Director, Safetyissues.com

I am really disturbed by the fact that the term “SAFETY” is being used so often to dupe the American people into submission. There is so much propaganda used as scare tactics that manipulates us into a call to action which is most times on false pretenses. What prompted me to no longer meditate and procrastinate on writing about this subject matter is this Preemie birth preventive spikes from $10 to $1,500 story from the Atlanta Journal.

It is a press release about a drug used to prevent premature births. The FDA finally approved it and gave an exclusive contract to KV Pharmaceutical of St. Louis. KV Pharmaceutical won government approval to exclusively sell the drug, known as Makena (Mah-KEE’-Nah) for the next seven years. The price of this “Makena” went from $10 to $20 per shot to $1500.00 per shot starting next week. Yes, you read that correctly. There is no typo!

But don’t worry , KV Pharmaceutical Inc. says there will be a KV subsidiary, named Ther-Rx Corp., that will market the drug and have a patient assistance program designed to help uninsured and low-income women get the drug at little or no cost. The article goes on to report that some of the financial “burden will fall on health insurance companies, which will have to raise premiums or other costs to their other customers. And some will fall on cash-strapped state Medicaid programs, which may be forced to stop paying for the drug or enroll fewer people”. The Ther-Rx patient assistance program promises free injections or much reduced prices based on income.

While I am glad this drug company is showing sensitivity to the poor and disadvantage population, I remain puzzled as to how they justify the 150% increase in price. KV Pharmaceutical executives claim that the cost is justified to avoid the mental and physical disabilities that can come with very premature births. They estimate the cost of care for a premature birth at approximately $51,000 in the first year.

“And taking Makena can help offset some of this costs by making sure the baby stays in gestation as close to full term as possible.” says a spokesman from KV Pharmaceuticals. With this kind of profit margin, I am not sure why the FDA does not just take on selling the drug itself. At least we the people whose taxes paid to develop this drug could get the benefit of the profit it helped to create. Did I say that loud enough! Since the FDA officially approved it and gave the exclusive manufacturing right to one company, thus, eliminating competition. FDA says it was done to improve safety. I don’t understand what is more safe about having one company produce this drug? And does that justify the enormous price tag on this drug?

For the amount of money that will be made on this drug the FDA could set up a Department of Pharmacy and make money for the people who invested in the development of Makena, we the tax payers. These major research and development efforts by corporations always write off on their taxes the losses to the taxpayers. It seems to me that there would be an argument for putting a few staff member on the payroll at FDA who would be in charge of product manufacturing, since there is one source. In addition this Department of  the FDA could be the distribution center sending out the product to healthcare clinics, doctors offices, hospitals for a price less or equal to that $1500 per shot and have money left over to through into our tax pool which could fund healthcare for the disadvantaged.

Think safety and Return on Investment!

~ Michelle Markey
Director, Safetyissues.com

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