Are lawsuits the way to ensure drug safety?

Are lawsuits the way to ensure drug safety?




Class actions are no substitute for post-market surveillance

http://www.network54.com/Forum/281849/message/1285238542/%26quot%3BAre+lawsuits+the+way+to+ensure+drug+safety-%26quot%3B


Andre Picard



From Thursday's Globe and Mail Published on Wednesday, Sep. 22, 2010 8:13PM EDT Last updated on Wednesday, Sep. 22, 2010 8:15PM EDT



We do a pretty poor job of ensuring drug safety in Canada. Sure, drugs go through a long and thorough approval process, but once on the market, there is little follow-up. Post-market surveillance is virtually non-existent, apart from a voluntary database of adverse drug reactions.



As a result, drug-safety issues are increasingly being resolved through the courts, with class-action lawsuits in particular.



When something goes wrong – unanticipated or undisclosed side effects (because drug companies have a bad habit of suppressing negative research) – consumers who are harmed band together to seek redress.



In theory, it's effective: Those who are wronged get compensation and companies get a financial spanking that should make them more cautious in the future.



But does this approach work in practice?



Are those who take harmful drugs adequately compensated? And does litigation actually make for safer drugs?

To help answer those questions, let's look at a recent case.



In June of this year, the courts approved a negotiated settlement in the class-action lawsuit related to Zyprexa, an antipsychotic drug used for the treatment of schizophrenia, bipolar disorder and other forms of psychosis.



The class-action lawsuits – filed in Ontario, Quebec and B.C. – alleged that the manufacturer, Eli Lilly Canada Inc., and its parent, Eli Lilly and Co., negligently manufactured, marketed and sold Zyprexa without properly warning of the risks prior to June 6, 2007.



In particular, the drug is alleged to increase significantly the risk of diabetes and related health problems.



Those allegations have not been proved in court and the settlement does not imply liability or wrongdoing.



Nevertheless, Eli Lilly agreed to pay about $26-million to settle the claims in Canada.



As much as $17.5-million will go to the claimants. Individuals will receive, on average, about $12,000 each. In exchange, they cannot make further legal claims against the manufacturer, even if their condition worsens. Provincial health plans will get a payout of $2.25-million to cover additional treatment costs.



The lawyers who initiated the suits will, for their part, share $5-million (including $500,000 for expenses), and an additional $1-million was allocated for administration of claims, including notification.



All in all, it was a modest settlement, a fairly routine resolution of a drug-related class action.



The amount of the settlement is based on an actuarial calculation that about 1,450 users of the drugs may have suffered harm and could come forward.



To date, a little more than half that number has made a claim. The deadline for doing so is Oct. 28. (Details are on the settlement website www.zyprexasettlement.ca) This raises an important question: How much effort is invested in finding people who are harmed? In this case, small ads were placed among the legal notices in 24 daily newspapers and in SZ Magazine (a magazine that specializes in coverage of schizophrenia.) Consumer groups such as the Schizophrenia Society, the Mood Disorders Society and the Canadian Mental Health Association were also informed in writing.



No TV ads, no Internet ads and, above all, no provision for actually contacting individuals who were prescribed Zyprexa through their drug plans. You could argue that this would be a violation of privacy: But is warning someone of potentially serious side effects and offering them thousands of dollars in compensation for harm suffered a violation or an affirmation of their rights?



Claimants who are aware of the settlement also have to jump through a few hoops, and quickly. They must provide "product ingestion documentation" that includes pharmacy records, medical records showing they took Zyprexa for at least 90 days, and medical records proving they suffered diabetes-related symptoms while taking the drug.



If you are already suffering from schizophrenia, bipolar disorder and maybe diabetes to boot, you've already got a lot on your plate. Is it fair to place so much of the burden on those who, already sick, suffered additional harm?



Then there is the larger question: Are Canadians safer as a result of this class-action settlement?



Zyprexa (generic name olanzapine) is still sold. That is not necessarily inappropriate. Treating psychosis is important, and every drug has side effects.



Since 2007, the labelling on the product has been improved so that the diabetes-related side effects are clear. But is that enough? Should a settlement of this nature not include a provision for education – after all, who reads the fine print on labels, especially in a state of psychosis?



Sales of Zyprexa were $4.9-billion (U.S.) last year, including about $225-million in Canada.



A $26-million payout (and it will be less, based on fewer claimants) is chump change for Eli Lilly.



For that matter, so too is the $1.4-billion the company has paid out to date to settle criminal and civil claims related to Zyprexa in the U.S. There, the issue was principally illegal marketing – promoting the drug for use in seniors with dementia when it is not approved for that use.



If there is a dissuasive effect, it is not at all obvious. Even if class-action lawsuits bring some redress, they cannot substitute for good post-market surveillance.



The one thing that is certain is that class actions are extremely lucrative for lawyers and claims administrators. They make out like bandits. Consumers who suffered harm, not so much.



So, is justice truly being served?