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Update on FDA’s Advisory Bisphosphonate Panel Meeting

By Pam Flores, Health Guide Friday, September 30, 2011
On September 9, 2011 the Food and Drug Administration (FDA) conducted a day-long meeting of experts in the field of osteoporosis, to consider the risk and benefits of bisphosphonates.  The meeting was an assembly of medical experts, doctors, drug company's representatives and patient advocates.&...
October is Breast Cancer Awareness Month!
10/ 1/11 6:15pm

Dear Pam and all your viewers:

 

I was one of the speakers that went to the meeting in Maryland and spoke before the Board. It was an eye-opening experience. I have had multiple reactions to the drug Reclast and I went before the Board to advise them of these reactions. As I said, it was an eye opening experience, but one I would do again in a hearbeat if the opportunity came to me again. Hopefully, this train will keep on moving and one day Reclast will just be a faded memory for everyone.

 

Sincerely,

 

BaseballGirl

Pam Flores, Health Guide
10/ 1/11 6:47pm

Hi BaseballGirl85:  I'm so glad you were able to attend this meeting and I hope that you feel you've accomplished a GREAT thing in at least getting the label changed for two very important side effects that can be life-threatening on bisphosphonates (Actonel, Reclast, Boniva, and Fosamax).  I hope you can own (like Orpah says ;0)) the accomplishments you and others made.

 

I know you've gone through way too many serious side effects and were hospitalized an inordinate amount of times with many on-going serious issues from these drugs.  What you and others did is absolutely commendable since you had to travel a long distance in poor and weak health, to be heard and to represent all the others who were too sick to go.  You've done a truly admirable thing and I hope you realize this

 

All steps towards a wonderful solution to a bad drug starts with one very dedicated step, which is what you did!  Give yourself a pat on the back for all of us, and we want to thank you from the bottom of our heart.  I also hope you'll be able to further work with the local government or advocacy groups to see that the drug that injured you will be removed from the market.  It may be an uphill battle, but I know you have the fortitude to accomplish this.

 

Take Care and thanks so much for telling us about your attendance at the meeting.  Feel free to upload a photo of the meeting if you wish to in your photo section of your home page.

 

Thank You Again!!!

 

Pam Flores

Community Leader/Writer/Moderator for OsteoporosisConnection.com

Pam Flores, Health Guide
10/ 1/11 10:29pm

Hi again BaseballGirl, do you have any ideas for Marcia that might explain her varying scores over the years?  You've been dealing with treatments and side effects that I thought you could add something I didn't think of.

 

No pressure, just a thought that you could help her out.

 

Pam

Eileen Bailey, Health Guide
10/ 2/11 6:22pm

Thank you for taking the time to go to Washington D.C. and speak up about this medication. It is so important for patients to be involved in this process and to talk about the "real" experiences from different medications. It is not only important for this medication, but for every medication.

 

Eileen

Pam Flores, Health Guide
10/ 3/11 6:43pm

Thanks Eileen, I know the ladies appreciate your support of their efforts at the FDA Advisory Meeting on Bisphosphonates.

 

We all thank you for reaching out on this important topic and your concern for those taking these drugs!

Marcia Purse, Health Guide
10/ 1/11 8:21pm

I was diagnosed with osteoporosis before the age of 40, then told a few years later I'd gained back enough bone mass that I didn't have it any more. Then many years later the osteoporosis diagnosis came back and I was put on Fosamax. The heartburn was like nothing I'd ever felt before - horrific! So it was "take calcium and exercise."

 

The last test showed osteopenia only. It's pretty hard to understand why my bone density scans keep changing over the years but - after reading the terrible possible side effects of this type of medication, I wouldn't go NEAR it.

Pam Flores, Health Guide
10/ 1/11 10:16pm

Hi Marcia, there could be several things going on with your varying scores.  Each time you have a DXA are you having it on the same machine and using the same tech?  If you aren't then each scan can't be compared.  Each DXA machine is callibrated differently, so this is why they tell us to always use the same machine and tech "if possible."  There can be great differences in scores between each scan done on a different type of scanner.

 

Also, were you taking any medication that would cause bone loss that you then stopped?  If so, that will have an affect as well.  There are also tons of secondary medical disorders that cause bone loss, which might explain it, where you might have had one of these medical problems but no longer do, or vice versa.  Check the 2 lists/links for secondary medical causes and medication causes to see if any apply.  This is just a shot in the dark, but prednisone/corticosteriods are the number 1 medication cause for bone loss and you don't have to take them long for this to happen.  They consider long-term use any regime over 3 months at approximately 10 milligrams per day.

