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Why is Daraprim So Expensive?

September 10, 2020

high drug prices

Wendy S. Armstrong, MD has seen what happens when the cost of Daraprim puts the drug out of reach for a patient in need. Armstrong, a Professor of Medicine in the Division of Infectious Diseases at the University of Emory School of Medicine, has watched as patients grapple with the difficult decision of choosing to take on the steep price of Daraprim or choosing an alternate medication that has not been as well studied.

In one case, one of Armstrong's patients was diagnosed with toxoplasmosis after receiving a kidney transplant. While in the hospital, the patient was successfully treated with Daraprim for four months.

However, when the time came to be transferred to a rehabilitation center, the facility turned her down because they weren't willing to take on the cost of Daraprim. As a result, the patient stayed in the hospital months longer than necessary causing further health complications.

What is Daraprim?

Daraprim, otherwise known as pyrimethamine, is an antiparasitic drug. It first became available in January 1953 as a treatment for malaria. Daraprim's mechanism of action involves preventing parasites from using folic acid which in turn prohibits the production of the proteins necessary to grow and develop new parasites.

Although it was initially developed as a treatment for malaria, its most common use today is to treat toxoplasmosis. It is often used in conjunction with sulfonamide, an antibiotic. Indeed, Daraprim and sulfonamide are the first choice of treatment when it comes to treating patients with toxoplasmosis.

What is Toxoplasmosis?

Toxoplasmosis is a disease caused by the parasite T. gondii. A person can become infected by eating contaminated raw meat, drinking contaminated water, or in rare cases by blood transfusion or organ transplant. T. gondii is also found in animal feces, therefore it can be found on fruits and vegetables that have not been properly washed. More specifically it can also be found in cat feces, and if hands are not washed after changing a litter box the parasite can then accidentally be ingested while eating food, although this is an incredibly rare or near impossible means by which the disease has been transmitted.

According to the CDC, "In the United States it is estimated that 11% of the population 6 years and older have been infected…" with toxoplasmosis. Very few of these infected carriers ever show symptoms due to their healthy immune systems.

It is those with compromised immune systems who develop the unfortunate signs and symptoms of this disease. For example: people suffering from HIV/AIDS, cancer patients undergoing chemotherapy, pregnant women, and newborns pose the highest risk for developing illness due to toxoplasmosis.

In other words, the most vulnerable among us.

Signs and symptoms of toxoplasmosis have a wide range of severity. Mild cases often only include swollen lymph nodes, fever, and general body aches. Severe cases will experience headaches, confusion, blurred vision, nausea, poor coordination, and seizures, eventually leading to death. Pregnant women who contract toxoplasmosis are at risk for miscarriage or stillbirth.

Treatment of toxoplasmosis with Daraprim in conjunction with sulfonamide has been found to be successful. Depending on the severity of the case and the comorbidities of the patient, the length of treatment can vary. In patients with functioning immune systems who are experiencing severe symptoms, treatment with Daraprim is only indicated for 2-4 weeks.

In immunocompromised patients, toxoplasmosis can be fatal if it is left untreated. According to the CDC, in those patients, Daraprim should be taken until there are no signs or symptoms of toxoplasmosis for several weeks. These patients will often take the drug for up to six months. In the case of patients who have HIV/AIDS, relapse is unfortunately common. HIV/AIDS patients may take Daraprim for the remainder of their lives.

Who Developed Daraprim?

Daraprim was developed by Gertrude Elion with the company Burroughs-Wellcome, which eventually became GlaxoSmithKline. GlaxoSmithKline maintained the marketing rights of Daraprim for several decades. They kept the cost of Daraprim low, at about $1 per tablet for many years. In 2010, GlaxoSmithKline sold the marketing rights to CorePharma.

Why is Daraprim So Expensive?

Once CorePharma purchased the marketing rights, the price of Daraprim began rising. Although the use of the drug stayed the same, profits began steadily increasing. As time went on, even with lower use of the drug, profits continued to creep upward. In 2014, Impax Laboratories purchased CorePharma, including the marketing rights of Daraprim. And finally, in August of 2015, Impax Laboratories sold the rights of Daraprim to Turing Pharmaceuticals.

This is where the wild ride begins.

Overnight, Turing Pharmaceuticals' CEO Martin Shkreli skyrocketed the price of Daraprim from $13.50 per tablet to $750 per tablet. That is an alarming 5,500% price increase. How is this even possible, let alone legal?

When Impax Laboratories purchased CorePharma and took over the marketing rights to Daraprim, they implemented strict controls over the drug. Daraprim was put in a closed distribution system. Patients could no longer go to the pharmacy of their choice, but to a specialty pharmacy. Hospitals had to order the drug through DaraprimDirect. The idea behind the closed distribution system was to prevent other manufacturers from getting their hands on Daraprim and releasing their own generic versions. Shkreli kept the closed distribution system when Turing Pharmaceuticals purchased the marketing rights from Impax, continuing to inhibit other companies from creating a generic option.

Further, while toxoplasmosis is a potentially deadly disease carried by nearly 40 million Americans, only roughly 2,000 Americans require treatment for it on a yearly basis. That is a very low number of people. It is possible for another drug company to take the chemical structure of Daraprim and manufacture a generic equivalent.

