Joel Lexchin

Health Canada committees risk financial conflicts of interest: ��ֱ�� expert

Christopher.Sorensen — Wed, 22 May 2019 19:43:57 +0000

Health Canada committees risk financial conflicts of interest: ��ֱ�� expert

Christopher.Sorensen Wed, 05/22/2019 - 15:43

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Research shows that six of 11 Health Canada scientific advisory committees had a majority of members with a direct or indirect financial interest (photo by Shutterstock)

Joel Lexchin

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Our Community

Faculty of Medicine

The Conversation

University Health Network

Health Canada supplements its in-house expertise on prescription drug therapy and policy through the use of scientific advisory committees and panels.

These committees and panels provide Health Canada with recommendations – such as adding a statement about disabling and potentially irreversible adverse reactions to information about fluoroquinolones (a widely used class of antibiotics) or putting a warning sticker on prescriptions for opioids – to highlight the risk of physical dependence, addiction and overdose.

Typically, people who sit on these committees and panels are experts in their field, although there are also representatives from drug companies and consumers. Those who are interested fill out an online application form listing their qualifications and expertise, and Health Canada chooses members from this list. Potential members then need to complete a second form disclosing any direct and indirect financial interests.

A direct financial interest includes current employment, investments in companies, partnerships, equity, royalties and a variety of other monetary relationships with a drug company. Indirect interests are things like consulting for a company, receiving personal educational grants, gifts or research funding.

I have just published a study in CMAJ Open in which I look at the extent of these financial interests in the 81 different individuals who sit on the 11 active committees and panels. Only a small minority have a direct financial interest, but 56 have an indirect interest and those with indirect interests were present on all 11 committees and panels.

In fact, six of the 11 committees had a majority of members with a direct or indirect financial interest. One chair had a direct financial interest and eight others had an indirect financial interest.

Troubling lack of information

The key question is whether those financial interests bias the advice that the committees and panels offer to Health Canada.

Even the receipt of a small amount of money, or a meal, can affect an individual’s behaviour, according to research (photo by Shutterstock)

Unfortunately, my research cannot answer that question because Health Canada doesn’t release enough information. We don’t know the names of the companies that committee and panel members have a relationship with, how much money they receive from the companies or when they received it. Crucially, we don’t know how individuals voted on matters they were asked to consider.

This lack of information is troubling. Even the receipt of small amounts of money or the equivalent can affect behaviour. Meals valued at less than US$20 are associated with higher prescribing rates for drugs made by the companies providing the meals.

Research on voting patterns of people serving on U.S. Food and Drug Administration advisory committees shows that members who have financial ties solely to the firm sponsoring a drug are more likely to vote in ways favourable to the sponsor. Similarly, the research shows that those who serve on advisory boards for sponsoring firms show “particularly strong pro‐sponsor bias.”

Importantly, conflict of interest declarations and waivers are publicly available on the FDA website. Financial conflict of interest is reported in dollar ranges (for example, $0-5,000, $5001-$10,000) and the way that individuals vote is recorded and made public.

Canadians need unbiased advice

Conflicts of interest among people who produce guidelines for doctors are considered such a serious problem that the U.S. Institute of Medicine recommends that the chair of any panel should be free of all conflicts, as should the majority of members on the panel.

Neither of these conditions are met by Health Canada’s current policies.

Health Canada should follow the Institute of Medicine recommendations when constituting its committees and panels. It should also publicly release all of the information about direct and indirect financial interests that it collects.

Finally, Health Canada should record the votes of individual committee and panel members and provide a transcript of meetings – so that everyone can see whether voting patterns are linked to different types of financial interests with particular companies.

The advice that these committees and panels gives to Health Canada can be key to ensuring that Canadians get the best possible value out of prescription drugs. It not only needs to be unbiased, it needs to be seen to be unbiased.

Joel Lexchin is an associate professor in the department of family and community medicine at the University of Toronto, a professor emeritus of health policy and management at York University and an emergency physician at University Health Network.

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Why Big Pharma must disclose payments to patient groups: ��ֱ�� expert

Christopher.Sorensen — Tue, 15 Jan 2019 17:58:15 +0000

Why Big Pharma must disclose payments to patient groups: ��ֱ�� expert

Christopher.Sorensen Tue, 01/15/2019 - 12:58

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(photo by Ajay Suresh via Flickr)

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University Health Network

A United States congressional report revealed last year that five opioid manufacturers made more than $10 million in payments to patient advocacy groups and professional societies between 2012 and 2017.

