Friday, July 30, 2010

Model describes universe with no big bang, no beginning, and no end

By suggesting that mass, time, and length can be converted into one another as the universe evolves, Wun-Yi Shu has proposed a new class of cosmological models that may fit observations of the universe better than the current big bang model. What this means specifically is that the new models might explain the increasing acceleration of the universe without relying on a cosmological constant such as dark energy, as well as solve or eliminate other cosmological dilemmas such as the flatness problem and the horizon problem.

Fascinating stuff.

Saturday, July 10, 2010

Alternet: "Pfizer: The Drug Giant That Makes Bank from Drugs That Can Kill You"

By Martha Rosenberg, AlterNet
Posted on July 10, 2010

The drug company Pfizer is best known for Lipitor, a drug that brings cholesterol down and Viagra, a drug that brings other things up.

But the "world's largest research-based pharmaceutical company" which sits between Goldman Sachs and Marathon Oil on the Fortune 500, is also closely associated with a seemingly never-ending series of scandals.

To say Pfizer's been accused of wrongdoing is like saying BP had an oil spill. Other drug companies have a portfolio of products, Pfizer has a portfolio of scandals including, but not limited to, Chantix, Lipitor, Viagra, Geodon, Trovan, Bextra, Celebrex, Lyrica, Zoloft, Halcion and drugs for osteoarthritis, Parkinson's disease, kidney transplants and leukemia.

During one week in June Pfizer 1) agreed to pull its 10-year-old leukemia drug Mylotarg from the market because it caused more, not less patient deaths 2) Suspended pediatric trials of Geodon two months after the FDA said children were being overdosed 3) Suspended trials of tanezumab, an osteoarthritis pain drug, because patients got worse not better, some needing joint replacements (pattern, anyone?) 4) Was investigated by the House for off-label marketing of kidney transplant drug Rapamune and targeting African-Americans 5) Saw a researcher who helped established its Bextra, Celebrex and Lyrica as effective pain meds, Scott S Reuben, MD, trotted off to prison for research fraud 6) was sued by Blue Cross Blue Shield to recoup money it overpaid for Bextra and other drugs 7) received a letter from Sen. Charles Grassley (R-Iowa) requesting its whistleblower policy and 8) had its appeal to end lawsuits by Nigerian families who accuse it of illegal trials of the antibiotic Trovan in which 11 children died, rejected by the Supreme Court. And how was your week?

Nor does Pfizer back down when faced with legal troubles.

Even as it was under the probation of a 5-year Corporate Integrity Agreement (CIA) with Health and Human Services for withholding $20 million in Lipitor rebates owed to Medicaid in 2002, it off-label marketed its seizure drug Neurontin and entered into another CIA in 2004.

Worse, it bought Warner-Lambert in 2000, which made Neurontin, knowing the drug's marketing practices were under criminal investigation. (And knowing its Rezulin had been withdrawn.)

And even as it entered into its 2004 CIA for Neurontin, it was off-label marketing the seizure drug Lyrica, called Son of Neurontin, and three other meds, and had to enter into a third CIA, last year's $2.3 billion Bextra settlement which was the largest health care fraud settlement in US history.

The same day the settlement news broke, Pfizer announced it bought the drug giant Wyeth despite its thicket of Fen-Phen heart valve suits and Prempro cancer suits.

And there was more "bring 'em on" chutzpah.

After Vioxx and Pfizer's Bextra were withdrawn from the market for cardiovascular risks, Pfizer sought FDA approval for its Celebrex, the last legal COX-2 inhibitor, also suspected of cardiovascular risks, for use in children as young as two.

And in June, days before Pfizer suspended development of the osteoarthritis drug tanezumab for worsening joints, it touted the drug as "well-tolerated."

