Monday, 25 November 2013

DANGEROUS  DRUGS:  Why  does  Canada  permit  them to  be  sold on the market?                         

Every country has stupid legislation that should have been removed a long time ago but still remains as law which haunts everyone who become victims of such stupid laws. Canada is no exception to this governmental stupidity.

Canada’s Health Products and Food Branch (HPFB) is regulated by Health Canada which is part of the Canadian government. That branch has approved 10,000 prescription drugs in Canada. What steps do these people take to ensure that the drugs they have approved of are not going to cause side effects that will bring about deaths or alternatively, serious complications for the wellbeing of those that take these drugs? 
Here is a horrible example of where sufficient testing didn’t take place and a great many people around the world suffered terribly as a direct result of the failure in properly testing the drug.  The drug I am speaking of is called thalidomide. This horrible drug was released into the market in 1957 in West Germany under the label of Contergan. Primarily prescribed as a sedative or hypnotic, thalidomide also claimed to cure “anxiety, insomnia, gastritis, and tension". Afterwards it was used against nausea and to alleviate morning sickness in pregnant women. Thalidomide became an over the counter drug in Germany around 1960, and could be bought without a prescription.

Shortly after the drug was sold, in Germany, between 5,000 and 7,000 infants were born with malformation of the limbs (phocomelia). Only 40% of these children survived. Malformation of their limbs meant that they would be born without arms and as a result, their hands grew out of their shoulders or their arms stop at their elbows. Many were born without legs or their limbs stopped at their knees.

Heath Canada approved of the drug in 1961 even though the people in the HPFB were aware of the disastrous effects the drug had on children born in Germany of mothers who took the drug. Why, you may ask, would they approve of such a drug to be prescribed in the first place? It appears that the regulator didn’t have the authority to remove the drug from the pharmacist’s shelves. However, they could have warned the public of the dangers of the use of thalidomide but instead, they kept silent. Subsequently, hundreds of Canadian babies were born deformed.

The Food and Drugs Act which had been in existence since 1951 had the authority to define what was in the drugs and what the uses of the drugs were for but it didn’t have the authority to remove them from the shelves of the pharmacists if they felt that the drugs would be detrimental to the wellbeing of those that use them.   

Currently, there is a pill sold in Canadian drug stores that supposedly fights acne. It is called Diane-35. These pills are a type of oral birth-control medication that can also help treat acne. Unfortunately, there are potential side effects associated with this medication, as there are with other types of birth-control pills.

If you have hypertension, diabetes or are obese, Diane-35 can cause water retention, which will make such medical conditions worse. For example, water retention can cause excess water to surround the heart thereby causing pressure against the heart. When fluid builds up in the lungs, liver, gastrointestinal tract, and arms and legs, brings about congestive heart failure. When you suffer from that ailment, you have difficulty in breathing. I know. I suffered from that ailment. It is a very scary situation to be in.

The most common side effects of Diane-35 include nausea, abdominal pain, bloating, vomiting, dizziness, breast tenderness or pain, excessive fatigue and feet or ankle swelling. Obviously the side effects far outweigh having the medicine to fight acne.

France found that the use of Diane-35 for birth control was putting women at risk of suffering from severe and sometimes fatal blood clots in their bodies. Thirteen Canadian young women have died as a result of blood clots forming in their bodies after using Diane-35.

So why is this drug permitted to be sold by pharmacists in Canada? The federal government doesn’t have the authority to remove the drug from the drug stores. To make matters worse, Health Canada has concluded that the drug’s benefits outweigh the risks.

What is really worse is that the drug manufacturers don’t even have to publicize the risks until they have decided to recall the drugs. By that time, many unsuspecting g victims may have died in the interim.

Consider what occurred after it was later learned about the useless affect that Alysena-28 had on women who used it.  Health Canada raised the level of the recall out of concern for women who had been advised not to get pregnant for medical reasons or who might be using drugs that “could be even be harmful to a developing fetus.” The updated recall advises women to check their packages and contact their doctors for advice, as well as to use an alternative birth control in the meantime. The decision to delay the more serious recall is upsetting to women who would consider an unwanted pregnancy a serious health consequence of using that particular drug.

Medicines have made enormous contributions to health. We are able to treat diseases like meningitis, tuberculosis and syphilis that used to be untreatable. We have powerful painkillers that help to make the last days of a cancer patient's life more bearable. Medicines can even prevent heart attacks. If they are used when needed, medicines can make a difference between life and death, or comfort and pain.

But taking medicines are always a risk. Some medicines react unfavorably to other medicines and sometime even with what he eat. Aspirin which is truly a wonder drug that has many benefits can also cause ulcers in your digestive system and dangerously thin your blood if you are already taking blood thinners as part of your medicines. This is why you should discuss your medicines with your doctor or your pharmacist. The best guide is to remember that none of the drugs are totally risk-free.

