DHMH Daily News Clippings





Wednesday, April 11, 2001
News Clipping Archive



Legislature makes some good moves on drunken driving (Annapolis Capital Editorial)
Gene Therapy Is Performed in Bid to Halt Alzheimer's (New York Times)
Herd on the Street (New York Times Commentary)
101 bills are signed into law (Baltimore Sun)
Warfield project funding provided (Baltimore Sun)
CareFirst conversion path eased (Baltimore Sun)
Campaign aims to combat prescription drug abuse (Baltimore Sun)
Health care emerges as legislature's gem (Baltimore Sun Editorial)
Distillers: Toughen Drunken Driving Standard (USA Today)
Doctors Gun-Shy on Newborns' Hepatitis Shot (USA Today)
Vote to Replace Agency Running D.C. General Expected Soon (Washington Post)
Drunken Driving Foes Ask More (Washington Post)
Lead Paint and Lawsuits (Washington Post Editorial)
The Tally From Annapolis (Washington Post Editorial)
Help for a Disabled Child (Washington Post Letter to the Editor)
Do Prescription Records Stay Private When Pharmacy Stores Are Sold? (Wall Street Journal)
Many States Study Legislation To Curb Prescription-Drug Costs (Wall Street Journal)
South Africa OKs blood substitute (Washington Times)

Legislature makes some good moves on drunken driving

Annapolis Capital Editorial

Tuesday, April 10, 2001

BY THE TIME you read this, the clock will have run out on the 2001 General Assembly session. We'll know how things turned out on key issues still in play in the session's final hours.

But before any other post-mortems, we should acknowledge things the legislature unquestionably did right.

For instance, both houses finally passed legislation reducing the state standard for drunken driving from a blood alcohol content of .10 percent to .08 percent.

The change -- repeatedly rejected in past sessions -- at long last puts Maryland into conformity with the evolving national and regional standard for drunken driving.

This shows that you can get the General Assembly to tighten drunken driving laws -- if you have the patience of Job and the persistence of Grant attacking Richmond, and if you're backed up by an attention-getting federal threat to cut off millions of dollars in highway money.

The bill passed the state Senate 45-2, with one of the votes against coming from Sen. Philip Jimeno of Brooklyn Park -- who insists on the primacy of his own anti-drunken-driving approach, which emphasizes a crackdown on repeat offenders.

The vote was nearly as lopsided in the House: 122-11. But it wasn't one of the Anne Arundel County delegation's shining moments: Four county delegates -- Robert Baldwin, Joan Cadden, Janet Greenip and James Rzepkowski -- were among the 11 House members who held out out against .08 to the bitter end.

The passage of one major drunken driving measure would have been noteworthy in most years. But this year legislators actually managed to pass a second. Overwhelming majorities in the House and Senate approved a bill that will allow prosecutors to tell judges and juries that a drunken driving defendant refused a breath test.

Although it can't be proven directly, there is a strong inference that this unusual loophole -- found in only a handful of states -- has been contributing to the growing number of people pulled over by police who refuse to take the test, in spite of the license suspension imposed for such refusals.

This bill got only one negative vote from a local legislator -- once again, Mrs. Cadden.

The votes of some local legislators aside, the passage of these two bills was one of the session's bright spots. It's true that other key drunken driving measures were killed. But any session in which the Maryland legislature passes two substantial bills cracking down on drunken driving is a good one for the state's law-abiding drivers.

Published April 10, 2001, The Capital, Annapolis, Md.

Gene Therapy Is Performed in Bid to Halt Alzheimer's

By SANDRA BLAKESLEE

New York Times

Wednesday, April 11, 2001

Six days ago, a woman in the early stages of Alzheimer's disease entered a California hospital, had a small hole drilled through her skull and was injected with millions of her own cells, in what researchers said was the first time gene therapy had been tried on an Alzheimer's patient.

The researchers who announced the experiment yesterday at a news conference held at the University of California at San Diego, where the surgery took place, said it was also the first time that doctors had tried to prevent progressive cell loss in a neurodegenerative disease.

The 60-year-old patient, who asked to remain anonymous, was discharged from the hospital last Saturday and is recovering well at home, said Dr. Mark Tuszynski, a neurologist at the university who led the research.

"We hope to learn within the next three months if the procedure is working," Dr. Tuszynski said in a telephone interview. "But this is just one patient. It may take years before we know if it works in a large number of people."

Dr. William Mobley, the chairman of the neurology department at Stanford University, who is familiar with the research, called the procedure "a very important first step" toward finding a novel way to treat Alzheimer's disease.

"The work is being done very carefully," Dr. Mobley said. "Their logic is very good."

That logic is based on 20 years of exploring the changes that accompany normal aging of the human brain and the disease processes that lead to dementias like Alzheimer's disease, Dr. Tuszynski said. Both conditions share certain biological mechanisms. For example, higher brain regions where language, memory and other cognitive functions reside are nourished by a chemical substance made in a small clump of cells, the nucleus basalis, found deep in the brain just under each frontal lobe. About the size of a human thumb nail, the nucleus basalis makes a substance, acetylcholine, which is sent to target cells all over the brain.

Acetylcholine modulates the excitability of distant neurons, increasing or decreasing their electrical activity depending on the amount of the chemical supplied by the nucleus basalis.

When a cell in a distant area gets particularly excited and needs more acetylcholine, it sends a signal, called nerve growth factor, back to the nucleus basalis telling it to make more.

In Alzheimer's disease, some still mysterious process kills cells throughout higher brain regions and the nucleus basalis does not get the nerve growth factor it needs to prod it into making more acetylcholine. Without acetylcholine, higher brain areas that control things like memory, attention, personality and the ability to navigate through space can be severely impaired.

The gene therapy experiments are designed to fix this state of affairs by putting a source of nerve growth factor back into the nucleus basalis. First, researchers took skin cells from the Alzheimer's patient and inserted the gene that makes nerve growth factor. By adding substances that promote gene expression, they turned her skin cells into tiny nerve growth factor pumps.

Then Dr. Hoi Sang U, the neurosurgeon on the team, injected two and one-half million cells that produce nerve growth factor next to the patient's right nucleus basalis. The new cells are expected to produce enough nerve growth factor to bring atrophied cells back to life.

In aged monkeys, the same procedure not only stopped cells from dying, it also revived them from their atrophied state, Dr. U said. "They got plump. And their many target cells made new connections."

Whether the therapy will restore memory loss in Alzheimer's patients is not known, Dr. Tuszynski said. The hope is that it will at least slow the disease process. The patient, a former teacher from Oregon, will be tested in coming weeks and months to see if her right hemisphere regains any function or if it maintains function compared with the untreated side of her brain.

Dr. Tuszynski said a second patient would receive genetically engineered cells in three months, again on one side of the brain. If no harm is detected, six more patients will receive the engineered cells in both sides of the brain.

Herd on the Street

By MAUREEN DOWD

New York Times Commentary

Wednesday, April 11, 2001

No one wants to talk about ruminant fears in polite society. But abattoir bêtes noires lurk.

