Anyone familiar with the devastating effects of this disease knows the need for early diagnosis only too well. That, actually, is old news. Thus, creating awareness about the need for an early diagnosis is warranted.  What is upsetting is that ASC is messing with the message.

The ASC’s “new” message this year is but a sequel to that of last year’s. In January, a study published by the Alzheimer’s Society repeated the warning that, “A delayed diagnosis results in a huge treatment gap and prevents people from getting valuable information about medications, support and better disease management”. The drug treatment message was re-enforced by Gouda who said, “The earlier you have access to the drugs that are available… the more likely these drugs are to help manage your symptoms and potentially even slow down the progression of the disease.”

Early diagnosis is very important for many, many reasons, but taking dementia drugs is not one of them.

The US Food & Drug Administration, for example, warned Eisai Co. Ltd that its TV ads for the Aricept, used to treat Alzheimers, were “misleading because they overstate the efficacy of the drug.” But this message probably was not heard by Canadians, many of whom see TV ads promoting Alzheimer drugs on US stations. Unfortunately, the Aricept ads were only removed when the patent for the drug was about to expire and a generic version was about to be introduced. Eisai had already made its money over the course of many years with its misleading advertising. The vast majority of those taking Aricept, or other dementia drugs (including their generic equivalents), experience no change in their condition or become worse over time (Wolfe, S., et al, 2005).

The published results of dementia drug trials have been met with a good dose of skepticism. The majority of these trials are Pharma-funded and most of the published results are positive. Few trials are funded independently of the drug industry but those that are sponsored by non-industry funding sources are more likely to find less positive results. In addition, family caregivers reveal that common tests, such as cognitive, behavioural and global assessments, used in investigating the effectiveness of these drugs are not reliable. These tests are taken only at a moment in time and do not reflect the nature of most dementias. Dementia, in most cases, is non-linear, protracted and the symptoms are variable and unpredictable. Studies testing dementia drug efficacy are also more easily open to distortion and subjectivity, similar to studies that test drug efficacy for psychiatric conditions.

Not only are these drugs ineffective for most people, but those that promote them often minimize their significant risks. These drugs carry the potential for dreadful, but common, side effects including, bradycardia, gastrointestinal disorders, muscle cramps, fatigue and, not least, psychiatric manifestations including hallucinations, agitation and aggressive behaviour. Some of these risks are very high. Bradycardia and syncope are rated to be about 10%. When affected by dementia, you become confused and disoriented. Do you need an ineffective drug that may make you agitated and aggressive at the same time or make these symptoms worse? An article that appeared in the journal Prescrire (2011) summarizes it best: Since the side effects are very serious and their minimal benefits, if any, are rare; do not use these drugs.

Instead, ASC’s Gouda neglects to mention these serious side effects and promotes false claims about the effectiveness of these drugs. Both the ASC and the drug industry offer false hope to vulnerable and desperate people with dementia and their caregivers. These caregivers, particularly at the disease’s onset, are unwittingly involved in helping persons with Alzheimer’s make sound decisions on their behalf, including decisions about taking drugs. Drug companies know full well that these caregivers know little about the disease or what to expect.

So the question is: why does the ASC’s message vigorously promote ineffective dementia drugs as a primary benefit of early diagnosis at the expense of other approaches that are critically important? Why is the ASC not aggressively demanding educational support and resources as early as possible that would certainly make a difference to persons with dementia and their caregivers?

The ASC depends on funding from the drug companies and this dependency leaves the agency open to influence. Researchers have exposed the harmful consequences of patient groups that receive drug company funding. As a 10 year volunteer of the organization, I observed firsthand how ASC relied on communications experts with ties to Alzheimer drug companies, as well as industry-funded medical advisors and researchers. Alzheimer drug companies have their own motives in wanting to promote an early diagnosis through patient groups. For example, patient organizations, such as ASC, serve as recruitment vehicles for clinical trials. The relationship between ASC and Alzheimer drug companies is very detrimental to those who suffer from the disease and their caregivers. Measures to limit the influence of drug companies in patient groups are sorely needed.

ASC has extolled the benefits of early diagnosis, but has focused on the promotion of ineffective and harmful dementia drugs. This focus misleads persons with dementia and their caregivers and prevents them from dealing with issues that are truly important. The way ASC has messed with the message is deplorable.

