pharmaceutical law suits - patients be aware...
 

Paxil suit settles for $63.8 million

GlaxoSmithKline denies liability in claims that company withheld information about medication’s safety, effectiveness -

11/2/06
In October 2006, pharmaceutical company GlaxoSmithKline agreed to pay $63.8 million to settle a lawsuit in which plaintiffs claimed the company promoted its antidepressant drug Paxil for children and adolescents but failed to provide negative information about the product’s safety and effectiveness.

Plaintiffs included US residents who bought Paxil and Paxil CR for their children and are eligible to receive full refunds if they have records of their purchases. Consumers without documentation may receive a return of $15.

The company denied the lawsuit’s claims, including that consumers paid too much for the drug, but said it settled because it wanted to resolve the matter to avoid further court costs.

Payments to consumers in this case will depend upon the number of claims. If claims exceed the settlement amount, consumers will receive a portion of their refund amount.

Source: "Glaxo settles Paxil suit for $63.8 million," Philadelphia Inquirer, November 2, 2006.
Paxil
The FDA has been investigating the potential harmful side effects the drug Paxil causes its users since June of 2003. There are reports that the drug has caused an increased risk of violent behavior, suicidal thinking, and suicide attempts, especially in adolescents. The FDA currently recommends that …

Effexor linked to overdose a letter from Wyeth -
 

Effexor linked to overdoses

Doctors urged to take precautions in prescribing antidepressant Effexor due to overdoses - 10/25/06

On October 17, 2006 pharmaceutical maker Wyeth sent doctors a letter about label changes regarding fatal overdoses for its antidepressant drug Effexor. The letter urged doctors to take precaution in prescribing Effexor to patients, recommending prescribing the drug in "the smallest quantity of the drug consistent with good patient management, in order to reduce the risk of overdose."

Deaths and serious injuries have been reported in patients who overdosed on the drug; the majority of overdose cases involved alcohol and/or other drugs.

The label changes apply to Effexor and Effexor’s extended-release version, Effexor XR. Overdosing on any antidepressant may be fatal. The changed labels refer to studies that show the drug’s risk of fatal overdoses may be higher than another class of antidepressant drugs, known as selective serotonin uptake inhibitors (SSRIs). The label also says that the fatal-overdose risk is lower than that of older depression drugs called tricyclic antidepressants.

Wyeth’s letter said reported Effexor overdose effects include:

Death
Slow heart rhythms
Toxic buildup of chemicals from dying muscle cells
Serious liver injury leading to liver cell death
Changes in consciousness (ranging from sleepiness to coma)
Seizures
Vomiting
Effexor works by maximizing the present of two brain-messenger chemicals, serotonin, which is believed to help regulate mood, and norepinephrine, which is a stress hormone. The SSRI drugs only maximize the present of serotonin.

Sources: Miranda Hitti, "New warning on Effexor overdoses," WebMD Medical News, October 25, 2006; "Effexor overdoses reported to FDA, Wyeth," Reuters, October 25, 2006; "Precautions urged against Effexor overdose," WashingtonPost.com, October 25, 2006.

Mirapex -Mayo Clinic study reveals about drugs for PD
 

Mirapex linked to compulsive behavior

Mayo Clinic study: Mirapex and other drugs for Parkinson’s disease can induce compulsive behavior in rare cases - 7/12/05

Researchers at the Mayo Clinic in Rochester, NY, have found a link between drugs used to treat symptoms of Parkinson’s disease and compulsive gambling, eating, drinking and sexual activity in patients with the disease. In a study published online Monday by the Archives of Neurology, researchers said that between 2002 and 2004 they identified 11 Parkinson’s patients at the clinic who reported sudden, inexplicable changes in personality and behavior after starting drug therapy. Since then they have identified an additional 14 patients who were not included in the original study.

Most often the behavior started within months of taking the drug Mirapex, the most commonly prescribed drug for Parkinson’s. Other drugs linked to the behavior include Requip and Permax. Parkinson’s in a slow, degenerative nervous system disorder caused when people do not make enough dopamine, a messenger chemical that carries information through the area of the brain that controls movement. Many Parkinson’s drugs are dopamine agonists, compounds that mimic the behavior of dopamine in the brain in order to control symptoms. Dopamine plays a key role in the pleasure and reward area of the brain. When it goes awry, people can develop serious addictions.

