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How Many People Have To Die Before The FDA Takes Action?

Filed under: FDA, pharmaceutical sales, pharmaceuticals, Big Pharma, prescription drug abuse, prescription drug addiction — Rod Malcolm @ 9:06 am

The “King of Pop” Michael Jackson is dead at only 50, joining many other celebrities, and thousands of others, who’s untimely deaths have been associated with painkillers like Demerol and OxyContin. What is it going to take for the FDA to end the prescription drug carnage in this country, especially the deadly OxyContin epidemic?

The unexpected and tragic death of Michael Jackson, allegedly addicted to painkillers for some 20 years or more, emphasizes the urgency with which the FDA should address the problems surrounding this country’s lax prescribing regulations, easy availability, and widespread abuse of opioid painkillers like OxyContin.

Early reports of the pop star dying less than an hour after receiving an injection of pethidine, or Demerol as it is better known, have since been denied by lawyer representing the pop star’s doctor. Whether true or false, numerous cases of sudden cardiac arrest have been traced to “serotonin syndrome”, a sudden, overwhelming and toxic excess of serotonin activity that can lead to failure of the central nervous system, which can then progress to cardiac arrest.

Serotonin syndrome, or toxicity, can be caused by dozens of drugs, including prescription drugs, over-the-counter remedies, and popular herbal preparations. Whether used therapeutically or recreationally, they can either bring about the deadly condition directly, or inadvertently through interactions with other drugs.

Jackson family members, friends, employees and co-workers have all been quoted in the media about Jackson’s long-term dependence on various prescription drugs. Some have alleged abuse, and even addiction, especially to opioid painkillers like Demerol and OxyContin. The star’s drug use was reportedly to help relieve chronic back and leg pain caused by dance injuries.

The drugs most commonly associated with serotonin toxicity include:

* Opioid painkillers
* Antidepressants
* Central nervous system stimulants
* Triptans
* Psychedelics
* Various Herbs
* Numerous other drugs and remedies

Jackson, who reliable family sources are saying suffered from a 20-year addiction to Demerol, OxyContin and other opioid painkillers, was also reportedly taking benzodiazepines and/or antidepressants along with the painkillers before his death.

Dr. Deepak Chopra, spiritual adviser and physician, and a friend of Jackson’s for many years, told Canada’s CTV News last weekend that the pop star sought and found supplies of narcotics from multiple physicians. Chopra said his suspicions that the singer was addicted were aroused in 2005, when Jackson asked him for drugs. Chopra says he refused, but learned later that Jackson was “able to find enabling physicians who co-operated with him. That’s something that people who are addicted are very good at.”

$50,000 A Year Prescription Drug Bill?

In a related story, the Associated Press reported back in January that Jackson owed a Beverly Hills pharmacy $101,926 for prescription drugs, covering roughly the years 2005 and 2006, a debt the pop star finally settled in 2007. This represents annual prescription drug costs of over $50,000! The average senior with chronic conditions in the U.S. spends an average of about $2,000 a year for prescriptions, the AP said. Whether addicted or physically dependent, there can be little doubt that the singer was consuming plenty of prescription drugs during the years, months, days and probably the hours leading up to his death.

Many questions remain about the exact cause of Jackson’s death. Toxicology screens will take four to six weeks, according to the Los Angeles medical examiner’s office. Should it be shown that the singer died from cardiac arrest, as has already been indicated, it will be no surprise to learn that serotonin syndrome, or some other central nervous system failure, will be directly attributed to prescription drugs — if not the pethidine he was alleged to have taken, then another opioid painkiller like OxyContin, or some lethal combination of drugs.

The most famous serotonin syndrome death occurred in New York in 2003, when the daughter of a prominent New York family, Libby Zion, died of cardiac arrest following treatment with pethidine by weary, overworked doctors who failed to first establish whether or not Libby was taking any other medications. It turned out she was, which led to a fatal drug interaction. The result was new state legislation, dubbed “the Libby Zion law”, regulating the number of hours that physicians can remain on post in New York State hospitals.

Pethidine acts exactly like morphine in some ways, affecting the same receptors in the brain. In many countries of the world, including Australia, the use of pethidine has been severely limited, or banned completely. The FDA should provide at least as good protection from deadly opioid painkillers for American citizens.

Deaths across the country have soared dramatically in recent years from prescription opioids, with OxyContin the most flagrantly abused. Deaths, widespread addiction and ruined lives from OxyContin dwarf those associated with any other opioid painkiller. The active component of OxyContin, called oxycodone, has been found to be even more likely to cause dangerous drug interactions than even pethidine and most other, if not all other, opioid painkillers.

For these reasons, a petition calling on the FDA to ban OxyContin, sponsored by a concerned pharmacist and a drug detox specialist who routinely sees the worst that OxyContin can do, has attracted nearly 3,000 signatures. We urge everyone who wants to see an end to the OxyContin carnage to sign the petition. And be sure to read some of the dozens and dozens of harrowing accounts from signatories, who share the personal tragedies that OxyContin has wrought in their lives.

