A4 EZ SU THE WASHINGTON POST.WEDNESDAY, AUGUST 7 , 2019
He added the agency has in-
spected the manufacturing facili-
ty used for the treatment and has
“no c oncerns” a bout the p rocess.
The gene therapy has been
hailed as “transformative” for
children with the genetic defect.
Left untreated, a child with the
disease is likely to be on a ventila-
tor and unable to raise his or her
head by t heir first birthday, M arks
said.
Zolgensma is the second gene
therapy approved by the F DA. The
first was Luxturna, made b y Spark
Therapeutics, which is used for a
rare i nherited type o f blindness.
lauri [email protected]volves tests comparing older and
newer versions of t he t herapy.
Spinal muscular a trophy i s con-
sidered an extremely rare disease,
affecting about 30 new patients a
month. It is caused by a defective
gene that is supposed to allow the
body to maintain cells called mo-
tor neurons. Without a properly
functioning gene, i nfants typically
die or live on l ife support.
Marks said he was most con-
cerned that the manufacturer
“submitted data that was inaccu-
rate to us as part of their applica-
tion and that led us to approve a
product potentially sooner than
we might have.”In a statement, Novartis said it
is “fully confident in the safety,
quality and efficacy of Zolgens-
ma.” The drugmaker said AveXis
investigated allegations of data
manipulation and “once we had
interim conclusions from our in-
vestigations, we shared our find-
ings with the FDA.” The data, the
company added, “were a small
portion of our overall submission
and a re limited t o an older process
no longer i n use.”
The FDA approved the gene
therapy on May 24. On June 28,
Marks said, AveXis told t he agency
about the data problem. Marks
said the manipulated data in-Peter Marks, director of the
FDA’s Center for Biologics Evalua-
tion and Research, said the inac-
curate information involved
mouse data and was a “small
amount of the totality” that was
submitted. The faulty data didn’t
raise concerns about the treat-
ment’s s afety a nd e ffectiveness, he
said. But he added the agency
takes data integrity i ssues serious-
ly and is c ontinuing to investigate.
He said the FDA “will use its full
authorities t o take a ction, if appro-
priate, which may include civil or
criminal penalties” against the
manufacturer, AveXis Inc., a sub-
sidiary o f Novartis.BY LAURIE MCGINLEYThe Food and Drug Adminis-
tration said Tuesday that a Novar-
tis subsidiary submitted manipu-
lated data as p art of its application
for a new gene therapy and didn’t
tell the a gency until a fter t he treat-
ment was approved.
However, the agency said, the
treatment costing $2.1 million —
considered the world’s most ex-
pensive drug — should stay on the
market. The therapy, called Zol-
gensma, is for children under 2
with spinal muscular atrophy, a
leading genetic cause of infant
death.
BY BEN GUARINOA federal watchdog challenged
the Trump administration’s au-
thority to move two Agriculture
Department science agencies out
of Washington, in a report issued a
few days after Mick Mulvaney, t he
acting White House chief of staff,
praised the move for encouraging
federal scientists to quit their j obs.
The plan to relocate the two
agencies from the District to Kan-
sas City may have run afoul of the
2018 appropriations act, accord-
ing to a report released Monday
from the USDA’s Office of Inspec-
tor General.
In August 2018, Agriculture
Secretary Sonny Perdue unveiled
a plan to relocate the National
Institute of Food and Agriculture,
which oversees $1.7 billion in sci-
entific grants and funding, and
the Economic Research Service, a
federal statistical agency that
publishes influential reports on
agricultural trade and rural
America. Both agencies lease of-
fice space in the D istrict.
USDA selected the Kansas City
region as the new home for these
agencies in June 2019, in what
Perdue has billed as a cost-saving
decision. About two-thirds of
nearly 400 employees refused the
reassignment and will lose their
jobs.
“This is the brain drain we all
feared, possibly a destruction of
the agencies,” Jack Payne, Univer-
sity of Florida’s vice president for
agriculture a nd natural resources,
told The Washington Post last
month.
In his keynote speech at the
Republican Party’s black-tie-
optional Silver Elephant Gala in
South Carolina on Friday, Mulva-
ney seemed to celebrate the attri-
tion a t the agencies. “You’ve heard
about ‘drain the swamp.’ What you
probably haven’t h eard i s what we
are actually doing. I don’t know if
you saw the news the other day,
but the USDA just tried to move,
or did move, two offices out of
Washington, D.C.,” he said.
