Keeping Watch: Health Care Topics and New Health Legislation (1)

The Laws of the Pharmaceutical Industry



Posted with permission from my colleague, Dr Arthur Evagelista, formerly with the FDA.

The main principles governing the pharmaceutical "business with disease" are:

..."It is not in the financial interests of the pharmaceutical industry to prevent common diseases - 

the maintenance and expansion of diseases is a precondition for the financial growth of this industry.."

1  The pharmaceutical industry is an investment industry <http://qualityassurance.synthasite.com/laws/law01.htm>  driven by the profits of its shareholders. Improving human health is not the driving force of this industry.

2  The pharmaceutical investment industry was artificially created and strategically developed over an entire century by the same investment groups that control the global petrochemical and chemical industries.

3 The huge profits <http://qualityassurance.synthasite.com/laws/law03.htm> of the pharmaceutical industry are based on the patenting of new drugs. These patents essentially allow drug manufacturers to arbitrarily define the profits for their products.

4  The marketplace for the pharmaceutical industry is the human body - but only for as long as the body hosts diseases. Thus, maintaining and expanding diseases  <http://qualityassurance.synthasite.com/laws/law04.htm>  is a precondition for the growth of the pharmaceutical industry.

5  A key strategy to accomplish this goal is the development of drugs that merely mask symptoms
<http://qualityassurance.synthasite.com/laws/law05.htm> while avoiding the curing or elimination of diseases. This explains why most prescription drugs marketed today have no proven efficacy and merely target symptoms.

6  To further expand their pharmaceutical market, the drug companies are continuously looking for new applications <http://qualityassurance.synthasite.com/laws/law06.htm>  (indications) for the use of drugs they already market. For example, Bayer's pain pill Aspirin is now taken by 50 million healthy US citizens under the illusion it will prevent heart attacks.

7  Another key strategy to expand pharmaceutical markets is to cause new diseases with drugs. While merely masking symptoms short term, most of the prescription drugs taken by millions of patients today cause a multitude of new diseases as a result of their known long-term side effects
<http://qualityassurance.synthasite.com/laws/law07.htm> . For example, all cholesterol-lowering drugs currently on the market are known to increase the risk of developing cancer - but only after the patient has been taking the drug for several years.

8  The known deadly side effects of prescription drugs are the fourth leading cause of death in the industrialized world, surpassed only by the number of deaths from heart attacks, cancer and strokes (Journal of the American Medical Association, April 15, 1998). This fact is no surprise either, because drug patents are primarily issued for new synthetic molecules. All synthetic molecules need to be detoxified and eliminated from the body, a system that frequently fails and results in an epidemic of severe and deadly side effects.

http://qualityassurance.synthasite.com/resources/drugs%20kill%20more%20Ameri
cans.gif?timestamp=1318370943767.circa 1999 statistics

9  While the promotion and expansion of diseases increase the market of the pharmaceutical investment industry - prevention and root cause treatment of diseases decrease long-term profitability; therefore, they are avoided or even obstructed by this industry.

10  Worst of all, the eradication of diseases is by its very nature incompatible with and diametrically opposed to the interests of the pharmaceutical investment industry. The eradication of diseases now
considered as potential drug markets will destroy billions of investment dollars and eventually will eliminate this entire industry.

11  Vitamins and other effective natural health therapies that optimize cellular metabolism threaten the pharmaceutical "business with disease" because they target the cellular cause of today's most common diseases - and these natural substances cannot be patented.

12  Throughout the more than one hundred year existence of the pharmaceutical industry, vitamins and other essential nutrients, with defined functions as cofactors in cellular metabolism, have been the fiercest competition and the greatest threat to the long-term success of the pharmaceutical investment business.

13  Vitamins and other effective natural health therapies that effectively prevent diseases are incompatible with the very nature of the pharmaceutical "business with disease."

14  To protect the strategic development of its investment business against the threat from effective, natural and non-patentable therapies, the pharmaceutical industry has - over an entire century - used the most unscrupulous methods, such as:

(1) Withholding life-saving health information from millions of people. It is simply unacceptable that today so few know that the human body cannot produce vitamin C and lysine, two key molecules for connective tissue stability and disease prevention.

(2) Discrediting natural health therapies. The most common way is through global PR campaigns organized by the Pharma-Cartel that spread lies about the alleged side effects of natural substances - molecules that have been used by Nature for millennia.

