What's A Trillion Dollars Look Like? If We're Going To Waste It, We Ought To Know.

So What's a Trillion to ya?

Well, here's what One page tells us a $Trillion Dollars Looks Like.

A packet of one hundred $100 bills is less than 1/2 thick and contains $10,000. Fits in your pocket easily and is more than enough for week or two of shamefully decadent fun.

Believe it or not, this next little pile is $1 million dollars (100 packets of $10,000). You could stuff that into a grocery bag and walk around with it.

While a measly $1 million looked a little unimpressive, $100 million is a little more respectable. It fits neatly on a standard pallet…

And $1 BILLION dollars… now we’re really getting somewhere…

Next we’ll look at ONE TRILLION dollars. This is that number we’ve been hearing so much about. What is a trillion dollars? Well, it’s a million million. It’s a thousand billion. It’s a one followed by 12 zeros.

You ready for this?

It’s pretty surprising.

(And notice those pallets are double stacked.)

So the next time you hear someone toss around the phrase “trillion dollars”… that’s what they’re talking about.

Congress is yammering about throwing $1 Trillion More into an already Malfunctioning Healthcare System as "Reform", ...... to "Hold Down The Costs", through buying More, of the Same Malfunction we have now.

And the Real cost may well greatly exceed $1 Trillion, over the next 10 years, as we Further degrade our Healthcare through emulating Systems like the French have.

Health Care Bill Would Actually Cost 4 Trillion

Phillip Klein on American Spectator clears up some numbers for us by reporting this:


Health Systems Innovations Network, a consulting group, went ahead and estimated the full cost of a bill that included the subsidies and Medicaid expansion, and reduced the number of uninsured by 99 percent. With these assumptions, they estimated the cost at a staggering $4 trillion over 10 years, resulting in the shift of 79 million Americans to government-run health care. The report does not include possible tax increases or spending offsets, but notes that, "this would be a challenging proposal to finance with budget neutrality.

See full article here.

To help put this in perspective, let's consider what 1 trillion looks like.

A stack of one trillion one-dollar bills would reach 68,000 miles into space. If you spent $1 million dollars a day from the day Jesus was born until now, you would only have spent about three quarters of a trillion. If you laid one trillion one-dollar bills end to end, it would make a chain from the earth to the moon 200 times. One trillion dollars would stretch nearly from the earth to the sun. It would take a jet flying at the speed of sound, reeling out a roll of dollar bills behind it, four years before it reeled out one trillion dollar bills. A million seconds is 11.5 days. A billion seconds is 32 years. A trillion seconds is 32,000 years.

Now multiply this by 4. Kill this bill.

US Govt Mails $timulus Bucks, To 4,000 Cons

Boston Herald.com has:

Feds: Stimulus Money Sent To 4,000 Cons

One day after the Herald reported some surprised Bay State inmates - including murderers and rapists - were cashing in $250 stimulus checks, federal officials revealed the same behind-bars bonus was mailed to nearly 4,000 cons nationwide.

A federal watchdog is now probing how the cons were cut the checks. The same cash also may have been sent to fugitive felons, people kicked out of the country and even individuals now deceased. ....

, .... Among the 23 inmate recipients in Massachusetts mentioned in yesterday’s Herald are a prisoner convicted of first-degree murder, three prisoners jailed for second-degree murder and five convicted rapists, according to the state Department of Correction.

Is This our Same Federal Govt which wants to Believe that IT, will improve Your Health care, by "Holding Down Costs" through Blowing Another $TRILLION BUCKS, over the next ten years into a system that Kills at Least 85,000 patients a year, & wastes $35 Billion per year, through Sheer Stupidity?

And, we Still have Govt Money to Poison Children, the Elderly, and all stops in between, who Think, or Speak thoughts which are deemed 'Ill' by Ideates, who are still 100% Incompetent to cure Any of their own, Junk Science Opinions.

Senate Finds U Minnesota Surgeon Took $1.2 Million From Medtronic

Star Tribune.com has:

Consulting Flap Drives U Surgeon From Board

"Polly, the head of the U's spine surgery department, has been a target in a congressional investigation exploring the financial relationships between doctors and medical device makers. Initiated by Sen. Charles Grassley, R-Iowa, the probe found Polly was paid $1.2 million between 2003 and 2007 by the Fridley-based medical technology company for consulting, expenses and honoraria.

Such relationships are common -- and legal -- in the $140 billion medical technology industry. Doctors offer medical device makers advice on how to improve products; sometimes they are paid royalties for inventions commercialized by device manufacturers.

Grassley's investigation revealed that by 2007 Medtronic paid Polly $4,750 a day, or $594 an hour, with an annual cap of $400,000, and that Polly gave congressional testimony on spine surgery research without disclosing his relationship with Medtronic."

Read the whole article


For analysis of this phenomena - IE: What Medical Ethics Really Means Today - see University Diaries:

Dr Polly And Fair Market Value

"Well, we know that he billed Medtronic at these rates for a Medtronic person simply entering his office. He billed them when he called them to chat, billed them when he did this, when he did that… Again, it’s very hard to quantify these things. Does a whore charge for taking off her bra and making small talk? Or is she just charging for the act itself?"

Senator Grassley Moves To Block Ghostwriting

AHRP has:

Sen. Grassley Moves to Block Ghostwriting

Until now, American medicine as a profession has turned a blind eye and deaf ear to ghostwritten journal articles that have corrupted the integrity of the medical literature, displacing science-based medicine with corporate propaganda masquerading as science. The New York Times reports (below) that Senator Charles Grassley has set about to put a stop to this fraudulent practice--a practice that undermines the integrity of medical journals, and by extension, the practice of medicine.

Shame on academic medicine for putting its collective head in the sand by failing to use its professional leverage to sanction academics who abuse their credentials--and sully the reputation of their institutions--by penning their name to ghostwritten, industry propaganda masquerading as science.

Shame on academic medicine--including, universities, the National Institutes of Health, and medical journals--for failing to take action against doctors who pen their name to ghostwritten articles for cash. Academic physicians who sign off on ghostwritten articles are participants in fraud, helping companies mislead practicing physicians who look to journals and academic "authorities" for guidance in their clinical practice.

How unseemly that medicine as a profession and prestigious academic institutions, the recipients of public substantial public funding, have not taken any steps to discipline faculty members who engage in scientific fraud.

Evidence of the breadth of the practice has come to light only gradually, in the process of litigation: most recently in court released documents released over hormone replacement drugs made by Wyeth. Those documents reveal that three professors who were authors of Wyeth-financed ghostwritten articles are on the faculty of Columbia University. The three are also recipients of N.I.H. grants, according to the letter from Mr. Grassley.

The Times reports that not until they universities were threatened with Congressional action--i.e., withdrawal of federal support, did they even acknowledge the issue:

Universities have been slow to react to evidence about the extent of the practice. In December, for example, Sen. Grassley released documents indicating that DesignWrite had drafted an article that was published under the name of a gynecology professor at New York University School of Medicine.

Eight months later, Deborah Bohren, the vice president for public affairs at New York University Langone Medical Center, said the school had not looked into the matter:
“If we had received a complaint, we would have investigated. But we have not received a complaint.”

This attitude demonstrates the inadequacy of conflict of interest disclosure policies, underscoring the need for Congressional enforcement requirements to prohibit conflicts of interest. Congress must use its persuasive leverage--its power of the purse--to restore the integrity of medicine. Requiring disclosure alone, as bioethicist Carl Elliott, MD, observes, “allows pharmaceutical companies to launder their marketing messages.”


Posted by Vera Hassner Sharav

THE NEW YORK TIMES
August 19, 2009
Senator Moves to Block Medical Ghostwriting
By NATASHA SINGER

A growing body of evidence suggests that doctors at some of the nation’s top medical schools have been attaching their names and lending their reputations to scientific papers that were drafted by ghostwriters working for drug companies — articles that were carefully calibrated to help the manufacturers sell more products.

Experts in medical ethics condemn this practice as a breach of the public trust. Yet many universities have been slow to recognize the extent of the problem, to adopt new ethical rules or to hold faculty members to account.

Those universities may not have much longer to get their houses in order before they find themselves in trouble with Washington.

With a letter last week, a senator who helps oversee public funding for medical research signaled that he was running out of patience with the practice of ghostwriting. Senator Charles E. Grassley, an Iowa Republican who has led a long-running investigation of conflicts of interest in medicine, is starting to put pressure on the National Institutes of Health to crack down on the practice.

That is significant because the N.I.H., a federal agency in Bethesda, Md., underwrites much of the country’s medical research. Many of the nation’s top doctors depend on federal grants to support their work, and attaching fresh conditions to those grants could be a powerful lever for enforcing new ethical guidelines on the universities.

Like many of the universities, N.I.H. appears reluctant to tackle the issue. A spokesman said the agency was committed to maintaining objectivity in science. But he added that in the case of ghostwriting allegations, universities and other institutions that employ researchers are responsible for setting and enforcing their own ethics policies.

