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[e-drug] FDC ARV meeting Botswana 29-30 March (2)

E-DRUG: FDC ARV meeting Botswana 29-30 March (2)
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[A response from Cipla, a manufacturer of a generic 3-in-1 FDC ARV (Triomune
30 and 40), on the upcoming FDC ARV meeting in Botswana. Crossposted from
IP-HEALTH with thanks. Sorry, long message. WB]

DELIVERY OF THE GENERIC TRIPLE ARV TO POOR NATIONS IS SERIOUSLY
THREATENED BY COMBINED ACTIONS OF THE US GOVERNMENT, PHARMA, WHO,
UNICEF, UNAIDS, HHS.

HARD TO BELIEVE, BUT TRUE.

PLEASE STAY WITH THIS LONG BACKGROUNDER; WE NEED IMMEDIATE ASSISTANCE.

For those of you who do not know me, I am a generic drug manufacturer
who volunteered three years ago to help Dr. Yusuf Hamied and Cipla
organize their campaign to reduce the price of AIDS medicines. At the
behest of WHO I organized all of the companies manufacturing generic
AIDS drugs into an association so we could have a voice at WHO. I am a
former Herald Tribune New York Post investigative reporter/editor;
worked with the Kennedys; helped to set up the Peace Corps and the
Poverty program. As CEO of the generic trade association I initiated and
negotiated Waxman-Hatch, the Drug Price Competition Act, that removed
the barriers to generic competition in the United States.

This memo addresses the efforts by an unusual coalition of forces to
remove from the market and continued financing the triple ARV
pre-approved by WHO. The triple ARV is the medicine most often sought by
poor nations based on its safety, effectiveness, price and its ease of
use. They want the Fixed Dose Combination (FDC) ...one tablet taken
twice a day... replaced by brand products in blisters and a return to a
regime of different medicines at various times. The barrier blocking
their effort is the WHO pre-approval process, the basis for most
international funding.

A Short Backgrounder for Those Unfamiliar With Recent Events:

As you know we have been successful in dramatically reducing prices for
the triple ARV, one tablet taken twice a day, from $12,000 to about $200
and under special circumstances as low as $140 per year . On AIDS Day
WHO announced the approval of the low cost, safe, effective triple and
this drug was as at the heart of their 3 X 5 program. The approval
process took two years.

This success can go down the drain if the United States government, UN
agencies, the MNCs and Pharma are successful in their renewed effort to
undermine WHO's pre-approval process and remove triple ARVs from the
market. Having failed twice before to do this, the United States, I have
strong reason to believe, pressured WHO, UNAIDS and others into a third
meeting...scheduled for March 29 and 30 in Botswana, a meeting that
excluded the experts that blocked their efforts earlier.

To date, this has been a virtually secret meeting. It needs to be
exposed to those who are concerned about low cost generics reaching
African and other nations.

Many of you know of the barriers we have crossed to get to Lima and
competitive bidding for AIDS medicines: the South Africa legal actions
from which Pharma withdrew when the media embarrassed them after Cipla
and MSF offered ARVs at less than a dollar a day; the UN Accelerated
Access to Medicines program originated with the UN (Jeff Sachs), WHO,
UNICEF, UNAIDS, the MNCs and the U.S. government... a program that
established a monopoly at ten times the generic price and banned generic
participation; the Global Fund's refusal to consider submissions from
poor nations that included generic drugs (now reversed); you know the
rest. In Lima, we finally broke the back of the Accelerated Program when
nine Andean nations and Mexico held an open bidding with generics
winning all but one bid (Abbott). We set a worldwide price of about
$249.00.

Ironically, one of the major steps forward was President Bush's
commitment in last year's State of the Union message, to AIDS
funding...based on the reduction in price from $12,000 to $300 a year
from generic manufacturers.

Bush: "...anti-retroviral drugs can extend life for many years. And the
cost of those drugs has dropped from 12,000 dollars a year to under 300
dollars 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..."

After his talk, Ralph Nader and Jamie Love visited Mitch Daniel, the
Budget Director, to confirm if the President knew of what he spoke...the
New York Times, among others, editorially noted this meant generic
medicines. Daniels, without hesitation, confirmed the President
understood this meant generic medicines. I asked a major conservative
newspaper to have a White House correspondent ask Daniels the same
question, and he got the same answer. I personally suspect that Mrs.
Bush might have had a role in that decision.

