Also, 75% want legislative role in sales of preserved parkland
By Stephanie Desmon and Ivan Penn
Baltimore Sun Staff
Sunday, April 17, 2005
The public's appetite for slot machines in Maryland - a centerpiece of
Republican Gov. Robert L. Ehrlich Jr.'s campaign in 2002 - appears to have
peaked, and, after three failed attempts to legalize them, opposition is at
its highest point in many years.
Three months ago, before the start of the recently adjourned session of the
General Assembly, 56 percent of likely voters surveyed supported bringing
slots to the state. In The Sun Poll conducted last week, 47 percent said
they wanted slot machine gambling legalized.
"You can't argue there's this extraordinary mandate for slots" anymore, said
Keith Haller, president of the Bethesda-based polling company Potomac Inc.,
which conducted the survey for the newspaper and baltimoresun.com. "The
proponents of slots really have not done a good job arguing their case to
the broader public."
The poll also found strong support for state funding of embryonic stem cell
research and for legislative oversight of the sale of preserved parkland.
Many voters - two in five - said they feel so strongly about slot machines
that they would make them something of a litmus test in deciding whether to
vote for a gubernatorial or legislative candidate in next year's elections.
More than one in five voters said they would oppose a candidate who
supported legalizing them.
Brenda Johnson, 59, said slots would be a make-or-break issue for her in a
statewide election. The lifelong resident of Prince George's County said she
remembers when gambling was allowed in the county decades ago and does not
want it to return.
'Bad
habits'
"They'll make gamblers out of everybody," said Johnson, a Democrat who took
part in the telephone poll. "You get into bad habits. I don't feel we really
need it."
W. Minor Carter, an anti-slots lobbyist, said many people like the idea of
having slots in Maryland
but do not want them in their communities. When Frederick County was
considered as a site for slots, that community rose up in opposition.
"Everybody wants slots in the abstract, but they don't want them in their
jurisdiction," Carter said.
Robert Wandell, an information security manager who lives in Ellicott City,
remains a supporter of Maryland's reaping the benefit of gambling money that
is seeping across its borders to Delaware and West Virginia.
"The way I look at it is, if someone is going to play slots, they are going
to play slots," said the 45-year-old Republican. "Why not have them here? It
is hypocritical of the state to say you can't play slots but you can play a
lottery. It's obvious we are not against gambling, so why limit the forms of
gambling?"
The two chambers of the legislature passed different bills to legalize slot
machines in this year's session, but leaders did not reach a compromise, and
Ehrlich watched what he once hoped would be his signature legislation die
for a third time.
That public wrangling - and the bills' failure - might have been one of the
reasons the General Assembly as a body got such low marks from the public.
Of those polled, 1 percent gave legislators an "excellent" score for how
they dealt with the state's problems. One in four gave the legislators
positive marks, and seven out of 10 gave them a negative rating.
'Dismal' ratings
"If you were a legislator, you might want to get out of town quickly before
the report cards are handed out back home," Haller said, calling the ratings
"dismal. ... It's hard to imagine the numbers being worse than that."
Legislators failed to get a bill to the governor's desk that would have
provided $23 million in state money for embryonic stem cell research. The
bill was opposed by anti-abortion activists and the Maryland Catholic
Conference, and Republicans stymied it by threatening a filibuster that
would have held up other legislation in the final days of the session.
But, according to the poll, there is better than 2-to-1 support in Maryland
for providing the funds, and that support is consistent across the state.
Democrats overwhelmingly support the proposal, and Republicans are evenly
split.
Dr. Seymour Rubin, an 81-year-old retiree whose specialty was internal
medicine, gave the legislature a rating of "fair" this year, primarily
because lawmakers didn't follow the leads of New Jersey and California and
approve stem cell research funding.
The Baltimore Democrat said he retired from practicing medicine 16 years ago
but continues to follow developments in the field and considers stem cell
research critically important.
"It's going to help a great many people in overcoming illness," Rubin said.
"I think it's a great step forward in medical progress."
Ruth Haworth, a retired factory worker from the Eastern Shore who is a lung
cancer survivor, said the state's longtime attitude against new ideas
thwarted the stem cell debate.
"I think that should be going through," the 72-year-old Republican said of
research on embryos left over from fertility clinics. "Heck, you're only
throwing them away anyhow, and if they can be of some use, let it be.
There's so many other people and so many other things it could possibly
help."
Those surveyed said they felt that one high point of the legislative session
was the stance that lawmakers took on the sale of preserved parkland in the
state, the poll shows. After the Ehrlich administration considered selling
some state land originally purchased for environmental conservation,
legislators moved to take that power out of the hands of the chief
executive.
Seventy-five percent of those polled said the legislature's approval should
be required for sales of public land. Fourteen percent said the governor
should be able to sell public land as he sees fit.
Amendment due for vote
Next year, a constitutional amendment will be on the ballot - a measure
Ehrlich endorsed - that would give the legislature approval power.
Legislators also passed a bill limiting the governor's power to sell the
protected property.
Support for gubernatorial land sales isn't high even among Ehrlich's
supporters. Of registered Republicans, 23 percent said they want to grant
him that power.
Elizabeth Johnson, a retired database analyst from Chevy Chase, said she
agrees with giving the legislature more oversight in this environmental
matter.
"Once it's gone, it's gone," the Democrat said, referring to open space and
public lands. "We are losing a lot of it."
Sun
staff writers Lynn Anderson and Rona Kobell contributed to this article.
UÍGE, Angola, April 16 - For nearly four weeks, teams of health experts have
been trying to set up a rescue operation in this town of windowless,
crumbling buildings with no running water, intermittent electricity, poor
sanitation and a perennially jammed telephone network.
They are trying to contain the worst outbreak of one of the world's most
frightening viruses, known as Marburg.
But with the death toll rising every day, no one is predicting success soon.
A
cousin of Ebola, the Marburg
virus has erupted periodically in Africa in sudden, gruesome epidemics, only to
disappear just as mysteriously. This time it has struck with a vengeance,
killing 9 out of 10 people infected - a total of 230 people so far,
including 14 nurses and 2 doctors who cared for the sick.
The virus is highly contagious, making any outbreak a cause for widespread
fear and fascination in a world shrunk by international travel and trade.
Marburg spreads through blood, vomit, semen and other bodily fluids. Even a
cough can prove fatal for someone hit by a few drops of spittle. Corpses,
teeming with the virus, are especially dangerous. A contaminated surface can
be deadly - the virus can find its way into someone's eyes, nose or mouth,
or enter the bloodstream through a cut.
Once in the body, it moves with terrifying speed, invading white blood cells
essential to fighting infection. On Day 3 of the infection, fewer than 200
viruses are in a drop of blood. By Day 8, there are five million.
"That's why dead bodies are kind of like bombs," said Dr. Heinz Feldmann, a
virologist from Winnipeg
who is here working with the teams of specialists dispatched by the World
Health Organization, the United States Centers for Disease Control and
Prevention, and the international aid group Doctors Without Borders.
Their efforts to curtail the outbreak turn on whether distrustful local
people in this poor and isolated town of 50,000 people alert health workers
to suspicious cases. So far, persuading them has not been easy. Victims who
are taken to the isolation ward are never seen again; their bodies, rapidly
buried for safety, cannot be honored in the traditional funerals so
important in this country.
Despite the best efforts of some dedicated doctors - like Maria Bonino, an
Italian doctor who ran a children's ward in the Uíge hospital - the virus
has a long head start, spreading for what may have been months from a brew
of poverty, ignorance and government inaction.
For the people of Uíge, rampant death is now joined by the near equivalent
of a space invasion: health workers encased in masks, goggles, zip-up jump
suits, rubberized aprons and rubber boots as they collect corpses in the
stifling heat. The garb is all white, a symbol of witchcraft here.
Teams of epidemiologists and provincial health workers have fanned out,
checking reports of potential new cases and tracking down people who had
contact with the dead or dying.
