[Ip-health] Glassman's faulty critique of the Ranbaxy de-listing and the Vioxx counter-example

[B.Baker@neu.edu]

GLASSMAN'S FAULTY CRITIQUE ON THE RANBAXY DE-LISTING AND THE VIOXX
COUNTER-EXAMPLE

Professor Brook K. Baker, Health GAP
November 15, 2004

Agents of deception and misinformation like James Glassman, posing as
independent researchers at the American Enterprise Institute, are once
again pursuing Big Pharma's beck and call and acting as "smokesmen" for
U.S. AIDS czar, Randall Tobias.  Glassman chortles over the Ranbaxy's
voluntary delisting of its AIDS medicines at the WHO Pre-qualification
Project and argues, without any proof whatsoever, that Indian generic drugs
are now proven to be unsafe and that Doctors Without Borders, the WHO, and
the Clinton Foundation should be sued for medical malpractice.

Glassman argues that use of Indian generics "is almost certainly making
people sicker."  "Generic makers are turning out to be the gang that can't
copy straight."  "Antagonism [toward U.S. research pharmaceutical products]
can kill."  "No one knows how many people have been taking deficient
medicines."  "A poorly made copy of a patented drug may deliver a dose of
medicine so weak that the virus could adapt to it through mutation and
become resistant."*  [*True in part, but erroneous in its implications
concerning Ranbaxy's products.]

Counter to Glassman's diatribe, the facts are relatively simple, but
admittedly disturbing nonetheless.  The WHO beginning in June and again in
August discovered, through its own initiative and review of independent
Contract Research Organizations, that proper record keeping standards and
good clinical practice had not been followed by certain CROs used by Cipla
and Ranbaxy to test the bioequivalence of their ARVs.  Promptly, the WHO
delisted the affected products and ordered the companies to submit new
data.  More recently, Ranbaxy voluntarily delisted its remaining ARVs
because its independent review of CROs confirmed that proper procedures to
establish bioequivalence had not been followed.

These delisting decisions are based on poor record keeping practices and
the absence of scientific verification of bioequivalence.  However, the
delisting did not prove that the medicines were unsafe or that they were
not in fact bioequivalent.  In fact, preexisting clinical evidence
presented by MSF and multiple other researchers has established the
clinical efficacy of the challenged products in resource poor settings:
patient viral loads have declined, T-4 cell counts have risen, and
patients' general well-being has increased.

No one pretends that it wouldn't have been better if Cipla and Ranbaxy had
crossed all their t's and if they had selected their independent research
labs more carefully.  However, both the WHO and the companies themselves
have responded appropriately and promptly to the recently discovered
discrepancies and they have not jumped to the unwarranted conclusion that
the medicines are presumptively unsafe or inefficacious.

It might be both fun and instructive to apply the structure of Glassman's
"analysis" to the now infamous Vioxx market withdrawal.

VIOXX COUNTER-EXAMPLE - PAIN RELIEF POLICY IN SHAMBLES

"The strategy of fighting pain throughout the world with questionable brand
name drugs produced in America now lies in shambles, as a major U.S.
producer, Merck, withdrew its Vioxx medicine three weeks ago because it
can't guarantee that Vioxx won't double or quadruple the risk of heart
attack.

It's now time for the United States and its number-one regulatory angel,
the FDA, to reverse a policy that has not only failed to increase pain
relief, but has only moderately reduced the risk of gastro-intestinal
bleeding at the cost of greatly elevating the risk of heart disease.  In
sum, U.S./FDA policy is almost certainly making people sicker.

The use of inadequately tested, researched-based medicines?which are
original versions of drugs developed and patented by research
pharmaceutical companies in the United State and Europe and then sold at
astronomical prices around the world?has been aggressively promoted by U.S.
agencies like the FDA and the Global AIDS Initiative and by NGOs like the
American Enterprise Institute.

The FDA and pro-PhRMA NGOs have been claiming that researched-based
companies like Merck (and like Pfizer which recently had to blackbox its
antidepressants with warnings about increased suicide risks for children)
can make sophisticated drugs by cobbling together clinical trials designed
to support exaggerated marketing claims.  Instead, the major pharmaceutical
companies have mainly succeeded in delaying investigation into the full
range of dangerous adverse drugs effects?in essence treating drug consumers
as guinea pigs in a cynical pursuit of profit.

The essential reason for the U.S. strategy is profits?profits necessary to
undertake research into the next generation of life-saving medicines.
However, studies by Families USA, Public Citizen, and MSF have established
that few PhRMA drugs are truly innovative, that drug companies neglect
disease indigenous in the Global South, and that drug companies spend far
less on research and development than on profits, executive salaries, and
marketing.

The real reason for the U.S. strategy is vicious political animosity toward
generic drug companies located overseas and toward the NGOs and activists
who promote greater access to affordable medicines for people living with
HIV/AIDS and other pandemic diseases affecting poor people in developing
countries.  Such antagonism can and has killed millions of people priced
out of the drug market by the unconscionable prices and protectionist
policy adopted by major pharmaceutical companies and their proxies in the
U.S. trade representative's office.

The root of the current debate is a simple question:  Do sick people in the
U.S. and elsewhere need to buy more expensive, patented medicines that
produce little or no therapeutic gain and that instead impose unexplored
adverse effects just to affect Big Pharma's profits?  Of course they don't.
But the U.S./FDA and their NGO pals act as if they do.

The WHO has set up a Pre-Qualification Project for AIDS drugs that employs
internationally recognized standards for assessing bioequivalence and for
testing good manufacturing practices at manufacturing sites.  When those
standards have not been met, WHO has not hesitated to refuse registration
and in two recent instances has even delisted previously pre-qualified
products when it double-checked record keeping at independent Contract
Research Organizations.  WHO oversight seems to have paid off more recently
when a major India generic company, Ranbaxy, voluntarily delisted all of
its AIDS medicines only weeks after undertaking its own independent review
of work performed by its CROs.

It would be nice to report that Merck and the FDA acted as promptly in
response to early warning about the heart-related dangers of Vioxx.
However, rather than acting within a matter of weeks like their
counterparts in India and at the WHO, Merck and the FDA suppressed rumors
and delayed studies designed to test the risk of adverse heart effects
nearly 5 years after the first negative effects were reported.  Even when a
major study of heart problems was reported in 2001, Merck and the FDA still
dragged their heels while annual sales rose to $2.5 billion/year, greatly
padding Merck's profit margins in the meantime.

No one knows how many people have been taking deficient, over-priced pain
medicines, though the estimates in the U.S. alone are in the tens of
millions.  Earlier estimates are that nearly 27,000 people suffered
unnecessary heartaches as a result of the unprincipled sale of a truly
defective product.

The danger extends beyond America.  Vioxx has been sold worldwide.  A
poorly tested product delivers me-too pain-killing while it increases
hypertension and clogs cardiac arteries.  A pilot taking Vioxx could have a
heart attack in the middle of a transatlantic flight killing hundreds of
international tourists in the process.

For years, well-respected organizations like the Consumer Project on
Technology and Health GAP have argued that patents kill and Big Pharma's
relentless drive for profits deforms therapeutic innovation and delays
access for monopoly priced medicines.  These defects occur not only with
respect to AIDS medicines, but even for simple pain relief.  Those warnings
are quickly becoming reality.  At the very least, Congress and
international agencies should investigate the U.S. strategy and reconsider
reliance on PhRMA's honesty and regulatory approval at its captive agency,
the Food and Drug Administration.  Stubborn advocates of the current
policy, in the White House, in the PEPFAR program, and in the Department of
Health and Human Services must stop playing deadly profit-driven game with
the world's health."