Just What Is Pharmaceutical Grade Fish Oil?

Sunday, December 27, 2009

By : Dave Woynarowski, M.D.

The answer to that question would depend on who you ask.

If you asked the typical manufacturer of vitamin supplements, using standard food grade material, the answer would be “There is no such thing as pharmaceutical grade fish oil”. If you asked a practicing physician like me, I would tell you, “Pharmaceutical grade fish all is the only type of fish oil I would ever put into my body”. So just what does the term “pharmaceutical grade” mean?

First, it's important for you to understand that the FDA does not, at this moment, regulate vitamin supplements; therefore, any manufactured vitamin supplement is not evaluated by the FDA, so it’s not really a pharmaceutical.

Prescription drugs require very stringent purity and ingredient testing before they are considered safe by the regulatory bodies. In this country, technically speaking, food supplements do not require that high a degree of stringent purity testing.

However, a small band of manufacturers like me have dedicated ourselves to producing only the finest quality nutritional supplements. We therefore, use the term "pharmaceutical grade" to describe our products.

Simply put, what this means is, if the FDA were to make fish oil a prescription drug tomorrow, our product would pass muster. This is because we have stringent purity testing and allow no detectable levels of pollutants in our fish oil or any other of our products, for that matter.

This is a time-consuming and often expensive process, but yields the absolute best product money can buy. For the past couple of years, the debate has raged over pharmaceutical grade terminology. Many companies that do not apply the stringent high-grade procedures to guarantee the quality of their products are literally furious at the term “pharmaceutical grade”. They would like to see it banished from use because it puts them at a serious disadvantage. It earmarks their product, especially fish oil, as substandard.

Lets take a look at a recent Consumer Reports article on the purity of fish oil. Several different brands of fish oil were tested in this particular study. The conclusion reached was that all fish oils have about the same amount of pollutant levels, 1 ppm of lead, for example. Therefore the consumer should go out and buy the cheapest brand of fish oil possible since there would be no difference between them other than price.

Well my friend, the devil is in the details. Let's take our product Dr. Dave's Best Pharmaceutical Grade Fish Oil as an example. Recent independent laboratory testing yielded no mercury, and no lead at any detectable level. What this translates into is a purity of parts per trillion rather than parts per million. Those three zeros make a big difference. This could be the difference between you ingesting mercury at detectable levels in as little as one year’s time, versus ingesting no mercury over a lifetime.

Why is this important?

Mercury is the most toxic metal that naturally occurs on planet Earth. It would take only a very small amount of mercury in a water supply to make it undrinkable by the Environmental Protection Agency standards. Mercury can cause brain damage that looks very much like Alzheimer's dementia. You may have heard the term “mad as a hatter” from reading Alice in Wonderland, or simply as a cliché. Many years ago, hat makers used dyes that contained mercury, so they often suffered from severe brain damage as a result. As our population continues to age and brain health becomes a critical issue not just from Alzheimer's disease, but from other forms of dementia, it should become apparent that we should all strive to keeps our brains as healthy and toxin free as possible. This is one way in which my pharmaceutical grade fish oil stands out.

Now let’s take a look at lead. Most people know that lead exposure is toxic. In a particular area where I grew up there were battery plants. In these battery plants constant lead testing of the employees was undertaken to prevent permanent damage. Lead toxicity can have many serious consequences, including nerve problems, mental problems, blood problems, and kidney failure.

Sadly, lead and mercury are not the only pollutants found in our water supplies and our fish. Byproducts of the petroleum industry, including polyvinyl chlorides and biphenyl compounds are also found throughout the world. Some manufactures of fish oil note that all their fish sources come from above the Arctic Circle. This is the case with our fish oil also; however, we still subject it to very stringent purification methods using a proprietary process called molecular distillation. We do this because we recognize that even fish caught above the Arctic Circle are exposed to pollution. Therefore, where you catch your fish really doesn't matter all that much. What matters the most is what you do with your fish oil after you get it. Please do not be misled by anyone claiming that they have found a pure source of fish that requires no processing.

Some of the physical health problems associated with these types of petroleum pollutants include breathing problems, kidney failure, weakness and fatigue.

Taken as a whole, it is very important, that whatever you put into your body maintains the highest purity standards you can get, because you don't want to load up any of your organ systems, especially your brain and your heart with toxic pollutants.

