Dopamine agonists like Mirapex have long been suspected of causing compulsive behavior. The suspicion was bolstered last June, when researchers investigating the link between dopamine agonists and compulsive behavior presented their findings at International Congress of Parkinson’s Disease and Movement Disorders conference in Chicago. The study, which looked at more than 3,000 patients from 46 medical centers in the United States and Canada, found that Parkinson’s patients on dopamine agonists are nearly three times more likely to have at least one impulse-control disorder - including gambling addiction - compared with patients receiving other treatments.
Parkinson's Disease occurs because of a lack of the neurotransmitter dopamine in certain areas of the brain. A dopamine agonist works by mimicking the effects of this chemical. However, dopamine is also known to produce a “rush” in the brain of people who are anticipating a reward or excitement. Many experts believe that such a biochemical reaction is behind the reports of compulsive behavior linked to dopamine agonists like Mirapex.
The Mayo Clinic study involved 267 patients treated between 2004 and 2006 in a seven-county area around the Mayo clinic. Sixty-six were taking a dopamine agonist at a therapeutic level, but only 38 were using doses in the therapeutic range, 178 were taking carbidopa/levodopa without a dopamine agonist, and 23 were untreated.
Six of the patients taking dopamine agonists developed a behavioral disorder (an occurrence rate of 18.4 percent for this group). Five developed a gambling addiction and five became hypersexual (both disorders developed in three of the patients). Other compulsive behaviors were noted as well. Though in some cases the behaviors continued for years, the Mayo Clinic researchers found that they abated when the patients stopped dopamine agonist therapy.
None of these behaviors were seen in untreated patients, those taking less than a therapeutic dose of a dopamine agonist, or patients receiving treatment with carbidopa/levodopa alone, the researchers said.
The researchers advised that the severity of the problems seen indicated that patients and doctors needed to be more aware of the behavioral side effects associated with dopamine agonists. In at least 2 cases, patients were subjected to intense psychiatric treatment before dopamine agonists were recognized as a likely cause of their disorder.
"Physicians treating Parkinson's Disease with dopamine agonists should obviously warn the patients, spouses, and families of such risks because they may not recognize the relationship to the drug until disastrous consequences have occurred," the study authors said.
Gary Charbonneau, who began taking Mirapex in December 1997, said he suffered from a gambling addiction from March 2002 to February 2006. In that period of time, he gambled away $260,000. Charbonneau's lawsuit not only claimed that Mirapex caused his gambling problem, but that the drug's makers, Pfizer and Boehringer Ingelheim, knew about its potential to cause compulsive behavior, but did not issue any warnings, or take steps to investigate the true scope of the problem.
Other Mirapex lawsuits claim that Boehringer Ingelheim received reports linking the drug to compulsive behavior during clinical trials conducted in the 1990s, and received additional reports of patients developing gambling addictions after it came on the market. It wasn't until 2005 - eight years after its introduction - that information about compulsive behavior was finally added to the Mirapex label.
The defendants argued that they were not liable for Charbonneau's addiction because the Food & Drug Administration (FDA) had not asked for any label changes, despite reports that Mirapex was causing compulsive behavior. They also argued that Charbonneau's gambling problem started years after he began treatment with Mirapex, and continued long after he stopped taking the drug.
The federal jury, however, agreed with Charbonneau and awarded him all of his gambling losses, along with $7.8 million in punitive damages. Neither Pfizer nor Boehringer Ingelheim have commented on Thursday's verdict, but an appeal is likely.
Mirapex, one of a class of drugs known as dopamine agonists, has long been suspected of causing compulsive behavior. The suspicion was bolstered in June, when researchers investigating the link between dopamine agonists and compulsive behavior presented their findings at International Congress of Parkinson’s Disease and Movement Disorders conference in Chicago. The study, which looked at more than 3,000 patients from 46 medical centers in the United States and Canada, found that Parkinson’s patients on dopamine agonists are nearly three times more likely to have at least one impulse-control disorder - including gambling addiction - compared with patients receiving other treatments.
This week, the first of three "bellweather" trials concerning Mirapex and its alleged linkage to compulsive gambling is underway in U.S. District Court in Minneapolis. More than 200 people are suing Boehringer Ingelheim Pharmaceuticals, the maker of Mirapex, over compulsive behavior they say it caused. These first three trials will be used by many legal experts to gauge the strengths and weaknesses of those cases.
