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Do You Know What FDA Approved Really Means?

Published on December 11, 2012

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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.

Thalidomide: an Apology 50 Years too Late?

by Lisbeth Prifogle, MFA

Published on September 6, 2012

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Fifty years ago, if you were pregnant you might have been prescribed or bought thalidomide over the counter for morning sickness. While the drug was labeled “harmless,” if a woman took this drug while pregnant, there was a good chance that she would have a child with phocomelia, or seal limbs. One of the many dangerous side effects was a birth defect where the bones of the arms and legs fail to develop properly and literally look like seal flippers.

Origins and Side Effects

Thalidomide was developed in Germany in 1957 and was considered safe enough to be sold over the counter in some countries. It was sold in 45 countries. The FDA in the US never approved it, but there were victims who were part of a clinical trial where 20,000 patients received the drug, as well as patients who obtained the drug abroad.

In 1967, the drug was pulled from the market. It is now reported that 10,000 – 20,000 babies were born with severe birth defects during the 5 years that it was on the market.

Martin W. Johnson, director of the Thalidomide Trust of Great Britain, stated that about 40 percent of babies with thalidomide-induced defects died before their first birthday, and approximately 50 percent of those living today live with chronic pain. Of course, phocomelia isn’t the only birth defect; many other babies suffered heart problems, damaged hearing or eyesight, and even brain damage.

Apology – Too Little Too Late?

It’s been over fifty years since this tragic drug mishap and the CEO of Gruenenthal, Harald Stock, is finally apologizing to the victims. Is it enough?

Geoff Adams-Spink, born in 1962 with multiple impairments caused by thalidomide and a BBC journalist for 22 years, wrote an Op-Ed piece about this apology stating:

“The Wirtz family [predecessors to Harald Stock] has grown fat on the backs of thousands of families whose lives have been torn apart by a medicine originally marketed as “totally without harm.” If they really want to make amends, they should put their entire wealth at the disposal of the world’s thalidomide survivors before it’s too late.”

He’s not alone; many of the victims feel more insulted than compensated by this financially absent, PR stunt of an apology. This includes an Australian woman, Lynette Rowe, who recently won a multi-million dollar settlement in July against Diageo Plc, the legal successor to thalidomide’s Australian distributor. Wendy Rowe, Lynette’s mother who took the drug while pregnant, told journalists, “Our family couldn’t have gone into silent shock. We had to get up and face each day and every day and cope with the incredible damage that Gruenenthal drug did to Lyn and our family.”

Today’s Uses and the Future of Thalidomide

In 1964, Israeli scientist, Jacob Sheskin, discovered thalidomide could control leprosy by reducing the inflammation caused by the disease. In 1998, the FDA approved it for multiple myeloma, a cancer of plasma cells in the blood. Because leprosy is still a serious problem for populations in Africa and South America, there are women taking thalidomide as treatment and giving birth to babies with phocomelia and other birth defects. Due to this ongoing use and therefore side effects, scientists have continued to study why thalidomide is so dangerous. They recently discovered that the protein cereblon latches on to the thalidomide and is a major reason for the tissue damage in the fetus.

In the US, thalidomide is used, but under extreme restrictions for both men and women. The FDA has put in place the System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.^®) to make sure that pregnant women do not take thalidomide and that women do not become pregnant while taking thalidomide. According to PubMed Health: “All people who are prescribed thalidomide, including men and women who cannot become pregnant, must be registered with S.T.E.P.S.^®, have a thalidomide prescription from a doctor who is registered with S.T.E.P.S.^®, and have the prescription filled at a pharmacy that is registered with S.T.E.P.S.^® in order to receive this medication.” Furthermore, it is only prescribed one month at a time and a doctor’s visit is required for additional prescription. Women must use two acceptable forms of birth control for four weeks prior to taking the drug. A weekly pregnancy test is also required every week for the first month and monthly thereafter if you have regular menstrual cycles (every two weeks if you have irregular cycles). And for the men, you are instructed to use a condom because thalidomide can be transferred through the sperm causing birth defects as well.