(3) Banning by law the dissemination of information about natural health therapies. To that end, the pharmaceutical industry has placed its lobbyists in key political positions in key markets and leading drug export nations.

15  The pharmaceutical "business with disease" is the largest deception and fraud business in human history. The product "health" promised by drug companies is not delivered to millions of patients. Instead, the "products" most often delivered are the opposite: new diseases and frequently, death
<http://qualityassurance.synthasite.com/laws/law15.htm> .

16  The survival of the pharmaceutical industry is dependent on the elimination, 'by any means', of effective natural health therapies. These natural and non-patentable therapies have become the treatment of choice for millions of people despite the combined economic, political and media
opposition of the world's largest investment industry.

Stay INFORMED ..

 

Creeping Diseases

How we're fooled into using more medicine than we need.

This is a guest post from independent medical investigative journalist Jeanne Lenzer. She is a former Knight Science Journalism Fellow and a frequent contributor to BMJ, and has published works in  The Atlantic, The New York Times Magazine, Discover, The New Republic, and other outlets.

When doctors recommend tests, drugs or surgeries to prevent bad outcomes (think cholesterol-lowering agents to prevent strokes or cardiac stents to prevent heart attacks) they tap into our deepest sense of what constitutes commonsense: An ounce of prevention. Catch it early. A stitch in time.

It can’t be a bad thing to catch problems early, can it?

Unfortunately, one of the toughest things to explain is why detecting some illnesses at their earliest stages can cause more harm than good. Take this example: Since elevated cholesterol is associated with a higher risk of cardiovascular disease, doctors often prescribe drugs known as statins to people with elevated cholesterol levels in the hopes of reducing their risk of a heart attack or stroke.

Here comes the part that’s tough to explain – because it is so counterintuitive: Statins only help individuals who already have had a heart attack or stroke (with a few exceptions, and more on that later).

Of course, this makes no sense to most people. Isn’t the whole point of taking cholesterol-lowering agents to prevent a heart attack? Why should anyone wait until after a heart attack or stroke to begin taking a drug designed to prevent a heart attack or stroke?

The answer rests with disease creep and the simple statistical quirks that come with it. In the past, doctors treated diseases that caused symptoms. But now we have tests and imaging machines that can detect risk factors and illnesses in their earliest stages. Like cholesterol. Elevated cholesterol is not a disease. It doesn’t cause symptoms. It is a risk factor. People with high cholesterol levels are somewhat more likely to develop a heart attack or stroke, but they are at far less risk than individuals who already have cardiovascular disease. This is the definition of disease creep: when pre-conditions or risk factors are treated as if they are the same as the actual disease state.

Here’s a thought experiment (with purposefully exaggerated numbers) to help understand this puzzle: Imagine a group of people who have the rare but awful Disease A, which is so terrible that all of its victims will die. Now imagine the discovery of Wonder Drug X, which cures half of the patients with Disease A. Unfortunately, Wonder Drug X does have a pretty bad side effect profile – it’s a very powerful drug, after all – and 10 percent of people who take it will die from liver failure. Despite this worrisome side effect, Wonder Drug X is truly an advance for patients with Disease A: For every 200 patients with the disease who are treated, 100 will now survive and only 10 of the 100 survivors will die of the drug’s side effects. That means 90 more people out of 200 will survive thanks to Wonder Drug X.

But now imagine a different group of 200 people, who don’t actually have disease A, but instead have a genetic marker which “is associated with” Disease A. In this scenario only 1 in a million people in the general population will get disease A. If you have the genetic marker, the risk ismuch higher, such that 2 of these 200 people will develop the disease at some time in the future. The genetic test gets highly promoted – “find out your risk early, because we now have a treatment that works, and the sooner you’re treated, the better!” There is a tiny grain of truth to this – of the 2 people identified by the genetic test, 1 (50%) will now be saved by Wonder Drug A.   This might sound just as good as before; here’s a group of people with 10,000 times (!) the risk of the general population to develop a uniformly fatal disease. Surely it’s worth taking a drug that can cure that disease in half the cases, isn’t it?

Read the complete article here

If vitamins are so bad why is FDA giving them to PhRMA

Update: April 2011 - CDC: Half of US adults take vitamins, supplements

By MIKE STOBBE, AP Medical WriterWed Apr 13, 1:50 pm ET

ATLANTA – About half of U.S. adults take vitamins and other dietary supplements — a level that's been holding steady for much of the past decade, new government figures show.