People with Parkinson's lack dopamine in key areas of the brain. Mirapex and drugs like it are known as a dopamine agonist, and they work by mimicking the effects of this vital hormone and neurotransmitter. Other dopamine agonists include Requip, Parlodel, Dostinex Apokyn and Neupro.
For years, people taking Mirapex and similar drugs have complained about problems with compulsive behavior. Most of those complaints involved people who had no history of compulsive behavior before they started dopamine agonist therapy, and most reported that the behavior stopped as soon as they quit using the drugs. Several small studies, including one published in 2005 by Mayo Clinic researchers, found a link between the drugs and compulsive behavior, especially gambling addiction. The drugs' labeling also includes warnings about possible compulsive behavior.
In June, results from the largest study ever to investigate the connection between compulsive behavior and dopamine agonists was presented at the at the International Congress of Parkinson's Disease and Movement Disorders conference in Chicago. That study found that more than 13 percent of patients taking dopamine agonists, sold under brand names suffer from at least one of four serious behavioral addictions.
The study, which looked at more than 3,000 patients from 46 medical centers in the United States and Canada, found that Parkinson's patients on dopamine agonists are nearly three times more likely to have at least one impulse-control disorder compared with patients receiving other treatments.
The growing evidence that Mirapex and other similar drugs are linked to compulsive behavior has changed the way some doctors approach these medications. Dr. Eric Ahlskog, a neurologist at the Mayo Clinic who has treated Parkinson's patients for 25 years, told The Chicago Tribune that he no longer is comfortable starting patients on dopamine agonists after three patients in his practice last year developed significant gambling and sexual problems.
Other doctors told the Tribune that while they still treat patients with dopamine agonists, they are using smaller doses. Many are also now asking the patients they treat with the drugs and their families about compulsive behaviors as part of routine patient checkups.
Simens’ lawsuit alleges that Mirapex made him into a "pathological" gambler and that his addiction "ruined me," the New York Daily News quotes. "I became like a robot." The lawsuit was filed in New York State Court on Tuesday and accuses the privately held drug maker of breach of warranty, negligence, and negligent misrepresentation. Simens said he took Mirapex, from 2002 to 2007 following his diagnoses with Parkinson's disease and also after suffering hand tremors. "It put a little tickle in me and then snowballed within a month," said Simens, who filed the lawsuit on his own because he said he cannot afford a lawyer. The defendants "had a duty to provide adequate warnings and instruction for Mirapex, to use reasonable care to design a product that is not reasonably dangerous to users, and to adequately test their product," the lawsuit said.
Simens is not the first gambling addict to sue Boehringer Ingelheim; however, Boehringer Ingelheim adamantly denies any scientific evidence proving a link between Mirapex and gambling addictions. A spokesperson for Pfizer said the company had not marketed Mirapex since 2005 when medical studies first linked Mirapex to compulsive behaviors, including compulsive gambling. Pfizer said it "acted reasonably and appropriately during the entire time period it was involved with Mirapex." Mirapex is still sold in the United States market and is also prescribed for restless leg syndrome. Boehringer Ingelheim updated Mirapex's label in 2005 to include reports of "compulsive behavior" among Mirapex patients.
Simens said he was a recreational gambler before being prescribed Mirapex, but that he quickly became reckless, spending entire nights gambling over the Internet and traveling to casinos. "It's stupidity. I just couldn't stop," he said. When he read an article that suggested a link between Mirapex and compulsive behaviors, including gambling, he said he felt a wave of relief. Simens said he has joined a gambler's support group and, within five weeks of stopping Mirapex, stopped gambling.
The lawsuit claims Boehringer Ingelheim should have done more to warn patients of the potential for compulsive gambling. According to the suit, Simens—a father of two—began taking Mirapex in 2002 but didn't learn about the label change until 2006, when he read about a film director who blamed a gambling binge on Mirapex. At that point he claims to have been already out of control, running through his children’s bank accounts.
A recent Canadian and American study found that people taking dopamine agonist drugs—Mirapex is in this class of drugs—which help control movement problems, were two-to-three times more likely to have at least one of four common impulse control disorders: Pathological gambling, compulsive buying, compulsive sexual behavior, and binge eating.
