Friday, March 25, 2011

Internal J&J E-Mails Detail Ugly Mismarketing Of Antipsychotics

BNET has;

by Jim Edwards

One of the reasons Johnson & Johnson (JNJ) lost a recent trial verdict over its misleading marketing of Risperdal was because jurors saw the company’s internal emails in which senior staff described their own actions as “ugly” and not “competent.”

Although the emails don’t reveal anything we don’t already know about Risperdal — J&J marketed the atypical antipsychotic for years by playing down the risk of weight gain and diabetes associated with the drug — the communications do give us a rare glimpse into the backbiting that happens inside drug companies when they fall afoul of the FDA. Pharmaceutical companies almost never discuss this kind of thing in public. (The documents can be downloaded atCourtroomView Network.)

In 2003, the FDA became increasingly concerned that use of drugs such as Risperdal and Eli Lilly (LLY)’s Zyprexa led to weight gain, diabetes and, in some patients, an early death. So it wrote to all antipsychotic drug companies to require them to send a “dear health care provider” letter to all U.S. doctors advising them of this risk (click to enlarge):

But J&J began trying to figure out whether the “dear doctor letter” could actually be used to promote Risperdal, which executives believed was not as risky as similar drugs. SVP/R&D Scott Reines (pictured) had seen a previous “dear doctor letter” from Eli Lilly that had used the same sleight of hand, and he asked a colleague, “how much commercial liability would we incur if we sent a similar letter about Risperdal”?:

When J&J’s letter went out, instead of heightening doctors’ awareness of the risk of diabetes it said the opposite: “Risperdal is not associated with an increased risk of diabetes”:

The FDA — unsurprisingly — hit the roof, and sent J&J a warning letter, blasting the company for being “false and misleading.”

Inside J&J, Reines was furious: “The whole management team almost got canned,” he wrote to chief medical officer Joanne Waldstreicher. “The warning letter is ugly … it’s really a black mark for J&J … [and] no competent person would have let [the 'dear doctor letter'] go out”:

J&J faces up to $36 million in fines as a result.

And make sure you read Mr. Edwards Related Reports.


And Don't try telling us that the pill pushers down at consultation cubicle level don't/didn't know Exactly what Risperdal, or any Other antipsychotic drug is.

Check the AIMS form. It's from 1976.

Tardive Dyskinesia is Risperdals' 9th most often FDA reported adverse Reaction, out of 1,935 distinct Adverse Reactions.

Who the Hell do you think has been filling out those forms, since 1976? It wasn't Bill Weldon or J&J's Board of Directors. And just in case any More of our State Attorney Generals are interested, Neuroleptic Malignant Syndrome was even More frequently reported than TD, occupying the number 7 spot.

Thursday, March 24, 2011

One Year Later, Is Obamacare Any More Popular?

The Heritage Foundation has;

One Year Later, Is Obamacare Any More Popular?

“I think that health care, over time, is going to become more popular,” then-White House senior advisor David Axelrod promised David Gregory about Obamacare last September. That same month, the Health Information Campaign, founded by high-profile leftist activists including former Senate Majority Leader Tom Daschle and former White House Communications Director Anita Dunn, spent $2 million on a national television ad campaign touting Obamcare’s first insurance mandates. Now, six months after Axelrod’s promise, and a full year after the bill was signed into law, the results are in: Obamacare is more unpopular than ever.

Look at any poll and you’ll see that Obamacare has only gotten less legitimate.Last year at this time Newsweek showed 40 percent of Americans supporting Obamacare and 49 percent opposing it. Today, only 37 percent support it while 56 percent oppose. According to Quinnipiac, after Obamacare passed last year, 44 percent of Americans approved of President Obama’s handling of health care while 50 percent opposed. Today, only 44 percent approve while opposition has grown to 56 percent. And according to the Kaiser Family Foundation, after Obamacare passed, 62 percent of Americans thought the law would either have no effect on them or make them worse off. Today that number is up to 69 percent.

The reason why President Obama and his liberal allies have failed to turn public opinion around is simple: The major claims made by the President in the effort to pass Obamacare have all been exposed as frauds, and the early implementation by his Administration has been a complete disaster.

