“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.