n a rare move, a trade group representing British
pharmaceutical companies has publicly reprimanded Pfizer (news/quote),
saying it promoted several medicines for unapproved uses and
marketed another drug before it received government approval.
The managing board of the group, the Association of the British
Pharmaceutical Industry, ruled in February that Pfizer had breached
the industry's code of conduct and discredited the industry by using
a team of employees known as medical liaisons to promote its
products to doctors improperly. The board's action was reported last
week by The British Medical Journal.
The case bears similarities to federal investigations in Boston
involving Pfizer. Dr. David P. Franklin, a former employee of
Warner-Lambert, a company acquired by Pfizer in 2000, has asserted
that the company aggressively promoted Neurontin, an epilepsy drug,
for more than a dozen medical conditions where the drug's use had
not been approved.
Mariann Caprino, a spokeswoman for Pfizer, said in an interview
that the company did not think the medical liaisons in Britain had
inappropriate discussions with doctors. Instead, she said, the
company failed to maintain the proper documentation to prove it was
following the British rules.
The British group's board took the action after reviewing
internal documents provided to it in an anonymous complaint by
individuals who said they were employees of Pfizer. The complaint
said Pfizer employees had promoted ziprasidone, an antipsychotic
medicine, before it was approved by the British government.
Ziprasidone was approved last year in the United States and is sold
under the brand name Geodon.
The complaint also said the company's medical liaisons had urged
doctors to prescribe products likeNeurontin, Viagra, Lipitor and
Istin, a heart drug known as Norvasc in the United States, for
unapproved uses.
Similar to rules in the United States, drug companies in Britain
can promote medications only for uses that have been approved by the
government after appropriate scientific studies.
Doctors are allowed to ask medical liaisons, drug company
employees who often have more extensive medical training than sales
representatives, for information on unapproved drugs and unapproved
uses of licensed medicines, but the company's employees cannot
actively promote drugs for unapproved uses or give the information
to doctors if they do not ask for it first.
Documents supplied by the British board describing the complaint
it received said Pfizer's medical liaisons had been trained, for
example, to give presentations to groups of doctors on Geodon, even
if only one doctor in the group had requested information on the
drug.
The British association's board said that it had performed an
audit of Pfizer's practices involving the medical liaisons and that
the company had agreed to carry out all its recommendations, which
it did not describe.
Pfizer told the board that Warner-Lambert had begun using the
medical liaisons in Britain in 1998 and that they became part of its
own marketing team after the merger.
Dr. Franklin has said that Warner-Lambert began aggressively
marketing Neurontin in the United States for unapproved uses ranging
from pain to attention deficit disorder in the mid-90's. Most
Neurontin prescriptions are now written for such uses. Dr.
Franklin's accusations are the subject of criminal and civil
investigations by the United States attorney's office in Boston.
Pfizer has said there is no credible evidence that
Warner-Lambert's employees made false claims about
Neurontin.