Will elegant Upper East Side socialites, lunching at Cipriani, suddenly start foaming at the mouth?

Will pouty young Gotham beauties, sipping sake-tinis at Nobu, begin running around in circles trying to bite their imaginary tails?

Will high-powered women in leather skirts and Holstein-patterned purses find themselves sidling up to the famous pool at the Four Seasons and slurping at it like a trough?

Will bee-stung actresses in New York and Hollywood drop their celery sticks and demand salt licks?

Now for another episode of "When Bad Things Happen to Rich People."

Fearing diseased livestock, Wall Street's erstwhile bulls may be giving up their two-week golf jaunts this spring to Scotland. But the more women hear about mad cow disease and foot-and-mouth disease, the more jittery they get.

Inside and out, women are putting on the cow. They inject buckets of bovine collagen into their lips and faces. They starve themselves on the Zone and Atkins diets, which entail massive infusions of red meat, cheese, butter and cream. They truss themselves up in leather. They slather on anti-aging creams featuring collagen. Not to mention the Ben & Jerry's they devour when depressed.

"Elsie did not die in vain; we're using every little bit of her," says Patricia Wexler, a New York dermatologist who is known as the Vermeer of fat injections.

It is telling that the latest chic table arrangement is a small plot of grass — perfect for grazing.

"Husbands have to start worrying now: if their wives are ranting and raving, is it menopause or is it mad cow disease?" Dr. Wexler says dryly.

British women are skittish. Andrew Markey, a London dermatologist, said many patients were switching from bovine collagen to hyaluronic acid, a line "filler" found in roosters' combs, even though his collagen comes from America. "It's not about science," he said. "It's an emotional response."

In America, vanity is still beating out health fears, according to Richard G. Glogau, a San Francisco dermatologist. "Most women would find the prospect of dying wrinkled a lot worse than the prospect of dying of dementia from collagen," he says. "As long as they don't drop dead 30 seconds later, they'll do it."

Dr. Wexler says vanity also trumps morality: "I've never had a patient ask about a kosher cow. I've never had a vegetarian model object to bovine collagen. I've never had an animal rights activist object to cows getting killed for collagen. When it comes to cosmetic matters, women have a `Don't ask, don't tell me, please!' policy."

The Queen of Fat injects herself with bovine collagen, and says she prefers the cow product to alternative fillers — including one drawn from human cadavers, which gets tested for H.I.V.

When her patients get antsy, she explains that the collagen comes from "a closed herd, a very elite club of cows. My patients want reassurance that they can go on guilt-free and wrinkle-free. They're not looking for written testimonials."

Some beauty-seekers are, however. "One woman wanted to visit the herd," says Arnold Klein, a Beverly Hills dermatologist.

Executives of the McGhan Medical Corporation, which supplies a large share of the world's collagen, say it has 2,000 cows, a "primary herd" and a "backup herd," on 2,000 acres on the California-Oregon border, that eat grain, breed with each other and are slaughtered on-site.

But McGhan also has a biogenetically engineered human collagen waiting for F.D.A. approval that may eventually supersede bovine collagen. The foreskin of one infant boy — the son of a company executive, according to Dr. Klein — will be engineered into a supply that will replicate endlessly and provide lips, etc., for women all over the world ad infinitum. A bris to remember.

But until women can start injecting infant-boy foreskin into their faces, they must confront the specter of being quarantined if they start drooling and slobbering.

Tina Alster, a Washington dermatologist who gives herself bovine collagen injections, is calm.

"I would rather be among the quarantined than on the outside of the ring," she says. "Let everyone else look horrible."

101 bills are signed into law

Blood-alcohol level for drunken driving reduced to 0.08%; Measure 'will save lives'; Auto registration fee raised $6 to support medical services

By M. Dion Thompson

Baltimore Sun Staff

Wednesday, April 11, 2001

Advocates applauded yesterday as Gov. Parris N. Glendening signed into law legislation that effectively lowers the standard at which motorists in Maryland will be considered drunk.

The governor signed yesterday 101 bills approved by the General Assembly during the 90-day session that ended Monday night. Many were local bills that attracted little attention. But nearly two dozen supporters crowded behind Glendening as he signed the drunken-driving legislation.

"No single law will solve the problem, but the steps we are taking will save lives and help prevent more families from experiencing the devastation of losing a loved one to a drunk driver," Glendening said.

For years, advocacy groups had tried and failed to reduce from 0.10 percent to 0.08 percent the blood-alcohol level needed to convict someone of the most serious drunken-driving offense. Each time, they lost to opponents who argued that the state should enforce laws on the books.

This year, the advocates were helped by the threatened loss to the state of millions in federal highway money.

"There's no question that this legislation should have passed on its merits years ago," said Sen. Ida G. Ruben, a Montgomery County Democrat and the bill's chief sponsor. "I think it's absolutely fantastic that we'll have safer roads for our constituents and for people driving through Maryland."

In addition to the 0.08 law, which will take effect Sept. 30, the governor signed a measure that will allow prosecutors to tell judges and juries when defendants refuse to take a Breathalyzer test. But advocates regretted losing a fight to ban open containers of alcohol in cars.

Del. Carol S. Petzold, a Montgomery County Democrat, said supporters will try to push the bill through next year. Again, federal dollars will be at stake. "That'll be the leverage," she said.

Auto registration fee

Another key measure signed yesterday raises the fee Marylanders pay to register their cars every two years from $70 to $76. The increase will bring in about $13 million a year and is designed to keep the state's emergency medical system on sound financial footing.

The system, which includes state police MedEvac helicopters and the Maryland Shock Trauma Center, was facing a $7.2 million deficit.

Major pieces of Glendening's agenda, such as bills to prohibit race-based traffic stops, raise the amount of state business targeted to minority-owned firms and extend Maryland's anti-bias laws to include homosexuals, will be signed in coming weeks.

Lumbee Indians bond

Yesterday's bill signing was a moment that Clark Oxendine and Tina Morgan did not want to miss. The Lumbee Indians posed behind Glendening as he signed an extension to a $250,000 bond bill they hope will bring new life to the Baltimore American Indian Center.

"This [bill signing] is something that we've never been a part of," Oxendine said. "It's a blessing."

The center at 113 S. Broadway has been a part of city life for 32 years, serving as a meeting place for the 6,000 Lumbee Indians living in the area. The center has lost several grants in recent years, forcing board members to cut hours and reduce staff from 17 employees to one part-time worker.

Morgan said the center has stayed open by raising money at weekly fish fries. Board members want to use the bond bill and matching contributions to renovate the center, add a gymnasium and expand hours.

Warfield project funding provided

Carroll and state contribute money for upfront costs

By Mary Gail Hare

Baltimore Sun Staff

Wednesday, April 11, 2001

Sykesville's efforts to renovate aging hospital buildings at the Warfield Complex into a business and academic center received a $300,000 boost from the Carroll County commissioners yesterday.

