The American Dilemma and How We Can Fix It

Posts tagged ‘Food and Drug Administration’

MYSTERY THEATER

I don’t remember whether this was a short story or something that aired on television and I certainly don’t remember the name or author.  But it was an intriguing tale that I thought would be worth sharing.

Set in Victorian England, a beautiful young woman marries an elderly member of the peerage who is in rather poor health.  She is delighted with her ascent into the nobility but less enthralled with the old duffer who served as her entrée.  But she doesn’t expect him to last long so she perseveres as his wife.

Sadly, the variety of maladies from which her husband suffered appear to be remediating and she decides to take matters about sending her husband into the next world into her own hands.

She begins to add the most minute quantities of poison to his meals – insufficient to kill him instantaneously which might draw suspicion on herself, but enough to make him start to experience physical malaise.  She continues this poisoning for months and finally the cumulative effect of the toxins begin to take their toll on the old man.  His vital organs start to fail and he succumbs to death.

Of course, today we would be able to prove the cause of this man’s death was due to poisoning but the physicians of that time would have concluded that his demise was due to natural causes.

By the way, the widow came under no suspicion and polite society grieved with her at the loss she had experienced.  It turns out this was the perfect crime.

Poisoning has been the preferred method of murder for women for centuries.  Lucrezia Borgia was quite proficient in the practice as were many other of our female ancestors.  Of course, men have also used this method to dispatch adversaries as was the fate handed down to Socrates.

Most of us would agree that murder in any form is heinous and those of us who are responsible members of society, other than perhaps saying in anger, “I’m so mad I could kill him,” have never seriously contemplated that as a way to resolve our differences with our fellow men.

But what if there were someone loose in our midst whose time framework for murder were not months, as in our story, but rather decades?  How would we ever see his handiwork after so great a time period – even with today’s modern methods of detection?  I suggest that we should consider just such a perpetrator – the government agency which oversees those foods it deems safe for us to eat – the FDA.

Perhaps the term murder is inappropriate.  Any crime has to contain several elements which include motive, means and opportunity.  I can think of no rational reason that the FDA would be motivated to cause the death of millions of Americans – other than the far-fetched one that by ensuring we consume a poor diet, we are more likely to then rely on pharmaceutical prescription drugs which it also oversees – thus adding to the term of the job expectancy of its employees.  But I am loath to make that suggestion.

But the FDA in its role as overseer of the foods we allow on the shelves of our supermarkets, does have both means and opportunity to carry out this plot – intentionally or unwittingly.  I would like to take one product with which many of us are familiar to illustrate my point.  That product is manufactured by General Mills and is called Hamburger Helper.

According to the General Mills’ website, Hamburger Helper is available in 40 delicious flavors.  Further, the company offers the following information about itself:

“Our Mission is Nourishing Lives.  Making lives healthier, easier and richer every day.”

“Our Values.  Everything we do reflects our strong core values and we live these values every day.”

Let’s look at what goes into this product and see how that is reflective of General Mills’ Mission Statement and their Value Statement:

Enriched macaroni made from bleached Durum wheat is the first ingredient.  What is that?  I mean enriched certainly makes it sound nutritious.  Well this is what it means.  Perfectly wholesome wheat is first stripped of its nutritive value (bleached) in order to extend its shelf life and then other nutrients (chemicals) are returned to it (enriched) in the manufacturing process.

A little further down the list of ingredients (after a variety of chemical additives which I would probably misspell and have thus omitted) we come to Partially Hydrogenated Soybean Oil.  This means that Soybean Oil has had hydrogen added to it (again for the purpose of extending shelf life).  Unfortunately this particular form of oil is one of those nasty things that tends to clog our arteries, thus causing all sorts of cardiovascular problems as we consume them over time.

And, of course, no good processed food would be worthy of the name if it didn’t contain sugar in some form.  In this case, the form which sugar takes is corn syrup.

Unlike our first two ingredients which are designed to allow the product to stay “fresh” on the shelf through the next Ice Age, sugar is added to a great number of our processed foods for one simple reason.  We are addicted to it and our food manufacturers realize giving the customer what she wants is a good way to keep her coming back for more.  With nearly $14 Billion in annual sales, apparently General Mills has found a winning formula.