As the crowd clapped, Mulva-
ney continued: “Yes, you can ap-
plaud that one. That’s what we’ve
been talking about doing. Guess
what happened? Guess what hap-
pened? More than half the people
quit.
“By simply saying to people,
‘You know what, we’re going to
take you outside the bubble, out-
side the Beltway, outside this lib-
eral haven of Washington, D.C.,
and move you out in the real part
of the country,’ and they quit —what a wonderful way to sort of
streamline government,” Mulva-
ney said.
Trump officials are planning
additional departures from Wash-
ington. By 2020, more than
80 percent of the headquarters
staff at the Bureau of Land Man-
agement will be moved west, the
Interior Department told law-
makers i n July. The Trump a dmin-
istration also wants to break up
the Office of Personnel Manage-
ment and split 5,500 workers
among t hree o ther departments.
J. D avid Cox Sr., president of the
American Federation of Govern-
ment Employees, which repre-
sents workers at the two USDA
agencies, said Mulvaney’s com-
ments confirmed the union’s con-
cerns. “The administration’s deci-
sion to transfer hundreds of USDA
jobs from D.C. isn’t about helping
federal employees do their jobs
better or delivering better services
to the American taxpayer,” Cox
said in a statement. “Their goal is
to drive out hard-working and
dedicated civil servants and si-
lence the parts of the agencies’
research that the administration
views as inconvenient.”
Congress questioned whether
USDA has the legal authority to
move the agencies. The depart-ment has this power, according to
the inspector general’s investiga-
tion. But USDA a lso needs budget-
ary approval from Congress to
fund the moves, the watchdog
group said, which the d epartment
did not obtain.
In the fall, USDA awarded a
$340,000 contract to the account-
ing firm Ernst & Young to assist
with the relocation. The 2018 om-
nibus spending bill required
USDA t o receive congressional a p-
proval before spending this mon-
ey. “That prior approval did not
appear to have been granted,” t he
inspector general report says.
This expense may have also vio-
lated the Antideficiency Act, the
report said, which prevents feder-
al employees from involving the
government “in a contract or obli-
gation for the payment of money
before an appropriation is made.”
Rep. Steny H. Hoyer (D-Md.)
and Del. Eleanor Holmes Norton
(D-D.C.), who requested the in-
spector general’s investigation in
September 2018, exhorted USDA
to follow the law. “The Secretary
must follow the will of Congress
and refrain from moving forward
with the relocation,” t hey said in a
joint statement Monday, “until
Congress approves the use of
funds for t hose purposes as direct-ed by the fiscal year 2018 Consoli-
dated Appropriations Act.”
Rep. G erald E. Connolly (D-Va.)
called the inspector general re-
port “very troubling” and said it
confirms “suspicions that the sec-
retary does not have the authority
to proceed with this relocation.”
G. William Hoagland, a vice
president at the D.C.-based Bipar-
tisan Policy Center think tank,
predicted that the failure to get
congressional approval “will cer-
tainly set in motion legal challeng-
es” from the union to halt the
move “until either the courts or
Congress act.”
In a list of recommendations in
the report, the inspector general’s
office advised USDA to seek ap-
proval from a congressional com-
mittee.
USDA management refused to
do so. “To say the department was
out of step with budgetary re-
quirements disregards the au-
thority given to the executive
branch by the U.S. Constitution,”
according to a statement provided
by USDA. It continued: “Since the
inspector general affirms the de-
partment has the legal authority
and we do not agree with the
unconstitutional budgetary pro-
vision, this case is closed.”
[email protected]Federal watchdog questions legality of USDA relocations
BY HOLLY BAILEYdes m oines — It was the 2 011 Iowa
State Fair, and things were going
well f or Mitt R omney.
After poor reviews of his visit
four years earlier, Romney had
dressed more c asually and trimmed
down his entourage. He gamely
flipped pork chops, posed with a
2,000-pound pig and admired an
intricately carved butter cow.
Then he stepped up to the fair’s
political soapbox.
With one leg propped up on a
bale of hay, Romney sparred with a
group of hecklers. When one inter-
rupted the former Massachusetts
governor to argue for tax increases
on large businesses, Romney testily
replied, “Corporations are people,
my f riend.”