The commissioners unanimously approved a $300,000 grant and made Carroll a partner with the town and state in the restoration of the Warfield Complex. The state recently budgeted $100,000 for the effort, bringing Maryland's contribution to nearly $400,000.

"The county has given us the spark to start the fire," said Sykesville Mayor Jonathan S. Herman. "You don't do a $20 million project without upfront costs."

The town of 4,200 annexed the 96-acre property along Route 32 two years ago and plans to restore the 14 buildings, lease them and share the profits with its partners.

Warfield could be a boon to Carroll's economic development. It promises as many as 1,200 jobs and several construction projects, including an 80-room hotel.

The county will not require the town to repay the grant. The money will cover costs of engineering and architectural studies and legal fees involved in the acquisition of Warfield, once part of state-owned Springfield Hospital Center.

The town can cut its initial infrastructure costs - for roads, gas lines and water and sewer - by working alongside the state, which has begun designing its Police Training Center in Warfield's two largest buildings.

"The state will dig out the old and put in new, and we will supply the difference in material costs," said Herman. "We are actually piggybacking on something that is already on the ground. They are laying down the infrastructure. All we have to do is tell them what we need."

The state expects to start construction of the police center next year and open it in fall 2003. With the state building an intersection on Route 32, the timing is ideal for the town to begin work on Warfield. But it must determine the scope of that work. Details such as the width of its water line are vital.

"We have to have funds to undertake the studies that will give the state the information it needs to help with our project," Herman said. "We have to study Warfield's existing infrastructure and see what needs we will have."

Matthew H. Candland, town manager, said it is critical for the town's engineering studies to be done at the same time as the state's.

"The worst thing for us would be for the state to install infrastructure and we find out later that we gave inadequate information," Candland said. "The worst thing would be to jury-rig this and not have it be the gem it could be."

Jack Lyburn, county economic development director, said money for the grant would be available possibly through the Industrial Development Authority, a quasi-public body that receives about $1 million annually from the county to spur economic development.

"This is a project we should support," Lyburn said.

CareFirst conversion path eased

Legislature removes a barrier to switch to for-profit status; Vote no longer required; Consumer groups gearing up in event insurer opts to shift

By M. William Salganik

Baltimore Sun Staff

Wednesday, April 11, 2001

Advocacy groups are beginning to gear up in case CareFirst BlueCross Blue- Shield, the state's largest health insurer, seeks to convert to for-profit status.

Shortly before it adjourned Monday night, the General Assembly removed one potential barrier to conversion by dropping a requirement that CareFirst members vote on a conversion plan.

"It wasn't a major hurdle, as far as we were concerned," John Picciotto, CareFirst's executive vice president and corporate counsel, said yesterday of the vote, which he said would not have been binding on state regulators.

He declined to say, however, how the legislative action will influence CareFirst's consideration of whether to convert. "We don't comment on the current state of the discussions," he said.

Frank Chase, legislative chairman of the Maryland chapter of the National Association of Retired Federal Employees, said representatives of several health advocacy, consumer and senior organizations have started to talk about forming a coalition to weigh in on whether CareFirst should be allowed to convert and how to deal with any proceeds from a conversion.

Blue Cross plans, historically nonprofits, have changed in several states, saying for-profit status allows them to compete better with commercial insurers.

Chase said he hopes that a consumer coalition would form to start examining the issues even before CareFirst takes any action.

If CareFirst did decide to convert - it has told state officials over the past few months that it is seriously considering such an action - it would have to file a plan with the state insurance commissioner, who would hold hearings on whether such a change would be in the public interest.

T. Michael Preston, executive director of the Medical and Chirurgical Faculty of Maryland, the state medical society, said he expected that his group would be commenting on any conversion plan.

"The burden's clearly on the company to explain exactly what they have in mind and why," he said.

Until they see a plan, Preston said, the physicians are skeptical.

"We have a strong belief that non-for-profit medicine is the proper model, and that the introduction of shareholders takes away the focus from the community."

Nancy Fiedler, senior vice president of the Maryland Hospital Association, is forming a task force to study conversion issues.

While the association has not yet taken a position, she expects it to participate in hearings.

Nomita Ganguly, staff attorney with Boston-based Community Catalyst, a national group which monitors for-profit conversions by hospitals and insurers, said she had had requests for information from several Maryland groups, and was beginning to hear from groups in the District of Columbia and Delaware, the other two jurisdictions in which CareFirst operates.

Ganguly said a review of laws in other states did not indicate that any required a vote of members for a Blue Cross plan to convert. Maryland did mandate such a vote under a 1997 law, but reversed itself with this week's legislative action.

The 1997 law also created the Maryland Health Care Foundation to receive proceeds from any conversion by an insurer or hospital.

Since a nonprofit has benefited from its tax status in building up its assets, a conversion generally triggers a contribution to a foundation or other public purpose.

Under one bill passed by the House of Delegates, but not the Senate, proceeds from a CareFirst conversion would have been set aside to create a new state-run program to provide coverage for uninsured people.

In the end, the legislature decided simply to set aside any money it receives this year.

Marilyn Maultsby, executive director of the Maryland Health Care Foundation, said her group would be conducting a study, including public forums, of how to cover the uninsured, with an eye to making recommendations before next year's General Assembly session.

The study would consider both what could be done with conversion money, and what could be done without it.

Preston said, "A decision on Blue Cross should be made on its own merits," without "a rush to cash out Blue Cross" to provide capital for a fund for the uninsured.

Campaign aims to combat prescription drug abuse

Nonmedical use can lead to addiction, health woes for millions, groups say

Associated Press

Baltimore Sun

Wednesday, April 11, 2001

WASHINGTON - Four million Americans are abusing prescription drugs, including sleep-deprived people who become addicted to sedatives and family members who sell spare pills on the street, the government says.

Pharmaceuticals designed to relieve pain, calm stress or bring on sleep provide great benefit for millions, but when used for nonmedical reasons they can lead to addiction and damaged health, said Alan I. Leshner, head of the National Institute on Drug Abuse.

Leshner announced at a news conference yesterday that the institute and seven organizations representing the elderly, pharmacies, drug manufacturers and patients are starting a campaign to combat what he called "a dangerous new drug abuse trend" - the nonmedical use of prescriptions.

Calvin Anthony, vice president of the National Community Pharmacists Association and one of a group of experts from the prescription drug industry at the news conference, estimated that misuse and abuse of medication has more than a $100 billion impact on the nation's health care costs.

The experts said that many patients taking sedatives, stimulants, tranquilizers or painkillers begin to use the pills inappropriately and can slip into an addiction cycle that dominates their lives and damages their health.

"Nobody starts out to be addicted," Leshner said.

"While prescription drugs can relieve a variety of medical problems and improve the lives of millions of American, they can be dangerous, addicting and even deadly when used nonmedically," he said.

The experts said that patients with chronic pain often keep supplies of drugs in their homes for legitimate use and that in some cases the drugs are stolen by family members for sale on the street.

