HealthLawProf Blog

Oklahoma Is Sued Over Required Ultrasounds for Abortions

The New York Times reports that an advocacy group is suing over an Oklahoma law that prohibits a woman from having an abortion unless she first has an ultrasound and the doctor describes to her what the fetus looks like.  The New York Times writes,

In the lawsuit filed Thursday in Oklahoma County District Court, the Center for Reproductive Rights says that the requirement intrudes on privacy, endangers health and assaults dignity.

The law, set to go into effect on Nov. 1, would make Oklahoma the fourth state to require that ultrasounds be performed before a woman can have an abortion and that the ultrasounds be made available to the patient for viewing, according to the Guttmacher Institute, a health research organization based in Washington. The other states are Alabama, Louisiana and Mississippi.

Backers of the lawsuit say Oklahoma is the only state to require that the ultrasound screen be turned toward the woman during the procedure and that the doctor describe what is on the screen, including various dimensions of the fetus.

Elizabeth Nash, public policy associate with the Guttmacher Institute, said the Oklahoma law appeared unique in that its intent was that the woman seeking an abortion view the ultrasound images.

Lawmakers overrode Gov. Brad Henry’s veto to pass the anti-abortion legislation in April. Mr. Henry, a Democrat, said he vetoed the bill because it did not exempt victims of rape or incest from the ultrasound requirement.

State Senator Todd Lamb, a Republican, said supporters of the law hoped that it would curtail abortions in the state.

“I introduced the bill because I wanted to encourage life in society,” Mr. Lamb said. “In Oklahoma, society is on the side of life.”

Mr. Lamb said he believed the lawsuit would stand a constitutional test. He disagreed with arguments that it forces a woman to view the ultrasound. The law says women may avert their eyes during the ultrasound.

“This bill provides more information to a mother,” he said.

The lawsuit against the state was filed on behalf of Nova Health Systems, doing business as Reproductive Services in Tulsa.

One provision of the law prohibits women from collecting damages based on claims that a baby born with defects would have been better off aborted. Abortion rights activists have said they fear that the provision could allow doctors to withhold information about abnormalities in the fetus that could lead to complications after birth.

“Anti-choice activists will stop at nothing to prevent a woman from getting an abortion, but trying to manipulate a woman’s decisions about her own life and health goes beyond the pale,” said Stephanie Toti, staff lawyer in the U.S. Legal Program of the Center for Reproductive Rights and lead lawyer on the case.

“Governments should stop playing doctor and leave medical determinations to physicians and health decisions to individuals,” Ms. Toti said.

Cancer Vaccine Used by 25% of Girls 13 to 17

The New York Times reports that one in four teenage girls have received the relatively new vaccine against cervical cancer, Gardasil, according to federal health officials.  The New York Times writes,

The figures represent the government’s first substantial study of vaccination rates for the vaccine, Gardasil, which is Merck & Company’s heavily advertised three-shot series that goes after the sexually transmitted human papillomavirus, or HPV. The vaccine protects against strains of the virus that cause about 70 percent of cervical cancers.

Health officials recommend that girls get the shots when they are 11 or 12, if possible, before they become sexually active. Also, 11 is the age when children are generally due for a round of vaccinations.

The survey covered children only from 13 to 17.

Proponents of the vaccine had been hoping for much higher vaccination rates, saying the shots could significantly reduce the nearly 4,000 cervical cancer deaths that occur each year in the United States.

Patti E. Gravitt, a Johns Hopkins University associate professor of epidemiology, said many families were cautious about the safety of new vaccines.

Other aspects of the vaccine may also give some families pause. It is expensive, selling for about $375, although many health insurers now cover it. And there are questions about whether it confers lifetime immunity or if a booster shot will be needed.

“Some parents may be adopting the attitude with their daughters that, ‘Well, you’re still young; I can wait a couple more years before you’re sexually active,’ ” said Dr. Gravitt, who was not involved in the research.

Merck officials said they were pleased with the vaccination rate.

The Centers for Disease Control and Prevention based the study on household telephone surveys in late 2007. The survey results cover from when the vaccine came on the market, in mid-2006, to when the survey questions were answered.

The results are based on nearly 3,000 girls ages 13 to 17 for whom the researchers could verify vaccination information through medical records.

