Millions rely on compounding pharmacies for natural hormones and other critical drugs. Will we lose them to a congressional/FDA power play?
About 14,000 patients received injections in the spine for back pain using steroids from the New England Compounding Center (NECC), based in Framingham, Massachusetts. According to the US Centers for Disease Control, 214 fungal meningitis cases in ten states have been connected to the injections, with the bulk of them in Tennessee (53), Michigan (41), Virginia (34), and Indiana (28). As of Monday, fifteen people have died.
Compounding pharmacies are terribly important to the integrative health community for several reasons. They combine or alter ingredients to create custom drugs that meet the specific needs of individual patients, such as a smaller dose or the removal of an ingredient that might trigger an allergy in a patient.
Very importantly, they also make compounded bioidentical hormones such as the estriol so many women take instead of dangerous synthetic estrogen replacement products like Prempro or Premarin. There are also complete thyroid products and many others. Compounders may also put natural hormones in a cream to be applied to the skin, which is by far the best way to take them. For some reason, drug companies generally put them into pills that must go through the stomach and liver system, which may change hormones in undesirable ways.
The bad steroid shots were different and do not fit this model. They were mass produced and somehow became tainted with fungus. Some older patients (the median age of those affected is 68) have experienced fungal meningitis symptoms, including headache, fever, stiff neck, and sensitivity to light, a few have suffered strokes, and some have died. This is a terrible tragedy that should never have occurred.
According to Reuters, emails to a customer indicate that the center sold drugs to doctors without seeing proof of individual patients’ prescriptions as required by Massachusetts law. However, it is not illegal for healthcare providers to buy in bulk from licensed pharmacies like NECC, so further investigation will be necessary before we know all the facts in this case.
From a natural medicine perspective, one also has to ask: why are doctors injecting powerful steroids into the backs of elderly people? Ostensibly for pain relief. But is this a safe or effective or lasting approach to pain relief? One thing we know for sure is that such powerful steroids are very hard on the bones, so is it sensible to inject something like this right into the spine? No one in the mainstream media to our knowledge is asking these questions—or is likely to.
Reps. Rosa L. DeLauro (D-CT) and Edward Markey (D-MA) have both announced they will introduce bills focusing on compounding pharmacies. We have also learned that Sen. Richard Blumenthal (D-CT) plans to propose giving the US Food and Drug Administration more authority—despite the fact that FDA already has more than enough authority to have prevented this tragedy. In fact, FDA sent the NECC a warning letter in 2006 “detailing significant violations witnessed” by investigators the previous year. The agency identified a problem at the facility but seems not to have followed up.
So what is the real purpose of these new bills from Reps. DeLauro and Markey and Sen. Blumenthal?
Some of the proposals for the bills being circulated would effectively outlaw all compounded drugs by classifying them as “new” drugs. In current law there is something of a blurry line on when a compounded drug becomes an entirely new one and therefore subject to the FDA drug approval process. In the past, FDA has tried to argue that any changes to the approved drugs used in the compounding formula—even changing the delivery method from oral to intravenous, for example—would make the compounded drug a new drug and therefore subject to the drug approval process.
Compounding pharmacists and doctors have argued that this is fully within the practice of medicine, which is regulated at the state level. The courts have agreed that it’s important for doctors to be able to prescribe individually tailored drug formulas for patients if what is needed is not commercially available.
If new legislation were to give FDA explicit authority to require compounded drugs to pass through FDA’s outrageously expensive drug approval process, it would dramatically limit the medications that practitioners could prescribe and patients could take. Many compounding pharmacies would be forced out of business.
Big Pharma is already using the NECC problem as an opportunity to ramp up attacks on compounded pharmacists. They want to eliminate the competition that compounding pharmacies present. Moreover, they’re suddenly questioning whether bioidentical hormones (which are made by compounded pharmacies) are safe in light of the scandal—they’re trying to scare practitioners with malpractice threats. Bioidentical hormones like estriol have long been under attack by the FDA and drug companies, essentially working together. Compounding pharmacies may also offer complete, time-release, desiccated thyroid compounds, which can be difficult to find elsewhere. Most thyroid medications made by drug companies are not complete, and some of these important thyroid medications are never available in time-release versions.
