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June 28, 2014
Jake J. Thiessen, Ph.D.

“Everything in life has some risk, and what you have to actually learn to do is how to navigate it.”

Reid Hoffman (Co-Founder and Executive Chairman at LinkedIn)

As a follow-on to the Context program regarding medicines, I present additional thoughts about risks, the Canadian approval of drugs, and some practical suggestions so that patients will get the most benefit from medicines. I trust this will be helpful. 

As stated above by Mr. Hoffman, life presents many dangers.  Even water, the Creator’s life-sustaining fluid, can be hazardous. We are reminded annually of tragic drownings due to natural catastrophes and accidents.  Furthermore, while most of the population is unaffected, hundreds of thousands of Canadians need to be on guard against some common food substances due to life-threatening allergies. This incidence appears to be increasing, especially among children.  One of our granddaughters, for example, has a severe peanut allergy that appeared terrifyingly, without warning. It poses considerable challenges. Even unintended exposure could spell a serious anaphylactic reaction with dire consequences.

Did the producers of peanuts intend to create harm?  ….of course not.

To protect her, we need to navigate this risk carefully. She has learned to question a trusted person when a new food is offered to her.

For Canadians who experience a broad spectrum of illnesses, medicines continue to offer a tangible remedy. For millions, treatment outcomes with medicines are successful, bringing relief and new hope.  Yet, medicines are like a double-edged sword, presenting both benefits and risks.  Many find this unsettling because they assume drugs are without risk when our country’s primary gatekeeper (Health Canada) approves them and announces that they are safe and effective. To discover that medications may cause adverse effects, sometimes of a serious nature, raises understandable concerns and reservations about the entire regulatory system.

How do drugs become available to Canadians? Briefly, the company must investigate and submit comprehensive information about the drug that includes:

  • Detailed physical, chemical, pharmaceutical and other non-clinical information about the medicine’s characteristics
  • Detailed observations from all human (that is “clinical”) investigations to provide clear evidence of what effects it has in people; typically thousands of individuals are studied
  • Evidence about the manufacturer to identify all aspects about its facilities, personnel, processes and methods, and assurance that these comply with regulatory standards

The ultimate objective is to establish that the new drug comes from a trusted manufacturer and can be regarded as safe and effective for treating an identified medical condition.  If on balance the evidence meets all the requirements, only then is the drug approved.  Importantly, this approval by Health Canada specifies that a full product description (“monograph”) must have been prepared and also accepted. This monograph is designed to inform physicians and other healthcare personnel all about treatment conditions, benefits and risks before using the drug.  

Despite all the precautions, there will always remain a measure of uncertainty because the new medicine has not been evaluated in the full spectrum of circumstances, which may arise. The everyday world can present situations and conditions that are different than the world of controlled medicine testing. It should therefore not be surprising that, after Canadian approval, a new drug’s expanded use in literally millions of patients may expose previously unrecognized, unintended effects. 

Health Canada takes great care in safeguarding Canadians not only regarding medicines but many other products.  Every year this agency builds on acquired experiences and brings improvements that are meant to further protect our population.  In addition, various partnering agencies, like the Institute for Safe Medication Practices (ISMP), are committed to the advancement of medication safety in all healthcare settings.  I would highly recommend the valuable information contained at the following sites:

http://www.hc-sc.gc.ca

http://www.healthycanadians.gc.ca

http://www.ismp-canada.org


Medicines need to be treated with a great deal of respect and vigilance.  It’s all about achieving the greatest likelihood of success. While everyone should take ownership of their health, medicines can be complicated. Therefore a trusted, very knowledgeable therapeutic expert is needed to manage and optimize the treatments.  To maximize the benefits and minimize undesirable outcomes of medicines, I would particularly recommend some navigation principles for patients and healthcare professionals:

  • Ensure that the medicines are really needed and that they address a root cause for an illness; overuse, underuse or misuse brings undeniable health risks
  • Avoid ‘one-size fits all’ prescribing; rather adopt an individualized approach wherein all known human variability factors are taken into account
  • Cautiously treat patients who are facing more than one disease and therefore potentially requiring a number of different medicines
  • Cautiously treat children and young adults who may be particularly sensitive and vulnerable
  • Cautiously treat the elderly to guard against unnecessary, multiple-medicine use; generally a good starting point is with low and/or divided doses and then gradually building towards an intended outcome
  • Stick carefully to a prescribed treatment program
  • Recognize that a variety of complicating factors like over-the-counter medications, foods, special diets and alternative therapies can shift the balance between a prescribed medicine’s benefits and adverse reactions

 

In conclusion, drugs need to be used with knowledge and discretion.  My advice is…..

