Facts on Prescription Drug Deaths and the Drug Industry

Facts on Prescription Drug Deaths and the Drug Industry

updated August 21, 2011  
   
 

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rescription drugs taken as prescribed in hospitals are the fourth leading cause of death in the U.S 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 U.S. (Source: Lazarou et al JAMA Vol. 279 No. 15 pp.1200-1205 Incidence of Adverse Drug Reactions in Hospitalized Patients)

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. (Source: Dr. Joel Lexchin, Associate Professor, School of Health Policy and Management, York University, Emergency Physician, University Health Network, and Associate Professor, Department of Family and Community Medicine, University of Toronto, Toronto, Ont.)

One out of four admissions to internal medicine in Canadian hospitals is related to prescription drugs, 70% of which are preventable. (Source: Drug Related Hospitalizations in a Tertiary Care Internal medicine Service of a Canadian Hospital: A Prospective Study Leslie Jo Samoy et al. Pharmacotherapy 2006:26 (II) 1587-1586)

Canadians now spend more on prescription drugs ($24 B) than we do on doctors ($18 B) Source: IMS

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.

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Ethics and Equity

 

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 Vioxx alone may have killed 55,000 – 65,000 patients before being withdrawn by the manufacturer – Merck in 2004. (The pulled drugs are Rezulin, Lotronex, Prepulsid, Redux, Pondimin, Durect, Seldane, Hismanal, Posicor, Raxar, Vioxx, Baycol, Serzone, Raptiva, Permax, Zelnorm.)

Over-the-counter drugs also cause many deaths. For example, every year over 15,000 patients die in North America from ordinary aspirin and Ibuprophen. Ordinary Tylenol is the cause of thousands of hospital admissions and hundreds of deaths annually in North America.

Safety Warnings are Grossly Inadequate

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. After a Saturday morning slide show extolling the virtues of the new drug, everyone heads out for the ski slopes or to the beach for two days. The drug’s sales rise exponentially in the following months based on debts of gratitude, not proven therapy.

Most Doctors Feel Continual Debts of Gratitude to Pharmaceutical Companies

Beginning in medical schools our doctors are taught that they are entitled to free meals and gifts from the big pharma companies. What starts out as coffee cups and pens, morphs into expensive dinners, tickets to sporting events and free trips to exotic locations, all under the guise of ‘continuing medical education’. The only way these debts of gratitude can be repaid is by putting new drugs still in Phase IV of testing into your bloodstream and organs.

The big pharma companies spend 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 reps’ dream.

Doctors in North America accept $ 4 billion/year in free samples of the newest a 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, the 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.

‘Effective’ Does Not Mean Effective

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 best seller for that condition. They only have to be proven slightly more effective than a sugar pill. (placebo) Yet every new drug offers new adverse effects. So there is often little chance that the benefits will outweigh the risks. No one tells the patients.

‘Safe’ Does Not Mean Safe

“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, 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 best seller. ‘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. No one ever tells the patients, so they can’t provide an informed consent.

Pharamaceutical companies are not required to report adverse reactions to their drugs using world wide totals, and so 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 web site.

Huge Savings are Available if Drug Injuries and Deaths are Reduced

The Canadian Pharmacists’ Association reported to The Romanow Commission that between $ 2 B and $ 9 B a year is wasted on overuse, misuse and under use of prescription drugs. This savings is available if Canadians only take drugs when they are truly needed and truly safe.

The savings to our health care system if the 70% of preventable drug reactions were eliminated is in the billions. (The Romanow Commission: “Errors that could have been prevented with better information systems and better integration of prescription drug care with the rest of the health care system have been estimated to cost about $10.9 billion a year (Kidney and MacKinnon 2001).”)

How Drug Deaths are Covered Up

Doctors simply do not report adverse drug reactions. (less than 1% are 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 that 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 anyway, adding a new ‘contraindication’ in the fine print. By the time Vanessa Young died from Prepulsid, there had been five label changes over ten years, yet sales had kept growing to $ 1 B/year.

Since the 1960s, forty-one 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.

What is wrong with Health Canada? Why is a new Drug Agency needed?

Conflicts of Interest and Potential Conflicts:

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 sales by promoting ‘Smart Regulation’ under the euphemism “Progressive Licensing”. Progressive Licensing would add new ‘post market’ surveillance they say, yet working to speed up drug approvals for their industry ‘partners’. Many the sixteen 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 that 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 make up over $100 M a year in sales possible for one drug. ( i.e. Losec) Health Canada drug reviewers are a kind of judge, yet over 60% of their revenues come from the companies whose products they review, and they are allowed to hold closed door meetings with pharmaceutical company officials where no minutes are taken. Any such meeting with a judge would be grounds for an automatic mistrial.

