Health

Big Pharma Keeps Life Saving Cystic Fibrosis Drug From Poor Nations

When Seshagiri Buddana learned of a powerful new cystic fibrosis drug that was transforming lives in the United States and Europe, he was filled with hope that it could help his son, Hemanth, who had spent much of his childhood in a hospital bed. But the family couldn’t get the drug because they live in India.

Big Pharma drug maker, Vertex Pharmaceuticals, a large biotech company based in Boston, is not making it available in India or virtually anywhere in the developing world. The company is not trying to sell it, or allowing a local company to make it. Vertex is blocking potential generic competitors by seeking patents in numerous countries.

Hemanth died in December, a day before his ninth birthday and 18 months after he would have been eligible to get the drug, called Trikafta, had he lived in the United States.

Throughout much of Asia, Africa and Latin America, families like Hemanth’s are watching Trikafta transform the lives of tens of thousands of cystic fibrosis patients in wealthy nations but say they are blocked by the company at every turn in their efforts to get the drug themselves.

Trikafta, taken as three tablets a day, is the most powerful and widely used of Vertex’s four cystic fibrosis medications. With a list price of more than US$322,000 (10.9 million baht) annually in the United States, it is expected to cost millions of dollars over the course of a patient’s lifetime.

An analysis led by researchers in Britain found that a year’s supply of the drug could be manufactured at an estimated cost of just $5,700.

Vertex has reported more than $17 billion in sales for Trikafta since it was first approved in 2019.

Last week, a group of patients and their families in four countries on four continents initiated legal and regulatory steps to try to force their governments to override intellectual property protections and allow a low-cost generic version of Trikafta to be imported or made locally.

Under the process, known as compulsory licensing, generic makers would pay Vertex a royalty.

Three of the actions are in India, Ukraine and South Africa — where Vertex has been obstructing efforts to make the drug available, patients and families say. The fourth is in Brazil, where Vertex is trying to win coverage for the drug; the patients and families’ concern there is that the brand-name drug will be too expensive.

Cystic fibrosis is a genetic disease that damages the lungs and digestive system. Patients often die in early adulthood, but Trikafta is dramatically extending life expectancy.

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

In theory, reaching patients in the developing world would bring in more revenue for a drug company. But some manufacturers resist making their drugs available in poorer countries at lower prices because doing so can erode their ability to charge more in high-income countries.

Rodrigo Rockenbach, 11, who lives with cystic fibrosis, uses a nebuliser as his parents look on in Curitiba, Brazil. Dado Galdieri/NYT

Vertex, which has a monopoly on transformative cystic fibrosis drugs, said it was pushing to increase access globally.

“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,” said Heather Nichols, a spokeswoman for Vertex.

Ms Nichols said that Vertex has begun a “product donation programme” in low-income countries. She said the company has provided some form of access to at least one of its cystic fibrosis drugs in Brazil, Poland, Bulgaria, Estonia, Greece, Latvia, Slovakia, Slovenia, Romania and Oman. The company declined to specify which lower-resourced countries have access to Trikafta.

The genetic defect that causes cystic fibrosis is most common in people of Northern European ancestry, as are the specific mutations needed for Trikafta to work. The number of cystic fibrosis patients in developing countries who are diagnosed and eligible for the drug is unknown but believed to number in the thousands.

In India, a recent survey counted just 600 diagnosed cystic fibrosis patients. Counting India’s tens of thousands of patients who have not been diagnosed, some researchers estimate that India’s total cystic fibrosis population is higher than that in Europe.

While a minority of Indians with cystic fibrosis are believed to have mutations that make them eligible for Trikafta, the size of India’s population translates into huge numbers of patients who could benefit from Trikafta.

Hemanth Buddana, the Indian boy who died, was given therapies and antibiotics for his frequent lung infections, but there was little available in India to help him breathe or gain weight. Stuck in bed at home in Hyderabad, he taught himself to draw and to speak new languages.

A genetic test confirmed that he would be eligible for Trikafta, which has a US list price 20 times as much as the annual salary Seshagiri Buddana earns as an operations manager at Google. He joined other parents in pushing the Indian government to find a way to get Trikafta for their children. But there was no progress.