“How long does it have to go on before it actually is stopped? One way to stop it would be if the actual authors were punished in some way,” said Dr. Carl Elliott, a professor at the Center for Bioethics of the University of Minnesota. “But the academics who are complicit in it all never seem to be punished at all.”

The full scope of the ghostwriting problem is still unclear, but recent revelations suggest that the practice is widespread. Dozens of medical education companies across the country draft scientific papers at the behest of drug makers. And placing such papers in medical journals has become a fundamental marketing practice for most of the large pharmaceutical companies.

“Just three days ago, I got a request to be the author of a ghostwritten article about the effectiveness of a cholesterol-lowering drug,” Dr. James H. Stein, professor of cardiology at the University of Wisconsin School of Medicine, said this month. “This happens all the time.” He declined to attach his name to the paper.

Allegations of industry-sponsored ghostwriting date back at least a decade, to scientific articles about fen-phen, the diet drug combination that was taken off the market in 1997 amid concerns that it could cause heart-valve damage. But evidence of the breadth of the practice has come to light only gradually, most recently in documents released in litigation over menopause drugs made by Wyeth.

The documents offer a look at the inner workings of DesignWrite, a medical writing company hired by Wyeth to prepare an estimated 60 articles favorable to its hormone drugs. In one publication plan, for example, DesignWrite wrote that the goal of the Wyeth articles was to de-emphasize the risk of breast cancer associated with hormone drugs, promote the drugs as beneficial and blunt competing drugs. The articles were published in medical journals between 1998 and 2005 — continuing even though a big federal study was suspended in 2002 after researchers found that menopausal women who took certain hormones had an increased risk of invasive breast cancer and heart disease.

Wyeth has changed its policy in the years since the hormone papers were published, according to Douglas Petkus, a company spokesman, and now requires that scientific articles acknowledge any participation by Wyeth or a Wyeth-sponsored writer. Some leading medical journals have also beefed up their disclosure policies for authors.

Some of the authors of the Wyeth hormone articles played significant roles in the work, while others made minor changes to drafts that were prepared for them, the documents show. But, in the main, the articles did not disclose that they had been drafted by outside writers paid to advance the drug company’s views.

Many universities have been slow to react to evidence about the extent of the practice. In December, for example, Mr. Grassley released documents indicating that DesignWrite had drafted an article that was published under the name of a gynecology professor at New York University School of Medicine.

Eight months later, a spokeswoman said the school had not looked into the matter.

“If we had received a complaint, we would have investigated,” said Deborah Bohren, the vice president for public affairs at New York University Langone Medical Center. “But we have not received a complaint.”

She added N.Y.U. never condoned ghostwriting and was now drafting a written policy to that effect. Faculty members, however, are responsible for the integrity of their own work, she said.

But bioethicists said that medical schools must take responsibility for faculty members whose publications do not explicitly acknowledge the work of writers receiving industry support. Such subsidized articles allow pharmaceutical companies to use the imprimatur of respected academics — and by extension, the stature of their institutions — to increase sales of certain drugs, ultimately skewing patient care, they said.

“To blow this off is not acceptable,” said Dr. Ross McKinney, the director of the Trent Center for Bioethics at Duke University Medical Center. Duke has a policy that prohibits ghostwriting and advises faculty to keep records of their participation in preparing scientific articles.

“Our ultimate responsibility is to provide good care, and research is the foundation of that care,” Dr. McKinney said. “Presenting information where the bias is not made clear is inconsistent with our mission.”

In one measure of the extent of the problem, the medical school of a single university, Columbia, is home to three professors who were authors of Wyeth-financed articles. The three are also recipients of N.I.H. grants, according to the letter from Mr. Grassley.

A spokeswoman for Columbia said that Dr. Lee Goldman, the dean of the medical school, who is not among the professors linked to Wyeth articles, was not available for an interview because he was out of the country. She did not answer a query seeking comment from Columbia.

One of the authors discussed in DesignWrite documents is Dr. Michelle P. Warren, a professor of obstetrics and gynecology at Columbia. Her article was published in The American Journal of Obstetrics and Gynecology in 2004, when women feared that Wyeth’s brand of hormone drugs could be causing particular problems. The thesis of the article was that no one hormone therapy was safer than another.

The published article acknowledged help from four people. But it did not disclose that DesignWrite employed two of those people and the other two worked at Wyeth. Court documents show DesignWrite sent a prepublication copy to Wyeth for vetting and charged Wyeth $25,000 for the article, information not disclosed in the paper.

In a phone interview, Dr. Warren said the article was intended to clear up confusion over the risks of hormone drugs. She said she worked on the project in phone conversations and in meetings — contributions not reflected in the court documents, she added. She said that it was a mistake not to have disclosed the writers’ payment and affiliations in the acknowledgment; articles published today involve more detailed disclosures, she said.

DesignWrite scoured the scientific literature on hormone therapy for the article, she said. “I would never undertake this without some help,” said Dr. Warren, who is the Wyeth-Ayers Professor of Women’s Health at Columbia. “It’s too much work. I am not getting paid for it.”

A new policy at Columbia took effect in January. It prohibits medical school faculty, trainees and students from being authors or co-authors of articles written by employees of commercial entities if the author’s name or Columbia title is used without substantive contribution. The policy, which does not retroactively cover articles like Dr. Warren’s, requires any article written with a for-profit company to include full disclosure of the role of each author, as well as any other industry contribution.

But Dr. Elliott, the bioethicist, said universities should go further than mere disclosure, prohibiting faculty members from working with industry-sponsored writers. Policies asking only for disclosure “allow pharmaceutical companies to launder their marketing messages,” he said.


Copyright 2009 The New York Times Company

FAIR USE NOTICE: This may contain copyrighted (© ) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available for educational purposes, to advance understanding of human rights, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a 'fair use' of any such copyrighted material as provided for in Title 17 U.S.C. section 107 of the US Copyright Law. This material is distributed without profit.


Thank you AHRP

Drunken, Illiterate Doctors & Death By Medicine: RANT

Ghost Writing, and Physician Diversion V the 14th Amendment.

Until our entire Healthcare Industry learns, .....

Basic Patient Safety Reforms Would Save 85,000 Lives and $35 Billion A Year.

to wash its hands after the lav. and to come to work Sober, the wounded screech of the Academically Entitled 'Dr. Rent My Name, Please' Ghost Authorship defending "That durned blamed Senator Grassley's a Pickin' on us again." will continue to Offend (Us at the Very least) with all the affected sanctimony of the pampered, tantrum tossing Pharmaceutical Money Protected Brat, it is.

Need a Nudge?

See Anderson & Anderson: who are doing a brisk, Nation Wide trade in teaching Dr. Academically Entitled to Quit Abusing Other People.

"Executive Coaching/Anger Management for Physicians & High-Profile Clients.

In response to the need for a one on one individual and sensitive intervention coaching model for physicians, Anderson & Anderson is now offering a twelve-hour coaching program with 6 months of aftercare for “disruptive physicians”. This course is available at our Brentwood, California office or on-site seven days a week anywhere in the United States. "

Comprehensive Emotional Intelligence Assessments are given at intake, focusing on the participant's level of functioning in managing stress, anger, communication and emotional intelligence. We do not provide psychological testing, nor is our intervention considered counseling or psychotherapy. Therefore, there are no stigmas attached.

Why so careful about Dodging Psych Slime? Especially when those Exact, same behaviors are Profitably Diagnosed and Condemned as Incurable by the Freud Fell Short informed Ideates peddling Pharma's $40.3 Billion last year alone worth of Psychdrugdangers.com?

Might that be because the Ideates inflicting those Toxins don't want to be slimed with their own BS (that's right: we're Still waiting for it) Bio-$cience based, Psychiatric Diagnostic micro-brew & caviar?

If they Were carted off in handcuffs, Who would be Left to peddle the stuff, which is FDA approved as 'safe and effective' in 6 to 8 week trials while FDA Long Term Effects Remain "Unknown" 14 years later?

Furthermore: Even when California HAD a State Govt program Extending Preferential Cover to its Drunk and Doped Up Doctors, Half of them just went into Hiding, on the job, so the State Program itself gave up, and Suicided last summer.

That's right. A State with 37 Million inhabitants has So Many, Useless, Incompetent, Brain Chemical, Self Imbalanced Bums practicing medicine, that even With, a Program run in Direct Violation of the Constitution to Shield its Medi-Bozos from the consequences of their self indulgence, the task proved So Insurmountable, that the State program actually KILLED ITSELF.

Now Remember: Govt Programs Don't Fail themselves out of business, because they're Always, Always and again, "simply, Underfunded". So why might this ailing mutt have run off from its bowl of tax payer filled Alpo, and into the night?

Could it have been that the Operators didn't want to have to Answer any Questions about what an Insurmountable problem they actually Tried to COVER UP, for 27 Years, as that Problem Continues to WORSEN?

Do we actually have to quote the 14th Amendment again?