Initiatives from these advocacy groups and professional societies often echoed and amplified recommendations to increase opioid use. For example, they promoted opioid for chronic pain, minimized the risk of addiction and criticized the Centers for Disease Control and Prevention (CDC) guidelines to limit opioid prescriptions.

In addition, opioid manufacturers used these groups to lobby Congress to change laws directed at curbing opioid use. This, according to the report, “may have played a significant role in creating the necessary conditions for the U.S. opioid epidemic.”

Patient advocacy groups play an important role in democratic societies, giving voice to vulnerable populations, shaping health policy debates and acting to influence public policies to promote their members’ interests and needs.

When funded by the industry, however, they often serve merely as a marketing tool – promoting corporate interest.

To date, in Canada, there has been no attempt to systematically investigate the relationships between opioid manufacturers and pain advocacy groups and societies. However, evidence shows that, similar to the U.S., opioid manufacturers fund such organizations in Canada.

Advocacy groups echo corporate interest

In Health Advocacy Group Inc: How Pharmaceutical Funding Changed the Breast Cancer Movement, bioethicist Sharon Batt explores the alliance between patient-group advocacy and pharmaceutical companies in Canada. She suggests that this relationship can distort policies that have been put in place to protect public health.

Batt questions the ability of such groups to speak on behalf of people who need help, and shows how advocacy groups today echo the demands of pharmaceutical companies that are often counter to its members' interests.

Christine Gagnon of Southington, Conn. protests with other family and friends who have lost loved ones to OxyContin and other opioid overdoses at Purdue Pharma LLP headquarters in Stamford, Conn., Aug. 17, 2018 (photo by Jessica Hill/Associated Press)

For example, in 2005 the Canadian Pain Society arranged a pain management event, supported by an unrestricted educational grant from Purdue Pharma Canada, the manufacturer of OxyContin. A conference held by the same society in 2007 included a Purdue Pharma symposium.

In another case, the Chronic Pain Association of Canada received money from several pharmaceutical companies, including Purdue Canada.

A blog post on the association’s website contains messages favourable to increased opioid use and criticizes arguments questioning opioid effectiveness, calling it “anti-opioid hysteria and propaganda” caused by prominent “anti-opioid activists.”

Two years ago, Purdue donated just shy of $1 million to Canadian health-care organizations, some of which could have been patient groups. (The way the information is reported doesn’t allow us to identify which health-care organizations received money.)

All payments should be disclosed

We believe this marketing tactic is undesirable and might have contributed to the opioid epidemic in Canada as it did in the U.S.

Furthermore, using the vulnerability and the suffering of patients as a tool for maximizing profit is morally wrong.

Lack of transparency surrounding the advocacy groups is a real problem. Neither the industry nor advocacy organizations are required to fully and routinely disclose their financial ties.

Indeed, some patient organizations question why they should disclose sources of donations in the first place. Two such groups commented: “We do not see the purpose of asking how much money has been contributed by any entity that may have an interest” in a recommendation about whether a drug should be funded by a provincial drug plan.

We call for the Canadian government to examine and disclose all payments from pharmaceutical companies to non-profit patients’ advocacy groups and societies.

Note: This is an updated version of a story originally published Jan. 13. The earlier story included a reference to payments to the Chronic Pain Association of Canada by Eli Lilly Canada and Merck Frosst Canada. Both provided funding to the association, but neither company manufactures or sells opioids now, nor did they at the time they made these grants.

Joel Lexchin is an emergency physician at University Health Network, an associate professor of family and community medicine at the University of Toronto and a professor emeritus of health policy and management at York University. Itai Bavli is a PhD candidate in interdisciplinary graduate studies (public health and political science) at the University of British Columbia.

This article is republished from The Conversation under a Creative Commons license. Read the original article.