The FDA is already holding public hearings on the problems associated with OxyContin. Enough signatures can help motivate the FDA to take steps to curtail, or better, outright ban this dangerous drug.

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Unsealed Documents Reveal More Unethical Marketing By Lilly

Filed under: Eli Lilly, Zyprexa, FDA, Big Pharma — Rod Malcolm @ 9:46 am

No matter how many lawsuits against Big Pharma we’ve seen in recent years, there doesn’t seem to be any end to them in sight. Ely Lilly, the biggest maker and pusher of psychiatric drugs, is currently under the gun from health insurers alleging massive overpayments due to the company’s illegal marketing practices.

Over the past month or two, Bloomberg News has been pretty much scooping everyone else on the grisly details surrounding the gigantic overpayment lawsuit filed by health insurers against Ely Lilly, for its unethical marketing practices of its antipsychotic drug Zyprexa.

The insurers contend that Lilly should pay as much as $6.8 billion in damages for downplaying Zyprexa’s health risks, and for illegally marketing it off-label to increase profits.

So far, about 10,000 pages of internal Lilly documents have been unsealed as part of the suit, and Bloomberg’s reporters have been sifting through them in great detail.

Bloomberg has found documents fully supporting the charge that Lilly brazenly and illegally marketed its antipsychotic Zyprexa off-label for dementia, knowing full well that the drug did nothing to help the condition, and in fact was actually killing elderly patients.

Lilly has already settled with the feds and more than 30 states, pleading guilty to a criminal misdemeanor in January, over the off-label marketing of Zyprexa for use in the elderly. But these new documents remove any vestige of doubt that the company was culpable.

The documents also reveal that a subsidiary of CVS Caremark Corp., the largest U.S. drug-store chain, used its extensive access to health care providers to market Zyprexa directly to mental health prescribers — and was paid for that by Lilly — all while simultaneously under contract to bargain with Lilly on behalf of health insurers.

That’s really got the health insurers up in arms.

In an April 30 filing, Lilly said it had settled suits involving about 32,670 individual claimants alleging damages from Zyprexa, including serious weight gain and diabetes. Some 140 claims are still unsettled, but Lilly has already paid out about $1.2 billion for the individual settlements.

Whether all the suits in recent years brought against Big Pharma by patients alleging damage, by irate insurers alleging overpayment, or by state and federal governments alleging both overpayment and various civil and criminal misconducts, the suits reveal that almost all the time the charges were well-founded.

And now, along with Big Pharma, we can no longer trust our corner drug stores. Our friendly pharmacist is now involved, however indirectly, in the endless litany of crimes against humanity that have permanently sullied Big Pharma’s reputation.

There are two things we must keep in mind if we are ever going to see real changes.

First, Big Pharma’s callous disregard for patient welfare, placing profit ahead of all else, is endemic in the industry. This fact should be trumpeted long and loud.

Second, people were killed outright by Zyprexa. The same is true for many other drugs from numerous drugmakers. Yet Lilly pleaded guilty to a “criminal misdemeanor”, and no drugmaker has spent a single day in prison for murder or manslaughter.

The problem is this: If a drug company is found guilty of a felony, the law states that they can’t do business with the federal government — so the enormous Medicare and Medicaid market is lost, meaning they are essentially out of business. However, if all Big Pharma has to do is pay a fine when they’re caught, like Purdue Pharma was over the OxyContin debacle, then it becomes just a “cost of doing business.”

But slaps on the wrist will never bring about the reform in Big Pharma that is so urgently needed. For a serious discussion of the thorny situation surrounding Big Pharma crimes, and specifically OxyContin and the FDA, please read Different Justice For A Drug Dealer, by Novus Detox director Steven Hayes.

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FDA Soft-pedals Study Linking Child Deaths To ADHD Meds

Filed under: pharmaceutical giants, pharmaceutical sales, FDA, pharmaceuticals, Big Pharma — Rod Malcolm @ 11:00 am

Kids haven’t been beaten down into ant-like goody-goody social behavior. They aren’t adults, shouldn’t be expected to behave like adults, and don’t deserve to risk death because of the irrational expectations of lazy parents and educators.

The FDA issued a “safety communication” this week admitting there “may be an association” between the use of ADHD amphetamine meds, like Adderall, Concerta, Vyvanse and Ritalin, and sudden death in healthy children.

The agency’s statement follows publication in the American Journal of Psychiatry the findings of a study funded by the FDA and the National Institute of Mental Health (NIMH) that compared sudden death among 564 previously healthy kids on the meds, and 564 kids, also on the ADHD meds, dying in car accidents.

Results: Drug-only unexpected deaths, 10; car accident deaths, 2.

In spite of frequent case reports raising concerns since the early 1990s that stimulants increase the risk for sudden unexplained childhood death, the FDA minimizes the study, and says more comprehensive studies are forthcoming.

Said the FDA: “Given the limitations of this study’s methodology, the FDA is unable to conclude that these data affect the overall risk and benefit profile of stimulant medications used to treat ADHD in children. FDA believes that this study should not serve as a basis for parents to stop a child’s stimulant medication.”

