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Warning: Fluoroquinolone Antibiotics may Ruin your Life

Published on May 12, 2015

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Much of the recent debate (in the media and at the FDA) about fluoroquinolone safety has focused on whether or not people are being adequately warned about the dangers of fluoroquinolones. This argument has always bothered me because it assumes that if people are adequately warned of the risks of fluoroquinolones (or other drugs), the adverse effects that they suffer from are somehow okay.

I don’t think that it’s possible for warning labels on fluoroquinolone antibiotics to be “adequate,” and I think that chasing adequacy on the warning label is the wrong goal.

How could a drug warning label adequately warn someone of the possibility of their life being ruined? How could someone possibly be properly warned that every aspect of their health could be stolen from them? How could it be described on a warning label that you may live in pain for the rest of your life, you may lose your mental health, you may never be able to do the physical activities that you used to love and that every aspect of life that you’ve established (your relationships, your career, etc.) can be taken away from you by an adverse reaction to a drug? (Some of the stories of pain caused by fluoroquinolones can be found on the FQ Wall of Pain.)

Just think about the adverse effect of chronic insomnia. If you can’t sleep: you can’t think—and it’s difficult to hold down a job when you can’t think, relationships are difficult if your mind is sleep deprived and you can’t take care of your children or spouse, hormones are thrown out of whack by lack of sleep and your ability to exercise and regulate your appetite is negatively affected—both of which adversely impact over-all health, your ability to handle stress is diminished and autonomic nervous system dysfunction can result from dysregulation of your sympathetic and parasympathetic nervous systems, and more. (And if you’re prescribed Ambien for your sleep difficulties, you’re 3-5 times more likely to DIE than those who don’t take sleep aids SOURCE). From just that one symptom of fluoroquinolone toxicity, a life can be seriously disrupted—and there is not a single victim of fluoroquinolone toxicity who only has just one symptom—most have dozens. The effects of any one of the symptoms of musculo-skeletal or nervous system destruction can be ruinous to a person’s life.

The warning labels on fluoroquinolones are not adequate, and they won’t be adequate until they say something pretty close to, “These drugs can ruin your life.”

Pharmaceutical Adverse Effects

Yes, all drugs have side-effects. We’ve all heard it a million times. Pharmaceuticals are inherently dangerous. We all know that. But other things that are inherently dangerous aren’t given a blank check for causing harm like pharmaceuticals are. For example, cars are inherently dangerous. You can die in a car wreck. You can die from a car hitting you. They are dangerous and we all know it. But if someone murders you with a car, you can still hold the driver responsible. If someone drives under the influence of alcohol or drugs, they can be held responsible for the damage they caused. If a car has a defect and harm is caused to a person because of that defect, the car manufacturer can be held responsible for the harm caused.

On the other hand, it is difficult–often impossible–to hold drug manufacturers responsible for the harm that their products cause. If an adverse effect is listed on a warning label, you cannot sue because “you were warned.” If an adverse effect isn’t listed on a warning label, you cannot sue because you can’t prove that the drug hurt you. And if you get the rare opportunity to sue when drug labels change, you’ll be out of luck if you took a generic drug, as the Supreme Court made several decisions that made holding generic drug manufacturers responsible impossible.

Drug Manufacturer Responsibility

People who have been maimed by prescription drugs should not be fighting for adequate warnings on drug labels (though it is a step in the right direction and I don’t object to any proposed fluoroquinolone warning label changes). We should be fighting for justice and being able to hold the pharmaceutical companies and doctors who hurt us responsible for the harm that they have done.

In “A Public Policy Plan to utilize the Pharmaceutical Industry and Pharmacogenomics to reduce serious Adverse Drug Reactions, develop Personalized and Individualized Therapy, and provide a Functional Map of the Human Genome” (which is highly recommended – click the link and read the essay – it’s well worth your time) by JMR on http://fluoroquinolonethyroid.com/, it is noted that:

“Currently, their (the pharmaceutical companies) responsibility in this issue appears to end with the “appropriate warnings” provided in size 5 font on the drug inserts or via fast-talking monologues over the “happy commercials” on TV as they market directly to the consumer. And it’s usually only until enough people are maimed or killed that legal action or the FDA will actually make a difference in their behavior. There is a “buyer beware” mentality under the guise of “informed consent” – which is essentially “blaming the victim” for their own adverse reaction – but as far as the drug companies are concerned, they’ve “done their part”. The reality is, if the pharmaceutical companies and the FDA were truly concerned about the “health and safety” of the population they market to, they would put their money where their mouth is and take some of their billions in profits to study and research 1) who and why some people have these adverse reactions, 2)how to prevent these adverse reactions from happening, and 3) how to effectively treat them so as to return health and functionality to those who have been severely hit. Ultimately, this will help patient consumers by better identifying risk factors for individuals, and preventing these adverse reactions from occurring as well as provide appropriate treatments when they do occur.”

Pharmaceutical company profits are astronomical. Yet they contribute NOTHING to solving the significant problem of adverse drug reactions. They do NOTHING to take responsibility for the role that they play in devastating lives with their chemical concoctions. A very good solution to this problem is proposed in “A Public Policy Plan to utilize the Pharmaceutical Industry and Pharmacogenomics to reduce serious Adverse Drug Reactions, develop Personalized and Individualized Therapy, and provide a Functional Map of the Human Genome,” and I hope that the plan that JMR outlines is, someday, enacted.

Lack of Justice for Victims

Every once in a while the media gets a hold of a story of someone being monetarily-compensated for an injury caused by a drug or vaccine. These stories give the impression that it is possible for people to gain compensation from drug companies for injuries incurred. This is not the experience of any of the victims of fluoroquinolones. Most fluoroquinolone victims have run into a dead-end when pursuing justice and recourse against the pharmaceutical companies that hurt them. (And is there any amount of money that can really compensate for chronic pain, or injury to all of the tendons in your body, or loss of your life as a person who could think, move and work?)