Law Equalizes Coverage For Mental, Physical Care

The Washington Post reports that an estimated 113 million Americans, including hundreds of thousands in the Washington region, will receive better insurance coverage for their mental health and substance abuse problems because of landmark legislation that for the first time requires mental and physical illnesses to be treated equally.  Chris L. Jenkins writes,

The law is a culmination of a decade of lobbying and negotiating among advocates for the mentally ill, the insurance industry, the business community -- including the U.S. Chamber of Commerce -- and doctors' groups. The change, which was included in the economic rescue package signed by President Bush last week, will take effect Jan. 1, 2010, for most plans. Businesses with 50 or fewer employees would be exempt.

For decades, insurance companies could offer less coverage for the treatment of depression, anxiety and bipolar disorder than of such diseases as cancer and diabetes -- so people with mental illness or substance abuse problems often had to pay for expensive treatment and medication out-of-pocket.

The new law bars companies from setting higher co-pays or deductibles for mental health and substance abuse treatment. Plans also will be prohibited from lowering benefit levels or restricting the number of outpatient therapy sessions or hospital treatment days. And if a health plan allows out-of-network visits for the treatment of physical illnesses, it will also have to offer identical out-of-network coverage for mental health care.

Advocates and experts said the change represents a fundamental shift in how the mentally ill are treated and could bring medical parity to tens of millions of people.

"This is absolutely milestone legislation for those people who have mental health and substance abuse problems," said Doug Walter, counsel for legislative and regulatory affairs at the American Psychological Association. "It ends the discrimination against people who have long needed the help."

The result, experts said, will be a significant expansion of services for the mentally ill. According to a nationwide survey this year by Harris Interactive in conjunction with the APA, 44 percent of Americans either do not have mental health coverage, or are not sure if they do.

Centreville resident Jackie Dantonio experienced the disparity two years ago when one of her children needed therapy for depression. She said that her insurance plan offered only 10 therapy visits a year and that she and her husband paid nearly $2,000 to ensure that the child got all of the visits the doctor said were needed.

"We were shocked. . . . We had no clue there were these differences," she said. The therapist initially wanted to see the child a few times a week, which quickly used up her covered visits, she said. "We were lucky we could afford to get . . . the help."

In the Washington region, the law will have the most impact on District residents because the city does not have any mental health parity laws on the books. Virginia and Maryland already require parity with some kinds of health plans. The change means that more than 480,000 District residents who have insurance will have access to equal coverage, according to Healthcare Visions, an Atlanta-based research firm. The law could affect an estimated 1.7 million people in Virginia and about 1.5 million in Maryland.

In addition, only a few mental health ailments are covered now under Virginia law; the federal legislation will require that more conditions be included.

Early in the organizing of the bill, opponents raised concerns that the law would increase premiums for all insurance holders. But the Congressional Budget Office found that the requirement would probably increase premiums by an average of about four-tenths of 1 percent.

"Millions of Americans will now be assured greater access to mental and behavioral health coverage while continuing to benefit from the innovative programs health plans have developed to promote high-quality, evidence-based care," Karen Ignagni, president of America's Health Insurance Plans, a Washington-based trade group, said in a statement.

Advocates said the law is also an important step in erasing the stigma often associated with such illnesses as post-traumatic stress disorder or anxiety-related conditions. "The bill normalizes mental illness and recognizes these are biologically based conditions, not bad parenting or being mentally weak," said Mira Signer, executive director of the Virginia chapter of the National Alliance on Mental Illness. "It puts these conditions on par with everything else."

Other supporters cited recent studies showing that employees who receive treatment for mental illness or substance abuse perform better at work. "It makes good business sense as well," said Laurel Stine, a lobbyist for the Bazelon Center for Mental Health Law.

The law has significant limitations, however. Carriers that do not offer mental health treatment in their current plans will not be forced to begin doing so. Insurers also will not be required to cover treatment for every condition listed in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), published by the American Psychiatric Association, as advocates had wanted.

And some proponents said they were concerned that the law might have unintended consequences, such as the possibility that some businesses may forgo offering mental health benefits altogether.

"Small businesses may say that they can't afford, or think they can't afford, to offer mental health coverage," said Carol Ulrich, a member of Virginia's Commission on Mental Health Law Reform. "That's the only potential downside I see."

John McCain and Barack Obama on Healthcare

The Los Angeles Times discusses the presidential candidates' health reform plans.  Susan Brink writes,

John McCain and Barack Obama's health reform plans are different both in their approaches to solving problems and their potential effects on voters. But to choose wisely, you have to do some homework. To help, we offer a guide to online resources that analyze how well the candidates' proposals might work.

