News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Improvements in technology are enabling individuals with basic clinical laboratory knowledge to reproduce expensive medical products using low-cost, less complicated methods

Advances in technology made it possible for a group of high school students in Australia to successfully replicate the primary ingredients of a pharmaceutical drug called Pyrimethamine, which is sold under the name Daraprim. It is another demonstration of how today’s sophisticated technologies can be harnessed by individuals with minimal scientific training to produce complex products.

In recent years, Dark Daily has chronicled the successes of high school students in the United States who did the following:

• Invented a test for prostate cancer;

• Used a home-made DNA sequencer to test the DNA of a brother to prove that his curly red hair was consistent with their parent’s genetic make-up; and

• Formulated a computer application that increases the accuracy of fine-needle aspiration (FNA) diagnostic testing for breast cancer to 99%.

Students Reproduce Drug’s Ingredients for a Fraction of the Cost

The students at Sydney Grammar School in Sydney, Australia, were motivated to experiment with manufacturing Daraprim because it was in the headlines in 2016 after the price of the drug was jacked up by the now-notorious Martin Shkreli, CEO of Turing Pharmaceuticals. The students wanted to see if they could manufacture the same drug for a much lower cost. Turing was launched as a new company in February 2015, headed by Shkreli, a former hedge fund manager.

Daraprim is primarily used to treat parasitic diseases such as Toxoplasmosis and Cystoisosporiasis. It is also used in some cases to prevent pneumonia in patients with Human Immunodeficiency Virus (HIV) and acquired immune deficiency syndrome (AIDS).

The students at the Australian high school recreated the primary components of Daraprim for a mere $20 per 3.7 grams, which translates to approximately $2 per pill. In a NewsMic article the students expressed their happiness with the success and outcome of their work.

“At first there was definitely disbelief,” said Brandon Lee, a student involved in the project. “But then it turned into happiness as we realized we finally got to our main goal.”

“It was ecstatic, it was bliss, it was euphoric,” added fellow student Milan Leonard, who was also involved in the project.

The Sydney Grammar School students (above), who ranged from 11-17 years old, replicated the anti-parasitic drug Daraprim. It took them a year to created their version of the drug in the school’s laboratory. (Photo copyright: University of Sydney.)

The Sydney Grammar School students (above), who ranged from 11-17 years old, replicated the anti-parasitic drug Daraprim. It took them a year to created their version of the drug in the school’s laboratory. (Photo copyright: University of Sydney.)

Due to patent laws and other regulations, the Australian students cannot market their drug in the United States.

“To take the drug to market as a generic, you need to compare it to Turing’s product,” explained Sydney Grammar School Associate Professor Matthew Todd, the students’ instructor, in the NewsMic article. “If Turing won’t allow the comparisons to take place, you’d need to fund a whole new trial.”

The World Health Organization (WHO) considers Pyrimethamine to be an essential drug for its utilization against parasites that usually only pose a danger to those with weakened immune systems.

According to the Center for Disease Control and Prevention (CDC), there are only about 4,400 hospitalizations and 327 deaths per year due to Toxoplasmosis in the United States. The parasites typically do not display any problems in healthy individuals. The CDC estimates that about 60 million people, or about 19% of the population of the United States, may be infected with the parasites but don’t realize it.

Massive Increase in Drug’s Cost Sparks Outrage

In August 2015, the exclusive rights to manufacture and market Daraprim were acquired by Turing Pharmaceuticals. After acquiring the rights for Daraprim, Turing immediately boosted the price of the 62-year-old drug from $13.50 per pill to about $750 per pill! This action represented a 5,000% price hike, which infuriated consumers as well as government officials, and turned Shkreli into one of America’s most hated individuals.

In response to the outrage, Turing reduced the price of Daraprim by half for hospitals, praising the move as a 50% reduction in the price of the drug, even though it still cost more than 2,500% of its initial price.

Shkreli was arrested in December 2015 on federal charges of securities fraud and may face additional charges in the future. The fraud charges are unrelated to the Daraprim price gouging scandal. Shkreli has since resigned as the CEO of Turing Pharmaceuticals.

Students’ Work Proves Drugs Could Be Manufactured More Cheaply

Meanwhile, there is no additional news about whether this group of Australian high school students plan to attempt manufacturing other types of therapeutic drugs. It may be that the next scientific milestone for intrepid high school students would be to manufacture a therapeutic drug, then design a companion diagnostic test that would show whether or not an individual would benefit from treatment by that drug. Maybe some equally intrepid clinical laboratory scientists or pathologists could coach some high schoolers on this type of science project.

—JP Schlingman

Related Information:

Teens Recreate Martin Shkreli’s Pricey Drug in High School Lab For Just $2 a Pill

Martin Shkreli Faces More Charges

‘Hated’ CEO Lowering Price Of $750 AIDS Drug Daraprim

Drug Goes From $13.50 a Tablet to $750, Overnight

Here’s Why Turing Pharmaceuticals Says 5,000% Price Bump is Necessary

Shkreli, Drug Price Gouger, Denies Fraud and Posts Bail

British Teen Builds DNA Testing Analyzer in His Bedroom, Wins Award as UK Young Engineer of 2013

High School Student Develops Diagnostic Pathology Testing Application That Increases Sensitivity of FNA Testing for Breast Cancer

High School Student Develops Diagnostic Test to Detect Early-Stage Pancreatic Cancer

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