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 ...

Dual Standard at FDA

Remember SARS?

I do, and back in 2002(2003 and 2004) there was a similar campaign by the FDA to ban any information about natural products useful for respiratory illnesses including the mass marketing of SARS.

Sound familiar? Seems like another mass marketing campaign is underway on the latest version of a created respiratory illness. The same ploy seems to be apparent according to Marc Ullman's article below about Alli and competing products from the natural products industry.

This has been a repetitive behavior for decades now, includes the tryptophan / Prozac war and a few other events.

I happened to have been attacked by the FDA when the SARS controversy was raging. In typical government style due process was absent and the charge of the light brigade was in full force.

How I learned about it was from an article in the Seattle PI where reference was made to the product I offered for flu at that time (and still offer) that may be helpful. The PI staff writer quoted me yet never made any effort to contact me and speak with me directly. I tracked him down and eventually after getting to the top gun managed to get a retraction in the on-line version of the PI.

Not being alone in the number of products attacked by Mark McClellan's goons I created a web page listing the products attacked along with information about them. Most of the data on this page, except for using Echinacea, works well for the current "swine flu" issue. (Echinacea and some other natural products cause too much of a stimulation of your immune system for this created virus compound.)

The other action I took was to contact McClellan, a Harvard grad, and provide him with the clinical data about the product on my web site. This product was studied thoroughly in clinical research at Dana Farber, the well known cancer institute, a part of Harvard. The product was also proven effective.

The only data that FDA allowed to be in the news was about experimental product under development at Roche, and not proven to be effective.

The mind set is that nothing can be used or considered effective against anything unless it comes from Big PhARMA. This of course is one major reason why the mainstream "health"industry is on its self-created collision course.

Now you see another instant replay over liver damaging Alli and a weight loss/diet supplement.

Another word to the wise from Natural Health News...

GSK vs. The Supplement Industry: Who Wins? Written by: Marc Ullman 8/26/2009

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FDA receives “32 reports of liver injury including 27 requiring hospitalization” in users of GlaxoSmithKline’s Alli OTC weight loss drug. FDA receives 23 reports of liver injury including one death in users of the dietary supplement Hydroxycut. Guess which one is still on the market.

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On May 1, 2009 FDA issued an urgent alert warning consumers “to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario.” According to the Agency’s press release, it had received 23 reports of serious health problems, including one death, that appeared to be associated with the use of the dietary supplement. At the same time, Iovate issued a “voluntary recall” of 64 different Hydroxycut products, covering, according to some news reports over 9 million product units.

On June 6 and June 18, 2009 FDA updated its list of drug products it was monitoring for “potential signals of serious risks” indicating that the Agency was reviewing the status of GSK’s Alli (orlistat) OTC weight loss drug and was “continuing to evaluate this issue to determine the need for any regulatory action” Alli was, however, allowed to remain on the market. On August 24, 2009 FDA issued an “Early Communication about Ongoing Safety Review of Weight Loss Drug Orlistat” stating that the “Review includes both prescription drug Xenical and OTC drug Alli”. The “communication” stated that “FDA received 32 reports of serious liver injury in patients taking orlistat. Of those cases, 27 reported hospitalization and six resulted in liver failure. Thirty of the adverse events occurred outside the United States. The most commonly reported adverse events included yellowing of the skin or whites of the eyes (jaundice), weakness, and stomach pain.” Despite this, the Agency advised that “consumers taking Xenical should continue to take it as prescribed, and those using over-the-counter Alli should continue to use the product as directed.”

Just in case you’re still wondering who wins as between the supplement industry and GSK, consider the following:

● In April 2004 FDA banned the sale of ephedra containing dietary supplements based upon the Agency’s conclusion that such products constituted an unreasonable risk to public health. As part of the basis for its action FDA cited a 2003 Rand Corporation study that concluded, in part, “Over the short term (four to six months), ephedrine, ephedrine plus caffeine, and supplements containing ephedra or ephedra plus caffeine promoted modest increases in weight loss, about 2 pounds per month more than the weight loss of persons taking the placebo.” This level of weight loss was found to offer no benefit to public health.

