In the last post [doing the right thing…], I was praising Canadian Bill C-17 to amend their Food and Drug Act to give the government needed powers to deal with Clinical Trial reporting and drug approval, but I was worried that I couldn’t find the details [that place where the devil lives]. I was helpfully pointed to some articles in the Toronto Star [Mar 10, 2014 Canadian Medical Association Journal says proposed drug recall bill has too many loopholes, May 30, 2014 Federal drug reform law approved for further review]. They, in turn, lead to an article in the Canadian Medical Association Journal published online in March and in print in May called Regulating prescription drugs for patient safety: Does Bill C-17 go far enough? [It is neither abstracted nor available on-line past page 1, so we’re going to have to go with my pulling out key quotes].
They began with the problems of the past [readable on page 1]. Then they have a section about what they think is right with the bill:
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Power to recall drugs: "Bill C-17 empowers the Health Minister to issue a recall, without first entertaining representations from the manufacturer, provided he or she ‘believes that a therapeutic product presents a serious or imminent risk of injury to health.’"
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Power to overcome information asymmetries: Bill C-17 enables Ihe Health Minister to compel manufacturers to provide information about drugs. eg information "about a serious adverse drug reaction that involves a therapeutic product or a medical device incident." "These information-sharing requirements are a major improvement on the status quo."
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Power to enforce conditions on market authorizations and compel changes to product labels: "In 2007, Ihe US Food and Drug Administration (FDA) was granted powers to enforce conditions and to compel changes to a product’s label in light of safety concerns that emerge after market approval. It is imperative that Health Canada be vested with these powers."
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Serious enforcement measures: "Finally, Bill C-17 creates much stronger penal- ties for failure to comply with some of the provi- sions of the Food and Drugs Act and accompa- nying regulations.These include lines of up to $5 million per day during which the offence is committed, and/or imprisonment for the most egregious oflences. "
Then they moved on to elements that should be added to the proposed legislation:
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Enhance the power of recall and alter the ability to suspend:
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Exempt the Health Minister from liability for drug suspensions and recalls:
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Ensure transparency in clinical trials: "… requiring registration by law, and creating a robust mechanism to enforce that requirement, is an important step toward improving the transparency of the evidence base behind drugs and other therapies, and avoiding potential harm to patients." In addition, making sure that clinical trial data, whether collected before market approval or in postmarket studies, are available for scrutiny by independent researchers is critical to ensuring that treatment and use decisions are evidence-based."
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Enhance transparency in Health Canada’s decision-making: "Bill C-17 should empower Health Canada to publish both positive and negative regulatory decisions. At minimum. Health Canada should publish the rationales lor decisions concerning all drugs approved for sale, drugs refused for reasons of safety or efficacy, and drugs that are suspended or recalled."
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Outline clear limits to the scope of proprietary information: "Meaningful transparency is hard to achieve in practice, in part because manufacturers often claim that the government is obliged to protect information about the safety and efficacy of a drug as "proprietary," either as a "trade secret" or as "confidential business information."" These assertions overstate what the law actually requires and prevent important information about safety and effectiveness from being released." International treaties simply require Canada to protect trade secrets and confidential business information without specifying the scope of those types of information. No Canadian court decision indicates that information about the safety or efficacy of a drug is proprietary, and current case law casts doubt on any such assertion. In principle. Health Canada can at present disclose greater amounts of safety and efficacy information. However, to clarify and to overcome manufacturers’ efforts to resist disclosure, Bill C-17 should explicitly state that the results of clinical trials, including de-identilied patient-level data, poslmarket studies, and adverse drug reactions reported by drug manufacturers and health care institutions, are not proprietary and therefore should be publicly disclosed."
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Do not allow trade to trump patient safety: "Bill C-17 gives the Governor in Council scope to impose stringent rules favouring data protection to the detriment of other powers in the Food and Drugs Act This proposal is fundamentally problematic and must not be enacted."
Conclusion: "Bill C-17 is an important step toward the safe regulation of drugs because it enhances the ability of Health Canada to act in the face of threats to public health. It also introduces meaningful enforcement mechanisms, including substantial penalties, for noncompliance. However, it requires amend- ment to incorporate several additional key compo- nents of prescription drug safety. Bill C-17 has the potential to make an important and positive difference to public safety in Canada We urge that Bill C-17 be revised and enhanced before it becomes law so that this potential can he realized."
