|
 The “Asbestos in Talc Symposium,” sponsored by the Food and Drug
Administration, was dominated by industry hands: Most of the 21
non-government participants had done work for talc companies, such
as testing and serving as expert witnesses and consultants,
symposium documents and other records show.
Key sessions were led by witnesses for Johnson & Johnson in lawsuits
alleging the company failed to warn customers that its Baby Powder
was tainted with cancer-causing asbestos, the records show. Others
who sought invitations were turned away, including a physician who
had testified against J&J in trials that resulted in billions of
dollars in damage awards against the company.
History was repeating itself.
Over the past 50 years, the FDA has relied upon - and often deferred
to - industry even as outside experts and consumers repeatedly
raised serious health concerns about talc powders and cosmetics, a
Reuters investigation found.
Again and again since at least the 1970s, the agency has downplayed
the risk of asbestos contamination and declined to issue warnings or
impose safety standards, according to documents produced in court
proceedings and in response to public records requests.
The agency said it lacks the authority to require manufacturers to
test for asbestos in talc or report any results. And it seldom has
ordered its own tests - until recently.
Amid heightened scrutiny in Congress, a criminal investigation of
J&J and costly jury verdicts against the company, the regulator
commissioned tests that found asbestos in 11 talc-based cosmetics,
including Johnson’s Baby Powder. J&J recalled 33,000 bottles.
Raja Krishnamoorthi, an Illinois congressman who chairs a U.S. House
subcommittee investigating talc safety, told Reuters it was time for
regulators to stop relying on manufacturers’ safety assurances.
“When something as serious as cancer or carcinogens are at issue,”
Krishnamoorthi said, “self-regulation doesn’t make a lot of sense.”
In written responses to questions from Reuters, the FDA said its
resources and authority to regulate the cosmetic industry are
limited. The agency said it has no power to ensure the safety of
cosmetics before they are put on store shelves, nor to force
companies to pull them off when potential hazards are discovered.
“We are dependent on manufacturers to take steps to ensure the
safety of their products,” the FDA said after announcing a voluntary
recall of tainted cosmetics in March.
FDA officials declined to comment on the decisions of former
employees over the years, saying only that the agency relies on the
best information available and that studies “have improved our
understanding of how and why asbestos fibers are hazardous.”
The agency said it now recognizes, as the World Health Organization
and other public health agencies did years ago, that there is no
known safe level of asbestos. FDA officials said their current
policy is to act swiftly - and if necessary encourage recalls - even
when small amounts are discovered.
The regulator has stood by its recent tests of Johnson’s Baby
Powder, despite pushback from the company.
J&J, the world’s largest producer of talc powders, said in a
statement that it recalled the 33,000 bottles of Baby Powder out of
an “abundance of caution.” Eleven days later, the company announced
that tests by labs it hired had determined that there was no
asbestos - other than some contamination it said came from an air
conditioner - in samples from the one bottle tested by the FDA and
the batch it came from.
In written responses to Reuters, J&J said it systematically tests
its talc and has always found its powders to be safe and pure.
“Throughout the 1970s and '80s, the FDA and other regulatory bodies
defended talc,” J&J's Chief Executive Alex Gorsky testified in an
Oct. 3 deposition. “FDA agreed overall with the position that we had
taken with the safety of our talc.”
The company told Reuters that it “has long cooperated (with) and
supported the FDA in its mission to protect the public health,” and
that any suggestion it has unduly influenced the agency to reduce
regulation or standards is “just false.”
The FDA now is under increasing pressure to ensure talc powders and
cosmetics are free from asbestos. The agency’s testing of talc-based
cosmetics this year followed jury verdicts totaling more than $5
billion against J&J in cancer lawsuits, as well as a Dec. 14 Reuters
report showing that J&J knew its raw talc and powders sometimes
tested positive for asbestos from the 1970s into the early 2000s and
did not report those findings to the agency.
J&J has disputed the Reuters report as "one-sided, false and
inflammatory."
In the wake of the Reuters report, the company announced it was
under investigation by the U.S. Department of Justice and the
Securities and Exchange Commission. According to people familiar
with the matter, these include a criminal grand jury probe into how
forthright J&J has been about the safety of its powders.
'NO HEALTH HAZARD'
The FDA began looking into talc safety in 1971 after researchers at
Mount Sinai Medical Center in New York found what appeared to be
asbestos in unnamed brands of talc powder.