John McCain would . . .

Eliminate current tax exclusion for employer-paid health insurance.

Provide refundable tax credits of $2,500 for individuals or $5,000 for families, for everyone who obtains private health insurance -- employed or not. If insurance costs less than the value of the credit, the remaining funds could be deposited in a health savings account.

Provide a variety of insurance choices, national and across state lines, that would not be dependent on a job.

Work with state governors to increase insurance pools for people uninsurable on the individual market.

Deregulate insurance markets, allowing insurers to sell across state lines. People could buy less costly, less comprehensive policies in states with fewer mandates.

Pass medical malpractice reform.

For more details, see McCain's full healthcare plan.

Barack Obama would . . .

Require employers (some small businesses would be exempt or subsidized) to either offer health insurance to employees or pay a tax that would be used to help uninsured people get insurance.

Provide subsidies for low-income Americans to help them afford coverage.

Create a new national health plan, similar to Medicare, for the uninsured and small businesses.

Require that all children have health insurance.

Regulate private insurance plans to end risk-rating based on health status -- a system that can render people like cancer survivors or diabetes patients uninsurable.

Establish a federal reinsurance program to protect businesses against the costs of workers' expensive medical episodes.

For more, details see Obama's full healthcare plan.

F.D.A. Says Cancer Test Failed to Get Its Approval

The New York Times reports that the FDA has told the Laboratory Corporation of America that it is illegally marketing OvaSure, a blood test to detect ovarian cancer.  Andrew Pollack writes,

The test, introduced in June, has raised hopes among women and their doctors because it promises to detect ovarian cancer at an early stage, when it is still treatable.

But some outside experts, including the Society of Gynecologic Oncologists, have said the test had not been proved accurate and might cause women to have unnecessary surgeries to remove their ovaries. The F.D.A. itself, in a previous letter to LabCorp, said the test “may harm the public health.”

In its new letter, which was sent Sept. 29, the F.D.A. said the test, called OvaSure, required agency approval before it could be marketed.

Typically, the agency has not regulated tests that are developed and performed by a single laboratory, as opposed to test kits that are sold to hospitals, laboratories and doctors. But the F.D.A. said that OvaSure did not qualify for this exemption because the test was developed at Yale University, not at LabCorp, and the materials for the test were not manufactured by LabCorp.

Eric Lindblom, a spokesman for LabCorp, said the company was in discussions with the F.D.A. over the next steps. He would not say whether the test would be removed from the market.

“Obviously, we are disappointed about receiving the warning letter,” Mr. Lindblom said in an e-mail message. LabCorp and Dr. Gil Mor, the lead developer of OvaSure at Yale, have said the test was accurate in studies done so far.

The F.D.A. has been under pressure to play a greater role in regulating genetic and protein-based tests now entering the market. But executives in the medical diagnostics industry say overregulation could slow innovation and make it economically infeasible to develop such tests.

An F.D.A. spokeswoman said the move against OvaSure did not represent a new policy. The agency had taken similar action a year ago against a colon cancer screening test that LabCorp was marketing because the test had not been developed by LabCorp.

The OvaSure test measures the level of six proteins in a sample of a woman’s blood and calculates a probability that the woman has ovarian cancer.

LabCorp is the nation’s second largest clinical laboratory company, after Quest Diagnostics. LabCorp shares fell nearly 2 percent to end the day at $60.63.

Financial Crisis May Increase Mental Health Woes

The Washington Post reports on the World Health Organization's warning that the global financial crisis is likely to cause increased mental health problems and even suicides as people struggle to cope with poverty and unemployment.  Stephanie Nebehay writes,

Hundreds of millions of people worldwide are already affected by mental problems such as depression and bi-polar disorders and the current market meltdown could exacerbate feelings of despair among people vulnerable to such illnesses.

The United Nations agency said the impact could be especially marked for those living in low and middle income countries where access to treatment is often limited.

"We should not be surprised or underestimate the turbulence and likely consequences of the current financial crisis. As it is we are seeing a huge gap in taking care of people in great need," WHO director general Margaret Chan told a meeting of mental health experts.

Poverty and its associated stresses including violence, social exclusion and "constant insecurity" are linked to the onset of mental disorders, she said.

"It should not come as a surprise that we continue to see more stresses, suicides and mental disorders," Chan warned.

Chan denounced the "abysmal lack of care" for some mental health patients, especially in low and middle income countries, home to three out of four sufferers. Governments must make mental health a vital part of primary health care, she said.