Center for Policy Innovation Senior Fellow and Why Obamacare is Wrong for America co-author Bob Moffit details just some of the Obamacare claims that have been exposed as fictions:

  • “Obamacare will bend the cost curve downward.” Not according to the Centers for Medicare and Medicaid Services (CMS), whose April 22, 2010, report shows Obamacare adding more than $310 billion more in health care spending;
  • “People who like their health plan can keep it.” Not according to CMS, which estimates that 14 million Americans will lose their current coverage if Obamacare is not repealed;
  • “The middle class will not see tax increases.” Yes, they will. In fact, most of Obamacare’s tax increases hit the middle class.

On the implementation front, Heritage analyst Brian Blase surveys the early returns:

  • Benefit Mandates Drove Up Costs. The generous benefit packages mandated by Obamacare are not free. Insurers across the country raising rates at record paces and unequivocally is part of the reason why. For example, Celtic Insurance Company in Wisconsin and North Carolina has attributed half of its 18 percent rate increase to Obamacare mandates.
  • Preexisting Condition Mandates Destroyed the Child-Only Market. Just one year after Obamacare forced all insurers to sell coverage to all applicants—no matter what—insurers in 34 states have exited the market entirely, and 20 states now have no insurers that offer child-only plans.
  • Shallow High-Risk Pools. The Obama Administration predicted that 375,000 previously uninsured Americans would benefit from Obamacare’s high-risk insurance pools. In reality, only 12,500 people (just 3 percent of the initial estimate) obtained coverage through this program.

And the worst of Obamacare hasn’t even been implemented yet. Starbucks CEO Howard Schultz told the Seattle Times yesterday: “I think as the bill is currently written and if it was going to land in 2014 under the current guidelines, the pressure on small businesses, because of the mandate, is too great.” Putting some hard numbers on that prediction, International House of Pancakes franchise owner Scott Womack told Heritage’s Tina Korbe: “Our average revenue per employee is $58,000. Our typical profit per employee is $3,000 and this legislation is going to cost anywhere from $7,000 to $10,000 per employee.” America’s businesses simply cannot afford Obamacare. It is, and is going to continue to be, a huge job killer.

And our nation’s taxpayer’s can’t afford Obamacare either. Last year, our nation’s oldest entitlement program, Social Security, paid out $37 billion more in benefits than it collected in taxes. This year, it will pay out $45 billion more than it collected. Over the next 10 years, Social Security will run a $600 billion operating deficit. Instead of making our existing entitlement programs solvent, President Obama created a brand new trillion-dollar entitlement in Obamacare. This trillion dollars in new spending is paid for by half-a-trillion in higher taxes and another half-a-trillion in stolen funds from the existing Medicare program. And the CBO just upped Obamacare’s final price tag by 8.6 percent to $1.44 trillion. This is simply unsustainable.

Two hundred and thirty-six years ago, while making the case for Virginia to enter the Revolutionary War, Patrick Henry said: “Give me liberty or give me death!” After just one year, it is already clear that President Obama’s failed health care policies are a betrayal of the founding sentiment.

You Can today, and Will today, be Drug/Electrically Executed for having a Disordered Mood by the Inheritors of the Same Crackpot Theories which utterly Devoured Germany, All of Europe, Western Russia and parts of North Africa 70 years ago.

The Men Behind Hitler

Obamacare, on top of it's hellish economic chains, will yet further accelerate the process of Nazification through its burgeoning bureaucracy, which Will provide the economic crevices into which even More of these junk science Psychiatric FRAUDS will seek their paycheck sustenance.

Wednesday, March 23, 2011

Ca. v. BMS: "Mammoth Insurance Fraud Case"

California State Insurance Commissioner Dave Jones has;


For Release: March 18, 2011
Media Calls Only: 916-492-3566

Insurance Commissioner Dave Jones today announced his intervention in a "qui tam" (whistleblower) lawsuit against Bristol Myers-Squibb (BMS), one of the largest pharmaceutical companies in the U.S. The lawsuit is the largest health insurance fraud case ever pursued by a California state agency.