ANH-USA will be working on Capitol Hill to preempt any bad legislative language, and ensure that any bill that is introduced will not threaten consumer access to compounded drugs. Although Big Pharma has enormous clout on the Hill, a few compounders—generally the ones who mass produce drugs—are big donors too (such as the California compounding company owner who donated over $1 million to a super PAC supporting President Obama). So it is difficult to predict how the money politics will play out.
Regardless of who is at fault in the tragic NECC meningitis case, this isolated incident—one where the FDA has full authority to act but failed to do so—should not be used to justify a whole new regulatory paradigm that will benefit the pharmaceutical industry alone while reducing access to important medications for the rest of us—including special-needs populations such as the autistic and those sensitive to particular ingredients or full potency drugs.
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What is missing for me here is a link or a suggestion or a petition — some way that we the people who need these compounding pharmacies can influence this legislation before it is too late.
I agree that this tragic situation with the NECC meningitis cases cannot be allowed to elicit legislation that will permanently hamper doctors from having routine access to compounded medications and hormones for their patients. To have such a situation brought about would be a travesty of healthcare justice. It appears that this particular compounding pharmacy responsible for these cases is not well run and has poor internal controls.
While the NECC case is certainly a tragic accident, and while NECC may or may not have been negligent, it is outrageous to stigmatize all compounding pharmacies for the problems of one company. Big Pharma and their paid hacks in our corrupt government and at the FDA are simply using this as an opportunity to attempt to close down competition and to restrict consumer choice.
If the same standards were applied to Big Pharma as are applied to compounding pharmacies then not one Big Pharma company would still be in business. Big Pharma has caused more harm to more people than the compounding pharmacies could ever possibly cause and, what is worse, they get away with it because of their insidious influence over, and bribery of, officials. No-one attempts to close down Big Pharma when they make “mistakes” and they have made a great many over the years – remember thalidomide? And that was only one instance. Celebrex? The list goes on………..
We would greatly appreciate the government limiting the abuse of power by the FDA and some other agencies which do not seem to be making decisions with the public in mind, but for the benefit of big corporations that want a monopoly on everything, including natural and alternative medicine. Please stop any further legislation to void our right to our own health decisions. Thank you.
Since Big Money can buy virtually anything in America, perhaps it’s time to thoroughly audit all decision makers at every level of our governments to see if anyone in Big Pharma is bribing anyone in the FDA as one possibility. As Big Oil bribing anyone in Big Gummint as another. Et cetera ad infinitum. Our Constitution enforces free speech (so long as the speaker buys a permit, of course) but that’s just speech — it’s neither fallacious campaign ads nor an allowance for Big Pharma TV ads., There’s not a word in our Constitution permitting free speech beyond taking a soapbox into a populated place and spouting forth!
Please look at all the details surrounding this situation. There is not a single good reason to scapegoat compounding pharmacy’s. Look at the tremendous amount of problems surrounding pharmaceutical companies failure to adequately test their synthetic drugs; especially those errors that resulted in serious reactions, disease and death. Spotlight these! Compounding pharmacies use successful methodologies and substances that are hundreds of years old. Compare these best practices with the checkerboard outcomes of the pharmacological industry.
Thanks you for this sane and sensible article
This proposed bill is another example of mega corporations such Big Pharma to dictitate and control our lives. This product was MASS produced which means that it was probably generic and did not have to be tested by the FDA as a Brand product. Because one compound pharmacy has poor practices does not mean they all should be closed down. There are many health care doctors and HMO’s that use generic because they are cheep but don’t really releave the symptoms targeted. Maybe the issue is to get rid of all “generic drugs” completely.
This proposed bill is another example of mega corporations such Big Pharma to dictate and control our lives. This product was MASS produced which means that it was probably generic and did not have to be tested by the FDA as a Brand product. Because one compound pharmacy has poor practices does not mean they all should be closed down. There are many health care doctors and HMO’s that use generic because they are cheep but don’t really releave the symptoms targeted. Maybe the issue is to get rid of all “generic drugs” completely.
We all know the FDA doesn’t have the best interest of the population at heart, but instead the pharmaceutical companies instead. Why do they want to regulate compound drugs? Is it a threat to the pharmaceutical companies and their profits? I am fed up with government agencies pretending to protect us, but instead let corporations make profits at our expense!
