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Trikafta, an inaccessible medical 'miracle': NYT

  • By Al Mayadeen English
  • Source: The New York Times
  • 13 Feb 2023 14:26
5 Min Read

Developing countries call on Vertex Pharmaceuticals to allow the sale of Trikafta in poorer countries.

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  • Vihaan doing physiotherapy after a session with the nebulizer. (NYT)
    Young Vihaan doing physiotherapy after a session with the nebulizer. February 8, 2023. (NYT)

An exclusive report by The New York Times (NYT) discussed on Monday a new cystic fibrosis drug by Vertex Pharmaceuticals, a sizable biotech company with headquarters in Boston. However, the drug manufacturer has prevented developing countries from purchasing the drug.

The company has no plans to market it or give a local company permission to produce it. Vertex is preventing potential generic competitors by requesting patents in numerous countries, according to NYT.

Seshagiri Buddana, whose son, Hemanth, has spent a large portion of his childhood in a hospital bed, was hopeful when he learned of the new drug that was changing lives in the United States and Europe, according to NYT, but the family was unable to obtain the drug because they live in India.

According to the newsletter, Hemanth died in December, 18 months after he would have been eligible for the drug known as Trikafta if he had lived in the United States.

Families are watching Trikafta transform the lives of tens of thousands of cystic fibrosis patients in wealthy nations, but they say the company is blocking them at every turn in their efforts to obtain the drug themselves.

What is Trifakta? 

Trikafta is the most potent and widely used of Vertex's four cystic fibrosis medications, taking three tablets per day. It is expected to cost millions of dollars over the course of a patient's lifetime, with a list price of more than $322,000 in the United States, according to NYT. 

An analysis led by British researchers discovered that a year's supply of the drug could be manufactured for as little as $5,700. Since Trikafta was approved in 2019, Vertex has reported more than $17 billion in sales.

The people call for Trikafta 

This week, a group of patients and their families in four countries across four continents took legal and regulatory steps to force their governments to waive intellectual property protections and allow a low-cost generic version of Trikafta to be imported or manufactured locally.

Generic manufacturers would pay Vertex a royalty under the compulsory licensing process.

Three of the actions are in India, Ukraine, and South Africa, where patients and families claim Vertex has been obstructing efforts to make the drug available. The fourth is in Brazil, where Vertex is attempting to secure coverage for the drug; where patients and families are concerned that the brand-name drug will be prohibitively expensive.

What is Cystic fibrosis?

Cystic fibrosis is a genetic disorder that causes lung and digestive system damage. Patients typically die in their early twenties, but Trikafta is significantly extending life expectancy, according to NYT. 

“Every patient in the world has access to the internet and wants this drug,” Christine Noke, a patient advocate in Turkey, said.

Theoretically speaking, reaching patients in developing countries would increase revenue for a pharmaceutical company. However, some manufacturers refuse to lower prices in poorer countries because that will prevent them from charging higher prices in high-income countries.

That said, Vertex, which has a monopoly on transformative cystic fibrosis drugs, stated that it is working to increase global access.

“Our teams are working every day to expand access to even more patients around the world through a range of routes, including in low-middle-income countries and low-income countries where access barriers are high due to challenging economic conditions and limited health care infrastructure,” Heather Nichols, a spokesperson for Vertex, said.

According to Nichols, Vertex has started a "product donation program" in low-income countries. She stated that the company has made at least one of its cystic fibrosis drugs available in Brazil, Poland, Bulgaria, Estonia, Greece, Latvia, Slovakia, Slovenia, Romania, and Oman, according to NYT. However, the company declined to specify which countries with limited resources have access to Trikafta.

Poorer countries deprived of Trikafta

Usually, it takes longer for new drugs to reach poorer countries. but cystic fibrosis patients banded together online and launched a coordinated campaign for mandatory licensing to access the drug. 

Governments are frequently hesitant to implement compulsory licensing, which capital markets see as an alarming breach in the wall of intellectual property protection. Even if governments refuse to issue a mandatory license, patient protests may put pressure on Vertex to make Trikafta available in those countries.

It is worth noting that prior to Vertex's drugs, patients had few options other than palliative treatment to help them breathe a little easier and, if available, a lung transplant. Vertex's drugs addressed the underlying cause of the illness by preventing sludgy mucus from clogging patients' lungs. 

For patients, Trikafta is a phenomenally effective treatment for improving breathing, keeping them out of the hospital, and extending their lives. According to patients and doctors, the drug's effectiveness is apparent almost immediately.

According to NYT, the difficulties in obtaining Trikafta in the developing world extend beyond the product's availability. A large number of patients are still undiagnosed and those who are diagnosed are unlikely to be able to afford the costly genetic testing required to determine whether they have one of the mutations required for the drug to work.

Moreover, the most common mutation required for the drug to work is found in approximately 90% of patients of Northern European ancestry, compared to far fewer people from the Middle East, Asia, and Africa. Estimates in India range from 19 to 44 percent, according to the NYT report. 

Read next: New cystic fibrosis treatment may end suffering for patients

  • Trikafta
  • Vertex Pharmaceuticals
  • pharmaceuticals
  • Medicine
  • cystic fibrosis

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