by Terence Young
Terence Young, Member of Parliament for Oakville, Ontario, is the founder and Chair of Drug Safety Canada, a research and public advocacy organization based in Oakville. He has been active in issues related to prescription drug safety since March 2000, after losing his 15-year-old daughter Vanessa to the Johnson & Johnson manufactured drug Prepulsid, marketed by Janssen-Ortho Inc.
Prescription drugs taken as prescribed in hospitals are the fourth leading cause of death in the US and Canada, after cancer, heart disease and strokes. They cause about 10,000 deaths a year in Canada and about 106,000 deaths a year and over two million serious injuries in the US. As many as another 10,000 deaths a year in Canada are thought to occur outside hospitals due to the wrong drug, dosage errors and adverse reactions. One out of four admissions to internal medicine in Canadian hospitals is related to prescription drugs, of which 70% are preventable. Canadians now spend more on prescription drugs ($24 billion) than we do on doctors ($18 billion).
All drugs cause adverse effects. The only difference between a drug and a poison is dosage. Many drugs are marketed at dosages that are risky for many patients, referred to as a narrow therapeutic index. Sixteen major drugs have been pulled off the North American market since 1997 for injuring or killing patients including the drug that killed Vanessa Young – Prepulsid. Vioxx alone may have killed 55,000-65,000 patients before being withdrawn by the manufacturer, Merck, in 2004.
Over-the-counter drugs also cause many deaths. Every year, more than 15,000 patients die in North America from ordinary aspirin and Ibuprofen. Tylenol is the cause of thousands of hospital admissions and hundreds of deaths annually in North America.
Patient information leaflets are dangerous because they create a false sense of security, listing only minor adverse reactions. Drug labels are 30-50 pages of fine print, written by lawyers. Very few doctors ever read them. Those who do are often confused. Instead, they get their drug information from commissioned ‘detail reps’ who exaggerate the effectiveness of the drugs and play down the risks.
Most doctors get the rest of their drug information at Continuing Medical Education conferences or meetings held at expensive restaurants, resorts or on exotic trips sponsored by the drug companies. Big pharma spends upwards of $20,000 per doctor a year to create debts of gratitude. Doctors do not believe these gifts affect their prescribing habits; a drug rep’s dream.
Doctors in North America accept $ 4 billion per year in free samples of the newest and most expensive drugs and use them to create debts of gratitude in their patients. Since most illnesses get better on their own and the placebo effect works 30-70% of the time, patients believe the samples worked and begin buying them unnecessarily, sometimes for life.
Specialists are paid up to $20,000 per patient to enroll patients in drugs trials out of their offices. They have to mention that this is a trial, but are not required to tell the patients they are being paid to do so. A specialist can make up to $2 million on the side out of their office with 100 patients and never have to tell them they are being treated like a canary in a mine in exchange for money.
All drugs must be approved as safe and effective by Health Canada. To get approved, new drugs do not have to be proven more effective or even as effective as the existing bestseller for that condition. They only have to be proven slightly more effective than a sugar pill (placebo). Yet every new drug has new adverse effects. So there is often little chance the benefits will outweigh the risks. No one tells the patients.
Safe does not mean safe by any measurable standard. Safe is a moving target. Safe means that the benefits of the drug outweigh the risks for the population the drug is intended to treat and for its intended use. However, 70% of doctors, with the direct encouragement and illegal promotion of the ‘detail reps’ prescribe drugs off-label, for uses the drugs were never approved for – the cause of most drug deaths. Few patients understand the risks they are assuming when they agree to off-label use.
A drug considered safe today can be considered not safe tomorrow if the drug company comes up with a new drug to replace a bestseller. Safe is an arbitrary standard set by drug companies and Health Canada based on what they have to sell. That leads to hundreds of injuries and deaths. No one tells the patients. Drugs are proven safe after four phases of testing. Phase four is selling a new drug on the open market. Any patient taking a new drug is becoming part of a giant drug trial. Because no one ever tells the patients, they can’t provide an informed consent.
