December 2012

The Soy Connection

Published on December 31, 2012

3304 views

As a firm believer in natural and holistic health, I believe that the food you eat can have a direct impact on your health. For those dealing with reproductive and or endocrine disorders simple dietary changes may help prevent or relieve a number of troublesome symptoms. For women across the board, especially those with estrogen sensitive diseases (e.g. endometriosis) minimizing soy in one’s diet can provide a lot of relief.

But, isn’t soy good for you? That’s not an easy question to answer. In moderation soy can provide a lot of benefits to one’s diet. However, soy should not be a staple in your day to day meal planning. To better answer the question we need to break it down.

Phytoestrogens

Soy is filled with phytoestrogens also known as “dietary estrogens,” which mimic the hormone estrogen that is naturally produced by the human body. Research has shown that phytoestrogens are beneficial for women going through menopause, since menopause is marked by a reduction in estrogen levels. Some menopausal women say that eating soy products helps relieve some symptoms of menopause such as hot flashes. Research has shown that phytoestrogens help maintain cholesterol levels and bone density in post-menopausal women. In addition phytoestrogens also help protect against a number of different cancers, such as prostate and breast cancer, cardiovascular disease and help with cognitive functioning.

However, soy being filled with phytoestrogens, can also be bad for you. Estrogens are female sex hormones – estradiol is the most common. Estradiol promotes the growth of female sex characteristics. Soy is also high in phytic acid which if consumed in high quantities can affect the absorption of other minerals. That is why third world countries that survive on grain and legume based diets have high rates of mineral deficiencies.

Too Much Dietary Estrogen

Increased estrogen consumption can be particularly detrimental to a number of people (i.e. babies, children, men, women sensitive to estrogens). Studies have shown that giving babies/infants soy formula is the estrogenic equivalent to giving them daily birth control pills. Obviously, such small children shouldn’t be on any form of contraception. It has also been suggested that this increased ingestion of estrogen can lead to estrogen sensitivities, earlier onset of puberty and reproductive diseases/disorders such as endometriosis. For older children increased amounts of estrogen also cause pubertal issues. Large quantities of estrogen can delay puberty for boys and lower the age of menarche (first menstruation) for girls. The average age of menarche decreases every year and a lot of researchers and medical professionals hypothesize that is has to do with the environment, toxins and the estrogen that comes from outside sources. Early puberty can also lead to short stature in women.

Estrogen in abundance is also bad for grown men. Men produce both testosterone and estrogen, with testosterone being the predominant hormone by far, and responsible for masculine features. Too much estrogen in males can offset their testosterone to estrogen balance, causing hormonal deficiencies. Lastly, estrogen is bad for women who are sensitive to estrogen, such as women with endometriosis. The endometrium that builds up in endometriosis responds to estrogen. The more estrogen you give your body the more the endometrium can build up, which leads to additional inflammation and bleeding.

Not all Soy Products are Created Equal

If you are still confused as to how soy can be both ‘good’ and ‘bad’ for you consider this: soy products come from a soy bean – however, if you take a good look at your soy-patties or chips made with soy you won’t see mashed up green beans. The invisible soy you eat come from processing the beans. ‘Asian’ soy which is usually quoted as being “good” soy is fermented soy. The process of fermenting soy can reduce a lot of the detrimental qualities of soy, but not entirely. Unfermented soy contains antinutrients such as tripsin inhibitors which can produce serious gastric distress, reduced protein digestion and create chronic deficiencies in amino acid uptake. When soy is processed and manufactured it isn’t always fermented. There are two popular forms of processed soy:

Soy Lechitin: Soy lecithin is basically a waste product of refining soybean oil. In small amounts it isn’t harmful, but if you look at food labels it is found in a large amount of products. Putting soy products in everyday foods provides a lot of nutritional benefits (lower fat, lower calories, higher protein) while being cost effective to the manufacturers. Unfortunately when you process soy it also increases the levels of estrogens and goitrogenics. Goitrogenics decrease the productivity of the thyroid and are bad for those with thyroid disease. Although ironically enough lecithin by itself (not soy lechitin just plain old lechitin) is good for you, it is a natural product high in choline.

