FDA 'WARNS' ADHD DRUGMAKERS — AGAIN

RECENT TV ADS AND PROMOTIONAL MATERIALS FOR ADHD DRUGS, INCLUDING STRATTERA, CONCERTA & ADDERALL ARE 'DECEPTIVE, FALSE, OR MISLEADING," ACCORDING TO A GOVERNMENT ACTION SPURRED ON BY A CONSUMER LAWSUIT. THE FDA SAYS THAT ALL OF THE ADHD DRUGS BEING ADVERTISED — INCLUDING CELEBRITY TY PENNINGTON'S ENDORSEMENT OF STRATTERA AS A 'TRANSFORMATIONAL' DRUG — "OVERSTATE THE SAFETY AND EFFECTIVENESS" OF STIMULANT DRUGS.

WASHINGTON -(Dow Jones)- The Food and Drug Administration said Friday certain advertisements and other promotional materials for attention-deficit disorder drugs like Adderall, Concerta and Strattera were misleading and omitted important safety information.

The agency sent formal warning letters to Eli Lilly & Co. (LLY), the maker of Strattera, and a U.S. unit of Shire Pharmaceuticals Group PLC (SHPGY), which makes Adderall, telling the firms to immediately stop disseminating "false or misleading" material about the drugs, which are approved to treat attention deficit/hyperactivity disorder, or ADHD. The agency also sent three so-called untitled letters to Johnson & Johnson (JNJ), which makes Concerta, and to two other ADHD drug makers. All of the letters were posted to the FDA's Web site Friday.

Warning letters are considered more serious and allow the agency to take regulatory action such as seizing products if companies do not comply with FDA requests. Most companies address concerns raised by the FDA without the agency taking additional action.

In Shire's case, the FDA said some material on Adderall's Web page as well as a YouTube video featuring celebrity Ty Pennington was misleading. The agency said the Web page and the video "raise significant public health and safety concerns" because they overstated the drug's effectiveness and omitted important safety information.

For example, the video showed Pennington stating Adderall changed his life and that the drug was "truly a transformation."
The FDA said "this video overstates the efficacy of Adderall XR by implying that this product will transform patients' lives and improve their confidence." The agency also said Shire violated FDA regulations for not submitting the YouTube video to the agency prior to using the video.

In a statement, Shire said the video was posted in error and was meant to be posted on Shire's site with the appropriate dosing and indication information for Adderall. "We are committed to complying with both the letter and the spirit of the FDA regulations in the promotion of our medicines," the company said.

Eli Lilly received a warning letter for Strattera after the agency reviewed material used by sales representatives. The agency said the material overstates how effective Strattera is, omits material facts and minimizes important risks associated with Strattera.

"These violations are concerning from a public health perspective because they suggest that Strattera is safer and more effective than has been demonstrated," the agency said in the letter.

A Johnson & Johnson spokeswoman said the company would "work closely with the FDA" to address issues raised in its letter. A request for comment left late Friday with a Lilly representative was not returned.

CLASS IS IN SESSION

SIXTEEN YEARS AGO, WITH ALL OF HIS SNARKY WISDOM, Ross Perot articulated what was to become a classic line in Presidential politics. “That giant sucking sound,” he said with characteristic good-ole-boy charm, “is the sound of jobs going to Mexico.” He was talking about NAFTA — the North American Free Trade Act, and his words came to symbolize and represent everything that has gone wrong for the Middle Class in America over the past 20 years. In 1992, Perot earned 18.9% of the popular vote, making him the most successful third-party presidential candidate since Theodore Roosevelt in 1912.

Long ago and far away, the Middle Class built America as we know it now. When my Dad finally retired in the 1980s, he was given a modest pension in return for his 27 years of service. It made it possible for him to support seven children, to own his own home, enjoy decent healthcare, and to live with a modicum of dignity until his death in 2007. Today, it’s 401(k)s and “best of luck to you” as you roll the dice and pray that con artists aren’t in control of your retirement accounts. In today’s market, that’s not exactly a solemn-clad guarantee.