So far, most reports from the community deal with the dead, not the sick. If
that continues, the teams could be reduced to a high-tech, specialized
burial service, helping prevent the transmission of the virus from the dead,
but not from the living.
At the cemetery on the edge of this town of pastel-colored, decaying
buildings, a section created for Marburg
victims is filling up with graves marked by simple wooden crosses bearing
names written in black.
But the 30-bed isolation ward for Marburg victims that was set up at the
hospital here two weeks ago rarely has more than a patient or two. "The
population is hiding sick relatives," said Col. Pascoal Folo, a military
doctor dispatched by the Angolan government to help coordinate the effort
here. "This upsets us very much."
Every morning between 9 and 10 at the World Health Organization quarters on
a busy street in Uíge, medical teams pile into jeeps and vans and head out
into the neighborhoods - bairros, in Portuguese - that surround the town.
The teams include a pair of doctors and several local people who have been
hired to help the outsiders find their way. Except for knee-high rubber
boots, which can be sprayed with bleach, they wear street clothes. Their job
is to check out "alerts" - reports of possible cases - or deaths, and to
look in on people who had close contact with someone who died of Marburg.
This shoe-leather epidemiology - finding every case, tracing every contact,
going door to door, day after day - is the backbone of the efforts here.
"This should be an easy day," William Pereira, a Colombian doctor who is in
charge of all the surveillance teams, said on Wednesday. "No deaths, no
alerts." But no news might be bad news, he said, a sign that new cases were
being hidden.
Dr. Pereira's first stop on Wednesday was at the home of man whose wife, a
nurse, had died of Marburg.
He was not ill. Standing outside his house, curious neighbors looking on, he
began berating and accusing the health team.
Where did this disease come from? he demanded. Why didn't they just give him
medicine, or a vaccine? When were they going to disinfect his house?
There is no vaccine, Dr. Pereira told him. No medicine. All we can do is
find the sick and isolate them so they cannot infect anybody else.
Then it will be gone.
On the way to their next stop, a message crackled across Dr. Pereira's
radio: all teams back to headquarters.
A
van had been attacked by an angry crowd armed with sticks. The day before,
rocks were thrown at a surveillance vehicle. The week before, all trips had
been suspended for two days because of rock-throwing.
Reluctantly, the health organization crossed three bairros off the list that
surveillance teams could visit. Now, if anyone died or got sick there,
health officials might not know - a breach of the defenses they were trying
to build.
Each person who may have been exposed to the disease has to be followed for
21 days, and hospitalized if symptoms develop. Symptoms usually appear
within 5 to 10 days of infection.
First come a headache, high fever, and aches and pains, followed by diarrhea
and vomiting. The virus invades the spleen, liver and lymph nodes and then
moves into other tissues all over the body, including skin and sweat glands.
The disease interferes with blood clotting, and about half the victims
hemorrhage. They may vomit blood and pass it in their urine, and bleed from
their eyes, gums, rectum or vagina.
It is a misconception that Marburg
victims bleed to death, said Dr. Feldmann, the Winnipeg
virologist. They actually die from shock as fluid leaks out of the blood
vessels, causing blood pressure to drop.
There is no specific treatment, but more patients would probably survive if
they could get the kind of intensive care available in developed countries.
In what is probably the only recorded outbreak outside Africa, in 1967,
among laboratory workers in Germany and Yugoslavia, the death rate was only
23 percent. That outbreak was traced to monkeys imported from Uganda for
medical research.
The much higher death rate in Angola has brought international health care
experts running.
In Uíge, workers from Doctors Without Borders sleep five to a room. The
World Health Organization's team has commandeered the only hotel and turned
a wing of the provincial health department into a command center. The
19-person team includes epidemiologists, virologists, two anthropologists, a
community outreach specialist, a computer programmer, two logistics experts
and a press spokesman.
Dr. Feldmann has created a high-tech laboratory at the Uíge Provincial
Hospital with a four-hour turnaround for Marburg
tests. Infection control experts are working furiously to disinfect wards,
closed after the first suspected case was identified here, so that the 390
beds can be used again. Now, the hospital takes on patients who need
emergency operations. When the cleaners did not show up Friday, the
international experts took up the mops themselves.
Adriano G. Duse flew into Uíge from Johannesburg,
where he is head of infectious diseases at the University of Witwatersrand.
"We went to a meeting from 7:30
to 9, and after that it was scrubbing and scrubbing and mopping and swishing
and scrubbing," he said, showing up for lunch in damp, soiled T-shirt.
At a training session on Friday for cleaners and laundry workers, Dr.
Michael Bell of the Centers for Disease Control and Prevention in Atlanta
was asked by workers how they could protect themselves.
Was it safe to carry a bundle of used sheets and blankets on her head, one
young woman wanted to know. "No," Dr. Bell said. "We want you to be safe."
Armand Bejtullahu set up a computer program for the team to record each
suspected death or new case and track hundreds of people who have had
contact with infected Angolans. The computer analysis allows the doctors to
map out geography of the epidemic and spot trends. Adults are gaining on
children as primary victims.
That data may help them, eventually, trace the virus back to its source.
No one knows where the virus lurks between outbreaks. Some scientists say
bats are its most likely host because they can be infected for long periods
without showing symptoms. In this outbreak, tests have shown only one strain
of virus, meaning the epidemic is likely to have started with the infection
of one person. Finding out who that was may also help identify where the
virus was hiding.
Dr. Bonino, from the charity Doctors With Africa, began suspecting that
there was something dreadful in the children's ward of the sprawling
regional hospital in March of last year, months before anyone else became
alarmed. The ward of 97 cots was crammed with youngsters suffering every
ailment that Angola's oppressive climate and primitive sanitation could
muster. She noted that one child stood out, suffering from vomiting, fever
and bleeding, symptoms she recognized as classic indicators of hemorrhagic
fever, her colleagues say. The child died within days.
Dr. Bonino had worked for 15 years in Africa,
including a spell in Uganda during an Ebola outbreak, and understood
hemorrhagic fevers. She moved to Uíge in 2003, and won the loyalty of the
children's ward nurses with her hard work, compassion and expertise in
illnesses unique to Africa.
"She was very, very, very experienced, " said Moco Henriques Beng, the
provincial health director.
In July, a new hospital director, Dr. Matondo Alexandre, was installed. He
said Dr. Bonino quickly told him of the possible case of hemorrhagic fever.
She pointed out another case in October, he said, and four blood and tissue
samples were sent to the capital, Luanda,
and then to the Centers for Disease Control and Prevention. The tests,
generally considered reliable, turned up negative; recent retests came up
negative again.
Between November and January, Dr. Alexandre said, he sent two more samples
to Luanda, taken from people apparently killed by hemorrhagic fever. He said
he got no response.
Dr. Alexandre said the initial negative test results might have blinded the
government. This is, after all, a country where one in four children dies
before the age of 5; the causes for a slew of deaths on the pediatric ward
could be legion.
"I think the results maybe influenced people to think that there is
something normal going on, and this was just one disease out of so many
diseases we have going on," he said.
On the pediatric ward, though, the situation seemed anything but normal
after October.
More than 200 patients filled the ward, according to Luiza Maria Costa
Pedro, the chief pediatric nurse, and two other doctors who worked at the
hospital. Children slept two to a bed. Mattresses were spread upon the floor
for those who could not fit in the bunks.
Dr. Bonino was increasingly worried. "She sat across from me in that chair
and said we are having too many strange deaths," said Dr. Enzo Pisani, who
works at the hospital, also for the Italian charity.
Mrs. Costa Pedro said the children were admitted with vomiting, diarrhea and
fever. Those symptoms are typical of malaria and many other tropical
diseases. But after October, the death rate went up from three to five
children a week to three to five a day, she said, and many died bleeding
from the mouth or other orifices.
"We were very, very upset," she said. "We didn't have any way to help the
patients, and we couldn't discover who brought here this sickness."
When national authorities failed to respond to requests for more tests, Dr.
