Drugs for Profit, the Same for Care

Pfizer worries about financial impact of the Aricept 10mg dose patent approval ending so it gets double dose OK from FDA.

Aricept 23 mg failed to demonstrate a clinically meaningful benefit

Public Citzen petitioned  FDA Commissioner to immediately removal from market Pfizer's Alzheimer's drug, Aricept  23 mg dose, because of serious safety hazards and failure to demonstrate efficacy. The petition also urges FDA to add a label warning on Aricept and generic donepezil (5 mg and 10 mg) stating: "Use of 20 mg per day is counter indicated."

Aricept  (donepezil) 23 mg was approved July 23, 2010 on the basis of a single clinical trial (Study 326) --despite the recommendation by both FDA medical reviewers and statistical reviewers NOT to approve the drug  because it had failed to demonstrate efficacy but significantly increased risks to patient safety.

Patients in the trial had already been taking Aricept 10 mg for three months. They were randomized to Aricept  at either 10 mg dose or 23 mg.  Complete article

Vitamins for Alzheimers

Natural Health News: The TSH Test Can't Tell You About Thyroid Health

May 04, 2011

UPDATE: 3 February 2010 In the brain of his low dose test animals, Isaacson observed a tangling of capillary blood vessels, reduced oxy... Vitamins for Alzheimer's. September 2010 Good News for B Vitamins and Your Brain Ranks now in the ...

Natural Health News: Vitamins for Alzheimer's

Dec 27, 2009

Vitamins for Alzheimer's. September 2010 Good News for B Vitamins and Your Brain Ranks now in the TOP10 out of 3.9 M Access the May 2007 issue of herbalYODA Says! that focuses on vitamin B12 with a donation to help us continue this work ...

Additional Resources: Health, Vitamins and Alzheimer's

Dec 13, 2008

REF: High-dose vitamin B12 for at-home prevention and reversal of Alzheimer's disease and other diseases. REF: Vitamin C, E, Selenium. Daniel Fabricant, Ph.D., writes about the JAMA study denouncing the benefit from Vitamins C and E. ...

For-profit hospice industry raises worries

BLOOMINGTON, Ind., May 19 (UPI) -- End-of-life hospice care is being dominated by investor-owned chains that cherry-pick patients and cut labor costs to maximize profits, U.S. researchers say.
Dr. Robert Stone, an emergency medicine physician in Bloomington, Ind., and Joshua Perry of Indiana University say end-of-life hospice care was once the province of charitable organizations, but 52 percent of hospices are now part of the for-profit sector.
For-profit hospice industry grew by 128 percent from 2001 to 2008, while the non-profit sector grew by only 1 percent. During the same period, government-sponsored hospices increased by 25 percent.
"Research shows that for-profit hospices, and especially publicly traded chain providers, generate higher revenues than their non-profit counterparts," Stone says in a statement. "They do this in part, studies show, by selectively recruiting longer-term patients, most of whom do not have cancer, thereby gaming the Medicare payment system."  Complete Article

Hospice Patients Alliance

Selections from Natural Health News

Paging Doctor Nurse

Apr 16, 2010

Dying hospice patients have been denied morphine in their final hours because a doctor couldn't be reached in the middle of the night, nurses told The Associated Press. Massachusetts, the model for the federal health care overhaul,

Ultrasound in Cancer Detection

Oct 07, 2009

Ellen Wild told The Times that her father died at a hospice in Edina, Minn., on Sept. 18. This information is provided by Creating Health Institute through our Health Matters(c) project.

Hawking Retires

Oct 24, 2008

This item is important to me in relation to a recent case of the demise of a person with ALS in N. Idaho, through the hospice system. Dr. Hawking is renown as one of the great minds of our times, and yet with ALS (Lou Gehrig's disease)

1984 is Now

Aug 15, 2008

I received this article from Hospice Patient's Alliance. If people contemplate and really see the sanctity of life, their "quality of life" arguments fall away and they will understand that we are here to care for each other, ...

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Posted in: a natural health news,a natural news,Alzheimers,Aricept,FDA,Hospice,Pfizer,Public Citizen

An Interesting Take on How You Can Trust the FDA

Most who know me know that I have worked in mental health and psych for many years, albeit, mainly with a keen interest in natural mental health.

