Monthly Archives: January 2011

See Where America Stacks Up In Life Expectancy

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The U.S. is lagging behind other high income countries in life expectancy despite spending more on health care than any other country.

A new report from the National Research Council finds that Americans can expect to live shorter lives than in other industrialized countries.  They council blames two things – smoking and obesity.

The popularity of smoking has gone way down in the last 20 years, but it was very popular from the 50’s and into the 80′.  The effects of smoking are not realized until much later in life and we are seeing now that it is affecting the life expectancy of the baby boomer generation and beyond.

The other factor, obesity, is an obvious one.  The U.S. has the third highest obesity rate in the world. Over two-thirds of Americans are overweight or obese.  The only countries with higher rates of obesity are Kiribati and American Samoa.

See the list below and where the U.S. falls in life expectancy.

Women

Australia 83.78
Canada 82.95
Denmark 80.53
England and Wales 81.73
France 84.39
Italy 84.09
Japan 85.98
Netherlands 81.89
Sweden 82.95
United States 80.78

Men

Australia 79.27
Canada 78.35
Denmark 76.13
England and Wales 77.46
France 77.43
Italy 78.62
Japan 79.20
Netherlands 77.63
Sweden 78.92
United States 75.64

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Want a better brain? Lift Weights!

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Exercise has long been known to increase brain function.  Most of the research, however, focused on the benefits of purely cardiovascular exercises like running.  New research shows that weight training has the same effect.

Conventional wisdom has stated that the benefits of cardiovascular exercise on brain function was from the significant increase in blood flow to the brain during aerobic type exercises.  It was concluded that because weight training didn’t cause this to happen for extended periods of time, it would not have the same benefit.

The creation of new brain cells, or neurogenesis, is thought to be dependent on a spike of blood flow to the brain. In fact, running and other aerobic exercises have been shown to increase neuron production in the areas of the brain associated with memory and thinking in both mice and humans.  However, this was thought not to apply to resistance training.  That is changing.

“In a study presented at the annual meeting of the Society for Neuroscience in November, researchers from Brazil secured weights to the tails of a group of rats and had them climb a ladder five sessions a week. Other rats on the same schedule ran on a treadmill, and a third group just sat around. After eight weeks, the running rats had much higher levels of brain-derived neurotrophic factor (B.D.N.F.), a growth factor that is thought to help spark neurogenesis, than the sedentary rats. So did the rats with weights tied to their tails. The weight-­bearing rats, like the runners, did well on tests of rodent learning and memory, like rapidly negotiating a water maze. Both endurance and weight training seemed to make the rats smarter.” (From The NY Times)

A similar study from Japan at the same conference came to the same conclusions.

“The animals that were assigned to the loaded wheels showed significantly increased levels of gene activity and B.D.N.F. levels within their brains. The higher the workload the animals managed to complete, the greater the genetic activity within their brains.” (From The NY Times)

The genetic activity is important.  That’s precisely how the human brain adapts.  It changes the expression of certain genes in order to respond to certain environmental input.  That input may be in the form of exercise like weight training or it may be more cognitively based like learning to play the piano.  Whatever the input may be, the brain changes in response to the activity being performed.  This is a phenomenon called plasticity.  And the brain remains plastic our entire lives!  That means it can change right up to the day we die.

Just how does this resistance training increase brain function?  No one knows for sure, but there are theories.  The researchers propose that because weight training reduces many cardiovascular risk factors and does increase the strength of the heart it may also help the brain through similar mechanisms that aerobic exercise does.

I have another theory.  Ninety percent, yes that’s 90%, of the input that comes into our brains during any given day comes from the receptors in our muscles and joints.  That means that if we take into account all of the sensory input that our brains receive during the day – light, sound, touch, smell, proprioception – a full 90% of that input is coming from our muscles and joints.  If the body requires that much input from our musculoskeletal system it must be important, right?  It is.  This input keeps the brain functioning normally and maintains the health of just about every type of neuron in the brain.

Resistance training makes this input more efficient.  By training the muscles with weights they send more regulatory information to the brain and you also increase the amount of information coming from the joints.  The stronger your muscles the more force is applied through your joints.  This combination is a winning one in terms of brain function.

The best type of exercise program is one that includes both cardiovascular and resistance type training.  People are often hesitant to start a weight training program because of lack of knowledge on how to properly do it.  If you are concerned hire a knowledgeable trainer to show you how to do it.  The benefits will far outweigh your hesitance to start.

 

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Reducing Your Risk of Cancer – 3 things you should include in your diet.

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Did you know that an estimated 1,529,560 people were diagnosed with cancer in 2010? That’s 4,190 new cases per day!

Unfortunately, we have become acutely aware that there are many things in our world that are carcinogenic and inevitably will find more things in the future.  Mutagens come from a variety of places including tobacco smoke and environmental pollutants.  Popular herbicides contain glyphosphate, a compound that depresses the function of important enzymes that are essential for detoxification.  The number one cancer causing mutagen, however, is our diet.  For example, the frying, baking, and roasting of carbohydrate rich foods produces acrylamide, which is a known cancer causing agent in animals.

Everyday we are surrounded by these mutagens that have the potential to cause a genetic mutation within our own cells resulting in a mistake in our genetic code.  According to the New England Journal of Medicine, “Cancer results from the accumulation of mutations in the genes that regulate cellular proliferation.”  As these mutations begin to accumulate the cells can no longer regulate their own production and begin to grow out of control.  They no longer demonstrate the innate ability of apoptosis.  Apoptosis is defined as programmed cellular death.  Healthy cells that develop abnormalities are programmed to destroy themselves when mistakes are made.  Cancer cells, because of excessive mutations, lose this ability and continue to reproduce despite the fact they are causing damage.

The human body has a very unique and effective way of dealing with chemicals that it may come into contact with.  This detoxification system has two phases within which it works.  They are aptly named Phase I and Phase II.  This system is able to detoxify even the most potent of chemicals, including pesticides and other foreign compounds found in the environment.  Although these systems are very complex, we will go over them briefly and broadly.

The molecules produced in Phase I may be even more toxic than the initial chemicals because the molecular groups that are added to them by the body’s detoxification system are very reactive.  This allows these molecules to act as free radicals in the liver.  This is not problematic as long as Phase II is working well. The Phase I molecules are usually quickly converted to harmless molecules for excretion in the urine or bile by Phase II.