Alexandre took to the radio. In February, he announced that he suspected an
outbreak of hemorrhagic fever in Uíge.
Now, he said, he has been cast as a scapegoat. Traditional leaders, he said,
circulated rumors that he had used witchcraft to create the virus in hopes
of winning a job promotion, a charge that can carry substantial weight in a
region where deep superstitions blend seamlessly with modern beliefs. He was
dismissed as hospital director.
His aunt was beaten by angry residents, he said. Last week, national
authorities sent a helicopter to carry him and his family to Luanda.
The radio broadcast did, however, provoke the national Health Ministry to
send a team to Uíge in early March. The World Health Organization quickly
followed.
Dr. Bonino gave the arriving teams a list of 39 suspected cases of
hemorrhagic fever. The investigators found two dozen more. New samples were
flown to Atlanta.
On March 21, 9 of 12 came back positive.
Less than a week later, Dr. Bonino died of Marburg virus. Fourteen nurses
and a Vietnamese surgeon who worked at the hospital have also died. The
surgeon was probably infected while performing an autopsy on a Marburg
victim, Dr. Pisani said.
On the whiteboard mounted on a wall in the pediatric ward, Dr. Bonino's
cellphone number is still scrawled.
"I feel a tremendous sense of failure because she died," Dr. Pisani said.
"We should have sent samples earlier."
Dr. Alexandre said many deaths might have been prevented had the authorities
acted more rapidly.
"The emergency public health service should have begun investigating right
in October, or at least in November," he said. "What happened was we lost a
lot of time."
Even now, health experts say, Angola's government has failed to mount a
full-scale response to the epidemic, leaving the bulk of the burden to the
outside groups that have come to Uíge. The government has sent only four or
five medical specialists to the province, and 30 to 35 soldiers, who are
mainly helping to collect and bury bodies.
Unless the government does a better job of explaining the epidemic to its
people, the health workers fear, they face a long, uphill battle.
"What we are doing now is having almost no impact," said Monica de
Castellarnau, who headed the Doctors Without Borders team here until Friday.
"We cannot replace the government."
Just three years after the largest and most serious shortage of childhood
vaccines in two decades, the federal government's stockpile of childhood
vaccines, designed as a buffer against shortages, is nearly empty -- and
without immediate prospects of being filled.
Three of the four companies that produce the shots recommended for every
American child told the federal government last year that they would not
sell their products to this little-known but important piece of the nation's
public health infrastructure.
Although opinions differ, it appears that the Pediatric Vaccine Stockpile
has become an innocent bystander wounded in the government's crackdown on
deceptive accounting practices.
No one has accused the vaccine manufacturers of wrongdoing. However, they
can no longer treat as revenue the money they get when they sell millions of
doses of vaccine to the stockpile because the shots are not delivered until
the government calls for them in emergencies. Instead, the vials are held in
the manufacturers' warehouses, where they are considered unsold in the eyes
of auditors, investors and Wall Street.
Today, the stockpile contains 13.2 million doses of vaccine, less than
one-third of the goal of 41 million doses. It is supposed to hold supplies
of eight shots that together protect against 11 childhood diseases. However,
for two of those products -- including the workhorse DTaP, which protects
against diphtheria, tetanus and pertussis -- it contains no doses. The
vaccine is not in storage in company warehouses or anywhere else. It simply
does not exist.
Created by Congress in 1983, the stockpile is supposed to contain enough
vaccine to supply the nation's needs for six months. Its virtual collapse is
an acute embarrassment to the Department of Health and Human Services, the
Centers for Disease Control and Prevention, and the vaccine makers.
The stockpile has never reached its full target amounts, but its depleted
state now means the nation could not easily weather another big vaccine
shortage, potentially putting the health of millions of children at risk.
Only two vaccines -- measles, mumps and rubella (MMR), and varicella
(chickenpox) -- are warehoused in the desired amounts.
Memories are still fresh of 2001 and 2002, when the country did not have
adequate supplies of five vaccines that together protect against eight
diseases. That shortage did not lead to an increase in death or disease, but
it did require physicians and clinics to ration and temporarily change the
routine schedule of shots.
In testimony before Congress, Walter A. Orenstein, then head of CDC's
National Immunization Program, called the situation "unique and
unprecedented."
Last winter, the United States
experienced a shortage of influenza vaccine. That product is not in the
pediatric stockpile, but the near hysteria that erupted when contamination
in a factory cut the supply of flu shots in half was further evidence of how
vulnerable the nation is to the decisions and fortunes of the few remaining
U.S. vaccine makers.
Although there have been informal discussions among the CDC, HHS, the
Securities and Exchange Commission, vaccine companies and congressional
staffers, there has been no concerted effort to find a solution that will
persuade the companies to resume sales.
"If it was up to me, I'd start the meeting at 1 o'clock, lock the door, and
wouldn't let anyone leave until they had found a solution," said Jerome O.
Klein, a pediatrician at Boston University School of Medicine and a member
of the National Vaccine Advisory Committee.
Klein's frustration is starting to be reflected in Congress.
"It's inexcusable that even though the administration had the money for
this, they haven't made any progress," Rep. Henry A. Waxman (D-Calif.) said
recently. "I don't care how they solve it -- they should just solve it."
The ranking Democrat on the Committee on Government Reform, Waxman said he
is willing to sponsor legislation to carve out a legal exception that would
allow companies to "recognize" revenue from sales to the vaccine stockpile
-- if such a radical step becomes necessary. One of the companies, however,
said its problem is not with "revenue recognition" but with the details of
managing the vaccine inventory.
Other parties were reluctant to discuss possible solutions or who, if
anyone, is to blame for the empty shelves. The SEC, which enforces
accounting practices, would not speak on the record. HHS officials would not
make available the person talking to the SEC on the matter. The department
referred questions to its subordinate agency, the CDC, whose officials said
important decisions about the stockpile are being made at the department
level.
The firms that have stopped selling vaccine to the stockpile provided some
information. Merck & Co. Inc., the one company still making new contracts
with CDC, was silent.
The stockpile's usefulness is not theoretical. The government has gone into
it nine times since 1984, the year after it was established. This was done
to get vaccine for immediate use in a disease outbreak, or to prevent supply
disruptions when a manufacturer had production problems or shut down a
plant.
In January 2002, the government withdrew 700,000 doses of MMR vaccine when
Merck, the manufacturer, had problems at a factory. In August 2003, CDC used
46,000 doses to fight a measles epidemic in the Marshall Islands.
In both cases, the government took out vaccine stored by the manufacturer
but owned by HHS under a "buy-and-hold" contract. That long-standing
arrangement benefits the government because it includes a provision to
prevent the stockpiled vaccine from expiring and having to be discarded.
While the government owns the vaccine, the companies are paid to store and
rotate the stock. When a vial's shelf life falls below 12 months, it is sold
on the open market and immediately replaced by newly made product.
Historically, companies could list as revenue the money they got for vaccine
sold to the stockpile this way. That is no longer true.
Although the vaccine makers may use income from the sales any way they want,
in accounting terms the money can no longer be "recognized" as revenue.
Because the amounts of vaccine are large -- the stockpile has a target of 10
million doses of DTaP, for example -- excluding those sales from the bottom
line makes some companies unhappy.
The accounting change came after the SEC issued a bulletin in December 1999
seeking to clear up confusion about revenue recognition.
Booking phony, theoretical or incomplete sales is the most common way
companies make themselves look more profitable than they are. According to
the Huron Consulting Group, over the past five years problems with revenue
recognition were the leading reason U.S. corporations had to amend or refile
financial reports. There were 253 such restatements last year, a record.
The SEC does not believe it created new accounting standards with its
bulletin, but it gave companies a timetable for compliance. Accounting giant
PricewaterhouseCoopers, which audits all four vaccine makers, sent clients
an analysis in January 2001 noting that "we expect the implementation . . .
to have a significant impact on the revenue recognition reporting practices
of a number of [companies]."
The vaccine situation came to a head late last summer when CDC asked the
manufacturers to make new sales to the stockpile. Three said no. Only Merck
said yes.