As a company, Pfizer, based in New York City with research headquarters in Groton, CT, looks better from the outside than the inside. Its Pac-Man like acquisition of drug companies, Warner-Lambert, Pharmacia (Searle, Upjohn), SUGEN, Vicuron, Rinat and Wyeth (also creating the world's biggest animal drug company) has created a silo structure in which the company's 90,000 employees in 90 countries feel unconnected to a corporate heartbeat. Loyalty is rare as employees in absorbed companies bought for their products alone fear getting pfired and 14,000 scientists bemoan that the company's biggies like Lipitor, Celebrex, Neurontin, Zithromax, Zyrtec and now Wyeth's Prempro weren't created inhouse.

Despite flying doctors to Caribbean resorts to attend drug pitches (by other paid doctors) and bestowing four figure honorariums on them, and Enron moments like a Bextra sales extravaganza with acrobats, dancers and gigantic "fist" logo, Pfizer's Midtown Manhattan offices consist of unimpressive cubes.

After becoming the world's biggest drug company in 2000, Henry A. McKinnell, former Pfizer CEO and a Bushmate (replaced by less conservative Jeffrey B. Kindler) vowed to make Pfizer the "the world's most valued company to patients, to customers, to business partners, to colleagues, and to communities where we work and live." But thanks to the parade of damaging safety and ethics scandals, Esprit de corps is lacking except in some sales units.

"Pfizer is a black hole," Peter Rost, MD, author of The Whistleblower: Confessions of a Healthcare Hitman and probably Pfizer's most famous former employee told AlterNet. "It is nothing but a maze of cobbled together drug companies that aggressively markets drugs it didn't create in a military-like command structure."

Still, Pfizer's vast product line, its $50 billion a year revenues -- exceeding some states' entire budgets -- and reputation for having the best trained sales reps make it the team to beat for competing salesmen and examples of Pfizer envy dot Cafepharma, the drug industry chatroom considered pharma's washroom wall.

"Glad they did it," wrote a poster about last year's Department of Justice (DOJ) Bextra settlement. "Pfizer is only sticking it to the American person when they perpitrate a fruad (sic) of this magnitude. The rest of you who sat by and said nothing are no better than a bunch of crooks. My father always said, 'you lie, you cheat, you steal; you can't do one without doing them all'. You must be so proud...I would take that name badge off when I walk into an office if I were you."

"If you think that Pfizer is the only drug company that has dealt with off-label promotion issues you are sadley (sic) mistaken," perpitrated the next poster.

"You are so right. All the other companies are doing it, so we did too. Waaah, waaah, waaaaah! (stomping my foot). It's not fair! It made us so much money! Patients don't matter, money does," wrote the next poster. Characterizations about wives and mothers followed.

Patients also resent Pfizer and have sued over Chantix, Lipitor, Celebrex, Bextra, Neurontin, Lyrica, Viagra, Zoloft and other drugs. Pfizer downplayed Lipitor's "serious and irreversible side effects" says Mark Jay Krum, an attorney representing plaintiffs in a class-action suit, and "is willing to promote the drug at any cost." Say that.

Even the DOJ calls Pfizer incorrigible. "...illegal conduct was pervasive throughout the company and stemmed from messages created at high levels within the national marketing team," it wrote in the Bextra sentencing memo. "Employees, including district managers, explained that they did not question their supervisors about the illegal conduct that they were being instructed to carry out, because to do so would be considered a 'CLM' or 'Career Limiting Move.'"

Still the FDA needs to take some blame for waving iffy Pfizer drugs through, especially under the 1992 Prescription Drug User Fee Act (PDUFA) in which drug companies "buy" accelerated approvals.

Why did the FDA allow Pfizer to make money for ten years on the leukemia drug Mylotarg, which was given an accelerated approval, and allow people to take it as guinea pigs for ten years while "confirmatory" studies establishing its safety and efficacy were still outstanding? Patients who took Mylotarg while on chemotherapy had more deaths than those just on chemotherapy in a clear example of the lethal metrics of rushed through drugs.

Why was Pfizer's pain drug tanezumab, an injected monoclonal antibody made from bio-engineered immune cells, even considered for knee pain except for the profits in such Frakendrugs?