 

I hope that helps.  If you have another DXA scan try to plan on having it at the same place/scanner/tech each time or it can not be compared at all.  I understand your reluctance with the osteo meds, but there are some other treatments available that aren't in this drug class.

 

Thanks for stopping by...

10/ 2/11 5:18pm

Marcia:

 

Were all your Bone Scans done on the exact same table? That can make a huge difference if they weren't. Also, did the same person do the scans? That also can cause a variance in your scans as well. It is amazing how different your scans can vary just by who does your scans as they may have a different way that they do the procedure. In addition, a different table could be calibrated differently than another and this can account for variance as well. Hope this helps!

 

Baseball Girl

 

10/ 2/11 8:33am

I was also a speaker at the FDA advisory panel.

 

I will make one correction to your article.  During the public hearing portion of the meeting,  ( the time when the public had a chance to speak about their experiences with these drugs) there was not a single patient out of all the speakers that spoke about a "positive "experience with these drugs, or how they personally benefited from taking them.  All of the speakers that were patients( guinea pigs) were victims of these drugs.  The only speakers that spoke about the positive, helpful aspects of these drugs were either Doctors or researchers , many of whom were paid for their research by the makers of these drugs.  I think that this is important to know.  There was not one single patient that stood up for these drugs , and touted their benefits.  

That being said, I am sure that there are people out there that think these drugs may be helpful, they are the lucky ones, whose lives have not been destoyed ...yet...

 

I lost my father to Reclast ( the worst, and most dangerous) of these drugs 54 days after his first IV infusion.  He had almost all the symptoms listed above , except ONJ , and femur fractures , but he really died too quickly to suffer those issues.

 

The meeting was truly heartbreaking to hear victim , after victim come forward to speak about incredible pain.  One woman experienced an atypical femur fracture in front of several elementary school students.  These are not pretty fractures!

 

I left feeling that the FDA had made up their mind in regards to these drugs before the public portion of the meeting began.  Unfortunately, the FDA is yet another Government agency that is more influenced by Drug money, than with the welfare of the public.

 

 I am pro business, and I believe that companies should be able to profit from their products.  However, Drug manufacturers have lost site of their true purpose. They no longer try and develop products that will truly help, and not harm, they develop to the biggest market they see.  Then they rush these drugs through the system ( with a lot of help from their cohorts at the FDA ), and then we, the trusting public act as their guinea pigs.  The most disturbing fact is that they build extra money into these products to offset the class action , and legal issues that they know will come.  Just listen to every commercial produced by a drug company, the list of side effects is longer than the propaganda they spew before hand.  This is a very sad commentary on these businesses and agencies that we should be able to trust.  

 

Unfortunately, my eyes were opened to this in a very hard reality, with the loss of a loved one.  I have gotten to know many, many victims of these very dangerous drugs.  I truly believe that these drugs should be pulled off the market period.  There is NO conclusive research that these drugs even work.  In fact they appear to cause our strongest bones to fracture, and our facial bones to die, and disintegrate. Let's use some common sense folks, does this sound like a product that will build and strengthen bone???

 

 

Pam Flores, Health Guide
10/ 2/11 2:48pm

Hi acook thanks for your passionate explanation of the events at the FDA meeting. Thanks for the correction...I thought you said there were some patients that had positive things to say about these drugs...but I guess I misunderstood - mea culpa!

 

You make some very good points about the drug companies, and the thing that amazes me is the amount of money allotted to their legal departments, millions, and the staff they employ of the countries top-notch attorneys. I believe their annual legal expenditure is close to what they spend, if not more, on their R&D expenses. If this is true, how will we ever make strides with class action cases against a financial giant?

 

I'm so sorry about your Dad, and I know you went to the Advisory Meeting with hope in your heart to remove Reclast from the market, but at least you brought his story to the forefront.

 

Thanks for representing the many that have been injured and bringing understanding to this issue.

 

Take Care...