Sanofi Pasteur (formerly Aventis Pasteur) wrote on Aug. 26: "Almost 2 years
ago, AvP raised the 'revenue recognition' issue with CDC. . . . We
understood from our conversations that we were the first manufacturer to do
so. . . . We stated then that short of SEC changes in the interpretation of
Staff Accounting Bulletin # 101, and/or changes to the stockpile terms, that
AvP would be out of the stockpile business."
Wyeth, which had previously sold vaccines against polio and Haemophilus
influenzae type b to the stockpile, did not mention revenue recognition when
it, too, declined. Nor did GlaxoSmithKline, which had never participated.
GlaxoSmithKline told CDC on Aug. 31 it would not sell DTaP, DTaP-hepatitis
B-polio vaccine or hepatitis A vaccine until "the structure for a . . .
stockpile agreement can be resolved."
A
GlaxoSmithKline senior vice president, David Pernock, said that accounting
issues are not a sticking point but that "costs associated with managing and
rotating inventory" are.
All three companies say they support the idea of a stockpile. A Sanofi
Pasteur vice president, Phil Hosbach, termed its diminished state "really a
threat to public health."
Without a solution, the stockpile is likely only to get smaller, and its
failure to meet its purpose even more glaring.
Neisseria meningitidis bacteria cause about 2,800 infections a year in the
United States, many in college-age adults. Ten to 15 percent of those
infected die, and up to 20 percent are made deaf or otherwise permanently
disabled.
In January, the Food and Drug Administration approved a vaccine against N.
meningitidis infection. Next month, CDC will add it to the list of shots all
American youngsters should get -- which means it, too, should be stockpiled.
Their letter could hinder budget resolution passage
By Joel Havemann, Los Angeles
Times
Baltimore Sun
Sunday, April 17, 2005
WASHINGTON - A letter signed by 44 House Republicans protesting proposed
Medicaid cuts emerged Friday as a serious threat to plans by President Bush
and GOP leaders to curtail spending on a range of benefit programs.
The Medicaid fight could hinder Congress' ability to pass this year's budget
resolution, which sets spending for federal programs and includes a new
round of tax cuts and legislation to open the Arctic National Wildlife
Refuge to oil drilling.
The House and Senate passed different versions of a fiscal 2006 budget a
month ago, with four votes to spare in the House and two in the Senate.
Formal negotiations to write a compromise budget have not begun, but
Republican leaders and budget committee chairmen have met to try to work out
a deal that could pass both chambers.
Congressional insiders said their job was made more difficult by the letter
written by Rep. Heather Wilson, a New Mexico Republican, and signed by 43
other House Republicans. In it, they asked House Budget Committee Chairman
Jim Nussle, an Iowa Republican, to abandon the effort to trim as much as $20
billion from the projected growth in Medicaid over the next five years.
Instead, the 44 Republicans endorsed a bipartisan commission to look for
ways to restructure the program.
Wilson
said the states, which run Medicaid jointly with Washington,
operate it with a combined 2,500 waivers of the program's rules. "That tells
me that it's time to change the rules," she said.
Her position is popular with the nation's governors. Democrat Mark Warner of
Virginia, chairman of the National Governors' Association, told the Kaiser
Family Foundation Thursday that it is time to take a serious look at
restructuring Medicaid. Federal and state costs for the program are
estimated at $338 billion for next year.
Bush proposed trimming $13 billion out of Medicaid's projected growth from
2006 to 2010. The House approved up to $20 billion in cuts in its version of
the fiscal 2006 budget.
The Senate voted 51-49 to restore the Medicaid cuts recommended by its
Budget Committee. That meant the issue would have become a point of
contention between House and Senate negotiators even without the House
Republicans' letter.
The
Los Angeles Times is a Tribune Publishing newspaper.
Recent withdrawals put approval, monitoring process under scrutiny
By Susan Baer
Baltimore Sun National Staff
Sunday, April 17, 2005
WASHINGTON
- Not so long ago, the Food and Drug Administration could be counted on to
approve a new drug or medical device - and approve it with some speed - if
its advisory committee recommended it do so.
But these days, facing intense scrutiny, political pressure and criticism
that it has rushed harmful drugs to market and cozied up to the
pharmaceutical industry, the agency appears to be adopting a more cautious,
conservative stance and shifting its calculus in evaluating a drug's risks
versus its benefits.
Because of high-stakes, high-profile controversies over the safety of
arthritis drugs such as Vioxx and antidepressants prescribed for teenagers,
the FDA has recently taken a tougher stand on a number of drugs.
Early this month, it pressed Pfizer to pull its arthritis drug, Bextra, off
the market. It required severe safety warnings on nearly all
anti-inflammatory drugs, including such popular over-the-counter medications
as Aleve and Motrin. In March, it required two popular topical treatments
for eczema to carry a "black box," the strongest warning available, advising
consumers of a possible link to cancer even though the data are far from
clear.
Whether the FDA will follow last week's recommendation by an advisory panel
to allow certain silicone breast implants back on the market is anyone's
guess - but certainly not a slam-dunk in the current climate.
"You're seeing a very typical pendulum reaction," says Arthur A. Levin,
director of the Center for Medical Consumers and a member of the FDA's
advisory panel on Drug Safety and Risk Management. He is heartened by the
more cautious approach. "Where there's uncertainty, you err on the side of
safety. That's not the rule usually."
William B. Schultz, a Washington
lawyer and former deputy FDA commissioner for policy, says the underlying
current in the agency's approach these days appears to be a desire to get
longer-term data in evaluating the safety of drugs.
Indeed, the cardiovascular problems associated with Vioxx didn't show up in
studies until after 18 months of use. Similarly, the agency found that the
ruptures and other problems from silicone breast implants typically occurred
after three years.
Last week, the FDA panel evaluating silicone implants made by two Santa
Barbara, Calif., companies rejected an application by one company, Inamed,
saying the manufacturer needed to present longer-term safety data.
But Schultz says it is not clear the FDA will follow the advice of its panel
to allow implants made by a rival company, Mentor, back on the market. In
late 2003, the last time the agency considered silicone implants, the FDA
staff "expressed a lot of doubts about the data," Schultz said. This time
around, the companies did not provide that much more proof of safety than
they had before.
"Vioxx was a wake-up warning," says Schultz. "The absence of problems isn't
enough. You have to have a strong showing of safety."
But not everyone thinks erring on the side of caution is a move in the right
direction. "People tend to think caution is a good thing," says Sam Kazman,
chief counsel of the Competitive Enterprise Institute, a public policy group
that advocates free enterprise and limited government. "If you're drowning
and I'm about to throw you a rope, but people want to first see the
paperwork on that rope, by the time I get that rope to you, you may be
gone."
Kazman says the FDA is reverting to what he calls "deadly overcaution" and
bowing to political heat in the aftermath of unexpected side effects in some
widely used drugs. "The flip side is that people don't get the medicines
they need," he says.
He would like to see the agency transformed from what he calls a "veto
agency" into an advisory agency in which doctors would be allowed access to
unapproved therapies as long as they and their patients understood the
risks.
The Pharmaceutical Research and Manufacturers of America, which represents
most brand-name drugmakers, has also expressed concern about the recent drug
withdrawals. "It's important to make sure the benefits of a product are
given equal weight as the risks," says spokesman Jeff Truitt. "It's patients
who benefit from the products."
He says he hopes the FDA does not get "stampeded into hasty, premature
action" to reform its drug approval process in response to the recent,
highly publicized problems.
Kathleen K. Quinn, a spokeswoman for the FDA, says the agency is approaching
decisions on drug approvals as it always has: "Do the benefits outweigh the
risks for the intended use in the intended population?"
But she notes that the agency is trying to evaluate its procedures in a
number of ways and is awaiting the recommendations of the Institute of
Medicine, which is reviewing the FDA's drug safety system, especially for
drugs already on the market.
For much of its recent history, the nearly century-old FDA was criticized as
too sluggish in approving new drugs.