This is the most comprehensive proposal that I’ve seen to date – one that directly addresses the Trade Agreements and PHARMA’s claims about proprietary ownership of Clinical Trial Data. And what’s totally amazing, it’s in a medical journal! a big medical journal! instead of just lolling on some blog at the rim of the galaxy. And from the blurb I’ve quoted already [House of Commons adopts government strengthened patient safety legislation], these suggestions look to have become the amendments that have passed the House of Commons and are headed to the Canadian Senate:
The amendments to Bill C-17 were introduced by Member of Parliament, Terrence Young and adopted by the House of Commons Standing Committee on Health on June 12. The Bill has now passed Third Reading in the House of Commons and moves to the Senate for consideration. The amendments include the requirement that both positive and negative decisions about drug authorizations be disclosed on a public website; and that clinical trial information be disclosed on a public registry. The amendments also better define the scope of confidential business information [CBI] and allow the Minister to disclose CBI about a product if the Minister believes the product may pose a serious risk to Canadians.
Like I said, Canada seems "poised to be quietly just doing the right thing." May the force be with them…
Any amount of this would be a step in the right direction!
I like the part about taking action “…without first entertaining representations from the manufacturer” — why waste time listening to those lying liars lying yet again?
We must remember that with a single payer system the Canadian’s are in a much better position to enforce such changes. They can request drug information with the full knowledge that this represents sales to the nation, not just a specialty.
A HPV vaccination or hep C testing mandate impacts the entire country, while here in the US doctors may have more flexibility in the way they practice medicine. We often find doctors continuing to prescribe questionable medications long after serious questions have been raised concerning effectiveness or safety.
The Canadians have the right idea, how do we transfer this concept of national practice standards while still allowing doctors the flexibility they need. We have seen the resistance to Choosing Wisely, and that is still a work in progress.
Steve Lucas
What is the resistance to Choosing Wisely? Have there been reports on this?
Thank you, again, for providing valuable information that can be put to good use in another single-payer health care system. Norway is a good market, expensive medications are on “blue” prescription, meaning free of charge, so the industrial interests are well taken care of in the false, but prevalent belief, that that they mostly do more good than harm. Canada is setting an example to follow, from the tragedy of a young girl and her family. There is much to learn from Terence Young. He has used his position wisely. Other parents can too, albeit few of us are parlamentarians, thanks to the always ongoing struggle for democracy and human rights. Truthful information about safety issues and adverse effects of medications is a human right.
Choosing Wisely is facing opposition on a number of fronts, as shown by this link:
http://blog.abimfoundation.org/malpractice-and-choosing-wisely-lessons-from-my-hometown/
The old monster under the bed of liability and malpractice is being used as an excuse to stifle this concept. My understanding is that very few doctors are sued, fewer still go to court, and the majority of those suing are sadly Medicaid patients. This has not stopped the CYA nature of many medical practices ordering any and all test available. We also have to consider the financial incentives for hospitals to order excessive test due to having a captive patient and equipment that must be maximized to produce a profit.
With limited uses this has not stopped the explosion of gamma knife surgical suites or the use of robotic surgery where not indicated, but at increased cost.
On a personal note I had a doctor tell me after asking if he used any electronic or web based information in his practice: “You get what you pay for and I rely on drug reps and journal articles.” Things went down hill after that, due in part to the staff telling a drug rep a lunch she had brought for the doctor was used to help a diabetic patient in distress and her only comment was; “Did the doctor get a lunch?”
The specialty societies with smaller numbers and less financial stress have embraced this model to a great extent than the general practitioner who has turned the practice of medicine into a check the box, order as many test as possible, and hope these fishing expeditions pay off in some condition that will generate a 90 day or less office visit.
We as patients have along way to go in trusting our doctors to act in our best interest or at least discuss medical options. Doctors who see 100 patients in a ten hour day, or have their elderly patients on two week schedules are not talking medical options. One doctor told me bluntly that they make my medical decisions and when I had a MD I could ask a question.
Steve Lucas