I believe nutrition has a very important role in health, physical and mental.  However, with the furor over S510 it does concern me that good, sound nutrition won't be part of the landscape.

And as you can see here in the following three articles, leaving it to the FDA leads us down a very slippery slope.

Looks like more and more no one in Congress or government is doing too much of a good job for the electorate these days.

And outside the issue of risky antidepressant drugs, FDA allows so many more that we have alerted our readers to their dangers for many, many years... 

The antidepressant reboxetine: A headdesk moment in science

By SciCurious Nov 30, 2010 08:44 AM 

Every so often there comes a truly "headdesk" moment in science. A moment where you sit there, stunned by a new finding, and thinking, blankly..."ok, now what?"
For psychiatry and behavioral pharmacology, one of those moments came a few weeks ago with the findings of a meta-analysis published in the British Medical Journal (Eyding et al., 2010). The meta-analysis showed that an antidepressant, reboxetine (marketed by Pfizer in Europe, but not in the US, under the names Edronax, Norebox, Prolift, Solvex, Davedax or Vestra) doesn’t work. Not only does it not work, it REALLY doesn’t work, and it turns out that Pfizer hadn’t published data on the putative antidepressant from 74% of their patients. Some people have reported that the study found that reboxetine was even "possibly harmful," but that’s not quite true. What the study DID find is that reboxetine produced more side effects (noted as "adverse events") than placebo (as might be expected), but with no positive effects at all. While many antidepressants on the market today are not great, most are effective in around 60% of patients, reboxetine turns out to be even worse than that.
SOURCE and complete article

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The next two reports come from the Alliance for Human Research Protection news feed, www.ahrp.org

A letter of complaint by the Project on Government Oversight (POGO) was sent to the director of the National Institutes of Health, documenting $66.8 million in NIH grants over the last five years awarded to a handful of psychiatrists who used ghostwriters for scientific publications. 

The instances in the letter involve ghostwriting by only one company--Scientific Therapeutics Information-- and involve only one drug--GlaxoSmithkline's antidepressant, Paxil.

Duff Wilson of The New York Times reports that previously sealed GlaxoSmithKline documents reveal that a textbook in psychiatry, whose listed authors are  Charles Nemeroff, MD and Alan Schatzberg, MD, was actually ghostwritten by Sally Laden of STI. GSK paid the ghostwriter and the "authors" who penned their names to the book.

The sheer audacity prompted former FDA commissioner, Dr. David Kessler to exclaim: "To ghostwrite an entire textbook is a new level of chutzpah. "I've never heard of that before. It takes your breath away."  Surely that is a
dubious distinction in academic medicine!

and

On November 23, 2010, Terry Vermillion, Director of FDA's Office of Criminal Investigation announced his  retirement next month amid a brewing scandal involving corrupt practices.

The announcement came after complaints by Republicans in Congress who raised concern about his misdirection of the Office's resources: instead of pursuing drug companies and researchers who commit crimes when seeking FDA approval for drugs, OCI pursued drug-abuse cases--which are the purview of the Drug Enforcement Agency.

The issue came to a head when Senator Chuck Grassley sent a complaint to the Acting Comptroller General of the General Accounting Office (GAO) about a "less than stellar" GAO investigative report which whitewashed misconduct at OCI. 

The investigation and the report were compromised by a GAO mole who tipped off someone at the Office of Criminal Investigations.
http://online.wsj.com/public/resources/documents/grassleyletter.pdf   

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Posted in: Alliance for Human Research Protection,Big PhRMA,FDA,GSK,OIG,Pfizer

Pfizer Pays Record Fines for Illegal Activity

WASHINGTON – Federal prosecutors hit Pfizer Inc. with a record-breaking $2.3 billion in fines Wednesday 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.

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

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 U.S. attorney in Massachusetts.

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

To prevent backsliding this time, Pfizer's conduct will be specially monitored by the Health and Human Service Department inspector general for five years.

