THE PLAIN DEALER
Sunday, February 28, 1993

an excerpt from DEADLY DELAYS:
RED TAPE COSTS LIVES

By KEITH C. EPSTEIN

They were four strangers going about the routine business of flying – in a hurry to get home.

Like the two million people passing through airports every day, they trusted that nearly 90 years after Kitty Hawk, commercial aviation had become as safe as the government and the airlines could make it.

But this time, these four people – Kendra St. Charles, Joan Forshew, Bart Simon, and Denise Miller – were wrong.

Their trip on Flight 405 from LaGuardia Airport would change their lives forever.

Jacksonville, Fla.,
March 22, 1992, 4:47 p.m.

As Denise Miller and her father, John Stanko, head for the gate, her  brother keeps the videocamera running. His baby is crying and the elderly  Stanko, pushed in a wheelchair, is laughing into the camera.

Stanko, at 72, thinks this might be the last time he sees his son, a Navy  seaman about to leave on another seven-year tour of duty.

Denise thinks how good it feels to be close like that, a family. She feels better about herself, too, for losing 30 pounds during workouts at the “Y”  before the trip and for bringing her father to Florida.

At the gate marked “Flight 405 LaGuardia” the USAir ticket agent assigns  Denise and her father seats 8A and 8B.

“Wait,” says Denise. A Euclid travel agent, she knows the layout of the  Fokker F-28. “Isn’t that an emergency exit row?”

Her elderly father can’t move around easily, she explains, and in an  emergency, might get in the way. She asks for seats near the bathroom in the  back.

The ticket agent wonders if Joan and Frank Forshew, who are assigned to row 13, are willing to swap.

“Oh, I’d trade in 13 any day,” says Joan, who is returning to her Bath  Township home after a break in Florida.

“That’s fine with me,” says Denise. “I’m not superstitious.”

LaGuardia Airport, 4:50 p.m.

Cleveland business executive Bart Simon has had a good weekend at a  regional trade show, pitching his company’s hair brushes to beauty supply reps from across the country.

When the show winds down, he checks the forecast; the afternoon will turn wintry. He knows that usually means delays, so he tries to get on an earlier flight. It’s booked. He heads for LaGuardia anyway.

Once there, instead of having his usual antidote to airport boredom – a  martini – he eats dinner.

Inside LaGuardia terminal,
6:30 p.m.

At last, as she approaches her 40th birthday, Kendra St. Charles feels as  if she has achieved it all. A decade after her divorce, she senses she can  support a daughter and be a good mother.

She has climbed quickly in her profession, selling high-fashion eyeglass  frames to optometrists. What excites her is that the firm has chosen her to  represent it at an optical convention.

After four days in New York, Kendra longs to get back to her home in Akron and her 16-year-old daughter. While waiting to board, she makes three calls to Tracy.

Approaching LaGuardia, 7:49 p.m.

As the flight from Jacksonville descends through the clouds, Joan Forshew  can see snow in the plane’s landing lights, so different from Florida, where  she and her husband, a gifted hand surgeon, attended a medical convention. The thick snow makes her uneasy.

The plane lands, and after passengers not continuing to Cleveland leave the plane, she asks if she can take a walk. A trim, athletic woman often mistaken  for somebody younger than her 49 years, she is always walking.

The pilot speaks of gridlock. Pointing out the window, he says, “No rush. I don’t think we’re going anywhere.”

Gate 1, LaGuardia, 8 p.m.

Fifty-one men and women find their seats on Flight 405 as snow falls just  beyond the windows.

When Kendra St. Charles finds her assigned seat, 5D, someone else is in it. So she settles into another. Eventually, she has to give that up, too.  Finally, she lands in a third seat, 6B.

Gate 1, 8:40 p.m.

Just as the plane is ready to pull away from the gate, a de-icing truck  gets stuck, blocking the flight. “We have an unusual situation,” the pilot  announces.

Joan Forshew looks out the window, then at her watch. She thinks: We’re not even leaving and we’re supposed to be in Cleveland already.

At her side, Frank remains calm, engrossed in his paperback, “The Firm.”

Technically gifted, he is one of the first doctors in Northeastern Ohio to  do microsurgery – reassembling severed limbs.

So painstaking is the work that  he sometimes operates for 15 hours.

Frank, meticulous, almost fanatical about proper procedure, never rushes.  As she checks her watch again, Joan wishes she had his patience.

In the row behind, Kendra St. Charles can hear a commotion. Another  passenger, having pushed the flight attendant button, is kicking up a fuss.

“You are going to de-ice again, aren’t you?” other passengers hear the  woman say. Her husband seems embarrassed.
It unsettles Kendra a bit, but she comforts herself with this thought: They wouldn’t let us fly if it weren’t safe.

Gate 1, 8:55 p.m

Again, the flight is delayed. Joan Forshew, looking through the window,  watches a crew de-ice the plane a second time.

They are on a ladder, out in  the blowing snow atop the wings, spraying back and forth.

Restless, John Stanko switches to the row just behind, leaving his daughter in row 13. As Denise watches the second de-icing, her father munches happily  on some candy and jokes with the flight attendant.

In the cockpit, 9:08 p.m.

As the snow continues to fall, the plane begins to taxi. Capt. Wallace  Majure and his co-pilot, John Rachuba, talk about a new de-icing station at  the end of the runway in Denver, where planes awaiting takeoff can get a  last-minute dousing of de-icing chemicals. Such pads are common in Europe, yet in the United States only Denver has them.

“Zip, zip, zip man, just you know, put it on the tab,” says Rachuba. “Just  cruise out and take off.”

Agrees Majure: “That’s really the only sure-fire safe way to do it.”

Rachuba jokes that they should pull up behind a large jet, allowing the  heat of its exhaust to “keep our wings clear for us.”

They laugh.

Near Runway 13, 9:15 p.m.

Denise Miller thinks to herself, If they don’t de-ice again, I’m getting up out of my seat. She has heard planes get de-iced every 20 minutes. Also, it’s  an instinct from traveling so often.

Her father notices her anxiety. “What’s wrong, Denise?”

She shrugs her shoulders. She doesn’t want to tell him she thinks the plane shouldn’t take off.

On the runway, 9:31 p.m.

After a backup on the taxiway, it is almost Flight 405’s turn.

“Ladies and gentlemen,” Rachuba announces. “We’re now No. 1 for departure  and we’d like our flight attendants to please be seated.”

Denise Miller can no longer contain her anger.

“Denise,” says her father. “What’s wrong?”

She starts to unfasten her belt buckle so she can stand up to protest. She  considers marching up that aisle to scream at the pilot: Don’t take off!

Meanwhile, Joan Forshew reaches across the empty seat for her husband’s  hand. “Good luck,” she says. “This is going to be an experience. Here we go.”

He doesn’t reply; ever-calm, he remains glued to his paperback.

Takeoff, 9:34 p.m.

“USAir 405 runway one-three cleared for takeoff,” says the ground  controller.

The engine’s whine rises as the plane rolls down the runway. From the  cockpit, you can hear the wheels thumping, gauges clicking. The craft lifts  slightly.

Suddenly, alarms sound, beepers go off, warning of a stall. The plane  drops, dipping to the left.

“Oh my God! Oh my God!” Denise screams.

“We’re gonna crash,” Joan Forshew says, squeezing Frank’s hand and putting  her head in her lap. Over in row six, Kendra St. Charles puts her head down  too.

Majure swerves. Five seconds before slamming into a pump house and flipping over into Flushing Bay, he utters one last word: “God.”

Then everything goes black.

In the cockpit, still strapped in, co-pilot Rachuba regains consciousness.  Water is rushing in up to his chin. The window is stuck.

When he cries out to Capt. Majure for help, he gets no answer. He sees only a mass of twisted metal.

As water rushes in, he thinks: I’ve awakened and gone to hell.

He calls out to Jesus, to God.

Somehow, Rachuba finds himself outside the plane.

In the water, 9:50 p.m.

Bart Simon can’t seem to get out of his seat, though the seat itself ripped from the fuselage. He hears water lapping at the plane, which looks as if it  cracked like an egg. In a panic, he tries to press the button on his seat  belt.

He thinks: I’m alive. I survived this crash, but now the plane is going to  blow up and I’m not going to get out of here.
Then he remembers: It’s not a car seat belt, there’s no button. You pull it open. He jumps into the water, manages to swim, thankful that he skipped his  usual martini.

Denise Miller tries swimming but, disoriented, sees only darkness. She  pivots, spots the lights of the runway and the fire, begins swimming toward  it. Jet fuel spreads on the water.

She looks to her right, and sees her father, his seat still attached to the bathroom wall. She can just make out the dark shape of the flight attendant,  too, with whom her father had been joking moments ago.

He can’t seem to get his seat belt undone.

“Hold on, Dad,” she screams. “I’ll be there in just a minute.”

Then, when Denise feels the bottom of the bay and tries to climb slippery  rocks encrusted with ice, it happens: The tail end of the plane explodes.  Flames shoot into the snowy sky.

Joan Forshew is still in the wreckage. She feels something mushy at her  feet. For an instant she thinks: Maybe that’s Frank. That’s it. I’ve just  buried my husband.

“Hey, lady!” another passenger yells at her. “You have to get out of  here!”

“I can’t move,” she pleads. “My leg’s caught.”

Somebody rips her sweater, eases her leg out, tells her to go toward a  light. That’s all she seems able to focus upon: a light. She falls out of the  plane into the dark icy water.

Kendra St. Charles becomes conscious. She is still strapped into seat 6B,  the seat she was forced to move to. She does not know it, but the passengers  in the two other seats have not survived.

She seems to be upside down in the cold water. She manages to right herself and spots the lights of the runway. A rib has punctured her lung; she has  trouble breathing. But the cold, the terrible cold, seems to overwhelm the  pain.

In the water, 9:55 p.m.

