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Those Firings at the Health Ministry Were Bad for Your Health

More than ever, we need prescription drug evaluation: MLAs.

By Judy Darcy and Adrian Dix 20 Jan 2015 | TheTyee.ca

Judy Darcy is the MLA for New Westminster and NDP spokesperson on health.

Adrian Dix is the MLA for Vancouver-Kingsway.

Are you a parent, a senior, or a person with aging parents? If so, the Liberal government's shameful handling of the fired health ministry researchers matters to your family's health.

The dismissal of these workers represents a significant injustice. And the determination of Premier Christy Clark to avoid accountability compounds the problem. But this issue goes far beyond the impact on the workers themselves.

By dismissing these researchers, and suspending access to data for the Therapeutics Initiative (a world-renowned independent drug evaluation group at the University of British Columbia), the government put a stop to critical independent research into the safety and effectiveness of prescription drugs.

The government's action also put a chill on independent research -- which already faces the burden of challenging the power and influence of large pharmaceutical companies.

One area of study significantly affected by the government's actions is the over-use of antipsychotic drugs. Researcher Bill Warburton (in collaboration with Ramsey Hamdi, David Scott and others) is a leader in assessing the impact of this kind of prescribing.

Antipsychotics are supposed to be used to help people with psychosis. You would think they would be used sparingly because not that many people need them. In fact, most of them are used for other purposes entirely -- known as "off-label" prescribing -- because, it turns out, these drugs have an interesting side effect: they make people docile. For seniors in understaffed care homes, this can be a significant factor. And children who are hyperactive are easier to "manage" when they are calm.

Independent research, which was conducted here in B.C. by researchers who were fired by the government, shows there is an increased risk in the growing number of people being prescribed off-label.

This represents a significant public health challenge in an age where information about drugs is dominated by the corporations that sell them.

'Off-label' prescribing on the rise

The top-selling drug in the United States is Abilify (Aripiprazole), an antipsychotic with $1.6 billion in sales for the quarter in the last reporting period. In 2011, the total value of sales of antipsychotics in the U.S. was $18.2 billion.  A U.S. study published for the journal Pharmacoepidemiology and Drug Safety reports that a majority of antipsychotic prescriptions -- drugs with a vast array of side effects -- are for off-label uses.

Here in British Columbia, off-label prescribing of antipsychotics has grown dramatically over the past 15 years with children and seniors being key growth markets for pharmaceutical companies. In B.C., more than half of patients in long-term care facilities are prescribed an antipsychotic, most of them for off-label use not approved by Health Canada. This level of prescribing is uniform across B.C.'s health authorities. Randomized studies show that atypical antipsychotics increase mortality in this patient group.

The prescribing of antipsychotics to children increased fourfold from 1996 to 2011, almost all of it off-label.

Yet there is virtually no evidence that such drugs are appropriate for children for most of the conditions for which they are prescribed: depression, Attention Deficit Hyperactivity Disorder and anxiety disorders.

Why is independent review so important? Because it is critical that the marketing of these drugs by pharmaceutical companies is checked by researchers who are free of conflict.

According to two reports based on the B.C. Ministry of Health data, the three most prescribed antipsychotics to seniors and to children are Risperidone (Rispeidol) by Johnson and Johnson, Quetiapine (Seroquel) by AstraZeneca and Olanzapine (Zyprexa) by Eli Lilly.

In the U.S., all three of these companies have been fined for improper marketing of these three drugs for off-label purposes. In 2012, Johnson and Johnson was fined $1.67 billion for downplaying the risk of Risperidone. In 2010, AstraZeneca was fined $520 million for illegal marketing of Quetiapine to children and seniors. Eli Lilly was fined $1.4 billion for improper marketing of Zyprexa.

Lilly's advertising campaign promoting the use of antipsychotics on children to doctors was bizarrely titled "Viva Zyprexa." This underlines the importance of the independent analysis undertaken by the Ministry of Health, the University of Victoria, the Therapeutics Initiative and others.

Needs evaluation

There are appropriate uses for these drugs. But their use has grown so dramatically, their overuse is so costly, and the side effects so significant that we absolutely need our public health system to rigorously evaluate their use.

Independent researcher Bill Warburton (whose contract with the government was terminated and whose case is still before the courts) found that patients, mostly seniors, who switched from anti-depressants to antipsychotics had statistically higher mortality. In other words, dying may well be a side effect of prescribing decisions that could be corrected with better information.

Yet this potentially life-saving research was interrupted when Dr. Warburton lost his Ministry of Health position and data access in 2012.

After the dismissals, an important research study by Dr. Warburton, Ramsay Hamdi, David Scott (all dismissed by the government), Dr. Constadina Panagiotopoulos, Dr. Roberta Ronsley and others, was published in the Canadian Journal of Psychiatry.

Using the Medical Services Plan of British Columbia and Pharmacare data, the study showed that the prescribing of antipsychotics to children is in fact a growth industry in B.C. and Canada.

The study concluded that "the high rate of antipsychotics for depressive disorders... requires further exploration given that there is no evidence to support the use of second-generation antipsychotics for depression in children and adolescents."

Doctors, patients and our health care system deserve access to just this kind of information in making prescribing decisions. The B.C. Liberal government's actions -- the curtailing of independent research and the firing of health researchers in 2012 -- have endangered public health.

B.C. is well situated to be a world leader in independent drug research -- as we have been in the past -- with a Pharmanet data system in place for 20 years and a public health care system that can support this work. 

It's time for the B.C. government to restore funding to the Therapeutics Initiative. It's time to rebuild the capacity of the Ministry of Health to ensure that our prescription drugs are safe and properly used.  [Tyee]

Read more: Health, BC Politics

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