Tag Archives: United States

Cancer Fighting Compounds!

Cancer is a leading cause of mortality here in the United States. As our population continues to get unhealthier because of sedentary lifestyles and poor eating habits, the numbers will continue to grow.

Many cancers are preventable, and there are compounds you can get from your diet that will reduce your risk.

See the video below!

Leave a comment

Filed under Public Health

Do Supplements Kill?

Nutritional supplements

Supplement Aisle

A study recently published in the Archives of Internal Medicine has concluded that taking multi vitamins and several other supplements was actually associated with an increased risk of mortality (or death).  We’ve seen these studies before and I have several thoughts on them.

First, I do not believe supplements will increase your risk of death.  Supplements are exceptionally safe.  They are so safe, in fact, that they are all sold over-the-counter.  However, supplements are also very effective in helping people with a wide variety of conditions.  With that power can come potential for unwanted side effects.  We must understand that if something has the power to do good it also has the power to do bad.  Let’s break down the study and see how the authors came to the conclusion that they did.

They assessed the use of vitamin and mineral supplements in relation to total mortality in 38,772 older women in the Iowa Women’s Health Study; mean age was 61.6 years at baseline in 1986.  Supplement use was self-reported in 1986, 1997, and 2004.  Their conclusion to the study was as follows:

“In older women, several commonly used dietary vitamin and mineral supplements may be associated with increased total mortality risk; this association is strongest with supplemental iron. In contrast to the findings of many studies, calcium is associated with decreased risk.”

I have several problems with this study. The first is that use of supplements was self-reported.  And the time frame with which they reported was years apart. This is a problem because you are asking people to remember what they are taking.  I do this every day in my practice and many of my patients can’t remember what they’re taking day-to-day and I see them on a monthly basis.

The study also only shows an association, not cause and effect.  This is dangerous because studies like this get huge headlines and inevitably the headlines shout about how dangerous supplements are when, in fact, they are very safe.

To show you just how flimsy an association link in a study may be here is a good example. Say you wanted to study breast cancer and you wanted to look at what is associated with an increased risk of breast cancer. You might conclude that wearing make-up is associated with a much higher rate of breast cancer than not wearing make-up.  You came to this conclusion because you noticed that people who wear make-up get breast cancer at much higher rates that people who do not.  This sounds legitimate of the surface.  Perhaps there is something in the make-up that is carcinogenic.  Or perhaps people who wear make-up are much more likely to get breast cancer than people who do not for another reason. We know that breast cancer is far more common in women and they also happen to wear the most make-up.  An association can easily be shown between people who wear make-up and breast cancer, but it likely not for the right reasons.

Another shortcoming of the study is that the researchers did not know whether the women were taking the supplements for a specific health condition.  People often begin taking supplements because they do not feel well.  They may be experiencing sleep problems, low energy,  head aches or worse.  These symptoms may be signs of deeper problems. We cannot be sure these women did not die from the very condition they were trying to treat and not the supplements.

Thirdly, the increase in mortality was exceptionally small and likely is not clinically significant. What that means is that the results were so minuscule they have almost no observable effect.  It was also noted that the women who used the supplements were almost twice a likely to use hormone replacement therapy (HRT) while going through menopause.  HRT is known to increase the rates of many cancers.

The researchers did take hormone therapy into account in their analysis, along with several other potentially mitigating factors (including age, educational attainment, body mass index, diet, and physical activity).  What I don’t see on this list is prescription drug use.  This must be known for this study to hold any water! Drugs are obtained via prescription for one reason and one reason only – they are dangerous!  They are a leading cause of death in the United States!  If they did not consider drug use then how can they possibly conclude it was the supplements that increased mortality rates?  They can’t!

While I don’t agree with the conclusion of the study, I agree that men and women should seek the advice of someone trained in nutrition and skilled at building a personalized program for each individual.  I never recommend going to the health food store and picking up one of everything and beginning to take them.  As a matter of fact, I rarely recommend multi vitamins.  Not everyone needs more of everything.  Targeted nutrition should be your goal.

Remember, supplements are extremely safe and just because one study concludes that there is an association between supplements and mortality does not mean you should stop taking them, especially if they’ve benefited you.

