Did Merck Use Good Laboratory Practices Getting Gardasil Approved?

In my circle of moms, the discussion about Gardasil has been quite active. A fellow fitness mom and friend Chris Caffey Heidel spoke eloquently about her concerns not only about Gardasil’s efficacy and potential side effects, but to laboratories to use Good Laboratory practices, rules and habits advocated by the Late Senator Edward M. Kennedy (later signed to law) to ensure that research laboratories follow a standard set of guidelines that will help ensure that  Americans are safe and healthy. Chris has graciously allowed me to reprint her blog post here. You can view the original blog post at http://librafitnessaustin.com/?p=270. So here in its entirety is Chris’s post. Thanks Chris!

August 26th, 2009

Thank You, Senator Kennedy

In addition to being a personal trainer, I have worked for over 10 years in the pharmaceutical research field, most of those years in Quality Assurance. My job is to make sure that laboratories and other companies working in pharmaceutical research are following FDA regulations and accurately reporting results. It’s not always pretty, but overall, drugs these days are much safer than they were before the 1970s. Prior to that time, there were no significant laws governing the quality of laboratory research. Mail fraud was about all anyone could be convicted of. In the 1970s, several cases of fraud in studies submitted to the FDA were uncovered that led to a series of hearings in the Senate, chaired by Senator Edward Kennedy (i.e., “The Kennedy Hearings”). These hearings resulted in the creation of the Good Laboratory Practice regulations. Laboratories conducting preclinical research are now required to follow these regulations and to also staff a Quality Assurance Unit. Hence, my field of expertise.

I appreciate these and other efforts by Senator Kennedy throughout his long career to do right by the American people. What an incredible legacy. Thanks, Teddy. I hope that our Congress will honor Senator Kennedy’s passing by truly working together in a bipartisan way to enact meaningful legislation that can help address the current health care crisis in this country. One can only hope.

Below is a favorite quote from Senator Kennedy that is often used in Good Laboratory Practice training sessions.

“Inaccurate science, sloppy science, fraudulent science—these are the greatest threats to the health and safety of the American people. Whether the science is wrong because of clerical error, or because of poor technique, or because of incompetence, or because of negligence, is less important than the fact that it is wrong. For if it is wrong, and if the FDA did not know it was wrong, then the protective regulatory barrier between a potentially dangerous drug and the patient is removed.” – Senator Edward Kennedy (D-Mass.), The Kennedy Hearings

Add a comment September 10, 2009

A must read for moms of young girls

I started this blog as a way to chronical my personal journey back to good health. Since having my son in 2003 I’ve struggled and am now just finding practitioners and treatment s that are really helping me.  But today I have to speak about something a little bit different, ensuring the safety of my daughter.

Those of you that know me know that I had uterine fibroids and had quite a journey having my children.  A large motivation for me to get healthy is so that I can pass on good health habits to my daughter. Always in my mind is her well being and how I can help her to avoid many of the health pitfalls that I encountered.  When Gardasil, the vaccine that is  touted to prevent cervical cancer, came on the market I immediately began tracking it and I have to say that I have not been impressed with what I have seen.  Now I am even more concerned.  I just recently received a news piece stating that one of the actually clinical researchers for the Gardasil Vaccine has serious concerns about the vaccine. (Read her comments here http://budurl.com/ekmf)  The vaccine is proving to have some very serious side effects and now there are questions as to whether or not the vaccine is effective after 5 years.

As many of you may know, I write and research a lot of women’s health issuses for Austinwoman Magazine as well as for my own business and personal edification. For the past couple of years I’ve been watching Gardarsil, the vaccine that is supposed to protect women from getting cervical cancer. I have to say as a former clinician and reseacher and as a mother of a young daughter I have been skeptical of this vaccine. First, my radar always goes up when something is rushed through the FDA when there is no clear danger to the public. Then when Gov. Rick Perry made that crazy Saturday Mandate that all girls going into middle school must take the vaccine, I was even more skeptical-especially when I saw that one of his former aides works for Merck and was “encouraging” the mandate. It’s was unclear to me if Perry’s support garnered him any funding, but if he did in fact receive funds from Merck as a result of Mandating Gardasil, isn’t this a conflict of interest?    I reviewed the FDA filing documents,  http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf as well as the Vaccine and Related Biological Products Advisory Committee report on Gardasil (one of the documents that explained the review process of the FDA).  In these documents Merck openly reports that there are 9 reported cases of systemic autoimmune disorders that presented after the subjects enrolled in the Gardasil trials and took the vaccine.  There was one case of Juvenile Arthritis, 2 cases of rheumatoid arthritis, 5 cases of arthritis and one case of reactive arthritis.  That is all that is said.  Merck does not go on to say whether or not these systemic cases arose as a result of taking Gardasil or that the subjects had a predisposition to autoimmune disorders.  Merck makes no comment on these findings.

