E-DRUG: Cipla on FDC Botswana meeting
-------------------------------------
[An inside view behind the stage at the Botswana meeting and the US
Government's efforts to support big farma agendas. WB]
April 4, 2004
Botswana Report from Bill Haddad, Chairman/CEO, Biogenerics, Inc.
Representing Cipla, Ltd. of India
�For Each Life Saved Using Bush AIDS Initiative Financing, Three Others Will
Die�
Summary
Basic Tenet Remains: The Botswana meeting was politics posing as science
organized on behalf of the multinational pharmaceutical companies by the
United States government. The goals were/are to discredit the WHO
pre-approval process for triple anti-retrovirals and to add U.S. Food and
Drug Administration approval as a pre-requisite for receiving the ten
billion dollars allocated over five years for AIDS assistance under the Bush
AIDS initiative announced by the President in his State of the Union message
in 2003.
The emergency Botswana Conference was conceived in Washington after a
similar WHO meeting in December, 2004 failed to achieve the Pharma
objectives. This time the U.S. government was taking no chances: they
cherry-picked the audience, found a remote location, controlled the agenda
allowing no changes and took total control of the decision-making process.
WHO was�by my interpretation and information� �blackmailed� into sponsoring
the Botswana meeting by threats that the U.S. government would curtail WHO
monies if they refused. The official explanation by AIDS Ambassador Randall
Tobias at a Congressional hearing said the meeting had widespread support
and was sponsored by FDA, WHO, UNAIDS, European regulators and selected
African nation. Their participation added much needed credibility to the
Tobias statement and silenced further Congressional questions.
Public, Congressional and media pressures forced the opening of the meeting
to others (although it was transferred to remote Botswana after the South
African cabinet objected to having the meeting in Johannesburg). The
political objective caused the European Union countries to withdraw; the FDA
sponsorship was replaced by HHS although several FDA regulators were present
and active in the meeting; and while WHO and UNAIDS continued as sponsors,
the selection of Dr. Lembit Rago of WHO as a co-chairman and his conduct of
the meeting provides the one ray of hope that the conclusions reached will
be rational.
The Committee of Sponsors met in a closed session after the two day meeting
(March 29-30) to review and include the statements and comments made at the
meeting to determine if the WHO process requires replacement. This
reconciliation of information will be placed on the web before April 19 for
comment. What remains undecided is how the information will be used. The
United States still holds the trump card and if post-Botswana statements
are any indication, nothing will change.
Although private assurances were conveyed in Botswana that � in a few
months� the situation would result in support of the WHO position, the
post-Botswana statement by Tobias deputy John Lange forcefully restated the
false scientific premise�e.g., that the WHO pre-approval process for triple
ARVS is flawed. Lange raised the specter, using images usually argued in
private, that if Africans do not take the medicines properly, resistance
will develop, transfer to the West where drugs would not be available to
fight the immunities. He said: Giving ineffective drugs could lead to a
buildup of resistance and �end up doing more harm than good.� He said the
issue would be resolved �by the fall of this year�...(e.g., after the
election; the multinational pharmaceutical companies remain among the
largest contributors to Republican candidates).
The Lange statement was a mile too far and aroused the ire of former
Ambassador Holbrooke, who has not participated in the debate to disqualify
the triples. Holbrook accused Lang, Tobias, HHS and the State Department
team of fronting for the pharmaceutical industry. He said �it is a big issue
and it is tearing apart all the good work people are doing because there is
a feeling that the United States is protecting the big (pharmaceutical
companies.�
Holbrooke, whose statement before the UN Security Council focused the world
on providing AIDS help, heads an organization of 147 major multinational
companies.
Documents now in the possession of NGOs will not permit Lange to deny he
directed the Botswana strategy. These documents clearly outline the U.S.
strategy and confirm from within what outside critics have charged.
Despite denials to the media and the public that U.S. government is still
considering its policy about requiring the approval of the U.S. Food and
Drug Administration as a prerequisite for Bush funds, it was revealed in
Botswana that recipients are covertly and routinely informed not to use US
monies to purchase the lower cost triple ARVS, the medicine most requested
in the poor nations of the world. This position renders any Botswana
decision as immaterial.