But the data also show a booming number of older women are taking calcium.

Federal officials released figures Wednesday showing that the use of dietary supplements has grown since the early 1990s when it was about 42 percent. The data shows use leveled off in 2003 through 2008, with about half of adults 20 and older taking at least one dietary supplement.

The biggest change was for calcium. Two-thirds of women 60 and older take it, up from 28 percent in the early 1990s.

Experts note the ranks of the elderly have been growing, and include many women who have been encouraged for years to take calcium to help protect against osteoporosis.

The information comes from national, in-home surveys in 1988-1994 and 2003-2008. The surveys in the past decade included more than 2,000 people each year. Interviewers not only asked participants what supplements they took, but also asked to see the bottles to verify their answers.

Use of multivitamins — the most popular supplement — crept up to nearly 40 percent.

Most people who take vitamins and other supplements are educated, have good incomes, eat pretty well and already get the nutrients they need from their diets, the surveys suggests.

"It's almost like the people who are taking them aren't the people who need them," said Regan Bailey, a nutritional epidemiologist with the National Institutes of Health.

Federal surveys have only recently started asking people why they take supplements, Bailey said.

The government supports some supplements as an option for certain people — such as iron for women who are pregnant, folic acid for women thinking of getting pregnant and calcium for older women.

But health officials say people should talk to their doctors first, and consider enriched foods that can accomplish the same goal.

Much of the new data is in a Centers for Disease Control and Prevention report released Wednesday. SOURCE

Online: CDC report: http://www.cdc.gov/nchs

Read more on Natural Health News

March 2011

Don’t Be a Victim of Drug Company Propaganda

It is in the economic interests of drug companies to steer Americans away from healthier lifestyles and dietary supplements. As more Americans fall ill to degenerative disease, drug company profits increase exponentially.

Enormous amounts of pharmaceutical dollars are spent influencing Congress, the FDA, and other federal agencies. The result is the promulgation of policies that cause Americans to be deprived of effective, low-cost means of protecting themselves against age-related disease.
The fact that the diets of more than 90% of Americans supply less than the 12 milligrams a day of vitamin E the government proclaims to be adequate is a startling revelation. It documents an epidemic deficiency of vitamin E among Americans who do not take supplements. Despite these grim statistics, the medical establishment continues to question the value of supplemental vitamin E. SOURCE

APRIL 2010
Help protect your right to supplements -

Alert: Protect Your Right To Natural and Bio-available Vitamin B-6!
ANH-USA On April 6, 2010 @ 3:18 pm

Human beings cannot live without vitamin B-6. It is also important for the prevention of cancer and the prevention and treatment of seizures, anemia, mental disorders including schizophrenia, carpal tunnel syndrome, and other conditions. Its effect on carpal tunnel can seem almost miraculous [1].

A natural form of the vitamin, Pyridoxamine, was recently yanked off the market by the FDA. Why? Because a pharmaceutical company, BioStratum, wanted sole use of pyridoxamine in a drug, a drug which may or may not ever appear. The company filed a so-called citizens petition and the FDA agreed, notwithstanding protests from ANH-USA, other organizations, and thousands of citizens. You might ask: how can Pharma take a supplement off the market and claim exclusive use of it as a prescription drug? The FDA does not presently feel obligated to answer this question.

Unfortunately, this isn’t all the bad news about vitamin B6. All forms of B-6, natural or synthetic, must be converted to P5P, another natural form, for the body to use it. Another drug company, Medicure Pharma, wants sole use of P5P and so has petitioned the FDA to ban its use as a supplement as well.

Medicure has yet to market a drug made from P5P, but wants the ban to take place now. And never mind that any individual unable to convert synthetic B6 to P5P would have to rely solely on Medicure’s product to stay alive.

How does Medicure think it can get away with this? Its petition states rather candidly: “Pharmaceutical companies developing new drugs must be protected from companies that may seek to market the ingredients in those drugs as dietary supplements. The marketing of such products has the potential to undermine the incentive for the development of new drugs because many people may choose to purchase the supplements rather than the drugs.”

This is not of course a case of supplement producers creating a product to compete with an existing prescription drug. It is just the reverse. P5P, the natural and bioactive form of B6, has existed in food for as long as there have been humans and has been available as a supplement for years. Medicure seems to be saying: If it seems profitable, let’s just turn a critical vitamin, one essential for human life, into a drug, make it available only by subscription, and mark up the price. This is truly outrageous.