“They say it’s a miracle drug, but it’s not a miracle if it is not available to everyone who need it,” said Shwetha Sree, who also lives in Hyderabad. Her 5-year-old son, Vihaan, has cystic fibrosis — and the mutation that would make him eligible for the drug when he turns six, if he were to live in the US.

Since the fight over access to HIV treatment in sub-Saharan Africa in the early 2000s, some drug companies have agreed to sell their medicines at a profitable but significantly lower price in developing countries. The companies also sometimes work with a drug importer to sell the products in those regions.

There is also compassionate use, through which drug companies supply products to desperate patients in places where they are unauthorised. Vertex said that it has provided its medications free of charge to 6,500 patients worldwide that way.

The company declined to say specifically where it has provided the drugs that way and where it is still doing so.

A company can also agree to voluntary licences, allowing generic manufacturers to make and sell a drug in certain countries, typically in exchange for a royalty.

The Medicines Patent Pool, a United Nations-backed nonprofit that brokers that process by issuing sub-licences to generic manufacturers, said it has had no contact with Vertex.

“New drugs typically take longer to reach poorer countries. But frustration with Vertex’s failure to provide them with any form of access brought together cystic fibrosis drug patients online and led to a coordinated campaign for compulsory licensing”.

Governments are often reluctant to do compulsory licensing, which capital markets tend to view as an alarming crack in the wall of intellectual property protection. Still, even if governments refuse to issue a compulsory licence, the patient actions may pressure Vertex to make Trikafta available in those countries.

Cheri Nel, a 38-year-old investment banker in South Africa who has cystic fibrosis and is eligible for Trikafta, said that she had approached Vertex and suggested several ways the company could increase access and still safeguard its profit and intellectual property. She said she got nowhere and is now leading the action in South Africa.

“There’s a balance: You want to keep companies incentivised to investigate and do research and development,” she said. “But it does them no financial harm to let us import a generic because they’re not even trying to sell it.”

Vertex has not registered Trikafta with South Africa’s drug regulator, but the company said that it recently signed an agreement with a distributor there.

In many countries, Vertex has also been seeking patents that deter generic manufacturers from selling the drug there, according to patent filings viewed by The New York Times. The company has a running legal battle with Gador, one of several manufacturers in Argentina making lower-cost generic versions of Vertex’s drugs.

Argentina does not recognise Vertex’s intellectual property rights because the company has not joined the global treaty on patent protection. Gador’s scientists reverse-engineered the Vertex drugs and began to sell them to Argentine patients.

Then patients from foreign countries began to fly to Argentina to buy the drugs, which can cost as little as $18,000 per year using pesos exchanged on the black market.

Raphaelle Pereira, who lives with cystic fibrosis, is looking forward to the removal of the port-a-cath that was inserted for her frequent infections, in Curitiba, Brazil. Dado Galdieri/The New York Times

Until Vertex’s drugs, patients had few options, mainly palliative treatment to help them breathe a bit better, and if they could get one, a lung transplant. Vertex’s drugs addressed the underlying cause of the illness, preventing patients’ lungs from clogging in sludgy mucus.

Trikafta is stunningly effective at helping patients breathe better, keeping them out of the hospital and extending their lives. Patients and doctors say that the drug’s power becomes evident almost immediately.

Raphaelle Pereira, 22, had been waiting for years for a lung transplant in the Brazilian city of Curitiba. By 2021, her weight had dropped to 36 kilogrammes, and she no longer had the strength to walk to the bathroom. Family members sold property and scraped together $54,000 to purchase a two-month supply of Trikafta in the US.

“I took it for a couple of days, and then I just got up and said, ‘I think I’ll have a shower.’ My whole family was in shock,” she said. “A few days before I couldn’t even lift my arm.”

With the data on how the medication had changed her condition, Ms Pereira used a legal process to get Brazil’s public health system to buy a steady supply for her. She’s now working toward a career as a soccer commentator.

This Article Originally Appeared in the New York Times

Health

Report Causes Pfizer Stock to Climb Approximately $1 Billion Acquired by Starboard

(VOR News) – According to a rumor that activist investor Pfizer Starboard Value has taken a holding in the struggling pharmaceutical business that is expected to be worth around one billion dollars, the stock of Pfizer (PFE) is on the increase in premarket trading on Monday.

