How to Petition Against Cipro & Other Quinolones at FDA! Read My Instructions!

I have filed a petition against quinolones use and prescription in doctors’ hands anywhere except in the case of life or death situations, or in ER or hospital surgical rooms. In order to be more effective, I must ask you all who have been hurt or know someone who is hurt to follow my instructions and either file your own petition (if it lets you given that mine is already there) or add to mine if that is your only option.

Please petition!

I copy-paste my petition here and also the instructions on how to file (or add to my petition) by all members hurt by or who knows someone hurt by any of these drugs (you will see some of the drugs listed in the petition but you can see all drugs involved here: https://en.wikipedia.org/wiki/Quinolone). The top part of the page is my instruction with links on how to get to the petition and how to write it.

Please file your own petition if you can or if it won’t anymore let you since there is one (mine), then add to it I was told by the FDA. Adding to it is just as good as filing a new one. The more petitions or the more names on the petition will increase the chances of our safety from this drug. Please follow instructions and read my petition:

Citizens Petition form at FDA:
http://www.fda.gov/regulatoryinformation/dockets/ucm379450.htm

Download or open the instructions on how to petition: http://www.regulations.gov/#!documentDetail;D=FDA-2013-S-0610-0002

Click on docket link that will take you here:
http://www.regulations.gov/#!docketDetail;D=FDA-2013-S-0610

and click on blue button “Comment Now!” to file a complaint. If you see a comment has already been posted (mine), add to that comment if you have something new to say or write your own separate one—in talking to the FDA it seemed to me that if there is one open, you can only add to that…

My updated petition:

This is a correction and stands as replacement of the petition filed on 10/2014 docket number: 1jy-8f1v-wjy4
Agency: Food and Drug Administration (FDA)
Document Type: Nonrulemaking
Title: Citizen Petition Submission; Technical Amendment
Document ID: FDA-2013-S-0610-0001

Petition’s Purpose:

1) recommending to withdraw the FDA permit from Fluoroquinolones drug class or

2) requesting to remove Fluoroquinolones drug class Cipro, Levaquin, Avelox, and the rest from prescription possibility without a cause to believe the infection is a life threatening emergency. This drug should only be available to hospitals in ER and operating room and not doctors with easy access.

Petition’s reason:

Thousands of people have received permanent or temporary damage as a result of the many adverse reactions that doctors either do not know or they ignore. I am a scientist and have done my research. I asked all the MDs I know and not one had any idea of the dangers of Quinolones and not one would recognize the adverse affects (Achilles Tendon and other tendon tear, neuropathy, and even I had no idea that Ciprofloxacin caused my Achilles Tendon partial tear and the now surfacing (over 6 months after taking Cipro) neuropathy, intracranial pressure, systemic mitochondrial magnesium depletion, UV B light caused damage to mitochondrial DNA, etc .

I have created a blog article (https://cluelessdoctors.com/2014/10/06/those-amazing-antibiotics-how-one-class-hurts-you/) as a result of my article research and the out-pour from people and associations that specialize in trying to get Quinolones off the market have come to thank me and explain what happened to them. By now I have received memos, emails, text messages, Facebook group comments, etc., from at least 3,000 people in the past 2 weeks on telling me their horror stories and how they do not know what to do. At the moment over 5 blog articles decorate my blog with many horror stories. Other blogs: http://www.hormonesmatter.com/side-effects-unintended-consequences-pharmaceuticals/ or http://floxiehope.com/ruths-story-cipro-toxicity/ and many more will tell you the story of people begging for a solution of this drug class be removed from use!

Their doctors are not informed, pharmacies tell them nothing. I have found several scientific articles that explain the dangers of quinolones, none of which is in the knowledge of the medical community.

Here are some links for you to guide you, some on your own website:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3760005/
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2094848/
http://www.facebook.com/FluoroquinoloneToxicity
http://www.en.wikipedia.org/wiki/Adverse_effects_of_fluoroquinolones
well.blogs.nytimes.com/2012/09/10/popular-antibiotics-may-carry-serious-side-effects/?_php=true&_type=blogs&_r=0
http://www.fda.gov/Drugs/DrugSafety/ucm365050.htm
http://www.survivingcipro.com/
http://www.floxiehope.com/
http://www.facebook.com/pages/The-Fluoroquinolone-Wall-of-Pain/209182505773463

And I have many more of course but you also have access to all.

Do doctors really have to prescribe such dangerous drugs for a sinus infection or a UTI? How many complaints must the FDA receive before they pull a drug from the shelves? I looked only at Cipro and its generic in the FDA complaints database and found 1800 adverse reaction complaints by consumers for the quarter ending June 2014. My search did not include all quinolones only the Cipro brand and generic.

There is no reason to have a drug whose benefit for the use of mild cases, such as a UTI, is not outweighed by the dangers of its adverse side effects!

Please act! On behalf of all quinolone-hurt patients and myself who was also hurt by quinolones, I ask you to consider to remove this drug from doctors’ access and just leave it in the hands of operating rooms and ERs.

Sincerely,
Angela A. Stanton, Ph.D.

Docket number: 1jy-8f1z-su92

Your comments and concerns are welcome!

Angela

Posted in Interesting reading, Must Read, This & That, Thoughts, Why Me | Tagged , , , , , , | 3 Comments

Starch? No problem! They are Fiber! Did You Know That?

You did not know? Me neither! That probably makes over 6 billion of us–minus the few people who specialized in the science of understanding what happens to starchy foods when they get chilled off after cooking and reheated. I did not know this was a science but apparently it is and it is a super one because now we know how to convert simple starchy carbohydrates into fiber rich low carbohydrate resistant starch, which is a fiber.