The FDA has not yet responded to Medicure’s petition. We have asked you in the past to send a message to the FDA and Congress protesting Medicure’s P5P grab, and the time has come to send some more messages. So if you haven’t sent in a message to the FDA and Congress yet, or even if you have, please send one today [2].

[2]

While we are discussing Vitamin B6, here is the latest scientific report. An analysis of 13 U.S., European and Asian studies of vitamin B6 and colon cancer, conducted from 2002-2009, has been published in a special edition of the Journal of the American Medical Association. Studies of the range of B6 doses found that vitamin B6 taken in higher doses reduced the risk of colon cancer by 21 percent. In one study, Dr. Susanna Larsson and her colleagues at Sweden’s National Institute of Environmental Medicine reported an inverse relationship between the intake of vitamin B6 or pyridoxine and the risk of colon cancer. Dr. Larsson linked the effect to bloodstream levels of pyridoxal-phosphate (PLP), the main active coenzyme form of vitamin B6 [3]. Pyridoxal-phosphate is also known as pyridoxal 5-phosphate or (as we referred to it above) P5P.

Don’t let the FDA take away our access to the natural and most bioavailable form of B6, P5P. Please take action now [2].


--------------------------------------------------------------------------------

Article printed from Alliance for Natural Health – US: http://www.anh-usa.org

URL to article: http://www.anh-usa.org/alert-protect-your-right-to-natural-and-bio-available-vitamin-b-6/

URLs in this post:

[1] Its effect on carpal tunnel can seem almost miraculous: http://search.vitasearch.com/search?q=pyridoxine+carpal+tunnel+syndrome&restrict=Summaries&site=CP&client=CP&proxystylesheet=CP&output=xml_no_dtd&filter=0&getfields=*

[2] please send one today: https://secure3.convio.net/aahf/site/Advocacy?cmd=display&page=UserAction&id=334

[3] inked the effect to bloodstream levels of pyridoxal-phosphate (PLP), the main active coenzyme form of vitamin B6: http://www.physorg.com/print187978106.html

Vaccines Ultimately Not Effective

“There is no evidence that any influenza vaccine thus far developed is effective in preventing or mitigating any attack of influenza. The producers of these vaccines know that they are worthless, but they go on selling them anyway.”-

J. Anthony Morris, MD (former FDA Chief Vaccine Control Officer)

PLEASE remember this when you are listening to Bill Gates' current PR spots for vaccines.  Gates has publicly stated that vaccines are good for population control.

In 1926 the AMA announced it was aware of neurological damage caused by vaccines, especially the pertussis (whooping cough) vaccine (DPT today).

Polio vaccine can cause cancer and other illnesses, including polio. 


Iodine was successfully used in Canada in the 1940s and 50s to cure polio.

Drug Death, the FDA, and You

UPDATE: 13 June - Doctor, Hold Those Drugs

(Reuters Health) - U.S. doctors are too quick to reach for their prescription pads, according to a new report urging them to think more about side effects and non-drug alternatives.

"Instead of the latest and greatest, we want fewer and more time-tested drugs," said Dr. Gordon Schiff, associate director of the Center for Patient Safety Research and Practice at Brigham and Women's Hospital in Boston, a non-profit organization that studies ways to improve safe practices in healthcare.

"We are really trying to promote a different way of thinking about practicing," added Schiff, whose report appears in the Archives of Internal Medicine.

Nearly half of all Americans have used at least one prescription drug in the past month, according to the Centers for Disease Control and Prevention, and experts say overprescribing is rampant.

By definition, that means people are being exposed to side effects, sometimes fatal, without the benefits that would justify those risks.

"Often what is really bothering them is not cured with a pill, but rather through exercise, physical therapy, or diet changes," Schiff told Reuters Health.

Yet many doctors are quick to prescribe a drug, partly because they have limited time to deal with individual patients or because they and their patients have been bombarded with ads from the pharmaceutical industry.

As for prevention and non-drug alternatives, Schiff said, "there are no drug reps coming to my office pushing that."

In an editorial in the same journal, researchers describe how opioid painkillers like Vicodin and Percocet have become increasingly common without good evidence that they help patients in the long run.

