Health regulators are reviewing the safety of a drug for Alzheimer's disease after data from two clinical trials indicated that people taking it had a much higher death rate than those taking a placebo.
The review of the drug, Reminyl, was announced Friday by Johnson & Johnson, which said it was in discussions with the Food and Drug Administration and regulators in Europe and Canada.
The trials, which involved about 2,000 patients in 16 countries, were looking at whether Reminyl could be used to treat mild cognitive impairment, a form of memory loss that is often a precursor to Alzheimer's disease. Reminyl is approved in 69 countries as a treatment for mild to moderate Alzheimer's but not for mild cognitive impairment.
In the trials, which lasted two years, 15 patients taking Reminyl died compared with five taking the placebo. There were various causes of death but many were from heart attacks and strokes, a company spokeswoman, Carol Goodrich, said.
The announcement comes at a time of heightened concern over the safety of widely used drugs after the withdrawal from the market of Merck's pain reliever Vioxx, which studies indicated posed an increased risk of heart attacks and strokes.
Johnson & Johnson said that the overall number of deaths in the trials was low for the elderly population in the trial and that the incidence of serious side effects was the same for patients getting the drug and the placebo. Also, it said, the investigators in the trials had not thought the drug caused any of the deaths. The results were reported to regulatory authorities in August and presented at medical conferences, a company spokeswoman, Carol Goodrich said. Asked why an announcement was being made only now, Goodrich said regulators in Europe and Canada had met with the company this week to obtain more data and were preparing to post information about the trials on their Web sites.
She said the information would still support the use of the drug for Alzheimer's disease.
A spokeswoman for Health Canada, Carole Saindon, said data was being analyzed and conclusions would be posted when ready. "It's very important that patients don't stop taking the medication without consulting their doctor first," Saindon said. A spokeswoman for the FDA, Kathleen Quinn, said the agency was looking at the data. European regulators could not be reached.
Reminyl was also approved on the basis of six-month studies but the mild cognitive impairment trials lasted two years, increasing their chances of detecting side effects. Nevertheless, the Johnson & Johnson analysis said the excess of deaths in the mild cognitive impairment trials was evident by six months, while no such excess was seen in the Alzheimer's trials.
Reminyl was not effective in the trials at preventing progression to dementia, so the company is no longer pursuing that use, Goodrich said. No drugs have been approved for mild cognitive impairment.
Reminyl, known generically as galantamine, was co-developed with Shire Pharmaceuticals of Britain. Sales for Johnson & Johnson are estimated at about US$200 million a year. The drug, extracted from daffodil bulbs, is a cholinesterase inhibitor, which works by increasing the levels of acetylcholine, a chemical that transmits nerve signals in the brain. Others in this class include Aricept, sold by Pfizer and Eisai, and Exelon from Novartis. Public Citizen, the watchdog group, recommends against using Reminyl or the other drugs in its class, saying they have minimal benefit and the effectiveness and safety of taking them longer than six months is not known, said Sidney Wolfe, director of health research.
Among the rows of vibrators, rubber torsos and leather harnesses at a Chinese sex toys exhibition in Shanghai this weekend, the beginnings of an artificial intelligence (AI)-driven shift in the industry quietly pulsed. China manufactures about 70 percent of the world’s sex toys, most of it the “hardware” on display at the fair — whether that be technicolor tentacled dildos or hyper-realistic personalized silicone dolls. Yet smart toys have been rising in popularity for some time. Many major European and US brands already offer tech-enhanced products that can enable long-distance love, monitor well-being and even bring people one step closer to
Malaysia’s leader yesterday announced plans to build a massive semiconductor design park, aiming to boost the Southeast Asian nation’s role in the global chip industry. A prominent player in the semiconductor industry for decades, Malaysia accounts for an estimated 13 percent of global back-end manufacturing, according to German tech giant Bosch. Now it wants to go beyond production and emerge as a chip design powerhouse too, Malaysian Prime Minister Anwar Ibrahim said. “I am pleased to announce the largest IC (integrated circuit) Design Park in Southeast Asia, that will house world-class anchor tenants and collaborate with global companies such as Arm [Holdings PLC],”
TRANSFORMATION: Taiwan is now home to the largest Google hardware research and development center outside of the US, thanks to the nation’s economic policies President Tsai Ing-wen (蔡英文) yesterday attended an event marking the opening of Google’s second hardware research and development (R&D) office in Taiwan, which was held at New Taipei City’s Banciao District (板橋). This signals Taiwan’s transformation into the world’s largest Google hardware research and development center outside of the US, validating the nation’s economic policy in the past eight years, she said. The “five plus two” innovative industries policy, “six core strategic industries” initiative and infrastructure projects have grown the national industry and established resilient supply chains that withstood the COVID-19 pandemic, Tsai said. Taiwan has improved investment conditions of the domestic economy
Sales in the retail, and food and beverage sectors last month continued to rise, increasing 0.7 percent and 13.6 percent respectively from a year earlier, setting record highs for the month of March, the Ministry of Economic Affairs said yesterday. Sales in the wholesale sector also grew last month by 4.6 annually, mainly due to the business opportunities for emerging applications related to artificial intelligence (AI) and high-performance computing technologies, the ministry said in a report. The ministry forecast that retail, and food and beverage sales this month would retain their growth momentum as the former would benefit from Tomb Sweeping Day