When a new FDA drug-and-money scandal has doctors, US senators, and even the March of Dimes in an uproar, you know it’s bad. A new Action Alert!
A drug which the FDA approved more than half a century ago—which doctors have been prescribing for their patients with high-risk pregnancies through compounding pharmacies with great success—was designated by the FDA an “orphan drug.” Now KV Pharmaceutical has been given the exclusive right of production and sale (not to mention drug trial tax breaks!). They immediately raised the price from $10 per dose to $1,500—simply because they could.
The drug is a synthetic form of progesterone given as a weekly injection. It has been made cheaply for years and produced in compounding pharmacies. The price hike means that the total cost during a pregnancy could be as much as $30,000.
Doctors say the $30,000 price tag will almost certainly deter low-income women from getting the drug, leading to more premature births. Dr. Roger Snow, deputy medical director for Massachusetts’ Medicaid program, was quoted as saying, “That’s a huge increase for something that can’t be costing them that much to make. For crying out loud, this is about making money!” And Dr. Arnold Cohen, an obstetrician at Albert Einstein Medical Center in Philadelphia, observed, “I’ve never seen anything as outrageous as this.”
Besides the grave jeopardy placed on the mothers and their infants, this will create a huge financial burden for the health insurance companies, private citizens, and government programs that have to pay for it. In the long run, because of birth complications, the babies will need to be hospitalized for perhaps months—and, for low-income mothers, all at the expense of taxpayers. On top of that, lung issues at birth can have lifelong repercussions on the individual’s health with an increased propensity toward asthma, bronchitis, and pneumonia, among other early birth issues.
The March of Dimes—a nonprofit organization dedicated to preventing birth defects—received funding from KV Pharmaceutical and supported the company’s New Drug Application. Now the organization has started backtracking in the face of all the public outrage. They just sent a letter to KV “expressing our serious concern about the price of Makena.”
Sen. Sherrod Brown (D-OH) has sent a letter to KV Pharmaceutical asking the company to “immediately reconsider” its pricing. “I am deeply concerned that your company appears to be taking advantage of FDA approval at the expense of women, children and federal and state budgets,” Brown wrote. “By ratcheting up prices, fewer women will be able to afford the drug, increasing rates of preterm birth nationwide. This isn’t in the interest of children, new mothers, or taxpayers.” Sen. Brown, along with Sen. Klobuchar, followed this with a letter to the FTC commission to investigate potential anticompetitive conduct from the increase in price.
Not surprisingly, the backlash over the unconscionable price hike has been significant—so much that KV hired the public relations firm Golin Harris to handle the mess.
Compounding Pharmacies to the Rescue
The FDA originally approved 17-hydroxyprogesterone caproate (17OHPC, or 17P for short) under the trade name Delalutin in 1956 to halt impending miscarriages. It was deemed safe but the manufacturer took it off the market in 2000 because it was eventually shown to be ineffective in stopping miscarriages.
When the drug was no longer available, compounding pharmacies were able to compound 17P’s ingredients and sell the product to patients whose physicians had prescribed it. Pharmacists can legally compound FDA-approved products when a drug is not commercially available (as was the case when the manufacturer pulled it from the market), or when a prescriber determines that the compounded preparation is more clinically appropriate for an individual patient (as when someone is allergic to one particular element in the preparation but another can easily be substituted).
After large controlled trials in the mid-2000s showed that 17P could prevent premature births, the compound was given “orphan drug” status by the FDA. An orphan drug is a pharmaceutical agent that has been developed specifically to treat a relatively rare medical condition, and the designation gives the manufacturer clinical trial tax incentives. It also gives the manufacturer the exclusive right for seven years to manufacture and sell the drug. Of course in this case, premature birth is not a rare condition at all.
As soon as FDA gave the drug (now trademarked as Makena) orphan drug status, its manufacturer, KV Pharmaceutical, sent a cease-and-desist letter to compounding pharmacists, stating that “FDA…views compounded drugs to be ‘new drugs’ within the meaning of 21 U.S.C 312(p) and as such they may not be introduced into interstate commerce without FDA approval.”
The Orphan Drug Act is meant to encourage pharmaceutical companies to develop drugs for diseases that have a small market, and it has resulted in medical breakthroughs that may not have otherwise been achieved due to the economics of drug research and development. But this is a drug which was already developed, already approved, already in use, and has been costing $10 per treatment for many years. To raise the price to $1,500 per injection just because they can is unconscionable.
This is just another attempt by Big Pharma to monopolize substances. You may recall our campaign to keep pharmaceutical companies’ hands off bioidentical estriol and bioavailable B6.
Please take action on this issue! Ask the FDA to allow compounding pharmacies to continue making a compounded version of 17P. Even if KV Pharmaceutical now has exclusive right to sell the original formulation that was developed in 1954, compounding pharmacies should be allowed—since it is their legal right to do so—to make and sell compounded formulations that are similar but more clinically appropriate for an individual patient.
