The U.S. Food and Drug Administration (FDA) regulates medical devices in the U.S. The FDA keeps extensive databases on these devices containing lists of the devices, their safety records, pre-market notifications, and pre-market approval notices, to name a few.

Section 510(k) of the Food, Drug and Cosmetic Act requires regulated medical device manufacturers to notify the FDA at least 90 days in advance of their intent to market a medical device. This is known as Premarket Notification — also called PMN or 510(k). It allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories.

This allows “new” (unclassified) devices (those not in commercial distribution prior to May 28, 1976) to be properly identified. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time.

The 501(k) notification must also be submitted when reintroducing a device that has been significantly changed or modified to the extent that its safety or effectiveness could be affected. These changes or modifications might relate to the design, material, chemical composition, energy source, manufacturing process, or intended use of the device.

The FDA has established classifications for approximately 1,700 different generic types of devices. These devices are grouped them into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes (Class I, II or III) based on the level of control necessary to assure the safety and effectiveness of the device.

This 510(K) database can be searched by 510(k) number, applicant, device name or FDA product code. The database is updated monthly and is found online at .accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

Call your laser hair removal clinic or doctor, and ask for the manufacturer, model, and 510(K) number of the medical device to be used in your cosmetic surgery procedure. The 510(K) number always starts with a “K” and is the preferred item. Enter the 510(k) number into the appropriate field in the database search form.

An example of a 510(K) number is K002890. An example of a trade name or device name for that 510(K) number is “IntraLase 600C Laser Keratome.” The intended use for this particular medical laser is eye surgery.

When the search results are returned, click on the link to the right of the “Summary” line. The summary lists the characteristics of the laser device and when it was cleared for use. An approval letter should also be listed in the summary.

You may also wish to examine the FDA MAUDE (Manufacturer and User Facility Device Experience) database. This database contains reports of adverse events involving medical devices. The link to this database is .accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm

To Search the MAUDE listings by Brand Name, Manufacturer, Event Type, 510K Number, PMA Number, Product Code, or date, select use the Advanced Search button. No results were returned for the 510(K) number K002890, indicating that no adverse events were reported for that medical laser device during the reporting period.

The chances are very high that a licensed doctor will be using a licensed and approved laser device for your laser hair removal or other cosmetic surgery. However, with the quantity of online data available to the public, it doesn’t hurt to check.

Remember that the FDA keeps safety records of many medical devices, not just those that use lasers. It is better to learn about possible complaints or problems with the medical device about to be used on you before the cosmetic surgery procedure, rather than afterwards.

Learn more about medical laser applications, especially laser hair removal, at the resources below.

Another Vioxx-like occurrence may be on the rise, as warnings about Pfizer’s arthritis pain drug, Bextra, continue to mount.

According to a study of more than 1,500 patients who had previously undergone cardiac surgery, those who were treated for pain with Bextra were more likely to have heart and blood clotting problems than those who received no drug at all.

Associated problems included:

* Stroke

* Heart attack

* Blood clots in the lung

* Deep vein blood clots in the leg

Regardless of the fact that taking Bextra presents such serious health risks, the Food and Drug Administration (FDA) still believes the benefits of the drug outweigh the risks when used by the right patients. In light of these health concerns, however, the FDA approved a new label for the drug, which warns that those who recently had heart surgery (or who are allergic to sulfa products) should not take the drug. The revised label also strengthens the warning of the likelihood of severe skin reactions — two of which may result in death.

Bextra is a cox-2 inhibitor, which is a class of painkillers that are popularly used due to their efficiency in treating arthritis pain and other ailments. Vioxx is also a cox-2 inhibitor and was pulled from the market due to the cardiovascular risks linked to taking the drug.

Considering the health risks involved with cox-2 inhibitors, the FDA will be holding a public advisory meeting to discuss the safety concerns of these and other related drugs.

USA Today December 9, 2004

Dr. Mercola’s Comment:

I have previously posted an article warning that Bextra’s risks are even higher than Vioxx’s. And, as this article stated, the FDA is now modifying Bextra’s label to state that taking the drug after having cardiac surgery could increase one’s likelihood of heart and blood clotting problems.

