Showing posts with label big pharma. Show all posts
Showing posts with label big pharma. Show all posts

Wednesday, May 04, 2016

Are prescription drugs destroying America? Why is the government protecting the legal drug dealers? Is anybody listening? Does anybody care?

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America's Collective National Trip - Legal Prescription Drugs
Is Prince the latest victom?

Perhaps the fallout of the Germanwings A320 airplane crash in France caused by a depressed and psychotic co-pilot on prescription drugs should be a wake up call to America.  You are not safe in society now that 70% of Americans are on prescription drugs.

Over the years, I have closely followed the relationship between "isolated" cases of extreme violence and prescription drugs, and more often than not, the perpetrator of the crime was on some type of prescription drug, just like the pilot who killed 150 people.

From mass murders in schools to suicide airplane crashes, the world has gone crazy and we need to know the role prescription drugs are playing in this nightmare.

It was forty-five years ago when then Vice President Spiro Agnew declared that America was on a collective national trip because of the increasing abuse of prescription drugs along with the use of illegal drugs.


Jun 17, 1971

Nixon Begins War on Drugs

President Richard Nixon coins the phrase, "War on Drugs," promising in a major speech to defeat "public enemy number one in the United States.  If we cannot destroy the drug menace, then it will destroy us."

That was forty-four years ago that America launched a war on drugs, both illegal drugs, and the pre-occupation of Americans with legal prescription drugs.

Drug statistics, conveniently, it may seem, run about five years behind in reporting.
     
Prescription drug use
Percent of persons using at least one prescription drug in the past 30 days: 48.5% (2007-2010)
Percent of persons using three or more prescription drugs in the past 30 days: 21.7% (2007-2010)
Percent of persons using five or more prescription drugs in the past 30 days: 10.6% (2007-2010)

Physician office visits
Number of drugs ordered or provided: 2.6 billion
Percent of visits involving drug therapy: 75.1%
Most frequently prescribed therapeutic classes:
Analgesics
Antihyperlipidemic agents
Antidepressants


Hospital outpatient department visits
Number of drugs ordered or provided: 285.1 million
Percent of visits involving drug therapy: 74.4%
Most frequently prescribed therapeutic classes
Analgesics
Antidiabetic agents
Antihyperlipidemic agents

Hospital emergency department visits
Number of drugs ordered or provided: 286.2 million
Percent of visits involving drug therapy: 80.3%
Most frequently prescribed therapeutic classes
analgesics
Antiemetic or antivertigo agents
Minerals and electrolytes


The report -- titled "Health, United States 2013" -- found the percentage of Americans taking prescription drugs has increased dramatically.  During the most recent period, from 2007 to 2010, about 48% of people said they were taking prescription medication, compared with 39% in 1988 to 1994.

Prescription drug use increased with age. About one in four children took one or more prescription drugs in the past month, compared to nine in 10 adults 65 and older, according to the study.

"This is really not earth-shattering news. There's an increasing number of people with chronic illnesses, and the primary management tool available for dealing with chronic illness is medication," said William Lang, vice president of policy and advocacy for the American Association of Colleges of Pharmacy.



One in 10 Americans said he or she had taken five or more prescription drugs in the previous month. That raises concerns about potential drug interactions, said Anne Burns, senior vice president for professional affairs at the American Pharmacists Association.

"We know that the number of adverse drug events a patient is likely to experience increases as the number of medications they are taking increases," Burns said. "You've got everything from potential interactions between medications to timing issues taking a variety of medications throughout the day."


People who took five or more drugs in the past month tended to be older. Only 10.8 percent of people taking that many drugs were between 18 and 44, while 41.7 percent were between 45 and 64 and 47.5 percent were 65 and older.

Drugs to manage cholesterol, high blood pressure, heart disease and kidney disease are the most widely used medications among adults, the CDC report found.

In particular, the use of cholesterol-lowering drugs among people 18 to 64 has increased more than six-fold since 1988-1994, due in part to the increased use of statins.  Also, nearly 18 percent of adults 18 to 64 took at least one cardiovascular drug during the past month.


The CDC report noted some headway in efforts to combat the development of antibiotic-resistant bacteria. Prescriptions of antibiotics for cold symptoms during routine medical visits declined 39 percent between 1995-1996 and 2009-2010.