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 doctor’s offices to demand the most expensive new drugs that may or may not help them, but do cause new adverse effects. Research has proven most doctors will give them to them.

From 2000 the name Health Protection Branch disappeared in 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. They track the adverse drug reaction reports on their web site. That’s like police officer taking crime reports and never investigating them.

Since the 1960s, forty-one 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.

It is an obvious conflict of interest that Health Canada is supposed to keep unsafe drugs off the market, while working to help pharmaceutical companies market their drugs. There are many other safer therapies that help patients deal with medical conditions, including diet change, exercise, better sleep habits, reductions in alcohol and tobacco use, sanitary solutions, chiropractic care, light therapy, and massage. The big pharma companies only have one idea: a pill for every ill.

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.

Conclusion:

My motion in the house will recommend that a new Independent Drug Agency be established by Parliament, modeled after the Transportation Safety Board to help make and keep Canadians safe when using prescription drugs.

This agency would have the proposed powers to:

  • Approve all safety information given to patients and doctors, including preparing truly effective patient information leaflets.
  • Order any drug off the market with 48 hours notice.
  • Keep records of which drugs were pulled off the market and why.
  • Issue and place effective safety warnings in the media regarding risky drugs.
  • Investigate drug crashes and make recommendations to avoid similar crashes.
  • Collect and analyze adverse drug reaction reports in a timely fashion, and enforce a new rule that requires compulsory reporting of suspected adverse drug reactions to for health care professionals.
  • Enforce the law regarding Direct to Consumer Advertising of prescription drugs.
  • Enforce new rules regarding pharmaceutical company gifts to doctors, including all ways doctors receive money from these companies.
  • Help keep the drug reps out of our doctor’s office and medical schools.
  • Advise the government on how to establish independent CME for our doctors without undue influence of the industry.
  • Advise the government on how to make sure patients are not used as test subjects by their doctors and the industry, without truly informed consent and only when the potential benefits of taking a drug are based by the best available independent evidence on the balance of probabilities going to exceed the risks.
  • Communicate with regulators in other countries to ensure drug safety information is not withheld.
  • Additional drug safety matters as required, and other possible responsibilities as recommended by the Romanow Commission.

Rationale; in addition to the foregoing:

Safety Management systems with regards to prescription drugs are decades behind other industries like transportation and nuclear, which both have independent regulators.

Since 1997 sixteen drugs have been taken off the market for injuring or killing patients. Obviously these drugs should not have been approved, yet Health Canada is quietly moving ahead on the industry agenda: faster drug approvals; the exact opposite of what patient safety demands.

Since 1997 when the Health Canada drug labs were closed and budgets cut, Health Canada were directed to “partner” with the industry. Their role of protecting patients became secondary to industry priorities of higher sales and faster approvals. This was evident for example, when the name of the Health Protection Branch disappeared to be replaced with the title Marketed Health Products Directorate. Protection was replaced with marketing, the exact reason patients suffer so many drug injuries and deaths.

Using the term Smart Regulation, in 2003 the government of the day through the Privy Council proceeded to promote the drug industry standard of risk management. This standard allows deadly prescription drugs like Prepulsid or Vioxx to stay on the market with inadequate safety warnings until the potential punitive damages in law suits appear they will exceed profits. This is a pattern of behaviour that repeats itself again and again in the drug industry.

Health Canada has been hopelessly compromised since 1997 through its directed industry ‘partnership’ and has done dismal job of keeping Canadians safe when using prescription drugs. Its record keeping on key matters is almost non-existent and track record regarding effective drug warnings and recommending drug withdrawals weak. Based on their poor past performance and numerous conflicts of interest, the people at Health Canada are not the best ones to implement the proposed new powers in the Food and Drugs Act. The only way to begin to make the changes we need is a new drug agency for Canada.

In 1992 The Gagnon Report recommended a new drug safety system. (Gagnon D. Working in partnerships . . . drug review for the future. Ottawa: Health and Welfare Canada, 1992.)

In 2002 The Commission on the Future of Health Care in Canada (Romanow Commission) recommended a National Drug Agency for Canada, saying:

“In 1992, a group appointed by the federal and provincial deputy Ministers of Health also recommended the creation of a national agency, independent of Health Canada and other governmental agencies. Provincial and territorial ministers came to a similar conclusion at their meeting in January 2002. And various experts have continued to call for Health Canada to create an independent agency to evaluate and approve prescription drugs (Rawson 2002).”

 

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