Denise Miller can’t feel her legs, unable to move. Fire from the tail  section is spreading, lapping at the jet fuel leaking into the water – heading toward her on the rocks. She can’t get away from it. It rushes closer. It  flares at her, then shoots up her body. She becomes a screaming ball of fire.  She thinks: I’m going to burn to death.

A stranger runs over, at first keeping his distance.

She tries running back into the water, but stops. Then the man grabs her  and rolls her on the icy rocks to extinguish the flames. It works.

When he sees she can’t stand, he runs for help.

“No!” she screams after him, looking at the flames still spreading nearby.  “Please don’t leave me!”

Bart Simon crawls through the water and sees Joan Forshew on the edge of  the embankment. Blood streams down her face.

She has no idea how she got there, and she can’t seem to see, but now all  she can think is: I’m cold, so cold.

“Go help that woman!” somebody yells at Simon.

He thinks: What am I gonna do? Shocked, he doesn’t move at first. Then,  somehow, he edges closer.

“It’s gonna be all right,” he reassures her. “Hang in there.”

Unable to walk, she is carried to an ambulance. “My husband,” she says. “Do you see my husband? I don’t think he made it.”

Kendra St. Charles sees a man when she comes to the edge of the water. “I’m so cold,” she tells him. The snow pricks her face like so many needles.

“Just lean on me,” he says. “You’ll be OK.”

She passes out.

Cleveland, shortly before 10 p.m.

Denise Miller’s husband, Peter, over at her mother’s house, is on hold with USAir, trying to find out when the plane is due at Cleveland Hopkins  International Airport. As he waits, a recording repeats that all lines are  busy. On TV, a news flash spells out USAir Flight 405 crashes in N.Y.

“Oh my God,” cries her mother, Mary. “I can’t believe my baby is dead.”

Denise’s husband slides off his wedding ring, looks inside, where it says  today, tomorrow and always, and breaks down.

He has always depended on  Denise.

He asks aloud: “Now what am I going to do, Ma?”

Bellevue Hospital Center,
Manhattan, 11:45 p.m.

A psychiatrist asks Denise Miller what she’s most afraid of.

“My husband not wanting me because I’ll be disfigured.”

Her long hair is gone. It came out, on a brush, in a smelly dark clump. She has third-degree burns on her hands, arms and face. She still can’t feel her  leg.

A little later, the psychiatrist returns, having telephoned Denise’s  husband.

“He has a message for you,” the doctor says. “He says he loves you very  much and can’t wait to be with you.”

Injuries

Joan Forshew: Four-inch gash in her head. Badly fractured pelvis. Large  three-way puncture wound to the thigh. Burns on her face, ears, hands and  feet. Her hair is, as she puts it, “like a frayed Brillo pad full of jet  fuel.”

Kendra St. Charles: Six broken ribs, one of which punctured her right lung. Unable to breathe on her own, she is put on a respirator for four days. Her  lips remain caked with blisters, and she is unable to eat. Torn ligaments in  leg. Burns on face, ankles, feet, knee and hands. She has no eyebrows or  eyelashes.

Bart Simon: Seven stitches on his head and he is a free man. The crash was  on a Sunday. He flies out of LaGuardia the next day and is back at work  Tuesday morning.

Denise Miller: Broken nose. Swallowed jet fuel. Badly fractured bones in  her left leg, from the knee down, so crushed that doctors at first decide to  amputate. “No way,” insists her husband when he arrives. “She’s too young. She’s only 30.”

They get a second opinion. A specialist will attempt to “transfer” a muscle from her stomach and the bone from her right leg into her left leg. It sounds  miraculous. She thinks of him as “a surgeon from heaven at the hospital from  hell.” ‘

But nobody knows if it’s going to work.

It is just the kind of microsurgery that distinguished Joan Forshew’s  husband.

For six days, Denise Miller stays in intensive care. Since she is unable to talk, her husband points to a board with letters on it. She blinks her eyes  once if he points to the letter she wants, twice meaning no.

“Am I going to die?” she spells once.

And another time: “Where’s Dad?”

Her husband doesn’t answer.

Life after the crash

In November, Bart Simon flies to the Far East. Every takeoff conjures up  images of that night. In Taipei, he checks his ticket for the number of the  flight to Hong Kong.

It’s 405.

He thinks: Somebody must be testing me.

“This whole thing has sobered me up,” he says. “I don’t want to, but  sometimes I can’t help thinking about death and dying, about how close I was,  why I survived and somebody else didn’t.”

Joan Forshew wonders what her relationship with Frank would have been if  they had both survived. She has learned to slow down.

Denise Miller remains in a wheelchair. On the rare occasions when she  leaves home, it is usually to see doctors or for physical therapy. She is  gaining back the 30 pounds she lost before the crash. She is laid off from her job; “It’s like a slap in the face.”

The fear of going to sleep keeps her awake. “I don’t want to relive it  again,” she says. “I don’t want to see his body burn again.

“I’m still working on myself. I’m not ready to mourn my Dad yet.”

A moment later, she is crying. “It was supposed to be just a little  vacation.”

Kendra St. Charles’ hands are burned so badly she is unable to bend her  fingers or open a door. For months she is unable to button a blouse or a  jacket. It will take more months of rehabilitation before she can make a  fist.

She is supposed to wear special gloves to push down the scar tissue. Her  hands sometimes tingle, sometimes sting, and she feels as if they might crack  open at any time. When she takes off her gloves, she can see where her watch  and ring were.

After a family visit in the fall, Joan Forshew takes her daughter, Heather, to the airport, to catch a plane back to Charleston, S.C. Forshew is in for a  shock.

Heather’s plane is a USAir Fokker F-28.

“Heather!” she says.

Joan decides to confront her fear. “I really want to be able to get on  again,” she tells Heather.

She gets permission to board and follows Heather. Once inside, she looks  back at the doorway, and is overtaken with uncontrollable shivers.

Quickly, she hugs her daughter and rushes off the plane. She runs to the  observation deck. She wants to be alone, though it is foggy and raining, to  see how she is doing. She seems fine.

She walks back to her car. That’s when it hits her.

“I absolutely shivered from top to bottom. I didn’t know whether I’d be  able to walk. I started to shake. I got back to my car, got in, and just cried and cried.”

At Christmas, she goes to Florida again – by car.

—————-

Other stories from this series:

Deadly Delays: Bureaucracy is Killing Us – Long after wreckage is examined for clues, causes determined, and solutions urged – thousands of Americans still risk death or injury in similar accidents. (The Plain Dealer)

Ice on Jets – Recurring Risk, Tolerated for Years – Despite pinpointing causes of multiple commercial airliner crashes, Washington does nothing to require simple, proven remedies advocated for years

Flight 405: The Story of Four Passengers- Strangers on a plane, going about the routine business of flying, trusted that commercial aviation had become as safe as airlines and the government could make it.  They were wrong.

Killer Trucks – Why the Slaughter Won’t Stop – Trucks with self-adjusting brakes would have fewer accidents, causing less damage and saving hundreds of lives.  Yet the government dawdled in requiring them.

While Grownups Squabbled, Children Died – Battles between automakers and regulators for more than a decade stalled development of safer child seats.

Feds Shrug Off a Life-Saver for Commuter Planes – Commuter airline flights crashed repeatedly into the ground for lack of a simple device  urged for years by federal safety officials. The  FAA declined. Planes kept crashing.

Cessnas Crash, but Agencies Do Nothing -  For decades, Cessnas chocked from a carburetor flaw known to the manufacturer and the government. Yet pilots had never heard of the problem, and the government required no fix.

Yellow Coffins – Modern school buses are among the safest means of transport. Yet when accidents occur, children are often trapped. Still, the government for years allowed preventable tragedies to recur.

Safety Board Has No Teeth – The National Transportation Safety Board is widely known for investigating accidents. What many people don’t realize is that it’s powerless – a toothless tiger.

Travel is more than destinations and activities. It’s experiences, emotions and relationships. Hence RelationTrips.com and the column, RelationTrips, in The Washington Post and other newspapers. A sampling:

Passion Takes a Holiday (July 29 2001)

Honeymoonstruck (August 1, 2001)

The Plain Dealer

Sunday, June 9, 1994

By KEITH EPSTEIN

Squealing to herself, 3-year-old Becky Furmann bounds into the room in Barney shoes, an imaginary Tinker Bell in tow.

Above her bed, stuffed animals cavort in rainbow colors. On the wall, a poster of Big Bird blazes yellow. Circling the room, Becky – and Tinker Bell – play with a toy truck.

In this child’s room, though, are somehow too many cabinets. They hold boxes of syringes. Pumps for intravenous feedings. Plastic gloves. Containers labeled “Reglan,” “Bactrim,” “Morphine.”

Suddenly, Becky stops playing. The Barney shoes freeze upon the floor, motionless. She forgets even Tinker Bell.

“My tummy hurts,” she moans, obviously in pain.

Within her tiny body a microscopic bug is ravaging her intestines, invading her gall bladder, cutting its nasty way through her pancreas.

It got there from the water she drank.

Ordinary tap water.

The same city water that sickened an estimated 403,000 people here a year ago, sending 44,000 to doctors, 4,400 to hospitals, accounting for 479,000 lost days at work, costing employers tens of millions.

Now health officials are acknowledging another statistic, little noticed elsewhere in the country: the number of dead and dying. They say at least 104 people have been hastened to their deaths – months and sometimes years sooner than expected – by the parasite that last April somehow slipped through the usual safeguards at a water plant only blocks from Becky’s home.

“The health impact has turned out to be far more severe than we ever suspected,” says Paul W. Nannis, Milwaukee’s health commissioner. “For most of us, it was like a bad flu. For some, it’s a tragedy.”

The toll has been largely missed outside Milwaukee. Some say that’s because most – of those afflicted have human immunodeficiency virus, HIV.

People like Becky.