Ooops. Forgive us. Our bad. In the current Brouhaha over yet More of the above Free Health Care at our neighbors expense somehow mystically morphing into an Inalienable Right, the Constitution Itself is being Murdered by these Medical Ghosts (both those Writing/Corrupting/Post Incident Sweeping it under the rug, and those being Turned Into Ghosts, by it) so we need not further concern ourselves with That irrelevant old document. (Lord knows, most of DC, and Medicine, don't, so Why should You?)

But then again, you might look over This document:

Death By Medicine

This fully referenced report shows the number of people having in-hospital, adverse reactions to prescribed drugs to be 2.2 million per year. The number of unnecessary antibiotics prescribed annually for viral infections is 20 million per year. The number of unnecessary medical and surgical procedures performed annually is 7.5 million per year. The number of people exposed to unnecessary hospitalization annually is 8.9 million per year.

The most stunning statistic, however, is that the total number of deaths caused by conventional medicine is an astounding 783,936 per year. It is now evident that the American medical system is the leading cause of death and injury in the US. (By contrast, the number of deaths attributable to heart disease in 2001 was 699,697, while the number of deaths attributable to cancer was 553,251

And 1500 ghost written articles Couldn't be contributing to this problem, Right? Just hire a Jaquelin Suzanne to write up the Research for publication in Bio-$cientific Medical Journals where the whole schmeer is subsequently discovered to be Marketing Hogwash. And the Marketing Success of Bio-$cienced, Pill Peddling Hogwash, of course, is predicated upon the all too often swallowed (with tragic consequences) assumption, that the State Licensed Incompetent even knows what the chemicals S/he's killing people with are even FDA approved for.

"Physicians frequently prescribe medications for off-label uses, mistakenly believing there's FDA approval for those indications, according to a survey of clinicians.

More than 40% of respondents believed one or more drugs had FDA approval for indications that have uncertain or no supporting evidence, said G. Caleb Alexander, MD, of the University of Chicago, and colleagues."

And into the Arena of THIS Roman Circus, comes Iowa Senator Charles Grassley to stand accused (in certain financially interested bleachers) of 'Jumping The Shark' ..... onto a tiny few, selected, above reproach, 6 & 7 figure income, Life Endangering Rent A Names

We'll salute Senator Grassley with thumbs up over Industrial, Assembly Line Medicine's Elitist, "How Dare you cast unwarranted aspersions upon our Spotless Honor" (even when they Are sober) FDA label ignorant Lethal Incompetents anyday.

Until Industrial Medicine cleans its own house it wears No Purple Toga authorizing it to launch invective at a US Senate Committee earnestly Trying to Help it clean its own house before its Money Grubbing, Physically Assaultive, Drunken, Sexually Predating, Incurably Incompetent Psychiatric Sales Team Tridents this Nation's bank, and back, into Oblivion.

And frankly, We Don't Care one Whit what Psychiatry's Publicly Stated Intentions are. Because we All know just Which road to Where is Paved with Good Intentions.

It's 1984 & 1 In Every 5 Are Incurably Mentally Ill.

But these Drugs Must be Good for Something, Aren't they?

The 4 Cent Dollar & Pharmacide

The Drugs are Peddled under the Ruse of Suicide Prevention, and the numbers of Suicides tell us, "They Ain't Getting The Job Done, at All."

"Yet in 1987, the year Prozac was approved, and not coincidentally, the year the bogus epidemic in mental disorders began in this country, the number of suicides was 30,796, according to the National Center for Injury Prevention and Control."

In the latest year posted of 2006, after hundreds of billions of dollars were thrown down a psych drug rat hole, the number of suicides was 33,292."

Top FDA Officials Compromised By Conflicts Of Interest

AHRP has:

Top FDA Officials, Compromised by Conflicts of Interest
Tuesday, 18 August 2009

Two high ranking FDA officials' conflicts of interest have led one to resign, the other is under investigation by the Inspector General of the Department of Health and Human Services:

Dr. Daniel Schultz, who has been FDA's chief medical device official, is the first high ranking FDA official whose controversial device approvals have resulted in his leaving the agency "by mutual consent."

Earlier this year, nine scientists spoke up to incoming President Obama that they had concerns about how medical devices were approved without adequate checks for effectiveness and safety.

Read more:

The approvals had been issued by Dr. Schultz, over the objections of FDA scientists.

Dr. Janet Woodcock, director of the FDA's all-powerful, Center for Drug Evaluation and Research (CDER), is under investigation by the Inspector General.

The investigation was commenced after an ethics complaint was filed by Amphastar Pharmaceuticals Inc. which charges that Dr. Woodcock has a conflict of interest favoring its competitor, Momenta Pharmaceuticals Inc.

Both companies seek approval for the generic version of the drug, Lovenox, a blood thinner with multi-billion-dollar sales.

The Wall Street Journal reports (below) that Dr. Woodcock' close contacts with Momenta in the middle of a drug-approval process were (to say the least) ethically questionable. Morgan Stanley characterized the Woodcock / Momenta connection as a "game changer" whereupon Momenta's stock jumped 17% in a day.

It is further reported that Dr. Woodcock co-authored journal articles with Momenta scientists, then co-authored two medical journal articles last year that won scientific -- as well as Wall Street -- kudos for Momenta.

The WSJ notes: "It is unusual for FDA officials to co-author journal articles with industry researchers, though the FDA said it encourages publication in journals in collaboration with noted scientists. Dr. Woodcock, who joined the FDA about 20 years ago, has done so only a handful of times in recent years. In addition, this instance occurred in the middle of a drug-approval process."

Another high ranking FDA official, Dr. Thomas Laughren, FDA's director of psychiatry products, overruled FDA's team of safety officers, much as Dr. Schultz did:

On April 29, 2007, Dr. Laughren issued an approvable letter to Eli Lilly for pediatric use of Zyprexa (olanzapine) - despite serious concerns about the integrity of the data obtained in Russia.

Dr. Thomas Laughren has been in a pivotal high ranking position at FDA's powerful CDER center that has authority over the review and drug approval process since 1983.

Throughout his tenure at the FDA Dr. Laughren has maintained close ongoing collaborative ties with pharmaceutical industry officials and industry financed psychiatrists in academia and professional associations.

Dr. Laughren has participated in influential industry sponsored consensus panels convened by the American Academy of Child and Adolescent Psychiatry (AACAP) that recommended expanded use of psychotropic drugs-primarily SSRI antidepressants and the so-called 'atypical' antipsychotics-for unapproved, off-label uses in children.

The Alliance for Human Research Protection has compiled a list of influential journal articles, a book chapter, and industry sponsored consensus statements that list Dr. Laughren as co-author--thereby greatly enhancing their influence.

Dr. Laughren participated in consensus forums whose purpose was to influence regulatory policy and /or expanded use of psychotropic drugs and to influence practice guidelines. His name and position are penned to articles whose authors include Eli Lilly's chief medical officer, and unabashed industry-subsidized drug promoters -even a convicted felon.

For more than a decade Dr. Laughren endorsed industry's denials that SSRI antidepressants increased the suicide risk for consumers. He dismissed safety concerns raised by FDA medical reviewers: instead, he penned his name to articles and consensus statements that recommended broadening the criteria for diagnosing psychiatric illness and expanded use of SSRI antidepressants, antipsychotics, and combinations.

For example, Dr. Laughren's name is penned to consensus statements recommending broadening the criteria for pediatric bipolar disorder. Such an endorsement by Dr. Laughren provides an authoritative green light to physicians to prescribe antipsychotics--the most hazardous drugs in pharmacopoeia for children--even as the drugs had not been approved for children.

Dr. Laughren not only co-authored major articles promoting industry's marketing goals but his name is penned to an apparently ghostwritten article:

"Mood Disorders in the Medically Ill: Scientific Review and Recommendations," published by the Journal of the Society of Biological Psychiatry, 2005.

The article promotes the notion that depression accompanies practically all patients with medical illnesses-e.g., cardiovascular disease, cancer, AIDS, Alzheimer's, Parkinson's, Diabetes, Osteoporosis, Obesity, and Pain. Dr. Laughren, a co-author, recommends the use of antidepressants for presumed underlying depression, even claiming that "SSRIs may be cardioprotective."

Dr. Laughren's name has lent the appearance of legitimacy of what is clearly industry propaganda that has no basis in science or evidence-based medicine.

See, AHRP letter of complaint addressed to the former FDA commissioner, Dr. Andrew von Eschenbach (June 2007)

and a follow-up letter (April 2008) at: http://www.ahrp.org/cms/images/stories/articles/fda-double-agent2008.pdf

Dr. Schultz, Dr. Woodcock, and Dr. Laughren are among top echelon FDA officials who have held sway for years, serving the interest of the industry they are supposed to regulate. These pivotal FDA officials--and several others--have approved unsafe--indeed, dangerous--prescription drugs and medical devices disregarding the recommendations of the agency's safety scientists.

The beneficiaries of ill-considered FDA marketing approvals have been drug and device manufacturers, while the American public has been badly served: millions have suffered serious harm, hundreds of thousands have died as a result of poorly reviewed FDA-licensed drugs and devices.