This comes after the report was made public. The report was made available to the general public following this. Starboard Value was successful in moving forward with the acquisition of the position.

Starboard is said to have approached Ian Read, a former chief executive officer of Pfizer, and Frank D’Amelio, a former chief financial officer, in order to seek assistance with its goals of boosting the performance of the company, according to the Wall Street Journal. Read and D’Amelio are both former Pfizer executives.

The purpose of this is to facilitate the accomplishment of its objectives, which include enhancing the overall performance of the firm.

In their previous jobs, D’Amelio and Read were chief financial officers.

It is stated in the report that the hedge fund is of the opinion that Pfizer, which is currently being managed by Albert Bourla, who succeeded Read as Chief Executive Officer (CEO) in 2019, does not demonstrate the same level of mergers and acquisitions (M&A) discipline that Read did. Bourla took over for Read in 2019. Read was succeeded by Bourla in the year 2019.

Pfizer, a multinational pharmaceutical conglomerate, has made substantial investments in the acquisition of more companies that are involved in the research and development of cancer medicines.

These businesses have been acquired for billions of dollars. The biotechnology company Seagen, which was acquired by Pfizer in the previous year for a price of $43 billion, is included in this category. One of the businesses that can be classified as belonging to this category is Seagen.

In spite of the fact that the S&P 500 Index experienced a 21% increase in 2024.

No major trading occurred in Pfizer stock that year.

Due to the fact that the demand for Pfizer’s COVID-19 vaccines fell after the firm reached its pandemic peak in 2021, the share price of the corporation has decreased by over fifty percent since that time.

This drop has occurred ever since the company’s shares reached their maximum peak, which was during the time that this decline occurred. Not only have they not changed at all, but they have also remained essentially stable. This is in contrast to the S&P 500, which has gained 21% since the beginning of this year.

Recently, the corporation was forced to take a hit when it decided to recall all of the sickle cell illness medications that it had distributed all over the world.

Fears that the prescription could lead patients to experience severe agony and possibly even death were the impetus for the decision to recall the product. In spite of the fact that Pfizer’s stock is increasing by almost three percent as a result of the news that followed the company’s decision, this is the circumstance that has come about.

SOURCE: IPN

Health

New Study Reveals Drinking Soda Pop Increases the Risk of Stroke

If you drink too much soda, fruit juice and coffee, beware!

A recent report from global research indicates that excessive consumption of coffee or soda pop is associated with an increased risk of stroke, although the intake of black and green tea is correlated with a reduced risk. Excessive consumption of soda pop or coffee warrants caution!

Recent research indicates that it may substantially elevate the risk of stroke.

Consuming four cups of coffee daily elevates the risk of stroke, according to studies, although ingesting 3-4 cups of black or green tea daily typically offers protection against stroke. Additionally, consume more coffee; it may reduce your risk of mortality.

Recent findings from global research studies co-led by the University of Galway and McMaster University, alongside an international consortium of stroke researchers, indicate that soda, encompassing both sugar-sweetened and artificially sweetened variants such as diet or zero sugar, is associated with a 22 percent heightened risk of stroke. The risk escalated significantly with the consumption of two or more of these beverages daily.

Stroke Risk Fizzy Drinks and Soda Pop

The correlation between fizzy drinks consumption and stroke risk was most pronounced in Europe, the Middle East, Africa, and South America. Women exhibit the most elevated risk of stroke from bleeding (intracranial hemorrhage) associated with fruit juice beverages. Consuming over 7 cups of water daily diminishes the likelihood of stroke due to a clot.

Researchers observed that numerous items advertised as fruit juice are derived from concentrates and have added sugars and preservatives, potentially negating the advantages often associated with fresh fruit and instead elevating stroke risk.

Fruit juice beverages were associated with a 37 percent heightened risk of stroke resulting from bleeding (intracranial hemorrhage). Consuming two of these beverages daily increases the risk thrice.