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74 thoughts on “How the FDA Turned a $10 Treatment into a $30,000-Per-Pregnancy Pharmaceutical Money-Maker”
KV beginning to understand that the backlash has serious repercussions. Unfortunately do not know if they realize how much worse it will be when the additional stillbirths and premature births are attributed to their actions. The only chance that a tragic can be averted and this can fade into the background as a short term fiasco is for KV to revise their price point. If they don’t it’ll be small recompense that they’ll be put out of business within a year of causing this senseless tragedy. I can think of a half dozen ways to legally take them down (fasttrack the gel, shut KVs manufacturing down again, no more FDA approval, march in rights, approve Makena2 w/ a slighly revised oil..) .a mid size company with a shady past really doesn’t want to embarrass the FDA and enrage the medical community, charities, and the public. Please continue to spread the message, the tragedy can still be averted
I watched a major cancer hospital sell my sister all kinds of expensive cancer treatments. They put her through hell. When she was in better health, they told her she had to have a bone marrow treatment, [big bucks there] because you have to to get it when you’re well. It doesn’t work when you are sick; is what her doctor told her. After they did that to her she never recovered,and then they preceeded to lie to her, to get her out of their hospital and get their bed back, so they could go and do that to the next unsuspecting poor scared soul of a patient. It was all about making money. They left her in the bed to die a miserable death, and took away her blood platelets, and then the blood, saying to me , ” she doesn’t need them anymore”. Her kidneys failed, and my nephew walked out of that hospiital and said, they just murdered my mother. It was all in the name of the almighty buck. It doesn’t surprise me a bit that they don’t care about pregnant women. They don’t care about anything except the green dollars. It’s time that doctors WAKE UP !!! It’s time everyone wakes up. Pharmaceutical companies are too powerful. They influence everything. Look how much money they give the government. When a doctor goes to medical school they are groomed with that influence from day one. The patient doesn’t have a chance unless they are constantly educating themselves to what is really medicine and what is a concoction the big pharma has made up to sell for a billion. I think it’s time for the people to stand up and say, we are not standing for this crap any longer. It’s time the that doctors start researching the natural cures. Take the initiative to find out for themselves. Stop going to big pharma dinners and listening to what the next happy crap they want them to push to patients. Maybe it’s time for war., and the compounding drugists need to say this is what we are going to doing, like it or not, because it’s what the people want.! I don’t want to be ruled vy the pharma co. do you? The condition of our medical treatsments by the medical industry are a disaster. People are dying of cancer when there are treatments out there that will cure them. Chemotherapy cures 2% of the time, and it harms the good cells in your body. Why would any educated person want that? The problem is that people are not educated, but rather snowed with what they are being sold. I can’t say here what I’d like to do with the company that is producing a $1500 medicine for pregnant women that should only be costing $10, but we should all be thinking it and we need to do more than we do. Our letters to Washington help to win small battles and then we step back and lose a few, but big pharma marches on doing whatever they please, because they tower over us. The FDA needs to be dismantled and some how we all need to go back to natural medicines that are produced for the sole purpose of healing, and not making money. A naive thought? Maybe, but if we all don’t get back to caring about each other and not the almighty buck , we will cease to exist. Pharmaceutical drugs of today are making people sick! If you’re not sick, you’re being charged throuh the wasoo! Either way you’re screwed, if you depend on big pharma. .
You spoke of the hospital killing your sister with cancer treatments. A radiologist here in Charleston did the same thing to my father in law. He had come through chemo and was in pretty good shape. This doctor used my son as a lever to get my father in law to take radiation treatments. Each successive treatment left him weaker than the last, and he died not too long after completion of the treatments. The mortician who prepared his body for burial told us the radiation had literally burnt his body up. Another murder in the name of big medicine!
My sister, my mother and my best friend all died from their cancer TREATMENT. We need to fight back, alright—by not buying into the system in the first place. Once they have you in the oncologist’s office, you’re dead, but not until they have milked your insurance and/or your assets dry.
Knowing up close and personal how things would end for me when I got cancer, I just refused to enter their realm. My tumor is gone and I never got a single chemo or radiation treatment, nor any surgery, and didn’t even take a single prescription drug. I was fortunate to have been successful, but if I hadn’t been, I’d still rather die with cancer than with an oncologist because I believe my chances are much better with the cancer.
Perhaps the Middle East isn’t the only place that needs to fight back.
Amen!! I agree with everything you say. I know about this drug. I am 74 years old and, following miscarriage with my first pregnancy, took this drug (then known as stilbesterol). It allowed me to carry my next three pregnancies to term.
I am hypothyroid and am convinced (after reading “Hypothyroidism: The Unsuspected Illness”, by Dr. Broda Barnes) that thyroid deficiency is behind the epidemic of premature births as well as many (if not MOST) of the degenerative illnesses as we progress through life. BIG PHARMA controls what is taught in medical schools, and by refusing to diagnose and treat this condition they assure a continuous stream of profits from treating all of the many and varied symptoms of thyroid hormone deficiency leading inevitably to heart disease, type II diabetes and Alzheimers, to name just a few. You are right. It is time the people WAKE UP and educate themselves. It is a serious MISTAKE to put your health in the hands of doctors educated and brainwashed by BIG PHARMA. To begin your education, just “google” hypothyroidism” to read testimony from the many (mostly women) suffering from this condition and being denied treatment with REAL, NATURAL THYROID HORMONE.
Dr. Broda Barnes died in 1982. Prior to medical school he held a Ph. D. in Physiology, doing research on the functions of the thyroid gland for his doctoral dissertation. He then taught endocrinology at the University of Chicago. For more than 35 years his practice of medicine clearly illustrates the many and varied symptoms that respond to administration of even small dosage of thyroid hormone. He cites a child of 7 months who had to be confined to a straitjacket since birth to prevent scratching himself to death from hemorrhage. “Two hospitalizations and repeated dermatological consultations had been to no avail. Five months of thyroid therapy cleared is skin.” Symptoms of thyroid deficiency are many and varied and can occur at any age, but it is a condition that doctors refuse to even consider. So called “chronic fatigue syndrome” is simply a refusal to treat obvious symptoms of thyroid deficiency.
EVERYONE NEEDS TO READ UP ON DR STANISLAW BURZYNSKI AND HIS CURES FOR CANCER. THIS MAN HAS BEEN AROUND FOR MANY YEARS, HAS A CLINIC IN THE US AND IS TREATING MOSTLY STAGE 4 CANCERS AND A SUCCESS RATE OF CLOSE TO 30% WITHOUT SIDE EFFECTS. HE HAS BEEN BROUGHT TO TRIAL AT LEAST 5 TIMES AND HAS WON EACH TIME ALL THE WHILE CONTINUING HIS RESEARCH. TO SAY HOW RIDICULOUS IT IS HE HAS BEEN APPROVED TO DO THIRD PHASE CLINICAL TRIALS WHILE BEING PROSECUTED LEGALLY BY THE FDA!! CHECK OUT HIS WORK, IF I GOT CANCER THIS IS WHO I WOULD GO SEE. IF HE WINS THIS BATTLE HE WILL BE THE FIRST PERSON TO EVER HOLD A PATENT PERSONALLY, NO DO YOU THINK THE DRUG CO’S WANT THIS. ERIC MERCOLA HAS DONE A MOVIE ON HIS LIFE AND IT IS VERY INTERESTING. WE NEED TO TAKE CARE OF OUR OWN HEALTH DECISIONS!!