What about Other Victims of Other Drugs

Fifty years and a verbal apology is all the victims of thalidomide have received. The apology stated:

“We also ask for forgiveness for not reaching out to you from human to human for almost 50 years … We ask that you see our long speechlessness as a sign of the silent shock that your fate has caused us.”

This is what happens when we do not hold the pharmaceutical or medical device industries responsible for their products. It makes me wonder how long it will take before Gardasil and Cervarix are taken off the market? How long will it take for the victims, like Alexis in A Life Ruined by Gardasil, who suffer from mild to severe side effects, including death, to receive any sort of compensation, if ever? What about other drugs with more side-effects? To the victims of thalidomide the apology might not seem like enough, but I see it as an admittance of guilt that the company, and those who approved the drug, put profits above safety. This apology is a start and maybe someday soon we’ll see more pharmaceutical companies taking responsibility for the damages they leave on their patients.

The photo is a work of the National Institutes of Health, part of the United States Department of Health and Human Services. As a work of the U.S. federal government, the image is in the public domain.

Gardasil: Miracle or Deadly Vaccine?

by Lisbeth Prifogle, MFA

Published on July 16, 2012

8706 views

I normally don’t speak for a larger population because we are all unique individuals; however, I think in this case I can speak for all women. Dread is the only emotion that is drudged up when you get the friendly reminder card in the mail that it’s time for your annual appointment. Stripping down and wearing a stiff hospital gown with your feet up in cold metal stirrups while a doctor sticks a cold, duck-lip looking contraption up your nether regions for a Papanicolaou (pap) test. I don’t think there is a single woman on earth who enjoys this necessary torture, but it is the primary way to detect diseases and/or conditions including cervical cancer.

That is until 2008, when Merck released a vaccine that is advertised to protect against the strands of the Human Papillomavirus (HPV) that cause cervical cancer and genital warts. The shot is being administered to young girls and boys (who can carry the disease, but do not suffer from any health conditions because of it). The shot is administered to girls ages 11-26 years-old and boys age 9-26 years old, but do the pros outweigh the cons? I’ve heard of doctors tell parents, I wouldn’t give this shot to my own child, how can I recommend it to my patients. And I’ve heard doctors say, it’s the greatest vaccine we have that actually protects against cancer.

Let’s look at whether or not prevention outweighs the serious side effects and risks.

HPV

Carolyn Vachani, RN, MSN, AOCN writes that, “The Human Papilloma Virus (HPV) is one of the most common sexually transmitted infections (STI) in the world. It is estimated that 5.5 million people worldwide are infected annually. Sexually active individuals have an 80 to 85% chance of being infected at some time in their life.” It’s not just a sexually transmitted infection; the virus invades the epithelial cells (type of skin cell) on other parts of the body including the oral mucosa, esophagus, larynx, trachea, and conjunctiva of the eye. Further more Vachani writes, “Researchers have identified 100 different strains of HPV, 40 of which can infect the anal and genital areas.”

On Merck’s Gardasil website it boasts, “GARDASIL is the only human papillomavirus (HPV) vaccine that helps protect against 4 types of HPV.” So, what about the other 96 strands, 36 of which infect the anal and genital areas?

Like HIV, there is no cure for HPV; but unlike HIV, the body can fight HPV and win 80% of the time. For the 20% whose body cannot fight off HPV there is a risk that cervical cancer can develop. If it is a strand that causes genital warts there are various methods to treat and get rid of the warts until the body is able to fight off the infection on its own.

Cervical Cancer

In spite of the high odds the body can fight off an HPV infection, cervical cancer is the second most common cancer in women worldwide. Forty years ago, cervical cancer was the leading cause of death of women in the US, but thanks to the availability of the pap test that has decreased 75% over the past 50 years. With annual pap tests, precancerous cells can be detected and removed from the cervix rather simply. According to the CDC, in 2008:

12,410 women in the United States were diagnosed with cervical cancer.
4,008 women in the United States died from cervical cancer.

