Monday, June 18, 2018

Gold Standard: Clozapine & Finland.


Autumn Gold and Gold Standard in Finland:


Tiihonen said the pharmaceutical industry is partly to blame for why clozapine has often been overlooked. "Clozapine's patent expired long ago, so there's no big money to be made from marketing it," he said.



© 2012 Am Ang Zhang

There have been many challenges to Clozapine but to the Cockroach Catcher it will remain the Gold Standard for the treatment of Schizophrenia for a long long time.

An extract from The Cockroach Catcher:

……...Martina was already at the adolescent inpatient unit when I arrived. She was supposed to be schizophrenic. The family were refugees from Sudan. They were a small Sect of Catholics that were said to be persecuted.
Martina was not very communicative but her records and observations by her outpatient psychiatrist indicated that the diagnosis was robust enough. However, after over a year in hospital she was not improving and we had tried the newer antipsychotic without making much headway.
There was one thing left to do – to put her on Clozapine.
I was once at one of these big drug firm meetings when all the big boys on the newer antipsychotics were there.
Having filled my plate from the delicious buffet, I sat next to two nicely clad representatives.
“So you ladies are from Novartis?” I did my usual stunt.
“How did you work that one out?”
“Well, you two have the best designer outfits and I guessed you must be from the makers of Clozapine.”
They were there to see what the opposition might come up with but as far as I was concerned no other pharmaceutical would touch them for decades.

After today’s Lancet publication they might not need to worry at all!

The Lancet, Early Online Publication, 13 July 2009
11-year follow-up of mortality in patients with schizophrenia: a population-based cohort study (FIN11 study) Jari Tiihonen et al. 

According to Reuters:
…………An analysis of 10 years' records for 67,000 patients in Finland found that, compared to treatment with the first-generation drug perphenazine, the risk of early death for patients on clozapine was reduced by 26 percent.

By contrast, mortality risk was 41 percent higher for those on Seroquel, known chemically as quetiapine; 34 percent higher with Johnson & Johnson's Risperdal, or resperidone; and 13 percent higher with Eli Lilly's Zyprexa, or olanzapine.
"We know that clozapine has the highest efficacy of all the antipsychotics and it is now clear, after all, that it is not that risky or dangerous a treatment," study leader Jari Tiihonen of the University of Kuopio said in a telephone interview.
"We should consider whether clozapine should be used as a first-line treatment option."Tiihonen estimates clozapine is given to around one fifth of Finnish schizophrenia patients, but less than 5 percent in the United States.Clozapine's side effects include agranulocytosis, a potentially fatal decline in white blood cells, and current rules stipulate the drug can only be used after two unsuccessful trials with other antipsychotics.Tiihonen and colleagues wrote in the Lancet medical journal that these restrictions should be reassessed in the light of their findings, since not using the drug may have caused thousands of premature deaths worldwide.
According to AP:

James MacCabe, a consultant psychiatrist at the National Psychosis Unit at South London and Maudsley Hospital, called the research "striking and shocking." He was not linked to the study.
"There is now a case to be made for revising the guidelines to make clozapine available to a much larger proportion of patients," he said.
Tiihonen and colleagues found that even though the use of anti-psychotic medications has jumped in the last decade, people with schizophrenia in Finland still die about two decades earlier than other people.


Tiihonen said the pharmaceutical industry is partly to blame for why clozapine has often been overlooked. "Clozapine's patent expired long ago, so there's no big money to be made from marketing it," he said.


Clozapine Data: FinlandRCPU.K.NEJM
Abstract:The Lancet.

Related Posts
Abilify/aripiprazole: Akathisia-gate
Alaska Zyprexa: DOJ at last.
Alaska, Good Friday Earthquake and Zyprexa 
Alaska Zyprexa: Follow Up
Bipolar and ADHD: Boys and Breasts
Antipsychotics: Really?
Humber Mental Health Teaching NHS Trust: Learning From The Past.

Monday, June 4, 2018

NYBG: Peony time!

It is that wonderful time of the year to enjoy peonies as they lasted just a very short time!






 All photos ©2018 Am Ang Zhang

Book I recently read: 

Fragile Lives by Stephen Westaby


Hello Summer: BBG4.


Photography: Best lens for portrait & landscape!



