24 Şubat 2013 Pazar

Woman escorted from Vermont Medical Center at author Robert Whitaker's speaking event

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This blogger, who describes herself on her blog:

"My name is Jeanne and I'm a writer and artist living in VT. I worked as a peer supporter from 1995 til 2010. I survived psychiatric iatrogenic injuries and went on to sue for damages. I'm not a medical professional, if you want to taper from psych chemicals consult a professional. My dream is to have a small solar farm and to continue to be a pain in the neck to the arrogant everywhere."

Was Escorted out of the building when attempting to show support for ["support his work"] Robert Whitaker, author of 'Anatomy of an Epidemic' who was speaking at the Vermont Medical Center, in June 2012.

"She said it was private corporate property and I was trespassing. She said I was causing a disturbance. Then a Nancy T. showed up and got in my face about the situation. I had asked Ms. White for her last name and she was kind enough to tell me, but Ms. T. refused to tell me her name. I got out my handy iphone and asked if I could tape what they were saying to me. They said no. I was rolling up my posters when Ms. White yelled, “Call Security!”"


Take a look at her posters on her blog. Outrageous, that she was removed from the building.

Whistleblowers and GSK's record $ 3 Billion dollar settlement: Paxil, Wellbutrin, Avandia

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via PR News Wire:

PRESS RELEASE
July 2, 2012, 10:42 a.m. EDT
Whistleblowers played major role in Glaxo case, leading to Glaxo's record settlement

WASHINGTON, July 2, 2012 /PRNewswire via COMTEX/ -- Two whistleblowers represented by Phillips & Cohen LLP provided the government with overwhelming evidence that was at the heart of the government's case against GlaxoSmithKline GSK +1.34% and the record-setting settlement announced today.

The whistleblowers - Thomas Gerahty, a former senior marketing development manager for Glaxo, and Matthew Burke, a former regional vice president -- provided invaluable insider information that Glaxo was engaging in corrupt nationwide schemes to push sales of Advair, Wellbutrin, Imitrex and other popular prescription drugs for "off-label" (unapproved) uses, that it used improper financial inducements to market its drugs, and that it misrepresented the safety and efficacy of those drugs. Glaxo's illegal practices caused Medicare, Tricare - the healthcare program for the military -- and Medicaid to incur huge losses.

The civil settlement of Gerahty and Burke's whistleblower case and a separate whistleblower lawsuit filed in Colorado total $1.017 billion out of total settlement. It is the largest civil, False Claims Act (whistleblower) settlement on record. (Two other whistleblower lawsuits that alleged another improper practice concerning Advair marketing settled for $25 million, for a total of $1.042 billion paid under the settlement agreement for the four whistleblower cases.)

Gerahty, Burke and Phillips & Cohen worked closely with the U.S. Attorney's Office in Boston and the Justice Department since they filed their "qui tam" (whistleblower) case in early 2003 in Boston's federal district court.

Gerahty and Burke gave the government new and detailed information about Glaxo's nationwide improper marketing practices, including the use of financial inducements to doctors to prescribe Glaxo's drugs and the promotion of Advair, Wellbutrin, Imitrex, Lamictal, Zofran and Valtrex for off-label, unapproved uses. Unapproved use of prescription drugs can create significant risks to patients, and drug manufacturers are prohibited by federal law from promoting their drugs for unapproved treatments.

As the government investigation progressed, the whistleblowers and their attorneys made a significant difference in particular in the government's case against Glaxo for its off-label marketing of Advair for mild asthma. Gerahty, Burke and Phillips & Cohen devoted substantial effort and time preparing the legal case that helped demonstrate Glaxo improperly marketed Advair as a first-line asthma treatment and for asthma patients previously treated with only a short-acting inhaler.

As a result, Glaxo paid $686 million out of the total settlement to resolve claims involving the off-label marketing of Advair to treat mild asthma - by far the largest amount Glaxo paid to settle any of the civil charges. (See the settlement agreement at www.glaxowhistleblowers.com .)