Those numbers are low compared to developing countries. Out of the approximately 500,000 new cases of cervical cancer annually, 83% are in developing countries. The annual death rate of cervical cancer worldwide is approximately 273,000, of which developing countries account for 75% of the deaths.

There are no symptoms of cervical cancer and no way to detect it except a pap test, which isn’t available in most developing countries explaining the higher mortality rates. A vaccine that protects against the most common strands of the virus is better than nothing, right? Well, let’s take a closer look and see what the controversy is all about.

Gardasil

FDA approved Gardasil on June 8, 2006. As Chandler Marrs reported in Why Few Women Trust the FDA, the FDA doesn’t always have the best record in women’s health, making it difficult to believe everything they pass is safe or effective. The vaccine is a series of three shots taken over the course of a year. On the FDA website it states, “Given the large number of doses distributed, it is expected that, by chance alone, serious adverse events and some deaths will be reported in this large population during the time period following vaccinations.”

How many deaths and serious side effects are acceptable for the FDA? Apparently quite few; Natural Society reports, “Between May 2009 and September 2010 alone, Gardasil was linked to 3,589 harmful reactions and 16 deaths. Of the 3,589 adverse reactions, many were debilitating. Permanent disability was the result of 213 cases; 25 resulted in the diagnosis of Guillain-Barre Syndrome; and there were 789 other “serious” reports according to FDA documents.”

What does the FDA have to say? “Concerns have been raised about reports of deaths occurring in individuals after receiving Gardasil. As of December 31, 2008, 32 deaths had been reported to VAERS [Vaccine Adverse Event Reporting System]. There was not a common pattern to the deaths that would suggest they were caused by the vaccine.”

On the website Classaction.org, where you can get legal advice on class action law suits against the makers of Gardasil if you or your child has suffered from side effects, they state, “As of Feb. 14, 2011, the CDC has reported that there have been 51 reports of deaths among females who received the HPV vaccine. A total of 32 of these death reports have been confirmed, meaning that a doctor has reviewed the report and any associated records. There have been two reports of deaths among males who were injected with Gardasil.”

That is just in America where cervical cancer can be detected early with annual pap tests. The vaccine against HPV is given worldwide to girls and boys to prevent spreading of HPV. It is now marketed as prevention against anal cancer even though only 10% of women with HPV will develop cancer and cancer associated with HPV is only responsible for 1% of all cancer deaths.

Judicial Watch

In 2011, Judicial Watch, a conservative, non-partisan educational foundation that promotes transparency, accountability and integrity in government, politics and the law stepped in. They reported that they, “received new documents from the U.S. Food and Drug Administration (FDA) under the provisions of the Freedom of Information Act (FOIA), detailing reports of adverse reactions to the vaccination for human papillomavirus (HPV), Gardasil. The adverse reaction reports detail 26 new deaths reported between September 1, 2010 and September 15, 2011 as well as incidents of seizures, paralysis, blindness, pancreatitis, speech problems, short term memory loss and Guillain-Barré Syndrome. The documents come from the FDA’s Vaccine Adverse Event Reporting System (VAERS).”

The report also states, “Not only will Gardasil not cure pre-existing HPV, it can also make symptoms worse. Women who already have the virus without knowing it could suffer massive outbreaks of genital warts or abnormal precancerous lesions, both of which require extensive treatment.” The vaccine is suggested for women who test positive for HPV in order to prevent them from contracting the other strands. (The 25 page report can be viewed here.)

Conclusion

Merck’s website advertises “You/your son or daughter could be one less person affected by HPV disease.” It is important to research all the possible side effects and the rate of occurrence, as well as your/your daughter’s ability to have annual pap tests before making this decision. We are all exposed to numerous strands of the HPV virus. Of the 100 strands, 40 are contacted through sex or genital skin contact. Of those 40, Gardasil only protects against the 4 most common strands because adding more strands to the vaccine caused even more severe side effects. In 80% of the cases of genital HPV, the body fights off the infection. With pap tests, doctors can detect cervical cancer before it becomes deadly (as long as women are getting them done annually). As much as we all hate that annual appointment, it may be a better solution to stick our legs in the stirrups for an exam rather than risk the side effects of the Gardasil vaccine. You decide.