But the report also found a tripling of overdose deaths due to prescription narcotics. Painkillers taken among people 15 and older caused 6.6 deaths for every 100,000 people in 2009-2010, compared with 1.9 deaths per 100,000 in 1999-2000.

There has been a fourfold increase in antidepressant use among adults, but Holmes said that's not necessarily a bad thing.


Seeking help for a mental health disorder isn't as stigmatized as it once was, she noted. In addition, companies have introduced more effective antidepressants, and researchers have found that antidepressants also can be used to treat panic and anxiety disorders.

"If antidepressants enable people to function fully in their social roles, that's a good thing," Holmes said.

All that said, prescription drug use has spiraled out of control since 2010 as health officials now say antibiotics, antidepressants, and opioids are used by seven out of ten people.  

Drug overdose death rates have never been higher. In the United States alone, 100 people die from drug overdoses every day, most of them caused by prescription drugs. The Centers for Disease Control and Prevention (CDC) has officially declared prescription drug abuse in the US an epidemic.


Antibiotics -

Number one on the list of prescribed drugs, we continue to be subject to levels of antibiotics far in excess of our needs, and the shift of antibiotics to animal feed from human treatment assures our contamination for years to come, even if we stop taking antibiotics for a toothache, and for many other reasons.

It is also important to note that antibiotics are frequently used in settings where they will not provide any benefits. An example of this sort of inappropriate use of antibiotics is for viral infections, such as the common cold. In fact, there is a tendency for patients to believe that if they are ill with an "infection", an antibiotic is the solution. Well, it's not always.

As recently reported in the news, For The Love Of Pork: Antibiotic Use On Farms Skyrockets Worldwide.
   

The love of meat is exploding in Asia, and with it, comes antibiotic consumption by chickens (top) and pigs (bottom). Green represents low levels of drug used; yellow and orange are medium levels; and red and magenta are high levels.

Pig farmers around the world, on average, use nearly four times as much antibiotics as cattle ranchers do, per pound of meat. Poultry farmers fall somewhere between the two.

That's one of the conclusions of a study published Thursday in the Proceedings of the National Academy of Sciences. It's the first look at the amount of antibiotics used on farms around the world — and how fast consumption is growing.

The numbers reported are eye-opening.  In 2010, the world used about 63,000 tons of antibiotics each year to raise cows, chickens and pigs, the study estimated. That's roughly twice as much as the antibiotics prescribed by doctors globally to fight infections in people.

"We have huge amounts of antibiotic use in the animal sector around the world, and it's set to take off in a major way in the next two decades," says the study's senior author, Ramanan Laxminarayan, who directs the Center for Disease Dynamics Economics & Policy in Washington, D.C.

In all cases, since we know the over-use of antibiotics increases drug resistance in cells in our bodies, which make us susceptible to many new mutant, drug-resistant bacteria and virus's such as staff infections and others.  It may also be a contribution factor to increases in well known diseases like cancer.


Antidepressants - Feel Good Medicine

Antidepressants Aren't Taken By The Depressed; Majority Of Users Have No Disorder

Depression’s increase in the U.S. has been persisting for years, and it’s going on decades. And while the increase in antidepressant use has followed a predictably similar path, not all cases can be explained by the parallel rise in disease. Many people, in fact, take antidepressants regardless of a diagnosis.


A new study published in The Journal of Clinical Psychiatry reports some 69 percent of people taking selective serotonin reuptake inhibitors (SSRIs), the primary type of antidepressants, have never suffered from major depressive disorder (MDD). Perhaps worse, 38 percent have never in their lifetime met the criteria for MDD, obsessive compulsive disorder, panic disorder, social phobia, or generalized anxiety disorder, yet still take the pills that accompany them.

In a society that is increasingly self-medicating itself, capsules, tablets, and pills are turning from last resorts to easily obtained quick fixes. Between 1988 and 2008, antidepressant use increased nearly 400 percent. Today, 11 percent of the American population takes a regular antidepressant, which, by the latest study’s measure, may be a severe inflation of what’s actually necessary.