2 Comments

Filed under Diet, Public Health

The New “Food Guide Pyramid”

Well, it’s not really a pyramid anymore.  It’s a plate.  And it’s still wrong.  But before I get into that let me focus on the

New design, same old (incorrect) message.

positives about it.

First, the design.  I like it.  It’s simple and much easier to understand than the old pyramid.  It’s also eye-catching.  It looks very modern and should attract more attention.

Secondly, fruits and veggies make up half of the new plate meaning that, essentially, half of your diet should be made up of fruits and vegetables.  I could not agree more.  When I make a meal I always include fruits and vegetables and I strive to have half of my plate at each meal filled with brightly colored fruits and/or vegetables.

That’s it.  That’s all I like about this new “MyPlate” setup from the USDA.

Here is what I don’t like.

First and foremost there is no area for healthy fats on this plate.  None!  That is a major disservice to the American public.  Every single cell in the entire body has fat in it.  Fat is necessary and essential to life.  If we don’t consume fat, we die. Period!

Additionally we know that omega-3 fats from nuts, seeds and fish are exceptionally important for maintaining cardiovascular health.  These are only briefly mentioned when you click on the protein section of the new plate.  There is also an “oils” section on the main website (www.choosemyplate.gov) that explains a little about oils and their properties.

My point is that the new “MyPlate” design is intended to be something that people can look at quickly and get a gross idea of how they should be eating.  When people glance and this plate they will infer that they shouldn’t eat any fat and that’s a major problem.  People should consume fat and they need to consume fat.

My second major problem is that grains are still too dominant in this design.  Yes, they stress whole grains, but they say that you only need to make half  (HALF!) of your grains from whole sources.  I would never encourage my patients to eat any refined grain on a regular basis, let alone half of their grains on a daily basis!

In my opinion, grains should be a very small of the diet, even if they are whole grains.  They don’t need to be eliminated from the diet, but they should never make up a full quarter of what you eat.  A diet high in grain leads to many problems such as inflammation and heart disease.  Human beings should consume a paleolithic type diet.

Unfortunately, despite the new design, this is still the same old information regurgitated based on science that is decades old.  The USDA needs to get with the times and reduce the grain recommendations and increase the healthy fat recommendations.  Until they do that I fear Americans will continue to lead the world in obesity.

2 Comments

Filed under Diet

Common Pain Killers Increase Stroke Risk

Medicine Drug Pills on Plate

The news on non-steroidal anti-inflammatory drugs just keeps getting worse and worse.  Just a month ago I posted about how this class of drugs was associated with an increased risk of heart problems.  Now a Danish study has found that these drugs are associated with an increased risk of stroke.

This class of drugs known as NSAIDs are used mainly as pain killers.  They are also used to effectively reduce fevers.  They are available over the counter and are used by millions upon millions of Americans every day.  This new

study finds that even short-term use of these drugs leads to an increased risk of having a stroke in the future.  What’s even scarier is that they studied a healthy population.

In many instances these types of studies are done on people with already existing conditions that make it difficult to assess whether the increased risk is associated with a person’s previously existing condition or the medication.  Not this time.

Over 500,000 healthy Danish people were included in this study.  The authors used a prescription registry to track which of these people were prescribed an NSAID.  About 45% of them took an NSAID from 1997-2005.  They then used stroke data from further hospitalization and death registries and estimated the risk of fatal and nonfatal stroke associated with the use of NSAIDs.

Results showed that NSAID use was associated with an increased risk of stroke. This increased risk ranged from about 30% with ibuprofen (Advil) and naproxen (Aleve) to 86% with diclofenac (Voltaren). The data were controlled for age, gender, and socioeconomic status.

They noted that there was a dose dependent relationship as well.  With doses over 200mg of ibuprofen the risk increased by a staggering 90%!  This is quite problematic as the base dose for over the counter ibuprofen is 200mg.  Millions of Americans take much more than that on a daily basis.

The authors of the study were not terribly surprised by the data considering the recent studies that have surfaced regarding the negative effects these medications seem to have on the cardiovascular system.  They did say it is hard to make absolute conclusions because no randomized controlled studies exist to date.  In light of this most recent evidence I doubt you will ever get an institutional review board to approve such a study because the risk seems to be too high.