At this point you may be asking, “Why do I need to worry about it if Phase II acts so quickly?”  For one, the process is slowed with age and some people metabolize slowly while others metabolize much faster.  This shows the need for nutritional supplementation which maximizes the efforts of Phase I and II and reinforces the idea that we should provide the liver with ample amounts of antioxidants.

So the question remains.  What can you do to help protect yourself from dangerous mutations that may lead to cancer in the future?  Many nutrients have been found to be essential cofactors for the detoxification system, but three have recently been found to directly enhance its activity.

Curcumin

The first is curcumin.  It is a nutrient that is derived from turmeric.  Turmeric has been used for centuries throughout India and Asia for a myriad of different maladies ranging from upset stomach to arthritis.  It has also been shown to reduce total cholesterol and inhibit LDL oxidation.

In a study at India’s Panjab University, researchers found that curcumin inhibited mutagenicity by as much as 80% against mutagens in cooked foods.  Curcumin has also been shown not only to be preventative but also helps reduce the progression of cancer.  Curcumin appears to act by boosting the activity of glutathione S-transferase which is an important Phase II enzyme.

Curcumin has also been shown to be a potent antioxidant.  Antioxidants are important because they scavenge free radicals throughout the system.  Free radicals act on the body on a cellular level producing damage in whatever they come in contact with.

Chlorophyllin

Another potent inhibitor of mutagenicity is chlorophyllin.  This is derived from the green pigment in plants called chlorophyll.  Chlorophyllin is beneficial because it is water soluble and is easily transported in the blood.  It has been shown to inhibit mutations in bacteria when placed in a Petri dish with known mutagens.

Although its precise mechanism of action is unknown, it is thought to act as a powerful antioxidant as well.  In one study, chlorophyllin was shown to promote apoptosis in human colon cancer cells.  This is important because it is thought that the alteration of the process of apoptosis is one mechanism by which cancer continues to reproduce.  Chlorophyllin is has also been shown to be heat stable which is important because it will maintain its powerful properties after ingested.

Broccoli Extract

The third powerful nutrient is broccoli extract.  That’s right. Mom knew more than she thought when she was force feeding you broccoli and cod liver oil!  According to an article in Life Extension magazine, “Broccoli is a plentiful source of glucosinolates, which are converted enzymatically into isothiocyanates. In the body, the isothiocyanates in broccoli boost production of several Phase II detoxification enzymes, enhance antioxidant status, and protect animals against chemically induced cancer.”

A study at Johns Hopkins University showed that broccoli extract significantly reduced incidence, multiplicity, and weight of mammary tumors in rats after exposure to known mutagens.  Its activity is thought to work by enhancing enzymatic activity in Phase II of the detoxification system.

Cancer levels continue to be very high in the United States.  With the never ending influx of new chemicals into our world it is important to protect ourselves with nutrients that have been proven to be beneficial in the prevention of cancer.  Curcumin, chlorophyllin and broccoli extract have been shown to be very effective.  Traditional medicine promotes early detection as a crucial weapon in defeating cancer.  Early detection is of course important, but it is not prevention.  We propose that all of our patients take an active role in their health and prevent serious illness through good nutrition.

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Fatigue? Weight Gain? Depression? Maybe it’s your thyroid.

Low thyroid function is very common.  It is especially common in women.  And your doctor may not diagnose you with it because of one simple mistake.

The thyroid controls how quickly the body uses energy, makes proteins, and controls how sensitive the body should be to other hormones.  It is exceptionally important.  Without thyroid function one cannot survive.

The thyroid is located in the neck just below the Adam’s Apple.  The average person should not be able to feel it.  It may become enlarged if you have low thyroid function.  In that case, one would be able to feel it and it may even be visible in the neck.

The thyroid is controlled by the pituitary gland in the brain.  The pituitary secretes a hormone called thyroid stimulating hormone or TSH.  TSH tells the thyroid to secrete its hormones.  These hormones are called T3 and T4.  When these hormones are secreted they make their way back to the pituitary via the blood stream and this tells the pituitary to stop secreting TSH.  This is known as a negative feedback loop.

 

The pituitary secretes TSH which tells the thyroid to secrete its hormone. This hormone then tells the pituitary to stop secreting TSH.

An under active thyroid is known as hypothyroidism.  The symptoms are varied and include the following:

  • Poor muscle tone (muscle hypotonia)
  • Fatigue
  • Cold intolerance, increased sensitivity to cold
  • Constipation
  • Depression
  • Muscle cramps and joint pain
  • Goiter
  • Thin, brittle fingernails
  • Coarse hair
  • Paleness
  • Decreased sweating
  • Dry, itchy skin
  • Weight gain and water retention
  • Bradycardia (low heart rate – fewer than sixty beats per minute)

The most common symptoms I see in practice of low thyroid function are the inability to lose weight and fatigue.  Depression is common as well but that can have many causes.

How is the thyroid tested?

The thyroid is tested with a blood test.  TSH is generally considered the gold standard to asses thyroid function.  A high TSH indicates that the pituitary gland is working too hard to get the thyroid gland to produce its hormone.  This means one has hypothyroidism.

I’ve had my TSH tested and it’s normal but I have all the symptoms

This is very common.  Unfortunately most doctors do not assess the thyroid completely.  There are many other parameters to check besides TSH.  Remember TSH is a brain hormone and while it can be valuable it is not the whole picture on the thyroid.

Let’s start with the controversy over the reference levels that most U.S. labs (and therefore doctors) use for a normal TSH.  Generally speaking, they use a reference range of 0.5-5.0.  If your TSH falls in that range then you are considered healthy, even if you have all of the hypothyroid symptoms.  This can be frustrating for many patients.  That reference range that most doctors rely on is far too broad and outdated.  Unfortunately, medicine is very slow to adapt.  This puts the patient at the disadvantage.  A more appropriate reference range for TSH is 0.3-3.0.  This is a much smaller range and would appropriately diagnose many more people with hypothyroidism.

So, if your doctor uses the old range of 0.5-5.0 and your TSH tested at 4.0 your doctor will tell you that your thyroid is doing just fine and will not treat you.  If he were to use the most updated range set forth by the American Academy of Clinical Endocrinologist in 2003 you would be appropriately diagnosed as hypothyroid and be treated accordingly.

What else can be tested?

Remember, TSH is just one parameter to be tested.  You can also test for the actual thyroid hormones themselves.  When testing for T3 and T4 there are two things to remember.  You must test the free and total T3/T4.  What’s the difference?