Opioids - Pain Killers
Although many types of prescription drugs are abused, prescription opioids take the lead. Chronic pain is frequently treated with prescription opioids, the clinical use of which nearly doubled from 2000 to 2010. This increase was accompanied by a rise in opioid abuse; it’s estimated that over two million people in the US currently abuse prescription opioids. Nearly 75% of prescription drug overdoses are caused by prescription opioid painkillers; these drugs are involved in more deaths than cocaine and heroin combined. In 2010, pharmaceutical drug overdoses were established as one of the leading causes of death in the US; drug overdoses were more lethal than firearms or motor vehicle accidents.


If you take any of the following you could be subject to drug abuse.

Opioids include:
Fentanyl (Duragesic®)
Hydrocodone (Vicodin®)
Oxycodone (OxyContin®)
Oxymorphone (Opana®)
Propoxyphene (Darvon®)
Hydromorphone (Dilaudid®)
Meperidine (Demerol®)
Diphenoxylate (Lomotil®)

Central nervous system depressants include:
Pentobarbital sodium (Nembutal®)
Diazepam (Valium®)
Alprazolam (Xanax®)

Stimulants include:
Dextroamphetamine (Dexedrine®)
Methylphenidate (Ritalin® and Concerta®)
Amphetamines (Adderall®)


The Most Popular Drug in America is an Antipsychotic—and No One Really Knows How it Works

The Raw Story – November 16, 2014

By Martha Rosenberg

Does anyone remember Thorazine? It was an antipsychotic given to mentally ill people, often in institutions, that was so sedating, it gave rise to the term “Thorazine shuffle.” Ads for Thorazine in medical journals, before drugs were advertised directly to patients, showed Aunt Hattie in a hospital gown, zoned out but causing no trouble to herself or anyone else. No wonder Thorazine and related drugs Haldol, Mellaril and Stelazine were called chemical straitjackets.

But Thorazine and similar drugs became close to obsolete in 1993 when a second generation of antipsychotics which included RisperdalZyprexaSeroquelGeodon and Abilify came online. Called “atypical” antipsychotics, the drugs seemed to have fewer side effects than their predecessors like dry mouth, constipation and the stigmatizing and permanent facial tics known as TD or tardive dyskinesia. (In actuality, they were similar.) More importantly, the drugs were obscenely expensive: 100 tablets of Seroquel cost as much as $2,000, Zyprexa, $1,680 and Abilify $1,644.


One drug that is a close cousin of Thorazine, Abilify, is currently the top-selling of all prescription drugs in the U.S. marketed as a supplement to antidepressant drugs, reports the Daily Beast. Not only is it amazing that an antipsychotic is outselling all other drugs, no one even knows how it works to relieve depression, writes Jay Michaelson. The standardized United States Product Insert says Abilify’s method of action is “unknown” but it likely “balances” brain’s neurotransmitters. But critics say antipsychotics don’t treat anything at all, but zone people out and produce oblivion. They also say there is a concerning rise in the prescription of antipsychotics for routine complaints like insomnia.

They are right. With new names and prices and despite their unknown methods of action, Pharma marketers have devised ways to market drugs like Abilify to the whole population, not just people with severe mental illness. Only one percent of the population, after all, has schizophrenia and only 2.5 percent has bipolar disorder. Thanks to these marketing ploys, Risperdal was the seventh best-selling drug in the world until it went off patent and Abilify currently rules.


More manipulations

Just as Big Pharma has camped out in Medicare and Medicaid, living on our tax dollars while fleeing to England to avoid taxes, Pharma has also camped out in the Department of Defense and Veterans Affairs.

Arguably, no drugs have been as good for Big Pharma as atypical antipsychotics within the military. In 2009, the Pentagon spent $8.6 million on Seroquel and VA spent $125.4 million—almost $30 million more than is spent on a F/A-18 Hornet.


Risperdal was even bigger in the military. Over a period of nine years, VA spent $717 million on its generic, risperidone, to treat PTSD in troops in Afghanistan and Iraq. Yet not only was risperidone not approved for PTSD, it didn’t even work. A 2011 study in the Journal of the American Medical Association found the drug worked no better than placebo and the money was totally wasted.
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Tuesday, November 10, 2015

Health Care in America - Big Pharma Fraud, Cover Ups & Corruption

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The Hals Report

 
Fraud, Cover-Ups, and Corruption: Welcome to the Drug Industry

Erik Hals,  January 6, 2011
The Broken American Health Care System

There are no short cuts to the truth, and especially when it comes to the cutthroat world of big pharma and big bucks.  In this article we take a story that appeared in The Hals Report by Erik Hals.  It is another example of the extent big pharma is willing to go to secure business in the ruthless legal drug addiction market in America.

