Men should be included in clinical trials of breast cancer drugs, says US FDA

Breast cancer is rare in males, with less than one percent of all breast cancer cases occurring in male patients. Hence, they have been usually excluded from clinical trials.

The US FDA has published draft guidance for including men in clinical trials of breast cancer drugs. It recommends that eligibility criteria for clinical trials of breast cancer drugs should allow for inclusion of both males and females. It further recommends that “Scientific rationale should be included in the protocol when proposing to exclude males from breast cancer trials. FDA does not intend to consider low expected accrual rates of male patients with breast cancer to be a sufficient scientific rationale for excluding them from a clinical trial”.

When males have not been included or when inclusion of males is very limited in clinical trials for a specific breast cancer drug

• It may be possible to extrapolate findings to include male patients in the FDA approved indication for the drug where no difference in efficacy or safety is anticipated between males and females based on the mechanism of action of a drug. The use   of extrapolation should be supported by data from earlier stages of development (e.g., nonclinical testing), literature, or both.
• Further data may be necessary to support extrapolation of findings to support an FDA-approved indication for male patients with breast cancer where there is a concern for differential efficacy or safety between males and females.

(Source: FDA)

Healthcare News Monitor

Your pharmacy is probably spoiling medicines

The New Indian Express – V Nilesh

The medicines you consume probably aren’t working as effectively as they should, because pharmacies often don’t adhere to the specified storage conditions. Most medicines — including tablets, capsules, ointments and injections — carry labels mentioning the conditions under which they must be stored. While a common condition is a ‘cool and dry place’, another important specification is the temperature. Apart from medicines that require refrigeration, most mention that they must be stored at less than 30 degree Celsius, an international standard as per the World Health Organization (WHO) guidelines. Some mention that they must be stored at ambient, room, or normal temperature, which means the same. Unfortunately, in tropical places like Hyderabad, where temperatures even climb beyond 40 degree Celsius, many pharmacies have no air conditioning (AC) system to control the temperature. As a result, medicines are not stored in the required conditions, affecting their efficacy and shelf life. When a group of researchers from a well-known private research institute in Hyderabad conducted a study on 108 pharmacies selected from all zones under the GHMC, they found that 83 per cent of the pharmacies did not have ACs to maintain the right temperature, and argued that having ACs at pharmacies must be mandated by law.

Haryana Health Minister launches Electronic Vaccine Intelligence Network

The Pioneer

Haryana Health Minister Anil Vij on Wednesday launched Electronic Vaccine Intelligence Network (eVIN), Safe Delivery App and ASHA Soft mobile application, to improve healthcare services in the state. He said eVIN App would support the Government of India’s Universal Immunisation Programme by providing real-time information on vaccine stocks and flows, and storage temperatures across all cold chain points in Haryana. The minister added that eVIN is an innovative technological solution for strengthening immunization supply chain systems in India. It has been implemented by the Ministry of Health and Family Welfare (Mohfw) with the support from the United Nations Development Programme (UNDP). Vij said that during the programme, Vaccination Col Chain Managers of all 22 districts, were given smartphones. He said that eVIN is such an app, which would help in providing the information of vaccine or medicines inventories to the cold chain managers. This App would help in providing information of vaccine stocks and storage temperatures in all cold chain points of the state. Additional Chief Secretary, Health, Rajiv Arora said that eVIN has created a big data architecture that generates actionable analytics encouraging data-driven decision-making, accountability and positive behavioral change in the public health system. He said that vaccine inventories and stocks, and storage temperatures at 675 functional cold chain points in all 22 districts of Haryana, are being digitised with eVIN. These Apps would be helpful for all the government staff, ivaccine store-keepers and cold chain handlers.

Karnataka: Use of allopathy by Ayush doctor proves fatal

ET Healthworld- Shyam Prasad S

An ‘Integrated Medical Practitioner’ is claiming his right to practice modern medicine even after the death of a patient under his treatment. The authorities have suspended the licence of this Ayush practitioner and he approached the High Court against it. Due to a fault in procedure, his suspension was quashed by the court. Dr Kulkarni PN is a registered ‘integrated medical practitioner’ working at Ashwini Hospital in Madikeri. The District Health Officer, by an order on April 12, 2018, suspended his licence to practice medicine. This followed the death of a patient who was administered medicine by Kulkarni. Approaching the High Court, Kulkarni claimed he was a registered Integrated Medical Practitioner under the Karnataka Ayurvedic, Naturopathy, Siddha, Unani and Yoga Practitioners’ Registration and Medical Practitioners’ Miscellaneous Provisions Act. Since he was an Integrated Medical Practitioner, he claimed he was entitled to practice Allopathy. Kulkarni claimed in the HC that his suspension was unilateral and therefore wrong. The HC considered the fact that the suspension order was “passed without affording an opportunity of hearing to the petitioner, the impugned order cannot be sustained in the eye of law.”

Delhis GB Pant Hospital to get advanced Transmission Electron Microscope

The New Indian Express

NEW DELHI: The Delhi government run, GB Pant Hospital received a Transmission Electron Microscope, the second hospital in the city to have this machine. “Earlier, the hospital would refer cases to AIIMS but now the reverse has started happening. AIIMS is sending patients to GB Pant. This government has never stopped any proposal for health requirement,” Delhi Health Minister Satyendar Jain said after unveiling the advanced tool on Wednesday. He added that the hospital will get a new MRI machine next month. “The device which will assist medical experts in research related to kidneys, liver, brain and muscular diseases. It is a state-of- the-art machine which will help us research cancer, nephritis or any other malignant disease,” said Dr Sunil Raheja, Medical Superintendent, GB Pant Hospital. A special room has been assigned to the device which costs more than Rs 5 crore. “This will help improve the health infrastructure of Delhi hospitals. Cases can be studied in-depth for faster treatment. This will also increase the number of cases being referred to GB Pant,” Dr Raheja said.

Swine flu death: Hospital guilty of not testing youth, to pay Rs 25L

ET Healthworld- Aamir Khan

In a significant judgment, the Delhi State Consumer Disputes Redressal Commission awarded Rs 25 lakh to a man after finding a city-based hospital guilty of not testing his son for swine flu, though the entire city was under its grip 10 years ago. The commission observed that the 24-year-old victim’s condition deteriorated as the H1N1 test was delayed and the hospital was ill-equipped to treat his case.“What is expected from the medical practitioner is to take due care and caution while giving treatment as per the established medical jurisprudence avoiding delay,” commission member Anil Srivastava said. The observation of the commission could also be a lesson for other hospitals. In its view, if the hospital was “handicapped” in treating the patient, it should have either not admitted him or made all possible arrangements to make up for its deficit. “Their guilt is further aggravated as the hospital admittedly had no laboratory to conduct the test,” it said.