Soy Protein Isolate: Soy Protein Isolate is the key ingredient in most imitation meat and dairy products. It is also found in other manufactured goods and protein powders. To make soy protein isolate, the soy beans must first be mixed with an alkaline solution to remove fiber, then rinsed and separated using an acid wash and, lastly, neutralized in an alkaline solution. The resulting products are finally dried at high temperatures to produce a high-protein powder. A similar process is used to make textured vegetable protein which is a high-temperature, high-pressure extrusion processing of soy protein isolate. With natural almost always being better for you, a process like this is by no means healthy. It doesn’t sound good for you and it isn’t. This process can also increase the amount of trypsin inhibitors.

So… Is soy good for you? Studies show that a glass of red wine at dinner is good for you. But we all know that washing dinner down with a bottle of red wine every night would not be good for us. Approach soy in the same way; some soy products several times per week, especially if it is fermented, organic soy (think tofu cubes and not ‘fake pepperoni’) will provide more benefits than detriments. In general be smart about what you put in your body, be an educated consumer and read your labels. Just because it has soy doesn’t make it good. But, that doesn’t mean you need to take all soy products out of your life.

5 Health and Science Trends to Watch in 2013

by Chandler Marrs, PhD

Published on December 31, 2012

2169 views

As the New Year beckons several trends that emerged in 2011-2012 are certain to explode in 2013. Here is a look at the trends I’ll be watching.

Trend 1: Open Science

Although open source and collaborative software development have been the norm for decades, the notion of open science has only recently gained a foothold. Bolstered by recent access to large data sets from government entities, an array of mobile health applications, an explosion of data-hackers, and a growing mistrust of industry sponsored research, scientific research, especially health and medical research, is about to move from the lab to the social sphere.

Trend 2: Citizen Science

From volunteer classifiers and armchair tinkerers to full-fledged data analytics and engineering, the next decade is sure to see an explosion of scientific discovery coming from the most unlikely places. In health and medical research, the tools to measure and analyze one’s own health are becoming more readily available to consumers. Every person is potentially his or her own science experiment. Every social network a data set. How we choose to utilize that information, who we share it with and how we share it will likely determine the next major corporate players in the marketplace. At the very least, this new found access to health data, whether it be our own or others with similar diseases and health issues, is changing the very dynamic of the doctor-patient and patient-industry relationship.

Trend 3: The End of Academic Publishing

Peer-reviewed, industry-sponsored, closed-sourced publishing has been the gold-standard for scientific publishing for decades, but the model is broken and everyone knows it. In much the same way that the internet and blogosphere have damaged traditional media, open access to data and information has made the closed nature of academic publishing an all-but obsolete model for the dissemination of information. Add to the mix the growing problem of significant publishing biases, fraudulent and errant data, the once vaulted anonymous, peer-review process – the process that arguable defines academic publishing – is crumbling.

Perhaps the final straw of what will ultimately be the sector’s unraveling (lest the model change quickly) was Elsevier’s unsuccessful attempt to privatize and profit from taxpayer funded research through shady legislation called the Research Works Act (RWA). Coming on the heels of the failed Stop Internet Piracy Act (SOPA), scientists and major universities loudly protested RWA and succeeded in blocking the bill. Elsevier suffered and continues to suffer significant economic losses.

As a result, open access publishing which had been growing quietly over the last decade, exploded in 2012. Even more interesting, a bevy of new collaborative and open source research and publication sites (ResearchGate, for example) emerged heralding a complete shift in the control and dissemination of scientific and medical information.

Trend 4: The Rise of the Social Entrepreneur and the B Corporation

One of the most innovative trends in recent decades is the emergence a new corporate structure, called the B-Corporation that will codify social goals alongside corporate profits. The B Corp is a hybrid of sorts that combines the social intentions of the non-profit with the fundraising and profit potential of a C corporation. Though the B Corp has no teeth or tax benefit per the federal tax code and is only recognized in 16 states thus far, it has legs. There is a real hunger to create pragmatic business solutions for social problems. Social entrepreneurism is on the rise and B Corps may provide the structure to help them succeed.

Currently, B-Corps are focused primarily on social and environmental problems. Should the B-Corp gain traction in the healthcare industry, it could usher an entirely new class of innovation in traditionally ignored and underfunded areas of the healthcare sector- orphan diseases/drugs or maybe even women’s health.

Trend 5: The Power of Women

Hell hath no fury like a woman scorned was proved over and over again during this last election season. Though narrowly framed as the abortion debate, the fight over women’s reproductive healthcare rights goes much deeper. It is a battle over fundamental human equality under the law and spans every aspect of the modern economy, but most especially the healthcare sector.

