Parabens: an ongoing controversy about their safety

Parabens are a group of compounds that naturally occur in blueberries, prunes, cinnamon and other types of fruits. Synthetic parabens are petroleum derived and are used as a preservatives and shelf- life stabilizers in a wide range of products including cosmetics, deodorants, face creams, shampoo, toothpaste, in small amounts as food preservatives and in certain baby products.

They are considered ‘safe’ within the pharmaceutical industry due to their apparently low level of toxicity. Members of this group of compounds include methylparaben, ethylparaben, propylparaben, butylparaben, isobutylparaben, isopropylparaben, and benzylparaben.

While the occasional use of a OTC skin or face cream containg parabens may pose no risk to human health, the concern is what happens with long term use and exposure. When applied to the skin parabens are readily absorbed and enters the blood stream. Once in the blood steam it is metabolized, it can be stored in various types of tissues and it can interact with various cellular receptors to instigate a cellular response. Below are some links to the controversy. Become informed and make your own decision about the use of parabens.  Check your toiletries and cosmetics… do they contain parabens?

Most recent research – an Abstract

Barr L, Metaxas G, Harbach CA, Savoy LA Darbre PD. Measurement of paraben concentrations in human breast tissue at serial locations across the breast from axilla to sternum.J Appl Toxicol. 2012 Jan 12. doi: 10.1002/jat.1786.   http://www.ncbi.nlm.nih.gov/pubmed/22237600

About Parabens from the David Suzuki Foundation: http://www.davidsuzuki.org/issues/health/science/toxics/chemicals-in-your-cosmetics---parabens/

Read about what the FDA has to say about parabens: http://www.fda.gov/cosmetics/productandingredientsafety/selectedcosmeticingredients/ucm128042.htm

Another abstract

Golden R, Grandy J, Vollmer G. A review of the endocrine activity of parabens and implications for potential risks to human health.

Crit Rev Toxicol. 2005 Jun;35(5):435-58.   http://www.ncbi.nlm.nih.gov/pubmed/16097138

Beware of Parabens  By Ted Waszkuc, Ph.D., Methods Development Scientist, NOW Foods  http://www.nowfoods.com/M095620.htm

Very lengthy with pharmaceutical using jargon.

European Commission - Scientific Committee on Consumer Safety SCCS

Opinion on Parabens

http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_041.pdf

Generic verses brand named drug

Drug Name or ‘Drug Nomenclature’

Drugs are known by either their chemical, generic, or brand name. Understanding the differences between these names can be frustrating to consumers and practitioners alike who are not familiar with pharmacology.

The general process of assigning a name to a drug from the time of its discovery to its’ entry into the market place is illustrated in the diagram to the right. This is a very simplistic overview and the reader should appreciate the rigorous regulatory processes that are involved.

Generic Name

The generic name of a drug is a simple name or is sometimes described as a shorthand version of the drug’s chemical name, structure, or formula. The generic name of a drug reflects the official chemical name and structure of the drug.

In the example below the generic name diazepam is much simpler and easier to use that the official chemical name of the same compound.

Brand Name

When a drug is developed, researched, tested and produced for sale in the marketplace by a drug manufacturing company the generic formulation is assigned a ‘brand name’ or ‘Trade name’. The brand name is the registered trademark ® for a generic drug by a drug manufacturer.

For example, the generic drug acetaminophen is more commonly know by the brand name Tylenol. The generic drug ibuprofen is also known under brand names such as Advil, Motrin, and Brufen.

Why do manual therapists need to know the differences between generic and brand name preparations?

You will no doubt encounter clients who have changed their medication either from the brand named drug to the generic version or from the generic version to the brand name version. If it is a prescribed change, more than likely, the client is observed and monitored by the attending physician to ensure safety and effectiveness of the medication. If however a client voluntary changed their medication by obtaining a prescription from another doctor, or by ordering it over the internet, and this change was not professionally monitored, because of the medication switch the client may experience signs of adverse reactions.

The Food and Drug Administration defines a generic drug as:

‘A generic drug is identical, or bioequivalent to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use’. To obtain FDA approval a generic drug must meet the following requirements:

·      contain the same active ingredients as the innovator drug (inactive ingredients may vary)

·      be identical in strength, dosage form, and route of administration

·      have the same use and indications

·      be bioequivalent

·      meet the same batch requirements for identity, strength, purity, and quality

·      be manufactured under the same strict standards of FDA’s good manufacturing practice regulations required for innovator products

Although generic preparations meet the official requirements, concerns about their therapeutic effectiveness and tolerability sometimes do arise when compared to their ‘brand name’ counterparts.

