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 ...

The Dying

Here's an update on this topic from a trusted source, and a health professional I have followed and respected for many years.

Original post-
Today I had the opportunity to comment on a medical website to which I subscribe. The M.D. in the video, an editor at large for the site,  was speaking to the issues of CAM (complementary, alternative medicine), and as usual attacking it as non sense.


I posted this retort -

There is an inherent conflict of interest here because allopathic medicine is and has been engaged, since the early 1970s in refuting what has been coined to be referred to as CAM or "alternative medicine". Going back to the Flexner Report of 1910 is also a guide to see the basis of discontent. As an advanced nurse practitioner since the 1970s I find it always amazing how gullible so called "educated" health care providers are in regard to the history of medicine, for starters. Beyond that concern of gullibility to believe such marketing hacks as defrocked MD heading up "Quackbusters", do you recall when medical schools taught herbal medicine and homeopathy? Do you recall that coffee enemas were used for years in allopathy yet now are considered 'quackery'. Have you even bothered to look into the plethora of scientific research, completed independently and not paid for by Big PhRMA? Having worked with drugs and natural medicine and nutrition in my work for decades I will take it over the 80% or mainstream medicine any day, because I see how it heals people. And if you are so inclined, I am happy to discuss it further off list. As space is limited I will close by saying, do your due diligence and stop promoting non-facts first.

Another site from the UK ran this story -  "HOW THE EU PLANS TO WRECK ALTERNATIVE HEALTH"

Within 2 years, alternative medicine will be a shadow of its current self. By then - thanks to 4 laws being ratified by the European Union right now - only low-dose vitamins will be available on the shelves, most Chinese and Ayurvedic herbs will have disappeared, and many herbal practitioners in the UK may well have gone out of business.

An MD colleague of mine said this (slightly edited by me) -

On August 17, 2010, at the 105th Annual Meeting of the American Sociological Association in Atlanta, Dr. Donald Light presented his research in a paper titled, Pharmaceuticals: A Two-Tier Market for Producing 'Lemons' and Serious Harm. Dr. Light is a professor of comparative health policy at the University of Medicine and Dentistry of New Jersey.
It seems that this bombshell was not reported on mainstream media. Dr. Light's research validates what many of us already know. He found that 85% of new drugs being created are more harmful than beneficial. But will that information ever make it to CNN?
It's an unfortunate fact that a disproportionate amount of TV, radio, internet, and magazine advertising is controlled by drug companies. So, it's no surprise that there are no alternatives discussed on mainstream venues. Media doctors quickly learn they have to toe the line and promote the standard practice of medicine, which boils down to drugs and surgery.
My frustration at the Machiavellian turn that medicine had taken into the rabbit hole of drugs is why I wrote Death by Medicine in 2003. You can obtain that paper freely on the Internet.
As I said, I don't like to focus on the negative and this is the only one example that sheds light on the sickening turn of medicine to the dark side. If you or your friends think that drug companies are looking out for YOUR best interests and want to see you healthy and off drugs, think again.

There are effective alternatives to mainstream medicine, and we have been providing it since the 1960s. We help you become your best health advocate so you can deal with what you are up against in the health care maze.

" ...the only solution is if you become an advocate for your own health."

More on the dark side here

Health Reform? or More Death by Medicine?

As MSM bombards us with news of the horrendous Senate bill proposal for "reform" and we look forward to what may be more problems when the House and Senate try to merge the erroneous ideas these proposals contain we encourage our readers to think about what may be coming and to share their concerns with friends and colleagues, as well as the corporate lackys in Congress aka "elected representatives". 

Coming in 2010 is a new book by Gary Null, PhD, and several medical collaborators, including my colleague Carolyn Dean, MD, ND.

Also for 2010 is our year long focus on Natural Nutrition for health & healing. Look for great new information starting with the first issue of our long-running newsletter, herbalYODA Says! due out in mid January. You can sign up to receive this opt-in newsletter at http://www.leaflady.org/.  Stay tuned to Natural Health News for health and natural health information (as always) on the cutting edge.

The medical environment has become a labyrinth of interlocking corporate, hospital, and governmental interests increasingly controlled by drug companies. Drug company representatives write glowing articles about pharmaceuticals, which are then signed by physicians paid handsomely for their cooperation, though they may not fully understand the adverse side effects of the drugs they promote. The most toxic substances are often approved and used first, while milder and more natural alternatives are ignored largely for financial reasons. It’s DEATH BY MEDICINE.

DEATH BY MEDICINE:

· Reveals closely guarded secrets about the relationship between the pharmaceutical industry, the government, and the medical research establishment.

· Discloses through its research how drug companies are paying our legislators, television and radio stations, schools, and news outlets to keep information about dangerous medications from the public.

· Shows that more Americans are dying each year at the hands of medicine than all American casualties in WWI and the Civil War combined.

· Contains eye-opening information on why healthcare is the only business where you keep paying whether you get good results or not

How American Health Care Killed My Father

While this article is lengthy, it offers a very good picture of the state of mainstream medicine in the US today.

American Health Care contributed to killing my mother, who recently passed away, and I am sure it did the dame to many others.

Having seen this first hand during the years I worked in ICU and other medical venues, I', pleased to have found an ally in Mr. Goldhill.

How American Health Care Killed My Father - The Atlantic (September 2009)

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