FDA

Adverse Drug Reactions (ADRs): We’re ALL at Risk

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I’m lying in my bed, with my arms and legs straight out. I figured out pretty fast that any stress whatsoever on the tendons, makes things worse for days, weeks even. “Stress” includes not only trying to walk or use my arms or legs for any reason at all, but also simply bending my arms, or my knees, or my fingers, in one position for too long. What’s “too long”?  Maybe 3-5 minutes or so. I can’t use crutches or a wheelchair, because both of those involve use of my arms and shoulders and hands, which are also out of commission. I can’t type or use the computer, because every tendon in my fingers, hands, wrists, and arms are affected and severely painful. I can’t hold up a book to read, because the weight of the book is too much and I can’t bend my arms, without increasing the tendon pain. The weight of the sheets on my toes causes severe pain in the tendons there. There must be tendons around the eye muscles too, because it hurts simply to move my eyes. So I lay there in my bed, with my arms and legs flat out, with my head still and my eyes closed, waiting. Waiting for what, I’m not sure. It’s hard to believe that I went jogging and bike riding and swimming only a few days ago. I’m also in shock. How in the world could a simple antibiotic that I took for a simple UTI do this to me?

My Journey into the Frustrating World of ADR’s Begins

In March 2010 I took the antibiotic Ciprofloxacin for a simple UTI, and within days became one of the millions of people in this country who experience an Adverse Drug Reaction (ADR) every year to a pharmaceutical drug that is deemed “safe” for use. My adverse reaction, as extreme as it was, unfortunately is not as “rare” as the public is led to believe. It turns out there were tens of thousands of other people, and possibly many times more that, also suffering from the same and similar reactions as I was as a result of this class of very popular antibiotics. There were no “Black Box Warnings” on my drug insert, and the warnings that were listed on the insert didn’t even remotely accurately describe what I was going through then, and continue to go through today.

I’ve been disabled ever since, often times going months without leaving the house, or even getting out of bed, as a result of those few pills. As I lay there waiting, I didn’t know if I was waiting to die or to live. With no known treatment, cure, or detox, or even any idea of why this happens in the first place to some of us, there was nothing left to do but wait.  Whatever was known about these reactions came from the victims themselves, observations painstakingly accumulated over time, sharing information that was now available on the internet. Pharma, the FDA, and the medical and pharmacy professions were noticeably and conveniently absent in having any knowledge, concern, clue, or curiosity about these reactions and why this happens in some people, or what to do about it. Their role in all this apparently ended the minute I took the drug.

I’ve had plenty of time to lay around and think about things in the past five years, given that I can’t do much else.  And understandably, I’m not too happy about this situation. It didn’t take me too long to figure out that my life, or what was left of it, was simply going to be a nameless, faceless, long lost forgotten statistic when it came to my ADR. There was no help on the way for me from the medical profession, the FDA, or Pharma to help me with my ADR, and as far as I could tell, absolutely no interest in learning anything from it by any of these parties either. And if there was one thing that became quite clear, it’s that everything was skewed in everyone else’s favor but mine when it came to my ADR. My physicians, pharmacists, the FDA, and of course Pharma, didn’t want to even acknowledge my ADR due to culpability and liability issues – which meant none of the numerous physicians I saw even bothered to report my ADR to anyone anywhere or the FDA. Without this acknowledgement, insurance companies didn’t want to pay for any “excessive testing” outside of the basic “Top 40 Diagnoses” screening tests for a non-existent problem. With “nothing wrong” on paper, I was denied any form of disability payments and probably considered to be a hypochondriac and/or malingerer trying to commit disability fraud. Even the legal profession, as hungry as they are for business, wasn’t interested in me once they found out I took the generic, since there is no legal recourse available with generic drugs. Everyone else in this chain of events walked away from my ADR unscathed, except, of course, me. I’m the one stuck living with it every minute of every day, with no assistance, and no end in sight. I’m the one scouring the internet, reading everything I can about my symptoms, reviewing the available research, paying for my own medical testing, looking for something, anything that will give a clue as to what this drug did to me and how to fix it.

The only other thing I can say about this scenario is that I’m actually not alone in my frustration and anger about this. There are millions of people out there who have been harmed by a pharmaceutical drug, vaccine, or medical device, in the same boat I am. Most of us have felt this same sense of abandonment by “the system”. Each one of us does the best we can, trying to figure out how to pick up the pieces of a life destroyed by a pharmaceutical prescribed to us by the medical profession, and deemed “safe” for use by Pharma and the FDA.

We’re All Sitting Ducks, Sacrificial Lambs, and Play Russian Roulette When it Comes to ADR’s

Several issues have become quite clear to me since I got hit with my ADR. First, is that for the most part, everyone, from Pharma to physicians and pharmacists, to end consumers like you and me, accept that ADR’s are a part of the deal. A lot of rules and regulations are in place in a supposed effort to ensure that a pharmaceutical is safe for “most” of the population. And therein lies the unspoken fact. At the end of the day, no matter how much effort has been put into safety, it’s accepted that there will always be some people that will react negatively to a drug. There’s an implicit acceptance, regardless of how unpalatable it might be, that “some always have to be sacrificed for the greater good”. We just hope that sacrificial lamb won’t be us or those we love.

Secondly, is that pharmaceutical use, and their ADR’s, are here to stay. In the US, nearly 70% of the population is on one prescription drug, more than 50% are on two, and 20% are actually on five or more prescription medications.  Between 1990 and 2008, U.S. spending on prescription drugs increased from $40 billion to $234 billion. And this doesn’t even include all the over the counter meds. As a society, “Just Say No” has never worked for any drug, and that includes legal pharmaceuticals. Increasing right along with this pharmaceutical epidemic, are the “serious and fatal event” ADR’s, which have quadrupled in the past decade, even by the woefully inaccurate and under reported FDA records. Every single person reading this is at risk for experiencing one or more ADR’s in their lifetime. These ADR’s may be mild and transient, or severe, disabling, and long term or lifelong. They might even be those “fatal events” the fast talking monologues on the drug commercials always warn you about. The point is, no one reading this is safe or exempt from them.  Even people who are very “anti-Pharma” may find themselves on the operating table in the ER someday, being given any number of pharmaceuticals without the opportunity for “informed consent”. We are all at risk, and basically sitting ducks when it comes to ADR’s. I rarely took any medications or supplements, and had only taken antibiotics a few times in the first 50 years of my life. Despite that, I let my guard down once — it only took a few pills, and there was no going back from that mistake. I read the drug insert carefully, which talked about how a little transient mild nausea or GI upset might be the worst ADR, and further on down, mentioned “if you develop a pain in your Achilles tendon, call your doctor”. There was no hint in these warnings that these symptoms could be so extreme, permanent, disabling, and that “my doctor” had never heard of it and had no clue what to do about it either.

Third, is that pharmaceutical companies of course want to minimize, downplay, and outright deny ADR’s because they don’t want to open themselves up to culpability and liability issues and lose profits. From the limited “safety studies” that Pharma does on a drug pre-market, to “publishing bias” of only publishing research studies with data in their favor, to minimizing and hiding the adverse effects as they sell their products to the medical profession and us, Pharma does all they can to get a drug to market and profit from it. Once the drug gets to market, the big experiment occurs, as the drug is unleashed en masse on the general population. For those taking the drug, it’s essentially a game of Russian Roulette, no matter how “informed” you are. At that point in time, if things go wrong, it usually takes tens of thousands, hundreds of thousands, or millions of people suffering severe ADR’s before any action, if any, is taken (think Thalidomide, DES, and more recently, Vioxx). YOUR life may be wrecked, but it’s no big deal to Pharma, the FDA, or even your doctors. If you experience a severe ADR, their lives will continue on, while your life becomes just another long lost statistic, simply considered the “cost of doing business”.

Pharma: The Untouchable Behemoth

It can seem pretty hopeless at times. Physicians and pharmacists get their extremely biased information on the drugs they prescribe directly from Pharma via Pharmaceutical Sales Representatives. These reps get more training in marketing and selling, than in knowing anything about the products they’re selling. If the more curious and ethical physicians actually do take the time to look up the research, they will see biased research studies funded by Pharma, all minimizing the risks while highlighting the benefits. The FDA, who relies on Pharma to do the research studies and present the findings on safety and efficacy of drugs, as well as relies on Pharma as a large source of funding for their own organization, is equally in the dark and basically impotent, as they now see Pharma as their main client to serve, and not the public. And we, the people?  We’re the sacrificial lambs, the sitting ducks, and the true massive post surveillant “research study” when we play Russian Roulette with safety and efficacy of any drug Pharma puts out. The icing on the cake for Pharma is that they can laugh all the way to the bank, no matter how many people are harmed, in the meantime. If, despite Pharma’s best attempts, a drug indeed is found to be unsafe, their main goal is to sell the hell out of it to keep bringing in profits until they are absolutely and overwhelmingly forced to remove it from the market.

