The Washington Post - 07.09.2019

(vip2019) #1

SATURDAY, SEPTEMBER 7 , 2019. THE WASHINGTON POST EZ RE A


Politics & the Nation


BY WILLIAM WAN
AND LAURIE MCGINLEY

Responding to ubiquitous on-
line marketing by stem cell clinics
selling unapproved treatments
for ailments from achy joints to
Alzheimer’s, Google announced
Friday that it will no longer accept
ads for “unproven or experimen-
tal medical techniques,” including
most stem cell therapy, cellular
therapy and g ene therapy.
The Internet giant said it was
taking the step after seeing “a rise
in bad actors” trying to take ad-
vantage of patients by offering
“untested, deceptive treatments.”
Often, Google said in a post ex-
plaining the new policy, “these
treatments can lead to dangerous
health outcomes and we feel they
have no place on our platforms.”
The policy will prohibit ads for
treatments that have “no estab-
lished biomedical or scientific ba-
sis.”
The new position comes as
stem cell clinics have grown into a
sprawling direct-to-consumer in-
dustry. Some clinics have told pa-
tients that their treatments can
help with health issues such as
macular degeneration, ALS, mul-


tiple sclerosis and degenerative
lung diseases. Scientists and med-
ical associations have likened the
procedures to modern snake oil
and have accused the purveyors of
preying on the hopes of seriously
ill patients. The untested treat-
ments, many researchers say, are
imperiling patients and the repu-
tation of a promising f ield.
After years of little enforce-
ment, federal regulators have be-
gun to crack down on the clinics.
And the new Google policy will
add to the growing scrutiny and
pressure, industry experts said.
When asked by The Washing-
ton Post last December about its
policies on advertising by stem
cell clinics, Google declined to an-
swer questions about actions
against specific companies. In a
statement, the company said: “If
we find ads that violate our pol-
icies, we take immediate action,
which can include taking down
violating ads or suspending an
account altogether.”
At the time, the company said
its existing policies already pro-
hibited the marketing of poten-
tially dangerous and fraudulent
health products — a stance some
stem cell experts criticized as in-

sufficient.
“Google’s new policy banning
advertising for speculative medi-
cines is a much-needed and wel-
come step to curb the marketing
of unscrupulous medical prod-
ucts,” said Deepak Srivastava,
president of the International So-
ciety for Stem Cell Research, a
leading group of scientists that
gave Google advice on the policy.
“The premature marketing and
commercialization of unproven
stem cell products threatens pub-
lic health, the confidence in bio-
medical research a nd undermines
the development of legitimate
new therapies,” he said.
Some treatments have resulted
in severe injuries, including sepsis
and blindness.
Stem cell clinics say that they
are offering treatment to patients
who have few other options and
that their treatments may have
ways of helping patients that sci-
ence can’t y et e xplain.
Some industry representatives
criticized Google’s new ad policy
Friday. The ban will unfairly dev-
astate “good” companies along
with “bad actors” without dis-
criminating w hich ones are trying
to treat patients safely and follow

evolving Food and Drug Adminis-
tration regulations, said Andrew
Ittleman, a Miami lawyer who
represents several stem cell clin-
ics.
In the past two years, Google
already began refusing ads from
several stem cell companies on a
case-by-case basis, said Ittleman,
who has been hired by a few such
businesses to try, unsuccessfully,
to appeal such decisions with
Google.
“It puts Google in the position
of being a quasi-regulator, taking
on quite a significant amount of
jurisdiction,” Ittleman said.
“They’re painting the industry
with a broad brush, and compa-
nies with legitimate arguments
are going to be collateral damage.”
Many clinics have shown an
ability to adapt nimbly to new
rules and changes such as
Google’s a d policy.
“This kind of ad ban hits hard
because most companies rely on
Google for a large share of their
quality sales leads,” s aid a former
marketing head for a Florida s tem
cell company. “But there are plen-
ty of other channels you can
switch to — Facebook, Bing, Ya-
hoo.”

The marketing executive, who
spoke on the condition of ano-
nymity to avoid professional retal-
iation, said: “These kinds of busi-
nesses are pretty savvy and have
had to adapt a lot already. Many
have previously been kicked off
Google already. You learn to pivot
and be resourceful.”
Another recent example of the
industry’s ability to adapt, experts
note, came when the FDA won a
landmark lawsuit in June against
a company selling stem cell pro-
cedures that extract clients’ fat
tissue, spin it to isolate certain
cells a nd inject t hem back into t he
body.
Health officials hailed the case
as a turning point in the govern-
ment’s struggle to regulate the
booming industry. But before the
ruling, the industry had already
begun to shift. Because the FDA
was focusing on fat-based treat-
ments, many clinics switched to
treatments derived instead from
blood, bone marrow, amniotic flu-
id or umbilical cord b lood.
Google officials said Friday that
they would continue to accept ads
for clinical trials cleared by the
government.
The ban will take effect across
Google’s ad services, including
YouTube and ads that Google
helps place on third-party web-
sites. The policy includes treat-

ments that are rooted in scientific
findings and preliminary clinical
experience “but currently have i n-
sufficient formal clinical testing”
to justify widespread use. The
ban, which w ill take effect in Octo-
ber, was detailed in a blog post by
Adrienne Biddings, the compa-
ny’s p olicy adviser.
The post said that the “digital
ads ecosystem can only flourish if
it’s a place that is safe and trust-
worthy for users.” The company
said it will use a combination of
machine learning and human re-
view to enforce the ban.
To formulate the new ap-
proach, a spokeswoman said, the
company’s policy team reviewed
the literature on the field and
worked with various stem cell ex-
perts.
Paul Knoepfler, a stem cell biol-
ogist at the University of Califor-
nia at Davis and a longtime critic
of the for-profit stem cell i ndustry,
called the new policy a big deal.
Many patients who have been se-
riously harmed, he noted, were
initially recruited as customers
via Google ads.
“A number of us have pushed
for this kind of policy over the
years, so this news is a welcome
surprise,” Knoepfler s aid.
[email protected]
[email protected]