Morphine is often used in large doses by patients with terminal cancer or other conditions, and stolen packages of the drug are in high demand on the street.

Some people recovering from surgery use painkillers far longer than needed and eventually become addicted. Poor sleepers take sedatives and may mix them with alcohol or other drugs. Eventually, they need more and more of the drug to achieve the same effect.

Patients habituated to the drugs may "doctor shop" to find physicians who will prescribe the pills, and some addicts will establish accounts at different pharmacies to disguise the number of pills they are actually using.

Health care emerges as legislature's gem

General Assembly: Lawmakers put prescription drugs, mental health on governor's radar screen.

Baltimore Sun Editorial

Wednesday, April 11, 2001

LEADERS of Maryland's General Assembly can rightly claim that the defining moments of their just-concluded 90-day session were initiatives of their own making and not the governor's.

By the time the final gavel sounded at midnight Monday, health care had emerged as the dominant concern. Slowly, the governor came around to support lawmakers' views.

It took strong, persistent pressure from lawmakers to convince Gov. Parris N. Glendening to pump over $58 million into a prescription-drug program for poor seniors and into community mental health clinics.

The governor was harshly criticized for his lack of attention to the state's growing health care crisis. Lawmakers demanded more money during negotiations on his $21 billion budget.

In the end, Mr. Glendening agreed to a one-time tax amnesty, with the first $30 million going to pay off accumulating bills from the state's struggling mental health clinics.

Then the General Assembly mandated that the state begin to pay higher reimbursement rates for Medicaid and children's health programs, starting next year.

That could be an expensive long-term item -- as much as $200 million from state coffers. But Maryland must end its practice of starving medical programs for the poor. Fees to doctors and providers should be in line with rates paid by private health insurers.

Another expensive future cost was acknowledged by the governor when he agreed with demands of lawmakers that more be done to help those who work with the developmentally disabled.

The state's unacceptably low reimbursement rate is less than the minimum wage. But starting next year, there will be a five- year, $80 million phase-in of pay increases.

That's welcome news for the 32,000 workers who care for 21,000 adults with developmental disorders.

It comes on top of the latest installment in Mr. Glendening's five-year, $68 million drive to enlarge the pool of programs for this needy population.

The governor added another $1.4 million to help move more developmentally disabled adults out of state hospitals and into community settings. This must be done to comply with a Supreme Court ruling.

In its final hours, the General Assembly reversed course on a hotly debated issue fought by the state's medical society. It gave a one-vote victory to the nursing profession: From now on, members of HMOs will be able to select nurse practitioners as their primary care providers.

That's a small step toward making nursing a more appealing career.

Mayor Martin O'Malley got his prime health care desire -- $8 million more for city drug-treatment slots and an additional $8 million next year. This is a crucial step in bringing down the city's addiction -- and crime -- rates.

Prescription drugs turned into an obsession for both Sen. Thomas Bromwell of Baltimore County and Del. Michael Busch of Anne Arundel County, two powerful committee chairmen. They had sharply different approaches in mind, but found common ground. As a result, as many as 100,000 Maryland seniors could get drugs at reduced cost.

It's a risky move, though. The three-pronged approach is billed as a temporary, two-year fix until Congress enacts its own drug program. But there's no guarantee this will happen, especially with the shrinking amount of federal money available for domestic programs as the president implements his tax-cut plan.

Additionally, politicians in Annapolis may find it hard to withdraw money for this program after a two-year run. Lobbyists for seniors may insist that the state continue and even possibly expand its role.

This could pose a fiscal threat, especially when you add up future extra money flowing into programs for the developmentally disabled, drug treatment and mental health clinics.

But that is a problem lawmakers put off until 2002 or later.

Also on the next legislative agenda could be a move to increase the rates hospitals are allowed to charge patients. The state commission that sets these rates came under withering attack from influential lawmakers for being so stingy that hospitals may have to cut back on services.

That's not acceptable to legislators. They want the commission to pay less attention to profit-making insurers, who favor tough cost controls, and more attention to the unmet needs of Maryland's not-for-profit hospitals.

Distillers: Toughen Drunken Driving Standard

Call on states to lower legal blood-alcohol level

By Adam Marcus

USA Today HealthScout Reporter

Wednesday, April 11, 2001

TUESDAY, April 10 (HealthScout) -- Citing a rise in alcohol-related traffic deaths, a consortium of distillers today called on all American states to set a tougher legal standard for drunken driving.

The Century Council, made up of five alcohol producers including Guinness, Bacardi and Seagram, says the new standard should be a blood-alcohol content (BAC) of 0.08; most states have set the limit at 0.10.

The group says the lower limits should be part of a comprehensive program to target "hard-core" drunken drivers with repeat offenses or whose BAC has been measured at 0.15 or higher at least once. Nearly 60 percent of drunk drivers meet that definition, the group says.

In addition to setting stricter blood-alcohol levels, the group is also calling for license revocations and enhanced penalties for drunken drivers, mandatory treatment policies and more aggressive vehicle sanctions.

"There is no single, silver bullet, but together these strategies will cause alcohol-related fatalities and injuries to decline," says Bill Georges, vice president for programs at the spirits group, which until now had maintained a "neutral" stance on the stricter blood-alcohol standards.

Preliminary traffic figures show that while the share of fatal accidents in which alcohol was a factor held steady last year, at 38 percent of wrecks, the number of people killed in these collisions rose from 15,786 in 1999 to 16,068 in 2000, the highest level in roughly five years.

Implementing the more stringent BAC policy throughout the United States could save 500 to 600 lives a year, experts say. Blood-alcohol content is a measure of the weight of alcohol in milligrams compared to a given volume of blood, usually in deciliters. It can be given as both a percentage and a proportion. To reach a BAC of 0.08, a 160-pound man would have to

consume two 8-ounce glasses of wine in a half hour.

Several factors involved

However, a number of factors -- from a person's weight to the time of his last meal to his experience with drinking -- can affect their blood alcohol level, says Georges, who adds that seven in 10 Americans say they don't know what BAC means. "Each person is different. There's no absolute standard," he says. As a result, the council is also promoting "blood-alcohol

awareness" to educate drinkers about the effects of alcohol on their body.

"We've been calling on the alcohol industry for a while to step up to the plate to fight for 0.08" and other laws to combat impaired driving, says Tresa Hardt, a spokeswoman for Mothers Against Drunk Driving (MADD). "We're just pleased that they've come out" in favor of the restrictions.

The two groups, along with the National Transportation Safety Board, recently began a coordinated effort to crack down on the most intransigent drunken drivers.

Last fall, Congress passed a transportation package that lowered the legal blood alcohol limit on federal roads to 0.08, and has for several years offered states financial incentives to do the same.

Doctors Gun-Shy on Newborns' Hepatitis Shot

Temporary problem has long-term effect

By Edward Edelson

USA Today HealthScout Reporter

Wednesday, April 11, 2001

TUESDAY, April 10 (HealthScout) -- A large percentage of newborn babies aren't getting the recommended hepatitis B vaccination (HBV) because hospitals were thrown off their routine by a precaution that was intended to be temporary, doctors say.

