Another year gone by, another year older, and another blog. Hope everyone who reads this is doing better from whatever ails you. People suffer from all types of maladies, emotional problems, illness, the loss of someone you love, etc.
Life as I knew it changed for so many, for me not so much. Yes inflation affected me, when I see the prices in a grocery store I still do a double take. I don’t like what is going on in the U.S. as well as the rest of the world but as most do, I try to live for the day. I am not a complainer by nature, maybe that’s good, maybe not. My father had a huge impact on me, he was a happy-go-lucky type of man even when he was dying. He knew he was dying and he said “put me out with the garbage”… He didn’t want the family to fuss over him. I still miss my Dad so much. Sometimes I can feel him looking over me and saying to me “Denise, I’m proud of you”… We were so very close.
What can I tell you that I haven’t told you before? Hmmm, okay, don’t buy into fear. Many of us bought into that fear these past 3 years and because of that it turned some lives around. I didn’t buy into any of it, in fact sometimes I became angry at people I knew very well who did buy into it. But I couldn’t say anything or I would threaten their world of thinking (yes, I tried with a couple of people). Oh no!! I think you know what I’m talking about.
Don’t listen to the news unless you want to know what the weather is. After that get your information from other sources, not the media. Why? Because the media has an agenda which is in my opinion 99% inaccurate. I’m a truth seeker and I know I’m not going to hear the truth from the media. If you must turn on the TV watch something entertaining or educational. Learn to laugh!
We all have a choice, to be positive or negative. Choose to be positive. You may ask how do I do that? Well, start doing good things for yourself whether it’s exercising, helping others, stop being involved with yourself. Give yourself a pat on the back when you do a service that helps another. You deserve that credit. We all deserve to be proud in one way or another. Clean out that extra spare room, do you really need that stuff? Then after you clean it out celebrate that moment.
Life may seem dim at times but it doesn’t have to be that way all the time. Sure, we all have our days, we are only human. So when we have a rough day forgive yourself, it’s not your fault. Don’t blame yourself because it doesn’t do any good.
I’m a bit late this year from blogging, been very busy! To be blunt I really don’t think about lyme disease anymore, yet I will never forget the pain and suffering that lyme caused me. These days I may complain about the aches and pains of getting older, the gray hairs I have, the back pains from lifting heavy things I shouldn’t, etc. But stubborn me still lifts heavy items. Guess I will always be stubborn.
I remember when I was a young girl taking the bus to elementary school. One day one of my neighbors sat next to me and said “Denise, you have pizzazz!” I asked him what the word meant because I had no idea. He explained that I had a certain type of magnetism and it felt good to get this compliment especially from such a serious boy.
Throughout my life many different people told me I had this magnetism even though I never felt it. Looking back I realized I had always been a positive person. I don’t know if one can learn how to have a positive attitude or if it comes naturally. I guess anything can be learned if someone wants to learn it badly enough.
When I was 17 and hit by a car as I was crossing a busy road it never occurred to me that I might die. I remember almost every detail from that accident as I never became unconscious. I almost lost one of my legs due to gangrene setting in but thanks to the wonderful doctors I didn’t. After 7 hours of surgery I woke up and was told that I wouldn’t be able to walk on my left leg for 6 months. I said to myself “no way!” and that night I turned my body over and kicked my left leg with my right to force it to move up and down. I did this all night long.
The next morning, I asked my nurse to get my doctor because I’m going to walk without a crutch. I was hooked up to IV but she got a doctor and sure enough I walked with a walking IV, no crutch. Many doctors came to see me and called me a miracle case. I don’t consider myself a miracle case, just a stubborn person. One week later I was out of the hospital. Sure, I needed over 10 surgeries to put me back together again and it was a harrowing experience.
Of course I have PTSD from that experience, and I guess I always will. Yes, I saw therapists and it may have helped a little bit. Mostly driving and walking across busy roads scares me. Yes, I drive but driving doesn’t bother me especially after I moved to Vermont since it’s mostly country roads. I truly enjoy the scenery from my car and if I see something that interests me, I will pull over and check it out such as a moose or any type of wildlife.
I guess you know where I’m going with this. Attitude is so important! No matter what disease or disability one may have, the attitude you choose can either help you or hurt you. Your choice. When I first joined a lyme forum someone who was very smart said to me that because of my attitude I was going to get better. She was right.
I do understand that being ill is a horrible feeling. Believe me my days were not all sunshine and flowers. I had my days where I would just cry and cry. Not being diagnosed for over 5 years was extremely frustrating. I was sick of seeing doctors who kept telling me that there was nothing wrong with me when I knew full well that there was. I wrote in another post of mine that I ended up diagnosing myself with lyme and finally met a doctor who sent my blood to IgeneX which confirmed my diagnosis of ehrlichiosis. I also blogged that conventional antibiotics didn’t work for me, they only made me sicker, and I listened to my body.
Again, if you are the type who feels hopeless, please try to have hope as hope is a beautiful and positive feeling. Try to say 10 words to yourself each day that are positive even if they sound stupid to you. Just do it. Try to remember the person you were before lyme took away your life. Then say to yourself that you can be that person again and you will! I promise you that. You may be older, maybe you put on weight, maybe you can’t exercise anymore. So, walk 10 steps if you can and be proud of that. The next day walk 15 steps and so on.
That’s one way of changing your attitude. Be good to yourself, treat yourself with kindness. And just accept today as it is as tomorrow may be better.
When you think you tried everything, and you are still not getting better what does one do? You explored all treatments whether they were different doctors, various antibiotics, alternative treatments, you even tried to detox more, changed your diet and after all this you still feel you have not had any positive results. You may even feel stuck and have no idea what to do next. You may say to yourself “I have done what others suggested and I’m still not making any progress, what’s wrong?”.
Like you I tried many different treatments and didn’t heal until I found the protocol that worked for me which was Dr. Jernigan’s protocol from his book (I wrote about the protocol in my previous blogs).
I also did something that some people are scared to do, I made changes in my life even though I knew they would cost me financially. I looked for triggers that were causing me stress and I knew I had to take action. I no longer associated with toxic, negative people even though I cared greatly for them. There were people in my life that were trying to bring me down and I chose not to have anything to do with them anymore.
Change? Yes, change is scary yet as scary as it is it’s necessary in order to heal. Perhaps you will not receive money (if you are with a partner who supports you) from the toxic relationship you are in, perhaps you may lose someone that you’re dependent on, but the end result may be worth it. Yes, I understand there are times when you can’t make any changes due to young children and other situations thus you put up with it. But don’t let that stop you from dreaming of the day you can move on.
I not only ended toxic relationships, but I also moved to another state which brought my stress levels way down. Leaving the town you grew up in and moving to a state that you know little about can be a major change but a positive one. Yes, I have a good friend who found me an apartment and I only saw photographs but I was happy to pack up my 2 cats, hire a moving company, and finally move. Bye, bye stress, hello nature with mountains and waterfalls. No traffic since most roads were country roads. 12 years later and I’m still in love with Vermont! That said, you still take yourself wherever you may go yet changing your surroundings can help. It certainly helped me in many aspects.
I understand that some people get too comfortable whether it’s a relationship that’s not healthy, or a house that costs too much to maintain, whatever the reason.