Of 122 HIV patients, 82 have died what Nannis terms “very accelerated deaths.” Among them were five children, including Becky’s best friend, Brandon. Becky is the only child still alive. Other people are dying. A national search is on for still more people who may have ingested “crypto” while visiting here.

Yet for all the political impact of Milwaukee’s crisis, which underscored the potential for peril in household taps in many communities, little has changed for the 230 million Americans who depend on public systems to safeguard them from a variety of contaminants.

The Senate last month weakened standards. States and cities had complained of the cost of complying with so many rules, such as testing Ohio water for an insecticide used only in Hawaii. Debate resumes in the House, probably later this summer.

You might be tempted not to care about Becky: Her mother was a prostitute. You might be tempted to say to yourself, well, she was going to die anyway; after all, she had HIV at birth.

You may be troubled by her non-traditional family: She’s being raised by two gay men, the only people who seem to have loved her in her short life.

Larry Furmann, the man Becky calls Daddy, knows how you might feel.

But he wants you to consider this:

“Did Becky have a choice?

“People can say gays deserve HIV or that drug addicts will have to stop using needles. Fine, we can debate that. But this precious child, this beautiful little girl, had no choice in being born this way and then having drinking water that comes out of a faucet bring her a quicker death and so much more pain. It just wasn’t her fault.”

Who’s to blame?

Just how did the parasite cryptosporidium get into Lake Michigan and then through the Howard Ave. water plant, causing one of the largest outbreaks of waterborne disease in U.S. history?

How did so much get through that even a person who took a sip at an airport water fountain got terribly ill? The answer remains as murky as the water was last March and April.

Health authorities knew, figuring backward from when people got sick, that the parasite must have begun surging through city pipes around March 23, 1993. What else might have been happening then?

Seeking answers, investigators combed records of dairy farms and slaughterhouses, reviewed documents from the water plant, analyzed water flows from streams and rivers.

Milwaukee gets its water through an intake pipe in Lake Michigan, only two miles downstream from the outflow of a sewage plant and near the mouth of the Milwaukee River.

Experts thought they might have some valuable clues when somebody told them a large quantity of city water had been frozen that March for an ice sculpture contest. But studies of the melted ice also proved inconclusive.

“We assume a massive infusion of a high level of crypto,” said Nannis. “But from where? There are three rivers and a big lake. It’s hard to prove anything.”

Mysteries encourage people to concoct theories of their own, some of which involve fanciful coverups involving water workers who go missing.

“Everybody wants to know who to blame,” said Nannis.

One of the most popular theories is the most obvious, considering that the parasite – most often associated with cattle – turned up in a big dairy state.

Was runoff from dairy pastures or a Milwaukee packing plant to blame? Had somebody illegally disposed of dead calves?

“Each industry came forward saying, ‘Don’t implicate us. It’s not us,’ said Nannis. “People don’t want to be tarnished.”

No evidence surfaced suggesting they should be.

Less murky is what happened once the contaminated, brownish water arrived at the water plant.

Workers “had a difficulty in maintaining a proper … dose” of water treatment chemicals that were new to them, concludes Kim Fox, an Ohio-based Environmental Protection Agency researcher who investigated the event. “The big lesson is you need to test your water all the time, continually, maintaining vigilance.”

As a result, Milwaukee is one of the few cities now doing so. Its equipment includes lasers that constantly count particles in the water as it moves through the treatment plant. Too many particles warn of potential contaminants. Mayor John Norquist advocates a fancy ozone treatment system to more effectively treat water – at a cost of up to $40 million.

Forty communities are experimenting with similar methods of disinfecting water with ozone gas instead of chlorine, byproducts of which have been linked to cancer.

Larry Furmann has heard about the theories, the equipment, the costs.

“I’m just filled with rage,” he said. “I fully believe there was some jerk who didn’t care about looking at some dial or gauge.” There’s talk of a lawsuit.

“But what good does that do Becky now?”

Letting Becky go

Ric and Larry, now in their 50s, once dreamed of running a foster home for young children with HIV. Ric, whom Becky calls “Papa,” is a teacher-turned-homemaker. Larry – “Daddy” – is a former drug abuse counselor who now works part-time so he can help care for Becky.

Ric says he always wanted a child. For Larry, a divorced father of two, adopting Becky was the result of what he calls his “do-gooder” tendencies. At first, anyway.

“But now,” he sighs as Becky runs over and cuddles up to him, “I feel like parent and child with her.”

He loads her syringe with pain-killing morphine.

“She’s really got to me,” he continues. “It’s gonna hurt like hell when she goes.”

Becky calls the broviac catheter on her chest “Freddy,” like a friend. It’s a plug through which Daddy or Papa can pump medicine or, when she can’t keep any food down, liquid nutrition directly into a vein. Her doll has a catheter into her chest, too.

“Freddy is nice,” Becky volunteers as Ric clears the table of medicines and syringe wrappers. “Fred is nice because he’s in my heart.”

Concerned that Becky might be taunted in elementary school, both men changed their last names – to Becky’s.

Elementary school. They’d actually expected she’d attend, at least until kindergarten or first grade.

But then, two months ago, after alarming lab tests, doctors warned Larry and Ric to start watching Becky for signs of hemmorhaging. “When it’s time,” says Larry, “hopefully we’ll have the strength to let her go.”

As gay men, they knew too well the realities of AIDS, the inevitability of death, the fact that it can arrive sooner than expected. Both had young friends, sick and dying before their “time,” long before anything turned up in Milwaukee’s water.

But they weren’t prepared for this: A chubby little girl with a pink ribbon in her hair who has little chance of living much beyond her fourth birthday.

In August.

“She’s so young, so innocent,” Ric says softly.

Becky, now smiling blankly at the TV, slips into the haze of narcotic-induced tranquillity.

Risks beyond Milwaukee

Sudden severe and widespread sickness from drinking water – more commonly associated with places like Mexico or Turkey – is still a rarity in the United States. Yet almost weekly, health officials document examples of contamination at documented examples of contamination, sometimes leading to illness and death.

Here in Milwaukee, supermarkets still do a brisk business in bottled water. Yet even that is rarely pure. Other substances dissolve too easily into water: Polluted runoff, chemicals from lawns, cow manure, pet waste, and in places such as Cleveland, sewer overflows that wash human feces into lakes and rivers.

The Centers for Disease control estimates that bacteria, viruses and other pathogens sicken 940,000 Americans each year, of whom 900 die. Between 1970 and 1992, according to the CDC, more than 100 outbreaks of microorganisms sickened more than 140,000 people in 40 states.

Even cryptosporidium, usually found in mice, turkeys and calves, has turned up three other times in water systems since 1984 – in Carollton, Ga., Medford, Ore., and Braun Station, Tex.

Healthy people with normal immune systems usually suffer cramps, nausea and diarrhea, but survive. But people with immune system disorders, older people and young children can die.

Even so, most attention focuses on the perils of chemicals, including those use to disinfect untreated water.

In one study, published in the American Journal of Public Health, doctors from Harvard and Wisconsin medical schools estimated that chemicals such as trihalomethanes – byproducts of the use of chlorine to treat water – may cause 10,700 rectal or bladder cancers a year. Last week, the federal EPA, environmental groups, cities and water service and supply companies agreed to steps that would reduce trihalomethanes, but actual results may be years away.

Lead still poses problems, especially for children, and environmental advocates such as the Natural Resources Defense Council warn of the perils of nitrates, arsenic and other contaminants in public water supplies.

Testing for every possible contaminant is impractical. “You could bankrupt this and every other city by testing for every carcinogen and bacteriological agent known to man,” Nannis said.

But even though the federal government will take at least another year to come up with safeguards against crypto, Milwaukee has adopted its own standard:

Zero tolerance.

“We’ve learned never to be complacent again,” said Mayor Norquist.

Can it happen again?

“No,” said Nannis. “But of course,” he added calmly, “good science dictates that we can never say never.”

I’m dying’

Last Christmas, Ric made a nativity scene on the dining room buffet. Larry, the decorator in the family, was arranging the figurines when Becky wandered over.

“Papa,” she said. “I need to talk with you.” Her tone seemed out of character, too somber for a three-year-old.

“What is it, honey?” asked Larry.

“I’m dying,” she replied.

Ric and Larry exchanged stunned glances.

“Who told you that?” asked Ric.

Becky thought for a moment, then answered: “Santa Claus.”

“What happens when you die?” asked Larry.

“I go out,” she answered.

“You go out? You mean outside?”

“No,” said Becky. “I just go out. My hair falls off. I go out. Then I meet Daddy. And Papa fixes me.

And then I’ll be all better.”

THE PLAIN DEALER
Sunday, November 8, 1998

FIRST OF TWO ARTICLES

By KEITH EPSTEIN and BILL SLOAT
PLAIN DEALER REPORTERS

A legacy of medical exploitation, from secret Cold War radiation experiments to notorious syphilis studies on unwary blacks, has led the United States to adopt some of the world’s toughest protections for people on whom scientists test new drugs, devices and vaccines.
So firm is the underlying presumption that patients in experiments must be treated fairly and honestly that the protections of federal law apply not just to Americans but to any person, anywhere in the world, used in U.S.-financed research.

But federal and foreign records disclose that the nation with some of the world’s strictest research safeguards has flouted its own rules in dozens of countries, and has a history of “systemic deficiencies.”

On nearly every inhabited continent, the U.S. government has fashioned scientific partnerships with foreign officials and undertaken scores of medical research projects without obtaining basic agreements to avoid human rights abuses, as the law requires.

The contracts, known as “assurances,” serve as formal government-to-government accords that overseas scientists spending federal dollars are treating their patients as Americans would be treated. The contracts were missing in all 96 research projects conducted by the Centers for Disease Control and Prevention over the last decade.

The research alliances, most formed within recent years, have been sponsored by the Atlanta-based CDC, an agency with a storied reputation for protecting public health.

