Food Drug Administration and Prescription Drug Manufacturer Partnership

Something to know about if you rely on prescription medications to control pain in your knees or other joints.

The Prescription Drug User Fee Act (PDUFA) was passed into law by Congress in 1992 and allows the Food and Drug Administration (FDA) to collect feeds from Prescription drug Manufacturers to fund the new drug approval process.

The PDUFA declares that the FDA is allowed to collect a fee, called an application fee, from these Prescription Drug Manufacturers whenever a new drug is introduced through a new Drug Application (NDA). The fee was up to $250,000 per new NDA.

Kinda looks like the FDA is working for the Prescription Drug Companies. In fact, a comment from the Public Citizen’s Health Research Group stated “The review of new drugs is too important to leave to ‘user fees’ and likened the drug industry’s financial support of the FDA review process “similar to criminals paying user fees to the police department.”

Originally a short term experiment slated for 5 years, it was “improved” by The Food and Drug Administration Modernization Act of 1997 (FDAMA). This act extended user fees for NDA’s for another 5 years and introduced three amendments: Off Label Use of Drugs; Drug Labeling for Children: and, Fast Track or Accelerated Approval of new drugs.

Off Label Use pertains to using drugs for other than it was approved for. The FDA did away with thus prohibition on the Drug Companies promoting other than approved uses for their drugs, opening the door for Drug Salesman to promote new drugs with no proof of safety or effectiveness for the off label use.

The Drug Labeling for Children amendment. Previously drugs approved for adults were presumed to be safe in children albeit with different doses. This is not always the case. Now drug companies were required to do additional clinical trials to provide information for prescribing to children.

The Accelerated Approval and Parallel Tracking amendment opened up the door for new drug approval based on one “well controlled” Phase 3 clinical trail when the previous standard was two. There is no denying this amendment made drugs available that have saved countless lives, however with much less of a process to ensure safety.

The PDUFA III continued user fees and integrated a Medical Device User Fee as well. PDUFA IV was signed into law in September 2007 represents a significant addition to FDA authority. Among the many components of the law, the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee and Modernization Act (MDUFMA) have been reauthorized and expanded. The FDA claims these programs will ensure that FDA staff will have the additional resources needed to conduct the complex and comprehensive reviews necessary to new drugs and devices. However, the FDA and Drug Manufacturers continued to share the same bed.

Allowing the industry to “negotiate” with the FDA on recommendations and “pay” the FDA user fees for new drugs undercuts the agency’s original true role as an independent, drug safety regulator. If the FDA and the prescription drug manufacturers are going to regain the respect and trust of the American public, the FDA must be seen as an objective regulatory entity with a clear and inviolable mission to serve the public, and its reliance on the fees and goodwill of the industry they are supposed to oversee must end.

The bottom line is that the prescription drug consumer needs to live by the old adage “let the buyer beware”. Do your own research and be careful for the drug interactions if you are taking multiple prescriptions, especially from multiple Doctors and Pharmacies. In a perfect world, you would be able to mitigate much of the problems you are addressing by living a healthy lifestyle, eating low glycemic foods and taking the best nutritional supplements.

How Inflammation and Essential Fats Affect Joint Pain

There are two essential fats: Omega 3 and Omega 6 essential fatty acids. These are polyunsaturated fats and are very god fats when not highly processed or heated. Our bodies cannot make them so we have to get them from our diets.

Generally, we get plenty of Omega 6 Fatty Acids, however most of us are deficient in Omega 3 Fatty Acids. For a related article on Omega 3 Fatty Acids, see: Omega 3 Fatty Acids for Back Joint Pain
Although as you'll read, Omega 3 Fatty Acids balance out the Omega 6 Fatty Acids therefore combating inflammation which is the cause of much joint pain.

Omega 6 Fatty Acids produce prostaglandins that promote inflammation, blood clotting and cell growth. Omega 3 Fatty Acids produce prostaglandins that have the opposite effect. In the event your are injured your body produces a inflammatory response to bring about quicker healing. This inflammatory response brings blood and immune cells to injured areas of your body.

The body also has on-going inflammation caused by free radicals created by oxidative stress and this inflammation can damage tissues creating major problems, sometimes slow damage, but damage none the less.

It is critical that we balance our essentials fats so the prostaglandins will be created in balance to control inflammation. Unbalanced prostaglandins can cause serious health problems such as cancer, heart disease and of course, arthritis and joint pain.

Omega 6 Fatty Acids can be found in meats, margarines, peanuts, poultry as well as many of our processed foods. Omega 3 Fatty Acids are found in cold water fish, flaxseed and flaxseed oil, soybeans, organic eggs, and almonds.