Next week, I will look at how Gardasil was approved by the FDA, how states are mandating it for school children, and how states are passing legislation to make it legal for health professionals to administer the shot to minors without parental consent.

Additional Resources

IARC Monographs on Human Papillomavirus Virus and Studies of Cancer in Humans

Is Gardasil mandated in your state? Read more here
How does a Pap Smear Test prevent cervical cancer? Read more here.

Participate in Research

Hormones Matter^TM is conducting research on the side effects and adverse events associated with Gardasil and its counterpart Cervarix. If you or your daughter has had either HPV vaccine, please take this important survey. The Gardasil Cervarix HPV Vaccine Survey.

Male Birth Control – Myth or Available Science?

by Lisbeth Prifogle, MFA

Published on July 5, 2012

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I’ve never been able to take hormonal birth control. I have tried and the side effects were so extreme that I almost ended up in the ER more than once. After telling each new doctor my past horror stories, they would each reassure me that I simply had the wrong doses and had to try a different brand. I tried three times in my adult life and every single time was a disaster that seemed to progress from the last. So, I gave up on hormonal birth control.

Most women I know have been on birth control most of their adult life, some even since they were teenagers. While I always tell myself that there might be long-term side effects outside of the ‘clinical trial’ time frames (not that I wish bad health on anyone, but would be my top concern if I was on any medication long term), most women are happy poppin the pill (or now the other various forms of hormonal birth control like IUD, rings, patches, etc). Furthermore, most men are happy letting their lady take on that responsibility.

For the most part, I’m okay not being on a hormonal birth control. It is awkward when dating someone and getting to that point where things might lead to more than just dinner a movie and I have to bring up that little, unpleasant fact, but otherwise I’m happy with my natural mood swings and erratic hormones.

I’ve been with my boyfriend for over 3 years now, so I haven’t had to have “the talk” recently. However, back in my dating days, I was always shocked at how shocked men were that I wasn’t on the pill. It was like the idea of a woman not being on some form of birth control was absurd to them. What I love about Brent (well, I love a lot of things about him) is that after witnessing the extreme effects of hormonal birth control in my body first hand, he has accepted that we have to take other measures to prevent pregnancy. He’s also assured me that if a male birth control comes available he would be willing to try, but only after many clinical trials and a year or two of being on the market (I can’t blame him with the controversial drugs the FDA has approved in the past).

Male Birth Control

Turns out there are forms of male birth control. Quite a few actually and very few of them are hormonal, which would have the most risk and side effects. Some sound weird, and lots are still in clinical trials (And there is no way in hell we would even consider a clinical trial – can you imagine being in the placebo group?!). Let’s look at some of the new forms of birth control that share the reproductive responsibility.

It is important to remember that, like female contraceptives, these treatments do NOT protect against sexually transmitted diseases.

RISUG

In India, they have developed a long-term, reversible solution that is 100% effective in clinical trials. The Reversible Inhibition of Sperm Under Guidance or RISUG might be a good option if your man doesn’t mind needles. According to Techcitement the simple procedure is as follows: “A doctor applies some local anesthetic, makes a small pinhole in the base of the scrotum, reaches in with a pair of very thin forceps, and pulls out the small white vas deferens tube. Then, the doctor injects the polymer gel (called Vasalgel here in the US), pushes the vas deferens back inside, repeats the process for the other vas deferens, puts a Band-Aid over the small hole, and the man is on his way. If this all sounds incredibly simple and inexpensive, that’s because it is.” How does it work? “The two common chemicals – styrene maleic anhydride and dimethyl sulfoxide – form a polymer that thickens over the next 72 hours, much like a pliable epoxy, but the purpose of these chemicals isn’t to harden and block the vas deferens. Instead, the polymer lines the wall of the vas deferens and allows sperm to flow freely down the middle (this prevents any pressure buildup), and because of the polymer’s pattern of negative/positive polarization, the sperm are torn apart through the polyelectrolytic effect.” Another benefit, RISUG does not cause the common side effects of a vasectomy: granulomas and an autoimmune response.