Kelton and Phillips & Cohen also represented the whistleblower whose qui tam lawsuit against Pfizer alleging the off-label marketing of the prescription painkiller, Bextra, helped the government recover $1.8 billion as part of a record-setting $2.3 billion settlement in 2009.

"The gravity of Glaxo's conduct cannot be overstated," Kelton said. "The company's improper marketing practices extended across a wide range of its prescription drug portfolio. Given what we saw with Glaxo, Pfizer and other pharma companies, it's fair to conclude there has been almost no limit to what pharma companies have done to sell their products."

Read the rest here

More on the massive GSK fine

Here GlaxoSmithKline to pay $3 billion for health fraud.

Here (Reuters) - GlaxoSmithKline Plc has agreed to plead guilty to misdemeanor criminal charges and pay $3 billion to settle the largest case of healthcare fraud in U.S. history.

The settlement includes $1 billion in criminal fines and $2 billion in civil fines in connection with the sale of the drug company's Paxil, Wellbutrin and Avandia products, according to filings in federal court on Monday.

Deputy U.S. Attorney General James Cole said at a news conference in Washington that the settlement "is unprecedented in both size and scope."

Also at Pharmagossip MONDAY, JULY 02, 2012--

GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data--
Largest Health Care Fraud Settlement in U.S. History
Global health care giant GlaxoSmithKline LLC (GSK) agreed to plead guilty and to pay $3 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of certain prescription drugs, its failure to report certain safety data, and its civil liability for alleged false price reporting practices, the Justice Department announced today. The resolution is the largest health care fraud settlement in U.S. history and the largest payment ever by a drug company.

And Pharmalot Biggest Deal Ever: Glaxo Pays $3B For Bad Behavior.




And Seroxat Sufferers Stand Up and Be Counted.

~~

GSK Press Release: CEO Andrew Witty nearly apologizes, but doesn't--uses word "regret" and read to part that says it is not an admission of liability or wrongdoing regarding the sales of certain drugs listed in the lawsuit settlement:

GlaxoSmithKline concludes previously announced agreement in principle to resolve multiple investigations with US Government and numerous states

"Commenting on the agreement, GlaxoSmithKline CEO Sir
Andrew Witty said: “Today brings to resolution difficult, long-standing matters for GSK. Whilst these originate in a different era for the company, they cannot and will not be ignored. On behalf of GSK, I want to express our regret and reiterate that we have learnt from the mistakes that were made.
“We are deeply committed to doing everything we can to live up to and exceed the expectations of those we work with and serve. Since I became CEO, we have had a clear priority to ingrain a culture of putting patients first, acting transparently, respecting people inside and outside the organisation and displaying integrity in everything we do.
“In the US, we have taken action at all levels in the company. We have fundamentally changed our procedures for compliance, marketing and selling. When necessary, we have removed employees who have engaged in misconduct. In the last two years, we have reformed the basis on which we pay our sales representatives and we have enhanced our ability to ‘claw back’ remuneration of our senior management.
“We have a vital role to play in bringing innovative medicines to patients and we understand how important it is that our medicines are appropriately promoted to healthcare professionals and that we adhere to the standards rightly expected by the US Government.”
Under the terms of the settlement, GSK will plead guilty to misdemeanor violations of the Federal Food, Drug, and Cosmetic Act related to certain aspects of the marketing of Paxil for paediatric use and of Wellbutrin for certain uses, and for failure to include information about the initiation or status of certain Avandia studies in Periodic and Annual Reports submitted to FDA.
The civil settlement reached with the Government does not constitute an admission of any liability or wrongdoing in the selling and marketing of Lamictal, Zofran, Imitrex, Lotronex, Flovent, Valtrex, Avandia or Advair products, nor in its nominal pricing practices. "


How does this work? part 2 Grassley's question number 6

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from page 13 of this document, that Dr Steve Balt placed on Twitter, in attempt to expose a colleague

Question 6

Have any of the prescribers identified to this Committee been referred to your state medical board?