Total T3 and T4 takes into account the total hormone you have.  This includes biologically active and inactive forms.  The total hormone you have might be normal, but the free hormone might be low.

The free fraction of the hormones can often be low despite a normal total hormone reading.  The free hormone is what is actually available to your body to use.  It is unbound and biologically active.  Think of it like your cash flow.  A person might be worth a lot of money with real estate holdings and investments but if they don’t have any actual cash they can’t purchase anything.  If you have a low free hormone you will have symptoms of hypothyroidism.  However, if it’s not tested it might be missed.

You should also have the anti-thyroid antibodies tested.  These are antibodies that some people make their thyroid.  The body’s immune system mistakes the thyroid for an invader and begins to attack it.  High antibodies alone are enough to cause the symptoms of low thyroid function despite all other parameters being normal.

The bottom line is if you think you might have low thyroid function, don’t rely on just the TSH to tell you.  Have the full workup done.  That includes:

TSH, free and total T3 and T4 and the anti-thyroid antibodies.

And don’t forget; don’t rely on the outdated TSH scale.  Use the smaller more appropriate scale.

Getting an appropriate diagnosis is important and if you use these tips there shouldn’t be any more confusion for you.

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Before you take that Ibuprofen, read this!

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A recent study consisting of 116,000 people has supported other research that NSAIDs pack a dangerous risk for your heart.

NSAIDs, or non-steroidal anti-inflammatory drugs, are a very popular class of drugs that are used for many things including fever reduction and pain management.  They are most commonly used to reduce the aches and pains of every day life such as headaches, back pain and arthritis.  Below is a list of NSAIDs that are approved in the U.S.

The names you will recognize are probably aspirin, ibuprofen and naproxen.  They are the best-selling of the NSAIDs.

This new research was a meta-analysis of 31 other studies that looked at prescription strength NSAIDs.  The data, however, likely applies to the over the counter NSAIDs one can buy right off the shelf.  It is very easy to take prescription strengths simply by taking too many of the over the counter version, something millions of Americans do every day.

What was found was that by taking these medications there is a significant increase in the risk of stroke, heart attack and cardiovascular death.  The study did not take into account the known risk of bleeding associated with the entire NSAID class of drugs.  (Click here to read about “baby” aspirin and its dangers.)

So what do you do if you have pain?

The most important thing you need to do is consume an anti-inflammatory diet.  The principles of this diet work on the same metabolic pathways that the NSAID class of drugs does, but without the nasty side effects.  Plus, by changing your diet you get the added benefit of more energy, a better cholesterol profile and reduction in total inflammatory load.  These are things the NSAIDs could never claim to do.

How to eat an anti-inflammatory diet

There are also supplements that work quite well.  First, fish oil is a must.  It is potently anti-inflammatory and there are many studies to back up its usefulness in pain reduction.  Be sure to get a high quality fish oil.  Low quality fish oils are filled with toxins and will do more harm than good at worst and do nothing beneficial at best.

For pain reduction I recommend 6 grams (6,000 mg) per day of fish oil.  The number of capsules that will take depends on the potency of the brand you buy.  You will likely get more for your money if you buy the oil and take it by the teaspoon.

Other supplements that work quite well are the anti-inflammatory herbs such as ginger and turmeric. When taken consistently, they significantly impact pain levels.  They are also available in many products over the counter.  I always recommend, however, that one sees a health care practitioner that is trained in functional medicine before trying this on your own.  Your results will be much better if you see a doctor who can manage your care with you.

Enzymes such as bromelain are also of benefit.  Bromelain is an enzyme derived from pineapples.  It is potently anti-inflammatory.

NSAIDs are overly used and are often misused.  This, in part, leads to their problems.  If people could change their diet and use natural alternatives for pain management, heavy reliance on NSAIDs could be a thing of the past.  In my book, that would be a great thing.

 

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Pharmaceutical Deceit – How Big Pharma misleads the FDA and gets away with it.

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Below is an article I read in, of all places, Vanity Fair.  It does a nice job showing you just how sneaky the pharmaceutical industry can be to get their drugs approved.  I have re-posted the entire article.  It’s a bit long, but a good read.  Enjoy.

Vanity Fair Article

Prescription drugs kill some 200,000 Americans every year. Will that number go up, now that most clinical trials are conducted overseas—on sick Russians, homeless Poles, and slum-dwelling Chinese—in places where regulation is virtually nonexistent, the F.D.A. doesn’t reach, and “mistakes” can end up in pauper’s graves? The authors investigate the globalization of the pharmaceutical industry, and the U.S. Government’s failure to rein in a lethal profit machine.

You wouldn’t think the cities had much in common. Iaşi, with a population of 320,000, lies in the Moldavian region of Romania. Mégrine is a town of 24,000 in northern Tunisia, on the Mediterranean Sea. Tartu, Estonia, with a population of 100,000, is the oldest city in the Baltic States; it is sometimes called “the Athens on the Emajõgi.” Shenyang, in northeastern China, is a major industrial center and transportation hub with a population of 7.2 million.

These places are not on anyone’s Top 10 list of travel destinations. But the advance scouts of the pharmaceutical industry have visited all of them, and scores of similar cities and towns, large and small, in far-flung corners of the planet. They have gone there to find people willing to undergo clinical trials for new drugs, and thereby help persuade the U.S. Food and Drug Administration to declare the drugs safe and effective for Americans. It’s the next big step in globalization, and there’s good reason to wish that it weren’t.

Once upon a time, the drugs Americans took to treat chronic diseases, clear up infections, improve their state of mind, and enhance their sexual vitality were tested primarily either in the United States (the vast majority of cases) or in Europe. No longer. As recently as 1990, according to the inspector general of the Department of Health and Human Services, a mere 271 trials were being conducted in foreign countries of drugs intended for American use. By 2008, the number had risen to 6,485—an increase of more than 2,000 percent. A database being compiled by the National Institutes of Health has identified 58,788 such trials in 173 countries outside the United States since 2000. In 2008 alone, according to the inspector general’s report, 80 percent of the applications submitted to the F.D.A. for new drugs contained data from foreign clinical trials. Increasingly, companies are doing 100 percent of their testing offshore. The inspector general found that the 20 largest U.S.-based pharmaceutical companies now conducted “one-third of their clinical trials exclusively at foreign sites.” All of this is taking place when more drugs than ever—some 2,900 different drugs for some 4,600 different conditions—are undergoing clinical testing and vying to come to market.