Natural progesterone is better than a synthetic progestin and is available either through a compounding pharmacy, as a cream found on the internet (not yam cream), or as a prescription drug in capsule form. You are looking for micronized progesterone b/c it’s better absorbed thru skin or mucus membranes. Physicians will need education about the benefits of natural progesterone so they can prescribe that. Better for menopausal symptoms also
Hey, it’s nolt gonna embarrass the FDA, they’re in bed with big pharma!
Does anyone now doubt that Obama’s Margaret Hamburg, MD, FDA Commissioner is in bed with the Pharmaceutical Industry?
My Question is, does Congress have the guts to put an end to this malignancy?
This is an egregious misuse of the orphan drug designation and a truly evil (if not criminal) abuse by KV. I worked in medical research as a biochemist and one of the “drugs” we researched in a government supported study was lithium chloride, now used as a successful (and I believe , reasonably priced) treatment for mania. This designation is meant to make drugs that would not otherwise be available because they are not patentable available to patients to whom they would not otherwise be available. In the case described above, the opposite has been achieved. The food and drug administration needs to reverse this awful decision.
I worked in the Biotech field for years, but this kind of price gouging and monopolizing is yet another reason that my confidence in the FDA has faltered. Human health is no longer in the FDA’s best interests… only padding the pockets of big pharma. Disgusting.
This does not suprise me. In the United States of Amerika, no longer a “democracy” but rather a fascsit-korporatist plutocracy as envisioned by Mussolini, making huge amounts of money for those who are already wealthy beyond the wildest dreams of Croesus at the expense of the rest of the planet is far, FAR more important than human life.
The filthy Repuke hypocrites need to shut up with the “pro-life” Christianist lies and propaganda, because the ONLY god they worship is MAMMON – to whom the make HUMAN sacrifice in just this way.
It appears your distain is misplaced. Isn’t this Obama’s FDA? Isn’t Obama the one who is putting death panels in place to deny lifesaving care to the young and the old, justifying it as “too expensive”? If I remember correctly, it was a democrat administration, senate and house of reps that rammed this ‘Improved Health Care” down our throats, in the dark of night, without allowing for reading and ammendment. I thought it’s “healthcare for everyone”!? Oh my god, its not true? We have been lied to! IMPEACH, IMPEACH!
don’t be ridiculous. the FDA in place is the same one in place during eight years of bush. the FDA (and USDA, EPA, etc.) have, for decades, been a revolving door for people from their corresponding agencies. when nothing is outrageously amiss, any incoming president usually only replaces a chief director–everyone else is pretty much status quo, but all of them regularly rotate in and out of the industries they regulate. this has been long established.
how can this be changed when lobbyist influence on our directly-elected officials on both the state and national level are on the take from industry? wherever there’s an industry (e.g. NJ and PA are rife with pharma companies, you’ll find lobbyists doing their bidding, coercing our electeds with generous contributions).
thanks for the laugh with your mention of “death panels”!
I am so sick of people like you blaming Obama cause the sun rises. You can not hide your racists attitudes behind blaming Obama for everything that happens under the sun.
The FDA has been in bed with Big Pharma for DECADES. Do some research are look how long it’s revolving door has been swinging.
If you knew anything you would at least know that Donald Rumsfeld is one of the more notorious politicians to go through this door after writing and instilling legislation at the FDA for Monsanto then right back to Monsanto for a high level job.
Michael Taylor is another famous swinger as he wrote the legislation to get rBGH approved for use in American dairy cattle, then back to Monsanto for a really cushy job.
So stop blaming Obama for everything and stop trying to push a wedge between Americans. There are some people here with some good ideas of how we can join together and put and end to the hypocrisy at the FDA… and that is the only way it is ever going to happen… is if we come together!
It’s big Pharma’s FDA Sez, and supposedly yours and mine. we don’t have anything misplaced. Whatever obama did, does, he came long after the FDA was established. .
Not all christians are worshipping mammon. True the US government is securely bought by big pharma and name calling does not help but adds to the problem. Sign the petition and make others aware. Talk is cheep and hateful words solve nothing. Cut some bucks loose for ANH as they are one of the few organizations fighting for our health and right to choose.
Hey skippy, take a look at the administration in power. The colors of the uniforms change, but the players are all after the same goal, and it isn’t the public good. Name calling one or the other party is EXACTLY what the power elites want you to focus on.
This is just outrageous, why do our elected officials stand for this, yet seemingly just look the other way?
Because Big Pharma gives these people campaign donations. It makes it much easier to look the other way.
Sadly I don’t think they look the other way, I think some if not all of them actually LIKE this type of thing.
Why would I think that?
Well, why do they want so much money? I mean how much does a person need? After a while it would just be a bunch of zeros and not even mean anything anymore.
Money is power right?
So if they want HUGE power and the feeling that goes with it, they have to start playing God.
No amount of money makes a decent person make decisions like what the FDA and KV have done. They know what the price in lives is. They know it perfectly well. They know exactly how many it is. The money does not make them forget that price, They know it and they probably like it.
Just because they wear expensive suits doesn’t mean they can’t be rotten to the core.
There will come a day when we as a species look back at this time in our history and we will shake our heads and wonder how we were ever that way.
But for us to be able to achieve that place we have to speak up about things like this and we need to raise our children to see what is right and what is wrong and turn society away from worshiping the dollar.
There is light up ahead, but we can’t stay silent and expect to get there.
The real reason is that no one will stop them.
We aren’t told the truth about drugs being worse than the diseases or that the side effects cause more death and damage than being sick causes.
Nobody is protesting loudly, vigorously or demanding that big pharma stop making expensive and useless or deadly drugs.
Too many doctors, senators and hospitals are making a fortune off these deadly drugs. Ever watched “House”?
Yes, he finally heals his patient but not before some drug nearly kills the patient at least twice.