Two years later, FDA records show, the agency found asbestos in a
sample of Shower to Shower, a J&J powder at the time that was made
with the same talc as Johnson’s Baby Powder. The FDA never publicly
announced the finding.
J&J told Reuters the result was not final, citing findings in an FDA
table issued in 1976. But that table, reviewed by Reuters, is
ambiguous, listing no result for the type of asbestos found in 1973.
J&J told Reuters the gap means no asbestos was found.
Assured by J&J and other manufacturers that their talc was safe, the
FDA eventually ended its inquiry without taking action because “the
potential hazard did not warrant a recall,” Heinz J. Eiermann, a
former J&J researcher who at the time ran the agency’s cosmetics
division, wrote in a March 1976 memo.
That same year, J&J, other talc companies and their trade group, the
Cosmetic Toiletry and Fragrance Association, persuaded FDA officials
that manufacturers could monitor the safety of their own products,
according to records J&J and the group produced in litigation.
The FDA dropped plans to impose testing and purity standards for
talc powders and cosmetics. The trade group published its own test,
which was voluntary for companies to use. The written standard for
that test acknowledges that it cannot detect most types of asbestos
at low levels, nor one common type - chrysotile - at all.
In a statement to Reuters, the trade group said it believed that
chrysotile was not commonly linked to talc used in cosmetics.
Chrysotile is the type of asbestos the FDA-commissioned test found
in Baby Powder this year. It also was found in several tests
conducted by labs for J&J on its talc from 1972 through 2003,
according to records produced in litigation. J&J has said that some
of the tests were on industrial talc and that others, on Baby Powder
talc, reflected background contamination.
Asbestos is a loose term for a group of six minerals that readily
separate into needles or fibers. Easily inhaled, they are known to
cause lung, ovarian and other types of cancer. While most people
exposed never get cancer, for some even small amounts are enough to
trigger the disease. Just how small has not been established.
'A BIG ISSUE'
Talc safety concerns resurfaced in 1983 when a graduate student
scouring geology journals for a toxicology class came across
information he considered disturbing: Talc deposits are commonly
laced with asbestos, a similar mineral.
Philippe Douillet immediately thought of the talc powder his sister
used on her baby, he recalled in an interview with Reuters. He urged
her to stop using it. Then he petitioned the FDA to require an
asbestos warning on talc powders.
“It was really obvious to me there was a big issue there,” said
Douillet, who now runs a biotechnology company in Miami.
When the FDA began evaluating Douillet’s petition, it looked to J&J
for key information, agency records show. The FDA’s June 1985 risk
assessment relied upon a decade-old letter from the company for the
agency’s estimate of the amount of dust babies were exposed to
during diapering.
That 1974 letter from J&J to the FDA said that, hypothetically, even
if babies were exposed to talc powder with as much as 1% asbestos,
it would be a far lower concentration than allowed at the time for
industrial workers.
J&J told Reuters in a statement that “at no point has Johnson &
Johnson taken the position that it would consider talc containing 1%
asbestos appropriate for sale to consumers.”
In the end, the FDA decided there was no need for an asbestos
warning on talc powders. In a July 1986 letter to Douillet, acting
associate FDA commissioner J.W. Swanson wrote that the quality of
cosmetic talc had improved “and that even when asbestos was present,
the levels were so low that no health hazard existed.”
What’s more, Swanson wrote, agency officials had come to question
earlier reported findings of asbestos in talc powders. Those doubts,
he wrote, were based in part on a paper published in the proceedings
of a 1977 scientific conference.
Both of the paper’s authors had worked for J&J, one as an asbestos
testing contractor and the other as its longtime talc supply
manager. The authors argued that some testing methods were apt to
misidentify microscopic lookalike rock splinters as asbestos. The
industry’s test, the paper said, was designed to avoid this
confusion.
Other U.S. and European public health authorities have come to
regard such splinters as presumptive toxins because of their
similarity to asbestos.
The FDA defended its 1986 decision to reject Douillet’s petition. In
a statement, it said the graduate student “did not provide
persuasive evidence that the cosmetic talc produced at the time
contained significant amounts of asbestos minerals.”
NOT A PRIORITY
Eight years later, the regulator received a new request for a
warning label on talc powders. This one came from Dr. Samuel
Epstein, a University of Illinois environmental medicine professor
who chaired the Cancer Prevention Coalition, an advocacy group.
Epstein’s 1994 petition didn’t concern asbestos. It raised the
possibility that talc, by itself, was a hazard worthy of a warning
label. His petition was based on research showing that talc, when
used as an antiperspirant and deodorant in underwear, was associated
with ovarian cancer.
