Facts on Prescription Drug Deaths and the Drug Industry

Prepulsid, the drug that killed Vanessa Young, was one of sixteen important drugs that have been pulled off the North American market since 1997 because they were harming or killing patients. Before Merck, the product’s producer, recalled it in 2004, Vioxx alone may have killed 55,000 to 65,000 individuals. Among the drugs removed are Rezulin, Lotronex, Prepulsid, Redux, Pondimin, Durect, Seldane, Hismanal, Posicor, Raxar, Vioxx, Baycol, Serzone, Raptiva, Permax, and Zelnorm.)

Over-the-counter medicines are another factor in a large number of deaths. For instance, Ibuprofen and regular aspirin cause the deaths of roughly 15,000 individuals annually in North America. Each year in North America, Tylenol results in thousands of hospital admissions as well as hundreds of fatalities.

WARNINGS FOR SAFETY ARE ENTIRELY INAPPROPRIATE.

Patient education materials do patients harm by emphasizing only minor side effects, which gives patients a false sense of security. On medicine labels, lawyers craft exquisite prose spanning 30 to 50 pages. Doctors hardly ever read them. Those who do are often confused. Instead, they obtain their drug knowledge from paid “detail salespeople,” who exaggerate the benefits of the medications while downplaying their risks.

The remainder of their drug knowledge comes from “Continuing Medical Education” seminars or events that are conducted at upscale eateries, resorts, or on exotic vacations that are funded by pharmaceutical companies. On Saturday morning, after a slide presentation extolling the virtues of the new drug, everyone heads to the ski slopes or the beach for two days. In the months that follow, the drug’s sales soar rapidly because of debts of gratitude rather than effective treatment. The majority of physicians experience ongoing gratitude debts to pharmaceutical companies.

In medical school, our doctors learn that they are qualified for free meals and presents from major pharmaceutical companies. What starts with coffee mugs and pencils under the guise of “continuing medical education” develops into expensive meals, sporting event tickets, and complimentary trips to far-off places. You must administer brand-new drugs that are currently undergoing Phase IV testing into your bloodstream and organs in order to satisfy these debts of appreciation.

Up to $20,000 per doctor is spent by big pharma each year to create responsibilities of gratitude. A pharmaceutical sales representative’s fantasy, doctors do not believe that these gifts have any impact on their prescribing habits.

Each year, doctors in North America accept $ 4 billion in free samples of the priciest medications and utilize them to show their patients how appreciative they are. Patients feel the samples worked and keep buying them unnecessarily, sometimes for the remainder of their lives, because most illnesses get better on their own and the placebo effect works 30–70% of the time.

Specialists who sign up patients for drug studies outside from their offices might make up to $20,000 per patient. The patients are not required to be informed that they are receiving payment for their time, but they must disclose that this is a trial. With 100 patients, a specialist can earn up to $ 2 million on the side without ever having to disclose to the patients that they are being treated like canaries in a coal mine.

THE WORD “EFFECTIVE” DOES NOT MEAN “EFFECTIVENESS.”

All medications must receive “safe and effective” certification from Health Canada.

For new medications to be approved, they do not even need to outperform or even compare favorably to the current top-selling medication for that ailment. They only need to slightly outperform a sugar tablet in terms of effectiveness. (placebo) But every new drug has its own unique set of negative effects. Therefore, there is typically little chance that the advantages will outweigh the disadvantages. Nobody alerts the victims.

THE WORD “SAFE” DOES NOT MEANS SAFETY.

“Safe” does not necessarily mean “safe” by any quantified standard. The concept of “safe” is a moving goal. “Safe” denotes that the drug’s advantages for the target demographic and its intended use outweigh its risks. However, 70% of doctors prescribe medications off-label—for uses for which they were never approved—with the direct cooperation and illegal marketing of the “detail reps,” which is the cause of the bulk of drug-related fatalities. When patients agree to off-label use, few are aware of the hazards they are accepting.

If a new drug is created to take the place of a best-seller, a medication that is currently considered “safe” may be declared “unsafe” tomorrow. ‘Safe’ is a subjective standard created by drug companies and Health Canada based on what they have to give. As a result, hundreds of individuals suffer fatal or serious injuries. Nobody alerts the victims.

Drugs are deemed “safe” after going through four testing rounds. By Phase Four, a new drug is being offered for sale on the general market. Every person who uses a new medication joins a large-scale drug trial. Patients aren’t informed, hence they can’t offer informed consent.