There is yet another pollutant and a problem, which as far as I know, we are the only manufacturer who addresses. This is the problem of radiation.

Again, depending on where you catch your fish, you will see high levels of pollutants, among them radiation. For example, Pacific caught salmon have a higher underlying level of pollutants, including radiation.

You may have heard the term, Pacific Rim of Fire. The Pacific Rim of Fire stretches from the coast of California, up to Alaska, all the way down through Japan, and some of the islands of the Far East. This term basically refers to volcanic activity in the area where the bowels of the earth churn. They release extra radiation. Sadly, radiation pollution is a problem in this area of the world. No one is sure why there is extra metallic pollutants in Pacific salmon. It is simply a fact of life. At this time therefore, we use only Atlantic caught salmon, herring and other such oily fish from above the Arctic Circle.

It is amazing that some of this pollution can actually come from sunken Soviet nuclear submarines. This is in addition to background radiation. The chemical that is tested for in radiation testing is cesium. We maintain an extremely low level of background radiation in all of our products. Again, as far as I know, no one else even bothers to test for.

Is this stringent testing, that makes our product superior to all the rest on the market. Now let's look at some human examples. Let's say you wanted your mother or father to experience the benefits of my pharmaceutical grade fish oil. You could rest assured that you would not be in any way, causing harm to the fragile brain of an elderly person. Studies have shown that fish oil may indeed improve memory behavior and performance in the demented patient. Now let's look at the opposite end of the spectrum, a pregnant mother or newborn baby. There are many studies that show improved hand eye coordination and increased fetal development before birth. Fewer diseases of childhood and adult especially allergic diseases and in some cases, even a higher IQ in children who are adequately supplemented with omega-3 fatty acids from fish oil. For the teenager, there may be some serious benefits to acne, attention deficit disorder and concentration levels from taking fish oil as well. In each case, we cannot use the term treatment, because the FDA will not allow it, however in my own clinical practice, this is exactly the term I use. I do essentially use fish oil as a medicine. Therefore, I insist on only the highest quality for my products. Once again, if you were to take this and make it a prescription drug tomorrow, it would pass all the stringent testing the FDA would subject to. For this reason, we proudly use the term pharmaceutical grade fish oil.

There is another thing you should know about Pharmaceutical Grade Fish Oil. Because of its absolute purity, the most common side effect, "Fish Burp" is a rare occurrence indeed.

Dr. Dave's Best Pharmaceutical Grade Fish Oil, physician used, physician tested, my best to you and your family.

New Health Miracle -- Pharmaceutical Grade Fish Oil

Saturday, December 26, 2009

By : Bev Storer

“High-dose pharmaceutical-grade fish oil is as close to a medical miracle as we will see in the 21st century.” – Dr. Barry Sears

Dr. Barry Sears revolutionized nutritional thinking around the world with his 1995 landmark #1 New York Times best seller The Zone. With The Zone, and his subsequent bestselling Zone books, Dr. Sears describes how a scientifically proven plan of moderate carbohydrate consumption balanced with appropriate amounts of protein and fat may help you live a longer and better life.

In his latest best seller, The Omega Rx Zone, Dr. Sears greatly expands the potential of the Zone to alter how we think about optimal health in general. Drawing upon his own research, as well as recently published studies, he reveals how a revolutionary new technological advance in fish oil manufacturing, never before available to the general public, may be the magic bullet...

This new high-dose, pharmaceutical-grade fish oil is very rich in omega-3 fatty acids. Scientific evidence reveals a diet rich in long-chain Omega-3 fatty acids helps support:

* a healthy brain
* a healthy heart
* a healthy immune system
* healthy joint movement
* healthy kidneys
* balanced mood and sense of well being
* and, helps maintain cholesterol levels that are already within the normal range.

This new generation of fish oil is much different from the historical, impure, terrible-tasting cod-liver oil. As Dr. Sears points out, the fish oil doled out by our mothers and grandmothers, and currently sold at health food stores, has never been pure enough to be used in the quantities it takes to realize its potential benefits. The new pharmaceutical-grade fish oil is more concentrated, free of dangerous toxins, and has been clinically tested with spectacular results.

By following the Zone Diet and adding pharmaceutical grade fish oil to your daily routine, Dr. Sears believes that each of us will reach our maximum potential for optimal health.