Why was Pfizer allowed to continue clinical trials on children, or anyone, after the FDA found Geodon overdoses in April -- and why is Geodon, rejected once by the FDA and promoted by Richard Borison MD who is in Hancock State Prison for research fraud -- hello -- on the market? Obama appointees Commissioner Margaret Hamburg, MD and principal deputy commissioner Joshua Sharfstein, MD come from public health backgrounds but it will be hard to turn the FDA ship around.

And speaking of dangerous drugs, what's up with Pfizer's anti-smoking drug Chantix?

In 2007, Texas musician Carter Albrecht, who played with Sorta and Edie Brickell & New Bohemians, became a poster boy for Chantix' unpredictable mental effects when he was fatally shot trying to kick in a neighbor's door. In 2008, with 988 adverse effects reported including seizures, heart trouble and suicides, the FDA banned airline pilots and air traffic controllers from taking it. Thanks for that. Last year it gave Chantix a black box warning to "highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs."

Most pharma watchers agree that financial penalties, including last year's $2.3 billion Bextra settlement, won't upend Pfizer whose one year budget for R & D alone is in the billions. Yet the DOJ repeatedly lets Pfizer pawn off guilty pleas to the False Claims Act (which include a ban on Medicare, Medicaid and VA eligibility) on its shell companies and keep doing business with the government. Why?

"Pfizer is the largest drug company in the world and if you include its generics unit it makes literally hundreds of different drugs. Getting tough would mean no Lipitor, no Viagra, no Bacitracin, no Cipro, no Zithromax, no Sutent, et cetera," says Jim Edwards, a pharmaceutical reporter on Bnet and former managing editor of Adweek. "The government is not really in a position to be cutting itself off from all that medicine."

"So many Medicaid, Medicare and VA drugs come from Pfizer, the government would never convict them," agrees Peter Rost. "It would stop the drug flow."

And then there's lobby power.

Just as former Louisiana Republican representative Billy Tauzin left the House Committee on Energy and Commerce which oversees the drug industry and resurfaced as head of PhRMA, Pfizer recently hired Gregory Simon who served on Obama's transition team and as chief domestic policy advisor to Vice President Gore to head its "global policy effort." Its senior corporate counsel until 2008, Arnold Friede, had an FDA background and Pfizer's former senior vice president for worldwide public affairs, Richard Bagger, has re-emerged as New Jersey Governor Christopher Christie's chief of staff. Hey, you guys look familiar!

Even the Bextra settlement arouses cynicism since $102 million of it went to a doctor and five former Pfizer reps who served as whistleblowers on the case, one getting $51 million.

Isn't making big money off pharma how the trouble started?

Martha Rosenberg frequently writes about the impact of the pharmaceutical, food and gun industries on public health. Her work has appeared in the Boston Globe, San Francisco Chronicle, Chicago Tribune and other outlets.

© 2010 Independent Media Institute. All rights reserved.
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Friday, July 09, 2010

5th day of fasting - something happened . . .

I got invited to dinner with some friends tonight.

And, there is no point in going crazy, so I'll have to interrupt the fast.

Since I'm dreaming about grilled beef steaks and other corrupting food and I've learned that you can get sick if you eat tooooo much right away I decided to warm up with some grain cereals and skim milk for breakfast.

That went over well. Never have those cereals had such a full body of flavor and the milk was like something tinged with honey.

Tomorrow I'll continue the fast for two days.

As far as dinner tonight, I simply can't wait to eat RED MEAT.

Thursday, July 08, 2010

4th day fasting: My new love is a Bloody Mary for dinner

I've never had a glass of tomato juice. Pretty much ever. Or a Bloody Mary.

But since I'm fasting, and I figured I didn't want to mess up my electrolytes too much, and a tiny glass of skim milk and orange juice before running in the morning may not be enough to offset all those salts pouring out of my body as I run in ninety-five degree sveltering heat in the morning, perhaps I should try something a bit salty.

So I tried a Bloody Mary.

Oh my gosh.

It was probably the best thing I've had for ages and it tasted like a full meal.

That's the thing about fasting, you start to really, really appreciate the small stuff.