ALL DRUGS ARE DANGEROUS, SOME MORE THAN OTHERS. DO YOU KNOW WHICH ARE WHICH?
My mother retired from nursing when the hospital started charging the patient a dollar for each aspirin he got. The hospital was making so much more money charging by the pill that the included everything, pills, bandages, shots, by the dose! I got an x-ray of my toe that cost less than the one band aid and cotton ball and piece of gauze they half-assed wrapped my toe with. And they handed me an itemized bill showing that the x-ray was only $38 by itself out of a $100 bill! The doctor’s charge was separate and came later in the mail.
You are a captive audience, you get hurt, who do you go to, how to you fix a broken leg or stitch up a cut that needs 10 stitches?
Who’s going to tell you that there are better, natural ways to stop a heart attack or stroke before it kills you or even that it can be done at all.
We are trained to believe that the hospital and magic pills are the way to heal, the only way to get well or fix our bodies.
We have been made slaves to the medical system thru ignorance and relying on PAID DRUG COMMERCIALS FOR ALL OUR HEALTH INFORMATION TODAY.
We need to set ourselves free and learn about true healing without drugs. We also need to stop waiting for the FDA to help the people, we need to picket and protest against the FDA and any drug maker who makes dangerous drugs and watches calmly while people die, mothers and fathers, babies and little kids dying daily because nobody stopped them from making deadly drugs.
Because we let them?
Better to take the real thing! Many ills are cured by taking Dr. Raymond Peat’s natural Progesterone in a Vitamin E oil base. It helps balance out high estrogen levels and protects the body in many ways and it’s 1/45,000 of the cost of the corporate-produced progesterone. See Dr. Peat’s or Lita Lee’s sites for more info. The high price of medicines are pushing many people into becoming healthier by learning about natural substances.
Sadly, Big Pharma along with the FDA wants to do away with all natural supplements so we have no choice but their expensive, toxic patent medicines. I read recently that the UK either has or is on the verge of outlawing all natural supplements. Big pharma propaganda is that natural supplements are dangerous, but that simply is not so. I use several natural supplements (glucosamine, chondroitin, saw palmetto, fish oil), they have done me nothing but good, and all their side effects are beneficial. Eating cherries relieves gout, but the FDA has raided and threatened to shut down cherry growers for making health claims about their product. The real reason they want natural cures stiopped-they don’t want competition. Pure and simple. For more on what lengths the FDA will go to to stop natural cures, do a lookup on Greg Caton.
I am not at all suprised by this, this is why our medical costs is out of sight, Greed by the FDA and Pharmacetucial companies. Greed is destroying America,between these people and the Unions America is lost. THIS is the reason why we have such a high cost in medical costs and I at the age of 78 am careful what I eat and dont use any of thier garbage, I do not want to be a prisoner of thier chemicals…They should all be hung…
Dorsa, AMEN !!!!
This is yet another example of the numerous corporate/government partnerships AGAINST citizens and consumers. It’s a byproduct of a political system dominated by two corporate-funded parties.
Another name for this type of alliance is “fascism”. Voting for either of these two corporate-funded parties makes YOU part of the problem.
The Green Party and the Socialists are two excellent alternatives that don’t accept corporate money. Supporting them sends a message to the politicians in power that their business-first agenda will lose them votes.
Until we the people show them there will be consequences, the corruption will continue.
I am so tired of major corporations (of all types, not just big pharm) bleeding us dry, we need to get our nation and our lives back, if we have to do like Egypt did, and other countries are doing, storm the Capitol and force them out of office, then so be it.
Now you’re making sense, Richard. It looks like that’s the only solution that will be totally effective.
I’d hate to see the destruction of the two party system,but when one party is determined to destroy our economy, make us financially unable to defend ourselves and rebuild the country in a marxist mode, (hope and change), I don’t see many alternatives.
Nice to hear from you. God bless you
I’m with you!
It’s both parties because they have all the money!
how can they relate to us when none of them makes under $100,000 and have stock in all the corporations that are stealing from us.
Only when it cost the govt too much money, like Medicaid insurance payign for the useless vaccines that cost $135 a shot.
Too long we have tried to do the nicey-nice way, give them the benefit of the doubt while they keep screwing us over and robbing us blind!
I say throw all the bums out and replace everybody with real people who have actually worked jobs ran a small business alone or lives in the same neighborhoods we do and have had to pay for insurance, food, gas, housing and car notes! No more 3rd generation rich kids without a clue about real life and families.
Imagine what being able to spend $27 million of your own spare money to run for state governor, and still lose but never complain about the money you lost! Because it was only spare change for you, it didn’t matter.
What kind of governor would that make had he won?
A dictator, just like the man that was sponsored by the rich guy is, Michigan’s new dictator!
Do we need pitchforks or can we bring baseball bats?
Better yet, can we declare an emergency and make them all run out of the building and we can take it over and lock them out?
Well done Patricia Tursi if what she says is accurate about natural progesterone. I myself take natural ZELNORM now and other natural forms of meds are not only cheaper but safer. I am NOT surprised by the FDA’s collusion with Big Pharma, what has happened to our country? BP, Halliburton, Monsanto, Big Pharma, the Banks!!!, I could go on and on. Our dreams have been hijacked; out lives are for sale.
I too Rose, take a compounded natural progesterone, although I don’t know if that is exactly what they would use for the pregnant women. I would think anything synthetic would not be as good for your body, [molecular build being different] but also don’t understand exactly what makes the drug for pregnant women effective. So fed up with money mongers, and side-affected drugs.
What took them so long to realize the first drug didn’t work?
Who got harmed by a useless drug?
They claim that it’s drug testing and years of research that makes new drugs so expensive, but today they test for only a few weeks and sometimes only on 20 people or less,
Where’s the big cost?
Other times they go to some remote African village and test a few women and kids for a month and then pay off the FDA (fees charged for approval)
and put the drug on the market after about 3 weeks, 6 weeks if the FDA drags its feet.
Where is the expense?
The plane tickets to Africa or setting up temp lab in the bush?
This is just one more example of why I have come to highly mistrust and have very little confidence left for the FDA.