Does money buy happiness? In my experience it does not. Inner peace brings happiness, getting comfortable within yourself by accepting yourself for who you are including the positives and the negatives and all the in-betweens. There is no perfect human being.
These are lessons I have learned in life and perhaps they will inspire you. Wishing all a Happy 2022!
Yes, it’s been over 15 years that I have been healed from chronic lyme disease, hard to believe. No, I don’t have the secret to the magic bullet, what I do is try to keep it simple. Eating as healthy as I can, exercising, watching my stress levels, and still detoxing (detox baths, dry skin brushing).
I am still a full time caregiver for my now 95 year old Mom and believe it or not I enjoy it since my Mom is so sweet and not demanding. I do admit there are mornings where my Mom sleeps late and the thought enters my mind that she passed which scares me as I know I won’t handle it well. Yes, logically I know she is 95 yet I believe we are never prepared to lose a person we love.
My Mom loves to play cards everyday and even though there are times when I’m too busy taking care of the house I still stop what I’m doing to play with her.
Getting back to me, I really don’t know what to say about being healed all these years. I guess I believe that stress plays a huge role in healing and/or learning how to deal with stress. Exercise helps, talking to a therapist also helps (I have done that when I felt overwhelmed). So instead of avoiding what’s really bothering you please vent to someone even if it’s your pet.
Now we have this Covid-19 virus and many people are rattled by it. I’m not. No, I’m not in denial but I’m not going to let it control my life. I’m used to being home all the time (way before this virus emerged) and I protect myself by wearing a mask when I go food shopping and run other errands (I admit I hate wearing a mask). I do question this virus in many different aspects because I’m a naturally curious person. Well guess what? There are no facts on the internet probably due to the powers high up. We don’t know how many people have died from getting the vaccine but I will tell you I refuse to get it. It’s too soon. If you want to be an experiment that’s your choice. I’ll wait and see.
The head of the Food and Drug Administration just wrapped up a trip to India. This unusual visit abroad was to address growing concerns at the regulatory agency about the safety of prescription drugs made in India. In the last few months, the FDA has banned the importation of several popular drugs made there, like Accutane and Cipro. The U.S. has come to rely on medicine made overseas. Today, 80 percent of prescription drugs consumed in the U.S. originate in India and China. This has lowered costs, but raised new questions on safety. Diane and her guests discuss prescription drugs made outside the U.S.
Dr. Jesse Goodman Director of the Center on Medical Product Access, Safety and Stewardship and professor of medicine at the Georgetown University Medical Center; attending physician, MedStar Georgetown University Hospital and Washington DC VA Medical Center. He was formerly chief scientist for the Food and Drug Administration.
Heather Bresch CEO, Mylan.
Dr. Margaret Hamburg Commissioner of the Food and Drug Administration.
Gardiner Harris South Asia correspondent for The New York Times. He is the author of the mystery novel “Hazard.”
Allan Coukell Director of drugs and medical devices, The Pew Charitable Trusts.
Transcript:
10:06:53
MS. DIANE REHM Thanks for joining us. I’m Diane Rehm. For most of the last century, the drugs we consumed were made in the U.S., but today, the picture is much different. Most of our prescription drug supply originates in a foreign country. Here with me to discuss medicines made outside the U.S., Dr. Jesse Goodman of the Georgetown University Medical Center, Allen Coukell of the Pew Charitable Trust.
10:07:28
MS. DIANE REHM Joining us by phone from New Delhi, India, Gardiner Harris of the New York Times. But first, I’ll talk with Dr. Margaret Hamburg, commissioner of the Food And Drug Administration. She’s just returned from India. Dr. Hamburg, thanks for joining us.
10:07:47
DR. MARGARET HAMBURG Thank you for having me. It’s an important topic.
10:07:50
REHM I’m so you’re here. Tell us why you made the trip to India.
10:07:56
HAMBURG Well, as you noted, today the FDA must behave like a global agency with a global mission because the products we regulate for the promotion and protection of health of Americans here at home depends on the quality and safety of products that are now coming from all over the world.
10:08:19
HAMBURG And in the pharmaceutical space, it’s very striking. Eighty percent of the active pharmaceutical ingredients in drugs taken here are actually manufactured in other countries and about 40 percent of the finished drugs are coming from other countries. So we have a global responsibility and now we must have a global presence and reach.
10:08:39
REHM And Gardiner Harris, to you, you wrote from India about serious safety issues there in the drug manufacturing plants. Tell us what the regulatory environment is like there.
10:08:59
MR. GARDINER HARRIS Well, there really isn’t one, Diane. I mean, and that’s a real reason why I think the Indians were sort of gobsmacked by Peggy’s visit. The FDA, because of legislation that passed in 2012, has gotten a lot of extra money, $300 million annually, to step up its inspections of pharmaceutical plants around the world.
10:09:26
MR. GARDINER HARRIS And so Peggy has sent out a whole raft of new inspectors to Delhi here and they have tripled the number of plant inspections they’ve done in the last two years. And not surprisingly, you look, you find and they have found a whole raft of problems at large Indian drug plants. And it’s expected that those problems will continue to crop up.
10:09:50
REHM Now, Dr. Hamburg, who has the upper hand in this situation, India or the U.S.?
10:10:00
HAMBURG Well, we want to look at it as a partnership and something where quality matters to everyone, for the Indian people, for the American people and for the global marketplace because drugs that are manufactured in India or in other countries are actually distributed all around the globe.
10:10:17
HAMBURG But if you’re a manufacturer, wherever you’re located, if you want to sell you product in the United States, you have a responsibility to meet the standards and regulatory expectations of the U.S. Food and Drug Administration. And that was one of the tough but important messages that I think the Indian industry had to really hear and understand.
10:10:38
REHM Gardiner Harris, do you have any questions for Dr. Hamburg?
10:10:46
HARRIS Well, I think, you know, she did exactly what she needed to do and she’s talking in ways that she needs to talk. I mean, she does not this relation to become a combative one. Her best hope, of course, is that the Indians cooperate in what Dr. Hamburg is trying to do. But for her, it’s a bewildering, I think, experience for a lot of the inspectors because they can inspect what is before them, the plant that has been registered to sell drugs in the United States.
10:11:19
HARRIS But what’s difficult about the Indian environment is that there are a whole range of facilities here…
10:11:24
REHM Exactly.
10:11:24
HARRIS…some of which export to the United States, some of which export to Africa and some of which make drugs for the Indian market. And one always has to worry about what is coming in the back door of the facilities that Dr. Hamburg’s inspectors are inspecting because in a place where there’s a lot of things happening, it’s very difficult for the U.S. to control that.
10:11:49
REHM Now, Dr. Hamburg, you’ve already excluded Cipro and Accutane. Now how many other potential exclusions might you make on the basis of the trip you just made?
10:12:10
HAMBURG Well, my trip was at a higher level than actually doing onsite inspections.
10:12:13
REHM I understand that.
10:12:15
HAMBURG But we are present there in an ongoing way. We actually have U.S. FDA offices now in New Delhi and Mumbai with inspectors there and a cadre of international inspectors who can go there or go other places. And we have offices in China, Latin America, South America — South Africa, I’m sorry, and other places as well because of this need for a global presence.