It would be unfair to single out General Mills and say they are manufacturing junk food under the guise of its being “nutritious” and foisting this off on an uneducated public.  They are not alone.  They and their competitors who manufacture similar products all fall under the supervision of the FDA.

We have seen how government has difficulty dealing even with short term issues – let alone ones whose ramifications are long term.  In this regard, the FDA is probably no more or less guilty than others in the bureaucracy or than those whom we elect to public office.  When something will not manifest its bad effects for years or decades it is not only easy but convenient to sweep it under the rug and leave it to someone else to deal with at a later time.

We are all dealing with the effects of that sort of thinking in the massive overload we have placed on our healthcare system, much of which could have been avoided had we spent our lives consuming nutritious foods instead of junk and rearing another generation who is learning to consume the same unhealthful items.

Once upon a time, people who believed that “You are what you eat,” were considered off-base and a little kooky, not only by the general populace but by the medical establishment as well.  Today that thinking has changed and we understand more fully the relationship between good food and good health.  But we still fill our grocery carts with products that do anything but meet the definition of “good” other than, perhaps, as far as taste is concerned.

The Federal government still allows these items into the food chain – even at a time when it is grappling to find ways to cut “fraud” from Medicaid and Medicare.  What greater fraud is there than that a tremendous number of products available for consumption are at the heart of our medical conditions and are approved by the FDA for sale?

If you go to the FDA’s web page the by-line reads, “Protecting and Promoting Your Health.”  That is a noble cause and one we should all applaud.  But it plays better as theater than fact.  How they can make that statement in light of the ever increasing evidence that we are eating our way into illness is a mystery to me.

IT’S NOT NICE TO FOOL MOTHER NATURE (PART TWO)

Before the advent of antibiotics if a person developed an infection they either depended on their body to overcome it or they succumbed to it and died.  That we have greatly reduced the number of these deaths through dispensing pharmaceuticals is undeniable.  That’s the good news.

The bad news is that by allowing pharmaceuticals to do the work that in many cases our own bodies could and should do – by taking a prescription at every drop of a hat – we are lessening our own bodies’ abilities to fight off these infections.  And in many cases, the bugs we are fighting with drugs are becoming resistant to them.

As useful as antibiotics are I was surprised to learn that only 20% of them are taken by humans – most of the rest going to animal livestock and the vast majority of those are being fed to our chicken population.  What are the effects of this practice which is overseen by the FDA?  Well, for about 8 million at-risk women, the news is not good.

The problem is E.coli which has now evolved as a “superbug” –  and a chicken is apparently the perfect place for it to grow.  Because of the nature of factory farming, even healthy chickens are fed a diet of antibiotics to enable them to survive the unhealthy, overcrowded, (and may I add), inhumane conditions in which they briefly live and die.  Many of these chickens receive antibiotics from the time they are in the egg until the time they appear in your local supermarket meat counter.  And we are the unwitting “beneficiaries” of this drug therapy – designed not only to overcome disease but to make these animals grow faster and larger.

The specific risk that researchers at McGill University and others have noted is that for at-risk women who consume these chickens there is a significant increase in the number and severity of bladder infections which simply won’t go away.

Naturally, the poultry industry denies any evidence correlating the transfer of E.coli from chickens directly to humans and alleges that the reason this superbug is so drug resistant is because of our own willing overuse of antibiotics.  That is a point well-taken.

But is there a rational person who does not believe that if we feed our bodies with sub-standard food, we will get sub-standard and perhaps unexpected outcomes?  As the phrase goes, “Garbage in – Garbage out.”

The reason that we avoid eating foods that contain fast acting toxins is because we realize what will happen if we consume them.  The difference between consuming a poisonous mushroom and eating a lifetime’s worth of “over-medicated” meat is that we can see the effect the mushroom has on us almost immediately.  The evidence takes time to manifest itself when the toxins appear in only small quantities.  But they will appear over time.