Now one can say that these are completely unrelated reactions, but no one knows this for sure. One can also say that statistically, this is not a significant number.  The total number of people on this particular study who received the vaccine was 11,813 and only 9 who took Gardasil ended up with an autoimmune disease. So 0.0762% of the participants had an autoimmune reaction.  That’s pretty small.  However, multiply this percentage by the number of girls who are targeted to get the vaccine which according to the CDC is approximately 30 million girls.  A simple algebra equation reveals that 22,860 girls could be at risk for developing an autoimmune disease if the 9 girls who developed autoimmune diseases in the clinical trials actually developed their diseases as a result of taking Gardasil. For all of the clinical trials there were 102 serious adverse events reported for all of the study participants, 21,514 (the 11, 813 who took Gardasil + 9701 who took placebo). This number translates to 14,220 potentially serious adverse events if 30 million girls are vaccinated. I don’t know about you, but 14,000 girls developing an autoimmune disease from a vaccine is a pretty significant number to me.

Merck claims that by making Gardasil a mandatory vaccine, the estimated annual 9710 new cervical cancer cases and estimated 3700 deaths (Data for 2006) would be significantly reduced but not avoided altogether.  However, if  women continue to get annual pap smears and pelvic examinations and to act promptly if they receive an abnormal pap smear, rates for cervical cancer are similarly reduced.

Everyone has to make their own decision when it comes to caring for their children.  But in light of these findings from one of the clinical researchers, My daughter won’t be getting the vaccine.

1 comment September 5, 2009

Which Came First?

So I finally got my saliva test results back last week. There really was no surprise. My adrenals are shot and my cortisol pattern bears this out. Apparently cortisol levels should be lower in the early morning, enabling you to get up and to get busy, rise during the day when you need to be productive and fall later in the day as you should be relaxing and winding down. My pattern was the complete opposite. My levels were highest in the early morning, hence my early morning awakening complete with my mind rushing and not being able to go back to sleep. During the day I would get progressively more fatigued and weary, as if dragging through the mud. Then at night, I’d become somewhat wired and often have trouble falling asleep. Dr. Edgerton started me on a 3 month adrenal support plan and we’ll see how things go.

My adrenal patterns have made me wonder what came first, my increasing anxiety and insomnia leading to hormonal imbalance and adrenal fatigue or my hormonal imbalances leanding to insomnia and anxiety?? It’s really a tough call.

Our fast paced society really does not lend itself to periods of rest, reflection and contemplation-those times of rejuvenation. However, without them, one ends up in a state of internal and external turmoil much like I experienced. I am very cognizant now of the effect that sleep (or the lack there of) and stress have on my health. One may say, “Well duh!!” but in my case, while I knew it in my head, it was something else entirely as I lived it. While I am a full blown believer, I still struggle with keeping things in perspective, allowing time to rest and rejuvenate and letting go of the “small stuff.”

Christiane Northurp, MD speaks extensively about heeding the body’s cues and tuning into its wisdom in her book, The Wisdom of Menopause. She actually states that the when  a woman is experiencing physical and emotional unrest it may in fact be due to hormonal imbalance, but it is also due to the imbalances in our lives. The pain and discomfort is a wake up call that something is wrong, out of balance and we need to attend to it.  Boy did I get that message loud and clear! And like any good pupil, I am studying the events leading up to my state of imbalance, seeing what I need to change and rectify and doing my best to move forward.

Now I take a thyroid supplement, DHEA, iron, Vitamin D, and adrenal supplements daily. In addition to my multivitamin and Calcium tablet it looks like a lot and my 3 y.o. was quick to point this out. Sometimes I feel a bit like a fool for ever getting so far out of whack and yet, in an effort to be kinder to myself, I acknowledge the struggle, congratulate myself on those days when I am able to refrain from over exertion, excessive stress and taking on that last little task “to help someone out.” Each day is another in the journey. I’m just glad that the damage was not irreparable and that I can continue on.

Add a comment September 1, 2009

A Good Night’s Sleep

It’s been two weeks now since I’ve started on my bio-identical hormones and I have to admit that I am feeling better. For the first time in over a year I don’t feel like I am slogging through mud. Although I was keenly aware of how badly I’d been feeling, the confirmation has come in the contrast of how much better I am feeling now. I am still a bit tired and I expect that it will take some time for me to replenish my sleep given the deficit I have been in.

