FDA links anti-smoking drug to more than 500 suicides

smoking-gun

In the past five years, the Food and Drug Administration has received reports implicating the smoking cessation drug Chantix in 544 suicides and 1,869 attempted suicides, according to documents obtained by Al Jazeera America.

Since its introduction to the U.S. market in 2006, Chantix has been linked to an array of adverse psychiatric events, including suicidal behavior, depression, psychosis, and aggression. In 2008, senior researcher Thomas J. Moore of the Institute for Safe Medical Practice concluded that the drug was associated with more adverse effects than any other medication on the market. A concomitant health advisory released in May 2008 eventually prompted the Federal Aviation Administration (FAA) and the U.S. Department of Defense (DoD) to ban the drug among pilots and air traffic controllers…

That said, FDA has so far been reluctant to indicate a distinct causal relationship between adverse psychiatric events and Chantix, which is distributed in the U.S. by Pfizer Inc. In a safety review released last year, the agency noted that while reports of alarming side-effects have been filed regularly, it is exceedingly difficult to determine whether these actually resulted from Chantix use…

Study limitations notwithstanding, the FDA concluded that the benefit-risk profile of Chantix was unchanged, and recommended that the drug remain on the market under its current “black-box warning” – the most serious health warning the agency issues. Some would argue that the health warning, which lists as side-effects most adverse events reported to the agency, is an adequate precautionary measure that informs patients and physicians about the drug’s psychiatric influence…

“The use of a black box warning is to help physicians identify early symptoms that so that you can prevent the adverse event from occurring,” Michael Siegel, a professor at Boston University’ School of Public Health, told reporters. “In the case of Chantix, the black box warning is basically telling physicians, ‘Be careful because your patients might die taking this.’ What use is it to monitor patients for suicide? Once they commit suicide, it’s over.”

How many doctors, how many smoking cessation specialists – how many members of Congress – does Pfizer own? Is it a sufficient number to keep medication with this kind of track record on the streets?

The FDA admits studies used to justify approval may be flawed. Then, pull the stuff off the market until legitimate studies reexamine the safety of this product.

Italian Senate strips Berlusconi of his seat

berlusconi crocodile tears

The Italian Senate voted Wednesday to strip ex-Prime Minister Silvio Berlusconi of his seat because of a tax fraud conviction he insists will be reversed.

Berlusconi maintains the tax fraud conviction, which Italy’s supreme court upheld during the summer, is politically motivated by blah, blah, blah!

Berlusconi was convicted Aug. 1 with several other defendants of using offshore companies in tax-haven countries to buy movie rights for his TV networks and grossly inflating the payment amounts to avoid $502 million in taxes…

Prime Minister Letta’s Democratic Party and the anti-establishment 5-Star Movement backed the decision to eject Berlusconi…

His center-right Forza Italia party withdrew its support for Letta’s left-right coalition government and joined the opposition Tuesday…

He was sentenced to four years imprisonment, but three years were automatically pardoned, along with a public office ban for two years. Because he is older than 70, he was exempted from imprisonment and instead must do community service.

If he actually ever performs any community service, I hope his first attempt at real labor in a life of fraud and crime is dedicated to the senior citizens of Italy. They are dishonored by counting him among their peers.

EU asks for protection against US/NSA data surveillance

The European Commission has called…for new protection for Europeans under United States’ law against misuse of personal data, in an attempt to keep in check the U.S. surveillance revealed by former NSA contractor Edward Snowden.

EU justice commissioner Viviane Reding said she wanted Washington to follow through on its promise to give all EU citizens the right to sue in the United States if their data is misused. “I have … made clear that Europe expects to see the necessary legislative change in the U.S. sooner rather than later, and in any case before summer 2014,” she said.

Reding’s message was reinforced in a draft report obtained by Reuters that called for “very close attention by the EU” in monitoring data-exchange agreements given the “large-scale collection and processing of personal information under U.S. surveillance programs”.

The remarks underline a growing sense of unease in Europe at a delicate moment in transatlantic relations, when the globe’s two biggest economies seek a trade pact to deepen ties…

In the report, they highlighted the need for improving transparency in the ‘Safe Harbour’ scheme that allows companies in Europe who gather personal information about customers, for example, to send it to the United States…

We are an economic giant and we behave like a political midget,” said Sophie in’t Veld, a Dutch member of the European Parliament. “The Commission and the member states are extremely timid and soft. They are failing their citizens.”

“It’s not a legal question,” she said. “It’s about Europe behaving like a politically self-confident entity…”

The EU is preparing to establish new rules, regulations and protection of data for member-states. Though it talks about a “right to erasure” some critics feels the members of the Euro Parliament still have little understanding of where the world has come to with the advent of the World Wide Web.

Should we expect them to be more or less behind the times than Congress or the UK Parliament, eh?

Mario Batali just bought 200 pairs of orange Crocs

U.S. celebrity chef and television personality Mario Batali told Details magazine he recently ordered 200 pairs of his favorite orange Crocs shoes.

Asked how many pairs he owns, the co-host of “The Chew” replied: “Probably 30. I just ordered 200 more because they’re about to take orange out of the field. They made a special run for me before they retired the color.”

“They’re gonna stop the Mario Batali orange!” he added. “It’s preposterous! But they’re doing pretty well without me. Nothing lasts forever, baby.”

Mario should know better. Remember when Creuset said they were going to eliminate Orange Flame from the color choices for Le Creuset enameled cast iron cookware a decade or so ago?

Get pissed off. Let folks know what you like to buy – or not buy. We stopped them dead in their tracks. You’ll still find Le Creuset offered by cooking suppliers. In Orange Flame.

I’ve had my original basic set since 1963. Orange Flame, baby.