Thursday, February 26, 2015

Snookered Again: FCC Approves Net Neutrality

For anyone thinking this is somehow going to improve service or lower the price of delivering Hollywood, just wait six months.

Via Politico:
The Federal Communications Commission voted along party lines Thursday to approve sweeping changes to how it regulates the Internet, capping more than a year of noisy debate that sparked millions of public comments and drew the attention of President Barack Obama and congressional leaders.
The agency’s three Democrats voted to approve Chairman Tom Wheeler’s net neutrality order, which would treat broadband like a utility to ensure all Web traffic is treated equally. The commission’s two GOP members, Republican lawmakers and the nation’s telecom giants oppose the rules, saying they will dampen innovation and investment. AT&T has already threatened a legal challenge.
“The Internet is the most powerful and pervasive platform on the planet. It’s simply too important to be left without rules and without a referee on the field,” Wheeler said at Thursday’s FCC’s meeting. “Today is a red-letter day for Internet freedom, for consumers who want to use the Internet on their terms, for innovators who want to reach consumers without the control of gatekeepers.”
In a separate decision Thursday, the FCC’s Democratic majority voted to override state laws that prevent community-run broadband networks in Chattanooga, Tennessee and Wilson, North Carolina from expanding their geographic reach. The move will help such locally managed networks compete with incumbent cable and telecom companies.
Thank You Politico and Zip.

Senator Ted Cruz: Top Priority Is Abolishing The IRS

( – Sen. Ted Cruz (R-Texas) said among his top five priorities for the United States is to “abolish the IRS” at the Conservative Political Action Conference (CPAC) in Oxon Hill, Md., on Thursday.
Sean Hannity of Fox News asked Cruz what his top five agenda items are for the country.
“Number one,” said Cruz. “Repeal every blasted word of Obamacare.”
“Number two, abolish the IRS, take all 125,000 IRS agents and put them on our southern border,” said the senator. “Number three, stop the out of control regulators at the EPA and the alphabet soup of Washington. Number four, defend our constitutional rights – all of them, and number five, restore America’s leadership in the world as a shining city on a hill.”
Thank You Senator Cruz, CNSnews, and Mr Stone.

Wednesday, February 25, 2015

JNJ Loses Trial Over Risperdal And Male Breasts

Bloomberg News
In a setback to Johnson & Johnson JNJ +0.51%, a Philadelphia jury decided the health care giant must pay $2.5 million in damages for failing to warn that its Risperdal antipsychotic could cause gynecomastia, which is abnormal development of breasts in males. The lawsuit was brought by the family of an autistic boy who took the drug in 2002 and later developed size 46 DD breasts, according to a lawyer for the family.
The case has drawn attention for a few reasons. For one, this was the first lawsuit claiming J&J hid the risks of gynecomastia to go to trial after a handful of cases were settled in recent years. The trial also served as a reminder that J&J paid $2.2 billion two years ago to resolve criminal and civil allegations of illegally marketing Risperdal to children and the elderly.
Moreover, former FDA commissioner David Kessler served as a paid expert witness for the family and testified that J&J knew about the risks associated with Risperdal, but failed to disclose the data showing the extent to which youngsters may develop gynecomastia. In a report prepared for a 2012 case that was settled, Kessler wrote that J&J’s Janssen unit, which marketed the drug, had violated the law.
“There was grave mistreatment of children,” says Stephen Sheller, the attorney for Austin Pledger, who took the drug between 2002 and 2006, when he was first seven years old. At the time, Risperdal was not approved for children. J&J “hid data from the FDA, prescribing doctors and parents. Documents showed they knew there was much higher percentage of children getting gynecomastia than they admitted.”

Thank You Mr Silverman.

University of California at LA Students Objected To Undergrad's Appointment To Governing Body Because She's Jewish

According to the students on the council, being Jewish is a “conflict of interest.”

