FDA’s own employees are starting to question the agency’s reckless drug approval process.
In 1998, the FDA approved a new class of anti-inflammatory drugs called TNF-alpha blockers. The best-known drugs in this class are Enbrel and Humira, which are used to treat juvenile rheumatoid arthritis, Crohn’s disease, and other inflammatory diseases. Because TNF-alpha blockers are immunosuppressants, patients are at increased risk of developing serious infections that may lead to hospitalization or death due to bacterial, mycobacterial, fungal, viral, parasitic, and other opportunistic pathogens.
In 2008, 2009, and 2011, the FDA determined that these drugs increase the risk of different—but all potentially fatal—infections and cancers, including tuberculosis and childhood leukemia:
- In 2008, the FDA ordered makers of TNF-alpha blockers to carry black box warnings for the risk for histoplasmosis and other invasive fungal infections.
- In 2009, the FDA confirmed that TNF-alpha blockers cause cancer in adolescents and children. They required an additional black box warning.
- In 2011, TNF-alpha blockers received yet another black box warning for serious, and sometimes fatal, infections from two bacterial pathogens, legionella and listeria.
- Enbrel (which is genetically engineered in a process that involves the cells of Chinese hamsters) carries black box warnings for serious and sometimes fatal fungal infections; risk of serious and sometimes fatal TB infections; and risk of lymphoma and other cancers in children and teenagers.
- A child with Chrohn’s disease or ulcerative colitis is already in deep trouble. Giving these drugs just makes the situation infinitely worse, even threatening rapid death.
- Although the black box warnings refer to children and adolescents, the drugs are used for adults and have resulted in adult deaths as well.
Despite all their well-documented dangers, as of 2013, TNF blockers remain on the market. The FDA has simply asked manufacturers of TNF blockers to let them know when someone got cancer—essentially taking a “wait and see” approach to a drug that has caused at least thirty-five deaths from cancer, at least fourteen deaths from Legionnaire’s Disease, and at least seven deaths from listeria infections. Over fifty people have died, and the FDA is still at the “information-gathering” stage.
Moreover, there are reasons to believe the number of such deaths is greatly underreported. ANH-USA staff know of two such deaths among our own friends and doubt that these deaths were reported in this category.
In recent years, FDA has accelerated its rubber-stamping of dangerous drugs. This issue has become so serious it has caused internal strife at the agency. In particular, one FDA official, Thomas A. Marciniak, is seeking stronger warnings about a different class of drugs—angiotensin receptor blockers, or ARBs—in direct conflict with his bosses. The drugs, which are taken by millions of people (and generated $7.6 billion in US sales in 2012), have been linked to higher cancer rates, Dr. Marciniak argues. While this view is shared by other independent doctors, top FDA officials say the evidence is not yet clear.
Critics say the drug safety agency devotes so much attention to new drugs that it is ignoring the safety of long-marketed blockbusters. If a drug is profitable, the FDA seems to turn a blind eye to its dangers.
For example: the FDA recently approved a drug that cuts “bad” (LDL) cholesterol, even though it does nothing to reduce the risk of heart disease or death. The new drug takes Lipitor, which lost patent protection in 2011, and combines it with a new ingredient; this new combination is patentable (which is clearly an attempt by Pfizer to recapture Lipitor’s blockbuster sales). After initially rejecting the new drug last year, the FDA approved it because, as they put it, “LDL is a known risk factor for heart disease.” But again, this drug does nothing to reduce the risk of heart disease. Even cardiologists are questioning the logic of this approval.
Keep in in mind also, as we have pointed out, that so-called “bad” cholesterol is also a vital part of our body, one which we absolutely need. If it gets too low, it leads to numerous complications and even hasten death.
Why doesn’t the FDA pull deadly drugs like TNF blockers from the market? As illustrated by the FDA’s arbitrary hearings on Avandia that we told you about last month, they could just be trying to save face and avoid accountability.
At the same time, the US is experiencing a major drug shortage. The American Society of Health-System Pharmacists (ASHP), which keeps a drug shortage database, tracked a total of 211 drug shortages in 2010 alone. (By comparison, they identified 224 drug shortages between January 1996 to June 2002—an average of only 34 per year.) The main reason for the shortages is that drug companies are more and more required to get FDA approval for any operating step, no matter how trivial or unrelated to health. The shortages, in turn, can be used as a specious excuse to put more and more pharmaceutical drugs, many of them dangerous, on the fast track to approval, despite the complete lack of connection.