See: QuarterWatch analysis of FDA adverse event reports for the third quarter of 2008--bear in mind that adverse events reported to the FDA comprise only between 1% and 10%:

"During the third quarter of 2008 the FDA received 24,872 serious adverse drug event reports identifying 854 different drugs.

For the third quarter of 2008 reported serious, disabling adverse drug events were 30.5% higher than the same quarter one year ago.

There were 2,778 patient deaths, 1,162 cases of disability and 20,932 cases of other kinds of serious injury.

Reported patient deaths in the third quarter were 41% higher than the same quarter in the previous year.

See, synopsis of this QW report at: http://www.ahrp.org/cms/content/view/588/9/


Posted by Vera Hassner Sharav

The Wall Street Journal
AUGUST 12, 2009, 5:06 A.M. ET
FDA Medical-Device Regulator Resigns
By ALICIA MUNDY

WASHINGTON -- The Food and Drug Administration's top medical-device regulator said Tuesday he is resigning.

The departure follows internal dissent over device-approval decisions that the regulator's critics said were too friendly to industry.

Daniel Schultz said his move comes "by mutual agreement" with FDA Commissioner Margaret Hamburg, who took office in May.

An FDA spokesman said Dr. Schultz's decision came as the result of talks with Dr. Hamburg, and had nothing to do with any specific issue related to a device's approval process.

Dr. Schultz has worked at the FDA's Center for Devices and Radiological Health for 15 years and led it for the past five years.

Sen. Chuck Grassley (R., Iowa) held hearings two years ago on Dr. Schultz's approval of a nerve stimulation device to treat depression, approval that came over the objections of several FDA doctors. Mr. Grassley complained at the time that science was being ignored in favor of industry. Dr. Schultz said his decision was based on sound medical data.

In March, Sen. Grassley opened an investigation into a knee-surgery device made by ReGen Biologics Inc., after The Wall Street Journal reported that Dr. Schultz approved it over the objections of numerous FDA scientists and reviewers.

FDA Deputy Commissioner Joshua Sharfstein said in May that the agency would re-examine the approval process for the ReGen knee device to see if proper procedures were followed.

A group of nine device division employees wrote to the House Energy and Commerce Committee last October to complain that the division's leaders had approved devices despite formal safety and efficacy concerns raised by FDA.
They also alleged some scientists who objected to the decisions faced retaliation from leaders of the device division. The FDA at the time declined to comment.

The Advanced Medical Technology Association, a medical-device industry group, praised Dr. Schultz, saying he ensured stable funding for the FDA via industry user fees.

Dr. Hamburg said in a statement that Dr. Schultz left a strong legacy and helped the division enhance understanding of medical-device use in children.

Write to Alicia Mundy at alicia.mundy@wsj.comThis e-mail address is being protected from spam bots, you need JavaScript enabled to view it Printed in The Wall Street Journal, page B2 ~~~~~~~~~~~~~~~~~~~~~~~~~

The Wall Street Journal
AUGUST 12, 2009
Drug Chief at the FDA Is Accused Of Conflict
By ALICIA MUNDY

WASHINGTON -- The inspector general of the Department of Health and Human Services is investigating a conflict-of-interest allegation involving the official in charge of drug approvals at the Food and Drug Administration, the FDA said.

The investigation of Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research, stems from an ethics complaint filed by Amphastar Pharmaceuticals Inc., a California company that says it has been delayed in its six-year effort to win approval for a generic version of Lovenox, a multi-billion-dollar blood thinner.

In its complaint, Amphastar alleges that its competitor had special access to Dr. Woodcock at critical times in the prolonged approval process, which is ongoing. Amphastar points out that Dr. Woodcock co-authored a scientific paper with scientists at Momenta Pharmaceuticals Inc. while both companies were battling to win FDA approval of their generic blood thinners.

Amphastar contends that Dr. Woodcock's collaboration with Momenta is a conflict of interest and has asked that she recuse herself from the entire matter at the FDA.
"The FDA is aware of the situation, takes it seriously, and is looking into the matter," an agency spokesman said. He said Dr. Woodcock isn't recusing herself.

The FDA, responding to repeated queries over a week, declined to make Dr.
Woodcock available for comment. An HHS official said the department cannot confirm or deny ongoing investigations.

In separate FDA news, the agency on Tuesday said its top medical-device regulator, Daniel Schultz, is resigning, following internal dissent over decisions that his critics said were too friendly to industry.

Both Amphastar and Momenta, which is based in Cambridge, Mass., submitted applications seeking FDA approval of their generic versions of Lovenox heparin sold by Sanofi-Aventis SA. Amphastar applied in 2003, two years before Momenta.

Lovenox, a low-molecular-weight heparin, is a blockbuster biologic drug that brought in $3.5 billion in world-wide sales last year.

On Nov. 2, 2007, the FDA rejected Amphastar's application, although the agency acknowledged that Amphastar had passed a key hurdle in demonstrating its drug's chemical equivalence to Lovenox. The FDA told Amphastar that it needed more data to show that the product wouldn't cause dangerous immune reactions.

Momenta was also asked to submit such data. Both companies said they have complied and are awaiting the FDA's response.

Amphastar, in letters sent to the FDA in April and June, cited some public contacts and email between Dr. Woodcock and one of Momenta's founders, Massachusetts Institute of Technology biological engineering professor Ram Sasisekharan, beginning in February 2007. Among those contacts were their attendance at an international medical conference in Thailand in November 2007.

Mainly, however, Amphastar points to Dr. Sasisekharan's appointment to lead an FDA task force in early 2008, which put him and Momenta in regular contact with the agency. That task force was investigating tainted Chinese-made heparin, a crisis that led to nearly 100 deaths.

Drs. Woodcock and Sasisekharan, along with other Momenta scientists, then co-authored two medical journal articles last year identifying the cause of the contaminated Chinese heparin imports, a finding that won scientific -- as well as Wall Street -- kudos for Momenta.

It is unusual for FDA officials to co-author journal articles with industry researchers, though the FDA said it encourages publication in journals in collaboration with noted scientists. Dr. Woodcock, who joined the FDA about 20 years ago, has done so only a handful of times in recent years. In addition, this instance occurred in the middle of a drug-approval process.

Dr. Woodcock has held her post since 1994, except for two years as deputy commissioner under George W. Bush.

In April 2008, after the tainted-heparin article was published, an investment report from Morgan Stanley cited Momenta's FDA connection as a "game-changer," and Momenta's stock jumped 17% in a day.

Dr. Sasisekharan didn't respond to calls or emails seeking comment.

Momenta's chief executive, Craig Wheeler, said contacts between representatives of his company and Dr. Woodcock were appropriate. He said they were part of an effort to persuade the FDA that it should use a higher standard of equivalence in approving generic versions of Lovenox -- a standard that he believes Momenta's technology enables it to meet.

"I'm not sure why having lower [generic] standards would be in the public interest," said Mr. Wheeler.

He noted that the FDA's demand for more information about immune reactions affected Momenta as well as Amphastar, and caused Momenta's share price to fall nearly 60% on Nov. 6, 2007.

Without addressing the specific case, an FDA spokesman cited "evolving science" as having raised agency concerns about immune-system issues with complex drugs such as Lovenox.

While the tainted-heparin crisis offered rival Momenta a chance to shine, it added to the delays for Amphastar. At the height of the Chinese heparin crisis in 2008, Amphastar learned that one of its Chinese suppliers for the main ingredient used in its experimental heparin had misled the company about where the raw material had been produced, although the FDA didn't find contamination.

The FDA sent warning letters to two Chinese suppliers of Amphastar in April this year.

Momenta has teamed up with a unit of Swiss drug giant Novartis AG to bring its product to market.

A Novartis spokeswoman said the company was unaware of the ethics complaint filed by Amphastar.
-Jake Sherman contributed to this article

Write to Alicia Mundy at alicia.mundy@wsj.comThis e-mail address is being protected from spam bots, you need JavaScript enabled to view it Printed in The Wall Street Journal, page B1

Copyright 2009 Dow Jones & Company, Inc. All Rights Reserved

FAIR USE NOTICE: This may contain copyrighted (© ) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available for educational purposes, to advance understanding of human rights, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a 'fair use' of any such copyrighted material as provided for in Title 17 U.S.C. section 107 of the US Copyright Law. This material is distributed without profit.


Thank you AHRP


And of Possibly Related Interest (Especially in light of the Current, Proposed Federal Takeover of America's Health Care system)

FDA CDRH: Nov 17 2008: The Letter

FRPAA Seeks To Protect Public Access To Govt Funded Research

And it matters, Why?

Because:

HR 801 Would END FREE ACCESS To GOVT FUNDED RESEARCH

Considering the ghost writing and skewed writing underwriting the purported safety and efficacy of Psych Drugs the Public Must retain the Right to Read and Critique what they already got written up for, ...... or we'll never get the rewrite: the one with the Truth in it.