Former employees of BMS filed a whistleblower action under seal in Superior Court in Los Angeles alleging that BMS bribed doctors to prescribe BMS drugs. The lawsuit alleges that the company provided illegal kickbacks to doctors in order to increase the company's pharmaceutical sales in California. The Commissioner seeks monetary penalties and the disgorgement of millions of dollars in unlawful profits the company made as a result of kickbacks, plus treble damages. The kickback scheme ultimately came at the expense of the private health insurance industry, which paid for the drugs, and California consumers.

"This sort of fraud has long plagued our health insurance system, leading to billions of dollars annually in added health care costs nationally," Commissioner Jones said. "Besides the obvious and deplorable ethical violations in such cases, health care fraud also leads to higher premiums for consumers and an unnecessary and unjust increase in health care costs. As Insurance Commissioner, I will use the full force and resources of this department to root out insurance fraud and hold all responsible people and companies accountable. In this particular case, we are uncertain whether the kickback scheme is still occurring. If discovery discloses that violations are continuing, the Department will seek an injunction and penalties to address those violations."

The case in which Commissioner Jones is intervening was initially filed by former BMS employees Michael Wilson and Lucius and Eve Allen, all of whom are represented by the law firm of Waters Kraus & Paul in Los Angeles. The suit alleges that BMS instructed its sales representatives to court doctors with sports tickets, fancy meals, honoraria, all-expense-paid trips, and gifts to induce them to prescribe BMS drugs. The complaint alleges that the result of the scheme was to increase prescriptions of BMS drugs, which private health insurers (and, ultimately, the policy holding public) in California ended up paying for. It is believed that insurance companies in California have spent over $3.5 billion to cover the costs of the drugs the lawsuit claims BMS sought to promote with its kickback scheme.

"We need to be sure that doctors are prescribing drugs because those drugs are best for their patients and not because a pharmaceutical company provided doctors with trips and kickbacks," Commissioner Jones said. "These illegal practices drive up the cost of health insurance for millions of Californians. Besides the illegality involved in this case, such actions are plainly and simply unjust, and I will seek to stop such unlawful practices."

The case will be decided by a jury in Los Angeles.

For a copy of the complaint, please select this link.

And you Wonder how America finds itself virtually Bankrupt, with shenanigans like this parading out into the sunlight. Are you enjoying that $4.00 & $5.00 a gallon gasoline too? Because This is what you get by electing people who promise to make life ´Fair´, so that everyone will 'feel better'.

Aren't BMS the people who've foisted Abilify upon the world too?

0:26 "Call your Doctor if you have," ..... the Ability remaining to even Reach for the phone.

And ask them if they're on the take, after you've read the Insurance Commissioner's complaint.

And of course, Johnson & Johnson are no strangers to allegations of Kickbacks Either.

Tuesday, March 22, 2011

South Carolina Sues J&J/Risperdal For $360 Million

J&J and their Risperdal just can't seem to keep out of Court.

Bloomberg has:

"Johnson & Johnson executives deceived South Carolina doctors about the safety of the antipsychotic drug Risperdal, and the drugmaker should be held liable for that deception, a lawyer said.

J&J made misleading claims about Risperdal’s health risks and effectiveness in a letter to more than 7,000 South Carolina doctors and that violated consumer protection laws, John Simmons, a lawyer for the state, said in closing arguments of the trial of a lawsuit seeking at least $360 million in penalties.

The drugmaker, based in New Brunswick, New Jersey, used “unfair and deceptive acts” in a marketing campaign designed to dupe doctors into signing off on Risperdal for mental-health patients, Simmons told jurors today.

The state’s case centers on drug-safety claims that J&J and its Ortho-McNeil-Janssen Pharmaceuticals unit made in November 2003 correspondence to 700,000 doctors across the U.S., including 7,200 in South Carolina. The U.S. Food and Drug Administrationresponded with a warning letter saying J&J made false and misleading claims that minimized the potentially fatal risks of diabetes and overstated the drug’s superiority to those from competitors.

Continue Reading Bloomberg J&J/Risperdal Coverage

Pharmalot has back story galore

And Fierce Pharma offers at least $29 Million possible explanations.

"Well, if you'd just collected almost $29 million in compensation and won heaps of praise from your board of directors, would you want to exit stage left?"