In 1907 in Minamata, Japan the villagers convinced the Chisso Corporation to build a plant in their fishing village.  Chisso manufactured drugs, plastics and perfumes which contained a chemical compound which was known as acetaldehyde.  Mercury was a key ingredient in the manufacturing process which began in 1932.  The waste from the production lines was dumped into Minamata Bay.

By the mid-1950’s people started developing symptoms of what has become known as “Minamata Disease.”  People with this disease exhibited a range of different symptoms which  included a degeneration of their central nervous systems.  Some had slurred speech and blurred vision.  Others experienced numbness in their limbs or in their lips.  Others exhibited behaviors which were similar to those that people with Tourette Syndrome display including involuntary body movements and suddenly shouting out words in an uncontrolled manner.

The disease not only affected people but animals as well.  There were numerous reports of cats committing suicide by running into the Bay drowning themselves and birds began dropping from the sky.

One of Chisso’s employees, Dr. Hajime Hosokawa said that an “unknown disease of the central nervous system had broken out.”   He speculated that the disease was linked to the consumption of fish that the people in Minamata ate – fish that were feeding in the waters into which Chisso poured their waste materials.

The company denied any wrongdoing but a few years later transferred their dumping operations from the bay into the Minamata River.  Several months after they began doing this, the people who lived downstream also started exhibiting the same symptoms.  It was clear that Chisso was to blame for this and Dr. Hosokawa proved the effects of consuming acetaldehyde to the corporate officers of Chisso.  They buried his research and the evidence and continued to proclaim their innocence.

By 1974 the board of physicians of Kumamoto Prefecture had certified 798 victims of the disease with another 3,000 waiting to have their cases evaluated.  The pollution of Minamata Bay and Minamata River went on for 36 years and would have continued but that the production method which produced the toxins became obsolete.

Even though many suspected that the fish that they were eating was the cause of their disease, consider the plight of people who had only two choices.  The first was to continue to eat tainted food.  The second was to starve to death.  Fish and rice were the villagers’ only staple food supplies.

We in the United States are more fortunate.  Our supermarket shelves are overflowing with food.  And we have the FDA to protect us from companies which don’t adhere to their standards.  That should make us all feel secure – until we read about superbugs and E.coli.

As powerful as mankind thinks he is, Mother Nature has not exited the stage.  She offers us the richness of an incredibly bountiful earth.  But she also brings us tempests of wind, fire and flood.

She has loaded the revolver and handed us the pistol.  Now it is up to us to see if we pull the trigger.

“IT’S NOT NICE TO FOOL MOTHER NATURE” (PART ONE)

If you’re old enough you may remember the Chiffon Margarine commercials featuring a rather annoyed Mother Nature who was irritated that this new man-made product tasted so similar to the butter which the world had been consuming for years.  As with all other foods and drugs which are sold in America, the FDA has the responsibility of evaluating and passing on the safety of these products.

The Food and Drug Administration has its origins in the year 1862 when the Department of Agriculture was entrusted with the responsibility for conducting chemical analyses of various agricultural products.

The actual agency was officially established in 1930 as an outgrowth of the Pure Foods and Drug Act which Congress passed in 1906.  The FDA has an extremely long history of trying to make sure that the foods and drugs which enter our supply chain are safe and beneficial.  So how are they doing?

I don’t remember if the catch phrase, “Bald is beautiful,” started when the late Telly Savalas played Kojak on television but at one point you heard that statement (notably expressed by bald and balding men) whenever someone discussed hair and hair loss.  In light of recent developments regarding drugs that are intended to reverse this process, perhaps we should change the phrase to, “Bald is safer.”

The following is excerpted from a Yahoo News story:

Kevin Malley was almost 30, and he was starting to lose his hair.  He went to his doctor to see if there was a way to keep from going bald, and his doctor prescribed Propecia.

“I looked young for my age, so I wanted to hold off my hair loss for a little bit,” Malley said.  “I didn’t plan on taking Propecia for more than a year.”

Malley started taking the drug in May 2011, and by October he was completely impotent and had no sex drive whatsoever.  His body changed, even his genitals shrank, and he slipped into a mental fog that he just couldn’t clear.  His doctor told him the side effects would go away if he stopped taking the drug, so he did.  But nothing changed.