In its convuluted way, the FDA instead of seeing this for what it is, a contaminated batch of a steroid, which should have never left the facility, it is now trying to take all compounded products off the market by instead of overseeing the facility,it would impose overly expensive regulations that would in essence take the compounded products off the market, as they would be then too expensive to produce. Remembe the tryptophan debacle, where because of one tainted batch, all tryptophan was taken off the market , no matter where it was producted, and trytophan was unable for a full decade? The same convoluted logic. It would be a shame if we could no longer get compounded natural thyroid or natural hormones because of this tainted steroid, which of course was not a natural product. In my opinion, natural products are much better produced and less toxic than their drug counterparts, irregardless of any “tainting”. The FDA would make any excuse to make these compounded natural products unavailable, because it courts the vast kickbacks it gets from Big Pharma.
the politicians seem to be unaware of this fact.
I take a specially formulated T3 for my hypothyroid condition. It has to be compounded and time release. I cannot take any T4. I also take bio-identical progesterone and bi-est (estradiol plus estriol).
My life depends on the compounded T3. I would not want to live without it.
Sounds to me like this issue is way ahead of itself without all the facts! No natural compounds should not be limited by FDA in any form! Now if this company is negligent in anyway, this does not constitute regulations but does constitute punishment and/or ability to operate ANYWHERE!
Thank you for your informative and clear information that helps the public know what is going on. We need compounding pharmacies and will support any action to keep them available.
I am using compund farmacy for over 35 yaers.
U se testesterone prescripction do to a phisical condiction it is prescription, I pay $68.00 for a 3 mounths suply,, the pharma suply for a mounth is about $300.00. wich i nevercan aford.
iiF THEY STOP THAT IT WILL BE DEVASTED TO ME,
It is unreasonable to consider outlawing lawfully compounded natural drugs on the basis of one isolated incident of tainted product, particularly in light of the fact the FDA had already issued a warning to the offending company, and did not follow up.
I cannot comprehend why there would be any reason (as in reason-able!) to effectively remove bioidentical hormones from the market when there has been no problem with them, no evidence of them being in any way inappropriate… other than greed and competition on the part of those producing non-bioidentical products.
Please, think and act responsibly – beyond the $$.
Get the petitions started so we can sign them.
Quit wasting time.
The FDA must be stopped from hamstringing the ability of compounding pharmacies to provide high quality medicines to doctors and their patients!
we need more health freedom of choice,be prp-choice now!!! jiummy Mack
I will die without my compounded drugs. HOW DARE THEY?
Another example of Government wanting to go hunting.. for a rabbit with a machine-gun……going from extreme to extreme is not the intelligent approach…. I think Congress Should be made aware of the impact that it will have.. if interrupts a lot folks access to obtain what they need to be healthy and to live…..I guess these morons we have in Congress these days never hear… about What’s Reasonable …and prudent …..
The FDA did not stop Tylenol manufacturing after many people died from tainted bottles, so hopefully they will not restrict compounding but hopefully will enforce better standards no matter who is mixing drugs. If politics enters the stage then the pharmaceutical industry could influence the FDA and then we would lack the flexibility to be able to prescibe compounded drugs.
it was probably Big Pharma that infected the steroids in the first place to cause this kind of action.
I have allergies and chemical sensitivities and always have to have my medications compounded. It is very expensive and not covered under any Plan D Drug Plan with Medicare. But I would not know what would happen to me if I could not have meds compounded. I have dealt with the same compounding pharmacy for many, many years now and have never had any problems. One last comment – without estriol numerous women including myself would be left without a safe option.
I have Parkinson’s disease, have had for 24 years. The past ten years I have been taking glutathione injections under the supervision of my MD to counter oxydative stress in the brain. David Perlmutter, MD, a Florida neurologist, has written a book about this. Under a prescription from my MD, I have been obtaining glutathione from compounding pharmacies in California and Alabama. I have never had a problem with any supplier. I hope to be able to continue to obtain these injections from these compounding pharmacies, which are the only places to obtain them.
Since the FDA had authority to do something and didn’t, it signals nothing less than a false flag attack, as far as I’m concerned. This will pave the way, as you suggest, for other compounding pharmacies to be deep-sixed and it will happen soon. Kill off the competition, so to speak, as if it’s actually hurting bigPhRma in any way at all.