Last week, I attended a council meeting to support my roommate, sorority sister and best friend, Rachel Beyda, as she went through the last step of being confirmed by the council as an appointed justice to the Judicial Board of the Undergraduate Students Association Council. I greatly admire Rachel’s academic success and the passion and determination she has demonstrated toward her goal of becoming a lawyer. I have seen her accrue immense leadership skills and experience in the legal field, both at UCLA, as the current law clerk for the Judicial Board and beyond. Therefore, as I ascended the stairs to Kerckhoff 417, I incorrectly assumed the confirmation of Rachel’s appointment would be quick and simple.
Rachel had been unanimously approved by the Appointments Review Committee consisting of three council members before she flawlessly introduced herself to the council. However, the first question directed at her by General Representative 3 Fabienne Roth was an attack on Rachel’s ability to be a justice based on her involvement in the Jewish community. At President Avinoam Baral’s insistence, the question was phrased slightly more considerately by Transfer Student Representative Negeen Sadeghi-Movahed, but this first question set the tone. Rachel finished the interview, making two important points: first, anyone qualified for the position would be a critical thinker who is knowledgeable about campus issues and therefore, has his or her own opinions and second, she has no significant political affiliations. Furthermore, she demonstrated an understanding of what actually having a conflict of interest means and acknowledged that a justice should remove herself from the decision-making process under those circumstances. Rachel was asked to leave the room for council discussion. What followed was a disgusting 40 minutes of what can only be described as unequivocal anti-Semitism during which some of our council members resorted to some of the oldest accusations against Jews, including divided loyalties and dishonesty.
All council members swiftly agreed Rachel was amply qualified for the position, but half of the council had strong reservations stemming from Rachel’s Jewish identity. “My issue is, I’m going to be upfront about it, I think she’s pretty great. She’s smart, she like knows her stuff, she’s like probably going to be a really great lawyer. But I’m like not going to pretend this isn’t about conflict of interest. … It’s not her fault … but she’s part of a community that’s very invested in USAC. … Even if she’s the right person for the job,” claimed Roth. Sadeghi-Movahed added, “For some reason, I’m not 100 percent comfortable. I don’t know why. I’ll go through her application again. I’ve been going through it constantly, but I definitely can see that she’s qualified for sure.” Throughout this discussion, Rachel anxiously paced outside, where, she later informed me, she could hear “conflict of interest” being yelled and concluded that it could only be about her being Jewish. Undoubtedly, the Israeli-Palestinan conflict is one of the most contentious issues on our campus. However, Israel was not mentioned during the discussion of Rachel’s appointment, only her affiliation with Jewish organizations, making the extensive deliberation a definitive act of discrimination.
Thank You Daily Bruin and Zip.

This is what a University Degree is worth today.

Absolutely disgusting.

Hilarious: Net Neutrality Signs Pop Up In DC Calling FCC Chair Tom Wheeler "Obama's B*tch"


Posters and signs appeared early Wednesday morning around the nation’s capital and the upscale Georgetown neighborhood where embattled Federal Communications Commission chairman Tom Wheeler lives. The posters read “Boot Licker” with Wheeler’s face printed over a repeating series of “Obama’s Bitch” in the background in an apparent indication that the commissioner is kowtowing to President Obama.
Wheeler has stated in the past that he’s not bound by the direction of the president.
Stop signs in the Georgetown neighborhood, directly in front of Wheeler’s house, were amended to say, “Stop Wheeler — Don’t Brake the Internet’ [sic].
Thank You Truth Revolt and Mr Stone.

NO Proven Treatments of ANY Kind For Psychosis or Schizophrenia In Children or Youth


There are no proven treatments of any kind for children or adolescents experiencing psychosis or schizophrenia, according to a systematic review and meta-analysis of randomized comparison trials published in PLOS One.
The study was led by researchers from the UK Royal College of Psychiatrists National Collaborating Centre for Mental Health as part of the development of guidelines for psychosis in children, adolescents and young adults.
The researchers examined randomized trials "comparing any pharmacological, psychological, or combined intervention for psychosis and schizophrenia in children, adolescents and young adults", assessed them for bias, and evaluated them according to a variety of outcomes. They identified twenty-seven trials including 3,067 participants.
They found only "low quality" evidence that antipsychotic medications may have "small beneficial effects on psychotic symptoms." However, they found strong evidence that these drugs caused significant weight gain and other adverse side effects.
"There were no trials of psychological treatments in under-18 year olds," they wrote. "There was no evidence of an effect of psychological interventions on psychotic symptoms in an acute episode, or relapse rate."
"For children, adolescents and young adults, the balance of risk and benefit of antipsychotics appears less favourable than in adults," they concluded. "Research is needed to establish the potential for psychological treatments, alone and in combination with antipsychotics, in this population."
Stafford, Megan R., Evan Mayo-Wilson, Christina E. Loucas, Anthony James, Chris Hollis, Max Birchwood, and Tim Kendall. “Efficacy and Safety of Pharmacological and Psychological Interventions for the Treatment of Psychosis and Schizophrenia in Children, Adolescents and Young Adults: A Systematic Review and Meta-Analysis.” Edited by Inez Myin-Germeys. PLOS ONE 10, no. 2 (February 11, 2015): e0117166. doi:10.1371/journal.pone.0117166. (Full text)
--Rob Wipond, News Editor


Thank You Mr Wipond and MIA.

You can't 'treat' an 'Illness' or disease which is neither.

