Medical Detox Programs in a stress-free environment

October 6, 2008

Judge Rules Against GSK, Allows Teenage Paxil Suicide Case To Proceed

Termed “hypocritical “ by a federal judge, GSK’s argument for federal preemption failed last month, and now multiple other arguments for dismissal have been rejected.

A federal judge in Pennsylvania ruled this week that a lawsuit filed by the parents of a 16-year-old New Jersey boy who committed suicide while taking Paxil can proceed to a jury trial.

In their suit against GlaxoSmithKline (GSK), Marion Knipe and Gerald Garrison, the parents of teenager Jake Garrison, allege that GSK had known about the increased risks of suicide associated with its drug Paxil, yet intentionally hid these risks from the public and medical community. Jake Garrison was prescribed Paxil in 2001, and committed suicide within three days of resuming his Paxil treatment in 2005.

In March, 2004, a year before Jake died, the FDA mandated a black-box warning on all SSRIs and other antidepressants of the increased risk of suicide in teenagers and young adults. Several months after Jake’s suicide in 2005, GSK finally placed the warning on Paxil labels — a year after the FDA mandate. And remember, Paxil was never approved for children in the first place.

In his rejection last month of GSK’s attempt to invoke federal preemption, Senior Judge Ronald L. Buckwalter, of the United States District Court for the Eastern District of Pennsylvania, said the vital role tort (state level) litigation has played in protecting the health and safety of its citizens cannot be ignored. Judge Buckwalter’s rejections this week of GSK’s other arguments contain fascinating and very telling legal reasoning — you can read some of them here at the web site of Baum, Hedlund, Aristei & Goldman, who represent Jake’s family. For 18 years, the LA-based law firm has litigated more SSRI cases — more than 3,000 — than any other law firm in the country.

The judge’s response to GSK’s preemption defense was so enlightening I offer most of it here:

“Finally, the Court takes note of the inherent hypocrisy in Defendant’s argument. On one hand, Defendant contends that it had no duty to warn of known risks involved in off-label usage of the drug, whether or not it had reason to know of such off-label uses. On the other hand, it contends that once its drug was approved by the FDA for some indications, it was protected by the presumption of adequacy for FDA warnings for usage in all indications, even where the FDA had never considered the propriety of the warning. On a hypothetical third hand, it claims that any attempt to rebut the presumption by proof of nondisclosure is preempted by federal law, thereby making the presumption effectively unrebuttable. Applying such logic, a pharmaceutical manufacturer possessing information regarding hazards associated with off-label use of its drug would never have to warn the medical community of any off-label usage dangers or submit data regarding these dangers to the FDA. Such a result is contrary to New Jersey’s ‘strong interest in encouraging the manufacture and distribution of safe products for the public and, conversely, in deterring the manufacture and distribution of unsafe products within the state’…”

A Paxil Primer — Why GSK Mustn’t Skate On This Case

Paxil (paroxetine) is a selective serotonin reuptake inhibitor (SSRI) antidepressant, released in 1992 by GSK. In 2006 it was the fifth-most prescribed antidepressant in the United States with more than 19.7 million prescriptions.

Since the FDA approved paroxetine in 1992, approximately 5,000 Americans have sued GSK, most claiming they were not sufficiently warned of the drug’s side effects — particularly the horrendous withdrawal symptoms, considering GSK specifically advertised the drug as “not habit forming.”

On January 29, 2007, the BBC broadcast a documentary about Seroxat, the UK brand of paroxetine, focusing on three GSK pediatric clinical trials on “depressed” children and adolescents that showed Seroxat could not be proven to work for teenagers. And one trial indicated that adolescents were six times more likely to become suicidal after taking it.