In these international collaborations, the United States provides money, manpower and the best available medical technology. The foreign partner provides whatever scientists it can muster and access to a vast living laboratory of human test subjects, often undereducated and desperate for medical care.
In a number of instances, drugs were given, samples taken and research completed without a written assurance of compliance with rules that patients be fully informed, monitored for safety, told of known treatments and free to refuse experimental drugs:

• On the Ivory Coast, pregnant women with HIV got dummy pills but were not told the drugs wouldn’t work.
• In Zambia and Malawi, children in a malaria project got medical treatment but their guardians weren’t told whether it was “standard” or “experimental.”
• In Niger, consent forms for parents of babies vaccinated for diphtheria and meningitis conveyed vital details but not in the local language. Consent forms for a rabies vaccine trial in Ethiopia also had not been translated.

Altogether, the CDC “was engaged in 96 active research studies in 32 countries” where it “did not have approved assurances” from foreign collaborators they would abide by U.S. ethics laws, Marjorie A. Speers, the CDC’s deputy associate director for science, wrote in a July 1997 memorandum.

At the time, that involved every foreign research project sponsored by her agency. Some of those projects had been going on for 10 years or more, Speers said in an interview last week. Most involved tuberculosis, HIV, malaria and syphilis.

“The volume of what was out of compliance is startling,” said Gary Ellis, director of the National Institute of Health’s Office for Protection from Research Risks, to which the CDC quietly confessed last year. He said the scale of failures was unprecedented in two decades of enforcing the regulations.

J. Thomas Puglisi, director of human subjects protections at OPRR, said the amount of research that had failed to abide by the regulations “bothered me greatly,” because it demonstrated that a handful of controversial CDC experiments on foreign mothers with HIV were not isolated incidents.

“The identification of numerous international studies where all the required protections for human subjects were not in place was an indication of a need for systemic improvement at the CDC,” Puglisi said.
Speers, while acknowledging the rules were violated, said the CDC was confident no foreign research subjects had been harmed.

“What was missing was the procedural requirement to have this written assurance,” she said, “a document where an institution is saying we will follow ethical principles and abide by the rules.” Speers also said that the CDC had had to correct some overseas consent forms to make them clearly disclose to patients that they were taking part in health research.

It wasn’t the first time OPRR, the government’s main internal investigative agency on human experimentation, uncovered “systemic deficiencies” at the CDC.

Documents obtained by The Plain Dealer reveal recurrent failures, bureaucratic upheaval and broken promises of reform at the Atlanta-based public health agency.

Among the reasons: The government’s inability to police itself. A recent report to a presidential advisory commission described OPRR, the enforcer of the rules, as virtually powerless, especially when it comes to the CDC.
The human protections bureau is too “small and weak” to compel the CDC to correct problems, concluded the report by John C. Fletcher, former chief of bioethics at the National Institutes of Health.

The U.S. regulations are plain: Researchers cannot camouflage the truth. They cannot omit vital information about risks. They must offer any appropriate alternative medication. Doctors must disclose what they know and don’t know – whether in Cleveland or Cairo.

“We’re ethically bound to observe our regulations in the U.S. and overseas – because they’re based on principles we all agree on. And there’s no ethical principle I’m aware of that says we can treat other people in another country differently than ourselves,” said Dr. William Freeman, president of the Applied Research Ethics National Association, the leading U.S. membership organization of scientists and others overseeing the ethics of research.

Freeman, also director of medical research at the U.S. Indian Health Service, which oversees experiments on America’s Indian reservations, noted the grossest examples occurred when researchers treated other people differently than they would treat themselves.

Most notable, he said, was a federal study beginning in 1932 at Tuskegee, Ala., where 412 poor, black men were allowed to sicken with syphilis without being told and without being offered a known and effective treatment. The argument in Alabama, as overseas today, was that the patients probably would have received no better treatment anyway – a rationale Freeman doesn’t buy.

“The rules aren’t just rules but an expression of our morality and sense of community that you should do unto others as you would have them do unto you. If you want to be respected when you’re dependent on others, you’d better show respect to people dependent on you. If you want to be told the truth when you don’t have any way of knowing whether it’s true, then you’d better tell the truth yourself. If you want to be given a chance to say no to something, you’d better offer that chance to others.”

Said OPRR’s Puglisi: “It’s not that researchers are bad people. But sometimes they get so caught up in their immediate goals and the sense of the goodness of what they’re doing that they fail to see the larger ethical implications of their actions.”

Speers said that overseas studies supported by the CDC often operate with lower standards than in the United States.
Among the projects lacking a legally binding promise from the foreign country to follow the rules was a tuberculosis prevention study in Uganda, in which 464 Africans in a control group were given a placebo, or fake pill, instead of an established and inexpensive U.S. medication for which the CDC had long found “strong evidence and substantial clinical benefit.”

In September 1997, the CDC’s Speers confirmed that “at the time the study was done” her agency lacked an agreement with Uganda to abide by U.S. rules.
“However,” she added, “we’ve been working on getting one for the past few months.”
By then, the study was finished and results had been published by the New England Journal of Medicine.

Ethical rules challenged

CDC officials in recent months have been arguing that U.S. ethical rules ought not to apply in many of the very nations where the agency failed to adhere to the regulations.

For instance, Speers said, language differences can make it extremely difficult to follow U.S. rules for getting a patient’s informed consent.

The CDC also argues that in countries where no better care is available, scientists need not live up to U.S. standards of care.

The CDC’s sister agency, the National Institutes of Health, has more than 700 assurances in place for research in more than 110 countries.

Those assurances are generally negotiated by universities receiving NIH grants.

But Speers said the CDC had had trouble obtaining assurances because other countries strongly object to having ethics rules imposed on them by the U.S. government.

“We shouldn’t be dictating a code of ethics for other countries. Telling them how things should be done is often viewed as imperialistic,” said Speers.

The CDC has been anything but imperialistic, federal and foreign records show. Sometimes, the health agency has chosen to play by the local rules in places where there are no clear rules, according to internal e-mail traffic, memoranda, directives, compliance audits and other government documents obtained by The Plain Dealer through the Freedom of Information Act.

In Kazakhstan in 1997, nobody could be found to approve or monitor the “Central Asian Infectious Disease Project.”
Referring to a requirement for the use of ethical review committees to monitor patients’ safety, a CDC epidemiologist noted that in Kazakhstan the committees “or anything resembling them simply do not exist.”

In the Slovak Republic, a study of children with allergic diseases, launched in 1996, had to be halted.
During the study, laboratory samples were being collected for unspecified “future research” – but the children and their parents were not told what it was about, or asked for their permission.

In Egypt in 1997, a study assessing blood lead levels in children included consent forms that neglected to mention the project was “research.”

In Sierra Leone, the problem wasn’t getting a foreign government to form an alliance with the CDC, it was finding the government.

“We cannot acquire a government signature at this time due to the fighting and disturbances in Freetown,” a CDC official wrote from Africa in June 1997. “The U.S. Embassy is evacuated and we have no way to communicate at this time or know who to address.”

In Washington last fall, the National Institutes of Health was dispatching directives to CDC-affiliated researchers around the world to comply with the rules or close down.

“If your review does uncover any questionable situations we request that all further collections of biological materials be suspended until such time as the necessary [ethical] assurances are obtained,” one directive stated.

An internal chronology compiled by human protections agency and obtained by The Plain Dealer reveals ethical lapses from February 1993 through May 1997 that recurred despite attempts at reform.

CDC promised it could do better. The lapses ought not to happen again.

“CDC officials pledge their commitment to ensuring full protections for human subjects in all research conducted or supported by CDC,” the agency promised in August 1993. “They further pledge … concrete actions.”

By October 1996, ethics managers were reshuffled and CDC took the step of assigning a top official – a deputy associate director, Speers – to oversee protection of human subjects on a daily basis.

Then, in 1997, Dr. Sidney Wolfe, the Cleveland native who works for Ralph Nader, went public with his discovery that in nine government studies, including two sponsored by the CDC in Thailand and the Ivory Coast, pregnant women in control groups were not offered an expensive form of AIDS treatment available in the United States.

That aroused the curiosity of OPRR’s director, Gary Ellis, who wondered whether the CDC had obtained the necessary written contracts to abide by the rules. At the suburban Maryland office building where he works, Ellis ensconsed himself in a room of file cabinets containing copies of more than 10,000 such contracts, mostly from universities and government agencies.
He could find none for the CDC studies, so he called the agency.

Three days passed without an answer.

He called Atlanta again – and guessed. He was right. The CDC hadn’t gotten any “assurances” the AIDS studies would follow the rules. The studies were halted immediately.

A few hours later, there was another call and another confession. The problem, the CDC reported, had somewhat larger dimensions. The agency was having trouble figuring out how many international alliances it had formed. Records were in disarray.

“It takes a long time to change a culture, but there are people at the CDC now who are getting it,” said Puglisi. “They’re learning. But we’ve also learned when it comes to human subject protections, one has to be ever-vigilant.”

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Related stories:

In the Name of Healing Doctors infused a solvent also used as a gasoline additive into Laura Michalski’s abdomen. Within hours, she died. Eight years later, her family learned it had been an experiment.

“They Used Our Kids as Guinea Pigs.” Medical research records show the U.S. government is still in the business of conducting and paying for clinical trials on unsuspecting Americans.

Foreign Tests Don’t Meet U.S. Criteria The cycle of hype, hope and heartbreak surrounding clinical trials has become a chronic condition in the global pharmaceutical industry, which now initially tests two-thirds of all products for Americans overseas. The experiments often involve fraud, concealed side effects, improvised experiments and human rights abuses.

Living Proof: U.S.-Run Study Gave Ugandans Dummy Pills Instead of Treatment American researchers let tuberculosis worsen, unchecked by an effective drug, in a control group of 500 Ugandans with HIV, as they charted its deadly progression. Some thought “placebo” was a medication that would help them. In the U.S, the practice would have been unethical.

One morning,  hospital workers began infusing a solvent also used as a gasoline additive into Laura Michalski’s abdomen.