It has been estimated that between 75,000 and 100,000 people die from medicine use each year in the U.S. This would make harmful drug reactions the fourth to sixth leading cause of death. If their higher estimate is correct, only heart disease, cancer and stroke claim more lives. At the same rate in Canada, about 10,000 people would die each year from harmful effects of medicines. You can be one of these people who die.

To get a drug approved for sale in Canada, the company manufacturing the drug has to test it on cells and tissues, on animals, and finally on people to show that it is acceptably safe and effective.

Health Canada's Health Products and Food Branch then reviews the company's application and decides whether or not the drug can be marketed. If it is approved, the HPFB also approves specific labeling to accompany it. This labeling includes a listing of the health conditions the drug has been shown to treat effectively, warnings about possible harmful effects and about interactions with other medicines, as well as information about who should and who should not use the drug; for example, labeling would indicate whether it can be used safely by children, pregnant women, the elderly, or by people with certain health problems.

Unfortunately, In Canada, these decisions are made behind closed doors and neither the public nor physicians have access to the reports of Health Products and Food Branch reviewers or to the information on safety and effectiveness a company submits for review. Further, a company is under no obligation to publish the effectiveness and safety studies submitted for review, and these studies often remain unpublished. Therefore, without access to the reports that are submitted to Health Canada, physicians and the public often have very limited information on which to base decisions about whether to try a new drug.

Even if these unpublished studies were to be made available in Canada, our knowledge about the effects of new drugs would be limited. Usually, between 2000 to 3000 people will have taken the drug in pre-marketing studies, and often only for short periods of time. After it is then released on the market, thousands or even millions of people may use the same drug. If 2000 to 3000 people who tested a particular drug and long-term serious harmful reactions occurred in less than about 1 in 800 people of the people tested, millions of people who buy the product are unlikely to be aware of the possible risk. By the time the bad effects of the drug has been discovered, you could be one of thousands of people who are suffering from the side effects of a drug you thought was safe.

 Remember, it is to the advantage of the drug manufacturers to be silent about the side effects of their drugs if they think that the harm is slight or limited to only a few users of the drug. Money is their goal, not your welfare.

The Canadian Adverse Drug Reaction Monitoring Program in Health Canada, which is responsible for monitoring harmful drug reactions, has started to disseminate information through a newsletter and by making regular reports in the Canadian Medical Association Journal. These reports are a good way to warn physicians of harmful drug effects that have been reported to the Centre or that have been observed in other countries. Unfortunately, they usually do not reach the public. I notice that National Geographic Magazine which advertises various drugs includes a very comprehensive description of the side effects of those drugs being advertised in their magazine. They do this because they don’t want to be sued by people who suffer from the side effects of the medicine advertised in their magazine.

Women and Health Protection is a coalition of community groups, researchers, journalists and activists concerned about the safety of pharmaceutical drugs. They have made the following suggestions that in  my opinion, may alleviate this ongoing problem of bad drugs.

·        STRENGTHEN the drug approval system, and only allow new drugs on the market in Canada that show an advantage over existing treatments, whether it is better safety, effectiveness or convenience.

·        MAKE the drug approval system a participatory process, and allow full public access to the information on drug safety and effectiveness used by Health Canada, as well as to the reasons why Health Canada decided to accept or refuse a new drug.

·        DEVELOP detailed, clear conflict of interest guidelines for scientific, advisory and decision-making committees involved in drug regulation. People with financial ties to the company manufacturing a product should not be involved in decisions about whether that product is approved.

·        REQUIRE systematic, scientifically designed follow-up studies once a drug is approved, during the first years it its use, to collect information on its safety when it's used in a large population and under relatively uncontrolled conditions. These post-approval studies should not be a trade-off for weaker drug approvals.

·        MAKE adverse drug reaction reporting mandatory for doctors, pharmacists and other health professionals and give it a prominent place in health education.

·        USE existing computerized provincial drug prescribing databases for routine, less intense monitoring of health effects of new drug treatments. This type of monitoring should be done in a way that maintains confidentiality and protects privacy.

·        HAVE an effective warning system in place to let health professionals and the public know if a problem is suspected, or if a drug has been banned or restricted for safety reasons in another country.

·        SET UP special safety studies for drug use in pregnancy and breastfeeding and for drugs used by healthy women over long periods of time. These should be long-term as well as short-term studies.

·        IMPLEMENT drug approval processes that allow for the full participation of a wide range of women’s organizations and women’s health activists in the assessment and approval of new products that are used primarily by women, including all new hormonal products for women.

·        GIVEN the problem of unnecessary medicalization of women’s lives, a full public review is needed of all drugs currently on the Canadian market that are intended for healthy stages of women’s lives (menstrual cycle, menopause, pregnancy, breastfeeding), for disease prevention in healthy women (for example osteoporosis prevention), or for treatment of mental health problems (anti-anxiety drugs, sleeping pills and antidepressants). This review should involve full participation of women’s organizations, as described above. The aim would be to re-examine licensing decisions and labeling, and to develop policy options to deal with current and future problems related to unnecessary prescribing of drugs to women.                                                                                                                        
I hope you have found this article useful.



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