��ֱ�� expert on why we need answers to the thalidomide tragedy to ensure drug safety now

noreen.rasbach — Thu, 25 Oct 2018 19:23:00 +0000

��ֱ�� expert on why we need answers to the thalidomide tragedy to ensure drug safety now

noreen.rasbach Thu, 10/25/2018 - 15:23

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Members of the Thalidomide Survivors Task Group hold a news conference in Ottawa in December 2017. Clockwise from left are Fiona Sampson, Mary Ryder, Alexandra Niblock and Lee Ann Dalling (photo by Fred Chartrand/The Canadian Press)

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In 2015, after decades of fruitless lobbying, Canadian survivors of thalidomide finally received compensation from the federal government.

The drug was a supposedly mild sleeping pill, a “wonder drug” that helped pregnant women with the symptoms of morning sickness. It caused an estimated 24,000 babies to be born with severely deformed limbs and other major medical problems globally.

Now, a new book, The Thalidomide Catastrophe, by three European campaigners for people affected by thalidomide, raises new questions about the conduct of governments and the companies involved.

It only mentions Canada in passing, but the questions it poses are equally relevant here.

What was the basis for approving thalidomide (sold in Canada under the name Kevadon by the William S. Merrell Co.)? When did the government first learn about the side-effects from thalidomide? How quickly did it act after learning about these side-effects?

Canada slow to act

According to a history of events put together by the company, Merrell submitted data on animal and clinical studies to the Department of National Health and Welfare (the predecessor of Health Canada) on Sept. 8, 1960, and received approval to market thalidomide on Nov. 22, 1960.

This means government officials worked their way through a 500-page document in under 11 weeks. This raises questions about how comprehensive that document was. What information did it contain?

April 1, 1961, saw the actual appearance of thalidomide on drugstore shelves. Merrell claims it didn’t know about birth defects until Nov. 29, 1961. According to a Globe and Mail story from Aug. 2, 1962, health officials were informed about this problem two days later.

However, Chemie Grünenthal, the company that discovered thalidomide and marketed it in Germany, should have had grounds for strongly suspecting problems with the drug long before that.

The Thalidomide Catastrophe documents how the American company Smith, Kline and French tested the drug in 1958 with a view to licensing it from Grünenthal but declined, partly because in its testing there were deformed babies born to two women.

In 1959, a doctor working at Grünenthal was told about additional babies with birth defects. Was this information not given to Merrell when it licensed thalidomide for sales in Canada?

As the news about babies with severe birth defects due to thalidomide became increasingly difficult to ignore, it was pulled off the German market in late November 1961 and at about the same time in the United Kingdom. However, it remained available in Canada for another three months until the federal government asked Merrell to withdraw it.

Health Minister J. Waldo Monteith, in a Globe and Mail story of July 27, 1962, denied that the government had delayed taking action and claimed that the additional three months was because reports of safety problems were “sketchy.” Is it likely that two European governments would have acted on sketchy information?

Moreover, in December 1961, an Australian doctor named W.G. McBride published a letter in the major British medical journal, The Lancet, about birth defects among women who had used thalidomide in pregnancy. How long would it have taken Canadian health officials to contact Dr. McBride?

Drug safety blamed on patients

One reason for the slowness of Canadian officials might be due to the person in charge of the Food and Drugs Directorate, Dr. C.A. Morrell.

Henning Sjöström and Robert Nilsson reported in their book, Thalidomide and the Power of the Drug Companies, that after thalidomide was removed from the Canadian market a number of doctors wrote to the government protesting the move.

In reply to one such letter, Morrell responded: “I think if the medical profession would take a stand… that there is every possibility that thalidomide could indeed be reinstated on the Canadian market and to this end I would encourage you to urge strongly your colleagues to express themselves to us on this question.”

Subsequently, in 1964, in testimony before a House of Commons Committee, Morrell seemed to place the safety problems on the users of the drug: “I think the hazard is the inability to control the user of thalidomide after it is on the market. I am referring now to the medicine cabinet at home; you do not know who will take a pill today. Everyone wants to take pills.”

After Morrell left the government in 1965, he joined the board of Ciba-Geigy (now part of Novartis), a major multinational Swiss drug company.

More than 400 babies affected

Did the officials at the Department of National Health and Welfare make mistakes in approving thalidomide? Did Merrell tell them everything it knew? Why did Canada wait three months longer than Germany and the U.K. to decide that thalidomide was too unsafe to be sold?

Some may wonder why we need answers to questions almost 60 years later. But if there were mistakes and withholding of information, we can learn from this – to prevent similar tragedies happening in the future.