● On February 7, 2007 FDA approved the sale of Alli as an OTC weight loss remedy. The Agency took this action despite reports of severe side effects including “incontinence” (uncontrollable diarrhea) and “oily spotting” (anal leakage). Among the factors cited by FDA in support of its decision was evidence that Alli users lost 5-10 pounds over 6 months, about a 50% increase compared with diet and exercise alone. Unless FDA uses some kind of “new math” that I have yet to hear of, this amounts to slightly less than the 2 pounds a month it found insignificant for ephedra.

9 million units of recalled Hydroxycut and one ban of ephedra later, it seems that as between the supplement industry and GSK there is little doubt who wins at FDA.

The Benefits of Zinc

UPDATE: 6/4/10 - Zinc Reduces Oxidative Stress

An article published in the June, 2010 issue of the American Journal of Clinical Nutrition describes a clinical trial involving older men and women which found reductions in markers of oxidative stress and inflammation among those who supplemented with zinc. Oxidative stress and chronic inflammation are risk factors for atherosclerosis, and zinc deficiency has been observed in a number of other diseases associated with these conditions, including rheumatoid arthritis, diabetes and cancers. "We previously observed that healthy elderly subjects had increased concentrations of plasma lipid peroxidation byproducts and endothelial cell adhesion molecules compared with concentrations in younger adults," the authors write in their introduction. "Zinc was proposed to have an atheroprotective function because of its antiinflammatory, antioxidant, and other properties."

In a double-blinded trial, 40 healthy men and women between the ages of 56 and 83 were randomized to receive 45 milligrams zinc from zinc gluconate or a placebo for 6 months. C-reactive protein (CRP), interleukin-6 and other markers of inflammation were measured before and after treatment, as were malondialdehyde and hydroxyalkenals, which are markers of lipid peroxidation.

Zinc concentrations were higher in the zinc group by the end of the study, while remaining relatively unchanged among those who received the placebo. Plasma antioxidant powers were higher, and malondialdehyde and hydroxyalkenals were lower in the zinc supplemented subjects after 6 months, indicating a reduction in lipid peroxidation. Additionally, plasma C-reactive protein, interleukin-6, and other inflammation-associated factors were reduced among those who received zinc. “To our knowledge, this is the first documentation to show the down-regulation of plasma CRP concentrations by zinc supplementation in human subjects,” the authors remark.

In another experiment involving cell cultures, zinc also reduced indicators of inflammation and lipid peroxidation as well as the activation of nuclear transcription factor kappa-beta, which is involved in the initiation and development of atherosclerosis.

"This study showed that zinc increased antioxidant power and decreased CRP, inflammatory cytokines, adhesion molecules, and oxidative stress markers in elderly subjects after 6 months of supplementation," the authors write. “These findings suggest that zinc may have a protective effect in atherosclerosis because of its antiinflammatory and antioxidant functions,” they conclude.

ORIGINALLY POSTED: 06/09
Zinc is an important mineral for immune health. It is however one that is hard to absorb. Because of this issue we always suggest to use a low dose, food-based compound, taking several daily.

On the other hand, too much zinc can suppress your immune system so we do suggest not taking more than 50-60 mg a day.

Zinc is helpful for people with diabetes and any hormonal imbalance (think endocrine system and glands). It is good for teens with acne and is the generally considered to be the key nutrient for prostate health. Additionally, loss of taste is related to zinc deficiency.

While some people may have developed some sort of a problem with Zicam, a 2X dilution of a substance in a homeopathic remedy is not a very high dose.

What concerns me more is the total avoidance by the FDA of the issue of common steroid and fluoride-containing nose sprays and the over-prescribing of antibiotics and antihistamine drugs that lead to more serious problems, including loss of function of the natural body protective mechanism that causes the mucous membrane lining of the nose (and respiratory system) to secrete more mucus in order to keep invading irritants and allergens out of the body. These drugs also have been known to interfere with the function of nasal hairs as part of this process.

So, FDA, how about blocking all these Rx drugs while you're blocking Zicam? Your Big Pharma bias is just too prevalent.

