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How
safe are the drugs we take?
By
Michelle Roberts
BBC News health reporter
Recent
concerns over the safety of painkillers used by millions of
patients call into question whether regulatory checks on the
medicines we take are adequate.
One
of the US Food and Drugs Administration's own scientists,
Dr David Graham, has publicly accused the drug regulator of
profound failure in its role.
Both the FDA and the European Medicines Agency (EMEA) are
reviewing their policies.
"It
is not until drugs go out into the world and they are used
in real patients that they hit larger populations"
--- A spokesman from the EMEA
COX-2 inhibitors are used mainly for arthritis and are designed
to be gentler on the stomach than other non-steroidal painkillers.
The COX-2 story began in September when Merck voluntarily
withdrew its blockbuster drug Vioxx (rofecoxib) from the market
after data showed users had a 50% higher chance of a heart
attack and sudden cardiac death.
Three months later, research showing another COX-2 inhibitor
Celebrex (celecoxib), produced by Pfizer, posed a similar
threat to users led to fears that it might be an effect common
to all drugs in this family.
The safety of other approved drugs also came into question
last year.
There was controversy over the possible increased risk of
suicide in children taking SSRI antidepressants.
The Lancet accused drug companies of failing to publishing
"unfavourable" studies.
Researchers made similar allegations in the Journal of the
American Medical Association related to data on a statin drug
and some 100 deaths.
Stringent enough?
The FDA said it evaluated the safety and effectiveness of
all drugs independently on a case-by-case basis before they
are approved to enter the marketplace.
It also evaluated reported adverse events with all drugs already
on the market to assess whether unforeseen safety concerns
need to be addressed.
Dr Steven Galson, Acting Director, Center for Drug Evaluation
and Research said: "The FDA takes all allegations of safety
risks seriously and will continue its longstanding practice
of assessing the safety of all drugs using only sound science
and peer-reviewed analysis and literature."
In Europe, the European Commission referred the COX-2 issue
to the EMEA and its scientific committee, the Committee on
Medicinal Products for human use (CHMP) for evaluation.
"The
regulatory system regarding the licensing and monitoring
of drugs urgently needs tightening up" ---
Jane Tadman of the Arthritis Research Campaign
US drug safety checks 'slack'
On 21 December the summary data from two clinical trials on
the cardiovascular risk related to celecoxib were provided
to the EMEA.
Based on these summary data the EMEA/CHMP decided to accelerate
its review of COX-2 inhibitors.
Its verdict will influence how drugs are prescribed in the
UK.
A spokesman said: "The drug companies followed all of the
licensing and regulatory requirements.
"It is not until drugs go out into the world and they are
used in real patients that they hit larger populations.
"Sometimes then you may pick up side effects that we hadn't
been able to see during clinical trials.
"We have a system in place to monitor these side effects.
Both the companies and doctors report side effects to the
regulators.
"This allows us to change the indication if need be or in
extreme cases pull the drug off the market."
'Debacle'
Jane Tadman of the Arthritis Research Campaign said: "The
heart and stroke risks associated with Vioxx were known about
for almost five years, and yet none of the drug regulatory
bodies did anything about it.
"The regulatory system regarding the licensing and monitoring
of drugs urgently needs tightening up to prevent this kind
of debacle happening again.
"We'd also like to see pharmaceutical companies acting more
responsibly and to be legally required to make public any
data that is unfavourable to their product, in the interests
of public safety.
"We're glad that the EMEA are speeding up their safety review
of all COX-2 inhibitors, and should be announcing its recommendations
later this month.
"To be fair to the EMEA, it carried out a similar review a
couple of years ago, and as a result the warnings about the
drugs and who should be prescribed them were tightened up,
so that no-one at risk of heart attack or stroke should be
given them."
A spokeswoman from Merck said the drug regulators had been
very rigorous in their conduct and that Merck had shared its
drug safety information at the soonest opportunity and acted
quickly.
Pfizer said: "We have a sophisticated system to ensure that
we fully comply with national reporting standards.
"We review all medicines proactively and take appropriate
action working with regulators if we discover any signals
which may be of concern."
Lessons learned
Some say the FDA needs to change the way it monitors drugs
and decouple the process from the original licensing procedure.
The FDA says its Center for Drug Evaluation and Research is
already an independent office separate from the Office of
New Drugs.
In England, drug regulators will be barred from having any
links to the pharmaceutical industry in the future.
A new commission will be formed to advise ministers on the
safety and effectiveness of medicines combining the responsibilities
of the Medicines Commission and the Committee on the Safety
of Medicine.
The EMEA said new legislation that will come into effect this
November will mean drug companies can be required to provide
longer-term data on the safety of their products post-authorisation.
A spokesman said: "That could help. We are also working towards
a massive electronic database that companies and all the national
authorities can use to input adverse events.
"It will allow us to identify [safety] issues much more easily."
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