Currently, the only thing that victims of fluoroquinolones can sue for is “failure to warn.” It’s the only thing lawyers are taking cases for. Victims can’t sue for catastrophic, life-altering, debilitating adverse effects that are listed on the warning label. Some of the things listed on the Cipro/ciprofloxacin warning label include seizures, psychotic reactions, insomnia, tendon ruptures, peripheral neuropathy, pain, and a lot more. If symptoms are listed on the warning label, the patient/victim is considered to be “warned.” Again, how is it possible to adequately warn someone of the risk that their life may be ruined by seizures, psychotic reactions, insomnia, tendon ruptures, peripheral neuropathy or debilitating pain?

If the warning labels for Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, Floxin/ofloxacin, and all other fluoroquinolones, had a highlighted black-box warning that said the following, maybe the argument of “you were warned” would hold a little weight:

“WARNING: THERE IS A SMALL, BUT SIGNIFICANT RISK THAT THIS ANTIBIOTIC MAY CAUSE WHOLE BODY TENDON, LIGAMENT, AND CARTILAGE DAMAGE, PERIPHERAL NERVE DAMAGE, CENTRAL NERVOUS SYSTEM DAMAGE, AUTONOMIC SYSTEM DAMAGE, ENDOCRINE SYSTEM DAMAGE, CARDIAC DAMAGE, GENOME (DNA) DAMAGE, AND MITOCHONDRIAL DAMAGE. These adverse effects may range from mild to severe, and may cause temporary or permanent crippling and partial or total disability. These reactions may occur immediately, or may be delayed for up to an unknown period of time after stopping the drug. It is unknown at this point in time who may be affected, and for what severity and duration. Prior exposure to these antibiotics may increase this risk in subsequent exposures. Taking this drug safely in the past does not guarantee that you will not have a reaction in the future. If this risk is acceptable to you for your current condition, then take this drug. However, if this is an unacceptable risk to you, be aware there are many alternative antibiotics available for most people with equal efficacy and less risks for your condition.” From “Responsible Use of Fluoroquinolone Antibiotics: The responsible, moral, and ethical approach (vs. the profit approach).”

Additionally, the list of items on Cipro is Poison that are not currently on the warning labels for fluoroquinolones, should be added to the warning label in order to “adequately warn” patients and physicians alike.

Objective: Real Change, Real Responsibility

The failure of the FDA to force the pharmaceutical companies to take responsibility for the harm that their drugs do is reprehensible. The failure of the legal system to give justice and recourse to victims of pharmaceuticals is also abhorrent.

Permanent, devastating harm is being done by fluoroquinolones and other pharmaceuticals. Though better information on warning labels may be helpful, the objective of those seeking systemic change shouldn’t be changes in the warning labels, it should be pharmaceutical company responsibility for harm done, and justice for victims.

Postscript: Responsible Use of Fluoroquinolones

Please click the links on “A Public Policy Plan to utilize the Pharmaceutical Industry and Pharmacogenomics to reduce serious Adverse Drug Reactions, develop Personalized and Individualized Therapy, and provide a Functional Map of the Human Genome” and “Responsible Use of Fluoroquinolone Antibiotics: The responsible, moral, and ethical approach (vs. the profit approach).” They are both insightful, informative, thoughtful proposals. Just a small sampling of the stories of victims of fluoroquinolones can be found on the FQ Wall of Pain.

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.

Participate in Research

Hormones Matter^TM is conducting research on the side effects and adverse events associated with the fluoroquinolone antibiotics, Cipro, Levaquin, Avelox and others: The Fluoroquinolone Antibiotics Side Effects Study. The study is anonymous, takes 20-30 minutes to complete and is open to anyone who has used a fluoroquinolone antibiotic. Please complete the study and help us understand the scope of fluoroquinolone reactions.

Hormones Matter^TM conducts other crowdsourced surveys on medication reactions. To take one of our other surveys, click here.

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Antibiotics during Pregnancy: Finally Pharmacokinetic Research

by Chandler Marrs, PhD

Published on February 5, 2015

2791 views

A common refrain of mine is the lack of drug testing in women, especially pregnant women and relative to the enormous hormone changes women experience across a cycle, across pregnancy or postpartum and frankly across the lifespan. Hormonally, a 16 year old is not the same as a 45 year old. A woman’s biochemistry is not the same early in her cycle as it is late in her cycle. Nor is it the same when she is on oral contraceptives or hormone replacement therapies compared to when she is not and most especially, the pregnant woman’s biochemistry is hugely different than that of a non-pregnant woman. And yet, despite the lack of testing, lack of data, and limited understanding about how medications work relative to a woman’s hormonal state, women, pregnant and non-pregnant alike, are routinely prescribed medications for which we have a very poor understanding of the basic pharmacokinetics (how a drug travels through the body) or pharmacodynamics (what it does and how it works).

Ever so slowly, this may be changing. A group of researchers from the University Chicago, recently published a study on the Influence of Body Weight, Ethnicity, Oral Contraceptives and Pregnancy on the Pharmacokinetics of Azithromycin in Women of Childbearing Age. Though the study was small with only 53 pregnant women and 25 non-pregnant women, it represents one of the few published pharmacokinetic studies done on a drug routinely prescribed to pregnant women that evaluates hormone state.