During this political “silly season” we hear a lot about Liberals and Conservatives. We hear a lot about “liberals who want to raise your taxes,” and “small government.” But we don’t hear much about how to fix the nightmare that has befallen our middle class — and we sure as hell don’t hear about how to restore what made America great: the ability to own a home, to empower the majority, and give them back the security they once had in their grasp.

So for all who rail that all government protections against fraud run contrary to the free market system, and for those who equate all government programs as “socialism,” well, perhaps New York Times Finance reporter Gretchen Morgensen said it best on Bill Moyers Journal this past Friday. “I can only imagine what the right wing would be saying if a liberal Democrat had decided to nationalize the biggest insurance company in America.”

Imagine, ah yes. . .and then grasp how imperfect the idea of free-market-at-all-costs has become.

The ugly thing about this, Morgensen states, is that the $1 trillion bailout is testimony to the fact that we privatize the financial industry in the “good times,” ala Gordon Gekko from the film "Wall Street" — and then we socialize it (through the forced use of our tax dollars), when times are bad. . .times like now. “Greed is good,” was the famous line from Michael Douglas’ character in Wall Street, and that mantra is alive and well today.

For in modern times, that greed comes complete with a golden parachute worth tens of millions of dollars for the very people guilty of ripping off the middle class in the first place. “When things are going well, management makes out, shareholders make out. . .the private sector people do well. But when something goes wrong — when decisions are made that turn out to be bad decisions, the U.S. taxpayer has to take on the problem,” says Gretchensen.

This hypocrisy in endemic in corporate America, which, since the Reagan years, has demanded de-regulation and the removal of any government oversight within the financial sector. It is true with Big Pharma, which receives corporate welfare in the tens of billions of dollars annually, and it is true elsewhere, as this week has proven.

The shadowy financial markets, which created “products” like the murky world of derivitives (for example, oil speculators who “predict” what the price of oil will be on any given day, thereby affecting its price) — and the mass sell-off of sub-prime mortgages to a crazy-quilt of faceless entities, these events betray the folly of our ways. This is the dark underworld of American capitalism, circa 2008, a place where rules don't apply to the kingmakers. When Federal Reserve chief Alan Greenspan adamantly fought for no regulation on this new brand of capitalism, small and moderate investors were literally forced to take more risk without ever knowing it, throwing good money after bad, into a cesspool of conjecture and greed.

So the middle class, more vulnerable now than at any time since World War II, gets hit both ways: they no longer have the pensions that promised a modest return for retirement, and they have no choice but to make riskier investments through 401(k)s. . .and hope for the best. In other words, middle class society is more dependent on the financial markets than at any time since the “Greatest Generation,” and that, my friends, has proven to be a very sobering reality indeed.

It is “the greatest story never told,” says author Kevin Phillips, who also appeared with Moyers. As he explains, 21% of our GDP in now directly tied to the financial services sector. Since the 1980s, we have rescued the financial industries time and again. It began with the Savings & Loan scandal — one that engulfed Senator McCain and four other Senators. It continued in 1987 when there was another financial sector crash-and-grab phase, only to be bailed out by taxpayers. From 1986 – 2006, in fact, Alan Greenspan, Congress and others have approved turning on the spigots for some $46 TRILLION of our hard-earned money to bail out those who held all the keys to the Temple.

And for what? Justice? Equality? Financial security for the masses?

No.

We did so only to resurrect Gordon Gekko. . .and burden the middle class with his debt.

IF I COULD ASK ONE QUESTION of either Mssrs. McCain or Obama at one of those “town hall meetings,” it would surely be the following: “Senator, if elected, do you commit — here and now — to rebuild bridges, roads, and ports using the labor of middle class and poor Americans — the very people you profess to care so much about?"