In Canada, there were more than 100 babies born with problems attributed to thalidomide, but the authors of The Thalidomide Catastrophe estimate that there could have been over 400 babies, many dying early in life.

These people and their families deserve answers. It’s the duty of the Canadian government to find out the answers.

Joel Lexchin is an associate professor of family and community medicine at the University of Toronto, professor emeritus of health policy and management at York University, and an emergency physician at the University Health Network.

This article is republished from The Conversation under a Creative Commons license. Read the original article, including his disclosure statement.

NAFTA negotiations may threaten pharmacare: ��ֱ�� expert

noreen.rasbach — Mon, 10 Sep 2018 18:26:32 +0000

NAFTA negotiations may threaten pharmacare: ��ֱ�� expert

noreen.rasbach Mon, 09/10/2018 - 14:26

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The ongoing NAFTA renegotiations could put a Canadian national pharmacare program in jeopardy, and could have a particular impact on Canadians who need expensive arthritis drugs, says ��ֱ��'s Joel Lexchin (photo by Shutterstock)

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Around 91 per cent of Canadians want a national pharmacare plan, according to a recent national poll, so they don’t have to choose between buying groceries or paying for drugs to keep them healthy.

The same public opinion survey has also found that prescription drug access and affordability are issues for almost 25 per cent of Canadian households.

But depending on what happens with the ongoing North American Free Trade Agreement (NAFTA) renegotiations, the cost of such a pharmacare plan could go up, possibly dramatically.

This has to do with something called intellectual property rights (IPRs). Usually when talk turns to IPRs people think about patents. But there’s also something called data protection.

The data that’s being protected is information about the effectiveness and safety of drugs that comes out of the clinical trials that brand name drug companies do when they want approval to market a new drug.

Generic drugs essential to pharmacare

The data is the private property of the brand name companies and can’t be used by anyone else, including generic companies, for a period of time.

It would be very costly for generic companies to do the original testing all over again, and it would also be unethical because the results of the trials are already known. So generic companies use the data once it’s no longer protected.

Data protection is not a sexy topic, but it’s important in determining how quickly some low-cost generics can reach the market. The presence of generics keeps public drug plans affordable and will be essential for any pharmacare plan.

Right now, seven out of every 10 prescriptions are filled with generic drugs, but paying for generics only uses up 21 cents out of every dollar that is spent on prescription drugs in Canada. A generic prescription is about one-third the price of a brand name one.

Patents already mean that brand name drugs are on the Canadian market for more than 12 years without any competition. When patents run out, generic drugs can be sold, but sometimes patents expire before the data protection period is up. Until the data protection period ends, there can’t be any generics. What’s more, unlike patents, data protection can’t be challenged in the courts.

Ten years of data exclusivity

Canada used to offer five years of data protection but both the lobby group for Big Pharma here and in the United States found that time period unacceptable.

In the end, as a result of the lobbying efforts by the pharmaceutical industry, Canada amended its regulations on data protection to allow for eight years of data exclusivity. An extra six months is possible if the company marketing the drug is able to determine that children need the drug.

Now comes word that in the bilateral United States-Mexico NAFTA talks, there was an agreement that biologics will have 10 years of data exclusivity.

Biologics are injectable drugs that are used to treat various forms of arthritis, Crohn’s disease and ulcerative colitis (inflammatory bowel conditions), multiple sclerosis and a variety of other diseases.

Biologics can be very effective but they come with a high cost.

Big money spent on biologics

According to the latest report from the Patented Medicine Prices Review Board, a federal agency that sets a maximum introductory price for new patented medicines, biologics accounted for seven of the top 10 patented drugs in Canada based on the amount spent in 2017.

No. 1 on the list is infliximab (Remicade), used in the treatment of rheumatoid arthritis and ulcerative colitis, among other illnesses. The average annual cost for a course of treatment with Remicade is close to $29,000 and, in total, just shy of $1 billion was spent on this one medicine alone in 2017 by patients, provincial drug plans and private insurers.

No. 6 on the list is etanercept (Enbrel) also used for various forms of arthritis. The average annual cost for Enbrel is $13,600.

