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Part
2
TGA “Protecting the Health
and Safety of All Australians”
A three Part Feature Article on who was behind the world’s largest
recall.
Filed May 12, 2003 By Eve Hillary
[Part 1]
[Part 3]
Like its US FDA counterpart, the Australian TGA states that it “is obligated to take action where there is concern in relation to the quality, safety and effectiveness of medicines.” The regulator also oversees the safety of food and chemical products as well as consumer items and medicines. The TGA states its role is to “…protect the health and safety of all Australians.” However, an audit of the regulator’s performance reveals an astonishing picture.
TGA Regulating Chemicals
In 1999 a woman lodged a complaint with the TGA about a chemical product that she had used, as
directed on the label. Using this product had caused her to be violently ill and she required hospital treatment. She was pregnant at the time of the toxic exposure. Serious health effects became apparent as a result of the poisoning, affecting both the woman and her child for many years. Both were subsequently diagnosed with chemical poisoning by two Australian doctors and one U.S. specialist physician. She reported this to the then director of the Chemicals and Non-prescription Medicines Branch of the TGA, Mr. Graham
Peachey. The director replied to her complaint, claiming that all chemicals are rigorously tested and regulated by Australian government departments. He maintained that her claim that this chemical product had caused serious illness was a result of “a strong interaction with personal belief factors”. By this, he dismissed her complaint, alleging that she was imagining the (medically diagnosed) serious effects the chemical exposure had on herself and her child. The woman wrote back enquiring as to what kind of testing is done by the regulators on toxic chemicals that are manufactured by large multi-national companies and that stream directly onto the Australian market. She received no reply. She later found out that no independent testing of any kind is done on these products before they reach the consumer. Meanwhile she encountered others who’d had similar experiences with the same chemical and other toxic consumer products. She discovered that they too had written letters of complaint to the TGA, and they had received the same response. She joined a support group for chemically injured persons, and became the group’s newsletter editor. Soon she was inundated with letters from persons who related the identical or similar responses from the TGA after they had lodged complaints to the regulator about harmful effects from toxic chemicals in consumer products. Intrigued, she investigated these allegations and found that the TGA had dismissed all of them. None of these dozens (and possibly thousands) of complaints alleging serious and sometimes life threatening effects on consumers by various chemical products were ever investigated by the TGA. The multi-national chemical manufacturers were never held accountable and the TGA never co-operated with calls to start an adverse events register for chemical products despite years of lobbying by individuals, advocates and support groups.
Like its U.S. FDA counterpart,
the TGA regulates and approves drugs. Ten years ago in 1994 there
were 157.5 million prescriptions issued annually. That figure has
now increased exponentially as hundreds of new drugs have come on
line. It would be reasonable to assume that a large part of the huge
modern TGA building in Canberra would be devoted to ensuring public
safety through monitoring of potent pharmaceutical drugs. However
more oversight committees and manpower is devoted to herbs and
vitamins. Why? A quick overview of just one drug regulating example
will yield some disturbing answers and raise even more
questions.
In the mid 1980’s GlaxoSmithKline marketed buproprion as an
antidepressant, released under the brand name of Wellbutrin and
later Zyban. In 1986 bupropion was briefly withdrawn due to the high
rate of convulsions associated with its use, and later inexplicably
returned to the marketplace. By 2002 bupropion was recognised as the
third most common cause of drug related seizures with cocaine found
to be the number one cause (2). Buproprion is often placed in the
same category as Prozac type drugs, but its exact mode of action
remains unclear after many years of study. Since 1998, statistics
indicated some serious adverse effects were occurring among patients
taking the drug. Complaints were flowing in to Health Canada, to the
UK regulator and to the manufacturer, GlaxoSmithKline. The company
had received 1127 adverse reports about the drug from Canada alone
between May 1998 and May 28, 2001. This included 19 deaths.
Meanwhile the Medicines Control Agency, UK’s version of the FDA/TGA,
reported 3,457 adverse reaction reports to the drug including 18
deaths. Since then there have been 7,500 adverse reactions and 58
deaths in the UK up to April 2002.
In 2000, GlaxoSmithKline lodged an application to the TGA to approve
bupropion, to be marketed in its new guise, not as an
antidepressant, but as an anti smoking drug called Zyban. By then
the drug had collected a number of skeletons in its closet. The drug
had enjoyed another life as a weight loss pill, and was written up
in an Obesity Journal as being a fat buster, since loss of appetite
had been determined in 3% of the side effects reported while in use
as an antidepressant. However, the “research” was far from
ethical, as it was commissioned and paid for by the drug’s
manufacturer. (3,4) Shortly after the pharmaceutical giant lodged
its drug application to the TGA in Canberra the regulator commenced
its stringent “pre-market evaluation” of bupropion, now known as
Zyban. The registration process involved an in depth assessment of
the drug, its efficacy, and safety. The regulator was required to
review the adverse effects including convulsions and death
associated with the drug’s use overseas, figures that were by then
readily available. While the TGA was still busy “protecting the
health and safety of all Australians” with its rigorous safety
assessment of the drug, the global death toll was still escalating.
By mid 2002 the manufacturer had already received reports of 245
deaths associated with the use of this drug. (5)
After the TGA experts finished their stringent review of bupropion,
now marketed Zyban, the drug enjoyed the approval of the Australian
regulator. It was introduced into Australia late in 2000, and
extensively promoted to doctors as an anti smoking drug (1).
The Australian Zyban experience proved to be tragically identical to
the reported overseas experience. Not long after TGA approved its
use in Australia serious reports of adverse reactions started to
pour into the TGA’s adverse drug reactions advisory committee
ADRAC. Since Zyban’s approval, 1237 reports of adverse reactions
linked to Zyban, have been reported to the TGA, including: 74
episodes of convulsions/twitching, psychiatric effects such as
depression and anxiety, serious skin rashes including a serum
sickness type syndrome, impotence, chest pain. And 18 Australians
died. (1)
When complaints came into the adverse drug advisory committee about
Pan’s Travacalm after persons experienced sedative and other side
effects from the product, the TGA perhaps understandably applied a
class 1 recall, even though there were no irreversible effects or
deaths. (Class 2 recall is in case of adverse events that are
reversible or mild, and class 3 recalls are reserved when no serious
adverse events are expected to occur) Oddly the vitamins included in
this recent haul attracted a Class 1 recall when no effects at all
had been reported.
However, despite the high numbers of adverse events and deaths, the
TGA has no serious concerns about the safety of Zyban. To protect
the health and safety of all Australians the regulator will review
“each report with a fatal outcome” through its ADRAC (adverse
drug reactions advisory committee), which meets every six to seven
weeks and “is keeping the drug’s safety under close review.”
The committee’s experts are not certain as to whether the deaths
and serious side effects are caused by the drug or are “coincidental.”
(1)
While the TGA is still “reviewing” and “monitoring” the
ever-increasing death toll linked to an apparently dangerous drug,
it has acted immediately to affect a class 1 recall of a calcium
supplement, which it recalls “Due to serious concerns”. Calcium
is a naturally occurring mineral that is required for good health on
a daily basis, and no one has ever died from it. Closely followed by
a class 1 recall of 1369 other natural supplements.
The regulator has no plans to withdraw Zyban from the Australian
market. It is not the only dangerous drug widely prescribed and
approved by the TGA. 10,000 fatal events occur annually in
Australia, attributed to medical procedures and drug associated
deaths. Most of these deaths could have been avoided if the
regulator recalled the drugs that caused deaths and left the
vitamins and nutrients essential to life available to the public.
The disturbing questions raised by this paradox must now be
answered.
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