She died within hours.

Eight years later, her family learned the truth: It had been an experiment.

(The Cleveland Plain Dealer)

December 15, 1996 (Day 1 of 4)

By KEITH C. EPSTEIN and BILL SLOAT

She was given a code name, “TE3.”To this day, the federal government won’t say who she was or what it knows about how she died.

It hasn’t even told her family.

Laura Michalski’s husband, naturally, knew her as the center of his life.

They met one night in 1938 at a 15-cent jitterbug dance. He recalls “we floated on that floor as if it was ours. I thought right then: This girl I have to marry.”

Laura and Alexander taught their five children to be proud Polish Catholics and oversaw their chores in the family’s grocery a floor below their Philadelphia apartment.

Come Christmas and Easter, she would stuff kielbasa for the store, and still manage to assemble a lavish holiday spread for her own large family.

“You could have invited the president,” Alexander would say.

At suppertime, everyone was expected at the table. No excuses allowed.

She was strict, but spiritual, too. She knitted angels, crocheted angels, collected figurines of angels.

By the time Laura Michalski checked into Philadelphia’s Hahnemann University Hospital, she was 64, the beloved grandmother of 19. Her kidney system was failing. There were gallstones, the pain intense.

“I can’t find a comfortable place in this bed,” she would say. “Sometimes, I wish to God the angel would come for me.”

One morning, “they told me she was going to have this new treatment,” said Alexander.

It was June 7, 1988. Around 10:40 a.m., the medical records show, hospital workers began infusing a solvent also used as a gasoline additive into Laura Michalski’s abdomen.

A pioneering radiologist, Dr. Steven K. Teplick, believed the solvent, methyl tertiary butyl ether, held promise as a method of dissolving gallstones. Physicians at the Mayo Clinic, and in Germany, had conducted similar experiments.

The idea was that MTBE would help patients avoid surgery. Researchers had to convince the federal Food and Drug Administration that it worked and was safe.

By midafternoon, records show that from 142 to 360 cubic centimeters of the solvent, nearly enough to fill a small coffee cup, had been infused.

Michalski’s heart speeded to between 140 and 150 beats per minute. Her blood pressure fell. Her fingernails began turning blue. After she was rushed to intensive care, her heart weakened, then gave out.

At 6:50 p.m., a few hours after the infusion ended, Laura Michalski was pronounced dead.

“When all my kids got there, I was still crying,” Alexander said. “This was my love, my friend. We’re together 47 years. I’d hoped to God for 50. . . . Then, suddenly – after it seemed like there was going to be no problem – she’s not there.”

Listed on her death certificate as contributing causes: heart arrest, aspiration of body fluids and a disease of the gallbladder known as cholangitis.

The Plain Dealer identified Laura Michalski as TE3 by matching information from an FDA file to her death certificate. The documents matched on time, place and cause of death.

“We were never told it was ^after] an experiment. We had no idea what was going on,” or what the federal government eventually learned about the clinical trial, said Michalski’s daughter, Bernadette McCloskey.

A year later, inspectors from the FDA happened to be conducting a routine audit when they found out about TE3 – as well as TE4, TE7, TE8, TE10, TE11, TE15, TE19, TE21 and TE25.

Both before and after Michalski’s death, nine of 29 patients suffered “adverse effects . . . in close proximity” to infusions.

The forms had stated “the drug will probably be effective.” Consent forms “failed to adequately address the foreseeable risks and discomforts,” the FDA found.

Teplick said he had obtained consent from every patient and did not believe that any harmful side effects were caused by MTBE.

The FDA halted further research “due to unreasonable and significant risk to human subjects.”

It was hardly the first time the government had made such a discovery.

And after the fact.

On the frontiers of medical science, for the greater good of society, well-meaning doctors sometimes employ an ounce of salesmanship for a pound of cure.

Since 1977, the FDA has conducted 4,154 inspections of researchers testing new drugs on people. More than half the researchers, 53 percent, were cited by FDA inspectors for failing to clearly disclose the experimental nature of their work, a Plain Dealer analysis shows.

The risks, alternatives or uncertainties were obscured or incompletely explained.

In 46 clinical trials, drugs were tested on people without written evidence they had consented. The records are key safeguards required by law, signed receipts showing patients agreed to roll the dice with their health.

Altogether, at least 1,000 men, women and children were participants in the 46 pharmaceutical studies questioned by the FDA. The experiments, in 23 states, were sponsored by federal agencies and drug companies.

The analysis of the FDA files is strikingly similar to what a White House advisory committee discovered in 1995 when it examined patient-consent documents from more than 100 ongoing government research projects. The experiments, or clinical trials as they are more commonly known in scientific circles, are research studies designed to evaluate the safety and effectiveness of new treatments.

“Some consent forms currently in use are flawed in morally significant respects, not merely because they are difficult to read but because they are uninformative or even misleading,” the Advisory Committee on Human Radiation Experiments concluded.

Asked about the FDA’s inspection reports, Mary Pendergast, the agency’s associate commissioner, said she considered them “representative of biomedical clinical research as a whole.”

Many experiments do occur with appropriate safeguards. The fact that nearly half of all inspected research is conducted without deficiencies in informed consent suggests that following proper procedures is hardly impossible.

Ruth Macklin, bioethics professor at Albert Einstein College of Medicine in New York, said even complex human research could be conducted in an ethically responsible manner. The challenge is to determine needed changes to ensure that clinical trials are “in accord with the highest standards,” she added.

Each year, government and industry spend at least $20 billion financing research on hundreds of thousands of human beings, yet the government discloses surprisingly little about those people, the risks they face, the injuries they endure or the benefits to them.

“Most people don’t understand they’re in clinical research. They think it’s therapy,” said Case Western Reserve University bioethicist Thomas Murray, appointed this year to a new National Bioethics Advisory Commission.

How many experiments are there? How many people take part? At best, the experts can hazard little more than wild guesses.

Asked how many clinical trials take place, senior FDA official Paul Goebel Jr. replied with an ancient riddle. It has no answer. “How many angels can dance on the head of a pin?”

What the government lacks in hard data about humans, it more than makes up for with volumes of statistics about laboratory animals. Wonder how many guinea pigs were used in U.S. research? The Agriculture Department knows: 333,379. How many hamsters in Ohio? 2,782.

“There are more inspections for laboratory animals carried out by the Department of Agriculture than there are for human subjects carried out by the entire Department of Health and Human Services,” observed Charles McCarthy, a consultant on the use of laboratory animals and until 1992 director of a federal office meant to safeguard people in government research.

His successor, Gary B. Ellis, a University Heights native, is the first to acknowledge the government is more aggressive about protecting laboratory animals than humans. “Research subjects are real people, our fellow Americans. But in 1996, we do not have the tools necessary to ensure that they – and all human subjects – are protected.”

Only this month, the FDA for the first time required consent forms to be dated “in response to problems . . . verifying that informed consent was obtained” before clinical trials started.

Just one of the clinical trials in the FDA files, obtained under the Freedom of Information Act, involved at least 500 adults and children at a Miami Beach hospital who were injected with a radioactive dye without their permission.

Researchers acknowledged to the FDA they didn’t think consent was necessary.

The FDA’s Pendergast said it was a “company-to-researcher miscommunication. We got strong assurances and “mea culpas’ from the researchers that they recognized the problem and that they wouldn’t do it again.”

The experiment took place at Mt. Sinai Medical Center between 1980 and 1982.

The investigational drug, known as pipida, was mixed with a radioactive tracer and injected.

Dr. William M. Smoak, who worked on the team studying pipida, said he knows of no one harmed by the drug.

Earlier tests “convinced us it was a safe material, and then we were just doing tests adding volume [numbers of patients], looking for more unusual side effects. What are you supposed to tell people about hazards if you don’t know any for sure?” Smoak said.

“Juveniles as young as 15 years of age received injections and there was no informed consent,” an FDA supervisor, Melvin Zymash, noted in an internal report.

As for the men, women and children who received the injections – the FDA abandoned efforts to identify them when it closed the case in 1983.

By then, the era that allowed the use of unwitting patients for the sake of science and the greater good was supposed to be history.

What happened in Tuskegee, Ala., is still the most widely talked about medical experiment of our time. The U.S. Public Health Service wanted to find out what happened to men with syphilis. So, starting in 1932, the government diagnosed more than 400 black men with the disease but didn’t tell them.

It just observed them.

While distinguished scientists collected data, at least 28 men died.

When the world learned about Tuskegee in 1972, the outrage triggered new rules. Explicit informed consent was required. Ethics committees had to weigh predictable risks against anticipated benefits.

Today, every human subject is supposed to understand hazards, uncertainties and – even if chances of physical harm are remote – be able to say no.

As Yale University Professor Jay Katz, who served on the advisory committee that examined the Tuskegee experiment 22 years ago, puts it: “Research is a voyage into the unknown.”

Last month, for the first time, the FDA relaxed the nation’s informed consent rules. In an emergency, medical researchers can administer experimental drugs without a patient’s permission. The patient must be insensible, relatives unavailable and the condition life-threatening.

It was a sea-change in policy and eroded the first principle of an ethics code enacted by The American Medical Association on Dec. 11, 1946: “The voluntary consent of the person on whom the experiment is to be performed must be obtained.” The code of ethics was developed for prosecutors at the Nuremberg medical trial in Germany at the end of World War II. It evolved into a system of rules, laws and international standards governing informed consent.

Before a drug can be tested on people, it must be tested on animals. If the animal studies go well, the sponsor, usually a drug company or government agency, asks the FDA for permission to begin a clinical trial of the “investigational new drug.”

The experiment, normally in three phases, each involving a larger number of people, is intended to answer: What happens to the body? What is the best dose? What side effects surface? How does the drug compare to those already approved?

Only one in five investigational drugs makes it to market.

Thus, test subjects are critical to medical advances.

That pressure to recruit, says CWRU’s Murray, may tempt some researchers to camouflage risks and uncertainties.