We have yet to see the full backlash of the political attempts to limit women’s healthcare decision-making, but make no mistake, fail to recognize the power of millions of angry women, and your business, your political career will be over (how many local and federal legislators were voted out of office by women’s groups?). Sorry guys but you wouldn’t stand for a bunch old women regulating your seminal excursions, why would you expect women to forfeit their healthcare choices, safety and survival to a bunch of old men with less than honorable motivations. As 2013 beckons, expect women to wield much more political and economic power. The companies and politicians that recognize this will unseat those that do not.

From Humans to Pigs and Back Again: the Latest Strain of MRSA

by Chandler Marrs, PhD

Published on December 26, 2012

2582 views

Responsible for over 250,000 hospitalizations annually in the US, methicillin-resistant staphylococcus aureus (MRSA) infections are quickly becoming the next great threat to modern medicine.

In February of this year, the threat escalated when scientists and medical epidemiologists identified a new strain of MRSA that originated in humans (first as a methicillin susceptible strain), then infected nearby livestock (pigs). With the heavy prophylatic use of antibiotics in commercial livestock farming, the ST398 strain of MRSA quickly became resistant to not only methicillian but also a host of other antibiotics including at least dozen beta-lactam antibiotics and tetracycline. It then jumped back to humans in a more deadly form.

The ST398 strain of MRSA has also been found in milk from commercial dairy farms in Europe and in animals from 19 countries and four continents.

The presence of MRSA on commercial livestock is growing. One recent study in Belgium found MRSA in 26 of 30 farms tested and the prevalence of MRSA in pig farmers was 760 times greater than in the general population.

A study comparing organic pig farms to non-organic commercial livestock operations in the Netherlands found the presence of MRSA in only 17% organic facilities and 3% of the pigs themselves. This is compared to a larger study a couple years earlier where 71% of non-organic commercial facilities tested positive for MRSA, with 38% of all pigs testing positive. In the US, MRSA ladden pork products can be found in at least 6% of retail meats and methicillin susceptible staph bacteria was identified in 64% of retail meats tested.

Experts warn that commercial livestock farming is becoming a public health threat that should not be ignored any longer.

Humor in a Hospital Vein?

by Will Murphy

Published on December 26, 2012

1729 views

For those who do not know, I am living a year (so far) of finding incurable prostate cancer metastasizing throughout by lymph system. A previous blog showed the cancer has sneaked through my vigilance.

But I can still smile, occasionally.

Humor in a Hospital Vein?

I know I have lost many pounds during the last year of medical procedures. Mostly muscle mass. I can tell. When the wind blows I fear I might take flight. Not yet. I also fear that I might lose my sense of humor. So, I have decided to record some the events during the recent medical onslaughts to have and to hold them later… just for laughs.

During my several hospital hideouts I threatened to write a book about all the medical mishaps… “How not to take it lying down.”

Every day a different nurse would tell me “you’re funny.” I remember my mother making a distinction, “funny ha-ha or funny peculiar.” Someone from the hospital heard of my humor and asked if I would like to write for the new internet site they were creating. I admitted, “I don’t think you want to hear what I have to say.” She went away.

These events occurred over three years in three different hospitals. No matter. It was all centered on one “victim”, me. For the most part the service was fine. Yet, there were quite a few anomalies along the way. I even took notes. But, when I got home, most of those were untranslatable. Muddy thoughts.

The Spanish Heart Attack

One Sunday morning in November 2009 I did not know I was suffering a heart attack while walking five blocks to work as a Guest Services/Tour Guide at the Lucas Oil Stadium. One of my compatriots also going to work, a former EMT, knew what was happening when I told him I could not keep up any longer. He assisted me to the door of the facility and into a medical unit. They checked and hauled me off to a hospital of choice… even at a difficult moment.

Always the tour guide I was pointing out things along the way. “There is the time clock.” One gurney journey guy said, “Don’t worry. You are not checking in. You are checking out.”

Lucky for me, the chief of the heart department was the on-call that weekend. And he was very attentive. Another heart surgeon said I was talking with him during the five stent procedure … in Spanish. He is from Valencia, Spain. In recovery, the nurse heard me speak to the doctor in Spanish. She turned and just stared. I said, “It is something new I picked up while under anesthesia.”