Some might view that as a rather “socialist” question, one that undercuts the free market system and its ability to do its work unfettered. I, however, see it though a different lens. If we are ever to rebuild the middle class and restore our true wealth as a nation, we must first stop the “giant sucking sound" emanating from the financial markets. . .and we must provide Americans with the ability to protect themselves outside of the reckless whims and greed of Wall Street. It is, after all, our money and our personal sovereignty at stake.

As Ross Perot might say, "Y'know what I mean?"

What I’m Watching: Generation RX

By Jason Buchanan, ALL MOVIE GUIDE

Last week I received an unexpected telephone call from Emmy-nominated documentary filmmaker Kevin P. Miller. Apparently, the health-conscious filmmaker and President/CEO of Well TV had stumbled across the All Movie Guide pages for his previous films, and was seeking to get the word out about his latest project – a passionate and informative look at the questionable methods often used to diagnose and treat children deemed to be afflicted by the behavioral disorder du jour. The call couldn’t have come at a more serendipitous time: Just two nights prior, my parents-in-law and I had engaged in an extended conversation about this exact topic, and having witnessed firsthand the shattering effects that Prozac had on a close family friend, the subject was still very much fresh in my mind when the telephone rang. Kevin seemed like a very sincere guy, and much to my surprise, he asked if I would be willing to take a look at his latest documentary, Generation Rx.

The following week I received an envelope containing the film and, being curious as to what Mr. Miller would have to say about the topic my in-laws and I had discussed just a few days back, I immediately went home and fired up my DVD player. Eighty minutes later, as the screen went black and the credits began to roll, I found myself struggling to process the heartbreaking stories and blistering testimonials that had just flashed so forcefully before my eyes.

Anyone who knows me personally knows that I’m an avid horror geek, but few films have genuinely frightened me as much as Generation Rx. Back when I was in high school, my parents took in a close friend whose home-life quickly turned violent after her mother began taking Prozac. The experience made me worry about the increasingly prolific use of pharmaceutical drugs in treating so-called “behavioral disorders.” Not only in terms of the averse effects they may have on the patient, but also in terms of their ability to inflict serious damage on those surrounding the patient. It was obvious to me that so-called “mood stabilizers” and lifestyle drugs of this nature could destroy entire families when taken under the right (or wrong, as it may be) circumstances.

Of course, I had read the articles and seen the news magazine specials about ADHD, but it wasn’t until watching Generation Rx that the implications and complications of diagnosing this disorder became so undeniably clear to me. Reactionaries and moralists like to point the finger at Marilyn Manson and violent video games when students load up on guns and head out on a shooting spree, but what if the true catalysts for these and other youthful tragedies is something far more sinister; the result of something we’re doing as parents that’s actually intended to help our children, but instead ends up harming them in ways we could have never anticipated? While the answer to this question may be difficult for some parents to fathom, as a father I believe that it’s one worth asking.

Generation Rx is a film that every parent should see, especially if they’re considering putting their child on any form of antidepressant or mood-altering drug. I’ll have a full review up for the film shortly, but for now I encourage those seeking to learn more about Generation Rx to head on over to filmmaker Kevin P. Miller’s blog, or e-mail him directly at Kevin@CommonRadius.com.

ARE WE ALL ON DRUGS?

IT'S THE STUFF CONSPIRACIES ARE MADE OF, and yes, there may be an element of that involved here as well, but the situation seems far more dangerous every single day. When I was filming GENERATION RX, I met a British psychiatrist and we talked about the revelation that Prozac had been discovered in the Thames River. . .and had entered the water supply consumed by millions of Brits.

"Are people in London really that depressed?" I asked him, somewhat sheepishly. "No, no. . .no," was his response while laughing.

Over the past few years, events have proven that concern over drugs excreted through the user's urine were not limited to the UK. In America, millions of pounds of unused pharmaceuticals are being flushed down the drain, and we are "pumping contaminants into America's drinking water," according to an investigation by the Associated Press.

Maybe THIS is what they mean by "the trickle-down" theory: for the 50 million+ Americans who are uninsured, the healthcare delivery option of choice is to. . . just turn on the water faucet!