Azithromycin: the Most Common Antibiotic Prescribed During Pregnancy

Azithromycin, more commonly known as Zithromax, Azithrocin, Z-Pack or ZMax, is the most frequently prescribed antibiotic for a range of bacterial infections of the ears, skin, throat. It is believed to be safe during pregnancy, despite having a pregnancy category rating B (a designation given a medication that has not been tested in human pregnancy but appears to be safe in animal studies). Some research shows that Azithromycin appears to have no more adverse reactions than other antibiotics, but whether it is truly safe, whether pregnant pharmacokinetics are different than non-pregnant or how they are different had never been determined. The University of Chicago study demonstrated what many have always suspected:

pregnant women metabolize medications differently (more slowly) than non-pregnant women
oral contraceptives slow drug metabolism
and interestingly enough, African American women show different pharmacokinetic patterns than Caucasian, Hispanic, Pacific Islander or Asian women

Pharmacokinetics: The Basics of Drug Disposition

The disposition of a drug (how it travels through the body), is affected by a number of physiological variables including plasma volume (greater when pregnant, lower when dehydrated), protein binding (fat soluble drugs travel through the system bound and protected from metabolism-preparation for excretion- by carrier proteins), liver and kidney function (our waste removal systems). Any alteration to these variables affects how long a drug stays in the body, how much of the drug is available to exert its effects on the tissues or organs, and how effectively it is cleared from the system. Determining the disposition of the drug- the pharmacokinetics- is very important for drug dosing and ultimately, safety. Every one of those drug disposition variables is affected by the hormone changes of pregnancy, postpartum (menstruation, menopause, oral contraceptives, HRT, etc.).

In the case of Azithromycin, pregnancy significantly slowed metabolism and clearance of the drug in pregnant Caucasian, Hispanic, Pacific Islander and Asian women, but not apparently in African American women or women not taking oral contraceptives. Translated, this means that pregnant Caucasian, Hispanic, Pacific Islander and Asian women were exposed to more drug, for a longer period of time, than were African American women. Ditto for women taking oral contraceptives versus those who were not taking oral contraceptives.

The researchers did not investigate whether hormonally-related changes in immune function interacted with the pharmacodynamics of the drug–rendered it more or less clinically effective. Nor did they evaluate whether or how other medications may have influenced drug disposition. As an aside, women in the pregnant group were taking more medications, in addition to the antibiotic in question, than the non-pregnant group.

What this research does show, however, is that hormones, or at least ‘hormone state’ affects drug disposition significantly. Additional studies are needed to determine how and if more customized dosing is required in pregnant and non-pregnant women alike.

This article was posted previously in September 2012.

Who’s in Charge of GMO Regulation?

by Lisbeth Prifogle, MFA

Published on May 9, 2014

3427 views

We’ve all seen, and probably shouted, the catchy slogans – Say No to GMO! Keep your genes out of our meats and greens! We’ve read countless articles on the dangers of the genetically modified organisms (GMO) as well as the chemicals and foods they are sprayed and fed. We sign petitions, hit the “share” button to the various social media outlets, and get into screaming matches with friends and family members who don’t see the harm in GMOs. But do any of us really know how GMOs are approved? Do we know the best way to fight them? I’m going to guess no since it’s the eighth day of an open public commenting period about the use of DOW’s 2,4-dichlorophenoxyacetic acid (2,4-D), one of the main components of Agent Orange used in Vietnam, at the Environmental Protection Agency (EPA) and there are only a whopping 340 comments at this time. It actually didn’t occur to me that I didn’t really understand the full approval process until stumbling across the “public commenting period.” What I found was rather shocking.

Genetically modified foods and the chemicals that are sprayed on them as a result of their herbicide and pesticide resistance properties fall under the regulatory span of the United States Department of Agriculture (USDA), Food and Drug Administration (FDA), and EPA. What follows is a brief explanation how each agency works and what acts have been passed to monitor, or attempt to monitor, GMOs. Under the regulations of all three of these agencies, only the following categories of GM crops are monitored:

Plant-Incorporated Protectant (PIP) – a plant that produced pesticidal proteins or other chemicals as a result of genetic material from a bacterium into the plant. In these plants, scientists add modify the genes of corn, for example, to express a pesticidal property so that when pests digest the crop it releases a bacterial protein that will kill the pest. Yes, if we digest this plant we are also digesting this poisonous bacterial protein.

Genetically Modified Microbial Pesticides – bacteria, fungi, viruses, protozoa, or algae that has been modified to express a pesticidal properties like a PIP. In this case, the microbial pesticides are sprayed on the crop.

Herbicide-Tolerant Crops – this is the answer to the problem of weed-killer killing the crop it’s sprayed on. Like PIPs, the crop has been genetically modified to withstand the herbicides by adding the herbicide to the genetic make-up of the crop. The most commonly herbicide-tolerant crop is tolerant to glyphosate, a known carcinogen and hormone disrupter. Like most chemical substances, the weeds are becoming resistant to glyphosate in Monsanto’s Round Up. Thus Monsanto has teamed up with DOW Chemical to create crops resistant to 2, 4-D, as I mentioned before this is the main chemical ingredient for Agent Orange. Like PIPs, we are not only ingesting and breathing 2,4-D, being sprayed on our food, but it is actually part of our food.

Other GMOs that interchange DNA from one plant or animal species to another do not fall under the regulation of these agencies (and as far as I have researched, they do not seem to fall under any other regulating agency either).

USDA

The USDA is the U.S. federal executive department responsible for developing and executing federal government policy on farming, agriculture, forestry, and food. It aims to meet the needs of farmers and ranchers, promote agricultural trade and production, work to assure food safety, protect natural resources, foster rural communities and end hunger in the United States and abroad. The USDA is not responsible for monitoring the safety of GMOs for human or animal consumption, but rather how it affects plant health. Within the USDA is the Animal and Plant Health Inspection Service (APHIS), which is responsible for protecting agriculture from pests and diseases. Under APHIS is the Biotechnology Regulatory Services (BRS) which is part of a science-based federal regulatory framework to protect America’s agricultural resources and the broader environment. The BRS has strict regulations for any new organism either imported, crossing state lines or being introduced, but only to ensure that it does not present a plant pest risk.

As long as GMOs either introduced to American farms or imported do not present a risk to plants, the USDA does not have regulate it. The responsibility of safety for human and animal consumption is passed to the FDA.