In the late 1980s and early 1990s, patient activists stormed the agency,
pressing it to quickly make experimental and potentially lifesaving drugs
available to those with AIDS.
Major drug companies, too, complained of foot-dragging at the FDA and
threatened to move their operations overseas.
Congress responded, passing a law in 1992 that ensured a speedier review
process with the help of "user fees" from the drug industry. The fees
provided resources for more reviewers and thus expedited action.
The new speed had the intended effect - the agency quickly approved more
than a dozen experimental drugs that took the death sentence out of AIDS, as
well as treatments for other serious diseases.
But critics contend the user fees and faster review process that was in full
swing by the mid-1990s had unintended effects as well, some of which are
just playing out now. By 2000, the agency had to withdraw nearly a dozen
drugs, including a diabetes drug, Rezulin, that caused liver problems and
even death.
The Vioxx episode - in which a drug that was approved by the FDA in six
months, widely marketed and used by millions of Americans was linked to
increased heart attacks and strokes - cast a spotlight on the agency's drug
review process once again.
Republican Sen. Charles E. Grassley of Iowa, the FDA's chief critic in
Congress, wrote in a letter to acting and nominated commissioner Lester M.
Crawford last month: "The culture of FDA has tilted too far in favor of the
interests of pharmaceutical companies, in some cases at the expense of
public health."
Grassley, who is investigating the agency, said he was encouraged by the
FDA's recent move to rein in Bextra and other painkillers "if it is a
turning point and indicates a more independent Food and Drug
Administration."
But he and others are pushing for agency reforms in which the FDA division
that monitors a drug's safety once it is on the market is completely
divorced from the office that reviews applications for new drugs.
Levin of the Center for Medical Consumers says the agency needs additional
authority to require companies to perform and report post-market studies of
its drugs and levy fines if they don't. He would also like to see the agency
have an intermediate step in which drugs could be approved for limited
distribution while the risk-benefit equation continues to be studied.
Still, he is encouraged by what he believes is a higher safety bar that drug
companies will now have to clear. "The burden on them to prove the safety of
their drugs will be much, much greater," Levin says.
Two members of Congress have asked National Institutes of Health Director
Elias A. Zerhouni to delay for 90 days the implementation of controversial
new rules that aim to minimize conflicts of interest among NIH scientists.
The request to place the pending rules on hold, faxed to Zerhouni late last
week by Reps. Chris Van Hollen (D-Md.) and Thomas M. Davis III (R-Va.),
echoes a similar bipartisan call by senators who recently told Zerhouni that
the proposed rules, while well intentioned, "go overboard."
The letter arrived as yet another prominent NIH scientist let it be known he
would resign: Arthur J. Atkinson Jr., a clinical pharmacologist who advises
the director of the agency's newly expanded $635 million clinical research
center. Atkinson, 67, had been considering retirement, but the looming rule
changes precipitated his decision, sources said.
Among other changes, the new rules will require thousands of NIH employees
and their spouses to divest all stock holdings in medical and biotechnology
companies -- a move that many employees have said will place them in serious
economic jeopardy, especially given the market's current slump.
"Our concern centers around the likelihood that the regulations in their
current form will seriously erode the ability to recruit and retain
scientists and medical professionals," wrote Davis and Van Hollen, whose
Maryland district includes the NIH's Bethesda
campus. "We urge you to immediately suspend the new regulations for 90 days
until you have had time to fully assess the impact these regulations will
have on NIH."
Zerhouni announced the new rules in February after learning that some NIH
scientists had not properly disclosed consulting arrangements with drug and
biotechnology companies. The changes were negotiated with the Department of
Health and Human Services and the Office of Government Ethics.
The new rules ban all biomedical company consulting; severely restrict other
paid and unpaid outside professional activities; and place strict limits on
-- and, for thousands of employees, totally ban -- ownership of biomedical
company stocks.
Last week, in an e-mail that drew a fresh round of groans from NIH
scientists, some research leaders were advised to file formal "outside
activity" requests for every scientific journal for which they occasionally
review article submissions -- a routine, unpaid professional activity not
previously subject to oversight.
The stock rules, which have been most divisive, were delayed for 90 days in
early April by HHS Secretary Mike Leavitt and are now set to take effect
July 3.
A
handful of scientists, including one institute director, have already said
they will depart because of the new rules. A Duke University researcher
selected last fall to direct the agency's environmental science institute
also recently told Zerhouni he was reconsidering that appointment, which was
to begin this month, in light of the changes.
On April 6, the two ranking members of the Senate Appropriations
Subcommittee on Labor, Health, Human Services and Education -- Sens. Arlen
Specter (R-Pa.) and Tom Harkin (D-Iowa) -- criticized Zerhouni about the
changes.
"These are too onerous. They've got to be redone, and they've got to be
redone soon before you start losing more people out of there," Harkin said
to Zerhouni after relating a story of an NIH scientist who was leaving the
agency because the divestiture rule would gut the nest egg she'd saved for
her retirement and for her child's college education. "I mean, sometimes we
tend to see a conflict of interest and we go overboard," Harkin said, "and I
think we've gone overboard here."
Zerhouni has recently begun to emphasize in his comments that he is not
personally responsible or even supportive of the divestiture rules, which
are virtually the same as those in place for regulatory scientists at the
Food and Drug Administration. "I'm as concerned as you are," he told Harkin
at the hearing. "That part of the rule, frankly, is the one that I think we
need to reevaluate very quickly."
In a brief interview yesterday, Zerhouni said the rule changes are still "a
work in progress" and noted that "nobody has been asked to divest anything
yet." He said Leavitt has been "very responsive and is very concerned that
we end up with a fair and balanced rule that protects the public trust while
not creating an undue burden on our employees."
Atkinson, the latest to depart from NIH, could not be reached for comment
yesterday. In addition to his advisory duties at the clinical center, he has
been serving as director of the clinical pharmacology research associate
training program -- a role that won him plaudits from PhDs for his teaching
abilities.
In 2000, he was named a "master" in clinical pharmacology by the American
College of Physicians-American Society of Internal Medicine, "for his
distinguished contributions to internal medicine." In 2003, he was the
recipient of a distinguished service award from the American Society for
Clinical Pharmacology and Therapeutics, of which he once served as
president.
Staff
researcher Meg Smith contributed to this report.
Maryland's
lawmakers are meddling with America's
free enterprise system with passage of a bill that sets a minimum percentage
of payroll large employers in the state must spend on employee health-care
benefits. Not only that, but the legislation could stop a major employer
from locating in Somerset County, a depressed area that could use the influx
of jobs.
The Fair Share Health Care Fund Act is written to require that companies
employing more than 10,000 people in Maryland
spend at least 8 percent of their total payroll expenses on health-care
benefits for workers. It mandates that companies spending less than that
percentage would be forced to pay the different to the state for use in
funding Medicaid costs. Failure to file required reports could result in a
$250 per-day civil penalty and failure to make payment could result in a
$250,000 penalty.
Only one company now doing business in Maryland meets the criteria --
Wal-Mart, which employs more than 14,000 Marylanders and says it spends less
than 8 percent of its payroll on employee health care. Indeed, Wal-Mart has
been a target in other states for similar deficiencies, and is specifically
mentioned in a fiscal and policy note issued to the Maryland General
Assembly during its 2005 session.
It is feared that Wal-Mart may now reconsider whether to locate a
distribution warehouse in Somerset
County, given the new requirements.
Gov. Robert Ehrlich has said he will veto the bill, and expressed amazement
that Dels. Norman Conway, D-38B-Wicomico, and Bennett Bozman,
D-38B-Worcester, supported the bill. Legislative spokesmen have, however,
said they have more than enough votes to override the governor's veto.
This legislation steps over the line between government control and free
enterprise. It is the role of government to provide safety nets to citizens
who fall onto hard times, and workers are not required to work for a
specific employer. People who need good insurance benefits should continue
to seek employment elsewhere, where the benefits are better. If Wal-Mart (or
any other employer) finds that better health-care benefits are preventing it
from attracting and/or retaining the kind of workers it needs, it will be
forced by the market to revise its benefits package.