As you will note from the information below, one courageous woman already
financed by the Bush initiative spoke �truth to power� about US demands. It
is surprising that the media has yet to pick up her statement and
investigate her charges.
In addition to unanimous field testimony from professionals at Botswana
that the triples have been in widespread use, are effective, affordable and
easy to administer, they also reported segregating the Bush monies to
purchase the high priced brand products would further complicate an already
difficult delivery system (e.g. one set of patients on a multi-tablet,
expensive regime funded by the United States and another set of patients
serviced with one pill in a twice a day regime of triples).
The unrepresentative meeting crammed with an HSS financed team was
embarrassingly programmed to the pre-determined position of the U.S.
government. The handful of subsidized African nations present argued
uniformly that they wanted safe medicines and just because they were African
they should not get inferior products�an outdated discredited argument used
by brand companies to delay generic entry into many markets including those
in the United States. Then there was the major contractor to the US
government who shouted that if the NGOs were concerned about using the FDA
as a requirement for US monies, they should �go talk to your Congressman.�
When confronted privately by a representative from the US Congress, he
backed down and said �if there is no law, then create a law��but he served
his purpose and earned his keep.
As noted, the two day meeting ended with a closed meeting of sponsors who
are to determine what to include in a report that will be placed on the web
on or before April 19th for comment. There is no methodology for
implementation other than the one now in place that will result�at a
minimum�in a mistrust of the WHO process and a continued diversion of the
monies President Bush sincerely promised to use to buy generic ARVS.
This is not the first, but the twelfth effort since 2001 by the
multinationals using various U.S. government agencies to sidetrack the
dramatic arrangement between Dr. Yusuf Hamied of Cipla and MSF (Doctors
Without Borders) to provide the triple at less than a dollar a day. Prices
at the time ranged between $12-15,000 a year. The cost of a year�s the WHO
recommended first line treatment now ranges between $220 and $140 (with
certain conditions). Two companies now manufacture Fixed Dose Combinations
in one tablet and other companies are currently seeking WHO pre-approval for
similar products.
We still have a chance to convert the lemon of Botswana into lemonade is we
continue the actions already underway. At the end of the day�I think�we have
three clear objectives: reaffirmation of the WHO pre-approval process;
removing the confusion now being created with front line organizations
dealing with patients; and having the Bush monies used to help patients and
not enrich the multinationals pharmaceutical companies.
It is hoped that the media, at some point, will realize Botswana is only the
latest attempt to block use of readily available lower priced easily
administered AIDS medicines. The result is that three hundred people die
each hour.
Again, without the help of those on this network, the US government would
have succeeded in their plans. More detailed information on the meeting
follows ending with some suggestions for further action.
(A more detailed journalistic review follows)
�For Each Life Saved Using Bush Initiative Financing, Three Will Die�
One of the four awardees of the Bush AIDS initiative monies, the Catholic
Relief Services Consortium (CRSC) reported United States purchasing
restrictions will result in three of every four patients not receiving the
medicines that can prolong their lives.
In a quietly delivered, courageous statement that spoke �truth to power� at
the U.S. sponsored meeting in Gaborone, Botswana, Ms. Jacqueline Patterson,
the manager of the HIV/AIDS portfolio for the Interchurch Medical
Assistance� a member of the CRSC that was awarded $24.7 million of Bush
initiative monies� said the purchase of the Fixed Dose Combination (FDC)
drugs, the triple anti-retroviral, would allow treatment of four patients
rather than a single patient.
The three patients that remain untreated would die. That is the hard logic
of what is happening in Africa and the poorer nations of the world today
where a small percentage of ailing and dying victims receive the available
and now affordable medicines they require to stay alive.
Overall the meeting in remote, virtually media-free Gaborone was a cross
between a chapter from Orwell�s 1984 and a Moliere farce. The U.S.
delegation maintained that the meeting was designed to protect poor Africans
from substandard medicines that would endanger their lives while the purpose
is to deny them the medicines they need to live.