It took me half an hour to slowly sip that Bloody Mary, and to relish the aroma from the tomatoes, the texture of some of the lemon pulp, and the sting on my tongue.

Tonight, I'll have another Bloody Mary.

That's something to look forward to.

Here is a Bloody Mary recipe courtesy of the New York School of Bartending, although I prefer the thing virgin, or with just a few drops of vodka:

1 oz. to 1½ oz. (30-45 ml) vodka in a Highball glass filled with ice.
Fill glass with tomato juice
1 dash celery salt
1 dash ground black pepper
1 dash Tabasco
2-4 dashes of Lea & Perrin's Worcestershire sauce
1/8 tsp. horseradish (pure, never creamed)
Dash of lemon or lime juice

Wednesday, July 07, 2010

Day 3 of the fast . . . so what happens in my body right now?

So, I've never done this before . . . fasted and only drunk water and some skim milk. Surprisingly enough, I don't feel tired or terribly hungry. And it hasn't slowed down my running in the morning.

Makes me wonder a bit, perhaps we evolved to cope with fasting pretty well? I mean, those hunters and gatherers, may not have had food all the time. And they had to run around a lot to find it. So all this eating three or four or five times a day may be just a bad habit?

Then again, it is a lot of fun to eat . . . not having lunch to look forward to is NOT fun.

So I started to wonder what happens in my body when I fast.

There are quite a few studies out there on fasting. Many of them have been done on Muslims, not surprisingly, considering their religious reasons for fasting.

Here is what appears to happen in the body, according to the scientific data:

•Liver glycogen levels are depleted within 8-10 hours. Muscle glycogen falls by 50% over 24-hours, even without exercise.
•After depleting glycogen, amino acids are recycled to be broken down for glycogen through gluconeogenesis.
•We see increases in three of the four hormones driving lipolysis, indicating a propensity towards fat burning. Somewhere around 12-18 hours, lipolysis becomes a major energy pathway, producing energy from body fat.
•T3 levels fall slightly, indicating a slightly lower metabolic rate. Urinary nitrogen excretion falls, indicating less catabolism of muscle proteins.
•Beta-hydroxy butyrate, hGH, and IGF all increase. Proteins that protect cells from stress also increase.
•Inflammatory markers decrease. Insulin sensitivity improves. AGEs likely decrease.
•Cancer protection increases, healthy cells are better protected from chemotherapy, and markers of heart disease decrease. General immunity seems to improve.
•Brain neurons are protected from stressors, BDNF increases (helps grow brain neurons), and the brain is better protected from Alzheimer’s and Parkinson’s Diseases. Fasting after a brain injury lessens the damage of the injury.
•Exercise during a fast shows a higher rate of fat burning for fuel.
•Learning is enhanced and jet lag may be reduced.

Tuesday, July 06, 2010

Day 2 of the fast . . . still alive

So far so good.

Actually not terribly hungry.

Did a three mile run this morning, before the temperature hit ninety degrees, had a glass of skim milk and some juice. I guess that's it for food today.

I've noticed that drinking a ton of water seems to fill the stomach and give an illusion of having eaten a meal.

Six more days to go . . .

Monday, July 05, 2010

Testing my will power: One week water fast

SO . . . I'm going to check if I can make it.

Fast for a week. Only water.

And excercise as usual, run about 45 minutes every day, in the morning before the temperature reaches 95 degrees.

Should be interesting.

First day, so good so far.

I guess I've gulped down a gallon of water.

Thursday, July 01, 2010

Will Pfizer mention Peter Rost and his false claims case to Senator Grassley?

Grassley Asks Pfizer, Drugmakers How They Treat Whistleblowers - BusinessWeek

By David Voreacos

July 1 (Bloomberg) -- U.S. Senator Charles Grassley asked 16 drugmakers, including Pfizer Inc., AstraZeneca Plc and Eli Lilly & Co., to reveal how they treat whistleblowers who file complaints under the False Claims Act.

Grassley, an Iowa Republican, sent letters June 28 that posed eight questions such as how companies notify employees of the law, how they treat whistleblowers and what changes they have made in response to a 2009 law extending anti-retaliation protections. Grassley’s office provided copies of the letters.

