NIH bars employees from jobs as consultants 
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 NIH bars employees from jobs as consultants

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Baltimore Sun (subscription), MD

NIH bars employees from jobs as consultants
New ethics rule aimed at biomedical companies

By Susan Baer
Sun National Staff
Originally published February 2, 2005

BETHESDA - Under sweeping new ethics rules aimed at halting conflict of
interest charges at the nation's premier medical research facility, the
National Institutes of Health has barred all agency employees from
working
as consultants to private biomedical companies.

The regulations also prohibit top government researchers from owning
stock
in drug and biotech companies and restrict stock ownership for all
other NIH
employees.

"My goal is to create a bright line that is so clear that crossing that
line
will not be allowed," said Dr. Elias A. Zerhouni, the NIH director, at
a
news conference yesterday. "Nothing is more important for NIH than
preserving public trust."

Zerhouni, who had resisted such far-reaching restrictions last year,
said he
hopes the new regulations will maintain the reputation of NIH as "the
one
source of public health information in the country that is completely
trusted and void of any conflict of interest or appearance of conflict
of
interest."

The reforms were drawn up over the past year by NIH, the Office of
Government Ethics and the Department of Health and Human Services in
response to revelations that a number of government scientists had been
receiving lucrative consulting fees from biomedical companies, deals
that in
some cases related to their NIH work.

The conflicts of interest were revealed in a series of articles by the
Los
Angeles Times, beginning in 2003, and led to congressional hearings
over the
past year that examined the financial arrangements.

The new ban on outside employment by NIH employees extends to work for
pharmaceutical and biotechnology companies, research institutions that
receive grants from the NIH, health-care providers and insurers, and
related
trade associations.

Scientists will be allowed to teach courses, write and edit articles or
textbooks and give lectures related to their work.

"I don't want to isolate our scientists from the mainstream of
science,"
Zerhouni said.

In other changes, senior employees cannot receive any award of more
than
$200, with exceptions made for such prestigious prizes as the Nobel and
Lasker prizes.

The stock restrictions "could potentially affect every employee on
campus,"
said Holli Beckerman Jaffe, director of the NIH ethics office.

NIH employees who file public or confidential financial disclosure
reports
will be required to immediately sell any stock they own in drug or
biomedical companies. All other employees will be allowed to own such
stock,
but only up to $15,000 in any one company.

The Times articles revealed that NIH employees had received hundreds of
payments from biomedical companies totaling millions of dollars, most
of
which were not publicly reported. In some cases, the scientists were
receiving fees from drug companies that stood to benefit from their
recommendations to doctors for treating patients.

Private consulting arrangements between agency scientists and outside
companies had been rare until the 1980s when they began to be
encouraged as
a way to speed the transfer of the government's laboratory research to
medical products and cures.

Such collaborations - in which NIH scientists were typically paid by
private
companies for their expertise - increased greatly in the 1990s.

Dr. Harold E. Varmus, Zerhouni's predecessor, saw such arrangements as
a way
to make NIH more financially competitive with the private sector and
lure
top-notch researchers to government.

In 1995, he lifted many of the restrictions on the outside income
scientists
could earn from drug and biotech companies and also relaxed disclosure
policies about such activities, adopting a case-by-case approach to
reviewing the arrangements.

'More severe' rules

Zerhouni noted yesterday that the new ethics rules are "more severe"
than
those in place before 1995, but said they are necessary "to
re-establish the
trust" in an agency with an annual budget of $28 billion.

Zerhouni, who in the past also favored a case-by-case analysis of such
collaborations, had resisted proposing a blanket ban on consulting.

In June, under increasing pressure from members of Congress who
discovered
dozens of deals between NIH scientists and private companies that
agency
officials had not known about, the NIH director proposed a ban on paid
consulting for only the agency's most-senior officials. The ban did not
include most of the more than 5,000 scientists working there.

The Office of Government Ethics concluded a month later that tougher,
more
far-reaching measures were required to reverse the "permissive culture"
it
found at NIH and to restore public confidence.

In September, Zerhouni proposed a one-year moratorium on consulting
fees for
all agency employees.

Yesterday, he said the new regulations, which are to take effect as
soon as
the guidelines are published, will stand permanently unless they need
to be
re-evaluated.