A unique picture book consisting of 20 beautiful 9 x7 in. full bleed photos by the author of: corals, turtles, anhinga, blue tang, file fish, butterfly fish, cleaner shrimp, pompano, barracuda, flounder, star fish, and sting ray. A first of the kind tale of aquatic creatures in child-speak. A good introduction of nature to a young child, especially good as a follow-up to a visit to the aquarium; plus two pages of detailed companion




A coffee table quality photobook for a special child, introducing wild life in Africa. Photos of the animals (impala, nyala, kudu, wildebeest, warthog, gruffalo, zebra, rhinoceros, waterbuck, hippopotamus, giraffe, buffalo, elephant, saddlebilled stock) were taken by the author himself during safari trips in Africa.






Multiple Sclerosis: Never say never!

Latest from Dr Weldon:


Note
Over the course of the last ten years I have received a number of emails from persons who, having read these pages, assert that Sarah never had multiple sclerosis. These persons inform me that she had Acute Disseminated Encephalomyelitis (ADEM). Some of these amateur neuroscientists (who have never spoken to, taken a history from, or examined the lady) have been quite strident in their assertions.

Well, Sarah's illness was completely typical of Relapsing-Remitting MS developing into Secondary Progressive disease. Sarah experienced seven relapsing-remitting episodes involving different parts of the CNS over two decades; remissions became partial; then her illness began to slide into the secondary progressive form over two years. This is not seen in ADEM, where the picture is of acute post-infective encephalitis. Although ADEM is seen in adults, it is more often seen in children, peaking between 3 and 10 years. ADEM is rare (7 per 1,000,000); MS is common (1.2 per 1,000). MRI imaging shows different appearances; lesions in ADEM have poorly defined margins; those of MS are more sharply defined. The spatial arrangement and the shape of lesions in the two diseases is different. Sarah's MRI showed lesions typical of MS.

Here is a link to an article on the differences between ADEM and MS: http://adc.bmj.com/content/90/6/636.full
So, it is certain that Sarah had Secondary Progressive MS, a diagnosis made by a consultant neurologist. She (and others) recovered because she was treated rationally using evidence-based medicine. And by evidence-based I mean evidence-based.
Sarah's story has been made public, to assist others, at her request.

Link: http://www.davidwheldon.co.uk/ms-treatment.html

There is suddenly a great interest in one of my earliest posts: 

Multiple Sclerosis, Iguanas and Wrong Foot


In the summer of 2005 I read a rather compelling story in Hospital Doctor. The headline was: “Ignoring the EvidenceDiagnosis of his wife’s progressive multiple sclerosis would not have taken so long had doctors taken a proper history, says Dr David Wheldon.”


It was an extremely well written article. It had to be, as Dr Wheldon’s hobby is poetry writing. He is a microbiologist by profession.
His wife is an accomplished painter and a violin restorer and dealer. As early as 2000, she noticed that she was dragging her right foot on a walking holiday in the Auvergne. She was referred to an orthopaedic surgeon. “Congenital spinal stenosis,” he confidently diagnosed. She got worse. In 2003 she was referred to a neurologist but during the months when she was made to wait for an MRI (why was it not done immediately?) she deteriorated rapidly and was soon unable to walk unaided and had a multitude of other neurological symptoms.
“Progressive multiple sclerosis,” proclaimed the neurologist. "No treatment is available. Just let the disease evolve."
Dr Wheldon at this point commented that a proper history would have allowed for the diagnosis to be made earlier, as his wife had had two transient episodes of weakness of an arm and dimmed vision in one eye.
There was no time to waste and having been given a “no hope” verdict, Dr Wheldon thought that alternatives had to be found. How often have we found patients seeking alternative treatment and sometimes very very alternative treatments once they were told what was thought to be the “truth”? Luckily I learned early on in my medical training that one should “never say never” (as mentioned in the chapter “Miracles” in my book.)
He found the Vanderbilt University work on Chlamydia pneumoniae. The rest, so to speak, was history. His wife was put on two antichlamydial agents and later metronidazole. After some typical reactions his wife started to recover. Eighteen months later, she was able to paint and walk a mile or so.
Some may argue that the recovery had nothing to do with the treatment, but was just one of those rare spontaneous recoveries. I am aware that this is only an isolated case, but there is ongoing research in this area.