 

Pam

10/ 2/11 5:40pm

ACooke:

 

You were right on with your description of the FDA meeting! It was like we didn't speak at all. I was so appauled when we got done speaking and there was so much emotion in the room and then it was just like a wall went up. They adjourned our part of the meeting and then started back up the Board meeting. It was like it was a total about face. Suddenly it was like they had put earplugs in their ears for the last hour plus while we were speaking or had been amusing themselves in some other manner. It appeared that they were unmoved by what they had heard totally. I couldn't believe it. I was devastated. Suddenly I couldn't remain in the room any longer or I was going to be physically sick. I had to get out of there. You and I then left the meeting, but I still carry that feeling with me today of emptiness. But yet if the opportunity came to me again today, I would take it. We still need to speak out at every opportunity to speak out on the evils of these drugs at every road we can so one day they are no more.

 

BaseballGirl

Anonymous
David
10/ 2/11 5:58pm

 

"You make some very good points about the drug companies, and the thing that amazes me is the amount of money allotted to their legal departments, millions, and the staff they employ of the countries top-notch attorneys. I believe their annual legal expenditure is close to what they spend, if not more, on their R&D expenses. If this is true, how will we ever make strides with class action cases against a financial giant?"

 

Pam,

 

For some drugs, the sheer amount of profits earned from sales would more than mitigate losses from ANY lawsuit due to "problems" with that particular drug. For example, if they generate a billion dollars in profits on a drug but a judgement against the company comes out at $250M, the attitude would be that they still made a huge profit on that drug. There isn't anything punitive to the company. So, why not continue along with their merry way?

 

After all, any and all drug companies are in the business of earning a return on investments for their investors. Unfortunately, this mostly comes at a high cost to the patients that their drugs are used on.

 

As for physicians, they have become pawns in the overall scheme of things due to their propensity for accepting free trips, gifts and the like. Despite the fact that this is definitely a "conflict of interest" the practice continues!

 

[Most of us recognize that "most" med students enter med school with a genuine desire to benefit mankind. However, once they've gone through the system, it appears that the system changes this noble attitude. The God-complex sets in (doesn't apply to ALL physicians) and their ego inflates and over-inflates. Then, the belief comes in that "I deserve.... because..." It's human nature, isn't it?  Sad but true!

 

Patients also need to take responsibility for their own situations. For example, it's incumbent on the patient to do whatever they can to mitigate their own health problems. For example, a healthy diet and exercise can contribute to their overall health by reducing the incidence of a variety of diseases including high blood pressure, heart disease, high cholesterol problems, cancer, diabetes, osteoporosis, and the list goes on and on. However, rather than taking on this responsibility, it's so much easier to go to the doctor for the "magic pill" that they saw advertised on television or in a magazine.

 

The doctor, on the other hand, doesn't have the courage to say "NO" to the patient when he/she knows it's the best and most prudent way to manage the patient's condition. It is soooo much easier to pull out the prescription pad and succumb to the patient's demands because, after all, who enjoys confrontation and there's more time available to bring in another patient... ka-ching!"

 

And, of course, the cycle continues. And, at the end of the day, why wouldn't it?

 

 

Anonymous
David
10/ 2/11 5:58pm

 

"You make some very good points about the drug companies, and the thing that amazes me is the amount of money allotted to their legal departments, millions, and the staff they employ of the countries top-notch attorneys. I believe their annual legal expenditure is close to what they spend, if not more, on their R&D expenses. If this is true, how will we ever make strides with class action cases against a financial giant?"

 

Pam,

 

For some drugs, the sheer amount of profits earned from sales would more than mitigate losses from ANY lawsuit due to "problems" with that particular drug. For example, if they generate a billion dollars in profits on a drug but a judgement against the company comes out at $250M, the attitude would be that they still made a huge profit on that drug. There isn't anything punitive to the company. So, why not continue along with their merry way?

 

After all, any and all drug companies are in the business of earning a return on investments for their investors. Unfortunately, this mostly comes at a high cost to the patients that their drugs are used on.

 

As for physicians, they have become pawns in the overall scheme of things due to their propensity for accepting free trips, gifts and the like. Despite the fact that this is definitely a "conflict of interest" the practice continues!

 

[Most of us recognize that "most" med students enter med school with a genuine desire to benefit mankind. However, once they've gone through the system, it appears that the system changes this noble attitude. The God-complex sets in (doesn't apply to ALL physicians) and their ego inflates and over-inflates. Then, the belief comes in that "I deserve.... because..." It's human nature, isn't it?  Sad but true!

