Vanessa’s Law Reinforces Need for Integrative Medicine

Our not-for-profit organization, known as People’s Right to Integrative Medicine (PRIM), defines integrative medicine as a healing-oriented approach that takes the whole person (body, mind, spirit) into account. This includes all aspects of lifestyle. Integrative medicine emphasizes the therapeutic relationship between practitioner and patient, is based on evidence, and makes use of all appropriate therapies to achieve positive outcomes.

Although this might seem like a definition that all healthcare practitioners, including medical doctors, would support, the last few decades in medicine have been greatly influenced by the pharmaceutical industry that promotes a “pill for every ill.” This approach appears to have little concern for the practitioner-patient relationship and pharmaceutical companies have virtually no interest in having doctors provide therapies other than prescription drugs for treating acute and chronic health conditions.

It is becoming increasingly evident that the pharmaceutical industry has built its reputation, and profits, on how they have defined evidence-based medicine. Government regulators have been influenced by the industry to believe that all therapies need to be tested for safety and efficacy through clinical trials, with the gold standard being randomized control trials.

In reality, this gold standard has been built on a fraudulent research and communications platform with the most serious side effects, including those that can cause death and debilitation, rarely being published in medical journals or shared with doctors by pharmaceutical sales representatives. Adverse drug reaction is the fourth leading cause of death behind heart disease, cancer, and stroke. (1) And 62% of people taking prescription drugs are not fully informed about the most serious side effects by their doctors, with 10% of people actually experiencing a serious adverse drug reaction.(2)

With growing concern that doctors and the public are not aware of the most serious side effects of prescription drugs, there is also growing skepticism and cynicism about evidence-based medicine.

Conventional Medicine Tainted by Drug Agenda

In 1996, Dr. David Sackett, Professor Emeritus in Clinical Epidemiology and Biostatistics at McMaster University, along with his colleagues, defined evidence-based medicine in a British Medical Journal article as “the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients.”(3)

Using this definition, evidence-based medicine has not lived up to its promise.  In fact, the last couple of years several news organizations have published stories about what the pharmaceutical industry has been doing in recent decades to hide the emerging evidence about adverse drug reactions so they can preserve profits. Medical journals throughout the world have even retracted articles that were based on misleading data, particularly those that were ghostwritten by public relations firms for pharmaceutical companies.

Public Citizen, a U.S. not-for-profit watchdog organization, considers pharmaceutical companies to be the biggest defrauders of government based on penalties the industry has paid for violating the False Claims Act (FCA). Public Citizen found that pharmaceutical cases accounted for at least 25% of all penalties paid to the feds for violating the FCA between 1991 and 2010 (compared to 11% paid out by the defence industry).(4)

Between 1991 and 2012, pharmaceutical companies paid more than $30 billion in state and federal government penalties in the U.S., with $10 billon of it paid between 2010 and 2012. For example, according to The New York Times, “In the largest settlement involving a pharmaceutical company, the British drugmaker GlaxoSmithKline agreed to plead guilty to criminal charges and pay $3 billion in fines for promoting its best-selling antidepressants for unapproved uses and failing to report safety data about a top diabetes drug” in July 2012. (5a)(5b)

According to data from Public Citizen, seven pharmaceutical companies paid more than $1 billion in penalties for violating the False Claims Act between 1991 and 2012:

Violators of the False Claims Act

1. GlaxoSmithKline – $7.56 billion
2. Pfizer – $2.95 billion
3. Johnson & Johnson – $2.25 billion
4. Merck – $1.85 billion
5. Abbott – $1.77 billion
6. Eli Lilly – $1.71 billion
7. Schering-Plough – $1.34 billion

In a January 2014 article in the British Medical Journal, Dr. Les Spence, a general practitioner from Scotland, described how evidence-based medicine has been distorted by the pharmaceutical agenda. He explained that in the 1990s pharmaceutical sales representatives had difficulty selling drugs because of the void in evidence. But by the turn of the century, pharmaceutical companies had a firm grasp of the concept and would promote only the positive results from clinical trials to pressure doctors to “do as the evidence says.”(6)

In the BMJ article, Dr. Spence went on to explain that doctors did not question the evidence that pharmaceutical sales representatives provided, and consequently they started prescribing a pill for almost every health condition. As a result, prescriptions in England alone skyrocketed by 66% in one decade to one billion a year in 2012.