Iguana iguana, Costa Rica

So what is the iguana doing in today’s blog? Many iguanas kept as pets are wild, truly wild caught and they carry various bacteria including Chlamydia pneumoniae, which also infect and cause diseases in Koalas, snakes, chameleons, frogs, and green turtles.
According to National Geographic, one of my favourite reads,
“Green, or common, iguanas are also among the most popular reptile pets in the United States, despite being quite difficult to care for properly. In fact, most captive iguanas die within the first year, and many are either turned loose by their owners or given to reptile rescue groups.”
Perhaps we should leave them to stay in the wild.
Dr Zhang should have checked if Tommy, his Wrong Foot patient, kept an iguana. His mother was diagnosed with multiple sclerosis.

Chlamydia pneumoniae site: CPNHELP.ORG


Other Posts on Multiple Sclerosis:

Multiple Sclerosis Treatment – an Update

Links

“Multiple Sclerosis:  A Curable Infectious Disease?”, July 7, 2010, http://perfecthealthdiet.com/?p=157.
“Is Multiple Sclerosis an Autoimmune Disease?”, July 5, 2010, http://perfecthealthdiet.com/?p=151.
“Eleven Steps for Overcoming Alzheimer’s and Other Chronic Infectious Diseases,” July 1, 2010,http://perfecthealthdiet.com/?p=134.
Popular Posts:

Picasso and Tradition?Teratoma: One Patient One Disease?
Teratoma: An Extract,A Brief History of Time: CPR (Cardiopulmonary Resuscitation)
House M.D.: Modern Tyranny
House M.D. : 95% vs 5%


9 comments:

Sarah Longlands said...
Dear Dr Zhang,

My name is Sarah Longlands, the wife of Dr Wheldon, mentioned above. I found your blog by accident when looking up "David Wheldon" on Google, something I do from time to time to see who is linking to both our web sites.

I thought I would give you a small update:nearly three years on again since the publication of "Ignoring the Evidence" I am still going strong, not having had an adverse MS event since starting treatment in August 2003. When I started I couldn't even hold a paintbrush but now I have worked through watercolours to acrylics and have now moved back to my favourite medium of oil paints and of no mean size. My progressive multiple sclerosis was so aggressive, I really shouldn't be here now, but I am.

I have not seen my neurologist since being given the diagnosis. David has, since they work in the same hospital, but although at one point the man showed some interest, this soon passed and the man has never looked at my subsequent improved scans. In fact, he once ran out of the radiologists room exclaiming "I can't look at this!" He is obviously very good at saying "Never."

There are always going to be people willing to put my recovery down to "spontaneous recovery" but I think it very odd that this should have happened within a few hours of downing my first ever doxycycline, after having my first multiple sclerosis relapse twenty years previously, age 24. Then and for many years it was untroubling, with few, easily resolved relapses. Over the years I had been able to forget about it, so I readily accepted the diagnosis of the orthopaedic surgeon. I have since discovered that David married me thinking I might well have MS, because of my clumsiness although by that time I has already decided that it couldn't possibly be the case.

Since starting to recover, David has seen many patients abandoned by the neurological establishment and has written two papers with Charles Stratton of Vanderbilt University about chlamydia pneumoniae and multiple sclerosis. I started writing on http://www.thisisms.com, where a psychologist named Jim Kepner, a sufferer of another disease caused by chlamydia pneumoniae, saw me and started to treat himself. Two and a half years ago this led to him starting a wonderful site: http://www.cpnhelp.org where people from all over the world suffering from any of the many diseases in which CPn is implicated can come together for freely given help and reassurance.

Very best wishes,

Sarah Longlands. 12th April, 2008
Am Ang Zhang said...
Many thanks Sarah for taking the time to make the comment. All the best.

Dr Am Ang Zhang
Anonymous said...
Copied from CPNhelp because I thought you might not see it there:

"Hello again Dr Zhang! I hope you enjoyed your hols, but it was only a tiny flurry really, like the small snowfall we had the other Sunday morning which was gone before most people knew it had been there.