 

Patients also need to take responsibility for their own situations. For example, it's incumbent on the patient to do whatever they can to mitigate their own health problems. For example, a healthy diet and exercise can contribute to their overall health by reducing the incidence of a variety of diseases including high blood pressure, heart disease, high cholesterol problems, cancer, diabetes, osteoporosis, and the list goes on and on. However, rather than taking on this responsibility, it's so much easier to go to the doctor for the "magic pill" that they saw advertised on television or in a magazine.

 

The doctor, on the other hand, doesn't have the courage to say "NO" to the patient when he/she knows it's the best and most prudent way to manage the patient's condition. It is soooo much easier to pull out the prescription pad and succumb to the patient's demands because, after all, who enjoys confrontation and there's more time available to bring in another patient... ka-ching!"

 

And, of course, the cycle continues. And, at the end of the day, why wouldn't it?

 

 

Eileen Bailey, Health Guide
10/ 2/11 6:20pm

First, I am so sorry for the loss of your father. I know that is difficult no matter what, but when it could have been prevented I am sure it is that much more difficult.

 

Thank you for taking your time to go to the FDA hearing. It is so important that patients speak up and talk about their experiences, it is the only way for us to move forward and find better ways to treat any medical condition.

 

You have done everyone that takes any type of medication a great service.

 

Eileen

10/ 2/11 6:37pm

Thank you for your kind remarks. You are right that we need to make the FDA accountable for all drugs that they allow to harm us that they just blatently pass by, rather than just sit here with our mouths closed and do nothing. If we do this, then we become part of the problem, instead of the solution.

 

BaseballGirl

10/ 3/11 8:13am

Pam,

 

No apology necessary, who knows in my zeal and "passion" after the meeting, I could have said that some spoke for these drugs.  Out of 17 speakers, about 4 spoke with a pro bisphosphonate position.  All 4 of these speakers were either Drs. or researchers, and all, save one was being compensated by a drug manufacturer.

 

I apologize for confusing you , and not being clearer...

 

I thank you for bringing these issues to your blog.

Pam Flores, Health Guide
10/ 3/11 7:07pm

Hi David, thanks for your astute comments which I agree with for the most part.  It is disgusting that some physicians take gifts from drug companies, but I do know of quite a few doctors that don't allow this at all.  I don't know if this applies to all teaching facilities, but I know the one I go to will not let the drug companies come into the office.  I know they do accept grants for research projects, as the Univ I get treatment from is an osteoporosis research facility, and I doubt the Hospital/University could afford all the cost for this expensive research all on its own.  They also receive private donations as well, and if they didn't we wouldn't see the progress in DNA research for a link to the very disease they treat.  If we could understand how bone loss is inherited, we may find a way to prevent it through gene therapy.

 

I'm sure you don't want to lump all physicians into your analogy, but I do totally agree that this God complex, and Pharma relationships impede our patients treatments. 

 

It's easier to take that magic pill than to make lifestyle changes, but honestly I don't know that many who do that.  Those patients that I'm familiar with would rather avoid pharmaceuticals and look to their diet, exercise and supplements, and are constantly doing research on the latest food source or vitamin that helps stave off bone loss.

 

I do have a problem with DTC marketing and how it causes some to turn to the latest osteo med, but I took a drug that had a marketing black-out on it so there were no advertisements, and this was the drug I chose for severe bone loss with 6 spinal fractures, so this may be an example of DTC not applying successfully in all cases.  You could read research on the drug but no advertising was allowed, as a term set into its FDA approval.  If I see an ad on T.V. or magazine about a new treatment, I'm not one to say Oh I'll try that.  I first need to read as much as possible, that isn't authored by the drug companies, and I know many who do that, but I realize this may not be the norm.

 

Thanks for your comments they are right on in many cases, but not all, thankfully!

 

Join us any time to help continue this on-going discussion.

 

10/ 5/11 6:44am

I wanted to say thank you for going to the meeting and representing the rest of us.  I would have gone, had I been able.  I know it took a lot, physically, financially and especially emotionally to get up there and speak.  I also want to thank Pam for posting this.  LovetoCrochet

Anonymous
David
10/ 5/11 3:58pm

Hello Pam,

 

Thank you for your reply to my posting... always interesting to hear other people's thoughts and opinions on this potentially volatile subject.