Congress voted the authorization but without the McCain and Kennedy
amendment to insure generic use. Later Dr. Faucci at NIH (one of the
good guys) said that to obtain the US monies, more than the WHO
pre-approval would be required; this was repeated by Secretary Thompson,
but the NGO and media questioning reversed that position. The
unnecessary additional western approval would not only delay but derail
the low cost generic efforts.

Then came Lima. The MNCs were watching Africa, assured that had Latin
America in their pocket. The nine Andean nations and Mexico surprised
them and abandoned the UN sponsored Accelerated Access program, created
a competitive bidding process, again lowering the price for AIDS
medicines. At the Paris Global Fund meeting, I asked Secretary Thompson
from the floor if the President continued to support the $300 generic.
(As a Kennedy Democrat, I had called the Bush statement, courageous,
faith-based and personal.) Thompson grew angry at me ( and later
perennially confronted me) but as chairman of the meeting that included
most African Ambassadors, he angrily asked me what made me think the
President would not stand by his word. As many of you may remember the
NGOs had crisscrossed Africa during Bush's trip to get him to restate
the generic price. They failed.

Later the price of the triple continued to decline ...under specified
circumstances and prerequisites to as low $140 a year for certain
countries.

On December First, AIDS Day, WHO approved ... after two years ... the
triple ARV in one tablet taken twice a day developed by Dr. Yusuf Hamied
of Cipla (Triomune) and the Ranbaxy's clone...as the product that was
essential to Dr. Lee's 3 X 5 program. As noted above, we know the triple
is the most requested medicine not only for its medical impact, but its
ease of administration.

The WHO decision set in motion a rather violent political reaction by
the MNCs operating behind closed doors and with direct access to WHO.
The only way to challenge the WHO decision was to undermine the entire
WHO pre-approval process...essential for Global Fund and other
international monies.

It soon became apparent that another goal was an additional level of
western approval to insure that the Bush monies, greatly reduced, but
still a major contribution over the next few years, would only go to the
MNCs.

I personally believe that WHO was dragooned into holding a conference in
Geneva between December 15, 18, 2003 (at which some of were present) to
examine Fixed Dose Combinations and opened up the question of whether it
was better to use blister pacts...this is pharmacology 101 but the forty
or so people attending the Conference had to address this nonsense
seriously. Since no evidence was presented to challenge Dr. Lee's
action, the resolution was to proceed but to look for possible adverse
reports...a fair action. The draft of the WHO announcement was sent to
the participants. My comment: not a single declarative sentence and no
news lead that would commit WHO. The report was never issued. Why?
Pharma or US pressure?

The United States government has now arranged for the same discussion
but before a new audience, western regulatory agencies, African nations
receiving US assistance...a meeting given authenticity by the
sponsorship of FDA, WHO (correct, WHO), UNAIDS (yes, UNAIDS). India and
Brazil, the two major suppliers of generic ARVs were not invited; the
NGOs were not included; neither were the generic manufacturers making
the product. I am not sure how many MNCs were asked to participate but
they were there for the planning meeting in South Africa in February. We
were not officially informed of this meeting and we were not permitted
to attend...we being those of us concerned about continuing the use of
generic ARVs.

The anti-generic viewpoint was made public policy during the appearance
of Ambassador Tobias before the Hyde Committee last week. In answer to a
direct question, he defended the African Conference and went on to
disparage generic medicines gaining credibility from the sponsorship of
the second meeting. After praising the FDA process for approval generic
drugs...for those of you who do not know the story, there was almost a
thirty year battle in which the same anti-generic statements that are
now used to discredit generic ARVs were used....Ambassador Tobias said:

"...\when people using the term generic drugs in referring to HIV/AIDS
drugs, they are not the generic drugs that we are talking about here.
And one of the things that has to happen, is that we need to have
principles in terms of dosage, safety, effectiveness, strength, active
ingredients, purity, stability, quality, performance, intended use, and
so forth. In other words, they are identical...etc..."

Tobais continued: " ..we have taken the initiative of bringing together
a number of organizations and in conjunction with the U.S. government
under the lead of the FDA, by in partnership and cosponsorship with the
World Health Organization, UN aids, SATIC--Southern African Development
Community...that's a consortium of African regulatory agencies and a
broad number of others took place in February, another meeting will take
place on the 29th and 30th of March....with the expected outcome of that
meeting, the development of principals that can be used by countries in
establishing specific technical standards to make these decisions.
UNFORTUNATELY, WHEN PEOPLE TODAY SAY WE OUGHT TO BUY GENERIC AIDS DRUGS,
THEY ARE NOT DESCRIBING IN MANY CASES WHAT WE IMAGINE WHEN WE THINK OF
GENERIC DRUGS IN THE UNTIED STATES.. IT WOULD BE A DISASTER...."