The juiciest part of this Risperdal Implosion - to us - is that Psychiatrists, Excuse Us, Illuminati, who are SO Brilliant, that without any actual Bio-Science beyond their reviews of the Wizard Of Oz, can infallibly diagnose incurable disorders/diseases which only They can treat, ..... oops, excuse us, Symptom Control/Chemically Lobotomize, .....while simultaneously Losing 2 Psychiatric Hospitals and their staffs, SFMHB 06/13/2007 ..... never saw it coming, ..... as their University was sitting on $12 Million Dollars of RWJF/J&J/Risperdal Grant Monies.

Saturday, March 19, 2011

Drug Commercials: Quack In Hi Def.

RN has;

Here's a few samples of the stupid that drags itself nightly right before your very eyes, in High Def, .....

The worst of it is that it's All right there in plain view, and America isn't hopping mad demanding that it Cease and these Noxious Quack Remedies be dragged off the market.

Thanks and a Hat Tip to Hooked, Ethics, Medicine And Pharma

"Dear Sir (or Madam):--I try every remedy sent to me. I am now on No. 67. Yours is 2,653. I am looking forward to its beneficial results.

- quoted in My Father Mark Twain, by Clara Clemens"

Wednesday, March 16, 2011

PTSD: Military Polypharmacy, & Military DEATHS

AHRP has;

Military Polypharmacy, PTSD, Deaths

"The problem of prescription overdose in the military has its parallel in civilian life. The tragic overdose victims in both spheres represent canaries in the coal mine--only the most obvious victims of what has become our national orgy of over using psychotropic drugs."
Allen Frances MD

Dr. Allen Frances, psychiatry professor emeritus and former chairman of psychiatry, Duke University who chaired the DSM-IV Task Force revision --i.e., psychiatry's diagnositic / practice manual--has emerged as one of the most outspoken, thought provoking critics of psychiatry and its diagnostic and prescribing practices.

Dr. Frances recognizes what few US doctors--and hardly any psychiatrists--do:

The "Hippocratic injunction of "FIRST DO NO HARM" evolved in ancient Greece specifically to discourage practitioners from being overly aggressive in using dangerous treatments for conditions that are not responding (and may not respond well) to existing interventions. It is important to recognize that sometimes the treatment becomes worse than the disease.

Indeed, psychiatrists' overprescribing psychotropic drugs have worsened the disease or mental disorder they are presumed to be suffering from. Presumed, because as Dr. Frances--who chaired the Task Force of the DSM-IV revision-- has acknowledged, the concepts that define mental disorders in the DSM are just concepts lacking scientific authenticity:

“there is no definition of a mental disorder. It’s bullshit. I mean, you just can’t define it....these concepts are virtually impossible to define precisely with bright lines at the boundaries.”

Below, Dr. Frances identifies the problems that have led to increased deaths among US troops--and he offers corrective steps to stem the tide of treatment-related deaths.

Vera Hassner Sharav


Polypharmacy, PTSD, and Accidental Death From Prescription Medication

By Allen Frances, MD | February 13, 2011 / March 9, 2011

The New York Times of February 14 carries the disturbing news of an alarming increase in deaths from accidental overdose among our active duty military personnel and our war veterans. The usual scenario is a diagnosis of PTSD (often accompanied by a pain syndrome) unsuccessfully treated with a wide array of psychotropic drugs, which in their aggregate wind up killing the patient-- often at a very young age. Autopsy reveals significant blood levels of prescribed medication reflecting the heavy drug cocktail and no other apparent cause of death.

PTSD/pain patients are often prescribed a combination of psychotropics that may include--one antidepressant, one antipsychotic, one antianxiety, one sleep, and one pain medicine. Sometimes, the enormous medication burden is worsened even further--either by the simultaneous prescription of more than one drug from a given class or the additional self medication effected by the sharing of pills among patients.

Individual psychotropic drugs can have serious side effects--in excessive combination they sometimes threaten respiratory and cardiac function in a potentially lethal way. And the whole is even more dangerous than the sum of its parts since the medications can interact to increase each other's blood levels. Prescription drugs are overtaking illegal drugs as the primary cause of accidental overdose and death.

To its credit, the military is catching on and beginning to initiate procedures to restrict and review heedless and excessive polypharmacy. But this is a tough problem with no ready solutions. Some of the factors involved are:

The over prescription of multiple drugs that is also rampant in civilian life. There is no research literature to guide and restrain polypharmacy--so it becomes subject to individual physician whim, often under patient pressure for relief.