Some medical researchers question whether the results of clinical trials conducted in certain other countries are relevant to Americans in the first place. They point out that people in impoverished parts of the world, for a variety of reasons, may metabolize drugs differently from the way Americans do. They note that the prevailing diseases in other countries, such as malaria and tuberculosis, can skew the outcome of clinical trials. But from the point of view of the drug companies, it’s easy to see why moving clinical trials overseas is so appealing. For one thing, it’s cheaper to run trials in places where the local population survives on only a few dollars a day. It’s also easier to recruit patients, who often believe they are being treated for a disease rather than, as may be the case, just getting a placebo as part of an experiment. And it’s easier to find what the industry calls “drug-naïve” patients: people who are not being treated for any disease and are not currently taking any drugs, and indeed may never have taken any—the sort of people who will almost certainly yield better test results. (For some subjects overseas, participation in a clinical trial may be their first significant exposure to a doctor.) Regulations in many foreign countries are also less stringent, if there are any regulations at all. The risk of litigation is negligible, in some places nonexistent. Ethical concerns are a figure of speech. Finally—a significant plus for the drug companies—the F.D.A. does so little monitoring that the companies can pretty much do and say what they want.

Consent by Thumbprint

Many of today’s trials still take place in developed countries, such as Britain, Italy, and Japan. But thousands are taking place in countries with large concentrations of poor, often illiterate people, who in some cases sign consent forms with a thumbprint, or scratch an “X.” Bangladesh has been home to 76 clinical trials. There have been clinical trials in Malawi (61), the Russian Federation (1,513), Romania (876), Thailand (786), Ukraine (589), Kazakhstan (15), Peru (494), Iran (292), Turkey (716), and Uganda (132). Throw a dart at a world map and you are unlikely to hit a spot that has escaped the attention of those who scout out locations for the pharmaceutical industry.

The two destinations that one day will eclipse all the others, including Europe and the United States, are China (with 1,861 trials) and India (with 1,457). A few years ago, India was home to more American drug trials than China was, thanks in part to its large English-speaking population. But that has changed. English is now mandatory in China’s elementary schools, and, owing to its population edge, China now has more people who speak English than India does.

While Americans may be unfamiliar with the names of foreign cities where clinical trials have been conducted, many of the drugs being tested are staples of their medicine cabinets. One example is Celebrex, a non-steroidal anti-inflammatory drug that has been aggressively promoted in television commercials for a decade. Its manufacturer, Pfizer, the world’s largest drug company, has spent more than a billion dollars promoting its use as a pain remedy for arthritis and other conditions, including menstrual cramps. The National Institutes of Health maintains a record of most—but by no means all—drug trials inside and outside the United States. The database counts 290 studies involving Celebrex. Companies are not required to report—and do not report—all studies conducted overseas. According to the database, of the 290 trials for Celebrex, 183 took place in the United States, meaning, one would assume, that 107 took place in other countries. But an informal, country-by-country accounting by VANITY FAIR turned up no fewer than 207 Celebrex trials in at least 36 other countries. They ranged from 1 each in Estonia, Croatia, and Lithuania to 6 each in Costa Rica, Colombia, and Russia, to 8 in Mexico, 9 in China, and 10 in Brazil. But even these numbers understate the extent of the foreign trials. For example, the database lists five Celebrex trials in Ukraine, but just “one” of those trials involved studies in 11 different Ukrainian cities.

The Celebrex story does not have a happy ending. First, it was disclosed that patients taking the drug were more likely to suffer heart attacks and strokes than those who took older and cheaper painkillers. Then it was alleged that Pfizer had suppressed a study calling attention to these very problems. (The company denied that the study was undisclosed and insisted that it “acted responsibly in sharing this information in a timely manner with the F.D.A.”) Soon afterward the Journal of the Royal Society of Medicine reported an array of additional negative findings. Meanwhile, Pfizer was promoting Celebrex for use with Alzheimer’s patients, holding out the possibility that the drug would slow the progression of dementia. It didn’t. Sales of Celebrex reached $3.3 billion in 2004, and then began to quickly drop.

“Rescue Countries”

One big factor in the shift of clinical trials to foreign countries is a loophole in F.D.A. regulations: if studies in the United States suggest that a drug has no benefit, trials from abroad can often be used in their stead to secure F.D.A. approval. There’s even a term for countries that have shown themselves to be especially amenable when drug companies need positive data fast: they’re called “rescue countries.” Rescue countries came to the aid of Ketek, the first of a new generation of widely heralded antibiotics to treat respiratory-tract infections. Ketek was developed in the 1990s by Aventis Pharmaceuticals, now Sanofi-Aventis. In 2004—on April Fools’ Day, as it happens—the F.D.A. certified Ketek as safe and effective. The F.D.A.’s decision was based heavily on the results of studies in Hungary, Morocco, Tunisia, and Turkey.

The approval came less than one month after a researcher in the United States was sentenced to 57 months in prison for falsifying her own Ketek data. Dr. Anne Kirkman-Campbell, of Gadsden, Alabama, seemingly never met a person she couldn’t sign up to participate in a drug trial. She enrolled more than 400 volunteers, about 1 percent of the town’s adult population, including her entire office staff. In return, she collected $400 a head from Sanofi-Aventis. It later came to light that the data from at least 91 percent of her patients was falsified. (Kirkman-Campbell was not the only troublesome Aventis researcher. Another physician, in charge of the third-largest Ketek trial site, was addicted to cocaine. The same month his data was submitted to the F.D.A. he was arrested while holding his wife hostage at gunpoint.) Nonetheless, on the basis of overseas trials, Ketek won approval.

As the months ticked by, and the number of people taking the drug climbed steadily, the F.D.A. began to get reports of adverse reactions, including serious liver damage that sometimes led to death. The F.D.A.’s leadership remained steadfast in its support of the drug, but criticism by the agency’s own researchers eventually leaked out (a very rare occurrence in this close-knit, buttoned-up world). The critics were especially concerned about an ongoing trial in which 4,000 infants and children, some as young as six months, were recruited in more than a dozen countries for an experiment to assess Ketek’s effectiveness in treating ear infections and tonsillitis. The trial had been sanctioned over the objections of the F.D.A.’s own reviewers. One of them argued that the trial never should have been allowed to take place—that it was “inappropriate and unethical because it exposed children to harm without evidence of benefits.” In 2006, after inquiries from Congress, the F.D.A. asked Sanofi-Aventis to halt the trial. Less than a year later, one day before the start of a congressional hearing on the F.D.A.’s approval of the drug, the agency suddenly slapped a so-called black-box warning on the label of Ketek, restricting its use. (A black-box warning is the most serious step the F.D.A. can take short of removing a drug from the market.) By then the F.D.A. had received 93 reports of severe adverse reactions to Ketek, resulting in 12 deaths.

