Tuesday, November 10, 2015

Health Care in America - The Sword of Damocles - Antibiotics

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The Broken American Health Care System

Classics scholar Daniel Mendelson on the metaphor of the Sword of Damocles from the ancient Greek parable by Cicero:

"The real point of the story is very clearly a moral parable. It's not just, oh, something terrible is going to happen, but it's about realizing that what looks like an enviable life, a life of wealth, a life of power, a life of luxury is, in fact, fraught with anxiety, terror and possibly death."

What are Antibiotics?

Bacteria are everywhere, including on the skin and in the digestive system of humans. While bacteria are critical to normal bodily functions, some types can cause illness. In humans, antibiotics are used to treat health conditions caused by bacteria, including ear and skin infections, food poisoning, pneumonia, meningitis and other serious illnesses. Antibiotics are also used to treat or prevent infections that can complicate critical medical procedures including surgery, cancer therapy, and transplants.

Antibiotics belong to a category of drugs called "antimicrobials," and include penicillin, tetracycline, amoxicillin and many other formulations that can kill or inhibit the growth of bacteria without causing significant harm to the patient. Antibiotics were initially derived from natural compounds. Many organisms, including various types of fungi, produce substances that destroy bacteria and prevent infection.

Penicillin, perhaps the most famous of all antibiotic drugs, is derived from a common fungus called Penicillium. Many other fungi also produce antibiotic substances, which are now widely used to control diseases in human and animal populations. The discovery of antibiotics revolutionized health care worldwide.

Today, there are hundreds of antibiotics in use, most of which are synthetically produced.


What are Antibiotic-Resistant Bacteria?

Just as immunization helps the human body fight disease by exposing the body to small amounts of a virus or bacteria, when bacteria are continually exposed to small amounts of antibiotics they can develop immunity to them. Over time this leads to the development of new, stronger strains of bacteria, with the antibiotic immunity passed on to subsequent generations.

It's a case of "survival of the fittest," with the strongest bacteria, that are least susceptible to a specific antibiotic, living on, adapting and multiplying. These are called "resistant bacteria" because they have adapted to the point where antibiotics can no longer kill them. As a result, some antibiotics have lost their effectiveness against specific infectious diseases. For example, certain strains of tuberculosis are now resistant to antibiotics that were previously effective in fighting them.

Another example is staphylococcus aureus, a bacteria that is the most common cause of staph infections, and that can cause pneumonia, meningitis, toxic shock, skin abscesses, heart valve infections and other serious and deadly medical conditions. In the United States, almost every strain of s. aureus is now resistant to the antibiotics oxacillin, penicillin and amoxicillin, and strains of the disease have begun developing resistance to newer drugs like methicillin and vancomycin. The threat of prolonged illness or death from an s. aureus infection has increased as it has become more resistant and fewer drugs are able to effectively control or eliminate it.

Antibiotic resistance has been accelerated by extreme overuse of antibiotics in humans and animals. Over-prescribing antibiotics for viral-caused conditions like the flu or common cold, against which antibiotics are useless, contributes to antibiotic resistance. As the American Academy of Pediatrics notes, "When antibiotics aren't used the right way, they can do more harm than good."

For example, children who are given antibiotics for ear infections are more likely to get another ear infection, sooner, than those who are not prescribed these drugs. In recent years the academy has urged its members to drastically reduce the antibiotic prescriptions they write.


Penicillin: the first miracle drug

Many of you are here only because penicillin saved your life, or the life of one of your parents or grandparents. Penicillin's ability to cure people of many once-fatal bacterial infections has saved so many lives that it is easy to understand why it was once called a "miracle drug".

Antibiotics are chemicals, effective at very low concentrations, created as part of the life process of one organism, which can kill or stop the growth of a disease-causing microbe--a germ.

In 1929, Alexander Fleming, a doctor and researcher at St. Mary's Hospital in London, England, published a paper on a chemical he called "penicillin", which he had isolated from from a mold, Penicillium notatum. Penicillin, Fleming wrote, had prevented the growth of a neighboring colony of germs in the same petri dish.

Dr. Fleming was never able to purify his samples of penicillin, but he became the first person to publish the news of its germ-killing power. Howard Florey, Ernst Chain and Norman Heatley expanded on Fleming's work in 1938, at Oxford University. They and their staff developed methods for growing, extracting and purifying enough penicillin to prove its value as a drug.

World War II (1939-1945) had begun by the time their research was showing results. The main research and production was moved to the United States in 1941, to protect it from the bombs pounding England. Work began on how to grow the mold efficiently to make penicillin in the large quantities that would be needed for thousands of soldiers.