All drug preparations consists of an ‘active ingredient’ and ‘excipients’ Excipients have specific properties such as improving the stability of the drug, increasing the shelf life of the preparation, assisting with the dissolution of the preparation and controlling the rate of release of the product. 

Depending on the quality of the ingredients used including the excipients, the stability, dissolution, rate of release etc. of the drug can be altered, and this in turn can have an effect on the therapeutic profile of the drug.

A serious effect of this medication switch is that the client may experience variations in therapeutic effectiveness. While this point is somewhat controversial it can be life threatening depending on the client’s condition; for example, if the client had epilepsy and decided to switch versions of their medication without the appropriate medical supervision. 

Massage practitioners are encourage to be alert to such medication changes by their clients, and inquire if it is medically supervised and about adverse reactions or side effects experienced since the change. 

Drug News: Pfizer pays $1 billion fine

The marketing of a drug to doctors is supposed to follow guidelines for the 'labelled' use of the drug. The labelled use is the approved use ( by the regulatory authorities) in the management and treatment of a specific disease/s or condition/s. Drug giant Pfizer admitted to falsely and aggressively using ' off label' marketing practices to promoted the drug Neurontin for a string of unapproved uses.

A bit about Off-label prescribing
After approval of the drug by the regulatory body, and once it is available for medical use, a physician may choose to prescribe the drug for a use that was not officially sanctioned; in other words the off-label indication is the practice of prescribing drugs for a purpose outside the scope of the drug's approved label use. Physicians will often prescribe drugs for off label indications if there is enough scientific evidence or research to suggest that the drug may be effective when managing conditions other than what it was approved for.

A common example of this off label use is seen with aspirin. Aspirin’s official use is for pain and inflammation, however, in recent times aspirin is increasingly recommended and used for the prophylactics of cardiovascular disease because it thins the blood. Aspirin is also showing very promising results when used in the treatment and management of certain types of colon cancer. Recent data collected suggest that up to 20-25% of drugs prescribed, are prescribed for off label use.

When doing an internet search about this topic several websites including drugawareness.org reports that 'a division of Pfizer Inc., the world’s largest drugmaker, has agreed to plead guilty to two felonies and pay $430 million in penalties to settle charges.' In addition, the website businessweek.com reports that 'this is actually the fourth settlement with Pfizer or one of its subsidiaries since 2002 over illegal marketing.'

The company admitted to aggressively marketing the epilepsy drug by illicit means for unrelated conditions including bipolar disorder, pain, migraine headaches, and drug and alcohol withdrawal.

The settlement (September 2009) includes $152 million to pay back amounts spent on Neurontin by the federal Medicare program and 50 state Medicaid programs for the poor. In addition, Pfizer will pay a $240 million criminal fine, the second-largest such fine ever imposed in a health care fraud prosecution.

To read more about this go to the website: http://www.stopmedicarefraud.gov/pfizerfactsheet.html

Why manual therapists must know about medications

Massage therapists are faced with many 
challenges when treating a client who is taking medications. For example, consideration must be given to the patho-physiology of the medical condition or disease, the current symptoms experienced, the health of the person’s tissues and the medications used for managing the condition. The therapist is expected to exercise ‘critical thinking and clinical reasoning’ skills when developing a treatment plan. The diagram to the right ( click on it to make it larger) suggests that both drugs/pharmaceuticals and the application of massage techniques can be used either alone or in combination in the management and/or prevention of many medical conditions. It’s also quite clear that the use of medications and the effects of massage, either alone, or in combination has an effect on the physiological responses of the body. When treating a person who is taking medications, to ensure the outcome is safe and effective the therapist must have knowledge in the following areas:

• A clear understanding of the patho-physiology and the progression of the presenting disease or disorder
• a general understanding of the drug’s pharmacology including it’s side effects
• the ability to integrate and apply the above knowledge to the practice of massage therapy

The internal use of medications will have a systemic effect on the body. This systemic effect is a combination of the drug’s desired effect and it’s side effects. It is therefore reasonable to suggest that the effects of the drug can influence, the outcome of the assessment, the timing of the massage session, the use of specific manual techniques and the recommendations of home care activities.

Below is a summary from The Harvard Mental Health Letter that looks at the side effects associated with the selective serotonin reuptake inhibitors, a widely used group of antidepressant drugs.