Complete article from AP

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Posted in: FDA,illegal drug promotions,Pfizer,record fines

TV Drug Ads, Celebrities and FDA Propaganda

UPDATE: May 27, 2010 - FDA Adds Liver Injury Warning to Diet Drug

WASHINGTON -- The weight-loss medication orlistat, marketed both by prescription as Xenical (120 mg) and over-the-counter as Alli (60 mg), will carry a warning about the potential for severe liver injury, the FDA announced ... full story http://www.medpagetoday.com/InfectiousDisease/PublicHealth/tb/20310

UPDATE: August 25 - FDA probes liver damage with weight loss pill alli
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Originally posted 2/13/09
As we shall see over comings months the stimulus package is not going to be all you think it is because of smoke, mirrors and an ever expanding bureaucracy.

Not too far removed from the stimulus issue is how TV ads for drugs push up profits for Big Pharma.

One example of just how thick as thieves things are between drug companies and their PR programs is a recent story about how Wyeth promoted risky HRT through a media program aimed at increasing prescription writing for their well know hormone product just as they moved to be bought out by Pfizer.

Now, as if this $12 million isn't enough of a tax write off for the drug industry, GSK is leading us all down the pike to fairy land with its ad featuring Wynonna for its over-the-counter weight loss drug 'alli'.

During the commercial featuring Wynonna, whom we all know has had some serious weight problems, is shown serving herself some vegetables during a family meal. Then the camera moves to a tight head shot where we learn that she could not erccomend anything that sin't safe but she is gald that alli is FDA approved.

These days FDA approval and a quarter don't get you a cup of coffee.

And here is probably a fairly reliable take on what the glossy ad that cost plenty of money alone, not including air time fees, might be what GSK doesn't want you to know.

Alli Weight Loss Pill: Expectations Vs. Reality
January 02, 2008 by Big Momma
It's the time of year when our thoughts focus on shedding a few pounds. We are inundated with commercial advertisements promoting the best, easiest or fastest way to lose weight.

Alli is the newest over the counter weight loss pill that promises hope to the masses by blocking fat absorption in the body. Alli is FDA approved, is not absorbed into your body and works only in the digestive track.

My first red flag regarding Alli was the product statement that Alli is to be used together with a reduced calorie diet to promote weight loss. A reduced calorie diet by itself will promote weight loss, but let's see the results that one Alli user has had.

An acquaintance of mine has been using Alli for several months, her expectations from the Alli pills were to help her jump start a weight loss program that she could stick with and ultimately help her reach her goal weight.

The Alli usage pamphlet warns users of 'treatment effects', which include greasy/oily leakage in undergarments, gas with discharge, change in stool color and/or fatty deposits in stools, inability to control bowel movements, stomach pain, rectal pain, teeth/gum problems or flu like symptoms. Alli users are advised to wear dark clothing and pads to protect against the leakage.

This is the reality she got from using Alli: Large amounts of uncontrollable leakage of a greasy substance that permanently stained her clothing. Dark clothing and pads could not contain or hide the leakage most of the time. She had a significant increase in gas and odor, with gas bubbles being expelled along with the greasy substance. She had no control over this.

Abdominal cramping became a part of her daily life, she likened the feeling to a gall stone attack. She felt tired all the time, even though she was taking the additional vitamins that are recommended by Alli. She also experienced hair loss while taking Alli.

After using Alli for six months, she had lost a total of 15 pounds. Yes, 15 pounds.

Another 'treatment effect' of Alli is that even after you stop taking it, you experience the greasy leakage and abdominal pains for up to two months, until the product works it's way completely out ofyour system.

A new wardrobe is eagerly anticipated at the end of a diet, but having to buy new clothing during the diet due to your body leaking grease, is altogether different.

Six months and 15 pounds later, the expectations from the weight loss pill Alli and the reality of it did not even come close.

NB: Natural Health News posted this information in 2008.  It took Mike Adams another 2 years to inform you, yet his backers are continually continually monitoring this website, now for 6 years, to get their story ideas. 1 June,10.

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Posted in: alli,consumer health,drug ads on TV,FDA,GSK,natural health news,Pfizer,Wyeth

What money buys

Perhaps Pfizer growth is not best for your health -

US drug maker Pfizer, the world's largest pharmaceutical firm, is to buy rival Wyeth in a deal worth $68bn (£50bn), the two companies have announced.

At the same time it announces at least 240 layoffs.

Its third quarter earnings show total revenues of 12 billion.

Pfizer manufactures Lipitor and Viagra. One-fourth of its profits come from Lipitor, but patent protection will be disappearing soon.

Legal settlements have shown that the firm needs to protect itself from downturn and losses.