Folks, I saw this one coming years ago: In 2001 I warned my readers of the adverse effects from taking Bextra. This drug is just another cox-2 inhibitor disaster waiting to happen. Pain-killing drugs — meant to relieve symptoms but never the true condition — are rarely necessary.

Why take the risk of serious side effects from anti-inflammatories when you can create your OWN anti-inflammatory, merely by changing the ratio of omega-6 to omega-3 fats in your diet?

These two types of fatty acids are BOTH essential for human health. However, the typical American consumes far too many omega-6 fats and not enough omega-3 fats to be healthy.

While the ideal ratio of omega-6 to omega-3 fats should be 1:1, most people’s intake ratio averages from 20:1 to 50:1! This unbalanced intake could lead to several health problems, whereas proper consumption of omega-3 can help prevent disease or improve many chronic conditions such as:

* Breast cancer

* Diabetes

* Heart disease

* Ulcerative colitis

* Arthritis

* Childhood asthma

* Depression

* Hyperactivity

The easiest way to balance your ratio is to consume more omega-3 fats from good sources and to reduce your intake of omega-6 fats. The primary sources of omega-6 are corn, soy, and canola, safflower and sunflower oils; these foods are overabundant in the typical American diet, which explains our excess omega-6 levels. You want to avoid or limit these oils in order to be optimally healthy.

On the other hand, the best omega-3 fats are those found in fish. That’s because the omega-3 in fish is high in two fatty acids crucial to human health: DHA and EPA. Unfortunately, eating most fresh fish — whether from the ocean, lakes and streams or farm-raised — is no longer recommended.

This is because (if you are an avid reader of the newsletter then you already know) mercury levels in almost all fish around the world have now hit dangerously high levels, and the risks of mercury now heavily outweigh the benefits gained from fish-derived omega-3 fats.

Fortunately there are clean sources of fish oil you can access without having to worry about mercury levels and added toxins, Vital Choice Alaskan Wild Red Salmon comes from the relatively pristine waters of Alaska that have virtually no mercury pollution

Not only is this salmon mercury-free, but it is also loaded with omega-3 fatty acids EPA and DHA, is high in antioxidants to help you live longer and tastes absolutely delicious!

You can also achieve omega-3 benefits by taking fish oil and cod liver oil, as this is a clean, safe and pure alternative to fresh fish. I have researched brands and types of fish oil and cod liver oil extensively and can say with absolute confidence that I recommend Carlson’s brand fish oil and cod liver oil. Carlson’s fish oils are rigorously tested for potency and purity and is a healthy addition to most any diet.

This must be a mistake! How could his drug costs rise from $150 a month to $1101 in just three weeks? My hands shook while I read the pharmacy bill.

There was no mistake. The bill I held recorded the drugs ordered by my fathers Alzheimers’ care unit. In only three weeks at this eldercare facility, his drug expenses had soared an incredible 734%. Ironically, his quality of life had plunged about the same percent. Walking and talking when he entered, he now spent his days confined to a wheelchair, unable to walk, drugged into a persistent stupor.

“I’ve got to do something.” The thought haunted me all day.

Then, that evening, an incidental trip to the grocery delivered the help I needed. It came in the form of a thick paperback book, The PDR Pocket Guide to Prescription Drugs (PDR Pocket Guide).

The PDR Pocket Guide provides tons of information for all prescription drugs on the market when it was printed. Specifics include:

• generic equivalents,
• why the drug is prescribed,
• how it should be taken,
• when it should not be taken,
• side effects and special warning, and
• possible interactions with other drugs and food.

The PDR Pocket Guide is available through Amazon.com, or you might find a copy like I did at your local grocery or bookstore. Jam-packed with almost 1700 pages of information, this paperback is a surprisingly affordable $6.99.

Using the pharmacy’s bill as a list of medications, I read the PDR report for each drug my father was using. What I found astonished me.

Two of fifteen drugs prescribed were being used “off-label” (not FDA approved for the condition it is used to treat). One of those was specifically contraindicated for use with Alzheimer’s patients. Two more were from drug families that I had previously identified as causing allergic reactions in my father.