Routine vaccination against hepatitis B, a viral liver infection that can be fatal, was recommended for all newborns in 1991. That recommendation was changed in 1999, when the American Academy of Pediatrics (AAP) and the U.S. Public Health Service said most infants should not get the shots until a few months after birth. The change was based on concern that

thimerosal, a mercury-based component of the vaccine, might damage the babies' nervous systems. The recommendation for routine newborn vaccination was renewed in September 1999, when a thimerosal-free vaccine became available.

But when University of Chicago physicians surveyed 46 hospitals in Ohio last year, they found widespread failure to observe the renewed recommendation.

"Before July 1999, 74 percent of surveyed hospital nurseries offered hepatitis B virus vaccine to all neonates. Only 39 percent did so in August 2000," reports Dr. Ronda J. Oram and colleagues in the April 11 Journal of the American Medical Association.

"The problem has been that it is difficult to make sweeping recommendations for a brief period and then revert to the old rule. It is hard to make people change their ways and then go back to the old way," says Dr. H. Cody Meissner, chief of pediatric infectious diseases at the New England Medical Center in Boston and a member of the AAP's committee on infectious

diseases.

Dr. Thomas N. Saari, professor of pediatrics at the University of Wisconsin Medical School and a member of the AAP committee, says his recent survey of Wisconsin hospitals found the same lower rate of immunizing newborns. Saari says when the thimerosal-based recommendation was made, many doctors switched to a combination vaccine given at two months of age, and they are reluctant to switch back to vaccinations in the first days after birth.

That two-month window of vulnerability can be important, Saari says. "Hepatitis B is a silent disease. It is asymptomatic until the child develops complications."

The Chicago report says one problem of delaying vaccination is that babies born to mothers carrying the hepatitis B virus are not protected against maternal transmission of the virus. A second problem is that "delay in the receipt of the first HBV dose in the nursery is associated with delay in completion of the on-time vaccine series."

Three doses of the vaccine, given in the first 18 months of life, are recommended. The full series provides protection for at least nine years, and possibly much longer.

Saari says parents should be aware of the importance of early hepatitis protection, but that awareness often doesn't come easy. "When the hepatitis B program started, there was a lot of concern on the part of parents as to whether a brand-new baby should be given a vaccine when it is just one-day old. It is the only vaccine given that early. Overcoming this is not easy, because it is easier to sell parents on protection against a disease that produces a rash or a fever. Hepatitis B vaccination has always been a difficult concept to get through to parents and to physicians," he says.

What To Do

Meissner says, "It is critical for parents to be informed and understand the importance of the hepatitis B vaccine, as well any other vaccine. It is an important element in the health of the child."

If you're pregnant, you should get tested for the hepatitis B virus. Vaccines are frequently tough for parents to watch; they hate to see a baby, especially a newborn, wince in pain, but it's better than the alternative.

The Centers for Disease Control and Prevention has a primer on hepatitis B.

SOURCES: Interviews with H. Cole Meissner, M.D., chief of pediatric infectious diseases, New England Medical Center, Boston, and Thomas N. Saari, M.D., professor of pediatrics, University of Wisconsin Medical School, Madison; April 11, 2001 Journal of the American Medical Association

Vote to Replace Agency Running D.C. General Expected Soon

By Avram Goldstein

Washington Post Staff Writer

Wednesday, April 11, 2001; Page B01

The D.C. financial control board could approve an agreement as early as today to replace the bankrupt Public Benefit Corp. as the city's main provider of charity medical care, officials said yesterday.

District leaders reacted positively yesterday after hearing presentations from the network of private firms that has agreed to replace the PBC.

"I felt reassured that it was a really good program and the various parties were working together and eager to make it work," said control board Chairman Alice M. Rivlin. "I was gratified. It's been a difficult procedure for all of us, and we all wish it had gone more quickly."

The decision would lead to phasing out inpatient services at the PBC's main facility, D.C. General Hospital, a historic Washington institution that has for generations provided free care to those unable to pay.

Rivlin and control board Executive Director Francis S. Smith said that when the panel acts, perhaps this afternoon, the decision will quickly be sent to Mayor Anthony A. Williams (D) and the D.C. Council.

The mayor will approve it, according to his aides, but the council has strongly opposed the plan. D.C. Council Chairman Linda W. Cropp (D) doubted that the restructuring would win a council majority, she said at the meeting.

However, the control board has the authority to override the council.

The private health care network -- the Washington Alliance for Community Healthcare (DC-WACH) -- promised the control board yesterday that it would deliver comprehensive medical services to the poor.

The proposed five-year agreement with the network, which would allow for $66.3 million in fees the first year, would be one of the largest government contracts in District history.

Partisans fighting to preserve 195-year-old D.C. General have attacked DC-WACH, which is headed by Greater Southeast Community Hospital. They contend that it will leave residents from eastern portions of the District literally dying in the streets.

They argue that public safety would be compromised by the proposed closing this year of D.C. General's trauma center and because of longer ambulance travel times from Wards 6 or 7 to Greater Southeast on Southern Avenue in Ward 8.

But the DC-WACH presentations apparently gave many officials at the meeting confidence that privatization could improve public health in a city with some of the nation's worst health statistics.

People at the meeting said later that the presentations offered hope that DC-WACH could deliver better care to more than 65,000 uninsured District residents.

"I think it sounds like a workable plan," said PBC Vice Chairman Nancy Taplin McCall. "I was very pleased to see that they thought a lot about issues such as trauma and the specialty clinics. It was a pretty comprehensive plan."

Said Jacqueline Bowens, a top official at Children's Hospital: "It's hard to argue that the plan doesn't make sense. You've got a comprehensive network of services." Children's has contracted to provide pediatric services and might also take over the District's school nurse program, which the PBC now operates, she said.

"The overall reception was good," Bowens added. "People certainly felt that the plan as laid out made sense."

The contractors at the meeting included top officials of Greater Southeast and key subcontractors D.C. Chartered Health Plan, Unity Health Care, Children's Hospital and George Washington University Hospital.

George Washington hospital officials have agreed to provide whatever adult trauma and specialty services that Greater Southeast cannot offer. Greater Southeast plans to add its own trauma capability.

Negotiations with the city were supposed to take a few weeks, but they lasted for eight and became a burden for Williams. He was subjected to a drumbeat of criticism from ministers, hospital workers, physicians and demonstrators who oppose the plan.

Yesterday's closed-door meeting included the congressionally appointed control board, Williams and representatives of the D.C. Council, the chief financial officer and the PBC.

When Cropp suggested yesterday that the council wanted time to sketch out an alternative proposal, she was told it was too late, according to people at the meeting. Offering false hope about preserving D.C. General would be needlessly inflammatory, several officials said.