Sanofi Pasteur has recalled four lots of its pediatric H1N1 vaccine in the US

Thursday, December 24, 2009

Sanofi Pasteur has recalled four lots of its pediatric H1N1 vaccine in the US that were found to have fallen below potency limits despite being be in spec at the time of manufacture.

The Centers for Disease Control and Prevention (CDC) said that the voluntary recall, which affects some 800,000 doses, is not related to any safety concerns and stressed that the vaccine is still expected to elicit a protective immune response.

The CDC also stressed that children who have already received the vaccine, which was shipped in November, do not need to receive a second shot apart from those aged under 10 in whom two doses of vaccine are recommended anyway.

To date, only Maryland and Virginia have confirmed they received vaccines from one of the affected lots, UTO23DA, UTo28DA, UTo2CB and UTo30CA, but neither could said how many doses had been used.

While the recall is obviously a concern for Pasteur and its French parent Sanofi Aventis, of perhaps more significance is its likely impact on public confidence in influenza vaccines, particularly those for H1N1 or “swine flu”.

Public concerns

Despite considerable public demand when the World Health Organisation (WHO) declared the H1N1 pandemic in June , anecdotal reports suggest that influenza vaccine uptake has been lower than expected.

Part of the problem is the perceived lack of severity of the circulating H1N1 virus which, while still responsible for significant numbers of deaths worldwide, has not hit the figures some predicted when the pandemic began.

There is also a vociferous anti-vaccination lobby, which has raised concerns that regulatory dispensations used to accelerate production mean that the available H1N1 vaccines have not been subjected to the same safety assessments.

This idea is reflected in a September survey by the Harvard School of Public Health’s opinion research program, which revealed that concerns about potential side effects was the leading reason (38 per cent) respondents said they would not the vaccination.

Unfortunately, this type of opinion is likely to be re-enforced by the Sanofi recall, which follows hot on the heels of a GSK request that Canadian authorities do not use 172,000 doses of its H1N1 vaccine .

Qualified Person (QP)

Qualified Person (QP) is a technical term used in European Union pharmaceutical regulation (Directive 2001/83/EC for Medicinal products for human use). The regulations specify that no batch of medicinal product can be released for sale or supply prior to certification by a QP that the batch is in accordance with the relevant requirements.(EudraLex, Volume 4, Chapter 1) The QP is typically a licensed pharmacist, biologist or chemist (or a person with another permitted academic qualification) who has several years experience working in pharmaceutical manufacturing operations, and has passed examinations attesting to his or her knowledge. The requirement for QP oversight has been extended to material for use in clinical trials since the introduction of EU Directive 2001/20/EC.

In countries that are part of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), the same role may be termed Responsible Person (RP) or Authorized Person (AP).

In Construction practice in the United States, a "qualified person" is someone who, by possession of a recognized degree, certificate, or professional standing, or who by extensive knowledge, training, and experience, has successfully demonstrated his ability to solve or resolve problems relating to the subject matter, the work, or the project.

wikipedia

Product Quality Reviews

A recent amendment to the EU Guidelines for Good Manufacturing Practice has introduced a requirement for holders of pharmaceutical Marketing Authorisations to carry out regular quality reviews on all of their products.

The incentive for this change came from a number of high-profile inspection failures and product recalls. Inspectors found that, over time, modifications had been made to manufacturing or testing procedures, specifications, equipment etc, which had not been incorporated into the regulatory approvals for the products.

The final version of the guideline was published in October 2005, and came into effect on 1 January this year. Medicines Inspectors will be looking for evidence that these reviews are being carried out and properly documented. Failure to do so will be highlighted as a deficiency in the inspection report, and could lead to action against the company and their Qualified Persons.

Companies that supply products to the USA will be used to providing Annual Product Reviews in the FDA format. The information required in the EU Product Quality Review is slightly different, so a separate document will be needed. The FDA review is intended to confirm that every batch of product released during the review period complied with the registered process and specification. The EU review concentrates on the quality systems and processes, to show that they continue to produce consistently good quality product. Inspectors will not expect to see reams of raw data, but the results of the analysis of these data and the implementation of appropriate process improvements.

