Story by Lacey Jarrell
Photos by Marcie Giovannoni
“This really isn’t a fair position to put a mom in,” Cherie Lennox thought to herself. She was 12 weeks pregnant and had just discovered that Makena, a medication she needed to help carry her at-risk baby to term, was going to cost almost $1,500 a treatment. She quickly did the math: one treatment per week for the next 28 weeks would cost $42,000—more than her $32,000 a year teacher’s salary. The prognosis did not look good. Lennox began to wonder how she would come up with the extra money. Would she have to sell her house in order to save her baby?
Up until February 2011, compound pharmacies had been legally manufacturing 17P, a generic version of Makena, under the Food and Drug Administration Modernization Act of 1997. The Act states that compound pharmacists are only allowed to sell medications that are not already commercially available. Therefore, in February when KV Pharmaceutical acquired the rights to hydroxyprogesterone caproate, or Makena, as an “orphan drug,” competitive production of the drug nearly ground to a halt. The “orphan” classification granted the pharmaceutical company seven years exclusive rights to sell it and made it illegal for compounders to manufacture a drug they’d been making since another pharmaceutical company lost its patent on the formula a decade earlier.
If forced to pay KV Pharmaceutical’s asking price, even after the company decided to lower the cost to $690 per injection, Lennox was doubtful she would be able to afford the treatments. Alternatively, most compound pharmacies had sold 17P for a fraction of that price. If Lennox could get 17P, she would have the medication she needed to help keep her unborn child safe in her womb. As she weighed her options, the choice seemed clear. At the time, however, a legal battle for the ability to make Makena set corporate interest against patient welfare, placing compound pharmacies square in the middle.
“We’re talking about life and death for these babies,” says Kate James, R.Ph., owner of Broadway Apothecary in Eugene, Oregon. “It’s easy to get frustrated with big pharmaceutical companies—‘big pharma’—because once a drug company begins making a product, I can’t legally make it anymore.” Facing severe penalties, James found herself required to turn away expectant mothers, many of whom were already on the medication.
The pharmaceutical atmosphere remained tense until March 30 when, in the wake of national outcry from both patients and the medical industry, the FDA released a statement explaining “the FDA does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate” for all valid prescriptions and as long as compounded products follow FDA safety guidelines.
Although Broadway Apothecary purchases 17P’s raw ingredients in small quantities and therefore pays premium prices compared to large corporations that can buy in bulk, James says the materials are relatively inexpensive. KV attributes Makena’s higher price to research and development costs, a claim that has been called into question by industry critics since KV acquired the drug after the National Institutes of Health had completed much of the needed testing. Whatever the reason, the result is a wide gap in prices: James’s pharmacy sells 17P for $12.50 a dose. KV charges more than 50 times that amount.
A Compounding History
In the late nineteenth century, physician and pharmacist Francis E. Stewart coined the phrase “a patented thing is a thing divulged” in reference to his quest for medical reform and federal patent laws. He believed that patented medical formulas would ensure widespread accessibility to drugs, as well as offer incentives for research and collaboration. Stewart’s platform embraced ideals of strong medical industry relationships coupled with a revolving partnership with the public, therefore ensuring that information shared would indeed be information divulged. However, as pharmaceuticals rose to become one of the largest industries in the United States, the knowledge that benefits so many became controlled by only a select few.
Medical compounding has a history that began, by some estimates, as early as 80,000 years ago. For centuries, the esoteric knowledge of plants with healing properties belonged solely to tribal healers.
However, as the compounding process evolved from simple botanical compounds to elixirs and nostrums and finally to modern capsules and injectables, compounding became a widespread, reliable form of treatment. In fact, compound pharmacies were the main source of prescription medications for Americans until the mid-1940s. It wasn’t until World War II and the mass production of penicillin that the industry began to push for a one-size-fits-all mantra.
“At the time, we needed medications that were quick, uniform, convenient, and cheap,” says Ann Williams, R.Ph., owner of Emerald Valley Compounding Pharmacy in Junction City, Oregon. Williams admits that while the big pharma approach has seen some success—making much needed medications available globally—it is not without its drawbacks.
“The downside is that you must work within the doses you have. What happens when you need 14 milligrams of a drug? You can’t get that from a 25-milligram tablet,” Williams says.
The competitive pharmaceutical marketplace of the pre-1940s produced a kaleidoscope of tailor-made remedies. A prescription could garner a patient any number of medications in a customized form, dosage, or flavor. Even today, while large pharmaceutical companies struggle and sometimes fail to deliver suitable medications, compound pharmacies are still able to cater to every patient’s unique needs.
A Viable Medical Resource
When Kirsten Wolfe’s cat Ralphie, a seven-year-old domestic shorthair, was diagnosed with an anxiety disorder (most likely caused by her family’s move to a new home) her veterinarian prescribed Prozac.
“It was unpleasant for everyone,” says Wolfe, who had to force-feed Ralphie broken up pieces of 10-milligram capsules. “Feeding him like that defeated the purpose of the Prozac because it was already an anxiety inducing experience.”
Returning to her veterinarian once again, Wolfe acquired another prescription. This time, Ralphie’s medication would be tailor-made for him in a tuna-flavored, 5-milligram dose that Wolfe could pick up at her local compound pharmacy.
“It is incredibly hard to give a cat medication but he ate these like treats,” says Wolfe, who believes that without the specially made medication, Ralphie might still suffer from anxiety attacks.
Experiences like those of Lennox and Wolfe illustrate the unique and vital role compound pharmacies play in the medical arena. According to the Pharmacy Compounding Accreditation Board, an estimated 30 to 40 million compound prescriptions are filled annually. These millions of patients, however, can only be served when compound pharmacists are legally allowed to make the necessary medications.
“I get angry when I think about what these big pharmaceutical companies are doing,” says Lennox, who was only able to purchase 17P after navigating a barrage of red tape and legalities with her insurance company. “They are putting real people’s lives at risk.”
While administrative offices like the FDA can and sometimes do concede jurisdiction over products such as Makena, this seems to be the exception rather than the rule. Many similar trademark issues have arisen with medications such as colchicine, a compounded gout medication. Since being acquired by West-Ward Pharmaceuticals, colchicine has increased significantly in price and is now only available at commercial pharmacies under the patented name of Colcrys.
Over 100 years ago Stewart spoke of his goal to “harmonize the interests of science and commerce, so that one may aid the other without jeopardizing the interests of either.” In modern times, science and commerce may have been merged, but the integration Stewart dreamed of has not been wholly successful. Consequences resulting from conflicts between the pursuit of profit and patient interests continue to plague the medical industry. Until a true collaboration of interest can be made, compounders will be left to deal with the collateral damage that big pharma leaves behind.

Gallery • 2 Photos

Remaking the Remedy: Compound Pharmacies