When I was young, my father used to kid me by saying, “Up with this I will not put!” Up with this I wasn’t about to put either, so I called his doctor.

“My father is allergic to Furosemide.”

He bristled. “Where did you get an idea like that?”

“Furosemide is a sulfa drug. He’s allergic to sulfa drugs.”

“I never heard anything like that about Furosemide,” he barked. “Who told you that?”

“The PDR Pocket Guide.”

“Well, the PDR has a lot of stuff you don’t need to know.” His arrogance grated on my nerves.

“No more Furosemide.” Now I wasn’t asking, I was demanding. “You’ve seen his rash. He didn’t have it when he came to the care unit.”

“You’re not qualified to say what he should or should not have.”

“What am I doing,” I wondered, “arguing with a doctor who should be helping?” I wish I’d spoken the words I thought next. “Bye-bye! You’re fired!”

But, in that moment, I resolved to be fully in control of all my father’s drugs. I would learn everything I could and provide drugs direct to the facility. . .or not. There would be no more ordering drugs without my specific authorization

I enlisted the expertise of a pharmacist I found just down the street. She graciously took time from her crowded day to answer all my questions and explain anything I didn’t understand. She took a brief history of my father’s illness, made note of his allergies, and offered money-saving suggestions. She focused on providing excellent service. In short, she was, and is, an angel.

I immediately began to look for another physician to take over my father’s care, but I was too slow. Within a few weeks, my father died of complications from a massive insulin overdose.

Was my experience unusual? Probably not, according to a study from the Medical Expenditure Panel Survey (MEPS). On the subject of the increased cost of pharmaceuticals for people over-65, the study’s author, Marie Stagnitti, MPA, reports:

Every year from 1997-2000, the average out of pocket expense for prescription medicines for those with a purchase and age 65 and older was more than three times as high as the average out of pocket expense on prescription medicines for those with a purchase and under age 65.

The potential for overmedication in the elderly is clear in Stagnitti’s chart showing an average 23.5 prescriptions in both 1999 and 2000 for the over-65 group that used prescription drugs. The number of prescription drugs used by the under-65 group seemed high to me as well: 9.5 for 1999 and 10.1 prescriptions for the year 2000.

Overmedication is not only crushingly expensive for our elderly, it represents a real and present danger. You can do something about it. Please, learn about and oversee medications. You will help elders save money. You might even save a life.

Millions of Americans suffer with Peripheral Neuropathy and until recently there was no specific treatment available. Peripheral Neuropathy is often associated with Diabetes, but can occur on its own. Typical treatments in the past included physical therapy, medication and in severe cases even surgery, all of these therapies offer little or no relief. Neurologist, Family Physicians and Podiatrists are now referring their patients for Anodyne Therapy with excellent results.

Anodyne Therapy is the only FDA approved treatment specifically for Peripheral Neuropathy. Anodyne Therapy utilizes the healing power of infrared light to stimulate increased nerve function and blood flow to decrease pain and improve feeling. Anodyne Therapy is completely painless, covered by Medicare and extremely effective. Medical research has shown that patients treated with Anodyne therapy experience the following results:

Significant pain relief : 88% , Increased sensory perception 96%, return to normal sensory perception 60% and an overall 72% increase in daily activity levels. There are no side effects and few contra indications for Anodyne Therapy and because it works on the underlying cause of the problem the results are long lasting.

The symptoms of Peripheral Neuropathy usually effect the feet and calves but can also effect the hands and arms. Peripheral Neuropathy can present itself in a number of different ways including; numbness, pain, loss of feeling, weak muscles, difficulty walking and an odd feeling often described as ” a wet sock squeezing the feet.” These symptoms often effect older patients with diabetes and lead to secondary problems including difficulty with walking, balance and the basic activities of daily living.