Monday, February 23, 2015

Stopping SSRI Antidepressants Can Cause Long, Intense Withdrawal Problems


In the first systematic review of withdrawal problems that patients experience when trying to get off SSRI antidepressant medications, a team of American and Italian researchers found that withdrawing from SSRIs was in many ways comparable to trying to quit addictive benzodiazepine sedatives and barbiturates. Publishing in Psychotherapy and Psychosomatics, they also found that withdrawal symptoms can last months or even years, and entirely new, persistent psychiatric disorders can emerge from discontinuing SSRIs.

The authors analyzed 15 randomized controlled studies, 4 open trials, 4 retrospective investigations and 38 case reports of SSRI withdrawal. They found that paroxetine (Paxil) was the worst, but that all the SSRI antdepressants could cause a wide range of withdrawal symptoms from dizziness, electrical shock sensations and diarrhea to anxiety, panic, agitation, insomnia and severe depression.

The prevalence of such withdrawal syndromes was "variable" and difficult to estimate from the studies, they wrote, but generally seemed very common. "Symptoms typically occur within a few days from drug discontinuation and last a few weeks, also with gradual tapering. However, many variations are possible, including late onset and/or longer persistence of disturbances. Symptoms may be easily misidentified as signs of impending relapse."

"Clinicians need to add SSRI to the list of drugs potentially inducing withdrawal symptoms upon discontinuation, together with benzodiazepines, barbiturates, and other psychotropic drugs," they concluded. "The term ‘discontinuation syndrome' that is currently used minimizes the potential vulnerabilities induced by SSRI and should be replaced by ‘withdrawal syndrome'."

An accompanying editorial noted that, "This type of withdrawal consists of: (1) the return of the original illness at a greater intensity and/or with additional features of the illness, and/or (2) symptoms related to emerging new disorders. They persist at least 6 weeks after drug withdrawal and are sufficiently severe and disabling to have patients return to their previous drug treatment. When the previous drug treatment is not restarted, post-withdrawal disorders may last for several months to years."

The editorial also stated that, "With SSRI withdrawal, persistent postwithdrawal disorders may appear as new psychiatric disorders, in particular disorders that can be treated successfully with SSRIs and SNRIs. Significant postwithdrawal illnesses found with SSRI use include anxiety disorders, tardive insomnia, major depression, and bipolar illness."

While the study authors found no difference between gradual tapering over relatively short periods and abrupt discontinuation of SSRIs, the editorial authors argued that there was evidence to suggest benefits to tapering.

Chouinard G, Chouinard V, -A, New Classification of Selective Serotonin Reuptake Inhibitor Withdrawal. Psychother Psychosom 2015;84:63-71. DOI:10.1159/000371865 (Abstract and full text)
Fava, G.A., A. Gatti, C. Belaise, J. Guidi, and E. Offidani. 

“Withdrawal Symptoms after Selective Serotonin Reuptake Inhibitor Discontinuation: A Systematic Review.” Psychotherapy and Psychosomatics 84, no. 2 (2015): 72–81. (Abstract and full text)

--Rob Wipond, News Editor

September 26, 2014

Thank You Mr Wipond and MIA.

Sunday, February 22, 2015

Shanghai Official Linked To GSK Bribery Sentenced To 19 Years In Prison

February 17, 2015 | By 

The GlaxoSmithKline ($GSK) officials accused of orchestrating its $489 million Chinese bribery scandal may have dodged prison sentences in the country, but a Shanghai health official linked to the British pharma won't be so lucky. He'll spend nearly two decades behind bars for accepting pharma company bribes and embezzling more than 4.4 million yuan, China's state news agency says.

The Shanghai Number One Intermediate People's Court has jailed Huang Fengping, former deputy director for the Shanghai Municipal Commission of Health and Family Planning, for 19 years, according to a Xinhua report seen by the South China Morning Post. Media reports have tied his case to the GSK scandal, though the Shanghai court made no public mention of the drugmaker.

Police arrested Fengping back in December 2013, just months after officials accused Glaxo of using travel agencies to funnel bribes to local doctors and healthcare professionals. At the time, investigators found more than 400 envelopes stuffed with cash at Fengping's home--not to mention gold bars and foreign currency in the boot of his car, the SCMP reports.

Both cases are part of an ongoing country-wide corruption crackdown that has ensnared both foreigners and locals. But compared with Fengping's sentence, Glaxo's punishment looks like a slap on the wrist. Last September, China saddled the company with a $500 million fine, and former China head and Briton Mark Reilly--considered the mastermind behind the bribery scheme--reportedly received a three-year suspended sentence and deportation.

