Latest drug shortage update

Today the Health Subcommittee of the House Energy and Commerce Committee held a hearing on 'Examining Drug Shortages and Recent Efforts to Address Them.' See video here...

The testimony  from the GAO and FDA discussed the issue, quantified it, and spoke of efforts to combat drug shortages...The main reasons cited (GAO) for shortages? "... quality problems resulting in supply disruptions and constrained manufacturing capacity...", suggestions that "... changes in FDA inspections of manufacturing establishments also played a role...", and "... a number of additional factors that can cause supply disruptions and ultimately result in shortages —such as permanent product discontinuations or the unavailability of raw materials."  

The reason for all the quality problems? GAO testimony mentioned studies that point towards "...underlying causes generally suggested that such causes led to low profit margins, which limited infrastructure investments or led some manufacturers to exit the market." And when one manufacturer has a problem there usually isn't enough spare capacity in the system for the (few) others to make up...

The GAO's recommendations?  That the FDA "develop policies and procedures for the use of the existing drug shortages database (and, ultimately, the new drug shortage information system) to ensure staff enter information into the database in a consistent manner and to ensure the accuracy of the information in the database; and,conduct periodic analyses using the existing drug shortages database(and, eventually, the new drug shortages information system) to routinely and systematically assess drug shortage information, and use this information proactively to identify risk factors for potential drug shortages early, thereby potentially helping FDA to recognize trends, clarify causes, and resolve problems before drugs go into short supply."

Recommendations that may be characterized as fairly "generic."

The main reasons cited (FDA) for shortages? "... In 2012, for example, based on information collected from manufacturers, FDA determined that 66 percent of production disruptions leading to a shortage resulted from either (1) efforts to address product-specific quality problems (31 percent) or (2) efforts to address broader problems at a manufacturing facility (35 percent)." Also mentioned: product discontinuations (for economic reasons), natural disasters, and problems with raw materials availability... 

Finally, beyond working on measures to improve their response when shortages are already on their way (when the FDA is notified of production disruptions), the FDA is also looking for longer-term fixes, e.g. "... a focus on encouraging and sustaining improvements in manufacturing quality... encouraging development of techniques that can help advance drug manufacturing... actions to encourage manufacturers to adopt new manufacturing technologies, to facilitate their use of modern quality management techniques, and to ensure that FDA regulatory policies reflect state-of-the-art manufacturing science..."

Previous blog entries on drug shortages: 
A drug shortage comment - Jan 11th, 2014 
Drug shortages - update - Nov 21st, 2013
Random charts - drug shortages -  Aug 10th, 2013
Follow up (drug shortages) - Jul 5th, 2013
Random charts - drug shortages - Jan 31, 2013
Random charts - drug shortages - Jul 25th, 2012
Diagnosis - muddled thinking - Jan 21st, 2012
Polarization? - Dec 2nd, 2011
Help on the way? - Jul 31st, 2011
Random charts - Apr 6th, 2011

And a 2011 reprint of a 2002 entry with a dozen  real-life examples of reasons for drug shortages:

The why's of drug shortages - Mar 30th, 2011

Comment spam...

 

Example of comment spam  received by this blog, about 99% of all comments received by this blog! Clearly some bot and not a real person. Google catches them all, but you have to shake your head at most of them!

Random charts - curbing immigration

Source: Vote Results 

The cantonal breakdown of the vote, unsurprisingly la Suisse francophone voted against... plus Zurich, Zug, and Basel-Stadt.

Press release of the Federal Authorities of the Swiss Confederation: "The Swiss population has adopted a popular initiative aimed at stopping mass immigration. This brings with it a change of system in Switzerland’s immigration policy. The new constitutional provisions require that immigration be restricted by means of quantitative limits and quotas. The Federal Council will set to work on implementing these without delay. 

The new constitutional provisions require that residence permits for foreign nationals be restricted using quantitative limits and quotas. These limits and quotas will apply to all permits covered by legislation on foreign nationals, including cross-border commuters and asylum seekers, and must be geared towards Switzerland’s overall economic interests. Businesses must give Swiss nationals priority when hiring staff. 