When they personally affected me with their meddling in bioidentical hormones I took a stand to take control of my health. I stood firm, refused to go down the road of using synthethic hormones and paid out of pocket for compounded bioidentical as many of my friends have done.
They are meddling where they need not and failing to address issue after issue they are authorized to deal with. The FDA no longer has our health in their main focus. They have gone astray and allowed themselves to corrupt into the hands and controls of the “big boys”.
Let this be held up as an example of why we have such a high cost of health care. The US public should be made aware of this 30,000% increase in the cost of a drug through complicity with a Drug company, the FDA, and even a health charity accepting funding from that drug company. There may be room for adding the cost of additional studies for a substance in use, but this is way way over the top.
Make that 300,000%
The only way to correct situations like this is to get marketing out of medicine and have proper regulatory oversight by government which does not seem to be the FDA. Crony capitalism does not work when the lives of people are at stake and this should be one area where private interest groups in government should not hold sway over our representatives. It is absolutely insane that so much of our gross national product is in medicine. This is all a false build-up of the economy based on illness. We need to get the marketing courses out of our medical schools. We all know marketing does not provide any health benefits so why do we keep allowing it? Medicines should not be “products” to gouge the public with. At the very least the government should have a fair price index for medicine and make it a public document so the people can get a fair shake.
So, what is new with the FDA, which poisons and murders about 200,000 a year with approved poison drugs and only to increase the PROFITS of the Pharmaceuticals Co. Here I will inject a Quote statement from Herbert Ley, M.D. Former FDA Commissioner. Quote,”THE THING THAT BUGS ME IS THAT PEOPLE THINK THE FDA IS PROTECTING THEM. IT ISN’T. THE FDA IS PROTECTING THE PROFITS OF THE CORPORATIONS THAT PAY US AND THE POLITICIANS!” Yet your own Corrupt Politician has just lately sold the Citizens out, by increasing the powers of the of the FDA to RULE you on Poison Drugs you will have to take and what Toxin laden foods that you will eat and all for the Profits. Did you know that the FDA has it own Gestapo Swat Teams, so just do not get out of line and disrupt or threaten the Profit line. The FDA has no Controls or over site from any Elected Official and they will not do anything as it my lessen the their 30 pieces of blood stained silver they receive as bribes. The FDA is a government unto it’s self and now is the Accuser, Judge, Jury and Executioner, where in the FDA Kangaroo Court you have no rights under the Constitution as they are voided. One more thing, Vioxx was only removed after the Profits were received, but not before 125,000 died from taking this poison approved by the FDA. “If people let the government decide what foods they eat and what medicines they take, their bodies will soon be in a sorry state as are the souls who live under Tyranny.” THOMAS JEFFERSON.
YOU ARE ABSOLUTELY RIGHT!
IT IS TRUE, THE FDA PROTECTS THE CORPORATION, NOT THE PEOPLE!
VIOXX, CELEBREX, ZOLOFT, PROZAC, AVANDIA, TYLENOL, ALL CHEMO DRUGS AND RADIATION TREATMENTS.
Why did the FDA state that they will not pull a drug, even if it kills 50,000 or more, as long as it helps 1-2 people?
They should have stopped the FDA years ago when they made that statement about VIOXX AND CELEBREX.
After reading about the drug briefly, I see why they jacked up the price. If you go to their site or the patent sites, the first use listed for Makena is “gender reassignment”. They see a way to make mega bucks off of the sex change industry. They do not care about the premature births or miascarriage prevention uses of the product. I buy vet supplies from KV Vet, but no more. No matter how good their prices are.
There needs to be a congressional investigation of this. I’d like to know where the FDA gets the authority to grant exclusive rights to KV on a drug that has been around for over 50 years and is thus totally ineligible for patenting, and how KV gets to exercise exclusive rights without any patent on it. This seems to me to be an open violation of patent law. – – – – But sadly, I fear many of our congressmen are just as much in the thrall of big pharma as the FDA is, in which case it probably will never happen.,
Can I also suggest that people inundate the company’s website? Here’s their contact page:
Senator Brown, where did you go to school? Of course it isn’t in the interest of children, new mothers, or taxpayers, unless they are shareholders of the KV Pharm. Corporation. That’s what a corporation exists for…they only thing they consider (and are REQUIRED to consider by law) is maximizing profit for those with stock in the company. It doesn’t matter who gets hurt in the process of making money. I also find it laughable how the doctors quoted in this article seem to be so surprised that something as ominous as greed could ever find it’s way into the western medical system. Please! When western MDs allot 15 minutes (max!) per office visit per patient, why do you think this is? Is it so that they can help as many people as possible in a workday? I would love to believe that. But unfortunately, it is so that they can maximize their PROFIT. Have you ever had a question for your doctor? Try to get a hold of them? I mean, actually talk to the doctor. Good luck! And it’s not entirely the doctors faults. The western system of diagnosing and treating illness (not people, mind you) is rotten to the core. But the future isn’t all dark…
There are people like myself in our country who are practicing Chinese medicine, using acupuncture, herbalism, massage, nutrition counseling, and movement therapy (the 5 branches of Chinese medicine) to not only treat disharmony once it has arisen in the body, but to keep people from becoming imbalanced in the first place. Once you realize what western science (quantum physics) has proven – that the entire universe is just energy vibrating at different frequencies – you can see that nothing is impossible. So if you don’t have a relationship with one yet, go meet your local acupuncturist. Chances are they even offer a free consultation to answer any questions you may have about acupuncture or Chinese medicine in general. Bless…
Unfortunately we natural medical practitioners are too expensive for most and we have been very limited in what we can practice. The majority of this nation (western world) is ignorant about what is truly going on and accept that the doctor/government knows best. It may be too late but we need to get the word out there. I refused cancer treatments and healed without taking their poisons. Unfortunately I have to eat vegetables, fruits, and grains that are deficient in nutrients and poisoned. Sad to say but the greed has spread into the natural health movement also. So I just await death and do what I can for those who will accept it. Meanwhile I study and do the best I can as my insurance is worthless. Humans will destroy ourselves. Keep up the work and make a difference where you are.