 


The United States health care industry is one of the largest in the world, with over 300 billion dollars spent on prescription drugs per year. (1) For many, these drugs have brought undeniable benefits, but in recent months the health care industry has fallen upon scandal after scandal.

Recently, two of the worlds largest pharmaceutical companies were fined billions of dollars after investigations into their secret working practices brought several fraudulent activities to light. Now, new revelations have emerged including pervasive fraud, corruption and huge kickbacks which were paid to doctors.

So, what do doctors receive kickbacks for and how do they work? We will begin with a man named David. A decade ago David was prescribed Risperdal for a psychiatric illness, a drug made by Johnson and Johnson. U.S. authorities never approved Risperdal for treating his disorder but the doctor prescribed it to him anyway, it had devastating consequences. He is now in a wheelchair with diabetes and Parkinson’s. In a current lawsuit against Johnson and Johnson, he blames Risperdal. (2)

The pharmaceutical companies didn’t trick the government though. U.S. regulators ruled Johnson and Johnson misled doctors about potential fatal risks associated with the drug, including diabetes. (3) There are more than 2,000 people bringing legal actions against Johnson and Johnson. The company claims the actions are without merit. (of course they do!) The U.S. government and several states are also suing the company in related cases.

Surprisingly, most of the leading pharmaceutical companies in the United States have been fined for fraud in the past. One of the most common types of fraud in the pharmaceutical world is known as off-label marketing. Off-label marketing is a technique in which pharmaceutical companies advise doctors to prescribe drugs for unapproved uses. This is known as fraud against the government because medicare ends up paying the expense for the drugs if they do not work.

Sharon Ornsby, a member of the FBI financial crimes unit, in an interview on Al Jazeera television said, “pharmaceutical fraud is one of our top three threats.”

The U.S. government is slowly beginning to show a fighting facade, but is that all it really is, a facade? In the last 2 years alone the U.S. government has fined six of Americas top ten pharmaceutical companies for fraud. Ongoing investigations continue against three of the four remaining companies. During this specific period in time the industry has paid out over five billion dollars in fines.


In September of 2009 Pfizer settled civil and criminal charges in the amount of 2.3 billion dollars with the federal government for illegally marketing four types of drugs. (4) The Pfizer corporation made over 180 billion dollars selling twelve twelve kinds of drugs and only paid 2.3 billion dollars in fines, talk about a phenomenal business plan!

Details of Pfizer’s behavior came to light when several insiders decided to become whistleblowers. Glen Demott was a top Pfizer representative selling the drug Bextra while earning 100,000 dollars per year. He claims he was trained to lie to physicians, “they were training us to say things to physicians that weren’t accurate. Bextra was not approved to be used for acute pain and we were out there trying to get standing orders for acute pain.” Eventually, Demott was forced out of his position with Pfizer. (5)

Demott is one of a growing number of whistleblowers exposing medical corruption across America. This is largely thanks to a U.S. law called Qui Tam. The law allows individuals with knowledge concerning fraud against the government to bring a legal case on its behalf and share in the proceeds.

Lewis Morris is chief lawyer for the U.S. health department and increasingly uses Qui Tam to expose drug industry corruption. Today there are over 1000 outstanding Qui Tam cases in the United States and they are slowly beginning to open up the secretive world of big pharma. For the first time, we can see millions of dollars in payments to doctors throughout the U.S.

Drug companies now publish physician payment figures online and in 2009 just a few companies paid doctors in the United States over 200 million dollars. (6) These giant sums of money pouring into the medical field will inevitably lead to corruption on every level of the pharmaceutical industry. (if it hasn’t already?)

We already know Risperdal can cause diabetes and Parkinson’s as we saw in Davids case, but now there is evidence the drug can cause serious complications in adolescent boys as well. (Gynecomastia: breast development.) (7) As we speak, federal investigators are still looking into claims concerning Johnson and Johnson. They believe the company illegally marketed Risperdal for use in children, including those with ADHD. But with so many drug scandals flooding the news, the countries regulators have begun to run low on resources.

