Thursday, November 5, 2009

Welcome to the Wonderful World of Biologics

Got your jug of water handy? Makes the pills go down easier.

What is BIOLOGICS?

"House panel would give biologics 12-year window" by Bloomberg News | August 1, 2009

WASHINGTON - Biologic drugs would get 12 years of protection from competing medicines under a provision passed by a US House panel in legislation to overhaul the nation’s $2.5 trillion healthcare system.... Biologic drugs cost Americans $60 billion a year....

Translation: the new "health" bill will have PROFIT PROTECTION for "THERAPEUTICS"!!!

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Ready for your pills, readers?

Take the BIG FAT ONE first!

Taking Your Temperature

"Last year, the company’s revenue grew 8 percent to $10.5 billion with profits of $994 million"

Related: "Thermo Fisher Scientific, CEO Marijn E. Dekkers, $18,705,572"

Yeah, you do seem a little hot, readers.

Let me check something....


Alkermes Heel

"Alkermes chief executive suddenly leaves Cambridge biotech company" by Robert Weisman, Globe Staff | September 12, 2009

Cambridge biotechnology company Alkermes Inc., which has suffered a string of setbacks this year, yesterday said its chief executive has abruptly left after two years on the job and is being replaced by its board chairman. In a terse statement, the company said David Broecker “has resigned, effective immediately’’ from his roles as president, chief executive, and a director of Alkermes, which makes drugs to treat alcoholism, depression, and other diseases....

Maybe they should start taking some of their own poisons, I mean, pills!

Last year, Alkermes said it would cut 150 jobs and close a Chelsea manufacturing plant after Eli Lilly & Co. dropped out of a joint venture to market inhalable insulin as an alternative to injections....

Yes, there IS some SENSITIVITY there, isn't there, readers?


Alkermes, like other biotechs, has been feeling the squeeze over the past year as drug development projects have slowed and financing has been harder to come by.

BAD DEAL, Bay-Stater: Biotech Giveaway Was Borrowed Money

Seeking cost savings, the company said in April it will be moving out of its Cambridge headquarters to cheaper space in suburban Waltham by early next year, hoping to trim annual expenses by $8 million....

Well, you better stay off that foot for a while. I wouldn't want you walking those jobs out of state.


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Maybe we can get you a prescription
:

Pfizer Painkillers

"Trial over Pfizer drug ends with mystery donation to woman’s daughter" by Associated Press | July 30, 2009

TRENTON, N.J. - The first personal injury trial over a Pfizer Inc. drug linked to suicide ended abruptly yesterday when the victim’s family accepted $50,000 from an anonymous donor to drop the case....

All right, let's not prescribe this one.

The family’s lawyer, Mark Lanier, said the offer was made to the 10-year-old daughter of Susan Bulger. Bulger had been taking Pfizer’s epilepsy drug Neurontin for unapproved uses - depression and rheumatoid arthritis - when she hanged herself on Aug. 4, 2004....

The daughter, who was 5 at the time, found her 39-year-old mother hanging from an electrical cord. “It was going to be a tough case for us to win,’’ said Lanier, because Bulger “had arguably [made] up to six suicide attempts’’ previously. The case, which was being heard in Boston, was permanently dismissed yesterday by US District Judge Patty Saris. It is the first case to come to trial out of about 1,200 lawsuits alleging Neurontin led people to attempt or commit suicide, according to Lanier, a high-profile plaintiffs attorney who handled hundreds of lawsuits over Merck & Co.’s withdrawn painkiller Vioxx.

Need some more water, readers?

New York-based Pfizer said Neurontin, which is approved by the Food and Drug Administration and has been on the market since 1993, has been prescribed to millions of patients safely and effectively.

Do YOU trust the FDA these days?

Pfizer said there’s no evidence Neurontin, which is approved only for treating epilepsy seizures and nerve pain, causes suicidal behavior....

But WHY TAKE the CHANCE?!!

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WASHINGTON - Pfizer Inc.’s Pharmacia & Upjohn unit pleaded guilty to a felony violation of the Food, Drug and Cosmetic Act for misbranding the drug, Bextra, with the intent to defraud or mislead....

So YOU DON'T EVEN KNOW WHAT is IN the VIAL, do you?