Will it be approved? It has yet to get approval in India, and, according to Science Based Medicine, trials on rabbits are just starting in the US (published May 2012). Perhaps this birth control is just too good to be true and pharmaceutical companies stand to loose too much if men have to get a shot once every ten years and without side effects, are 100% reversibly infertile.

What’s more – this treatment might actually prevent HIV transmission from male to female during intercourse.

Male Hormonal Birth Control

In Denmark, studies are being conducted in hormonal birth controls that rather than taking a pill daily (because men can’t bother with that?), tiny rods are inserted under the skin of the arm that deliver the hormones. These rods deliver etongestral, a progesterone often used in female birth control pills. The etongestral blocks sperm production and is considered reversible. The downside: to block sperm production, it blocks testosterone production as well. Participants of the study have to get testosterone replacement therapy injections every 4-6 weeks to maintain their sex drive, as well as their male characteristics. If approved, patients would only have to change the rods every three years.

There are other hormonal birth controls on trial. Some involve topically applied gels, others pills, or shots every few months; but they all work the same and have the same side effect of blocking testosterone production in the testes.

Other Odd ‘n’ Ends

There are surprisingly lots of clinical trials and products out there for male birth control. And maybe not-so-surprisingly, those that were not hormonal had very few side effects. I suppose it makes sense that it would be easier to control men’s sperm that are located externally, opposed to internally manipulating our eggs.

Suspensories, a pair of brief-like garments holds the testes closer to the body, raising the temperature of the testes and suppressing sperm count and making the remaining sperm poor swimmers. Here are other heat treatments.

Intra Vas Device (IVD), is a set of implants that block the flow of sperm. According to malecontraceptives.org, “These tiny, pre-formed, flexible silicone plugs are inserted into the vasa deferentia, the tubes carrying sperm from the testes. The device is sized to the width of each recipient’s vas deferens, filling the lumen (the opening in the vas tube) but not stretching the tube. Two plugs are inserted in the same vas with a small space between them. If sperm pass around the first plug and enter the space between the two plugs, the second plug blocks them. In order to prevent the plugs from moving within the vas deferens, they are anchored with small sutures to the wall of the vas deferens itself. Once implanted, they can not be felt. The IVD is similar in function to a vasectomy, but it leaves the vasa deferentia intact.”

Hopefully these new forms of birth control will soon be on the market and women like me, who can’t or choose not to, take hormonal birth control will be able to share the responsibilities of reproduction. All I can say is it’s about damn time!

For more information on clinical trials and other treatments check out MaleContraceptives.Org, it had the most inclusive, detailed and reliable information I could find on the subject.

Answering Infertility with Genetic Modification: Evolution or Playing God?

by Lisbeth Prifogle, MFA

Published on July 2, 2012

3743 views

I am the middle of 5 children. We are all from the same parents who are still married. Since the time I was 5 years old, there has never been a time when there wasn’t a toddler in our house. I’m 30 years old now. I think I’m officially immune to baby fever. The gene to love shopping at malls and having babies somehow skipped me and I’m happy for that. However, the older I get I see it happen. First, one of my girlfriends gets infected and then, it quickly passes to each and every one. I don’t know if it’s through touch or some sort of mental telepathy, but it happens quick and there’s no stopping it. I call it the, I want a baby and I want it now syndrome. The only known cure is reproduction.

More and more I watch couples around me struggle with infertility. I had one friend go to multiple fertility centers across the US trying to get pregnant with endometriosis. She was finally successful and jokes that her baby, “spent his inheritance getting here.” My sister, happy mother of 2, has had a horrible year with two miscarriages. After multiple tests, they discovered that she has a blood clotting disorder and hopefully she will be able to carry full term next time.
Keep Reading

Why Few Women Trust the FDA

by Chandler Marrs, PhD

Published on July 2, 2012

4016 views

Critics of Lucine and our e-journal Hormones Matter often suggest that we are biased against the pharmaceutical and medical device industries and that, we should trust the FDA on all matters of women’s health. After all, we wouldn’t want to be considered one of those wacky conspiracy, alternative health blogs or a bunch of mommy bloggers (for reference, I rate moms as some of the best arbiters of BS when it comes to health). Admittedly however, much of the information on the blogosphere is horribly slanted or so devoid of actionable intelligence that it offers no more than pablum – even from the more reputable sources. But I digress.

