In their rush to bring Mirapex to market, there is now proof that the Pharmaceutical company witheld information from studies about the compulsive behaivior some patients receive when they released the drug. Not only did they not release the information, even when increasing numbers of people effected by compulsive behaivior reported the symptom, they did little to change their warnings to patients. Found this on a Parkinson forum message today.



BBC News Story - MIrapex Class Action Lawsuit in Britain
Posted by: "torontolou" torontolou@yahoo.com torontolou
Mon Feb 4, 2008 2:32 am (PST)
Follow this link and watch the news report; it is a very
comprehensive report.

http://news.bbc.co.uk/2/hi/programme...ht/7223068.stm

Drug 'led patients to gamble'

By Meirion Jones
BBC Newsnight

Tricia Wragg says her urge to gamble led to debts of £35,000.

Major drug companies are to be sued over claims that they didn't warn
patients quickly enough of the possible bizarre side effects of a
drug for Parkinson's Disease. The law firm Leigh Day alleges that the
drug - Mirapex - can lead to some patients becoming compulsive
gamblers.

Two companies, Boehringer Ingelheim and Pfizer were involved in the
manufacture and distribution of the drug. BBC Newsnight talked to
Mirapex patients and doctors. One man said he lost £1m, while a
female patient said she attempted suicide after facing financial
ruin. Doctors say the compulsion vanished once the medication regime
was changed.

Pfizer said they no longer promote the product and suggested we
contact Boehringer Ingelheim (BI). BI said it was company policy not
to comment on litigation but they said it was, "the first
pharmaceutical company... to add information about reports of
pathological gambling associated with patients", using Mirapex and
other dopamine agonists.

BI added that, "pathological gambling may also be both part of the
disease itself and potentially related to all dopamine agonists," as
well as other treatments for Parkinson's such as levidopa.

Proceedings

A partner at Leigh Day, Bozena Michelowska-Howells, said the writs
would be issued this month. "We are about to issue proceedings on
behalf of complainants who are bringing a claim against the
manufacturers of Mirapex for damages suffered as a result of the
compulsive behaviour brought on by the drug", she said.

"Prior to taking the drug none of them had any record of compulsive
behaviour particularly pathological gambling. They started to develop
a compulsive urge to gamble which was uncontrollable. This urge
effectively led them to financial ruin and in many cases suicide
attempts."

When they stopped taking the drug [patients] gambling habits ceased
Erika Driver Dunckley, Mayo Clinic, Arizona

The Parkinson's Disease Society say that as many as one in seven of
patients on drugs such as Mirapex can be at risk of developing
compulsive behaviour disorders but research is continuing to discover
how widespread the problem is. Mirapex and other similar drugs which
are called dopamine agonists attempt to compensate for the lack of
dopamine in Parkinson's patients which makes them shake
uncontrollably.

They have improved the life of many patients but the legal case is
likely to focus on whether the company should have given earlier
warning of the potential side effects.

Compulsive disorders

Newsnight has learned that from the mid 1990s clinical trials showed
Mirapex patients were reporting compulsive disorders which
investigators thought might be linked to the drug.

In 1996 a Mirapex patient was hospitalised for depression after
developing a gambling addiction. By 2000 scientific papers began
linking gambling problems to Parkinson's drugs and in 2003 the
scientific journal Neurology published a study by researcher Erika
Driver Dunckley which concentrated on Mirapex and suggested gambling
addiction "appeared to begin with an increase in (dopamine agonist)
therapy." The paper continued, "it may be appropriate to inform
subjects of a potential risk of this behaviour".

Tricia Wragg

Erika Driver Dunckley is Assistant Professor at the Mayo Clinic in
Phoenix Arizona which specialises in Parkinson's treatment. She told
Newsnight she was sure the compulsive behaviour was caused by
Mirapex. "When they stopped taking the drug," she told us, "their
gambling habits ceased."

But despite the call for a warning in 2003 it was not until March
2005 that drug company Boehringer Ingelheim put a warning on package
leaflets. It read: "There have been reports of patients treated with
Mirapexin, especially at high doses, showing pathological gambling".

It wasn't till 2006 that the warning was strengthened and placed
higher up the leaflet: "Patients and caregivers should be aware of
the fact that behavioural changes can occur (eg pathological
gambling, increased libido, binge eating.)"

Urge to gamble

Newsnight talked to Tricia Wragg who lives on the edge of the Peak
District and was diagnosed with Parkinson's in her early 40s. When
she went on Mirapex she turned overnight into a reckless gambler. She
says it was, "totally, totally out of character. I knew exactly what
money was worth. I had to work hard for it".

She was given the drug Mirapex to treat the symptoms. But something
began to happen. From the odd game of bingo, she developed an
uncontrollable urge to gamble. "I was using my debit card until there
was no money in the bank to use. I used my daughter's credit card, my
husband's credit card. It made me very devious, I would do anything
to get money off anyone. I would tell lies."

Tricia ran up debts of more than £35,000. When she stopped taking
Mirapex, her urge to gamble vanished.

Meirion Jones produced Liz MacKean's investigation into Mirapex which
will be broadcast on tonight's Newsnight at 22.30 on BBC2.

Story from BBC NEWS:
http://news.bbc.co.uk/go/pr/fr/-/2/h...ht/7223068.stm

Published: 2008/02/01 17:50:21 GMT

So now the patients sue the pharmacy company with lawful reason, those patients who have been helped by Mirapex, will loose one of the few agents to control their symptoms. The pharmacy company will settle for an affordable settlement and spend more money for advertising to get a creditable reputation and all patients will suffer as taxes and the cost of drugs will rise.

No one will take responsibility because the power is distributed as laterally as possible in our oversized political system. Socialized medicine doesn't work as the patients bringing the lawsuit were from a country that practices socialized medicine. Steve, time to take a deep breathe and recite the serenity prayer. Thanks for sharing it. This Alice's head is spinning. Maybe I'll go chase the hedgehog for a while through some hoops.

Peace to you,
Vicky