By Steven DiJoseph
Up until now, Mirapex has been the medication most often associated with the mounting medical evidence linking certain drugs used to treat Parkinson €™s disease (PD) to the development of compulsive behavior, including pathological gambling.
Now, however, a second drug has been thrust into the same spotlight with the filing of a $14 million lawsuit by a retired doctor who claims that Requip, a drug very similar to Mirapex, turned him into a compulsive gambler.
Dr. Max Wells alleges in the action commenced in U.S. District Court in Austin, Texas, that his addiction made him a habitual high roller at Las Vegas casinos where he lost $7 million by late 2005 and another $7 million by January of this year.
As reported by The Oxford Press (Oxford, Ohio), the complaint names the drug €™s manufacturer, GlaxoSmithKline (GSK €“ sued as SmithKline Beecham), the world €™s second largest pharmaceutical company, and seven casinos, including Mandalay, Treasure Island, Bellagio, Wynn Las Vegas, Las Vegas Sands, Harrah's Las Vegas and Hard Rock Hotel.
At the heart of the doctor €™s lawsuit is the Mayo Clinic study published last July in the Archives of Neurology that identified 11 Parkinson €™s patients who developed a gambling habit while taking Mirapex or Requip between 2002 and 2004. After the study was released, 14 additional Mayo patients were diagnosed with the problem according to lead author Dr. M Leann Dodd, a psychiatrist at the Clinic.
Previously, in August 2003 in the journal Neurology, Drs. E. Driver-Dunckley, J. Samanta, and M. Stacey published an article entitled €œPathological gambling associated with dopamine agonist therapy in Parkinson €™s disease. €
That study found extreme cases of compulsive gambling in nine (of 1,884) patients using pramipexole (8 or 1.5%)) and pergolide (1 or 0.3%). Both results were well above the overall incidence rate of all PD patients of 0.05%. Both drugs that showed an increased risk were dopamine agonists (DA).
The Mayo Clinic study also analyzed the findings in five prior studies (including the 2003 Driver-Dunckley study) and confirmed that: €œAll of the commonly prescribed dopamine agonists have been associated with pathological gambling € with pramipexole being €œdisproportionately represented in both our series (82% of our patients) and in prior reports (59%).
Mirapex (pramipexole dihydrochloride) is in the dopamine agonist class of drugs and is believed to work by mimicking the action of dopamine in the brain to help control the symptoms of Parkinson €™s disease.
Dopamine also affects brain processes that control emotional responses and a person's ability to experience pleasure and pain. It is thought to play a role in addictive behavior.
As we previously reported, these medications present another example of drugs whose benefits come with a very high price tag for some patients. The ones who become addicted to gambling often wind up losing their life savings, fall deeply into debt, and even jeopardize or destroy their marriages or other personal or family relationships.
In the past, the victims of this harsh side-effect had no idea what had come over them. Their brain was literally taken over and their gambling became constant and compulsive. Simply stated, they were out of control and had no idea why. For these people, the situation was frightening and inexplicable.
As a result of this completely bizarre and damaging side-effect, many Mirapex and Requip users suffered long periods of debilitating and destructive behavior during which they were unaware that the drug was causing the problem and that it would cease if they discontinued taking it.
Mirapex is manufactured by German-based Boehringer Ingelheim Pharmaceuticals, the world's biggest family-owned drug company, in cooperation with New York-based Pfizer, the world's largest drugmaker. Its sales for 2004 topped $200 million in the U.S. alone.
.Boehringer Ingelheim lists "compulsive behaviors (including sexual and pathological gambling)" as a possible side effect associated with taking Mirapex. That seven-word phrase on page 17 of a 21-page highly technical document is all the warning that is given concerning the potentially detrimental side-effect.
While Boehringer-Ingelheim has repeatedly claimed there is no scientific evidence upon which to base the conclusion that Mirapex causes addictive or compulsive behavior, the multiple reputable studies on the subject would seem to indicate otherwise. In addition, the company revised its package insert to include the warning with respect to €œcompulsive behavior € despite its denial of the connection.