In the earliest exploratory surgery [TURP – trans urethral resection of the prostate] I was given an epidural anesthetic rather than a general because of concern for my heart during the process. When I came to, I told the medical personnel, “Women get epidurals all the time and they get babies. I asked, Where’s mine?” Blank stares all around.

The Scent of Illness

Next year, during my stay for a cholecystectomy [gall bladder removal] at least once a day, often more, the nurse might say “come on, we are going to another room.” One time they wanted my private room for an incoming prisoner. He needed privacy. On one occasion (about mid-week) my private double room was invaded by a loud patient declaring all the things he would not let them do. “I won’t have anybody sticking me with needles hundreds of times. And I won’t go three miles on the thread (sic) mill.”

The opinionated one in the next bed continued his harangue while I finally connected with a laxative attempt. The stench caused him to blurt, “Get that crap out of here.” I told him it was the first time he was correct since he arrived.

Across the hall, maintenance workers were repairing a tiled floor with a resulting acrid smell of their own. My allergy reacted to the fumes and the nurse began moving me to another room without warning. The other patient yelled, “If you didn’t like me you could have just told me.” Two smells and him. I did the best I could.

Hot Flashes and Room Havoc

My urologist and my oncologist are not yet certain which way to proceed with my condition. They say new treatments are coming soon. So far, I get a hormone shot (Lupron) every three months in an attempt to curtail the aggressiveness of the cancer through my lymph system. Like some other men with those hormone shots we get to experience the thrill of hot-flashes. A woman sitting next to me in the lobby said simply, “Welcome to the club.”

Already, we have found a large tumor on the left femur just below the hip and had it removed by RFA (radio frequency ablation) so I could walk again. No humor here.

It is not official but I might hold the record for the most rooms (four on one day) used during my one-week stay in that hospital. Actually it was nine days if you count the emergency room Saturday night and the Monday morning departure a week later when the nurse assistant hit me in the teeth without a warning at 6am. My reflexes almost hit her in the face. She yelled at the other patient, “Don’t yell at me” when he blurted the same phrase. Good, go after him. Maybe then she won’t poke me with the thermometer again.

The best odd event? It came mid-week when my tall Tanganyikan nurse, single mother of three, came to check on me very early on Wednesday. I had been warned I was not taking my meds. I thought I had. “No, here they are on your table.” They were out of sight behind my head in the bed. “I put them there when I left because the doctor came in. I told you.” That was the problem in this particular hospital. The nurses run when the doctor arrives. The rule used to be the nurse would/should monitor the patient taking the meds. SO, I saw one pill in a small cup at 5am. I took it… because I was supposed to comply. At 6am the tall Tanganyikan asked where is that pill? I said I took it. She screamed, “You Did What? That was your suppository~”

How not to take it lying down (in hospital)! They’re building a new hospital. Buy not in my name.

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?

Should your Guy be Taking Testosterone

by Chandler Marrs, PhD

Published on December 17, 2012

3126 views

Testosterone prescriptions for men have increased almost 4-fold over the last decade. It’s marketed to treat everything from low libido, depression and middle-aged weight gain to improved cardiovascular health. Is it safe? Does it work? Should your guy be taking testosterone? Here is the research.

Testosterone Treatment

Trials in older men with low testosterone levels have shown beneficial effects, such as increased strength, muscle mass, bone mineral density, insulin sensitivity, and libido. However, in elderly men, the treatment effects were short-lived (<6 months).

An observational study of over a 1000 male veterans aged >40 years compared mortality rates between those treated with testosterone and a group of controls with low testosterone. The treatment group showed almost half the rate of mortality, all causes, and lived longer compared to the control group. Other research shows that testosterone replacement lowers HDL levels but only in younger men taking supra-physiological doses (anabolic steroids).

In contrast, a recent research trial with frail, elderly men (>65 years of age) was stopped early due to a greater occurrence of cardiovascular-related events in testosterone treated men.

Conclusion: The Jury is Still Out

Although some testosterone treatment trials report positive results, there is ongoing concern about the risk of incident prostate cancer or prostate cancer mortality because studies have not been large enough or long enough to address this. The report of adverse cardiovascular events associated with treatment highlights the need for further data on the risks and benefits of testosterone treatment in older men, particularly given the large numbers of older men who are prescribed testosterone. And data supporting the libido boost is still out with only some studies reporting benefits. Should your guy be taking testosterone- the jury is still out.