FDA

The FDA is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics and veterinary products. As far as GMOs go, under the Federal Food, Drug, and Cosmetic Act (FFDCA), as long as the bioengineered food is substantially equivalent to non-GM crops or is generally recognized as safe, it does not require pre-market approval. There are no specific regulations for GMOs and they fall under the same regulation as conventional foods. In 1992, the FDA published a policy statement titled: Food for human consumption and animal drugs, feeds, and related products: Foods derived from new plant varieties; policy statement, 22984. This policy statement specifically addresses genetically modified foods, but disturbingly there is little regulation within this policy:

Under this policy, foods, such as fruits, vegetables, grains, and their byproducts, derived from plant varieties developed by the new methods of genetic modification are regulated within the existing framework of the act, FDA’s implementing regulations, and current practice, utilizing an approach identical in principle to that applied to foods developed by traditional plant breeding. The regulatory status of a food, irrespective of the method by which it is developed, is dependent upon objective characteristics of the food and the intended use of the food (or its components).The method by which food is produced or developed may in some cases help to understand the safety or nutritional characteristics of the finished food. However, the key factors in reviewing safety concerns should be the characteristics of the food product, rather than the fact that the new methods are used.

In other words, as long as a protein remains a protein and a carb remains a carb, it doesn’t matter how it’s produced. In 1997, the FDA started a voluntary consultation process for GM crop developers, but seeing as it is voluntary, I would hardly call that legitimate legislation. In 1998, Monsanto’s then director of corporate communications, Phil Angell, stated:

“Monsanto should not have to vouchsafe the safety of biotech food. Our interest is in selling as much of it as possible. Assuring its safety is the FDA’s job.”

The FDA’s role should be to monitor the safety of these new genetically modified plants that are used both as human food and animal food, however, there are simply no regulations specifically for GMOs.

GMO Labeling

In regards to labeling, per the FFDCA, the only labeling required from the producer is the common or usual name, or in the absence thereof, an appropriate descriptive term. The only exception is if a safety or usage issue exists due to the genetic mutation and consumers must be alerted. For example, if peanut genes are added to a tomato, the tomato can no longer be called a tomato because potential allergic reactions. I’ lettersizeLogo m sure in cases like this, the marketing department is full of clever titles like tomatut or peanato. Currently, 25 states have introduced mandatory GMO labeling legislation. Vermont and Connecticut have actually passed laws forcing GMO products to be labeled. The Non-GMO Verification Project is a nonprofit organization that provides third party volunteer testing and labeling for products. I always look for Non-GMO Project Verified label when I shop.

The USDA only cares about the plant, the FDA doesn’t care as long as a tomato remains a tomato. A majority of people don’t believe the various reports of cancer and infertility caused in lab mice fed GMOs and ignore the fact that there have not been any comprehensive studies on the affects of human consumption of GMOs, but even if we deny that GMOs could be dangerous, there is no denying that spraying dangerous chemicals such as glysophate and Agent Orange on fields and backyards is dangerous and should be regulated, right? That’s where the EPA comes into play.

EPA

The EPA is another regulatory agency. It has primary responsibility for enforcing many of the environmental statutes and regulations of the United States. Congress authorizes the EPA to write regulations that explain the critical details necessary to implement environmental laws and Presidential Executive Orders.

The EPA’s role in the environmental safety of GMOs falls under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). According to the EPA website:

FIFRA provides for federal regulation of pesticide distribution, sale, and use. All pesticides distributed or sold in the United States must be registered (licensed) by EPA. Before EPA may register a pesticide under FIFRA, the applicant must show, among other things, that using the pesticide according to specifications “will not generally cause unreasonable adverse effects on the environment. FIFRA defines the term ”unreasonable adverse effects on the environment” to mean: “(1) any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide, or (2) a human dietary risk from residues that result from a use of a pesticide in or on any food inconsistent with the standard under section 408 of the Federal Food, Drug, and Cosmetic Act.”

FIFRA was first passed into law in 1947, but has been amended since then. In 1972, FIFRA was essentially rewritten and amended by the Federal Environmental Pesticide Control Act. In 1996, it was again significantly amended as the Food Quality Protection Act.

While the EPA seems to hold the strictest regulations of the three agencies discussed in this article, it seems they are still coming up short. In order for a new pesticide to acquire a license from the EPA, the producer must provide more than a hundred scientific tests and studies. But, like the FDA, the producer of the pesticide provides the tests and the EPA does not actually conduct any tests on the new product. Furthermore, if it is being licensed for use on a crop less than 300,000 acres it is not considered sufficient economic incentive for registration.

EPA and GMO Regulation

Whether or not the EPA is actually regulating safe limits of pesticide aside, let’s look at their role in GMOs. Under FIFRA, the EPA provides legal requirements for registration and licensing of pesticides and therefore only monitors GMOs that are pesticidal in nature (PIP, Genetically Modified Microbial Pesticides, or Herbicide-Tolerant Crops).

The EPA also sets tolerances, and exemptions from tolerances, for the allowable residues of pesticides applied to food and animal feed under the FFDCA. However, given the pollution levels and a new study conducted by the California Department of Public Health showing a high number of California children being exposed to high level of pesticides at schools located near farms, I don’t have much faith in the EPA’s ability to safely regulate the use of pesticides.

Are GM Foods Safe?

In the end you have to ask – are GMOs safe for me and my family? Some people believe that the USDA, FDA, and EPA regulations are enough proof that they are safe, however, studies in rats fed GMO food over the course of a life time suffered premature deaths (up to 50% of males and 70% of females) and had severe organ damage (specifically liver and kidney). Also, the rats drank trace amounts of Roundup in their water (within legal limits set by these regulatory agencies) and had a 200% to 300% increase in large tumors (for more information and photos, click here).

What can YOU do?

Learn more. Do your own research on whether or not GMOs and the chemicals used on our crops are safe for consumption and the environment.

Spread the news. My friends and family are sick of hearing me telling anyone who will listen about the dangers of GMO, but I believe one person can make a difference so I keep fighting the good fight.