The U.S. sponsored Botswana meeting was another in a series of failed
attempts to discredit the use of the generic ARVs recommended by WHO as a
first line treatment for AIDS. The Botswana meeting also served as a thinly
disguised effort to direct the Bush monies to the brand name companies that
for several years denied and are continuing to create artificial barriers to
Africans use of the lower priced AIDS medicines. The multinational
pharmaceutical companies hide behind a fa�ade recently created for them by
the U.S. State Department and AIDS Ambassador Randall Tobias, a former Lilly
executive.
Currently and covertly the U.S. government is advising recipients of the
Bush monies not to purchase the lower priced generic FDCs that have been
pre-approved by the WHO while simultaneously advising the media and the
public that a decision on use of the Bush monies has not been made. That
action is in stark contradiction to President Bush�s promise in last year�s
State of the Union message to use the monies to purchase the lower priced
generics.
(The Bush quote: ��anti-retroviral drugs can extend life for many years.
And the cost of those drugs has dropped from $12,000 a year to under $300 a
year�which places a tremendous possibility within our grasp. Ladies and
gentlemen, seldom has history offered a greater opportunity to do so much
for so many.�)
The Botswana Conference, originally planned as a closed door meeting of
countries and regulators supporting the U.S. position was opened to a larger
audience as a direct result of those who responded to appeals made through
this network especially NGOs (Doctors Without Borders, MSF; Oxfam; Act Up),
hundreds of AIDS activist groups, a letter to President Bush from Senators
Kennedy and McCain and a well documented report to the President from
Congressman Waxman. These appeals to open the meeting and a call for an
abolition of restraints on use of pre-approved WHO triple ARVs was widely
reported and editorialized (Washington Post, San Francisco Chronical; Boston
Globe, others).
As reported in the Atlanta Constitution on April 3, Ambassador Richard
Holbrooke, who brought the AIDS issue to the United Nations Security Council
and now heads the Global Coalition on HIV/AIDS, a coalition of 140
multinational companies, lectured John Lange, a Tobias deputy, about efforts
in Botswana to block the use of low priced AIDS medicines.
Holbrook said the U.S. policy is based on a desire to support the big
pharmaceutical companies and is �tearing apart� efforts to fight the
epidemic in poor countries.
�I am very disturbed about this,� Holbrook said. �It is a big issue and it
is tearing apart all the good work that people are doing because there is a
feeling that the United States is protecting the big (pharmaceutical
companies).�
After the Botswana meeting, Reuters reported that Lange said the United
States was mainly concerned that much cheaper versions of the drugs made by
Indian companies may end up doing more harm than good if they are widely
distributed.�
He also repeated a theme that if the Africans do not take the medicine
properly or do not meet quality standards �could build up resistance that
could do more harm than good.�
(Unknown to Ambassador Tobias and his deputy, internal State Department and
HSS documents reveal Ambassador Lange was personally directing the Botswana
program. The State Department and HSS secret �talking points� paper is now
in the hands of non governmental organizations. It reports as facts
scientific fictions and outlines �nasty� attacks on dissident nations).
NOT A SINGLE EXAMPLE OF FAILURE OF THE TRIPLE ARV WAS REPORTED IN THE
BOTSWANA MEETING A RESULT IDENTICAL TO THE PREVIOUS MEETING ON FIXED DOSE
COMBINATIONS CONVENED IN GENEVA LAST
Testimonials from NGO field programs operated by medical specialists
reported that the triple was effective, easier to use than the multi-tablet
brand products, was affordable and no side effects were reported.
Others reported the use of the multiple tablet regimes for U.S. funded brand
products and the Global Fund support for triple ARVs (one pill twice a day)
is already creating confusion in field operations. It is difficult enough to
operate one program in resource short locations much less operate two
programs with different medicines and regimes.
All field reports presented in Botswana preferred the use of the triple ARV.
Uniformly participants from nations who used subsidies from the sponsors to
attend the Conference cited their concern that safety was the major issue
and as Africans they did not want to be victims of substandard treatments.