A friend of mine from the UK told me about this and I searched on the Internet and lo and behold found the BBC Two program “Trust me I am a doctor” with the episode online that examines what happens to starchy foods in our bodies when we eat them freshly prepared hot, chilled, or reheated. Here they tested pasta in an Italian restaurant on 10 volunteers who then had to take blood samples of and by themselves like diabetes blood collection for 2 hours after meal every 15 minutes.

The results show what has apparently been known for well over 20 years that cooked starch once chilled converts into what is called resistant starch.

I have been skeptical but I actually found proof of this on Wikipedia and that there are four types of such resistant starches–there are nearly a million results in the search engine about resistant starches so I suspect there is some truth to this:

  • RS1 Physically inaccessible or digestible resistant starch, such as that found in seeds or legumes and unprocessed whole grains
  • RS2 Resistant starch that occurs in its natural granular form, such as uncooked potato, green banana and high amylose corn
  • RS3 Resistant starch that is formed when starch-containing foods are cooked and cooled such as in legumes,[2] bread, cornflakes and cooked-and-chilled potatoes, pasta salad or sushi rice. Occurs due to retrogradation, which refers to the collective processes of dissolved starch becoming less soluble after being heated and dissolved in water and then cooled.
  • RS4 Starches that have been chemically modified to resist digestion. This type of resistant starches can have a wide variety of structures and are not found in nature.

In fact, many foods we eat have such resistant starches without our knowledge. On a recent trip I was in Scandinavia for three weeks. I noticed that everywhere they ate the same rolled oats we do in the USA except they eat it raw! They mix dried fruits and nuts but that is not necessary. I actually liked the taste of the raw better so I started to eat that for my lunch since that is when I usually crave it–it is quite a heavy food. As it turns out, it is heavy because, as uncooked, it has a ton of resistant starch and my body cannot digest it! A 1/4 cup of uncooked rolled oats has 4.4 gr resistant starch in it! Frozen green peas also naturally have this mysterious naturally occurring resistant starch–1 cup cooked has 4 grams. I medium raw and slightly green banana, exactly how I like it, has 4.7 grams of resistant starch!

What a wealth of information! Now before you get the wrong idea, the conversion from starch to resistant starch type fiber has more benefits than you now eat more fiber. Since starchy foods are off the menu for most diabetics as a result of insulin rise, as it turns out, once the pasta or potato or rice was allowed to cool completely and then you reheat it, it reduces the insulin spike by 50% according to the BBC Two TV program. The chart clearly showed that eating chilled pasta after cooking had some such benefits but reheating it had a significantly higher benefit.

So, the benefits are several fold actually:

  1. Because your body cannot digest resistant starch, you are reducing your caloric intake without dieting!
  2. Obviously the 50% less insulin spike benefits everyone even if one has no diabetes!
  3. You gain a lot of fiber that helps your gut flora feed and produce better health
  4. You can put away your bacteria pills… Once you have good quantity of resistant starch fiber in your gut, the bacteria will live happily ever after since the one thing they are absolutely perfect at is reproduction.
  5. You can finally stuff yourself with pasta and not feel bad about it!

This is good news! We are having leftovers tonight with pasta… ummm… fiber of resistant starch in that! 🙂

Enjoy! The world’s best kept secret is not such a secret anymore!

Comments and pasta are welcome!

Angela

Posted in Interesting reading, Must Read, This & That, Thoughts, Videos | Tagged , , , , , , , , , , , , , , , , , | 5 Comments

6% Commission Goes to Doctors for Prescribing Drugs!

I have been meaning to write this article for several weeks but the drug Cipro and its family of Quinolones have stolen the show and importance. But now that we know how dangerous they are and hopefully everyone is aware enough to not allow it to be prescribed  to them (there are many safer alternatives!), maybe now it is time to show you the real bad, the evil, and all the sins pharmaceuticals do when it comes to their brand name drugs.

Some of you may have watched 60-Minutes Sunday night on CBS a couple of weekends ago but probably not everyone. I would like to take you to a segment of that 60-Minutes, and discuss that a little bit.

http://www.cbsnews.com/news/the-cost-of-cancer-drugs/

In short, we all know that drugs are very expensive and that those of us with medical insurance pay only a deductible. We also know that seniors on Medicare also just pay a deductible—usually 20% according to this video. There is nothing new or interesting about this until you listen to the rest of the story.

The first thing that I think most of us had no idea of is that Medicare or the insurance companies are not allowed to negotiate prices by law. They must pay whatever they are charged. This also explains (to me anyway) why hospitals and healthcare centers have such insane prices where a single headache medicine may be charged at $50. I now understand that the $50 is the cost to Medicare or the insurance company even if I can get the same drug in the drugstore over the counter for $1. So the first problem we are facing is Medicare and the insurance companies and their inability of negotiating a lower price. Note to self: investigate who the heck came up with this idea?!

The second problem we are facing of course is that in the US we pay much more for the same drugs than other countries pay and that comes down to the fact that the government in other countries can negotiate with pharmaceutical companies but in the US the government cannot. Note to self: Why can other governments negotiate and not the one that approved the drugs the first place?! Whose idea was that?

