Monday, 7 July 2014

The excessive use off-label prescription drugs by the United States and  Canada                         

Doctors often prescribe medication to treat problems with drugs that aren't officially approved by the U.S. Food and Drug Administration (FDA) and Health Canada, which can be both good and bad for patients. These kinds of drugs are not called, off-label drugs because they don’t have labels on them. They are given this name because the drugs are not approved by the aforementioned agencies.

Has your doctor ever prescribed an antidepressant to curb your hot flashes or a blood-pressure pill to calm your stage fright? How about an antipsychotic drug to help you sleep? Like most Americans and Canadians alike, you probably assume that when your doctor prescribes a medication, the U.S. Food and Drug Administration and Health Canada has approved it for your specific ailment. But about one in five prescriptions are written “off-label”—that is, for a use not approved by either of these governmental agencies.  While legal and common, drugs prescribed off-label present both opportunities and challenges for consumers and for doctors. 

Drug manufacturers benefit from this policy also. They can save millions of dollars by not submitting an application or safety and efficacy testing results to those governmental agencies to get a drug approved for treating a second (or third) condition or for a new group of patients, like children. And they profit from additional sales of a drug prescribed for unapproved uses. A result is that many of those drugs have little or no scientific support.
Some doctors will often prescribe an off-label drug without realizing it has not been approved for use by their patients. Despite the prominence of off-label drug use, experts say few patients are aware that they are receiving a drug off-label. And doctors are not required to tell a patient that a drug is being used off-label. Further, doctors are free to prescribe a drug for any reason they think is medically appropriate.

According to the American Cancer Society, cancer treatment often involves using certain chemotherapy off-label drugs because a chemotherapy drug approved for one type of cancer may actually target many different types of tumors. Off-label use of a drug or combination of drugs often represents the accepted standard of care by many doctors.
Beta-blockers are another example of beneficial off-label prescribing. Such medications are FDA-approved for the treatment of high blood pressure, but are widely recognized by cardiologists as a standard of care for patients with heart failure. And in fact, some beta blockers are now formally approved to treat heart failure. It's not uncommon for off-label uses to eventually get approved by the FDA. Other drugs commonly prescribed off-label include tricyclic antidepressants for chronic pain, and antipsychotics for attention deficit hyperactivity disorder (ADHD) Name the drug, and one can come up with off-label uses.

Unfortunately, there are dangers that are inherent with the use of such drugs. For example, a 15-year-old Canadian girl who wanted to clear her acne was prescribed the antibiotic minocycline. The teen developed lupus-like symptoms — her immune system attacked her own tissues and organs — and she died. The drug was not approved for this use by Health Canada.
A 23-year-old Canadian woman suffering from convulsion was given the anticonvulsant drug ‘valproic acid’. The medication was not approved for a patient with her condition. She developed a kidney cyst and a nervous system disorder before her kidneys failed. She also died as a direct result of being prescribed with an off-abled drug that was not approved for that kind of treatment.

An 85-year-old man received the antipsychotic Seroquel to treat insomnia. Again, this was an unapproved use of a powerful drug. Neither the drug company nor Health Canada had enough scientific evidence to claim the pills could safely treat sleep disorders. In this case, the man suffered diarrhea and nausea before dying from a heart attack, which a doctor suspected was caused by the drug.

These cases are just a few of the hundreds of recent reports of side-effects suspected to have been caused by the “off-label” prescribing of antipsychotics, anti-inflammatories and other popular drugs in Canada.
Drug companies in the United States have been investigated for illegally promoting off-label uses to doctors and have paid billions in fines, but Health Canada does not appear to be probing if that is happening in Canada.
The Toronto Star (of which I obtained much o this information about these drugs) did an analysis of this problem and their investigation revealed nearly 400 cases between 2010 to 2013 that involved a wide and disturbing range of reported side-effects: deaths such as heart attacks,  strokes, birth defects, organ failures and spontaneous abortions.

Like the FDA, Health Canada collects the data on these off-label drugs they omit stating that the drugs are off label drugs before publishing them in their public side-effects database. This information could help both doctors and their patients make better prescription decisions if they know in advance what the acute or long-term side effects are to the patients or how they react to other drugs the patients are getting.  This knowledge would save lives rather than extinguishing them.

There is a failure to communicate in both of these agencies. Their jobs of health regulators are to protect public health.  If they’re withholding information that could do that, then they’re abandoning part of their job.

Health Canada claims that it has been collecting this information for six years but they claim that technical limitations with the database have prevented their public release. Give me a break. I suppose it is better to have a bad excuse than none at all.

When pressed by the Star over several months, Health Canada gave the newspaper some information on 20 drugs commonly prescribed as off- label but the regulator didn’t release that information to the public. Why not? If the information included side effects, surely the public and the medical professions should have been warned.  Further, in some cases, Health Canada is not even reviewing all the troubling data that it collects. Procrastination is the maxim of sluggards.