Acknowledging that he once favored a more-limited ban on outside
consulting
activities, he said he had changed his mind and now saw how even
lower-level
NIH scientists could be used as a "marketing tool" by private
companies.

The conflict of interest cases had included both working scientists and
senior administrators.

For instance, Dr. P. Trey Sunderland III, a senior researcher at the
National Institute of Mental Health, received $508,000 from Pfizer Inc.
at
the same time he was working with Pfizer in his government capacity in
a
study of Alzheimer's patients, and endorsed one of its {*filter*}.

{*filter*} transfusion expert Dr. Harvey G. Klein accepted more than
$240,000 in
fees and more than $76,000 in stock options from companies working on
{*filter*}-related products.

Dr. H. Bryan Brewer Jr., chief of the National Heart, Lung and {*filter*}
Institute's molecular disease branch, helped develop new federal
cholesterol
guidelines and wrote an article promoting the benefits of the
cholesterol-lowering drug Crestor as he received $31,000 from its
maker,
AstraZeneca.

Review under way

NIH officials said they were reviewing all of the potential conflicts
of
interest and soon will move into the "penalty phase" if violations are
found. Penalties could range from advising employees on their
activities to
firing them, said Dr. Raynard S. Kington, an agency deputy director.

Zerhouni said NIH scientists, with whom he planned to meet today at a
town
hall meeting on the Bethesda campus, were "mixed" in their reaction to
the
new rules.

He said the 5,000 or so scientists who've had no outside income feel
they've
been swept into "a tsunami of regulations they had no responsibility
for."

But members of Congress who had pressed for tighter regulations praised
the
director.

"The NIH is one of the crown jewels of government research agencies,"
said
Rep. Henry A. Waxman, a California Democrat. "This action by NIH will
help
restore integrity and trust in the agency."

Zerhouni said he realized that academic researchers all over the world
are
increasingly collaborating with drug and biotech companies, but said
the NIH
had to "hold itself to a higher standard than the rest of the world."

"We do have a national public health responsibility," he said.

------------------------------

NIH Workers Angered by New Ethics Rules
Restrictions on Outside Income Meet With Derision at Meeting

By Rick Weiss
Washington Post Staff Writer

National Institutes of Health Director Elias A. Zerhouni stood before
hundreds of NIH employees yesterday to explain why it had become
necessary for him to impose, in his words, "drastic" restrictions on
stock ownership and other forms of outside income, which take effect
today for all agency employees.

"What I'm asking you to do is hold your fire until you hear the
details," he told the crowd assembled in an auditorium on the agency's
Bethesda campus.

They held.

And when he was done, they let him have it.

One after another, scientists, doctors and other agency staffers
stepped
up to the microphones and raged against the new rules, made public
Tuesday. By the time it was over, 90 minutes later, nary a positive
word
had been uttered about the new policy and there was more vented spleen
around than a busy medical center like the NIH might normally see in a
year.

The goal, as Zerhouni repeatedly explained, was to save the venerable
agency's reputation, which had become badly sullied after 14 months of
embarrassing revelations about conflicts of interest among NIH
scientists.

"This issue was standing between the prestigious history of the NIH and
its future," Zerhouni told the restive crowd.

But the solution, many argued yesterday, was unjustifiably extreme,
punishing virtually all of the agency's 18,000 employees for the bad
actions of a few.

"Even my secretary is going to have to sell her stock. How much sense
does that make?" fumed Ezekiel Emanuel, chairman of the agency's
department of clinical bioethics.

The event, which NIH officials dubbed a "town hall meeting" for
employees, marked an extraordinary climax to a convoluted tale of
science, politics and money that had grown increasingly unmanageable in
recent months. After trying to "stand up for his troops," Zerhouni
said,
he was "shot in the back" with the discovery, made by congressional
investigators, that more than 100 NIH employees had not disclosed
various relationships they had with pharmaceutical and biotech
companies, in violation of government ethics rules.

 From that point, Zerhouni said, he knew he had no choice but to put
draconian measures in place -- measures he acknowledged were sure to
have ripple effects on NIH's ability to recruit and retain talent for
years to come but that he hoped would ultimately strengthen the
institution.

A few attendees expressed a modicum of sympathy for Zerhouni, who ...

read more »



Wed, 25 Jul 2007 08:57:05 GMT
 NIH bars employees from jobs as consultants
"Wise man" take note!