The third problem comes down to illegal activity actually. It appears to be legal but I am questioning that–it is certainly unethical and while ethics and law are typically not good friends, in this case I am questioning the legality of the practice. On the 60-Minutes segment you hear that the pharmaceutical company Sanofi came out with a cancer drug (colon cancer) called Zaltrap that they originally charged the doctors, insurance, and patients for $11,000 per month. An older drug called Avastin for the same cancer, working exactly the same miracle the same way, only reducing (possibly) the life expectancy after treatment by 42 days relative to Zaltrap, cost only $5,000. So this one particular hospital decided to not carry the new drug; it was too expensive and did not provide better outcome than the old (except for the 42 days of additional extended life) and had more toxic side effects as well. The hospital doctors published their opinion in The New York Times which then amazingly turned Sanofi around and said: OK doctor, I will sell you the drug for $5,000 provided you charge the insurance company and the patient $11,000. We will send you dear doctor a check for $6,000. This is an amazingly lucrative business! I suppose for unethical cancer doctors this is a lottery win equivalent.

The doctors also receive what is called “commission” of 6% when they prescribe a particular drug. I finally understand why a private doctor’s office is usually full of free samples!

I finally also understand why a family doctor of a relative of mine kept on switching the drug from the generic cholesterol pill Simvastatin, which was cheap and worked great without liver issues, to Lipitor, which did not work, cost a lot of money to Medicare, and caused a lot of liver issues. Every time I went to pick up a refill for Simvastatin for my relative, a bottle of Lipitor was waiting for me instead! I never accepted the change for health reasons of that family member but now I finally understand the cause! That family doctor was receiving 6% each time he prescribed the brand name Lipitor but nothing when he prescribed the generic Simvastatin so his unethical choice was to switch the prescription every time!

I bet it is happening to many people only they are not as vigilant about checking what they are getting and why, as I am. I called this doctor and gave him my opinion… no need to repeat it… you know what I said. I am glad I fired him and switched my relative to another family doctor.

It is good to know that the medicine we pay $1,000 for in the US is available to other countries for $300 or less. Apparently their governments can negotiate and refuse if they do not like the prices. But our government, Medicare, insurance companies, and the ill are powerless!

Can anyone please explain why the US Government, Medicare and the insurance companies cannot negotiate? Will the people responsible for this craziness please this stand up and show your faces? I bet they won’t dare!

Your comments are welcome as always!

Angela

Posted in Fibromyalgia, Interesting reading, Migraine-Blog, Must Read, This & That, Thoughts, Videos | Tagged , , , , , , , , , , , , , , , , , , , | 18 Comments

Well Ciprofloxacin is Back on My Radar! Read the New Info!

A couple of amazing new facts showed up on my radar screen as strong blips I cannot let go without a show to the general public. Some of you thought that perhaps all the discussion on Cipro (ciprofloxacin, which by the way is just one of the many quinolones but is the most prescribed) was over but it has now two additional facts that were the best kept secrets until now.

One is that if you take anti-anxiety drugs from the class benzodiazepines such as Valium or Lunesta or Ambien (atypical benzo ligaments that attach to the benzo receptors and act like benzo even though they are not true benzos), interact with ciprofloxacin such that it can seriously hurt you. The list of fluoroquinolones that are known to do these serious damages:

  • ciprofloxacin (CIPRO, CILOXAN)
  • enoxacin (PENETREX)
  • levofloxacin (LEVAQUIN)
  • moxifloxacin (AVELOX)
  • norfloxacin (NOROXIN, CHIBROXIN)
  • ofloxacin(FLOXIN, OCUFLOX)

And the damage is copy-pasted from the above link just so you can read it without having to link to the site:

In addition to being associated with other serious side effects such as the rupture of the Achilles tendon and retinal detachment, this class of antibiotics has impacts on the central nervous system and for this reason SHOULD NOT BE USED BY PEOPLE WHO ARE USING OR WHO HAVE WITHDRAWN FROM BENZODIAZEPINES. We do not have the information on their impacts on people using or withdrawn from other psychiatric drugs. There have been reports of people who have withdrawn from benzodiazepines for many months and have had a severe neuro-muscular or nervous system response (i.e. a return of withdrawal symptoms) after taking only a few of these antibiotic pills.

Dr. Heather Ashton has also issued a warning about this class of antibiotics. … ‘quinolone antibiotics which displace benzodiazepines from their binding sites and should not be taken by patients on, or recently on, benzodiazepines.’

The U.S. FDA requires Fluoroquinolones to have “black box” warning about the risk of tendinitis, tendon rupture and the drug’s ability to block neuromuscular activity (seen by prescribing doctors; seldom by patients). However, Health Canada’s warnings are only for those with Myasthenia Gravis, a relatively-rare condition” (emphasis is in the original).

This is amazing information because many people with migraines, depression, fibromyalgia, and veterans who return from war and have nightmares receive some type of benzodiazepines. I think this should have been number 1 on the doctors’ radar as well—including my doctor—who has been prescribing both benzodiazepines and Cipro for me for years. I have been on benzodiazepines since I was 19 after a traumatic event—very low dose but still it is there. So I have personal issue as well! I did have my Achilles tendon partially tear and I thought it was unrelated to anything in my life but odd since it happened for no reason.

The reason is clearly stated above as the first serious side effect of the drug even without taking benzodiazepines but with that the chances of getting hurt is significantly higher.