The evidence of harm, on the other hand, is clear, write Dr. Deborah Grady of the University of California, San Francisco, and her colleagues.

In 2007 alone, for instance, there were nearly 11,500 deaths related to prescription opioids -- "a number greater than that of the combination of deaths from heroin and cocaine," according to the researchers.

Some four million prescriptions for long-acting opioids are written every year, with side effects ranging from addiction to constipation to sleepiness.

To counter some of this overprescribing, Schiff and colleagues urge doctors to think beyond drugs and to prescribe new ones much more cautiously.

When it first hits the market, new medicine has usually only been tested in a few thousand patients, often healthier and younger than the ones doctors see in their offices.

That leaves a lot of questions about safety, especially since patients often are taking several drugs at the same time. More than a third of people over 60 take five or more drugs, for instance, and the number of prescriptions continues to rise.

But Dr. Lisa Schwartz and her husband Dr. Steven Woloshin, both of Dartmouth Medical School in Hanover, New Hampshire, told Reuters Health it's difficult for doctors to get unbiased information about new drugs.

"We need to be making this information much more easily accessible to doctors," said Schwartz, an expert in risk communication. "There are billions of dollars being spent on new drugs with unproven benefits."

Schwartz and Woloshin said one way to do this would be to have the U.S. Food and Drugs Administration, which approves new drugs, send out simple summaries about the medications.

They also emphasized that overprescribing, while real, goes hand in hand with underprescribing of drugs to high-risk patients.

"We have both problems in this country," Schwartz told Reuters Health.

According to Schiff, patients also have a role to play.

"Patients need to ask critical and skeptical questions, too," he said. "They really should learn about the side effects of the drugs they are taking and be on the lookout for them."

Schiff's "Principles of Conservative Prescribing" study was funded by government grants supporting consumer healthcare education and healthcare quality research.

SOURCE: bit.ly/lwuNm0 Archives of Internal Medicine, June 13, 2011.

UPDATE:  Since most of the major pharmaceutical companies are global, it may be that FDA is overlooking offshore study problems in their FastTrack pay-for-approval process Foreign Drug Trials: A Challenge to FDA 

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Jeff Rense and Jonathan Emord  http://www.youtube.com/watch?v=kNuYSqK7pVU06/13/11

12/16/10 In his important interview with George Noory, Washington attorney Jonathan Emord talked about the approximately 300,000 deaths annually from FDA approved and properly prescribed drugs.

Noory's web site states the issues of "conflict of interests found within the FDA and their history with hiding the negative aspects of prescription drugs as well as the benefits of natural remedies. Additionally, he also talked about his research into unmanned military technology. "The agency is a captive of the drug industry, unfortunately," Emord lamented about the FDA, "that has caused it to be a broken agency. It approves unsafe drugs, knowingly." To illustrate his point, he detailed the saga of the drug Avandia, where reviewers inside the FDA repeatedly warned of dangerous side effects but were continually dismissed by their superiors. He cited one reviewer who was told by his superior in the agency that the FDA "had to maintain good relations with the drug companies because they are our customers."
Emord asserted that 15 to 20% of prescription drugs on the market today are "so obviously unsafe as to warrant their removal from the market." He explained that these are newer drugs, aggressively pushed into the marketplace by pharmaceutical companies in order to replace older and safer drugs whose patents had expired. According to Emord, the effect of this dangerous favoring of profit over safety has resulted in "over 290,000 deaths a year from the proper use of drugs prescribed by doctors." Compounding the problem, he said, the FDA is so beholden to the pharmaceutical industry that it also aggressively "forbids any statement that a nutrient treats a disease" whether there is proof or not. The simple reason for this, he said, is because if people started using nutrients to improve their wellness, then they would no longer need to turn to the drugs sold by pharmaceutical companies."

Now today, to further the discussion the FDA calls out more problematic supplements because "These tainted products can cause serious adverse effects, including strokes, organ failure, and death," said FDA Commissioner Margaret Hamburg. "The manufacturers selling these tainted products are operating outside the law."

Of course I have yet to hear Hamburg make the same statements about and pharmaceutical drug that we know causes "serious adverse effects, ...strokes, organ failure, and death."  I'm sure you have not heard this either.

And now today, the Alliance for Human Research Protection sends this gem based on a report from PLoS

If you aren't telling your representatives and senators to stop the PhRMA payola, you should consider it now, after reading this important information.