Mary Poppins would have called it a spoonful of sugar.

In 1992, nearly 16,000 women across the United States and Canada were being asked to take part in a test of a synthetic hormone called tamoxifen. The National Cancer Institute wanted to learn if the drug could prevent breast cancer in healthy women.

A variety of consent forms were prepared. Some stated the pill had been approved by the FDA; it was, but only as a follow-up therapy for women already diagnosed with breast cancer.

Some consent forms said nothing about lab mice on tamoxifen developing liver cancer.

The FDA’s Goebel found another problem: It wasn’t clear in every consent form that the drug was being tested for safety.

“The toxicities are minimized and the positive benefits emphasized, resulting in undue influence being placed on women to enter the trial,” an internal memo said. “Use of the word “therapy’ to describe this study is inappropriate, as it implies treatment of a disease rather than the conduct of well-controlled research.”

Contemporary experiments on people for the pharmaceutical industry are more shrouded in secrecy than the radiation studies of the Cold War.

The existence of a clinical trial involving an investigational drug, and the identity of the sponsor, “is confidential, commercial information,” said Pendergast.

The names of errant researchers, too, are closely held. They rarely face severe consequences.

Neglecting to fully inform test subjects. Failing to disclose deaths or injuries. Failing to get permission from ethics committees of their peers. Faking data. In each instance, written criticism and a letter usually satisfies the FDA.

Those who face the harshest penalty, having their names added to a list of 82 researchers barred from obtaining investigational new drugs, need have little fear of being found out by peers or patients.

Names of “Disqualified Investigators” – the FDA’s “blacklist” – are distributed only among an inner circle of agency bureaucrats.

As Bernadette McCloskey studied the 47-page FDA file on the Philadelphia experiment, provided to her by The Plain Dealer for the first time last summer, she turned the pages slowly.

Whatever emotions she felt, she tried to keep to herself. Only for the briefest moment did her forehead wrinkle, chin quiver, eyes water.

She fought for composure, laboring to absorb this new picture of her mother’s last hours.

“We had no idea,” McCloskey said. “No one has ever told us anything. It’s certainly upsetting to find out there’s something we weren’t told.”

Six years after her mother was buried in Philadelphia’s Holy Redeemer Cemetery, the agency “disqualified” Teplick from conducting clinical trials with investigational new drugs.

FDA Commissioner David A. Kessler signed the formal notice. “You have repeatedly and deliberately failed to comply with the regulatory requirements regarding investigational new drugs,” Kessler wrote. Besides “failing to document informed consent,” he noted, Teplick had not reported adverse effects “probably caused by” the investigational drug.

Teplick, now on the faculty of the University of South Alabama in Mobile, said he never saw Kessler’s order, nor had the opportunity to challenge it. Every patient consented, he said, and MTBE caused no harmful effects.

McCloskey, the administratrix of her mother’s estate, has hired a lawyer, whoin September filed a malpractice lawsuit in the Court of Common Pleas in Philadelphia County against the hospital and the doctor. In a preliminary ruling Dec. 6, a judge dismissed the portion of the lawsuit dealing with informed consent, on grounds that under Pennsylvania law “a claim for lack of informed consent only applies to surgical procedures. The administration of a therapeutic drug is not a surgical procedure.”

Alabama granted him a medical license in 1994 as a “distinguished professor,” after peers from around the country wrote letters of praise. “Conscientious, honest and thoughtful physician,” one Wisconsin professor wrote. “Well-respected.”

“It’s amazing that the FDA, with all the expertise at its fingertips, can’t tell the state what it finds out about a researcher,” said John M. Goldberg, a lawyer with the Illinois Department of Professional Regulation. He learned of FDA action against a doctor while Illinois prepared its license revocation case against her.

The Illinois doctor, Chavonee Aroonsakul, had been reprimanded by Kessler for “repeatedly and deliberately” failing to comply with the regulations. “You failed to obtain informed consent,” Kessler stated when he placed her on the “blacklist” in 1991.

She said the charges were “false and unfounded” and that she always got consent from her patients. She says her only goal was to help people – administer her patented treatment for Alzheimer’s disease – and that the government had conspired to stop her.

“The FDA didn’t want to tell us anything,” said Goldberg. “Who are they trying to protect? The doctor? Some drug company? The system is nuts.”

——

Other stories in this series:

“They Used Our Kids as Guinea Pigs.” An investigation of medical research records shows the U.S. government is still in the business of conducting and paying for clinical trials on unsuspecting Americans.

Foreign Tests Don’t Meet U.S. Criteria The cycle of hype, hope and heartbreak surrounding clinical trials has become a chronic condition in the global pharmaceutical industry, which now initially tests two-thirds of all products for Americans overseas. The experiments often involve fraud, concealed side effects, improvised experiments and human rights abuses.

Living Proof: U.S.-Run Study Gave Ugandans Dummy Pills Instead of Treatment American researchers let tuberculosis worsen, unchecked by an effective drug, in a control group of 500 Ugandans with HIV, as they charted its deadly progression. Some thought “placebo” was a medication that would help them. In the U.S, the practice would have been unethical.

U.S. Medical Researchers Flout Rules Around World On nearly every continent, the U.S. government and its clinical trials partners have hidden risks and undertaken medical experiments without legally required  agreements to avoid human rights abuses.

Minorities and the poor — the largest group of uninsured Americans — suffer disproportionately from health problems. But would guaranteed coverage make everything better?

The short answer: No.

According to a little-noticed finding in a recent Institute of Medicine report: “Health insurance by itself will not eliminate ethnic and socioeconomic disparities in health.” [2]The conclusion is based on a University of California at San Francisco analysis of research spanning 16 years.

“While health insurance may alleviate financial barriers to care and improve the choice of providers,” the analysis said, “it does not address other individual and societal determinants of poor health experienced by ethnic minorities and the disadvantaged.” [3]

In short, the authors cautioned, the United States “should not be content to focus only on insurance [to correct] social disparities in health.” Scandinavia, Japan and the United Kingdom, for example, have failed to erase socioeconomic differences despite their well-established systems of universal health coverage. [4]

Less affluent persons might use a free health system more often, but that hardly guarantees the health outcomes enjoyed by the better off. For instance, a study of death rates among English civil servants — all covered by health insurance — determined that unskilled laborers and clerical staff had the greatest risk of dying within 10 years, while professionals and top administrators could be expected to live longer. [5]

In the United States, many assume that disadvantaged minorities would substantially benefit from equal access to medical practitioners, prevention and treatment. After all, racial and ethnic minorities with incomes below the federal poverty level represent a substantial proportion of the uninsured. Hispanics are three times more likely than whites to lack health insurance, and African-Americans twice as likely. [6]Indeed, some researchers suggest that racial and ethnic differences in health are due mostly to differences in socioeconomic status. [7]

Yet the University of California team showed that better care frequently failed to improve the health of minorities, the poor or the lesser educated. A study of 5,986 men, women and children with one of 17 chronic illnesses, all receiving free care or sharing in the cost, found that the poor were less likely to receive “appropriate” care than their better-off counterparts. [8]

Other studies suggest that the rates of receiving hospitalization and preventive care from health professionals depend not solely on whether people have insurance but also on race and ethnicity. Insurance also could narrow but not close the substantial gaps between the races in mortality — whites live an average six years longer than non-whites. Even when adjusting for differences in income, one-third of the difference in the mortality rate remains. [9]

Several factors tend to offset the potentially positive impact of free insurance on a person’s health, including low literacy skills, which make it harder to either understand a doctor’s instructions or choose between treatments. A person’s health beliefs, lifestyle practices and environmental influences can also affect his health. [10]People who are less educated may be less capable of communicating with a doctor, understand possible risks, appreciate the significance of symptoms, schedule an appointment or manage their conditions. [11]

The prejudices of medical professionals, cross-cultural communication failures and overt discrimination also may play a role, experts say. Other studies suggest an association between poor health and crowded neighborhoods, exposure to stressful life events and the inability to take time off from work to see a doctor.

Said Harold Freeman, president of the Ralph Lauren Cancer Center at New York City’s North General Hospital and for three decades a surgeon in Harlem: “Giving everyone an insurance card won’t solve health disparities.” [12]

[2] Committee on the Consequences of Uninsurance, Institute of Medicine, “Care Without Coverage: Too Little, Too Late,” May 2002. Copies also available athttp://www.nap.edu/.

[3] Jennifer S. Haas and Nancy E. Adler, “The Causes of Vulnerability: Disentangling the Effects of Race, Socioeconomic Status and Insurance Coverage on Health,” Institute of Medicine, October 2001.

[4] A.E. Kunst and J.P. Machenbach, “The Size of Mortality Differences Associated with Educational Level in Nine Industrialized Countries,” American Journal of Public Health, June 1994, pp. 932-937.

[5] M.G. Marmot, M.J. Shipley and G. Rose, “Inequalities in Death: Specific Explanations of a General Pattern?” Lancet, May 1984, pp. 1003-1006.

[6] Institute of Medicine, “Coverage Matters: Insurance and Health Care,” 2001. See also J. Rhodes and M. Chu, “Health Insurance Status of the Civilian Non-Institutionalized Population: 1999,” Agency for Healthcare Research and Policy, 2000.

[7] Paul D. Sorlie et al., “Mortality in the Uninsured Compared with that in Persons with Public and Private Health Insurance,” Archives of Internal Medicine, November 1994, pp. 2409-2416.

[8] The study, known as the “Rand Health Insurance Experiment,” is by R.H. Brook et al.., “Quality of Ambulatory Care: Epidemiology and Comparison by Insurance Status and Income,” Medical Care, May 1990, pp. 392-433.

[9] Jan E. Mutchler and Jeffrey A. Burr, “Racial Differences in Health and Health Care Service Utilization in Later Life: The Effect of Socioeconomic Status,” Journal of Health and Social Behavior, December 1991, pp. 342-356.