Avandia used to be the worlds best selling diabetes drug for years. It earned its maker Glaxo Smith Kline billions of dollars, but now it is linked to over 100,000 heart attacks in the United States.

In July the U.S. food and drug administration held hearings related to the dangers of Avandia. (It’s license has already been suspended in Saudi Arabia) An investigation by the U.S. senate finance committee found the totality of evidence suggests Glaxo Smith Kline was aware of the possible cardiac risks associated with Avandia years before the evidence became public. (8) Glaxo Smith Kline also tried to prevent heart attack warnings from being printed on their products box.

Many of Americas leading pharmaceutical corporations appear distraught and amass in corruption. Will fines alone prevent this?

The U.S. government is continually reaching for stronger powers and controls over the industry. The department of health is even considering breaking up drug companies found guilty of corrupt and unethical practices. In the meantime, 1000′s of doctors continue to take cash payments from the drug industry and would argue they are doing nothing wrong. This deeply entrenched culture of corruption within the drug industry is a serious problem that will inevitably cripple our healthcare system beyond repair if something isn’t done about it . Say NO to big pharma.

Sources:
1.
Reuters: prescription drug sales 300b$
2. Health Freedom Alliance
3. J&J Told to Pay $257.7 Million Over Risperdal Marketing Tactics
4. Pfizer pays a record $2.3 billion to settle criminal charges
5. Whistleblower Glen DeMott on False Claims Act Settlement Reached
6. PFIZER INC Officers & Directors
7. RISPERDAL
8. Avandia Maker Hid Risks for Years, Probe Finds

© The Hals Report 2012. All rights reserved.

Health Care in America - Big Pharma Convictions in Civil and Criminal Courts

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The Broken American Health Care System

In this article we update you on the convictions of the pharmaceutical companies in various criminal and civil actions against them.  Are there the type of people we want dictating our health care needs and options?


By Dr. Joseph Mercola

A nearly decade-long civil investigation into the fraudulent marketing of Johnson & Johnson's antipsychotic drug Risperdal may soon be coming to a close, with the drug giant agreeing to pay more than $1 billion to the United States and individual states to resolve the matter.

Negotiations over a criminal plea are still ongoing, and individual states may choose to pursue their own cases rather than join in to the federal government's settlement.

This means J&J may be liable for far more money… considering the state of Texas alone is asking for more than $1 billion over Risperdal marketing.

In most cases, a billion-dollar (or more) fraud settlement would be a death-sentence for a business, but for the drug industry, it's just another cost of doing business.

J&J Markets Drug for Unapproved Uses to Boost Profits at the Expense of Patients' Health

At the heart of the latest settlement is J&J's, and particularly their Janssen unit's, attempt to market Risperdal for bipolar disorder, dementia, mood and anxiety disorders, when it had only been approved, initially, for psychotic disorders such as schizophrenia.

Of course, only so many people have schizophrenia, so marketing the drug for the slew of conditions noted above boosted their customer base tremendously. Never mind that it wasn't approved for those conditions …

J&J's Janssen sent out an army of salespeople to doctor's offices, nursing homes, Veteran's Administration facilities, and jails to tout Risperdal as a proverbial miracle drug for mental illness and dementia. The U.S. Food and Drug Administration (FDA) told the company to stop the false and misleading marketing claims not once, not twice, but three times from 1994-2004, but the company reportedly continued to include marketing the drug for unapproved uses right in their business plan. In the years to follow, the FDA did eventually approve Risperdal for bipolar disorder and autism symptoms, but it was never approved for dementia (even though it was heavily marketed as a dementia drug).

In 2006, research showed that up to two-thirds of prescriptions for Risperdal were for unapproved uses that had little or no scientific support. Worse yet, elderly dementia patients who were prescribed Risperdal for off-label uses were found to increase their chances of death by 54 percent within the first 12 weeks of taking it!

Other research published in the Journal of the American Medical Association (JAMA) found Risperdal is no more effective than a placebo, and is associated with a long list of potentially devastating side effects.