Benedetto Saraceno, director of WHO's mental health and substance abuse department, said mental health disorders affect one in four people at some point in their lives.

Mental and neurological disorders are often chronic and disabling, he said. Nearly 1 million people commit suicide worldwide every year, a large proportion of them young adults.

Asked about the financial crisis, Saraceno told Reuters: "Poverty can be the consequence of such events -- the debts, despair and sense of loss that may reach middle and lower classes. Even the poor can be affected by this crisis."

"There is a clear evidence that suicide is linked to financial disasters. I am not talking about the millionaire jumping out of the window but about poor people," he said.

The global crisis could be expected to affect the "stability of communities and families," according to Saraceno.

The WHO launched a program on Thursday -- the annual World Mental Health Day -- aimed at increasing funding and services for the mentally ill over the next six years.

More than 75 percent of people suffering from mental disorders in the developing world receive no treatment or care, and many are stigmatized and subject to neglect and abuse, according to the agency.

Globally, the WHO said most countries spend less than 2 percent of their national health budget on mental health.

"I am convinced that even in middle income countries reached by the economic crisis, it (the financial crisis) means less money and access to treatment," Saraceno said.

Congress Vows $100 Million to Red Cross After It Asks for Aid

The Washington Post reports that Congress will give the American Red Cross $100 million in emergency funding to replenish its disaster relief reserves, which were depleted as the charity plunged into debt to provide shelter, food and other services during a string of hurricanes this summer.  Philip Rucker writes,

In an unusual move, the Red Cross asked Congress for $150 million last month. The nonprofit organization, which operates largely on private donations, last turned to the federal government for help in responding to disasters in 2004, when it received $70 million in federal aid after four hurricanes hit Florida. Some critics say that by seeking federal assistance, it risks blurring its status as an independent charity.

Congress appropriated $100 million last week for the Red Cross, to be distributed through the Department of Homeland Security. Although Congress did not meet the full request for $150 million, Red Cross officials said they are relieved to receive any federal aid, considering both chambers have been grappling with upheaval in the financial markets.

Red Cross President Gail J. McGovern said she "crawled around on my hands and knees begging" on Capitol Hill for federal aid. She said senators and representatives thanked her in meetings for the Red Cross's response to the latest hurricanes.

"I really was stunned with how pleased Congress was with how we were performing, particularly in the post-Katrina world," McGovern said.

An unusually high number of U.S. disasters this year -- from spring tornadoes and California wildfires to Midwestern floods and Hurricanes Gustav and Ike -- has taxed charities, which have struggled in a sour economy.

The Red Cross has spent about $260 million this year responding to natural disasters, and took out loans totaling $200 million to cover costs, McGovern said.

"This has been an absolutely extraordinary year in terms of these big disasters and the challenges they bring," McGovern said.

The Red Cross launched a national campaign last month to recoup some of those costs. The campaign had raised $42 million as of yesterday, McGovern said. The charity needs about $60 million more to pay off its debt, and McGovern said she believes it will reach that goal.

Small Type and Large Loopholes in New Labeling Laws

The New York Times reports on the new labeling laws that will give retailers until March 30 to label the country of origin for different fruits and meats.  Marian Burros writes,

AFTER six years of political skirmishing, labeling laws that are supposed to tell shoppers whether their tomatoes, apples or chicken are homegrown or imported have taken effect.

The new law gives retailers until March 30 to label the country of origin for foods including fruits, vegetables, beef, lamb, chicken, goat meat, ginseng, peanuts, pecans and macadamia nuts. Until now, only seafood has been subject to the labeling rule.

Some proponents say the labels will help consumers avoid products from countries like China, where food safety has been a problem.

But an inspection of how seafood is sold in many New York stores suggests that the law contains a significant loophole that, when coupled with a lack of resources for enforcement, raises questions about how great an effect the rules have.

Any stores that sell less than $230,000 worth of fresh and frozen fruits and vegetables are not required to label imports.

That immediately eliminates all fish markets as well as butcher shops, of which there are a considerable number in New York City. It also eliminates small grocery stores.

To see how well the seafood regulation has been implemented, and to get an idea of what consumers might find next April, I visited the fish counters of 25 supermarkets, grocery stores and fish markets in New York last week.

The supermarkets were all in compliance, although some country-of-origin labels were more clear than others and several were virtually illegible.

