[Ip-health] Interpol Seizes > 16m Counterfeit HIV, M, TB Rx

[Jay Purcell]

--
[ Picked text/plain from multipart/alternative ]
This is troubling, especially following FDA's pulling several Ranaxby from
PEPFAR, and US shelves, drugs earlier this year.
There is a positive way to spin this, however - it highlights the demand for
essential rx, and shows what happens when supply-side constraints (licenses,
patents) prevent adequate quantities of a therapy from reaching patients.


   *Interpol Seizes $6.65M in Counterfeit HIV/AIDS, Malaria, TB Drugs in
   Southeast Asia*
   [Nov 17, 2008]

      The International Criminal Police
Organization<http://www.interpol.int/> recently
confiscated $6.65 million worth of counterfeit HIV/AIDS, malaria and
tuberculosis drugs in Southeast Asia and made 27 arrests as part of a
five-month investigation involving nearly 200 raids, Aline Plancon, an
officer involved in the operation, said on Monday,
Bloomberg<http://www.bloomberg.com/apps/news?pid=20601080&sid=ajuZjQ3DmPwU&refer=asia>
 reports. During the investigation, called Operation Storm, authorities
seized more than 16 million pills between April 15 and Sept. 15 in Cambodia,
China, Laos, Myanmar, Singapore, Thailand and Vietnam. The operation was a
joint effort between Interpol, the World Health
Organization<http://www.who.int/en/> and
the World Customs Organization <http://www.wcoomd.org/>. It was the first
time customs officials, drug regulators, health authorities and police from
different countries have collaborated to prevent the distribution of
counterfeit medicines, Plancon said.

According to Bloomberg, health officials particularly are concerned about
fake artemisinin-based combination therapies used to treat malaria.
According to a recent study, counterfeit ACTs containing insufficient
amounts of artemisinin are contributing to the development of drug-resistant
parasites near the border of Cambodia and Thailand. The rise in drug
resistance has reduced the effectiveness of genuine ACTs, thus placing more
people at risk for developing drug-resistant malaria, Bloomberg reports.

According to WHO and the Center for Medicine in the Public
Interest<http://www.cmpi.org/>,
worldwide sales of counterfeit drugs could reach $75 billion by 2010, an
increase of more than 90% since 2005. An Organization for Economic
Cooperation and Development <http://www.oecd.org/home/> report released last
year identified Asia as the largest producer of counterfeit products
worldwide. Of the 1,047 arrests made in 2007 related to counterfeit
medicine, about 40% took place in Asia, the Pharmaceutical Security
Institute <http://www.psi-inc.org/index.cfm> reports (Bennett, Bloomberg,
11/17).

*Related Opinion Piece *
The seizure by Belgian authorities in September of more than two million
fake malaria drugs and painkillers manufactured in India for African
distribution "shines a light on one of the most pressing problems in
delivering life-saving medicines to the world's poorest patients: the
proliferation of low-quality and counterfeit products," Roger Bate, a
director of Africa Fighting Malaria <http://www.fightingmalaria.org/> and
fellow at the American Enterprise Institute <http://www.aei.org/>, writes in
a New York Times
<http://www.nytimes.com/2008/11/15/opinion/15bate.html> opinion
piece. He adds, "If aid organizations are serious about combating the spread
of deadly diseases in the developing world, they must do more to ensure the
safety and quality of drugs."

Although WHO reports that about 30% of the world's population lacks
essential medicines, "this problem cannot be solved by supplying bogus
medicines," Bate writes. According to Bate, insufficient access to drugs has
led many governments in developing countries to allow local drug makers to
produce cheaper medicines. However, "local producers often make low-quality
drugs," he writes, adding that this should be "no surprise" because "[e]ven
countries with stringent regulatory systems sometimes turn up bad
pharmaceuticals." According to Bate, many developing countries "lack the
regulatory structure needed to monitor safety and effectiveness," do not
have "laws against selling sub-standard drugs" and lack "sophisticated
agencies like the FDA <http://www.fda.gov/> with the trained inspectors and
laboratories needed to analyze pharmaceuticals."

According to Bate, it is "essential" for these countries to enact
regulations, establish monitoring agencies and build scientific capacity to
oversee drug manufacturing and inspect imported and local drugs. Bate also
identifies three ways that international aid organizations can help ensure
drug quality: providing financial and technical support; refusing to
subsidize low-quality drugs; and insisting that only medicines approved by
"stringent drug agencies like the FDA" be distributed. Bates writes, "If aid
organizations are serious about combating the spread of deadly diseases in
the developing world, they must do more to ensure the safety and quality of
drugs." He concludes, "Thousands of lives depend on their efforts" (Bate, New
York Times, 11/15).