The second warning came as an even bigger surprise on my radar screen since it came from the FDA via the Air Force Times. The title of the article is telling without any further explanation: “New FDA warnings on Cipro may tie into Gulf War illness.“ I must say I am not even surprised by this news after the two links I received from readers to my original blog post. One to an article from Toxicologial Sciences; Oxford Journals titled “Inhibition of Human Topoisomerase Iiα by Fluoroquinolones and Ultraviolet A Irradiation” and the other from chemist Stephen J. Telfer’s who sent his article link in Medical Hypotheses Journal titled “Fluoroquinolone antibiotics and type 2 diabetes mellitus,” which goes a step further from “just” UV damaging the mitochondrial DNA. His hypothesis suggests that it also leads to diabetes II.

Boy do we have a handful of information against this drug and drug class of Quinolones in general!? So my natural question is this: why is this class of drugs still possible to prescribe for a common urinary tract infection or a sinus infection, when clearly the risks in these simple illness cases outweigh the benefits of the drug!?

This drug class, and particularly Cipro, which has been prescribed for just about everything without concern to its danger, should only be used when no other drug can do the treatment! Interestingly a large number of our bugs are already resistant to many of the drugs in this class and so it is no longer such a super drug that it must be prescribed since there are alternatives that do better when the situation is so dire.

Why UV light you may ask?

I wanted to grab two more important factors in the drug and the side effects listed on consumer type inserts in the package when one gets the drug so you understand the UV connection.

  • First of all, if the drug is a generic, there is no box. The pharmacy types up the information and most people just trash that without reading. Please read albeit it gives you very little useful information.
  • Secondly, one of the listed items on the printout (and on the bottle) is “avoid excessive sun since you burn easier while taking this medication” or something equivalent. From this point on, when you see this on a drug, DO NOT LEAVE HOME! This is a sign that UV light modifies something in the drug and thus in you! If it did not, there would be no warning on the drug about the sun and you would not burn easier than when not taking the drug. We are not told that this little happy warning actually causes major damage.

The damage apparently that UV light causes—in case you don’t have the time to read the links above—is that the UV light activates an enzyme that attacks the DNA in the mitochondria in your cells. Mitochondria are the little energy manufacturing machines in every one of our cells, without which we have no living cells. It may be difficult to comprehend all this in one reading but I must add what mitochondria really are and why we potentially are facing this problem.

Mitochondria are bacteria that have become symbiotic with our cells. They have given up their “bacteria” nature and all they do is function as a “half bacteria” if you will. They digest all the food we take in and convert that to little energy packets our cells live on. When our cells take a breath, it is actually the mitochondria that take the breath. Thus when we take an antibacterial agent that attacks bacterial DNA and mitochondria are bacteria in their DNA, it is obviously very tricky to kill all bacteria except the mitochondria. Not all antibiotics are after the DNA approach but the quinolones class is. This is one of the reasons why we are having so much trouble with them.

In addition to modifying the DNA of the mitochondria, the drug also pulls massive amounts of magnesium and ATP, the fuel that allows the cells to actually open and close their sodium-potassium pumps among other things. No magnesium, no ATP, and nothing comes or goes in or out of the cells except by little channels where osmosis is the method. Since the outside of our cells is full of nutrient rich liquid and the inside of the cells is full with old used up stuff that needs exchange, some of the liquid may go into the cell and come out of the cell but not sodium (part of salt) because it is too big in size. Thus your cells get dehydrated as well. Plus no ATP and so no energy.

It is a very complex problem that I recommend we all avoid! Take charge of your own health and do not allow your doctor to prescribe to you the 6 drugs listed above!

I have a suspicion that what we today call fibromyalgia is actually toxicity from Quinolones drugs.

Comments are welcome as always!

Angela

Posted in Fibromyalgia, Interesting reading, Migraine-Blog, Must Read, This & That, Thoughts | Tagged , , , , , , , , , , , , , , , , , , , , , , , , , , , , , | 41 Comments

Dear Ebola!

Please help us understand a few things about you.

There is so much we don’t know and are confused about. Depending on what time of the day we read, even on the most prominent medical websites like the CDC or the WHO, your contagious date starts anywhere on the following days from contamination: 1 day, 2 days, 5 days, 6 days, 7 days, all the way to 21 days and you remain contagious for as long as 60 days after the person is cured or 61 days. One article says a man cured of Ebola can infect anyone with his sperm for 7 weeks after he is cured but in a scientific paper it is 90 days though in 98% of the cases the semen was only contagious for 42 days according to the same publication.

I have also found a very interesting sentence dear Ebola that totally confused me. The CDC says:

“Once someone recovers from Ebola, they can no longer spread the virus. However, Ebola virus has been found in semen for up to 3 months. People who recover from Ebola are advised to abstain from sex or use condoms for 3 months.”

So men should refrain from sex because they cannot spread the virus that is still in their semen active and ready to infect? Can you please clarify this sentence or the quote above that the sentence summarized?

I also have another question since there is so much confusion and even the CDC admits that “Because the natural reservoir host of Ebola viruses has not yet been identified, the manner in which the virus first appears in a human at the start of an outbreak is unknown” yet other research and the history of our familiarity with Ebola virus is that it comes from the Fruit Bats.

The interesting thing is that fruit bats do not get sick, have no symptoms, yet infect others.

I find that interesting since the CDC said and the New York Times published the statement that a person cannot infect anyone until he/she has the symptoms. This is in stark contrast to the previously noted statistics that suggests that men who have recovered and are no longer symptomatic, carry active Ebola in their semen for 60 to 90 days.

So if the men have no symptoms (similarly to the bats) but are carriers (similarly to bats), how can they infect when they cannot infect without symptoms? I am confused. Sorry if I am confusing you too dear Ebola.