However, three stores that should have had the labels did not: Eli’s Manhattan and Grace’s Marketplace, on the Upper East Side; and the Garden of Eden on 23rd Street.

Kristyn Zylka, director of marketing for Garden of Eden, which has four stores in the city, said the company was embarrassed that the labels were not present because it is the store’s policy to label its seafood.

Both Ross Breen, general manager of Eli’s, and Joseph Doria Jr., one of the owners of Grace’s, said they did not know about the law.

On Monday, fish was properly labeled at all three stores.

By far the most informative and most readable country-of-origin signs observed were those at Wild Edibles in Grand Central Market, even though the store is exempt from the law.

“We do it for the customers,” said Steve Schafer, the manager.

At D’Agostino on Broadway and 110th Street, the signs’ lettering was small and very difficult to read.

One reason store owners might not know their requirements for imported seafood is that the Department of Agriculture has $1 million for enforcement of country-of-origin rules nationwide.

That money was meant to cover seafood, but for now, at least, it must also cover the new commodities. Lloyd Day, administrator of the department’s Agricultural Marketing Service, estimated last week that full rule enforcement would take $9.6 million.

Stores are not required to label fish if it has been processed in any way, like marinated catfish or shrimp on a skewer.

Similarly, stores are not required to label shrimp that has been peeled and cooked.

But those who prefer American shrimp will be able to identify it in most big stores, as long as the shrimp is still in its shell and uncooked.

The stores that were visited last week were also ignoring earlier regulations governing farmed salmon and fish that has been previously frozen and thawed.

The Food and Drug Administration requires that labels for farmed salmon say “color added.” Farmed salmon, naturally grayish, turn pink when they are fed various sources of carotenoids.

Only at Whole Foods at Columbus Circle and Eli’s was the farmed salmon so labeled.

Another F.D.A. regulation requires that previously frozen fish, thawed before sale, be labeled “previously frozen.” Freezing fish twice plays havoc with its texture and doesn’t do much for its flavor.

In the stores that were visited, only some thawed shrimp carried that information. Other thawed fish had no hint that it had been frozen.

On several occasions, employees behind the counter would point out the previously frozen fish when asked.

An F.D.A. spokesman said that the agency takes labeling violations seriously. But, he said, “Since it isn’t a safety issue, a violation of this type would not be a priority.”

Food Stamp Participation Increases as Economy Lags

The Washington Post reports that latest federal statistics indicate that participation in the low-income nutrition supplement program has risen sharply, highlighting economic troubles.  Michael E. Ruane writes,

Almost a million more people participated in the federal government's food stamp program for the needy between April and July, according to the U.S. Department of Agriculture, which oversees the program.

The latest federal statistics indicate that nationally, participation in the low-income nutrition supplement program rose from 28.08 million in April to 29.05 million in July, the last month for which the figures are available, a department spokeswoman said.

The July figure is the highest since the all-time peak of 29.8 million in November 2005, in the wake of Hurricanes Katrina and Rita, spokeswoman Jean Daniel said.

She said the current national numbers probably reflect economic troubles, such as the spring flooding in the Midwest, that were at work in the early summer and spring. There often is a delay of a few months after a crisis before people sign up for the program.

"From a historical perspective, it's usually a lag time of two to three months," she said.

Experts said yesterday that the figures also reflect the broader national economic distress.

"The economic downturn is the obvious reason that most people are turning to the food stamps program at this point," said Colleen M. Heflin, an assistant professor at the Truman School of Public Affairs at the University of Missouri. "I think it's a much better barometer of the pain on Main Street than the larger economic barometers."

James P. Ziliak, a visiting fellow at the Brookings Institution and director of the Center for Poverty Research at the University of Kentucky, said low-income families are "turning to the food stamp program for assistance because they're having difficulty making ends meet" as a result of stagnant wages and rising prices for gas and other essentials.

"The food stamps program is quite sensitive to changes in the overall macroeconomy," he said.

In the Washington area, food stamp use has risen sharply over the past year.

The District had a 9.2 percent jump, from 83,000 in July 2007 to almost 91,000 in July this year.

In Maryland, participation went up 14.9 percent over the same period, from 324,000 in July 2007 to almost 373,000 this past July.