With those criticisms come claims that begin with the ‘FDA approved…’ a particular treatment or device, or ‘after reviewing the data, the FDA found no merit to’ research suggesting that a certain drug or device was indeed dangerous. I have to admit that it often feels like I am biased. Perhaps I am little less apt to trust this industry or the regulatory oversight than others. I am certainly wary of the magic pills (oral contraceptives, HRT, anti-depressants) that are marketed as cures for all that ails the female population (without supporting data). But then, just when I think it is safe to trust again, reports like this come to light.

J&J Sold Vaginal Mesh Implant After Sales Halt Ordered

Bloomberg News reported last week that Johnson and Johnson (J&J) continued to sale Gynecare Prolift, a vaginal mesh implant, for a full nine months after FDA ordered it to halt sales. Prolift is a surgical mesh device used to treat pelvic organ prolapse, a common condition in women who have had children.

The basis of the complaint was the five-fold increase in death and serious injury associated with this product.

Bloomberg News reports:

J&J began selling the Prolift in 2005 without filing a new application after determining on its own that it was substantially similar to the Gynemesh, a company device already approved by the FDA, said Matthew Johnson, a J&J spokesman, in an e-mail. The device maker relied on FDA guidance for when companies must submit new applications, Johnson said.

J&J determined the safety of this product on its own. Called ‘equivalence’ this is a common form of FDA approval requiring the applicant show merely that a device or test is ‘equivalent’ to some older, previously approved device or test. With low risk devices or tests this is a mostly reasonable way to garner approval. In higher risk devices, however, such as those that are surgically implanted, meeting equivalence is hardly sufficient for approval, especially if the older devices are themselves, dangerous or otherwise inadequate.

While the FDA ultimately “…disagreed with J&J’s interpretation and required a new application that prompted questions in the August 2007 letter…” to halt sales, this was 2 years after J&J had already been selling the products to surgeons. By then hundreds of millions of dollars had been made and tens of thousands of mesh products had been implanted in women. J&J ignored the letter and continued to sell Prolift.

What’s worse than J&Js blatant disregard for the human safety is that the FDA ultimately caved and cleared the product in 2008, despite the fivefold increase in death and serious injury. Even a halted clinical trial failed to incite sufficient motivation to remove this product from the market. In 2009, the clinical trial designed to evaluate the safety of Prolift was halted when researchers found that >15% of women experienced erosion. Erosion of the mesh caused “pain, scarring, painful intercourse, bleeding scarring and closing of the vagina eroding into the bladder and bowel. Mesh erosion through the vagina is also called exposure, protrusion or extrusion. Many of these problems required additional medical or surgical treatments and further hospitalizations.” Despite the findings of the clinical trial, the products remained on the market.

As of 2010, J&J had reported sales of $295 million in the US alone. J&J did agree to re-label the device and in 2011 the FDA began considering re-classifying vaginal mesh products from a moderate risk product to a high risk product. I guess we should be grateful (insert snark). In the mean time, women continued to suffer and die. It is only recently, after hundreds of lawsuits, that J&J applied to recall Prolift and other vaginal mesh products. According to a J&J spokesperson:

“We came to this decision after carefully considering numerous factors” including “the commercial viability of these products in competitive and declining worldwide markets, the complexities of the regulatory environments in which we operate, and the availability of other treatment options for women,”

Notice, that it was market factors, not product safety, behind the decision. The report goes on to say that products will be phased out on a region by region basis over the next year. I guess there is no rush to recall these products since J&J admits no health or safety concerns and the FDA approved the product. I sure would hate to be the last region in the recall.

So no, I do not trust the FDA to protect my health. I am afraid many other women, some of whom are mommy bloggers (yes, I am a mom and I blog), scientists and proponents of better health don’t either. Yet, we still must make decisions that affect our health and our family’s health. To all the women responsible for family health decision: verify, then trust.