This is nothing really new. If you live long enough, or read history, you will see the same old story over and over again, whether in the pharmaceutical industry or any other industry. And if you think your doctor or the medical profession is any smarter than the rest of us, think again. As I discussed here, in another writing:

My own mother was “prescribed” cigarettes – yes, that’s right – as part of her “prenatal care”, she was told to start smoking by her doctor while pregnant with my younger sister “to prevent hemorrhoids”.  We can laugh, or be aghast now at such a notion, but an entire generation, including the medical profession at the time, was repeatedly brainwashed by the corporations manufacturing these products, and they would leave no stone unturned in promoting the “health and safety” of their products for the sole interest of their own profits.”  (See:  here, and here.  And for anyone wondering, the ‘science’ behind this is that nicotine constricts blood vessels.  And yes, this is exactly how my mother started smoking at age 32).

I provide this example simply to highlight the fact that medical professionals are subject to the same corporate and cultural forces that we all are.  Drugs that would never be blithely and indiscriminately prescribed today, such as Thalidomide, DES, Vioxx, and many others were routinely prescribed by physicians in the not too distant past, and this apparently includes “cigarettes” as well. The point being, is the drug your doctor prescribing you today the result of a judicious, prudent, and well thought out approach deemed absolutely necessary for your health?  Or is it simply the latest fad promoted by Pharma, the next big blockbuster drug for their coffers, being offered you even when safer, less expensive, or better alternatives may exist?

“Your doctor” is subject to the same forces everyone else is, and they happen to be a very important target for Pharma in particular.  Most physicians are honorable, trying to do the best they can with the information they have, but the fact is, they might not know any more than you do if what they’re selling (prescribing) you is a necessary and lifesaving drug, or a ‘cigarette’ of a drug. It turns out, when it came to my particular ADR, plenty of medical professionals have been hit and suffer from the same ADR’s. I sure wish I had known that before I took the drug, because now I’m one of them.

The odds are overwhelmingly in Pharma’s favor and against us.  And despite everything I’ve written, I’m not really “anti-pharmaceutical”.  I’m well aware pharmaceuticals and modern medicine have helped and saved many lives. I happen to love both science and medicine, and I’m a big believer in using the fruits of ethical, curiosity-driven science and medicine in its truest, most honorable and noble form — to improve the health and welfare of individuals and society as a whole. The problem is, that’s not a description of current day Pharma. Phrases more apt to come to mind with the word “Pharma” now include:  Corporate Greed, Profits at All Costs, America’s legal Drug Cartel, White Collar Drug Dealers, and  “Pharmageddon”. The medical profession is allowing themselves to be reduced to Pharma’s “drug pushers”, pushing pills for everything and everybody even if they’re not necessary or downright dangerous, with drugs as the first and sole option offered even when other options such as healthy lifestyle changes can help.

Given these odds, is there anything we can do to protect ourselves? Is there anything we can do to demand change?

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More people than ever are reading Hormones Matter, a testament to the need for independent voices in health and medicine. We are not funded and accept limited advertising. Unlike many health sites, we don’t force you to purchase a subscription. We believe health information should be open to all. If you read Hormones Matter, like it, please help support it. Contribute now.

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This article was first published on June 8, 2015.

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The FDA Legacy: A Dereliction of Duty

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“Meet the new boss. Same as the old boss.” 

– The Who (Pete Townsend, Songwriter), 1971

The FDA recently finalized its ruling to ease informed consent requirements for “Minimal Risk Clinical Investigations.”

As you might expect, legacy media turned a blind eye. Admittedly, “easing requirements” and “minimal risk” do not readily inspire hard-hitting headlines, but this is precisely the type of ruling that should, at the very least, give us pause.

The entirety of our faith in the medical system relies on two tenets. First, we assume the precepts of informed consent provide a guaranteed layer of protection for both patients and test subjects of scientific research. Second, we assume that doctors take an oath to “first, do no harm.”

So, before we simply dismiss this new ruling as inconsequential, let’s first look at the system in which we have placed such great trust.

Is it Hippocratic or Hypocritical?

We will begin with the latter since it is easier to tackle. Most of us outside the medical industry still tend to think that the Hippocratic Oath is as much a part of becoming a doctor as spending time in a residency program. However, that is not the case, and a recent survey of over 2,800 physicians and medical students confirmed an alarming trend for those of us who may take a bit of comfort in the oath.

Among doctors 65 and older, 70% said the oath was very meaningful, while less than 40% felt that way among those physicians under the age of 35. Of the younger group, nearly one out of every five said the oath was not meaningful at all.

Does this mean the young doctors and medical students lost faith in the oath? Not necessarily. One doctor’s comment suggests he may have lost faith in the system. He wrote that the oath is “sadly, irrelevant. Medicine has evolved from a profession into a huge service industry that involves many other players. These players, like health insurance, hospital employers and pharmaceuticals, do not pray to the same god as the medical profession. Their priority is financial profit ― within or without the Hippocratic Oath.”

The Evolution of Informed Consent

The dubious state of medical oaths means our safety depends much more on informed consent.

The concept of informed consent began to evolve very slowly after the creation of the Food and Drug Administration (FDA) in the early 1900’s. At first, a smattering of landmark lawsuits began to highlight the need for greater protections for patients and test subjects. Some of the lawsuits revolved around doctors going rogue, while others delved into the intricacies of health illiteracy and a patient’s need for more complete information delivered in layman’s terms.

As so often happens within bureaucracy, the FDA recognized the need for better regulations, but potential solutions floated around nebulously in the ether until things reached a breaking point on the global stage.

A Serious Catalyst

Nothing could have demonstrated the need for informed consent in medical research more than the atrocities committed by Nazi doctors in World War II. The subsequent Nuremberg Trials put the world on high alert. Across the globe, citizens were horrified to witness the depths of depravity that human souls could engage.

At the conclusion of the trials in 1947, the judges issued what is now known as the Nuremberg Code, a document outlining ten essential points necessary for any medical trial to be permissible. The first principle of that code states, “The voluntary consent of the human subject is absolutely essential.”

The authors added further context to reinforce the absoluteness of their statement, “…before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment. The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs, or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.”

In No Hurry

The FDA followed this up with an amazing display of inertia. In fact, it would be another decade before a judge (once again, it was the judicial system rather than congress or the agency) coined the term “informed consent” in a ruling against a doctor who paralyzed a patient with a procedure after not properly warning him of the risks.

It took two and half more decades, 1981 to be exact, for informed consent to be codified in U.S. federal law through coordinated policies of the FDA and the U.S. Department of Health and Human Services.

The most devilish of Devil’s advocates might argue that the war crimes occurred under a despot in Germany. So, why would a federal agency in the U.S. feel any pressure to react?

Well.. it is precisely what did happen on this soil that makes their lethargic approach to patient protection all the more jarring.

Lesson Learned

Around the same time a judge in California gave “informed consent” its name, the Merrell drug company pressured a young Pharmacology Ph.D. at the FDA  to approve a new drug, but she refused, citing a lack of evidence. Despite their repeated attempts to strong-arm her, Dr. Frances O. Kelsey never signed off on thalidomide. Her tenacity likely saved tens of thousands of Americans from suffering horrific birth defects and earned her distinguished recognition from President John F. Kennedy. I wrote about these events in greater detail in my book, In the Name of The Pill.

The close call with Thalidomide left many in Congress more concerned than ever about ineptitude at the FDA. The resulting legislation, the Kefauver-Harris Drug Amendments, gave the FDA more control over the approval process and required the drug companies to report adverse reactions. The amendments also put a greater emphasis on proving the efficacy of a drug during clinical trials.

Not So Much 

Undoubtedly, when Congress approved Kefauver-Harris, they recognized that the thing that made Dr. Kelsey’s story unique was not that she was being strong-armed by a drug company, but that she stood her ground. 

In fact, the similarities (which would not become public until much later) are eerie when compared with the details of the approval of another potent drug, hormonal birth control. Dr. John Rock went on record to boast about how he browbeat the FDA into approving The Pill despite insufficient safety data.

Ironically, when the FDA later assembled a committee to investigate whether The Pill had ever been proven safe, it would be the greater emphasis on efficacy imposed by Kefauver-Harris that the committee chairman would contort to give a friendly nod to The Pill.

When Dr. Louis Hellman was appointed chairman of this FDA advisory board, his cozy relationship with the drug companies was not yet obvious. However, by the time the Nelson Pill Hearings rolled around in 1970, it was clear that Sen. Gaylord Nelson held a level of contempt for Dr. Hellman’s lack of ethics as a shill for the drug companies.