What the FDA and conventional physicians never seem to consider is a more natural approach. In the case of systemic inflammation—which underlies a host of health conditions like diabetes, high blood pressure, sleep apnea, asthma, and many other conditions—there are natural treatments that should be explored instead of TNF-alpha blockers, including:
- An abundance of Omega-3 fatty acids, particularly from fish oils;
- Optimized levels of vitamin D, either from direct sunlight or careful supplementation;
- A healthy diet full of anti-inflammatory foods like turmeric, ginger, shiitake mushrooms, green tea, and rosemary, while avoiding pro-inflammatory items like trans fats, fried foods, and grains;
- Supplements like probiotics, boswellia, bromelein, resveratrol, the ursolic acid in Holy Basil (also called tulsi), and other substances targeted at bowel problems; and
- Stable insulin levels, regular exercise, and a normal waist size (see last week’s article on obesity).
Why, then, does the FDA continue to approve (and doctors continue to prescribe) drugs that can cause tuberculosis and leukemia, when herbs, natural treatments, and lifestyle modification will address patients’ health problems more effectively, more safely, and far less expensively?
The FDA has apparently become the Federal Death Administration.
The ‘Revolving Door’, greed, and corruption facilitate approval of inadequately tested and dangerous drugs.
Our bodies are undernourished, overfed and poisoned from too many chemicals and the environment.We are losing the health of our people. No matter how many Ipods, cars or clothes we buy we can never make up for that.
With the genetically engineered medicines now flooding the market place in an attempt to keep people sick now is the time to stop the crimes in there tracks.
Sadly, it’s all about the money… just like when the FDA removed Cylert from the market. .. claiming “it was due to (fewer ) deaths… and definatley did not contribute to fatal diseases, other than, Liver Disease… knowing all the while that newer, more costly ADHD medications, like Straterra, Vivance, etc. were going throught the research stage and was about to be launched into the market.
Just sayin’
Thanks for watching out for us FDA!! Ha!! Getting paid real good on this one. Huh!?
The FDA cares nothing for our health. They are completely in the pockets of Big Pharma.
On another note, in your section about natural remedies for treating inflammation and related diseases you neglected to mention cannabis, an herb which is loaded with anti-inflammatory compounds known as cannabinoids (which also have other medically beneficial effects, such as anticarcinogenic and antioxidant). Cannabis is known to help people with many if not all of the conditions you mentioned (such as Crohn’s and ulcerative colitis), without all the nasty side effects of other medications commonly prescribed for them. The US Government even has a patent on the use of cannabinoids as neuroprotectants and anti-inflammatories. Cannabis users have also been demonstrated by studies to have smaller waists and improved blood sugar control over nonusers (both mentioned in your last bullet point).
Note that for medicinal and anti-inflammatory use it is important that it not be smoked (which is pro-inflammatory), but rather vaporized or consumed orally instead.
well put !
Hi ANH,
You write:
•An abundance of Omega-3 fatty acids, particularly from fish oils;
•Optimized levels of vitamin D, either from direct sunlight or careful supplementation;
•A healthy diet full of anti-inflammatory foods like turmeric, ginger, shiitake mushrooms, green tea, and rosemary, while avoiding pro-inflammatory items like trans fats, fried foods, and grains;
•Supplements like probiotics, boswellia, bromelein, resveratrol, the ursolic acid in Holy Basil (also called tulsi), and other substances targeted at bowel problems; and
•Stable insulin levels, regular exercise, and a normal waist size (see last week’s article on obesity).
Non manufactured herbals and exercise work well for many sufferers of immunological conditions, but people with RA often suffer such excruciating pain plus joint destruction that their suffering and destruction can only be controlled by access to DMARDs/TNF blockers.
Also, today a lot of curcumin is sold in health stores that will not pass the blood brain barrier—the only kind that is biologically available is liposomal curcumin. Using Turmeric (powdered curcumin) in cooking is healthful but it won’t do much for active and already destructive RA.
Liposomal or phytosomal curcumin can be purchased online.
I wish to add that I have been a victim of RA for over thirty years.
I find that bioavailable curcumin does help, but it has emerged for sale only recently.
Please be your own advocate if you use the embrel, etc. My friend’s husband used these drugs for his RA. He died with three cancers caused by this drug.You must be proactive and make sure your Dr. is monitoring your blood levels, liver and other safe guards. Ask for a copy of your tests and have the Dr.go over the meaning of your tests with you. If he/she puts you off or gets defensive or does not explain the tests with a sensible conversation, get another doctor. You know your body better than anyone. Take note of changes in your health. Read and know all side effects of the meds you are on. Our son died at 17 yrs old. from side effec ts of Depakote. We learned this lesson the hard way.
First, the FDA is owned by the corporations they are supposed to be regulating! The FDA is not doing the job which it is tasked to do! The Republicans have cut the budget so the top 1% can keep raking in the $’s. They (1%’s) own the companies that the FDA is supposed to be regulating! The biggest threat to this Nation is not terrorists; it is GREED and the worship of MONEY! Until the citizens of this Nation wake up and realize they are being duped by the Republicans’ agenda, nothing will change. How can a country survive without believing in FACTS, EDUCATION, SCIENCE and HEALTH? I am agitated with the Government, but I’m more aggravated with the idiots that put them in office in the first place!