Pfizer, based in New York, agreed to the plea and a $1.3 billion criminal fine, the largest in US history, on Sept. 2 to close a federal probe into allegations that the painkiller Bextra and other medicines were promoted for uses not approved by US regulators.

Is that enough?

Related:
Drug-Addicted Doctors

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But wait, that's not all....


"Pfizer to pay record $2.3b penalty over promotions; Marketing of 13 drugs scrutinized" by Devlin Barrett, Associated Press | September 3, 2009

WASHINGTON - Federal prosecutors hit Pfizer Inc. with a record-breaking $2.3 billion in fines yesterday and called the world’s largest drug maker a repeating corporate cheat for illegal drug promotions that plied doctors with free golf, massages, and resort junkets.

I think we will try a different company, patient/reader.


Announcing the penalty as a warning to all drug manufacturers, Justice Department officials said the overall settlement is the largest ever paid by a drug company for alleged violations of federal drug rules, and the $1.2 billion criminal fine is the largest ever in any US criminal case. The total includes $1 billion in civil penalties and a $100 million criminal forfeiture. Authorities called Pfizer a repeat offender, noting it is the company’s fourth such settlement of government charges in the last decade.

And yet, THEY GET a SEAT at the HEALTHCARE TROUGH, 'er, TABLE!!!


The allegations surround the marketing of 13 drugs, including big sellers such as Viagra, Zoloft, and Lipitor.

But, but, but, their television ads are so soothing and convincing!


As part of its illegal marketing, Pfizer invited doctors to consultant meetings at resort locations, paying their expenses and providing perks, prosecutors said. “They were entertained with golf, massages, and other activities,’’ said Mike Loucks, the US attorney in Massachusetts.

Prostitutes?


Loucks said that even as Pfizer was negotiating deals on past misconduct, they were continuing to violate the very same laws with other drugs.

Liar, criminal, thief, all rolled into one!


Pfizer’s top lawyer, Amy Schulman, said in her statement:

[The settlements] bring final closure to significant legal matters and help to enhance our focus on what we do best - discovering, developing and delivering innovative medicines. We regret certain actions taken in the past, but are proud of the action we’ve taken to strengthen our internal controls and pioneer new procedures.’’

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In an unusual twist, the head of the Justice Department, Attorney General Eric Holder, did not participate in the record settlement, because he had represented Pfizer on these issues while in private practice.

It's NOT THAT UNUSUAL! It's called CONFLICT-of-INTEREST, and WHAT is UNUSUAL is RECUSAL!

Associate Attorney General Thomas Perrelli said the settlement illustrates ways the Justice Department “can help the American public at a time when budgets are tight and health care costs are rising.’’

Yes, we are here from the government and we are here to help.

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Then why all the lying?

Biogen on the Brain

"Biogen partner sues over $1.5b J&J agreement" by Sean Sposito, Globe Correspondent | August 7, 2009

A partnership between the Irish drug maker Elan Corp. and Cambridge biotechnology company Biogen Idec Inc. has turned into a legal battle over a multiple sclerosis drug, Tysabri. The drug “has blockbuster potential,’’ said Jennifer Neiman, a spokeswoman for Biogen, and is projected to gross more than $1 billion in sales. Yesterday, Elan filed a federal suit against Biogen to stop it from interfering with a recent $1.5 billion deal with Johnson & Johnson....

I think you need the pill to numb the pain of job-loss, readers.

Related: British Reoccupy Boston

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Hey, they ain't Irish!

NEW YORK - Biogen Idec Inc. said a patient taking its multiple sclerosis drug Tysabri was diagnosed with a life-threatening brain illness, the eighth case reported in the last year.... The likelihood of getting progressive multifocal leukoencephalopathy from Tysabri is about 1 in 1,000, according to the drug's label.

NOT GOOD ENOUGH ODDS!

The infection occurs when a common germ mutates, then evades the body's immune defenses and penetrates the brain, causing irreversible damage. Researchers theorize that Tysabri may subdue defenses meant to keep the virus out of the brain. The virus breeds in brain cells, destroying them when it replicates....

Ever see John Carpenter's "The Thing?"

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Well, I'm still human, and I know some of you are, readers.

