But recently it was designated an "orphan drug" by the FDA, meaning that the company KV Pharmaceutical was given the exclusive right of production and sale.
They immediately raised the price from $10 per dose to $1,500. Since the drug comes in the form of a weekly injection, that means a price hike for at-risk pregnant women that could be as much as $30,000.
According to the Alliance for Natural Health:
"An orphan drug 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."
Any time a company is able to turn a common $10 therapy into a "rare" $1,500 therapy, greed is at work, and greed is something Big Pharma knows a little something about. But this particular instance by KV Pharmaceutical is especially egregious and unconscionable – potentially damaging the health of every pregnant woman at risk for pre-term labor (along with their unborn children) who don't have health insurance.
Because anyone without insurance surely can't afford the $1,500 per dose price tag, and this fact will certainly lead to more premature births in the US.
That's going to cost all of us, according to the article above:
"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 [born prematurely due to eliminated access to the $10 drug therapy] 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 treatment of which will also be paid for by taxpayers]."
You would think public outrage, political pressure and calls to reconsider your decision from your partners in medicine would lead this company to rethink its decision, but don't count on it. Big Pharma really doesn't care about the damage they might do to your health, or the high costs their reckless decisions impose on society, they only seem to be interested in maximizing their profits (even when people are dying from their products).
What is 17P?
The $1,500 drug therapy in question here is a synthetic version of the hormone progesterone called hydroxyprogesterone caproate. Progesterone is one of the most common hormones produced by a pregnant woman, and supplementing with 17p had been prescribed "off-label" by US doctors for the last 50 years to lower the risk of pre-term birth.
Treatment with this synthetic progesterone can begin as early as 20 weeks into a pregnancy and continues until week 37. Births after 37 weeks are considered "full-term".
Then, after 50 years of "off-label" use for pre-term birth risks, a landmark study in 2003 by the NIH "officially" found that 17p reduced the risk of premature birth in one-third of the pregnant women studied who had already suffered a pre-term birth in a previous pregnancy. Having a pre-term birth is the greatest risk factor for having another pre-term birth in future pregnancies, and the rate of pre-term births has been increasing in the US for many years.
From BusinessWeek.com :
"According to the March of Dimes, preterm birth -- or the birth of a baby at less than 37 completed weeks of pregnancy -- affects one in eight babies born in the United States.
What's more, the rate of preterm birth has increased more than 35 percent in the last 25 years in the United States, and late preterm births -- babies born at 34 to 36 weeks of pregnancy -- account for nearly three-quarters of such births."
With a steadily rising US rate of pre-term births and an effective off-label drug now a potential new blockbuster source of revenue, the stage was set for the drug industry to make their play. But before I tell you about that, I want to talk about the difference between synthetic hormones and some more natural hormone options.
Benefits of Natural versus Synthetic Progesterone
While it may be an effective tool against pre-term labor, synthetic hormones are not my preferred choice when it comes to hormone therapy. I prefer natural bio-identical hormone supplementation, and I also advise against EVER taking oral hormones, or putting them on your external skin.
More about that in a minute.
Natural progesterone is a steroid hormone made by a woman's ovaries when she is either pregnant or ovulating, and it is also made in smaller amounts by a woman's adrenal gland.
Natural progesterone supplementation, besides reducing pre-term birth risks, can also be very useful to help balance excess estrogen in your body (excess estrogen can put you at major risk of developing breast cancer). Natural progesterone is a precursor hormone that your body uses to make other hormones, such as adrenal hormones. Your body can even convert progesterone into estrogen or testosterone if your body needs a greater supply of those hormones.
A full discussion about bio-identical vs. synthetic hormones, and the effect of hormones on your body and how and when hormone supplementation might be right for you can be found in more detail here.
Natural (not synthetic) progesterone is made from a substance called diosgenin, which is commonly extracted from wild yams or soybeans. Even though natural progesterone may be extracted from soy it's a highly purified hormone and there are absolutely no remnants of soy substances that would lead to any problems.
So if you are looking into hormone therapy of any kind, I strongly encourage you to consult with a natural health care specialist so you can determine if it makes sense to supplement with natural bio-identical hormones.
When considering natural hormone therapy, remember to avoid using oral hormones, my recommendation for both men and women is to administer them trans-mucosally.
How KV Pharmaceutical Cornered the Synthetic Progesterone Pre-Term Labor Market
KV' synthetic progesterone was approved by the FDA in 1956 in the form of a drug called Delalutin, which was used to treat female hormone disturbances and cancer, but ever since the 1950's Delalutin had been used off-label as a pre-term labor drug.
In other words, the FDA never approved Delalutin to be used for pre-term labor, but it was widely prescribed by U.S. doctors for that purpose.
