The drug industry wants us to think Martin Shkreli is a rogue CEO but is isn’t.
#Shkreli #FDA #FDA Approval Some Notes Toward a Comprehensive Plan For Screwing Martin Shkreli
Why not trust European drug regulators? Actually, it turns out to be even weirder than that. Take the case of Fansidar. It’s a combination of pyrimethamine and sulphadoxine made by Roche. It was approved by the FDA in 1981 and went on the market in 1982, primarily as an anti-malarial drug.1 Roche has sold bazillions of tablets since then, and the cost seems to vary from a dollar or two in small quantities to a few cents in large quantities. It’s even been tested for toxoplasmosis and found to be pretty effective. So: Roche already manufactures pyrimethamine.
They already have FDA approval for a drug that contains it. They already have a well-respected manufacturing capability. And they already have distribution in the US. All they’d have to do is make the same tablet but without the sulphadoxine and put it on the market. If the FDA were willing to streamline the approval, the startup costs would be very low. Now, for a company the size of Roche, it might still not be worth it. But there are plenty of other companies that make pyrimethamine/sulphadoxine combinations. If the FDA offered quick approval for a pyrimethamine-only tablet, I wonder if someone would take them up on it? Legally, the FDA is not supposed to consider cost in its approval process, but surely it would be worth making an exception just to see Shkreli take a bath on his cute little scheme.
Tag: Law
cyberplayground
1958 National Defense Education Act, PL85-864 (graduate fellowship program and the National Defense Student Loan Program (NDSL), the precursor to the Perkins Loan Program, first Federal student aid program for low-income students)
http://nndb.com/
Carl D. Perkins Vocational and Technical Education Act
Carl Dewey Perkins (October 15, 1912 – August 3, 1984, a Democrat, was a politician and member of the United States House of Representatives from the state of Kentucky.
Perkins, Carl Dewey (1912-1984) — also known as Carl D. Perkins — of Hindman, Knott County, Ky. Born in Hindman, Knott County, Ky., October 15, 1912. Democrat. Lawyer; member of Kentucky state house of representatives, 1940; served in the U.S. Army during World War II; U.S. Representative from Kentucky 7th District, 1949-84; died in office 1984. Member, American Legion; Freemasons. Died in Lexington, Fayette County, Ky., August 3, 1984 (age 71 years, 293 days). Interment at Perkins Cemetery, Leburn, Ky.
Relatives: Father of Carl Christopher Perkins (1954-).
http://www.nndb.com/people/288/000129898/
Perkins, Carl Christopher (b. 1954) — also known as Carl C. Perkins;
Chris Perkins — of Leburn, Knott County, Ky. Born in Washington, D.C., August 6, 1954. Democrat. Member of Kentucky state house of representatives, 1981-84; U.S. Representative from Kentucky 7th District, 1985-93; minister. Baptist; later Presbyterian. Pleaded guilty in 1994 to bank fraud in connection with the House banking scandal; he wrote overdrafts totaling about $300,000 (covered by the House bank) and made false statements to obtain loans from commercial banks; also pleaded guilty to charges of filing false statements with the Federal Election Commission and false financial disclosure reports. Sentenced to 21 months in prison. In March 2000, pleaded guilty to criminal contempt of court for lying to a federal probation officer about his income. Still living as of 2013.
http://politicalgraveyard.com/bio/perkins.html
1986 Reauthorization of the Higher Education Act (added Congressional Methodology as a second federal need analysis methodology, gave financial aid administrators broad discretion through “professional judgment”, required financial need for the GSL interest subsidy, NDSL renamed Perkins Loan, created Supplemental Loan to Students (SLS) for graduate, professional and independent students, restricted PLUS loans to parent borrowers, added FFEL consolidation loans)
http://www.finaid.org/educators/history.phtml
A History of Vocational and Career Education in Ohio: 1828-2000
http://www.scribd.com/doc/85309209/A-History-of-Vocational-and-Career-Education-in-Ohio-1828-2000
iUniverse, Inc. New York Lincoln Shanghai
To fulfill an eligibility requirement of the Carl Perkins Vocational and Applied Technology Education Act, an assessment was conducted of the public vocational … Carl D Perkins Voc and Appl Techn Educ Act 1990
http://eric.ed.gov/?id=ED330816
The Carl D. Perkins Vocational and Technical Education Act was first authorized by the federal government in 1984 and reauthorized in 1998. Named for Carl D. Perkins, the act aims to increase the quality of technical education within the United States in order to help the economy.
On August 12, 2006 President George W Bush signed into law the reauthorization of the Act of 1998. The new law, the Carl D. Perkins Career and Technical Education Improvement Act of 2006, was passed almost unanimously by Congress in late July, 2006.
The new law includes three major areas of revision:
1) Using the term “career and technical education” instead of “vocational education”
2) Maintaining the Tech Prep program as a separate federal funding stream within the legislation
3) Maintaining state administrative funding at 5 percent of a state’s allocation
The new law also includes new requirements for “programs of study” that link academic and technical content across secondary and postsecondary education, and strengthened local accountability provisions that will ensure continuous program improvement.