Read the list of questions and ask yourself if Senator Grassley would be interested in the 2009 top 10 prescriber of Seroquel
Dr Steve Balt, and his medical license being suspended (on probation) during the 2009 writing of over 1000 rx for Seroquel. Seroquel is known to be used off-label, and one must question the medical office setting where Balt worked at the time as being a player in the Medicaid, Medi-Cal fraud investigation. Were those patients rx'd Seroquel (antipsychotic) for indication use approved in 2009? or was it off-label? were the bulk of the recipients of the prescriptions Medicaid patients?

It's National VNA Week!

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The following is from an email I just sent to our fantastic staff:
This week, we celebrate National VNA Week and acknowledge and celebrate the invaluable work we do to keep patients home, where they most want to be. It’s even more special this year because we also are celebrating 125 years of providing excellent care for our community. We have a proud history and we can look forward to our future…. the VNA of Boston & Affiliates is more relevant now than ever before.

We are there at the start of life and we are there at the end of life providing compassionate care so that patients have the best quality of life they can with dignity and independence. Here is a sampling of some of the comments we receive from our patients:

“VNA of Boston is consistently excellent! VNA has improved my quality of life & sense of wellness!!!”

“I was treated with the greatest respect and courtesy.”

“They made me feel safe and secure in helping me get better and made a good recovery in regaining my health back.”

“We have had multiple experiences - OT's, PT's, nurses - all have been great.”

“I was very impressed with the professionalism of all who helped me. Thank you very much!”

“The care was excellent and I would highly recommend the VNA to anyone. Everyone was great.”

Thank you all – to all the clinicians in the field and the staff in the office who support their work – for your expertise, your passion and commitment, and your contribution to the future of the VNA of Boston & Affiliates.
Rey

"It's what we do... we are nurses..."

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For most of my career, I've been fortunate enough to work with clinicians who heal and who care.  Who bring skill and experience, and a frequently unquenchable compassion, into situations that many of the rest of us would do nearly anything to avoid.  I may be inclined to exit... while they rush in.

Meet Barbara, a nurse manager from the Visiting Nurse Association of Boston.  And here are a few of her photos of her native Haiti.  Idyllic and beautiful, as in the sunlit bay above.  Tragic and devastating, as in what follows.

Tuesday, January 12, 2010.  A catastrophic magnitude 7.0 earthquake with an epicenter only 25 kilometers west of capital city, Port-au-Prince.  Ultimately... 316,000 dead.  300,000 injured.  1,000,000 homeless.

And Barbara rushed in.

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Here's her story... from the beginning.

Barbara grew up in Carrefour, a suburb of Port-au-Prince, with her mom, a teacher, and dad, an owner of an auto repair business, and brother and sister.  It was a happy, largely uneventful time... until her father became sick.  Among his ailments, Barbara's father also suffered from decubitius skin ulcers, which then (and even still today in Haiti) were poorly understood.  Barbara, then 13 years old, remembers being angry when her father, a proud man who resisted family pressure to move to the United States, told her "not to worry" and that he would be around for "another ten years".  Unfortunately, that was not to be the case.

At the age of 16, Barbara and her remaining family members moved to Florida and then eventually to Cambridge, Massachusetts.  Barbara and her sister, Beatrice, held a variety of jobs and when Barbara decided she wanted to become a nurse, Beatrice, then a medical assistant, helped her to pay for the training.  When Barbara completed nursing school, she began working and then helped to finance Beatrice's nursing education.  Barbara continued on to earn her bachelor's degree and is now studying for a master's in health care administration.

Barbara remembers well that day in January, 2010.  Reports of an earthquake began surfacing, with no one fully aware of its magnitude or impact.  Beatrice called Barbara and gave her an update.  It was far worse than expected.  Far worse.