The study included 123 veterans with PTSD who received Risperdal, and another 124 who received a placebo. After six months of treatment, about 5 percent of the participants in both groups recovered, and between 10-20 percent in each group reported minor improvement. According to the lead author, Dr. John H. Krystal, who is also the director of the clinical neurosciences division of the Department of Veterans Affairs' National Center for PTSD:
"We didn't find any suggestion that the drug treatment was having an overall benefit on their lives."
So it appears in many cases the joke is on the patient -- who takes a drug for no benefit, and is exposed to serious risks of side effects, some of which may be permanent.
And all the while, Johnson & Johnson is laughing all the way to the bank. More serious side effects include:
·              Neuroleptic Malignant Syndrome, which can be fatal
·              Hormone disruption (including breasts producing milk and breast development in males)
·              High blood sugar and diabetes


Drug Companies are the Top Thugs of the Medical World

Johnson & Johnson is no stranger to being slapped with billion-dollar lawsuits. You probably don't need to be reminded of all the recalls this company has had over the years with its pain products, specifically Motrin, Tylenol and Fentanyl (pain killer patches). The fact that Johnson & Johnson has paid out over $1 billion in the last few years in fines and judgments alone probably comes as no surprise either.

But did you know that in May 2011 the company pleaded guilty to illegally promoting its epilepsy drug Topamax for psychiatric purposes, and in so doing, settled a civil lawsuit in the case for $75 million? You probably didn't realize, either, that last January the U.S. Department of Justice accused Johnson & Johnson of paying tens of millions of dollars in kickbacks to Omnicare Inc to buy and recommend Johnson & Johnson drugs.

This latest scheme is the subject of a federal lawsuit that has 18 states suing not just Omnicare, but 14 other major drug companies, alleging that they ran this scheme together.
The bottom line is this: pharmaceutical companies – the same ones you trust to safely manufacture medications that could alter your very life – are the top corporate criminals on the planet, and this is not unique to only Johnson & Johnson. A large number of pharmaceutical companies are guilty of fraud, cover-ups of fatal side effects, and huge kickbacks paid to doctors.
Charges run the gamut from international price-setting, illegal marketing, false claims, hiding serious problems with their drugs and, in one case (Ortho, a subsidiary of Johnson & Johnson), obstruction of justice and eight counts of persuading employees to destroy documents in a federal investigation.
Yet toxic drugs designed, manufactured, and peddled by these top criminals are what the medical industry and government health agencies try to pass off as the "best" route to good health … despite the fact that pharmaceutical drugs, taken as prescribed, are also directly responsible for the death of at least 125,000 people annually, on top of everything else.

What Common, Illegal Drug Company Practice Earned the Most Penalties from the U.S. Government in the Last 20 Years?

Off-label drug promotion! By scouring through comprehensive databases of all major criminal and civil settlements between federal and state governments and pharmaceutical companies occurring between 1990 and 2010, the Public Citizen's Health Research Group made some sobering discoveries.
For example, they revealed the illegal practice that has earned the largest amount of financial penalties levied by the U.S. government:

"Of the 165 settlements comprising $19.8 billion in penalties during this 20-year interval, 73 percent of the settlements (121) and 75 percent of the penalties ($14.8 billion) have occurred in just the past five years (2006-2010).
… The practice of illegal off-label promotion of pharmaceuticals has been responsible for the largest amount of financial penalties levied by the federal government over the past 20 years. This practice can be prosecuted as a criminal offense because of the potential for serious adverse health effects in patients from such activities.

Deliberately overcharging state health programs, mainly Medicaid fraud, has been the most common violation against state governments and is responsible for the largest amount of financial penalties levied by these governments. This type of violation is also the main factor in the considerable increase in state settlements with pharmaceutical companies over time."

 What We Can Learn From How Doctors Choose to Die

What is perhaps most poignant of all of this is not the fact that corporations could be engaged in so much fraud and deception – it is the fact that so many have embraced the products of these deceptions as veritable life lines.

In the face of illness, we are taught, often from a young age, that pharmaceuticals are the answer. In reality, your own body has healing potential that is, in many cases, far superior to that offered by synthetic drugs, provided it is given the proper tools to harness its healing potential. Yet, those who are at the front lines – the doctors themselves – will often choose to forgo these "solutions" because, quite simply, they've seen the cycle before. Oftentimes, drugs only serve to create more problems – new symptoms and serious, sometimes deadly, side effects with little or no measurable benefit.