In May 2007 a US court approved a settlement in a class action lawsuit brought on behalf of everyone in the United States who purchased Paxil or Paxil CR prescribed for a minor. The lawsuit alleged that GlaxoSmithKline promoted Paxil or Paxil CR for prescription to children and adolescents while withholding and concealing material information about the medication’s safety and effectiveness for minors (emphasis is mine). GSK denied all claims, but the settlement entitled everyone who purchased Paxil or Paxil CR for their child or ward to recover up to 100% of documented out-of-pocket expenses or $100 if documentation was not available.

Read more about Federal Preemption in these earlier Novus blogs:
Preemption and the FDA: Placing Our Trust In A Failed System
Lies And Misdirection From Big Pharma About Preemption

October 3, 2008

Female Immigrants Forced To Accept Merck’s Gardasil Vaccinations

The news has stunned the head of the CDC’s Advisory Committee for Immunization Practices, and the single vaccination may be harming more than it’s helping.

The Department of Homeland Security is requiring girls and young women immigrating to the US to take a single vaccination of Merck’s Gardasil, against the recommendation of the Centers for Disease Control, reports TheStreet.com.

Since Homeland Security’s U.S. Citizenship and Immigration Services (USCIS) began the requirement in April 2007, an estimated 233,000 females ages 11 to 26 who entered the country as prospective citizens have paid roughly $52 million for one dose, based on the $223 cost for one treatment borne by the typical U.K. emigrant.

Whereas three doses are needed for effectiveness, according to the drugmaker and part of the FDA approval for the controversial drug, immigrants must only receive one dose, and there is no follow-up requirement to ensure succeeding treatments are taken.

There is no prescreening to test for existing human papillomavirus (HPV) infections among immigrants — or in fact, for anyone receiving the vaccination — but according to adverse event reports released through Freedom of Information Act channels to Judicial Watch, administering Gardasil to people already infected may exacerbate the condition.

Concerned about the rush to market and mandate a drug with possible serious adverse effects, Judicial Watch filed its first Freedom of Information Act (FOIA) request on May 9, 2007, and received 1,637 adverse event reports. Since then it has requested and received thousands more, including reports of deaths and permanent serious injury.

Jon Abramson, an infectious diseases expert and chairman of the CDC’s Advisory Committee for Immunization Practices, or ACIP, when Homeland Security implemented the requirement in April 2007, advised against making the HPV vaccine mandatory at the time.

“I am stunned. It was not the intention of the policy to mandate vaccination of immigrants,” Abramson said, adding that vaccination policies are designed to protect the populace, not individuals. “This is not a disease that is communicable like SARS or pandemic flu or even measles.”

September 19, 2008

Drug Safety Issues Are Reaching The Minds Of Middle America

Filed under: Big Pharma, FDA, Uncategorized, pharmaceutical giants — Rod Malcolm @ 1:22 pm

A strong statement this week on the shortcomings of Big Pharma and the FDA concerning drug safety appeared in an unlikely place — The Buffalo News of Buffalo, NY.

The way I see it, when a middle-America newspaper like The Buffalo News takes up the drug safety issue — not the usual venues like New York Times or Wall Street Journal or Washington Post — America is waking up to the drug safety nightmare.

A Buffalo News editorial this week says that the American people and the FDA are “too reliant on the good graces of drug companies” to make sure that medications “not only help with disease but also don’t cause any horrible problems along the way.”

Although that sounds like all the blame falls on Big Pharma, the editors do go on to also include the FDA itself as a source of the problems.

“The highly complex nature of evaluating drugs, the ever-improving marketing savvy of the drug companies and the weakness of the Food and Drug Administration are clearly combining to tilt the deal too far on the side of profits and too little on the side of human health,” say the editors.

The editorial describes the situation we face in this country with some drugs already causing serious problems, and others under investigation for possible problems. Assurances of efficacy and safety require extensive premarket trials and exhaustive after-market follow-up, say the editors. Providing this is a moral responsibility, and if Big Pharma doesn’t realize that, then the responsibility should mandated, they say.

I may be wrong, but that responsibility already is mandated, and the FDA, on behalf of the federal government and the American people, oversees these specific laws.