I believe we must do what we can to protect the natural healing prodocals as well as protecting the Compounding pharmacies. We know that the pharmacudical industry would also include in their drugs genetically modified products into the drugs because it would be cheaper. But we saw what happened with L-Tryptophan it hurt many people because genetically modified substance was used. Leave the natural substances alone! I say to the pharmacudicals and politicians. We know that many people have been heald and cured, using the natural products. I have not seen any pharmacudical drug cure like natural products can. In fact more people have been killed by pharmacudical drugs, of over doses, wrong drugs that do not mix, wrong prescription given, allergic reactions, sensitivities to the drugs, etc.
Keep up the fight to protect compounding pharmacies! Both my wife and I depend on our compounding pharmacy to supply my testerone cream and her Biest and progesterone.
The FDA strikes again. They pharmacy drugs through their ancient system like a leaking dam, but the better thing in life are always being jacked around. When will they learn, the customer is right, not federal government.
Stay out of my business…..
Give us the tools and information needed to protest this attempt names email addresses, phone numbers etc. thank you
Question: How do we know that this was an accident at New England Compounding Center (NECC), based in Framingham, Massachusetts?
With Corporate Espionage, perhaps one, or more of the major Pharmaceutical Industrial Companies sent in a saboteur, and deliberately placed that rare fungal meningitis into the compounds, thereby causing the problem, and was done deliberately to promote reason for more FDA intervention, as well as give Congress something to do to increase governmental control over the lives of all the citizens of this country. Has this possibility been investigated before Congress goes off half-cocked, and causes another governmental misfire?
Just a conspiracy thought on my part.
Sirs,
Alchemists have mixing compounds for thousands of years to help heal the masses. Why try to shut down the compound labs now? This is not is the public interest. This is the pharmaceutical companies trying to monopolize all of what we do for their proffits. We need to be able to find ways to get closer to the natural components that God has placed on this earth, not farther down the test tube.
ANH – Thank you so much for all that you do.
Good article. However, if you saw the 60 Minutes segment on NECC, you would be calling for the government or the FDA to put these sleeve-ball owner-operators of NECC, out of business. Let’s concentrate on getting rid of the bad apples that taint an entire industry, thereby tempting our intellectually challenged Democrat politicians to over react.
I rely on a compounding pharmacy for the medication I require. It pains me to see an industry that has served people for a long long time in jeopardy because of one company. I use a nature hormone and would have to switch to a synthetic one which I would prefer not to have to do. I’ve been on the one I use for 31 years with no problems.
If you want freedom of choice regarding foods/supplements NEVER vote Democrat!! (Communists)
Compounding Pharmacies need to be left alone by the Pharmaceutal Companies aka FDA.
I have Peripheral Neuropathy with painful/cramping legs. I am unable to take any of the drugs for it as the side effects are too severe for me, rendering me non-functional. My physican has ordered 2 different rub on compounded lotions for the pain. and they are a life saver. They do away with the pain I was suffering from and there are no side effects from them. If I were unable to continue getting these products I would be non-functional once more and totally devistated. They have given me back the life I lost due to the pain I was suffering from.. Please do not deprive those of us who depend on these products for regaining a quality of life. Big Pharma would like us to just take their killer pils, be sick from side effects, but make more $$$ for them.. People die from legitimate drugs, yet they are still being prescribed. Do not deprive those of us who depend on compounded drugs to give us a quality of life once more.
Big Pharma; Big Phooey
Compound pharmacies should not be eliminated! What if the product that you are trying to eliminate was a life sustaining prescription that either yourself or your loved one needed, would you deny them of this? Not to mention look at the number of people that would be losing their jobs for something a manufacturing company mass produced and messed up. You are going to deny people of prescriptions that make a better quality of life for what subsidized medical health plans that prescribe the cheapest drug possible that could possibly kill people with allergies to certain fillers. Now that’s freedom.
Please leave compound Pharmacies alone, If we truly so live in a free country, then why are you working so hard to take all our freedoms away
I am very grateful to ANH-USA for writing such clear articles. I wish more people would read them.