Pharmaceutical companies simply report the injuries and deaths that take place in each jurisdiction, which is a far lesser quantity because they are not required to reveal adverse drug reactions using worldwide totals. Safety information is thought of as “business secrets.” This makes it impossible for regulators to determine how dangerous the drugs actually are.

Health Canada reviews and approves new pharmaceuticals based on data that is kept confidential, preventing independent researchers from reviewing or disputing it. The FDA frequently posts this data on its website.

IF DRUG INJURIES AND DEATHS ARE REDUCE, SAVINGS COULD BE MASSIVE.

The Canadian Pharmacists’ Association estimates that between $ 2 billion and $ 9 billion is wasted annually on the abuse, misuse, and underuse of prescription drugs. If Canadians only utilize medications when they are truly essential and secure, this savings will be feasible.

If 70% of unwanted pharmaceutical reactions were avoided, our healthcare system would save hundreds of millions of dollars. (The Romanow Commission stated that “errors that could have been prevented with better information systems and greater integration of prescription drug care with the rest of the health care system are projected to cost approximately $10.9 billion per year (Kidney and MacKinnon 2001)”)

DRUG DEATHS: HOW ARE THEY COVERED UP?

Simply simply, medical professionals do not document negative drug effects. (less than 1% of cases have been documented) Due to the lack of data, authorities are unable to identify serial killers or take harmful medications off the market before they cause severe harm or death to a large number of patients. Drug labels usually only list a small portion of the adverse drug reactions that actually occur, making patients the victims of their doctor’s poor reporting.

The current Coroner’s Act in Ontario classifies all prescription and over-the-counter medication deaths as “natural.” Legally, everyone is cleared in this.

Before sending adverse drug reaction reports to their “partners” at Health Canada, drug companies change them. They frequently place the blame on the patient, claiming (sometimes without supporting documentation) that they overdosed, had a condition that had not yet been identified, or were “poor metabolizers.” They never reach the conclusion that the medication is defective in any way. If they can’t put the responsibility on the patient, they simply change the label—which few doctors read anyhow—and insert a new “contraindication.” Although there had been five label modifications in ten years prior to Vanessa Young’s death from Prepulsid, sales had risen to $1 billion annually.

41 drugs have been taken off the Canadian market during the 1960s, several of them were shown to be dangerous or even fatal to patients. Health Canada hasn’t even kept track of the reasons why these medications were recalled.

WHAT IS HEALTH CANADA’S PROBLEM? WE NEED A NEW DRUG AGENCY, BUT WHY?

Conflicts of interest, actual and potential

Drugs crash, much like planes. Nobody would advocate for Air Canada to investigate its own accidents. The Transportation Safety Board, an impartial organization, handles that. Therefore, why should we ask that Health Canada look into its crashes?

Beginning in 1997, Health Canada was required to promote the pharmaceutical industry as a “partner” in healthcare. Under the pretext of “Progressive Licensing,” they have achieved this by promoting “Smart Regulation,” which has raised the number of drug approvals and sales. Progressive Licensing asserts that it is accelerating medicine approvals for its corporate “partners” while also introducing new “post-market” surveillance. The sixteen drugs that were removed from the market received ‘fast track’ clearances for many of them. Because it’s unsafe, we don’t rush air traffic controllers, and the same goes for rushing drug approvals.

The career path for senior officials at Health Canada entails an early retirement followed by the beginning of a new job in business. An individual drug might generate over $100 million in annual sales as a result of a single decision made by a senior Health Canada officer or drug reviewer. (Take Losec, for instance) Drug reviewers at Health Canada are like to judges in that they are employed by the companies whose medications they evaluate and have the authority to meet in secret without taking minutes. Any such run-in with a judge would automatically result in a mistrial.

Health Canada has decided not to enforce the laws prohibiting Direct to Consumer Advertising of Prescription Drugs in Canada, which use fear to induce people to visit doctors’ offices and demand the most expensive new medications, some of which may or may not be beneficial to them but do have new negative side effects. Most doctors will prescribe them, according to study.

The name Marketed Health Products Directorate has been used in place of Health Protection Branch since 2000. Instead of protecting Canadians, Health Canada now works with pharmaceutical companies to promote pharmaceuticals to them.

Officials at Health Canada and pharmaceutical businesses communicate when a drug results in injury or death or creates negative headlines, so our regulators receive instructions from those who make and distribute the drug about what to say to the media.

Health Canada does not frequently look into drug-related deaths. They track complaints of negative medication reactions on their website. That would be the same as a police officer accepting crime reports but never looking into them.