"Tysabri linked to 13 brain infections" by Bloomberg News | September 17, 2009

WASHINGTON - The drug Tysabri, from Biogen Idec Inc. and Elan PLC, has been linked to 13 cases of a deadly brain disease since it was reintroduced in July 2006, regulators said yesterday.

And EXPECT the toll to KEEP RISING!

See: Biogen Benefits From Brain Disease

There is Money to be Made in Multiple Sclerosis

Now I need a pill.

New safety information about the treatment for relapsed multiple sclerosis and Crohn’s disease was posted on the Food and Drug Administration’s website.... Fewer than one patient in 1,000 develops PML, with those who get more monthly infusions having increased risks, according to the FDA.

Oh, it is a NEEDLE you are getting?

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What is it with these sick scientists and their jabbing, 'eh?

"European panel reviewing infections linked to Tysabri" by Robert Weisman, Globe Staff | October 24, 2009

Shares of transatlantic biotechnology partners Biogen Idec Inc. and Elan Corp. tumbled yesterday after European regulators said they were examining 23 cases of patients who developed potentially fatal brain infections after taking the companies’ multiple sclerosis drug Tysabri.

And they are ALSO FIGHTING AMONGST THEMSELVES!

That is twice as many cases as previously reported.

Translation: Cover-up or lie, you decide.

The European Medicines Agency, which regulates drugs in Europe, said it will review the risks and benefits of Tysabri and discuss whether added measures are needed to assure safety....

Oh, so Europe MAY be smartening up.

Al Sandrock, senior vice president and head of neurology research and development at Biogen Idec, said the company was discussing with global regulators a change to the wording on Tysabri’s label that would reflect an increased risk the longer patients took the drug.

We ALREADY HAVE GLOBAL GOVERNMENT, readers!

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Related:
"Biogen Idec, CEO James C. Mullen, $11,323,986"

Why is it that the CURE is worse than the DISEASE?

And MORE EXPENSIVE?


Gulping Down Genzyme

"Genzyme struggles to recover from virus" by Robert Weisman, Globe Staff | September 21, 2009

CAMBRIDGE - The lucrative market for Cerezyme which, like Fabrazyme, costs about $200,000 a year per patient, most of it covered by insurers in the United States or governments elsewhere....

Related: The Lies of Genzyme

The Needs of Genzyme Outweigh the Needs of All

An Enzymatic Insult

Think you are being LOOTED, readers?

Genzyme executives have sought to defuse the strong and sometimes angry reaction from patients, doctors, and investors by hosting meetings, making website postings, and setting up call-in lines to update the progress being made....

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That will not help you at all, reader/patient.

What you say? Your pooper feeling a bit sore, readers?


There has to be something for you out there, readers.


Checking Your Altus

"Altus says it has begun shutting down" by Globe Staff | September 17, 2009

Altus Pharmaceuticals Inc.’s days are numbered. In documents filed with regulators, the Waltham company said it is starting the process of closing down. Like many other biotechnology firms that do not have products on the market, Altus, founded in 1992, has found it especially difficult to raise cash during the recession. This year, Altus cut 75 percent of its workforce, or 107 employees, in a bid to survive....

Yes, SAY GOODBYE to THAT TAX LOOT, Bay-Stater!

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I think I found you one!


Home of the Hobbit

"Shire plans to add 750 Mass. jobs" by Robert Weisman, Globe Staff | August 20, 2009

Shire PLC plans to invest $460 million over the next eight years and hire 750 full-time employees in Lexington as its expands its Human Genetic Therapies division, the British drug maker said yesterday....

Back to the British again!

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All right, doc, just write the prescription.

Doctor's Signature

And how odd that I can't even read it (brief NOT in my printed paper?)!

"Doctor sentenced for phony prescriptions

A Virginia doctor who pleaded guilty to tax evasion and writing thousands of prescriptions over the Internet for people he never met was sentenced yesterday in federal court in Boston, acting US Attorney Michael K. Loucks announced. Dr. Torrino Jennings, of Mechanicsville, Va., was sentenced to a year and a day in prison, followed by three years of supervised release. Jennings pleaded guilty in July to issuing between 50,000 and 100,000 prescriptions, Loucks said.

That's all?