The Product Quality Review can be used as part of a continuous improvement quality system to highlight where development resource can most effectively be targeted. It can:

  • Decrease the risk of out-of-specification results
  • Minimise the risk of rework/reprocessing
  • Decrease downtime
  • Increase productivity
  • Decrease the risk of product recalls
  • Meet all regulatory commitments/requirements
  • Improve communication between production, engineering, quality and regulatory functions

The last point can be very important when activities such as production, distribution, stability testing or regulatory affairs are outsourced to other companies.

If the product is contract manufactured on behalf of the Marketing Authorisation holder, the Product Quality Review needs to be a joint activity between the MA holder and the manufacturer. In addition, the Qualified Person at the manufacturer must assess the final review document, to satisfy themselves that the process is in control, and that they can release batches for sale. This will require Technical Agreements detailing which company will be responsible for each aspect of the review, and the procedure for analysing data and producing the final document.

The review should cover the following:

Starting materials and packaging materials

Are they still being supplied by the source specified in the Marketing Authorisation? Has the specification changed, and is it appropriate to ensure the quality of the final product? Have the suppliers of active ingredients been audited to ensure that they comply with GMP? Have there been any problems with the suppliers, eg rejections of incoming batches?

Critical in-process controls and finished product results

Are these still the same as the ones in the Marketing Authorisation? Do the controls ensure that the finished product is of suitable quality? Are all test methods validated according to current standards?

Batch failures

How many batches were rejected during the review period? What investigations were carried out at the time? Were there any trends or similarities about the failures? Have any process changes been made to prevent recurrence?

Deviations and non-conformances

How many have occurred during the review period? What investigations were carried out, and what corrective and preventative actions were introduced to prevent recurrence? Were these actions effective? Was the Marketing Authorisation varied?

Changes to processes or analytical methods

Have these changes been properly authorised and validated? Has the Marketing Authorisation been varied to incorporate them? Have new or modified equipment or procedures been introduced that will require revalidation?

Marketing Authorisation variations submitted during the review period

This includes not only those that were granted, but also those refused, and those for third country (export only) dossiers. Does the Marketing Authorisation correctly reflect the manufacture and testing of the product? Why were variations refused; is more data needed?

Stability testing results

What are the results from routine stability testing of production batches? Do they still demonstrate that the product will meet the shelf-life given in the Marketing Authorisation? Are any adverse trends becoming apparent? (This may require additional statistical analysis of the results from all stability trials on the product). Are the tests and methods still appropriate for assessing the stability of the product? Do any changes to starting materials or processing methods mean that a full stability trial should be repeated?

Returns, complaints and recalls

How many of these have occurred during the review period? Were they adequately investigated, and what changes were implemented to prevent recurrence? Were these changes effective? Are there any trends to the complaints?

Adequacy of previous process or equipment corrective actions

Corrective and preventative action (CAPA) programmes will have been instituted to resolve problems arising during the review period, but did they fully achieve this? The Product Quality Review is a good time to confirm that CAPA programmes were appropriate, or to introduce further changes.

Post marketing commitments

Regulatory authorities often approve Marketing Authorisations provided that the MA holder commits to provide further information when available (eg samples of finished packs, ongoing stability data etc.). These are sometimes forgotten in the push to get a new product marketed and distributed. The Product Quality Review is a good time to confirm that these commitments have been fulfilled.

Qualification status of relevant equipment and utilities

Are utility systems such as HVAC, water or compressed gases still working appropriately? Have ongoing testing or monitoring results been reviewed for trends or failures? What investigations were carried out and were any corrective actions effective? Have any changes been made to these systems, and was requalification carried out?

Technical Agreements

Are there Technical Agreements with all suppliers and contractors, and are they up to date? Do they adequately reflect the activities and responsibilities of each party, and meet the requirements of the GMP guidelines?

Unlike the FDA Annual Product Review, there is no defined format for the completed report. The company is able to choose the format that is most appropriate for the product and the quality system.

Companies will need to establish where the information is currently held, and set up procedures and agreements to obtain it. While the final document must be assessed and signed off by the Qualified Person and the Marketing Authorisation holder, it would be acceptable to outsource the assembly and review of the raw data to an expert consultant.

Medicines Inspectors will be expecting to see the first Product Quality Review Reports, for a minimum review period of at least six months, during their inspections in 2006. Subsequent reports should cover the full twelve months review period.

It will require a significant resource to assemble, collate and review all of these data, but the cost savings from reduced batch failures and improved regulatory compliance should outweigh the cost of producing these reviews.

Robert Haslam
Somerset House Consultants