As the destruction of the war grew, so did interest in penicillin in laboratories, universities and drug companies on both sides of the Atlantic. The scientists knew they were in a race against death, because an infection was as likely to kill a wounded soldier as his wound.

Creating the right environment for growth was the first step in producing enough penicillin to be used as a drug. In Oxford, experiments showed that Penicillium notatum grew best in small shallow containers on a broth of nutrients. Penicillium need lots of air. In the United States, it was discovered that huge "deep fermentation" tanks could be used if sterilized air was pumped continually through the tanks.

Production increased even more when corn steep liquor, a thick, sticky by-product of corn processing, was added to the tanks. Corn steep liquor contained concentrated nutrients that increased the yield 12-20 times. Formerly considered a waste material, corn steep liquor became a crucial ingredient in the large-scale production of penicillin.

Scientists were also determined to find another strain of Penicillium that might grow better in the huge deep fermentation tanks. Army pilots sent back soil samples from all over the world to be tested for molds. Residents of Peoria, Illinois, were encouraged to bring moldy household objects to the local U.S. Department of Agriculture laboratory, where penicillin research was being conducted. Laboratory staff members also kept an eye out for promising molds while grocery shopping or cleaning out their refrigerators.

In 1943, laboratory worker Mary Hunt brought in an ordinary supermarket cantaloupe infected with a mold that had "a pretty, golden look." This Penicillium species, Penicillium chrysogenum grew so well in a tank that it more than doubled the amount of penicillin produced.

The deep fermentation method, the use of corn steep liquor and the discovery of P. chrysogenum by Mary Hunt made the commercial production of penicillin possible. Researchers continued to find higher-yielding Penicillium molds, and also produced higher yielding strains by exposing molds to x-rays or ultraviolet light.

Penicillin kills by preventing some bacteria from forming new cell walls. One by one, the bacteria die because they cannot complete the process of division that produces two new "daughter" bacteria from a single "parent" bacterium. The new cell wall that needs to be made to separate the "daughters" is never formed.

Some bacteria are able to resist the action of antibiotic drugs, including penicillin. Antibiotic resistance occurs because not all bacteria of the same species are alike, just as people in your own family are not exactly alike. Eventually, the small differences among the bacteria often mean that some will be able to resist the attack of an antibiotic. If the sick person's own defenses can not kill off these resistant bacteria, they will multiply. This antibiotic-resistant form of a disease can re-infect the patient, or be passed on to another person.

Taking antibiotics for viral illnesses like colds can also cause antibiotic resistant bacteria to develop. Antibiotics have no effect on viruses, but it will kill off harmless and even the beneficial bacteria living in the patient's body. The surviving resistant bacteria, free from competition, will live and multiply and may eventually cause disease.

Patients with bacterial infections, who don't finish their antibiotic prescriptions completely, also allow resistant bacteria to develop. This happens because a small number of semi-resistant bacteria, which needed the full course of antibiotics to kill them, survive. Instead of being a small part of the bacteria causing an infection, the more resistant bacteria take over when sensitive bacteria are killed by the antibiotic.

Today, in the United States, deaths by infectious bacterial diseases are only one-twentieth of what they were in 1900, before any antibiotic chemicals had been discovered. The main causes of death today are what are referred to as "the diseases of old age": heart disease, kidney disease and cancer. We would be shocked to hear of someone dying from an infection that started in a scratch, but, before antibiotics like penicillin, it was common for people to die from such infections.

Humans can slow the creation of antibiotic resistant diseases by understanding the uses and limits of antibiotics. Take all of an antibiotic, and only take them when prescribed by a doctor. Research to develop new antibiotics to treat resistant bacteria continues, but research takes time. Time is running out because the world's biodiversity is decreasing--the source of half of our disease-fighting chemicals.


How antibiotics are used and abused

Perhaps you are wondering about the use -- and abuse -- of antibiotics in general. Let me give you an example. One of the most common diagnoses given at a doctor’s office is the upper respiratory infection (URI). It accounts for up to 70 percent of all antibiotics dispensed (Annals of Internal Medicine. American College of Physicians. American Society of Internal Medicine. March 20, 2001).

However, according to Dr. Carol Kauffman, most URIs are not caused by the bacteria that antibiotics are designed to fight. Rather, Kauffman says, they are caused by fungi. So, unless a secondary, bacterial infection presents itself -- and even then, the rules change -- most URIs do not require the use of antibiotics.