During the hearings, Sen. Nelson pointed out that, despite having issued a chairman’s statement that The Pill was “safe within the intent of the law (Kefauver-Harris),” Dr. Hellman had previously lamented that the committee had to come up with the “right” statement. They had to issue an opinion, but if they stated that the drugs were not safe, the FDA Commissioner might have to take them off the market. They needed some way to affirm that The Pill was safe enough, although their “scientific data did not really permit that kind of statement.”

Coordinated Entropy

There is a basic law of entropy, which states that any spontaneous process will tend toward greater entropy (disorder) over time. But, that is a spontaneous process. When it comes to medical research, the entropy seems to be engineered as a direct affront to law and order.

Anytime Congress or a regulatory agency tries to define a suitable order for their practices, the drug companies skate right up to the newly drawn line and begin testing it – first sticking a hand over the line and then a foot. Before you know it, they have Hokey Pokey’ed their way back into business as usual.

Consider that in the wake of Nuremberg, Dr. Gregory Pincus conducted hormonal birth control trials in Puerto Rico, in which the women were not told they were participating in a trial. Five of those healthy, young women died and were buried without autopsies because the doctors believed their little miracle pill could not have been a factor. And, when 65% of the women complained about the side effects, Dr. Pincus dismissed the complaints as psychological in nature because of the “emotional super-activity of Puerto Rican women.”

The history of shameful trials do not end with Dr. Pincus. In 1966, Dr. Henry Beecher cited dozens of examples of dubious medical practices to highlight the need for stronger protections. Shockingly, many of his colleagues ostracized him, calling his accusations a “gross and irresponsible exaggeration.”

Mounting Evidence

Examples from Beecher’s Bombshell, as it became known, included instances of doctors transplanting melanoma into healthy patients, withholding penicillin from soldiers, and infecting disabled children with hepatitis to study the disease.

Other well-known instances of less-than-ethical medical practice and research include:

Mississippi Appendectomies, where minority women were surgically sterilized without their consent.

Tuskegee syphilis study, a 40-year non-therapeutic “study” that documented the affects of untreated syphilis on black men in the deep south.

Milgram Experiment, a troubling study of obedience to authority where subjects believed they were administering shocks to people they had just met, potentially to the point of death, in order to satisfy the commands of an authority figure.

Whether these examples are the exception, the rule, or somewhere in between, they do confirm one thing. Medical professionals with no moral compass pose a threat from which we, the public at-large, need to be protected. The only solution is informed consent, without mitigation.

Same Difference

History shows us we need to be concerned about doctors who would push back against informed consent – even if their language says it is only relevant to matters of “minimal risk.”

Doctors developing The Pill were convinced they were only affecting ovulation, and would have, no doubt, argued it posed minimal risk.

Somewhere in the USA, a doctor injected hepatitis into children because, oh well, they’re already disabled.

Somewhere in the USA, doctors performed full hysterectomies on black women because they were deemed unfit.

Somewhere in the USA, a doctor intentionally transplanted cancer into healthy patients.

Dr. Beecher ultimately ended up with hundreds of examples of research gone wrong. He struggled to understand how these “men of science” could willingly “cause harm to patients with no possibility of benefit.”

It would be foolish to assume that doctors like this no longer exist. They personify the reason we should not be chipping away at the policies that protect us. Where will these “little” changes end? And that question is precisely why this new ruling is indeed newsworthy. The legislation was already amended to allow for an exception to informed consent in life-threatening situations, when “it is not feasible to get the consent of the subject or the subject’s representative.”

The new ruling also suggests that the FDA will be taking a very hands-off approach to defining what constitutes “minimal risk.” The power to waive informed consent requirements based on minimal risk now resides in the hands of Institutional Review Boards (IRBs), meaning that a board designated by the very institution wishing to perform the study will be interpreting the meaning of “minimal risk.” Conflict of interest much?

Maybe it is no big deal that they already eliminated protections for the most extreme cases, and now they are eliminating protections for the least extreme cases. Maybe it is no big deal that we are going to have to trust researchers to define what falls into that still-protected middle ground. But, maybe it is a big deal.

On another note, the quote at the beginning of this article comes from a song titled, Won’t Get Fooled Again.

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More people than ever are reading Hormones Matter, a testament to the need for independent voices in health and medicine. We are not funded and accept limited advertising. Unlike many health sites, we don’t force you to purchase a subscription. We believe health information should be open to all. If you read Hormones Matter, like it, please help support it. Contribute now.

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Back to School, Back to Flu? Elderberry to the Rescue

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I am many things: a writer, a researcher, a women’s health advocate, a teacher, a yogi. I’m also a few not so great things. Add my persistent desire to help with my passion for research and sprinkle in my ego-driven need to be right and you have a recipe for a real know-it-all. At best those traits make me a useful resource to my friends and family, at worst… unbearable? Well, I hope I’m not that bad.

My quest to detoxify my life came somewhere around the time I was trying to get pregnant and I was diagnosed with chemical allergies. I became a bit of a natural health junky. I’ve tried turmeric and macca powder and spirulina and chia seeds. While my track record with the rest is spotty, elderberry has become a staple in my life.

Why? Because I teach college. College students are walking germ factories. They don’t get enough sleep, they don’t eat properly, they live in close quarters, they make out with each other. Probably the only people who encounter more germs than I do are pre-school teachers and flight attendants. That said, you’ll notice germaphobe wasn’t on the above list of my identities. That’s because I know if I keep my immunity strong, I’ll be fine. I do that by taking elderberry (sambucus). And I tell anyone who will listen that they should take elderberry, too.

What is Elderberry?

Elderberry, or sambucus nigra (black elderberry), is a plant native to North America and Europe that produces dark purple to black berries. These berries and extracts from them have been used medicinally for centuries. “It was first referred to as a healer in the 5th century BC and received mentions in the writings of Hippocrates, Dioscurides and Plinius.”

The researcher in me says:

The natural health enthusiast in me says:

Thank goodness! We’ve got to start using safe and natural alternatives to antibiotics and chemicals. With least 30% of the antibiotics prescribed in the country found to be unnecessary, we have created drug-resistant strains of bacteria.  According to the National Institute of Health, “the way we’ve been using antibiotics is helping to create these new drug-resistant “superbugs.” The fear of these bacteria is real.

The FDA has finally taken steps to fight this problem by banning triclosan and 18 other anti-bacterial chemicals found in soaps and cosmetics.”There’s no data demonstrating that over-the-counter antibacterial soaps are better at preventing illness than washing with plain soap and water,” the agency said in a press release issued shortly after the rule was announced.

In fact, “There’s some evidence suggesting that widespread use of triclosan, which is used in liquid soaps, and triclocarban, which is used in bar soaps, could lead to the development of germs that are resistant to antibiotics. Other studies have found that exposure to these chemicals disrupts hormone cycles in animals.”

Between our overuse of antibiotics and some of the chemicals created under the guise of keeping us safe, we’ve made bacteria even more dangerous. Protecting our natural immunity may be the smartest thing we can do this cold and flu season.

The know-it-all in me says:

I told you so! Elderberry works.*

I take it when I’m short on sleep, when I’ve been around people who are sick, when I travel, or when I feel myself coming down with something. So this coming cold and flu season, consider trying elderberry before you reach for that Zpac and save us all from the superbugs.

*In no way do I profit from you taking elderberry. I don’t work for a natural health company, an elderberry farm, or hippie commune. Yet…

We Need Your Help

More people than ever are reading Hormones Matter, a testament to the need for independent voices in health and medicine. We are not funded and accept limited advertising. Unlike many health sites, we don’t force you to purchase a subscription. We believe health information should be open to all. If you read Hormones Matter, like it, please help support it. Contribute now.

Yes, I would like to support Hormones Matter.

This article was published originally in September, 2016. 

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Topamax: The Drug with 9 Lives

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Is Topamax a Wonder Drug?

Over the past week alone, I have talked to several people about their doctor visits. Each one of them had a different illness and each one of them was prescribed the drug Topamax.  I cannot help but wondering, how it is possible that one medication can treat so many disparate illnesses. I suspect it cannot and the overreach is driven more by marketing than medicine. This led me to do some digging into Topamax.

What I found is not good. Topamax is prescribed for a broad scope of illnesses for which there is likely little evidence of its efficacy. Take a look at the list below.

Illnesses or Conditions for which Topamax is Prescribed

  1. Obesity1. Medicine: Topamax
  2. Seizures1. Medicine: Topamax
  3. Migraine1,2. Medicine: Topamax
  4. Impulsivity3. Medicine: Topamax
  5. Diabetes with nerve damage4. Medicine: Topamax
  6. Bipolar disorder5. Medicine: Topamax
  7. Depression6. Medicine: Topamax
  8. Alcohol addiction7: Topamax
  9. Fibromyalgia8. Medicine: Topamax

I would like to add a 10th to that: I have broken a nail…can I get Topamax?