Here's A Press Release from Senator John Cornyn:

http://cornyn.senate.gov/public/index.cfm?FuseAction=
ForPress.NewsReleases&ContentRecord_id=1959bcce-
802a-23ad-4dbe-e2aece171fb3

Sens. Cornyn & Lieberman Team Up To Increase Public Access To Taxpayer Funded Research
Thursday, June 25, 2009

U.S. Sens. John Cornyn, R-Texas, and Joe Lieberman, I-CT, introduced legislation today to expand the public’s access to the research they help fund by shedding additional light on federal research projects. Their legislation, the Federal Research Public Access Act (FRPAA), would require every federal department and agency with an annual extramural research budget of $100 million or more to make their research available to the public within six months of publication.

“Our legislation would give the American people greater access to the important scientific research they help fund, which will accelerate scientific discovery and innovation, while also making sure that funding is being spent appropriately to ensure taxpayers are receiving a return on their research investments and they are not having to pay twice for the same research - once to conduct it, and a second time to read it. I will continue to advocate for greater transparency measures across all of our governmental departments and agencies, and I urge our Senate colleagues to support this legislation,” said Sen. Cornyn.

“The United States has some of the best and brightest researchers,” said Lieberman. “I continue to be impressed by their ideas and feel strongly that the American public should have access to what they discover. The internet makes it possible to provide public access to federally funded research and I am pleased to lead the effort to make this information more accessible.”

Background:

Sens. Cornyn and Lieberman first introduced this legislation in the 109th Congress. In 2008, the National Institutes of Health (NIH) implemented their public access policy. It is estimated that approximately 80,000 papers are published each year from NIH funds.

Specifically, the FRPAA would:
* Require every researcher with an annual extramural research budget of $100 million or more, whether funded totally or partially by a government department or agency, to submit an electronic copy of the final manuscript that has been accepted for publication in a peer-reviewed journal.
* Ensure that the manuscript is preserved in a stable digital repository maintained by that agency or in another suitable repository that permits free public access, interoperability, and long-term preservation.
* Require that each taxpayer-funded manuscript be made available to the public online and without cost, no later than six months after the article has been published in a peer-reviewed journal.

And LibraryJournal.com Also has FRPAA:

http://www.libraryjournal.com/article/CA6668699.
html?nid=2673&source=title&rid=1999395792

FDA Approves Another Dangerous Antipsychotic, Asenapine

AHRP has:

FDA Approves Another Dangerous Antipsychotic, Asenapine

At the July 30, 2009 FDA advisory committee hearing, the only formal presentations at the meeting were a summary of the safety and efficacy data by the sponsor.

The FDA has approved Schering Plough's new antipsychotic, asenapine (Saphris), for the treatment of schizophrenia and mania associated with bipolar disorder in adults.

Dr. Thomas Laughren, FDA's director of psychiatry products, indicated that FDA will not be making separate presentations, "since we are in essential agreement with the data to be presented by the sponsor."

The drug's approval is highly controversial: the primary biopharmaceutics (OCP) reviewer raised numerous safety concerns but was not afforded an opportunity to present his analysis to the committee.

Asenapine's approval for the treatment of schizophrenia is based on four short-term (6-week) randomized clinical trials, of which only two studies (Studies 41004 and 41023) were presented as showing "statistically significant," though clinically insignificant, efficacy findings.

However, contrary to Dr. Laughren's assertion,

"As summarized in Dr. Chen’s review, there were 2 positive (41004 and 41023) trials and one negative (41021) trial supporting adequate efficacy to recommend approval of asenapine for adults in the acute treatment of schizophrenia"

those efficacy claims were disputed by Dr. Yeh-Fong Chen, FDA's statistical reviewer, who raised concerns about the high dropout rate in study 41004, (60% overall, 66% among placebo group): suggesting the possibility of bias.

She also raises "a reasonable concern…whether a study with >50% dropout rate can still be accepted as a pivotal study."

Furthermore, "Regarding Study 41023, the fact that asenapine 10 mg BID performed numerically worse than asenapine 5 mg BID also adds difficulty to the interpretation of the asenapine’s efficacy finding."

FDA's review of the application for bipolar disorder focused on 2 short-term (3-week), double-blind, randomized, flexible dose, placebo- and olanzapine-controlled, parallel group studies of asenapine in adult patients with manic or mixed episodes of bipolar 1 disorder. See, FDA Background package :

The drug was approved in the form of sublingual tablets: it is stated that this is due to its "very poor oral bioavailability."

Are there safety issues for concern regarding the drug's potential toxicity?

Concerns about serious, potentially life-threatening risks are linked to this drug:

FDA's primary biopharmaceutics (OCP) reviewer, Dr. Ron Kavanaugh, who analyzed the all phase II and III trials’ adverse events data submitted for review, raised concerns about cardiotoxicity in young healthy volunteers, hepatoxicity (blood toxicity), and suicide/ suicide attempts. See: Table 185, p.772 FDA Background package

Serious safety issues emerged in early trials conducted in young, healthy volunteers, resulting in the termination of several studies due to severe cardiac events:

"Study 25506 was a pharmacokinetic study of intravenous administration of asenapine at four different doses, with each dose to be administered to two healthy male volunteers which was then to be followed by a pilot bioavailability study of 30 mg orally in the two volunteers who received the highest tolerated intravenous dose.

The study was stopped after the first two subjects due to asystole requiring external cardiac massage and atropine. Although attributed by the sponsor to a vasovagal effect, an external cardiologist deemed it a serious AE of asenapine affecting the conducting system of the heart." p.785 FDA Background package

Study 25501 was a multiple rising dose study to examine the pharmacokinetics in 12 young, healthy, male volunteers using [asenapine] both after a single oral dose (30 mg) and at steady state (5 days, 15 mg twice daily orally).

Study 25509, the sponsor's summary of the initial sublingual (SL) Single Rising Dose Study states:

"From a safety point of view, the administration [of asenapine at] doses greater than 4 mg / day is precluded for two reasons (1) risk of hepotoxicity (2) due to the fact that low oral bioavailability predisposes to highly variable plasma levels, patients may be put at increased risk of cardiovascular adverse experiences." p. 792 FDA Background package

Dr. Kavanaugh's Table 192 "Summary of Selected Cardiac AEs" as described in the sponsor's summaries of early trials. p.798 FDA Background Package

Dr. Thomas Laughren, FDA director of psychiatry products, dismissed out of hand the safety concerns raised by FDA primary pharmacology reviewer and the efficacy concerns raised by FDA's statistician.

There were 27 deaths in the asenapine program overall, including 22 deaths in patients taking asenapine.

Of the 22 asenapine deaths, 8 were suicides and 9 of the asenapine deaths were from serious medical events: e.g., pulmonary embolism (2), pneumonia, CVA, complications of seizure, metastatic lung cancer, fetal death in premature delivery, heart failure, MI.

However, most (about 94%) of the serious adverse events were exacerbations of psychiatric illness. This raises additional doubts about the drug’s efficacy for schizophrenia or bipolar disorder, two major psychiatric conditions.

Dr. Laughren strongly endorsed approval of asenapine. (T)he formal presentations at the advisory hearing were limited to the following study reviews by Schering Plough, the sponsor:

Study 041004 compared asenapine 5 mg bid, risperidone 3 mg bid, and placebo.
There were roughly 60 patients per group. Dropouts were substantial (more than 60%), with completion rates for the 3 groups, as follows: asenapine-46%; risperidone-42%; placebo-34%.

Study 041021 compared asenapine 5 mg bid, asenapine 10 mg bid, olanzapine 15 mg qd, and placebo.

Neither asenapine group was statistically superior to placebo, however, the olanzapine group was superior to placebo (p=0.017). Thus, this was a completely negative study for asenapine.

Study 041022 compared a flexible dose of asenapine (5-10 mg bid) with olanzapine and placebo. Neither active drug group was statistically superior to placebo. Thus, this was a failed study.

FDA's statistician, Dr. Yeh-Fong Chen, noted in her written review: "Not only did the study drug and the active control fail to show any efficacy findings, but patients in the placebo group even performed numerically better than those in the study drug group."

Study 041023 compared asenapine 5 mg bid, asenapine 10 mg bid, haloperidol 4 mg bid, and placebo. There were roughly 110 patients per group. Completion rates for the 4 groups were as follows: asenapine 5 mg bid-63%; asenapine 10 mg bid-67%; haloperidol-59%; placebo-57%.

Dr. Chen notes in her written review: "Based on the protocol specified primary analysis, data only showed statistically significant findings for asenapine 5 mg BID. This reviewer plotted the visit-wise LOCF and OC analysis results and noted that... the observed effect size for 10 mg was smaller than that for the 5 mg regardless of analysis methods."

FDA's review of the application for Efficacy in Bipolar Disorder focused on 2 short-term (3-week), double-blind, randomized, flexible dose, placebo- and olanzapine-controlled, parallel group studies of asenapine in adult patients with manic or mixed episodes of bipolar 1 disorder. Dosing was 5-10 mg bid for asenapine and 5-20 mg qd for olanzapine.