Buy organic, non-GMO foods. There are plenty of websites, like the Environmental Working Group, dedicated to helping families buy organic on a tight budget. Buying from local farmers can reduce cost (depending on where you live) or even buying your online. Another budget friendly tip – don’t eat out. We vote for or against GMO every time we check out at the grocery store or favorite fast food chain – make your vote count!

Get involved. I don’t mean you should quit your job to travel across the country leading protests (although if you can, go for it!). Simply watching legislation and writing in to the EPA and FDA and telling them you DON’T want Agent Orange sprayed in your backyard, is something everyone can do. We have until May 30th to tell the EPA we do not approve. Click here to add your comments. There are numerous organizations that write and submit petitions against GMOs. The Center for Food Safety is running a campaign against the use of DOW Chemical’s 2,4-D.

What do you and your family do to stop the spread of GMOs? What are your favorite NON-GMO products?

What’s in Your Meat?

by Chandler Marrs, PhD

Published on February 13, 2013

3122 views

A lot of antibiotics, growth hormones and myriad of antibiotic-resistant strains of bacteria, that’s what’s in your meat. The FDA’s Center for Veterinary Medicine released its third annual report on antimicrobials sold or distributed for food-producing animals in 2012. Guess what, the 2008 ‘guidance’ offered to industrial meat farmers to reduce the use of prophylactic antibiotics in their livestock isn’t working out so well. According the report, both antibiotic use and antibiotic-resistant strains of bacteria are increasing, rather rapidly, especially in poultry. In 2011:

29.9 million pounds of antibiotics were sold in the US for meat and poultry production
7.7 millions pounds of antibiotics were sold in the US for humans

Out of some 1840 retail meats tested (meats destined for sale, not the animals, the packaged meats in your supermarket):

Escherichia coli (E. coli) bacteria was found in 64% of the samples. Pork chops had the lowest prevalence (39.8%) and ground turkey had the highest (80.2%). (Remember the connection between E. coli in poultry and treatment resistant urinary tract infections in women.)
Salmonella bacteria was found in 44.5% of meats sampled and antibiotic resistance grew from 10-44% depending upon the strain of bacteria.
Multi-drug resistance grew by 43% in chicken breast and 33% in ground turkey since 2010.

And that’s just the beginning. Earlier this year, researchers found the deadly methicillin-resistant staphylococcus aureus (MRSA) bacteria in pig farms and retail meats. MRSA was not tested in these samples, neither were growth hormones or growth promoting drugs like ractopamide – banned in other countries but not in the US – though fed to 60-80% of the livestock here and thought to be responsible for more sickened or dead pigs than any other drug on the market. Nope, those endocrine disrupting chemicals weren’t measured.

It seems we humans are a veritable garbage dump for chemical waste disguised as food. Thank you Big Ag! And thank you FDA for such a stellar job ‘regulating’ these chemicals. It was a stroke of brilliance letting these companies decide the safety of their own drugs and chemicals. It is much more efficient that way. And providing gentle ‘guidance’ to nudge them to do to the right thing – that shows leadership and an unparalleled commitment to human health.

I think it’s time for a new model, how about you?

Will the Sunshine Act Curb Pharma Payments to Doctors?

by Chandler Marrs, PhD

Published on February 12, 2013

2632 views

Just two weeks ago, as part of the Affordable Care Act, the Centers for Medicare and Medicade Services published its final rule on the reporting mandates for physician payments from pharmaceutical and medical device makers. Called the Physician Payment Sunshine Act, this law requires:

applicable manufacturers of drugs, devices, biologicals, or medical supplies covered by Medicare, Medicaid or the Children’s Health Insurance Program (CHIP) to report annually to the Secretary certain payments or transfers of value provided to physicians or teaching hospitals (“covered recipients”).

Why Is This Important?

For too many physicians, the medications they choose to prescribe are influenced by these payments. A case control study at a university hospital found that physicians who requested a new drug be added to the formalary were 19X more likely to have received money or gifts from the drug company. According to the New England Journal of Medicine as of 2007 fully 94% of all physicians accepted gifts from pharma, although by 2009, only 84% of physicians accepted gifts from pharma.

In their Dollars for Docs series, Propublica not only detailed the trail of money from the pharmaceutical industry to physicians and the changes in prescribing practices that ensued, but also, found that over 250 of the physicians receiving these payments had been disciplined by their state’s medical boards with the public never the wiser.

Wouldn’t you want to know if your physician was receiving payments to ‘consult’ on a particular drug or medical device? What if that drug or device turned out to be dangerous like, Avandia or Vioxx or in the case of women’s health Yasmin, Yaz or Ocella or even the vaginal mesh implants? I would. And soon, you will be able to find this information, at least for those physicians that accept medicare or medicade. For the remaining physicians, we’ll have to rely on the stellar, investigative reporting of organizations like Propublica.

What Is the Physician Payment Sunshine Act?

The Physician Payment Sunshine Act mandates payments or ‘transfer of value’ to physicians be reported to the Secretary of Health and Human Services. Collection of this information is set to begin in August with full compliance and reporting expected in 2014.

The cool thing about this act, if it is implemented correctly, is that payment or transfer of value includes money for marketing activities, such as promotional or conference talks and consultation services. It also will include research grants and “charitable” contributions (which usually come with some promotional strings attached), funding to attend conferences, honoraria and royalties and license fees. The pharmaceutical and device companies making these payments will be required to list names, address, amount of payment, date of payment(s) and describe the service for the payment made for anything over $10. The database will be searchable so that patients can determine what monies their physicians received from pharma or device companies.

Where the Sunshine Act Fails

From the original to the final regulations, a work-around for paying physicians to speak at pharma sponsored continuing medical education (CME) events was added. According to the regulations, so long as the sponsoring company doesn’t pay the physician/speaker directly, those fees are acceptable and need not be listed publicly. Instead, the pharma company must pay a third party vendor to arrange and pay the speakers. CME conferences are where most physicians learn the latest drug therapy, device or medical technique. It is unlikely that speakers at these conferences will speak against the sponsor’s product. Funneling the payments through a third party vendor, who is also paid by the sponsor, is no more than a quick pass at laundering the fees.