In fact, in the face of death, many doctors will choose to skip drugs and medical interventions entirely, choosing, instead, to die naturally. Ken Murray, MD, a Clinical Assistant Professor of Family Medicine at USC, said it well in a recent essay:

"It's not a frequent topic of discussion, but doctors die, too. And they don't die like the rest of us. What's unusual about them is not how much treatment they get compared to most Americans, but how little. For all the time they spend fending off the deaths of others, they tend to be fairly serene when faced with death themselves. They know exactly what is going to happen, they know the choices, and they generally have access to any sort of medical care they could want. But they go gently.

… To administer medical care that makes people suffer is anguishing. Physicians are trained to gather information without revealing any of their own feelings, but in private, among fellow doctors, they'll vent. "How can anyone do that to their family members?" they'll ask. I suspect it's one reason physicians have higher rates of alcohol abuse and depression than professionals in most other fields. I know it's one reason I stopped participating in hospital care for the last 10 years of my practice.

How has it come to this—that doctors administer so much care that they wouldn't want for themselves? The simple, or not-so-simple, answer is this: patients, doctors, and the system."

The truth is, you cannot trust that the companies making your medications have your best interest at heart. Their behavior is among the most criminal on the planet! The only way to avoid all risk, including death, from prescription drugs is to not take them at all. It is your body, not your doctor's and not your pharmacist's, so it is up to you to make the decision of what drugs to take, if any. Be SURE you are aware of the risks of any medication prescribed to you, and weigh them against any possible benefit. Then you can make a well-informed decision of whether it's a risk you're willing to take.

Of course, of paramount importance is also taking control of your health so you can stay well naturally, without the use of drugs or even frequent conventional medical care. If you adhere to a healthy lifestyle, you most likely will significantly reduce your need for medications in the first place.


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Thursday, November 05, 2015

Health Care in America - Increasing Criminal and Civil Monetary Penalties Against the Pharmaceutical Industry

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The Broken American Health Care System

Rapidly Increasing Criminal and Civil Monetary Penalties Against the Pharmaceutical Industry: 1991 to 2010

Sammy Almashat, M.D., M.P.H, Charles Preston, M.D., M.P.H, Timothy Waterman, B.S., Sidney Wolfe, M.D.

Public Citizen’s Health Research

Group EXECUTIVE SUMMARY

Background

U.S. spending on prescription drugs has increased from $40 billion in 1990 to$234 billion in 2008. In this era of rapidly rising drug costs, the illegal pharmaceutical company activities that have contributed to such inflated spending have garnered a significant amount of media attention. Recent billion-dollar settlements with two of the largest pharmaceutical companies in the world, Eli Lilly and Pfizer, provide evidence of the enormous scale of this wrong doing.  However, the total size, varied nature, and potential impact of these illegal and potentially dangerous activities have not been previously analyzed. This study examined trends from 1991 to the present in federal and state criminal and civil actions against pharmaceutical companies in order to address these questions.

Analysis

The purpose of this study was to compile a comprehensive database of all major criminal and civil settlements between federal and state governments and pharmaceutical companies. Press releases from both federal and state governments, in addition to existing online databases, were used to identify all settlements of at least $1 million during the past 20 years.


Main Findings

  • Of the 165 settlements comprising $19.8 billion in penalties during this 20-year interval, 73 percent of the settlements (121) and 75 percent of the penalties ($14.8 billion) have occurred in just the past five years (2006-2010).
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  • Four companies (GlaxoSmithKline, Pfizer, Eli Lilly, and Schering-Plough) accounted for more than half (53 percent or $10.5 billion) of all financial penalties imposed over the past two decades. These leading violators were among the world’s largest pharmaceutical companies.
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  • While the defense industry used to be the biggest defrauder of the federal  government under the False Claims Act (FCA), a law enacted in 1863 to prevent defense contractor fraud, the pharmaceutical industry has greatly overtaken the defense industry in recent years. The pharmaceutical industry now tops not only the defense industry, but all other industries in the total amount of fraud payments for actions against the federal government under the False Claims Act.
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  • The practice of illegal off-label promotion of pharmaceuticals has been responsible for the largest amount of financial penalties levied by the federal government over the past 20 years. This practice can be prosecuted as a criminal offense because of the potential for serious adverse health effects in patients from such activities.
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  • Deliberately overcharging state health programs, mainly Medicaid fraud, has been the most common violation against state governments and is responsible for the largest amount of financial penalties levied by these governments. This type of violation is also the main factor in the considerable increase in state settlements with pharmaceutical companies over time.
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  • Former pharmaceutical company employees and other “whistleblowers " have been instrumental in bringing to light the most egregious violations and have been responsible for initiating the largest number of federal settlements over the past 10 years. From 1991 through 2000, qui tam (whistleblower) cases made up only 9 percent of payouts to the government, but from 2001 through 2010, they comprised 67 percent of total payouts.