I totally agree with you about the state controls, first set in place in our country when the fat man in hush puppies was health minister, I had only recently both got my MA and acquired MSi and chlamydia pneumoniae was not even realised to be a serious pathogen. I'm glad we have original thinkers over at Vanderbilt and I am so glad I am married to one here, who discovered what they were doing and thought that it was better to get on with treating me rather than waiting for endless double blind trials that would never happen, antibioticsi not being profitable things.......Sarah




An Itinerary in Light and Shadow by a real "Painter of Light"...........Completed Stratton/Wheldon regime for aggressive secondary progressive MS in June 2007, after four years, three of which intermittent. Still slowly improving and no exacerbation since starting. EDSS was 7, now 2, less on a good day."
Anonymous said...
that is the case too, the antibiotics on the protocol used to treat are long off patent & sport the least amount of side effects from the abx themselves. The pharma companies have no interest.

but wow, they now have something they can make money on! a drug for Fibromyalgia pain (packed with a plethora of side effects)!
Gill said...
Hi, I have been recently diagnosed with MS and was also told there was nothing that could be done. My options appeared to be nil or joining the MS Society for group hugs and "learning how to live with my disease". Not a chance I was putting up with that so I started to scour the web and talk to friends recently diagnosed.

I thank my lucky stars that one friend pointed me straight to David Wheldon's site and having met with him, I'm about to start on the protocol. With the help of the pioneering stalwarts on the CPn Help forum mentioned above, David Wheldon, and the inspirational Sarah, I fully intend to see this through. If it's possible to cure it then I'll have a darn good try.

My GP and Neurologist have refused to have anything to do with the Protocol which I find exceedingly strange. I always thought the medical profession were tasked with making patients well by whatever means, it seems however that unless the drug companies are waving some new miracle drug at them, they're not open to looking at old medication used in a new way.

Having read your blog though, I'm going to spend the afternoon scouring the house in case I have a recalcitrant Iguana hiding in a dark corner. Or maybe I'll round up the frogs in the pond and force them to take a Chlamydia Pneumoniae test. :-)
Am Ang Zhang said...
Hello all, back from Hols and the blog engine has restarted.
Am Ang Zhang said...
Sarah's letter is now posted here.

The Cockroach Catcher

Wednesday, May 30, 2018

Whistleblower: Genius & Fraud

It is interesting to come back to somewhere where I can start catching Cockroaches.


Before then, I realised what a genius our Ex Health Secretary really is:

The Guardian: Lansley's claims about hospital PFI debt 'misleading'!
He has managed to turn so many to now love PFI. Wow!
But wait: he has also set out the justification to sell off the 22 hospitals to the likes of Circle or Netcare. Win! Win!

But is the genius ready to deal with Medical Fraud?

Baltimore Sun:
September 17, 2011

Something didn't look right. Maxim Healthcare nurses were showing up at Richard West's house according to one schedule. But Maxim was billing the government according to another.

West complained to the state: The company was charging for hundreds of hours of work it never did. Officials blew him off, he said. He alerted Medicaid, the state and federal program that paid for his care. Nothing happened.
 
He told a social worker. She expressed concern, but did nothing. But West, a Vietnam vet with muscular dystrophy, kept pushing and pushing, building a giant, accusatory snowball that landed last week — eight years later — on Maxim's Columbia headquarters.

Maxim has signed a criminal and civil settlement related to allegations that it schemed to rip off $61 million from state and federal governments, law enforcement authorities said last week. The company is paying $150 million in penalties and recompense. Eight former Maxim employees so far have pleaded guilty to felony charges in several states.

If Washington is as serious about fighting medical fraud as it pretends to be, it will recruit an army of Richard Wests to burn off leeches like Maxim. Nobody is in a better position to see fraud than patients, who can check the care they receive against what's on the invoice.

Now that West has shown that patients can get rich in the bargain, there's plenty of incentive. Not that his motivation was his $14.8 million share of the settlement. Anger was. He didn't even know about such whistleblower rewards at first.

"Somebody decided to make a profit on my disability," West said in a telephone interview. "This is your country. You see fraud, you should turn them in. That is part of being an American."

Whistleblower rewards under the federal False Claims Act have been around since the Civil War. The recent caseload has been dominated by allegations of Medicare and Medicaid fraud, which costs taxpayers billions of dollars a year.

In almost every instance, the person who alerts law enforcement is a corporate insider, not a patient. West's information in the Maxim case was so compelling, however, that the government credited him as the "original source," with independent and direct knowledge of the fraud.

He kept spreadsheets on the gaping discrepancy between the hours Maxim nurses spent in his home north of Atlantic City, N.J., and the hours Maxim billed Medicaid. Eventually he documented more than 700 hours of bogus charges, according to the New Jersey attorney general.

After a couple months of detective work, West got in touch with Baltimore lawyer Robin Page West (no relation), who specializes in whistleblower lawsuits. Together they built a case, filed it under court seal in 2004 and turned it over to law enforcement. And waited.

