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June 19, 2009

FDA Soft-pedals Study Linking Child Deaths To ADHD Meds

Filed under: Big Pharma, FDA, pharmaceutical giants, pharmaceutical sales, pharmaceuticals — 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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June 10, 2009

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.

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June 8, 2009

Should OxyContin Be Banned? The Evidence Says “YES”

Filed under: Big Pharma, FDA, drug addiction, pharmaceutical giants, pharmaceutical sales, pharmaceuticals, prescription drug addiction — Rod Malcolm @ 12:39 pm

Since Purdue Pharma began producing and selling it in 1995, OxyContin has been implicated in many times more U.S. deaths than were caused by 9/11 and the Iraq War combined.

OxyContin is molecularly almost identical to, and acts in the body in the same manner as, the illegal street drug heroin.

Heroin — the target of billions of our tax dollars in drug-war funding, as any school kid knows, is the main source of income for Afghanistan’s tens of thousands of rural opium poppy farmers and their Taliban supporters.

So the question must be asked: “If heroin is illegal, why is OxyContin legal?”

In fact, that was the $64 million question asked of FDA officials at a Maryland public hearing recently on the dangers of the OxyContin. Not one of them could — or would — answer the question.

In 1898, heroin was introduced by the Bayer company as a substitute for morphine, which unlike morphine, said Bayer, was not addictive. It was widely promoted as an effective treatment for coughs and colds and even treatment for morphine addicts.

After various Acts and laws affecting it, heroin finally became an illegal drug in the United States in 1924, with passage of The Heroin Act. (The Bayer company, in 1913, had long since stopped manufacturing it.) The Act spawned a thriving black market, which persists to this day in one form or another.

It had taken a while for scientists to discover that heroin metabolizes into morphine in the body, and is devastatingly addictive. But tens of thousands of people had already learned how viciously addictive it is, thousands of them fatally, during the preceding decades. The Heroin Act was too little, too late.

OxyContin, from Purdue Pharma, has had an almost identical history: Made by a prominent drug company, which promotes it as non-addictive compared to other narcotics, but it soon becomes known as an addictive killer. More than a decade passes, while nothing is done, and thousands die.

And ironically, OxyContin becomes the drug of choice among heroin addicts, when their heroin supply is interrupted. In fact, thousands prefer it, because it offers pharmaceutical purity and predictability. And although it’s available at any pharmacy for someone with a gun or a knife, it’s also available in vast quantities on the street for a decent price — just high enough to ensure drug crime becomes a way of life for addicts.

In 2007, as we all know, Purdue and three top execs pled guilty in to misleading the public about the addictive nature of OxyContin. The company paid fines totaling over $634 million, including the individuals, who were also assigned hundreds of hours of community service.

But no Purdue exec went to jail, the U.S. Attorney allowed a Purdue affiliate to take the fall and be barred from doing business with the federal government, the FDA has allowed OxyContin to remain on the market, and thousands continue to fall victim to OxyContin addiction and abuse, injury, and early death.

Anyone with a shred of good sense and compassion should pop over to the Ban OxyContin petition website and sign the petition, and while there, browse the tales of tragedy associated with the drug shared by hundreds of visiting petitioners.

OxyContin is a viral epidemic that has infected every community in America. There are plenty of other drugs that work just as well than OxyContin, essentially just legal heroin, at controlling chronic pain, that do not cause widespread addiction and death.

Ideally, the FDA should remove OxyContin from the marketplace entirely. At the very least, OxyContin should be reclassified and prescribed only for chronic end-of-life pain.

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June 4, 2009

New FDA Transparency Task Force Could Save Lives

Filed under: Big Pharma, FDA, pharmaceuticals — Rod Malcolm @ 1:41 pm

If they do it right, and put human life ahead of Wall Street, greater transparency can only lead to greater assurance of public health — the essence of the agency’s mandate.

The FDA has formed a “Transparency Task Force” to recommend ways to improve public transparency concerning agency decisions, according to an FDA news release.

To support the transparency efforts, a June 24, 2009, public meeting has been scheduled to ask the public for recommendations on how the agency can make its activities and decisions “more available, useful and understandable”. A second meeting in the fall of this year is also planned.

“Our administration is committed to making government open and transparent,” said Health and Human Services Secretary Kathleen Sebelius in the release. “The Transparency Task Force will give the American people a seat at the table and make the FDA more open and accountable.”

The task force will investigate ways to make information more readily available to the public “in a manner compatible with the agency’s goal of protecting confidential information, as appropriate,” the FDA release said.

