Health Highlights: April 29, 2006

Former FDA Head Crawford Under Investigation FDA OKs Drug for Rare Children's Disease Pioneer in Genetics Gets Medicine's Top Prize Lawsuits Claim Illness from Stolen Body Parts UnitedHealth, Humana Leaders in Medicare Drug Plan Sign-Ups

Here are some of the latest health and medical news developments, compiled by editors of HealthDay:

Former FDA Head Crawford Under Investigation

Former U.S. Food and Drug Administration commissioner Dr. Lester M. Crawford is under criminal investigation by a federal grand jury, accused of financial improprieties and false statements to Congress, his lawyer told the New York Times Friday.

The lawyer, Barbara Van Gelder, did not elaborate further on the accusations, the Times said. She told a federal magistrate Thursday that she would instruct Crawford to invoke his Fifth Amendment rights against self-incrimination if he was ordered to answer questions regarding actions during his tenure as FDA head. Crawford did not reply to requests for comment from the Times.

Crawford resigned as FDA commission in September after serving less than three months in the post after his Senate confirmation. At the time, he said it was simply time for someone else to lead the agency.

The following month, the Department of Health and Human Services released disclosure forms showing that either Crawford or his wife, Catherine, had sold shares in companies regulated by the agency when he was deputy commissioner and acting commissioner.

The criminal investigation against Crawford was made public as part of a lawsuit over the FDA's action on the emergency contraceptive Plan B. The drug became the center of a bitter controversy during Crawford's tenure as head of the agency, after the FDA repeatedly delayed approval of over-the-counter sales of the drug.

Abortion rights activists and others claimed the agency's delay was politically driven, although Crawford insisted its actions were based on scientific and legal concerns. An advocacy group, the Center for Reproductive Rights, sued the FDA in federal court over the delays and were allowed to interview Crawford and other top FDA officials.

FDA OKs Drug for Rare Children's Disease

The U.S. Food and Drug Administration on Friday approved the first-ever treatment for a rare and deadly illness in newborns called Pompe disease, the New York Times reported.

Studies show the drug, Myozyme, successfully treats the inherited enzyme deficiency, which destroys muscles and is usually lethal before newborns reach one year of age. The drug was developed by Cambridge, Mass.-based biotech company Genzyme with help from federal government incentives aimed at developing medicines for rare, so-called orphan diseases.

Most of the 18 Pompe disease-affected infants given Myozyme in a 2003-2005 clinical trial remain alive today, although two did succumb to the disease and 7 require a ventilator to breathe.

Myozyme is extremely expensive -- about $200,000 to $300,000 per year -- but Genzyme has promised it will supply the drug free of cost to any child whose family is unable to pay for it via insurance or other means.


Pioneer in Genetics Gets Medicine's Top Prize

An 84-year-old biologist who was among the first to suggest that genetics, not just environment, plays a key role in animal and human behavior was awarded the United States' richest prize for medicine and biomedical research, the Associated Press reported on Friday.

Seymour Benzer, now of the California Institute of Technology, received the prestigious $500,000 Albany Medical Center Prize for work that began decades ago and laid the foundation for much of modern genetics research, including the Human Genome Project.

Benzer has said his interest in genetics and behavior began when he noticed that his second child behaved radically different than his first, soon after her birth. His subsequent work in flies revealed that the substitution of a single gene could bring about major changes in their behaviors.

Benzer told the AP that his work's impact lies in "opening up the whole idea that behavior can be dissected by manipulation, studying the genes."

Among medical awards, the Albany Medical Center Prize is second only to the $1.4 million Nobel Prize for Medicine in cash value.


Lawsuits Claim Illness from Stolen Body Parts

U.S. patients who unknowingly received tissues obtained from a company accused of illegally harvesting body parts are launching lawsuits claiming they contracted hepatitis C, HIV or syphilis from the transplants, the Associated Press reported Saturday.

"It pretty much turned my life upside down," one patient, Ned Jackson, 49, of Omaha, Neb., told the Associated Press. Jackson claims he contracted hepatitis B and C from lower back surgery involving the transplanted tissues.

The lawsuits are the latest chapter in a ghoulish saga involving now-closed Biomedical Tissue Services (BTS), a New Jersey company which is accused of failing to gain proper consent to take various tissues from cadavers. The tissues were then sent to hospitals where they were used in routine procedures involving an estimated 8,000 patients.

BTS' owners and three others accused in the case have pleaded not guilty to the charges laid against them.

According to the AP, so far about two dozen legal actions, most of them class-action lawsuits representing hundreds of tissue recipients, have been filed across the U.S.

The U.S. Food and Drug Administration assert that the chance of any patient contracting a serious infection from the BTS tissues remains very low. But lawyers representing patients say that's not necessarily so.

"There has never been a widespread dissemination of recalled tissues. What's happened here presents a whole new scenario," Larry R. Cohan, a Philadelphia lawyer representing about 130 plaintiffs, told the AP.


UnitedHealth, Humana Leaders in Medicare Drug Plan Sign-Ups

Two companies -- UnitedHealth Group and Humana -- are the frontrunners among insurers enrolling people for the new U.S. Medicare drug benefit.

About 90 companies are administering more than 3,000 plans, but a handful of companies are pulling in the bulk of enrollees, according to the Centers for Medicare and Medicaid Services.

The leader is UnitedHealth, which has a joint marketing relationship with AARP. The company has enlisted 3.8 million people, which represents 27 percent of the enrollment so far in stand-alone drug plans, the Associated Press reported.

UnitedHealth is also first in Medicare Advantage offerings, with 20 percent (1.2 million enrollees) of the market share.

Humana is second in the market in stand-alone drug plans, with about 2. 4 million beneficiaries (18 percent). The company ranks third in terms of Medicare Advantage offerings, with about 800,000 enrollees (13 percent), the AP reported.

Companies with the largest number of people enrolled at an early stage will have a major marketing advantage later on, noted Dan Mendelson, president of the consulting firm Avalere Health.


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