The best research of today states that Omega 6 and Omega 3 Fatty Acids should be consumed at a 2:1 ratio. Currently it is believed that most Americans have a diet with an Omega 6 to Omega 3 Fatty Acid ratio of 20:1 and in some cases much higher. Hence the need to supplement our diets with Omega 3 Fatty Acids and the most assured and easy method to do this is to consume a pharmaceutical grade Omega 3 nutritional supplement which will eliminate the chances of toxins such as mercury that is associated with Omega 3 supplements derived from Fish Oils.

With unchecked inflammation we take the chance of increasing pain in our joints especially with over use and damage sustained over years.

Joint Pain Medications - OxyContin and Side Effects

Oxycontin (oxycodone hydrochloride) is a pain reliver that is prescribed in 10 mg, 15 mg, 20 mg, 30 mg, 40 mg and for opioid tolerant patients, 60 mg, 80 mg 160 mg doses. Many, perhaps too many, people routinely take this drug - how many do you know?

OxyContin is an opioid agonist and a Schedule II controlled substance used for the management of moderate to severe pain, such as joint pain – knee pain-arthritis type symptoms and pain, when a continuous, around-the-clock analgesic is needed for an extended period of time.

A single dose greater than 40 mg, or total daily doses greater than 80 mg, may cause fatal respiratory depression when administered to patients who are not tolerant to the respiratory depressant effects of opioids.

Side effects can depend upon a lot of factors including dosage, opioid tolerance of the consumer, and other factors specific to the health of the consumer. The more frequent side effects include nausea, headache, dry mouth, sweating, dizziness, vomiting, and somnolence.

Severe reactions which may be associated with OxyContin includes respiratory depression (especially in larger doses), respiratory arrest, circulatory depression, hypotension, and shock.

Lesser common severe reactions include: Blood and lymphatic system disorders; Cardiac disorders; Ear disorders (tinnitus); Endocrine disorders; Abnormal vision; Gastrointestinal disorders; increased appetite; chest pain; facial edema; Infections; Dehydration; Neck and Back Pain; Hypertension; Speech disorder; Tremor and Vertigo; Agitation and Depression; Urinary retention or impairment; Decreased libido and impotence; Respiratory distress; and Skin problems.

I don’t know,… OxyContin just may be a miracle drug for some in relieving joint pain. I will never use it, if my Nutritional supplements start not working then maybe surgery, but to take prescription pain relievers every day,…well, it’s not just in me to take that risk just to treat the symptoms.

Acupuncture for Joint Pain

Acupuncture is a subject and potential form of treatment for Joint Pain sufferers that many will not investigate for several reasons; fear of needles, a belief that Acupuncture is quackery or getting an opinion (usually un-asked) from some “expert” who told them not to waste their time and money.

My belief is that you have to know the details of anything before you accept it or discount it. So what is Acupuncture? What potential does Acupuncture have to alleviate Joint Pain?

To understand Acupuncture you must understand the concept of the body’s essential life energy, called “chi” or “ki” flowing through your body in invisible routes called “meridians”. There are several thousand Acupuncture points connected to these meridians. Accessing and stimulating these Acupuncture points with needles corrects the flow of energy and alleviates pain and problems.

One of the possible ways Acupuncture alleviates pain is by reducing muscle tension thereby reducing tension or pull on joints. Another reason why Acupuncture may help is through the release of endorphins which naturally fight pain or our perception of pain.

Some believe that a method from which Acupuncture is effective is getting the body to react to the micro trauma that Acupuncture needles cause and therefore sending resources to that part of the body to “fix” it.

Another version of Acupuncture is Electro-Acupuncture where pulsing electrical current is delivered through the needle stimulating the intended afflicted area.

Without a doubt there are studies that suggest Acupuncture can and has alleviated joint pain caused by arthritis, rheumatoid arthritis and osteoarthritis. This fits well with MyAchingKnees.com beliefs that all non-invasive methods to alleviate joint pain should be considered before prescription medications and/or surgery as these more invasive joint pain solutions have more potential for serious side effects.

Acupuncture may involve multiple needles being inserted into Acupuncture points on a meridian to a depth of 10 to 20 millimeters. One inch would be 25.4 millimeters to give you an idea of the depth a needle would go.

Acupuncture is becoming more and more accepted by the conventional medical community, however not all Medical Insurance Plans will cover Acupuncture.

MyAchingKnees.com highly suggests the joint pain sufferer research and consider Acupuncture as a form of treatment for any joint pain particular arthritis, rheumatoid arthritis and osteoarthritis.

The Role of Anti-Oxidants in Our Joint and Overall Health

Oxidative stress is a major cause of degenerative disease, including diseases and inflammation that effects our joints. Free radicals developed and released in our bodies, as a result of oxidative stress, effects all organs, body functions and our joints through cellular degeneration.