“A typical patient receiving Anodyne Therapy will receive 24-30 sessions and start to notice results about half way through their treatment plan. A patient is seen three times a week until the therapy is concluded states Maricel Lazo, PT of Monmouth Advanced Medicine in Freehold. She also stated,” Our patients receive Anodyne Therapy, ultrasound, joint mobilizations and strengthening exercises with our physical therapist to insure their long term success. I have seen patients who have been suffering for 20+ years and those requiring walkers return to near normal function in just a couple on months.” Anodyne Therapy is available in only a hand full of clinics in New Jersey and proper diagnosis is a key to the therapy’s success.

America’s war on drugs, which has been fought in the opium fields of Afghanistan and the cocaine plantations of Columbia, will have to reinvent itself to combat what is set to be America’s biggest drug abuse problem, pharmaceuticals. One in five American’s, nearly 48 million, have used prescription drugs for non-medical purposes at least once in their lives. The current past month misuse rate among Americans is 6.2 million. According to a recent white paper by Carnevale Associates, this rate of use is already higher than the historical highs of both cocaine and heroin epidemics.

For some, the road to illicit use of prescription medications starts innocently. After a car accident, back injury, or, even, a mental/emotional breakdown a physician prescribes medication for a legitimate use. Over time, tolerance builds up so that more and more of the drug is needed until a state of dependence is reached. At this point, there is no easy way to get off the drug, and stopping can involve painful withdrawal symptoms. Some doctors have been known to become afraid and cut their patients off at this point. Patients have been known to steal prescription pads, or visit numerous doctors to get the drugs they have become addicted to.

However, contrary to popular belief, it is not older adults or any adults who are most likely to abuse pharmaceuticals. In the past decade, abuse of prescription meds among youth has been growing at an alarming first-time use rate of more than fifty percent each year. In 2002, the latest year for which there are statistics, approximately 2.5 million American’s misused prescriptions for the first time and 44% of them were under the age of 18.

Unfortunately, as the media fixes its gaze on the methamphetamine problem; and the Office of National Drug Control Policy spends much of its time focusing on Marijuana the opportunity to address the pharmaceutical addiction and abuse is being missed. While certain steps have been taken they have been tentative. The ONDCP has drawn up a strategy for addressing synthetic drugs, but no serious media campaign to educate Americans about the problem has been undertaken. Nor has any pharmaceutical company been brought to heel for manufacturing drugs with high abuse potential even when alternatives may exist.

The next battle in America’s war on drugs must draw a bead on pharmaceuticals. The ONDCP must be willing to launch the same type of hard hitting ad campaigns against prescription drug abuse as it has against, marijuana, ecstasy and cocaine. The FDA must not be afraid to sanction drug manufacturers who continue to make unsafe drugs where safe alternatives exist. Pharmaceutical manufactures must become better citizens and spend the research and development dollars to make safe and effective drugs, rather than taking the easy way out.

This new phase of the war on drugs, without easily targeted foreigners to blame for America’s drug abuse problems, will take unwavering political resolve, corporate citizenship and ingenuity. Even then it is likely to take years before the trend of increases in prescription medicine abuse and addiction can be reversed.

Common Prescription Drugs of Abuse:

Opioids: these are synthetic versions of opium. Intended for pain management opioids are the most commonly abused prescription drugs. OxyContin (oxycodone), Vicodin (hydrocodone) and Demerol (meperidine) are the most popular for abuse. Short-term side effects can include pain relief, euphoria, and drowsiness. Overdose can lead to death. Long-term use can lead to dependence or addiction.

Depressants: These drugs are commonly prescribed to treat anxiety; panic attacks, and sleep disorders. Nembutal (pentobarbital sodium), Valium (diazepam), and Xanax (alprazolam) are just three of the many drugs in this category. Immediately slow down normal brain functioning and can cause sleepiness Long-term use can lead to physical dependence and addiction.

Stimulants: Doctors may prescribe these to treat the sleeping disorder narcolepsy or attention-deficit/hyperactivity disorder, ADHD. Ritalin (methylphenidate) and Dexedrine (dextroamphetamine) are two commonly prescribed stimulants. These drugs enhance brain activity and increase alertness and energy in much the same way as cocaine or methamphetamine. They increase blood pressure; speed up heart rate, and respiration. Very high doses can lead to irregular heartbeat and hyperthermia.