And finally, originally the CDC suggested that we need to watch out for fever and cough, which later they updated with watching for cough only in terms of the spraying of fluids but then Ebola patients do not seem to cough. However there appears to be a strain of Ebola virus (there are 5 strains: – Bundibugyo ebolavirus (BDBV), Zaire ebolavirus (EBOV), Reston ebolavirus (RESTV), Sudan ebolavirus (SUDV), Taï Forest ebolavirus (TAFV).) that only infect animals and monkeys where they do sneeze and cough.

So dear Ebola, please tell us about you because we are obviously not capable to discover much about you without your help.

I just watched CNN while having dinner and they were talking about you. The question asked was: should Americans fear you Ebola!? The answer may surprise you. They said: fear the CDC instead! The CDC seems to say one thing one minute and another the second minute and do different from what they instruct. So dear Ebola, please pay a visit to the test tubes of the research centers of the CDC and introduce your true self so they can tell us if tapes around the breathing mask in the Dallas Hospital is enough to keep you from entering.

Please also tell the CDC that next time a nurse who was sent home for solitary self monitoring (she was member of the staff that handled the first Ebola victim) calls asking that she has a little high temperature, can she fly? Please tell them to say “NO.”

Thank you Ebola for all your help!

Sincerely,

Angela

Posted in Interesting reading, Must Read, This & That, Thoughts | Tagged , , , , , , , , , , , , , | 3 Comments

Academic Research, Rivalry, Hidden Lies, & Now You Know Why Your Drugs Kill You!

This is a hell of a title. I have been thinking about a good crazy title for several hours because I wanted to shock you with it and to make sure you read this article. So please take a seat and put on your seat belt while reading this.

It is quite well-known that academia has its quirks that force many ethical academicians out of the field because the stuff that goes on. You probably know by now that I also left academia and returned to art as my solace just as Dr. Walter Nelson-Rees has, except that he became an art dealer and I am an art creator; same thing only different ends of the rope. Dr. Nelson-Rees was at the University of California at Berkeley working on cancer research from 1975 through 1981 according to the Discover Magazine article “Trial and Error” by Jill Neimark. The magazine is by subscription only but I highlight some of its key points and bring a parallel with the bad drug syndrome we seem to be facing these days. I will also explain the connection of this finding to my leaving academia. I think you will understand all this now in one swell swoop. So let’s begin.

Cancer Research at its Best (or Worst):

For scientists around the world who want to work in drug research, they often need to work on live cultured cells, cells that have an infinite life (long science story, I will not explain infinite life here). Infinite live cells are valuable assets that are hard to create and thus hard and pricey to purchase. Only a few labs carry cancerous cells specific to a certain cancer that have infinite lives. Thus if a researcher wants to work on say thyroid cancer, he/she must obtain cells with only thyroid cancer to work on. However, some cancers are more virulent than others and with improper care, contamination may result. All is well since one can identify that the cells are contaminated and order new ones. Right?…Maybe not…

Dr. Kenneth Ain is one of the lead thyroid cancer cell repository founders and after discovering the contamination of his cells with another cancer, he sent letters to all institutes and all cancer research laboratories in the country and to 69 investigators directly. Of all of these only 2 responded back to him–the paper does not detail if the response was “yay, thank you” or “so who cares” but note all the rest have ignored it and continued their research on thyroid cancer knowing that the cells they were working on had other cancer infections. HeLa cancer cells – a very fast growing line of cervical cancer cells – are the most likely culprits. They have taken over – by cross-contamination of equipment – many other types of cancer cells in research labs, no matter what the original cancer cell line may have been. Thus if scientists continue their research for thyroid cancer cure on cervical cancer cells I don’t think their results will be reliable and promising… what do you think?

Is this a new story? No. The knowledge that cross-contamination occurs is actually quite old. 1967 (yes, nearly a half a century ago) it was discovered that there was something wrong with the cancer cells in research, since experiments showed inconsistent and unexpected results. HeLa apparently contaminated over 20% of the cancer cell lines used for research and so most cancer research, be it breast, thyroid, melanoma, you name it, used cells that were infected with the HeLa cervical cancer.

Hundreds of publications later and after the many drug trials using the wrong cells, 11 patents and several NIH funded research grants, the whistle was blown again by Dr. Nelson-Rees. This move unfortunately ended his career. He published an article in Science, reintroducing the same truth that years earlier was already announced, that all these papers, drug tests, and drugs that were the results of tests on the contaminated cancer cells were bogus because they used cultured cell lines with cancers unrelated to the disease they were finding cure for. His colleagues were, of course, angry with Nelson-Reese even though they already were told by Dr. Ain long time earlier that the cells were contaminated. To top it off, the then editor-in-chief of Nature (John Maddox) wrote a very critical article on Dr. Nelson-Rees’ effort closing the door behind Nelson-Rees’ option to remain in academia. The NIH terminated Nelson-Rees’ contract, and with his colleagues keeping a distance as if he had Ebola, he left academia and joined the arts.

In 2009, a conscientious cell biologist sent letters to 45,000 scientists telling them to test their research cell lines for contamination. Most of the cells were of course contaminated and so the NIH set up a new standard to fund research that works only on uncontaminated cell lines. But do you suppose they actually followed that standard? The NIH continued to fund research regardless, so the work on the wrong cells continued, with everyone knowing that the work was a total farce… business as usual in medical research!

Today, after nearly 50 years of knowing that many of the cells used are contaminated, research in cancer still continues on those cells! Luckily some of the drugs failed clinical trials and were not made available for the public–those are the ones we know of. How many do we not know of?