Continue reading "Food Stamp Participation Increases as Economy Lags"

Supreme Court Seeks Consultation on Food Labeling Law

The Los Angeles Times reports that the U.S. Supreme Court asked the Justice Department on Monday for advice on a bid by the nation's largest grocery chains to block customers from suing over violations of government food-labeling rules.  The Los Angeles Times writes,

Supermarkets led by Supervalu Inc., Safeway Inc. and Kroger Co. contend that only government regulators, and not customers, can enforce federal and state labeling laws. The companies are seeking to stop a suit accusing them of concealing that salmon they sold contained artificial coloring. The California Supreme Court cleared the customer suit to go forward.

In their appeal, the supermarkets said the California court ruling was "an open invitation to private plaintiffs nationwide to bring class actions."

The high court's request, directed to U.S. Solicitor Gen. Gregory Garre, signals that the justices may add the case to their 2008-09 docket.

The central question for the court in the new case is whether the Food, Drug and Cosmetic Act, which governs food labeling at the federal level, bars private efforts to enforce similar state laws.

Bailout Provides More Mental Health Coverage

The New York Times reports that more than one-third of all Americans will soon receive better insurance coverage for mental health treatments because of a new law that, for the first time, requires equal coverage of mental and physical illnesses.  Robert Pear writes,

The requirement, included in the economic bailout bill that President Bush signed on Friday, is the result of 12 years of passionate advocacy by friends and relatives of people with mental illness and addiction disorders. They described the new law as a milestone in the quest for civil rights, an effort to end insurance discrimination and to reduce the stigma of mental illness.

Most employers and group health plans provide less coverage for mental health care than for the treatment of physical conditions like cancer, heart disease or broken bones. They will need to adjust their benefits to comply with the new law, which requires equivalence, or parity, in the coverage.

For decades, insurers have set higher co-payments and deductibles and stricter limits on treatment for addiction and mental illnesses.

By wiping away such restrictions, doctors said, the new law will make it easier for people to obtain treatment for a wide range of conditions, including depression, autism, schizophrenia, eating disorders and alcohol and drug abuse.

Frank B. McArdle, a health policy expert at Hewitt Associates, a benefits consulting firm, said the law would force sweeping changes in the workplace.

“A large majority of health plans currently have limits on hospital inpatient days and outpatient visits for mental health treatments, but not for other treatments,” Mr. McArdle said. “They will have to change their plan design.”

Federal officials said the law would improve coverage for 113 million people, including 82 million in employer-sponsored plans that are not subject to state regulation. The effective date, for most health plans, will be Jan. 1, 2010.

The Congressional Budget Office estimates that the new requirement will increase premiums by an average of about two-tenths of 1 percent. Businesses with 50 or fewer employees are exempt.

The goal of mental health parity once seemed politically unrealistic but gained widespread support for several reasons:

¶Researchers have found biological causes and effective treatments for numerous mental illnesses.

¶A number of companies now specialize in managing mental health benefits, making the costs to insurers and employers more affordable. The law allows these companies to continue managing benefits.

¶Employers have found that productivity tends to increase after workers are treated for mental illnesses and drug or alcohol dependence. Such treatments can reduce the number of lost work days.

¶The stigma of mental illness may have faded as people see members of the armed forces returning from Iraq and Afghanistan with serious mental problems.

¶Parity has proved workable when tried at the state level and in the health insurance program for federal employees, including members of Congress.

Dr. Steven E. Hyman, a former director of the National Institute of Mental Health, said it was impossible to justify insurance discrimination when an overwhelming body of scientific evidence showed that “mental illnesses represent real diseases of the brain.”

“Genetic mutations and unlucky combinations of normal genes contribute to the risk of autism and schizophrenia,” Dr. Hyman said. “There is also strong evidence that people with schizophrenia have thinning of the gray matter in parts of the brain that permit us to control our thoughts and behavior.”

The drive for mental health parity was led by Senator Pete V. Domenici, Republican of New Mexico, who has a daughter with schizophrenia, and Senator Paul Wellstone, the Minnesota Democrat who was killed in a plane crash in 2002. Mr. Wellstone had a brother with severe mental illness.

Prominent members of both parties, including Betty Ford, Rosalynn Carter and Tipper Gore, pleaded with Congress to pass the legislation.

Representatives Patrick J. Kennedy, Democrat of Rhode Island, and Jim Ramstad, Republican of Minnesota, led the fight in the House. Mr. Kennedy has been treated for depression and, by his own account, became “the public face of alcoholism and addiction” after a car crash on Capitol Hill in 2006. Mr. Ramstad traces his zeal to the day in 1981 when he woke up in a jail cell in South Dakota after an alcoholic blackout.