10:12:39
HAMBURG And what we’re doing is trying to do in India and in other countries what we do here. We’re trying to achieve the same levels of inspection and enforcement and compliance that we would expect of any company manufacturing drugs for consumption by the American public.
10:12:55
REHM Do I understand correctly that 80 percent of our antibiotics have some ingredient coming here from China, which is then incorporated into drugs manufactured here and that the Chinese will not allow FDA inspectors into their plants?
10:13:25
HAMBURG Well, it’s not quite that situation. It is certainly the case that in antibiotics and in other important medications, that active pharmaceutical ingredients’ components are coming from other countries. And I mentioned the number of 80 percent overall coming in from other countries, China and India being major suppliers of these active pharmaceutical ingredients.
10:13:48
HAMBURG Just as in India, we are working in China. We actually have office in three different Chinese cities now, Beijing, Shanghai and Guangzhou. That may change a little bit over time, but we’re bringing more inspectors into China as well.
10:14:04
REHM Have they allowed you into their plants to investigate?
10:14:09
HAMBURG They have. You know, in China, in India and elsewhere in the world, this is a process. They’re not used to this kind of more hands on presence. Other countries, I would add, are starting to do more international inspections as well. And one of the things I wanted to mention that I talked a lot about with both the Indian regulators and industry representatives in India, is that India now, given their incredible and growing role in the global marketplace for pharmaceuticals, really needs to become part of a partnership of regulatory authorities and really be at the table in the discussions that heads of drug regulatory authorities, like myself, have about working together to address what is a global challenge.
10:14:57
REHM Dr. Hamburg…
10:14:59
HARRIS And Diane, what…
10:14:59
REHM Go ahead, Gardiner.
10:15:01
HARRIS What she is not saying, because she’s playing nice and, you know, the extraordinary thing that what Dr. Hamburg has brought to the commissioner’s office is that she’s become a, per se, a diplomat for the United States. And what she’s not really saying is that the Indians have just disappeared. They have not shown up at multiple conclaves that Dr. Hamburg and many other top regulators around the world have been holding to try to create a kind of a global network of regulators.
10:15:31
HARRIS And that’s because, you know, the problem with the Indian government is that it just is not there. It’s not present in the plants and it’s not present in this sort of global set up that Dr. Hamburg is trying to create. And so in many ways, her trip, you know, is sort of — if Mohammed can’t go to the mountain, the mountain comes to Mohammed.
10:15:54
HARRIS You know, she had to go to India because it was the only way she was going to be able to talk to them. And she needed to get their attention. And I think her trip did that.
10:16:04
REHM Do you believe your trip did that, Dr. Hamburg?
10:16:08
HAMBURG I think it was an absolutely crucial step at a critical time. It was not always an easy trip. There were tensions between the U.S. government and India as a backdrop to my visit, but also between U.S. FDA as the regulator having just taken some pretty stiff actions against some Indian companies so the industry representatives and the government officials were a little bit wary, a little bit defensive and a lot concerned.
10:16:40
HAMBURG But I think we laid a groundwork for a constructive relationship. We entered into the first statement of intent with the Indian government about a framework for action going forward and our FDA offices in India really are there to both do the inspectional and compliance work that’s necessary, but also to build a sustainable oversight and educational system for India and for us.
10:17:04
REHM Dr. Hamburg, I understand the need for diplomacy, getting along, working with other countries, but at the same time, Americans are concerned about safety of the drugs they’re taking. How can they know whether a drug they’re taking is made in India, is coming from China, how can they know?
10:17:32
HAMBURG Well, yeah, that is an issue and, of course, many Americans are in healthcare plans where they can’t choose which generic version of a drug they’re gonna receive as part of their program. So I think, you know, Americans are asking more questions, but, you know, what we are really striving for is a global supply chain that has real integrity, quality built into it and where the products that are coming from other countries meet those same standards.
10:17:59
HAMBURG That’s why we’ve taken some of the strong actions that we have when we’ve seen quality problems because that is not acceptable and in those kind of contaminated counterfeit substandard products will not be allowed in the United States.
10:18:15
REHM Can we expect any other bans on drugs in addition to Accutane and the other one?
10:18:24
HAMBURG Well, we have been doing an ongoing series of inspections. As Gardiner said, when you look, you often find. Our goal over time is to have fewer enforcement actions because more compliance with quality.
10:18:35
REHM Dr. Margaret Hamburg, she’s commissioner of the Food and Drug Administration. Thank you for being here.
10:18:44
HAMBURG Thank you so much.
10:18:46
REHM Short break, right back.
10:20:02
REHM And welcome back. Here in the studio Dr. Jesse Goodman. He is director of the Center on Medical Product Access, Safety and Stewardship at Georgetown University Medical Center. He was formerly chief scientist for the Food and Drug Administration. Allan Coukell is director of drugs and medical devices at the PEW Charitable Trusts. And joining us from New Delhi is South Asia correspondent Gardiner Harris of the New York Times. I do welcome your questions, comments. Join us on 800-433-8850.
10:20:52
REHM Gardiner Harris, how serious a problem do you see this importation of drugs from places like India and China to be considering the fact that inspection is so difficult?
10:21:11
HARRIS Diane, there are basically two issues here and Dr. Hamburg, as good as she is, can only address one of them. There is the safety issue which how safe are these drugs considering that we haven’t been there. Some of these suppliers in China, frankly Dr. Hamburg’s people have not gone into in 10 to 15 years. What she did not say to you was that she has not gotten anywhere close to visas out of the Chinese government that the FDA wants. The FDA’s been asking for those additional visas for two years. The Chinese government has refused to give them to the FDA, or at least has not given them to the FDA.
10:21:49
HARRIS But a second and arguably just as important issue is the security issue. What she did not also say is that we’re getting all of our antibiotics from China right now. We are getting all of our steroid medicine — if you go down the list of medicines that are absolutely essential in hospital settings, and nearly all of them have their crucial ingredients coming from China, were we to get into a bad situation with China and some of these imports were to stop, our health care system would collapse fairly quickly. And no one is addressing this.
10:22:25
HARRIS The last antibiotic plant in the United States was up in Syracuse, New York. It closed in 2004. No one said a thing. And no one still is saying a thing. That is a real concern that Dr. Hamburg can do nothing about.
10:22:41
REHM And Dr. Goodman, it was not until 2012 that a law actually required the FDA to do these inspections abroad.
10:22:53
DR. JESSE GOODMAN Well, and very importantly began to provide substantive resources, as Gardiner said, so that new people could be hired, could go in and begin the process of looking much more careful at this plant. And I agree that while there’s some great initial progress and we’re seeing these actions out of that progress, there’s a huge way to go. I’m really also glad that Gardiner raised the shortage and security of supply issue. This is something I’ve been very concerned about.
10:23:24
DR. JESSE GOODMAN There are many medicines essential to health care or even emergency response in this country were there to be a disaster where it’s not just a matter that they may be — have their ingredients made in foreign countries, but there also may only be a very limited number of suppliers. So if the supply was disrupted for either accidental or intentional reasons there could be serious consequences.