Study A7501004 was a multinational trial (61 centers, including both US and nonUS sites). There were roughly 200 patients per each active group and 100 for placebo. Completion rates were as follows: asenapine-67%; olanzapine-79%; placebo-58%. Both active drug groups were statistically superior to placebo on both the primary and key secondary endpoints.

Study A7501005 was a multinational trial (55 centers, including both US and non US sites). There were roughly 200 patients per each active group and 100 for placebo. Completion rates were as follows: asenapine-63%; olanzapine-80%; placebo-62%.

FDA acknowledged: The sponsor presented no data pertinent to longer-term efficacy of asenapine for the treatment of either schizophrenia or mania/mixed episodes.

It is astonishing that FDA would approve Asenapine for the treatment of bipolar disorder disorder--inasmuch as its efficacy remains in doubt, and 94% of the drug's serious adverse events were exacerbation of psychiatric illness.

FDA's failure to consider the compelling evidence of hazards posed by the so-called 'atypical' antipsychotics-- from two major government-sponsored, long-term NIMH studies when assessing the safety / efficacy of asenapine--is irresponsible.

1. The CATIE (Clinical Antipsychotic Trials of Intervention Effectiveness) in schizophrenia study overturned industry-promoted assumptions about the safety and efficacy of antipsychotics of asenapine's class. The CATIE study demonstrated the lack of improved efficacy by the so-called 'atypical' antipsychotic drugs from older neuroleptics, while documenting these drugs' severe, debilitating, life-shortening adverse effects and poor patient outcomes.

The data from the sponsor's asenapine trials raise even greater concerns about this drug's safety--as analyzed by FDA's primary biopharmaceutics (OCP) reviewer.

2. The STEP-BD (Systematic Treatment Enhancement Program for Bipolar Disorder) found that the use of second generation antipsychotic (Risperdal) was LEAST effective (4.6%) compared to an anti-convulsant (Lamitcal, 23.8%) or even a sugar pill (Inositol, 17.4%).

Furthermore, evidence from STEP-D shows that "Suicidal ideation was significantly more prevalent among patients who were taking a second-generation antipsychotic than those who were not (26 percent and 17 percent) and those who were taking an antidepressant and those who were not (25 percent and 14 percent)."

See, Suicidal Ideation and Pharmacotherapy Among STEP-BD Patients, Psychiatric Services, 2007.

There were 12 suicides in the asenapine program overall, including 8 on asenapine and 4 on olanzapine.

FDA acknowledges: "The distribution of time of treatment to occurrence of suicide was somewhat unusual for asenapine, i.e., 8, 12, 18, 31, 33, 96, 152, and 257 days. The comparable numbers for olanzapine were as follows: 13, 37, 191, and 376 days."

Asenapine's poor performance is underscored by an even higher drop out rate in head to head trials against olanzapine (Zyprexa), whose drop out rate in pre-marketing trials was a matter of concern that has been justified by the drug' link to debilitating, chronic, life-shortening disease.

Dr. Laughren' background memorandum to the advisory committee acknowledges:

"A major deficiency in the application from a biopharmaceutics standpoint is a failure to adequately determine what moieties are circulating in plasma. OCP maintains that the sponsor has identified only about 3% of circulating material in plasma. Also from the standpoint of mass balance, OCP maintains that only about 30% of the dose has been characterized regarding elimination pathways. They feel that the application cannot be approved before these deficiencies are addressed. The sponsor disputes these findings, and claims that they have identified up to 30% of circulating metabolites and 70% of the dose. At this point, however, this issue is unresolved." See, FDA Background Package

With numerous serious "unresolved" concerns about safety and efficacy, how can FDA claim Asenapine is "Safe and Effective"?

According to the American Society of Health System Pharmacists (below), Asenapine label warnings will include:

"Instances of tardive dyskinesia, a serious movement disorder, were reported during clinical trials of asenapine. The labeling states that if this condition occurs, consideration should be given to discontinuing therapy when "clinically appropriate."

"Cessation of therapy is also recommended if neuroleptic malignant syndrome (NMS), a life-threatening neurologic condition associated with the use of antipsychotic drugs, occurs during treatment with asenapine. Symptoms of NMS include "high fever, sweating, unstable blood pressure, stupor, muscular rigidity, and autonomic dysfunction," according to the National Institute of Neurological Disorders and Stroke.

"Other serious conditions that may occur during treatment with asenapine or other atypical antipsychotic drugs include hyperglycemia, diabetes mellitus, and orthostatic hypotension."

How can a drug that failed to even meet the low efficacy level of existing antipsychotics-- Risperdal, Zyprexa--whose documented debilitating and life-threatening risks emerged within the very short duration of the trials, be declared "Safe and Effective" for long-term chronic use?

One cannot but wonder what standards FDA officials are following before issuing the government seal of approval to drugs that offer no improved clinical benefit--and whose serious risks have not been fully evaluated.


Posted by Vera Hassner Sharav

American Society of Health System Pharmacists
Asenapine Approved for Treatment of Schizophrenia, Bipolar Disorder
Kate Traynor

BETHESDA, MD 14 August 2009—FDA and Schering-Plough Corporation today announced the approval of asenapine sublingual tablets for the acute treatment of schizophrenia and manic or mixed episodes associated with bipolar I disorder in adults.

Schering-Plough expects the atypical antipsychotic drug to be available during the final quarter of this year under the brand name Saphris.

As with other drugs in the class, the labeling (PDF) for asenapine includes a boxed warning stating that the drug is "not approved" for use in elderly patients with dementia-related psychosis. Patients with this condition who are treated with antipsychotic drugs are at increased risk of death, the labeling warns.

The labeling also warns that cerebrovascular accidents and transient ischemic attacks have occurred in elderly patients with dementia-related psychosis when treated with antipsychotic drugs.

Efficacy data on asenapine were collected during three six-week clinical trials in patients with schizophrenia and two three-week trials in patients with bipolar disorder. According to FDA, the drug outperformed placebo in both bipolar-disorder trials and two of the schizophrenia studies.

The most frequent adverse events reported by clinical trial participants with schizophrenia were restlessness, decreased oral sensitivity, and drowsiness. Among patients with bipolar disorder, the most frequent adverse events were drowsiness, dizziness, movement disorders, and weight gain.

Instances of tardive dyskinesia, a serious movement disorder, were reported during clinical trials of asenapine. The labeling states that if this condition occurs, consideration should be given to discontinuing therapy when "clinically appropriate."

Cessation of therapy is also recommended if neuroleptic malignant syndrome (NMS), a life-threatening neurologic condition associated with the use of antipsychotic drugs, occurs during treatment with asenapine. Symptoms of NMS include "high fever, sweating, unstable blood pressure, stupor, muscular rigidity, and autonomic dysfunction," according to the National Institute of Neurological Disorders and Stroke.

Other serious conditions that may occur during treatment with asenapine or other atypical antipsychotic drugs include hyperglycemia, diabetes mellitus, and orthostatic hypotension.

The recommended starting dosage of asenapine in adults with schizophrenia is 5 mg taken twice daily. For patients with bipolar disorder, the recommended starting dosage is 10 mg taken twice daily. If this dosage is not tolerated, the labeling recommends reducing the dosage to 5 mg taken twice daily.

Asenapine 5- and 10-mg tablets will be sold in 10-tablet blister packs in boxes of 60 or 100. Each tablet should remain in the blister pack until needed and then removed with dry hands. The tablet should be placed under the tongue and allowed to dissolve completely, and the patient should not eat or drink for 10 minutes after taking the tablet.

The labeling warns against crushing, chewing, or swallowing the sublingual tablets.

FAIR USE NOTICE: This may contain copyrighted (© ) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available for educational purposes, to advance understanding of human rights, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a 'fair use' of any such copyrighted material as provided for in Title 17 U.S.C. section 107 of the US Copyright Law. This material is distributed without profit.


Thank you AHRP

Economics & Eugenics

Loose Fiscal Policy has brought America to its Knees. Much of that Policy stems from the Theories of:

John Maynard Keynes

John Maynard Keynes, 1st Baron Keynes, CB (pronounced /ˈkeɪnz/) (5 June 1883 – 21 April 1946) was a British economist whose ideas have been a central influence on modern macroeconomics, both in theory and practice. He advocated interventionist government policy, by which governments would use fiscal and monetary measures to mitigate the adverse effects of business cycles, economic recessions, and depressions. His ideas are the basis for the school of thought known as Keynesian economics, and its various offshoots.

In the 1930s, Keynes spearheaded a revolution in economic thinking, overturning the older ideas of neoclassical economics that held that free markets would automatically provide full employment as long as workers were flexible in their wage demands. Following the outbreak of World War II Keynes's ideas concerning economic policy were adopted by leading Western economies. During the 1950s and 1960s, the success of Keynesian economics was so resounding that almost all capitalist governments adopted its policy recommendations.

Keynes's influence waned in the 1970s, due to critiques from Milton Friedman and other economists who were less optimistic about the ability of interventionist government policy to positively regulate the business cycle. However, the advent of the global financial crisis in 2007 has caused a resurgence in Keynesian thought. Keynesian economics has provided the theoretical underpinning for the plans of President Barack Obama, Prime Minister Gordon Brown and other global leaders to rescue the world economy.