Tainted?…or Tampered with?…”Big Pharma is already using the NECC problem as an opportunity to ramp up attacks on compounded pharmacists. They want to eliminate the competition that compounding pharmacies present. Moreover, they’re suddenly questioning whether bioidentical hormones (which are made by compounded pharmacies) are safe in light of the scandal—they’re trying to scare practitioners with malpractice threats. Bioidentical hormones like estriol have long been under attack by the FDA and drug companies, essentially working together.” FDA will stop at nothing to discredit natural therapy which would be an unmitigated disaster for health and wellbeing world-wide. How many “FDA-approved” drugs and interventions, i.e. mercury filled vaccines, have destroyed lives…unfortunately the sword is being wield in a very destructive way in the world today. All the best with the fight!
I get several prescription hormones compounded for me by a very reputable laboratory. These prescriptions were submitted by my physician. I hope the problem regarding the very sad, but isolated, incident of one compounding pharmacy being careless in their production, doesn’t shut down companies who are diligent in compounding prescriptions properly.
I can’t thank you enough for bringing attention to this matter. I use a compounded thyroid product and it makes an immeasurable difference in my health and well-being. Thank you!
“They were mass produced and somehow became tainted with fungus.”
And just in time to mount a well planned attack on a competitor of Big Pharma and an advocate for our health.
Does anyone else smell a RAT?
Want to eliminate a competitor of Big Pharma simple arrange for the competitor to ship a tainted product.
What’s next people?
Fine just so they KNOW they are NOT fooling anyone!
Get the funding to these bills cut and they won’t be a threat anymore.
Please tell the FDA to leave compounding drug rules as they are. The FDA has enough power. Them regulating more won’t prevent mistakes of this nature to occur. These compounded drugs are clearly needed! I think it should be up to the MDs to decide if these drugs are needed! But out FDA!
The FTA wants to take us back to the days of old. Obama wants us bankrupt. Take them both out, vote Gary Johnson.
I really wish I would not have to keep writing about the threats of Congressmen and women to limit or stifle our access to vitamins supplements and compounded drugs, etc. We should be able to decide for ourselves whether we want to take a vitamin, herb or supplement or whatever, instead of a drug made by big Pharma.
They need to stop trying to run our lives. We are adult, logical thinking human beings with the knowledge, for the most part, of which supplement or herb we want to try or continue to take. We don’t need Congressional babysitters or caregivers to watch over our every move. This is becoming a nanny state here in the United States and I don’t like it!
Congress and the president need to tell the FDA that they must approve all natural substances and bioidentical hormones that have a proven safety record when used according to esrablished guide lines over the past 20 years. Effectiveness needs to be left to the doctors. State medical boards should be ordered to respect the prescribing of all such substances with proven 20 year safety records. No doctor should be disciplined for prescribing these substances in accordance with guide lines for such substances. This would give doctors the freedom they need in the practice of medicine.
If the products of Big Pharma as approved by the FDA worked well and were within the reach of most, then the competition by compounding pharmacies would be marginal. If we pass legislation that punishes suppliers because of of an FDA failure to act, we are aiming at the wrong target, and many voting citizens will not be able to get the succor they wish. If I can’t get my (whatever I’ve been getting for years because it works) because of a new regulatory paradigm, I will make it a point to find out who voted in favor of it and work for their opponents in the following election(s). One or two old cranks may not make much difference in most elections, but roiling up a large minority would not be advisable.
The FDA already has too much power over what people put into their bodies.
It is unfortunate that at conventioanl Phara-Industrial-Complex is taking over the government of this country so they can feed us poison, make us pay for it so they can occupy that 1% that rules the money in this country. Natural remedies and compounding pharmacies are a boon to the people and whoever in the government has no moral character or integrity to represent the peoplle, owned by large pharnaceutical interests, unable to stand the logical grouind should be stood up against a wall and shot, in my opinion. I am quite tired of this Capitalist/Communist/Facist form of economical government. There is no America.
more FDA approved drugs have killed people in the past and we have not shut down all pharmacies that provide these drugs. I am for compounded meds such as hormone replacement .
They are far safer than synthetic medications that are available. We cannot fix the problem by outlawing componded drugs.
Thank-you,
Donna DiLeo
The FDA sucks as a consumer protection agency. It is part of the marketing arm of the drug manufacturers now. It also helps prevent legal actions against those who make dangerous/deadly medications. The sooner the FDA is ended the better. Bring back suits and criminal prosecution for individuals and organizations who kill or injure folks!