10:23:48
REHM Allen Coukell, how does the PEW Charitable Trusts get into this?
10:23:55
MR. ALLAN COUKELL PEW has had a relatively long term focus on drug manufacturing and drug quality issues. And beginning a couple of years ago in the wake of a tragic contamination of a blood thinner called Heparin, we became involved in the issue. And that was a case where the drug was coming from China. Someone in the upstream supply chain of that drug substituted something that was not the correct active ingredient but tested like the correct active ingredient. Made its way all the way into the drug and into the U.S. supply chain and made large number of patients quite sick.
10:24:31
MR. ALLAN COUKELL And that was pretty clearly a deliberate adulteration for economic reasons. So that was not just…
10:24:38
REHM That takes my breath away.
10:24:39
COUKELL That was not just a case of a lapse in quality standards. That was somewhere somebody deliberately substituting a low-cost ingredient for economic gain.
10:24:48
REHM Sabotage.
10:24:51
COUKELL Fraud. An economic crime with health consequences.
10:24:55
REHM An economic…
10:24:56
HARRIS Diane, a deeply evil one. Like, let me be clear that someone substituted a substance that they knew would (unintelligible) initial tests, but what they also knew would probably kill a lot of people afterwards. And this sort of thing is not all that uncommon in the global pharmaceutical industry. You know, the WHO has cited estimates that up to 1 in 5 of medicines sold in India are spurious.
10:25:28
HARRIS And many of these medicines — there was a case recently in Cashmere where hundreds of thousands of antibiotic pills were distributed in public hospitals. Thousands of cases of infants that were in trouble were given an intravenous antibiotic. And those — and the antibiotic had absolutely no active ingredient whatsoever. And likely this incident caused hundreds, perhaps thousands of deaths. And it’s that sort of safety concern that Dr. Hamburg is hoping does not come to the shores of the United States. But as Allen said, it has happened already with the Heparin scare and may have happened in smaller ways that we just don’t know about.
10:26:09
REHM So explain, Allen, if you would, why that last plant closed in Syracuse in 2004 and why we began transferring manufacture abroad.
10:26:25
COUKELL Well, I think that you can look at it in two ways. One is we are part of a global economy, and the trends you see in drug manufacturing are the same as the trends you see in almost everything else. But you can also look at the fact that a significant component of the cost of drug manufacturing is the cost of complying with quality standards. And so manufacturers that are operating in an environment where they are not having to comply with those quality standards also have a competitive advantage.
10:26:53
REHM So, Dr. Goodman, it sounds as though the U.S. is clearly playing a role here. Because we are willing to transfer a manufacturer to other countries, they are accepting it because we cannot do the kind of investigation and regulation abroad that we could’ve done here.
10:27:22
GOODMAN Well, I think as Allen said, the globalization of certain kinds of manufacturing and the fact that it’s going on now in other countries is a common phenomenon across the…
10:27:31
REHM Yeah, but wait a minute. Wait just a minute. I can see the manufacturer of furniture going abroad. I’m not ingesting furniture. I’m not depending on furniture for my life.
10:27:46
GOODMANRight. So this is…
10:27:47
REHMThis is very serious stuff.
10:27:51
GOODMAN…this is why this is so important. And in fact, you know, I want to also point out that there’s tremendous demands from the people in China, the people in India, that their regulatory agencies perform inadequate function and protect them. So many of these problems, as Gardiner said, there have been — you know, while we’ve shut down facilities that we saw as putting risk of harm here, there are facilities providing drugs that raise concerns of the ordinary citizen.
10:28:24
GOODMANSo one thing that Dr. Hamburg is working to work on is that there are also incentives for companies producing in these countries to up their game, improve their quality, etcetera.
10:28:39
REHMHow long is that going to take, Gardiner Harris? It would seem if they began doing this years ago and their own people have begun complaining, hot long is it going to take to bring that manufacturer of medications up to U.S. standards?
10:29:03
HARRISOh, I think it’s going to be years. And let’s be clear, if you are presently taking vitamin C, you are taking a product that has almost certainly been made in China in plants that Dr. Hamburg’s people have never gotten into. If you are taking aspirin you are almost certainly taking a product that is being made in either Thailand — there is one facility down in Brazil, but nearly all of them are from China. And because it’s over the counter and the FDA doesn’t consider over-the-counter to be sort of risky, those facilities have almost never been inspected by the FDA.
10:29:38
HARRISSo, you know, again we have these two issues of both safety and security. Now the U.S. government, particularly the Bush Administration, got extremely concerned about the manufacture of flu vaccines that were mostly being done abroad. They started worrying about what would happen during a pandemic. They created and they — and billions of dollars to try to create a manufacturing infrastructure in the United States for flu vaccines. But to me, it is just astonishing that the government has never expressed concern about what are far more dire medications were the borders to close.
10:30:15
HARRISIf you don’t have infused steroids in a hospital setting, people will die. If you do not have infused antibiotics, people will die. And, you know, our whole system would collapse fairly quickly if these imports were stopped.
10:30:31
REHMAllen.
10:30:32
COUKELLNo, I agree. On the question of how long it will take, I think it’s an important question. And, you know, one thing we can think about is the analogy to Japanese cars. And you probably remember when they first started coming here in the ’70s, they were terrible. And then in relatively short order they completely leapfrogged U.S. manufacturing and became incredibly high-quality automobiles. That potential is here too. This could be fixed fast if there’s a commitment on the part of the industry in these countries and the regulators in this countries to do it.
10:31:03
REHMLet me interrupt you for a moment. People know if a car is not working well. People do not get sick immediately getting into a car that’s not working well. I do not think the analogy applies.
10:31:23
COUKELLIt’s an imperfect analogy but there is clearly a risk to a company that can no longer export to the U.S. And so I think when you have the commissioner going with two messages, one is we are going to be there doing stepped-up enforcement. And that’s important and we need more of that, but also, that commitment to upgrading the scales of the Indian regulator. Because ultimately we need them to step up.
10:31:43
REHMOkay. So how long is that going to take, Gardiner, to step up both inspection and enforcement and get the Indians, the Chinese to do their own enforcement? What incentives are there for them if they can continue to send these drugs to us?
10:32:08
HARRISWell, the incentive is money of course. And, you know, the Indians — the pharmaceutical industry exports $15 billion worth of products out of India. It is a hugely important industry here. And you — you know, look, this just happened with their airlines. The FAA in the United States decided that the Indian air regulators were not up to snuff and downgraded India’s air safety rating. Their small cars just were determined to be all unsafe by this, you know, global car regulator.
10:32:40
HARRISSo across the board, Indians are starting to hear back from their counterparts in the rest of the world. And their counterparts are saying, I’m sorry but you’re not up to snuff.
10:32:50
REHMGardiner Harris of the New York Times and you’re listening to “The Diane Rehm Show.” I want to open the phones, 800-433-8850. Let’s go first to York, Penn. Margaret, you’re on the air.
10:33:11
MARGARETHi, good morning.
10:33:12
REHMHi.
10:33:13
MARGARETI’m a physician assistant and I prescribe Ciprofloxacin pretty often. And I’m wondering with that drug but more with the others that would be banned down the pike, when can we expect shortages to happen? And how high can we expect prices to go?