But from current and past experience, the system of drug approvals and safety is far from perfect.

A few members of Congress are trying to make a difference on an issue-by-issue basis, and recent additional FDA funding for more staff I supposed to help. But that’s really a drop in the bucket, when you consider what really needs to be done.

So the problems within the FDA of failing to catch so-so and bad drugs from reaching the market continue. And Big Pharma continues its fiddling with test results, outrageous marketing irresponsibility, and outright fiscal fraud.

Clearly, fundamental changes are needed to improve our lousy record of drug approvals and safety.

August 18, 2008

Preemption: What It Is, And What It Means To America’s Drug Consumers

Should a patient harmed by an FDA-approved drug or device be allowed to sue under state consumer protection and safety laws? The Supreme Court will hear a case in November that could decide the issue of federal “preemption” that would end state-level suits against Big Pharma and medical device makers.

In the murky, money-swirling world of Big Pharma, medical device makers, and high-priced defense lawyers vs. hungry litigation lawyers representing Americans who have been harmed by mislabeled or inadequately-tested drugs and devices, “preemption” is the catch-word of the day. And billions of dollars in potential product-liability lawsuits are at stake.

“Preemption” refers to federal law superseding state law, rendering state law, such as personal injury cases, null and void.

In the case of Wyeth vs. Levine, to be heard this November by the U.S. Supreme Court, the concept of preemption and its legal facets are expected to be tested more rigorously than ever before.

Wyeth v. Levine is an appeal from Wyeth, following the firm’s loss in a Vermont case that awarded $6.8 million to guitarist Diana Levine. A mishap involving Wyeth’s anti-nausea drug Phenergan led to the loss of her right arm, ending her musical career.

The Vermont jury and the state’s Supreme Court found that Wyeth failed to adequately warn the public and doctors about the drug’s dangers if improperly injected.

Wyeth’s appeal to the U.S. Supreme Court argues that the company is protected, because the Food and Drug Administration approved the label — a clear case of federal regulation preempting state law.

Preemption has been the subject of litigation since the 1990s, with numerous decisions from the U.S. Supreme Court already delivered — but none fully covering all the bases. This new case could take it all the way to an end of personal injury lawsuits as we know them, and could spill over into all other federally-regulated products, not just drugs and devices.

The Bush government has been whittling away at various laws for years, making preemption more of a reality with each subtle tweak. Now the government — the Solicitor General, along with bigwigs at Justice and over at Health and Human Services — is supporting Wyeth’s position on behalf of the FDA. It has filed a brief calling for preemption and a reversal of the Vermont decision.

All the usual suspects — corporate lawyers and political lobbyists — are lining up with their bottomless bags of $millions to help fund Wyeth’s case — including the American Chamber of Commerce, which, according to reports in the media, has pledged to raise $40 million to hand over to any supportive congressmen running in November.

Meanwhile, the attorneys-general of 47 states, two world-famous physician-educators who are both former FDA commissioners, several members of Congress (they may not have heard about the COC’s $40 million yet), constitutional experts, and no less than the editors of The New England Journal of Medicine, have all filed briefs arguing against preemption. The law firm representing Levine is blue-chip, but they certainly don’t have the kind of money behind them that the pro-preemption forces have.

For those of you with the time and interest in this far-reaching issue, Ed Silverman’s Pharmalot blog contains links to the case briefs and media coverage that you really don’t want to miss. The Wall Street Journal has continuing coverage, some favorable to preemption and some not so favorable.

Personally, I don’t trust FDA’s record on labeling to favor preemption in this case. There’s been far too many cases where labeling corrections came way too late — long after catastrophic losses of life and limb.

Until the mess at the FDA is cleaned up — in other words, when all traces of Big Pharma’s influence at the agency have been removed — and a decent record of real public safety is established, state level injury suits must be allowed to continue.

