Doctors & Drug Makers_World Health Organization & Drug Makers

An article in The New York Times, Doctors and Drug Makers: A Move to End
Cozy Ties By STEPHANIE SAUL, February 12, 2007
http://www.nytimes.com/2007/02/12/business/12drug.html reports that
"Institute on Medicine as a Profession," a research group at Columbia
University,  has received a $6 million grant from the Pew Charitable Trusts
to dissuade doctors from accepting free lunches from pharmaceutical
companies.

This is an example of disingenuous focus on trivia while avoiding the real
issues that are corrupting medicine. Free lunches impress the junior staff –
it's the big bucks that Big Pharma provides in the way of research grants
that determine practice and prescribing guidelines.

The real source of corruption in medicine is at the policy, education and
publication levels:

Big Pharma spends billions of dollars in research grants, consultancy fees,
stock options, continuing medical education, conference sponsorships, and
cash payments to gain influence with institutions and key individuals who
formulate medical practice guidelines and public policies. It is the
policies and practice guidelines that determine the sales cash flow of
drugs. 

Examples of industry-influenced clinical guidelines were highlighted in
Selling Sickness (Ray Moynihan and Alan Cassels) and Overdosed America (John
Abramson, MD): *the hormone replacement therapy hoax–which Barbara Seaman
coined The Greatest Experiment Ever Performed on Women lasted for more than
40 years; *a current drive to medicalize women's sexuality by defining FSD
(female sexual dysfunction); *in psychiatry, the formulation of the DSM-IV
diagnostic criteria; the prescription drug guidelines known as the Texas
medication algorithm project (TMAP); and the epidemic diagnosis and
treatment of "bipolar disorder" in children; the treatment of sepsis has
been abducted by the Zigris Surviving Sepsis campaign; the drive to diagnose
and medicate osteoporosis in women was fuelled by a study group of the World
Health Organization… the list goes on

The greatest responsibility for the corruption of medicine rests not on a
few "rotten apples." it rests on prestigious research centers, professional
associations, authoritative leaders in medicine, and on patient "advocacy"
groups that serve as industry's lobbying fronts.

So, until we hear that the Institute of Medicine as a Profession–and any
other physician group at a major medical center has embarked on a campaign
to sever the major financial ties between industry and senior researchers
and the university–we will view this as a diversion from the real problem.

The more important barometer of pharmaceutical industry influence is to be
found in the British Medical Journal expose revealing that Benedetto
Saraceno, director of mental health and substance abuse of the World Health
Organization, and the European Parkinson's Disease Association, had
apparently tried to circumvent the WHO prohibition on accepting
pharmaceutical industry money either directly or indirectly.

In 2002,  the WHO issued a report, Nations for Mental Health, whose
stated goals concealed the market expansion intent.
"Nations for Mental Health was designed to be an Initiative within the UN
system for mental health in underserved populations. WHO initiated this
programme following the publication,in May 1995, of a report on world mental
health by a team at Harvard Medical School."
The first named sponsors of this WHO report:
Eli Lilly
and Company Foundation, the Johnson and Johnson Corporate
Contributions Europe Committee.

The power brokers initiating the expansion of the psychotropic drug market
world wide: Harvard–Lilly–Johnson & Johnson.
You can be certain there was more than free lunches that were served!

Ironically in the current dust storm GSK vice-president, Alastair Benbow,
appears to have been appalled to learn that the WHO attempted to conceal the
GSK donation–so the offer was withdrawn.

"Serious questions have been raised about whether the World Health
Organization is using patient groups as a conduit for receiving proscribed
donations from the pharmaceutical industry. Email correspondence passed to
the BMJ seems to show that in June 2006 Benedetto Saraceno, the director of
WHO's department of mental health and substance abuse, suggested that a
patient organisation accept $10 000 (£5000;  7000) from GlaxoSmithKline
(GSK) on WHO's behalf. The sum was then to be passed on to WHO—ostensibly
with the intention of obscuring the origins of the donation. GSK withdrew
its offer of funding when it learnt that acceptance was conditional on
obscuring its origin. However, the email exchange indicates that other sums
of money originating from drug companies may have already been channelled to
WHO through patient groups."

Underscoring the fact that this is an institutional problem NOT merely one
individual who demonstrated poor judgment:
When the BMJ referred its concerns about the Saraceno correspondence to WHO,
a spokesman replied: "It's astonishing that the BMJ thinks there's a story
here. Dr Saraceno sent a second email saying that he had not meant to ask
for the money. So I don't think there's anything to answer."

