Saturday May 25, 2019

Low Quality Drugs, Medicine Costs More Than Just Money

Even in high-income countries, purchasing cheaper medicines from illegitimate sources online could result in obtaining substandard or falsified medicines.

0
//
Medicines
A seized counterfeit hydrocodone tablets in the investigation of a rash of fentanyl overdoses in northern California is shown in this Drug Enforcement Administration (DEA). VOA

About one in eight essential medicines in low- and middle-income countries may be fake or contain dangerous mixes of ingredients that put patients’ lives at risk, a research review suggests.

Researchers examined data from more 350 previous studies that tested more 400,000 drug samples in low- and middle-income countries. Overall, roughly 14 percent of medicines were counterfeit, expired or otherwise low quality and unlikely to be as safe or effective as patients might expect.

“Low-quality medicines can have no or little active pharmaceutical ingredient [and] can prolong illness, lead to treatment failure and contribute to drug resistance,” said lead study author Sachiko Ozawa of the University of North Carolina at Chapel Hill.

“Or it may have a too much active ingredient and cause a drug overdose,” Ozawa said by email. “If it is contaminated or has other active ingredients, then the medication could cause poisoning, adverse drug interactions or avertable deaths.”

Much of the research to date on counterfeit or otherwise unsafe medicines has focused on Africa, and about half of the studies in the current analysis were done there.

 

medicines
One in five medications tested in Africa were fake. Pixabay

 

Almost one in five medications tested in Africa were fake or otherwise potentially unsafe, researchers report in JAMA Network Open.

 

Another third of the studies were done in Asia, where about 14 percent of medicines tested were found to be counterfeit or otherwise unsafe.

Antibiotics and antimalarials were the most tested drugs in the analysis. Overall, about 19 percent of antimalarials and 12 percent of antibiotics were falsified or otherwise unsafe.

While fake or improperly made medicines undoubtedly harm patients, the current analysis couldn’t tell how many people suffered serious side effects or died as a result of falsified drugs.

Researchers did try to assess the economic impact of counterfeit or improperly made medicines and found the annual cost might run anywhere from $10 billion to $200 billion.

While the study didn’t examine high-income countries, drug quality concerns are by no means limited to less affluent nations, Ozawa said.

Medicines
Different vaccines. Pixabay

“Even in high-income countries, purchasing cheaper medicines from illegitimate sources online could result in obtaining substandard or falsified medicines,” Ozawa said. “Verify the source before you buy medications, and make policymakers aware of the problem so they can work to improve the global supply chain of medicines.”

The study wasn’t a controlled experiment designed to prove whether or how counterfeit or poorly made medicines directly harm patients, however. And the economic impact was difficult to assess from smaller studies that often didn’t include a detailed methodology for calculating the financial toll.

Also Read: Eating in 10-hour Window May Boost Health

The report “provides important validation of what is largely already known,” Tim Mackey of the Global Health Policy Institute in La Jolla, California, writes in an accompanying editorial.

“It is important to note that although the study is comprehensive, its narrow scope means it only provides a snapshot of the entire problem, as it is limited to studies conducted in low- and middle-income countries and to those
medicines classified as essential by the World Health Organization.” (VOA)

Next Story

Most Expensive Medicine Treats Rare Inherited Disease for $2M

The medicine, sold by the Swiss drugmaker Novartis, is a gene therapy that treats an inherited condition called spinal muscular atrophy

0
expensive medicine
FILE - The logo of Swiss pharmaceutical company Novartis. VOA

U.S. regulators have approved the most expensive medicine ever, for a rare disorder that destroys a baby’s muscle control and kills nearly all of those with the most common type of the disease within a couple of years.

The treatment is priced at $2.125 million. Out-of-pocket costs for patients will vary based on insurance coverage. The medicine, sold by the Swiss drugmaker Novartis, is a gene therapy that treats an inherited condition called spinal muscular atrophy. The treatment targets a defective gene that weakens a child’s muscles so dramatically that they become unable to move, and eventually unable to swallow or breathe. It strikes about 400 babies born in the U.S. each year.

The Food and Drug Administration on Friday approved the treatment, called Zolgensma, for all children under age 2 who are confirmed by a genetic test to have any of the three types of the disease. The therapy is a one-time infusion that takes about an hour.

Novartis said it will let insurers make payments over five years, at $425,000 per year, and will give partial rebates if the treatment doesn’t work.

The one other medicine for the disease approved in the U.S. is a drug called Spinraza. Instead of a one-time treatment, it must be given every four months. Biogen, Spinraza’s maker, charges a list price of $750,000 for the first year and then $350,000 per year after that.

expensive medicine
FILE – This Oct. 14, 2015, photo shows the Food and Drug Administration campus in Silver Spring, Md. VOA

‘Dramatically transforms’ lives

The independent nonprofit group Institute for Clinical and Economic Review, which rates the value of expensive new medicines, calculated that the price of the new gene therapy is justifiable at a cost of $1.2 million to $2.1 million because it “dramatically transforms the lives of families affected by this devastating disease.”

ICER’s president, Dr. Steven D. Pearson, called the treatment’s price “a positive outcome for patients and the entire health system.” The defective gene that causes spinal muscular atrophy prevents the body from making enough of a protein that allows nerves that control movement to work normally. The nerves die off without the protein.

In the most common type, which is also the most severe, at least 90% of patients die by age 2, and any still alive need a ventilator to breathe. Children with less-severe types become disabled more slowly and can live for up to a couple decades.

Zolgensma works by supplying a healthy copy of the faulty gene, which allows nerve cells to then start producing the needed protein. That halts deterioration of the nerve cells and allows the baby to develop more normally.

In patient testing, babies with the most severe form of the disease who got Zolgensma within 6 months of birth had limited muscle problems. Those who got the treatment earliest did best. Babies given Zolgensma after six months stopped losing muscle control, but the medicine can’t reverse damage already done.

expensive medicine
The medicine, sold by the Swiss drugmaker Novartis, is a gene therapy that treats an inherited condition called spinal muscular atrophy. Pixabay

Success story

Evelyn Villarreal was one of the first children treated, at eight weeks. Her family, from Centreville, Va., had lost their first child to spinal muscular atrophy at 15 months. Two years later when Evelyn was born a test showed she also had the disease, so the family enrolled her in the gene therapy study at Nationwide Children’s Hospital in Columbus, Ohio.

Evelyn is now 4½ years old and showing no muscle problems other than minor trouble standing up, said her mother, Elena Villarreal. She has been feeding herself for a long time, she draws and speaks well, and will be starting kindergarten in the fall. “She’s very active and goes to the playground a lot,” said Elena Villarreal. “She’s walking and even jumping.”

ALSO READ: WHO Chief Emphasizes the Importance of Universal Health Coverage

It is too early to know how long the benefit of the treatment lasts, but doctors’ hopes are rising that they could last a lifetime, according to Dr. Jerry Mendell, a neurologist at Nationwide Children’s. Mendell led one of the early patient studies and is Evelyn’s doctor. “It’s beginning to look that way,” he said, because a few children treated who are now 4 or 5 still have no symptoms.

Early diagnosis is crucial, so Novartis has been working with states to get genetic testing for newborns required at birth. It expects most states will have that requirement by next year. The FDA said side effects included vomiting and potential liver damage, so patients must be monitored for the first few months after treatment. (VOA)