Democrats quickly seized on that
line, using it to define Romney as a
cold, out-of-touch businessman.
That narrative ultimately helped
doom his effort to unseat President
Barack Obama.
Romney’s r emark serves as a cau-
tionary tale for the n early two dozen
Democratic presidential candi-
dates who will descend on the Iowa
State Fair this week.
The fair is a rite of passage for
anyone with White House aspira-
tions, a photo op that often serves
up funny and weird moments —
and sometimes political catastro-
phe. It “is just dotted with land
mines,” said David Kochel, Rom-
ney’s senior adviser in Iowa during
his 2012 run. The “corporations”
remark “ended up being one of
th em.”
The 11-day event is a political
obstacle course that’s been damag-
ing to a number of candidates, es-
tablishing a narrative that when set
is often hard to shake. And it will be
especially challenging this year, as
candidates struggle to strike the
right tone while the nation con-
tends with the aftermath of a vio-
lent w eekend.
In 2007, former senator Fred
Thompson (R-Tenn.) launched a
la st-minute bid for the GOP nomi-
nation, built around his aw-shucks
appeal to working-class voters. He
undermined that message when he
showed up at the fair in what a
television reporter initially de-
scribed as a pair of Gucci loafers.
(Thompson, a former t elevision and
film star known f or his stint o n “Law
& Order,” later clarified that they
were Salvatore Ferragamo shoes.)
Thompson’s “Gucci shoes”
haunted him for the r est of his c am-
paign, which went belly up a few
months later.
In 2003, then-Sen. John F. Kerry
(D-Mass.) arrived at the fair just
days after he’d been labeled snooty
for ordering a Philly cheesesteak
with Swiss cheese instead of the
usual Cheez Whiz. Robert Gibbs, a
former White House press secretary
working for Kerry at the time, re-
called going ballistic when he spot-
ted the senator b uying a strawberry
smoothie with a n umbrella in it.
“Somebody get a [expletive] corn
dog in his hand now!” Gibbs yelled
to an aide.
But Kerry got into trouble any-way. During his tour of the fair, he
met a man who had just moved to
Iowa from Massachusetts. “Why?”
the senator asked, in what aides
later insisted was a dry attempt at a
joke.
The man d idn’t l augh.
“You can’t come to the fair and
fake it,” said former senator To m
Harkin (D-Iowa). “People here have
what they call their ‘phony antenna.’
Are you real or are you just putting
on a show? Are you trying too hard
to be like us?”
“They look very closely for a poli-
tician to do or say something that is
indicative of what their real person-
ality is,” Harkin said. “People aren’teasily fooled.”
Some missteps have been more
damaging than others. Perhaps no
one understands that better than
Joe Biden, whose bid for the 1988
Democratic presidential nomina-
tion was derailed by a plagiarism
scandal that began during his first
Iowa State Fair a ppearance.
During his closing remarks at a
candidate debate held at the fair in
August 1987, Biden quoted without
attribution several phrases from a
speech previously given by Neil Kin-
nock, a British Labour Party politi-
cian. Biden had used the lines be-
fore in stump speeches, crediting
Kinnock, b ut later said he forgot.
The ensuing scandal led to rev-
elations that Biden had also been
accused of plagiarism in law school.
He quit the race about a month
later.
Watching this crop of Democrat-
ic contenders at the fair could also
offer some early signs of organiza-
tional strength. Since Romney’s
speech in 2011, campaigns have
made a practice of packing the area
around the soapbox with volun-
teers and supporters, some claim-
ing seats hours ahead of time. In2015, one of the earliest signs of
Bernie Sanders’s growing strength
in Iowa was when his soapbox
speech attracted a few thousand
people.
Hillary C linton skipped the soap-
box, citing security concerns, but
toured the f air with a chaotic scrum
of several hundred people that in-
cluded members of the media, vol-
unteers, staff, supporters and secu-
rity. But in a foreshadowing of the
tumultuous general election to
come, it was Donald Trump who
stole the show.
As C linton emerged from a n agri-
culture building where she had paid
her respects to the butter cow, her
entourage was suddenly distracted
by Trump’s low-flying helicopter,
which flew in slow circles around
the fairgrounds, a scene reminis-
cent of “The Wizard of Oz.”