[10] Haas and Adler, op. cit., p. 26.

[11] S.K. Behera and Marilyn Winkleby, “Low Awareness of Cardiovascular Disease Risk Among Low-Income African-American Women,” American Journal of Health Promotion, May/June 2000, pp. 301-305.

[12] Quoted in Gabriele Amersbach, “Through the Lens of Race: Unequal Health Care in America,” Harvard Public Health Review, winter 2002.

Tampa’s Do-It-Yourself Health Care

Faced with overburdened emergency rooms and sharp drops in state and federal funding for the poor, some local governments are providing health care for their uninsured residents — in some cases with surprising success.

Florida’s vast Hillsborough County — a community the size of Rhode Island — raised its sales taxes to buy medical coverage for 29,000 uninsured low-income residents in the Tampa area. The scheme has dramatically lowered hospital admission rates and reduced complications from treatable ailments, such as diabetes and asthma. It also saves the county $50 million a year in property taxes that finance local public hospitals.

The county’s benefits “package” — including preventive care, pharmaceuticals, referrals to specialists, hospital services, home health care and vision and dental coverage — rivals the most expensive plans of private health insurers. And yet it costs taxpayers virtually nothing.

Meanwhile, the emergency rooms at Tampa General Hospital are no longer overrun. And the county’s costs for covering the uninsured are down from $600 a year per uninsured patient to $262, and average hospital stays are down to only five days — about half what they used to be. Complications from asthma, which accounted for nine in 10 visits to emergency rooms, now amount to fewer than one in 100 visits. Diabetes also is being detected earlier.

“We give better health to more people for less money,” says Toni Beddingfield, community relations director for Hillsborough County’s Department of Health and Human Services. “We’ve saved property-tax dollars — and we’ve saved lives.”

Local officials from around the country began taking note of the Hillsborough HealthCare program even before the federal Health Resources and Services Administration two years ago endorsed it as a “model that works.”

Similar experiments are under way in other urban areas that have large numbers of uninsured citizens, including Miami, El Paso, Texas, Augusta, Ga., and Kansas City, Mo.

Communities are trying other approaches as well. In Jackson, Miss., and Washington state, public health programs for the poor are financed with money from the $246 billion settlements in the huge 1998 class action lawsuit against tobacco companies. [1]In Portland, Maine, and Detroit, hospitals pool their money to provide primary care — keeping people healthier and out of hospitals.

But Hillsborough is trying to make do with money from the sales tax alone. Since 1999, the Robert Wood Johnson Foundation has been encouraging other communities to follow suit, as have the Ford Foundation and the National Association of Counties.

Tampa’s program grew out of the increasing burden of providing care for an estimated 117,000 uninsured residents — nearly 14 percent of the county’s population. With health-care costs escalating 17 percent annually, community leaders worried that property taxes would not be able to support the care of the poor forever.

In 1991, the state legislature agreed to a half-cent increase in the sales tax to start the new program. Despite a drop in funding to a quarter-cent after the program reported a surplus in 1997, it still manages to serve the same number of patients, who can earn no more than the federal poverty level — $8,500 for an individual, $14,500 for a family — in order to qualify.

Chief among the beneficiaries are men and women who don’t qualify for federal and state medical safety nets like Medicaid and Medicare — mainly mothers of children, young working men and middle-aged women.

All receive care through a network of five hospitals and 1,700 physicians. Generally, doctors are reimbursed at 75 percent of Medicaid rates. The doctors and hospitals bill the county directly.

County officials say the biggest fear when the program started — that it would attract people with HIV, sapping the system of resources — never materialized.

Beddingfield acknowledges that because of politics and other factors most communities may find it difficult to start a local health-care program by raising sales taxes. And yet, she argues, they should try.

“What’s the alternative? Raising property taxes? Letting all these people fall between the cracks? Filling emergency rooms and ending up having to spend far more money than you could save?” Emergency room care is far more expensive than primary or preventive care in a doctor’s office.

Back in his days as a state legislator, U.S. Rep. Jim Davis, D-Fla., enthusiastically backed Tampa’s program. Now, he says proudly, “It’s really working. It’s made the difference we all expected to see.”

[1] For background, see Kenneth Jost, “Closing In on Tobacco,” The CQ Researcher, Nov. 12, 1999, pp. 977-1000; and Kenneth Jost, “High-Impact Litigation,” The CQ Researcher, Feb. 11, 2000, pp. 89-112.

The quest for guaranteed health care is an old one. Reformers have sought major changes five times during the last century, and at astonishingly regular intervals. From the sweeping pronouncements of Theodore Roosevelt at the dawn of the Progressive Era to President Clinton’s foundering attempts led by first lady Hillary in the mid-1990s, the story mostly repeats: Proposals to expand coverage are often considered but rarely enacted, and then only on a piecemeal basis.

Every 15 years or so, movements arouse great enthusiasm, only to fail spectacularly. [47]In the end, peripheral improvements have benefited specific populations — the elderly, the disabled, low-income children and certain low-income adults. But universal coverage, though enticing to both politicians and the body politic, is as elusive as the Holy Grail.

Theodore Roosevelt’s “Bull Moose” Progressive Party made national health insurance, modeled on workmen’s compensation, a main plank in its party platform in 1912. One of the most sweeping health-reform attempts ever advanced by a presidential candidate, it called for employers, employees and society at large to pay for safeguarding Americans “through insurance” from “the hazards of sickness, accident, invalidism, involuntary unemployment and old age.” [48]

Like every major plan to follow, it went nowhere. And yet certain ideas were set in motion. By 1917, model health-insurance bills began popping up in state legislatures, and in 1929 the forerunner of Blue Cross emerged, establishing the pattern: Major proposal, major defeat, small steps forward.

After Social Security was created in 1935, supporters began urging a second step — a national health-insurance system.

In 1945, President Harry S. Truman sought to include universal health insurance with Social Security, noting that “in a nation as rich as ours, it is a shocking fact that tens of millions lack adequate medical care.” [49]

In a stirring speech four years later, he again declared his commitment: “We need — and we must have without further delay — a system of prepaid medical insurance which will enable every American to afford good medical care.” [50]

Yet Truman faced formidable foes. The AMA branded his plan “socialized medicine.” Enemies kept asking his physician, Wallace H. Graham, “are you a socialist, doctor?” [51]By the end of his time in the White House, Truman had given up his vision of universal coverage.

During World War II, health insurance had become a common employee benefit, primarily as a way to attract workers in a tight labor market. During the four decades after the war, the number of Americans with some form of health insurance increased dramatically. In the 1960s, unions made health benefits a key demand in collective-bargaining negotiations. Many experts believed that because so many workers now could visit the doctor without ever seeing a bill, health insurance actually drove up demand for medical services.

Perhaps because of the growing popularity of health insurance, Truman’s idea of insuring Social Security beneficiaries persisted. In 1965, President Lyndon B. Johnson signed legislation launching Medicare in a ceremony held, as a tribute, in Truman’s hometown of Independence, Mo. It was the cornerstone of Johnson’s so-called Great Society program to end poverty.

Johnson also signed Medicaid into law, providing health benefits for low-income pregnant women and children, disabled Americans and low-income elderly needing long-term care. “No longer will older Americans be denied the healing miracle of modern medicine,” Johnson said. “No longer will illness crush and destroy the savings they have so carefully put away over a lifetime.” [52]

President Richard M. Nixon briefly revived the idea of universal health insurance when he proposed making comprehensive, high-quality health care “within the reach of every American.” In his 1974 State of the Union address, he suggested expanding Medicaid and Medicare to provide health insurance “to millions of Americans who cannot now obtain it or afford it.” [53]His proposal got serious attention in Congress — only to be doomed by the Watergate scandal that engulfed his presidency.

Meanwhile, skyrocketing hospital costs had caught the government’s attention. Nixon and another Republican president embraced HMOs as a way to control costs. In 1973, Nixon signed the Health Maintenance Organization Act, requiring businesses with more than 25 employees to offer at least one HMO as an alternative to conventional insurance. Then, in 1982, President Ronald Reagan gave Medicare patients the option of signing up for an HMO. Managed-care organizations composed of loose networks of doctors began to proliferate, and by 1995, nearly three-quarters of covered workers were insured by an HMO. [54]

Clinton Debacle

Suddenly, in 1991, health care resurfaced as a potent political force. Harris Wofford, an upstart Democratic Senate candidate from Pennsylvania, declared: “If a criminal has a right to a lawyer, working Americans have a right to a doctor.” His message had such appeal that he resoundingly defeated a popular two-time governor.

On the advice of Wofford’s adviser, James Carville, then-Gov. Clinton appropriated Wofford’s thunder, riding the health-care theme to the Democratic nomination in 1992. In his acceptance speech, Clinton vowed to “take on the health-care profiteers and make health care affordable for every family.”

In 1993, Clinton unveiled his “Health Security Act,” a plan largely crafted under the direction of Mrs. Clinton. Employers would pay 80 percent of the premiums to insure all workers, while the government subsidized coverage for everyone else. Clinton said he wanted “to reform the costliest and most wasteful system on the face of the Earth.” [55]

Yet the president’s own party fractured badly. Some Democrats proposed a “single-payer” government system, similar to Canada’s, which would pay private health-care providers. Others sought a scaled-down version of managed competition, which would have failed to guarantee coverage to many Americans. Republicans, meanwhile, preferred compelling every American to buy insurance, using government dollars only to help the poor.

Congressional Republicans accused Clinton of trying to establish yet another inefficient, expensive and uncaring big-government bureaucracy. Hillary Clinton, too, attracted criticism, in part for her secretive management style. A single, compelling television ad, part of a $17 million campaign by the Health Insurance Association of America, also helped torpedo the plan. Its simple message — in which a fictitious couple, Harry and Louise, tried to make sense of the 1,342 pages of details — preyed on public anxieties. Would people still be able to choose their own doctors? Could employers afford to cover workers? Would health-care decisions be left up to government bureaucrats?