Regarding ear infections, in one study, children administered antibiotics for acute otitis media suffered double the rate of adverse effects compared to children in the study who took placebos (Clinical Evidence. 2000). The difference in outcome for those children in the study who took antibiotics compared to those who do not was almost negligible. Some scientists counter that children who take antibiotics run lower risks of secondary ear infections such as meningitis or mastoiditis (infection of the angular bone located behind your ear).

Of course, the landscape is complicated by noncompliance. The portion of people who take their antibiotics as prescribed has been estimated at anywhere between 8 to 68 percent. So it’s difficult to say just how effective antibiotics actually are.

Antibiotics in use today

Alexander Fleming, by the grace of God, brought us a mixed blessing in 1928 with his accidental discovery of penicillin produced by, of all things, a fungus. Medicine’s interest treating people for exposure to fungi dropped dramatically in succeeding years, until the microbes were only thought important insofar as their ability to produce increasingly diverse varieties of antibiotics.


Antibiotics and the Animal Industry

Industrial farms have been mixing antibiotics into livestock feed since 1946, when studies showed that the drugs cause animals to grow faster and put on weight more efficiently, increasing meat producers' profits. Today antibiotics are routinely fed to livestock, poultry, and fish on industrial farms to promote faster growth and to compensate for the unsanitary conditions in which they are raised.

Modern industrial farms are ideal breeding grounds for germs and disease. Animals live in close confinement, often standing or laying in their own filth, and under constant stress that inhibits their immune systems and makes them more prone to infection. According to the Union of Concerned Scientists, as much as 70 percent of all antibiotics used in the United States is fed to healthy farm animals.


When drug-resistant bacteria develop at industrial livestock facilities, they can reach the human population through food, the environment (i.e., water, soil, and air), or by direct contact with animals (i.e., farmers and farm workers).

Industrial livestock operations produce an enormous amount of concentrated animal waste, over one billion tons annually—that is often laden with antibiotics, as well as antibiotic-resistant bacteria from the animals' intestines. It is estimated that as much as 80 to 90 percent of all antibiotics given to animals are not fully digested and eventually pass through the body and enter the environment, where they can encounter new bacteria and create additional resistant strains.

With huge quantities of manure routinely sprayed onto fields surrounding CAFOs, antibiotic resistant bacteria can leech into surface and ground water, contaminating drinking wells and endangering the health of people living close to large livestock facilities.


Antibiotic Resistance, Public Health and Public Policy

Antibiotic-resistant bacteria is a growing public health crisis because infections from resistant bacteria are increasingly difficult and expensive to treat. As of this writing, the U.S. Congress was considering legislation, staunchly opposed by industrial farm lobbyists, which would ban seven classes of antibiotics from use on factory farms and would restrict the use of other antibiotics. This is a response to the fact that modern industrial livestock operations threaten to increase the prevalence of antibiotic-resistant bacteria.

Thousands of Americans die every year from drug-resistant infections. In addition, the National Academy of Sciences calculates that increased health care costs associated with antibiotic-resistant bacteria exceed $4 billion each year in the United States alone—a figure that reflects the price of pharmaceuticals and longer hospital stays, but does not account for lost workdays, lost productivity or human suffering.

Although everyone is at risk when antibiotics stop working, the threat is greatest for young children, the elderly, and people with weakened immune systems, including cancer patients undergoing chemotherapy, organ transplant patients and, in general, people whose health is compromised in some way.

The following excerpt is from an article by Carol R. Goforth.

The headlines are sensational enough that it wouldn’t be surprising to see them in the most notorious supermarket tabloids. The stories behind the headlines are scary enough that they might be the plot of a horror movie. Unfortunately, it is often the scientific press that is reporting on the spread of antibiotic-resistant bacteria, and the threat to human health and life is very real and growing.

The increase in public awareness about the spread of antibiotic-resistant bacteria has been occasioned by a significant increase in the number of reported cases of human illness associated with antibiotic resistance. Studies show that infectious disease mortality rates have risen nearly 60%, with the Centers for Disease Control (CDC) estimating that more than half of the infection-related deaths involve resistant bacteria.

Dubbed “super-bugs” in the popular press, multi-drug resistant bacteria are becoming more and more common. Newspapers and magazines carry stories of bacterial infections that do not respond to the antibiotics typically prescribed to control them. As one legal commentator observed, “many of the killer diseases of the past such as tuberculosis, typhoid fever, diphtheria, and pneumonia have returned to wreak havoc as bacteria are increasingly resistant to antibiotics.” While antibiotics were once regarded as an unending miracle of modern medicine, we are fast approaching a time when the miracle may come to an end.