Resource to Verify Medication Safety

AdverseEvents.com : this is a fantastic site run by a private company that allows individuals to list and view adverse events and side effects for every medication on the market. It is free to the user. If you are an Yaz, Yasmin or Ocella user, I encourage you to look up those medications and compare their side effect profiles to other drugs. This site does not list medical devices. If any of our readers know of a similar site for adverse events associated with devices, please share.

Toxins in Cosmetics – Contaminants in Your Personal Care Products

by Lisbeth Prifogle, MFA

Published on April 10, 2012

5615 views

In the US alone, women spend 50 billion dollars on cosmetic products annually. Each day women smear anti-aging, anti-blemish, cover-up, foundation, powder and more on our faces and bodies in the name of beauty. The FDA does not monitor toxins in cosmetic and personal products because we don’t ingest it; however, our skin is the largest organ in our body and absorbs chemicals directly into the bloodstream faster than if it were digested. The digestive system has a natural process to filter toxins, whereas the epidermis acts more like a sponge. This will be the first in a three part series.

We are what we eat AND what we wear.

What are these nasty chemicals lurking in our beauty and bath products, how do we avoid them and most importantly how do we make changes in legislation to protect us?

There are over 10,500 ingredients in personal care products, but the most common and most dangerous are:

Please click on the chemical name for more information.

Cosmetic Toxin – Triclosan – used as an antimicrobial in soaps and hand sanitizers. Triclosan is a known hormone disrupter and provides a suitable environment for the emergence of antimicrobial drug-resistant bacteria.
Cosmetic Toxin – Synthetic Musks – used to create scents. Did you honestly think, ‘Midnight Jasmine Hummingbird Orchestra Love Song’ was bottled in a lovely, toxin-free field? The chemicals galaxolide and tonalide are used to make synthetic scents, but also bind to and stimulate human estrogen receptors and have been shown to affect androgen and progesterone receptors. Tonalide increases the proliferation of estrogen-responsive human breast cancer cells and has been identified as a photosensitizer, a chemical that becomes more toxic when exposed to sunlight on the skin. It has also been linked to liver toxicity.
Cosmetic Toxin – Formaldehyde/Formaldehyde-Releasing Preservative (FRP) – A preservative found in nail polish, eyelash glues, hair gels, hair-smoothing products like Brazilian keratin treatments. FRPs do not have to be listed as an ingredient and can be found in personal care products including baby shampoos, soap and body washes. Formaldehyde is recognized as a known human carcinogen by the United States Department of Health and Human Services and the International Agency for Research on Cancer and has been linked to leukemia. Common ingredients likely to be contaminated with formaldehyde or FRPs include: quaternium-15, DMDM hydantoin, imidazolidinyl urea, diazolidinyl urea.
Cosmetic Toxin – 1,4-dioxane – Commonly seen as, “sodium laureth sulfate” on shampoo and soaps is used as a foaming agent. It is listed by the California Environmental Protection Agency as a suspected kidney toxicant, neurotoxicant and respiratory toxicant. Other ingredients likely to be contaminated: PEG-100 stearate, polyethylene, ceteareth-20.
Cosmetic Toxin – Hydroguinone – Used as a skin lightener and considered one of the most dangerous toxins in cosmetics. Hydroguinone is also found as an impurity in ingredients in facial and skin cleansers, facial moisturizers and hair conditioners. The Environmental Working Group (EWG) found the ingredient tocopheral acetate, and any ingredient with “toco” in the root, is at risk for contamination. Hydroguinone decreases the production of melanin pigments in the skin and simultaneously increases exposure to UVA and UVB rays, thus increasing skin cancer risks.
Cosmetic Toxin – Phthalates – Used to hold color and scents and aren’t usually listed except for in nail polish. A loophole in regulations allows phtalates to be added to fragrances (and therefore almost every cosmetic and personal care product) without being added to the label. Extensive research suggests that phthalates disrupt hormonal systems by reducing the level of sex hormones. Exposure in pregnant women has been linked to shortened distance between the anus and genitals of male babies indicating feminization occurred during genital development. Exposure in adult human males is associated with poor sperm quality and infertility. In women, phthalates have been shown to cause an increase of breast tumor cells and reduces the effectiveness of anti-estrogen treatments against tumors.
Cosmetic Toxin – Parabens – Used in products to prevent growth of microbes. “Parabens,” actually describes several chemicals with similar molecular structure, but the most common to cosmetic products are: ethylparaben, butylparaben, methylparaben and propylparaben. Parabens have been linked to cancer, endocrine disruption, reproductive toxicity, immunotoxicity, neurotoxicity, and skin irritation.
Cosmetic Toxin – Lead and other heavy metals – Metals including arsenic, mercury, aluminum, zinc, chromium, and iron have been found in lipstick, foundation, whitening toothpaste, eyeliner and more; both as intentional ingredients and as contaminants. Titanium dioxide and zinc oxide are often used in sunscreens (I will get into the dangers of sunscreen in a separate post), foundation, concealer, and diaper rash ointments. Iron oxides, aluminum, and chromium are used as a colorant in make-up. Color additives like D&C Red 6, may contain contaminants including arsenic, lead, and mercury. Zinc is used in moisturizers, shampoos and foundations. Heavy metal poisoning in the body can have a variety of adverse health concerns including neurotoxicity, endocrine disruption, birth defects, cancer, and more.
Cosmetic Toxin – Nitrosamines – An impurity and, therefore, not a labeled ingredient. Nitrosamines is a known impurity in 53 ingredients and virtually every cosmetic and personal care product including baby products, sunless tanning lotion and pain relief salves. They are actually created in products when nitrates and various amino acids are combined. Specifically, when diethanolamine (DEA) or triethanolamine (TEA), used to adjust the pH of products, are used in products with preservatives that break down into nitrates. Numerous studies have linked nitrosamines to cancer. They are listed by the EPA, International Agency for Research on Cancer, the US National Toxicology Report on Carcinogens and the California Prop 65 as chemicals known to cause cancer or birth defects. And if that wasn’t severe enough, nitrosamines are linked to endocrine disruption, developmental or reproductive toxicity, immunotoxicity, neurotoxicity and systemic toxicity.