In 1999, Time Magazine named Keynes one of the 100 most influential people of the 20th century and reported that, "His radical idea that governments should spend money they don't have may have saved capitalism". He is widely considered the father of modern macroeconomics, and by commentators such as John Sloman, the most influential economist of the 20th century. In addition to being an economist, Keynes was also a civil servant, a patron of the arts, a director of the Bank of England, an advisor to several charitable trusts, a writer, a private investor, an art collector and a farmer.

The Instrument Enacting Keynes Interventionist Macroeconomics is America's:

Federal Reserve System

(also known as the Federal Reserve, and informally as The Fed) is the central banking system of the United States. It was created as a result of the Panic of 1907, which was a particularly severe panic after a series of other panics (from previous decades), in which people raced to their banks to withdraw their deposits, which caused banks to fail, which in turn wreaked havoc throughout the U.S. economy. With the passage of the Federal Reserve Act on December 23, 1913, the Federal Reserve System was created "to address these banking panics" and "that would help prevent and contain financial disruptions" like the Panic of 1907. Over time, the roles and responsiblities of the Federal Reserve System have expanded and its structure has evolved, with events such as the Great Depression leading to major changes in the system. Its duties today, according to official Federal Reserve documentation, fall into four general areas:

1. conducting the nation's monetary policy by influencing the monetary and credit conditions in the economy in pursuit of maximum employment, stable prices, and moderate long-term interest rates;
2. supervising and regulating banking institutions to ensure the safety and soundness of the nation's banking and financial system and to protect the credit rights of consumers;
3. maintaining the stability of the financial system and containing systemic risk that may arise in financial markets;
4. providing financial services to depository institutions, the U.S. government, and foreign official institutions, including playing a major role in operating the nation's payments system.

Ask a representative selection of British Citizens what They think of the Reign of Gordon Brown, with His embrasure of Keynes Interventionism in Their Personal, Household Economies. We don't have to travel That road farther than to note that we've just Traveled it, AGAIN.

So what Else has Keynes contributed to the Improvement of the Sovereign, Individual, Citizen?

Wiki has:

The Galton Institute/British Eugenics Society

Check Their List of Prominent Members.

John Maynard Keynes, Director 1937-1944 V.P. 1937

What conclusion might You Draw from summing up these snippets?

Returning to Keynes Wiki expose:

"Keynes was always confident he could find a solution to whatever problem he turned his attention to, and retained a lasting faith in the ability of government officials to do good."


As in Weeding out the Bad Genetic Stock infesting the under classes, through Eugenics?

If you need a Refresher in just how Nothing, Psychiatric Genetics has actually Proven to date:

Psychiatric Genetics: Another Empty Box Of Bio-$cience.

Macroeconomic Interventionism IS, what it IS: the Brain Fart of a Eugenicist.

Psychiatric Intervention IS, what it IS:

Medical Publishing Co. Calls Bull Shit

Psychiatry lacks the fundamental elements of ANY field claiming to be a science.

Psychiatric Drugs ARE, what they ARE:

FDA Reported Adverse Reactions

America's Outrage over surrendering Their Health Care to Govt, IS, what it IS:

Town Hall Meeting Says NO To Govt Health Care;

The CITIZEN outrage over this Interventionist Fiasco is NOT simple political partisanship. These CITIZENS, are UNITED in their Opposition.

Join them and Make Your Voice Heard.

Unless of course you Want your kids Drugged, for some Non-Disease which exists only through being Voted into existence by a Show of Drug Money Conflicted hands.

ADHD, 100% FRAUD: Dr. Fred Baughman

Diabetes Charitable Group Dumps Medtronic

Pharmalittle has:

Diabetes Charitable Group Dumps Medtronic

IPump.Org, Inc. Will Refuse Diabetic Supplies Made by Medtronic

"In what could become an unprecedeted kind of initiative, IPump, Inc. has issued a statement that it will no longer accept donated products manufactured by Medtronic.

IPump is a 501(c)3 organization founded to get needed supplies to diabetic children in families that cannot otherwise afford that care. It is no small thing, therefore, for such an organization to close the door on a corporate donor.

IPump's statement on the matter can be accessed at:

http://www.ipump.org/blog/2009/08/08/why-we-
are-no-longer-accepting-medtronic-insulin-pumps-
and-pump-supplies/

There is discussion both of recurrently failing Medtronic devices, cover-ups, and Medtronic's role in the the fight for FDA preemption in the arena of medical devices.

The statement begins:

"Legal and Ethical Concerns Over Medtronic’s Business Practices

Medtronic has a court-documented track record of failing to properly notify its customers in a timely fashion of known product defects. Product failure has resulted in deaths, hospitalizations, and both individual and class action lawsuits against the company. Their inexcusable behavior has even prompted new proposed legislation because legal rights for patients who died or were injured by Medtronic products were substantially limited when it came to suing for tort damages."

IPump further describes Medtronic collecting used and returned devices and "donating" them to IPump, so that the organization has become (their phrase) a "medical device dumpster." Presumably, it is also a tax write-off for the company and, until now, good PR.

Quite extraordinary development, I think."

Visit iPump, Inc. and see what they have to tell you. And check back with Pharmalittle over the next week or so. The comments may become, Interesting, to say the least.

America's Children have just within the last few years been put at a 4000% INCREASED RISK of developing Diabetes, thanks to Harvard's $4.2 Million in Drug Money COI-ed Child Psychiatrist Joe Beiderman, & his 2 associates.

We've also already touched briefly upon Medtronics here.

FDA Approves (Medtronics) Brain Implant For OCD Based On 26 Patients

Industry Influence Must be taken out of Govt & vice versa.

Govt Influence/Money/Health Care Benefits Must be taken Out of/Away From, Industry.

Mental Health: Comes With FREE Diabetes

All 23 of the Psychiatric Poisons in our FDA Adverse Reaction section feature Diabetes, in one form or another, as an FDA reported Adverse Reaction with each Drug Individually identified as 'The Primary Suspect Drug' responsible for that Adverse Reaction