During the congressional hearings, lawmakers heard from former F.D.A. scientists who had criticized their agency’s oversight of the Ketek trials and the drug-approval process. One was Dr. David Ross, who had been the F.D.A.’s chief reviewer of new drugs for 10 years, and was now the national director of clinical public-health programs for the U.S. Department of Veterans Affairs. When he explained his objections, he offered a litany of reasons that could be applied to any number of other drugs: “Because F.D.A. broke its own rules and allowed Ketek on the market. Because dozens of patients have died or suffered needlessly. Because F.D.A. allowed Ketek’s maker to experiment with it on children over reviewers’ protests. Because F.D.A. ignored warnings about fraud. And because F.D.A. used data it knew were false to reassure the public about Ketek’s safety.”

Trials and Error

To have an effective regulatory system you need a clear chain of command—you need to know who is responsible to whom, all the way up and down the line. There is no effective chain of command in modern American drug testing. Around the time that drugmakers began shifting clinical trials abroad, in the 1990s, they also began to contract out all phases of development and testing, putting them in the hands of for-profit companies. It used to be that clinical trials were done mostly by academic researchers in universities and teaching hospitals, a system that, however imperfect, generally entailed certain minimum standards. The free market has changed all that. Today it is mainly independent contractors who recruit potential patients both in the U.S. and—increasingly—overseas. They devise the rules for the clinical trials, conduct the trials themselves, prepare reports on the results, ghostwrite technical articles for medical journals, and create promotional campaigns. The people doing the work on the front lines are not independent scientists. They are wage-earning technicians who are paid to gather a certain number of human beings; sometimes sequester and feed them; administer certain chemical inputs; and collect samples of urine and blood at regular intervals. The work looks like agribusiness, not research.

What began as a mom-and-pop operation has grown into a vast army of formal “contract-research organizations” that generate annual revenue of $20 billion. They can be found conducting trials in every part of the world. By far the largest is Quintiles Transnational, based in Durham, North Carolina. It offers the services of 23,000 employees in 60 countries, and claims that it has “helped develop or commercialize all of the top 30 best-selling drugs.”

Quintiles is privately owned—its investors include two of the U.S.’s top private-equity firms. Other private contractors are public companies, their stock traded on Wall Street. Pharmaceutical Product Development (P.P.D.), a full-service medical contractor based in Wilmington, North Carolina, is a public company with 10,500 employees. It, too, has conducted clinical trials all around the world. In fact, it was involved in the clinical trials for Ketek—a P.P.D. research associate, Ann Marie Cisneros, had been assigned to monitor Dr. Anne Kirkman-Campbell’s testing in Alabama. Cisneros later told the congressional investigating committee that Kirkman-Campbell had indeed engaged in fraud. “But what the court that sentenced her did not know,” Cisneros said, was that “Aventis was not a victim of this fraud.” Cisneros said she had reported her findings of fraud to her employer, P.P.D., and also to Aventis. She told the congressional committee, “What brings me here today is my disbelief at Aventis’s statements that it did not know that fraud was being committed. Mr. Chairman, I knew it, P.P.D. knew it, and Aventis knew it.” Following her testimony the company released a statement saying it regretted the violations that occurred during the study but was not aware of the fraud until after the data was submitted to the F.D.A.

The F.D.A., the federal agency charged with oversight of the food and drugs that Americans consume, is rife with conflicts of interest. Doctors who insist the drug you take is perfectly safe may be collecting hundreds of thousands of dollars from the company selling the drug. (ProPublica, an independent, nonprofit news organization that is compiling an ongoing catalogue of pharmaceutical-company payments to physicians, has identified 17,000 doctors who have collected speaking and consulting fees, including nearly 400 who have received $100,000 or more since 2009.) Quite often, the F.D.A. never bothers to check for interlocking financial interests. In one study, the agency failed to document the financial interests of applicants in 31 percent of applications for new-drug approval. Even when the agency or the company knew of a potential conflict of interest, neither acted to guard against bias in the test results.

Because of the deference shown to drug companies by the F.D.A.—and also by Congress, which has failed to impose any meaningful regulation—there is no mandatory public record of the results of drug trials conducted in foreign countries. Nor is there any mandatory public oversight of ongoing trials. If one company were to test an experimental drug that killed more patients than it helped, and kept the results secret, another company might unknowingly repeat the same experiment years later, with the same results. Data is made available to the public on a purely voluntary basis. Its accuracy is unknown. The oversight that does exist often is shot through with the kinds of ethical conflicts that Wall Street would admire. The economic incentives for doctors in poor countries to heed the wishes of the drug companies are immense. An executive at a contract-research organization told the anthropologist Adriana Petryna, author of the book When Experiments Travel: “In Russia, a doctor makes two hundred dollars a month, and he is going to make five thousand dollars per Alzheimer’s patient” that he signs up. Even when the most flagrant conflicts are disclosed, penalties are minimal. In truth, the same situation exists in the United States. There’s just more of a chance here, though not a very large one, that adverse outcomes and tainted data will become public. When the pharmaceutical industry insists that its drugs have been tested overseas in accordance with F.D.A. standards, this may be true—but should provide little assurance.

The F.D.A. gets its information on foreign trials almost entirely from the companies themselves. It conducts little or no independent research. The investigators contracted by the pharmaceutical companies to manage clinical trials are left pretty much on their own. In 2008 the F.D.A. inspected just 1.9 percent of trial sites inside the United States to ensure that they were complying with basic standards. Outside the country, it inspected even fewer trial sites—seven-tenths of 1 percent. In 2008, the F.D.A. visited only 45 of the 6,485 locations where foreign drug trials were being conducted.

The pharmaceutical industry dismisses concerns about the reliability of clinical trials conducted in developing countries, but the potential dangers were driven home to Canadian researchers in 2007. While reviewing data from a clinical trial in Iran for a new heart drug, they discovered that many of the results were fraudulent. “It was bad, so bad we thought the data was not salvageable,” Dr. Gordon Guyatt, part of the research group at McMaster University in Hamilton, told Canada’s National Post.