                        - Heed the available information and alerts

                                                - Navigate treatments with care

                                                                        - When uncertain, seek the advice of trusted experts


Jacob (Jake) J. Thiessen, PhD

B.Sc. (Pharm): University of Manitoba; M.Sc.: University of Manitoba; Ph.D.: University of California, San Francisco.

Jake is a former Professor, Associate Dean, and current Professor Emeritus at the Leslie Dan Faculty of Pharmacy, University of Toronto. Following 33 years at the University of Toronto, he spent 6 years at the University of Waterloo (UW) where he had strategic responsibility for the development of a new Health Sciences Campus and Canada’s 10th School of Pharmacy.

 Education, research and administrative leadership have been central to his academic career of about 40 years. He specialized in pharmacokinetics and pharmacodynamics, which basically describe quantitatively those forces that affect how the body handles medicines and how medicines affect the body. The dynamic of these two areas influences strategies around patient treatment regimen in all disease states. Research collaborations included some years working with medical oncologists and basic scientists at Princess Margaret Hospital. In more recent years, the UW research with scientists in cognate fields explored a special region of light and its illuminating benefits in the pharmaceutical and medical fields. This led to the formation of a start-up company (Verisanté) that is traded on the TSX Venture Exchange. The first product (Aura™) is a revolutionary technology allowing skin irregularities to be scanned and thereby assist in the early diagnosis of skin cancer.

Jake’s broad experience has included international projects in countries like Taiwan, Saudi Arabia, Sudan and Nigeria, the role of CCAPP President, Chair for the Drug Quality and Therapeutics Committee of the Ontario Ministry of Health, and Chair for Health Canada’s Scientific Advisory Committee on Bioavailability and Bioequivalence. Currently he serves Health Canada as the Chair of the Scientific Advisory Committee on Pharmaceutical Sciences and Clinical Pharmacology.  Most recently, he served the Ontario Minister of Health and Long Term Care as an independent reviewer of the under-dosing of oncology medicines discovered in Ontario.

 



Comments

The airing of such an important issue & the opportunity to comment on DANGEROUS PERSCRIPTION MEDICATIONS is a blessing. To protect patients it should be ILLEGALL FOR ALL DRUG COMPANY SALES REPS TO BOOK 2hour APPT TIME BLOCKS THAT PROVIDE free yet expensive catered lunches for Doctors & their office staff in order to UPSELL their Companys drugs. This is HIGHLY UNETHICAL but a very common practice that robs patients of timely medical care & brings safety of medicines into question since Dr. appt time is paid for in exchange for the "free customized catered" lunch perk. Which of course Drs do not have ability to do for staff with the high costs & overhead of running a private practice. This selling tactic is a form of buying Doctors off in order to market drugs for them to perscribe for "AFTER MARKET USAGE" is despicable! MOST Sales Reps often skew or misrepresent the drugs completely as they ARE NOT TRAINED in PHARMACOLOGY & ARE PAID TO SELL DOCTORS on recommending THEIR PRODUCTS to their patients. Government intervention is URGENTLY NEEDED to stop this kind of back door entry for dangerous medications drugs being perscribed for uses other than WHAT THEY WERE "designed" for. Once drugs are approved for one condition then it becomes a "free for all" with patients being used as guinea pigs for other conditions that safety trials never even investigated. All that is said is some patients experienced improvement with a particular symptom unrelated to condition drug trial was done for, so why not try this drug for patients that hav this symptom as well & "SEE IF IT HELPS". Hence pandoras box bursts open & it only worsens when adverse drug reactions arent reported in any regulated way & are left up to the discretion of the ER doctor treating reaction or the perscribing Drs ethics & time restraints. CLEARLY MORE REGULATION NEEDS TO BE ENFORCED SO THAT BIG PHARMACUETICAL GIANTS ARE CURTAILED BY THEIR DRIVE TO SELL SICKNESS INSTEAD OF GOOD HEALTH! Kindest regards ~^~ ~^~
June 29, 2014 | Deborah


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