31 Prescription Drugs Linked to 387 Homicides

Wednesday, 15 December 2010
"Prescription Drugs Associated with Reports of Violence Towards Others, " identifies 31 drugs linked to 1,527 acts of violence... After two decades of contentious denials about the suicidal risk posed by certain psychoactive prescription drugs, numerous drugs now carry label warnings about suicidal behavior. Now, a new study in PLoS One , identifies 31 drugs in FDA's MedWatch adverse drug reports that are disproportionately linked to 1,527 acts of violence--defined as "Homicide," "Physical assault," "Physical abuse," "Homicidal ideation" or "Violence-related symptom." The violence events in these widely prescribed drugs--for diverse patient populations--were reported to the FDA between 2004 and Sept. 2009. The authors, Thomas J. Moore, Joseph Glenmullen, MD Curt D. Furberg, MD, identified 1,937 reports of violence submitted to FDA's MedWatch that met a restrictive criteria: The violence cases included 387 reports of homicide, 404 physical assaults, 27 cases indicating physical abuse, 896 homicidal ideation reports, and 223 cases described as violence-related symptoms. The patients were 41% female and 59% male with a mean age of 36 years (SD=17.9) Of all currently marketed prescription drugs, those linked to most of the violent events reported to the FDA are drugs that increase dopamine and /or serotonin in the brain-- irrespective of the patient population. The worst offender with the strongest association to uncontrollable, murderous violence--within days of ingesting the drug--is the smoking cessation drug, Chantix (varenicline), which increases dopamine: it ranks 18.0 in the proportional reporting ratio (PRR) with 408 cases of violence--including murder.  There are two other smoking cessation drugs that do NOT pose serious risks of violence. The next drugs most often linked to unprovoked violent outbursts--some resulting in murder--are 11 of 13 SSRI antidepressants. These not so, "magic bullets," whose mode of action (reuptake inhibition) increases serotonin, were involved in 578 cases of violence. Two drugs within the SSRI class--Prozac and Paxil--have been linked to the greatest number of reported cases of violence toward others: Prozac ranks 10.9 in the PRR, with 72 reported cases of violence, and Paxil (Paroxetine) ranks 10.2 in PRR, with 177 reported cases of violence. The authors note that there was no signal for violence linked to mood stabilizers such as valproic acid, carbamazepine, and phenytoin, even though these drugs are commonly used in bipolar patients who may experience psychosis in the acute manic phase and therefore be more prone to violence. On the other hand, SSRI's, which are clearly linked to violent actions in patients with no history of violent behavior, are being prescribed for patients with bipolar disorder. That is a prescription for disaster. The other class of drugs that are demonstrably linked to violence are 3 drugs prescribed for ADHD--amphetamines, atomoxetine and methylphenidate--and 5 hypnotic /sedatives. Only 0.25% of all serious adverse drug events met the PLoS study's restrictive criteria of violence. Thus, it is likely that the number of cases included in the analysis is understated. Not only does the FDA disregard the precautionary principle of medicine--"First, do no harm"-- the agency is unleashing drugs whose mode of action--accelerating dopamine and or serotonin in the brain--poses serious threats of violence to bystanders in the community!  Think of the school shootings....the postal shootings...the troop "friendly fire" deaths... Read the complete article at PLoS One , "an interactive, open-access journal for the communication of all peer-reviewed scientific and medical research,"

"For the triumph of evil it is only necessary for good men to do nothing." Edmund Burke

In some earlier discussions, FDA hero Dr. David Graham points out more problems with "approved" pharmaceuticals and the danger they pose for your health if you are using them.

Read these two informative articles, Are These Dangerous Drugs in Your Medicine Chest?  and Revealing "Fraud Magazine" Interview with Dr. David Graham

Selections from Natural Health News 

Here's What's Up

Jul 31, 2007

The people's hero, David Graham, MD, a drug safety officer at the FDA, called for Avandia's withdrawal. Dr. Graham estimated that its toxic effects on the heart had caused as many as 205000 heart attacks, strokes and death from 1999 to ...

Protecting the Bottom Line at Your Expense

Mar 02, 2005

David J. Graham, associate director of the Office of Drug Safety, testified about the toxicity of Vioxx and several other drugs before a Senate panel. He suggested that Bextra, Crestor (the cholesterol-lowering drug), Accutane (acne), ...