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Barbara recalls: "We were looking at the news.  We couldn't believe it.  Nobody knew what was happening.  We started calling our family there but no lines were open.  We were so worried.  We couldn't sleep.  We tried calling the UN but couldn't get through.  We just didn't know what to do.  I was desperate..."

The overwhelming emotion was helplessness.  "People there were dying and I thought, I'm a nurse.  I have to help."  Partners in Health, an organization dedicated to improving the quality and access to health care services in poor and developing areas, called Beatrice on Saturday and asked to deploy her to Haiti on the following Monday.  A month later, Barbara's call came.

It was a two week assignment.  The lead time was limited.  According to Barbara, "you just pack your bag and go."

She recalls departing the airport in Haiti.  She remembers looking around at the rubble, the devastation, the places where buildings once stood.  "It was tough to see a country you left and is no longer there."

Barbara was stationed at the General Hospital in Port-au-Prince.  "Once you got there, the gate was closed and you couldn't leave."  And once there, she and her companions worked for 10 days straight, during 7PM to 7AM shifts.  Barbara remembers being struck when she saw the former sight of a nursing school next to the hospital which she had seen as a child.  "It was no longer there.  It was completely flat.  I wondered how many people were trapped underneath."

After a quick orientation from the physician-in-charge, Barbara was given a brief tour and was immediately "put to work."  She described the first day as "one of the worst days of my life.  There were 300 to 400 patients there all needing care... from TB to fractures to missing limbs to wounds... to people who were just dying.  Just name it - it was right there looking at you..."

When asked how she responded to that, Barbara describes: "You start to work.  Your forget about everything else.  You just tried to save everyone you could.  You just do whatever you can."

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She remembers one young girl at the hospital.  She had lost nine members of her family in the tragedy.  "She was so thin.  You could see only bones.  She would not eat or drink... and she never spoke... except at night, she would scream out the names of her family who were now lost to her.  I remember seeing a lady who stayed with her.  She was from the local church and she slept on the floor, giving the girl a sip of water."  Despite their efforts, the patient passed away.

Another patient, a 27 year old woman with renal failure and high blood pressure, was experiencing significant physical and emotional stress.  Barbara knew the patient needed oxygen and fast, so she ran down the hall looking for a tank.  A simple tank of oxygen.  Plentiful in every hospital where Barbara has worked, but scarce in Port-au-Prince's General Hospital.  Barbara called out: "This girl's going to die, her heart's going to give out soon... "... and remembers seeing the desperate look in the woman's eyes.  The patient said to Barbara: "Please don't leave me.  If you leave me, they're going to let me die."  Barbara knew she was right.

The patient eventually received the oxygen and the vital dialysis she required and lived.

There was also an older woman patient who "could have been my mother."  She had two wounds in her lower legs; "it looked to be a diabetic ulcer".  Barbara watched this patient fade from an amiable, even joking, favorite among the nurses, to one who became more and more ill and despondent.  At one point, she had no clothing or even sheets, leaving one of the nurses to donate some of her own clothing to the patient.  The patient died, alone and in pain.  Per Barbara, "there was no reason for her to die that way..."

Barbara looks back at the experience and feels that: "We didn't do enough.  There's so much more to do there.  And it's not over there.  It's terrible what's happening in the tent cities there now.  It's just horrible still... but I want to go back."

When asked why she wants to return, Barbara lowered her eyes and said, simply and solemnly: "It's what we do... we are nurses..."


If you're interested in learning more about Partners in Health, please click here.

If you'd like to help, click here.