This is horrible, yet totally characteristic of the pharma industry. Good thing that natural progesterone is available without a prescription and is low cost. Not that they want anyone to know that.
The numbers $10 vs. $30,000 are not unique. I would like to see attention to another kind of expensive treatment, this one characterized by permanent harm, that is given to over 100,000 Americans annually, about half of them women over 60, and often with complete disregard for the persons refusal to consent. Let me tell you of just one person in this situation.
Elizabeth K. Ellis (aged 67, retired school counselor, MA in counseling, of Moorhead, MN) was at her sister’s death in the hospital last fall, not eating well during her sister’s losing battle with cancer. Elizabeth takes Prilosec, which can lead to vitamin B12 deficiency, which in turn can lead to loss of appetite and not eating. Not eating also leads to B12 deficiency. Elizabeth was acting a little odd, such as holding her head at a tilt with her mouth open. Her daughter, just hours after The sister’s death, “because Elizabeth was already at the hospital,” locked Elizabeth in a room there and asked for a psychiatric evaluation.
Had a neurologist or savvy MD or naturopath been called instead, I have to think both Elizabeth’s highly probably severe B12 deficiency AND her hypothyroidism (probably crashing downwards both due to stress, and again, from not eating, food being where we get the thyroid hormone precursors, tyrosine and iodine) would have been evaluated and treated.
The psychiatrists prescribed ECT–electroconvulsive therapy. Cost of a bottle of orally absorbed methyl B12: $10. Cost of ongoing forced, unwanted ECT and associaated hospitalization: about $30,000 a month. Costs of thyroid hormone precurssors, tyrosine and iodine: about $10. Medical approach of rxing synthroid dosage increase–I don’t know, but it doesn’t compare to ECT.
But the REAL costs are to Elizabeth’s health and life, including that the REAL underlying issues go unassessed and unaddressed. Also she is kept from her husband, and from the supports she needs during grief. Cost of an ECT unit? $15000. It can easily pay for itself the first day it is used, and then, except for the anesthesia and muscle relaxants, the rest of the $1000 to $2000 is free and clear profit. BIG BIG BUCKS, and big big brain damage, always. A longitudinal study of ECT at 7 NY hospitals concluded, “persistent cognitive damage characterizes ECT.” Some people don’t recognize family members afterward. They can lose decades of memory as well. Some doctors claim that is part of the benefit–not remembering, the patients will have no reason for grievances or complaint.
I understand an FDA panel in January deemed ECT to be hazardous, untested, unsafe. Except, someone told me, ECT for “catatonia” was left out of that decision. Ironically, “catatonia” can result from either untreated B12 deficiency ( common in the elderly) or hypothyroidism. Elizabeth is rarely talking these days, making a diagnosis of catatonia easier to fix on her. The doctors from the beginning called her catatonic, even when she was home (briefly, until refusing any more ECT for which she was forcibly rehospitalized) with her husband, eating and talking and glad to be free.
Elizabeth lives in daily terror of more ECT, and separated from her husband. The doctors go to court NEXT WEEK on March 31, 2011 to seek a new court-order for more sessions of ECT and maybe drugs as well. PLEASE call Gov. Mark Dayton’s office 651-201-3400 and ask them to intervene for the safety of Elizabeth K. Ellis, and she that she be given the right to doctors of her own choice, including the psychiatrist Dr. Langsted (who does NOT condone ECT) and those who will treat real medical issues. If she can’t speak up for herself in the current situation, let her husband tell what she would want, as he believes she has a right to her own decisions, and is most familiar with her choices, and with her real needs. Or emphasize to Dr. Dayton’s office the need for all seniors with health issues or receiving psychiatric attention to have critical objective lab work done to asses basic underlying issues that lead to symptoms some have long seen as psychiatric and nonbiological.
I deeply thank you. I hope that the end of this 6 month ordeal for Elizabeth shall also be the beginning of the end for 100’s of 1000’s of other Americans, sold or forced into ECT treatments at the expense of real needs and permanent injury to their brains. Please also, ANH-USA, take on this issue. Again, I deeply thank you for caring and helping.
Unfortunately many of the premature births caused by the inability of some to pay the inflated price will be blamed on smoking and secondhand smoke. Why face the truth when there’s a ready scapegoat?
…If it aint broke, don’t fix it! This is just so wrong. Pharmacies gauge us and promote chemical solutions that make us worse, and then cry to FDA about people using natural products to stay healthy so the FDA regulates NATURAL remedies.
What’d wrong with this picture!!??
Thanks for this article. It sheds light on a really important problem that many people don’t know about: the cost to the public of FDA approval.
Actually, there are many instances of low-cost, effective drugs that are made by compounding pharmacies and that are, hence, affordable for patients. The trouble often starts when a pharmaceutical company gets FDA approval for the drug and sells it at a huge markup.
One of the drugs I write about in my recently published book, “HONEST MEDICINE,” is Low Dose Naltrexone (LDN), used off-label for 25 years by many doctors for autoimmune diseases, such as MS, Lupus, Rheumatoid arthritis, Crohn’s disease, etc. LDN costs $40 a month (maximum) through compounding pharmacies. (Naltrexone was approved in the mid-1980s by the FDA for another purpose—drug and alcohol addiction—at TEN TIMES THE DOSE that doctors are now using it off-label for autoimmune diseases.)
I understand that the physician who championed LDN’s off-label use for autoimmune diseases was in conversation years ago with a drug company to put it through trials for this “new” use. But the pharmaceutical company in question told him that—if they paid the freight to put LDN through clinical trials—they would have to charge patients (and insurance companies) a huge amount of money. He refused. He simply couldn’t condone patients (and insurance companies) having to pay exorbitant amounts of money for a drug they could get so cheaply through compounding pharmacies. So, LDN is still produced by compounding pharmacies; patients still pay $40 or less per month for it. LDN has a HUGE patient following, but because it doesn’t have FDA approval for use for autoimmune diseases, many doctors still refuse to prescribe it for their patients—despite the fact that it helps so many people.