If you are like many Americans, you are without health insurance. And the ranks of the uninsured are growing. According to the National Coalition on Health Care (NCHC), the number of uninsured was a record breaking 45 million in 2003. The growing number of uninsured is in large part being driven by individuals abandoning the corporate life to pursue their dreams as entrepreneurs and small business owners.

Unfortunately, this trend comes at a time when more and more medications are available to help treat the serious (and the not so serious) illnesses that many of us face today. But as you probably already know, without health insurance coverage, the prescription medications that you need are oftentimes too far out of reach; they are simply too expensive!

To make matters worse, most prescription medications cost far more in the United States than they do in other industrialized nations. These cost differences in conjunction with the fact that so many Americans do not have prescription medication coverage have spurred a national dialogue and heated debate. Despite these discussions, the needed regulatory changes have not materialized. Thus, the uninsured are left feeling that no affordable prescription coverage options exist.

Don’t Give Up Hope: There Are Options!

Fortunately, however, you are not without options. In fact, it is likely that you can afford the medications that you need. How, you ask, is this possible? Well, read on!

There are two primary ways you can afford or save money on your prescription medication. They include participating in one of the many (National, State, and Pharmaceutical) assistance programs and/or purchasing your medication from pharmacies located outside of the U.S.

Assistance Programs: Save From 25% to 100%!

Most persons are not aware that there are hundreds of programs available that provide either discounted or even free prescription medications to eligible US citizens. In fact, there are over thirty different national programs, virtually every state in the U.S. offers some sort of prescription medication assistance, and there are more than 250 different assistance programs offered by the many domestic and foreign pharmaceutical companies.

As you can probably guess, navigating the many programs to find the one that best fits your needs can be difficult. Each program has different eligibility requirements, application requirements, etc. However, the work required to take advantage of the program that best fits your needs will likely pay off. If you are eligible for assistance through one these programs, you can expect to save from 25% to 100% on the cost of your prescription medication. Savings like that are hard to ignore. And luckily, there are powerful tools available to help you find the program that is best for you.

Purchasing Your Medication from Pharmacies outside the US

Assuming that you don’t qualify for an assistance program, there is always the option of purchasing your medication from pharmacies located outside the US. While there are many pharmacies in many different countries that are willing to sell to US consumers, the best option is Canada. Why? The answer is twofold. First, buying from Canada is safer. The Canadian equivalent of the FDA, Health Canada, is stricter than the FDA (and other countries’ regulatory agencies) in its approval of new drugs. Second, Canadian pharmacies, on average, can sell medications for far less than pharmacies in the U.S. and other countries. They can do so for the following reasons:

• The Federal Patented Medicine Prices Review Board (PMPRB) regulates medications that are under patent. The PMRB dictates the maximum prices that can be charged in Canada for patented drugs.
• Health insurers, such as the provincial drug benefit plans, negotiate with the major pharmaceuticals to secure more favorable pricing on the medications that they cover.
• On average your $1 will buy you approximately $1.40 to $1.60 in medication from Canada.
• Health Canada is much quicker to approve generic versions of patented medication. The result is generic medications, which always cost less than patented medications, are available sooner in Canada.

Although there are many Canadian pharmacies, there are only a select few that you will want to buy from. Just like in the US, there are plenty of people willing to rip you off. And where your health is concerned, you do not want to take a chance. As a result, navigating the Canadian pharmacy option can be confusing and difficult. Luckily, as with the assistance programs, there are powerful tools available to help you find the pharmacy that is best for you.

It’s Simple to Start Saving

Just because you don’t have health insurance doesn’t mean that you can’t afford the medication that you need. The many assistance programs available to US citizens combined with the viable option of buying your prescription medication from Canada present the uninsured with the ability to purchase the medication that they need. Visit Rx Savings Guide to learn more about the tools available to help you afford your prescription medication.

The author, Garin Clark, is a co-founder of O2M Marketing. O2M is committed to delivering solutions to the marketplace that improve the lives of entrepreneurs while attempting to address some of the major social issues affecting us all.