West, 63, speaks precisely but with difficulty, in a high-toned voice. He says he commanded an Army track vehicle with 40 mm guns in Vietnam in 1968 and 1969 — the deadliest years of the war there. Yet biding his time while investigators built their file, he said, "was the hardest thing I've ever done."


See also:



Sunday, June 8, 2014

NHS & Wine: Simon Stevens----Sale or Sail?

The Cockroach Catcher was privileged to be having dinner with his good friend.

He covered the bottle when he served his favourite red wine.

"See what you think."

"Fully of blackberry and long with good tannin that has softened."

"1996 and the tannin will keep it going for another 5 years."

"Of all the recent great wines that you have served and that included the second wines of Lafite and Margaux, this is the most impressive. Just like our NHS!"

"But now you have one of the most impressive guys running it."

"Selling it, you mean!"

"I did not want to upset you."

"So you know about Simon Stevens. Not just wines then."

"You need to know that Britain is responsible for producing all the great doctors in the old commonwealth. My cardiologist was trained there. Look at Singapore, Australia & New Zealand, generations of doctors were all trained in the UK and in turn the next generations.
Why do you think that UnitedHealth paid so much to get one of the top UK guys to add a new perspective?

UnitedHealth is based in Minnesota, home of the famous Mayo Clinic and Simon Stevens is married to an American and they have school age children. As you well know, it is not easy for Americans to adjust to British life."

"So you think he is not going to last that long?"

"He has a very natural excuse!"

"Family!"

"Lets see what Bloomberg say:"
BRITISH EXPERIENCE

UnitedHealth followed up on June 30 with another report for lawmakers pinpointing $332 billion in savings through better use of technology and administrative simplification. If enacted, those changes would potentially benefit UnitedHealth's Ingenix data-crunching unit. Ingenix, with annual revenue of $1.6 billion, is poised to establish a national digital clearinghouse to ensure the accuracy of medical payments and provide a centralized service for checking the credentials of physicians.

Stevens, an Oxford-educated executive vice-president at UnitedHealth, once served as an adviser to former British Prime Minister Tony Blair. In that capacity, Stevens tried to fine-tune the U.K.'s nationally run health system. Today he tells lawmakers that the U.S. need not follow Britain's example. Concessions already offered by the U.S. insurance industry—such as accepting all applicants, regardless of age or medical history—make a government-run competitor unnecessary, he argues. "We don't think reform should come crashing down because of [resistance to] a public plan," Stevens says. Many congressional Democrats have come to the same conclusion.

UnitedHealth has traveled an unlikely path to becoming a Washington powerhouse. Its last chairman and chief executive, William W. McGuire, cultivated a corporate profile as an industry insurgent little concerned with goings-on in the capital. From its Minnetonka(Minn.) headquarters, the company grew swiftly by acquisition. McGuire absorbed both rival carriers and companies that analyze data and write software. Diversification turned UnitedHealth into the largest U.S. health insurer in terms of revenue. In 2008 it reported operating profit of $5.3 billion on revenue of $81.2 billion. It employs more than 75,000 people. 


Stevens argues that while UnitedHealth will likely benefit financially from health reform, the company will also aid the cause of reducing costs. He cites what he says is its record of "bending the cost curve" for major employers. 

During a media presentation in May in Washington, Stevens said medical costs incurred by UnitedHealth's corporate clients were rising only 4% annually, less than the industry average of 6% to 8%. But that claim seemed to conflict with statements company executives made just a month earlier during a conference call with investors. On that quarterly earnings call, UnitedHealth CEO Hemsley conceded that medical costs on commercial plans would increase 8% this year. 

Asked about the discrepancy, Stevens says the lower figure he is using in Washington represents the experience of a subset of employer clients who fully deployed UnitedHealth's cost-saving techniques, including oversight of the chronically ill. "These employers stuck at it for several years," he says. "We are putting forward positive ideas based on our experience of what works."

"Wow!"

"So there is not reason for him to leave UnitedHealth! They love him. The best of British & of Oxford!"

"Perhaps he has not left UnitedHealth!"

"So perhaps a sort of UnitedNHS then!"

"Well despite what people say about Obamacare, even Stevens concede that:
.....the U.S. insurance industry—accepting all applicants, regardless of age or medical history—make a government-run competitor unnecessary, he argues.