Pharmaceutical companies are not required to report adverse reactions to their drugs using worldwide totals and only report the injuries and deaths that occur in each jurisdiction, a much smaller number. Safety information is viewed as “commercial secrets.” This makes it impossible for regulators to determine how dangerous the drugs truly are.
The information Health Canada analyzes to review/approve new drugs is kept secret, preventing independent researchers from reviewing it or challenging it; the same information that is routinely published on the FDA website.
The Canadian Pharmacists Association reported to the Romanow Commission that between $2-$9 billion per year is wasted on the overuse and misuse of prescription drugs. Doctors simply do not report adverse drug reactions (less than 1% is reported). This lack of data prevents regulators from spotting killers and getting risky drugs off the market before they injure or kill many patients. Drug labels often report a number of adverse drug reactions, which is about 1/100th of the reality, making patients victims of their doctor’s reporting negligence.
In Ontario, under the current Coroner’s Act, all prescription and over-the-counter drug deaths are identified as “natural.” This keeps everyone off the hook legally.
Drug companies take adverse drug reaction reports and manipulate the data before reporting them to their ‘partners’ at Health Canada, usually blaming the patient by assuming (often with no evidence) it was an overdose, the patient had a previously undiagnosed ‘condition’ or they were a “poor metabolizer.” They never conclude there is anything wrong with the drug itself. If they are unable to blame the patient, they simply change the label, which few doctors ever read, adding a new “contraindication” in the fine print. By the time Vanessa Young died from Prepulsid, there had been five label changes over 10 years, yet sales had kept growing to $1 billion per year.
Since the 1960s, 41 drugs have been taken off the Canadian market, many or most for injuring or killing patients. No one at Health Canada has even kept a record of why these drugs were withdrawn. Drugs crash, as planes do. No one would ask Air Canada to investigate its own crashes. The independent Transportation Safety Board does that. So why do we ask Health Canada to investigate its crashes?
Beginning in 1997, Health Canada was directed to support the pharmaceutical industry as a ‘partner’ in health care. They have done so by supporting the industry agenda: increasing drug approvals and sales by promoting “Smart Regulation” under the euphemism “Progressive Licensing.” Progressive Licensing would add new post market surveillance it says, yet working to speed up drug approvals for its industry ‘partners’. Many of the drugs taken off the market were ‘fast track’ approvals. We don’t rush air traffic controllers because that would be dangerous and we should not rush drug approvals, period.
There is a career track at Health Canada for senior bureaucrats, which includes taking an early pension and then starting a new job in industry. One decision made by a drug reviewer or senior Health Canada official can mean more than $100 million a year in sales for one drug (i.e. Losec).
Health Canada has refused to enforce the rules against Direct to Consumer Advertising of prescription drugs in Canada, ads which use fear to drive patients into doctors’ offices to demand the most expensive new drugs that may or may not help them, but which have new adverse effects. Research has proven most doctors will give their patients these drugs.
From 2000, the name Health Protection Branch disappeared from use and Marketed Health Products Directorate took its place. Health Canada went from protecting Canadians to helping the drug companies market drugs to them.
When a drug is injuring or killing patients or gets bad publicity, officials at Health Canada and the pharmaceutical companies exchange notes so our regulators are directed what to say to the media about the drug by the people who make and sell it.
Health Canada does not routinely investigate why drugs kill patients. It tracks the adverse drug reaction reports on their website. That’s like a police officer filling out crime reports and never investigating them.
Health Canada does not order risky or dangerous drugs off the market although no responsible Minister of Health would refuse to take bureaucratic direction on such an action. Instead they ‘negotiate’ the fine print on safety warnings and the drug labels to help keep the drugs on the market, knowing most doctors never read them.
From article in To Your Health newsletter October 2011 by Citizens for Choice in Health Care Association, www.citizensforchoice.com