According to the Los Angeles Times, the California Association of Physicians and Surgeons, and even the Center for Diseases Control’s own admission, well over 100,000 people in this country die each year from “properly” administered prescription drugs. This is absolutely shocking!

One study has shown that more than two million American hospitalized patients suffered a serious adverse drug reaction (ADR) within a 12-month period and of these, over 100,000 died as a result. Likewise, roughly 36,000,000 adverse drug reactions are reported annually, resulting in more than 33.6-million admissions or hospitalizations all from drugs that the FDA has pronounced “safe effective.” Sources for these statistics can be found at: http://www.cancure.org/medical_errors.htm.

The media is not doing a very good job of reporting this ADR crisis. Instead, we hear the constant media drumbeat about the dangers of firearms, which are currently politically incorrect yet represent a miniscule fraction of the deaths in this country. Doctors who want to politicize gun deaths should clean up their own glass houses first. The real crisis is the failing health care or more accurately described as the sick care system. There are numerous reasons for this crisis.

One reason is that conflicts of interest represent a very real problem for public servants and those entities which have relationships with various government agencies. Numerous researchers have reported that the FDA receives money from the very entities it is suppose to be regulating and one consequence of this is the suppression rather than advancement of disease cures. Consider the following:

“According to a USA Today study, more than half of the experts hired to advise the government on the safety and effectiveness of medicine have financial relationships with the pharmaceutical companies that will be helped or hurt by their decisions. These experts are hired to advise the Food and Drug Administration on which medicines should be approved for sale, what the warning labels should say and how studies of drugs should be designed. The experts are supposed to be independent, but USA TODAY found that 54% of the time, they have a direct financial interest in the drug or topic they are asked to evaluate. These conflicts include helping a pharmaceutical company develop a medicine, then serving on an FDA advisory committee that judges the drug.

The conflicts typically include stock ownership, consulting fees or research grants.

Federal law generally prohibits the FDA from using experts with financial conflicts of interest, but according to the article, the FDA has waived the restriction more than 800 times since 1998.” (1)

The corruption of undisclosed financial ties to the pharmaceutical companies by supposedly unbiased researchers along with the staggering cost involved in bringing new drugs to market, which conveniently eliminates competition from all but the cartel heavyweights has been sparingly reported in the mainstream press. Consider one exception to this silence:

In the book a “World Without Cancer” by G. Edward Griffin. Griffin describes the politics of cancer therapy, in which he blows the lid off the all powerful international chemical and drug cartel that has dominated the direction of health care since early in the Twentieth Century in the United States. Griffin argues that not only has the Rockefeller-Farben cartel (2) been instrumental in fostering chemical based drug treatment as the basis for health care and they have been the dominant adversary against safer non-drug treatments. If Griffin is correct, who is the FDA protecting and serving? Clearly, not the consumer!

It should be noted that pharmaceutical drugs have absolutely no nutritional value, and at best offer temporary relief of symptoms while doing nothing to address the root causes of disease. Additionally, pharmaceutical drugs should be used very carefully because of the toxicity factor also known as the LD50 rating. LD stands for “Lethal Dose” and LD50 is the amount of a drug, given, which causes the death of 50% of a group of laboratory test animals. Also, it is well known that drugs can damage the liver and kidneys.

Do not forget, as sited above, adverse drug reactions are responsible for over 100,000 deaths each year plus the pain and suffering for those lucky enough to survive an ADR. The way to good health does not necessarily include the ingestion of toxic chemicals. Likewise, the reason for disease is not that we are deficient or lacking in deadly debilitating pharmaceutical drugs. In many cases, disease is the result of nutritional deficiencies and the resulting weakening of the immune system.

The recent ongoing attempt to abolish and subvert the Dietary Supplement Health and Education Act (DSHEA) of 1994, which brought a measure of freedom back to consumers, in regards to their personal choices in the area of nutritional supplementation, should raise the ire of everyone who is concerned about their own health. This is an example of the pharmaceutical cartel and their political cronies within and along side of the FDA at work. Never forget, America is about freedom, especially freedom to make informed decisions concerning our own health care information, services we choose, our choice of treatments and products that we believe to be beneficial for our own health and wellbeing.