WHO: 10% of drugs sold in developing world dubious

Two WHO reports released on Tuesday estimated that roughly 10.5% of medicines being sold in Low and Middle Income countries (LMIC) could be substandard or falsified.

Hence, they concluded, the size of the dubious drugs market in these countries at about $30 billion. However experts slammed the basis for these estimates and said they were grossly exaggerated.

While substandard medicines have been a matter of concern in many countries, several member states are expressing concern with the findings, especially the estimation of prevalence of substandard and falsified medical products in Low and Middle Income countries using an “unscientific methodology”, said a statement issued by Third World Network (TWN), a transnational alternative policy group aimed at strengthening cooperation among countries of the Global South.

Of the two reports, one was on the cases reported to the WHO’s Global Surveillance and Monitoring System (GSMS) for dubious drugs launched in July 2013.

The cases reported between 2013 and 2016 were categorised under various heads such as “falsified”, “suspected falsified”, “substandard”, “diverted”, “stolen” and “unlicensed” medical products.

However, after the World Health Assembly decided in 2016 to categorise compromised medicines as “substandard” and “falsified” and adopted working definitions for the same, the Global Surveillance and Monitoring System cases appear to have been automatically categorised as one of these two, said Third World Network.

Source: The Times of India.

FDA approves first digital pill that tracks patients

For the first time, the Food and Drug Administration has approved a digital pill — a medication embedded with a sensor that can tell doctors whether, and when, patients take their medicine.

The approval, announced on Monday, marks a significant advance in the growing field of digital devices designed to monitor medicine-taking and to address the expensive, longstanding problem that millions of patients do not take drugs as prescribed.

Experts estimate that socalled nonadherence or noncompliance to medication costs about $100 billion a year, much of it because patients get sicker and need additional treatment or hospitalisation.

“When patients don’t adhere to lifestyle or medications... there are really substantive consequences that are bad for the patient and very costly,” said Dr William Shrank, chief medical officer of the health plan division at the University of Pittsburgh Medical Center.

Patients who agree to take the digital medication, a version of the antipsychotic Abilify, can sign consent forms allowing their doctors and up to four other people to receive electronic data showing the date and time pills are ingested.

A smartphone app will let them block recipients anytime they change their mind. Although voluntary, the technology is still likely to prompt questions about privacy and whether patients might feel pressure to take medication. A controversial use might be requiring digital medicine as a condition for parole. Abilify is an arguably unusual choice for the first sensor-embedded medicine. It is prescribed to people with schizophrenia and bipolar disorder and, in conjunction with an antidepressant, depressive disorder. Symptoms of schizophrenia and related disorders can include paranoia and delusions, so some doctors and patients wonder how widely digital Abilify will be accepted.

The newly approved pill, called Abilify MyCite, is a collaboration between Abilify’s manufacturer, Otsuka, and Proteus Digital Health, a California company that created the sensor.

The sensor, containing copper, magnesium and silicon (safe ingredients found in foods), generates an electrical signal when splashed by stomach fluid said Andrew Thompson, Proteus’s president and chief executive.Dr Jeffrey Lieberman, chairman of psychiatry at Columbia University and New York-Presbyterian Hospital, said many psychiatrists would likely want to try digital Abilify. But he noted it has only been approved to track doses, and has not yet been shown to improve adherence.

Proteus has spent years bringing its sensor to commercial use, raising about $400 million from investors, including Novartis and Medtronic, Thompson said. Until now, the sensor could not be embedded in pills, but pharmacies could be commissioned to place it in a capsule along with another medication. In 2016, the encapsulated sensor started being used outside of clinical trials, but commercial use is still limited, Thompson said.

Nine health systems in six states have begun prescribing it with medications for conditions including hypertension and hepatitis C, the company said, adding that it has been found to improve adherence in patients with uncontrolled hypertension and others. How patients will view Abilify MyCite is still unclear.
Source: The Times of India

2.8 million TB cases in India, but WHO notes higher funding

At 27.9 lakh, India’s TB incidence in 2016 was down marginally from the previous year’s
 

28.4 lakh. The number of TB-related deaths was 4.35 lakh. down 15% from 5.17 lakh.