August 11, 2008

Merck And Schering-Plough Get Beefier RICO Threats

A federal judge recently said Lilly could be ‘barely’ liable under RICO for off-label marketing practices, and now Merck Schering-Plough is accused of “indictable” RICO offences in a civil suit filed by a New York county government.

The Shearlings Got Ploughed blog reports that the local Suffolk County, NY, government has filed a civil suit in New Jersey federal court against Schering-Plough and its joint venture with Merck, among others, that “takes important new strides in alleging RICO pattern activity — calling Schering’s and Merck’s conduct here ‘indictable’.”

Although there have been other RICO putative class action cases against Schering-Plough and Merck over its cholesterol drugs Zetia and Vytorin, the new Suffolk County complaint is significant because it “represents a new level of gravitas in the ENHANCE litigation maelstrom now besieging Schering-Plough and its executive leadership,” the blog says.

It’s more serious, the blog suggests, because “a local-governmental agency is now effectively swearing that Schering has committed RICO-indictable pattern racketeering by concealing the results of ENHANCE research for almost two years — while the good people of Suffolk County, New York were forced to pay greatly-inflated prices for a drug that was no more effective than those much cheaper statins.”

Click here to see a marked-up copy of the relevant page in the complaint.

The suit alleges consumer protection, false advertising, securities and other violations in connection with the ENHANCE study delays and non-disclosures, various statements by the company and executives, that relate to the drugs’ effectiveness.

With similar charges being suggested against Lilly over Zyprexa, and all the other legal problems Big Pharma continues to face, it’s obviously time for pharmaceutical execs to get out of the huddle with PR flacks and sit themselves down in front of a mirror. Crafting evasive media statements for investors, doctors, patients, employees, and all the rest is not cutting it.

The Emperor Isn’t Wearing Any Clothes

The abandonment of psychotherapy by thousands of psychiatrists in favor of prescription drugs tells us that psychiatric ‘talk therapy’ never worked. And since drugs don’t provide any answers either, and in fact carry enormous risks, what has psychiatry ever really done for anybody?

An article in the August issue of Archives of General Psychiatry reports that the use of anti-depressants is replacing psychotherapy for a significant number of psychiatrists. Thousands of them, the article says, are dropping ‘talk therapy’ in favor of the quick prescription, and it’s an expanding trend.

Financial incentives, the author suggests, have brought about the switch from talk therapy to drugs, motivated by reductions in insurance payments for psychotherapy, increases in the number of ‘managed care’ patients (HMOs and PPOs), and rapid growth in ‘psychopharmacology’.

Study author Dr. Ramin Mojtabai of Johns Hopkins Bloomberg School of Public Health in Baltimore said insurance company reimbursements for a 45-minute psychotherapy visit are now less than an equivalent amount of time consumed by three 15-minute ‘medication visits’ — patient pit stops for a quick prescription.

And don’t forget the thousands of patients who seldom, or never, see their doctor again after the first visit, depending instead on phone-in prescription renewals.

Meanwhile, the number of psychiatrists studying psychotherapy as a specialty is also dropping, the article says, with a corresponding increase in pharmacotherapy specialists. This portends that even more legal drug-pushers will soon be hanging out their shingles.

These developments clearly say what most of us have always known or suspected:

Psychotherapy, and basically, let’s admit it, that means psychiatry itself, is no more than a failed experiment.

Many cogent arguments also exist, beyond the scope of this blog, that detail how psychiatry, in general, has done more harm than good, and continues to do so at an accelerating rate through its complete devotion to drugs. The gallop, nay the stampede, to push drugs on a troubled population instead of helping it find the answers it needs is among the most telling of those arguments.

We already know — come on, everyone knows — that psych drugs, or any drugs, provide absolutely zero answers to the meaning of life and one’s place in the scheme of things. And these are answers that almost anyone with a functioning mind needs and wants.

Plus, psychoactive drugs bring with them the constant risk of dependency, and a list of side effects as long as your arm — everything from feeling plain lousy to taking an arsenal to school and murdering a dozen or two classmates.

If psychotherapy had ever actually worked, psychiatrists’ medical ethics would have led to demands for adequate compensation from insurers. It’s called the Hippocratic Oath. There was no effective demand, and that speaks volumes about psychotherapy.

And psychiatry hasn’t just abandoned psychotherapy, it has abandoned its very raison d’etre — to help mankind achieve a higher level of existence by actually explaining life and solving his problems. That never happened either, which says everything.

I think psychiatry acknowledged its failure a long time ago, when it found, or was found by, Big Pharma. Either way, it was a match made in, well, somewhere. And for both of them it’s been the pot of gold at the end of the rainbow, and a leap from the frying pan into the fire for anyone else who buys into the psych drug lie.

With Big Pharma as its supplier, psychiatry has become the biggest drug cartel in history. Under its malevolent care, and with the approval and encouragement of educational, health care and governmental institutions, everyone from the cradle to the grave is persuaded to bury their questions about life in an impenetrable pharmaceutical fog, forever.

That is not a higher level of existence by anyone’s reckoning.

Most appalling has been how psychiatry has gathered unto itself an almost unlimited god-like power and clout. With few if any successes, and many would argue no statistics at all to back up its claimed omniscience, it’s clear that psychiatry’s power is utterly unwarranted.

As the child in the old fable said, ‘Look, the emperor isn’t wearing any clothes!’

August 5, 2008

Big Pharma’s Money And Political Clout Gutted The FDA

An analysis of the problems plaguing the FDA suggest that Big Pharma’s money and influence with the political right systematically gutted the FDA’s capabilities and ruined public confidence in the once-respected agency.

In a recent blog on Big Pharma’s propensity for marketing off-label uses for drugs, I quoted from a GAO review of the FDA’s policing of pharma marketing that says the FDA is “ill-equipped to catch even blatant marketing abuses by drug companies” — the finger of blame pointed squarely at the b-a-d agency.

Such a view is generally the public’s ‘take’ on the FDA — it’s bad to the bone, caring more for the health of its Big Pharma, Big Food and Big Politic masters than it does about the health of the people it’s supposed to protect, American consumers. And it’s pretty darn incompetent at doing what little it does do, too, judging from comments in the media.

But there was a time, only 20 or 25 years ago, maybe a bit more, when the FDA was a trusted and respected institution. In that two decades or so, something dreadful happened, not just to the agency’s image, but to its actual ability to do the work for which it was created.

There have been no end of published opinions about the agency’s faults and failings, its inner machinations and personnel problems, but very little about how all this came to be — and differing opinions about that, too.

Greg Anrig, vice president of policy at The Century Foundation, recently published a very succinct and telling analysis of what really crippled the FDA and poisoned public opinion against it.

Anrig’s article “Who Strangled The FDA?” in The American Prospect, reveals facts and figures that clearly suggest a concerted campaign begun during the two-term Reagan presidency, when the FDA staff was cut 30 percent and Reagan himself accused the agency of “murdering” Americans by taking too long to approve new drugs.

“After a reprieve from 1988 to 1994,” Anrig continues, “when more moderate presidents and a Democratic Congress provided ample boosts in the agency’s budget and staffing, the FDA’s garroting resumed with a vengeance in the wake of the 1994 Republican landslide that catapulted Gingrich to the House Speaker’s chair.

Gingrich “led a highly effective jihad against the agency, pushing to privatize many of its activities . . . [dubbing] the FDA the ‘number-one job killer in America.’ That accusation was applauded by the pharmaceutical, medical-device, and food industry funders of both the Republican Party and conservative think tanks, reinforcing their threats to relocate to countries with less stringent regulatory oversight.”

Under George W. Bush and the Republican Congress, the onslaught continued with a further decline in staff, from 9,167 to 7,856, while its funding increased by only two-thirds of the amount needed to match inflation.