Honestly, off-label prescribing has gone too far! Does Topamax really treat so many disparate conditions that doctors prescribe it for everything, even when it is not FDA approved for these conditions? I must add that Topamax is one of the most dangerous drugs in the prescription market today. Not only is it a diet pill made from sugar derivatives  (actually a sugar substitute) but it uses two dangerous methods (blocking both voltage dependent calcium and voltage gated sodium channels at once) to achieve what several classes of drugs normally do separately; and thus, with one medicine it affects and potentially damages the two circuits that are critical for brain function. Topamax (an anticonvulsant under additional name Topiramate (generic) and in time release Trokendi XR) is important to discuss because it was initially formulated as a diet pill. Yet over 50% of the new members who join my migraine group arrive with Topamax on their prescription list.

I have yet to find a single person on this drug who is not seriously considering dropping it due to its adverse effects, not to mention that it does not appear to work as a pain killer. Unfortunately, Topamax is difficult to quit. The most difficult problem is that doctors are under the false impression that a drug that blocks the voltage dependent calcium and potassium channels can just be easily stopped by a few days of reduction. However, since the voltage dependent calcium channel is a high voltage channel, for some people the discontinuation may end in seizures.

Evidence is also accumulating that Topamax can cause brain damage 4. Personally, I have heard of many cases where it in fact has done just that.

Topamax is a sugar substitute that failed as a diet pill but is somehow permitted by the FDA to be used for epileptic seizures. It also received approval for use against migraines. The reasons for such a turn of events is unclear; how can a drug that fails approval for a diet pill suddenly be a perfect match for seizures and migraines? Don’t we all wish for sugar pill to be a pain killer? Unfortunately, sugar or sugar substitutes do not have such serious adverse effects  as Topamax (they happen to have different ones).

Adverse effects of Topamax

If we look at the list of adverse effects associated with this drug (as provided by Wikipedia – Topamax), it is clear that Topamax is not very safe. Indeed, the list is very long.

Dizziness, Weight loss, Paraesthesia (pins and needles), Somnolence, Nausea, Diarrhea, Fatigue, Nasopharyngitis – common cold, Depression, Weight gain, Anaemia, Disturbance in attention, Memory impairment, Amnesia, Cognitive disorder, Mental impairment, Psychomotor skills impaired, Convulsion, Coordination abnormal, Tremor, Lethargy, Hypoaesthesia, Nystagmus, Dysgeusia, Balance disorder, Dysarthria, Intention tremor, Sedation, Vision blurred, Diplopia, Visual disturbance, Vertigo, Tinnitus, Ear pain, Dyspnoea, Epistaxis, Nasal congestion, Rhinorrhoea, Vomiting, Constipation, Abdominal pain, Dyspepsia, Dry mouth, Stomach discomfort, Paraesthesia oral, Gastritis, Abdominal discomfort, Nephrolithiasis, Pollakisuria, Dysuria, Alopecia (hair loss), Rash, Pruritus, Arthralgia, Muscle spasms, Myalgia, Muscle twitching, Muscular weakness, Musculoskeletal chest pain, Anorexia, Decreased appetite, Pyrexia, Asthenia, Irritability, Gait disturbance, Feeling abnormal, Malaise, Hypersensitivity, Bradyphrenia, Insomnia, Expressive language disorder, Anxiety, Confusional state, Disorientation, Aggression, Mood altered, Agitation, Mood swings, Anger, Abnormal behavior, Crystal urine present, Tandem gait test abnormal, White blood cell count decreased, Bradycardia, Sinus bradycardia, Palpitations, Leucopenia, Thrombocytopenia, Lymphadenopathy, Eosinophilia, Depressed level of consciousness, Grand mal convulsion, Visual field defect, Complex partial seizures, Speech disorder, Psychomotor hyperactivity, Syncope, sensory disturbance, Drooling, Hypersomnia, Aphasia, Repetitive speech (stuttering), Hypokinesia, Dyskinesia, Dizziness postural, Poor quality sleep, Burning sensation, Sensory loss, Parosmia, Cerebellar syndrome, Dysaesthesia, Hypogeusia, Stupor, Clumsiness, Aura, Ageusia, Dysgraphia, Dysphasia, Neuropathy peripheral, Presyncope, Dystonia, Formication (the sensation of insects crawling under the skin), Visual acuity reduced, Scotoma, Myopia, Abnormal sensation in eye, Dry eye, Photophobia, Blepharospasm, Lacrimation increased, Photopsia, Mydriasis, Presbyopia, Deafness, Deafness unilateral, Deafness neurosensory, Ear discomfort, Hearing impaired, Dyspnoea exertional, Paranasal sinus hypersecretion, Dysphonia, Pancreatitis, Flatulence, Gastrooesophageal reflux disease, Hypoaesthesia oral gingival bleeding, Abdominal distension, Epigastric discomfort, Abdominal tenderness, Salivary hypersecretion, Oral pain, Breath odour, Glossodynia, Calculus urinary, Urinary incontinence, Haematuria (blood in urine), Incontinence, Micturition urgency, Renal colic, Renal pain, Anhidrosis, Hypoaesthesia facial, Urticaria, Erythema, Pruritus generalized, Rash macular, Skin discolouration, Allergic dermatitis, Swelling face, Joint swelling, Musculoskeletal stiffness, Flank pain, Muscle fatigue, Metabolic acidosis, Hypokalaemia, Increased appetite, Polydipsia, Hypotension, Orthostatic hypotension flushing, Hot flush, Hyperthermia, Thirst, Influenza like illness, Sluggishness, Peripheral coldness, Feeling drunk, Feeling jittery, Learning disability, Erectile dysfunction, Sexual dysfunction, Suicidal ideation, Suicide attempt, Hallucination, Psychotic disorder, Apathy, Lack of spontaneous speech, Sleep disorder, Affect lability, Libido decreased, Restlessness, Crying, Dysphemia, Euphoric mood, Paranoia, Perseveration, Panic attack, Tearfulness, Reading disorder, Initial insomnia, Flat affect, Thinking abnormal, Loss of libido, Listless, Middle insomnia, Distractibility, Early morning awakening, Panic reaction, Elevated mood, Blood bicarbonate decreased, Neutropaenia, Apraxia, Circadian rhythm sleep disorder, Hyperaesthesia, Hyposmia, Anosmia, Essential tremor, Akinesia, Unresponsive to stimuli, Blindness unilateral, Blindness transient, Glaucoma, Accommodation disorder, Altered visual depth perception, Scintillating scotoma, Eyelid edema, Night blindness, Amblyopia, Calculus ureteric, Renal tubular acidosis, Stevens-Johnson syndrome, Erythema multiforme, Skin odour abnormal, Periorbital oedema, Urticaria localized, Limb discomfort, Acidosis hyperchloraemic, Raynaud’s phenomenon, Face edema, Calcinosis, Mania, Anorgasmia, Panic disorder, Disturbance in sexual arousal, Feeling of despair, Orgasm abnormal, Hypomania, Orgasmic sensation decreased.

The FDA Black Box on Topamax

According to the FDA and their listed label update in 2014, Topomax includes a black-box warning that has the following known adverse effects:

  • Acute myopia and secondary angle closure glaucoma: Untreated elevated intraocular pressure can lead to permanent visual loss. The primary treatment to reverse symptoms is discontinuation of TOPAMAX as rapidly as possible (5.1)
  • Visual field defects: These have been reported independent of elevated intraocular pressure. Consider discontinuation of TOPAMAX (5.2)
  • Oligohidrosis and hyperthermia: Monitor decreased sweating and increased body temperature, especially in pediatric patients (5.3)
  • Metabolic acidosis: Baseline and periodic measurement of serum bicarbonate is recommended. Consider dose reduction or discontinuation of TOPAMAX if clinically appropriate (5.4)
  • Suicidal behavior and ideation: Antiepileptic drugs increase the risk of suicidal behavior or ideation (5.5)
  • Cognitive/neuropsychiatric: TOPAMAX may cause cognitive dysfunction. Patients should use caution when operating machinery including automobiles. Depression and mood problems may occur in epilepsy and migraine populations (5.6)
  • Fetal Toxicity: TOPAMAX use during pregnancy can cause cleft lip and/or palate (5.7)
  • Withdrawal of AEDs: Withdrawal of TOPAMAX should be done gradually (5.8)
  • Hyperammonemia and encephalopathy associated with or without concomitant valproic acid use: Patients with inborn errors of metabolism or reduced mitochondrial activity may have an increased risk of hyperammonemia. Measure ammonia if encephalopathic symptoms occur (5.10)
  • Kidney stones: Use with other carbonic anhydrase inhibitors, other drugs causing metabolic acidosis, or in patients on a ketogenic diet should be avoided (5.11)
  • Hypothermia has been reported with and without hyperammonemia during topiramate treatment with concomitant valproic acid use (5.12) (FDA Topamax Label)

According to the label, Topamax is only indicated for seizures as a secondary medication in support of a primary kind and for migraines and nothing else (not even for diet anymore). Yet, I see people being prescribed this drug for all types of off-label use that are unrelated to either seizures or migraines. The large migraine group I run on Facebook grown to over 4000 migraineurs in the past two years.