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accounted for 33% of global TB deaths among HIV-negative people, and for 26% of the

combined total of TB deaths in HIV-negative and HIV-positive people.

Following a 2012 decision to mandatorily notify TB cases, India has registered a 37% jump

in cases between 2013-16, shows a new global TB report released by WHO, which also takes

note of the Indian government’s moves towards increased funding for TB elimination.

At 27.9 lakh, India’s TB incidence in 2016 was down marginally from the previous year’s

28.4 lakh. The number of TB-related deaths was 4.35 lakh. down 15% from 5.17 lakh.

India, however, accounted for 33% of global TB deaths among HIV-negative people, and for

26% of the combined total of TB deaths in HIV-negative and HIV-positive people. “An

estimated 10.4 million people fell ill with TB in 2016… 56% were in five countries: India,

Indonesia, China, the Philippines and Pakistan,” the report states. China, India and Indonesia

alone accounted for 45% of global cases in 2016.

The report noted that TB is the ninth leading cause of death worldwide and the leading cause

from a single infectious agent, ranking above HIV/AIDS. “In 2016, there were an estimated

1.3 million TB deaths among HIV-negative people (down from 1.7 million in 2000) and an

additional 374,000 deaths among HIV-positive people,” it states.

On the other hand, the TB mortality rate is falling at about 3% per year worldwide and TB

incidence at about 2% per year; 16% of TB cases die from the disease. Most deaths from TB

could be prevented with early diagnosis and appropriate treatment.

“India is still doing poorly in TB control. At this rate, unless there is serious investment by

the Indian government, we will not eliminate TB by 2025,” said Prof Madhukar Pai, director,

McGill Global Health Programs; and Associate Director, McGill International TB Centre.

Government health authorities, however, stressed that the findings were consistent with

efforts to detect more TB cases. Dr Sunil Khaparde, deputy director general, Central TB

Division, Ministry of Health and Family Welfare, told The Indian Express: “We have started

intervention and early detection programmes due to which the MDR-TB cases have shown a

decline from 1.2 lakh cases in 2015. The number of deaths has also come down,” Dr

Khaparde said.

About India’s increased funding, the reports states: “India stood out as a country in which the

budget envelope for TB was substantially increased in 2017 (to $525 million, almost double

the level of 2016), following political commitment from the Prime Minister to the goal of

ending TB by 2025. The budget is fully funded, including $387 million (74%) from domestic

sources (triple the amount of $124 million in 2016) and the remainder (26%) from

international donor sources,” says the report.

Last February, the government released the National Strategic Plan for Tuberculosis

Elimination 2017-2025 that, while describing TB as India’s “severest health crisis,

emphasised the government’s commitment to end TB in the country by 2030, five years

ahead of the global target of elimination by 2035”.

Source: The Indian Express

Japan scientists grow drugs in chicken eggs

Japanese researchers have genetically engineered hens whose eggs contain drugs that can

fight serious diseases including cancer, in a bid to dramatically reduce the cost of treatment, a

report said on Monday .

If the scientists are able to safely produce “interferon beta“, a type of protein used to treat

illnesses including multiple sclerosis and hepatitis, by rearing the hens, the price of the drug -

currently up to 100,000 yen (approx. Rs 58,000) for a few microgrammes -could fall

significantly , said the English edition of the `Yomiuri Shimbun'.

Researchers at the National Institute of Advanced Industrial Science and Technology (AIST)

in the Kansai region kicked off the process by introducing genes that produce interferon beta

into cells that are precursors of chicken sperm, the newspaper reported.

They then used these cells to fertilise eggs and create hens that inherited those genes,

meaning the birds were able to lay eggs containing the disease fighting agent.

The scientists now have three hens whose eggs contain the drug, with the birds laying eggs

almost daily , the report said. The researchers plan to sell the drug to pharmaceutical

companies, halving its price, so the firms can use it first as a research material, the newspaper

said. Consumers may have to wait a while, as Japan has strict regulations concerning the

introduction of new or foreign pharmaceutical products, with screening processes that

routinely take years to complete. But the team hopes that the technological breakthrough will

eventually help drive down the cost of the drug to 10% of its current price, the newspaper

reported. Officials at the institute could not be reached for comment.

 

 

Source: The Times of India