In a brief July 1995 letter, FDA acting cosmetics chief John Bailey
told Epstein's coalition that the agency had taken no action because
it had other priorities.
[to top of second column] |
Bailey told Reuters in a statement that he issued this “interim”
response because the petition lacked scientific support.
In 2002, having taken no action on the petition, Bailey moved to the
cosmetic trade group, now known as Personal Care Products Council.
The council considered him a “key employee” because of his “former
employment with the FDA,” according to a tax filing by the group.
Now a consultant, Bailey serves as a litigation expert witness to
J&J and other talc companies. In his statement to Reuters, Bailey
said he had been hired at the council “as a scientist responsible
for applying sound science to decision making.” He disputed Reuters’
finding that the FDA deferred to industry, saying the agency takes
potential health concerns seriously and does its own evaluations.
In 2006, the World Health Organization’s International Agency for
Research on Cancer classified use of talc powder in the perineum
area - the pelvic region between the legs - as “possibly
carcinogenic.” Two years later, Illinois medical scientist Epstein
filed a second petition to the FDA seeking a cancer warning label on
talc products.
J&J went to work to defeat it. In a May 2008 email to colleagues,
J&J executive Kathleen K. Wille wrote: “Our response could be a
potential source of data and information on which the FDA can base
their response.”
Together, J&J, its talc supplier and the Personal Care Products
Council arranged for a pair of scientists to assess the published
studies that linked talc and ovarian cancer, according to emails and
other records produced in litigation. The scientists concluded that
the evidence was too weak to consider talc as a cause.
At a May 2009 meeting, Bailey, Wille and other industry
representatives briefed FDA officials on the assessment, according
to a meeting memo produced in litigation by J&J’s talc supplier.
Three days later, Wille told colleagues in an email, “We have every
confidence that the FDA will dismiss this petition once they have
reviewed our submission.”
J&J told Reuters in a statement that the company had been confident
because it believed the agency would be swayed by science, which it
said supported J&J’s position that talc does not cause ovarian
cancer.
Before the FDA ruled on the warning requests, however, concerns
about asbestos contamination flared again. This time, the FDA’s
South Korean counterpart reported finding asbestos in talc powders.
Acting on that 2009 report, the FDA commissioned talc tests for the
first time in 40 years, hiring Maryland-based AMA Analytical
Services Inc, which analyzed 34 samples of talc powders and
cosmetics, including Johnson’s Baby Powder. It found no asbestos in
any of them.
The lab had no experience testing for asbestos in talc. Its prior
work focused on building materials such as vinyl flooring, according
to the deposition testimony of AMA lab director Andreas Saldivar.
The FDA has said Saldivar’s lab used “the most sensitive techniques
available” but cautioned that the results were limited to the 34
talc powders and cosmetics tested.
The testing had other limitations as well. Saldivar’s lab looked at
less talc per sample than other labs that have found asbestos in
talc powders. And it did its work in a fraction of the time typical
for such analyses, according to a Reuters review of the lab report
and interviews with experts who test talc for asbestos.
Saldivar’s lab was recently rehired by the FDA. This time, it found
the asbestos that led to the first recall of J&J’s iconic Baby
Powder. Saldivar declined to comment.
DUTY TO WARN
In the first verdict of its kind, a South Dakota jury found in
October 2013 that J&J had a duty to warn women that research had
linked its talc powder to ovarian cancer. No damages were awarded.
Then the FDA weighed in on the issue. In April 2014, 20 years after
Epstein first contacted the agency, the FDA rejected both of his
petitions for warning labels. Its announcement said the science
wasn’t strong enough to support a cancer warning, echoing the
assessment J&J and its industry partners had presented to the agency
in 2009.
In court, such arguments have not always proved convincing. In early
2016, a Missouri jury concluded J&J’s powders caused a woman’s
ovarian cancer death and awarded her survivors $72 million. An
appellate court later set that verdict aside, ruling that the woman
had filed her suit in the wrong state.
In the aftermath, the FDA asked J&J for “safety literature and data
regarding talc,” correspondence shows. The company submitted a
report saying no asbestos had “ever been found during any testing”
of its talc.
Since then, lawsuits have compelled J&J to produce internal
documents that show the company knew its talc and powders had tested
positive for asbestos on occasion for decades.
The company now faces more than 16,000 lawsuits alleging that its
powders caused ovarian cancer and mesothelioma, an incurable cancer.