Med School Students Receive an Education Sponsored by Big Pharma

In Canada, there have been few financial penalties levied against the pharmaceutical industry, and drug companies have had tremendous influence over medical doctors, starting with medical students. For example, in 2004 at the University of Toronto, medical students participated in a week-long course on how to treat patients suffering from chronic pain. A few students realized that something was missing from the lessons when the negative side effects related to opioids such as OxyContin were hardly discussed – this in spite of growing public awareness of the risks of addiction, overdose, and death caused by opioids. Some students complained and an inquiry was held in 2010.

During the inquiry, it was discovered that the lecturer in 2004 had been paid by Purdue Pharma L.P., the maker of OxyContin, to speak to medical students about pain management and to provide a free textbook to medical students that the company published. The inquiry also discovered that, in 2007, Purdue had paid more than $600 million in penalties for violating the False Claims Act in the U.S. The penalties were levied in order to resolve criminal charges and civil liabilities for misleading doctors and other healthcare providers about the safety and efficacy of OxyContin, particularly its addictive properties.(7)

David Carmichael (right) with MP Terence Young

Vanessa’s Law is Long Overdue

Canadians, including medical doctors, have little understanding of how dangerous and potentially deadly many prescription drugs can be. However, awareness is now growing due largely to the efforts of Conservative Member of Parliament (MP) Terence Young, who has been the driving force behind Bill C-17 since he was first elected MP for Oakville in 2008.

Bill C-17 officially became Vanessa’s Law when it received Royal Assent on November 5, 2014. It was named by Health Minister Rona Ambrose in honour of Terence Young’s 15-year-old daughter, Vanessa, who died in 2000 from an adverse reaction to the heartburn drug Prepulsid.

Vanessa’s Law Works to:

• Empower Health Canada to recall drugs without the consent of pharmaceutical companies;
• Increase fines for the illegal promotion of prescription drugs from $5,000 to $5,000,000 per day and includes potential prison sentences of up to two years for criminal negligence;
• Enforce transparency of clinical trial data held by pharmaceutical companies.

At a “Celebrating Vanessa’s Law” event that was hosted by People’s Right to Integrative Medicine on October 16, 2014 in Toronto, MP Terence Young explained that in addition to empowering the Minister of Health to recall drugs and penalize pharmaceutical companies, Vanessa’s Law allows the Minister to make sure that plain language information about safety is prominently displayed on drug labels and in leaflets. It also mandates healthcare institutions to report all serious adverse drug reactions to Health Canada.(8)

Until the passage of Vanessa’s Law, Canada was considered by many to be a prescription drug haven for the pharmaceutical industry. In fact, if there was litigation, it was more likely to be pharmaceutical companies suing the government. For example, in September 2013, Eli Lilly, the fifth largest pharmaceutical company in the U.S., filed a $500 million lawsuit against the Government of Canada for violating the North American Free Trade Agreement (NAFTA) with its existing patent standards because Canada’s federal courts invalidated the patent for a couple of its prescription drugs.(9)

When Vanessa’s Law starts to be enforced, Canada will become recognized as a world leader in prescription drug safety. Diana Zlomislic, a health reporter at the Toronto Star, describes Vanessa’s Law as “potentially one of the most significant reforms to federal drug safety legislation in 50 years.”(10)

Timing is Right for Integrative Medicine

As people start to understand why Vanessa’s Law is needed in Canada, they are likely to become more concerned about consuming prescription drugs, particularly multiple drugs, and might explore other options for treating acute and chronic health conditions.

Integrative medicine provides many options. Physicians can use conventional treatments such as prescription drug therapy when necessary, but they and other practitioners can also use complementary therapies for treating health conditions, thereby healing people and restoring health.