So, you buy organic and natural products to protect yourself and your family, right? Well, more bad news: In the world of cosmetics the words natural, herbal, and even organic have no legal definition. Unfortunately, companies slap an organic sticker on products and then raise the price for unsuspecting consumers more often than not. The only way to truly protect your family is to make your own personal care products or research the products you buy. The good news is the EWG has created an electronic database analyzing 70,547 products and 2,912 brands of these dangerous products. The EWG’s Skin Deep database is an amazing tool to protect both your health and your wallet.

Furthermore, we can take action. First, stop buying products containing these chemicals. Second, spread the word. Not only are you saving someone’s health and potentially life, but you are taking away more customers, eventually forcing these companies to change their ingredients. Third, join or start a campaign to force legislation and regulations to protect the consumer. Organizations like the Environmental Working Group and The Campaign for Safe Cosmetics are dedicated to awareness and change, and have tools for consumers to lobby for change.

Photo by ehensley, Creative Commons

Conflict of Interest? No Problem

by Staff

Published on October 22, 2011

2755 views

One hopes that when defining the clinical practice guidelines for a given disease and the prescribing practices for a particular drug, the physicians on the panel who determine these things would have no vested interest in suggesting one medication or another. To the contrary, a recent study on diabetes and cholesterol prescribing recommendations found that this is most certainly not the case. Fully 52% of the panel members and 50% of the panel chairs convened to determine diabetes and cholesterol care, had a financial conflict of interest with drug companies. Though some disclosed their ties to drug companies, many others did not. Moreover, many of these panels have no disclosure rules. Beyond simple disclosure, a good first step, I think we all agree that those in charge of deciding the course of our care, should have no financial ties to the industry.

Hormones Matter

Where health, hormones, and a whole bunch of other stuff, make sense.