Because I have found that Topamax is the #1 prescribed medicine to migraineurs when they join the group in despair and hopelessness, I have decided to designate Topamax also as the #1 medicine discussed on the series titled drugs of shame. This is apt because it affects (and often damages) the neurotransmitters (hormones of the brain) and thereby puts the whole hormonal structure of the body in chaos.

The Problem: Brain Slowing

Topamax may cause brain function slowing. Why? Topamax is a voltage dependent calcium channel blocker (also called voltage-gated calcium channel blocker), which is a key channel for neuron communication via neurotransmitter release. Topamax is systemic, meaning it doesn’t just act on a particular type of neurons but all neurons. This means that neurons that are responsible to organize how the heart beats, how the lungs function, how you blink, and how you digest are all affected by Topamax in a negative way: the neurons cannot release neurotransmitters and so the communication between hormones of the brain and the hormones of the body are broken. Many of the side effects of Topamax are so strong that migraineurs who start Topamax stop within weeks (some on day 3) of initiating this medication. The drawing below shows how voltage dependent calcium channels work and what happens when they cannot work because they are blocked.

Voltage Dependent Calcium Channel Blockers

Voltage gated calcium channels plugged and unplugged
Voltage gated calcium channels plugged and unplugged.

Figure 1. How Voltage Dependent Calcium Channels Work

 

In figure 1 you see a simplified neuron on the left and the axons of another neuron on the right. In the synaptic cleft normally neurotransmitters work like a domino effect. One neuron receives a signal from a sensory organ that stimulates the release of neurotransmitters that are specific to the type of stimulus. The neurotransmitters then get to be picked up by the neuron connected to the releasing neuron and pass the signal along. When the signal volume, intensity, frequency reaches a particular threshold, the brain sends a command to the body: wipe nose, for example.

Blocking the voltage dependent calcium channels from firing means that no neurotransmitters can be released and thus no message is passed on to the necessary number of neurons to reach the threshold. Since Topamax is systemic, every function of the body is hampered to some degree.

Neurons have five types of voltage dependent calcium channels based on voltage requirements:

  1. L-type that directs skeletal muscles, cardiac related muscle cells, endocrine cells, adrenal, etc., associated with contraction, hormone release and synaptic integration (neurons working together)
  2. P/Q-type that activate neurons and neurotransmitter and hormone release
  3. N-type works at the nerve terminals similarly to P/Q for neurotransmitter and hormone release
  4. T-type think of it as the pacemaker of the brain for firing with a particular frequency
  5. R-type that works with cerebral cells and some neurons

For each of these, the current required is different so fine-tuning is necessary. The calcium channel must go through all stages of voltage levels to be able to perform all five types of actions, as the body requires all of them. Note that when the voltage gated calcium channels are blocked, none of these 5 types of actions can properly function. The body will utilize its reserves to maintain vital functions. People who take Topamax can still breathe and their hearts beat – but they have serious issues, for example, with body cooling, which is a pretty basic, built-in automatic motor function. People who take Topamax overheat and cannot cool themselves. Most interestingly Topamax prevents the very functions a migraine brain needs for relief the most because it blocks those channels that would instruct the brain to cool the body.

In addition, Topamax blocks both voltage dependent sodium-potassium channels. I have written extensively on voltage dependent sodium-potassium channels in previous articles so here I just present a short summary. Voltage dependent (or gated) sodium-potassium channels have the critical function of sodium and potassium exchange in the cell to ensure that proper voltage is created in the cell membrane. Proper voltage is required so that the channels can open and close their gates, nutrients can enter and waste products can leave. Neurons cannot manufacture neurotransmitters without the availability of various minerals, many of which must be able to enter the neuron via voltage gated sodium-potassium channels. When these channels are not able to generate the proper action potential, nothing moves in or out of the neuron. By blocking voltage dependent channels, the high voltage needed to release the neurotransmitters is dulled as well.

Topamax robs the brain from its most important vital roles: making neurotransmitters that transmit messages and regulate brain and important autonomic body functions such as, cooling the body when it is too hot,  maintaining and appropriate heart beat, or simply making a decision1.  I think, Topamax is one of the more dangerous drugs on the market. From what I can gather from the research and my work with migraineurs, Topamax does not appear to work for pain. It only slows brain function. I would not be surprised to see researchers soon showing a connection between Topamax use and dementia. Until then, proceed with caution.

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Sources

1          Sommer, B. R., Mitchell, E. L. & Wroolie, T. E. Topiramate: Effects on cognition in patients with epilepsy, migraine headache and obesity. Therapeutic Advances in Neurological Disorders 6, 211-227, doi:10.1177/1756285613481257 (2013).

2          Nelles, G. et al. Prevention of episodic migraines with topiramate: results from a non-interventional study in a general practice setting. The Journal of Headache and Pain 11, 33-44, doi:10.1007/s10194-009-0163-x (2010).

3          Navarrete, F., Pérez-Ortiz, J. M. & Manzanares, J. Pregabalin- and topiramate-mediated regulation of cognitive and motor impulsivity in DBA/2 mice. British Journal of Pharmacology 167, 183-195, doi:10.1111/j.1476-5381.2012.01981.x (2012).

4          Garvey, W. T. Phentermine and topiramate extended-release: a new treatment for obesity and its role in a complications-centric approach to obesity medical management. Expert Opinion on Drug Safety 12, 741-756, doi:10.1517/14740338.2013.806481 (2013).

5          Geddes, J. R. & Miklowitz, D. J. Treatment of bipolar disorder. Lancet 381, 10.1016/S0140-6736(1013)60857-60850, doi:10.1016/S0140-6736(13)60857-0 (2013).

6          Campayo, J. G. et al. Effectiveness of topiramate for tobacco dependence in patients with depression; a randomised, controlled trial. BMC Family Practice 9, 28-28, doi:10.1186/1471-2296-9-28 (2008).

7          Johnson, B. A. & Ait-Daoud, N. Topiramate in the New Generations of Drugs: Efficacy in the Treatment of Alcoholic Patients. Current pharmaceutical design 16, 2103-2112 (2010).

8          Pereira, A. G., Michael J.; Gross, Robert A.; Posner, Kelly; Dworkin, Robert H. Suicidality associated with anti-epileptic drugs: implications for the treatment of neuropathic pain and fibromyalgia. Pain 154, 345-349 (2013).

This article was first published on September 10, 2015.

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Aspartame: A History of Controversy, but is it Safe?

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Pink, Yellow or Blue? Which Low-Calorie Sweetener are You?!

I’m sure somewhere in a women’s magazine there is a quiz that associates the reader’s personality, or the type of man she should date, or some other unassociated trait with random questions playing up on the fact that women have been trained like Pavlov’s dogs to diet. In recent years, beverage companies have started rolling out campaigns that appeal to the other 50% of the population. Most notably, Dr. Pepper Ten is advertised as the “manliest low-calorie soda in the history of mankind.” This soda is also advertised as “not for women.”

Yet, in spite of million dollar marketing campaigns, consumers are making better choices. According to Beverage Digest, the sales volume for Coke fell 1% last year, but Diet Coke sales dropped by 3%. Similarly, Pepsi fell by 3.4% and Diet Pepsi fell by 6.2%. Diet sports beverages also dropped in sales compared to their regular product.

Due to these declines, Coca-Cola is rolling out a set of advertisements about the safety of aspartame, a low-calorie sweetener with a controversial history. There is as much “evidence” that this artificial food additive is safe as there is evidence that it causes health problems including brain tumors, seizures, blindness, the auto-immune disease Lupus, and much more. I’ll let the history of this product speak for itself on the controversy of consumer safety, but first what is it?

Aspartame Ingredients

Aspartame is a man-made chemical that is approximately 50% phenylalanine, 40% aspartic acid, and 10% methanol. Today, it is made using genetically modified bacteria developed by none other than Monsanto, of course. The ingredients occur naturally, so they are safe, right?

Phenylalanine is a neurotoxin and can build up in the blood due to the high levels in aspartame. Phenylalanine causes serotonin levels to decrease leading to depression. It can also cause behavioral symptoms in kids including ADD and ADHD. Individuals who have the genetic disorder Phenylketonuric (PKU) cannot metabolize phenylalanine and the high levels in aspartame can cause death (overtime the chemicals in aspartame can build up in the body and cause death even if an individual does not have PKU).