The Senate passed a mental health parity bill in September 2007. The House passed a different version in March of this year.

A breakthrough occurred when sponsors of the House bill agreed to drop a provision that required insurers to cover treatment for any condition listed in the Diagnostic and Statistical Manual of Mental Disorders, published by the American Psychiatric Association.

Continue reading "Bailout Provides More Mental Health Coverage"

Infertility Patients Caught in the Legal, Moral and Scientific Embryo Debate

The Los Angeles Times reports that an estimated 500,000 embryos are in cryopreservation in the US, showcasing the debate about what to do with unused embryos and the ambiguity of when life actually begins.  Shari Roan writes,

Six years of frustration and heartbreak. That's how Gina Rathan recalls her attempts to become pregnant.

Finally, she and her husband, Cheddi, conceived a daughter, now 3, through in vitro fertilization. About a year later, she became pregnant with a second child, naturally. Their family was complete.

Then, a year ago, the Fountain Valley couple received a bill reminding them that their infertility journey wasn't quite over. They owed $750 to preserve three frozen embryos they'd created but hadn't used.

"I don't see them as not being life yet," says Gina Rathan, 42, a pharmaceutical sales representative. "I thought, 'How can I discard them when I have a beautiful child from that IVF cycle?' "

Many other former infertility patients also appear to be grappling over the fate of embryos they have no plans to use: An estimated 500,000 embryos are in cryopreservation in the United States.

As with the Rathans, this unexpected conundrum often arises well after the infertility crisis has passed, triggering impassioned and highly personal debates about the science and ethics of human life. The discussion boils down to a fundamental question: What is this icy clump of cells smaller than a grain of sand?

Across the country, people with less personal stakes in the matter are asking that question as well.

Colorado voters will decide in November whether to amend the state's constitution to assert that an embryo is a person. Indiana lawmakers have proposed legislation that would allow abandoned embryos to be adopted for implantation by another couple. New Jersey legislators have moved to allow unused embryos to become wards of the state. And Georgia and West Virginia are considering legislation that would give embryos "personhood" status.

Although these proposals are sponsored in large part by abortion opponents, infertility patients nationwide -- whose feelings about abortion run the gamut -- are finding themselves ensnared in a debate about when life begins.

"They are in the middle of this ideological war, although they may not be aware they are in the middle of a war," says Renee Whitley, co-chairwoman of the national advocacy committee for Resolve, an organization supporting people with infertility. "This is the politics of embryos."

Couples with leftover frozen embryos have three choices: discard them, donate to research or donate to another couple for pregnancy. The default option is to leave the embryos in a vat of minus-310-degree liquid nitrogen, paying for the storage and deferring the decision; in some cases, their children or other relatives may someday have to decide what to do with a most peculiar inheritance.

Embryo-protection legislation could ultimately winnow those options and, say doctors and consumer advocates for the infertile, possibly limit future infertility treatments.

"This is taking a pretty private decision and placing it squarely in the public's eye," says Nanette Elster, director of the Health Law Institute at DePaul University in Chicago.

Freezing excess embryos is a common strategy for in vitro fertilization. To make embryos, a doctor injects a woman with potent hormones to produce eggs. These are then harvested in a surgical procedure. The eggs are mixed with sperm in the laboratory, and some of the developing embryos are transferred into the uterus. A single cycle with fresh embryos costs more than $15,000, often not covered by insurance.

Subsequent attempts at pregnancy are less costly if frozen embryos are on hand, and the supply of extras spares a woman another round of harsh drugs to produce eggs. About half the people who undergo in vitro fertilization end up with one or more frozen embryos.

But no one can predict how many embryos will be produced and used. And as the success of the treatment has improved over the last two decades, doctors are now transferring fewer embryos to avoid multiple births.

Meanwhile, the glut of stored embryos grows and more families find themselves in a position some liken to playing God.

"They are wrestling with how to think of embryos. A person? Nothing? Something in between?" says Dawn Davenport, an adoption researcher who has an online radio show and a website called Creating a Family.

Infertility clinics report that they lose contact with about 15% to 25% of families with frozen embryos. According to the American Society for Reproductive Medicine's guidelines, a clinic can consider embryos abandoned and dispose of them if five years have passed without contact with the couple and if significant efforts have been made to reach the couple. But few doctors dispose of the embryos, says Dr. Richard J. Paulson, chief of reproductive endocrinology and infertility at USC's Keck School of Medicine.