And if you'd like to know more about natural ways to take care of your cold or allergy, you can find more information at our main domain. Add a little vitamin C and vitamin A to the mix and you'll always come out ahead.

If you need clinical information please refer to our ASK program.

FDA: Zicam nasal spray can cause loss of smell
WASHINGTON (AP) — Consumers should stop using Zicam Cold Remedy nasal gel and related products because they can permanently damage the sense of smell, federal health regulators said Tuesday.

The over-the-counter products contain zinc, an ingredient scientists say may damage nerves in the nose needed for smell. The other products affected by the Food and Drug Administration's announcement are adult and kid-size Zicam Cold Remedy Nasal Swabs.

The FDA says about 130 consumers have reported a loss of smell after using Matrixx Initiatives' Zicam products since 1999. Shares of the Scottsdale, Ariz.-based company plunged to a 52-week low after the FDA announcement, losing more than half their value.

"Loss of the sense of smell is potentially life threatening and may be permanent," said Dr. Charles Lee, of FDA's compliance division. "People without the sense of smell may not be able to detect dangerous life situations, such as gas leaks or something burning in the house."

Matrixx defended the safety of its products, but said late Tuesday it will withdraw Zicam Cold Remedy Swabs and Zicam Cold Remedy Gel from the market.

The FDA said Zicam Cold Remedy was never formally approved because it is part of a small group of remedies that are not required to undergo federal review before launching. Known as homeopathic products, the formulations often contain herbs, minerals and flowers.

A warning letter issued to Matrixx on Tuesday asked the company to stop marketing its zinc-based products, but the agency did not issue a formal recall. Instead, regulators said Matrixx would have to submit safety and effectiveness data on the drug.

"The next step, if they wish to continue marketing Zicam intranasal zinc products, is for them to come in and seek FDA approval," said Deborah Autor, director of FDA's drug compliance division.

The agency is requiring formal approval now because of the product's safety issues, she added.

"It won't bring my smell back, but at least I feel like there's some justice that's starting to take place," said David Richardson, of Greensboro, N.C., who lost his sense of smell after taking Zicam for a cold in 2005. He said he hopes the product will be formally banned.

Medical records appear to support Richardson's claim that his lost sense of smell was linked to using Zicam.

The global market for homeopathic drugs is about $200 million per year, according to the American Association of Homeopathic Pharmacists. The group's members include companies like Nutraceutical International Corp. and Natural Health Supply.

Matrixx has settled hundreds of lawsuits connected with Zicam in recent years, but says on its website: "No plaintiff has ever won a court case, because there is no known causal link between the use of Zicam Cold Remedy nasal gel and impairment of smell."

The company said in a statement Tuesday that the safety of Zicam Cold Remedy is "supported by the cumulative science and has been confirmed by a multidisciplinary panel of scientists." Matrixx said it will comply with the FDA's requirements, but will seek a meeting with the agency to "vigorously defend its scientific data."

But government scientists say they are unaware of any data supporting Zicam's labeling, which claims the drug reduces cold symptoms, including "sore throat, stuffy nose, sneezing, coughing and congestion."

The products accounted for about 40% of Matrixx's $111.6 million in sales last year.

Health officials said they have asked Matrixx executives to turn over more than 800 consumer complaints concerning lost smell that the company has on file. A 2007 law began requiring manufacturers to report such problems, but FDA regulators declined to say Tuesday whether the company broke the law.

The 130 reports received by the FDA came entirely from physicians and patients, not the manufacturer.

Regulators said the relatively small number of complaints accounted for the agency's lengthy investigation.

"FDA doesn't take action against drug products without evaluating all of the circumstances surrounding the issues with the product," Lee said.

Shares of Matrixx Initiatives Inc. plummeted $13.46, or 70%, to $5.78 Tuesday. The company said based on the FDA's recommendation, consumers should discard any unused product or contact Zicam at 1-877-942-2626 or www.zicam.com to request a refund.

Copyright 2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Find this article at:
http://www.usatoday.com/news/health/2009-06-16-fda-cold-medicine_N.htm?POE=click-refer