Conclusion

Over the past two decades, especially during the past 10 years, there has been a marked increase in both the number of government settlements with pharmaceutical companies and the size of the accompanying financial penalties.  The reasons for these increases are likely related to a combination of increased violations by companies and increased enforcement on the part of federal and state governments.  The danger to public safety and the loss of state and federal dollars that comes with these violations require a more robust response than the government’s current practices. Given the relatively small size of current financial penalties when compared to the perpetrating companies’ profits, both increased financial penalties and appropriate criminal prosecution of company leadership may provide a more effective deterrent to unlawful behavior by the pharmaceutical industry.

Worst Offenders and Largest Settlements

Individual Companies: Total Penalties, 1991-2010

There are 20 pharmaceutical companies that paid a total of at least $100 million each in financial penalties over the past 20 years. The four worst offenders, with at least $1 billion in penalties each, were GlaxoSmithKline, Pfizer, Eli Lilly, and Schering-Plough. Together they accounted for more than half (53percent) of all financial penalties paid out by pharmaceutical companies.

Twenty Largest Settlements, 1991-2010

The 20 largest settlements over the past two decades follow. In the largest settlement of the past 20 years, GlaxoSmithKline agreed to pay the federal government $3.4 billion in 2006 for failing to pay required taxes over a 17-year period.

The second and third largest settlements included the two largest criminal fines ever levied by the federal government against any company. In January 2009, Eli Lilly was forced to pay $515 million (the largest criminal fine ever received by a corporation at that time) and Pfizer, later that year, was fined$1.2 billion (the largest criminal fine ever imposed in the U.S.). Both companies were fined for illegal off-label promotion.

The majority (14) of the 20 largest settlements have occurred within the past five years (2006-2010), consistent with the dramatic increase in pharmaceutical industry financial penalties in recent years.  Of note, almost all cases (16 of 20) involved violations of the federal FCA, at least in part. Multiple blockbuster drugs (i.e., those with sales exceeding $1 billion per year), such as Neurontin (gabapentin), were involved in these settlements. For example, in the Pfizer case of 2004, the company was charged with illegal off-label promotion of Neurontin, a drug which in 2002 generated 94 percent of its $2.27-billion revenue from off-label use.

Table 2. Pharmaceutical Company Penalties: Worst Offenders


Company - Fine in millions of dollars - Percent of Total


GlaxoSmithKline                                     4501              22.7

Pfizer                                                            2935             14.8

Eli Lilly                                                        1712               8.6

Schering-Plough                                      1339               6.8

Bristol-Myers Squibb                             890                4.5

AstraZeneca                                               883                4.5

TAP Pharmaceutical Products            875                4.4

Merck                                                           806                4.1

Serono                                                          704                3.6

Purdue                                                         620                3.1

Allergan                                                      600                3.0

Novartis                                                       524                2.6

Cephalon                                                     425                 2.1

Johnson & Johnson                                353                 1.8

Forest Laboratories                                313                 1.6

Sanofi-aventis                                           310                 1.6

Bayer                                                            301                 1.5

Mylan                                                           267                 1.3

Teva                                                              181                 0.9

King Pharmaceuticals                          167                 0.8

Other                                                          595                 3.0

*Parent company names are current names without corporate (e.g. inc. or plc) designations. If company is non-existent now, name at time of most recent settlement was used.**Data for 2010 include only the first 10 months of the calendar year (through Nov. 1, 2010)***Percent of $19.813 billion in overall penalties. Percents do not add up to 100% as some cases were excluded due to inability to determine individual company share in settlement.
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