The new constitutional text does not specify how high these quotas should be, nor does it specify who should set and allocate them and according to what criteria. These details now need to be defined at the legislative level. The new constitutional provisions stipulate that the Federal Council and parliament have three years to implement the new system"

Two posters in favor of the measure, one against:

 

 

Swiss Vote to Curb Immigration in Referendum
Swiss vote to set limits on immigration from EU
Swiss agree to curb immigration and rethink EU deal

Random picture - pro-democracy? Updated 3/1

Source: Reuters on Yahoo! The caption: "U.S. Assistant Secretary of State for European and Eurasian Affairs Victoria Nuland (R) and Ukrainian opposition leaders Vitaly Klitschko (3rd L), Arseny Yatsenyuk (2nd L) and Oleg Tyagnibok (L) gather to hold talks in Kiev December 10, 2013."

Leaders of the "pro-democracy" protest against the Ukrainian government with Victoria "here are some cakes" Nuland. Oh, Tyagnibok, the leader of the Svoboda party, recently called out by the Wiesenthal Center and figuring at number five on their list of  '2012 Top Ten Anti-Semitic/Anti-Israel Slurs.'  "... In recent elections the radical right party won 41 seats in the Ukrainian Parliament (10.44% of the popular vote). Tyagnibok has called for purges of the approximately 400,000 Jews and other minorities living in Ukraine and has demanded that Ukraine be liberated from what he calls, the “Muscovite Jewish Mafia.”..."

Svoboda's anti-Russian and pro-NATO program points apparently resonate with Victoria "'Fuck the EU' Nuland and the administration.... apparently willing to overlook other points, including:  

"Set the graph "nationality" in the passport and birth certificate. Determine the nationality by birth certificate or birth certificate of the parents, considering the requests of the citizen.... 

Provide an opportunity to employees to acquire right of ownership of state and communal companies, participate in their management and fair distribution of profits. Allow employees to sell their share in the company exclusively to the appropriate company. Require employees who have stopped the employment relationship with the enterprise to sell their share to the enterprise.... 

Allow persons who acquired ownership of agricultural land by lawful means (when shared, or obtained by an inheritance by law) to sell these plots of land exclusively to the state. Disallow any other means of transfer of such sites...  

Develop the cooperative movement in rural areas in accordance with a separate comprehensive state program... 

Implement a "Reproductive Health of the Nation" program. Disallow abortion except due to medical issues, and/or rape, which were proved in court. Align the implementation of illegal abortion to attempted murder in the criminal law....

Criminalize promotion of drug use (including so-called 'soft drugs') and sexual perversions...  

Restore the nuclear status of Ukraine..."

Oleh Tiahnybok

3/1/2014 update: 

The link to Svoboda's "Program for the Protection of Ukrainians" above seems to be scrubbed, all one gets is an 'Error 404.' But not to worry, it is still accessible, see the 'Error 404, cleaning up?' blog entry...

Random picture - WWII poster

Source: The Enemy: Windows on War

 "This gruesome scene plays on human phobias about rats, eating dead bodies to the bone. Both specimens here, Hitler to the top and the diminutive Goebbels below, have vampire-like blood dripping from their jaws. The fires of destruction rage in the background, and ruined buildings are the detritus of Allied action.  A poor unfortunate German soldier gnawed to death must have died in his boots, bottom left, and his rifle is thrown down, bottom right. The discarded German helmet and the words imply these are Germans suffering at the hands of their own leader. Designed on the one hand to capture the death and destruction of Hitler’s policy, this poster plays on deep-seated feelings of revulsion and vengeance."

Random picture - gold

Source:World Government Gold Reserves and many other charts...

NEC Medias W N-05E second look

NEC Medias W N-05E first look -  Jan 28th, 2014

A further looks at the N-05E... The external aspects of the phone:

Pop off the back and you get to the battery compartment, with slots for the SD card and Micro-SIM as shown...

Some additional screenshots, showing app space (used & free). Ditto for the SD card (see below) and RAM (not pictured):

 

 

So, how do the two screens work? When you turn on the phone the 'front' screen turns on, then if you open up the screens the second 'subscreen' comes on (Note: there is a setting so that you can choose what mode you start up in e.g. single screen mode, dual screen mode, or the last mode you were in. You also have the ability to set the apps up to use either only one or one/both screens).  The first pic shows the single screen mode - your app is in the top screen while the second 'subscreen' has a choice between saved pages, your browser, or a view of the gallery. 

You can extend the app to both screens via the icon (see arrow). If extended to two screen you can revert to one screen by using the same icon...

A few screen shots of the various combos possible - using one screen, using both for one app, and using both with two different apps: