Page 5 - Pharma eZine 140828

“

The need to be

properly informed

and to demand

y from transparenc

these companies is
”

essenial, now more

than ever.

Only allowed in the US and New Zealand, direct-

to-consumer adverising is widely considered to
be a controversial pracice - the World Health

Organisaion claims it further encourages the of-

label uses of drugs. According to Ken Johnson, m
Senior Vice President of Industry trade group co
ess.
Pharmaceuical Research and Manufacturers of xpr
America, direct-to-consumer adverising informs oto
ph
paients potenially sufering from disease and
raises their awareness of treatment opions.

It is vital that we ensure that our people and While it’s legally required to clearly list the side-
those who work on our behalf, understand their efects of all medicaions, they are oten downplayed However criics claim this approach is more about

responsibiliies and operate to the highest ethical through slick adverising tacics, or outright shaping consumer choices to the pharmaceuical
standards.”
covered up, while the beneits are highlighted and companies’ advantage as paients will oten

exaggerated.
ask about speciic medicaions by name. The

GSK has also said it would publish all clinical studies adverisements encourage consumers to ‘ask
of its medicines and launch an online system so that The Financial Times reported that Takeda and Eli Lilly their doctor if x is right for them,’ which usually

independent researchers could get anonymous hid evidence that their Actos diabetes drug could results in the doctor prescribing that paricular
data from drug trials. The misrepresentaion of expose paients to a greater risk of bladder cancer. drug - and oten not for the symptoms the FDA has

data from such trials is another serious problem, The two companies had to pay USD 9 billion puniive approved it for. A study conducted by researchers
and oten goes hand in hand with bribery issues.
damages ater a US federal jury found them guilty.2
at Harvard University and Massachusets Insitute

of Technology showed that companies gained an
Japan’s Health Ministry has iled a criminal Meanwhile, J&J’s Janssen Pharmaceuicals Unit increase of USD 4.20 in drug sales for every dollar

complaint with the Tokyo public prosecutor’s was accused of the of-label promoion - that is, spent on direct-to-consumer adverising in the US. 4
oice against Novaris Pharmaceuical Company uses not approved by the FDA, of its ani-psychoic

for using falsiied research to adverise Diovan. drug Risperdal and ofering incenives to sales The medicalizaion of condiions including PMS,

The request for a criminal invesigaion was made representaives to do so. While the company was shyness, and insomnia - condiions which arguably
shortly ater the New York atorney general iled allegedly aware of the increased risk of diabetes may beneit from medical treatment in extreme

suit against the company’s US unit over an alleged faced by users of the drug, it promoted it as safe.
cases, have also come to be seen, thanks to the
kickback scheme related to Exjade in China and percepion presented by the pharmaceuical

the US. Novaris allegedly bribed the pharmacy Another J&J subsidiary, Scios, also allegedly industry, as condiions that should commonly
BioScrip to promote the iron-reducing drug, while marketed Natrecor for of-label uses. The company be treated medically. The outcome is of course,

failing to warn paients about the drug’s potenially has since agreed to pay a USD 2.2 million setlement again, bigger proits for these corporaions.5
fatal side efects.
for this along with bribery charges in other countries.

Astellas Pharma US also had to pay USD 7.3 million As pharmaceuical companies keep their eye on the
Pharma companies are also facing increasing to resolve false claims act allegaions that the money, so too must consumers keep an even closer

criicism from the FDA and other organizaions company knowingly marketed and promoted the eye on their own health. The need to be properly

for markeing their drugs in a misleading manner. sale of Mycamine for children, for which it was not informed and to demand transparency from these
The agency says some companies are atemping approved.3
companies is essenial, now more than ever.

to dodge the transparency requirements for side-
efects that could cause serious health problems
2 htp://www.t.com/intl
4 htp://connecion.ebscohost.com
and even fataliies.
3 htp://www.jusice.gov/opa
5 htp://news.harvard.edu

ISSUE 6 Pharmaceuicals l 5