The author also stated that in Denmark the availability of NSAIDs over the counter is relatively low compared to the United States. He stressed the need for closer monitoring of these drugs.

He also said, “If half the population takes these drugs, even on an occasional basis, then this could be responsible for a 50% to 100% increase in stroke risk. It is an enormous effect.”

In my opinion, we need to regulate these drugs as closely as possible.  If one were to watch the evening news you would see these drugs being advertised as health food practically.  It is studies like these that make it abundantly clear  they are not without risk.

Options abound for people who take these on a regular basis for mild to moderate pain.  Exercise and diet are a great start.  Reducing the use of NSAIDs would likely have a very positive effect on the cost of health care in the U.S. We need all the help we can get in that department.

1 Comment

Filed under Big Pharma, Public Health

How Your Diet Affects Your Mood

Depression and Bipolar

Food is fuel.  The fuel we put into our body determines how efficiently it runs.  It’s a pretty simple concept yet when it comes to brain function there is a disconnect for many physicians.

When people come to me for help with various conditions, dietary changes are almost always part of the program.  They are especially important if someone if suffering from a mood disorder.

If a poor diet can lead to poor function of the heart, gall bladder, immune system, pancreas, intestines, etc., then why couldn’t it lead to poor brain function? It can, but it’s always overlooked by traditional medicine.  Let me explain.

The Basics

Remember, food is fuel.  The neurons in your brain consume up to 40% of your circulating blood sugar at a resting state.  That figure can jump up to 80% when your brain is working hard like studying for a test or doing your taxes. Your blood sugar is the fuel your brain needs to keep going.

Low blood sugar occurs when people do not eat frequently enough or in an amount that satisfies the demands for energy of the entire body, including the brain.  Low blood sugar, or hypoglycemia, causes mood to change.  Most notably, people experience irritability. This irritability is relieved by simply eating food and allowing your blood sugar to rise back to a normal level.  Next time you’re feeling irritable and you haven’t eaten in a few hours, try eating a healthy snack.  It might just be the fix you’re looking for.

If something as simple as low blood sugar can alter your mood, what else can?

Alcohol

Alcohol is consumed the world over mainly for one reason and one reason only – it has mind altering properties. Let’s face it; alcohol does not taste good in the way that ice cream does.  People are not consuming it solely for the taste. The per capita consumption of ethanol in the United States is 2.31 gallons per year.  That means, on average, every American over the age of 15 consumes 2.31 gallons of pure alcohol per year.  This is equivalent to 702 beers, 410 glasses of wine or 197 shots per year, per person.

Alcohol works on the brain by affecting the neurotransmitter GABA.  GABA is an inhibitory neurotransmitter in the brain.  Initially, consuming alcohol elevates mood and reduces anxiety and stress.  As a matter of fact, most current pharmaceuticals aimed at reducing anxiety work by acting on GABA.

However, continuing to consume alcohol has a downside.  When consumed to excess, moods begin to go down and depression is often the consequence.  It also causes sleepiness which illustrates alcohol’s powerful depressive effects.  Always remember, alcohol is a depressant and it’s this way because it acts on the inhibitory neurotransmitter in the brain called GABA.

How Foods Affect Our Neurotransmitter Levels

A few weeks ago I wrote a post about neurotransmission and how getting your neurotransmitters measured is a good way to assess your mood status and possibly change it for the better.  I went into the details of some neurotransmitters and it would be good to read before continuing to read this post.  Click here to view it.

The neurotransmitters in our brain allow one nerve to talk to the next.  It is the level of these neurotransmitters, to a large extent, that govern how we feel.  Low levels of some neurotransmitters lead to anxiety while others may lead to depression.  The interplay between all of them is complex and a problem with mood is often due to more than low levels of a single neurotransmitter but there are primary players to blame in each mood disorder.

Carbohydrate Heaven

Many people have noticed that when they eat a meal that is high in refined carbohydrates they notice an elevation in mood.  So much so that people can often become addicted to this type of food just to feel good.  This is for one very real physiological fact – eating refined carbohydrates increases serotonin production in the brain.

Serotonin is the neurotransmitter that most of the anti-depressant drugs like Prozac and Paxil work on.  They work by tricking the brain into thinking it has more serotonin than it actually does.  Consuming refined carbohydrates works by actually increasing serotonin levels.  Here’s how.