The Perkins Act provides almost $1.3 billion in federal support for career and technical education programs in all 50 States, including support for integrated career pathways programs.
http://www2.ed.gov/policy/sectech/leg/perkins/index.html
http://www.clasp.org/ a national picture of infant-toddler child care policies and finds that, collectively, states could be doing far better meeting the needs of our youngest children and their families
Corilie Perkins
http://web.archive.org/web/20100305131140/http://www.citizendia.org/Episcopal_Church_in_the_United_States_of_America
When Must Lawyers Ethically Encrypt Data? Texas Answers.
When Must Lawyers Ethically Encrypt Data? Texas Answers.
http://ridethelightning.senseient.com/2015/07/when-must-lawyers-ethically-encrypt-data-texas-answers.html
July 07, 2015
When Must Lawyers Ethically Encrypt Data? Texas Answers.
The times they are a-changing when it comes to the transmission of confidential data by lawyers. In 1999, ABA Formal Opinion 99-413 approved the use of unencrypted e-mail for the transmission of confidential information with the caveat that under circumstances where the information to be communicated is highly sensitive the lawyer should forgo e-mail, just as he or she would from making a phone call or sending a fax, and consult with the client about the best way to transmit the information.
Most of the opinions from those “early days” took the view that e-mail is appropriate for lawyer/client communication, since it is just as illegal to intercept an email as it is to tap a phone call. A couple of states, including Arizona and Missouri, were a little more cautious.
Then both the ABA Ethics 2000 Commission (E2K) and the Ethics 20/20 Commission expanded the caution, advising in paragraphs 18 and 19 of the Comment to Rule 1.6 Confidentiality of Information that, in effect, the more sensitive the nature of the information that is to be transmitted, the more the lawyer should consider whether it is appropriate to consult with the client about the extent to which additional safeguards should be employed.
An Ethics 20/20 inspired amendment to Rule 1.1 Competence requires lawyers to have a basic understanding of the technology that they use so that they can advise their clients as to the risks and advantages of different means of communication.
Few people think of e-mail as private anymore, given the ease with which it can be monitored by employers and intercepted by hackers and law enforcement.
The pendulum began to swing toward considering encryption with opinions issued by the State Bar of California and the Pennsylvania Bar Association’s Committee on Ethics and professional Responsibility.
Most recently, the State Bar of Texas addressed the issue squarely and provided specific guidance. Opinion 648 (2015) identified several instances where encryption or some other method of security may be appropriate, including:
Most of the opinions from those “early days” took the view that e-mail is appropriate for lawyer/client communication, since it is just as illegal to intercept an email as it is to tap a phone call. A couple of states, including Arizona and Missouri, were a little more cautious.
Then both the ABA Ethics 2000 Commission (E2K) and the Ethics 20/20 Commission expanded the caution, advising in paragraphs 18 and 19 of the Comment to Rule 1.6 Confidentiality of Information that, in effect, the more sensitive the nature of the information that is to be transmitted, the more the lawyer should consider whether it is appropriate to consult with the client about the extent to which additional safeguards should be employed.
An Ethics 20/20 inspired amendment to Rule 1.1 Competence requires lawyers to have a basic understanding of the technology that they use so that they can advise their clients as to the risks and advantages of different means of communication.
Few people think of e-mail as private anymore, given the ease with which it can be monitored by employers and intercepted by hackers and law enforcement.
The pendulum began to swing toward considering encryption with opinions issued by the State Bar of California and the Pennsylvania Bar Association’s Committee on Ethics and professional Responsibility.
Most recently, the State Bar of Texas addressed the issue squarely and provided specific guidance. Opinion 648 (2015) identified several instances where encryption or some other method of security may be appropriate, including:
- communicating highly sensitive or confidential information via e-mail or unencrypted e-mail connections;
- sending an e-mail to or from an account that the e-mail sender or recipient shares with others;
- sending an e-mail to a client when it is possible that a third person (such as a spouse in a divorce case) knows the password to the e-mail account, or to an individual client at that client’s work e-mail account, especially if the e-mail relates to a client’s employment dispute with his employer;
- sending an e-mail from a public computer or a borrowed computer or where the lawyer knows that the e-mails the lawyer sends are being read on a public or borrowed computer or on an unsecure network;
- sending an e-mail if the lawyer knows that the e-mail recipient is accessing the e-mail on devices that are potentially accessible to third persons or are not protected by a password; or
- sending an e-mail if the lawyer is concerned that the NSA or other law enforcement agency may read the lawyer’s e-mail communication, with or without a warrant.
Texas is now at the forefront of a swelling movement that lawyers should heed – encrypting e-mail is now so simple and inexpensive that it may be unethical NOT to use it in many instances. If you are not encrypting your e-mail where appropriate, you certainly are not managing risk well – and you may find yourself in ethical hot water sooner rather than later. The current Rules 1.1 and Rule 1.6, which have been adopted in many states, are enough to potentially sustain a finding of unethical conduct where encryption should have been used and was not. And as state bars begin to issue opinions essentially mirroring the Texas opinion, and they will likely do so, adoption of encryption where appropriate will become an ethical necessity.