But while GSK has already publicly apologized and tried to put the matter behind it, other drugmakers could potentially find themselves in the spotlight. In 2013, Chinese authorities visited several of Glaxo's Big Pharma peers and rumors circled that they were investigating a handful of others, including France's Sanofi ($SNY). And while there hasn't been much noise on that front since, China's government has cautioned other foreign companies that if they cross the line, they could be next to face penalties.
"The case is a warning to other multinationals in China that ethics matter," it wrote in a Xinhua editorial last May.

- get more from the SCMP

Special Report: Top 10 drugmakers in emerging markets - GSK | Top 10 pharma companies by 2013 revenue - GlaxoSmithKline
Related Articles:
GSK China scandal resolved with $500M fine and suspended jail sentence
Xinhua: Multinationals, beware--or end up like Glaxo
Top GSK exec faces life in Chinese prison for alleged 'massive bribery network'
Glaxo trims CEO Witty's bonus in face of China probe
GlaxoSmithKline exec admits 'breaches,' promises price cuts in China

Thank You Ms Helfland and FiercePharma

Corrupted Drug Trials Frequently Found, But Facts Hidden From Journals, Public


The US Food and Drug Administration frequently uncovers evidence of corruption and improper conduct in drug trials, but those improprieties are almost never mentioned in the medical journals that subsequently publish the findings of those same studies, according to research in JAMA Internal Medicine.
The study was conducted by Charles Seife of the Arthur L. Carter Institute of Journalism at New York University, who has also written an article for Slate about his study of documents between 1998 and 2013 "describing FDA inspections of clinical trial sites in which significant evidence of objectionable conditions or practices was found."
"Fifty-seven published clinical trials were identified for which an FDA inspection of a trial site had found significant evidence of 1 or more of the following problems," wrote Seife. "Falsification or submission of false information, 22 trials (39%); problems with adverse events reporting, 14 trials (25%); protocol violations, 42 trials (74%); inadequate or inaccurate recordkeeping, 35 trials (61%); failure to protect the safety of patients and/or issues with oversight or informed consent, 30 trials (53%); and violations not otherwise categorized, 20 trials (35%)."
Nevertheless, Seife found, "Only 3 of the 78 publications (4%) that resulted from trials in which the FDA found significant violations mentioned the objectionable conditions or practices found during the inspection. No corrections, retractions, expressions of concern, or other comments acknowledging the key issues identified by the inspection were subsequently published."
Seife blamed the FDA. "When the FDA finds scientific fraud or misconduct, the agency doesn’t notify the public, the medical establishment, or even the scientific community that the results of a medical experiment are not to be trusted," wrote Seife in Slate. "On the contrary. For more than a decade, the FDA has shown a pattern of burying the details of misconduct. As a result, nobody ever finds out which data is bogus, which experiments are tainted, and which drugs might be on the market under false pretenses."
JAMA Internal Medicine also has an audio interview with Seife.
Seife, Charles. "Research Misconduct Identified by the US Food and Drug AdministrationOut of Sight, Out of Mind, Out of the Peer-Reviewed Literature." JAMA Intern Med. Published online February 09, 2015. doi:10.1001/jamainternmed.2014.7774. (Abstract and full text)
Are Your Medications Safe? (Slate, February 9, 2015)
--Rob Wipond, News Editor

Thank You Mr Wipond and MIA.

Saturday, February 21, 2015

J&J Hid Risks Of Boy Breast Development, Jury Told



(Bloomberg) -- Johnson & Johnson, which paid more than $2 billion to resolve a criminal probe over its antipsychotic drug Risperdal, knew the medicine caused boys to develop female breasts and failed to alert regulators, doctors and patients, a lawyer argued.
J&J kept quiet about research showing Risperdal caused abnormal breast development in boys to protect billions of dollars in sales of the drug, an attorney for the parents of an autistic man who developed size 46 DD breasts while on the medicine told a jury Friday. J&J misled the U.S. Food and Drug Administration about the antipsychotic’s safety, he added.
“All of you know something the FDA still doesn’t know and that is the increased statistical risk of kids on Risperdal” developing abnormal breasts, the lawyer, Thomas Kline, told jurors during closing statements at a Philadelphia trial over the drugmaker’s handling of the product.
J&J, based in New Brunswick, New Jersey, faces more than 1,000 cases over the Risperdal side effect in state court in Philadelphia. The current case is the first in which a jury will decide whether J&J and its Janssen unit are liable for mishandling the medicine.
In 2012, the company settled the first case to go to trial in Philadelphia over claims Risperdal caused gynecomastia, or abnormal breast development, and has settled at least five other cases over allegations involving the drug.