They associated lower prices with substandard products.
(Note: As someone who has watched how Big Pharma operates both in the United
States and offshore, the interchangeability of �cheap� and �substandard�
combined with a Colonial twist, has often delayed effective medicines from
reaching populations in the United States and in the poor nations of the
world).
The second argument advanced by a company that owes its existence and most
of its financing to the U.S. government vociferously argued that if those at
the Conference had objections to the �U.S. law that prevents monies from
going to products not approved by the FDA� they should complain to Congress
and get the law changed� (applause from the U.S. delegation). Confronted
afterwards by a physician on the staff of a U.S. Congressman demanded to
know what law he spoke about. �Well, if there isn�t a law there should be
one.� The Congressional assistant reminded him that was not the argument he
made to the U.S. delegation�s applause.
Unfortunately, both the agenda and the add-on secret meeting after the
approval process for anyone in the pharmaceutical business it was amateur
night.
All of the issues could have been easily resolved by technical experts
sitting
quietly reviewing scientific presentations, subjecting their views to peer
review, reporting their results in a scientific paper released for comment.
That is the process used by almost every regulatory agency in the world
seeking to have its procedures revamped.
If the effort was sincere, the regulations for approval of triples from the
United States, Canada, and the European nations, Scandinavian, Australia and
South Africa would be reviewed and compared to each other and to the WHO
process. Requirements that differed from the WHO process would be examined
and a collective scientific determination made as to whether they could
improve WHO procedures in the future.
Fortunately, Dr. Lembit Rego who developed the WHO pre-approval process with
the assistance of European, Scandinavian and Australian regulators (the US
FDA refused to participate) was co-chair of the meeting and he insured all
who wanted to comment had their opportunity. At the last minute, general
comment�apart from the structured agenda� was permitted prior to the meeting
and in the final session. He also participated in the sponsors review. He is
the hope that a ration�if immaterial�decision is reached in an expedited
time frame. Yet the United States is free to act on its own and all it needs
is to instill doubt to win.
WHAT CAN WE DO NOW?
There appears to be a disconnect between the political side of the White
House and the �bulls� pushing the effort to undercut WHO. Earlier dependable
reports from within the White House confirmed President Bush�s personal
commitment to use of the lower priced generics as a crucial part of his AIDS
initiative.
A similar disconnect seems to exist between Secretary Colin Powell, his
pragmatic deputy, Richard Armitage and Ambassador Tobias who reports to
them. Both men are genuinely committed to assisting poor nations to in
combating the AIDS pandemic and neither Powell nor Armitage are regarded as
�in Pharma�s back pocket.�
From reading the internal correspondence generated by State and HHS, there
is little chance of logic converting Tobias, Lange et al. Unlike Powell and
Armitage, they are in Pharma�s back pocket. The Lilly background of Tobias
and the scientific training of Lange provides them with the experience to
dismiss the arguments their internal �talking points� paper authorizes.
We need to provide the media with the tools to separate the alleged science
from politics and to understand the consequences of this farce.. We also
need to provide a countervailing pressure on WHO and the other UN agencies
for them to maintain their commitment to the generic AIDS medicines.
(For the International Association of Generic AIDS Manufacturers: you must
have your governments contact WHO with your views).
Also, if you will permit, some suggestions for expanding our base to
religious organizations:
---I believe by using the Pope�s powerful anti-Pharma statement and the
concern of Ms. Patterson, we may be able to recruit local churches and
religious organizations to complain to the White House and Congress about
what is happening. Many conservative Christian organizations are active in
poor nations and enjoy support from their congregations. These actions
should produce local press.
Also:
---When the Botswana statement is produced we will have it analyzed by
pharmaceutical experts and compared to the WHO process. The results will be
broadcast to this network. It is hoped this analysis along with expert
professional comment can become a ramrod to use with the White House, State
and the Congress.
---We should not underestimate the Holbrook statement because the
organization he represents includes many important multinational
corporations.
Thanks for listening. If I can be of help, please do not hesitate to reach
out.
Bill Haddad
WFHADDAD@aol.com
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