Last year, a Senate committee investigating the issue heard that the regulator did not have the analytical ability to track the consequences of off-label prescribing, according to Senator Art Eggleton, deputy chair of the committee investigating this problem. Then train those damn fools! Eggleton told the Star that his committee was left with the impression the data did not exist. When told by the Star that it does, and that it is Health Canada secret, he was shocked. It makes me wonder if his committee was less thorough than it should have been or if alternatively, Health Canada is more secretive than it should be. Who are they protecting if not the general public? It it the drug manufacturers?
The senator also said, “We have to go to the FDA to find out what’s happening in our own country? That’s incredible. It’s unacceptable.”  It is time to remove the people in Health Canada who are responsible for this medical fiasco.

The Canadian cases in the FDA database likely represent just a fraction of the actual number of cases where off-label drugs are thought to be the cause of serious side-effects in Canada. Side-effects are grossly under reported, and only a small number of those from Canada make their way into the U.S. database. Americans beware.  Health Canada is permitting some creepy crawlies to enter your bodies with the approval of the FDA.

Health regulators and researchers across the globe are expected to review side-effect reports in search of trends or patterns that may expose unknown problems with a drug that’s already on the market. But that is not enough. They should also inform doctors and pharmacists so that they can also warm the general public.

I also blame doctors use uses these deadly drugs for this fiasco.  Doctors can learn of potential off-label uses of drugs from a range of sources, including published medical research and word-of-mouth from other doctors. But some doctors are not paying attention to what they are being told or they aren’t that concerned.  Pharmacists are also to blame because they have to pay close attention to what off-label prescriptions are being given so that these drugs don’t interact improperly with the approved prescribed drugs that their customers are already given. 

Health Canada says it is the responsibility of doctors to safely prescribe medications, using their expertise and experience to determine whether an unapproved use is right for a patient. I agree.

Doctors should know every drug’s risks, and experts say side-effect reports with information about unapproved uses would help build what is known as a medication’s safety profile. That is where Health Canada has failed. It is not passing the information on to the doctors and pharmacists.

If this information was passed on to the doctors and pharmacists, it is conceivable that the manufacturers would have greater difficulty in selling these off-labeled drugs. Please excuse me for a moment. I have to get a thimble in which I can let a tear drop into it if I can actually wring out a tear from my tear ducts.

Health Canada has the temerity to say that doctors need to be informed in their decisions when it comes to prescribing drugs to their patients when in actual fact, Health Canada is excluding the pertinent information that the doctors need to  have when it comes to side effects of off-labeled drugs.

Doctors however may learn of potential off-label drug uses from pharmaceutical sales reps, though it is illegal for drug companies to promote unapproved uses of their products. It is the role of Health Canada to reign in these drug companies and this they are not doing satisfactorily.

In 2012 alone, the U.S. government won in court more than $5 billion in settlements with drug companies accused of illegal promotion, including a $3-billion settlement with GlaxoSmithKline.

Investigators alleged Glaxo marketed the off-label benefits of several drugs, including the company’s brand-name version of ‘Ondansetron’. The company told the Star that as part of the settlement it admitted no wrongdoing “in connection with physician prescribing of ‘Ondansetron’ in the United States.

It seems that the Americans hit their drug manufacturers’ backsides who offend with a heavy strap where as Health Canada merely uses a wet noodle as an instrument of punishment.

Several companies prosecuted for illegally marketing unapproved uses in the U.S. are selling the same products in Canada with Health Canada’s approval or alternatively, by its indifference.

A Health Canada spokesperson said the regulator “has not been made aware of any specific similar issue in Canada and has not received complaints concerning these companies promoting off-label uses of their products in Canada.” If you believe that statement, I have some swamp land I want to sell you.

Despite repeated requests by the Star, Health Canada provided no evidence it has ever investigated, prosecuted or fined a single drug company for off-label promotions.

I think that Health Canada should be classed as a dangerous commodity. It is worse than useless. By doing nothing about these dangerous off-label drugs, it is tantamount to giving these drugs its approval.
Stephen Sheller who is based in Philadelphia, said that the federal and provincial governments, which spend billions of dollars on drugs under public health insurance plans should try to recover costs from companies for inappropriate off-label prescriptions—prescriptions that may have been encouraged by illegal promotion. Sheller worked alongside the U.S. Department of Justice in its case against Janssen Pharmaceuticals Inc. over its alleged off-label promotion of the antipsychotic drug Risperdal. The case was resolved in 2013 with Janssen’s parent company paying more than $2.2 billion (U.S.) in criminal fines and civil settlements.

I get all excited when I learn of these punishments being handed out to these rogue drug manufacturers in the United States but when I consider what Health Canada is doing to put an end to these abuses in Canada, all I can do is close my eyes and go to sleep with the hope that when I awake, the people in Health Canada will have been replaced.
My message to Health Canada is paraphrased by what Cromwell said to the rump parliament in England. “Be gone, you knaves. You have sat long enough.”

Fortunately, on July 2nd, 2014, Health Canada announced that it will disclose what dangerous substances are mixed with the medicinal drugs. 

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