 

I applaud your institution for their stand on not allowing Big Pharma to come in and make their sales pitches to the physicians on staff. In the past, I know some major universities have taken a similar stand and, in fact, instituted policies confirming this. And, of course, when some of their physicians on staff were asked whether they had any financial relations to any pharmaceutical companies, their answer was negative. However, upon further investigation, it was found that some of these same physicians were, in fact, receiving payments. The responses were all similar and that they received the funds as a

payment for teaching seminars on specific medications. So, this really tends to jade the public's perception about the ethical beliefs of "some" doctors.

 

Of course, I do recognize that there are some morally/ethically upstanding doctors out there in the practice of medicine. And, I dare say that I believe the majority of them are of this category. As with any industry, there will definitely be good apples and bad ones.

 

As for research funding, yes, I fully comprehend the need for this from not only governmental agencies but also from the private sector. It's a huge challenge these days to procur funding strictly from governmental agencies especially in light of the financial restrictions of the economy and budgetary concerns. I don't really have an issue with this as long as there is a degree of autonomy and, IF the research is fact based with the analysis of results being governed by proper protocol and analysis. My problem would be if Big Pharma applied pressures on to ensuring that the results are skewed to favor their research product in terms of safety and efficacy. We all like to think that this doesn't happen but...

 

My personal belief is that one day, with the Human Genome Research Projects, medicine will be flipped over on its head because of the technological advances gained. Hopefully, cancer, diabetes, Parkinson's, etc will be cured via the switching on and off of contributory genes that lead to pathogenesis of the disease. Also, the nature of cloning will contribute to new advances in limb and organ replacements. After all, they've already achieved this with human eyeballs. What will come next will be monumental steps albeit, at the current time, these steps will be small. Time!

 

No, I do not lump ALL physicians into the same god-complex. Frankly, while taking a clinical biochem course back some 20+ years ago, a British physician who was instructing the course started talking about this very topic. His comment was that the god syndrome wasn't as prevalent in the UK. But, his experience was that many of his peers of the day (in America) suffered from the anomaly. I nearly lost the coffee I had just taken a swig of! Anyway, he was not only one of the best instructors I'd ever had but, he was also one of the most down-to-earth persons I've ever had the pleasure of knowing.

 

So, I do apologize if it sounded like I'd lumped them all into one category but that was certainly not my intention. :)

 

You may be in a group of enlightened individuals and that's a good thing. But, take a moment and think about the sheer numbers of over-weight people out there (and, I'm speaking of those without medical involvement) who are flocking to have gastric banding performed. Or, those taking the latest and greatest weight loss supplements.

 

Let's also apply this to those individuals who knowingly consume copious amounts of sugar (diabetes), tobacco users (cancer et al), alcohol users (liver and kidney) or drug users, and the list goes on and on. They are ALL cognizant of the ill effects of their lifestyle practices on their health but the question is, "Will they make the effort to change knowing that their health conditions would improve?" For some of them, the answer is a definitive "NO" and they wouldn't change until they're on their death beds.

 

[Yes, I agree that addiction problems are a huge part of the problem and that some of these individuals require medical interdiction in order to change. But, for the most part, I'm referring to those users who CHOOSE to engage in their specific practices. Then, when an illness sets in, they're at the physician's office asking WHY it's happening to them.]

 

Yes, I agree that you and some others may not be the norm when it comes to tv advertisments. Like you, I do my due diligence and question to the nth degree what is presented by Big Pharma via the media. But, Big Pharma is intelligent enough to recognize that new users can, AND WILL, be generated through modern day mediums. If they didn't believe this, there would be absolutely NO need for them to promote their products on tv, magazines, etc.  That is why I firmly believe that DTC marketing should never have been allowed in the first place. But, money does speak! And, very loudly at that!

 

Yes, at times and under certain conditions, the "magic pill" may work more efficaciously than natural supplements and lifestyle changes. But, they also come at a cost to some patients. Imagine being one of the "few" who contract osteonecrosis of the mandible because of taking bisulphonates. Scarry, isn't it?

 

Or, those people who are taking cholesterol lowering, statin meds suffering from rhabdomyolysis, memory fog, etc. Scary, isn't it?

 

[And what is absolutely more frightening is the drive by some physicians to have patients take these cholesterol lowering statins as a preventative medicine... just in case their levels increased! Thankfully, I believe that this has now been circumvented and no longer something they're trying to entrench.]