However, Pfizer has infiltrated the natural health market place (and supplement companies) through many subsidiaries, placing key corporate personnel in these related venues.

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Posted in: health news,independent health news,natural health news,natural news,Natural Products Association,Pfizer

Pfizer hedging its bets? UPDATE

Today Pfizer agrees to pay out $894 million to settle lawsuits over Celebrex and Bextra. Other NSAIDS still show a link to heart disease but this is one of the most readily preventable health conditions we know of and other posts on this blog give you some of that data. For pain and inflammation there are many excellent natural remedies as well as one of the natural products I use from time to time that has been tested at Dana Farber.

$894 million deal ends pain of Pfizer's lawsuitsBy Linda A. Johnson, Ap Business Writer
17 October, 2008
TRENTON, N.J. – Drug giant Pfizer Inc. has reached an $894 million deal to end most of the lawsuits over its two prescription pain relievers, the popular Celebrex and a similar drug, Bextra, no longer on the market.

The world's biggest drugmaker said Friday it has agreements in principle to end more than 90 percent of personal injury lawsuits brought by people claiming the pills caused heart attacks, strokes or other harm.

The settlement includes roughly 7,000 personal injury cases, mainly plaintiffs who took since-withdrawn Bextra, said plaintiff attorney Perry Weitz. He represents nearly 2,000 claimants, about 10 percent of them relatives of people who died.

"It gives Pfizer closure and the claimants their money sooner, rather than later or never at all," Weitz said.

Pfizer hopes to finalize claims covered by the settlement, which now includes up to 92 percent of plaintiffs, by year's end. It also hopes to include many of the remaining claimants in the settlement and will fight any remaining personal injury suits with court motions or at trial, General Counsel Amy Schulman told The Associated Press.

"I don't think either side has an interest in protracting this," Schulman said in an interview.

Weitz said plaintiff lawyers will "have issues" with Pfizer "if their claimants aren't paid before the end of the year."

In early trading, Pfizer shares were down 47 cents, or 2.8 percent, at $16.50.

Schulman said the deal comes after two important court rulings — one by a New York state judge overseeing many of the state-level personal injury cases and the other by a federal judge in San Francisco coordinating pretrial steps in federal lawsuits over the drugs.

"We teed up some pretrial motions for a court ruling on whether there was significantly reliable evidence that would allow an expert to testify as to whether there was an increased risk of heart attack and stroke at the most common dose," 200 milligrams, Schulman said. Both judges ruled that was not the case, she said.

The proposed deal also would end suits by insurers and patients seeking to recover what they spent on Bextra and Celebrex, as well as claims by 33 states and the District of Columbia that Pfizer improperly promoted Bextra.

Out of the total settlement, $745 million will go to settle personal injury cases, $60 million will cover settlements with attorneys general in the 33 states and the District of Columbia, and $89 million will cover consumer fraud class action cases over reimbursement for money spent on the two drugs. Two additional states, Louisiana and Mississippi, still have pending cases regarding Pfizer's promotion of the drugs.

New York-based Pfizer withdrew Bextra from the market in 2005, a year after Merck & Co. withdrew its Vioxx, a similar drug.

The Vioxx withdrawal, which triggered an avalanche of lawsuits against Merck, also raised concerns about the safety of other medicines in the same class, called Cox-2 inhibitors. They were heavily touted by their makers as superior to traditional nonsteroidal anti-inflammatory drugs, or NSAIDs, such as ibuprofen, because they block an enzyme involved in promoting inflammation but — unlike NSAIDs — don't block an enzyme that protects the stomach from bleeding and other side effects.

Other NSAIDs, such as ibuprofen and naproxen, have also been linked to increased heart risks.

Celebrex is the only Cox-2 inhibitor that the Food and Drug Administration has allowed to remain on the U.S. market.

Attorney Christopher Seeger, a member of the plaintiffs steering committee, said he'll "have no problem recommending" the settlement to the roughly 400 clients he represents.

"We're very satisfied with the deal," Seeger said.

Schulman said the company's negotiations with opposing lawyers had been under way for some time but picked up in the late summer.

"Litigation can be distracting, and putting these matters behind us helps our shareholders and, most importantly, patients and doctors," Schulman said.