The vast majority are awaiting trial. In court, there have been
mixed verdicts, mistrials and some appellate rulings in J&J’s favor.
Last year, in response to renewed asbestos concerns, FDA cosmetics
chief Linda Katz began organizing the November 2018 symposium and a
public hearing on talc testing, now planned for next year.
She reached out to J&J for help. J&J vice president Jethro Ekuta
responded by sending Katz a letter in June 2018 recommending a list
of three talc testing experts. All three had served as defense
witnesses or consultants for J&J.
Two of the experts Ekuta recommended, as well as a third J&J defense
witness, led sessions at the closed-door “Asbestos in Talc
Symposium” on Nov. 28, 2018. None of the sessions were led by
medical experts who had questioned the safety of talc powders and
cosmetics.
J&J said that apart from recommending experts, it did not advise the
FDA on the symposium. Ekuta, who has left J&J, declined to comment.
NOT INVITED
In a statement to Reuters, the FDA downplayed its role in the
symposium, saying the event was “hosted” by the Joint Institute for
Food Safety and Applied Nutrition (JIFSAN), a research group
co-founded by the FDA. “No formal or regulatory recommendations were
expected or made,” the agency said.
In fact, records show, the FDA initiated and paid for the meeting,
set the agenda and chose the participants.
The meeting set the stage for formal recommendations on how to test
products used every day by millions of people. The FDA said a
government committee tasked with proposing a standard test for
asbestos in talc powders and cosmetics is “continuing to work
through issues discussed at the JIFSAN symposium.”
Many FDA meetings are held in public and invite comment. Details on
the talc symposium were hard to come by, however, even after it was
over.
The FDA declined Reuters’ requests to provide a list of participants
or any information on what transpired. After Reuters filed a public
records request with JIFSAN, the research group posted meeting
information online and released planning emails.
The guest list showed that more than half of the 54 participants
were employed by or recently retired from FDA and other agencies. Of
the 21 non-government participants, 17 had either worked for talc
companies, done lab testing or served as expert witnesses for the
industry, Reuters found. Five of the participants affiliated with
talc companies also have served as expert witnesses for plaintiffs.
Most of the non-government participants were experts in geology or
minerals testing.
In a statement, the FDA said it would ordinarily avoid having
sessions led by defense or plaintiff witnesses. However, the agency
said there are a “limited number of experts worldwide with
scientific knowledge” on asbestos testing, standards and results
analysis.
Not everyone was welcome.
Among those turned away was Dr. David Egilman, a clinical professor
of family medicine at Brown University. He testified last year in a
trial that ended in a $4.69 billion verdict for women alleging J&J’s
talc powders caused their ovarian cancers.
Egilman told Reuters he was concerned that if the FDA was guided by
geologists and industry consultants, it might overlook fundamental
questions about which mineral fibers cause cancer. He wanted to
offer his expertise, as a physician and researcher, on what
technicians should look for under the microscope.
Testing hinges “on the determination of what particles or elements
should be tested for,” he wrote in a November 2018 email to
organizers asking to be included in the symposium. “This is a
medical question and not a technical question.”
Katz took a different view. In an email forwarded to Egilman, she
said: “This meeting is not intended to discuss health-related issues
or concerns.” She met with Egilman later.
Katz also told Egilman that the symposium was not intended to reach
any consensus. At its conclusion, however, session leaders,
including three who have served as defense witnesses for J&J,
drafted what they called “consensus” or “concurrence” reports.
Two of the reports reviewed by Reuters embraced industry positions
on what fibers should be counted as hazardous, an issue of fierce
contention in courtrooms across the country. The reports discouraged
counting fibers that may or may not be asbestos, saying that doing
so might exaggerate the hazard.
That view runs contrary to the positions of other U.S. and European
public health officials, who presume mineral fibers that even look
like asbestos are toxic.
As Arnold Brody, a professor emeritus at Tulane University Medical
School, told jurors in a talc powder trial last year, “The lung
doesn’t care" what it's called.
These issues are likely to be aired at the public hearing the FDA
said it is planning for next year. The gathering could signal how
the agency intends to navigate between industry and consumer
interests in coming years.
Krishnamoorthi, the congressman heading the House investigation into
talc safety, said the agency needs to bring consumers and their
advocates into the discussion.
“In light of the public interest around this particular issue,” he
said, “we need to find out what’s going on.”
(Editing by Julie Marquis and Mike Williams)
[© 2019 Thomson Reuters. All rights
reserved.] Copyright 2019 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.
Thompson Reuters is solely responsible for this content. |