I am sleeping through the night and I just can’t believe what a difference it is making in my overall outlook. I used to go to bed at 10 or 11 pm and by about 3am, I’d be awake. If I was lucky, I’d get back to sleep within an hour or so. But often  I’d lay there, staring into the darkness and listening to my husband snore. The more that I tried to will myself to sleep the worse things seemed to get. I’d get even more agitated each time I looked at my clock and saw the night slipping by. Sometimes I’d take Benadryl because I knew that I had a busy day and needed to sleep. Other times I toughed it out and just dealt with the consequences the next day. My gyn’s solution was Ambien, but I found that made me groggy the following day if I did not allow for a full 8 hours of sleep, so couldn’t always take it.

Dr. Edgerton, the doctor treating my hormone imbalances,  first gave me magnesium capsules to take one hour before bed. I could take up to 4. They did the trick, but I often felt weird in the morning, sometimes had a bit of a headache and a weird taste in my mouth. But I would sleep most of the night and if I did wake up, I would fall back to sleep in less than an hour. But the best thing has been prescription Melatonin. The Melatonin capsules are 10mg and I began by taking one a night, then another and another until I slept through the night. Initially it took 6 capsules for me to sleep through the night. While on vacation last week I was able to drop back to 4 and just last night I actually slept through the night with no medication at all! It has been months since I’ve slept a full night, without interruption and without medication. I hope this is the start of my body resetting itself and being able to sleep on its own.

I still have pangs of anxiety but I realize that much of it is stress. Having a family, a home and a business to run are stressful. It’s been tough on all fronts and many has been the night when I’ve awakened and my mind begins whirling with all manner of thoughts about the kids, work, bills…That is slowing down. I don’t know whether to contribute the improvement to the thyroid replacement or to the DHEA but I am inclined to think the DHEA. I started taking the thyroid medication one week before the DHEA and now have been on both for a week. I honestly don’t recall not having the “mind whirling” before this week, so it must be due to the DHEA which I just started taking.

I have a follow up appointment in 2 weeks when I’ll see how really fried my adrenals are when I get the result of my cortisol saliva tests. You know it ain’t good when they tell you that you have to come in for the results. But I’m not concerned. If Dr. Edgerton can figure out what is going on with me and make me feel better, it’s all good.

Add a comment August 14, 2009

Hormones To The Rescue!

I have just started Hormone Replacement Therapy.  I had my follow up visit with Dr Edgerton 5 days ago. I have to admit, all things considered, I’m not as hormonally whacked as I had thought I’d be. However, there were definitely some imbalances.

Let’s start with the good news. Overall, my body is functioning pretty well-all things considered. My cholesterol is good as is my Homocysteine level hence my risk for heart disease is pretty low right now. I’ll have to watch this as the years go on because there is a really strong family history of heart disease on both sides of my family. Another good level was my fasting blood sugar. Given that 3 of 4 grandparents died with/from complications of diabetes and heart disease, it’s nice to know that I am currently not in iminent danger of these dreaded diseases. And with my low blood pressure I am not at risk of metabolic disease. To further avoid that little bullet, I have to get my weight down and hopefully getting my hormones balanced will help that. My other systems-liver, kidney, etc.. all seem to be functioning well.

So let’s take a look at the things that weren’t so good. My thyroid hormone level is on the low end of normal. No news there. Although I have been taking a supplement, it hasn’t been able to fully replace me to an acceptable level so Dr. Edgerton is prescribing thyroid hormone. The good news is that my pituitary gland sends the proper message to my thyroid to produce the hormone, and my thyroid does produce hormone enough to keep me just within the normal limits. But as far as having functional levels of thyroid hormone, I’m not even close so Dr. Edgerton is prescribing thyroid hormone.

Working our way down, my testosterone level was also borderline. Given that I am not having trouble with my libido yet have been extremely fatigued and with low energy, Dr. Edgerton has opted to replace my DHEA hormone, a precursor to testosterone. This should not only help my testosterone levels, but also my energy levels.

My estrogen levels were okay but my progesterone levels were pretty crappy. Classic case of estrogen dominance. No surprise there given that I just had an endometrial ablation for recurrent uterine fibroids and heavy menstrual bleeding. So I’ll be taking prescription grade bio-identical progesterone.

What did come as a surprise is that my Vitamin D levels were really quite low. I know that there is currently an almost epidemic low of Vitamin D amongst most Americans but given that I take a calcium supplement that contains Vitamin D and a multivitamin with Vitamin D, I thought that I was doing okay. So I’m now taking prescription grade Vitamin D. (I’ll discuss vitamin D and its actions and benefits in the next post!)

Finally, my iron stores were low. Again, so surprise there given that I’ve been having periods from Hell. It’s interesting that my Hemoglobin and Hematocrit levels were normal, so I’m not anemic but heaven help me if I get injured or otherwise hemorrhage.  So I’m starting Ferritin.

Overall there were really no surprises, except for perhaps the Vitamin D. I feel pretty confident that once I start on the hormones I’ll be able to get back to my normal self.