5G the Free WiFi Killer
From: Dave Burstein dslprime.com
Date: Monday, August 24, 2015
Subject: “5G the Free WiFi Killer” EE Times
The Intel/Verizon/Ericsson model of future wireless has everything controlled by a (carrier-managed) gateway. This report from the Intel Developers’ Forum suggests troubling consequences.
The EE Times article below may be making some assumptions I don’t share, but the underlying point is on target. The author fears a carrier gateway will impede WiFi and more. To be proven.
50-70% of wireless traffic now goes over WiFi, a figure that will increase as faster WiFi routers become common and more home gateways are configured to share unused bandwidth.
That’s an existential threat to phone companies depending on revenue from expanding data usage. They are fighting back in industry fora, including defining LTE-U/LAA as “LTE spectrum owners only” and seeking to dedicate 40 MHz of current WiFi spectrum to the 4 telcos.
Anyone who believes in a “multi-stakeholder” “open” Internet should be worried. In particular, the carriers are bringing this to industry only organizations especially 3GPP (the LTE standard setter), EU 5G groups, the Flex5GWare project and Horizon2020.
We badly need to get a consumer voice in these groups. I’ve raised the issue to Larry Strickling (U.S. Gov) and Kathy Brown (ISOC). vocal supporters of “multi-stakeholder.” The decisions being made in these groups will have more impact on consumers than the limited scope of the ITU/ICANN debate. I’m only one voice and I hope more speak up on the importance of the public interest.
5G the Free WiFi Killer
http://www.eetimes.com/document.asp?doc_id=1327482&
Integrating comm comes at a price
8/21/2015 09:50 AM EDT
SAN FRANCISCO, Calif.—5G may be not much more than a moniker for what comes after 4G, but Intel clarified its vision recently at a keynote during the Intel Developer Forum 2015 (IDF, San Francisco, Aug.18-20). “Seamless” is the goal and it comes at a price.
The top-line is that Intel hopes to apply all its expertise in computing, networking and wireless communications to make a seamless 5G solution that incorporates distributed intelligence at all levels–from the smartphone to the router to the basestation aggregator to cloudlets, clouds and our fastest supercomputers.
The bottom line is that cellular, WiFi, centimeter- and millimeter wavelength bands must be seamlessly integrated from the user’s point-of-view, according to Aicha Evans, vice president of platform engineering group and general manager of the communications and devices group at Intel.
“5G is not about faster, but about integrating all types of connectivity,” Evans told her keynote attendees at IDF. “The building blocks of 5G are already here today.”
To the carriers this integration will come at a price, since 5G-for-all presents the opportunity to kill free WiFi and instead charge users for every data packet they send or receive, no matter which of the integrated communications technologies is used. At Evans’ keynote she gathered together carriers, service providers and strategists to outline what it is that they expect from 5G, including Alex Choi, chief technical officer (CTO) of SK Telecom (Asia), Bin Shen, Verizon’s vice president of strategy (U.S.) and Paul McNamara, vice president of Ericsson’s corporate strategy group (Europe).
The top-line is that Intel hopes to apply all its expertise in computing, networking and wireless communications to make a seamless 5G solution that incorporates distributed intelligence at all levels–from the smartphone to the router to the basestation aggregator to cloudlets, clouds and our fastest supercomputers.
The bottom line is that cellular, WiFi, centimeter- and millimeter wavelength bands must be seamlessly integrated from the user’s point-of-view, according to Aicha Evans, vice president of platform engineering group and general manager of the communications and devices group at Intel.
“5G is not about faster, but about integrating all types of connectivity,” Evans told her keynote attendees at IDF. “The building blocks of 5G are already here today.”
To the carriers this integration will come at a price, since 5G-for-all presents the opportunity to kill free WiFi and instead charge users for every data packet they send or receive, no matter which of the integrated communications technologies is used. At Evans’ keynote she gathered together carriers, service providers and strategists to outline what it is that they expect from 5G, including Alex Choi, chief technical officer (CTO) of SK Telecom (Asia), Bin Shen, Verizon’s vice president of strategy (U.S.) and Paul McNamara, vice president of Ericsson’s corporate strategy group (Europe).
However, before the panel painted the world-changing picture of extraordinary speeds and ultra-low latency–at a price–Intel’s Sandra Rivera, vice president of the data center group and general manager of the Internet of Things (IoT) described the benefits of 5G to the users.
“Intelligence will begin with at the base station,” Rivera asserted to the crowd at IDF. <snip>
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Editor, Fast Net News, Net Policy News and DSL Prime
Author with Jennie Bourne DSL (Wiley) and Web Video: Making It Great, Getting It Noticed (Peachpit)
Author with Jennie Bourne DSL (Wiley) and Web Video: Making It Great, Getting It Noticed (Peachpit)