Anrig points out that:

• During the past 35 years, the decrease in FDA funding for inspection of our food supply has forced FDA to impose a 78 percent reduction in food inspections, at a time when the food industry has been rapidly expanding and food importation has exponentially increased. FDA estimates that, at most, it inspects food manufacturers once every 10 years.

• Even as the number of “adverse events” from prescription drugs has increased by 146 percent from 1996 to 2006 — to 471,679 last year — there has been no increase in FDA personnel to review those reports.

In the 1970s, Anrig says, the FDA was “among the most respected public agencies, with a public confidence rating of 80 percent. By 2000, that level had dropped to 61 percent; last year, it was just 36 percent. Quite clearly, the conservative movement has accomplished its mission of causing the general public to share its hostility toward what was once an admired governmental institution.”

July 18, 2008

Are ‘Black Box’ Label Warnings Still Doing Their Intended Job?

An FDA panel has voted against Black Box warnings for 11 epilepsy meds with proven increased risks of suicide, raising questions about the effectiveness of such labeling and a possible shift in the agency’s commitment to them.

The FDA has requested ‘Black Box’ label warnings, its most serious recommendation to drug makers for label warnings, many more times in recent years than in previous decades.

Then last week, after two committees unanimously agreed that 11 different epilepsy drugs can cause increased suicide risks, they turned around and voted against calling for Black Box warning labels on them.

In his Pharmalot blog, Ed Silverman poses the question: ‘Is the FDA overreacting?’ with so many label warnings recently, and suggests that the infamous Black Box may be “losing its luster” — its effectiveness — because of so many warnings.

Silverman asks his readers to vote with their opinions about whether or not the FDA has been overreacting in recent years. I voted ‘No’, but it turned out I was in a minority of 36%. The majority, 65% of voters, think the FDA has been overreacting with all the safety warnings, the net effect being less weight with physicians and possibly even patients.

One reader, claiming to be a doctor, was particularly illuminating: “Black-box warnings cause much more hand wringing among pharma marketers than they do among prescribing physicians. That said, more black boxes may dilute their intended effect (something slightly less than a skull and crossbones?), but I suspect more-so for consumers than physicians, who are much better equipped to take a very small increase in an absolute risk with the appropriate grain of salt.”

Doctors taking Black Box warnings with a grain of salt? Does this commenter even know what the expression means?

Here’s part of the definition, from Wikipedia:

“‘A grain of salt’ means that a copious measure of skepticism should be applied regarding a claim; that it should not be blindly accepted and believed without any doubt or reservation. According to the Oxford English Dictionary “to take ‘it’ with a grain of salt” means “to accept a thing less than fully”. It dates this usage back to 1647.”

Silverman points out that these drugs generated more than $10 billion in sales last year, and are taken by an estimated 10 million Americans. He suggests that the decision to forego Black Box warnings on the epilepsy medications was “a boon to several drug-makers, notably Pfizer, which sells Lyrica.”

But this observation contradicts the idea that doctors ignore label warnings, which by inference, suggests that warnings don’t affect sales.

What’s needed right now is a serious, in-depth survey of prescribing physicians across the country to ascertain just how effective Black Box labeling actually is, in terms that we can all understand. Maybe then the FDA will make more informed decisions.

Meanwhile, if physicians are indeed taking Black Box warnings with a grain of salt, patients are in even more trouble than I thought.

July 16, 2008

Grassley Wants Details Of Big Pharma’s Funding Of Psychiatry Ass’n

The Senate Finance Committee has looked into funding of academic psychiatry, but now it wants the American Psychiatric Association to reveal all psychiatric funding from Big Pharma.

Antipsychotic and antidepressant medications are pretty much newsworthy any day of the week. That’s usually because someone taking them has either committed a violent crime, has committed suicide, or has just plain up and died — it’s pretty much the nature of the drugs. And meanwhile, Big Pharma and the psychiatrists rake in billions.