In addition to monitoring trials abroad, which it does not really do, the F.D.A. is responsible for inspecting drug-manufacturing plants in other countries, which it also does not really do. In 2007 and 2008, hundreds of patients taking the blood thinner heparin, which among other purposes is used to prevent blood clots during surgery and dialysis, developed serious allergic reactions as a result of a contaminant introduced at a Chinese manufacturing facility. It took months for the F.D.A., its Chinese counterpart, and Baxter International, the pharmaceutical company that distributed the drug, to track the source of contamination to Changzhou, a city of 3.5 million on the Yangtze River.

The delay was perhaps understandable, given the manufacturing process. The raw material for Baxter’s heparin comes from China’s many small pig farms. To be precise, it’s derived from the mucous membranes of the intestines of slaughtered pigs; the membranes are mixed together and cooked, often in unregulated family workplaces. By the time the source of the contaminant was pinpointed, many more patients in the United States had experienced severe reactions, and as many as 200 had died. It later turned out that the F.D.A. had indeed inspected a Chinese plant—but it was the wrong one. The federal regulators had confused the names.

The good news was that, in this instance, the F.D.A. at least knew which country the heparin had come from. The bad news is that it does not always know where clinical trials are being conducted, or even the names or types of drugs being tested, or the purpose for which they will be prescribed once approved. Companies may withhold the foreign test data until they actually submit the application to the F.D.A. for approval. By then the agency has lost the ability to see whether the trials were managed according to acceptable standards, and whether the data collected was manipulated or fabricated.

$350 per Child

If the globalization of clinical trials for adult medications has drawn little attention, foreign trials for children’s drugs have attracted even less. The Argentinean province of Santiago del Estero, with a population of nearly a million, is one of the country’s poorest. In 2008 seven babies participating in drug testing in the province suffered what the U.S. clinical-trials community refers to as “an adverse event”: they died. The deaths occurred as the children took part in a medical trial to test the safety of a new vaccine, Synflorix, to prevent pneumonia, ear infections, and other pneumococcal diseases. Developed by GlaxoSmithKline, the world’s fourth-largest pharmaceutical company in terms of global prescription-drug sales, the new vaccine was intended to compete against an existing vaccine. In all, at least 14 infants enrolled in clinical trials for the drug died during the testing. Their parents, some illiterate, had their children signed up without understanding that they were taking part in an experiment. Local doctors who persuaded parents to enroll their babies in the trial reportedly received $350 per child. The two lead investigators contracted by Glaxo were fined by the Argentinean government. So was Glaxo, though the company maintained that the mortality rate of the children “did not exceed the rate in the regions and countries participating in the study.” No independent group conducted an investigation or performed autopsies. As it happens, the brother of the lead investigator in Santiago del Estero was the Argentinean provincial health minister.

In New Delhi, 49 babies died at the All India Institute of Medical Sciences while taking part in clinical trials over a 30-month period. They were given a variety of new drugs to treat everything from high blood pressure to chronic focal encephalitis, a brain inflammation that causes epileptic seizures and other neurological problems. The blood-pressure drugs had never before been given to anyone under 18. The editor of an Indian medical journal said it was obvious that the trials were intended to extend patent life in Western countries “with no consequence or benefit for India, using Indian children as guinea pigs.” In all, 4,142 children were enrolled in the studies, two-thirds of them less than one year old. But the head of the pediatrics department at the All India Institute maintained that “none of the deaths was due to the medication or interventions used in clinical trials.”

For years, American physicians gave anti-psychotic medicines to children “off label,” meaning that they wrote prescriptions based on testing for adults, sometimes even for different conditions. That didn’t work out so well for the children, who, when it comes to medicine, really are not just little adults. To provide the pharmaceutical industry with an incentive to conduct clinical trials on children’s versions of adult drugs, Congress in 1997 enacted legislation, known as the Pediatric Exclusivity Provision, extending the patent life of certain drugs by six months. It worked so well that the industry has, in the ensuing years, been able to put younger and younger children on more and more drugs, pocketing an extra $14 billion. Between 1999 and 2007, for instance, the use of anti-psychotic medications on children between the ages of two and five more than doubled.

A study of 174 trials under the Pediatric Exclusivity Provision found that 9 percent of them did not report the location or number of sites of the clinical trials. Of those that did, two-thirds had been conducted in at least one country outside the United States, and 11 percent were conducted entirely outside the United States. Of the 79 trials with more than 100 subjects participating, 87 percent enrolled patients outside the United States. As is the case with adult studies, many children’s trials conducted abroad are neither reported nor catalogued on any publicly accessible government database. There is no public record of their existence or their results.

In the mid-90s, Glaxo conducted clinical trials on the antidepressant Paxil in the United States, Europe, and South America. Paxil is a member of a class of drugs called selective serotonin re-uptake inhibitors. The class includes Zoloft, Prozac, and Lexapro. In the United Kingdom, Paxil is sold as Seroxat. The clinical trials showed that the drug had no beneficial effect on adolescents; some of the trials indicated that the placebo was more effective than the drug itself. But Glaxo neglected to share this information with consumers; annual sales of the drug had reached $5 billion in 2003. In an internal document obtained by the Canadian Medical Association Journal, the company emphasized how important it was to “effectively manage the dissemination of these data in order to minimize any potential negative commercial impact.” The memo went on to warn that “it would be commercially unacceptable to include a statement that efficacy had not been demonstrated.” After the document was released a Glaxo spokesperson said that the “memo draws an inappropriate conclusion and is not consistent with the facts.”

“Smoke and Mirrors”

It may be just a coincidence, but as controversy swirls around new drugs, and as the F.D.A. continues to slap medicines with new warning labels—especially the black-box warnings that indicate the most serious potential reactions—most of the problematic drugs have all undergone testing outside the United States. Clinical-trial representatives working for GlaxoSmithKline went to Iaşi, Romania, to test Avandia, a diabetes drug, on the local population. Glaxo representatives also showed up in other cities in Romania—Bucureşti, Cluj-Napoca, Craiova, and Timişoara—as well as multiple cities in Latvia, Ukraine, Slovakia, the Russian Federation, Poland, Hungary, Lithuania, Estonia, the Czech Republic, Bulgaria, Croatia, Greece, Belgium, the Netherlands, Germany, France, and the United Kingdom. That was for the largest of the Avandia clinical trials. But there have been scores of others, all seeking to prove that the drug is safe and effective. Some took place before the drug was approved by the F.D.A. Others were “post-marketing” studies, done after the fact, as the company cast about for ways to come up with more positive results so it could expand Avandia’s use for other treatments. Based on the initial evaluations, Avandia was expected to—and did—become another Glaxo multi-billion-dollar best-seller.