Drunken Driving Foes Ask More

Glendening Signs Bills; Speaker to Push for Others Next Year

By Daniel LeDuc

Washington Post Staff Writer

Wednesday, April 11, 2001; Page B01

Even as they celebrated passage of new crackdowns on drunken driving in Maryland yesterday, advocates and legislative leaders promised to come back next year to tackle still more efforts to get repeat drunk drivers off the road.

Gov. Parris N. Glendening (D) signed into law a measure that allows judges and juries to be informed when a drunken driving defendant has refused to take a breathalyzer test and another measure that lowers the legal limit for drunken driving from 0.10 to 0.08.

The new laws, which take effect Oct. 1, were major goals of Mothers Against Drunk Driving and other advocacy groups. Two other changes sought by advocates, new sanctions for repeat offenders and a ban on open containers of alcohol in vehicles, died in the House Judiciary Committee.

Yesterday, House Speaker Casper R. Taylor (D-Allegany) promised to push for those proposals next year and to make them part of his priority agenda.

"All of it together was too big [this year] because you are very aggressively trying to change our culture," Taylor said. "As a society we accepted drunk driving far too long. Not only that, but we laughed at it. But I think we're starting to turn a corner."

Advocates said that with Maryland facing a cutoff of federal highway funding if it doesn't pass the repeat offender legislation and open container ban next year -- and with 2002 being an election year -- the measures have a better chance.

Lawmakers did close a loophole in Maryland law that said judges and juries cannot be told when people stopped on suspicion of drunken driving refuse to take a breathalyzer test.

The proposal had been a top priority for the state's prosecutors, who often were left without breathalyzer test results to prove their cases and unable to tell judges and juries why.

Habitual drunk drivers have long learned the system and routinely refuse breathalyzer tests. "For too long that refusal allowed repeat offenders to break the law without consequences," Glendening said as he signed the legislation at a State House ceremony.

Next year, advocates said they may push to make it a crime to refuse to take a breathalyzer test.

By lowering the blood-alcohol limit for drunken driving, Maryland joins the District, Virginia and nearly half of the rest of the states that have adopted 0.08.

"It's a deterrent," said Wendy Hamilton, the Maryland public policy liaison for MADD. "You're going to get people to think more before they get behind the wheel . . .because the risk of being arrested and convicted is higher."

An average 170-pound man must have four drinks in one hour on an empty stomach to reach 0.08, according to MADD's studies. A 137-pound woman would reach that concentration after about three drinks. The organization's reports said that at 0.08, a driver's judgment about such basic driving skills as speed control, braking and lane changes are affected.

Last year, about 17,000 people were stopped for drunken driving in Maryland. Of them, about 1,500 had a blood-alcohol level of 0.08 or 0.09, which will make them subject to stiffer penalties under the new law.

"People can drink all they want," said Sen. Ida G. Ruben (D-Montgomery), who helped sponsor the legislation. "Just don't get behind the wheel of a car and make it a lethal weapon."

Lead Paint and Lawsuits

Washington Post Editorial

Wednesday, April 11, 2001; Page A26

THE IDEA of suing paint manufacturers to pay for efforts to clean up lead paint hazards is naturally attractive to state and local governments for whom lead abatement is a major problem. The success of the tobacco lawsuits has trial lawyers looking for new targets, and -- like the tobacco companies -- the paint industry is plagued with some unflattering memos suggesting that

officials knew early on about the dangers of their product. Lead paint litigation is clearly gathering steam. This week, Milwaukee became the latest city to sue paint manufacturers. And a judge recently allowed portions of a suit by the state of Rhode Island to proceed. But any similarity to the tobacco suits is only superficial. There is, in fact, good reason to be skeptical

of a tobacco-style litigation effort.

The dangers of lead are real, and the problem is vast. Particularly in inner-city neighborhoods, where housing is not well maintained, children eat paint chips or dust, and the lead causes serious health problems -- including mental retardation. In some cities, the rate of elevated lead levels in preschoolers remains alarmingly high long after lead paint was banned. The problem is chiefly one of forcing landlords to ensure reasonable conditions in their properties, an effort that has gone on for years. While individual litigants have long sought to sue the paint-makers as well, these suits typically have not been successful.

Unlike the tobacco companies, whose misconduct continued right up to the time of the lawsuits, the paint manufacturers have not made lead-based products in decades. The industry claims that it voluntarily eliminated the lead in paint when it became clear it was hazardous and later, in 1978, supported the government's ban on it. The industry's critics, however, dispute this tale

of good corporate citizenship, and they offer evidence that the companies knew about the hazards of their products since the early 1900s but nonetheless marketed them aggressively as safe. Even if this were true, the misconduct is in the past and is a far cry from the nicotine manipulation and outright lying to regulators and Congress that the tobacco companies engaged in. The problem of lead long ago became a public policy problem, rather than one the tort system is well suited to address.

The advocates of litigation know this and see the suits in policy terms -- as an attempt to force the companies that created the mess to help clean it up. This sounds reasonable in theory, but it is far less so in practice. It is unlikely that many shareholders in today's paint companies held stock at the time of any improper conduct. Whom exactly would liability punish? Moreover, it's

hard to imagine any deterrent value for current corporations in the possibility of liability 50 years from now. To hold the paint companies financially responsible now may offer a cash cow for trial lawyers and governments looking for revenue streams to fund lead-abatement programs. But it would be arbitrary and could otentially ruin an industry that provides a necessary and useful product. It's hard to see what good that would do. Protecting children from lead poisoning requires a sustained enforcement and abatement effort, from which the trial lawyers can offer no shortcuts.

The Tally From Annapolis

Washington Post Editorial

Wednesday, April 11, 2001; Page A26

MARYLAND LAWMAKERS handed Gov. Parris Glendening a plateful of victories in the session that wound up Monday night. Though they trimmed back some of his spending plans and nudged him to support some health care priorities that weren't initially among his proposals, by and large they endorsed his agenda. In doing so legislators embraced some worthwhile

initiatives, but they also accepted a budget whose long-term costs may come back to haunt them.

Long-stalled efforts to tighten drunk driving laws finally bore fruit, as legislators passed bills lowering the blood alcohol level at which drivers are judged to be drunk and closing the loophole that blocked judges and juries from being told when drivers refused breath tests. Though it took until the last hours of the session, lawmakers also passed an important reform tightening the

rules governing lobbyists who work the halls of the legislature on behalf of business and special interests. They approved bills banning discrimination on the basis of sexual orientation and requiring law enforcement agencies to actively work to stop racial profiling. A proposed moratorium on executions couldn't get past the Senate, but its surprisingly strong showing helped pull through a bill requiring DNA testing for those convicted of murder and rape if a judge thinks that evidence might prove their innocence.

Legislators cut back some of Gov. Glendening's budget proposals but left enough in place to begin significant efforts to boost mass transit in the state and to protect open lands. After complaining rightly that the governor wasn't providing sufficient support to health care needs, legislators won more spending for the state's struggling mental health programs and set up a system to help some elderly citizens pay spiraling prescription drug costs. They left mostly intact his proposal for $30 million in new early childhood education spending, but the budget still falls short of providing adequate support for all-day kindergarten and programs to help students who are in danger of failing the tests soon to be required for graduation.