Thank you for posting this, Georgia!
Lisa

Quote:

> http://www.***.com/ +companies
> Baltimore Sun (subscription), MD

> NIH bars employees from jobs as consultants
> New ethics rule aimed at biomedical companies

> By Susan Baer
> Sun National Staff
> Originally published February 2, 2005

> BETHESDA - Under sweeping new ethics rules aimed at halting conflict
of
> interest charges at the nation's premier medical research facility,
the
> National Institutes of Health has barred all agency employees from
> working
> as consultants to private biomedical companies.

> The regulations also prohibit top government researchers from owning
> stock
> in drug and biotech companies and restrict stock ownership for all
> other NIH
> employees.

> "My goal is to create a bright line that is so clear that crossing
that
> line
> will not be allowed," said Dr. Elias A. Zerhouni, the NIH director,
at
> a
> news conference yesterday. "Nothing is more important for NIH than
> preserving public trust."

> Zerhouni, who had resisted such far-reaching restrictions last year,
> said he
> hopes the new regulations will maintain the reputation of NIH as "the
> one
> source of public health information in the country that is completely
> trusted and void of any conflict of interest or appearance of
conflict
> of
> interest."

> The reforms were drawn up over the past year by NIH, the Office of
> Government Ethics and the Department of Health and Human Services in
> response to revelations that a number of government scientists had
been
> receiving lucrative consulting fees from biomedical companies, deals
> that in
> some cases related to their NIH work.

> The conflicts of interest were revealed in a series of articles by
the
> Los
> Angeles Times, beginning in 2003, and led to congressional hearings
> over the
> past year that examined the financial arrangements.

> The new ban on outside employment by NIH employees extends to work
for
> pharmaceutical and biotechnology companies, research institutions
that
> receive grants from the NIH, health-care providers and insurers, and
> related
> trade associations.

> Scientists will be allowed to teach courses, write and edit articles
or
> textbooks and give lectures related to their work.

> "I don't want to isolate our scientists from the mainstream of
> science,"
> Zerhouni said.

> In other changes, senior employees cannot receive any award of more
> than
> $200, with exceptions made for such prestigious prizes as the Nobel
and
> Lasker prizes.

> The stock restrictions "could potentially affect every employee on
> campus,"
> said Holli Beckerman Jaffe, director of the NIH ethics office.

> NIH employees who file public or confidential financial disclosure
> reports
> will be required to immediately sell any stock they own in drug or
> biomedical companies. All other employees will be allowed to own such
> stock,
> but only up to $15,000 in any one company.

> The Times articles revealed that NIH employees had received hundreds
of
> payments from biomedical companies totaling millions of dollars, most
> of
> which were not publicly reported. In some cases, the scientists were
> receiving fees from drug companies that stood to benefit from their
> recommendations to doctors for treating patients.

> Private consulting arrangements between agency scientists and outside
> companies had been rare until the 1980s when they began to be
> encouraged as
> a way to speed the transfer of the government's laboratory research
to
> medical products and cures.

> Such collaborations - in which NIH scientists were typically paid by
> private
> companies for their expertise - increased greatly in the 1990s.

> Dr. Harold E. Varmus, Zerhouni's predecessor, saw such arrangements
as
> a way
> to make NIH more financially competitive with the private sector and
> lure
> top-notch researchers to government.

> In 1995, he lifted many of the restrictions on the outside income
> scientists
> could earn from drug and biotech companies and also relaxed
disclosure
> policies about such activities, adopting a case-by-case approach to
> reviewing the arrangements.

> 'More severe' rules

> Zerhouni noted yesterday that the new ethics rules are "more severe"
> than
> those in place before 1995, but said they are necessary "to
> re-establish the
> trust" in an agency with an annual budget of $28 billion.

> Zerhouni, who in the past also favored a case-by-case analysis of
such
> collaborations, had resisted proposing a blanket ban on consulting.

> In June, under increasing pressure from members of Congress who
> discovered
> dozens of deals between NIH scientists and private companies that
> agency
> officials had not known about, the NIH director proposed a ban on
paid
> consulting for only the agency's most-senior officials. The ban did
not
> include most of the more than 5,000 scientists working there.

> The Office of Government Ethics concluded a month later that tougher,
> more
> far-reaching measures were required to reverse the "permissive
culture"
> it
> found at NIH and to restore public confidence.

> In September, Zerhouni proposed a one-year moratorium on consulting
> fees for
> all agency employees.