From the AP Investigation: "One thing is clear: The massive amount of pharmaceuticals being flushed by the health services industry is aggravating an emerging problem documented by a series of AP investigative stories - the commonplace presence of minute concentrations of pharmaceuticals in the nation's drinking water supplies, affecting at least 46 million Americans."

The AP series follows one by the New York Times last Spring, the BBC last year, the UK's Guardian newspaper and probably countless others. Millions of tons of narcotics, antipsychotics, antidepressants, stimulant drugs and more are being ingested by children, the elderly, and well, ALL of us who do not use some kind of sophisticated water purification system.

Yikes.

Normally I never try to push "products" onto my readers, but it seems clear that anyone who can afford a water purification system should buy one. I got mine (20 years ago) through a company based in New York City, but there are good ones nationwide. If you live in New York or the Tri-State area, though, call Jim Artress at Water and Air Service Specialties. He is extremely knowledgeable and reasonably priced, even though he services dozens of New York's top celebrities. He can be reached at 646-325-4339.

If you cannot afford a professional system, try to protect yourself by getting an inexpensive and portable purification system. They are available at Home Depot's and other stores throughout the U.S.

COURT FINES COMPANY $500M — ORDERS 25 YEAR JAIL SENTENCE

This is an open letter to Lorraine Heller, a reporter for Decision News, who wrote a story about the recent sentencing of Berkeley Nutraceuticals, a dietary supplement company located in Ohio. Ms. Heller is also seeking comment on this story from readers, as you will note below.

Ms. Heller writes:

"At the end of last month, the founder of a US supplements company received the most severe punishment yet to be handed out for fraud in the industry: a 25-year jail sentence. NutraIngredients is calling for comments on this historic decision." You can see the article at Nutraingredients.com. You can write Ms. Heller at: lorraine.heller@decisionnews.com



Dear Ms. Heller:

As a documentary filmmaker who has followed and reported on the industry and various "medical freedom of choice" issues, I wholly disagree with the severity of the sentence against Berkeley. Good God. 25 years in jail. . .and the company was ordered to forfeit $500 million?"

Whether or not Berkeley "sullied" the name of the industry or not — which is questionable — my investigation revealed that the Company had indeed offered to pay a refund anyone who was displeased with the product, no questions asked.

Since the lofty days of DSHEA, which I featured in my film "Let Truth Be The Bias" in 1994, the FDA and FTC have ignored the will of Congress and refused to implement the protective measures written into the Bill itself. Rather, these two agencies have continued the dangerous and illegal pattern of creating two separate sets of rules for enforcement: allowing drug companies to knowingly inflict harm upon consumers, while penalizing dietary supplement companies with outrageous fines and now, ridiculously inappropriate jail terms for products that never harmed one person who took them.

My latest documentary film, called Generation RX, will be released in October. As the film clearly demonstrates, drug manufacturers and their regulatory watchdogs at the FDA colluded to hide the dark facts about both stimulant and antidepressant drugs — drugs that are routinely given to millions of children. The film also uncovers how FDA ignored stark warnings about Ritalin from the U.S. Drug Enforcement Administration (DEA), and provides incontrovertible evidence that FDA — years prior to the drug’s approval in 1989 — was aware of suicides, murder and other violent acts attributed to the antidepressant Prozac®. Despite this damning evidence to the contrary, FDA and medical doctors have continued to argue vehemently that “no scientific evidence of harm exists” from these powerful drugs, and have imposed no fines or proposed any legal remedies for families who lost loved ones to the horror of murders, suicides and horrible adverse reactions. In fact, they have done just the opposite, and have helped block efforts to protect consumers.

This latest, sad chapter in FDA/FTC regulatory bullying should serve as a wake-up call to all Americans that another fight is needed to preserve the hard-fought victories of DSHEA. Otherwise, medical freedom of choice will be lost forever — and the health of our nation will be poorer than ever.

Kevin P. Miller
WRITER/PRODUCER/DIRECTOR
Cleveland, OH.