November 15, 2008
OP-ED CONTRIBUTOR
The Wrong Message in a BottleBy ROGER BATE

Washington

IN late September, the authorities in Belgium seized more than two million
counterfeit painkillers and antimalarial drugs that had been manufactured in
India and were en route to Africa. It was the largest seizure ever of fake
pharmaceuticals in Europe.

The incident shines a light on one of the most pressing problems in
delivering life-saving medicines to the world's poorest patients: the
proliferation of low-quality and counterfeit products, many of which are
dangerous. If aid organizations are serious about combating the spread of
deadly diseases in the developing world, they must do more to ensure the
safety and quality of drugs.

Thirty percent of the world's population lacks access to essential
medicines, according to the World Health Organization. In some Asian and
African countries, the number is as high as 50 percent. And this problem
cannot by solved by supplying bogus medicines.

"Better to have lack of access," Dora Akunyili, the head of Nigeria's drug
watchdog agency told me, "than access to counterfeits and substandard
medicines." In 1988, Ms. Akunyili's sister died from taking fake insulin to
treat her diabetes.

Imports of bad medicines like those seized in Belgium are only part of the
problem. To deal with the scarcity of drugs, many poor governments have
turned to local production. The international aid community has generally
approved this move, because local manufacturing expands the supply, cuts
down on transportation costs and creates jobs. But local producers often
make low-quality drugs.

In Senegal, a 2002 study found that 21 out of 22 samples of the antibiotic
ampicillin (of unknown origin) lacked the active ingredient and appeared to
contain only flour. Thirty-eight percent to 52 percent of artesunate pills
(an antimalarial drug) in Southeast Asia have been found to contain no
active ingredient. The W.H.O. estimates that 20 percent of the Indian drug
supply is either fake or adulterated. And one of my own studies found that
35 percent of malaria drugs in Africa are substandard.

That such a large share of the developing world's drug supply is subpar
should come as no surprise. Even countries with stringent regulatory systems
sometimes turn up bad pharmaceuticals.

Just this year, at least 95 Americans died after taking heparin (a blood
thinner) manufactured in China that had been contaminated with oversulfated
chondroitin sulfate, an inexpensive substance that mimics heparin in basic
chemical tests. And in September, the F.D.A. blocked the import of more than
30 drugs made by the Indian company Ranbaxy, citing its failure to meet
acceptable manufacturing standards.

The W.H.O. keeps a list of essential drugs, and its Drug Prequalification
Program does its best to keep a separate list of safe suppliers of these
drugs, which aid organizations refer to when buying medicines for developing
countries. But this list is both short and unreliable; in 2004, several
H.I.V. drugs produced by Indian drug companies were taken off the list
because of insufficient evidence that they were effective.

Many poor countries now allow local drug makers to produce cheaper copies of
patented drugs through what are called "compulsory licenses." But this
strategy has led to the manufacture of poor-quality medicine. Thailand has
issued many compulsory licenses to enable a state-financed company, the
Government Pharmaceutical Organization, to make various patented medicines,
including antiviral drugs used to treat AIDS. But the drugs it has made have
been of such poor quality that the Global Fund to Fight AIDS, Tuberculosis
and Malaria stopped buying them.

Many poor countries lack the regulatory structure needed to monitor safety
and effectiveness. Some do not even have laws against selling substandard
drugs, and none have sophisticated agencies like the F.D.A. with the trained
inspectors and laboratories needed to analyze pharmaceuticals. It is
essential that poor countries establish the laws, agencies and scientific
capacity they need to oversee drug manufacturing and conduct random checks
on imports and local drugs.

There are three things that aid organizations could do to help: They should
give technical and financial support to governments' sincere efforts to
maintain strict drug inspection standards. They should always refuse to
subsidize any low-quality drugs. And in countries that consistently fail to
ensure that locally produced pharmaceuticals are safe and effective, aid
agencies should insist that only brand-name and generic products approved by
stringent drug agencies like the F.D.A. be distributed.

Since taking over drug quality control in Nigeria seven years ago, Dora
Akunyili has reduced the amount of substandard pharmaceuticals to 16
percent, from more than half. And if Nigeria can improve drug quality so
drastically, other countries can, too. Thousands of lives depend on their
efforts.

Roger Bate, a director of the health advocacy group Africa Fighting Malaria,
is the author of "Making a Killing: The Deadly Implications of the
Counterfeit Drug Trade." He is also a resident fellow at the American
Enterprise Institute, which receives some support from pharmaceutical
companies.
--
____________________________________________________________________
j. purcell // purcell@berkeley.edu // uc berkeley law school  //
us#607.26.26.26.7





--
____________________________________________________________________
j. purcell // purcell@berkeley.edu // uc berkeley law school  //
us#607.26.26.26.7