Professionally, I wear many hats. I'm a psychiatrist, a pharmacist, and an educator. My area of expertise is educating my patients and colleagues about the rational and safe use of psychiatric medications. While drugs are one component of treatment for some patients, they are by no means the most important. The power of talk therapy (psychotherapy) is indisputable.
When I was in pharmacy school, I vividly recall a mother's agony as she told me about losing her child to leukemia. At that time, childhood leukemia was nearly always fatal but now the vast majority of children survive. This seismic shift occurred because of innovative research and novel drug development (R&D).
As an educator, I work with pharmaceutical companies because they provide the majority of high-quality education to practicing physicians. This is a controversial admission because some view the role of pharmaceutical companies in physicians' education as unethical. I strongly oppose that view.
Many believe pharmaceutical companies are repugnant. There were several serious issues that built the foundation of the anti-pharma movement. While not all companies are guilty or equally responsible, many behaved unethically. They didn't always fully disclose research and safety data if it didn't support their product. They attempted to prevent researchers from voicing serious concerns. They created inappropriate relationships with physicians, leaving the impression that doctors were being bought, and sometimes that was true. This had to change.
Regulations, largely driven by consumers, researchers and physicians worldwide, have led to dramatic changes in the disclosure and scrutiny of pharmaceutical company research data. Meteoric increases in financial compensation, resulting from class-action lawsuits provoked by serious adverse drug reactions, also propelled change.
"It can cost a billion dollars to bring a new drug to market. Governments cannot afford this enormous investment, so novel drug R&D is left largely to the private sector."
The relationship between pharmaceutical companies and physicians has also radically changed. In Canada, Innovative Medicines Canada regulates the professional interactions between doctors and pharmaceutical companies. Gifts, trips, or entertainment are forbidden. Product advertising targeting doctors is now tightly controlled. These changes were necessary and overdue, yet despite these advancements, the industry may never overcome the stain of their historical misdeeds.
Here's the rub: we need a thriving pharmaceutical industry in Canada. There are health-related arguments for this and economic realities.
Pharmaceutical companies are businesses, like grocery stores, but because medications impact health, some feel drug development should not be for profit. It's like expecting a grocer to give away food because you're hungry and need to eat. Should nurses work as volunteers?
It can cost a billion dollars to bring a new drug to market. Governments cannot afford this enormous investment, so novel drug R&D is left largely to the private sector. It's a monumental risk to invest a billion dollars on a product that might never make it to market, so there must be the potential for a healthy return on investment. Most pharmaceutical companies have shareholders (check your mutual funds) who wish to profit from their investment. Without adequate funding, there won't be R&D and if we don't do the research here, Canadians won't get the innovative products.
In return for their investment, companies are given patent protection, a period of time when they alone can sell their product. This is their opportunity to make a profit for their investors (so they continue to have investors) and reinvest in R&D. Once the patent expires, any company can produce and sell the product.
Many believe this is when benevolent generic companies come to the rescue, saving Canadians money. In fact, generic companies exist entirely for profit. They don't conduct novel drug R&D. In order to sell a generic, companies use the drug developer's research and test their product on a small number of healthy volunteers. That's it!
Generics are often priced just below the price of the branded product, despite costing far less. Recently, many provinces legislated lower prices for generic drugs reimbursed by Pharmacare. Pharmacies make more profit and "special bonuses" from generics, which is why you're rarely, if ever, asked if you want a branded product when a generic is available.
Generic drugs are supposed to contain exactly the same amount of drug and produce the same effect as the branded product. This not always the case, especially if the branded product has a special delivery system, like extended release (e.g. drugs with XR or XL). Many generic companies have moved their production to countries where there is little or no quality control, further compromising drug quality and safety.
Many countries, including Canada, necessarily have protocols to assess the value and price of new drugs, but because healthcare is a provincial responsibility, each province decides which drugs will be funded. This leads to uneven access to medications across Canada.
Price controls are necessary and appropriate but decisions should not be arbitrary. Decisions must be evidence-based and the process should include clinicians who actually prescribe. Without a fair pricing policy, companies will withdraw their new products, as has happened in some European countries.
Recently, reports of drug companies gouging consumers caused outrage. These companies bought old "orphan" drugs, desperately needed by a small number of patients, and increased their prices astronomically. This outrageous behaviour is not related to novel drug R&D. These companies sought to profit from the suffering of ill patients while offering no benefit to society. They should be subject to aggressive regulatory price controls.
I teach my colleagues about psychiatry and psychopharmacology. My credibility is tied to my ability to provide balanced, evidence-based information that also reflects my clinical experience (knowledge gained from working directly with my patients). I use every drug I can get my hands on because every patient is an individual with unique needs.
Whether a drug is fifty-years-old or it arrived on the market last week, I need to find what works best for every patient. I look forward to the day when we have treatments that prevent or cure mental illness but until then, my job is to treat symptoms and get patients back to life as fully, rapidly and safely as possible. To do that I need a big toolbox.
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