Because they are beholden to Big pHarma.
As I have said many times these obscene approvals are bought and paid for with the side benefit of shortening life spans of humans. As we go down we will make the medical industrial complex very rich. Only the well educated will survive the medical system. Sheeple will die younger.
And in the meantime, the FDA refused to ok cannabis, yet not 1 single death!
That’s right,the FDA and Big Pharma don’t want to see anything except $Dollar Signs$. They don’t care about us and I’ll bet when the executives of these 2 big corporations get cancer or other life threatening diseases ,they don’t take these drugs either !! Medical Marijuana helps cure more illnesses and helps with other conditions and there has never been a death or any side effects from it EVER ! Lots of people use it, so keeping it illegal doesn’t make it go away,how about doing more research on Marijuana instead of waiting for more people to get sicker and die ! I have several auto immune diseases that these drugs supposedly would “help” me , but I’m not willing to take a chance with my life on any of the biologicals !
Because it has never been, and is not now, about health, prevention or curing disease. It is about making profit by treating disease. A paradigm that is heavily invested in keeping people sick. It is immoral, unethical and criminal,and should be treated as such.
I do not believe the culture at the FDA can be changed they have a very long history of very poor decisions that seem to be based on what big pharma and a misguided medical system wants and large food processors want.
As to me I think the FDA needs to be dismantled and done away with. As an a side in casual one on one conversations I can not find a sole that has an use for the federal government at any level.
Why do doctors continue to prescribe these monstrous drugs? I’ll tell you why, because the state’s licensing board sends them literature that purports to suggest that there is science behind these drugs. Those MDs are basically saluting the authorities that grant their their license.
And why do the state licensing boards send out this literature? Because an organization called the Federation of State Licensing Boards sent it to the state’s board and that board fails to see that the pompous sounding federation is not anything but a drug industry front that gets its money for those literature operations from drug companies. The Federation has no high authority under law nor academia nor any other granter of authority. it’s a drug industry fraud, using the mindless bureaucracy as its insertion point for propaganda that then has the power of threat of violent removal of licenses added to the fraud.
To be fair, even aspirin can kill you and no one is talking about taking it off the market. I do see the reason to be cautious with these medications and I question as to whether they should be used on children. For adults however, as long as they know the risks then they should be allowed to take it. Every commercial I see has these warnings so it can hardly be said that the consumers are ignorant about this. While diet and herbs may work for some people, they may not work for everyone. For people who have an immune system disorder that is seriously affecting their quality of life then these medications might be their only option. It always comes down to the risk/benefit ratio. Adults should be allowed to make an informed decision as to whether to take these medications.
One more thing I will mention. Your information that says that these warnings are given only for children is inaccurate. Every time I see one of these commercials they give the warnings and their is no caveat that it applies only to children.
After being severely injured by a Flouroquinolone Antibiotic….CNS PNS, AUTONOMIC Nervous system, Tendons, GI, Liver, Vision, and Mobility Wheelchair and crutches for over 1.5 years…to a cane….and endless rehab…Excruciating torture from stabbing, cutting, nerve pain….All Compliments of THE FDA’s willingness to line their pockets and Big Pharma their Pimp to Knowingly profit off of the torture of innocent people. For 20 years the horror of this class of drugs has ravaged 100’s of thousands of lives…..some gradually, slowly after a few bottles over many years. Others like myself just a few tablets over 24hrs for a minor infection….The wicked ways of the FDA are equal to the rest of the Sadam Husseins, khomeni’s, Quadafi”s, Dictators that profit off the suffering of others knowingly. So this is another USELESS drug pimped out l like any dirty back alley drug but far more dangereous…..
If doctors would learn about nutrition on their own instead of being obnoxious takers (not all but many), they would teach their patients about GAPS or SCD protocols that will take the need for these meds off the table.
There was a doctor in the early 1900s who found out from trial and error that 3 lbs. of organic fresh fruit will get rid of TB faster than any med out there. I’m sure it still works.
My mother took Enbryl for about 3 years (she would give herself an injection into her thigh), and then Remicade – two hour infusion done at the Seattle Arthritus Clinic. These are two of the biggest money makers for RA. My mother developed a brain tumor after taking Enbryl, loss of CNS function and then MS / ALS symptoms while on Remicade. The doctors ingnored all the warning signs – every one of them! They just kept pumping these harmful drugs into her system, even when she was in a wheel chair, disabled and couldn’t speak for herself.
And then when her health was so bad and her body was so diabilitated by these harmful meds – sorry…we don’t know what’s wrong with your mother….they had the hospice henchmen come in and take her out with morphine.
I am outraged that these drugs are still on the market.
Remicade worked for me for 4 years, but the infusions at the hospital took 5 hours!!