"NHS as such was the most serious competitor to the Health Insurance Industry. It is serious because there is not even any co-pay!"

"And quality is the same as the actual specialist doctor on either side are the same."

"Only the coffee is better!"

"Whatever Stevens plan to do is not something most of us can begin to guess but my suspicion is that it would not be to anyone's liking..."

"Except the Health Insurance Industry."

"So, he will not follow the US example of insurance industry accepting all applicants, regardless of age or medical history."

"No way!"

"You see, UnitedHealth has decided to leave California because of that."

"Not profitable!"

"If Insurers need to cover everything in England, they would think twice and most likely do a California thing."

"And Stevens can go back to America then!"

"So what is the wine?"

"Big Sail Boat!"                                                              

"Big Sail Boat?"

That the logo might have helped to sell a wine is unthinkable if the wine is no good. Ch. Beychevelle was fortunate enough to have a boat on its label and the Chinese just embrace it now that Lynch Bages hit the roof and there are too many fake 1982 Lafites around.

When my friend stock up on his Beychevelle, it was he told me, just a third of the price right now.

"It will be the next Lynch Bages."

"That is why 50% has been sold to the Japanese!"


"Wow!"             


So will Simon sell or sail? Or sell then sail!



I recently learned that this month a class-action lawsuit has been filed against California United Behavioral Health (UBH), along with United Healthcare Insurance Company and US Behavioral Plan, alleging these companies improperly denied coverage for mental health care.
According to the class action lawsuit, United Behavioral Health violated California’s Mental Health Parity Act, which requires insurers to provide treatment for mental-health diagnosis according to “the same terms and conditions” applied to medical conditions. Specifically, the insurer is accused of denying and improperly limiting mental health coverage by conducting concurrent and prospective reviews of routine outpatient mental health treatments when no such reviews are conducted for routine outpatient treatments for other medical conditions. 
New York:


Pomerantz Law Firm has filed a Class Action Against UnitedHealth Group, Inc. 
for Violations of Federal and State Mental Health Parity Laws - UNH
NEW YORK, March 12, 2013 (GLOBENEWSWIRE) Pomerantz Grossman Hufford Dahlstrom & Gross LLP has filed a class action lawsuit against UnitedHealth Group Inc. (“UnitedHealth” or the “Company”)(NYSE: UNH) and various subsidiaries, including United Behavioral Health.  The class action was filed in the U.S. District Court, Southern District of New York, and docketed under 13 CV 1599, alleging violations of federal and state mental health parity laws and other related statutes. The action has been brought on behalf of three beneficiaries who are insured by health care plans issued or administered by United and whose coverage for mental health claims has been denied or curtailed. These plaintiffs seek to represent a nationwide class of similarly situated subscribers. In addition, the action was filed on behalf of the New York State Psychiatric Association, Inc. (“NYSPA”), a division of the American Psychiatric Association, seeking injunctive relief in a representational capacity on behalf of its members and their patients.

The health insurer violated state law nearly 1 million times from 2006 to 2008 after it was bought by UnitedHealth Group, the Department of Insurance says. The fine, if there is one, is likely to be much less than the maximum allowed.'

UNITED HEALTHCARE INSURANCE AGREES TO PAY U.S.
$3.5 MILLION TO SETTLE FRAUD CHARGES


WASHINGTON, D.C. - United Healthcare Insurance Company has agreed to pay the United States $3.5 million to settle allegations that the company defrauded the Medicare program, the Justice Department announced today.
The government alleges that beginning in or about 1996 and continuing through 2000, United Healthcare's telephone response unit knowingly mishandled certain phone inquiries received from Medicare beneficiaries and providers and then falsely reported its performance information to the Centers for Medicare and Medicaid Services (CMS) concerning the company's handling of those calls. CMS is the federal agency charged with administering the Medicare program.
From October 2, 1995 to October 1, 2000, United Healthcare acted under contract with CMS as a Durable Medical Equipment Regional Carrier. Under that contract, United Healthcare processed Medicare Part B claims for durable medical equipment submitted to it by Medicare beneficiaries, physicians, and other health care providers and suppliers located in the northeastern United States.
"This settlement demonstrates our continuing commitment to pursue vigorously allegations of fraud and abuse in Medicare," said Peter Keisler, Assistant Attorney General for the Department's Civil Division. "Medicare contractors, along with other health care providers, can and will be held accountable for their billing practices. This settlement demonstrates our unwavering pursuit of fraud and abuse."
The allegations of improper conduct were brought to the attention of the government by a former United Healthcare employee, who filed suit under seal in November 2001 under the qui tam or whistleblower provisions of the federal False Claims Act. The United States recently intervened in the whistleblower suit.
As a result of today’s settlement, the whistleblower will receive $647,500 of the settlement amount. United Healthcare did not admit any of the allegations in the complaint in connection with the settlement. Under the False Claims Act, private citizens can bring suit on behalf of the government and share in any awards that are obtained through that legal action.
###