And aside from job market and employee benefit issues, by forcing this
legislation through over the governor's objections and overriding his veto
(if indeed that is what takes place), the Fair Share Health Care Fund Act
will drive a bigger wedge between Maryland government and business -- as
well as between the governor and the legislature, who already have a
somewhat dysfunctional relationship.
There are larger problems that our state government needs to address, some
of which could resolve this health-care benefits issue without direct
intervention or targeting any specific companies --medical malpractice
premiums, for example. Some related issues need to be dealt with at the
federal level --overall cost and quality of health care services in this
country, and the cost of prescription medications.
Writing a law that will dictate to corporate America how much must employers
must spend on health-care benefits for workers is not the right path.
ROBERT W. CURRAN is getting some razzing at his favorite Monday night haunt,
Jerry's Belvedere on York Road.
The Baltimore councilman is pushing legislation that would ban smoking in
public places, a proposal that bar, restaurant and tavern owners say would
torpedo business. But here's how Mr. Curran sees it: City Health Department
statistics show that smoking-related illnesses kill far more Baltimoreans
than alcohol, AIDS, car accidents, illegal drugs, murder and suicides
combined. In Maryland, 8,000 people die annually from smoking-related
illnesses. Given that dismal scenario, what's a little razzing?
A
former smoker, Mr. Curran has his priorities straight. The question isn't
whether an individual has the right to light up or not. It's whether the
person seated at a nearby table or, more pertinently, serving the drinks has
to suffer the consequences of this nasty habit. Secondhand tobacco smoke is
lethal: For every eight smokers the tobacco industry kills, one nonsmoker
dies with them. That's based on National Cancer Institute data.
This newspaper has supported legislation to extend the statewide workplace
smoking ban to bars, restaurants, hotels and other public places. That would
be a fairer way to safeguard the health of all citizens and level the
economic field for businesses - Montgomery and Talbot counties ban smoking
outright.
But the Baltimore City Council needn't wait for state lawmakers to muster up
the courage to act. It should take the initiative and spare city residents
and visitors any more damage to their health.
Restaurant and bar owners say a city smoking ban would mean lost business.
But an analysis by the Maryland Attorney General's Office of 97 studies on
the economic impact of smoking bans found claims of economic hardship to be
specious. Of 21 peer review studies with no ties to the tobacco industry,
none reported a negative impact on sales or employment.
City Council members who represent Fells Point, Canton and Federal Hill,
areas flush with restaurants, bars and music clubs, oppose the measure. They
say their constituents would lose patrons to establishments in nearby
Baltimore and Anne Arundel counties. But it's hard to imagine the bar scenes
in Fells Point and Federal Hill shifting to Towson and Brooklyn just for a
smoke.
Mr. Curran's bill defers the effective date of a ban until 2006 to give
businesses time to adapt. He also would support a tax credit for businesses
that create an exterior smoking area.
At his York Road
haunt, Mr. Curran says the razzing has been good-natured. But a bartender
did tell him he would probably quit smoking if a ban were enacted. If that's
the likely outcome of a ban, all the more reason for it.
THE FOOD and Drug Administration is having trouble finding the Goldilocks
formula for determining which pharmaceuticals should be approved for
commercial use.
During the outcry last fall after the pain reliever Vioxx was pulled off the
market by its manufacturer, critics complained that FDA regulators failed to
do the job themselves because they were too lax. In the wake of the FDA's
decision this month to withdraw approval of a Vioxx competitor, Bextra --
and order stricter safety warnings on some over-the-counter pain relievers
-- came complaints that the FDA was overcompensating the other way.
It seems unlikely the embattled agency will be able to instill confidence
that its judgment is "just right" until Congress changes a structure that
encourages FDA officials to get too cozy with the drugmakers they regulate.
In fact, the agency's recent vigilance is seen in some quarters as a gesture
to convince Congress that such an overhaul isn't necessary.
The lawmakers shouldn't fall for it.
The FDA's decision to yank Bextra may well have been just right. Like Vioxx,
the pain reliever has been linked in studies to increased risk of heart
attacks, strokes and a potentially fatal skin disease. The agency reasoned
that the pain-relieving benefits did not justify ignoring those risks
because patients can take a similar drug, Celebrex.
But the appearance of a wildly swinging pendulum in response to public
clamor -- enhanced by an advisory panel's split decision last week on
silicone breast implants -- isn't reassuring. Creating an independent office
within the FDA to review the safety of drugs already approved for market by
a different team of regulators would help restore the perception of balance.
Tinkering with science to produce a desired result is a widespread practice
by regulatory agencies under the Bush administration's control. The
president received strong political and financial backing from most
industries in anticipation that he would cut the red tape that impedes their
business. Stakes at the FDA are particularly high, though, and personal to
every American because medicine plays a huge role in maintaining health and
quality of life.
Doubts about the agency's judgment are heightened by signs that it is rife
with internal turmoil. That impression was reinforced last week by an
anonymous note to a Senate committee containing allegations of personal
impropriety against acting director Dr. Lester M. Crawford, whom Mr. Bush
nominated to officially take over the top job.
Meanwhile, the dietary supplement industry has been emboldened by a federal
court decision overturning the FDA's ban on the herbal stimulant ephedra,
blamed for the deaths of young athletes. Further challenges to the agency's
authority are likely.
All drugs and perhaps many dietary supplements pose some risk. The FDA can't
and shouldn't pretend that it can provide absolute protection. But the
agency must convince a wary public that it seeks a balance between benefit
and risk according to scientific, rather than political, considerations.
Putting distance between regulators who approve products and those who
monitor the safety record thereafter would do much to bolster public
confidence.
Children: Advocates strengthen call for public review of records as group
home problems come to light.
By Jonathan D. Rockoff
Baltimore Sun Commentary
Sunday, April 17, 2005
Getting detailed information about foster children is difficult. So is
finding detailed information about the group homes where they live.
All of that makes it very challenging to hold accountable the companies that
are entrusted and paid to take care of the children - and the state
regulators who are supposed to monitor that care.
"Everything right now is done with this shroud of secrecy, and there's no
way to oversee the overseers," said Kathleen Hughes, a managing attorney at
the Maryland Disability Law Center, a private watchdog group that the state
has designated to look after the interests of the disabled.
In a series of articles last week, The Sun described the state's failure to
adequately safeguard the 2,700 foster children living in 330 privately run
group homes. Regulators, the newspaper found, weren't properly overseeing
care, spending and staffing at the homes.
Youths placed by state agencies in the homes are among Maryland's most
vulnerable. They are victims of abuse and neglect, or they had been in
trouble with the law. Some have complex medical needs and require
round-the-clock nursing.
State law, however, largely blocks public review of the handling of their
cases, even after they have died.
Advocates, who suspect this is a problem nationally, say they've long
promoted improving public access to foster childcare records without
violating any privacy rights of the children or their families.
They've talked with lawmakers about a number of ideas. They suggest the
situation could be improved by giving lawyers representing the interests of
foster children the authority to decide what information can be released, by
establishing a watchdog agency that could review the records at the
department of human resources or by giving county "child fatality review
teams" that examine deaths of foster children the responsibility to share
more information with the public after their investigations.
In Maryland law, Article 88A only allows disclosure when prosecutors have
filed child abuse or neglect charges - a rarity, advocates say.
In such narrow circumstances, the state may give a limited amount of
information, including the name of the child and the date and circumstances
of the alleged abuse or neglect, along with the findings of an investigation
into the allegations.
Advocates complain that the information disclosed is too limited. They say
the public can't review the actions of the social services workers assigned
to the children.
Camille B. Wheeler, a former director of Baltimore County Department of
Social Services, said confidentiality shouldn't apply after a child has
died, and she said it is in the child welfare system's interest to discuss a
death.