10:33:30
REHMWhat do you think, Dr. Goodman?
10:33:32
GOODMANWell, I think it’s a complicated question and it sort of depends what other number of suppliers in capacity there is in the industry to absorb, in this case Ranbaxy’s inability to contribute to that supply. So in some cases when FDA takes an action against a company, there can be implications to supply. So FDA takes those into account because we don’t want to cause shortages that are more harmful than the risk of shutting down a plant. So it’s a risk-based decision.
10:34:03
GOODMANBut this problem of improving quality in manufacturing is very linked to shortages because many shortages occur when either a company or FDA or another regulator says, we need to fix a problem in manufacturing.
10:34:20
REHMAll right. And to Doreen in Trion, N.C. You’re on the air.
10:34:27
DOREENHi, Diane. It’s an honor to speak with you.
10:34:29
REHMThank you.
10:34:30
DOREENI was hit in the head about four years ago by a metal post which sent me flying through the air. I became ill after that. My thyroid had problems, I was weak, I was shaky, I had palpitations. I was really in bad shape. About a year ago we found out that I wasn’t producing any ACTH because the pituitary had been damaged. So I was placed on generic hydrocortisone. I never improved. My thyroid status did not improve. Every time I took a pill I would get shaky. I’d start to perspire. My heart would get more irregular.
10:35:07
DOREENI couldn’t think. I would stagger around. I fell. I broke my foot. I mean, I just had a lot of problems. And in the ensuing year I’ve developed a horrible colitis. And I blame it on the fact it was generic hydrocortisone. So around — just in November I asked my doctor to give me a prescription for Cortef, the brand name. I took it and I started to feel better. Just before — the Thursday before Christmas I called his office and asked that it be renewed instead of the generic. And there was a glitch in the faxing apparently because it wasn’t renewed.
10:35:40
DOREENSo when I went to pick it up there was no Cortef. I was forced to take the generic for four days because Christmas fell in there and they had to order the Cortef. After four days I became extremely unstable. I had rapid mood swings.
10:35:57
REHMAll right.
10:35:58
DOREENAnd I became very weak. I began to lose vision, which happens…
10:36:02
REHMSo it sounds as though you felt very strongly that it was the generic that did that.
10:36:06
DOREENOh, it was definitely the generic because now I’m on the Cortef and I’m doing much, much better. When I…
10:36:12
REHMOkay. Thank you. Here’s what I want to ask. Are more generics in trouble because they’re produced abroad than the real stuff, Dr. Goodman?
10:36:33
GOODMANWell, problems have occurred with both generics and brand name drugs.
10:36:36
REHMAll right.
10:36:37
GOODMANAnd brand name drugs, in many cases, their active ingredients or even the finished drug may be produced abroad. However, generic drugs are tightly regulated. FDA recently got increased funding to be able to do more inspections of generic facilities, etcetera. One of the things that our audience can do today is if you think you have a problem with the quality of a drug, whether branded or generic, and it doesn’t perform and you have an experience like this caller just related, please report it to FDA’s Med Watch so that it can be investigated.
10:37:12
REHMFDA Med Watch. Okay. Short break here. More of your calls when we come back.
10:40:00
REHMAnd welcome back. Joining us now by phone is Heather Bresch. She’s CEO of Mylan, that’s a generics and specialty pharmaceutical company. Thank you, Heather, for joining us. I know you were one of the leaders pushing for more inspections in countries like India. Tell us why.
10:40:28
MS. HEATHER BRESCHHi. Well, good morning, Diane.
10:40:29
REHMHi.
10:40:31
BRESCHMylan has been in the pharmaceutical business now for over 50 years, but for the first 45 years we were located in the United States. Our facilities were in the United States and we only sold in the U.S. market. So we were a domestic player for many years. And obviously very familiar with the FDA standards of inspections at least every two years to require good manufacturing practices. We then acquired companies and went global in 2007.
10:41:03
BRESCHIn learning and understanding the global industry became aware that there was unlevel playing field. That FDA did not have the resources, nor the standing, to get to foreign facilities at the same rate they were in the United States. So when I came back to investigate why that’s the case, I realized the law was silent. The law was written in 1938 and had not really been touched significantly since 1938. And we were a very domestic society in 1938. I think that as all your show so far this morning has discussed, we are a global industry and FDA was a domestic agency trying to govern a global industry without the right financial resources or standing to do so.
10:41:51
REHMOkay. But I have a question for you, and it comes from Susan. She says, “How many of the foreign plants, as in India, are owned by U.S. multinational pharmaceutical companies? And how helpful are these companies being in helping with safety inspections?” What about Mylan?
10:42:20
BRESCHWe own facilities all over the world and many in India. We have always said Mylan, as a company, holds all of our facilities to the same quality standard. So we don’t make product differently for the U.S., then we make it for Africa or India or anywhere else we sell our product around the globe. Not all companies can tell you that, whether they’re U.S. based or India based or China based. Many companies have different standards and sell different products to different parts of the world.
10:42:49
REHMAll right. But do you feel that your company is responsible for safety in those foreign plants or do you feel it’s the FDA’s responsibility?
10:43:06
BRESCHWe certainly feel responsible and have said that quality is not a department and can’t be one person. It’s the culture or the DNA of your company. I believe there are good companies and bad companies everywhere in the world, here in the U.S. included. I think as a society we’ve made the determination, though, that self-governing is not good enough. I think if that were the case, why do we govern anything here in the U.S., why do we have people go and inspect, why do we have policemen?
10:43:34
BRESCHBecause we want that oversight. So we absolutely hold ourselves responsible and hold our facilities to that standard. With that being said, I can’t speak for everybody else. So to have a level playing field is where you need regulators like the FDA that are holding — if you’re not looking for anything, you’re not going to find it.
10:43:54
REHMAll right. And, finally, are we too reliant? Have we become too reliant on drugs made abroad? Should generics come back to the U.S. where U.S. oversight can be right here?
10:44:16
BRESCHLook, I think that we have gotten ourselves into a huge issue here out of the United States by letting so much of the products being imported and losing sight — I think as Gardiner and others were talking about earlier — losing sight about almost now 100 percent, like antibiotics, 100 percent of antibiotics are made outside of the U.S. I think that’s a hugely strategic issue. And I think that as the United States government, we need to look at strategic sourcing, because right now we’ve let the leverage go into China and India.
10:44:52
BRESCHSo China can be reluctant to give us Visas, not even let FDA in to visit plants they need to, yet we’re not in a position to say you can’t come into the U.S. unless you allow that to happen. We need to reverse that. You can’t do it over night. This is something that’s happened over the last 30, 40 years, but we absolutely need to have that pendulum come back so that we have the leverage to say if your facility is not under good manufacturing practices you can’t ship into the U.S.
10:45:19
REHMHeather Bresch, she’s CEO of Mylan, that’s a generics and specialty pharmaceutical company. Thanks so much for joining us.
10:45:30
BRESCHAll right. Thank you.
10:45:32
REHMAnd, Dr. Goodman, you wanted to add to that.