In 1999 Delalutin was withdrawn from the market for business reasons, and after that 17p was legally prepared generically by any compounding pharmacy -- and continued to be prescribed by U.S. doctors off-label for reducing the threat of pre-term birth.
Then, after the 2003 study by the NIH documented that this synthetic progesterone was indeed an effective tool to use against pre-term labor, the corporate predecessors of KV Pharmaceuticals applied to formally make this synthetic progesterone an FDA approved drug for pre-term labor, and even though it had been used for the past 50 years off-label for that very purpose, they were able to secure the exclusive rights to it through the Orphan Drug Act.
Their new drug, Makena, is chemically the same as Delalutin. But there's one big difference – the FDA protects Makena as an "Orphan Drug" -- meaning KV Pharmaceuticals has an exclusive seven year license to sell it at $1,500 per dose, and has already sent cease and desist letters to compounding pharmacies who still offer an affordable alternative $10 therapy.
So, effectively, KV Pharmaceuticals cornered the market on synthetic progesterone for pre-term labor. And they raised the price tag exponentially simply because they could. Is this capitalism at its finest?
Or simply a perversion of the Orphan Drug Act?
According to the article above:
"An orphan drug is [supposed to be] 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.
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."
In other words, KV Pharmaceuticals and their corporate predecessors appear to have exploited a loophole in the Orphan Drug Act, and it's going to cost those who need this therapy dearly financially, not to mention the health consequences it's going to create for every uninsured pregnant women (and their unborn children) at risk for pre-term labor in the US for at least the next seven years.
KV Pharmaceutical's Checkered Past
According to the Philadelphia Inquirer, this isn't KV Pharmaceutical's first brush with negative publicity:
"KV landed in hot water with the FDA in 2009 for poor quality control after shipping out dangerously oversized morphine tablets. The company's former chief executive officer, Marc Hermelin, pleaded guilty a few weeks ago to federal charges of misbranding drugs and was sentenced to a month in jail and a million-dollar fine."
And according to the article above, this recent negative PR along with the public outcry over the the synthetic progesterone price hike has led KV Pharmaceuticals to recently hire the public relations firm Golin Harris to handle their current PR mess.
So when you soon see stories start to appear in the media related to KV Pharmaceuticals and the drug Makena that tout the value of free markets and American enterprise and the genius of our capitalist system, you can thank Golin Harris directly right here.
Congress is Getting Involved in this Fight
According to the above article:
"[US] Senator 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."
Senator Brown, along with Senator Klobuchar, followed this with a letter to the FTC commission to investigate potential anticompetitive conduct from the increase in price."
Yes We CAN Make a Difference!!
Grassroots activism on this issue produced swift results! After the original notice ran on the Alliance for Natural Health's website, the FDA was flooded with complaints from concerned citizens, some of whom even got their congressional members involved.
The FDA responded favorably, and has clearly stated that they will NOT prevent compounding pharmacies from making 17p, so this long-standing method of treating pre-term labor will still be available "off-label", and patients can obtain their 17p in this manner to circumvent KV's massive price hike on this treatment. The Washington Post recently quoted an FDA official on this matter:
"We have our hands full pursuing our enforcement priorities," said the [FDA] official, who spoke on the condition of anonymity because of the sensitive nature of the issue. "And it's not illegal for a physician to write a prescription for a compounded drug or for a patient to take a compounded drug. We certainly are concerned about access of patients to medication."
The FDA official went on to say that:
"…if requested, the agency [FDA] could approve a lower-priced generic version of the drug for another use that doctors could prescribe 'off label.'"
So the results are in and the FDA has agreed with the American public that an outrageous price hike for this common treatment available for the last 50 years at $10-20 a dose is not acceptable.
Remember, should you and your physician choose to supplement with progesterone for the risk of pre-term birth, I only recommend natural bio-identical progesterone, and even though the FDA is committed to keeping a low-cost synthetic progesterone available, you can still do better.
An Even Better Option
Although this article clearly serves as a powerful illustration of how the drug industry can pervert the system to gain huge financial benefit, it is important to remember that you can frequently side step their insanity.
Using natural progesterone costs 99% less than its clearly inferior synthetic option. If you do need it, using natural progesterone is not only less expensive, it is far more effective and has less side effects.
I will discuss this topic in future issues but it appears that iodine deficiency can also be a major issue here as it contributes to imbalance of the three estrogens, estrone, estradiol and estriol. About 95% of people are deficient in iodine and when you have enough iodine you are typically far more resistant to diseases like breast cancer.
It is my strong recommendation that all women start supplementing with iodine before pregnancy. The best form of supplement would be 2-10 drops of Lugol's solution, or 1-4 capsules of a 12.5 mg potassium iodide/iodine combination.