I had bad side effects after the last 2 infusions. When I asked one of the nurses about side effects I was having, she said (insightfully), “Your body doesn’t like this stuff!” I decided to quit Remicade. My rheuma doc exploded at me when I told him. After stating all the bad things that could happen to me for quitting, he ended up by saying that a Dutch study showed that one could be off it for a year with no bad side effects. My thought: Why didn’t he say that first??? He yelled at me so loud the office could hear him.
I quit this doc, now have another one. After 9 months the RA effects returned. At first I didn’t want any more big pharma infusions, but the only option absent DMARDs was prednisone and later steroid injections (kenalog). I saw that I was losing hair, a side effect of steroids. (No wonder so many athletes shave their heads?)
Finally I had to go back on a DMARD, Actemra. So far so good after the first 2 infusions. AND it only takes one and a half hours.
I tried out an off-label therapy (caps not injections) called Low Dose Naltrexone (LDN). It didn’t help me. A bio-scientist at Stanford is doing research on LDN re: MS. Nobody is researching its use with RA, possibly because they all know it doesn’t work for RA.
Now I make my political insight statement: why hasn’t any significant research on RA, especially gene replacement therapy research, reached a critical mass? I suspect it is because big pharma pays for most of the medical treatment research for immune. conditions, and they are making huge profits by charging outrageous prices for DMARDs. As long as they get away with that, the major research will not be done.
I agree with all the negative views on this page about the FDA and big pharma. Guess what folks? It is partly our fault, for continuing to elect bozos to Congress who get away with fat payments by the pharma lobbies.
My son was 19 when his GI doctor gave him Remicaide for Crohn’s disease and he was 20 when he was diagnosed with a fatal form of acute lymphocytic leukemia. The doctors told us his disease was 100% fatal and his only hope was a bone marrow transplant. We were very lucky that his sister was a perfect match for him. He escaped the fate of so many others who have taken these killer drugs. In the years since my son’s ordeal I have come to realize that most of the chronic diseases we suffer from are related to nutritional deficiencies and I would never turn to such poisons ever again. What I have been waiting for is the class action lawsuit to be announced.
This is a terribly tragic story. Thank you for the courage to share. I experienced the ‘beginnings’ of what immune-suppressing drugs did to me, and after a year, said No More. My condition persists but I have improved it over time with anti-inflammatory diet and supplements.
Lauren,
After your mother was diagnosed and the money-making drugs were being routinely used, it is very likely that the doc ever spent enough time with her to see problems ……. she was part of the routine ….. he was going to spend his time trying to make money from new patients …… the love of money has corrupted every institution in this country …… it is corrupt from the Supreme Court down to the local mqgistrate …
My friend has leukemia and I would like to help her. Thank you. Jane Goebel
It’s amazing that we have such credible evidence that causes so much havoc to our health and all we can do is provide warnings which seems to have .little effect on having these drugs removed. What will it take when we have a voice that matters and actually an affect on decisions made by the FDA. I don’t want my children reading these warnings while the FDA continues with their body count still trying to determine whether this drug is safe.
We would ALL choose a riskier or more expensive drug over an ineffective one and would fight any outsider who would ban it.
I use the ARB losartan and previously used valsartan. Physicians no longer doubt that they reduce strokes beyond what one would expect from reduction in blood pressure.
The claim that ARBs increase cancer risk is serial repetition of a poorly-designed and debunked study. Would I consume a dangerous ARB just to argue here? Is it not more likely that those who cry conspiracy are showing ignorance?
ARBs do not reduce non-infarct dementias. Centrally-acting (i.e. lipid soluble) ACE inhibitors do but are not effective against stroke. The choice depends on one’s personal risk.
I tried the direct renin inhibitor aliskirin which had strong theoretical support buttressed by in-vitro, animal and human trials. Clinical physicians eventually found patients who experience more rapid carotid intima thickening and more rapid plaque formation with aliskirin than without. The synergistic benefit of aliskirin combined with an ARB was obvious in controlled trials but disappeared with a less stratified population. Diabetics who benefitted independently from aliskirin and ARBs declined faster when prescribed the combination.
Diabetics with renal disease benefit from ACE inhibitors or ARBs but on the average do worse with both.
There was similar support for an aldosterone receptor blocker plus an ACE inhibitor or ARB. The combined side effects outweighed the combined benefits EXCEPT for post-coronary patients who were progressing into heart failure.
None of the experts (research or clinical) expected those results so it is unfair to expect the FDA (mostly attorneys and bureaucrats) to do so.
Those without hypertension can bloviate about lifestyle changes. I tried supplements, aerobics, weight loss, DASH, calorie restriction and vegan. Each was good for 5-10 points but faded to an even higher baseline.
The right drug combination (losartan plus chlorthalidone) has worked for years and is good for 30-50 points depending on how much hidden salt I consumed the day before. My health insurance covers it for about $1 per month. The pharmaceutical industry DOES compete with the supplement industry and sometimes it deserves to win.