10:45:35
GOODMANYeah, I wanted to build on something just said, and that Gardiner also mentioned. The flu vaccine experience was one where — and I was involved in some of the government decision making around this — where we knew that to protect the national security of this country, particularly in a pandemic, we needed to have domestic-based manufacturing capacity. And we also needed foreign capacity of high quality because a pandemic is a global event.
10:46:01
GOODMANBut as he said, the government invested in building an influenza vaccine manufacturing infrastructure in this country and a government partnership with industry capable of dealing with a public health crisis. And that stood us in good stead, for example, in 2009 and as we look at new viruses emerging from China all the time. I think, even if manufacturing overseas was perfect, that the situation where we may have 100 percent of certain critical antibiotics that we’re dependent on one area of the world — and we don’t necessarily have the capacity in the U.S. to do this — it reminds me of many other critical things.
10:46:40
GOODMANLike in defense, we don’t say that we can make all our tanks in one place and can’t make them in the U.S. And I think it is time for an examination, for some of the most critical drugs — and it’s not just drugs, medical supplies, masks are all made overseas. Do we need to think about having at least some resilient manufacturing capacity built in this country?
10:47:03
REHMGardiner Harris, do you want to comment?
10:47:06
HARRISWell, I think Dr. Goodman has got it right. I mean I think this is a real problem that the government has failed to address almost entirely. And all of this sort of happened without anybody noticing. I mean when that Syracuse antibiotic plant closed, I actually talked to the folks. It was a Bristol Meyers plant. I talked to the executives involved. And I asked them, “Did anyone ever call you guys from the government to sort of say, ‘Hey, geez guys, this is the last antibiotic plant in the United States. Maybe we can come to some sort of arrangement.'” Well, no. No one did.
10:47:42
HARRISAnd that’s true across the board with steroids and with all these other — with aspirin. I mean aspirin is a miracle drug and we don’t make it here. And the last Western plant was actually in France. And I went to that plant just before it closed and wrote a story about the last Western aspirin plant closing. And, again, nobody from any government went there and sort of said, hey, let’s talk turkey.
10:48:09
REHMAllan Coukell, you said during the break, it’s not just foreign products. It’s products made here in the U.S. as well.
10:48:18
COUKELLWell, I think it’s an important point. And there are serious quality problems in India and China. There are also great facilities in India and China. Similarly, one of your earlier callers talked about drug shortages. Over the past couple of years we’ve had huge problems of essential medicines not being available here because the plants that made them have had quality problems. And for a lot of those drugs, they’re sterile injectable drugs, and they’re made in the U.S. So quality is an issue everywhere.
10:48:45
REHMAll right. Let’s got to Harold, in Williamsburg, Va. You’re on the air.
10:48:51
HAROLDGood morning, Diane.
10:48:53
REHMHi there.
10:48:54
HAROLDFollowing on the tail of the aspirin remark, I’m reading my Bayer label, which says, “Made in Spain.” But that aside, I’m just wondering why someone hasn’t urged the government to come up with some type of subsidies or co-involvement in order to bring that manufacturing back. Cities are giving breaks, New York has the ten-year-no-tax thing. There’s all types of things that could be done in terms of the government encouraging and incentivizing the relocation of plants to here where we could inspect and control to a greater degree, than hoping someone in another country might do it eventually.
10:49:38
REHMAll right. Thanks for your call. Gardiner?
10:49:41
HARRISWell, there’s several things going on here, Diane. I mean 10 percent of the money that we spend on our healthcare system goes to drugs. So it’s a huge amount of money. And generic drugs have now become somewhere between 80 and 85 percent of the medicines that we all take. There is no question about sort of going back to the branded drugs. And as Allan said, it’s not like the branded drug makers have distinguished themselves in their own quality effort.
10:50:06
HARRISThey have gotten into trouble again and again and again. Two years ago, GlaxoSmithKline paid an $800 million fine because their manufacturing had been so woeful and they’d like about it so often that the Justice Department came down so hard on them. So these problems are global problems from a safety perspective. But I think from a strategic perspective, look, Jesse Goodman was deeply involved.
10:50:31
HARRISHe’s not giving himself enough credit. He and his wife, actually — they made most of these decisions over their breakfast table actually — but they were deeply involved in making sure that the United States had a much better capacity to deal with a pandemic. They were extremely successful. There’s really no reason why those sorts of efforts cannot be extended to a whole range of critical medicines.
10:50:58
REHMAnd yet, you don’t see it happening yet, Dr. Goodman.
10:51:03
GOODMANWell, I think this is a really important dialog. I do think, as Gardiner said, it’s unrealistic to turn back the clock. But I think we have to ask, can we restore some of the balance. And I don’t think — we are becoming one world. As I said, the people of India, the people of China, the people of Africa, they want the same things the people in this country want. They want good vaccines for their children. They want safe drugs.
10:51:27
GOODMANIt is moving in that direction. I think one of the things FDA can do, one of the things I hope to contribute to from academia, is helping other countries get there, helping us all collaborate.
10:51:38
REHMAll right. I asked this question earlier and Harold, in Williamsburg, just had one answer. He looked on the label of his aspiring, which was made in Spain. But how can I, with my prescription drug, know exactly where it’s coming from? There’s a lab label on that prescription, but it doesn’t give me a country of origin. Allan?
10:52:10
COUKELLThat’s absolutely right. And even in a case — and I can’t speak to Bayer aspirin specifically — but even in a case where it says made in country X, there is every chance that there’s an upstream supply chain, which perhaps the finished tablet was made in that country, but the active ingredient comes from further upstream.
10:52:25
REHMSo are you telling me there’s literally no way that consumers can know, other than to take that drug, find out it’s not working. Is that the only way?
10:52:40
COUKELLI think it’s fair to say that in general it would be hard for consumers to know where their specific product had come from.
10:52:45
REHMShouldn’t…
10:52:46
HARRISDiane, what’s frightening about this, is that even the FDA, until very recently, didn’t know where all these medicines were coming. Part of that 2012 legislation, was that FDA required these manufacturers to start paying an annual registration fee. And what FDA really was looking for was finding out actually who was going to pay the fee. FDA didn’t actually know who was an active manufacturer. They had this very long list. They were decades old.
10:53:14
HARRISMany of the companies on there had long ago stopped making it. So what FDA did, by requiring the manufactures pay an annual fee, is to find out who out there was willing to pay the fee. And it’s only if you’re actually making drugs that you can pay the fee.
10:53:29
REHMAnd you’re listening to “The Diane Rehm Show.” So let’s now go to Rosanna, in Miami, Fla. You’re on the air.
10:53:42
ROSANNAThank you so much, Diane, for taking my call.
10:53:44
REHMYes.
10:53:44
ROSANNAMy question is — I’m sure it’s not an original one — I’m a scientist. And I always wonder why the basic medications, the ones that we depend so much, are not made in a frame like NIH, so we make them, the government makes them. And we have already the regulation and the standard in a place that is ours and not contracted out and not have all these problems about being able to look at them and inspect them also. And I’m not saying…
10:54:14
REHMInteresting question, Rosanna. Thank you. Isn’t this a matter of national security, Dr. Goodman?