In a recent press release by The Harvard Mental Health Letter the potential side effects of the antidepressants drugs that belong to the ‘selective serotonin reuptake inhibitors’ (SSRI, such as Prozac) which are among the most widely prescribed medications, while they are relatively safe and effective, they also have real risks associated with them. The points below provide a good example of how the side effects of a drug may affect the general health, constitution and complaint of a client.

The Harvard Mental Health Letter lists / highlights 4 categories of the side effects developed by patients taking the SSRI’s:

Physical symptoms. May be mild and temporary and include insomnia, rashes, headaches, muscle and joint pain, gastrointestinal irritation including stomach upset, nausea, or diarrhea.

Bleeding problems. A serious potential problem is reduced blood clotting capacity that increases risk for stomach or uterine bleeding. The risk more than doubles if patients are concurrently using non steroidal anti-inflammatory drugs such as aspirin, ibuprofen, naproxen and other members of this group at the same time.

 Sexual effects. Many patients experience either diminished sexual interest, desire, performance, satisfaction, or all four.

 Suicide. While this side effect comes with controversy there is a risk that antidepressants will incite violent or self-destructive actions. There is an increasing number of children and adolescents receiving prescriptions for antidepressants and the research is showing that when compared with a placebo, all antidepressants, including SSRIs, seem to double the risk of suicidal thinking, from 1%–2% to 2%–4%, in both children and adults. (http://www.health.harvard.edu/press_releases/ssri_side_effects.htm).

 Let’s consider another group of drugs, the non steroidal anti-inflammatory drugs.

The non-steroidal anti-inflammatory drugs or NSAIDs are among the most widely used and readily available drugs on the market. Dr. Bryan Bingham in an article entitled “The safety of NSAIDs, and Alternatives” presents many interesting facts about the NSAIDs, their uses and side effects. Below are few of these facts.

• The NSAIDs are generally used for pain relief, headaches and arthritis
• Each year by some estimates, the side effects of long-term NSAID use cause nearly 103,000 hospitalizations and 16,500 deaths
• According to the American Gastroenterological Association an estimated 36 million people take NSAIDs on a daily basis
• Some side effects associated with the commonly used NSAID drug ibuprofen include:
• Chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance, black bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds, blurred vision or problems seeing colors, swelling or rapid weight gain, urinating less than usual or not at all, nausea, stomach pain, low fever, loss of appetite, dark urine, clay colored stools, jaundice, skin rash, bruising, severe tingling, numbness, pain, muscle weakness, fever, headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin and seizures. 

·       A study published in the British Medical Journal, showed that patients who took NSAIDs on a regular basis started to develop rebound headaches. Rebound headaches are headaches that are brought on by the use of the pain medications. Rebound headaches are not typical with short-term use, however individuals who take pain medications regularly may develop these types of headaches.

Some of the side effects described above from the two classes of drugs, selective serotonin reuptake inhibitors antidepressants and the non steroidal anti-inflammatory drugs include headaches, muscle and joint pain, bruising, severe tingling, numbness, pain, fever, and neck stiffness. These side effects illustrate the importance of why massage therapists need to have knowledge of a drug’s effects, or at least having the ability to ‘look up’ the side effects. The therapist must consider if the complaint of the client is in fact related to a side effect of the drug they are taking. And, if it is related, is massage therapy effective at all?

About this blog

This is my first time blogging. I hope the information presented here will be useful to all manual therapy practitioners including massage therapists, chiropractors, physiotherapists etc. It is always useful to promote dialogue amongst health care providers so we are better able to serve the public in a safe and effective manner.

The book entitled Massage Therapy and Medications I wrote in 2001 and is published by Curties-Overzet Publications. It is the first of it's kind - an attempt to provide basic information about pharmacology and to discuss potential interactions that can occur when a client is receiving a manual therapy modality while they are currently taking medications. For example, if a client was taking an over the counter analgesic such as aspirin or ibuprofen for muscular aches, as well as receiving deep tissue massage, they are more likely to be bruised due to the blood thinning effects of the analgesics, and the aggressiveness of the manual modality. 

Much more dedicated research is need in this area of drug interactions with manual modalities; as a result when I make suggestions regarding treatment modifications there is a careful reference to normal human physiology as well as to the generally accepted outcomes of manual therapy and hydrotherapy.

With subsequent posts I will be suggesting treatment guidelines that you can consider when working with a client who is taking medications. I value your feedback and suggestions about how I can share this valuable information with all.