About the Contributor

Linda Furlini has counseled many caregivers, and for 10 years was a volunteer for the ASC at the local, provincial (President) and national level. Her doctoral thesis focused on caregivers’ need for educational support. Results highlighted the need for an early diagnosis allowing caregivers to better protect the rights of persons with dementia and ensure they receive appropriate care.  She advocates that publicly-funded educational support, free from commercial interest, be available for persons with dementia and their caregivers. Both her parents were affected by Alzheimer’s disease and they, as well as their family, would have benefited from an early diagnosis, educational support and appropriate resources.

References

Wolfe, S., Sasich, L., Lurie, P., Hope, R., Barbehenn, E., Knapp, D., Ardati, A., Shubin, S., Ku, D. & Public Citizen Research Group. (2005). Pocket Books, NY

The problems start even before drugs are marketed. Although Health Canada has developed criteria to decide which clinical trials it should monitor it doesn’t collect the data to know what trials fit those criteria. It should be monitoring about 80 trials per year but barely does half that number because it doesn’t have the resources.

When Health Canada declines to approve a new drug it doesn’t bother to let Canadian patients and their doctors know about that decision. If the drug is similar to products already on the market then how safe are the ones already being used? Many drugs are used for unapproved indications. If the application was to get formal approval for use for that indication and the evidence showed that the drug was ineffective or unsafe then doctors may continue to prescribe and patients take the drug without knowing that crucial information.

In the face of these and other criticisms from the Auditor General, Health Canada has agreed with all of the findings in the report and promised to make the appropriate changes. If only it were so. None of these problems are new and Health Canada has been told about them many times before including by its own Science Advisory Board back in 2000 and by the House of Commons Standing Committee on Health in 2004. Each time Health Canada promises to reform its house and each time nothing substantial happens.

What’s going on here? It’s not as if Health Canada doesn’t have models for reform. While other regulatory agencies have serious problems some have taken steps that Health Canada seems to be deliberately avoiding. The European Medicines Agency has given out information about drugs that it refuses to approve since 2005. The United States Food and Drug Administration releases redacted versions of the reports that its reviewers generate about drug applications. Health Canada regards this information as commercially confidential and will only give it out if the relevant company agrees.

The Auditor General found that Health Canada systematically does not meet its own benchmarks for completing safety assessments. For example, five medium priority assessments took more than two years to complete and one took more than three years. On other safety issues Health Canada has explicitly declined to develop timelines lamely claiming that “development of quantitative service standards for post-market surveillance activities or compliance and enforcement activities is difficult given the unpredictability and volatility of the activities involved.” There is no such reticence about having timelines for how long drugs should be in the review process – 300 working days for drugs with a standard approval and 180 days for those with a priority approval.

Up until now these time frames have been aspirational but with the passage of the User Fees Act failure to meet these deadlines will have serious financial implications for Health Canada if service standards (completion of reviews of new drug applications within the targeted time) are not met. If the actual performance in a given fiscal year is more than 110% of the target for a particular fee category (different types of approval applications are subject to different fees), penalties apply for the amount in excess. Fees are then to be reduced for the next reporting year by a percentage equivalent to the performance not achieved, up to a maximum of 50%; so if approvals are 20% overtime fees will drop by 20%. Faced with the prospect of penalties it is possible that Health Canada might follow the pattern set by the FDA and rush to approve new drugs that are approaching the deadline in order to avoid incurring a financial loss in the next year. The American experience is that if the deadline is imminent the FDA does a less thorough job of reviewing drugs in order to avoid crossing the deadline and potentially jeopardizing its revenue from drug companies.

It might be reasonable to speed drugs to market, despite concerns about safety, if these drugs represented major therapeutic advances. But even a generous reading of the evidence about new drugs comes to the conclusion that only about 1 in 10 offer any significant benefit compared to older medications. The benefit of most new drugs is mainly to the coffers of the companies that make them.

Rushing new drugs to market already seems dangerous. Once the drugs that Health Canada approves through its priority review process are available, over the course of about 17 years almost half of them will be the subject of a new safety warning or have to be withdrawn entirely because of safety issues.

The mentality within Health Canada seems to be driven by the federal government’s (both the previous Liberal and current Conservative) philosophy of Smart Regulation best summed up in one of its documents as regulating “in a way that enhances the climate for investment and trust in the markets” and “accelerate reforms in key areas to promote health and sustainability, to contribute to innovation and economic growth, and to reduce the administrative burden on business.” Business 1, drug safety and consumers 0.

About the Contributor

Joel Lexchin saves lives in an emergency department in Toronto and tries to teach health policy at York University.

PharmaWatch and the PharmaWatch blog do not accept any money from pharmaceutical corporations, medical device manufacturers or their sponsored organizations. We have no relationship to industry sponsored organizations with similar names.

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