E-DRUG: Roger Bate's attacks on WHO Prequalification and generic drugs
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[Long posting. This is a follow up to previous postings 20 and 21 October. Moderator]
As evidenced by the story below and his earlier FT article, Roger Bate has
a long history of disparaging WHO prequalification and generic companies.
No one denies that substandard medicines are a problem and that drug
regulators should act promptly to investigate claims of poor quality.
Without prejudging the outcome of the Ranbaxy investigation, it is
important that the claims of cooking the books be investigated thoroughly,
promptly, and fairly.
The problem with Bate's "coverage" is that it is always one-sided and
always pro-Pharma. For example, when does he launch a publicity campaign
when a Pharma product is found to be sub-standard and is recalled as in the
case of Roche's Viracept? Unlike Ranbaxy's ARVs where no actual product
defect has been uncovered, Roche's product contained dangerous levels of a
known impurity, ethyl mesylate, produced during the manufacturing process.
Roche was roundly condemned for providing belated and inadequate
information about the product defect, and Viracept was removed from the
European market until the manufacturing process was rectified. But did
Bates launch an international publicity campaign to warn countries against
buying Big Pharma products because of the actual Viracept product defect?
Nope, not important.
In addition, in the case of the FT article and the one below, Bate tars the
entire generic industry, dragging in all generic manufacturers in India,
Thailand, and China because there have been some cases of
malfeasance, some extremely serious, like the heparin scandal from China,
and others seemingly minor, like poor record keeping at Ranbaxy. But, does
he tar the entire US/EU R&D based industry when major companies are accused
of hiding and distorting clinical trial data (Vioxx) or of promoting
unproven, off-label use or of many of the other known examples of dangerous
marketing? In a word, never.
Bate has been a long term critic of the WHO Prequalification Programme,
suggesting that it engages in regulatory shortcuts and that only the FDA
and other so-called stringent drug regulatory authorities can be relied
upon to certificate the safety, efficacy and quality of medicines. Of
course, we know that the FDA makes some egregious mistakes, but more
importantly the WHO Prequalification Programme uses stringent regulators to
make essentially the same assessments that are made in the U.S. and in
Europe and it now inspects all of the relevant manufacturing facilities.
Of course, Bate know better than anyone else, but no less that the U.S.
Institute of Medicines has recommended that the U.S. PEPFAR program rely on
WHO prequalification rather than enforcing its own duplicative and
time-consuming FDA fast-track approval system.
Let's agree to call a spade a spade, whether generic or Big Pharma. But
let's not, like Roger Bate, resort to scare tactics that seek always to
discourage use of assured quality generics in favor of higher price Pharma
products. I'm sure he doesn't care where his money comes from, but poor
countries and patients with little money to pay for drugs should be
encouraged to access cheaper generic medicines when they have been proven
by a credible source to be therapeutically equivalent and of sound quality.
Professor Brook K. Baker, Health GAP
Northeastern U. School of Law
Program on Human Rights and the Global Economy
400 Huntington Ave.
Boston, MA 02115
617-373-3217 (office)
617-259-0760 (cell)
B.Baker@neu.edu
Continent Consuming Sub-Standard ARVs
New Vision (Kampala)
OPINION
8 October 2008
Posted to the web 9 October 2008
By Roger Bate
Kampala
The US Food and Drug Administration (FDA) has just banned 30 drugs from
India's giant Ranbaxy Laboratories because of quality fears but Ranbaxy
continues to supply the developing world with other drugs that are not
checked for quality.
The US President's Emergency Plan for AIDS Relief (PEPFAR) later suspended
purchases of Ranbaxy drugs too, after buying $9m last year, mainly for
Africa, but this has not been matched by the other agencies and countries
that supply low-quality drugs to poor countries supplied in line with World
Health Organisation recommendations.
Deficiencies in HIV anti-retrovirals (ARVs) or in malaria drugs can
increase patient resistance to drugs and help the disease mutate into new
and virulent forms. Rising resistance in sub-Saharan Africa, Thailand and
Cambodia is a time-bomb that will increase deaths from AIDS and will
multiply the cost of treatment many times over.
The FDA says its action against Ranbaxy Paonto Sahib and Dewas plants is
"preventive." It has known about problems at Ranbaxy plants for several
years but it recommends that consumers continue taking their medications
manufactured by Ranbaxy, so the ban seems to be a punishment for Ranbaxy
refusing to allow an audit rather than any immediate fear about drugs sold
in the US: none of those has failed quality tests.
But back in 2005 a whistleblower from Ranbaxy contacted me with evidence of
safety-data manipulation, including data on HIV drugs for Africa. We
forwarded this to US authorities and the WHO. In June 2006, the FDA warned
Ranbaxy that it would recommend withholding approval of Paonto Sahib
products until deficiencies were corrected. A year later, the company
counsel admitted that it had not yet addressed all of the FDA concerns.
Early this year, the FDA inspected both suspect plants and found serious
violations.
Then in July this year, the US Department of Justice said allegations from
reliable sources and supporting documents indicate a pattern of systemic
fraudulent conduct. It said Ranbaxy uses active pharmaceutical ingredients
(API) from unapproved sources, blends unapproved API with approved API, and
uses less API in its drug than had been approved by the FDA.
But since its investigation began in early 2007, the FDA has approved 18
Ranbaxy drugs for the US, PEPFAR has bought $9m of its HIV drugs (not
certified in the US) and distributed more than 1.8 million packages to 15
countries, mainly in Africa.
Ranbaxy says except for issues that have already been fully aired with the
US government, it knows of no evidence to support the Justice Department
case and no charges have been laid.
The Indian government has called for a swift resolution and the Commerce
Department has hinted it will complain, perhaps through the World Trade
Organisation. But speed is not as important as establishing good precedent.
The FDA is right to insist on upholding standards: badly made life-saving
drugs can create life-threatening resistance.
It throws down the gauntlet to the Global Fund, the European Union, the
Clinton Foundation and all the agencies and countries using the WHO
pre-qualification list of medicines which are approved for developing
countries but which have not passed the tests demanded in rich countries:
the list is designed to encourage local production rather than to save
lives.
These donors and governments know about the FDA allegations against Ranbaxy
and the long-standing deficiencies of other suppliers but have not yet
altered procurement. The WHO did suspend Ranbaxy anti-retrovirals from its
pre-qualification list in 2004 but re-instated them in 2006.
As the contaminated milk horror grows in China, quality control in food and
drug manufacturing in the rapidly-developing world is a matter of life and
death. India already supplies 75% of the world's counterfeit and
sub-standard drugs.
US patients have the FDA, the Justice Department and Congress on their side
but no-one is protecting the interests of the poor in developing countries:
this scandal must be seized by governments, charities and pressure groups
to impose quality control on the WHO pre-qualification list and save
patients in Africa and Asia.
The writer is a resident fellow of the American Enterprise Institute
think-tank.