Avandia: Is it time to pull it off the market?

Jul 11, 2010

UPDATE: 15 July - FDA reviewer David Graham told the panel Avandia's risks were real enough "to put you in a hospital or a cemetery." Graham, who wants the pill banned, recently published an analysis estimating that as many as 100000

Remember Dr. Graham?

Aug 20, 2006

David Graham. Dr. Graham is the associate science director of the FDA's Office of Drug Safety and for several years now he's been an outspoken critic of the drug approval process at the FDA. In 2004, Dr. Graham testified before a Senate ...

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   

Rx Drugs Killing more than Heroin or Cocaine

This is a very good commentary I received from my colleague, Dr. Phil Bate.  Perhaps now you'll realize that your good health is not the goal in today's maintream medicine.  Get in touch with our ASK plan for more help, naturally.

Records show clearly that prescription drugs are killing more people than Heroin or Cocaine every year.  Since oxycodone came on the scene, researchers looking over 7000 records from 1991 to 2004 found that deaths from opium derived prescription drugs had doubled in this period. 

The records also show that since the FCC allowed the TV ads for prescription drugs,drug deaths in the US have doubled.  We don't allow TV ads for whiskey, so why allow these.  They are very clever, and disguise the side effect warnings of death and destruction with pretty scenes of beautiful people having fun. Listen carefully to the next Big Pharma ad with your eyes closed, and it's a different message altogether.  Money talks.  I wonder who got it at the FCC.

Why Insurance Reform Doesn't Get You Better Health

Senator Lieberman who is holding positive movement on insurance reform in limbo may have reason to be concerned, especially where women's health is concerned.

It seems as if the controversy over Hadassah Lieberman, the Senator's wife, is on the payroll of the Komen Foundation to the tune of about $300K a year.  Gary Locke's wife is on their payroll too, most likely lobbying while she's living in DC.

The problem with this is that Komen has no interest in CHANGE. For them it is PhRMA all the way, along with cancer promoting mammogram.

It might be why there is no effort to do more for prevention or more for research into the known environmental causes of cancer.

Nancy Brinkerman, CEO and sister of Susan Komen, is also suspect because she is on some PhRMA director's boards.

Do you wonder why the so-called health reform effort and the "race for the cure" keep circling the wagons and make deeper ruts?

WHO allows vaccine industry reps to advise on H1N1

Exposing WHO Influenza Advisers: They're Paid By The Pharmaceutical Industry


Exposing WHO's risk analysis process for declaring a pandemic: Who profits?
December 1, 2009
Back in June of this year the World Health Organisation (WHO), acting on the expert advice of its supposedly independent influenza advisers, declared the H1N1 Swine Flu as a world pandemic that activated a number of processes to combat the disease, obstentially to protect the world's population against the potentially deadly disease. Essentially the WHO influenza advisers conducted a risk assessment (risk analysis) which led to their recommendation to enact the pandemic classification.

Unfortunately, as with the case of the WHO risk analysis for power frequency hazards ( http://www.emfacts.com/papers/who_conflict.pdf ), again it is industry hacks who have the final say in direct violation of WHO conflict of interest policy.

Michael Repacholi, who founded both ICNIRP and the WHO's International EMF Project (IEMFP) stated in an Australian Senate inquiry in 2001 that the WHO had a firm policy against industry involvement in its processes. To quote:

"The World Health Organization does not allow industry to participate in either standard setting or in health risk assessment. The WHO takes the view that there cannot be industry representation on standard setting working groups. There cannot be someone on the working group who is having an influence on health effects for an industry when they derive benefit from that industry."

For the WHO, having a policy is one thing, following it is another thing entirely it seems.

Don Maisch
Source: http://www.emfacts.com/weblog/?p=1203

How About Political Reform over Health Reform

62% Disconnect between insured and uninsured in the US

and as you think about this Big PhARMA wants another 9% price increase as Medicare expects payment and service cuts.

WASHINGTON, Nov. 16 (UPI) -- U.S. drug manufacturers have been raising their prices at the fastest clip since 1992, industry analysts say.

Wholesale prices for brand name prescription drugs have increased by about 9 percent in the last year, even as the industry has agreed to support Obama administration healthcare reforms that would cut the nation's drug costs by $8 billion, The New York Times reported Monday.

