[Ip-health] Botswana Report from Bill Haddad, Chairman/CEO, Biogenerics, Inc. Representing Cipla, Ltd. of India

[Mike Palmedo]

Bill Haddad asked me to post his report on the Botswana meeting...
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April 4, 2004

Botswana Report from Bill Haddad, Chairman/CEO, Biogenerics, Inc.
Representing Cipla, Ltd. of India

=93For Each Life Saved Using Bush AIDS

Initiative Financing, Three Others Will Die=94 (See Below)

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=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
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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=85by my interpretation and information=85 =93blackmailed=
=94
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 =93 in a few
months=94 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=85e.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 =93end up doing more harm than
good.=94 He said the issue would be resolved =93by the fall of this
year=94...(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 =93it
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.=94

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 =93truth to power=94 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=85an 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 =93go talk to your Congressman.=94 When confronted privately by a
representative from the US Congress, he backed down and said =93if there
is no law, then create a law=94=85but 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 19^th for comment. There is no methodology
for implementation other than the one now in place that will result=85at a
minimum=85in 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=92s 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=85I
think=85we 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)

=93For Each Life Saved Using Bush Initiative Financing, Three Will Die=94

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 =93truth to power=
=94
at the U.S. sponsored meeting in Gaborone, Botswana, Ms. Jacqueline
Patterson, the manger of the HIV/AIDS portfolio for the Interchurch
Medical Assistance=85 a member of the CRSC that was awarded $24.7 million
of Bush initiative monies=85 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=92s 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=E7ade 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=92s promise in last
year=92s State of the Union message to use the monies to purchase the
lower priced generics.

(The Bush quote: =93=85anti-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=97which places a tremendous possibility within our grasp.
Ladies and gentlemen, seldom has history offered a greater opportunity
to do so much for so many.=94)

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 =93tearing apart=94 efforts to fight the
epidemic in poor countries.

=93I am very disturbed about this,=94 Holbrook said. =93It is a big issue a=
nd
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).=94

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.=94

He also repeated a theme that if the Africans do not take the medicine
properly or do not meet quality standards =93could build up resistance
that could do more harm than good.=94

(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 =93talking points=94
paper is now in the hands of non governmental organizations. It reports
as facts scientific fictions and outlines =93nasty=94 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 =93cheap=94 and
=93substandard=94 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 =93U.S. law that prevents
monies from going to products not approved by the FDA=94 they should
complain to Congress and get the law changed=94 (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. =93Well, if there
isn=92t a law there should be one.=94 The Congressional assistant reminded
him that was not the argument he made to the U.S. delegation=92s 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=85apart from the structured agenda=85 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=85if immaterial=85decisio=
n
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 =93bulls=94 pushing the effort to undercut WHO. Earlier
dependable reports from within the White House confirmed President
Bush=92s 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 =93in Pharma=92s back pocket.=94

>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=92s back pocket. The Lilly
background of Tobias and the scientific training of Lange provides them
with the experience to dismiss the arguments their internal =93talking
points=94 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=92s 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.