To help alleviate some of the safety concerns that people might have about integrative medicine, several Ontario medical doctors co-authored a book in 2014 titled Safety First: Dispelling Myths About Complementary Therapies. (11) The following ten therapies comprise the treatment interventions discussed in the book, which provide a platform for making the public and governments aware that integrative medicine should be an integral part of healthcare in Canada:

Complementary Therapies & Treatment Interventions

1. Nutritional counselling (Dr. Barbara Powell): Various aspects of nutrition have been observed and investigated for thousands of years. Such study has led to our current understanding of metabolism and the components of food, including proteins, carbohydrates, fats and micronutrients. Physicians may counsel their patients about what and how much to eat. The goal of such counselling is to help individuals to make and maintain dietary changes that treat or prevent illness and optimize health.

2. Herbal therapy (Dr. Barbara Powell): Herbal therapy is a method of medical treatment that relies primarily on the application or ingestion of plants and plant extracts. Plants have been used for medicinal purposes since long before recorded history. However, in the early 19th century scientists began making their own versions of various plant compounds, thereby establishing “medical science” and relegating herbal medicine to the status of an alternative modality. Herbal medicines are now sold in the form of teas, syrups, oils, liquid extracts, tinctures and dry extracts (pills or capsules).

3.  Acupuncture (Dr. Linda Rapson): Acupuncture is a system of medicine that involves the insertion of fine, solid stainless steel needles into specific sites on the body to reduce pain, achieve homeostasis, promote healing, treat disease and normalize physiology. Its origin and development occurred in China, beginning perhaps 2,500 years ago.

4. Homeopathy (Parul Sanduja and Dr. Jozef Krop): The word homeopathy derives from two Greek words, homios, meaning similar, and pathos, meaning suffering. Founded in 1810 by the German doctor, chemist and scholar Samuel Hahnemann, homeopathic medicine is based on the principle of “like cures like.” In its simplest terms, this principle states that a substance capable of causing disease can also be used to treat disease. To learn the symptoms that any given substance can produce, it must be taken in repeated doses. When experienced during an episode of disease, these symptoms can then be cured by taking the same substance in its homeopathic form (as a remedy).

5. Manual medicine (Dr. Craig Appleyard): Manual or musculoskeletal medicine is the medical discipline that deals with the most common causes of pain and disability, namely reversible dysfunctions of the locomotor system, including the spine. Manual medicine is as old as recorded history, with evidence in Thai statuary of manual techniques dating back 4000 years. Hippocrates is known to have used manual techniques, especially on the spine. Manipulation, the mainstay of modern manual medicine, is used to restore altered structure–function relationships.

6. Neural therapy (Dr. Robert Kidd): Neural therapy is an approach to illness and disease based on identifying foci of electrophysiological instability that are causing local areas of autonomic nervous system dysfunction. These foci, which may occur anywhere in the body, can be stabilized by “caine” anesthetics, in the same way that ventricular arrhythmias can be treated by lidocaine. The treatment usually involves injections of dilute procaine directly into the foci (which are called interference fields), as well as into a convenient vein on the ipsilateral side of the body.

7. Prolotherapy (Dr. Robert Banner): The concept of prolotherapy originated in the nonsurgical treatment of hernias, varicose veins and hemorrhoids, all of which are due to weakness of the connective tissue. Prolotherapy, as it is practised today, is also known as nonsurgical reconstruction of the ligament or tendon or as regenerative injection therapy. It is a permanent treatment for chronic pain due to laxity or nonhealing of ligament and tendon injuries. The prefix prolo, short for proliferation, indicates that this treatment causes the proliferation (formation and growth) of new tissue in areas where the existing tissue has become weak.

8. Environmental medicine (Dr. Jennifer Armstrong): Environmental medicine addresses the effects of environmental factors on individuals, within the context of clinical practice. As such, it contrasts with the realm of public health which focuses on the well-being of populations. Public health practitioners use statistical analyses to assess risks and then develop environmental and other policies to prevent or treat disease. Indeed, governments have regulated water, air, and food quality for much longer than they have been involved in modern “healthcare”.