Drug makers say they need to raise prices to plow money back into research and development to find new drugs, contending they need to replace popular drugs whose patents will soon expire. But critics say the manufacturers are trying to raise the price bar before Congress passes reform measures aimed at curbing future drug spending.

"When we have major legislation anticipated, we see a run-up in price increases," Stephen Schondelmeyer, a University of Minnesota pharmaceutical economics professor, told the newspaper.

Joseph Newhouse, a Harvard University health economist, told the Times a similar pattern of unusual price increases happened in 2006 just before Congress added drug benefits to Medicare, when prices shot up by their widest margin in the six previous years.

"Price adjustments for our products have no connection to healthcare reform," said Merck spokesman Ron Rogers.

At the same time, Michelle Obama calls for healthcare reform but you have to ask what her definition is.  Mrs. Obama is a former hospital executive and this discussion hasn't even begun to go past drugs and insurance.  We aren't even close to discussing health care except some hairbrained idea to change doctor pay as a best bet to curb costs when the number of primary care doctors is decreasing over income.

Following on this I am distressed to learn that so many people with chronic health problems have to cut drugs because of cost or no insurance, but no one in mainstream medicine is there to educated them about what natural remedies can replace the drugs and help them get well. (This is why we designed our services and educational programs.)

See NYT article on this topic

Health Care Debate?

UPDATE: 13 August - If you've missed it because mainstream media dis little to report it, Obama mad a deal with Big PhRMA some weeks back that basically let them off the hook regarding Plan D in Medicare and price negotiating.

Thanks to Huffington Post we have a story that confirms what Natural Health News knew when the "deal" was briefly reported.

Internal Memo Confirms Big Giveaways In White House Deal With Big PharmaA memo obtained by the Huffington Post confirms that the White House and the pharmaceutical lobby secretly agreed to precisely the sort of wide-ranging deal that both parties have been denying over the past week.

The memo, which according to a knowledgeable health care lobbyist was prepared by a person directly involved in the negotiations, lists exactly what the White House gave up, and what it got in return.

It says the White House agreed to oppose any congressional efforts to use the government's leverage to bargain for lower drug prices or import drugs from Canada -- and also agreed not to pursue Medicare rebates or shift some drugs from Medicare Part B to Medicare Part D, which would cost Big Pharma billions in reduced reimbursements.

In exchange, the Pharmaceutical Researchers and Manufacturers Association (PhRMA) agreed to cut $80 billion in projected costs to taxpayers and senior citizens over ten years. Or, as the memo says: "Commitment of up to $80 billion, but not more than $80 billion."
complete article

First of all, Listen up! The US does not have health care, The US has sickness care and every effort to make you think otherwise is just smoke and mirrors.

Sickness drives profit and for a minute don't believe that insurers or drug companies have one altruistic cell in their high rolling enterprises.

I've got plenty of examples collected over 3+ decades as I found myself in various positions in the medical industry. I'm just a very good observer with a photographic memory.

So here's the latest in the "debate" (more like forced pablum) that caught my eye this morning. And I am trying not to post on weekends...or so I tell myself, and really trying not to be cynical.

Drug industry backing Obama's health care plan

Consumer protections lost in health care debate

I happened to see news coverage of a meeting WA Rep Rick Larsen held in the district. I watch this district because I used to live in it. I'm also not a Larsen fan because he is, like Gary Locke and Maria Cantwell, one of those penultimate politicians who's in it for lining his pockets. He's also skilled in the art of the slippery and fork-ed tongue, the best any politician can hope for, eh?

If you see this news video, the look on Larsen's face was most telling when a fellow in the audience stated that he wanted the same health care as members of Congress enjoyed. There was a dead pan face and dead silence from Rick.

Now of course we did hear from Obama that the constituents would get the same care as members of Congress, but then you've probably noticed that's dropped off the radar of late.

What you do read and hear on every radio or TV channel is that Big Insurance and Big PhRMA are rolling out the big PR campaigns to reign in any substantive change in the way people get care from the medical establishment in the US.

Big PhRMA's already conned the Seniors by their pitiful deal with the Obama insiders to drop costs in Medicare D's "doughnut hole" by 50 percent. I'd personally rather see Obama scrap the Bush corporate welfare handout to PhRMA and re-create it with required price negotiation. I'm sure unsuspecting Seniors who've been made drug dependent via the medical industry would like this too!

However, the biggest jolt to getting reform off dead center would be required use of the universal claim form.