Pfizer, Moderna, skip White House vaccine summit

Pfizer and Moderna, the two pharmaceutical companies closest to gaining U.S. clearance for a Covid-19 vaccine, won’t attend a White House summit intended to build confidence in the shots.

With the Food and Drug Administration expected to decide on whether to allow the companies’ vaccines to be distributed in the coming days, there was worry that regulators and executives shouldn’t be seen rubbing elbows at the Tuesday meeting.

…The focus of the gathering shifted after Peter Marks, the head of the FDA center that reviews vaccines, volunteered to make a presentation…Since it would be would inappropriate to have vaccine company executives touting their shots while in the same room with their regulator, a decision was made not to include any drugmakers in the meeting, the official said on a call with reporters on Monday.

Predictably, Trump’s setup their “summit” to try to make it appear they had done something right in the fight against COVID-19. And fumbled the ball.

RTFA, though. Pfizer had already notified organizers they wouldn’t be attending. Something similar from Moderna. Both of these firms should be making announcements over the next week or two.

Transparency note: I own shares in Moderna in my retirement investment account.

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.

Pfizer cheated, deceived and cherry-picked Celebrex studies

A research director for Pfizer was positively buoyant after reading that an important medical conference had just featured a study claiming that the new arthritis drug Celebrex was safer on the stomach than more established drugs.

“They swallowed our story, hook, line and sinker,” he wrote in an e-mail to a colleague.

The truth was that Celebrex was no better at protecting the stomach from serious complications than other drugs. It appeared that way only because Pfizer and its partner, Pharmacia, presented the results from the first six months of a yearlong study rather than the whole thing.

The companies had a lot riding on the outcome of the study, given that Celebrex’s effect on the stomach was its principal selling point. Earlier studies had shown it was no better at relieving pain than common drugs — like ibuprofen — already on the market.

The research chief’s e-mail, sent in 2000, is among thousands of pages of internal documents and depositions unsealed recently by a federal judge in a long-running securities fraud case against Pfizer. While the companies’ handling of the research was revealed a dozen years ago, the documents provide a vivid picture of the calculation made by Pfizer at the time and its efforts ever since to overcome doubts about the drug…

In one e-mail, an associate medical director at Pharmacia (which was later bought by Pfizer) disparaged the way the study was being presented as “data massage,” for “no other reason than it happens to look better…”

The importance of Celebrex to Pfizer is indisputable. It is one of the company’s best-selling drugs, racking up more than $2.5 billion in sales, and was prescribed to 2.4 million patients in the United States last year alone.

The drug is the last of the so-called COX-2 inhibitor pain drugs, after Vioxx and Bextra were withdrawn in 2004 and 2005 because of safety concerns.

And that, at root and cause, is what it’s all about. Pfizer – like their peers – doesn’t care if the wonderful new pharmaceutical they’re preparing to inflict upon unhealthy Americans and citizens of every other nation cures warts on your genitals or prevents death by drowning. It’s a commodity and coming from the Pharma industry it is designed to produce mammoth profits on the order of billion$.

Ethics have little to do with it. Aid to individuals struggling with ill health only define the market. Profiteering is the name of the game and if that involves deceit and outright deception – hey, we’re all grownups in the boardroom.

Pfizer = too big for the Feds to penalize for all their crimes

Imagine being charged with a crime, but an imaginary friend takes the rap for you.

That is essentially what happened when Pfizer, the world’s largest pharmaceutical company, was caught illegally marketing Bextra, a painkiller that was taken off the market in 2005 because of safety concerns.

When the criminal case was announced last fall, federal officials touted their prosecution as a model for tough, effective enforcement. “It sends a clear message” to the pharmaceutical industry, said Kevin Perkins, assistant director of the FBI’s Criminal Investigative Division.

But beyond the fanfare, a CNN Special Investigation found another story, one that officials downplayed when they declared victory. It’s a story about the power major pharmaceutical companies have even when they break the laws intended to protect patients…

Pfizer said in court that “the company’s intent was pure”: to foster a legal exchange of scientific information among doctors. But an internal marketing plan called for training physicians “to serve as public relations spokespeople.”

According to Lewis Morris, chief counsel to the inspector general at the U.S. Department of Health and Human Services, “They pushed the envelope so far past any reasonable interpretation of the law that it’s simply outrageous…”

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Pfizer drug ripoff = biggest criminal fine in US history


Daylife/AP Photo used by permission

We sit out here watching Congress and tea-bagger Republicans whining about the sanctity of insurance and drug companies. They say these corporations require protection from competing with a public option in healthcare reform. Meanwhile, thugs like Pfizer steal the public blind.

Pfizer, the world’s largest drugs company, has been hit with the biggest criminal fine in US history as part of a $2.3 billion settlement with federal prosecutors for mispromoting medicines and for paying kickbacks to compliant doctors.

In a blow to its reputation in the eyes of doctors and patients, Pfizer pleaded guilty to misbranding the painkiller Bextra, withdrawn from the market in 2004, by promoting the drug for uses that were not approved by medical regulators.

The New York-based company also settled civil allegations concerning improper payments to doctors who prescribed nine other pharmaceutical products, although it continues to deny these charges.

Under an out-of-court deal with the US department of justice, a Pfizer subsidiary, Pharmacia & Upjohn, is paying a criminal fine of $1.3bn (nearly £800m), a record in American judicial history.

Pfizer is also paying $1bn in civil settlements to Medicare, Medicaid and other government health insurance schemes to reimburse improper prescriptions.

Prosecutors said the payments reflected the “size and seriousness” of Pfizer’s infringements. Tom Perrelli, the associate attorney general, said it was a victory for the public over “those who seek to earn a profit through fraud“.

We the People – are the ones who require protection. From insurance companies, from pharmaceutical companies – from the frauds who front for them in Congress.