With respect to ARB (angiotensin reuptake blockers) my husband was on Micardis for over 8 years, mostly for his blood pressure, along with another drug. He also had an abdominal artery aneurysm (AAA) with a penetrating ulcer sitting on top of it. After about 8 years, an obscure article came to my attention: the FDA found that Searle, which patented Micardis, had hidden facts regarding the drug, pertaining to undesirable side effects. Mainly, these were that mice given the drug developed cancer after being on it for longer than 4 years. No such warning was publicized to patients. I immediately notified his doctor and sent him the article, which was reprinted from the New England Journal of Medicine.
Specifically, prostate cancer and lung cancer were mentioned. My husband had already developed
prostate cancer and was being treated for it. The doctor who originally prescribed Micardis was out of
practice by then, and his new doctor found a non-ARB substitute medication.
However, there were a plethora of medications that could have been given to him at the onset, but
‘detail’ persons work for the drug companies to steer doctors in the direction of their company’s drugs, why else?
Allopathic medicine today is simply this: if you have a patient with a problem, make an effort to ID it, then consult the PDR or the latest handout by the detail person, if applicable, and prescribe the
newest member of the drug family, no matter how expensive or effective. Medicine now is no more
than sympton control, not cure. I was in the medical field for over 25 years and things really have
changed since I was working. As long as all medicine is drug based, we will rarely see ‘cures’, only
symptom control.
Be very careful how you question federal agency processes. In this country whistle blowers are labeled traitors and force to leave the country to avoid prosecution. Remember when this was a country to be proud of? We didn’t start preemptive wars, we didn’t torture suspects or incarcerate citizens & foreigners in makeshift torture facilities. Remember when whistleblowers were called heroes? Remember when we didn’t have roving bands of jackbooted thugs dressed in black who killed every type of suspect we know of? America used to be a country where the citizens could be proud! Pardon my discourteous and uncivil diatribe. I hope for something better!
why does the FDA continue to support drug companies, and refuses to support natural herbs and healthy remedies for people with health problems? Simple, because they’re in the pockets of big Pharma and Monsanto, and that’s where the money is.
You must be joking, asking why. It is obvious they are being bribed by the drug companies. There are millions of dollars of profits that are involved. They might go as far as to say, we will look into the deaths that are occurring, and when our attorneys feel that the law suits and bribes will cost us more than our profits, we will “discover” that the product should be withdrawn from the market.
What is the reasoning behind allowing Enbrel alpha blockers to be used when the evidence of the harm they cause is overwhelming?
Like Fred Jeffries says, in some cases they help, but I wonder if Fred and many others were notified of any other alternatives other than Drugs…Drugs are PUSHED upon us before anything else is recommended to even be tried.
Alliance for Natural Health, if you are so passionate about educating the public about current issues of health, why do you not have a response mechanism so we can contact appropriate parties who have the clout to effect positive change? Simply providing a forum for readers to share their constructive thoughts and criticisms among themselves excludes a stronger mission statement that could include concrete action.
Give us companies, specific names, and addresses so we can write, call and in various ways, make a difference. Talk should not be an end in itself.
Hi William–Thank you for your comment. Many of our articles provide an opportunity for action: mostly petitions to Congressional representatives and other decision-makers. For example, I encourage you to view our other article this week, which features an Action Alert to the FDA: http://www.anh-usa.org/government-against-farmers/ Best, ANH-USA
My original comment disappeared when my reply went up. Here is what I wrote:
Hi ANH,
You write:
•An abundance of Omega-3 fatty acids, particularly from fish oils; •Optimized levels of vitamin D, either from direct sunlight or careful supplementation; •A healthy diet full of anti-inflammatory foods like turmeric, ginger, shiitake mushrooms, green tea, and rosemary, while avoiding pro-inflammatory items like trans fats, fried foods, and grains; •Supplements like probiotics, boswellia, bromelein, resveratrol, the ursolic acid in Holy Basil (also called tulsi), and other substances targeted at bowel problems; and •Stable insulin levels, regular exercise, and a normal waist size (see last week’s article on obesity).
Non manufactured herbals and exercise work well for many sufferers of immunological conditions, but people with RA often suffer such excruciating pain plus joint destruction that their suffering and destruction can only be controlled by access to DMARDs/TNF blockers.
Also, today a lot of curcumin is sold in health stores that will not pass the blood brain barrier—the only kind that is biologically available is liposomal curcumin. Using Turmeric (powdered curcumin) in cooking is healthful but it won’t do much for active and already destructive RA.
Liposomal or phytosomal curcumin can be purchased online.
I wish to add that I have been a victim of RA for over thirty years.
I find that bioavailable curcumin does help, but it has emerged for sale only recently.