Then, with a flourish he read an extremely laudatory letter from the
Global Fund praising his work. He said that the US would donate a
billion dollars to the Fund. Those of us on the Hill who are working
this issue, know that the U .S. policy is to avoid the Global Fund and
go for TRIPS-Plus nations using bilateral agreements.

Unmentioned was the difficult WHO pre-approval process developed by
western regulatory agencies for WHO (the FDA refused to participate).
Not noted was the meeting in December. No mention that over the years
Cipla (and I not know the Ranbaxy numbers) has been supplying Triomune
for 50,000 patients, keeping most of them alive. Cipla provides
Nevirapine without cost to all those who need it.

I don't have to paint a picture for the recipients of this message. We
all can accurately guess what happened behind closed doors.

Even though we were successful in opening up the meeting ...India,
Brazil and Thailand will be invited...and I have been asked to recommend
who might attend (Under separate cover, I will send you the information.
Dr. Nightingale at HHS is arranging). FDA participated in the February
meeting, has been replaced as a sponsor by HHS (What the hell is FDA
doing messing around in politics)?

HOWEVER, WHEN WE GET THERE, WE WILL BE PAWNS ON A CHESSBOARD. NO MATTER
WHAT WE SAY, HOW EFFECTIVELY WE MAKE OUR ARGUMENT ON SCIENCE AND FACT,
IT WILL AMOUNT TO NAUGHT. THE SPONSORS WILL HEAR OUR RECOMMENDATIONS
THEN GO OFF TO A SECRET ONE DAY MEETING AND WITHIN TWO WEEKS MAKE THEIR
RECOMMENDATIONS TO AFRICA NATIONS.

The eye of the dragon is in Secretary Thompson's office where Bill
Steiger is the enforcer. He led the fight within the Global Fund to deny
US monies if the Fund insisted on generic medicines. Some of his power
comes from the rumor that he is Bush One's godson. As you know,
Thompson, ordinarily a decent, compassionate person, now heads the
Global Fund and it is rumored he is leaving the Bush Administration.

In their arrogance, the sponsors must think we were born stupid. We know
even doubt is victory; and there is nothing to stop the US from
insisting on the new approval. All I can say of those MNCs pursuing this
course is that they are greedy, cold blooded bastards. It is difficult
for me to believe that the two major AIDS medicines companies, Merck and
Glaxo are involved, but someone else will have to unravel that puzzle.
As we found out in Geneva in August, 2003, Pfizer makes is power and
presence known and some in this Administration bow in reverence.

For those of us who fought the thirty year generic war in the States,
this is politics disguised as science. What you do, scientifically, if
you feel there is a problem, is to bring in neutral academics (not those
on the Pharma payroll), have them collect and analyze the data, write a
peer-reviewed report and publish.

What can we do? Try to stop the meeting, get WHO to act in the interests
of the poor nations of the world; give this action visibility; this is a
political year and Karl Rove has his ear to the ground. Twice before he
has moved when generic issues became public and the polls reflected
concern. Pharma is not held in high regard anymore in the Congress or in
the States. And the President has committed himself.

I guess we should send credible scientists to the meeting to make a
record. I am going to go, but I doubt I will have a forum (you will see
why when I send you the schedule).

You know this is the first time we have a "body count" of how many
people die from lack of medicines that ...as Clinton said...can convert
a certain death sentence into a chronic illness and we are not using
them." Eight thousand or more die everyday.

You guys remember Barbara Tuchman's book, "The March of Folly" in which
she described institutions in power using that power to shoot themselves
in the foot. If she were still around, what is happening here
...especially with the UN agencies...would make a good chapter.

When we won the generic wars in the States, I was asked what happened in
the thirty-first year that had not happened before?

It was an easy answer: we moved the issue from behind the close
legislative doors of power where money talked to the public that the
legislators needed to get elected."

I will help anyone that wants to join this fight, but I would like the
NGOs to light up the sky together and for the media to spend the time to
understand what is happening. All of us have seen children dying in pain
when they could live and that should be all the incentive we need. But I
am reminded of what a Minister once said to his Sunday congregation: "I
am speaking to the converted."

Thanks for taking the time to listen.

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