“I kept expecting the side effects to go away, but they did not, they only got worse,” he said.

Malley is not alone.  A new study published today in the Journal of Sexual Medicine suggests that for some men, the sexual side effects of Propecia may last for months to years, even after they stop taking the drug.

Researchers from George Washington University interviewed 54 men under age 40 who reported side effects for three months or more after taking Propecia, also called finasteride, to treat their hair loss.  None of the men reported have any sexual, medical or psychiatric problems before they took the drug.  Some of the men took the drug for a few weeks, others took it for years, but all of them reported side effects such as erectile dysfunction, decreased sexual drive, problems with orgasms, shrinking and painful genitals, even some neurological problems, such as depression, anxiety and mental fogginess.

Propecia was approved by the U.S. Food and Drug Administration in 1997, and at that time Merck noted that a few men reported sexual side effects during clinical trials of the drug.  On its website, the agency said those side effects were resolved when patients stopped taking the drug.

But the agency received more than 400 reports over 13 years from consumers reporting sexual dysfunction, and nearly 60 men reported that those side effects lasted longer than three months after the men stopped the medication.

In a statement, Merck said no evidence has proved a causal relationship between Propecia and long-lasting sexual dysfunction.

But researchers say many physicians who prescribe finasteride are likely not aware that the side effects of the drug may haunt patients for years.

“These things just get handed out left and right for any urinary symptoms,” said Dr. Ryan Terlecki, an assistant professor of urology at Wake Forest School of Medicine, who has prescribed the drug for some of his patients with enlarged prostates.

Terlecki said the findings about long-term side effects from the drug are alarming, but more research will likely be needed before doctors can know for sure that the symptoms are completely attributed to the drug.

Steven Rossello, 29, said his doctor made no mention of the potential for any sort of side effects from finasteride when he prescribed it to treat Rossello’s hair loss in 2010.

“That’s what really makes me mad.  He never mentioned any side effects, not to mention that they last forever,” Rossello said.

But after four months of taking Propecia, Rossello said he began suffering anxiety and crippling depression, along with the drug’s sexual side effects, and decided to stop taking the drug.

But his symptoms only got worse.  He was demoted from his job as an investigator for the Department of Homeland Security in Texas after his symptoms were evaluated by a psychiatrist, who pronounced him unfit for duty.  Rossello said the psychiatrist was unfamiliar with the neurological side effects of Propecia.

Abdulmaged Traish, a professor of biochemistry and urology at Boston University School of Medicine, said scientists are just beginning to investigate finasteride’s effects on the brain and nervous system.

“We are just beginning to venture in that direction.  It might be in the next five to 10 years that we may find there’s more to this story than we know now,” Traish said.

Apparently the FDA has determined that only about three percent of patients who take finasteride experience the symptoms described in this story.  Perhaps their conclusion is that is an “acceptable casualty rate,” when we consider the drug’s benefits for the remainder of the population.

But this story is hardly unique.  There are countless drugs which have been approved by the agency and which have now been recalled as being unsafe – and a concurrent number of class action law suits which have been filed because the general public was prescribed these medications.

Let’s think about the process of how a drug gets approved as a clue to why this might happen.  The research for developing the drug and the various stages of testing it are left to the pharmaceutical company.  They have a responsibility to conduct their tests in an ethical and scientific manner and then present their results to the FDA to evaluate.  Literally, billions of dollars can go into the development of a particular drug – an investment that is no small matter – and in the case of smaller companies can mean the difference between life and death.

As I said, these companies are supposed to complete their testing in an ethical and scientific manner and I’m sure that most tests are conducted that way.  But when money is involved, sometimes even the highest theoretical standards might take a back door to the “root of all evil.”

Even assuming that a drug company meets its fiduciary responsibility to the FDA and ultimately to the public, let’s consider if that is sufficient.  A typical drug, once it has been developed might endure five years of rigorous testing.  Few side effects are noted in these tests – and those results are passed along to the FDA which, seeing nothing harmful, approves the use of the drug for the stated condition.