> Yesterday, he said the new regulations, which are to take effect as
> soon as
> the guidelines are published, will stand permanently unless they need
> to be
> re-evaluated.

> Acknowledging that he once favored a more-limited ban on outside
> consulting
> activities, he said he had changed his mind and now saw how even
> lower-level
> NIH scientists could be used as a "marketing tool" by private
> companies.

> The conflict of interest cases had included both working scientists
and
> senior administrators.

> For instance, Dr. P. Trey Sunderland III, a senior researcher at the
> National Institute of Mental Health, received $508,000 from Pfizer
Inc.
> at
> the same time he was working with Pfizer in his government capacity
in
> a
> study of Alzheimer's patients, and endorsed one of its {*filter*}.

> {*filter*} transfusion expert Dr. Harvey G. Klein accepted more than
> $240,000 in
> fees and more than $76,000 in stock options from companies working on
> {*filter*}-related products.

> Dr. H. Bryan Brewer Jr., chief of the National Heart, Lung and {*filter*}
> Institute's molecular disease branch, helped develop new federal
> cholesterol
> guidelines and wrote an article promoting the benefits of the
> cholesterol-lowering drug Crestor as he received $31,000 from its
> maker,
> AstraZeneca.

> Review under way

> NIH officials said they were reviewing all of the potential conflicts
> of
> interest and soon will move into the "penalty phase" if violations
are
> found. Penalties could range from advising employees on their
> activities to
> firing them, said Dr. Raynard S. Kington, an agency deputy director.

> Zerhouni said NIH scientists, with whom he planned to meet today at a
> town
> hall meeting on the Bethesda campus, were "mixed" in their reaction
to
> the
> new rules.

> He said the 5,000 or so scientists who've had no outside income feel
> they've
> been swept into "a tsunami of regulations they had no responsibility
> for."

> But members of Congress who had pressed for tighter regulations
praised
> the
> director.

> "The NIH is one of the crown jewels of government research agencies,"
> said
> Rep. Henry A. Waxman, a California Democrat. "This action by NIH will
> help
> restore integrity and trust in the agency."

> Zerhouni said he realized that academic researchers all over the
world
> are
> increasingly collaborating with drug and biotech companies, but said
> the NIH
> had to "hold itself to a higher standard than the rest of the world."

> "We do have a national public health responsibility," he said.

> ------------------------------

> NIH Workers Angered by New Ethics Rules
> Restrictions on Outside Income Meet With Derision at Meeting

> By Rick Weiss
> Washington Post Staff Writer

> National Institutes of Health Director Elias A. Zerhouni stood before
> hundreds of NIH employees yesterday to explain why it had become
> necessary for him to impose, in his words, "drastic" restrictions on
> stock ownership and other forms of outside income, which take effect
> today for all agency employees.

> "What I'm asking you to do is hold your fire until you hear the
> details," he told the crowd assembled in an auditorium on the
agency's
> Bethesda campus.

> They held.

> And when he was done, they let him have it.

> One after another, scientists, doctors and other agency staffers
> stepped
> up to the microphones and raged against the new rules, made public
> Tuesday. By the time it was over, 90 minutes later, nary a positive
> word
> had been uttered about the new policy and there was more vented
spleen
> around than a busy medical center like the NIH might normally see in
a
> year.

> The goal, as Zerhouni repeatedly explained, was to save the venerable
> agency's reputation, which had become badly sullied after 14 months
of
> embarrassing revelations about conflicts of interest among NIH
> scientists.

> "This issue was standing between the prestigious history of the NIH
and
> its future," Zerhouni told the restive crowd.

> But the solution, many argued yesterday, was unjustifiably extreme,
> punishing virtually all of the agency's 18,000 employees for the bad
> actions of a few.

> "Even my secretary is going to have to sell her stock. How much sense
> does that make?" fumed Ezekiel Emanuel, chairman of the agency's
> department of clinical bioethics.

> The event, which NIH officials dubbed a "town hall meeting" for
> employees, marked an extraordinary climax to a convoluted tale of
> science, politics and money that had grown increasingly unmanageable
in
> recent months. After trying to "stand up for his troops," Zerhouni
> said,
> he was "shot in the back" with the

...

read more »



Wed, 25 Jul 2007 21:57:34 GMT
 
 [ 2 post ] 

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