 

If it sounds like I'm entirely at odds with the medical system, please dismiss the notion. I think there are some great practitioners out there practicing REAL high quality medicine with the ethics of Hippocrates... those who are truly looking after the best interest of their patients. To these, I applaud!

 

It's the bad apples in the barrel I have a big problem with. And, I wish the overseers of Big Pharma would get their act in place and be held far more accountable than they presently are!

 

My wish is to encourage the public to stand up and start asking questions about the treatment they're receiving... and to do their due diligence and not be lead around like sheep. Only then can the system change and improve!

 

I do sincerely hope that the Osteo med(s) that you're using is/are working well and resolving your bone loss.

 

Best of luck to you Pam.

Anonymous
David
10/ 5/11 3:58pm

Hello Pam,

 

Thank you for your reply to my posting... always interesting to hear other people's thoughts and opinions on this potentially volatile subject.

 

I applaud your institution for their stand on not allowing Big Pharma to come in and make their sales pitches to the physicians on staff. In the past, I know some major universities have taken a similar stand and, in fact, instituted policies confirming this. And, of course, when some of their physicians on staff were asked whether they had any financial relations to any pharmaceutical companies, their answer was negative. However, upon further investigation, it was found that some of these same physicians were, in fact, receiving payments. The responses were all similar and that they received the funds as a

payment for teaching seminars on specific medications. So, this really tends to jade the public's perception about the ethical beliefs of "some" doctors.

 

Of course, I do recognize that there are some morally/ethically upstanding doctors out there in the practice of medicine. And, I dare say that I believe the majority of them are of this category. As with any industry, there will definitely be good apples and bad ones.

 

As for research funding, yes, I fully comprehend the need for this from not only governmental agencies but also from the private sector. It's a huge challenge these days to procur funding strictly from governmental agencies especially in light of the financial restrictions of the economy and budgetary concerns. I don't really have an issue with this as long as there is a degree of autonomy and, IF the research is fact based with the analysis of results being governed by proper protocol and analysis. My problem would be if Big Pharma applied pressures on to ensuring that the results are skewed to favor their research product in terms of safety and efficacy. We all like to think that this doesn't happen but...

 

My personal belief is that one day, with the Human Genome Research Projects, medicine will be flipped over on its head because of the technological advances gained. Hopefully, cancer, diabetes, Parkinson's, etc will be cured via the switching on and off of contributory genes that lead to pathogenesis of the disease. Also, the nature of cloning will contribute to new advances in limb and organ replacements. After all, they've already achieved this with human eyeballs. What will come next will be monumental steps albeit, at the current time, these steps will be small. Time!

 

No, I do not lump ALL physicians into the same god-complex. Frankly, while taking a clinical biochem course back some 20+ years ago, a British physician who was instructing the course started talking about this very topic. His comment was that the god syndrome wasn't as prevalent in the UK. But, his experience was that many of his peers of the day (in America) suffered from the anomaly. I nearly lost the coffee I had just taken a swig of! Anyway, he was not only one of the best instructors I'd ever had but, he was also one of the most down-to-earth persons I've ever had the pleasure of knowing.

 

So, I do apologize if it sounded like I'd lumped them all into one category but that was certainly not my intention. :)

 

You may be in a group of enlightened individuals and that's a good thing. But, take a moment and think about the sheer numbers of over-weight people out there (and, I'm speaking of those without medical involvement) who are flocking to have gastric banding performed. Or, those taking the latest and greatest weight loss supplements.

 

Let's also apply this to those individuals who knowingly consume copious amounts of sugar (diabetes), tobacco users (cancer et al), alcohol users (liver and kidney) or drug users, and the list goes on and on. They are ALL cognizant of the ill effects of their lifestyle practices on their health but the question is, "Will they make the effort to change knowing that their health conditions would improve?" For some of them, the answer is a definitive "NO" and they wouldn't change until they're on their death beds.

 

[Yes, I agree that addiction problems are a huge part of the problem and that some of these individuals require medical interdiction in order to change. But, for the most part, I'm referring to those users who CHOOSE to engage in their specific practices. Then, when an illness sets in, they're at the physician's office asking WHY it's happening to them.]

 

Yes, I agree that you and some others may not be the norm when it comes to tv advertisments. Like you, I do my due diligence and question to the nth degree what is presented by Big Pharma via the media. But, Big Pharma is intelligent enough to recognize that new users can, AND WILL, be generated through modern day mediums. If they didn't believe this, there would be absolutely NO need for them to promote their products on tv, magazines, etc.  That is why I firmly believe that DTC marketing should never have been allowed in the first place. But, money does speak! And, very loudly at that!

