the language of pain

Are generics safe? Zantac the latest problem

BBC reports on Zantac/Ranitidine recall.

article is lousy: Gives no reason and points no fingers, nor does it say if it is only generics or the brand name.

Bloomberg says it is made in China and India.

In the meantime, the Italian Drug Agency said last week it was ordering a recall of all versions of Zantac made with active ingredient from Saraca, the Indian manufacturer. Italian regulators also banned the use of some types of Zantac produced by other pharmaceutical companies pending analysis of the drugs.

Bloomberg has an article on the problem of generics.

this photo pretty well says it all:

the article discusses the contamination of Valsartan and other ACE2 inhibitor type BP meds.

Companies conduct clinical trials in humans over several years to prove a drug is safe and effective. But 90% of all medications prescribed to Americans are generics. They’re cheaper, they’re supposed to work the same way, and they receive less scrutiny right from the start. Companies manufacturing generic drugs have to show only that patients will absorb them at the same rate as the name-brand medications they mimic.At least 80% of the active pharmaceutical ingredients, or APIs, for all drugs are made in Chinese and Indian factories that U.S. pharmaceutical companies never have to identify to patients, using raw materials whose sources the pharmaceutical companies don’t know much about.The FDA checks less than 1% of drugs for impurities or potency before letting them into the country. Surveillance inspections of overseas factories have declined since 2016, even as the agency is under pressure to get more generics to market more quickly.

the article goes into a lot more detail about the Valsartan contamination and about China's growing pharmacy manufacturing business, but the clue is that the company switched to a different solvent, which was cheaper. Then other companies read the patent application and figured they too could make the drug cheaper and voila, many sources of the BP medicine also produced contaminated medicine.

Can Polio be eradicated?

A long article on the CDC website discusses.

Since the Global Polio Eradication Initiative began, the number of reported WPV cases has declined from an estimated 350,000 WPV cases in 125 countries during 1988 to 66 cases in two countries with ongoing endemic transmission during 2019 (as of August 20, 2019); an estimated 18 million paralytic poliomyelitis cases have been prevented during the past 30 years.

summary:

Top Discussion The new Global Polio Eradication Initiative Polio Endgame Strategy 2019–2023 (1) contains three important pillars: eradication, integration, and containment/certification.

 ...After global eradication of all WPVs and eventual bOPV cessation, fully certified containment of all polioviruses in research and quality control laboratories, vaccine manufacturing facilities, biomedical facilities, and biological repositories is crucial.

Containment efforts include minimizing the number of facilities retaining poliovirus materials and ensuring that all poliovirus research facilities comply with containment guidelines.

Ongoing poliovirus research facilitates the development and deployment of alternative, genetically stable polioviruses that are safe to use in vaccination and that can be produced and used outside containment.

Researchers have made important progress in replacing Sabin strains for diagnostic and serologic assays (e.g., with genetically stable novel OPVs) (4) and in developing IPVs made from Sabin and safer poliovirus strains to reduce risks from the use of live WPV in IPV production. These advances will result in a requirement for fewer poliovirus containment facilities and a corresponding reduction in overall risk for poliovirus release.

lt is ironic that few western "Anti vaxers" get hysterical about polio vaccine, but the dirty little secret is that the easily given oral version would mutate into the real thing in one out of a million cases, causing half a dozen cases a year in the USA before they went back to the (killed vaccine) shot, and even starting epidemics when given in populations that lacked immunity (usually because the Muslim crazies stopped the teams giving out vaccines and you lost "herd immunity").

I am old enough to remember the epidemics of the late 1950s, and had two friends with partial leg paralysis from polio, and one patient years later with "post polio" syndrome.

Ebola update

the Ebola epidemic in Central Africa is still going on and StrategyPage puts the fight against the virus into the perspective of the local wars and the heroism of locals to stop it (with the help of international agencies).

During the week that ended on September 22, Congo’s health teams conducted 2,546,148 Ebola virus screenings. Since August 2018 Congolese teams have conducted over 98 million screenings. That impressive number indicates Congolese health teams have done a lot of potentially dangerous work. Still, experience has shown the risk of Ebola transmission as very high at national (in Congo) and regional levels (central Africa) but low at the global level.

the lack of facilities, the corruption of officials, and the threats against those trying to stop the epidemic are all discussed.

Read the whole thing.