Harkin, who was with Clinton,
recalled staring up at the strange
scene, unable t o believe what he was
seeing. “I thought nobody was go-
ing to buy this. Iowans don’t like
showy types or people flaunting
their wealth,” Harkin recalled.
“How little did I know?”
[email protected]FDA: Drugmaker submitted manipulated data before approval
Iowa fair can make — or break — a candidate
Romney and Biden are
among those who know
the cost of a gaffe thereRACHEL MUMMEY FOR THE WASHINGTON POST
Democrat John Delaney (Md.), then still a congressman but already
declared for the 2020 contest, rides the Giant Slide at the Iowa
State Fair last year. Left, the carved butter cow is a standard stop.
The fair is a key event for anyone with White House aspirations.CHARLES OMMANNEY/THE WASHINGTON POSTBY KAYLA EPSTEINA lawsuit filed this week claims
to have uncovered hundreds of
previously unknown cases of sex-
ual abuse in the Boy Scouts, say-
ing that the organization and
other defendants engaged in
“reckless misconduct” in failing
to protect its young participants.
The lawsuit names one plain-
tiff, identified as S.D., who alleges
he was assaulted hundreds of
times, beginning when he was 12
or 13, by a Scout leader in Penn-
sylvania over about four years in
the 1970s.
The complaint names the Boy
Scouts, the Penn Mountains
Council and S.D.’s alleged abuser
as defendants and was filed in
Philadelphia’s Court of Common
Pleas.
The litigation stems from an
attempt to unearth previously
unreported cases of child sexual
abuse in one of the country’s most
prominent youth organizations,
spearheaded by Abused in Scout-
ing, a group of law firms that
collaborate on bringing such cas-
es to light.
In a statement to The Washing-
ton Post, the Boy Scouts said it
had made about 120 reports to
law enforcement based on infor-
mation provided by Abused in
Scouting.
“We care deeply about all vic-
tims of abuse and sincerely apolo-
gize to anyone who was harmed
during their time in Scouting,”
the Boy Scouts said.“The BSA has taken significant
steps over many years to ensure
that we respond aggressively and
effectively to reports of sexual
abuse,” t he statement continued.
“We recognize, however, that
there were instances in our or-
ganization’s history when cases
were not addressed or handled in
a manner consistent with our
commitment to protect Scouts,
the values of our organization,
and the procedures we have in
place today.”
The organization pointed to
the use of screening efforts and
background checks to prevent
abusers from joining its ranks.
The group also provides “youth
protection education” for mem-
bers and bars one-on-one interac-
tions between adults and chil-
dren. The Boy Scouts has a help
line with which participants can
report abuse.
For decades, the Boy Scouts
organization has kept detailed
files on “ineligible volunteers”
that documented thousands of
people considered to pose a risk
of abusing children. In the past
decade, a large tranche of the
documents became public
through lawsuits and investiga-
tive reporting.
But Abused in Scouting says it
has discovered new accusations
of abuse involving more than 350
people who do not appear in the
ineligible-volunteer files, S.D.’s al-
leged abuser among them.
Most of the alleged assaults in
the database of new cases viewed
by The Post happened decades
ago, though Abused in Scouting
says it also has a 17-year-old cli-
ent.
“This is the first time he’s ever
come forward,” said Stewart
Eisenberg, S.D.’s representative
and one of the lead lawyers from
Abused in Scouting. “He’s held it
in for all those years.”
The suit alleges S.D., now 57,
was the victim of an assistant
scoutmaster who “actively
groomed young boys under his
charge for later sexual molesta-
tion,” subjecting S.D. to “hun-
dreds of instances of fondling,
hundreds of incidents of oral
sexual assault and repeated at-
tempts of anal penetration” at
Camp Acahela, a Boy Scouts re-
treat in eastern Pennsylvania, as
well as at his abuser’s home, the
lawsuit says.
The lawsuit alleges that S.D.’s
abuse would not have been possi-
ble had it not been for the negli-
gence of the Boy Scouts. Requests
for comment sent to phone num-
bers and emails associated with
the alleged abuser were not im-
mediately returned.
[email protected]Suit claims
hundreds
more Scout
abusers
“This is the first time
he’s ever come forward.
He’s held it in for all
those years.”
Stewart Eisenberg, a lawyer for one
of the alleged victims with Abused in
Scouting, which says it found new
accusations of abuse involving over
350 people in the Boy Scouts