 

Yes, at times and under certain conditions, the "magic pill" may work more efficaciously than natural supplements and lifestyle changes. But, they also come at a cost to some patients. Imagine being one of the "few" who contract osteonecrosis of the mandible because of taking bisulphonates. Scarry, isn't it?

 

Or, those people who are taking cholesterol lowering, statin meds suffering from rhabdomyolysis, memory fog, etc. Scary, isn't it?

 

[And what is absolutely more frightening is the drive by some physicians to have patients take these cholesterol lowering statins as a preventative medicine... just in case their levels increased! Thankfully, I believe that this has now been circumvented and no longer something they're trying to entrench.]

 

If it sounds like I'm entirely at odds with the medical system, please dismiss the notion. I think there are some great practitioners out there practicing REAL high quality medicine with the ethics of Hippocrates... those who are truly looking after the best interest of their patients. To these, I applaud!

 

It's the bad apples in the barrel I have a big problem with. And, I wish the overseers of Big Pharma would get their act in place and be held far more accountable than they presently are!

 

My wish is to encourage the public to stand up and start asking questions about the treatment they're receiving... and to do their due diligence and not be lead around like sheep. Only then can the system change and improve!

 

I do sincerely hope that the Osteo med(s) that you're using is/are working well and resolving your bone loss.

 

Best of luck to you Pam.

Lene Andersen, Health Guide
10/ 4/11 1:15pm

wow. That's scary stuff. Kudos to all the people who have been involved in raising awareness about this issue, succeeding in making the FDA listen. You've made change happen that could protect others in the future.

Pam Flores, Health Guide
10/ 9/11 5:00pm

Thanks Lene for your support!  I would like to join you and say kudos again to the courageous ladies/patients that attended the meeting who told their very compelling life stories with these drugs.  I hope the stores were heard with open ears and hearts!

 

Thanks for stopping by...

Merely Me, Health Guide
10/ 7/11 8:24pm

Hi Pam!

 

I am late to your post but did want to comment.  This post and especially the discussion this post generates...shows what a great community leader you are.  This discussion goes beyond talking about specific osteoporosis medications. This conversation is about true patient empowerment.  Your commenters are making things happen that would not happen otherwise.  They are helping other patients to be wise consumers and more so to protect patients in the future.  This conversation about how these regulations affect the average patient and how this process can be changed...is information most people are not going to hear about anywhere else. 

 

Nowadays you hear these terms of "patient empowerment" and "patient advocacy" so much that the words become meaningless.  In my opinion it isn't about bumper stickers or different colored ribbons for each illness.  It isn't about self promotion or being wined and dined in different cities because you happen to be a blogger with a certain medical condition.  Patient empowerment is this.  What you are doing here.  It is grassroots.  You are giving people a voice to share their experience in order to help others.

 

I think your post is very balanced and fair as well. 

 

Bravo to you and all your members who are willing to make a difference!

Pam Flores, Health Guide
10/ 8/11 4:42pm

Hi Merely Me, thanks for your lovely comments to me and the ladies who attended the FDA advisory meeting.

 

I'm glad you made your points about patient empowerment, because after the attendees left the meeting there was feelings of discouragement.  They felt that the minds of the panel were made up before they even step foot on the panel meeting floor.  They also felt like it was somewhat a waste of time and money, but upon further reflection and after the vote came in later that day, they came to realize they did have an affect on what occurred and it wasn't something minor, but GREAT.  The panel decided to strengthen the language on the warning label along with notifying physicians about the added risks of renal failure, osteonecrosis, femur fractures and fatalities.  So I really hope these women read what you and others have said to see just how much they really did accomplish from someone else's eyes.

 

We never know what are actions will accomplish, but at least we can say we did our best at great physical and financial cost.  Of course, I wasn't there, I just informed them of the time and place and left it up to them to decide if they wanted to go.  There were so many that wanted to attend, but were too sick to make the trip, as a result of taking Reclast.

 

Your comments are greatly appreciated and I hope these courageous women can draw strength and satisfaction from what you've said and what they did.

 

Thank You from the bottom of my heart.

 

 

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By Pam Flores, Health Guide— Last Modified: 10/25/11, First Published: 09/30/11