In spite of their findings associating the meds with sudden childhood death, the study’s authors also downplayed the risk, using mushy statements such as: “Stimulants are not innocuous….However, it is equally clear that…it is not possible to quantify the risk beyond estimating that it is very small.”

Let’s say it again: The risk of sudden unexplained death of children is “very small”, and shouldn’t serve as a basis to stop a child’s stimulant medication.

Sorry, but the risk of sudden death is never too small to ignore, especially in kids who are given no choice in the decision. And the risk is off the charts considering many studies, both here and abroad, that have debunked ADHD as a valid condition, and one only treatable with powerful and dangerous drugs.

For example, the Netherlands has already denied the validity of America’s ADHD diagnoses, and other countries including the UK are at least in partial disagreement. ADHD is primarily an American social-cultural phenomenon, jumped on years ago by the profiteering, drug-pushing Big Pharma-psychiatric consortium, much to the detriment of American children, families and American society in general.

Of course, the authors of the current study, being American psychiatrists, are fully sold on the validity of ADHD, and ipso facto, the validity of treating kids with dangerous amphetamines. They blandly estimate that 2.5 million kids are now on ADHD meds in America — a low-ball figure according to some estimates.

And they quote that figure as some sort of proof of validity for ADHD and the drugging of an entire generation of children, rather than for what it really is — a horrifying statistic showing how far the psychs and Big Pharma are taking the hellacious idea to drug America’s population from the cradle to the grave.

Adding to the ADHD $billions rolling into Big Pharma’s coffers are the tens of thousands of adults now being encouraged to leap onto the “I’ve-got-ADHD-too-please-pass-the-amphetamines” bandwagon. Which, by the way, only further legitimizes the drug-our-kids movement.

It’s pathetic, really. I wouldn’t put any child on amphetamines for any reason short of an emergency life-saving treatment, if any condition might require it.

The millions of American parents whose kids already have been targeted by school officials, nurses and physicians for an ADHD prescription should insist on the full battery of heart and blood tests before agreeing to it.

Wait, no, they should just disagree to it, period. Instead, they should research the validity of ADHD itself, without listening to the psychs, Big Pharma, and their official spokespeople on this subject, the FDA.

Kids are kids — people who haven’t been beaten down yet into ant-like goody-goody social behavior. They aren’t adults, and shouldn’t be expected to behave like adults. And they don’t deserve to be forced to risk death from dangerous drugs for any kind of behavior.

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Movement To Ban OxyContin Gathering Momentum

Filed under: Big Pharma, FDA, OxyContin addiction, heroin addiction, prescription drug abuse, prescription drug addiction — Rod Malcolm @ 2:19 pm

Massachusetts State Senator Steven Tolman calls the OxyContin / heroin problem in his state a deadly epidemic.

In an op-ed piece in the Boston Globe recently, Steven A. Tolman, Democratic senator from Brighton, Mass., called the OxyContin and heroin addiction problem in his state “the deadly epidemic no one’s addressing”.

Sen. Tolman describes the widespread horror caused by OxyContin and heroin — essentially interchangeable drugs — and how the lack of available treatment is causing devastation.

“Recently, the OxyContin and Heroin Commission, established during the 2007-2008 legislative session, held the second in a series of public hearings throughout the state,” Tolman writes. “The commission’s purpose is to investigate the levels of addiction to OxyContin and heroin, study the laws regarding treatment, gauge the epidemic’s cost on state services, and offer solutions.

“We’ve heard from parents who have emptied bank accounts or remortgaged homes paying for private treatment because insurance won’t cover long-term care. Families have described reviving their dying children with Narcan [ed.: a brand of naloxone, a drug used to counter the effects of opioid overdose] or having them arrested for felony drug charges to get them off the streets. Otherwise good people appear in our courtrooms, end up in jail or the ER, or spend a lifetime on harm-reduction medication because there is no clear path to recovery,” he added.

Tolman’s experience in Massachusetts is mirrored in almost every state in the Union. The facts are, of course, that OxyContin is molecularly almost identical to illegal heroin, is just as addictive as heroin, is metabolized in the body into morphine (another illegal drug), and has become in many parts of the country the main gateway drug to heroin, and even preferred by long-time heroin addicts to heroin itself.

Back in February, at a public meeting called by the FDA’s Opioid Risk Evaluation Mitigation Strategy (REMS), Novus Detox’s medical director Steve Hayes asked the panel the same question he had been asked by a Novus patient coming off OxyContin:

“If heroin is illegal, why is OxyContin legal?”

No one on the FDA panel had an answer.

If you don’t have an answer either, you should take yourself right now to Ban OxyContin and sign the petition. More than 2,600 others have already done so.

And if you’re in doubt about signing the petition, read through some of the hundreds of comments left by petitioners telling stories of devastation and death at the hands of OxyContin.

Our Views

July 2, 2009

How Many People Have To Die Before The FDA Takes Action?

July 1, 2009

Unsealed Documents Reveal More Unethical Marketing By Lilly

June 19, 2009

FDA Soft-pedals Study Linking Child Deaths To ADHD Meds

June 10, 2009

Movement To Ban OxyContin Gathering Momentum