I can give you another angle of how many we do not know of based on what happened to me (and I am sure to many others). When I was working on my doctorate, I was nominated by my professor and invited to the University of Paris that held a 2-week special training session for promising doctoral candidates. Each candidate was paired one-on-one with a famous professor–the one I was paired with received his Nobel Prize a few years later. My work in that two-week period indicated that the theory this professor awaited the Nobel Prize for was wrong. Not surprisingly he did not agree with me on the spot. So back at home it took me a year to work out the proof – both using laboratory findings and mathematics – that his theory cannot be right. When I presented my findings to him I received the following short email: “You are right but keep it quiet.”

I think you now have a better idea on how many peer-reviewed journal articles are wrong yet get published anyway; how many laboratory research outcomes are wrong but the drugs are approved anyway, and how many drugs out there were meant to treat a pimple but are prescribed to cure bacterial infections or cancer.

To give you one little example of how bogus peer-reviewed journal articles are:

“In October 2013, Science correspondent John Bohannon published an article reporting a sting operation. He concocted a fraudulent scientific paper studded with anomalies and ethical approval problems, and sent it to more than 300 open-access peer-reviewed journals; more than half accepted the fake manuscript… Of 53 papers deemed ‘landmark’ studies over the last decade, only six held up and were reproducible… There is a rising tide of worry over the spike in fraudulent scientific papers.” (Quote from the article in Discover as linked to above, page 50)

As of the writing of the article in Discover for the November 2014 issue, 22 journals (a drop in the bucket) “require cell line authentication.” Nature, since 2013, requires that every author report the source of the cells they used for research and how the uncontaminated verification was reached.

So, starting all research published since 2013 in 22 journals plus Nature, we can have a certain level of trust that at least they used the right samples for the research. There are over 25 thousand scientific publications, from which several hundred focuses on cell research in some shape or form, from which 23 make sure the right samples are used for their experiments!

Whether the actual research is correctly reported, still remains in question based on the fake experiment submission and acceptance of John Bohannon’s article. And there is more. Every single journal submission is reviewed by 3 scientists, at least 2 of whom must agree on whether to publish or trash.  In my personal experience as a reviewer, I found that I rejected over 80% of the submissions, mostly because I was the only scientist who actually understood the inaccuracies in the mathematics and statistics required for the complex research. The other 2 reviewers approved and the articles got published anyway!

So much for science, and so much for your health! The fact that very capable and ethical researchers elect to work as artists or art dealers should tell you that the system is far from perfect.

Your comments are welcome as always!

Angela

Posted in Fibromyalgia, Interesting reading, Migraine-Blog, Must Read, This & That, Thoughts | Tagged , , , , , , , , , , , , , , , , | 3 Comments

Those Pesky Inactive Ingredients in Generic Drugs! Cipro vs. Ciprofloxacin.

I thought I wrote enough about generic versus brand name already but then the antibiotic dug class quinolone hit my radar screen and here we go again. In talking to friends and sufferers on Facebook and elsewhere who have access to attorneys specializing in cases like this, the subject of inactive ingredients came into question as a result of two cases that went in front of court where people tried to sue a generic manufacturer but were unsuccessful. Both cases ended up at the US Supreme Court, which is odd since their job is to decide on Constitutional matters and generic drugs would not seem to be appropriate for that.

The first case referred to was handled by the US Supreme Court in 2010: Pliva, Inc., et al v. Mensing and the second case in 2012: Mutual Pharmaceuticals Co., Inc. v. Bartlett. In both cases, however, the supreme court decided on the side of the pharmaceuticals, noting that “Once a drug is approved, a manufacturer [including generic drug manufacturer] is prohibited from making any major changes to the “qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications provided in the approved application…. [including] labeling,” which also consists of all adverse side effects listed on the brand name drug’s list of adverse side effects. (emphasis added)

Thus what the Supreme Court suggested is that the generic manufacturer’s active ingredient in the generic drug must be the same as the active ingredient in the brand name and since the active ingredients in the brand name and the generic drug are the same, and the FDA approved it “as is” already, there can be no changes made. The FDA approved the brand name drug based on the safety of the active ingredients in the brand name drug. Since the brand name drug and the generic drug active ingredients are the same, this relieves the generic manufacturer from any responsibility. Whether it caused adverse side effects not listed on the box label is irrelevant since there can be no changes made once the drug was FDA approved.

Note that there is no mention anywhere in the US Supreme Court case about the inactive ingredients!

Hold it right there! If I am a generic manufacturer and my inactive ingredients modify the absorption of the active ingredient and thereby convert the good drug under the brand name into a toxic generic drug then… well what then?!

As it happens, this is the case more often than not. In the case of Cipro in particular, the active ingredient is Ciprofloxacin. One of the most important inactive ingredients is a film coating (meaning it probably absorbs in a place other than the stomach) but the generic equivalents need not contain that film coating because it is considered to be an inactive ingredient.

So if the pill absorbs elsewhere in the body in the generic than in the brand name, does it not modify the generic drug to be a different drug from the brand name? Should the generic that works so differently not require a new drug application (NDA) and an FDA approval the same way as any new drug would have to? One of the reasons why brand name drugs are so expensive is precisely because of all the work it takes to pass the NDA process and all the clinical trials that come with that.

Thus this is the main problem: inactive ingredients matter in how the drug is absorbed but they are not considered to be necessary and are not active ingredients.