While there are doubtless many factors contributing to the spread of multi-resistant bacteria, one factor appears to be the widespread addition of antibiotics to livestock feed. A wide range of antibiotics are currently added, in subtherapeutic amounts, to animal feeds. A growing volume of research suggests that this practice is having devastating and potentially irreversible effects on the viability of antibiotics as agents to effectively treat diseases in human beings, but the legal community appears to be lagging far behind scientific experts in calling for an end to this practice in the United States.

At the current time, there are three primary uses of antibiotics in animal agriculture: therapeutic, prophylactic (to prevent potential infection), and growth promotion (with both of the latter two categories being at subtherapeutic concentrations).

The use of antibiotics to ward off infections and to promote growth in livestock is not new. For more than 40 years many farmers have fed their animals a diet laced with small, subtherapeutic doses of antibiotics.

The discovery that antibiotics could be used for prevention of infection and growth promotion was serendipitous. Veterinarians began administering antibiotics to sick animals in an effort to determine whether the “miracle drugs” that were saving human lives could also help livestock.

These experiments led to the discovery that feeding animals small doses of the drugs not only inhibited diseases but also enhanced growth. This discovery led in turn to an agricultural revolution, with farmers—especially those in very large operations relying increasingly on subtherapeutic doses of antibiotics to keep their livestock healthy and to promote animal growth.

In the past three decades, agricultural use of antibiotics has increased exponentially. One article has estimated that in the past thirty years, farmers have increased their use of penicillin-type antibiotics in farm animals by 600% and their use of tetracycline by 1500%. Recent statistical research continues to show an increasing reliance on the routine use of antibiotics for pigs and cattle. Larger operations also continue to be more likely to use antibiotics, and many rely on additives for periods of time in excess of ninety days.

Part of the increase in antibiotic use is attributable to the declining effectiveness of the drugs as growth promoters. Over time, the amount of antibiotics needed to promote growth in farm animals has increased significantly. Some sources have suggested that “roughly 10 to 20 times the amount used four decades ago were required to produce the same level of growth in the 1990s.”

Moreover, even at concentrations approaching therapeutic levels, “the benefits of growth promotion are less now than those reported several decades ago.”

Antibiotic use and abuse

There has been an astonishing increase in the use of antibiotics in spite of the dangers of abuse.  In 1954 2 million pounds of antibodies were produced inn America, while today estimates of production exceed 50 million pounds.

Approximately 16 million pounds are used on humans, the remaining 34 million pounds are used on livestock in our food supply, most used as a food supplement.

Included in the list of antibiotics used as food additives in American agriculture are a number of drugs that are either themselves used as drug therapies for human patients or are closely related to such drugs. Amoxicillin, ampicillin, erythromycin, neomycin, penicillin, and tetracycline are all used to treat human illness as well as being used in animal agriculture.



US General Accounting Office Report - GAO-11-406

July 1, 2011

Infections that were once treatable have become more difficult to treat because of antibiotic resistance. Resistance occurs naturally but is accelerated by inappropriate antibiotic use in people, among other things.

Questions have been raised about whether agencies such as the Department of Health and Human Services (HHS) have adequately assessed the effects of antibiotic use and disposal on resistance in humans.

GAO was asked to (1) describe federal efforts to quantify the amount of antibiotics produced, (2) evaluate HHS's monitoring of antibiotic use and efforts to promote appropriate use, (3) examine HHS's monitoring of antibiotic-resistant infections, and (4) describe federal efforts to monitor antibiotic disposal and antibiotics in the environment, and describe research on antibiotics in the development of resistance in the environment.

GAO reviewed documents and interviewed officials, conducted a literature review, and analyzed antibiotic sales data.

Federal agencies do not routinely quantify the amount of antibiotics that are produced in the United States for human use. However, sales data can be used as an estimate of production, and these show that over 7 million pounds of antibiotics were sold for human use in 2009.

Most of the antibiotics that were sold have common characteristics, such as belonging to the same five antibiotic classes. The class of penicillins was the largest group of antibiotics sold for human use in 2009, representing about 45 percent of antibiotics sold. HHS performs limited monitoring of antibiotic use in humans and has implemented efforts to promote their appropriate use, but gaps in data on use will remain despite efforts to improve monitoring.

GAO did not address the millions of pounds of use on livestock including beef, pigs, fish and chicken nor the implications of transferring drug resistant bacteria from animals to humans since 1946.  Nor did it address the huge discrepancies in the amount of antibiotics produced by pharmaceutical companies.
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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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