There is a barrier between our brain and our blood.  It prevents things from getting into the brain that should not.  It is very effective.  However, it also prevents necessary nutrients from getting in as well.  They need a special pass to  get in.  This includes the amino acid tryptophan. Tryptophan is what the body uses to make serotonin.  If one consumes a diet very low in tryptophan, serotonin levels are likely to be low.  Tryptophan is found in foods that contain protein.

In order for tryptophan (an other amino acids) to get into the brain a transporter system exists.  It is called the large neutral amino acid transporter or the LNAA.  Competition for the LNAA is fierce.  Tryptophan is a weak competitor.  It is often left out of brain except when refined carbohydrates are consumed. When refined carbohydrates are consumed high amounts of insulin are secreted.  Insulin sends free amino acids out of our blood into our muscles when it is circulating.  Because tryptophan is a bound to albumin it is left unaffected by this process.  It is now free to circulate up to the brain where competition for the LNAA is now low and it gets into the brain more easily.  It also allows more serotonin to be produced.

Now, I hear what you’re saying.  I am not suggesting you go eat tons of refined carbohydrates to feel good!  As a matter of fact you should avoid them because they just lead to a blood sugar crash later in the day resulting in irritability.  Now you’re irritable and depressed – not a good combination!

What you should do is make sure you eat foods that are high quality proteins.  This includes mostly animal products like meat and eggs.  Also, supplementing your diet with 5-HTP is helpful.  This is the direct precursor of serotonin and is in fact a type of tryptophan. It passes into the brain freely and does not compete for the LNAA.

Not Enough B6

Vitamin B6 is an essential vitamin in many ways.  In terms of brain health, it is essential to allow the conversion of the neurotransmitter glutamate into GABA.

Glutamate is the primary excitatory neurotransmitter in the brain.  When levels are too high seizures are known to occur.  At lower levels anxiety occurs.

GABA is the primary inhibitory neurotransmitter.  At very low levels seizures occur and when levels are slightly decreased anxiety is the result.

Glutamate ——–> GABA – GABA is converted from glutamate and B6 is required to do this.

A diet that is low in B6 will cause glutamate to build up in the brain and GABA levels will be low.  This may result in anxiety.  Foods that are highest in B6 are:

  • Spinach
  • Bell peppers
  • Turnip greens

Consuming these on a regular basis may help if your problem is the conversion of glutamate to GABA.  You may also have to supplement with B6.  This is easy to find over the counter.

No Fish? No Happy

Omega-3 fatty acids have been touted to help everything from heart disease to pain and inflammation.  Research also points to another aspect.  Brain health.  People who have the lowest level of a particular omega-3 called DHA report depression as a problem significantly more than people with the highest levels of DHA.

DHA is important for growing babies, but research is starting to show that it is important for overall brain health for adults as well.

Just how it wards off depression is not clear.  One theory suggests that because DHA is important for the insulation surrounding the nerves, low levels may prevent neurons from communicating effectively.  Whatever the reason, the research is pretty clear that low levels are not good for optimal brain function.

Consuming fish regularly is a good step.  However, more people will not be able to consume enough fish to get enough DHA.  Consider supplementing with a fish oil that is high in DHA.  Most nutrition companies now make fish oil that is high in DHA.  This may help ease your depression and prevent further episodes.

This list could go on and on.  The moral of the story is that what you eat can have a significant impact on how you feel.  If you want to feel good, inside and out, you must eat a healthy diet.  Hopefully some of these tips have helped.

1 Comment

Filed under Brain Health

See Where America Stacks Up In Life Expectancy

graph of female vs. male life expectancy at bi...

Image via Wikipedia

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

Leave a comment

Filed under Public Health

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

Fresh vegetables are important components of a...

Image via Wikipedia

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.

Leave a comment

Filed under Environmental Health, Public Health

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

:Original raster version: :Image:Food and Drug...

Image via Wikipedia

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.

1 Comment

Filed under Big Pharma

Hospitalizations from prescription drugs increase 98% in 5 years!

Various pills

Image via Wikipedia

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.