Aspartic Acid is an excito-toxin, which means it over stimulates certain neurons in the body until they die. When aspartic acid is in its free form, or unbound to proteins (as it occurs naturally in food), it leads to a high level of neurotransmitters in certain areas of the brain which kills neurons and leads to numerous neurological disorders including, but not limited to: multiple sclerosis, Parkinson’s disease, hypoglycemia, memory loss, hormonal problems, epilepsy, dementia, Alzheimer’s disease, and more.

The argument that phenylalanine and aspartic acid are safe is based on the fact that they are amino acids, the building blocks of protein that both occur in regular foods. In nature, however, these amino acids are consumed in more natural quantities and different combinations (oh, and they aren’t made in a lab).

Methanol – this is wood alcohol and when ingested becomes formaldehyde or embalming fluid. While there is naturally occurring methanol in fruits, it binds with the pectin in fruit, which the body cannot digest, and is excreted through the body’s natural waste process without doing damage. We do not digest high levels of methanol when eating organic, whole foods. Methanol is a neurotoxin and known carcinogen. The EPA recommends limiting consumption of methanol to 7.8 milligrams per day. One liter of an aspartame-sweetened beverage contains over 50 mg of methanol.

A Long History of Controversy

The history of getting FDA approval of this product is rich in corruption and deceit.

  • 1965 – James Schlatter, a chemist at G. D. Searle was researching an ulcer drug and accidentally discovers a zero calorie sweetener that is 180 times sweeter than sugar.
  • 1967 – G. D. Searle starts conducting tests on the new potential product. These are tests required by the FDA. In the first test conducted on 7 monkeys, 1 died and 5 suffer from grand mal seizures.
  • 1971 – Neuroscientist Dr. John Olney conducts a study and discovers that aspartame causes brain tumors. Previously Dr. Olney conducted safety tests on MSG and successfully had the food additive removed from baby food. He concludes that aspartic acid, one of the key ingredients of aspartame, causes holes in the brains of infant mice. One of Searle’s scientists makes the same conclusion during his testing.
  • February 1973 – After spending tens of millions of dollars testing the safety of aspartame, G. D. Searle submits over 100 studies to the FDA requesting approval for consumer consumption.
  • March 1973 – One of the first FDA scientists to review the aspartame safety data states that “the information provided (by Searle) is inadequate to permit an evaluation of the potential toxicity of aspartame”. Notes in her report that further clinical tests are needed.
  • July 1974 – FDA approves use of aspartame in dry food products.
  • August 1974 – Attorney Jim Turner, consumer advocate who worked helped get the previous reigning artificial sweetener, Cyclamate, off the market for its links to cancer, and Dr. Olney file objections of the approval of aspartame in dry foods.
  • 1976 – An investigation reveals that the required studies conducted by the G. D. Searle company and reported to the FDA were not conducted or reported properly. The investigators report they “had never seen anything as bad as Searle’s testing.”
  • January 1977 – The FDA requests the US Attorney’s Office to begin grand jury proceedings to investigate whether indictments should be filed against G. D. Searle for submitting false test results on the product. This is the first time the FDA requested a criminal investigation on a manufacturer.
  • March 1977 – G. D. Searle hires Donald Rumsfield as CEO. Donald Rumsfield hires numerous former politicians in order to save the company.
  • July 1977 – Samuel Skinner resigns from his position in the US Attorney’s Office to take a job with G. D. Searle’s representing law firm, Sidley & Austin. Skinner was the US Attorney in charge of the investigation. Due to Skinner’s resignation the grand jury investigation is postponed and it reaches its statute of limitations and the case is dropped.
  • August 1977 – The FDA releases the Bressler Report. The report finds that 98 of the 196 animals died during one of Searle’s studies weren’t autopsied until later dates, in some cases over one year after death. The report released many more inconsistencies. You can read the FDA’s findings here.
  • 1980 – The Public Board of Inquiry (PBOI) voted unanimously to reject the use of aspartame until further studies could be conducted. They were concerned with the high rate of brain tumors in animals used in studies.
  • January 1981 – The day after his inauguration, Ronald Reagan appoints Dr. Arthur Hull Hayes as FDA commissioner. His advisor for this decision was Donald Rumsfield, CEO of G. D. Searle, at that time.
  • March 1981 – Hayes establishes a commissioner’s panel to review issues brought up by the PBOI. During this review, three of the six FDA scientists reviewing the data on brain tumors advise against the approval of aspartame due to the unreliability of G. D. Searle’s tests.
  • July 1981 – Hayes overrules the PBOI, ignoring the recommendation of his appointed FDA Commissioner’s panel.
  • 1982 – Searle files a petition that aspartame be approved in beverages.
  • July 1983 – The National Soft Drink Association drafts an objection to the final ruling to permit the use of aspartame in beverages due to its questionable safety.
  • September 1983 – FDA Commissioner Hayes resigns and accepts a position as a senior scientific consultant at Burson-Marsteller, Searle’s public relation firm.
  • Fall 1983 – First beverages using aspartame as ingredient are sold.
  • 1985 – Monsanto buys G. D. Searle in spite of the controversy over aspartame.

For a more detailed timeline, click here for “How Aspartame Became Legal – the Timeline” on Rense.com.

Fast Forward Twenty Five Years to 2013

Today we are more aware and skeptical than ever about the politics and bribery involved in getting a product approved by the FDA, yet aspartame is in over 6,000 consumer products. Our diet obsessed culture has overlooked the corruption and dangers of this chemical food additive and let it poison our own bodies and our children. According to the Aspartame Information Center, “aspartame is consumed by over 200 million people around the world and is found in more than 6,000 products including carbonated soft drinks, powdered soft drinks, chewing gum, confections, gelatins, dessert mixes, puddings and fillings, frozen desserts, yogurt, tabletop sweeteners, and some pharmaceuticals such as vitamins and sugar-free cough drops.” Most consumers associate this food additive to diet drinks and products, but it is now added to most processed foods including those marketed for children. It is marketed as “safe” but as you can see in the history of the product, there have never been any properly conducted studies that conclude that this product is safe.

With the risk of obesity and type 2 diabetes on the rise, especially in children, we are looking for easy ways to cut calories. It’s much easier to reach for something labeled and advertised as “calorie-free” instead of eating healthy, whole foods low in sugar and free of chemical enhancements. However, this well marketed shortcut is not the solution to our nation’s health problems and is actually causing a rise in numerous health issues. Aspartame leads to behavioral disorders, seizures, brain tumors, auto-immune diseases, various neurological disorders, and it also causes weight gain and sugar cravings (which lead to obesity and type 2 diabetes which is what promoters argue it helps fight).

So, pink, yellow or blue? Pick your poison. Or ditch the women’s magazines’ various yo-yo DIEts and create a healthy LIFEstyle for yourself and your family so you can figuratively have your cake and eat it too.

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This article was published originally on Hormones Matter on August 20, 2013.

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The Healthcare System Collapse: Lessons from the Housing Market Crash and “The Big Short”

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The book (and movie) The Big Short got me thinking: What will be the next bubble to pop? I am certainly not a financial expert, and I have no idea what is involved in stocks or bonds, but I would venture to guess that at some point in the near future the healthcare system, and the pharmaceutical companies in particular, are going to crash.

The 21st Century Cures Act

As is pointed out in The Big Short, all people and institutions respond to incentives. The 21st Century Cures Act, which is passing through Congress right now, incentivizes pharmaceutical companies to produce ineffective drugs that are no better than snake-oils.

The 21st Century Cures Act will allow drug approvals to be based on biomarkers and surrogate measures rather than health outcomes. This means that drugs will not need to be shown to treat effectively or cure diseases or even symptoms—rather, they will only need to demonstrate that they change a particular biomarker.

A New England Journal of Medicine (NEJM) article, “The 21st Century Cures Act — Will It Take Us Back in Time?” notes that:

..though a drug’s effect on a biomarker can make approval quicker and less costly, especially if the comparator is placebo, it may not always predict the drug’s capacity to improve patient outcomes.

If a drug doesn’t need to improve patient outcomes, how, exactly, is it effective? And how is it any better than snake-oil?

All pharmaceuticals come with side-effects and risks. The 21st Century Cures Act’s encouragement of drugs to be approved based on biomarkers rather than patient outcomes will enable pharmaceutical companies to produce and market drugs that have risks but no benefits.

A current example of biomarkers being used instead of health outcomes that is currently working out poorly is the HPV vaccine, which hasn’t changed cervical cancer rates at all, while leading to debilitating adverse-effects for thousands of people (mainly young women).

Additionally, the 21st Century Cure act “could substantially lower the standards for approval of many medical products, potentially placing patients at unnecessary risk of injury or death.” (New York Times, “Don’t Weaken the F.D.A.’s Drug Approval Process”). The Act will decrease the standards that must be met for clinical testing, and will rush new drugs, especially antibiotics, to the market without conventional clinical trials.