BY LENA H. SUN

Health officials said Friday that
a fifth person has d ied of a mysteri-
ous lung illness tied to vaping.
Including the five deaths, there are
now 450 p ossible c ases i n 33 states
and one U.S. territory, t hey said.
Amid the surge in cases, physi-
cians and health officials pub-
li shed detailed descriptions of the
acute lung disorder in articles in
the New E ngland Journal of Medi-
cine and in reports released by the
Centers for Disease Control and
Prevention.
Although federal and state offi-
cials said the definitive cause of
the i llness remains u nknown, “the
severity of the illness and the re-
cent increase in the incidence of
this clinical syndrome indicates
that these cases represent a new or
newly recognized and worrisome
cluster of pulmonary disease r elat-
ed to vaping,” said a report by
health department officials in
Wisconsin and Illinois who con-
ducted a joint investigation of
53 p atients.
The CDC s aid t hat some v ictims
used marijuana-based products,
some reported using marijuana
and nicotine products, and a
smaller group r eported using nico-
tine products only.
The Food and Drug A dministra-
tion is analyzing samples c ollected
from patients across the country
who have fallen ill and is testing


them for a broad range of chemi-
cals, including nicotine, THC —
the ingredient in marijuana that
produces the high — “cutting
agents” to dilute solutions and
other s ubstances.
“We believe chemical exposure
is likely associated w ith the illness-
es,” said Dana Meaney-Delman,
who is heading CDC’s lung injury
response.
This week, New York state and
FDA labs told officials they found
vitamin E acetate, an oil derived
from vitamin E , in s amples of mar-
ijuana products collected from pa-
tients who had been sickened by
vaping. New York state officials
have said the oil is a key focus of
the state’s investigation. FDA offi-
cials have stressed, however, that
no one substance, including vita-
min E acetate, has been identified
in all s amples.
The Indiana State Department
of Health this week reported the
state’s first vaping-related death.
The person died because of “severe

lung injury linked to a history of
e-cigarette use or ‘vaping,’ ” the
health department said. The pa-
tient was identified only as being
over age 18.
On Friday, the Minnesota De-
partment o f Health said a 65-year-
old patient died in August of lung
injuries related to vaping. The pa-
tient died after a “long a nd compli-
cated hospitalization,” officials
said. Los Angeles County health
officials also reported the vaping-
related death of an older adult
with chronic health p roblems. Illi-
nois and Oregon each reported a
death.
The rising case counts drew an
angry tweet from Sen. Richard J.
Durbin (D-Ill.), who threatened to
call for the resignation of the act-
ing FDA chief, Norman “Ned”
Sharpless.
The mysterious lung illness is
coming into focus as officials and
clinicians identify clinical similar-
ities in illnesses among people
who v ape. Most p atients h ave been

young and healthy. They h ad simi-
lar symptoms, including cough,
chest pain or shortness of breath
that appeared to occur over sev-
eral days to several weeks before
hospitalization, the CDC report
says.
Clinicians in Utah and North
Carolina said they had identified
the p resence of abnormal immune
cells in the lungs of some patients,
which could be a “useful marker”
for a diagnosis of a rare form of
pneumonia known as lipoid p neu-
monia, according to findings re-
ported by University of Utah Hos-
pital clinicians in NEJM.
“That can o ccur when either oils
or lipid-containing substances en-
ter the lungs,” said Daniel Fox, a
pulmonologist and critical-care
physician a t WakeMed Health and
Hospitals i n North Carolina.
In the joint investigation by the
Wisconsin and Illinois health de-
partments, the earliest report of

symptoms was recorded in mid-
April. Most of the patients were
young, healthy men, with a medi-
an age of 19.
Nearly all patients said they
used THC in e-cigarette devices.
Patients reported using 14 differ-
ent brands of THC products; the
most common one was marketed
under the “Dank Vape” l abel. Vap-
ing p roducts bearing that label are
sold online, and industry sources
say marketers often fill an empty
cartridge with potentially unsafe
ingredients and sell to unsuspect-
ing customers. Patients also re-
ported using 13 brands of nicotine
products in a wide range of flavors.
Fifteen patients said they used
only THC products; seven said
they used nicotine-only products,
adding to the mystery of what ex-
actly has caused healthy teenagers
and young adults to suffer such
severe lung injuries. Doctors have
said that patients, especially teens,

are often reluctant to say whether
they have used marijuana prod-
ucts.
E-cigarette aerosol generally
contains fewer toxic chemicals
than conventional cigarette
smoke, officials have said. But e-
cigarette aerosol is not harmless
and can expose users to substanc-
es known to damage the health,
including ultrafine particles,
heavy metals, volatile organic
co mpounds and other harmful in-
gredients.
Many o f the chemicals in e-ciga-
rette liquids may “undergo ther-
mal degradation” when they are
heated so as to vaporize, produc-
ing new and potentially harmful
compounds. “A lone or i n combina-
tion, these substances could result
in a variety of pulmonary illness-
es,” t he authors of the NEJM paper
on the Wisconsin and Illinois in-
vestigation w rote.
[email protected]

Lung illness


tied to vaping


has killed 5


as cases surge


Google bars ads for unproven stem cell therapies


RICHARD VOGEL/ASSOCIATED PRESS
A woman puffs on a cannabis vape pen in Los Angeles in 201 8.
Officials warn of a link between vaping and serious lung injury.
Free download pdf