1 Comment

Filed under Big Pharma, Public Health

Anxiety or Depression? Test the levels of your neurotransmitters to guide therapy.

Depression

Image via Wikipedia

Happy New Year!  A new era began at the Vreeland Clinic on January 1st this year.  Dr. Carrie and I would like to thank all of our friends and family for their well wishes.  We looked forward to continuing to serve the community for years to come!

Today I’d like to touch on something that has revolutionized the way I practice.

People come to me for many reasons.  Some people come to my clinic for weight loss or to get more energy.  Others for help with a chronic condition that hasn’t responded to traditional care.  Still others come to see me for a wide range of neurologic conditions.  These include things like Parkinson’s disease, multiple sclerosis, depression or anxiety.  It is the last two that I’d like to focus on today.

Anxiety and depression are extremely common in America.  Millions of Americans suffer from anxiety, depression or both.  These conditions may have many etiologies but one theory is a chemical imbalance in the brain.

Just what is this chemical imbalance?  When someone states that they have a chemical imbalance they are referring to an imbalance in the neurotransmitter system of the brain.  These neurotransmitters are really just proteins that each nerve in the brain uses to communicate with its neighbors.  Sometimes people can have too little of a certain neurotransmitter or too much of another.  This is problematic because it alters the way the brain functions.  It may cause anxiety and/or depression.

The pharmaceutical industry has figured that out and makes a large class of drugs that alters neurotransmitter function in the brain.  These are drugs like Prozac, Zoloft, Wellbutrin and Lorazepam to name a few.

Neurotransmitters are broken down into two categories – they are either excitatory or inhibitory.  That means they either tell the brain to go or tell the brain to stop.  The complexities of the neurotransmitter system are extensive and there is much more to it than “go” and “stop” but that basic principle holds true in most cases.

Examples of neurotransmitters include serotonin, GABA, epinephrine, norepinephrine, glutamate and dopamine.  Serotonin and GABA are inhibitory while epinephrine, norepinephrine, glutamate and dopamine are excitatory.

If you have anxiety and depression often times an imbalance exists in the levels of these neurotransmitters.

For example, high levels of glutamate may cause anxiety or seizures.  Low levels of GABA may cause anxiety.  Low levels of serotonin may cause depression.  Same goes for norepinephrine.

So how do you tell which neurotransmitters are low or which are too high?

Measuring Neurotransmitters

Measuring your neurotransmitters with a urine test is the best way to estimate your levels of neurotransmitters.  We do this routinely in our office for many patients.  It is incredibly insightful and directs our care for patients with anxiety, depression and many other conditions.

The measurement of neurotransmitters in the urine has been around for many years.  I’ve read studies dating to the 1960’s of scientists using similar methods to evaluate neurotransmitter levels.

Until relatively recently, perhaps the last 10-15 years, it has not been used frequently in clinical practice.  Now, through specialized laboratories, it is available to the general public and it is very affordable.

The knock on urinary neurotransmitter testing is that it does not correlate with brain levels of these hormones because the urine test is in fact testing whole body levels of neurotransmitters.

The very neurotransmitters that exist in our brain to make us happy exist outside the brain to serve the body in other ways.  So, yes, it is true that checking urinary neurotransmitter levels is technically a check of the entire body’s store of neurotransmitters.  But, through hundreds of thousands of tests these specialized labs have shown with high correlation that when neurotransmitter levels are abnormal certain psychiatric and neurological conditions are much more common.

Clinically, I have seen an almost one to one correlation in my patients with certain conditions an alteration in their neurotransmitter system.

The lab that I use will test all of the basic neurotransmitters plus a slew of metabolites of these neurotransmitters.  It provides a wonderful window into the neurological system.

If I find that serotonin is low, I supplement with something called 5-HTP.  If dopamine is low, I like to use L-tyrosine or an herb called mucuna pruriens.  The list can go on and on.

Once someone has been on a program for 6-8 weeks we recheck their neurotransmitter profile to gauge our therapy and adjust it if necessary.  We find that once a person’s profile returns to normal, their symptoms resolve.

If you have anxiety or depression, consider seeking out someone who does this kind of testing to improve your outcomes.  The brain is incredibly complex.  It never hurts to have a little extra information to guide your therapy.

10 Comments

Filed under Brain Health