Weitz noted that it took four or five years to get through trials for less than 20 cases in the massive Vioxx litigation, because the court system can only handle a limited number of cases at a time.

Pfizer will take a pretax charge of $894 million to its third-quarter earnings, which it is scheduled to report on Tuesday.

Merck, based in Whitehouse Station, N.J., has begun paying a $4.85 billion settlement to end about 50,000 lawsuits brought by people claiming Vioxx cause heart attacks, ischemic strokes or death. It still faces other litigation over the former blockbuster arthritis treatment.

Copyright © 2008 The Associated Press.

Pfizer to Drop Development of Certain Drugs
by Shelley Wood, Heartwire 2008. © 2008 Medscape

October 3, 2008 (New York, NY) — Pfizer is getting out of the cholesterol-lowering game to focus on what it perceives to be more lucrative diseases, according to an internal memo obtained by Forbes [1]. And for the most part, the chosen "disease areas" don't include the heart.

In the memo, Martin Mackay, president of Pfizer Global Research & Development (R&D), informed his staff that the company plans to "exit" the fields of atherosclerosis/hyperlipidemia, heart failure, obesity, and peripheral arterial disease.

Instead, the company, whose cholesterol-lowering drug atorvastatin (Lipitor) is the world's top-selling drug, says it is turning its attention and R&D dollars to cancer, diabetes, Alzheimer's, pain remedies, and mental health as its "higher-priority areas."

The news comes in the wake of the flop of Pfizer's hoped-for new flagship, torcetrapib, a CETP inhibitor that was widely predicted to be the company's next blockbuster drug. While CV drugs have been the major moneymakers for Pfizer in recent years, those days are drawing to a close. In addition to Lipitor, which will lose patent protection in 2011, Pfizer's other major player in the CV drug arena is Norvasc (amlodipine), which came off patent in 2007.

Among the lower-priority "disease areas" where the company says it will continue working are thrombosis and transplant, the memo notes.

Contacted by heartwire, a handful of leaders for some of the major Pfizer-sponsored trials in cardiovascular disease over the past decade declined to comment on the company's announcement or speculate on what it might mean to the field of CV drug development--with one exception. Dr John Kastelein (Academic Medical Center, Amsterdam, the Netherlands), who was an investigator in the Pfizer-sponsored ASAP, TNT, and IDEAL trials, called Pfizer "a real powerhouse" in the CV drug arena.

"I kind of knew this was coming, but when you see it in print, it still hits hard," he told heartwire. "I think this is very, very significant both for the company itself and for the whole field of CV drug development. Pfizer had truly excellent people in the development arm of their company for CV and metabolic drugs, and they've contributed to this whole notion that you need more robust LDL lowering and that that's better than mild LDL lowering, which has become one of the axioms of CV prevention. And if they're stepping out now, that not only signifies their own problems, but it also signifies the problems in CV drug development, and how incredibly difficult and costly it has become to bring new drugs forward. And that's not good for patients."

Kastelein predicts that drug companies, having "lost faith" somewhat in HDL-raising therapies, will need to look more closely at anti-inflammatory drugs in the setting of coronary artery disease. "But there, the problem is, if you have no biomarkers whatsoever to do even dose-finding studies, you need to move from relatively small phase 2 trials to incredibly large, hard-outcome studies, which is taking quite a risk," he said. And that, at least for Pfizer, is too much risk.

"Everyone, not just Pfizer, is realizing that the days of the really big blockbuster drugs are over. And what is going to replace that are drugs in a class that are 10 times or 100 times more difficult to develop, so the risks are much higher. And these days, after Avandia and ezetimibe, everything is about safety. This means the FDA is forced, by public and colleague pressure, to demand even larger databases before drugs are going to market, which is of course making it more expensive. It's a cycle that's very hard to break."

Calls to Pfizer were not returned before this story was published.

Herper M. The Pfizer memo. Forbes, September 30, 2008. Available at: http://www.forbes.com/business/2008/09/30/pfizer-drug-agenda-biz-bizhealth-cx_mh_0930pfizermemo.html.

The complete contents of Heartwire, a professional news service of WebMD, can be found at www.theheart.org, a Web site for cardiovascular healthcare professionals.

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Posted in: health,health news,heart,heart disease,inflammation,natural,natural health news,natural news,News,NSAIDS,pain,Pfizer