Anti-Oxidants protect against Oxidative Stress. Imagine a fire place with a fire burning,......the sparks flying out and causing damage to the carpet or rug are those free radicals released through oxidative stress. The fire place screen to keep these sparks (or free radicals) from causing damage are the anti-oxidants our body produces and that we get from food from all plants.

The body produces anti-oxidants but requires vitamins, minerals and co-factors in order to do so. Anti-oxidants from plants are a major source of our overall oxidative stress protection however the nutritional value of foods have greatly declined due to packaging, processing and even reduced nutritional value of the soil they are grown in.

Oxidative stress is a slow, cumulative process. Choosing the right foods and ensuring proper supplementation using the synergy of multiple anti-oxidants is the optimal way to protect oxidative damage.

Not only should you consider taking nutritional supplements designed for joint health and to reduce joint pain caused from degeneration of the cartilage, you should also consider an overall nutritional supplementation program using the highest quality products that you can obtain to ensure you have optimal health through providing your body with the nutrients it needs to fight oxidative damage.

Omega 3 Fatty Acids for Back Joint Pain

When talking about adding Omega 3 Fatty Acids to a nutritional supplementation for Joint Pain has some people asking "Why Omega 3 Fatty Acids? What do they have to do with Joint Pain relief?"

A recent University of Pittsburgh study using a daily dose of 2,400 mg of EPA/DHA (Docosahexaenoic acid and Eicosapentaenoic acid), then reducing to a dose of 1,200 mg of EPA/DHA on subjects with back pain resulted in 60% of the subjects gaining relief from chonic back pain. However the big statistic is that 80% of the subjects stated they would continue to take Omega 3 as they saw or felt other benefits as well.

My Aching Knees believes that Omega 3 Fatty Acids (usually derived from Fish Oil) is not only effective for joint pain but studies have suggested other health benefits as well, which include:

May significantly inhibit the growth of liver cancer cells.

Appears to help the brain to work faster, it increases IQ scores and slows down the aging process by reducing inflammation. (Lawrence Whalley, a mental health professor at Aberdeen University)

Fish oil with a high EPA content improves behavior, concentration and learning resulting in better grades at school. (The Durham trials led by Dr Madeleine Portwood)

High levels of EPA fish oil, may be an effective treatment for ADHD. (Adelaide University)

Fish oil reduced the severity of the symptoms for Bipolar disorder. (Dr Andrew Stoll)

Omega 3 supplementation improves complex cortical processing with improvements in mood and a reduction in anger, anxiety and depression. (Italian study by Fontani)

We have witnessed changes not only in chronic joint pain when adding a pharmaceutical grade Omega 3 to Glucosamine, but we have also seen positive (and quick) changes in ADD/ADHD children when Omega 3's are added to a daily anti-oxidant/multi-mineral nutritional supplement.

Be careful not to take non-pharmaceutical grade Fish Oil Supplements and you cannot be guaranteed to purity or potency and the presence of toxins, such as mercury can be significant.

Osteoarthritis - Chronic Joint Pain

We recently reviewed some information and followed up on a couple of web sites concerned with osteoarthritis treatments and were dismayed to find that these sites, while providing good information on what causes osteoarthritis, these websites seemed to only consider conventional medical treatments for this cause of debilitating joint pain through prescriptions medicines and therapeutic exercise such as Yoga and Pilates.

We whole heartedly believe in physical therapy and exercise, however we think pain medications are not a first line resort.

Osteoarthritis is a chronic problem caused by cartilage degeneration in the joints causing pain upon movement. When cartilage breaks down, there is less cushioning for the joints and can even lead to bones rubbing against each other.

Cartilage loses it’s elasticity through age and daily use/misuse. In some cases lack of sufficient cartilage can damage the bones producing bone spurs. Cartilage, as it loses it’s elasticity, becomes “brittle” and can break off leaving “floaters” in the joint causing pain and immobility.

One thing we should be able to agree upon is that Osteoarthritis is a degenerative disease, hence it is sometimes called “Degenerative Joint Disease” or “Degenerative Arthritis”. If this is so, then rather than treat the symptoms of joint pain, while don’t we look towards treating one of the root causes of all degenerative diseases and that is lack of nutrition?

It makes no sense to live with this disease without trying to alleviate the discomfort or pain in your joints. The easiest, certainly the most cost efficient and the method with the least side effects has to be ensuring that your body is getting the nutritional needs for optimum health. For joint health I have found that pharmaceutical grade Glucosamine and adding an Omega 3 (Fish Oil) supplement has greatly alleviated my joint pain without resorting to prescription pain medications (which can have side effects) or having surgery even minimally invasive surgery.