Hi Jo, you are correct right to the point, it’s seemed you know a lots. But for RA and certain Sciatic nerve condition, I have been treating my family members and friends with a family secrete herbal for at least 15 years. It’s ingredients cost about $200.00 plus 16 hours to make them for 2 weeks use . 3 days, it stops the pain, 2 weeks RA and Sciatic are gone. All of people I had helped, none has any recurrent ! Since it take too many hour to make, I seldom do that unless some one I knew.
FDA was formed to protect us from corrupt businesses that might use poisonous ingredients. In order to protect us the FDA created an epidemic of regulations, and the payment of huge fees for the approval process, about $530 million. A process where you do your own testing and tell the FDA that your product is safe. This boneheaded policy brought the FDA under the control of corrupt business monies and power and back to exactly were we were before the FDA was created, corrupt businesses selling us poisonous products!
And why should the Food and Drug Administration and Health and Human Services who control them, care if the population is poisoned? Yes, why care, when they and corporate medicine are the very beneficiary of the sick people that they are creating via the poisons they allow, Gad, what deadly bureaucratic insanity this is.
Doc Blake
Natural approach to health is
1. Have animal fats with low omega-6
2.Level of vitamin D3 is more than 125 µmol/L (>50 ng/ml)
3.Low and stable insulin levels from low (less than 100 g/day) carbohydrate intake.
So eat natural food, skip grain based food and sugar based food.
It’s as simple as that
“So eat natural food, skip grain based food and sugar based food.
It’s as simple as that”?!
Nothing is simple with disease. These recommendations are great for maintaining good health, but if you have serious conditions and already-compromised immune systems, some stronger therapy is essential. One of the reasons I avoid health food websites is simpleton views like these, especially from people not trained in health care.
The FDA is not given to protect the citizens of USA ,but to further the interests and profits of the drug companies . Senator Durban is a puppet for the FDA which has no congressional oversight . The fox is protecting the hen house .
This is obviously written by someone who has never had any requirement for any of these drugs. To point to omega oils and nutrition and claim it can resolve serious medical conditions is disingenuous at best and dangerous at worse.
How about all of the patients treated with these tnf meds that have no adverse reactions and a vast improved quality of life? You know, the ones that constitute the majority of recipient patients.
While understanding the risks and being aware of the numbers are important when assessing treatment options, articles which present a biased perspective are scaremongering and unhelpful to anyone.
For shame.
I very much agree with you. I was diagnosed with MS in 1995 & took disease modifying drugs such as Avonex, Betaserone, & Copaxone. I was told of the risks & when the drug Tasabri came out my neurologist wanted me to consider switching but I felt the risks associated with the drug were too high – my MS is currently in a long period of remission. Yes, some times the FDA rushes through an approval & sometimes pharmacuetical companies hide data that is damning – and they should be held criminally accountable in these situations – but this site is often as misleading as well. Yes, people should lead healthier life styles & use medications sparingly, but I find a fair amout of reporting on this site to be nothing more than fear mongoring. They advocate for natural remedies that carry risks as well – sun exposure carries cumulative risk for melanoma, grounding (going shoeless out doors carries the risk of dangerous paracitic born diseases, and vitamin supplementation can actually kill you.I read many of the studies they post links to & have found that more often than not, they’ve cherry picked what they’ve chosen to include in the body of their article. I’m an RN (Masters) & have worked in the medical field over 30 years, so I know how to read research studies & I feel this site uses a great deal of “interperative license” in their parsing of the data.
I have been following the protocol in the book “Inflammation Nation” for 8 years now. When diagnosed with RA in 2005 the VA put me on 4 drugs that were toxic enough to get liver enzyme checks every month. After 5 months they called and asked if I was bleeding internally! After all the research and finding this book by accident in the airport, I decided to take my health into my own hands. Part of the protocol is a certain fat ratio involving fish oil and borage seed oil. My RF blood work has dropped for 115 to 37 and my walker is in the basement! NO meds are taken!
Do you work for either the drug companies or the FDA? Just look at the obituaries – people are dying younger all the time – The drug companies are getting rich and people are only temporarily seemingly better. Guess the infatuation with prescription drugs will solve the issue of SS insolvency.
I am one of many people here in the U.K. that are on Enbrel. This particular Ant-TNF has been a life changing experience for the better to me. I have suffered Ankylosing Spondylitis (A.S.) for 54 years. I have had every available treatment for my A.S. including radiotherapy (a treatment no longer used on A.S. patients due to it’s high risk of causing Cancer). I have had major .spinal surgery and double hip replacement. I have been swallowing Non Steroid Anti-Inflammatory drugs (NSAIDs) for 50 years. All the above treatments have their own risks. So I try to balance the risk against any benefit I get from the treatments I take. So as I said at the start of this Enbrel has been a life changing experience for the better for me. It may well shorten my life but the way I see it I will go for quality rather than quantity every time.
Dear Fred:
You wrote of all the terrible substances that you have been taking into your poor abused body for many many years…. so at this point in time, you might as well take the Enbrel if it temporarily “makes you feel better”. You really have little to lose, although that is perhaps a fatalistic thought for me to have.