Perhaps that issue could be addressed next year -- but there's room to wonder how much money will be available for new programs by the time that budget rolls around. The spending plan just approved was an aggressive one to begin with, allocating all of this year's surplus plus some money from the state's rainy day fund. In the middle of the session came word that revenue

projections for the coming fiscal year were being scaled back. Gov. Glendening's spokesman says that reserves are adequate to cushion against a future downturn, and that the governor has built in additional protection by devoting surplus money to capital projects that can be delayed if funds get too tight. But legislative analysts say he has underestimated future spending in several areas. A serious downturn in revenue could leave his successor stuck with harder choices than any we saw this year.

Help for a Disabled Child

Washington Post Letter to the Editor

Wednesday, April 11, 2001; Page A26

Regarding the story of Tyeisha Brown, the 10-year-old with cerebral palsy who must drag herself up a steep flight of stairs inorder to use the bathroom ["Disabled Sue District for Barrier-Free Housing," Metro, March 28]:

As a nurse working in home health care for many years, I must stay that Tyeisha's situation is untenable. A temporary, safe solution for her could be a bedside commode, portable and adjustable for height.

Assuming an adult is with Tyeisha at all times to assist her with the use of the bedside commode, this would be a safe, stress-free solution for her situation.

SUE RICHARDSON

Garrisonville, Va.

Do Prescription Records Stay Private When Pharmacy Stores Are Sold?

By MILO GEYELIN

Staff Reporter of the Wall Street Journal

Wednesday, April 11, 2001

A novel lawsuit over the privacy of prescription records at a former neighborhood drug store could complicate the way pharmacy chains buy up their competitors.

The suit challenges the common but little-known practice of "file buying," in which chains purchase customer prescription files from pharmacies they acquire and add them to their own. Launched by an AIDS patient in state court in New York, the suit contends that CVS Corp. illegally obtained his prescription records when it bought and subsequently closed a family-owned drug store he frequented and then logged his medical information into its huge database without his consent.

The case has already broken legal ground. A state court judge ruled earlier this year that both the former pharmacy in midtown Manhattan and CVS could be sued for damages on grounds that they breached a duty of confidentiality to the plaintiff, who was allowed to file the suit anonymously. The ruling, which now allows the case to go to trial, is the first to establish that drug-store customers have a right to expect that their pharmacy records, like their medical records, will remain confidential.

"Because pharmacists have a certain amount of discretion, and an obligation to collect otherwise confidential medical information, the court must find that customers can reasonably expect that the information will remain confidential," New York state Judge Charles Edward Ramos wrote in his opinion.

What's more, because CVS allegedly insisted that the local pharmacy not notify its customers about its sale of the files, according to the suit, the judge ruled that CVS may also have engaged in deceptive trade practices under New York law.

Last month, the case picked up further momentum when the judge certified it as a class action, covering an estimated 250,000 CVS customers in New York state whose prescription records were bought by the chain between 1993 and 1999. A CVS spokesman says the company "adheres to industry standards and applicable laws and regulations" when it buys pharmacy records.

Among drug-store chains, prescription files are coveted assets, offering instant access to potential customers and market share. While the file buying is an industry-wide practice, only CVS, the nation's biggest drug-store chain with more than 4,000 stores, appears to have been sued over it, according to Richard Lubarsky, a New York lawyer who represents the plaintiff in the case.

Last year alone, CVS bought files from 300 independent pharmacies it acquired; in Securities and Exchange Commission filings, the company calls the files "productive investments." CVS officials say the practice is also good for the public, allowing for the orderly transfer of prescription files when pharmacies change hands. It also says it draws on customer prescription records to send refill reminders, which are paid for by drug companies whose medications have been prescribed.

"Some people call it marketing, but there's a real societal benefit," says Carlos Ortiz, director of government affairs at CVS, based in Woonsocket, R.I. The company says it usually posts a notice on the doors of pharmacies it has acquired and shut down, saying that files have been transferred and directing customers to the nearest CVS for service. But rivacy experts say the notice is inadequate, and after the fact.

Consumers in other states are starting to complain, too. In Rhode Island and Massachusetts, CVS has been sued for allowing customer records to be used in direct-mail campaigns bankrolled by drug companies peddling new or alternative remedies. For a while, CVS was also turning over patient names and addresses to an outside marketing firm to handle the mailings, although the company says it stopped the practice after it became public when the suits were filed.

The suits are the first to test the legal limits of what drug-store chains can do with customer prescription files. Only two states, New Jersey and Virginia, require any kind of customer notification before a pharmacy can sell the records, according to CVS. But there are no uniform state laws regulating how drug stores handle the records. Even laws restricting what doctors can do with their medical files vary from state to state, says Janlori Goldman, coordinator of the Consumer Coalition for Health Privacy, a private group in Washington, D.C.

The issue caught the attention of the Clinton administration, which in its final days released new regulations to address medical-records privacy. The rules, now under review by the Bush administration, would require all health-care providers, including doctors and pharmacies, to get prior consent from individuals before disclosing any information from their files. But drug-company and pharmacy-industry officials have lined up against the rules, saying they would unnecessarily bog down pharmacists' ability to fill prescriptions, as well as slow the process of contacting insurers to confirm coverage and submitting claims for payment.

"The regulations could seriously impede the ability of pharmacies to efficiently and timely dispense medicines," says Phil Schneider, a spokesman for the National Association of Chain Drug Stores. Chain pharmacies fill about 60% of the three billion or so prescriptions in the U.S. every year, he says.

Privacy groups counter that the proposed regulations address those concerns and, in any event, the industry's opposition ignores legitimate patient interests. But Tommy Thompson, the Health and Human Services secretary, has said he plans to modify the rules taking the industry's complaints into account. The new rules had been scheduled to take effect this Saturday, but are likely to be delayed while Mr. Thompson's office reviews them.

The plaintiff in the New York case, who declines to give his name, said in an interview that only a handful of people know that he has AIDS. He said he had been dealing with the same pharmacist, with whom he felt comfortable, for years, and was surprised when he was stopped at the front door in August 1999 by three CVS employees and told that it had been sold. When he replied that his medical records were inside, he was barred from entering and directed to a CVS store around the corner, he said.

"I was stunned," he said. "All they really had to do is ask permission and give some warning ... or at least give me the opportunity to send the records to a pharmacy of my choice."

The client "has the most sensitive medical condition one can imagine," adds Mr. Lubarsky, the lawyer who filed the suit. "The last place he wanted his information to go was to a chain that has thousands of stores," where his condition was potentially more vulnerable to disclosure.

Nothing suggests that has happened, Mr. Lubarsky says, but that is not the point. "It's the transfer ... without his consent that we allege is wrongful," he says. "The injury here is the right to control who sees the information."