While sales soared, so, too, did reports of adverse reactions—everything from macular edema to liver injury, from bone fractures to congestive heart failure. In 2009 the Institute for Safe Medication Practices, a Pennsylvania-based nonprofit group that monitors the prescription-drug field, linked the deaths of 1,354 people to Avandia, based on reports filed with the F.D.A. Studies also concluded that people taking the drug had an increased risk of developing heart disease, one of the very conditions that doctors treating diabetics hope to forestall. The risk was so high that worried doctors inside and outside the F.D.A. sought to have the drug removed from the market, an incredibly difficult task no matter how problematic the medicine. As always, the F.D.A. was late to the party. In 2008 the American Diabetes Association and the European Association for the Study of Diabetes had warned against using Avandia. The Saudi Arabian drug-regulatory agency yanked it from the market, and the Indian government asked Glaxo to halt 19 of its Avandia trials in that country. In September 2010 the European Medicines Agency pulled Avandia from the shelves all across Europe. The F.D.A. still could not bring itself to take decisive action. This even though the F.D.A. knew that Glaxo had withheld critical safety information concerning the increased risk of heart attacks, and the F.D.A. itself had estimated that the drug had caused more than 83,000 heart attacks between 1999 and 2007. The agency settled for imposing new restrictions on the availability of the drug in the United States. Glaxo released a statement saying that it “continues to believe that Avandia is an important treatment for patients with type 2 diabetes,” but that it would “voluntarily cease promotion of Avandia in all the countries in which it operates.”

The Avandia case and others like it have prompted the U.S. Justice Department to mount an investigation under the Foreign Corrupt Practices Act. While it is legal for doctors in this country to accept money from drug companies for acting as consultants, this is not the case abroad, where doctors often are government employees, and such payments can be considered bribes. There are other legal issues. So far, Glaxo has paid out more than $1 billion to settle lawsuits arising from claims against Avandia and other drugs. The Senate Finance Committee calculates that, since May 2004, seven drug companies have paid out more than $7 billion in fines and penalties stemming from unlawful drug dealings. Pfizer paid the largest such fine in history—$2.3 billion for promoting off-label uses of the arthritis drug Bextra.

In theory, pharmaceutical companies are barred from selling a drug for any purpose other than the one that the F.D.A. has approved on the basis of clinical testing. But the reality is different. The minute a drug receives the green light from the F.D.A. for a specific treatment, the sponsoring company and its allies begin campaigns to make it available for other purposes or for other types of patients. The antidepressant Paxil was tested on adults but sold off-label to treat children. Seroquel, an anti-psychotic, was marketed as a treatment for depression. Physicians, often on retainer from pharmaceutical companies, are free to prescribe a drug for any reason if they entertain a belief that it will work. This practice turns the population at large into unwitting guinea pigs whose adverse reactions may go unreported or even unrecognized.

To secure the F.D.A.’s approval for Seroquel, which ultimately would go to treat schizophrenia, bipolar disorders, and manic episodes associated with bipolar disorder, AstraZeneca, the fifth-largest pharmaceutical company, conducted clinical trials across Asia, Europe, and the United States. Among the sites: Shenyang and more than a dozen other cities in China, and multiple cities in Bulgaria, Estonia, Hungary, Latvia, Lithuania, Croatia, Indonesia, Malaysia, Poland, the Russian Federation, Serbia, Ukraine, and Taiwan. The F.D.A. initially approved the drug for the treatment of schizophrenia. But while schizophrenia may have opened the door, off-label sales opened the cash register. Money poured in by the billions as AstraZeneca promoted the drug for the treatment of any number of other conditions. It was prescribed for children with autism-spectrum disorders and retardation as well as for elderly Alzheimer’s patients in nursing homes. The company touted the drug for treatment of aggression, anxiety, anger-management issues, attention-deficit hyperactivity disorder, dementia, and sleeplessness. Up to 70 percent of the prescriptions for Seroquel were written for a purpose other than the one for which it had been approved, and sales rose to more than $4 billion a year.

It turned out, however, that AstraZeneca had been less than candid about the drug’s side effects. One of the most troubling: patients often gained weight and developed diabetes. This meant a new round of drugs to treat conditions caused by Seroquel. In an internal e-mail from 1997 discussing a study comparing Seroquel with an older anti-psychotic drug, Haldol, a company executive praised the work of the project physician, saying she had done a great “smoke-and-mirrors job,” which “should minimize (and dare I venture to suggest) could put a positive spin (in terms of safety) on this cursed study.” After the e-mail was disclosed, in February 2009, the company said that the document cannot “obscure the fact that AstraZeneca acted responsibly and appropriately as it developed and marketed” the drug. In April, AstraZeneca reached a half-billion-dollar settlement with the federal government over its marketing of Seroquel. The U.S. attorney in Philadelphia, where the settlement was filed, declared that the company had “turned patients into guinea pigs in an unsupervised drug test.” Meanwhile, the company was facing more than 25,000 product-liability lawsuits filed by people who contended the drug had caused their diabetes.

Death Toll

The only people who seem to care about the surge of clinical trials in foreign countries are the medical ethicists—not historically a powerhouse when it comes to battling the drug companies. A team of physician-researchers from Duke University, writing last year in the New England Journal of Medicine, observed that “this phenomenon raises important questions about the economics and ethics of clinical research and the translation of trial results to clinical practice: Who benefits from the globalization of clinical trials? What is the potential for exploitation of research subjects? Are trial results accurate and valid, and can they be extrapolated to other settings?” The Duke team noted that, in some places, “financial compensation for research participation may exceed participants’ annual wages, and participation in a clinical trial may provide the only access to care” for those taking part in the trial. In 2007, residents of a homeless shelter in Grudziadz, Poland, received as little as $2 to take part in a flu-vaccine experiment. The subjects thought they were getting a regular flu shot. They were not. At least 20 of them died. The same distorting economic pressures exist for local hospitals or doctors, who may collect hundreds of dollars for every patient they enroll. In theory, a federal institutional review board is supposed to assess every clinical trial, with special concern for the welfare of the human subjects, but this work, too, has now been outsourced to private companies and is often useless. In 2009 the Government Accountability Office conducted a sting operation, winning approval for a clinical trial involving human subjects; the institutional review board failed to discover (if it even tried) that it was dealing with “a bogus company with falsified credentials” and a fake medical device. This was in Los Angeles. If that is oversight in the U.S., imagine what it’s like in Kazakhstan or Uganda. Susan Reverby, the Wellesley historian who uncovered the U.S. government’s syphilis experiments in Guatemala during the 1940s, was asked in a recent interview to cite any ongoing experimental practices that gave her pause. “Frankly,” she said, “I am mostly worried about the drug trials that get done elsewhere now, which we have little control over.”