Contact: Vera Hassner Sharav
212-595-8974
veracare@ahrp.org
~~~~~~~~~~~~~~~~~~

 BMJ  2007;334:338-340 (17 February), doi:10.1136/bmj.39119.519664.BE
Drug industry sponsorship
Who's funding WHO?
Michael Day, freelance journalist
miday@f2s.com

WHO guidelines state that it will not accept money from drug companies, but
how rigorous is it in enforcing this? Michael Day investigates

Serious questions have been raised about whether the World Health
Organization is using patient groups as a conduit for receiving proscribed
donations from the pharmaceutical industry. Email correspondence passed to
the BMJ seems to show that in June 2006 Benedetto Saraceno, the director of
WHO's department of mental health and substance abuse, suggested that a
patient organisation accept $10 000 (£5000; {euro}7000) from GlaxoSmithKline
(GSK) on WHO's behalf. The sum was then to be passed on to WHO—ostensibly
with the intention of obscuring the origins of the donation. GSK withdrew
its offer of funding when it learnt that acceptance was conditional on
obscuring its origin. However, the email exchange indicates that other sums
of money originating from drug companies may have already been channelled to
WHO through patient groups.

When asked about this correspondence, Dr Saraceno told the BMJ that his
email to the patient organisation was "clumsily worded" and that he had
"never intended to solicit donations from the pharmaceutical industry
through" the patient organisation. In the email dated 16 June 2006, Dr
Saraceno thanks Mary Baker of the European Parkinson's Disease Association
(EPDA), for raising the $10 000 "requested by the WHO." The money was to
have funded a report on neurological diseases, including Parkinson's
disease, for which GSK produces treatments.

Dr Saraceno then seems to advise Mary Baker on how to get round the WHO's
rules forbidding drug industry funding. "Unfortunately," he says, "WHO
cannot receive funds from pharmaceutical industry. Our legal Office will
reject the donation. WHO can only receive funds from Government agencies,
NGOs, foundations and scientific institutions or professional organisations.
Therefore, I suggest that this money should be given to EPDA and eventually
EPDA can send the funds to WHO which will give an invoice (and acknowledge
contribution) to EPDA, but not to GSK."

He adds: "This is in line with what we have done so far with other
contributions to the report which all are coming from other professional
organisations," — suggesting that less than transparent transactions were
the norm for this fundraising operation.

WHO guidelines
According to paragraph 13 of the WHO's guidelines on interactions with
commercial enterprises, which deals with cash donations, "WHO should avoid
indirect collaboration (particularly if arranged by a third party acting as
an intermediary between WHO and a commercial enterprise)." Paragraphs 15 and
16 of the guidelines state that funds may not be sought or accepted from
commercial enterprises that have a direct commercial interest in the outcome
of the project and that caution should be exercised even when the business
has an indirect interest. And paragraph 27 says that for reasons of
transparency, contributions from commercial enterprises must be
acknowledged.

Richard Nicholson, editor of the Bulletin of Medical Ethics, said: "It would
be very bad indeed if the WHO were trying to obtain money surreptitiously
from drugs companies. Unfortunately it's also under-funded, and sadly
there's always going to be the temptation of senior officials who ought to
know better than to accept such money. But they should remember that there's
always a price attached to such funding."

Even the senior GSK official who offered the money to the EPDA professes
outrage at the secretive means by which WHO attempted to obtain the drug
company grant. Alastair Benbow, vice president of GSK, withdrew the offer of
funding went he learnt of Dr Saraceno's response to GSK's proposed donation.
In an email to Mary Baker of 19 June 2006 he said: "Unless I am misreading
something here it sounds like they [WHO] will accept funding from you but
not from the industry. Worse than this, they will accept funding from you
even if they know it originally came from us, in order to bypass their own
rules. This is hypocritical in the extreme. It makes a complete mockery of
attempts at transparency, which should be welcome, and which the WHO have
called for."

Some critics said the vehemence of Dr Benbow's criticism of the WHO
reflected the sensitive nature of drug companies' relationship with patient
groups. Tim Reid, European director of Health Action International, which
campaigns for the rational and ethical use of drugs, said: "Patients groups
are so close to the industry, that they might as well be taking their money
straight out of the drug company advertising budgets." Graham Dukes, a
former head of the WHO's medicines programme for Europe, said: "We know that
patient groups are heavily influenced by drug companies. In the case of
attention deficit hyperactivity disorder, for example, we know that the
industry effectively financed the whole campaign—and we're not absolutely
sure the condition actually exists."

Dr Reid added that there were now moves afoot in the European Union to
sanction direct to consumer advertising in the form of private-public
partnership promotional campaigns. For this reason the industry was keen for
everything to be very transparent. "That's not to say we support such a move
in Europe," he said. "There may be some degree of transparency, but that
doesn't mean it's necessarily a good source of information for consumers."

Backtracking
A copy of Dr Benbow's email was forwarded to Dr Saraceno, who sent a further
email to Mary Baker on 20 June seeking to explain his previous email to her.
"It is obvious that my reply to your initial message was misunderstood and
misinterpreted," he wrote.

"As I stated very clearly in my message to you, WHO cannot receive funds