.
Sometimes people, who started out with a relatively small complaint, are put onto the track of “meds” by the “doctor” they went to for help, and then they are prescribed more “meds” for the effects on their bodies created by the first prescription….. and then more pain, dysfunction and loss of quality of life ensues, so back they go for more “help”.,…… and different “meds” are handed out……….
.
And so it goes….. You appear to be “The Poster Boy” for that scenario.
.
Many people believe that it is never “too late” for the human body to heal if it is given a break from the toxic chemicals, and provided with the nutrition and healing substances needed. But I have seen literally hundreds of people whose minds and hearts are controlled by resignation, depression and their “addiction” to the drugs that they have been depending on for a miracle for many years. They will NOT change their “belief system” and they will continue to look to Big Pharma and the pusher (doctor) they trust, and they WILL continue to go from the drug they are currently on…… to another one and trust that the new one will make the miracle for them….
.
So, my fellow human being. You ARE the master of your own ship…… even if you steer away from the wind & waves instead of INTO them.
I couldn’t agree more! These prescribed drugs are killing people!
To answer your question about why the FDA continues to fast track things and continue to keep harmful drugs in the market – because it is $ profitable$ and the general public does not know the harm – they are trusting of the “expert” doctor who is also paid to prescribe.
this post is right as rain.!!! the Phy.compines will send Dr’samples of their medicene and give the dr’s an incintive to prescribe their medicne..The dr’s will prescribe the medicine, and they they will prescribe another to the people and he will keep getting kickbacks. he could wind up with more money than you would think..In other words try and not take medicen at all. Try herbs first and then go back to medicen..I tell you this.A Dr will kill you, he sure don’t want you well..
PLEASE ADD METOPROLO TO THE LIST!!!!!! It nearly flat out killed me and caused disability in my arms!!! I couldn’t load or load dishwasher, washer, dryer or hang up clothes……the list goes on. I cried so much and woke up in the nights with them. It’s such a long story no one knew what was wrong. I stayed in the hosp with a 150 pulse for a week. Things kept progressing. A dr took me off of it and put me on another pill. It’s all gone, except a weakiness of my heart fluttering every once in a while. My Psychciatrist started having similar symptoms and he was on this pill. I told him of my situattion and he kept saying metoprolo doesn’t cause these symptoms. I told him if he wanted to continue to believe that then continue to keep suffering and watch them escalate like mine did.
TNF can be dangerous and do have warnings, but physicians weigh the risks against the benefits. When you are in such sever pain that you don’t have any quality to your life, then the risks from TNFs are worth it.
To anyone suffering Ankylosing Spondylitis, and to Mark and Fred in particular,
I was diagnosed with AS in the 90’s, but have suffered from it since my 20’s, I am now 48. I am living proof that AS can be absolutely reversed by wholesome nutrition, yes, omega oils AND nutrition.
I was offered Enbrel by the doctor who diagnosed me, I turned down that option and chose to heal it naturally. An MRI at the time showed fused vertebrae in my neck, mid-back, and lower spine and severe inflammation in the pelvis (sacroiliac joints). I have been on a Nutritional Balancing and Hair Mineral Analysis program for the past year and a half.
3 weeks ago my chiropractor, whom I have been seeing weekly for about the same length of time, while treating me, was amazed to find my spine is suddenly moving in ways he never thought would be possible. While he was moving my spine there was an incredible “release” involving the vertebrae of my thoracic region, all the way up into the base of my skull.. My chiropractor is very excited about this and now believes my AS is actively reversing. I am feeling more mobility in my back and neck than I have in years.
So I know for a fact, from living experience, that a program involving detoxification and eating whole, organic foods, can reverse AS.
The problem is that we have become to programmed to believe in the “quick-fix” mentality of pharmaceuticals. I ask you, how can a medicine that is going to cripple your immune system be good for you? Really, are we that far gone as a public that we have lost the ability for critical thinking?
I urge anyone suffering from AS and auto-immune diseases to look into healing it naturally. The reason the immune system is attacking the body’s tissue is that the body is trying to fight off toxins and/or bacteria, suppressing the immune system makes no sense!
I wish for those of you out there suffering from these diseases to have the faith and courage to look beyond Western medicine, as it’s goal is not to heal you, it is about profit, would you put your life in the hands of those motivated by money? Blessings to you all.
50 deaths? That’s small potatoes, collateral damage, to the FDA and industry. 10,000+ per year die from Non-steroid anti-inflammatory drugs.
A recent study determined that Vioxx caused 140,000 people to die from heart attack & stroke during the years it was on the market.