What Do Physicians Think About the Sunshine Act?

The opinions are mixed, at least publicly. Some physicians are fully behind the new efforts in transparency and have begun their own campaigns to disentangle the marketing relationships between pharma and physicians. The National Physicians Alliance sponsors the Unbranded Doctor campaign:

The National Physicians Alliance’s Unbranded Doctor is unmasking the pharmaceutical industry’s bogus claim that its marketing efforts are just educational ventures for physicians. By signing up physicians to renounce gifts, lecture fees, and “education” from companies, the Alliance is championing objectivity, integrity, and professionalism.

—Jerome Kassirer, MD
former Editor-in-Chief, New England Journal of Medicine

Similarly, the British Medical Journal (BMJ) has positioned itself as a lead proponent of transparency and open data. On the other hand, CME released a survey of over 500 physicians asking if the new regulations to list publicly whether industry sponsored their attendance at CMEs would curtail their attendance. The result was a resounding – yes.

75% of physicians said the disclosure rules would affect their decision to attend at least somewhat.
47% of physicians said the disclosure rules would affect their decision to attend to a great extent.
46% of CME speakers said the disclosure rule would affect their decision to participate as a panelist or presenter to a great extent
25% percent said it would somewhat affect their participation

Will the Sunshine Act Curb Pharma Payments to Doctors?

Probably not. Unless and until full transparency about medical research, clinical trials and adverse events are made open and accessible to patients and physicians, medical marketing, fabricated data or omitted data, publication bias, and conflicts of interest will continue to pervade our healthcare system. Dangerous medications like the Yasmin suite of birth control pills and unsafe medical devices like J&J’s Gynecare Prolift will remain on the marketplace long after any reasonable person could vouch for their safety.

The Sunshine Act will, however, give patients one more tool to evaluate their physicians and give researchers, investigators and others a way to identify and publicize bad behavior. Who knows, maybe it will even save some money.

To find out if your physician receives money from the pharmaceutical industry go to Dollars for Docs.

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What is DES and Why You Should Care

by Chandler Marrs, PhD

Published on February 6, 2013

6773 views

Diethylstilbestrol or DES is synthetic estrogen developed in the late 1930s. It was initially approved by the FDA in 1941 for vaginitis and as an early hormone replacement therapy for menopausal women. It was later approved a variety of low estrogen indications. In 1947, the FDA approved its use in pregnant women with a history of miscarriage. DES had been used off-label for miscarriage prevention since the early 1940s, despite the fact that little evidence supported its use and animal studies indicated clear carcinogenic and congenital reproductive abnormalities in the offspring.

After 10 years of widespread use and marketing, a double-blind, placebo-controlled study on the efficacy of DES was finally conducted. As one might expect, it was found ineffective in preventing miscarriage. In fact, women on DES had a higher risk of miscarriage. Later studies in the 1960s began detailing the adverse events associated with this drug. Despite mounting evidence of the dangers of diethylstilbestrol, it remained on the market and widely used through the early 1970s in the US and into the 1980s in some European countries. In the US alone, it is estimated that between 5-10 million women and their children were exposed to DES. Because the compound was never patented, 287 drug companies sold DES under a multitude of brands and for an array of low-estrogen conditions.

In addition to diethylstilbestrol use in humans, it was used widely in farm animals to fatten up the chickens and cattle, beginning in the early 1950s and through the 1970s. DES was found to cause cancer and interestingly enough, cause gynecomastia (man boobs) and sterility in the poultry workers. Well before DES was banned in humans, the FDA banned it in poultry under the newly enacted Delaney Clause to the FDA 1958. It seems man boobs and sterility was all it took to ban the product in chicken farms. Miscarriage, congenital abnormalities and cross-generation cancer risks, on the other hand, were not sufficient to initiate its ban in large cattle or humans. It was another 20 years before diethylstilbestrol was banned in cattle or humans and many years after before it was removed from the food chain (if it even is now). “In 1980, half a million cattle from one hundred and fifty-six feedlots in eighteen states were found with illegal DES implants.” Even upon FDA’s decision to withdraw its approval of DES in cattle and feed, it did so on grounds of the procedural non-compliance of the manufacturers, erstwhile maintaining the safety of diethylstilbestrol, “because there is no evidence of a public health hazard.” Despite its clear carcinogenic and teratogenic risks, it is still used in veterinary care.

Diethylstilbestrol Risk for Humans

Amongst those suffering the most from DES exposure are men and women who were exposed in utero as developing fetuses. DES was given to pregnant women from the 1940 through 1971 in the US and into the 1980s in some European countries. If you were born anytime between 1940 and 1980, ask your mom if she was given DES to prevent miscarriage. It was sold under dozens of brand names (click here for brand names).

Sons and Daughters of DES

The range of depth of reproductive abnormalities, endocrine and health issues found in the children and grandchildren of DES moms, is expanding regularly. If your mom or grandmother was given DES, here is a list of health issues to look for:

DES Daughters

In a large cohort study comparing the reproductive health of the daughters of women prescribed DES during pregnancy to the health of women whose mothers had not been given DES, researchers found a 2-8 times higher incidence of the following conditions:

Infertility
Spontaneous abortion
Ectopic pregnancy
Second trimester pregnancy loss,
Preterm delivery
Preeclampsia
Stillbirth
Neonatal death
Early menopause
Breast cancer
Cervical neoplasia
Clear cell adenocarcinoma

The increased risk of miscarriage and adverse pregnancy outcome in DES daughters is overwhelmingly linked to structural abnormalities with uterus. Fully 69% of DES daughters who have had difficult with infertility and miscarriage have an abnormally shaped uterine cavity or structural changes to the cervix (44%).