No wonder, then, that Rep. Chuck Grassley, ranking Republican on the Senate Finance Committee, is spearheading an investigation into the Niagara of cash flowing into the psychiatric community from Big Pharma. Psych drugs are news, cash-hungry psychs are news, and the news is where politicians like to be, especially in an election year.

But in this case, we’ll ignore any political ambitions, and hope for some real action. We need see an end to Big Pharma’s buckets-of-cash influence on the practice of all medicine in this country, and particularly its grotesque support of psychiatry.

We recently blogged about Grassley’s probe into three Harvard psychiatrists who received nearly $3 million from Big Pharma for “research” and other psychiatrists whose financial ties to pharma cast doubts on clinical judgment or independence of research findings.

Now, says the New York Times in a must-read article for anyone interested in health care costs and the independence of the American health system, Grassley is demanding that the American Psychiatric Association (APA), the shrinks’ professional organization, reveal its own sources of financing.

“I have come to understand that money from the pharmaceutical industry can shape the practices of nonprofit organizations that purport to be independent in their viewpoints and actions,” Mr. Grassley said in a letter to the APA.

Amen, say I.

The Times says that in 2006, the latest year for which numbers are available, Big Pharma accounted for about 30 percent of the association’s $62.5 million in financing. About half of that money went to psych journal drug ads and annual meeting exhibits, the other half sponsoring “fellowships, conferences and industry symposiums at the annual meeting.”

The psychiatry association’s board met behind closed doors this weekend to discuss “how to respond to the increasingly intense scrutiny and questions about conflicts of interest,” the Times said.

Meanwhile, read the APA’s letter to its membership announcing Grassley’s demands, reprinted in Ed Silverman’s Pharmalot blog. APA president Nada Stotland tells members that a work group has already been formed to provide “options for ending pharmaceutical support.”

Now that is something we’d like to see. Big Pharma’s cash should be flowing into research, testing and safety, not into the pockets of academic or practicing doctors.

July 15, 2008

Did Parkinson’s Drug Drive Banker To Gamble Away Millions?

Boehringer Ingelheim updated the label for Mirapex in 2005 to warn of impulse control disorders and compulsive behaviors, but it came too late to help this New York man.

There are drugs that are addictive, and drugs to treat addictions. But a former Wall Street banker claims in a suit against the makers and marketers of Mirapex (pramipexole), a drug developed to treat Parkinson’s and now also prescribed for Restless Leg Syndrome (RLS), caused his addiction to gambling.

According to a New York Daily News article, Randolph Simens, a retired executive at Prudential, says he became a compulsive gambler and lost $3 million after he began taking Mirapex for his Parkinson’s.

The man has filed suit in Manhattan Supreme Court against Boehringer Ingelheim and Pfizer, claiming his “pathological” gambling addiction was caused by the drug, and there was no warning from the drug companies that side effects could include compulsive behavior.

The drug makers “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 says.

“It ruined me,” he said. “I became like a robot and I was just pissing away money.”

Simens began taking Mirapex in 2002, after being diagnosed with Parkinson’s. He says he didn’t find out about the compulsive behavior side effect until 2006 by reading an article about a film director who blamed his gambling on Mirapex. But by then he was unable to control his visiting casinos, making risky stock plays, and even raiding his kids’ bank accounts.

The drug makers say the compulsive side effects didn’t surface until long after the drug was on the market, and they acted responsibly. Label changes did come in 2005, an added caveat that reads:

“Patients and caregivers should be informed that impulse control disorders/compulsive behaviors may occur while taking medicines, including pramipexole, to treat Parkinson’s disease and RLS.”

The wording is fascinating — “…while taking medicines, including pramipexole … etc.”, clearly suggesting that all Parkinson’s and RLS drugs cause the side effect.

If that isn’t true, then it’s a lie. And probably an attempt to create wiggle-room for lawsuits like this one.

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