The High Cost of Bad Birth Control: Yasmin and Yaz Lawsuit News

by Chandler Marrs, PhD

Published on December 17, 2012

5603 views

As the debate over birth control rages, an often ignored aspect of the debate is safety. Some feminist groups contend that we can’t talk about the dangers of certain oral contraceptives or other hormonal birth control methods lest we give ammunition to the anti-birth control crowd.

“If you’ve seen on TV somebody crying that their daughter died taking birth control pills, and you’re a mom, you may not remember the (particular) birth control pill,” said Diana Zuckerman, president of the National Research Center for Women & Families. “You’ll just say you can’t be on it to your daughter.”

That sentiment couldn’t be more wrongheaded. Of course, we should be talking about the safety of birth control. Indeed, we should shouting at the top of our lungs about the dangers of some oral contraceptives and many medications in general. What good is it to have access to birth control, only to be killed or chronically injured from those pills? Death and grievous injury would seem to defeat the purpose of the entire reproductive rights movement.

We Need Safer Birth Control Options

As we’ve reported previously Yasmin, Yaz and other drospirenone based oral contraceptives (generics Syeda, Ocella, Zarah, Loryna,Gianvi, Safyral and Beyaz) appear decidedly unsafe. No amount of marketing will overcome the safety issues.

As of April, there were over 11,000 lawsuits pending with 14,000 plaintiffs. By October of this year, Bayer, the makers of the Yasmin line of birth control, has agreed to pay $750 million to settle the first 3400 lawsuits. With only 7600 more lawsuits to go, this might be one of the most expensive drugs to date.

The Dangers of Drospirenone

Several large studies (here, here, here) have found that women taking drospirenone based oral contraceptives have a two- to threefold increase in deep vein thrombosis and pulmonary embolism compared to other contraceptives. Bayer contests those results with several company sponsored studies that indicate no such risk. Recent reports of withholding data, question Bayer’s assertions.

AdverseEvents.com, a website that tracks all medication side-effects both from FDA and patient reporting, shows that the Yasmin line of oral contraceptives carry with them a range of very serious side effects, including death.

Yasmin, Yaz and Pulmonary Embolism

Notice the number and percentage of deaths, life threatening conditions and hospitalizations compared to other potent and in some cases, already recalled medications.

Yasmin, Yaz and Deep Vein Thrombosis

Why are These Products Still on the Market?

Money.

The Yasmin line of birth control is one of Bayer’s most lucrative product lines with over 4 million women taking these pills monthly. Even with the negative publicity surrounding for these products, revenue for the Yasmin line of products neared 1.1 billion for the first nine months of 2012. After 11 years on the market, total revenue for these products was likely well over $10 billion. If the company pays out $1-2 billion in claims, but makes $10-15 billion, the cost-benefit ratio is skewed in favor of maintaining their market presence. The fines become just another cost of doing business.

What about the FDA?

The FDA relies heavily on some 50 advisory committees to review drug safety. Many of these experts have strong ties to industry. Reports of conflicts of interest abound. In the case of drospirenone, early reports are claiming the decision making was indeed skewed by industry sponsored experts.

At least four and possibly six experts on the panel convened to review the dangers of drosperinone, had financial ties to Bayer. Subsequently, efforts to remove the Yasmin products from the market failed by four votes: 15-11. Instead the panel voted to increase warnings on the labels of these drugs.

Worse yet, unsealed court documents from lawsuits in Illinois indicate the possibility that Bayer knew of the increased dangers associated with the Yasmin products, as early as 2004 and withheld (and continues to withhold) that data from the FDA. According to reporters at Pharmalot and a report by David Kessler, a former FDA commissioner and current advocate for many of the legal cases:

“For instance, in a draft of the August 2004 white paper, Bayer employees wrote: “Compared to the three other (oral contraceptives), Yasmin has a several fold increase in the reporting rates for (deep vein thrombosis), (pulmonary embolism) and confirmed VTEs…When considering only serious AEs, the reporting rate for Yasmin was 10 fold higher than that with the other products which were very similar in magnitude.” Bayer employees argued in a revised draft that “spontaneous reporting data do signal a difference in the VTE rates for Yasmin and other OC users.”

Who to Trust

It is no longer reasonable for patients to blindly assume an FDA approved medication is safe or right for us (Vioxx, for example). Even research in major medical journals is suspect, with publication bias and outright fraud. Medical decision making is not for the faint of heart.