10:54:23
GOODMANWell, I think that’s a really interesting question. It is a matter of national security that we have the essential drugs we need. I don’t think historically the government has been good or a place to do manufacturing. And, you know, for example, when I was at FDA we saw that the manufacturing expertise was with the companies that do it the best. Not the companies that don’t do it well, but the companies that do it the best.
10:54:49
GOODMANSo I think what we need to do to address this problem is work with industry, both where they have quality problems, to improve it, but where they don’t, to say how can we better prepare or prevent quality problems elsewhere. How can we prevent shortages? Is government investment needed? One thing I didn’t get a chance to raise, that’s an issue here, is that — and we saw this with flu vaccine. These very low-cost drugs save hundreds of billions of dollars to the healthcare system. That is a great thing.
10:55:21
REHMBut if they don’t do any good, it’s not saving anybody anything.
10:55:25
GOODMANNo, that’s right. And most generic drugs work and perform — and the law is that they have to do that. However, competition is largely based on price. And as you were saying comparing the car to the drug. You can’t tell from holding up a vial, is that something that was really produced in an A-plus way or C-plus way?
10:55:47
REHMAnd what about, Gardiner Harris, the idea of weeding out those plants that are not living up to standard?
10:55:58
HARRISWell, I think that’s actually what is really frightening the Indians right now. Because, as we talked about here, one of the reasons why India’s pharmaceutical industry has thrived so much was precisely because no one was in the plants watching what is going on. Heather Bresch, if you’d asked her, would’ve said basically that her plants, when she makes them to FDA standards, it’s about 25 percent more in costs. So these plants in India have had an enormous advantage for years and years and years.
10:56:31
HARRISAnd with the FDA going into India right now — I spoke to one of the major manufacturers there. He’s not sure he’s going to expand in India anymore. It’s tough.
10:56:43
REHMGardiner Harris, South Asia correspondent for The New York Times. Allan Coukell of the Pew Charitable Trusts. Dr. Jesse Goodman, formerly chief scientist for the FDA. He’s now at Georgetown University. Thank you all so much. I think we’ll be talking about this more as time goes on. Thanks for listening all. I’m Diane Rehm.
Since I enjoy researching not only about chronic illnesses but various treatments I came across articles about gutter oil being used in antibiotics.
Most know that the largest pharmaceutical plants are located in China and India. Cheap labor and the U.S. mark up the prices (big pharma).
What I found disturbing was that some manufacturing plants in China were using gutter oil as one of the ingredients in antibiotics instead of soybean oil to save on costs. The first articles I found were written by Gardiner Harris in the NY Times (I’m not posting them since I’m not going to pay for the articles). If you subscribe to the NY Times you can easily read the articles for yourself.
Who is Gardiner Harris? He is a former health, South Asia, White House and diplomatic correspondent for the New York Times.
Food and drug safety authorities in China have told pharmaceutical firms to check their suppliers as they investigate reports that so called gutter oil is being used to make antibiotics.
The reprocessed kitchen waste, dredged from restaurant drains, has been implicated in a number of food safety scandals in the country.
The BBC’s Martin Patience reports from Beijing.
Then I found this:
China probes use of ‘gutter oil’ in antibiotics
Recycled from restaurant waste and cheaper than soybean oil
CBC News ·
A man looks at cooking oil on sale in a market in Shenyang in northeast China in November 2008. Rising prices of edible cooking oils in recent years have pushed some restaurant owners and drug suppliers to turn to cheaper alternatives, including gutter oil, repurposed cooking oil salvaged from drains and restaurant waste. (Associated Press)
Chinese authorities are reportedly investigating allegations that several makers of antibiotics in China used so-called gutter oil — repurposed oil salvaged from restaurant waste, gutters, drains and animal fat — in their products instead of more expensive soybean oil.
The state news agency Xinhua and other Chinese media reported that several pharmaceutical companies used gutter oil instead of the more expensive soybean online in the manufacture of 7-aminocephalosporinic acid, or 7-ACA, a chemical used to produce a class of antibiotics called cephalosporins.
The companies reportedly bought the recycled cooking oil from a company called Huikang Grease Co., which is facing prosecution over its alleged processing and selling of thousands of tonnes of gutter oil in 2010 and 2011.
The Taiwanese paper Want China Times reported that Huikang originally bought the oil from a firm called Gelin Biology Company.
Reselling discarded oil lucrative
The names of several of Huikang’s suspected customers came out in court last week during the trial of several people charged in connection with the case, the Shanghai Daily reported.
Jiaozuo Joincare Biological Product Co., a subsidiary of the Joincare Pharmaceutical Group, Qilu Pharmaceutical and Charoen Pokphand Group are among the companies accused of buying the discarded oil and using it in their products.
Joincare issued a statement last Thursday saying it would work with the authorities looking into the matter, Xinhua reported.
Salvaging and reselling gutter oil is a lucrative business for the intermediaries who process it, filter it, blend it with edible oils and sell it on to restaurants, animal feed suppliers and drug makers looking for a cheaper alternative to vegetable, plant and other edible oils.
The Shanghai Daily reported that Huikang received around $22.5 million US for the roughly 14,700 tonnes of gutter oil it sold to Jiaozuo Joincare Biological Product Co.
Health effects unclear
Residue of the gutter oil may have ended up in antibiotics produced in China although it is unclear what health risks, if any, gutter oil poses. Some public health experts have said that the oil could contain excessive acid and cholesterol as well as possible carcinogens and other toxic substances.
China’s food and drug administration and local authorities in Jiaozuo, a city where the Joincare subsidiary operates, are looking into what potential health effects the inclusion of the substance in antibiotics may have, Chinese media reported.
It’s not the first time gutter oil has been in the news as authorities have stepped up efforts in recent years to stamp out the use of the recycled cooking oil and to generally improve the country’s dismal record on food safety.
Chinese suppliers have been involved in several high-profile scandals over the past five years involving food and health safety — including the tainting of infant formula, milk products, pet food and beer with various unsavoury chemical products not meant for human or animal for consumption.
From Natural News (I don’t know how accurate Natural News is, so come to your own conclusion):
As China continues to rise as the new Asian powerhouse, there has been a steady stream of reports which have detailed the country’s staggering lack of standards when it comes to producing manufactured goods, so it was only mildly shocking to learn that authorities there are now looking at charges that some of the country’s pharmaceutical companies are using disgusting “gutter oil” to make antibiotics.
For the uninformed (which included me before I came across this story), gutter oil is essentially reprocessed kitchen waste dredged from restaurant drains.
While you’re getting a mental picture, read on: Chinese authorities are responding to reports that drug makers may have used it to manufacture antibiotics instead of the more expensive (and, most likely, much cleaner) soybean oil.
What’s more, the gutter oil has apparently been at the heart of several food-safety scandals in China in recent months, the BBC reported, quoting Chinese officials – though in typical fashion, the government was secretive, saying it would release its findings soon without providing additional details.
I do not consider myself a fear monger but I think people should get as much information about what they put inside their bodies as possible.
I also found Diane Rehm’s show from 2014 interesting about the safety of prescription drugs made outside the U.S. which I will write about.
I skipped a blog about being 13 years healed, not because I’m superstitious about the number 13 but because I’ve been really busy.