Many States Study Legislation To Curb Prescription-Drug Costs

By RUSSELL GOLD

Staff Reporter of the Wall Street Journal

Wednesday, April 11, 2001

At least 40 states are debating legislation to control soaring prescription-drug prices, but tight budgets are sinking some of the first efforts.

The flurry of legislation, including proposed discount programs, manufacturer rebates and bulk purchasing programs, come as state lawmakers are being squeezed on two fronts by double-digit increases in prescription-drug costs. They are facing an increasingly loud chorus of constituents unable to pay their pharmacy bills. At the same time, state budgets are imperiled as rising prescription-drug costs create overruns in Medicaid programs and employee-health plans.

According to a National Conference of State Legislatures survey, 17 states are debating bills to expand the pool of people eligible for federally mandated discounts available to Medicaid recipients. Another 13 states are considering state-enforced price controls on prescription drugs, although these bills are running into stiff opposition from pharmaceutical-industry lobbyists. Meanwhile, a multistate purchasing pool is being considered in the Northwest, similar to previously reported efforts in the Northeast and Southeast.

"We're seeing a great deal of activity," says Richard Cauchi, prescription-drug project manager for the Denver-based research organization. But he adds, "Fiscal concerns do put at least something of a damper on the pace of these bills."

For example, on Friday, New Mexico Gov. Gary Johnson, a Republican, vetoed two prescription-drug-related bills, saying the combined $4.7 million price tag was too much for the state budget. One bill would have greatly expanded the number of people eligible for Medicaid prescription-drug discounts, and the other would have created a prescription-drug benefit for the elderly.

Twenty states already have passed subsidies to help low-income senior citizens pay for prescription-drug costs, mostly using money from the $206 billion tobacco settlement between 46 states and the tobacco manufacturers, says Mr. Cauchi. Another 13 states now are debating whether to create this new benefit.

A bill that passed the Missouri House last Thursday is typical of the effort. The state would pay the cost of prescription drugs for senior citizens after they meet a monthly deductible and co-payment. It would cost an estimated $70 million to $75 million. The state, which like many is struggling with declining tax revenue because of the slowing economy, would fund the program by using tobacco-settlement proceeds and eliminating an unrelated tax credit.

"It hasn't been a pleasant year, budget-wise," says state Rep. Marc Abel, a Democrat who is sponsoring the bill. Democratic Gov. Bob Holden has said he will sign the bill, but it faces an uncertain future in the Republican-controlled Senate.

Mr. Abel says he hopes Congress makes the Missouri program superfluous by passing a Medicare prescription-drug benefit, but he doesn't think state residents can wait. "My greatest day will be when this program is not needed," he says. "But until that time, what do we do for constituents [who are] living on $800 a month of Social Security and have $500 a month in prescription bills?"

Another emerging trend is states combining their purchasing power to negotiate lower prices from drug manufacturers. The Washington Senate, for instance, passed a resolution in March to create a prescription-drug purchasing pool, bringing together the public-employee health-insurance plans from Alaska, Idaho, Montana, Oregon and Washington in an effort to extract larger discounts from drug manufacturers.

The Pharmaceutical Research and Manufacturers of America, a national trade group, would prefer an expanded Medicaid benefit adopted by Congress, says spokesman Jeff Trewhitt. "This is a national problem that requires a national solution," he says. "We really don't want to see a patchwork quilt of differing and perhaps even conflicting state laws."

South Africa OKs blood substitute

Tom Carter

Washington Times

Wednesday, April 11, 2001

South Africa has become the first country to approve a substitute blood product for use in humans.

Called Hemopure, the solution is created from purified cow blood and is designed to carry oxygen to tissues. It can replace blood in transfusions but has medical limitations and does not eliminate the need for Red Cross blood drives.

"Every unit of blood you get is different, whereas ours is a consistent, reproducible, pharmaceutical-grade product," said Carl Rausch, chief executive officer of Biopure, the Cambridge, Mass., biotechnology company that has developed the blood substitute.

Mr. Rausch, speaking in Johannesburg, did not say how much his company would charge for the product, but indicated that wealthier countries could expect to pay more than poorer nations.

South Africa's Medicines Control Council approved Hemopure's use Monday, becoming the first country to permit its use in humans.

U.S. medical specialists said the product is an important breakthrough but will not replace the need for blood donors.

"We will still be knocking on your door asking you to give blood," Dr. Rebecca Haley, chief medical officer of the Red Cross, said yesterday. "I think something like this will be approved for the U.S. I think it will be a niche product."

Dr. Haley said the Red Cross collects some 6.3 million pints of blood a year. The average cost per unit is $130, but that does not cover the entire cost of collecting and preserving the blood.

"[Hemopure] is fairly safe. It wouldn't surprise me to see it approved in the United States within two years," said Dr. Barbara Alving, a hematologist and director of blood diseases at the National Institutes of Health.

The Jehovah's Witnesses, which has a religious prohibition against using blood for transfusions — even if it is used to save a life — last year approved Hemopure for its members to use in emergencies.

Hemopure is made using hemoglobin from cow's blood, taken at a Pennsylvania abattoir. The cows, which are raised and monitored from birth in controlled conditions, are raised for food. At the slaughterhouse, the animals are butchered for hamburgers and steaks, while the blood is removed to make Hemopure.

The raw blood is stripped of all its proteins and then purified. The process eliminates the possibility of passing diseases like bovine spongiform encephalopathy to humans, Hazel Forney of Biopure said yesterday. BSE, also called mad cow disease, is caused by a mutated protein.

Biopure will file an application by the end of this year to sell and use Hemopure in the United States and anticipates selling the product for worldwide use, Miss Forney said.

The U.S. Food and Drug Administration had no comment on Hemopure yesterday.

Dr. Alving said the product has been "extensively studied," undergoing at least nine human trials in the United States. She said it has been approved for study in non-cardiac surgeries and in trials for elective orthopedic surgeries in the United States.

"If I were an ambassador in a country with a questionable blood supply, it would make me feel much better to have this around," said Dr. Alving. "If someone had a car accident, they could be transfused with this and evacuated by air for further care."

According to Biopure company literature, Hemopure can be used by patients with any blood type. Biopure claims the product eliminates the risk of transmitting infectious diseases, like HIV/AIDS and hepatitis, in blood transfusions. While blood collected at Red Cross drives has a shelf life of just 42 days, Hemopure can be stored at room temperature for two years.

But Dr. Alving said a solution such as Hemopure that carries oxygen costs five times what normal blood costs and has a half-life of just 20 hours, which means that after it is infused in the body, half of it is gone within 20 hours.

"They have all kinds of uses, in severe anemia, an ambulance could carry this to a crash victim, in emergency rooms. The army has long been interested in something like this for their field hospitals," she said.

Those who receive Hemopure transfusions are at a slightly increased risk of nausea, stomach pain, jaundice and hypertension, but no greater than with normal blood transfusions, its makers say.

Biopure, started in 1984, has had a nearly identical product to Hemopure on the market in the United States since 1998 for dogs.

• This article is based in part on wire service reports.