I suspect that the 21st Century Cures Act will initially inflate the healthcare system and its stocks—after all, it will remove many of the regulatory barriers that keep drugs from being rushed to market. However, when people realize that they are being hurt by ineffective, dangerous drugs, they will lose faith in the medical system as a whole, and eventually the system will collapse. Confidence in the safety and efficacy of pharmaceuticals is necessary for people to continue to consume them. The pharmaceutical industry is foregoing their credibility in exchange for short-term gains. They do so at their own risk.

Inept Regulatory Agencies

Just as the ineptitude of Moody’s, Standard and Poor’s and other rating and regulatory agencies contributed to the collapse of the housing market, the failure of the FDA to properly regulate pharmaceuticals is likely (in my opinion) to contribute to a collapse in the healthcare market.

The FDA is not adequately regulating drugs to protect the public. More than 124,800 people die each year because of direct adverse drug reactions and medical mistakes—and that’s not even counting those who die indirectly from adverse drug reactions that lead to chronic illness. This situation is unacceptable, and it shows that the FDA is not doing its job of protecting the public from dangerous drugs.

Pharmaceutical companies with large amounts of money, power and lobbying influence, are writing the rules of the game, and neither the FDA nor anyone else is stopping them from putting dangerous drugs onto the market. Any system that lacks checks and balances will eventually destroy itself—the medical system is no exception.

In The Big Short it is noted that, “His (Steve Eisman’s) experience with household finance had disabused him of any hope that the government would intercede to prevent rich corporations from doing bad things to poor people.” I suggest that the American people likewise disabuse themselves of the notion that the FDA is protecting patients from pharmaceutical corporation malfeasance. Dangerous drugs are killing and maiming millions of people, and the FDA—a large branch of the American government, is doing nothing to fix the situation.

Complicated Instruments

The housing market crash was due, in part, to the fact that CDOs and other financial instruments, were so complicated, and so poorly understood, that few people (and certainly not those in the regulatory agencies) realized that they were enabling malfeasance, foolishness, and fraud.

Likewise, pharmaceuticals are so complicated that few people, and certainly not those at the FDA, know how they work. For example, it is well-known that fluoroquinolone antibiotics (Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin and Floxin/ofloxacin) damage tendons and other connective tissues (there is a black box warning on all fluoroquinolones noting that they have this adverse effect). However, it is not known HOW fluoroquinolones damage tendons and other connective tissues, or what factors put an individual at risk for experiencing tendon ruptures after exposure to fluoroquinolones. Additionally, the delayed adverse-effects and the tolerance thresholds for fluoroquinolones are not understood at all—by anybody. There are a lot of very smart biochemists in the world who try to understand drugs, but even (maybe especially) they understand that the complex feedback and feed-forward loops in our biochemistry are poorly understood. Our biochemistry is so complex that consequences of disrupting one system, or one interaction, are unknown.

Most people assume that someone understands how drugs work. Understanding is necessary for proper regulation and most people assume that the FDA knows how each drug works well enough to properly regulate them. This is a false assumption, and when people realize that their assumptions about the FDA understanding the consequences of the drugs they are supposed to regulate don’t hold, they will lose faith in the medical system.

Loss of Credibility

When people are hurt by the medical system, they tend to opt out of it entirely. There are certainly some exceptions to that statement, but if you look at patient groups for people who have been hurt by medical devices (like Essure), psychiatric drugs (like benzodiazepines), other pharmaceuticals (like fluoroquinolones), or vaccines (like Gardasil), you will find people who are highly suspicious of the medical system as a whole. They opt out of the system and avoid consuming pharmaceuticals entirely after they have been hurt by a medical device, pharmaceutical, or vaccine. Most of them trusted the medical system before they were hurt by it, but after being grievously injured by a medical device or pharmaceutical, they no longer trust the medical system and opt out of using it whenever possible.

For people to trust the medical system and for it to maintain credibility, medicine must truly be evidence-based science. If it is not based in science, it is no better than the snake-oils of the past. If it is no better than snake-oils, will people trust it as much as they currently trust snake-oils?

When enough people are hurt by the medical system, and enough people opt out of it, it will collapse. I have no idea when that will happen, or even if it will happen. I believe that the 21st Century Cures Act will increase the likelihood of a healthcare system collapse, and that a medical system that seeks profits over health for the American (or any other nation) public, is not sustainable.

I suspect that, at some point in the future, people will look back at the medical system of the early 21st century and think that we were all fools for letting the pharmaceutical companies hurt and kill so many people. People will look back at this time and wonder why we trusted profit-motivated corporations with chemical concoctions that can permanently damage our cells, and even our DNA.

We trusted the pharmaceutical companies based on faith in the system. We had faith that medicine was evidence-based. We had faith that the regulatory agencies were protecting us. We had faith that proper tests were being done. We had faith in the notion that side-effects were “rare.” But when people get hurt, and they become one of the “rare” people injured by pharmaceutical company greed, their perspective changes—and many people lose faith in the system entirely. If enough people lose faith in the system, and if the system destroys its credibility, it will collapse.

We saw the collapse of the subprime housing market in 2008 and The Big Short explained the collapse in easy-to-understand terms. A similar stage is being set in the healthcare industry—with legislation that abolishes safety standards, incompetent regulatory agencies, and complexity that is mind-boggling. Just as people woke up to the fact that subprime mortgage bonds were not worth anything, eventually they will wake up to the fact that there are too many drugs that are doing more harm than good—and once the medical system loses credibility, it will crash. This anticipated crash can be prevented, but I don’t see any systemic movement toward that. We shall see.

Information about Fluoroquinolone Toxicity

Information about the author, and adverse reactions to fluoroquinolone antibiotics (Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin and Floxin/ofloxacin) can be found on Lisa Bloomquist’s site,www.floxiehope.com.

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SCOTUS Decision on Medication Safety: No Product Liability

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Over two years ago, amidst the DOMA and Voting Rights cases, the Supreme Court of the United States (SCOTUS) quietly ruled in favor of pharmaceutical companies indicating that generic drug makers have no legal obligation to update labeling and warn patients of nasty side-effects should those reactions occur post FDA approval. The case, Mutual Pharmaceutical Co. v Bartlett is a decision that will affect medication safety, healthcare responsibility and states rights for years to come, but few in the media bothered to cover the ruling.

Background of the Case: Mutual Pharmaceutical Co. v Bartlett

In 2004 Karen Bartlett was prescribed a topical NSAID pain-reliever called Sulindac for her shoulder pain. Sulindac is generic version of Merck’s Clinoril that is manufactured by Mutual Pharmaceutical. Shortly thereafter she developed toxic epidermal necrolysis (TEN) – a severe, life threatening and debilitating adverse reaction to the drug. Sulindac caused her skin to peel away from her body, a gruesome, flesh-eating reaction that spread over most of her body.

According to documents discovered later, the drug makers, Merck originally and Mutual for the generic version, knew about the potential for TEN but failed to label it. (Merck has since changed their labeling). Ms. Bartlett sued Mutual under New Hampshire’s design-defect law and was awarded $21 million. Mutual appealed under the auspices that they were not responsible for labeling because that rested with the federal government and the FDA. Since the FDA had not, in its original approval of the drug included the warning, the generic company could not change the labeling without violating federal law. Moreover, even though not labeling the drug violated New Hampshire state law, under which the case was originally brought, state law was in conflict with federal law.

Ms. Bartlett’s case before SCOTUS rested on the fact that Mutual knew about the ‘defect’ and failed to warn consumers. In state court she won. But in the appeal, Mutual contended that even though they knew about the dangers of the drug, as a maker of generic drugs, which are essentially copies of the name-brand drugs, they were not only not responsible for the labeling, Merck and FDA were, Mutual could not change the labeling under federal law. The state’s remedy, and upon which much of the SCOTUS case rested, was to not permit the sale of the ‘defective’ product – the drug – in New Hampshire. In other words, to abide by state law, Mutual should not have sold and not be allowed to sell the product in New Hampshire. SCOTUS again disagreed, effectively forcing the sale of ‘defective’ products’ in states.

There was no question that the drug was responsible for Ms. Bartlett’s injuries, but the since the case rested on the eminence of federal versus state law and the work-around proposed by the state, there was ample precedence for SCOTUS to overturn the lower court’s ruling and they did so, 5-4, mostly along party lines.

SCOTUS documents:

We must decide whether federal law pre-empts the New Hampshire design-defect claim under which respondent Karen Bartlett recovered damages from petitioner Mutual Pharmaceutical, the manufacturer of sulindac, a generic nonsteroidal anti-inflammatory drug (NSAID). New Hampshire law imposes a duty on manufacturers to ensure that the drugs they market are not unreasonably unsafe, and a drug’s safety is evaluated by reference to both its chemical properties and the adequacy of its warnings. Because Mutual was unable to change sulindac’s composition as a matter of both federal law and basic chemistry, New Hampshire’s design-defect cause of action effectively required Mutual to change sulindac’s labeling to provide stronger warnings. But, as this Court recognized just two Terms ago in PLIVA, Inc. v. Mensing, 564 U. S. ___ (2011), federal law prohibits generic drug manufacturers from independently changing their drugs’ labels.