When are you going to stop? Enough! This is supposed to be a country where we have a choice and if we choose to step away from pharmaceuticals, that our business. No one else has any right to make that choice for us. Stop letting greed get in the way of freedom – it’s time you stopped and you know it. Predetermine this and you predetermine freedom itself.
Really? I have suffered from autoimmune disease and sensory processing disorder all my life. The only relief I get is from Armour Thyroid and especially Low Dose Naltrexone. Since regular docs refused to prescribe it for me, I used a naturopath and a compounding pharmacy. So now the FDA gets to ruin my chances of having a semi normal life? And what about my son with autism, ADHD, ODD and PANDAS? He was so weak before low dose naltrexone he could hardly run. Now he can keep up with some of the typical kids his age on the playground. There goes his chances of any recovery, right out the window. Thanks, FDA, for ruining so many lives.
it’s simple – they were in that mountaineous category that is lost to F DA followup. Creating more rules doesn’t make sense if the F DA isn’t doing what they shuld be doing right now anyway. I find it humorous how they’re looking to puni sh the comp ounding ind ustry with flukes like th ese and when it comes to the ma jorly huge er rors, dru g companies make, how do they get pu nished? By rewa rding them with more con tracts, of course. When Bax ter was found by a can. company to have LI VE avi. fl u in their va ccines in ’09 , which is a MA JOR no no, they were gi ven more bu siness when the sw ine fl u came around. And somehow that makes sense?
I go to a compounding pharmacy it has improved my health. I do not believe that the goverment has the right to tell us where we can go for medicine. is this america or china?
More people dye from FDA approved drugs than that of componding drugs. I am 68 years oold and I have never heard of anyone dying from vitamins or minerals. I cant say the same for FDA approved drugs so please Let us make our own decissions on how we protect our bodies. Thank you very much………………………….
Everybody rags on the FDA over things like this. Haven’t you figured it out yet? Sticks ‘n stones people, these slime balls don’t care what you as a consumer thinks about them.. No threats or religious condemnation will affect them, they’re set for life and they know it. The only way to keep these zombies at bay is to change the laws and make them paid employees with both quotas and welfare for people as an incentive to keep their phony baloney jobs and if they fail in their tasks (that is, side with big pharma) then fire them and replace them with someone who cares. Otherwise this crap is going to continue and like in past issues, even if the petitions stop them, they’ll create some other big pharma plan to ream the citizens. It’ll never stop!!
My 2c I agree 160% w/ you. The problem is not the FDA, it is a collective US!!!!!!. We don’t fight like our parents taught us to in the 60’s, 70’s and 80’s. Why have we become so apathetic, patheic and complacent. Someone else doing it actually requires YOU fighting the good fight. How was women’s lib won?? How did we get cloe to Equal Pay with Men??? How did we get Child Labor Laws put in the Law Books? How did we get Labor Laws improved in this country alone. Oye people — we protested. We wrote letters. We signed and sent in petitions with hundreds and thousands of signatures. We flooded our elected officials offices with bags and bags of mail – ALL saying the same thing in one way or another. It is our fault. We allowed the FDA to run rough-shod over our rights; and, we’re still barely doing anything about it. Now let the collective people say amen. In hebrew it can be loosely interpreted as “this is so.” Therein lies the end of my message.
It just makes me sick thinking about big pharma’s power. When will it stop?
I think the government is trying to take over everything.We the people need to stand up for our rights we need to stick together.This has got to stop. what about the shots there trying to pass that law to be mandatory for all school children no exceptions why where is our choice.It is getting very scary when our rights are being taken away.We need to stop this get the word out more whats really going on in the world today. I will help in anyway I can. I need vitamins to survive since there is no vitamins left in the food. We will never survive on GMO. Thanx Rita
The constant assault on our right to our own bodies and health needs to stop!!! We need to just say no to the government and the corporations.
what is else is new with the FDA. They are lining their pockets while putting the American people on the path to a slow death. Please check out my petittion link on the FDA
http://www.change.org/petitions/it-is-time-americans-take-back-the-constitutional-rights-that-our-founding-fathers-work-so-hard-for