One thing that wasn’t really addressed was my overall anxious feeling. It has just been pervasive and it’s really obnoxious. Since this is a classic symptom of Adrenal Fatigue,  I have to do saliva tests for cortisol. Seems I’m in perpetual “flight or fight” mode & It’s been wreaking havoc with my sleep. Dr. Edgerton has given me some magnesium supplements to help (more about this in another post!), but they are not totally effective as I still wake up early in the morning around 3 or 4 am,  So he is also prescribing melatonin. My husband has been telling me to take this, but I tried some over the counter in the past without any help.  So I’m going to be trying the prescription grade.

Since this is a bio-identical hormone clinic, all of my hormones are compounded for me. They were ordered the day of my appointment and just arrived 2 days ago in the late afternoon. I’ve only been on them one full day, but I can already give kudos to the melatonin. I’ll keep you posted on how the others do and what if any adjustments are needed.

But I do offer this advice: don’t wait as long as I did to get help. So far my sleep is much improved on the Magnesium and Melatonin and that alone is making me feel better. If the other hormones are as effective as quickly, I am sure I’ll be back to my old self in no time.

I’m just sorry I waited so long, mostly hemming and hawing over the costs, to act. Ladies, there is no price one can give to feeling good. Don’t wait as I did. You (and I) deserve to feel good. You’d never let your child or your husband go about feeling poorly indefinitely so why should you?  Have the same respect for yourself and give yourself the same care!

Add a comment July 26, 2009

NovaSure? For Sure

I had a NovaSure endometrial ablation 4 days ago and so far it is proving to be one of the best decisions I’ve made in a while.  An endometrial ablation is a procedure that essentially fries the uterine lining so that it no longer causes heavy menstrual bleeding. In the process, it sometimes gets rid of or decreases uterine fibroids.

I’ve been battling the old “fibbies” for a long time now. First diagnosed in 1995, I used herbs and acupuncture to manage the symptoms. Once I got married we tried to get pregnant but miscarried and found it was due to the fibroids.  I had a myomectomy in 2001 and promptly got pregnant in 2002  with my daughter. Two years later I got pregnant again and miscarried again. This time, not due to the fibroids, just not a viable pregnancy.  I got pregnant for the last time in 2005 and had my son in 2006.

Things had been pretty good up until about 6 months ago. I started gaining weight, becoming increasingly more bloated with my periods and then the heavy bleeding returned. At first I thought perimenopause and this may in fact be a contributing factor.  But when the bad menstrual cramps returned, I knew it was the fibroids once again.

I made a decision a long time ago to leave this earth with as much of what I came here with as possible. That being said, I have no intention of having a hysterectomy.  So when the heavy bleeding and cramping started up, I went to my GYN to see what could be done.  She ran down the list; Birth control pills, Mirena IUD, another myomectomy, ablation, Uterine Artery Embolization, Hysterectomy. I opted for the ablation.

So bright and early 4 days ago my hubby drove me to my GYN’s office. We arrived at 7:15 am and I was taken back to a room at 7:30 am. Surprised that I only had to strip from the waist down, I was given a lovely powder blue IKEA fleece throw for my legs. I then met with the anesthesiologist. She asked me a few questions and then started an IV in my hand through which she put medication for nausea, some pre-sedation and later some antibiotics. We then casually walked across the hall and a very nice nurse helped me to get comfortable on an oversized lazyboy chair with stirrups. As I settled in, the last thing I remember is the room becoming hazy just before everything went black.

When it was all over, the nursed helped me into a wheelchair and I was taken back to my first room. I looked at the clock and was surprised to see that I had only been gone 15 minutes! My GYN stuck her head in to let me know that everything went great and after about another 15 minutes, I was being wheeled out to my car with my husband.  I was there for a total of 1.5 hours. Truly amazing!

Over the next couple of hours, things got a bit crazy. As the anesthesia wore off, the cramps set in and so did the nausea. I had to send the husband out to fill the Vicodin and Phenergan prescriptions. Once I took them, I slept for almost 6 hours (I’m sort of a light weight) but when I woke up, I felt just fine. I had a bite to eat, hung out a bit with my kiddos and fell asleep for the night at 8pm.

I’ve been well since. There is no major bleeding or pain and I actually feel great. I am anxious to see what my periods will be like in the coming months if I have them at all. As long as I’m not doing my version of hemorrhaging, I’m okay.

This NovaSure ablation system is really a slick little procedure. I don’t know what the future holds, but so far so good. I highly recommend it. (Photos courtesy of Hologic, Inc.,  www.novasure.com)

If you want to learn more about fibroids, visit my website www.nextstepfitness.com and listen to my podcasts.

2 comments July 14, 2009