Here is the example for you with Cipro brand name and one of the generic manufacturer’s Ciprofloxacin, generic for Cipro:

Cipro brand name:
Active ingredient: ciprofloxacin

Inactive ingredients:

cornstarch, microcrystalline cellulose, silicon dioxide, crospovidone, magnesium stearate, hypromellose, titanium dioxide, and polyethylene glycol

Cimprofloxacin generic:
Active Ingredient: Ciprofloxacin

Inactive Ingredients:
Hypromellose 2208 (15000 MPA.S), lactose monohydrate, magnesium stearate, modified corn starch (1-Octenyl succinic anhydride), sodium starch glycolate type a potato, titanium dioxide, triacetin, (cornstarch, microcrystalline cellulose, silicon dioxide, crospovidone, hypromellose, titanium dioxide, and polyethylene glycol)

Inactive ingredients that are in the generic drug but not in the brand name drug:

  • Hypromellose 2208 (15000 MPA.S), 
  • lactose monohydrate, 
  • modified corn starch (1-Octenyl succinic anhydride),
  • sodium starch glycolate type a potato,

Inactive ingredients that are in the brand name drug that are not in the generic drug:

  • cornstarch, microcrystalline cellulose,
  • silicon dioxide,
  • crospovidone,
  • hypromellose,
  • polyethylene glycol

Inactive ingredients in both the brand name and the generic drug:

  • magnesium stearate
  • triacetin, 
  • titanium dioxide

The differences between the inactive ingredients of the brand name and the generic drugs may explain why of the 1800 complains against this drug, in the quarter ending June 2014 in the FDA database, 1600 complaints were about generic and only 200 about the brand name drug!

The two lawsuits against the generic manufacturers were set up on the wrong legal base. Given that adverse side effects grow every day and are added to the FDA database but not to the drug’s warning–remember, once the drug is FDA approved, modifications are not possible, the list cannot be amended except in special circumstances. I now understand that fighting on the grounds of the adverse side effects not being listed cannot be done without a constitutional argument; hence these cases ended up at the US Supreme Court! A case fought on losing grounds cannot win. The attorneys should have known better!

Why did the attorneys not fight on the basis of the inactive ingredients instead? Apparently I am told some attorneys believe that the inactive ingredients must also be the same as the active ingredients (lawyers should not be believing anything until they researched the facts)! But if one reads the cases carefully, it is clear that only active ingredients matter in the eye of the law. There is room for a discussion (and a fight) on the inactive ingredients since they modify the active ingredient’s absorption, thereby creating a new drug that was not FDA approved

Do we have a case to fight generic drug makers whose inactive ingredients modify the drug to be different form the brand name? You bet! A generic drug that behaves in the body differently from its equivalent brand name drug is a different drug and needs FDA approval! It is an illegal drug that is sold without being approved by the FDA. It is that simple!

Are you an attorney? Please contact me!

Comments are welcomed!

Angela

Posted in Interesting reading, Must Read, This & That, Thoughts | Tagged , , , , , , , , , , , | 6 Comments

Clueless Doctors and Prop 46! Know the Truth California!

I am not a political person–I do not have a political bone in my body. I normally avoid any kind of politics in a circle of at least 3 feet in radius. However, this time I do want to get involved and ask you to vote YES on Prop 46 for the following reasons.

I see so many advertisements on TV that are paid by the doctors and their lobby against Prop 46 that by now I am not even watching the news. I stopped watching it because all I want to do is beat the TV up and that does no good. I also miss the ads supporting Prop 46! I know why we do not have them! The people who created Prop 46 are the suffering victims who cannot afford to pay for the ads! The sick have no millions of dollars to throw into TV ads.

You can pretty much measure how to vote on something that is good for you and the public at large by who is voting against it: if there are a lot of ads against it, chances are the Proposition is good for YOU!

The TV ads tell you the following lies:

1)  Your insurance costs will go up – this is probably the biggest lie I have ever heard. Why would our insurance go up? We are not the ones who have to pay for the doctors’ mistakes! They do! The doctors’ malpractice insurance will go up and not our medical insurance! The patients’ insurance never increases as a result of the malpractice costs of the doctors! The huge lie is a major sign that they are in trouble and trouble they will be for sure!

For now I just want to reassure you: Your insurance costs will not go up!

Note also that we currently have a cap on medical malpractice lawsuits of $250,000 which is too small for attorneys to take on any of the cases. Why? Because it is out of the attorney’s pocket to get all the evidence of malpractice, the expert witnesses, the medical records, so forth. By the time they file for the lawsuit in court, they spent more than the $250,000 permitted max to be returned to both patient and attorney combined today. So today there is no doctor accountability and they know it! I met those lack of accountability processes way too many times in person!

This financial cap was set in 1975! Wouldn’t you also like to have the gas and food prices of 1975? Oh yes! I also want to buy my house and car at 1975 prices! What this part of Prop 46 is asking is simply to adjust the cap of malpractice with the inflation rates we had since 1975 so we can go ahead and file a lawsuit if the doctor committed a malpractice.

Let me be clear: if there is no malpractice, there is no need to fear the increased malpractice insurance. And this is also the crocks of the matter because higher malpractice payments will bring about safer medical practices! Doctors will be more careful! They will actually have to act in a professional manner and be accountable for their actions! Imagine that!

2) The ads tell you that your prescription data will be online such that all doctors will have access to it and that is a bad thing because it compromises your medical information’s safety. Wow! The person who came up with this lie should be congratulated! This probably beats every lie I have ever seen or heard and it does so without a blink.