I have mentioned in my previous blog that I am a full time caregiver for my elderly Mom and still am. About a year ago my elderly Aunt (Mom’s sister) moved in with us so I help take care of her as well.
I feel blessed that my Mom is truly sweet and adorable so she is a very easy to take care of even though she has vascular dementia / alzheimer’s. No aggression. I’m not going to lie and say that I do not feel sad that I am witnessing her dementia progress. My Mom will be 94 years old and I’m happy that she is still with us (there were a few close calls in which I thought I was going to lose her).
Getting back to me what can I say to those who are reading this about chronic lyme disease that I have not blogged about before?
I think it’s important to accept that you are ill. Many are in denial which I totally get as lyme disease can be a scary fact to accept. In my case I was desperate for an answer to why I was sick thus when I learned I had lyme and ehrlichiosis I was relieved after searching for five years as well as seeing clueless doctors. Those five years were the longest in my life as I felt so helpless not knowing.
I still get asked if I take any medicines/supplements for lyme and the answer is no. I still drink Green Vibrance because it makes me feel good and I like the ingredients. This past year I did add a supplement due the risk of osteoporosis (yes, I am in my early 60’s) called New Chapter Bone Strength that contains calcium and vitamins K2 and D3. I also take magnesium citrate to keep my bowels moving.
Over the years I have formed my own opinions about healing from chronic lyme. First I do not believe in conventional antibiotics. Why? Because I healed without them and I believe there are too many side effects compared to herbal remedies. When I talk about herbal remedies there are many different ones so what works for one person may not work for another. Pharmaceuticals are too hush hush as far as the ingredients and being the curious person I am I like to know what the ingredients are in most everything.
Detoxing is a must in my opinion. I still continue to dry skin brush, take epsom salt with hydrogen peroxide baths, internal cleanses, etc. I feel great after a detox bath plus the bath gets rid of everyday toxins. Makes sense to me. I try to keep it simple as I believe less is more. Looking back when I first became sick I wish I had known about detox baths, infrared sauna’s, detox foot baths, etc. because I would have detoxed for a couple of months before taking any remedies. But we live and learn.
Do what you feel is right for yourself. Experiment a little if you are of the mindset to research. I experimented with different remedies before I found what worked for me. Everyone needs to find what works for them. Don’t follow others but do your own research as there are those who will swear by a certain antibiotic, remedy, whatever and just because that may work for that person does not mean it will work for you. We are all so very different.
Travel different roads on the internet, learn as much as you can from reputable sources as there is a wealth of information out there.
Wishing you positive healing and a very Happy Thanksgiving! Continue reading →
Yes, it’s 12 years since I healed from chronic lyme. This past year I had some added stress as I became a full time caregiver for my elderly Mom who suffers from Alzheimer’s / Dementia. I moved her long distance to live with me so I can take care of her.
Thus I am mindful of this new stress and deal with it the best I can by talking to others in the same situation as stress could cause relapsing which I do not want to happen! I am lucky that my Mom is very sweet and easy to get along with.
On another note I never want to forget how sick I was from chronic lyme because I believe if I do that I may forget all the tools I learned such as daily detoxing, eating healthy, exercising, etc.
It’s been a wild and crazy journey and I always “try” to look for the positives in my life and the people I care about… I’m not the type to dwell on negatives and I stay away from negative people as I have no use for them which brings me back to attitude… Yes, I believe we choose our attitude as Charles Swindoll said. One can google his quote about attitude if you never heard of it.
Wow, 11 years well and the sunrises are just as beautiful as they were back then except I didn’t notice them when I was sick. I was too involved with just being sick.
I’m a bit late in blogging about being well for 11 years now from chronic lyme. Been very busy and not spending much time on the computer..
For those who are reading this page first I became well using Dr. Jernigan’s protocol from his book “Beating Lyme Disease”… I still continue to detox (detox baths, dry skin brushing, internal cleansing such as a gallbladder liver cleanse that I do ~ instructions are on my blog, etc.). I will probably detox for life! I believe that we live in a toxic world and by detoxing it keeps me healthy..
My advice to others would be if you don’t feel better in a couple of months on your current protocol then it’s time to look into other protocols. What works for one may not work for another..
I suggest reading books such as Stephen Buhner, Dr. David Jernigan, etc. to learn more about this disease. There is a new book out that I haven’t read yet by Connie Strasheim called “New Paradigms in Lyme Disease Treatment” and Dr. Jernigan is in this book as well as 9 other doctors..
There are also free video’s as well as articles on the Internet thus avail this to yourself as you never know what you may learn! Go to youtube and search Hansa Center and you find many free videos that can help you..
Become your own advocate: all it takes is some researching on your own. I don’t believe anyone should suffer while trying to get better as there are better ways to get better without suffering! Yes, I am proof of that. You don’t have to suffer a herx (which really translates that you are full of toxins).
Detoxing should not feel good when one first starts as it’s a cumulative effect. The more you detox the better you will feel, yes, I promise you that. Don’t give up after the first few detox baths, you are ridding your body of toxins so of course it’s not going to feel great.
Stress is another factor in healing. Find out what causes you the most stress and find a way to lower it if you can. We all have stress in our lives and sometimes it’s worth it to find a counselor and talk to them about your problems.
Look for those sunrises and sunsets, they are there waiting for you just as the beauty of nature is. Take a moment and enjoy watching birds fly or even enjoy the beauty of a flower blooming! If you look hard enough you can find beauty in almost anything.. Yes, even those snowflakes landing on my face can bring about a smile. I guess it’s those little things in life that give me pleasure.
Yes it’s been 10 years for me that I have been healed from chronic lyme, woo-hooooo!! I’m sure that I have been bit by ticks as well as other vectors that carry lyme bacteria but I never became sick. I think I know the answer as to why which is I learned so much when I was sick that I incorporated all those tools into my everyday life.
Tools? My box of tools consist of detoxing as much as I can (I don’t detox everyday), dry skin brushing, exercise, eating as healthy as I can afford to, keeping my stress levels down which is not always easy as life is full of surprises many of them unpleasant and some we have no control over..
Yes, it’s January 7, 2016 and I must admit I am worried about my Mom who recently turned 90 and is suffering from high blood pressure, showing signs of early dementia. I am not ready to lose her and I wish I didn’t live 6 hours away from my Mom but I try to visit her as much as I can. So I am feeling stress from that…
On the bright side of the coin I am feeling really good physically and mentally, been on a diet (low carb), learning new recipes to keep my immune system strong and this past weekend I made fermented sauerkraut for the first time! I have to wait at least 7 days before I can refrigerate the canning jars. I am really curious to what my creation will taste like!
I feel lucky that there is a farmers market in town where I buy organic veggies so I know I am eating healthy and not GMO foods. I can’t afford to buy 100% organic so I do the best I can with what I have.
I really don’t have much to say about chronic lyme except it was a nightmare when I was living it but I learned so much from being sick that it turned my life around for the better and may it be the same with you! Learn as much as you can, watch the free online videos from reputable doctors who explain how the body works, yes, there is a wealth of information out there! One just needs to know where to look..
Wow, 11 years well and the sunrises are just as beautiful as they were back then except I didn’t notice them when I was sick. I was too involved with just being sick.
deejavu views 