E-drug: off-label use of mussels and free speech
------------------------------------------------
Sorry for the length of this entry but I think it is an interesting slant on
the off-label use of medicines and free speech. It begins with the Ministry
statement then reads backwards over the media hype on the product. As a
regulator we are of course now being castigated for denying access to an
"effective" cancer treatment.
Stewart Jessamine
MEDSAFE
Media hype no cure for cancer
The New Zealand distributor of a green-lipped mussel extract being touted as a
possible cancer cure has halted distribution after recognising that claims made
in promotional material far outstrip any evidence from research and are in
breach of the Medicines Act.
Ministry of Health spokesman Dr Stewart Jessamine said Pacific Pharmaceuticals
voluntarily stopped distribution after the Ministry's therapeutic unit,
Medsafe, pointed out that Lyprinol was not registered as a medicine.
"Basically anything which claims to cure a disease or condition, or to improve
it, is defined as a medicine," Dr Jessamine said. "But medicines have to be
quite rigorously assessed before they are licensed for distribution. That
assessment typically includes evidence from clinical trials involving at least
1000 people. To suggest, therefore, that Lyprinol is curative when we know the
Australians are only just embarking on a clinical trial of 100 people is clearly
in breach of the Medicines Act."
No application to register Lyprinol as a medicine has even been received, Dr
Jessamine said.
Pacific Pharmaceuticals had not initiated the publicity. The Ministry of Health
was still clarifying who had done so, posting material on the Internet and
alerting some media, and would then decide what action to take.
"We don't have all the information yet. But at this stage it appears commercial
interests have used media releases to drum up demand for a quite unproven
"cancer cure".
"While some agencies may believe that this is an acceptable way to operate we
would like to disabuse them of that notion. The Medicines Act makes it very
clear what the rules are both for licensing and for advertising."
"We would also like to caution people with cancer and their families against
such cynical marketing ploys," Dr Jessamine said.
"While we would all like to think that there was a prospect of a cure for people
with cancer sadly that is not the case," he said.
---
Wellington, Aug 2, NZPA - Shoppers snatched up green-lipped
mussels at supermarkets over the weekend despite warnings that the
shellfish may not work against cancer.
The mussel bin at New World Wellington City was empty today after
sales almost doubled on Saturday from 80kg to 140kg and other
supermarkets also reported increased sales.
People bought the mussels after hearing that Australian
researchers had discovered that lyprinol oil, found in the mussels,
could help cure cancer.
Queen Elizabeth Hospital researchers in Adelaide believe that the
oil inhibits two cell pathways which can spread cancer.
The researchers made the discovery while examining lyprinol's
effect on asthma and arthritis.
But Cancer Society medical director Peter Dady said today the
researchers had not yet tested the lyprinol extract on humans and
there was only a very small chance it would cure cancer.
Dr Dady, an oncologist at Wellington Hospital, described the
public and media reaction to the find as a frenzy.
``They've made an observation in the laboratory and that's right
to follow it up.... However, there are literally hundreds of
substances in laboratories that look as though they may be useful
cancer treatments but when they try them on humans they find, for
various reasons, they don't work.''
Dr Dady said publicity about the discovery was irresponsible
because it gave people hope when the product had not been tested.
``There has to be a reality check here -- I bet the first dozen
or so patients I see today say `What about those green-lipped
mussels, doc?'.''
Many supermarkets planned to increase orders this week, despite
news that only a tiny amount of lyprinol is in the mussels and that
the product probably only works when it has been processed.
Foodtown Lower Hutt seafood manager David Hicks said sales had
almost doubled.
``The machine was almost empty yesterday. We sold at least 20
kilos more than we normally would.''
Sales increased by about 25 percent at Big Fresh Johnsonville and
Woolworths Kilbirnie also reported significantly higher sales.
Marine Industry Association executive director Graeme Coates said
Marlborough mussel farmers were cautiously optimistic about the
discovery.
About 60,000 of the 75,000 tonnes of green-lipped mussels grown
in New Zealand are farmed in Marlborough.
Mr Coates said even if the research proved effective on humans,
it took at least a year for mussels to mature.
Fishing company Sanford, which has extensive mussel farming
assets, zoomed up 62c on the sharemarket this morning to 560 after
publicity about Lyprinol.
According to its Australian manufacturers, Lyprinol goes on sale
as a dietary supplement in New Zealand this week at $1 a tablet.
Cancer Society chief executive officer Jo Bransgrove was cynical
about the announcement of the cancer claim immediately before
Lyprinol's launch onto the New Zealand market.
``It has all the appearance of a pre-planned marketing
strategy,'' she said.
The manufacturers have said they need 25,000 tonnes of mussel
meat. Marlborough and Golden Bay's current output is 65,000 tonnes.
However, Mr Coates didn't expect the arrival of Lyprinol in shops
to affect mussel production.
``We can't just suddenly increase production -- it's not like
baked beans,'' he said.
Mussel farms looking to expand were subject to the resource
consents process.
Marlborough mayor Gerald Hope said the same process that had
always been in place for mussel farm applications would continue. He
said sustainability of the resource was the key.
``It's no different to stock numbers on pastoral farms -- there
is only a certain amount of feed available -- we have to acknowledge
that natural balance.''
Mr Hope said it was unwise for people to try and jump on the
mussel bandwagon.
``We have an established mussel industry that is 30 years old, we
have an innovative bunch of good operators and they're best left to
get on with the industry they know inside out,'' he said.
Meanwhile, the Nelson-based plant Maclab, which processes mussels
for its Australian counterpart, was this morning ``flat out''
fielding phone calls about the product.
The receptionist said she was referring all calls through to the
Australian office.
Health 2000, New Zealand's largest health product chain, today
urged caution over the supplement.
``We've got desperate people wanting to get hold of this product.
You're going to get all sorts of charlatans coming up with
alternatives. We've just got to be very careful,'' said marketing
director Tom Bleier.
He has told Health 2000 store owners to be responsible and
cautious about the product.
Arthritis Foundation public affairs and education manager Carol
Culling today said the effects of lyprinol on arthritis differed
from person to person.
``There hasn't been a giant breakthrough at all for people using
lyprinol. It's not as highly used as other alternative medicines,''
she said.
NEWSREADER:
IT HAS BEEN REVEALED THAT PHARMACISTS WERE ADVISED ON HOW TO
ORDER STOCKS OF LYPRINOL ON THE SAME NIGHT PUBLICITY WAS GIVEN TO CLAIMS
THAT THE GREEN-LIPPED MUSSEL EXTRACT KILLED CANCER CELLS IN LABORATORY
TESTS. CHEMISTS AROUND THE COUNTRY SAY THEY RECEIVED FAXES ON FRIDAY NIGHT
FROM THE NEW ZEALAND DISTRIBUTOR OF THE PRODUCT.
--
Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'.
Mail administrative requests to `majordomo@usa.healthnet.org'.
For additional assistance, send mail to: `owner-e-drug@usa.healthnet.org'.