Abilify: Diabetes Insipidus, Diabetes Mellitus, Diabetes Mellitus Inadequate Control, Diabetes Mellitus Insulin-Dependent, Diabetes Mellitus Non-Insulin-Dependent, Diabetic Hyperglycaemic Coma, Diabetic Hyperosmolar Coma, Diabetic Ketoacidosis, Diabetic Neuropathy,
Adderall: Diabetes Insipidus,
Celexa: Diabetes Mellitus, Diabetes Mellitus Inadequate Control, Diabetes Mellitus Insulin-Dependent, Diabetes Mellitus Non-Insulin-dependent, Diabetic Complication, Diabetic Hyperosmolar Coma, Diabetic Ketoacidosis,
Clozapine: Diabetes Insipidus, Diabetes Mellitus, Diabetes Mellitus Inadequate Control, Diabetes Mellitus Insulin-Dependent, Diabetes Mellitus Non-Insulin-Dependent, Diabetic Coma, Diabetic Complication, Diabetic Hyperglycaemic Coma, Diabetic Ketoacidosis,
Cymbalta: Diabetes Insipidus, Diabetes Mellitus, Diabetes Mellitus Inadequate Control, Diabetes Mellitus Insulin-Dependent, Diabetes Mellitus Non-Insulin-Dependent
Depakote: Diabetes Insipidus, Diabetes Mellitus, Diabetes Mellitus Inadequate Control, Diabetes Mellitus Insulin-Dependent, Diabetes Mellitus Non-Insulin-dependent, Diabetes Mellitus Non-Insulin-Dependent, Diabetic Coma, Diabetic Ketoacidosis, Diabetic Neuropathy
Effexor: Diabetes Mellitus, Diabetes Mellitus Inadequate Control, Diabetes Mellitus Insulin-Dependent, Diabetes With Hyperosmolarity, Diabetic Ketoacidosis, Diabetic Neuropathy
Geodon: Diabetes Mellitus, Diabetes Mellitus Inadequate Control, Diabetes Mellitus Insulin-Dependent, Diabetes Mellitus Non-Insulin-Dependent, Diabetic Coma, Diabetic Complication, Diabetic Hyperglycaemic Coma, Diabetic Ketoacidotic Hyperglycaemic Coma
Klonopin: Diabetes Mellitus, Diabetes Mellitus Non-Insulin-dependent, Diabetes Mellitus Non-Insulin-Dependent, Diabetic Coma
Lamactil: Diabetes Insipidus, Diabetes Mellitus, Diabetes Mellitus Inadequate Control, Diabetes Mellitus Insulin-Dependent
Lexapro: Diabetes Mellitus, Diabetes Mellitus Inadequate Control, Diabetes Mellitus Non-Insulin-dependent, Diabetic Nephropathy, Diabetic Retinal Oedema
Neurontin: Diabetes Insipidus, Diabetes Mellitus, Diabetes Mellitus Inadequate Control, Diabetes Mellitus Insulin-Dependent, Diabetes Mellitus Non-Insulin-dependent, Diabetic Coma, Diabetic Complication, Diabetic Foot, Diabetic Ketoacidosis, Diabetic Microangiopathy, Diabetic Neuropathy
Paxil: Diabetes Insipidus, Diabetes Mellitus, Diabetes Mellitus Inadequate Control, Diabetes Mellitus Insulin-Dependent, Diabetes Mellitus Malnutrition-Related, Diabetes Mellitus Non-Insulin-Dependent, Diabetes With Hyperosmolarity, Diabetic Cardiomyopathy, Diabetic Coma, Diabetic Complication, Diabetic Enteropathy, Diabetic Foot, Diabetic Foot Infection, Diabetic Gastroparesis, Diabetic Hyperosmolar Coma, Diabetic Ketoacidosis, Diabetic Ketoacidotic Hyperglycaemic Coma, Diabetic Nephropathy, Diabetic Neuropathy, Diabetic Retinopathy, Diabetic Ulcer
Prozac: Diabetes Mellitus, Diabetes Mellitus Inadequate Control, Diabetes Mellitus Insulin-Dependent, Diabetes Mellitus Non-Insulin-Dependent, Diabetic Ketoacidosis, Diabetic Retinopathy
Risperdal: Diabetes Insipidus, Diabetes Mellitus, Diabetes Mellitus Inadequate Control, Diabetes Mellitus Insulin-Dependent, Diabetes Mellitus Non-Insulin-Dependent, Diabetes With Hyperosmolarity, Diabetic Coma, Diabetic Complication, Diabetic Hyperosmolar Coma, Diabetic Ketoacidosis, Diabetic Neuropathy, Diabetic Ulcer,
Ritalin/Concerta: Diabetes Mellitus, Diabetes Mellitus Insulin-Dependent, Diabetes Mellitus Non-Insulin-Dependent
Seroquel: Diabetes Insipidus, Diabetes Mellitus, Diabetes Mellitus Inadequate Control, Diabetes Mellitus Insulin-Dependent, Diabetes Mellitus Non-Insulin-Dependent, Diabetic Coma, Diabetic Complication, Diabetic Hyperglycaemic Coma, Diabetic Hyperosmolar Coma, Diabetic Ketoacidosis, Diabetic Ketoacidotic Hyperglycaemic Coma, Diabetic Nephropathy, Diabetic Neuropathy
Strattera: Diabetes Mellitus, Diabetes Mellitus Inadequate Control, Diabetes Mellitus Insulin-Dependent, Diabetes Mellitus Non-Insulin-dependent, Diabetic Ketoacidosis
Tegretol: Diabetes Insipidus, Diabetes Mellitus, Diabetes Mellitus Inadequate Control, Diabetes Mellitus Insulin-Dependent, Diabetes Mellitus Non-Insulin-dependent, Diabetes Mellitus Non-Insulin-Dependent, Diabetic Coma, Diabetic Ketoacidosis, Diabetic Neuropathy
Wellbutrin: Diabetes Mellitus, Diabetes Mellitus Inadequate Control, Diabetes Mellitus Insulin-Dependent, Diabetes Mellitus Non-Insulin-Dependent
Xanax: Diabetes Complicating Pregnancy, Diabetes Mellitus, Diabetes Mellitus Inadequate Control, Diabetes Mellitus Non-Insulin-dependent, Diabetic Complication, Diabetic Eye Disease, Diabetic Neuropathy
Zoloft: Diabetes Insipidus, Diabetes Mellitus, Diabetes Mellitus Inadequate Control, Diabetes Mellitus Non-Insulin-Dependent, Diabetic Ketoacidosis
Zyprexa: Diabetes Insipidus, Diabetes Mellitus, Diabetes Mellitus Inadequate Control, Diabetes Mellitus Insulin-Dependent, Diabetes Mellitus Malnutrition-Related, Diabetes Mellitus Non-Insulin-Dependent, Diabetes With Hyperosmolarity, Diabetic Cardiomyopathy, Diabetic Coma, Diabetic Complication, Diabetic Enteropathy, Diabetic Foot, Diabetic Foot Infection, Diabetic Gastroparesis, Diabetic Hyperosmolar Coma, Diabetic Ketoacidosis, Diabetic Ketoacidotic Hyperglycaemic Coma, Diabetic Nephropathy, Diabetic Neuropathy, Diabetic Retinopathy, Diabetic Ulcer

Hospital Stupidity Costs 85,000 Lives & $35 Billion Per Year

Public Citizen has:

Aug. 6, 2009

Basic Patient Safety Reforms Would Save 85,000 Lives and $35 Billion a Year, Public Citizen Report Says

Consumer Group Urges Congress to Use Medicare Funding as Leverage to Implement Changes

WASHINGTON, D.C. - A report issued today by Public Citizen proposes 10 cost-cutting, patient safety measures that would save an estimated 85,000 lives and $35 billion a year. The report, "Back to Basics," analyzed the results of scientific studies of treatment protocols for chronically recurring, avoidable medical errors.

In contrast to the high-tech tests and procedures that many experts blame for staggering increases in the nation’s health care costs, most of the reforms in Public Citizen’s report involve fundamentals as simple as practitioners consistently washing their hands, sufficiently tending to patients to prevent bed sores, and following simple safety checklists to prevent infections and complications stemming from operations.

Aside from the tragedy of needless deaths and injuries, the financial toll of failing to follow accepted safety procedures is astounding. Severe pressure ulcers cost an average of $70,000 apiece to treat. A catheter infection costs $45,000. Each instance of ventilator-associated pneumonia costs $5,800. Collectively, avoidable surgical errors cost an estimated $20 billion a year, bed sores $11 billion and preventable adverse drug reactions $3.5 billion.

"There are many incentives to order expensive tests and procedures and too few rewards for providing basic, sensible care," said David Arkush, director of Public Citizen’s Congress Watch division. "As the largest investor in the nation’s health care system, the federal government should ensure that fulfilling basic patient safety standards is a condition of receiving federal reimbursements. And the government should pay providers for doing the right thing. It will save money in the long run."

Public Citizen proposes that health care providers:

• Use a checklist to reduce avoidable deaths and injuries resulting from surgical procedures (saves $20 billion a year);

• Use best practices to prevent ventilator-associated pneumonia (saves 32,000 lives and $900 million a year);

• Use best practices to prevent pressure ulcers (saves 14,071 lives and $5.5 billion a year);

• Implement safeguards and quality control measures to reduce medication errors (saves 4,620 lives and $2.3 billion a year);

• Use best practices to prevent patient falls in health care facilities (saves $1.5 billion a year);

• Use a checklist to prevent catheter infections (saves 15,680 lives and $1.3 billion a year);

• Modestly improve nurse staffing ratios (saves 5,000 lives and $242 million a year);

• Permit standing orders to increase flu and pneumococcal vaccinations in the elderly (saves 9,250 lives and $545 million a year);

• Use beta-blockers after heart attacks (saves 3,600 lives and $900,000 a year); and

• Increase use of advanced care planning (saves $3.2 billion a year).

Public Citizen proposes five steps to ensure near-universal adoption of these reforms:

• The federal government should use its enormous leverage from its $750 billion annual investment in health care to compel providers to use proven patient safety practices. The Department of Health and Human Services (HHS) has the authority to enact many of reforms proposed in Public Citizen’s report through the regulatory process. Congress could ensure rapid adoption by including instructions to HHS in legislation;

• Congress should require HHS to take responsibility for accrediting providers to receive Medicare reimbursements. At present, the federal government delegates most accrediting authority to the Joint Commission, a private entity that derives its income from the very hospitals it oversees and denies accreditation to less than 1 percent of these hospitals;

• Congress should make significant financial investments to increase the country’s supply of nurses and set federal minimums of acceptable nurse-to-patient ratios. Nurse shortages are often implicated in patient safety errors. Modest increases would yield significant improvements. A significant increase in the number of nurses could produce dramatic results. One study estimated that increasing the number of nurses by a little more than one-third would save an astounding 72,000 lives annually;

• Congress should require mandatory reporting of adverse events, including requiring hospitals to institute strong internal reporting systems, and creating whistle-blower protections for health care workers. National reporting of the most serious medical errors is largely left to the Joint Commission. However, that organization estimates that it learns of only about one-tenth of 1 percent of serious medical errors despite its stated requirement that doctors disclose all errors to patients. In 1996, the Joint Commission contemplated requiring mandatory reporting but succumbed to industry pressure and settled for voluntary reporting; and

• Congress should ensure that the requirements for hospitals to report doctor discipline and maintain viable peer review processes are followed. Hospitals have been required since 1990 to report to the federal government cases in which doctors are suspended for more than 30 days. But nearly 50 percent of hospitals have never reported a single disciplinary action. This may be due to hospitals flouting the law, evading the spirit of the law by customizing penalties to sail below the reporting threshold, or failing to carry out warranted doctor discipline altogether because of inadequate peer review processes.

READ the report.

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Thank You Public Citizen.