DES and Endometriosis

Of particular interest to Hormones Matter followers, DES exposure in utero is linked to an 80% increase in endometriosis. We will be digging deeper into the DES – endometriosis connection in the coming weeks.

DES Sons

Sons of women given DES during pregnancy are three times more likely to have structural abnormalities of the genitals including:

epididymal cysts
undescended testes
extremely small testes
hypospadias (misplaced urethral opening)
micropenis (some, but not all)
increased risk of infertility
increased risk of testicular and prostate cancer (although the research has just begun)

In the animal research, offspring of DES exposed mothers shows a vast array of structural and morphological changes across multiple physiological systems ranging from sex reversal in male fish to structural and functional changes in pancreatic cells. The full scope of damage from DES is yet to be determined.

DES Grandchildren

Yes, there are third generation effects from this drug. Researchers are just beginning to untangle the third generation effects. In women, menstrual irregularities appear more common as do the various forms of cancer, but the data are unclear. In men, hypospodias may be more frequent, but again the data are mixed.

Endocrine disruptors like diethylstilbestrol impact human health in ways we are only just beginning to understand. The current methods for measuring and calculating risk for endocrine disruptors is out-dated and based on standard, linear, dose-response curves that not only fail to account for how hormone systems work, but also fail to address possible transgenerational effects. Hormones matter and sooner or later we must address the broader endocrine system in pharmaceutical and environmental regulation. As women, we ought to be fighting for sooner.

FDA Approval: The Mighty Drug Label

by Lynda Chang

Published on January 23, 2013

2345 views

In the first two articles for our educational series on the U.S. Food and Drug Administration (FDA), we covered what the FDA is about, and what it means when an approved drug is used off-label. We now dive into Part 3 of our continuing series: The drug label.

The CDER and the FDA

The Center for Drug Evaluation and Research (CDER) is part of the U.S. Food and Drug Administration (FDA), and is responsible to evaluating and monitoring new drugs before they can be sold. CDER monitors both prescription and over-the-counter brand name and generic drugs to ensure they work correctly and that their health benefits outweigh their known risks.

Drug companies seeking approval for a drug must conduct their own research, and then provide their test findings to CDER, where a team of salaried physicians, toxicologists, chemists, statisticians, mathematicians, pharmacologists, project managers, and other scientists review the company’s data and proposed labeling. It should be noted that it is up to the drug company’s discretion on what they report to CDER. We assume they report the good, the bad and the ugly but one has to question if this is reality when the drug company has much at stake in the approval process. Indeed, many recent cases suggest not all data are provided, Vioxx, Bextra the most notable.

In the perfect world, the CDER team will conduct its independent and unbiased review to give the drug approval for sale, noting CDER does not test the drugs, but does its own limited research into a drug’s quality, safety and effectiveness as part of its responsibility to consumers. In the real world we see evidence that this is not a fail-proof system as there have been a bevy of recent cases where drug companies have not submitted all of their data. In the quest for approval, they submit only positive data and/or falsified data.

FDA Ethics

All FDA employees are subject to the following ethical standards, noting that this is in an ideal world:

Financial disclosure prohibiting certain employees from holding a financial interest in a significantly regulated company, whereby more than 10% of the firms products or income are derived from products or services regulated by the FDA.
Federal Conflict of Interest Statutes: The Federal conflict of interest statutes assure that Government employees conduct Government business effectively, objectively, and without improper influence. These statutes govern representational activities, financial interests, outside compensation, and use of official information by Government employees.
CDER Manual of Policy and Procedures: Outside Activities: FDA Conflict of Interest Regulations require advance administrative approval prior to an employee participating in certain outside activities, whether paid or unpaid.
FDA Ethics Program – Post Employment Restrictions: FDA employees are subject to certain restrictions after they leave Federal service

Drug History and Other Public Information

Anyone can search for FDA approved drug products at Drugs@FDA to look up official information and find:

Labels for approved drug products
Generic drug products for an innovator (brand name) drug product
Therapeutically equivalent drug products for an innovator (brand name) or generic drug product
Cnsumer information for drugs approved from 1998 on
All drugs with a specific active ingredient
The approval history of a drug

Off-label Versus New Approvals

Over the lifespan of an approved drug, new medical evidence often points to new uses for an already approved drug. Sometimes the drug is used off-label for these conditions – see my article,”Going off on the off-label trail” for details. Alternatively, a company may wish to gain official approval to use the drug in a new way for a new condition. To gain approval, the FDA requires additional studies to for each new use. It is up to each drug company to decide whether or not to target approval for new uses, with the target payoff being the ability to market and get a higher return on its investment than off-label use.

BOTOX® and the FDA

One such company that has been successful in this venture is Allergan with its blockbuster drug BOTOX® (onabotulinumtoxinA). BOTOX is widely known as an aesthetic treatment for facial wrinkles, however it was initially approved by the FDA in 1989 to treat blepharospasm (eyelid spasms) and strabismus (visual problem in which the eyes are not aligned properly and point in different directions, aka crossed eyes). Allergan then sought and received FDA approval for the following:

Year 2000: BOTOX® therapy for cervical dystonia to reduce the severity of abnormal head position and neck pain.
Year 2002: BOTOX® Cosmetic (onabotulinumtoxinA) – the same formulation as BOTOX® – with dosing specific to moderate to severe frown lines between the brows.
Year 2004: BOTOX® for severe underarm sweating when topical medicines don’t work well enough.
Year 2010: BOTOX® therapy for increased muscle stiffness in elbow, wrist and finger muscles with upper limb spasticity, and BOTOX® for the prevention of headaches in adults with Chronic Migraine who have 15 or more days each month with headache lasting 4 or more hours each day in people 18 years or older.
Year 2011: BOTOX® to treat leakage of urine (incontinence) in adults 18 years and older with overactive bladder due to neurologic disease who still have leakage or cannot tolerate the side effects after trying an anticholinergic medication.