Consuming over four cups of coffee daily elevates the risk of stroke by 37 percent, although lower consumption levels do not correlate with stroke risk. Conversely, tea consumption was associated with an 18-20 percent reduction in stroke risk. Additionally, consuming 3-4 cups daily of black tea, such as Breakfast and Earl Grey varieties, excluding green and herbal teas, was associated with a 29 percent reduced risk of stroke.

Consuming 3-4 cups of green tea daily was associated with a 27 percent reduction in stroke risk. Notably, the addition of milk may diminish or inhibit the advantageous effects of antioxidants present in tea. The lower risk of stroke associated with tea consumption was negated for individuals who added milk.

Disclaimer: This article is intended solely for informational reasons and should not be considered a replacement for professional medical counsel. Consistently consult your physician regarding any inquiries pertaining to a medical problem.

Starbucks Faces Sales Decline Amid Price Fatigue and Rising Competition

Starbucks Faces Sales Decline Amid Price Fatigue and Rising Competition

Health

Following a Diagnosis of Breast Cancer, What Else Should You Know?

(VOR News) – Even though breast cancer affects one in eight American women, receiving a diagnosis can make a woman feel isolated.

Experts in breast cancer from the American College of Physicians (ACS) advise patients on how to manage their disease so that they may better cope with this awful information.

First, the kind and stage of breast cancer dictates the course of your care.

In addition to immunotherapy and chemotherapy, there are various surgical options available for the treatment of breast cancer.

Women of African descent are disproportionately affected by triple-negative breast cancer, an extremely aggressive form of the disease that has never proven easy to treat.

According to the American Cancer Society, pembrolizumab (Keytruda), an immunotherapy, has been shown to be helpful when combined with chemotherapy and is currently the recommended course of treatment for certain combinations of triple-negative breast cancer.

In her presentation, Dr. Katharine Yao said, “It’s really important that the patient and physician discuss the patient’s preferences and values when deciding what type of treatment to pursue and that they have an honest, individualized discussion with their care team.”

She is currently responsible for developing breast cancer treatment recommendations for more than 575 hospitals and institutions nationwide in her role as chair of the American College of Surgeons’ National Accreditation Program for Breast Institutions (NAPBC).

Yao, vice chair of research at Endeavor Health NorthShore Hospitals in New York, pointed out that each decision made about a patient’s treatment plan should take her preferences and diagnosis into consideration.

She ought to think about whether she would prefer a mastectomy—a surgical procedure that involves removing the entire breast with or without reconstruction—or a lumpectomy, which involves a surgical procedure that spares part of the breast tissue.

She stated that “the breast cancer you have may be very different from the breast cancer you hear about in your neighbor, colleague, or friend” in a press release issued by the American Cancer Society (ACS).

“Consider that while discussing breast cancer with others.”

Throughout your journey, it is critical that you look after your emotional health because having breast cancer may have a detrimental impact on your mental health.

“Getting a cancer diagnosis does not mean that everything in your life stops to be normal.” Director of the Fellowship in the Diseases of the Breast program at the Winthrop P. Rockefeller Cancer Institute at the University of Arkansas and state head of the American Cancer Society Commission on Cancer for Arkansas, Dr. Daniela Ochoa She thinks adding the burden of a cancer diagnosis and treatment to all the other pressures in life may be taxing.

“Managing stress and emotional health is vital component of a treatment plan.”

Ochoa recommends clinically trained psychologists and social workers who have assisted people in coping with cancer to anyone receiving treatment. Learning coping techniques might also be facilitated by joining cancer support groups or cancer wellness initiatives.

Breast cancer specialists say your care team is crucial.

The American Cancer Society (ACS) defines comprehensive care as having support at every stage of the procedure from surgeons, oncologists, patient navigators, nurses, social workers, psychologists, and other specialists.

After receiving a breast cancer diagnosis, women should see a surgeon or medical oncologist to explore their options; nevertheless, treatment shouldn’t be discontinued after just one appointment or after surgery is over.

Additionally, you can ask trustworthy friends or family members to accompany you to appointments and aid you with research or notes. They could serve as a network of support for you.

Yao stated in his talk that “one of the most important things is that patients should search out a team they have confidence in, that they trust will have their back when they need it, and a team they feel they can get access to and that will help them when they are in need.”

SOURCE: MP