The announcement follows the new White House Open Government Initiative recently announced by President Obama.

Of course, The Pharmaceutical Research and Manufacturers of America, Big Pharma’s lobby group, insists that transparency could have a negative impact on public health.

Oh please. I think they’re referring to their bottom line, not public health.

Corporate secrets have always been the FDA’s stumbling block to transparency. The concept has been carried to extremes — too often to the serious detriment of public health.

In its coverage of the FDA announcement, the New York Times cites a widely prescribed heartburn drug found to be especially toxic to babies, a diabetes medicine and a painkiller that increased heart attack risks, and numerous antidepressants that increased suicidal thoughts — and behavior — in children and teenagers. And this is far from a complete list. There are dozens and dozens of instances where patient health has been put at grave risk because the public was not informed in a timely manner, or was ill-informed, about the dangers of drugs or devices.

Transparency will only improve patient care and public health. Researchers, medical journal publishers, and physicians, have said for years that greater transparency would save lives.

Quoting from a study published in 2008 in the Journal of the American Medical Association, The Times reports that five different companies in the 1990s were all testing similar blood substitute products, and each was found later to increase the risk of death.

“Had the findings been made public, the authors argued, some of the companies might have known sooner that their products were dangerous, sparing the lives of some patients in the studies,” the Times said.

FDA transparency: What a concept! It’s been a long time coming.

Yes, it’s a complex problem to protect real trade secrets while keeping the public properly informed. But the solution can be simplified. The new task force must consider one salient fact above all others: Pharmaceutical stock values cannot compare, ever, with the value of a single human life.

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June 1, 2009

OxyContin And Big Pharma’s Prescription Drug Bonanza

Filed under: Big Pharma, FDA, OxyContin addiction, pharmaceutical giants, pharmaceutical sales, pharmaceuticals, prescription drug addiction — Rod Malcolm @ 11:37 am

Between 1980 and 2003, Americans doubled their spending on new autos, tripled what they paid for clothing, but increased their spending on prescription drugs nearly 17-fold, thanks to the $billions Big Pharma spends on marketing. And with drugs like OxyContin in the mix, the entire world has fallen victim to the greatest epidemic in history.

There is a grass-roots movement afoot to restrict the use of the narcotic painkiller OxyContin to, at most, end-stage cancer patients and similar cases — or to ban it outright.

An online-petition to ban OxyContin is gathering thousands of signatures, and will be presented to the FDA and other relevant government agencies soon. We encourage all readers to hasten over and sign the petition now.

So why ban a painkiller that purportedly helps people get along?

It’s no longer a secret that prescription drugs can harm you. In the relentless search for the next billion-dollar blockbuster, Big Pharma’s aggressive marketing of unsafe drugs has become a painful thorn in the side for thousands of Americans.

Thousands of innocent people have been killed or maimed by drugs like OxyContin — drugs which were not just unsafe, but were heavily marketed by drug-makers who knew about its dangers and lied about it.

Big Pharma’s unethical, greed-driven marketing practices are creating an enormous backlash, a subculture of anti-pharma activists who have lost loved ones to the deadly side-effects of prescription drugs, or who have been injured themselves. We’re not talking about prescription drugs illicitly obtained and consumed recreationally — the majority of victims received legal prescriptions from family doctors.

One of the most publicized drugs in this category, OxyContin from drug-maker Purdue Pharma, ranks among the highest on prescription drug activists’ outrage list. Essentially legal heroin, OxyContin has caused or been involved in the deaths of thousands, and the devastation of addiction and ruined lives for many tens of thousands more.

It’s old news that Purdue was fined $600 million a couple of years ago for its lies about the dangers of OxyContin. And senior executives pleaded guilty to criminal charges, were personally fined more than $34 million, and were assigned to hundreds of hours of community service in drug rehab centers. Numerous other drug companies have also been charged with misleading the medical profession, regulators and the public about the dangers of their drugs. Lawsuits number in the many thousands.

As the horrific catalog of Big Pharma’s marketing lies and unethical excesses continues to be revealed in courtrooms across the land, citizens are calling for an end to the practice of promoting and distributing unproven, unsafe drugs — essentially turning the public into experimental guinea pigs.

And they want more punitive results from the legal system, which has thus far treated pharmaceutical companies and their complicit executives to slaps on the wrist, rather than the jail terms normally accorded drug dealers and admitted felons.

A heartless street dealer may be complicit in the harm of a few, but Big Pharma’s list of victims is in the hundreds of thousands. In any other situation, such statistics are considered genocide. In this light, corporate drug dealers deserve far more severe punishment than street dealers.

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