 

Posted by Rey

23 Şubat 2013 Cumartesi

UCLA Improves the Study of Single Cancer Cells Of Blood From Tumors & Those Circulating

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The nanowires grab the cancer cells flowing through and they can hand pick cells for study as relates to Melanoma. The goal is to have a clinically applicable liquid biopsy.  BD

Press Release:

UCLA RESEARCHERS FURTHER IMPROVE ‘NANOVELCRO’ DEVICE TO

ISOLATE AND STUDY SINGLE CANCER CELLS FROM BLOOD


Researchers at UCLA have further improved a method for capturing and analyzing cancer cells that break away from patients’ tumors and circulate in the blood. imageWith the improvements, even single cancer cells can be accurately detected and safely isolated from patient blood samples for continuous analysis.

These cells, called circulating tumor cells (CTCs), metastasize or spread from one tumor to other parts of the body and form new tumors, thus propagating cancer in the patient. When they are isolated from the patient’s blood early over the course of disease progression, they can provide doctors with critical information about the type of cancer, the characteristics of the individual cancer, and its possible progression. Doctors can also tell from these cells how to tailor a personalized treatment approach for a specific patient. 

In recent years, a UCLA research team led by Hsian-Rong Tseng, associate professor of molecular and medical pharmacology at the Crump Institute for Molecular Imaging and a member of the California NanoSystems Institute and the Jonsson Comprehensive Cancer Center (JCCC) has developed a “NanoVelcro” chip. Blood is passed through the chip, in which very small nanoscale hairs (nanowires or nanofibers) coated with protein molecules from the immune system (antibodies) that match proteins on the surface of cancer cells trap CTCs and isolate them for further studies.

The CTCs trapped by the chip also act as a “liquid biopsy” of the tumor, providing convenient access to tumor cells, and earlier access to potentially fatal metastases. This study of the microscopic structure of diseased tissue is called histopathology analysis of biopsy samples and is considered the “gold standard” for determining tumor status. Being able to extract viable cells allows detailed analysis of the type of cancer, and the various genetic characteristics of that patient’s specific cancer.

Tseng’s team has now improved the chip by replacing the original non-transparent silicon nanowire substrate inside the device. These nanowires grab the cancer cells as the blood passes by them. Using a new type of transparent polymer nanofiber-deposited substrate, Tseng and his colleagues were able to “pick” single CTCs immobilized on the transparent substrates by using a miniaturized laser beam knife, a technique called laser microdissection (LMD). An article on the improvement of the chip was published online today, and is featured on the cover of the March 2013 issue of the peer-reviewed journal Angewandte Chemie,

“This paper summarizes a major milestone in the continuous development of NanoVelcro assays pioneered by our research group,” said Tseng, “we now can not only capture cancer cells from blood with high efficiency, but also hand pick single CTCs for in-depth characterization to provide crucial information that helps doctors make better decisions.”

Using the new assay on patients’ blood that contained circulating melanoma cells (CMCs), Tseng’s team was able to isolate and preserve single CMCs. Melanoma is a deadly type of skin cancer that is prone to spreading quickly throughout the body. The ability to capture and preserve single CMCs allows doctors to analyze the DNA structure of the cells and determine genetic characteristics of the patient’s cancer, confirming that the circulating cells remained genetically similar to the tumor they came from.

The preservation of single captured CMCs in the proof-of-concept study also allowed researchers to conduct an analysis, called single-cell genotyping, to find within the cell a specific target (BRAFV600E) for a drug called vemurafenib. This designation describes a mutation in a protein called BRAF that appears in approximately 60 percent of melanoma cases. Drugs that inhibit BRAF are able to slow and often reverse the growth of melanoma tumors.

“With this technology we are getting closer to the goal of a widely clinically applicable liquid biopsy, where we can sample cancer cells by a simple blood draw and understand the genes that allow them to grow,” said Dr. Antoni Ribas, professor of medicine in the division of hematology-oncology and JCCC member, and one of Tseng’s key collaborators. “With the NanoVelcro chips we will be able to better personalize the treatments to patients by giving the right treatment to stop what makes that particular cancer grow.”