Now, additional evidence of the association between Mirapex and other dopamine agonists and impulsive behavior has appeared in the form of an analysis of adverse drug reports in the FDA €™s database. Of the reports specifically dealing with compulsive gambling, 39 (58%) involved Mirapex.
The report, which analyzes these adverse events, appears in the February issue of Archives of Neurology. The authors include a psychiatrist, P. Murali Doraiswamy (Duke University), and three FDA scientists.
According to Dr. Doraiswamy: "When you combine this with other pieces of evidence, it seems highly suggestive that there is a causal relationship."
While the evidence is consistent with other findings linking dopamine agonists with an increased risk of impulsive behavior, the researchers claim to have found no similar reports involving antipsychotic drugs, which inhibit dopamine.
Boehringer Ingelheim has now backed off its hard line denial of a link just a bit by stating that it is working with Parkinson €™s experts to €œinvestigate the relationship if any. €
GSK claims that its drug, Requip, is appropriately labeled with respect to potential side-effects.
Dr. Wells claims that the casinos were aware that he had PD and that he was on medication for the disease while he was gambling.
Wells had originally been taking Mirapex for his PD but, when he noticed his occasional recreational gambling had become more serious, he told his doctor that he thought that drug might be the cause. His doctor changed his medication to Requip and increased the dosage.
Although Wells then began running up massive gambling losses and some $1.2 million in debts that remain unpaid, his wife remained unaware of the problem since she was not present when the losses occurred.
When Wells finally told his wife about the losses, the problem was brought to the attention of his physician. As soon as the Requip was stopped, so did the compulsive gambling.
The behavioral changes witnessed in some Parkinson €™s patients whose therapy includes dopamine agonists can be wide-ranging indeed. On the mild side, some start buying lottery tickets and nothing more. Others, however, have been known to develop serious OCD (obsessive compulsive disorders) as well as aggressive sexual impulses, overeating, medication abuse, or pathological gambling.
Since these personality changes are dramatic and involve conduct that the patient has usually not exhibited in the past, relatives and associates should be aware of the potential problem and remain watchful for marked behavioral changes.
PD causes sufferers to gradually lose dopamine. Thus, they actually develop an aversion to the type of impulsive behavior associated with excess dopamine. When Mirapex, Requip, or another dopamine agonist is introduced, the behavioral changes in those adversely affected can be both quick and dramatic.
Currently, two major lawsuits against Boehringer Ingelheim and Pfizer have been commenced in federal court in California and in Superior Court in Ontario, Canada. They allege a number of addictive behaviors associated with Mirapex including gambling, shopping, having sex, eating, and engaging in other compulsive conduct.
It is likely that additional lawsuits will be commenced in the near future since the problem is as widespread as the locations of people who took Mirapex or Requip.
By Steven DiJoseph
As previously reported by newsinferno.com, the medical evidence has been mounting with respect to the rather odd connection between certain drugs used to treat Parkinson €™s disease (PD), especially Mirapex, and the development of compulsive behavior including pathological gambling.
Last July, a Mayo Clinic study published in the Archives of Neurology that identified 11 Parkinson €™s patients who developed a gambling habit while taking Mirapex or similar drugs between 2002 and 2004. After the study was released, 14 additional Mayo patients were diagnosed with the problem according to lead author Dr. M Leann Dodd, a psychiatrist at the Clinic.
---Mirapex Gambling Addiction Lawyers---
Previously, in August 2003 in the journal Neurology, Drs. E. Driver-Dunckley, J. Samanta, and M. Stacey published an article entitled €œPathological gambling associated with dopamine agonist therapy in Parkinson €™s disease. €
That study found extreme cases of compulsive gambling in nine (of 1,884) patients using pramipexole (8 or 1.5%)) and pergolide (1 or 0.3%). Both results were well above the overall incidence rate of all PD patients of 0.05%. Both drugs that showed an increased risk were dopamine agonists (DA).
The Mayo Clinic study also analyzed the findings in five prior studies (including the 2003 Driver-Dunckley study) and confirmed that: €œAll of the commonly prescribed dopamine agonists have been associated with pathological gambling € with pramipexole being €œdisproportionately represented in both our series (82% of our patients) and in prior reports (59%). €
---Mirapex Gambling Addiction Lawyers---
Mirapex (pramipexole dihydrochloride) is in the dopamine agonist class of drugs and is believed to work by mimicking the action of dopamine in the brain to help control the symptoms of Parkinson €™s disease.