PTSD has no effective medication treatment, encouraging the potentially dangerous scatter shot approach of treating the individual symptoms each individually with its own medication.

3.The recent ubiquity and
carelessness of prescription of dangerous pain medications that resulted as an over-compensation by the military after it was previously criticized for being too sparing in their use.

4. Because they are legal, accessible, and cheap, pain medications are now an attractive alternative to illegal recreational drug use--but with dangerous consequences given their interaction with other psychotropic drugs.

The tendency to always add and never sunset medications leads to the continued use of drugs that have not been effective, but will add on to the cumulative and interacting side effects.

Chasing the side effects of one drug by adding another to deal with them--eg if an antidepressant causes anxiety or insomnia it is usually a mistake to add yet another potentially harmful pill to deal with these side effects rather than reducing the dose or trying another antidepressant.

7. A shortage of mental health personnel that results in
pill pushing rather than the easy access to the one treatment with clear efficacy for PTSD- cognitive behavior therapy.

8. Forgetting
, the Hippocratic injunction of "FIRST DO NO HARM." This evolved in ancient Greece specifically to discourage practitioners from being overly aggressive in using dangerous treatments for conditions that are not responding (and may not respond well) to existing interventions. It is important to recognize that sometimes the treatment becomes worse than the disease.

This is exactly our modern dilemma with some cases of PTSD where restraint is safer and saner than unreasonable treatment perfectionism and optimism-- which can be costly and sometimes even lethal.

None of these problems will be easy to solve, but some immediate corrective steps seem obvious:

1. Greatly enhance the availability of CBT. If it is too expensive or difficult to recruit trained mental health professionals, train the needed cohort of medics and paraprofessionals.
CBT is readily teachable to those with limited previous training.

Educate doctors on the risks and limitations of polypharmacy for both PTSD and for pain syndromes, and especially the combination of both.

Require special explanations from physicians whenever they prescribe more than three psychotropic medications, or prescribe higher than standard dosages, or prescribe drugs that have significant interactions, or prescribe simultaneously two drugs from the same class.

4. Require automatic, thorough quality assurance auditing to ensure there are adequate reasons for exceptions.

Pharmacies should routinely use available drug interaction algorithms to spot dangerous doses and drug combinations and to alert clinicians.

6. Readily available detoxification and rehabilitation should be provided for those who have become addicted to prescription medications and/or other addictive substances.

This problem of prescription overdose in the military has its parallel in civilian life. The tragic overdose victims in both spheres represent canaries in the coal mine--only the most obvious victims of what has become our national orgy of over using psychotropic drugs.

Thank You AHRP

However, ..... .

1: CBT is Bullshit. It Doesn't work, and it's truly unfortunate but fully understandable, that More studies aren't as frank and detailed as this next CBT embarrassment. CBT is nothing more than an EXCUSE to (B)ILL an INSURANCE CARRIER. When CBT actually CURES rather than CONDEMNS just 1 single person as being certifiably, legally 'Mentally Healthy' rather than Bill-ably 'Mentally Ill' then and Only then will it be anything other than FRAUD.

2: The "Hippocratic Oath" is Also Bullshit. If You can find Anything even Resembling the ancient Greek Ideal of 'Do No Harm' You're probably a Mental Health Paycheck Scammer: IE: a Parasite Mooching off your fellow Citizens in order to Toss people onto our Already broken Social Security Roles while helping yourself to Their Medicare & Medicaid monies.

The Hippocratic Oath, which our Hit & Run Media Loves quoting without having Read the silly ass smoke screen does not contain the words, nor apparently even the sentiment, of "Do No Harm": neither the 1964 version, or the Classical version.

The Modern version speaks of 'respecting hard won scientific gains' and the Classical speaks of respecting, and 'holding confidential between Physician and Patient (as in State/World Police Registration due to their filthy Treatment's, non-disclosed Homicide Risk) everything which the Physician may learn.'

According to a 1993 survey of 150 U.S. and Canadian medical schools, for example, only 14 percent of modern oaths prohibit euthanasia, 11 percent hold convenant with a deity, 8 percent forswear abortion, and a mere 3 percent forbid sexual contact with patients.