ago, some studies, including those sponsored by Medtronic, reported in medical journals that Infuse produced superior patient outcomes than the traditional material used in the procedure, a bone graft, and posed little if any risk.

One 2003 report, for example, concluded that Infuse produced “statistically superior outcomes with regard to length of surgery, blood loss, hospital stay, reoperation rate, median time to return to work and fusion rates.”

Many of the Infuse reports were written by researchers who received millions of dollars over the years in consulting fees and other payments from Medtronic, including Dr. Thomas A. Zdeblick of the University of Wisconsin and Dr. J. Kenneth Burkus, a spine surgeon in Georgia. The early reports led to the widespread use of Infuse for the specific type of spinal fusion for which the Food and Drug Administration had given approval and by surgeons as an “off-label” treatment in other types of fusion procedures. By 2011, Infuse was used in about a quarter of the estimated 432,000 spinal fusions performed in this country each year, but by then it had become controversial because of its cost and growing safety complaints.

In 2008, for example, the F.D.A. warned that it had received reports of life-threatening complications when Infuse was used off-label to fuse together vertebrae in the upper, or cervical, portion of the spine.

The controversy reached a climax in 2011, when a medical publication, The Spine Journal, devoted an issue to reports that repudiated the Medtronic-sponsored research, calling it misleading and biased. The journal’s move was significant because it is published by the nation’s biggest group of spine surgeons, the North American Spine Society.