In an opinion written by Justice Alito:

Accordingly, state law imposed a duty on Mutual not to comply with federal law. Under the Supremacy Clause, state laws that require a private party to violate federal law are pre-empted and, thus, are “without effect.” Maryland v. Louisiana, 451 U. S. 725, 746 (1981) .

The Court of Appeals’ solution—that Mutual should simply have pulled sulindac from the market in order to comply with both state and federal law—is no solution. Rather, adopting the Court of Appeals’ stop-selling rationale would render impossibility pre-emption a dead letter and work a revolution in this Court’s pre-emption case law.

Accordingly, we hold that state-law design-defect claims that turn on the adequacy of a drug’s warnings are pre-empted by federal law under PLIVA. We thus reverse the decision of the Court of Appeals below.

Why This Matters

SCOTUS ruled that manufacturers of generic drugs have no safety or labeling obligations beyond what was expressly given by the brand name company and the FDA approval. If the FDA approved a particular label and adverse events appear later, even when associated with the generic drug, the manufacturer of the generic drug is not liable. The makers of the brand name drug are still liable, but only for their brand name drugs. When an individual is given the generic version rather than the brand name version, even if those two compounds are exactly the same, the individual cannot sue the generic manufacturer per this new ruling, nor can he/she sue the brand name manufacturer, because the adverse event occurred with the generic and the brand name company is not responsible for the generic.

Since the majority of all prescriptions are for generic medications, this ruling effectively absolves drug manufacturers of responsibility for adverse events, once FDA approved.  What’s more, where states could have stepped in and prevented the sale of defective products within their boundaries, this ruling preempts that protection as well. If the federal agencies say it is safe, the states can do nothing. For a conservative court, this is a pretty big usurping of states rights.

Can we sue the FDA for failing to protect consumers?

Hormones MatterTM is looking for a writers to cover healthcare politics, policy and everything in between. We’re not funded and can’t pay you, but if you think this stuff matters and want to help bring these topics to the fore, send us a note.

This article was published previously on Hormones Matter in July 2013. 

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Evaluating Endocrine Disruptor Research

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Every now and again, we see a flurry of press releases flooding social media about new research purporting to prove that endocrine disruptors are safe. Most recently, the press has been focused Bisphenol A or BPA. New FDA proclamations suggest that it has no impact on health. When one reads the actual research upon which these statements are based, it says no such thing. Unless of course, the research is funded by industry, then it is almost always positive. A report in Newsweek found:

In 2013, for example, the American Chemistry Council spent more than $11 million on lobbying expenses, according to the Center for Responsive Politics. Industry groups have also funded, and in some cases written up, research done by governmental scientists. One 2008 investigation, by the Milwaukee Journal Sentinel, found that “a government report claiming that bisphenol-A is safe was written largely by the plastics industry and others with a financial stake in the controversial chemical.”

The report goes on to state that the FDA

…dismissed as irrelevant the vast majority of the BPA safety studies its own scientists reviewed in preparation for that official position statement. According to the FDA, for example, all of the 48 epidemiological studies reviewed had ‘no utility’ for the agency’s risk assessment, the formal process it undertakes to decide if a chemical is safe for human health or not.

With such contradictory claims about safety, who should we believe? How do we evaluate the safety research about endocrine disruptors? Here is a primer.

Industry Sponsored Research Is Biased

In a mini-review of research on bisphenol A (BPA) – the endocrine disruptor in plastics, of the 115 studies published on adverse effects of BPA 81.7% (94) reported significant adverse health effects (2004). However, upon review, it was found that 90% of the government funded, academic research found significant adverse effects while 100% of the industry-sponsored research found no ill-effects of BPA – none. This is a common theme across all industries – pharmaceutical included. When billions of dollars are on the line, industry sponsored studies will show favorable results more often than not. Always check the author’s conflict-of-interest disclosures at the back the article. If none are reported though, don’t assume they do not exist. Not all conflicts of interests are disclosed. You may have to do additional digging to identify conflicts.

FDA or EPA Approved Does not Mean Safe or Risk-Free

Both agencies have long histories of approving and then failing to recall dangerous chemicals, drugs and devices from the market. Their work is particularly incompetent in reproductive (endocrine) and women’s health: thalidomide, DES, Yasmin/Yaz, HRT, Mirena, Prolift to name but a few that have garnered the seal of approval by the FDA. Phthalates, BPA, Glyphosate for the EPA.  Remember the EPA doesn’t even study the female reproductive dangers unless research shows that a chemical impacts the male reproductive system.

Research Methods Matter

Perhaps more so than in any other field of science, endocrine research requires serious consideration of all aspects of the study protocol. This means that you cannot rely on a press release about the research to determine the study’s relevance. You must read the original research and evaluate the methods. (Reading original research is a good habit to have for all matters that affect your health and well-being). Once you pull the research, here are some things to consider.

  • Length of study. Most hormone reactions are longer term and span generations. If the study is short duration, as in the case with the industry sponsored GMO research or doesn’t include third generation effects, as with BPA research – question the results.
  • Population studied. Whether one is investigating a chemical or a drug in humans or in rodents, the sample population matters. Ascertaining safety of efficacy by testing only healthy young men, when the drug or chemical is meant for the real world where women, children, elderly, healthy and not so healthy individuals reside, is common practice and recipe for disaster. Same is true for rodent research – the strain, sex, age and health of the animal must be considered if the work is to be extrapolated to real humans. I read one study claiming that BPA was safe, but they used a strain of rats that was resistant to environmental estrogens. Of course, BPA’s estrogens would not affect these estrogen-resistant rodents.
  • Outcomes measured.  What does the study measure and how does it evaluate change? More often than not, industry sponsored research will not measure the appropriate endpoints or reproductive dangers. Sometimes this is sleight of hand, other times it is simply ignorance of the endocrine system’s far-reaching regulatory control. In either case, one has to evaluate what the study actually measures before determining its validity. Here, you can use a bit of personal experience – what systems, organs or behaviors are affected by your hormones? If the study didn’t measure any of these variables, then it’s probably not a very solid protocol.
  • ‘Gold-standard’ protocols are not always golden. It takes years, decades even for ‘gold-standards’ to become the accepted methods – often well after their utility has run out and newer, more sophisticated tools have reached the market. This has been the case for endocrine testing and endocrine disruptor evaluation. If a study rests all of its findings using a gold standard, it may not be using the most sensitive testing methods.
  • Clinical significance is not the same as statistical significance. Clinical significance means the chemical/drug has some meaningful impact on the health or well-being of the individual or animal. Statistical significance is just a math equation. A simple increase in sample size while limiting or ‘restructuring’ outcome variables is all it takes to derive statistical significance in most research. Does that mean the drug or chemical has clinically relevant health effects – not necessarily. The opposite is also true. Want to obfuscate the dangers of a drug/chemical? Do a huge study (preferably by combining dozens of poor quality individual studies into a meta analysis), throw everything but the kitchen sink into the analysis, do simple stats and highlight the lack of statistical significance in the death or injury rates. Only a small fraction of the study population died – but it wasn’t statistically significant, so the drug/chemical is considered safe. If the study does not study distinguish between clinical and statistical significance or downplays the death and injury rates as statistically insignificant, approach cautiously.
  • Hormone reactions do not conform to linear statistics. Damn it, how dare our complex physiology not conform to the simplicity of linear statistics. A common dose-response curve is highly linear, where a small dose elicits a similarly small response and a larger dose increase the response size. This is not case when dealing with endocrine disruptors. Hormone systems are complex and highly non-linear. Hormone dose-response curves are often in the shape of an inverted U where low doses elicit huge responses, mid-level doses elicit minimal responses and high doses again elicit huge responses. And so, any study measuring hormone effects using simple, linear, dose response calculations is bound to miss the effects entirely.
  • Hormones have metabolites (as does everything else). Metabolites evoke their own reactions. We know that some of the metabolites from BPA are stronger, 1000X stronger in fact, than BPA itself. Studies that don’t address the full complement of hormone products that circulate in our bodies as a result of exposure to something like BPA will severely underestimate the safety issues.

In a nutshell, we have to do our homework. There is no simple ‘Good Housekeeping Seal of Approval’ for products that impact health and well-being. We wouldn’t trust the marketing put out by car manufacturers or, worse yet, a car salesmen, about the safety, gas efficiency, repair history and comfort of a new/used car; why do we trust the makers of chemicals to give us the straight story. We shouldn’t. We have to become educated consumers of health research in order to protect ourselves.

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Photo by Markus Winkler on Unsplash.

This article was published previously in March 2013 and updated and edit for republication in 2015.

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