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Preventing the Next Bad Pill

How I'm kicking Paxil. And how Pharmawatch is arming medication users to expose bad effects.

Jessica Werb 20 Oct 2004TheTyee.ca
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SECOND OF TWO PARTS


[Read Part One: My Paxil Nightmare]

I was a student looking for a quick lift from bouts with anxiety and depression when, nearly ten years ago, a doctor started me on Paxil. Nothing unusual about that. The anti-depressant has been prescribed with little fanfare to hundreds of thousands worldwide since its release in 1993.

But a lot of us Paxil users find ourselves today with something we never bargained for: an addiction. I certainly never expected to be on the drug this long, but when I've tried to quit - and I'm trying once again - I've felt intense vertigo, fatigue, nausea, headaches, extreme anxiety, drastic mood swings and slower mental reflexes.

A series of recent studies, lawsuits and government directives shows I'm far from alone. But how could so many suffer such symptoms and Paxil's side-effects remain so long under the health establishment's radar? After all, Health Canada does have an adverse drug reaction [ADR] reporting system, CADRIS [Canadian Adverse Drug Reaction Information System] mainly geared towards physicians and pharmacists, although consumers themselves can fill in ADR forms.

My story tells something about the limits of that system, and the promise of a new approach called Pharmawatch, a recently-launched Vancouver  pharmaceutical watchdog agency and lobby group geared to giving medication users more power to share information and sound alarms.

'People fall through the gap'

When I first tried to reduce my dose of Paxil, only to be set upon by intense anxiety, a feeling of total 'spaciness' and unexplainable feelings of aggression and despair, I thought it was my illness - not the drug.

As for the dizziness and nausea that I did attribute to withdrawal, I'm quite sure my doctor didn't report it.

And I definitely had no idea that there was any such thing as an ADR reporting system. The first I heard of it was when an acquaintance casually mentioned that she was getting involved with PharmaWatch. Her name was Kathy Ferguson, and she had lost a diabetic son due to an adverse drug reaction to a new form of insulin.

Colleen Fuller, PharmaWatch founder and consumer advocate, went through a life-threatening adverse drug reaction herself when, like Kathy's son, she was forced to switch to synthetic form of insulin. "One of the weakest parts of the drug policy spectrum is post-market surveillance," she says. "Drug companies push very hard for quicker drug approval, and they really don't like to have any public oversight of what's happening. …We wanted to set up a consumer advocacy organization that would push for much better post-market surveillance and monitoring of people's experiences with drugs."

She notes that there is a gap between the number of adverse drug effects, and those that are reported.

"People fall through the gap between the number of experiences that occur with any given drug, and the number of reports that actually make it to the regulator," she adds. "People don't know what the track record is of any given drug. So, if you're trying, for yourself, to make a decision about a prescription that has been given to you by your doctor, part of the information that's important to you is the adverse drug effects that have been experience by other people."

Skewed reporting patterns

Some estimates put the number of reported adverse drug effects at just ten percent of the true number. The reason for such a disparity is a lack of impetus in doctors and pharmacists to report, according to Dr. Warren Bell, family physician in Salmon Arm and another member of the board of PharmaWatch.

"Adverse drug reaction reporting is pathetic," says Dr. Bell. "The [pharmaceutical] industry itself doesn't want bad news, and it doesn't occur to people to generate it. … If you look at each involved sector, you can see a psychological battle to engage anyone in reporting. As physicians, we have a barrier because you have to acknowledge that your intervention was a disaster. To say: 'Oh my God, I've poisoned you,' is psychologically difficult. And the corporation, in a generic sense, is designed to improve profitability, so [from the point of view of business and pharmaceutical corporations] the less said the better, as far as adverse drug reactions."

He adds that while governments may be considered to be an unbiased source of information, a study done at the behest of the Canadian Institutes of Health Research (CIHR) and published September 28, 2004, in the Canadian Medical Association Journal has proven otherwise. The study, led by Dr. An-Wen Chan, a hospital resident at Toronto's University Health Network, found skewed results in patient trials funded by independent government agencies - not just those sponsored by commercial interests.

Chan looked at 48 patient studies funded by CIHR and found that in one-third of published papers on an intervention's effectiveness, and more than 60 percent of those looking at safety, complete results were not reported. She also noted that researchers were more likely to report positive results than negative results. In 40 percent of the trials, the major outcome reported did not reflect what researchers said would be their primary objective.

"It's been known that industry-sponsored research is predominantly favourable to the products researched," says Dr. Bell, "and it's been trusted that governments don't do that. But this review showed that that's not how it works at all, because researchers are intensely lobbied on a constant basis by industry. The result is that either consciously or unconsciously, they're promoting the industry perspective on research that they do."

Pharmacare saw need for alternative

As for the efficacy of CADRIS, Fuller claims that it hasn't been accessible to people. The CBC has now made the database public on its website through the federal Access to Information Act, but, as Fuller points out, it is still not accessible through Health Canada. So, part of Fuller's mission is to collect ADR reports through PharmaWatch to create an alternative database, but encourage consumers to also report to Health Canada.

"We encourage people to report an ADR that they may have experienced to Health Canada," she explains. "But we're an advocacy organization, and if we get a number of reports about a specific drug, and it causes some concern on our part and we feel that the regulator should step in and investigate the situation and intervene in a more proactive way, the information that consumers give us will put us in a good position to do that."

Health Canada, for its part, states that it is busy expanding its ADR monitoring and, in a statement, says: "Health Canada recognizes that the issue of increasing post-market surveillance of health products is a priority and has launched a number of initiatives designed to strengthen Canada's post market surveillance system." These initiatives include two new Adverse Reaction Centres to be added in 2005 to the country's five existing ones and a new online portal to provide a "single, convenient and accessible mechanism for reporting and receiving information about the safety of marketed health products."

Time will tell if these initiatives make much difference to the awareness of adverse drug reactions and their reporting. And with so much fog around how pharmaceuticals are tested and brought to market, it might not be so surprising that it's taken so long for any of Paxil's less beneficial results to be brought to light.

Tapering off the doses

If doctors aren't given the whole truth about a drug's effects, and pharmaceutical companies can pick and choose which studies to make public, how can a patient be sure whether what he or she is really experiencing isn't something completely unrelated to the drug?

I can't help but wonder what would have happened if there had been a group like PharmaWatch around nine years ago - would I have called them and asked about any adverse drug reactions regarding Paxil? Would their presence have allowed my doctor more access and knowledge of Paxil's addictive qualities? Would I have spent the last nine years convinced that I was married to the drug?

I can't change my past decisions, or those of my doctors, but armed with the accumulated knowledge about Paxil that I've had to seek out on my own, I am fighting it head-on. GSK claims that a tapering down to 20mgs a day and then nothing is the way to stop the drug. Well, my dose has only ever been 20 mgs. So, judging from my sensitivity to stopping it, I have taken an almost ridiculously slow approach to ending my dependence. With the help of a pill slicer, I have shaved off one eighth of a pill every two to three weeks.

Today, I'm on half the dose I was before - and the withdrawal effects, to date, have been manageable. The greatest help in dealing with them, though, has been the ability to recognize that what I thought was my so-called 'chemical imbalance' is simply a temporary withdrawal reaction. Something that, had there been more transparency in the drug policy sector, I would have known as a 22-year-old.

Jessica Werb is a Vancouver writer whose work appears regularly in The Georgia Straight, The Vancouver Courier and Shared Vision magazine. She has also written for The Knowledge Network's online resources as well as UK newspapers and magazines.  [Tyee]

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