On one hand, I am sad that women (and insurance companies) are now having to pay huge amounts of money for the drug described in this article—a drug they’ve been getting so cheaply from compounding pharmacies. But still, I am happy that this outrageous practice of price-gouging by pharmaceutical companies is getting so much media attention. Maybe it will make a real difference.
Thanks so much for this article.
The key words here are “because they can”. Forget about writing to anyone. It won’t help.
I agree with you D, but we can’t sit and do nothing. At least our voices should be heard. Sorta like the tortoise and the Hare; keep annoying them until we make enough progress to get the upper hand. They will eventually hang themnselves with their own greed. Oh,what a glorious day it will be.
D., there is certainly some truth to that statement. The problem being there are sooo many disbanded groups that have the same or similar goals to promote natural healing, challenge big pharma, the FDA, etc.. Until we have one voice that brings all these groups together, it may just stay this way. Unless these types of groups have a “Tea Party” style following it probably won’t change. Sad but true. My own research into this took hours and hours to just start to find sites like this. So getting these views and information out is a challenge indeed.
I don’t get it. Why do people even want to take pharmaceutical drugs in the first place? There are so many affordable natural, bio-identical progesterone creams available without prescription and they are superior. Just use them and screw the greed based drug industry.
Correct, but they are vulnerable to attack from Big Pharma, through its attack dog, the FDA. There has been a quiet little war against Compounding Pharmacies for years. Big Pharma won’t be happy until they can get orphan status for orange juice. They want all the power in the world to rake in profits in, and none of the responsibility when their actions cause misery and suffering.
All drugs aren’t bad. Some are quite helpful, some are life savers, some are marginal, and all are over prescribed.
Moderation, your aft-most. What I said is stark truth. If you can’t handle the truth, don’t solicit comments!
I repeat that Big Pharma, the FDA and the AMA, are just “In it for the money.” THEY ARE NOT YOUR FRIENDS!
My sympathy goes out to all the really caring doctors, who see this and are caught between those rocks and hard spots. That must be frustrating and discouraging to those having taken the Hipocratic oath.
I sincerely hope this all comes to a peaceful and a multiple-win, no-loss conclusion.
Questions: What does KV stand for? What can we do to spread the good word about the good works of Dr.Raymond Peat and those of his ilk? We need to start a grass-roots movement in support of corrageous folks like that. They deserve to prosper in their humanitarian endeavors.
This whole situation is no surprise to anyone who has been watching what is going on in Washington. It isn’t that corruption is a new thing, it is just that they have been getting away with so much for so long without any real consequence, that they no longer feel they have to pretend to be honest.
I treat uterine irritability with herbs, and have had 100% success in stopping preterm labor. People need to wake up and realize that we don’t need these thieves.
The time has come for us all to question if we really need all these expensive drugs that doctors are forcing on us. Time to wake up and look for answers elsewhere. These drugs often just cover up symptoms and don’t cure anything. I thought if we made a vow never to use the drugs that they spend absorbant amounts to advertise on TV maybe they would get the messge and we would not have to watch those tasteless drugs ads with many deadly effects. It’s time “We the People” vote with our wallets!
This is a classic illustration of why FDA is a cause of market protection of the Pharmaceutical industry. Passing on the needless increased cost to insurance companies, taxpayers and ultimate consumers. Why expect them to assist in controlling health care costs?
This has been an eye opening article. And I really got a lot of insight reading the comments. I have been battling Big Pharma with consumer groups for years, mostly to no avail. I found a doctor who is into alternative meds, but now I have no insurance.
The doctors who are paid by the county to provide services to seniors push drugs and really browbeat patients about how they will die without the drugs they prescribe. I only go in when necessary. Otherwise I depend on a Naturopathic doctor who is not doing well financially because the government won’t pay him for his services to patients when they lose their health insurance coverage.
Please keep us informed. I didn’t know someone could have you locked away because you are depressed and treat against your will; must be like having to sign off on your refusal to cancer treatments.
I have been reading about what is going on in the States now for some time and with a heavy heart. So much corruption and greed. The people are being screwed. You can see it in medicine and commerce. I hope one day soon that there will be enough of you who know the truth that you will be strong enough to stand up for what is right and just and say enough. These rich and powerful people at the top need to be stopped. The people need to make the rules not be slaves to the few. Hard times are just around the corner for the American people. You really need massive change. Good luck to you all. Much love from NZ.
Let’s be honest here -and I’m about to say something that will enrage a lot of people- first, all of you who blame the FDA, Big Pharma, insurance companies,politicians,etc. -all have told most of the truth. BUT – anyone who will take a drug because they have seen it on TV ( which , by the way, should be illegal ) ,or their highly educated, but ignorant doctor has shoved a prescription into their hand w/o explaining anything about the drug (probably because HE doesn’t know ), or even just because afriend tells them that they ought to ask for it -is just contributing to all the problems connected with the huge drug and medical industry! Don’t be sheep – educate yourself ! It doesn’t take that much effort, and it could mean the difference between health and chronic drug-induced illness; between being normally debt-free or being so bankrupt that you lose your home and everything you own – and finally ,even what’s left of your health and even sanity.America was built on the idea if individual free will and choice – what happened? Did we all forget how tothink for ourselves?
Big Pharma is slowly but surely trying to control more inexpensive treatment options by padding the pockets of the FDA, senators and the like. They have more then 5 lobbyists per senator. Who can resist that onslaught? As an integrated healthcare practitioner I have seen the FDA remove several chinese herbs from the market because of safety concerns (Ephedra for example had been misused in weight loss supplements) and 2 or 3 people died. Ephedra is the best herb to relieve asthma symptoms. Tylenol on the other hand, an over the counter medication, is highly liver toxic and every year more then 3 people die from this drug. More then 100.000 people per year die from drug interactions. But here the FDA does not step in and remove Tylenol from the market. So who are they really protecting? Big Pharma is not concerned about anybodies health. It’s all about the money and the bottom line. Big Pharma has a sweet deal in the old US of A, we pay the highest prices for pharmaceuticals in this country.