While a generic form of Daraprim was released in February 2020, until that point, Shkreli's company was free to demand whatever they wanted for the drug.

Martin Shkreli, while a pharmaceutical executive, was, in reality, a businessman who saw an opportunity to make millions of dollars at the expense of an at-risk population suffering from a deadly disease. In fact, Shkreli claimed:

If there was a company selling an Aston Martin for the price of a bicycle, and we buy that company and ask to charge Toyota prices, I don't think that should be a crime.

When those around Shkreli responded with outrage to the overnight price hike, he announced that the exorbitant price would be abandoned. Ultimately, this proved to be mostly untrue. The price was lowered for hospitals that were buying in bulk, but the cost of Daraprim remained the same for individuals who needed the drug outside of the hospital.

Many health insurance companies won't cover the cost of the drug and some hospitals can't afford to keep it in stock, putting doctors in the unfortunate position of prescribing a less effective drug. Even when health insurance does cover the cost of Daraprim, consumers are paying for it elsewhere. Preposterous drug prices drive up the cost of health insurance premiums for everyone and increase the amount that employers take out of their employees' paycheck. Americans might not be aware of it, but obscene drug prices affect everyone in the end, whether it's through taxes or insurance premiums.

According to Business Insider, Shkreli said the Daraprim price increase was to help keep his company profitable. While it is understandable that there is a cost to continue to run the business of manufacturing and distributing pharmaceuticals and a profit needs to be made, it is outrageous to expect an at-risk population made up of pregnant women, newborn babies, cancer patients and people with HIV/AIDS to be forced to pay exorbitant prices for Daraprim because there is no other company to buy it from. It is price gouging at its worst.

Another Option Besides Daraprim?

Daraprim has been successful in treating toxoplasmosis for decades. According to The Huffington Post, Dr. Carlos del Rio, an infectious disease expert and professor at Emory School of Medicine and Rollins School of Public Health, says, "it's clearly the best drug. If I had toxo, I'd want to get Daraprim."

Yet this was one of the reasons Shkreli gave for his extreme price hikes. According to Healio Infectious Disease news, they were told in September 2015 by a representative of Turing Pharmaceuticals that the manufacturer was "investing in the scientific development of new and improved formulations of [pyrimethamine], as well as investigating new therapeutics that we hope will help eradicate the disease."

According to Business Insider, Shkreli claimed that, "[Consumers] don't deserve a drug that's 70 years old. They deserve a modern medicine that can cure toxoplasmosis quickly," he added. He even called the drug "toxic."

The side effects of Daraprim can range widely. They vary from nausea, sore throat, mouth sores, low blood counts and heart problems. But if exorbitantly raising the price of Daraprim, and that's a big if, is the only way possible to have the funds to research a new drug, what happens to the patients who need immediate treatment and can't afford it?

First Generic Application Approval

As of February 28, 2020, the FDA of the United States approved the first application for a generic version of Daraprim. FDA Commissioner Stephen M. Hahn, MD stated:

Empowering patients and promoting choice and competition are top priorities for the FDA. These important efforts include improving access to safe, effective and high-quality generic medications. Today's approval is especially important for populations that are more susceptible to toxoplasmosis infections, such as pregnant women and individuals with HIV or AIDS by paving the way for more choices in treatment options.

But is it too little, too late? In the Huffington Post, Joey Mattingly, an assistant professor of Pharmacy Practice and Science at the University of Maryland School of Pharmacy, predicts that " ...other companies will offer cheaper Daraprim generics, [but] the price will never again go back to where it used to be."

Unfortunately, the cost of Daraprim will likely never be as affordable as it once was. Once drug prices in America go up, it is hard for them to come very far down even with the addition of a competitor on the market.

Why is the Price of Daraprim Lower in Canada?

The cost of Daraprim is significantly lower in Canada and internationally than it is in America. The average price for a Daraprim tablet in Canada is a little over $2. How is this possible, when Daraprim costs $750 just south of the border in America?!

In Canada, pharmaceutical companies are not allowed to price gouge their customers. The Canadian government has a Patented Medicine Prices Review Board, which reviews the cost and effectiveness of drugs and determines if the price is fair. Drug prices rise gradually with inflation, instead of overnight at the whim of a pharmaceutical company. If the government doesn't believe the cost of a new drug is reasonably justified, that drug simply won't be approved for sale in Canada.

This forces most manufactures to provide fair prices for drugs in Canada which earns drug makers a nice profit but without fleecing citizens and the government who effectively give them a patent – a government granted monopoly – to make and sell the product in the country.

Affordable Daraprim Prices from Canadian Pharmacies

It is not uncommon for Americans to feel hopeless when it comes to being able to afford the medication they or their family member desperately needs. The first step is talking to your health care provider and pharmacist. In some cases, there may be discount programs or payment plans available to allow you to receive the medication you need.

If you are interested in learning more about how you can save on the cost of Daraprim from a Canadian pharmacy and international drugstore, please don't hesitate to contact our customer service department to gather more information by calling 1-866-539-5330.

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