First of all, our prescription information is already online! In fact, in California, it is so online that the same person cannot purchase 2 boxes of Sudafed anywhere in the state within 2 weeks! Hello!!! We even need to give our driver’s licenses for buying a box of Sudafed–and may I remind you that Sudafed is an over the counter medication! So what the heck are they talking about?

Do I want doctors to have access to my medical allergies and prescription drugs I am already taking in case I get into an accident? YES!! Do doctors know today what medications I take or am allergic to? NO!! Which is safer in your opinion? I go for the one where they know my medical records and my drug history. As for safety of the medical records… huh? The ones I can pay $29 for on many online record storage and get in a second about anyone? Really? The doctors may not know my medical history now but my neighbors may! So that part is not only a lie but stupid and clueless as well!

3) Drug testing of doctors is silent on these advertisements… I cannot help but wonder why? Hummmm?? Maybe there is something in that particular part that is so measurably necessary that they do not dare putting it up on TV? See doctors are people just like you and I. They are not saints; they drink, some use drugs, some work without license (I had the pleasure of meeting one of these just recently treating with a black box psychotropic medication someone very dear to me), etc. But there is another side.

I recall when I was employed in Silicon Valley by companies like Intel and similar, we all had to go through drug testing. In fact I had to go into a special location, in a special room (not a bathroom!) with open doors and give my sample to be sure they witnessed that I did not swap my urine with someone else’s that I may have brought with me. So those who are against this proposition are saying that I as a potential patient MUST go through drug testing to work for a company but those who handle my health do not? A very interesting argument but it does not hold water. Sorry. Go get tested!

If I were to write Prop 46, I would also have added mandatory annual re-testing of medical knowledge because once a doctor threw his/her cap in the air after graduation, new science and discoveries can no longer penetrate their heads for some reason. It has to be forced into those heads by testing every year! Unfortunately this is not part of any proposition this year! I hope it will be on one next time!

In conclusion: if you want good for the people and for yourself and you are not a medical doctor, vote YES of Prop 46 California! If you are a medical doctor, you are excused to vote or not vote. 🙂 We will not hold a grudge against you not wanting to stand up for quality!

VOTE YES ON PROP 46 CALIFORNIA!

Feel free to ask questions!

Angela

Posted in Fibromyalgia, Interesting reading, Migraine-Blog, Must Read, This & That, Thoughts, Why Me | Tagged , , , , | 4 Comments

Ruth’s Story – Cipro Toxicity

Ruth’s Story – Cipro Toxicity.

When my doctor prescribed Cipro for a stubborn sinus infection in February of 2014, I thought I had never heard of it, and asked her if that was an antibiotic. The truth was, I had heard of it. I had taken it before and hated the experience so much that I had refused to take it again as a doctor laughed at me, treating me like a stubborn child refusing to take her medicine. Perhaps I had blocked out the experience. Perhaps I doubted my sanity at the time. I remember feeling that I was being tormented by a demon, sleepless night after sleepless night as I lay awake reading the name of the pills on the bottle: Ciprofloxacin. Gradually, the idea dawned on me that the demon was actually in the bottle of pills. I got up and threw them away as a hooded figure standing in the center of my parent’s kitchen watched me.

Until early February of 2014, while on Cipro, I kept noticing this odd, thin yellowish liquid coming out of my nose. It wasn’t infection, but it wasn’t a normal secretion either. Yet, it seemed familiar. This odd drainage had accompanied my experience with Cipro back in the 1980’s.  After the nightmare started again I remembered, but it was too late. From February 6th through the 9th I took seven 500 mg pills in all.  I had read the long list of side effects, but I was not told that these side effects (other than peripheral neuropathy) could become permanent. I was not told that these side effects were evidence of actual damage being done to my body and central nervous system. I was warned about tendonitis, but not told that Cipro actually causes tendonsosis (an abnormal formation of a tendon) and that the damage done by Cipro to connective tissue and cartilage can be irreparable.

I called my doctor with concerns about taking Cipro. She said…..

read the rest on her page

Posted in Fibromyalgia, Migraine-Blog, Must Read, This & That, Thoughts | Tagged , , | 1 Comment

What to Do If You Are a Victim of Quinolone (Cipro and others) Drugs!

I am very grateful for the Quinolone Vigilance Foundation that contacted me yesterday whose director wrote a lovely note in the comments field on the first blog I wrote on Cipro and the drugs falling into the same class, called Quinolones.

Because this drug class is so often prescribed, it is likely that you had in the past taken drugs belonging to this category. If you did AND if you had adverse side effect(s) from the drug–immediately or later–see the 43-page warning label of what kind of adverse effects you may have experienced–you have options. There is information for you at the website of the Quinolone Vigilance Foundation where you can even find contact information to attorneys who specialize in cases relevant to this drug class.

As a victim you have rights. Proving the connection to the drug class itself–if your adverse effects were not immediate–may be harder than if you had an immediate reaction. Please contact the attorney(s) listed and find out your options! Please do take your options seriously! One of the best ways to get a drug or drug class off the market is by having lots of complaints about the drugs.

I also strongly advise everyone who had an adverse reaction to any of the drugs in the Fluoroquinolones family to file a complaint about the drug at the FDA – you need to download the form I linked here, fill it out and fax it or mail it to the fax/address listed on the form. The link under the word “complaints” takes you straight to where you should complain about non-life threatening adverse reactions from drugs or foods if you got sick from something! Save this link! It is important that you complain!

Angela

Posted in Fibromyalgia, Interesting reading, Migraine-Blog, Must Read, This & That, Thoughts | Tagged , , , , , , , , , | 21 Comments