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Thursday, December 16, 2010

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: 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 
Jeff Rense and Jonathan Emord

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 
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.

Selections from Natural Health News 

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 ...
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), ...
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
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 ...


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