The word “botox” stirs up negative connotations; rat poison and over-plasticized vain men and women with frozen faces. In reality, it’s a two-chain polypeptide protein and neurotoxin produced by a purified form of bacterium Clostridium botulinum. It works by relaxing the contraction of muscles by blocking nerve impulses, resulting in muscles that can no longer contract. It was discovered by scientists in the 1950s to reduce muscle spasms, further studied as a treatment for crossed eyes in the 1960s and 1970s, and subsequently recognized by Allergan in the late 1980s for its potential multiple medical uses. Allergan has worked with the FDA to follow the process, but has also been in the hot seat with a 2010 settlement when it was charged with illegally promoting and selling the drug for unapproved uses.

FDA Framework is Not Perfect

The FDA provides a framework for reviewing products before they hit the market. It is not perfect and as we have seen in recent years, likely requires a large overhaul. Ultimately, however, the responsibility for our health and healthcare decisions lies with each of us. Do yourself a favor, explore the FDA and other medication websites. Learn about the medications you use. Do the research. Your health depends upon it.

Going off on the off-label trail

by Lynda Chang

Published on December 19, 2012

2392 views

Did you know that your doctor can send you to the pharmacy with a prescription for an antidepressant, with the goal of helping you stop smoking? Hold on, wait a minute… what? While the average consumer may not be aware of it, off-label use is very common, with up to one-fifth of all drugs prescribed as such according to the April 3, 2008 New England Journal of Medicine. Some of the most common off-label drug uses include the areas of cardiac, anticonvulsants, obstetrics and cancer medicine. Off-label prescriptions occur most often with older, generic medicines that have revealed themselves over time to alleviate additional symptoms or conditions such as:

Anti-seizure drugs to treat migraines, depression, nerve pain
Antipsychotics to treat Alzheimer’s Disease, autism, dementia, Attention Deficit Hyperactivity Disorder (ADHD)
Antidepressants to treat chronic pain, ADHD, biopolar disorder
Antihistamines to treat colds, asthma, ear infection symptoms, as sleep aids

In women’s health, perhaps because many drugs are not designed specifically for women, off-label prescriptions are common. A study published in Archives of Internal Medicine revealed that women received more off-label drugs than men (11.8% vs 9.7%), and was attributed to women being more likely to be treated for problems such as anxiety, nocturnal leg pain, and insomnia, and off-label prescribing is common for these conditions.

Oral contraceptives are prescribed as the first line of treatment for a range of conditions beyond birth control and for which these medications were not approved. Currently, Bayer, the makers of the Yasmin line of birth control, is facing lawsuits for marketing these drugs for lifestyle purposes, PMS and other ailments for which there were no data and the drugs were not approved.

In obstetrics, terbutaline, indomethacin, nefidepine and magnesium sulfate are medications that have been used off-label for years to halt pre-term contractions. None has strong data supporting their efficacy or safety, and this stems from pregnant women being routinely excluded from studies. Thus, most drug treatment during pregnancy is off-label. According to a June 1993 article in Obstetrics and Gynecology, reasons for such off-label use during pregnancy include:

Prevention of repetitive abortion
Inhibition of premature labor
Reduction of fetal or neonatal infection
Reduction in development of pre-eclampsia and its complications
Ripening of the cervix or induction of labor

What’s the difference between FDA approved labels and non-approved off-labels?

One of the FDA’s primary roles is approving the labeling on a drug; approving what can and cannot be said about the medication. Once the FDA has approved that a drug works and is safe, it works closely with the drug manufacturer to create the drug label, which is a detailed report of specific information about the drug. The FDA-approved drug label is provided to all health professionals who prescribe or sell the drug, and gives information about the drug, its approved doses and instructions on appropriate administration to treat the medical condition(s) for which it was approved.

“Off-label” use is when the drug is used differently from what its label states. This can be when the drug is used for a different disease or medical condition, given in a different way (such as injected versus orally) or given in a different dose than in the approved label. Off-label use is also called “non-approved” or “unapproved” use of a drug, which is not regulated, but is legal in the U.S. and many other countries.

It is legal for doctors to prescribe drugs off-label, but it is not legal for drug companies to market the drug for off-label use. It is important to note that off-label marketing is very different from off-label use, and drug companies can be fined if they promote drugs for uses that have not been approved by the FDA. .

My doctor has prescribed a medication for me – what should I do?

As always it is our responsibility, as patients to do our homework when it comes to our health and wellness. Here are some tips before venturing off on the off-label trail:

Ask your doctor if what they have prescribed is for an approved use, and then verify that information with your pharmacist.
Go to the U.S. National Library of Medicine National Institutes of Health’s DailyMed site and search for the drug you are considering taking. Click on the “Indications & Usage” tab to see if your condition is listed.
If the drug is for off-label use, ask your doctor if there is existing scientific support for your specific condition.
Ask your doctor for the reason why they believe the drug will work better off-label than approved drugs.
Check that your health insurer covers payments for off-label use as some may require evidence of effectiveness or failure with conventional treatments. This is most often the case with expensive drugs.

Check your medicine cabinet now. Have you already gone off on the off-label trail without knowing it?

FDA - Page 2

Pharmaceutical Adverse Effects

Drug Manufacturer Responsibility

Lack of Justice for Victims

Objective: Real Change, Real Responsibility

Postscript: Responsible Use of Fluoroquinolones

Information about Fluoroquinolone Toxicity

Participate in Research

What Else Can I Do To Help?

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Why Is This Important?

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What Do Physicians Think About the Sunshine Act?

Will the Sunshine Act Curb Pharma Payments to Doctors?

We Need Your Help

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Diethylstilbestrol Risk for Humans

Sons and Daughters of DES

DES Daughters

DES and Endometriosis

DES Sons

DES Grandchildren

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The CDER and the FDA

FDA Ethics

Drug History and Other Public Information

Off-label Versus New Approvals

BOTOX® and the FDA

FDA Framework is Not Perfect

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