"To my knowledge, no one in the United States has ever done that," he says. "We're all paranoid that a couple will show up the next day and say they want their embryos."

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EPA Makes No Rule On Chemical in Water

The Washington Post reports that the EPA has refused to set a drinking-water safety standard for perhclorate, finding that in 99% of public drinking water systems, perchlorate was not at levels of public health concern.  Juliet Eilperin writes,

The Environmental Protection Agency formally refused yesterday to set a drinking-water safety standard for perchlorate, a chemical in rocket fuel that has been linked to thyroid problems in pregnant women, newborns and young children.

With little fanfare, the agency issued a news release yesterday afternoon saying that it had "conducted extensive review of scientific data related to the health effects of exposure to perchlorate from drinking water and other sources and found that in more than 99 percent of public drinking water systems, perchlorate was not at levels of public health concern. Therefore, based on the Safe Water Drinking Act criteria, the agency determined there is not a 'meaningful opportunity for health risk reduction' through a national drinking water regulation."

Last month, The Washington Post reported that White House officials had extensively edited the EPA's perchlorate rule-making documentation to remove scientific data highlighting some of the risks associated with the chemical, which has been found in water in 35 states. The Defense Department and Pentagon contractors who face legal liability stemming from rocket fuel contamination have lobbied for six years to avoid a federal drinking-water standard for perchlorate.

In the document released yesterday, the EPA assumes that the maximum safe perchlorate contamination level is 15 times higher than what the agency suggested in 2002.

By that standard, the EPA estimates that more than 16 million Americans are exposed to the chemical at a level that is unsafe.

Congressional Democrats and environmentalists blasted the administration's decision.

"Once again on a Friday, when nobody is paying attention, the Bush administration announces a policy that will harm the American people," Sen. Barbara Boxer (D-Calif.), who chairs the Environment and Public Works Committee, said in a statement.

"The Bush EPA's failure to set a standard for perchlorate, a dangerous contaminant found in drinking water, is outrageous, and I will do everything in my power to reverse it. Perchlorate contamination endangers the health of our families, especially pregnant women and children, and to simply allow it to remain in our drinking water is immoral," Boxer said.

The EPA statement said that its regulatory determination will be open for public comment for 30 days and that once the rule is final, the agency will issue a health advisory to guide state and local officials.

Only two states -- Massachusetts and California -- set limits on the allowable amount of perchlorate in drinking water, both at levels far below what the EPA deemed permissible.

"States have the right to establish and enforce drinking water standards, and EPA encourages state-specific situations to be addressed at the local level," the agency document read.

The environmental law firm Earthjustice said it will file suit in federal court on behalf of several environmental organizations to try to overturn the decision.

"EPA's decision has industry's fingerprints all over it," said Earthjustice attorney George Torgun. "Weapons makers will benefit at the expense of millions of Americans drinking water spiked with rocket fuel."

Pentagon spokeswoman Cheryl Irwin did not comment on the ruling's substance but wrote in an e-mail: "This decision is not needed by DoD to undertake a cleanup, as we use EPA's established health risk assessment to conduct our clean-up decisions. DoD has, in fact, been cleaning up perchlorate from military facilities for ten years now."

Largest study of US children to begin in January

The Washington Post reports that the largest study of U.S. children ever performed, aiming to track 100,000 from conception to age 21, will start recruiting mothers-to-be in North Carolina and New York in January.  The Washington Post reports,

The ambitious National Children's Study aims to learn how the environment and other factors affect youngsters' health, especially development of such conditions as autism, asthma, learning disabilities, diabetes and obesity. Scientists will examine a range of factors, from the diets of pregnant women and young children to the effects of chemicals used in plastics.

Tight budgets from Congress have delayed the project, which in 2004 began selecting 105 locations where women and their children can participate.

But on Friday, the National Institutes of Health took a long-awaited step, announcing that two research centers will start signing up women for the study's pilot phase in January: The University of North Carolina, Chapel Hill, recruiting women from Duplin County, N.C., and the Mount Sinai School of Medicine, recruiting in Queens County, N.Y.

By spring, enrollment in the remainder of the pilot sites is planned, in parts of California, Pennsylvania, Utah, South Dakota and Minnesota. Nationwide enrollment for the full study is set for summer 2010.

No, scientists won't have to wait until participating babies grow up for results: Initial data on preterm births could come as early as 2012.

Friday's announcement came as the NIH expanded its list of research centers that ultimately will participate. For locations, see http://www.nationalchildrensstudy.gov.