Dr. Roger Lo, another key Tseng collaborator and an assistant professor in the department of medicine, division of dermatology and department of molecular and medical pharmacology, and JCCC member, added, “This scientific advancement being able to capture the melanoma cells in transit in the blood and then perform genetic analysis on them will in principle allow us to track the genomic evolution of melanoma under BRAF inhibitor therapy and understand better the development of drug resistance.”

UCLA's Jonsson Comprehensive Cancer Center has more than 240 researchers and clinicians engaged in disease research, prevention, detection, control, treatment and education. One of the nation's largest comprehensive cancer centers, the Jonsson center is dedicated to promoting research and translating basic science into leading-edge clinical studies. In July 2012, the Jonsson Cancer Center was once again named among the nation’s top 10 cancer centers by U.S. News & World Report, a ranking it has held for 12 of the last 13 years. For more information on the Jonsson Cancer Center, visit our website at http://www.cancer.ucla.edu.

Latest From Health Insurance Business Intelligence Analytics For Avoiding Risk and Saving Money, Break Up Marriages and Dump the Spouse Coverage

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Surcharge are becoming more well known for spouses and when the numbers are crunched, risk assessments are performed along with any other type of risk numbers such as mortality rates, etc. and the results must be saying “dump the spouse” according to this article in Market Watch.  This is pretty much talking about employer provided insurance.  There are people out there that marry for this, well almost but it certainly is a big consideration, and maybe they really do.  A couple years ago we had this story on the web.

Will Marry For Health Insurance Web Site – Nobody Cares, Responds, The Reality of A 30 Second Attention Span

Some companies have policies that discourage spouses and some just make it too expensive to add them.  The problem too is that some individuals can’t get insurance otherwise.  The surcharges can be as much imageas $100 a month and depending on income that can be a big issue or an inconvenience.  In 2014 we shall how this works as there will be exchanges for spouses to get insurance outside the company with the next provisions of the healthcare reform kick in.  Some companies will only allow the spouse added on if they already have their own insurance.  If plans are different and cover different doctors then both can’t see the same doctor.  Risk assessments and costs are working on all budgets today.  In some cases with Medicaid as this link below states, people get divorced to get coverage and it all comes back to income and how the numbers work out.  This sure doesn’t do much for keep the American tradition of family together.  BD

Divorce for Medicaid and Marry for Insurance – The American Healthcare System


By denying coverage to spouses, employers not only save the annual premiums, but also the new fees that went into effect as part of the Affordable Care Act. This year, companies have to pay $1 or $2 “per life” covered on their plans, a sum that jumps to $65 in 2014. And health law guidelines proposed recently mandate coverage of employees’ dependent children (up to age 26), but husbands and wives are optional. “The question about whether it’s obligatory to cover the family of the employee is being thought through more than ever before,” says Helen Darling, president of the National Business Group on Health

Such exclusions barely existed three years ago, but experts expect an increasing number of employers to adopt them: “That’s the next step,” Darling says. HMS, a company that audits plans for employers, estimates that nearly a third of companies might have such policies now. Holdouts say they feel under pressure to follow suit. “We’re the last domino,” says Duke Bennett, mayor of Terre Haute, Ind., which is instituting a spousal carve-out for the city’s health plan, effective July 2013, after nearly all major employers in the area dropped spouses.

About a fifth of companies had policies to discourage spouses from joining their health plan in 2012, according to Mercer, though most just charged extra—$100 a month, on average—to cover spouses who could get insurance elsewhere, rather than deny coverage entirely. Indeed, large firms including generics maker Teva and supply chain manager Intermec have spousal surcharges costing $100 a month, or $1,200 annually, while Xerox charges $1,000 for the year

Some companies drive spouses away using other tactics, such as making spousal coverage prohibitively expensive through higher surcharges or by making reimbursement rates so low that spouses can’t afford the plans.

http://www.marketwatch.com/story/why-your-boss-is-dumping-your-wife-2013-02-22?link=sfmw