"The public gets a worse impression not knowing what went on or what
happened," she said. "It's like saying no comment - it's an admission of
guilt."
Department of Human Resources Secretary Christopher J. McCabe, whose agency
oversees more than half of the children's group homes in Maryland,
acknowledged the importance of openness while testifying in Washington last
year about flaws a federal review was finding with the state's foster care
system.
"All states show the need for improvement, and I believe that the foundation
for change begins with transparency, owning up to our weaknesses, while
recognizing the inherent challenges in human service work as we seek to
serve those most in need," McCabe testified before a House Ways and Means
subcommittee.
State health officials give three responses to complaints about the
withholding of records.
First, they say more than the child's privacy is at stake - there's the
protection of the child's family and the reporter of any possible
mistreatment.
"Even alleged abusers may have a degree of legitimate privacy interest
unless and until their guilt is established by law," said Michael Walsh, a
spokesman for the Governor's Office for Children, Youth and Families, which
recently led efforts rewriting state regulations on group homes.
Second, the officials say that the restrictions don't mean child neglect,
mistreatment and death go without scrutiny, citing as many as a half-dozen
different investigations that may result.
But The Sun investigation found that at least three children's deaths lacked
thorough government reviews, and regulators didn't investigate two of them
at all.
Lastly, the officials say that the limited access to Maryland records stems
from federal law, which threatens states with the loss of millions of
dollars in child welfare funding if they release confidential information.
Yet Walsh, of the Governor's Office for Children, Youth and Families,
concedes that federal regulations "provide somewhat more flexibility" in
releasing information than Maryland
law allows.
State law, Walsh said, "has never been amended to the maximum limits allowed
by federal law." Child advocates say the stringency with which regulators
have interpreted federal law doesn't help youths receive good care at group
homes.
"It protects the agency," said Linda Koban, a former juvenile court official
who oversaw the cases of foster children living in group homes. "That's all
well and good as long as everybody is supposed to be doing what they should
and the care is good," but not when the system fails children.
Although lawmakers required one state agency, the Department of Health and
Mental Hygiene, to report deaths and serious injuries to the Maryland
Disability Law Center, the nonprofit group regularly faces roadblocks, its
lawyers say. "We have a very difficult time getting records from them,"
Hughes said. She suspects the agency is trying to hide sloppy oversight.
"From the records I've seen, the investigations are not necessarily timely,
thorough, on point," she said.
The newspaper's investigation found that regulators weren't properly
monitoring the state-licensed and -funded homes, allowing some to mistreat
or neglect children without investigation or consequences. Many group homes
employ unqualified or poorly trained workers, including some with criminal
records. With virtually no oversight of how they spend state funds, a number
of operators enrich themselves, relatives and friends.
While The Sun eventually examined 15,000 pages of state records, the paper's
reporters faced obstacles obtaining them.
Local departments of social services, which are branches of the Department
of Human Resources, initially cited Article 88A in rejecting requests to
review the case files of children assigned to group homes who died while in
state custody.
Months later, the department allowed reporters to review two of three files,
but advocates say that almost never happens.
"The Department of Human Resources has had the luxury of not coming under
public scrutiny because of its complex web of confidentiality shields," said
Jann K. Jackson, executive director of Advocates for Children and Youth.
"It's easy to let things slide if it's never going to come to public light."
Under the Public Information Act, reporters were able to study the licensing
and inspection records of 25 group home companies that ran 120 homes. But
the Human Resources and Health departments sometimes waited past the 30-day
deadline for releasing the documents. In some cases, DHR waited months.
In addition, the department either failed or refused to answer some
questions. Asked how inspectors could have missed a group home operator's
lack of qualifications, spokesman Norris P. West said, "The litany of
queries has really become onerous and overwhelming for our staff."
Neither he nor the department ever answered the question, which was first
asked in November.
Flu used to be the "Rodney Dangerfield of diseases," as Tim Uyeki puts it.
Uyeki is a flu epidemiologist at the Centers for Disease Control and
Prevention (CDC) in Atlanta,
and he's been concerned that for years people didn't give influenza the
respect it deserved.
But now flu has all the attention any germ can get. First, there was a flu
vaccine shortage over the winter, prompting long lines and provoking rage
from people who couldn't get their shots. Later, bird flu mesmerized the
world, with the CDC and the World Health Organization (WHO) keeping up a
steady drumbeat: A flu pandemic -- overdue for decades -- would be upon us
at any moment. Finally, it was announced that a pandemic flu strain had been
accidentally sent to influenza labs around the world as part of a testing
kit by Meridian Bioscience, a contractor for the College of American
Pathologists.
The jittery WHO, poised for catastrophe, insisted on the immediate
destruction of the strain, for fear of accidental release. And while the
threat posed by Meridian's error is far less than initial reports suggested,
the reality is that lab accidents do happen. What's more, the feverish
anxiety of public health officials to head off a new influenza pandemic may
be generating the greatest influenza threat we face.
The threat is man-made. Scientists in the United States and Great Britain
are studying the deadliest flu epidemic of the last century, the 1918
pandemic. In order to learn what made it kill so many, they are working on
producing artificial viruses that replace common human flu genes with 1918
genes. An accidental release of one of their constructs could make the
Meridian error look as menacing as a cauliflower.
The flu strain sent out by Meridian
is known as H2N2/Japan. H2N2 strains first appeared in 1957, causing a
world-wide pandemic. But H2N2/Japan is what virologists call a "reference
reagent," regularly used in laboratory tests. It's already in the freezers
of every serious flu researcher, says virologist Earl Brown of the
University of Ottawa. Furthermore, calling the H2N2/Japan strain a "killer"
-- as news reports across the globe have done -- makes little sense. It is
no deadlier than any other new strain, and may actually be less so.
According to microbiologist and pathologist Jared N. Schwartz, of the College
of American Pathologists, H2N2/Japan has been through lab processes that
typically weaken the virus. No one has contracted H2N2/Japan from these lab
kits. This is not surprising. As flu researcher Adolfo Garcia-Sastre of the
Mount Sinai School of Medicine in New York puts it, you'd have to aerosolize
the virus in some way in order to catch it -- not something that is likely
to be done with a reference strain.
Following the pandemic of 1957, which killed perhaps a million people, most
of them elderly, H2N2 became the dominant human flu virus for 11 years. In
1968, a new strain, called H3N2, caused a new pandemic, and H2N2
mysteriously vanished. People born after 1968 may have partial immunity
because of the N2 component of the virus, common also to the currently
circulating H3N2 strain. Still, no one born after 1968 has full immunity, so
WHO flu experts are concerned that a lab accident could cause another
pandemic. But H2N2, like most flu strains, is disproportionately deadly to
the elderly -- precisely the group most likely to have some immunity.
The WHO's frenzied demands that laboratories destroy this strain seem like
an overreaction. Apparently, WHO wants to show a nervous world that it is
taking action. But this mania to do something -- anything -- to stave off a
pandemic has been building for years and led to the imprudent decision to
re-create the dangerous 1918 strain.
The 1918 flu evolved its lethality on World War I's Western Front. This was
no accident. According to Carol Byerly, a historian of military medicine and
author of a new book, "Fever of War: The Influenza Epidemic in the U.S. Army
During World War I," the 1918 flu built up its unique virulence in the
trenches and the hospitals, the trains and trucks of the front, where the
deathly ill lay beside the uninfected, allowing lethal strains to be easily
passed on.
Tissue samples that prescient World War I Army physicians stored away,
combined with flu RNA taken from the partially frozen corpse of an Inuit
woman in Brevig Mission, Alaska, have yielded enough genetic information to
allow the sequencing of all eight genes in the 1918 influenza virus genome.
Molecular pathologist Jeffery Taubenberger and his colleagues from the Armed
Forces Institute of Pathology have brought these lost genes from 1918 back
from the dead; they've sequenced five of the genes, and are close to
completing the last three as well.
These sequences by themselves are harmless: They are strings of information.