Consider the use of cigarettes.  We know that long-term use of tobacco, however it is ingested, has serious adverse consequences – lung cancer and emphysema being two of the most obvious.  Yet if we evaluated cigarettes in the same way we evaluate new drugs using a five year time horizon, we might well conclude that there is really nothing harmful in smoking a couple of packs a day.

In other words, neither the company who has developed the drug nor the FDA really knows what, if any, the long-term consequences of taking it will be – just as we had no idea what the consequences of using DDT were.

Being un-PC I decided to begin this two part series by discussing an issue which might potentially  affect my male readers.  But ladies, take heart.  You’re up next.  What I hope that you take away from these two posts is that we’re all probably better off taking a natural rather than a man-made approach to health, diet and wellness.

Otherwise, we’re playing Russian Roulette with our lives – and Mother Nature is loading the chambers.

THE LAW OF LARGE NUMBERS

What is it about the number $3 Billion that makes it so popular?

First we had J. P. Morgan Chase and their nasty trading loss in that amount.  Now we have GlaxoSmithKline agreeing to pay a combined $3 Billion in fines to the Federal Government because of their unscrupulous marketing strategies and false claims for their products.  At least Chase merely made a mistake while GSK had an illegal and reprehensible marketing strategy in place to improve their bottom line.

What is particularly disturbing is GSK’s practice of offering physicians expensive gifts for prescribing their products – making claims that they were beneficial in ways for which they were never approved by the FDA.  From the pharmaceutical reps I know, this practice is hardly limited to GSK.  It is a nearly universal  industry-wide strategy.  In other words, your doctor may be more influenced by personal benefit than your health in determining which drug to prescribe for you.

Does that give you a warm and fuzzy feeling about your next appointment with your physician?  It certainly should not.

Even with FDA approved drugs that are thoroughly evaluated we have bad side effects.  If you question that statement flip on your television to virtually any station for a couple of hours and count the number of ads from trial lawyers who will be happy to represent you if you or a loved one suffered as a result of taking drugs which the FDA had approved.

If those drugs which have been “thoroughly tested” have adverse effects, consider the possibility of taking drugs which are untested to treat a particular condition.  (Just as a point of reference, during the time I have been writing this post, two such ads appeared on my television – and I type very quickly).

With healthcare representing an ever larger proportion of our GDP this is hardly a moot point.  The amount of waste and fraud in the system is mind-boggling – and even the Federal Government recognizes this problem.  The settlement with GSK is a small first step at correcting the situation – but far more needs to be done.

What more could be done?  A $3 Billion dollar fine sounds like a lot – but for GSK and many of its competitors this is truly a drop in the bucket.  What should have been done is that the company’s CEO, Sir Andrew Witty should have been forced to resign as part of the settlement with the UK drug giant.

Is this too harsh?  Well, let’s look at something else that happened today.  There is a growing scandal once again emerging from the financial industry.  Although it will be months before we learn the complete story, that is if we ever do, apparently the UK’s third largest bank, Barclays was involved in massaging interest rates to make its bottom line look better during the height of the 2008 worldwide financial crisis.

Even before we know what really happened, Barclay’s CEO, Bob Diamond resigned today.  Perhaps he was guilty of overseeing this strategy and perhaps not.

What is clear is that GSK knew that it was acting in both an illegal and unethical manner – which is why they are pleading guilty to the charges levied against them.  Until those who run corporations pay a personal price for their company’s malfeasance they will continue to implement policies designed to pad their bottom line.

I suspect that in the nine years during which the GSK investigation has been ongoing the company made many times the fine to which they agreed for the specific drugs in question.  And Sir Andrew continues in his position having suffered a little embarrassment and no other personal consequence.

When someone in the financial services industry acts inappropriately it has trickle down consequences for all of us.  They threaten the stability of our financial system and that affects each one of us.

When someone in the pharmaceutical industry acts inappropriately it also has consequences for us in terms of the cost we are all asked to pay for our healthcare system.  And for people who suffered adverse reactions to their products or death the consequences are far more personal and severe.

Trying to put my usual optimistic spin on this, I do see at least one beneficiary from the law of large numbers.  It’s the funeral industry.  Rest in peace.

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