Those who keep asking why these drugs are used need to listen to the people who have commented here who actually have rheumatoid arthritis and actually have been using and benefiting from Enbrel. It seems to me that some of you are shouting these commenters down, or simply refusing to pay attention to them, and yet they are the ones who most deserve your attention on this subject. I would hate to defend the pharmaceutical industry or the FDA, but sometimes a drug that carries certain risks is the best choice for a given patient. Until you are faced with the disease yourself, please do not judge a person’s choice.
I wish you could see the difference a patient of mine has had with a newer biologic RA drug. She had already changed her diet drastically, kept up taking supplements, and done acupuncture persistently with me. This drug transformed her life. She is still taking excellent care of herself and getting acupuncture in addition to the drug, but we just could not have seen this difference otherwise. She had many years of experience as an RA patient and had been the block quite a few times, and let me tell you, she was making an informed choice, not being pushed into anything by Big Pharma. If she could have done it without the drug, she would have.
It is not accurate to say that Enbrel or any other drug “causes” TB, listeria, or other infections. What they do is suppress the immune system so that infections are more likely and can be much worse. The pathogens still have to be there to create the infection. Fuzzy thinking does not serve the cause of making FDA do a better job or pushing manufacturers to act more responsibly.
We are thankful for these meds The one shown (Enbrel) sadly no longer works. Our child has had to move on to Orencia and it seems to be doing the job. This is a child that spent half a year bedridden and the following school year taking classes online, that is when she could sit upright long enough or concentrate through the pain.
I’d love it if there were equally effective natural alternatives, but (if we can be honest) there are none. (and again, I mean EQUALLY effective).
While I would never personally take a drug like Enbrel I have seen it give a new lease on life for a cousin of mine. She has experienced health issues since her late teens and by all rights should not even be here in her early 60’s. I’ve used a natural approach to maintain my health and have overcome many health issues. I have declined to use several recommended medications over the years and some I used for a brief while before finding a natural alternative. Medicine at best practice is a decision of risk vs benefits between a patient and their Physician. All drugs have a potential danger and a drug that is one persons miracle maybe anothers death sentence. Untill we wake up and focus on preventing disease there will always be Big Pharma ready to make money. No one is being forced to take any drug.
A corrupt FDA protected by the corporations that control it combined with a willfully ignorant public, who are obsessed with entertainment and read less than one book a year means it will only get worse.
While I do agree with most of what was said, I have to say that with any immune suppressive drug there are chances of nasty side effects. I do not think Enbrel should be pulled, but I do think it should carry notices of risks. I have a friend doing well on Enbrel for psoriatic arthritis. I am betting that Phil Mickelson won’t give it up either. One of its dangers is Thrombocytopenia, or low platelet count, and that can be permanent if drug not removed asap. However, most oncologists are monitoring labs and so most are careful. I remember when Methotrexate was, and is, used for psoriasis. Some do very well, but a few will develop a leukemia, which can be treated if the med is removed. Virtually nothing is free of side effects. Nothing. From personal experience, I found out I am allergic to ACE inhibitors, and all blockers. That’s me. I have friends on them, and they don’t have any problem. Let’s not throw the baby out with the bathwater. If the percentages of serious side effects is large, then remove the drug. but otherwise, if small, let time tell. And before I forget, I would like more physician education and cautions. I had another friend who’s idiot doctor gave her too high doses of Lipitor, and she ended up with Rhabdomyolisis which darn near killed her and her kidneys..
Lipitor in regular dosing with frequent patient and lab monitoring is fairly safe. Take a bad dr out of the equation and it’s safer. this could be said of most drugs!
I have RA, and tired many different approaches to healing. Some helped (diet changes, acupuncture, chiropractor, meditation, herbs, detoxing etc). But for me this was NOT ENOUGH. My symptoms were eased, but the joint destruction continued.
I wish I had listened to my doctor and taken TNF-alpha blockers from as early as possible. Then I might not be in the situation I am now – unable to work full time, with a shoulder that needs a full shoulder replacement, and wrists that are fused due to inflammation.
I am now on Humira, and it has been a godsend. It has given me my life back. I still continue to look after myself, and I would love to one day come off this, but to all of you people who are judging and weighing in on this argument and who have no direct experience in RA, please understand that sometimes it is the BEST choice for an individual. And we do not undertake the decision to go on these meds lightly.
Yes drugs, like Remicade can have horrible side effects. However, they also can provide a chance for life. I would have died 12 years ago if it were not for Remicade. So I’ll take the chance on the bad side effects as I am already better off no matter what happens.
The title of the article is misleading, borders on sensationalism and is at best done in poor taste to mislead. Tumor necrosis factor agents (like enbrel and humira) do not “cause” Tb or Listeria but can certainly unmask or worsen latent infections. There is a chasm of difference between causing a condition and unmasking one that is already present. Any medication and some natural herbs that alter the immune response can have similar effects (including cortisol that is naturally produced by the body during stress). I am certainly not a fan of the FDA but misrepresenting facts and pseudo-truths undermine the readers’ trust. Shame on this author.