9. Intravenous chelation therapy (Dr. Richard Nahas):  The word ‘chelation’ is derived from chele, the Greek word for claw. This term describes the way in which chelation agents bind to metal cations, thereby allowing their elimination from the body. The medical use of chelation therapy was pioneered in Germany in the 1930s, when EDTA (ethylenediaminetetra-acetic acid) was administered intravenously to shipyard workers with lead poisoning. In addition to EDTA, two other chelators are in modern use. DMPS (2,3-dimercaptopropane-1-sulfonic acid) can be given by the oral, transdermal, intravenous and intramuscular routes, and DMSA (2,3-dimercaptosuccinic acid) is given orally. Older chelators, including penicillamine and British anti-lewisite (2,3-dimercaptopropanol), are rarely used for medical purposes.

10. Bio-identical hormone replacement therapy (Dr. Robert Banner): Supplement-ation of the body’s existing hormones is a vast and controversial topic. Hormones are important for many biochemical activities in the human body. However, the synthesis and release of these compounds declines with age, resulting in the development of various symptoms and “illnesses”.

The most widely recognized hormone deficiencies in both sexes are those due to imbalances of cortisol (a condition known as adrenopause or adrenal fatigue), as well as thyroid hormones, estrogen and progesterone (menopause in women), and testosterone (andropause in men). The term bio-identical hormones refers to hormones that are molecularly the same as those produced in the human body, but synthesized from plants (specifically, yams). As such, although bio-identical hormones are natural compounds, they are not native to the human body.

Conclusion

The book, Safety First: Dispelling Myths about Complementary Therapies, is just one example of what medical doctors and other healthcare professionals are doing to promote the safety and efficacy of integrative medicine. To find out more and to join a grassroots movement about the right for people to have access to integrative medicine, contact People’s Right to Integrative Medicine (PRIM) at: (905) 534-4038, PRIM, 9255 Woodbine Ave, P.O. Box 4038, Markham, ON L6C 1Y0 or https://peoplesrim.blogspot.com/

REFERENCES

1. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA 1998; 279(15):1200-5.

2. PR Newswire. New educational campaign seeks to increase patient and healthcare provider communication about prescription medicines. News release. Rockville, Maryland. January 28, 2015.

3. Sackett, David L., Rosenberg, William M.C., Gray, J.A. Muir, Haynes, R. Brian, Richardson, W. Scott. Evidence based medicine: what it is and what it isn’t. British Medical Journal. Sept. 13, 1996.

4. Almashat S, Preston C, Waterman T, Wolfe S. Rapidly increasing criminal and civil monetary penalties against the pharmaceutical industry: 1991 to 2010. Report of the Public Citizen Health Research Group. Washington, DC. December 16, 2010.

5 (a). The New York Times: “Glaxo Agrees to Pay $3 Billion U.S. in Fraud Settlement”: https://tinyurl.com/njyvo73

5 (b). Almashat S and Wolfe S. Pharmaceutical industry criminal and civil penalties: An update. Report of the Public Citizen Health Research Group. Washington, DC. September 27, 2012.

6. Spence, Les. Evidence based medicine is broken. British Medical Journal. January 3, 2014.

7. Belluz, Julia. Future doctors demand boundaries with Big Pharma: Medical schools address conflict-of-interest. Maclean’s Magazine. September 24, 2013.

8. Young, Terence. Presentation at “Celebrating Vanessa’s Law” on October 16, 2014 in Jackman Hall, Art Gallery of Ontario, Toronto. Hosted by People’s Right to Integrative Medicine (PRIM).

9. Stastna, Kazi. Eli Lilly files $500m NAFTA suit against Canada over drug patents. CBC News. September 13, 2013.

10. Zlomislic, Diana. Federal drug reform law approved for further review. Toronto Star. May 30, 2014.

11. Kidd, Robert, Herr, Steven, Carmichael, David, Powell, Barbara, Rapson, Linda, Sanduja, Parul, Krop, Jozef, Appleyard, Craig, Banner, Robert, Armstrong, Jennifer, Nahas, Richard. Safety First: Dispelling myths about complementary therapies. The Ontario Society of Physicians for Complementary Medicine.