Compulsive behavior has been seen to stop once the drug is discontinued for a length of time. In one case, a 52-year old man began gambling daily, gained 50 pounds from compulsive eating, and engaged in numerous extramarital affairs. Paul Sanberg, distinguished professor of neurosurgery and director of the University of South Florida Center for Aging and Brain repair, said that the fact that patients were able to reduce the behavior by stopping drug therapy "implies that it was the drug" that caused the compulsive behavior.

Mirapex is manufactured by Boehringer-Ingelheim Pharmaceuticals, Inc., and was approved for sale in the U.S. in 1997. A class-action suit was filed against the company last year because of its link to compulsive behavior in patients. The company insists there is no scientific evidence that Mirapex causes compulsive behavior, but it has revised patient insert literature to include compulsive behavior among the drug’s potential side effects.

Source: Josephine Marcotty, "Parkinson’s drugs linked to gambling, other compulsions," Star Tribune, July 12, 2005; "Parkinson’s Treatment Linked to Compulsive Gambling," ScientificAmerican.com, July 12, 2005; Amanda Gardner, "Some Parkinson’s Drugs May Trigger Compulsive Gambling," HealthDay, July 11, 2005.

Having watched a family go through the trauma of mirapex induced compulsive gambling, and knowing that the class action on this drug was restricted to the US I wondered what redress there is for those in other parts of the world where things are handled differently.

There are big questions in my mind about issues aroune negative effects of prescription drugs and resulting liability. For instance, large class actions in the US may result in withdrawal of drugs from the market or amended info sheets, but mostly the drug in question will continue to be marketed worldwide, nothing presupposes that such actions result in better education for clinicians. Further there is the issue of finding the resource to fight such actions - in many parts of the world such a case would fall at this first hurdle. The fact is that drug companies are able to muster much more resource than sick people.

Incidentally if it had not been for the PD community's openness about discussing compulsive behaviours related to PD medication the family concerned would not have known what was causing the problem. The pharma certainly wasn't letting on. Issues like these can destroy lives - there should be a place at which the buck stops.

to sue or not to sue that's the question....
 

I have a different view. I agree the pharmaceutical industry's main aim is to make profits, not necessarilly to cure or help sick people., BUT...I also accept that it is commercially driven and not a charity, and I am grateful for the medicines it has made available to me. There are lots of medications that are borderline beneficial, of dubious value even and ALL have some or lots of side-effects. When such a side-effect has a greater impact than the beneficial effect of the medicine, we scream for punishment of the manufacturer and/or compensation. When everything works for us, we keep quiet. In the case of Mirapex there is a minority, I believe even a small minority, among worldwide a very large patient group, that suffers the compulsive behaviour side-effects to such a degree that it severily effects their lives. I take Mirapex, since 2001, have gained weight, like playing computer games too much and too long, but the other side of the coin is, that it also relieves my Parkinson symptoms and it is easy to take, not time sensitive or food sensitive. Court action by people against the manufacturer could lead to a substantial fine/pay-out, maybe even withdrawal of the product. Who is paying the fine? In the end this will result in higher prices for medicines, of course. So we pay. All in all I think the court action way is not very satisfactory . There should be another way of keeping pharmaceutical companies on the right track,(by "right" I mean honest information, reasonable prices and profits, proper research, and especially safety of their products always a first consideration). This should be the responsibility of goverments with clearer and better legislation ,better/stricter guidelines and policing all this by government agencies (or better still patient groups?) .Maybe in the case of Mirapex the number of participants in the pre-market trials was just not large enough to show the compulsion. I have always thought the patient groups for these trials are really quite small. This was just a thought....

Good points, however, what if you had lost your life savings and family to boot, as a result of not knowing the side effects. What then?

At present it seems that the only way to make a difference or to obtain any form of redress is via litigation. I would however agree that there ought to be other ways of dealing with things. I think in the case of Mirapex that there has been a significant minority of people who have had to deal with obsessive/compulsive issues that have affected their quality of live and that of their families - there ought to be enough education and information on this for patients to swiftly discontinue the drug in the event that they are affected, if this does not happen then surely the pharmas have an ethical obligation esp. in the light of the huge profits they make? That it is also a useful and beneficial drug is not in question.