from the pharmaceutical industry, but can receive funds from a variety of
other organizations including NGOs, such as EPDA, whenever there is no
conflict of interests. My suggestion that GSK should give funds to EPDA
might have been clumsily worded; my intention was to convey that EPDA can
raise funds for its activities from a variety of sources (including the
pharmaceutical industry) and use its funds for a variety of purposes
(including giving donations to WHO). This is not the case for WHO.

"At any rate, any donation can only be accepted in accordance with WHO rules
and regulations, and precisely this has been the case with all other NGOs
whose contributions are extremely useful to the production of the
publication ‘Neurological Disorders: Public Health Challenges'. Therefore,
in order to avoid a perception of conflict of interests for WHO, I would
prefer to decline any financial support for this publication, particularly
since I have never asked your NGO to mobilize funds from pharmaceutical
companies, and I now find myself in a situation that I have not solicited."

When asked about this correspondence, Dr Saraceno told the BMJ: "I was not
soliciting any funds. I was in the process of preparing a new report about
neurological disease in poor countries, and I was looking for some funding
to help with the report and I received an email from the patient group. And
the way I reacted was rather stupid. After sending this very unfortunate
email I sent another one saying that I had expressed myself in an ambiguous
way. I'm strongly against receiving any money from the pharmaceutical
industry that would pose a conflict of interest. I started here at the WHO
10 years ago at a time when the mental health division was much closer and
more reliant on the pharmaceutical industry, and I've spent ten years trying
to stop that."

The BMJ also spoke to Mary Baker:

"Dr Saraceno said he needed money for the report and I said I knew where I
might be able to get it. I approached GSK, who we've always worked closely
with in the past, and they have a clear understanding of transparency. They
said they would be able to give us the money for the report. There is
absolutely no doubt in my mind that Dr Saraceno knew the $10 000 was coming
from GSK and that he was intending to take it and disguise its origins by
getting the EPDA to accept it first before passing it on.

"This incident highlights the difficulty facing the WHO in balancing the
best interests of patients with a shortfall in funding. Their current policy
about not accepting money from pharmaceutical companies is prohibitive in
this sense. There needs to be a broader debate about how the WHO, patient
groups, and pharmaceutical companies can work together in partnership to
produce the best results for patients. The WHO needs to ask itself some
serious questions about how it will manage to fund projects in the future."

This is not the first time that questions have been raised about the nature
of the relation between the WHO's mental health division and the
pharmaceutical industry. In their book, Medicines Out of Control? social
campaigners Charles Medawar and Anita Hardon documented the controversial
links between the WHO's mental health division, the World Psychiatric
Association, and the drug industry.1
<http://www.bmj.com/cgi/content/full/334/7589/338#REF1#REF1
In the mid-1990s, at the suggestion of the World Psychiatric Association,
the division produced a report that advocated long term use of potentially
addictive benzodiazepine drugs.2
<http://www.bmj.com/cgi/content/full/334/7589/338#REF2#REF2
Benzodiazepine manufacturers purchased many copies of the report. And one
firm made a $500 000 donation to WHO's mental health division.

Funding pressure

However, as Ralph Edwards, the director of the WHO's drug monitoring centre
in Uppsala, Sweden, warns, it wasn't only the mental health division that
was being pushed by financial necessity to get closer than was desirable to
the drug industry. "These days it's so hard to find anyone completely free
of the pharmaceutical industry. A couple of years ago we wanted to publish a
safety report on Lapdap [chlorproguanil-dapsone], the combination malaria
treatment. The WHO's tropical disease research group had developed the
treatment jointly with Glaxo, but Glaxo weren't happy with what we wanted to
publish.

"This was a bad situation and it was very, very difficult. We raised the
issue with WHO because we thought that there had not been enough safety
studies done. We managed to get the report published eventually, after a lot
of lobbying and pressure—but it was delayed for more than a year," said Dr
Edwards.

"It's an example of how tortuous it is working with pharmaceutical industry
money. GSK stated at the time of the dispute that it "totally disagrees with
the assertion that there is concern about Lapdap" and maintains that it is
"an effective and well-tolerated therapy for the treatment of malaria." The
company claimed that "A draft [of the WHO Lapdap report] which GSK was given
sight of contained many inaccuracies."

When the BMJ referred its concerns about the Saraceno correspondence to WHO,
a spokesman [Q to A can you give his name?] replied: "It's astonishing that
the BMJ thinks there's a story here. Dr Saraceno sent a second email saying
that he had not meant to ask for the money. So I don't think there's
anything to answer."

________________________________

Competing interests: None declared.

References

1.       Medawar C, Hardon A. Medicines out of control? Antidepressants and
the conspiracy of goodwill. Amsterdam: Aksant Medical Publishers, 2004.

2.       WHO. Rational use of benzodiazepines. Geneva: WHO, 1996.

Related Article

Controversies revisited

Jane Smith
BMJ 2007 334: 0. [Extract]
<http://www.bmj.com/cgi/content/extract/334/7589/0>  [Full Text]
<http://www.bmj.com/cgi/content/full/334/7589/0

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