An Entrepreneur!         
UnitedHealth & Big Profits                                                                                                      - 

Thursday, September 3, 2009

Pfizer, Geodon (Ziprasidone ) & The Twist


“The pharmaceutical giant Pfizer agreed to pay $2.3 billion to settle civil and criminal allegations that it had illegally marketed its painkiller Bextra, which has been withdrawn.”

“The government charged that executives and sales representatives throughout Pfizer’s ranks planned and executed schemes to illegally market not only Bextra but also Geodon, an antipsychotic; Zyvox, an antibiotic; and Lyrica, which treats nerve pain. While the government said the fine was a record sum, the $2.3 billion fine amounts to less than three weeks of Pfizer’s sales.”

My main interest is in the antipsychotic Geodon (Ziprasidone )
From Reuters:
“Geodon is FDA-approved only to treat patients ages 18-65 diagnosed with schizophrenia or acute manic or mixed episodes associated with bipolar disorder. However, according to the whistleblower suit unsealed today, Pfizer illegally promoted the sale and use of Geodon for a variety of off-label conditions,
including depression, bipolar maintenance, mood disorder, anxiety, aggression, dementia, attention deficit hyperactivity disorder, obsessive compulsive disorder, autism, posttraumatic stress disorder, and for pediatric, adolescent and geriatric patients.”
That sounds like every known condition!!!
"Pfizer targeted pediatrics and adolescents to expand off-label use and maintained on its payroll an army of more than 250 child psychiatrists nationwide." Kenney stated that, "Pfizer regularly paid generous speaking fees to these child psychiatrists to give what were basically promotional lectures about the benefits of Geodon to their peers, who were naturally also child psychiatrists, despite the fact the drug is not FDA-approved or medically indicated to treat children at all."
"……the purpose and intent of paying so many child psychiatrists is clear-- to gain a foothold within the fastest growing market for antipsychotics --children. The practice of expansive off-label use is dangerous, particularly in children because the drug has not been evaluated for its safety for the unique physiological make up of children."
"……less than 5% of the United States population is diagnosed with schizophrenia or bipolar disorder, yet in 2008 Geodon surpassed the blockbuster benchmark of $1 billion in sales."
"……after drug makers obtain initial FDA approval for a specific use, they often don't bother with expensive testing that would allow them to request a label extension for other uses. They just market the drug off-label."
Danger:
"……among Geodon's most dangerous side effects is its potential to affect the heart's rhythm, a condition known as QT prolongation, which increases the risk of sudden cardiac death." 
Antibiotic as well?
As part of the overall settlement, Pfizer agreed to pay $100 million to resolve allegations that it engaged in the marketing of Zyvox for a variety of off-label conditions beyond the methicillin-resistent Staphylococcus aureus ("MRSA") infections for which Zyvox was FDA-approved.
Is anything sacred anymore?
 
The twist: this is better than a John Grisham Novel
“Authorities called Pfizer a repeat offender, noting it is the company's fourth such settlement of government charges in the last decade. The allegations surround the marketing of 13 different drugs, including big sellers such as Viagra, Zoloft, and Lipitor.”
I was wondering why they could be so blatant:
“In an unusual twist, the head of the Justice Department, Attorney General Eric Holder, did not participate in the record settlement, because he had represented Pfizer on these issues while in private practice.”
What other corporations did he represent?
“Eric Holder, has a net worth of $5.7 million and lobbied on behalf of three companies in the past five years, according to a questionnaire filed by Holder with the Senate Judiciary Committee.
“In the year before Obama appointed him Attorney General, he made more than $2.1 million as a partner at Covington & Burling, a prominent Washington law firm. The money is unsurprising given his high-profile client list, which includes companies like UBS Financial Services, Merck & Co., and Hewlett-Packard. He was also paid to sit on the boards of MCI and Eastman Kodak Company.”