41 drugs have been taken off the Canadian market during the 1960s, several of them were shown to be dangerous or even fatal to patients. Health Canada hasn’t even kept track of the reasons why these medications were recalled.

The fact that Health Canada is tasked with keeping harmful medications off the market while also supporting pharmaceutical firms in selling their goods is clearly a conflict of interest. Changing one’s diet, exercising, getting more rest, cutting back on alcohol and tobacco use, using sanitary products, getting chiropractic care, using light therapy, and getting massages are just a few of the safer treatments that people can use to treat medical conditions. The big pharmaceutical companies only have one concept: a medication for every illness.

Health Canada does not order hazardous or harmful pharmaceuticals off the market, despite the fact that no credible minister of health would object to receiving bureaucratic advice on such a move. Instead, they ‘negotiate’ the small print on prescription labels and safety precautions to keep the drugs on the market—even though the majority of doctors never read them.

CONCLUSION: With the support of the Transportation Safety Board-inspired Independent Drug Agency, I will propose in the House legislation to ensure that Canadians are safe when using prescription medications.

• Approve all safety information given to patients and physicians, including the design of highly effective patient information booklets.
• Withhold any medication from sale for 48 hours.
• Keep note of which medications were taken off the market and for what reasons.
• Release and disseminate sensible safety alerts regarding potentially harmful drugs.

Examine crashes involving drugs and make suggestions to prevent such occurrences in the future.

• Compile and analyze reports of adverse medication responses as soon as possible, and put into effect a new regulation mandating medical professionals to report possible adverse drug reactions.

Put into effect the laws governing direct-to-consumer advertising for prescription drugs.

• Implement new regulations that cover all means by which doctors are paid by the pharmaceutical sector, including gifts given to them.
• Assist in preventing drug salespeople from entering our medical schools and offices.
• Provide government advice on how to provide independent CME for our doctors without allowing undue business involvement.
• Provide recommendations to the government on how to prevent patients from being used as test subjects by their doctors or the pharmaceutical industry without receiving fully informed consent, and only when the potential advantages of using a drug are supported by the strongest independent evidence currently available regarding the likelihood that the advantages will outweigh the risks.
• Interact with regulatory bodies in other countries to make sure that information on the safety of medications is not withheld.
• Any additional drug safety concerns that arise, as well as any additional duties that the Romanow Commission may identify.

Along with the aforementioned: RATIONALE

Prescription drug safety management systems lag behind nuclear and transportation, which both have independent regulators, by decades.

Sixteen drugs have been taken off the market since 1997 due to patient injury or death. It is obvious that these medications should not have been approved, but Health Canada is covertly advancing an industry agenda that calls for quicker drug approvals, the exact opposite of what is necessary for patient safety.

Health Canada has been asked to “engage” with industry ever since Health Canada’s drug labs were shut down and funding were cut in 1997. In favor of industry goals like higher sales and quicker approvals, they neglected their duty to protect patients. For instance, when the Health Protection Branch’s name was changed to Marketed Health Products Directorate, this became abundantly evident. Because marketing has taken the role of protection, patients suffer from numerous drug-related injuries and deaths.

The current administration promoted the risk management standard used by the pharmaceutical industry in 2003 through the Privy Council under the banner of “Smart Regulation.” Until potential punitive damages in civil proceedings exceed revenues, this condition permits risky prescription drugs like Prepulsid or Vioxx to remain on the market with insufficient safety warnings. In the pharma industry, this is a pattern of behavior that frequently manifests.

Health Canada has done a bad job of ensuring that Canadians are safe when taking prescription pharmaceuticals since 1997 as a result of its directed industry “partnership.” Its record-keeping on critical issues is basically nonexistent, and it has a dismal history of issuing appropriate drug warnings and advice regarding medication withdrawal. Health Canada employees are not qualified to carry out the proposed enhanced powers under the Food and Drugs Act due to their dismal track record and numerous conflicts of interest. The only way to begin making the necessary changes in Canada is to establish a new drug agency.

In 1992, the Gagnon Report pushed for a new approach of medication safety. Drug Review for the Future: Working in Partnerships, by David Gagnon, was published in 1992 by Health and Welfare Canada in Ottawa.

The Commission on the Future of Health Care in Canada (Romanow Commission), which was established in 2002, noted that a group founded by the deputy ministers of health of the federal and provincial governments “also advocated the development of a national agency, independent of Health Canada and other governmental bodies” in 1992. In January 2002, ministers from the provinces and territories came to a similar decision. Additionally, a number of professionals have persisted in calling for Health Canada to create a separate agency to evaluate and approve prescription drugs (Rawson 2002).