Dopamine also affects brain processes that control emotional responses and a person's ability to experience pleasure and pain. It is thought to play a role in addictive behavior.
Unfortunately, this is another drug whose benefits come with a very high price tag for some patients. The ones who become addicted to gambling often wind up losing their life savings, fall deeply into debt, and even jeopardize or destroy their marriages or other personal or family relationships.
In the past, the victims of this harsh side-effect had no idea what had come over them. Their brain was literally taken over and their gambling became constant and compulsive. Simply stated, they were out of control and had no idea why. For these people, the situation was frightening and inexplicable.
As a result of this completely bizarre and damaging side-effect, many Mirapex users suffered long periods of debilitating and destructive behavior during which they were unaware that the drug was causing the problem and that it would cease if they discontinued taking it.
Mirapex is manufactured by German-based Boehringer Ingelheim Pharmaceuticals, the world's biggest family-owned drug company, in cooperation with New York-based Pfizer, the world's largest drugmaker. Its sales for 2004 topped $200 million in the U.S. alone.
.Boehringer Ingelheim lists "compulsive behaviors (including sexual and pathological gambling)" as a possible side effect associated with taking Mirapex. That seven-word phrase on page 17 of a 21-page highly technical document is all the warning that is given concerning the potentially detrimental side-effect.
While Boehringer-Ingelheim has repeatedly claimed there is no scientific evidence upon which to base the conclusion that Mirapex causes addictive or compulsive behavior, the multiple reputable studies on the subject would seem to indicate otherwise. In addition, the company revised its package insert to include the warning with respect to €œcompulsive behavior € despite its denial of the connection.
Now, additional evidence of the association between Mirapex and other dopamine agonists and impulsive behavior has appeared in the form of an analysis of adverse drug reports in the FDA €™s database. Of the reports specifically dealing with compulsive gambling, 39 (58%) involved Mirapex.
The report, which analyzes these adverse events, appears in the February issue of Archives of Neurology. The authors include a psychiatrist, P. Murali Doraiswamy (Duke University), and three FDA scientists.
According to Dr. Doraiswamy: "When you combine this with other pieces of evidence, it seems highly suggestive that there is a causal relationship."
While the evidence is consistent with other findings linking dopamine agonists with an increased risk of impulsive behavior, the researchers claim to have found no similar reports involving antipsychotic drugs, which inhibit dopamine.
Boehringer Ingelheim has now backed off its hard line denial of a link just a bit by stating that it is working with Parkinson €™s experts to €œinvestigate the relationship if any. €
The behavioral changes witnessed in some Parkinson €™s patients whose therapy includes dopamine agonists can be wide-ranging indeed. On the mild side, some start buying lottery tickets and nothing more. Others, however, have been known to develop serious OCD (obsessive compulsive disorders) as well as aggressive sexual impulses, overeating, medication abuse, or pathological gambling.
Since these personality changes are dramatic and involve conduct that the patient has usually not exhibited in the past, relatives and associates should be aware of the potential problem and remain watchful for marked behavioral changes.
PD causes sufferers to gradually lose dopamine. Thus, they actually develop an aversion to the type of impulsive behavior associated with excess dopamine. When Mirapex, Requip, or another dopamine agonist is introduced, the behavioral changes in those adversely affected can be both quick and dramatic.
Currently, two major lawsuits against Boehringer Ingelheim and Pfizer have been commenced in federal court in California and in Superior Court in Ontario, Canada. They allege a number of addictive behaviors associated with Mirapex including gambling, shopping, having sex, eating, and engaging in other compulsive conduct.
It is likely that additional lawsuits will be commenced in the near future since the problem is as widespread as the locations of people who took Mirapex.