Yet some of Clinton’s ideas have been adopted by managed-care plans, helping them achieve some efficiencies and savings. [56]Enrollment exploded between 1986 and 1995, from nearly 26 million to 58 million, according to the American Association of Health Plans — yet people grew disenchanted with having to change doctors, being refused services and losing access to specialists.

Managed care’s unpopularity led to the “patients’ bill of rights” legislation passed by the House last August, which would allow patients to sue their HMOs, but on a limited basis.

Deep-rooted ambivalence underlies America’s stance on health care. It is viewed as a social good, but also a market commodity. Americans seem to consider it a basic need to which everyone is entitled, but also something to be earned that should be subject to free-market forces. One commentator has described the conflict in health care as the “struggle for the soul of health insurance.” [57]

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[47] Jacob S. Hacker and Theda Skocpol, “The New Politics of U.S. Health Policy,” Journal of Health Politics, Policy and Law, April 1997, pp. 315-38.

[48] See Nathan Miller, Theodore Roosevelt: A Life (1992).

[49] State of the Union address, Jan. 5, 1945.

[50] State of the Union address, Jan. 5, 1949.

[51] See Niel M. Johnson, oral history for the Harry S. Truman Library, March 30, 1989.

[52] From a speech at Truman’s home in Independence, Mo., July 30, 1965.

[53] State of the Union address, Jan. 30, 1974.

[54] For background, see Sarah Glazer, “Managed Care,” The CQ Researcher, April 12, 1996, pp. 313-336.

[55] Address to Joint Session of Congress, Sept. 22, 1993.

[56] Health Research and Educational Trust, op. cit. Health-cost increases reached a low in 1996, but then began rising again. Average premiums increased nearly 5 percent in 1999, more than 8 percent in 2000 and 11 percent from mid-2000 to mid-2001.

[57] Deborah Stone, “The Struggle for the Soul of Health Insurance,” Journal of Health Politics, Policy and Law (1993), pp. 287-317. See also Rosemary Stevens, In Sickness and in Wealth: America’s Hospitals in the Twentieth Century (1989).

Drugs for the Elderly

Even before the distractions of national security, an economic slowdown and the deficits in federal and state budgets, few expected much to happen on the health-care front this year.

The Clinton administration’s blistering defeat fragmented and polarized Washington over the subject of health-care reform. With Congress so closely divided, only isolated, dike-plugging initiatives can survive, and action is more likely through the private insurance sector. Meanwhile, the numbers of uninsured undoubtedly will continue rising along with costs.

A longstanding barrier to change is the sheer clout of several players with a lot to win or lose. As commentator Robert G. Evans, a University of British Columbia economics professor, has pointed out, the U.S. health-care system is “inequitable, inefficient, unpopular and spectacularly expensive — but enormously profitable for some Americans.” [58]

The health-care industry, its profits severely diminished from the boom years of the 1990s, zealously guards its turf against any threat to the status quo. Health professionals so far have contributed nearly $58 million to the 2000 and 2002 presidential and congressional political campaigns, and the pharmaceutical industry has donated another $37 million. [59]

Another barrier to change is cost. Late last year, for example, while debating legislation to stimulate the economy, Congress avoided any discussion of extending coverage to all Americans, focusing instead on the less expensive option of providing coverage to those who lose their health insurance after losing their jobs.

But even that debate exposed an underlying fault line almost certain to keep Washington in gridlock. Democrats sought subsidies to help the newly unemployed keep their insurance or to cover them in the Medicaid program. Republicans favored giving the newly uninsured tax credits to help them buy insurance. The same philosophical debate underlies current sparring.

This year, at least one major health-care issue — the cost of prescription drugs for the elderly — appears to be emerging at the top of the political agenda. With both the House and Senate narrowly divided, the balance of power in Washington could rest in the hands of older Americans, who typically play a disproportionate role at the polls in midterm elections.

Winning seven more seats would give the Democrats control of the House; just one seat in the Senate would give Republicans control there. And though the issue certainly isn’t new, the volume at which it is being debated is a new wrinkle. Equally intense is the determination of skirmishing party leaders to pass a measure this year — or blame the opposition for the failure to accomplish anything.

“No senior should be forced to choose between putting food on the table or paying the rent or buying the medicines they need,” declared House Speaker J. Dennis Hastert, R-Ill., in May as he unveiled the Republicans’ $350 billion proposal to add a prescription drug benefit to Medicare. The same day, Senate Democrats unveiled their proposal, with a price tag of $400 billion to $500 billion. Other House Democrats and Senate moderates are working on alternatives, and President Bush has his own 10-year, $190 billion version.

A group supported by the drug industry, the United Seniors Association, launched a $3 million advertising campaign supporting House Republicans. The Democrats, meanwhile, released a video attacking a promise Bush made during the 2000 campaign to “help all people with prescription drugs.” Notes the ad: “By his own estimate, Bush leaves out more than two-thirds of seniors in need of prescription-drug coverage.”

A Republican campaign memo hinted at the reason for all the fuss: “Republicans passing a prescription-drug benefit would go a long way to leaving Democrats with very little on the table to try to use against us” in the midterm elections. [60]

Despite such traditional divisions, some compromise appears in the wind, given the coalescence of the once-adversarial special interests into the Covering the Uninsured coalition. The group, which includes older Americans, doctors, insurance carriers and hospitals as well as consumer and labor groups, is waging a huge media campaign urging an immediate solution to the problem of the uninsured.

Tax Credits

President Bush proposes to help the uninsured buy private health policies by offering tax credits — $1,000 for adults and $2,000 for families — costing a total of $89 billion. But only individuals with incomes below $30,000 or families with incomes below $60,000 would be eligible. “Too many workers get no coverage at all with their jobs,” the president said. Americans should receive “the help they need when they need it.” [61]

Economists at the University of Pennsylvania and Yale University say Bush’s plan could reduce the number of uninsured by about 8 million. The administration estimates that it would help 6 million uninsured people buy health insurance each year, but the amount of the tax credit and its reach are widely viewed as inadequate. [62]

“It’s like throwing a 10-foot rope to someone at the bottom of a 40-foot hole,” says Pollack of Families USA. For instance, a healthy, non-smoking 55-year-old woman living at the federal poverty level — less than $8,860 in income — would still have to spend $4,000 to buy health insurance, he points out.

Moreover, some opponents worry that the president’s proposal could unravel the current employer-based system, which, in effect, indirectly uses premiums of the relatively healthy to cross-subsidize those needing more care.

However, even the most generous expansion of prescription-drug benefits for the elderly or tax credits for select populations would not tackle the larger problems of rising costs and America’s uninsured. Nor will they make up for ground being lost every day, as governments drastically scale back the existing social net.

Shrinking Safety Net

With dwindling discretionary reserves in the federal budget, money for Medicaid and CHIP has vanished, and many private doctors are refusing to accept new Medicare patients, because Medicare HMOs are paying them less. Some Medicare patients who can’t afford drugs are turning to the Veterans Affairs hospital system, where rising numbers of patients and pharmaceutical costs — which have nearly doubled since 1996 — are overwhelming an already strained system.

Recession-crippled state budgets, which partially finance and administer Medicaid and CHIP, are running deficits and anticipate fewer revenues. States are tapping rainy-day funds, laying off employees and making across-the-board cuts. The recession, the economic fallout from Sept. 11 and the explosion in Medicaid spending have caused a $40 billion to $50 billion shortfall — the largest ever — in more than 40 states. Thus, legislatures are trimming services and making cuts in the safety net just when the uninsured need it most.

In Illinois, for example, a “welfare-to-work” initiative during the late 1990s added 100,000 women to Medicaid — yet by the end of 2001 Republican Gov. George Ryan felt compelled to eliminate it. The action netted $17 million in savings and sent many of the women — who work in low-paying jobs that lack benefits — back to the ranks of the uninsured.

“Governors are dealing with unprecedented fiscal pressure,” said Raymond C. Scheppach, executive director of the National Governors’ Association. “The growth rate is simply unsustainable.” With Medicaid at a “breaking point,” states need more than money from Washington. “Absent serious structural changes to the program down the road, states will be unable to meet the needs of recipients.” [63]

Even in better economic times, the safety net misses many. Millions of low-income people who are eligible are not enrolled in government programs. Welfare reform, otherwise known as the Professional Responsibility and Work Opportunity Reconciliation Act of 1996, successfully moved people from cash assistance into jobs — but often into jobs without health coverage. Among women who have been off welfare for more than a year, only half have either Medicaid or private coverage. The other half seek care from strained safety-net institutions like faith-based charities. [64]

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[58] Robert G. Evans, “Sharing the Burden, Containing the Cost: Fundamental Conflicts in Health Care Finance,” in Theodore J. Litman and Leonard S. Robins, Health Politics and Policy (1997).

[59] Center for Responsive Politics, April 2002.

[60] Quoted in The Associated Press, May 9, 2002.

[61] From remarks Feb. 11, 2002, at Medical College of Wisconsin in Milwaukee.

[62] Some 25 percent of the uninsured would have enough money to obtain the policy they need, and another 25 percent would be able to buy policies by adding up to $169 a year per person, according to Mark Pauly and David Song, “Tax Credits, the Distribution of Subsidized Health Insurance Premiums, and the Uninsured,” National Bureau of Economic Research, Working Paper No. 8457, September 2001.

[63] Comments made in releasing the association’s Fiscal Survey of States, May 16, 2002.

[64] B. Garret and J. Holahan, “Health Insurance Coverage After Welfare,” Health Affairs, 19(1), January/February 2000.

The CQ Researcher • June 14, 2002 • VOLUME 12, No. 23
© 2002 Congressional Quarterly, Inc. All rights reserved.

The CQ Researcher • June 14, 2002 • VOLUME 12, No. 23
© 2002 Congressional Quarterly, Inc. All rights reserved.