Many medical and drug stores including
those operating near Lahore’s hospitals are selling
banned medicines like Vioxx, which was internationally
withdrawn by its manufacturer on September 30 because
it had severe side affects and caused heart disease.
The federal, provincial and local governments
are still hush on the issue and have not taken any measures
to ensure the withdrawal of the banned medicines. Government
drugs inspectors haven’t even bothered to inform
the drug stores properly about the banned medicines. The
stores continue to sell their existing stocks of 45 different
drugs, which were de-listed by the Federal Health Ministry
in the first week of October. These drugs are still available
in pharmacies, most of which were willing to sell Vioxx
to a Daily Times correspondent without
asking for a prescription. At present, pharmacies near
hospitals such as Mayo, Services, Ganga Ram and the drugs
market in Lohari Gate (Walled City) are selling the banned
Vioxx.
Merck and Co, a large multinational, announced
a global withdrawal of Vioxx (generic name: rofecoxib),
its largest selling product, on September 30. The withdrawal
was announced after the company obtained evidence of increased
health risk on the usage of Vioxx, which was
proved to cause cardiovascular problems such as heart
attacks and strokes.The Network, a Pakistani non-government
organisation (NGO) protecting consumer rights, had been
raising concerns about the safety of Vioxx with the Ministry
of Health since 2002, however the government never took
these concerns seriously. After Merck and Co announced
to withdraw
the product; the Federal Ministry of Health banned Vioxx
and 44 other generic equivalents. All the 45 drugs contained
“rofecoxib” as a basic ingredient, the use
or sale of which was a crime punishable under the Drugs
Act of 1976. However, the government never implemented
the ban properly.
All the pharmacies’ salesmen offered
Vioxx to the Daily Times correspondent but when he sought
the drugs expiry date or showed surprise on its availability,
the salesmen referred with the purchaser managers and
then denied the store had the drug. “The company
has
withdrawn this drug,” a salesmen quoted the purchaser
manager as saying, adding, “But we do not know that
it has been banned.”
Even a reputed pharmacy outside Mayo Hospital
offered Vioxx and its substitutes and admitted that they
were still selling it. Asked about the ban on the drug,
a salesman said that he had no knowledge of it. Later,
he asked the purchase manager and confirmed that Vioxx
had been banned. Distributors have started withdrawing
Vioxx from the market, he added. However the stores were
not aware of the ban on the 45 drugs and were openly selling
it to customers.
However, most salesmen and mangers said
that the government was responsible because drug inspectors
had not informed the pharmacies about the ban on these
drugs. “The drug inspectors occasionally come for
‘routine’ surveys,” they said. When
contacted, various doctors confirmed that information
about the ban had not been disseminated effectively and
this had caused problems to many customers and patients.
Federal, provincial and local government authorities were
not available for comment.
Health Ministry sources told Daily Times
that the government would not take action unless the dealers
and stores sold their entire stock of the banned drugs.
Ayyaz Kiani, a representative of The Network,
told Daily Times that the study which led to Vioxx’s
withdrawal included an analysis of a 1.4 million people
database and found that those who took Vioxx were two
times more likely to suffer a heart attack or a cardiac
arrest compared to those who did not take it. Based on
their findings, investigators linked Vioxx to more than
27,000 heart attacks and cardiac arrests in the US from
the time it came on the market in 1999 till 2003. The
report estimated that more than 100,000 people could have
died
worldwide from the consumption of Vioxx.
“The Health Ministry and other departments
have no effective mechanism for monitoring the market
or taking remedial action once an emergency regulatory
measure like this becomes necessary in public interest,”
said the NGO representative. “The provincial government
shall take all such steps as may be necessary to ensure
compliance with the conditions subject to which the drug
is registered and to prevent the manufacture or sale of
a drug; which has not been registered (or); the registration
of which has been cancelled or stands suspended,”
he read clause 7 (12) of the Drugs Act of 1976 as stating.
There is still around one year’s
stock of these drugs in the market and many doctors contacted
were unaware of the product’s withdrawal and said
they were still prescribing it to patients.
The Network and Punjab Lok Sujag has demanded
the companies concerned withdraw these stocks immediately
and destroy them according to the World Health Organisation
(WHO) guidelines. “These drugs have fatal affects
and this liability will lie entirely with manufacturers,
retailers and ministry officials.” He said, adding,
“ The companies should launch a campaign to warn
doctors, pharmacists and the general public of this threat.”
The government must make regulatory authorities more efficient
to pre-empt and counteract such potentially catastrophic
events now and in the future, he demanded.