Filling the Prescription

The CVS is just around the corner.


"Zyprexa suit highlights CVS links to Lilly; Unit was paid to pitch drug to health insurers" by Jef Feeley and Margaret Cronin Fisk, Bloomberg News | June 14, 2009

.... The insurers suing Eli Lilly & Co., the biggest maker of psychiatric drugs, contend the drug maker should pay as much as $6.8 billion in damages for downplaying Zyprexa's health risks and marketing it for unapproved uses to increase profits....

Questions raised by the unsealed documents, including the "ghostwriting" of medical articles by the drug maker and the marketing of Zyprexa to the elderly....

But they "care" about our "health!"

Related: Breaking News: Because We Love You, Ladies!

Glaxo's Ghostwriters

"Genzyme Corp., CEO Henri A. Termeer, $12,699,301"

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The unsealed documents in the Lilly suits revealed company officials wrote medical journal studies about Zyprexa and then asked doctors to put their names on them, a practice called "ghostwriting."

No ghostwriting here, readers. I'm all too real!


Lilly employees compiled a guide to hiring scientists to write favorable articles, complained to journal editors when publication was delayed, and submitted rejected articles to other outlets, according to the documents. The use of ghostwriters has created "a huge body of medical literature that society can't trust," said Carl Elliott, a University of Minnesota bioethicist who has written about the practice.

Why are all these pills I gave you under the table, readers?


The documents also showed that Lilly urged doctors to prescribe Zyprexa for elderly patients with dementia, an unapproved use for the antipsychotic, even though the drug maker had evidence the medicine didn't work for such patients....

But it BOLSTERED the BOTTOM LINE!!!


Zyprexa costs $3,000 to $9,000 more per year than an older, generic antipsychotic drug called haloperidol, according to the Lilly suit, citing a study of Veterans Administration hospitals. The insurance plans sued the drug maker in 2005, contending it used researchers, pharmacy benefit managers, advocacy groups, and public agencies to promote Zyprexa....

So VETS were GOUGED for PHARMA PROFITS!


One of the "key issues" in the market for antipsychotic drugs was finding ways to "accelerate the growth of new patient starts," according to the proposal....

So they HAD DOCTORS over to PIMP their POISONS!


"There's no question that these folks are all in bed together," said Richard Beck, executive director of the Texas Pharmacy Business Council, a trade group. "They make these deals and never disclose them. It's the clearest example of a conflict of interest I can think of."

Beck, the Texas pharmacists' lobbyist, said the conflicts of interest for companies that both represent health insurers in their search for cheaper medicines and market those drugs for the drug makers "are just too obvious to ignore. How does marketing a manufacturer's drug help hold down costs?"

It doesn't.

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Why do you always have to wait forever in their lines? You said 15 minutes, I gave you 20, and I'm still waiting 20 more.

I'm feeling weak.

Side Effects

"Researchers question anemia drug benefits; Performs no better than placebo in trial" by Elizabeth Cooney, Globe Correspondent | October 31, 2009

.... The study results were released hours after attorneys general from Massachusetts and 14 other states sued Amgen in federal court in Boston alleging that the company offered kickbacks to doctors to boost sales of Aranesp.

This thing must cause upset stomachs, vomiting, and diarrhea, becaus e that's how I'm feeling.

The states, which joined a former company sales representative who earlier filed a whistle-blower suit under seal, allege that Amgen provided doctors excess amounts of the drug in product vials, and encouraged them to bill insurers, including state Medicaid programs and Medicare, for the free Aranesp.

That is WHY HEALTHCARE COSTS SKYROCKETED and WHY the U.S. has SUCH a PROBLEM with ADDICTION! Yeah, SPIKE the S***!!!!

Amgen issued a statement, saying, “We believe that the allegations are without merit, and we look forward to the opportunity to examine these matters with the states before the Court.’’

Well, you KNOW THEY are LYING THERE!!!!

There is NO WAY they are "looking forward" to COURT!

Dr. Preston Klassen, executive medical director of global development at Amgen, a spokesman for Amgen, said the landmark study answered important questions about Aranesp.

Related: Thar's Gold in Them There Bones!

Then why are mine so brittle?

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Maybe I should sell my bones for gold, huh?