As Garcia-Sastre puts it, "There's no smoking gun in the 1918 sequences. So
we really want to find out what made it kill, so that if it emerges again in
the future, we'd be able to recognize a virus with virulence characteristics
like 1918." Through a technique Garcia-Sastre and colleagues developed,
these sequences -- symbols on paper -- can be translated into actual viral
RNA. Since the whole genome hasn't yet been published, scientists can't
re-create the entire 1918 flu. But they can combine some 1918 genes either
with laboratory strains that have been adapted to grow in mice, which don't
normally catch human flu, or with ordinary human flu strains to yield new
artificial strains. Then the researcher infects mice with his new strain.
Strains using three of the 1918 genes are already known to kill mice.
These techniques are fascinating. But the work is also dangerous. Peter B.
Jahrling, chief scientist at the National Institute of Allergy and
Infectious Diseases, compares the research to "looking for a gas leak with a
lighted match." What concerns Jahrling and Brown, among others, is that
experiments involving 1918 genes are not being carried out under the highest
biosafety level, BSL-4. While most of the scientists use what is known as
BSL-3 plus, or enhanced, conditions, they do not use space suits, chemical
showers or gas-tight cabinets in their work.
Still, it's hard to say how much difference a higher biosafety level would
make: Work on dangerous agents is, by definition, dangerous. Even in BSL-4
labs mistakes can happen, and some of these mistakes have been fatal -- to
the experimenter. In addition to three laboratory escapes of the SARS virus
in 2003 and several resultant fatalities, a number of Russian researchers at
the Vektor laboratories in Siberia have died of Ebola, and several
scientists at
Boston University contracted tularemia, or rabbit fever, in recent years.
The 1918 flu is a particularly potent agent, and it isn't only the lives of
experimenters at risk if one of them contracts one of the artificial
constructs. As Brown puts it, "These are tried and true virulence strains
for humans. This virus and its genes have to be given a bit more respect.
You don't want it out in nature where it could cause serious disease." While
the antiviral drug oseltamivir, or Tamiflu, seems to protect against the
1918 constructs, Jahrling says "you'd really want a belt to go with those
suspenders." And Richard Ebright, a microbiologist at Rutgers University,
says that "using Tamiflu as a prophylactic makes it more likely that if a
strain is accidentally released, it's going to be a Tamiflu-resistant
strain."
There's an added danger. The scientists now known to be working on these
strains are all respected by their peers; no one expects them to be
careless. But the five published sequences are in the public domain, and
there is simply no way to know who else may be working on them at any given
time. Even more disturbing is what may happen when Taubenberger publishes
the remaining three gene sequences. Then the entire 1918 flu could be built
from scratch by anyone, anywhere, who has sufficient resources and skill. It
is quite conceivable that resurrected 1918 flu could someday be used as a
bioterrorist agent.
Clearly, if these genes had never been dug up, we wouldn't have to worry
about any of this. And how necessary is this admittedly remarkable work in
the first place? Evolutionary biologist Paul Ewald of the University of
Louisville points out that influenza is normally a relatively mild disease:
It keeps its hosts up and moving in order for it to spread. But the precise
conditions of the Western Front allowed the virus to evolve unprecedented
virulence. Without those conditions, lethal pandemic flu cannot evolve. Says
Byerly, "The 1918 flu epidemic most likely will not happen again because we
won't construct the Western Front again."
If Ewald and Byerly are right, then the principal rationale for this
research -- protection from another lethal pandemic -- blows away, though
the research remains a useful tool to show how lethal flu kills.
Indeed, if they are right, the greatest danger of lethal pandemic flu may
lie in some slip, some failure of lab protocol or Tamiflu, or even in
someone's malice. Then the vaunted cure may prove worse than the disease .
Wendy
Orent, an Atlanta-based freelance writer, is the author of "Plague: The
Mysterious Past and Terrifying Future of the World's Most Dangerous Disease"
(Free Press).
Years ago a wizened, cigar-chomping South Baltimore
pol was asked to describe a famously ineffective Maryland political leader.
"It's an abuse of power, this guy," he said. "He's got the power, and he
doesn't use it."
In his diaries describing life as governor, former New York governor Mario
Cuomo (D) described waking up at 5 each morning, worried that he might
squander precious moments in public office that could be devoted to
accomplishment.
William Donald Schaefer (D), as a two-term Maryland governor, was more
direct. He would begin each cabinet meeting -- and even his State of the
State address -- with his trademark reminder: "Time is not on our side. Do
it now."
This sense of urgency and purpose seems not to have infected the Ehrlich
administration, which just completed its third legislative session.
When Robert L. Ehrlich Jr. (R) took the oath of office in 2003, it seemed a
historic opportunity for Maryland Republicans. Ehrlich appeared to have none
of the personal flaws of his predecessor, and he had lots of goodwill and
political capital to spend. But that promise mostly has been squandered.
When Ehrlich took office, I expected that the centerpiece of his
administration would be a focus on failing urban schools. Education had
transformed Ehrlich's life, and he could fight to give the same chance to
poor families that otherwise had few educational opportunities. As a
Republican, he also was in a position to challenge Democratic capitulation
to the teachers unions on school reform.
But although the legislature reaffirmed a massive school funding increase, a
real focus on reform never came. The best we have now is Lt. Gov. Michael
Steele on a "school listening tour." Maryland will have better-funded
schools, but it is unclear whether it will have better schools.
Transportation funding seemed the logical next priority, and Ehrlich was in
a position to build a consensus for a major funding package. Again, it never
came. The governor jump-started project planning on the intercounty
connector, which his predecessor had abruptly terminated, but both Ehrlich
and the legislature punted on overall transportation funding, passing only a
stopgap registration fee increase.
As a candidate, Ehrlich justifiably criticized juvenile services, but things
haven't improved on his watch. Most of the infrastructure surrounding
Maryland's troubled kids is collapsing, and more reports of abuse have
surfaced. The state Department of Juvenile Services may face a deficit of
$31 million, and management problems are widespread.
The warning signs of governance-lite were there early, with few initiatives
except slots. Goodwill toward the rookie governor was strong, however, so
the lack of substance was excused. Now, though, the truth of the management
maxim has become clear -- if you don't know where you're going, you're not
likely to get there.
The administration has had one bright shining moment: The passage of the
"flush tax," which generates funding for $65 million each year to repair
aging sewage treatment plants. The administration showed innovation and
energy in collaborating with the legislature to pass this bill, which could
make a huge difference in water quality. It stands as a monument to what
could have happened in the rest of state government, but didn't.
Ehrlich had a chance to bring in the "best and brightest" to government, and
to be sure, the governor did attract some strong leaders -- Budget and
Management Secretary James "Chip" DePaula, Health and Mental Hygiene
Secretary Nelson J. Sabatini (now retired) and Business and Economic
Development Secretary Aris Melissaratos. There wasn't much of a second
string, though.
Historically, strong professionals have run Maryland's service departments.
Political hacks did get jobs, but they were posted to backwaters where they
couldn't do much harm.
When the Republicans came into office, though, they misread the workforce as
hostile and Democratic. They didn't realize that many state professionals
welcomed the new administration, believing it would restore standards that
had started to slip under the previous governor, Parris Glendening (D).
But incredibly, the Ehrlich administration far out-hacked Glendening,
filling important professional positions with Republicans with heavy party
credentials but light professional backgrounds. Indeed, the systematic
installation of Republicans was one of the few administration initiatives
executed with discipline and focus.
It didn't have to turn out this way.
Gubernatorial power in Maryland
is strong, probably more so than in any other state. The state constitution
gives the governor broad authority to initiate budgets, make appointments
and administer agencies. But the Maryland
governor's levers of power are gathering dust now because you can't govern
from radio talk show studios.
Lots needs doing in Maryland
-- in school reform, transportation, higher education and juvenile services.
What is missing now is an urgency and sense of purpose about doing it.
The
writer, a lawyer in Greenbelt, served for 16 years as a Democratic member of the
Maryland legislature. His e-mail address is
tmaloney@jgllaw.com.