The False Claims Act lets private citizens sue on behalf of the government and share in any recovery. Whistleblowers were paid $2.39 billion from 1987 to 2009, or 16 percent of the $15.19 billion collected in False Claims lawsuits in which the U.S. government joined the case, according to the Justice Department.

“What measures does Pfizer have in place to ensure fair treatment to those filing complaints?” Grassley wrote to Chief Executive Officer Jeffrey Kindler. “Of employees who have filed complaints, have any complained of unfair treatment and/or retaliation after the filing of the complaint?”

The False Claims Act was passed by Congress in 1863 and strengthened three times since 1986. Citizens file so-called qui tam cases that remain sealed from public view as the Justice Department investigates the claims and decides whether to join the suit. Twenty-five U.S. states have their own versions of the law.

Large Settlements

Drugmakers have reached some of the largest settlements in recent years. Pfizer agreed to pay $2.3 billion over improper drug marketing, Lilly paid more than $1.6 billion to settle claims over its marketing of the drug Zyprexa, and AstraZeneca paid $520 million over marketing of its drug Seroquel.

Chris Loder, a spokesman for New York-based Pfizer, the world’s biggest drugmaker, said the company is responding to the letter and “shares the senator’s desire to detect and report any false claims that may lead to unnecessary costs to our health-care system.”

Pfizer, he said, has invested “substantial resources” to “create a compliance program that consists of mandatory training for every one of our employees, proactive monitoring and surveillance, and strict enforcement of all federal and state health-care laws.”

The company also has a chief compliance officer reporting to the CEO, a corporate compliance committee, a code of conduct, a compliance hotline and extensive procedures to investigate and remediate possible non-compliance, he said.

Anonymous Reports

Tony Jewell, a U.S. spokesman for London-based AstraZeneca, the U.K.’s second-largest drugmaker, said the company encourages its employees to report any instances of misconduct through various channels, including anonymously.

“We respond to all complaints of wrongdoing through prompt investigations and appropriate remedial action,” he said. “Retaliation of any kind is explicitly prohibited under our policies.”

Edward Sagebiel, a spokesman for Indianapolis-based Lilly, confirmed that the company received the senator’s letter.

“We will be cooperating fully with this request for information,” he said.

Grassley was a sponsor of the Fraud Enforcement and Recovery Act passed last year, which restored powers under the False Claims Act that had been narrowed by court rulings. The new law limited the ability of companies to avoid liability under the False Claims Act and made it easier for the Justice Department to issue civil investigative demands, a type of subpoena power, in pursuing cases.

‘Public Responsibility’

“My appeal to drugmakers is based on the fact that they have a public responsibility to safeguard the tax dollars that pay for their products, and promoting a culture where those who speak up about possible fraud are rewarded rather than retaliated against is one way to fulfill that responsibility,” Grassley said in a statement. “There can never be too many taxpayer watchdogs, so I see this letter as an opportunity to foster a mindset that recognizes the value of whistleblowers and the duty these companies have to act honestly when seeking taxpayer dollars.”

Whistleblowers are routinely exposed to retaliation and blackballing from their industries, said Patrick Burns, a spokesman for Taxpayers Against Fraud, a Washington non-profit advocate for the False Claims Act.

“The goal for companies is to isolate, humiliate, and terminate,” Burns said. “They want to send a signal to anyone else in the company that this is what happens to you -- you will lose your job, you may lose your house, you may end up with a dissolved marriage.”

The Justice Department is investigating almost 1,000 whistleblower cases filed under seal, Assistant Attorney General Tony West said in an interview on June 3.

In the letters, Grassley, the ranking Republican member of the Senate Finance Committee, said he expects written responses to his questions by July 20.

--Editors: Peter Blumberg, Glenn Holdcraft

To contact the reporter on this story: David Voreacos in Newark, New Jersey, at

To contact the editor responsible for this story: David E. Rovella at


Hat tip PharmaGossip.