Jerrold Parker, managing partner of Parker & Waichman, a law firm with considerable experience in pharmaceutical and medical malpractice litigation nationwide, told us after the release of the Mayo Clinic study that: €œIt is difficult to imagine how the manufacturers of Mirapex can maintain there is no scientific evidence to support the addiction link when several studies leave little doubt of the connection. In addition, it is rather amazing that when the manufacturers finally decided to add a warning regarding compulsive conduct to the product insert they chose to hide it in the middle of 21 pages of technical data. €
When asked to comment on the most recent research report, Mr. Parker stated: €œThe evidence is only growing stronger. The link between Mirapex, and the dopamine agonist class of drugs, and an increased risk of dangerous compulsive behavior is really undeniable. Only a radically conservative scientist and the drug €™s manufacturer would still need more proof that a serious problem exists. €
In July, a Mayo Clinic study published in the Archives of Neurology that identified 11 Parkinson’s patients who developed a gambling habit while taking Mirapex or similar drugs between 2002 and 2004. Since the study was released, 14 additional Mayo patients have been diagnosed with the problem according to lead author Dr. M Leann Dodd, a psychiatrist at the Clinic.
Previously, in August 2003 in the journal Neurology, Drs. E. Driver-Dunckley, J. Samanta, and M. Stacey published an article entitled “Pathological gambling associated with dopamine agonist therapy in Parkinson’s disease.”
That study found extreme cases of compulsive gambling in nine (of 1,884) patients using pramipexole (8 or 1.5%)) and pergolide (1 or 0.3%). Both results were well above the overall incidence rate of all PD patients of 0.05%. Both drugs that showed an increased risk were dopamine agonists (DA).
The Mayo Clinic study also analyzed the findings in five prior studies (including the 2003 Driver-Dunckley study) and confirmed that: “All of the commonly prescribed dopamine agonists have been associated with pathological gambling” with pramipexole being “disproportionately represented in both our series (82% of our patients) and in prior reports (59%).”
Mirapex (pramipexole dihydrochloride) is in the dopamine agonist class of drugs and is believed to work by mimicking the action of dopamine in the brain to help control the symptoms of Parkinson’s disease. Dopamine also affects brain processes that control emotional responses and a person's ability to experience pleasure and pain. It is thought to play a role in addictive behavior.
Unfortunately, this is another drug whose benefits come with a very high price tag for some patients. The ones who become addicted to gambling often wind up losing their life savings, fall deeply into debt, and even jeopardize or destroy their marriages or other personal or family relationships.
In the past, the victims of this harsh side-effect had no idea what had come over them. Their brain was literally taken over and their gambling became constant and compulsive. Simply stated, they were out of control and had no idea why. For these people, the situation was frightening and inexplicable.
As a result of this completely bizarre and damaging side-effect, many Mirapex users suffered long periods of debilitating and destructive behavior during which they were unaware that the drug was causing the problem and that it would cease if they discontinued taking it.
Mirapex is manufactured by German-based Boehringer Ingelheim Pharmaceuticals, the world's biggest family-owned drug company, in cooperation with New York-based Pfizer, the world's largest drugmaker. Its sales for 2004 topped $200 million in the U.S. alone.
.Boehringer Ingelheim lists "compulsive behaviors (including sexual and pathological gambling)" as a possible side effect associated with taking Mirapex. That seven-word phrase on page 17 of a 21-page highly technical document is all the warning that is given concerning the potentially detrimental side-effect.
While Boehringer-Ingelheim has repeatedly claimed there is no scientific evidence upon which to base the conclusion that Mirapex causes addictive or compulsive behavior, the multiple reputable studies on the subject would seem to indicate otherwise. In addition, the company revised its package insert to include the warning with respect to “compulsive behavior” despite its denial of the connection.
Currently, two major lawsuits against Boehringer Ingelheim and Pfizer have been commenced in federal court in California and in Superior Court in Ontario, Canada. They allege a number of addictive behaviors associated with Mirapex including gambling, shopping, having sex, eating, and engaging in other compulsive conduct.
It is likely that additional lawsuits will be commenced in the near future since the problem is as widespread as the locations of people who took Mirapex.
Jerrold Parker, managing partner of Parker & Waichman, a law firm with considerable experience in pharmaceutical and medical malpractice litigation nationwide, told us that: “It is difficult to imagine how the manufacturers of Mirapex can maintain there is no scientific evidence to support the addiction link when several studies leave little doubt of the connection. In addition, it is rather amazing that when the manufacturers finally decided to add a warning regarding compulsive conduct to the product insert they chose to hide it in the middle of 21 pages of technical data.”