Luckily data are available online and though still convoluted, there is a degree of information availability never before possible. If you look, you can find the information needed to make a decision on almost any medication. We like and trust the data from Adverse Events. Their sole purpose is to expose and make accessible to the public the risks associated with medication.

Moving Forward

Demand better. We’ve long since moved away from the age of innocence where medications are concerned. Before deciding on the appropriate birth control method for you or your daughter, do the research, ask the questions and make an informed decision.

Do You Know What FDA Approved Really Means?

by Lynda Chang

Published on December 11, 2012

2579 views

We all take medicine, either prescription or over the counter (OTC) from the drugstore, but what do most Americans know about their medication’s journey into their hands? Do we just take a drug because it is what our doctor prescribed or what the commercial ads tell us? Do we know what it means when a drug is FDA approved, much less what the acronym “FDA” stands for?

I asked these same questions on my Facebook. The feedback poured in quickly, and ran the gamut from textbook Wikipedia type responses to heated opinions about perceived politics within the FDA and “greedy” pharmaceutical companies. The passionate debates were subdued and ended with a very personal story of a mother who is on a lifelong prescription regimen post-cancer, and who is thankful that a drug was approved in late 2011 for her young son’s rare, life-threatening genetic disease.

The U.S. Food and Drug Administration (FDA) is a government agency that regulates our country’s foods, dietary supplements, human drugs, vaccines, blood products and other biologics, medical devices, radiation-emitting products, cosmetics, veterinary products and tobacco products. Most are not aware of the agency’s governance is so many areas. Most are also not aware of what is entailed in a drug receiving FDA approval, which can include a process of 1-3 years of research and development, 7 years for clinical studies, additional years spent on the FDA review process and the continued surveillance and tracking of a drug once it has been approved, either as a prescription or OTC with dose or strength of the drug as the key difference between the two.

As human beings we inherently take our own selfish perspective on things. Naturopathic medicine follows a matrix of the healing power of nature (vis medicatrix naturae) that support our own self-healing process. On the opposite end of the spectrum are those such as the mother and her son who rely on what she termed “life-saving drugs” that allow them to function on a daily basis. She is on Synthroid® – a synthetic hormone for thyroxine a hormone made by our thyroid gland – for life due to her cancerous thyroid being removed. Her son has atypical hemolytic uremic syndrome (aHUS) and she is grateful for the September 2011 FDA approval of Soliris® for his condition after unsuccessful frustrating attempts to enroll him in clinical trials because he was deemed “too healthy” to meet the trial criteria. As a mother, she stated that while she does trust the FDA, she did her own research before putting her son on this life-saving drug. To respond to the feedback that pharmaceutical companies are motivated by greed, this mother pointed out that many of the researchers for the company that developed Soliris have family members who are affected by the same types of rare diseases and syndromes, and that is why they work so hard to develop new drugs.

Most agree that avoiding ingesting all things synthetic is the best way to go. If we are genetically healthy and financially lucky, we can be blessed to take that route. Others, however, do not have this luxury and are required to seek life-saving options such as the mother and her son.

Humans are not perfect or invincible, thus anything that man creates or touches is imperfect as well. Remember the Titanic! Anything man-made will have a shelf-life and carry risks and flaws. There is no such thing as 100% perfection. While the FDA does its best to protect us, there is no such thing as a drug that is completely safe for everyone under all conditions. Even aspirin or caffeine, if given randomly to a million people will have negative effects on a few.

In general, FDA approval means that a drug’s benefits have been found to appropriately outweigh its risks, for a given condition, for a given group of people, barring drug interactions or other complicating medical conditions. While the overlying goal is seemingly simple – to help improve the lives of patients needing relief from a particular symptom or disease – the reality is we are a society that is easily steered by advertisers and marketers for the pharmaceutical industry. It is up to us to educate ourselves instead of blindly following what our doctors or commercial ads tell us to do. Seek out the available information on OTC and prescription drugs. Find out what the FDA is all about on their Web site (www.fda.gov). Or better yet, keep reading Hormones Matter because we’ll be covering the FDA approval process.

Phytoestrogens

Too Much Dietary Estrogen

Not all Soy Products are Created Equal

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We Need Safer Birth Control Options

The Dangers of Drospirenone

Yasmin, Yaz and Pulmonary Embolism

Yasmin, Yaz and Deep Vein Thrombosis

Why are These Products Still on the Market?

What about the FDA?

Who to Trust

Moving Forward

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