The pharmaceutical industry, needless to say, has a different view. It argues that people participating in a clinical trial may be getting the highest quality of medical care they have ever received. That may be true in the short term. But, unfortunately, the care lasts only until the trial is completed. Many U.S. medical investigators who manage drug trials abroad say they prefer to work overseas, where regulations are lax and “conflict of interest” is a synonym for “business as usual.” Inside the United States, doctors who oversee trials are required to fill out forms showing any income they have received from drug companies so as to guard against financial biases in trials. This explains in part why the number of clinical-trial investigators registered with the F.D.A. fell 5.2 percent in the U.S. between 2004 and 2007 while increasing 16 percent in Eastern Europe, 12 percent in Asia, and 10 percent in Latin America. In a recent survey, 70 percent of the eligible U.S. and Western European clinical investigators interviewed said they were discouraged by the current regulatory environment, partly because they are compelled to disclose financial ties to the pharmaceutical industry. In trials conducted outside the United States, few people care.

In 2009, according to the Institute for Safe Medication Practices, 19,551 people died in the United States as a direct result of the prescription drugs they took. That’s just the reported number. It’s decidedly low, because it is estimated that only about 10 percent of such deaths are reported. Conservatively, then, the annual American death toll from prescription drugs considered “safe” can be put at around 200,000. That is three times the number of people who die every year from diabetes, four times the number who die from kidney disease. Overall, deaths from F.D.A.-approved prescription drugs dwarf the number of people who die from street drugs such as cocaine and heroin. They dwarf the number who die every year in automobile accidents. So far, these deaths have triggered no medical crusades, no tough new regulations. After a dozen or so deaths linked to runaway Toyotas, Japanese executives were summoned to appear before lawmakers in Washington and were subjected to an onslaught of humiliating publicity. When the pharmaceutical industry meets with lawmakers, it is mainly to provide campaign contributions.

And with more and more of its activities moving overseas, the industry’s behavior will become more impenetrable, and more dangerous, than ever.

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Hospitalizations from prescription drugs increase 98% in 5 years!

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Below is an article on prescription abuse and misuse in the U.S.  The numbers are startling.  If we want to begin to cut health care costs we need to reign in the pharmaceutical industry and their aggressive marketing.  See my comments at the end of the article.

NY Times Article

By ABBY GOODNOUGH
Published: January 5, 2011

The number of emergency room visits resulting from misuse or abuse of prescription drugs has nearly doubled over the last five years, according to new federal data, even as the number of visits because of illicit drugs like cocaine and heroin has barely changed.

The Substance Abuse and Mental Health Services Administration found there were about 1.2 million visits to emergency rooms involving pharmaceutical drugs in 2009, compared with 627,000 in 2004. The agency did not include visits due to adverse reactions to drugs taken as prescribed.

Emergency room visits resulting from prescription drugs have exceeded those related to illicit drugs for three consecutive years, said R. Gil Kerlikowske, President Obama’s top drug policy adviser.

“I would say that when you see a 98 percent increase,” Mr. Kerlikowske said, “and you think about the cost involved in lives and families, not to mention dollars, it’s pretty startling.”

In 2010, the Substance Abuse and Mental Health Services Administration reported that the number of people seeking treatment for addiction to painkillers jumped 400 percent from 1998 to 2008. And in a growing number of states, deaths from prescription drugs now exceed those from motor vehicle accidents, with opiate painkillers like Vicodin, Percocet and OxyContin playing a leading role.

In September, the Drug Enforcement Administration organized the first national prescription drug take-back program, and thousands of people dropped off old or unused drugs at designated locations around the country. While the effort captured but a tiny fraction of the addictive drugs in the nation’s medicine cabinets, law enforcement officials said it helped people understand how deadly such drugs can be. Another collection day is being planned for April, Mr. Kerlikowske said.

“The most important thing that actually seems to be gaining a lot of traction,” he said, “is the recognition that the prescription drugs sitting in your medicine cabinet can be dangerous. That’s huge.”

Dr. Court’s Comments

In a time when health care costs are through the roof and insurance premiums continue to rise this story explains a lot.

Since 2004 the number of emergency room visits has almost doubled because of complications from pharmaceutical agents that were misused or abused.  This does not take into account the number of people who are hospitalized because of adverse reactions or complications from taking their medications as prescribed.

There is a major war going on against illicit drugs like cocaine and heroin and rightfully so.  But according to this research hospitalizations for prescription drugs exceed those of the illegal drugs.  Why are we not fighting back against this problem?

In my opinion, the aggressive marketing of pharmaceutical drugs is partly to blame.  Just watch the nightly news.  You will see ad after ad for drugs. This leads people to believe that these drugs are basically harmless because of the happy and joyous people you see living their wonderful lives on these drugs.  It desensitizes people to their dangerous side effects.

Don’t believe me?  How much attention do you think the average American pays to the list of side effects that each company is required to state in their commercials?  The level of attention is directly related to how many times to you hear something.  The more you hear it, the less you pay attention to it.  And you hear it all the time!  You can’t get away from it on television.

Prescription drugs have their place, but that place should be as a last resort.  If all other methods have failed, perhaps  a drug will work. Tell me if this sounds familiar:

“If diet and exercise alone are not enough to control your cholesterol, adding Lipitor may help.”

You know what the problem with that statement is?  Diet and exercise are never given a chance.  The first thing that happens when someone is diagnosed with high cholesterol is a prescription is written.  No advice about diet or exercise is given.  Over prescribing has become a habit in the medical community and because of this, we pay the price.

If we want to reduce the number of hospitalizations from prescription drugs we need to reduce the number of prescriptions that are written in this country by using safe and effective alternatives and we need to stop the aggressive marketing of pharmaceutical agents to the general public.

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