Sen. Sherrod Brown has sent a letter to KV Pharmaceutical asking the company to “immediately reconsider” its pricing. I would suggest something stronger. They should be arrested for piracy. At a time when we are searching for ways to lower healthcare costs, this is the opposite direction to take. 17-hydroxyprogesterone caproate should remain a low cost treatment and its orphan drug status rescinded.
This right here shows how pitifully shallow and selfish some people are.
The CEO and the rest of them at that KV should be in jail for life.
Funny how people use the word humane when humans (not all, but a huge amount) don’t care at all about anything but the childish, emotionally and spiritually stunted game of “I have more money than you”.
While there are good people and while I do have hope that we will evolve, right now when I look around at what people are capable of I am ashamed.
It is time to get ALL people that see things that are wrong to realize they must speak up.
Never remain silent on things that matter, that’s why we are in this mess.
As has been said:
“Silence is Complicity”
IT IS ALL ABBOUT POPULATION CONTROLL IF YOU ARE FOR SOME REASON UNSUITABLE
OR UN ACCEPTABLE TO THE ELITES THEN YOU WILL NOT POPULATE. REMEMBER HITLER AND THE NAZIS WERE INTO THIS TYPE OF BELIEF. LETS LOOK A LITTLE CLOSER AND SEE IF PLANED PARRENTHOOD IS IN THIS MIX GIVING THE INCREASE IN INFANT MORTALITY RATES IT IS ALMOST ASSURED THEY ARE.
THANK YOU FOR READING.
This is a country with few exports, few ways to make money other than by charging its citizens outrageous amounts for prescriptions and medical procedures. Basically, how would the US make money if it had a healthy population? How would corporations make their money?
When will we ever learn. We need to learn to do our own independent research. Corporate America rules this country, not the people.
I LIVE IN CANADA BUT AM NOT UNAWARE OF POLICIES IN THE US. WE ACTUALLY LIVE IN A VERY SCARY WORLD OF THE LIKES WE HAVE NOT SEEN BEFORE. THANKFULLY WE CAN BE MORE EDUCATED WITH THE FLOW OF INFORMATION IN THESE TIMES. THE FDA SHOULD BE DISMANTLED, THE EXEC’S FLOW BETWEEN THE FDA AND BIG PHARMA WITH THEIR JOBS AND I DO NOT BELIEVE THAT THIS IS BY MISTAKE. IN CANADA, A FRIEND OF MINE JUST HAD HER SON DIAGNOSED WITH LEUKEMIA, A THIRD CANCER DIAGNOSIS FOR THIS YOUNG MAN. WITH THIS CANCER RETURN HE WAS TOLD THAT IT IS NOT UNUSUAL FOR PATIENTS TO EXPERIENCE A NEW TYPE OF CANCER YEARS AFTER BEING TREATED FOR CANCER. THE MEDICINE OFTEN DOES THIS TO OUR BODIES. HE IS NOW IN A BATTLE FOR HIS LIFE YET AGAIN!! WE NEED A HUGE REVOLT, NOT ONLY IN THE US BUT ALSO IN CANADA FOR OUR RIGHTS TO LIVE CLEAN, EAT HEALTHY, AND ENJOY THE TYPE OF TREATMENTS THAT WE HAVE RESEARCHED AND KNOW CAN HEAL OUR BODIES. THOSE OF US AWARE ARE DOING OUR BIT BUT THIS IS BIG AND WILL TAKE REAL ORGANIZATION TO MAKE CHANGE. IF WE THINK CANCER IS AN ISSUE NOW THEN WAIT 20 TO 30 YEARS AND ALL THE GENETICALLY MODIFIED FOODS ARE ON THE MARKET AND OUR CHILDREN AND GRANDCHILDREN WILL BE USED AS GINNY PIGS FOR A FOOD THAT CREATES IT OWN PESTICIDE THAT CAN TRANSFER TO OUR GUT AND CREATE MORE PESTICIDE INSIDE OUR BODIES. FOODS THAT CARRY WEIRD GENETICS THAT HAVE NEVER BEEN PROVEN TO BE OK FOR HUMANS BUT APPARENTLY THE RATS DON’T DO SO WELL ON THEM, GIVEN THE CHOICE THEY WON’T EAT THEM. NEITHER DO COWS WHEN OFFERED GENETICALLY MODIFIED CORN, THEY WON’T EAT IT. DON’T EAT CORN, SOY, CANOLA OIL OR COTTON UNLESS IT IS ORGANIC. WE NEED TO WAKE UP, SUPPORT OUR LOCAL FARMERS WHO SUPPORT ETHICAL AND ORGANIC FOOD! WE NEED TO STOP PURCHASING THOSE PRODUCTS THAT ARE DETRIMENTAL TO OUR HEALTH, BE IT MEDICINE OR FOOD AS MONEY TALKS AND MY BE THE ONLY WAY TODAY TO MAKE A DIFFERENCE. READ “SEEDS OF DECEPTION”, BY JEFFREY SMITH AND WATCH “THE WORLD ACCORDING TO MONSANTO” http://wideeyecinema.com/?p=105 WE ARE WHAT WE EAT!! POLITICIANS ARE NOT LISTENING!! VOTE WITH YOUR DOLLARS!!
I really don’t get it – don’t all of the people working for Big Pharma and all of the politicians supporting these horrendous decisions realize that it is also THEIR OWN HEALTH and that of their families that is being jeopardized?? What will it take to get them to see that??
More horror coming! “It takes al ong time to do the necessary administrative steps that have to be taken to put the legislation together TO CONTROL THE PEOPLE”. The above quote is from Congressman John Dingell (D-MI) explaining why it will take to 2014 to fully phase in ObamaCare. (News talk WJR Radio with Paul W. Smith, Mar. 23, 2010). I copied this from a story in either Judicial Watch magazine or an ACLJ (American Center for Law & Justice) newsletter last year. I really wonder if there is any hope for us so long as we are under the control of Big Pharma, FDA, etc.!
I came to believe that, unfortunately, the U.S. has become a confederation of dunces. Given all the tools of democracy it inherited, how else can one explain the FDA?