But for some of these biologics, there is the rough equivalent of a generic, known as a “subsequent entry biologic (SEB).” Whereas a single dose of Enbrel costs $406, a single dose of its SEB is only $255 – more than a third less expensive.

If the U.S. pushes Canada to accept the same data protection period that Mexico did, then data protection here goes up by another 1.5 to two years. Then we might very well be spending a lot more on some biologics, because the SEBs will be delayed.

If we want a national pharmacare system, then we need to make sure that our negotiators don’t give in to any American demands about medical data protection.

This article was originally published on The Conversation. Read the original article, including his disclosure statement.

��ֱ�� expert on how drug ads leave Canadians in the dark about safety risks

noreen.rasbach — Wed, 05 Sep 2018 04:00:00 +0000

��ֱ�� expert on how drug ads leave Canadians in the dark about safety risks

noreen.rasbach Wed, 09/05/2018 - 00:00

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The failure of TV ads to explain the safety risks of over-the-counter drugs can leave people in the emergency department with liver damage or psychosis (illustration by Shutterstock)

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When you watch Canadian television, it’s almost inevitable that you’ll come across advertisements for over-the-counter (OTC) drugs – the ones that you can buy without a prescription.

The ads are more than happy to tell you about the benefits – how your pain will be relieved, your skin cleared up, your allergic symptoms vanquished. Safety information in these ads, however, is virtually non-existent.

If you’re quick and have really good eyesight, you might catch a message in small print at the bottom of the ad that runs for two to three seconds. It says that to make sure that the drug is right for you, you should read the label. Missed that message? The other night I missed that message in three different ads.

One of the results is that in the emergency department in Toronto where I work, we see alcoholics who have further damaged their liver because they took too much acetaminophen.

We see people with psychotic symptoms because they took too many antihistamines.

There was no warning about these safety problems in the ads. Some of this information was in the label, but any message about reading the label was highly likely to have been missed.

Health Canada relinquished responsibility

It wasn’t always this way. Up until the end of February 1997, Health Canada was directly responsible for clearing the scripts for TV ads for OTC drugs. A 1993 review found that approximately one third of these scripts failed to comply with regulatory requirements.

TV ads for over-the-counter medicines tout their health-promoting benefits but explain none of their risks (photo by Shutterstock)

At the start of March 1997, the responsibility for clearing consumer-directed broadcast advertising for OTC drugs was transferred to Advertising Standards Canada (ASC), a national industry association.

Crucially, the role of ASC was only to review the ads, not to regulate them.

Health Canada continued to set minimum standards, but at the same time also stopped adjudicating complaints about ads.

After this transfer of responsibility, there is no public record of any evaluation of the adequacy of the new system in complying with Health Canada’s regulations.

Agencies regulate themselves

Despite never having done an evaluation, in August 2006, Health Canada announced its intention to further loosen control over this type of advertising.

Under the new proposed system, Health Canada would no longer endorse specific agencies performing these pre-clearance activities. Rather, it would let agencies self-attest that they had the ability to meet these criteria.

In other words, agencies would regulate themselves and the public would have to rely on them being honest.

The equivalent would be for students to “self-attest” that they had not cheated on an exam and for teachers to trust them.

Instructions on an over-the-counter pill bottle are shown in Toronto: Trying to decipher dose instructions written in small print on prescription medication labels can also be a daunting task for people with vision impairment or dimming eyesight due to age (photo by Graeme Roy/The Canadian Press)

ASC itself pointed out the weaknesses in what Health Canada was proposing. It noted that the new system “could…result in the mistaken belief [that agencies possess the requisite knowledge, expertise and systems to perform this function]. This lack of understanding and expertise could lead to review errors that compromise consumer health and safety.”

Virtually unreadable messages

Another part of the move to change the oversight of OTC promotion was a 2006 invitational roundtable, sponsored by Health Canada, on the inclusion of risk information in advertising.

At the roundtable, a wide variety of opinions were expressed as to how much safety information should be included in ads. Some participants wanted more detailed information provided, some advocated for “black box” warnings for certain drugs, others felt that labels and inserts should be more user friendly.

Health Canada’s position was that there should be a verbal cautionary statement in TV ads, but it was willing to accept visual disclosures – provided they were “clear, visible and of a sufficient duration to be effectively read and understood by consumers.”

What we got was self-attestation with virtually unreadable messages.

People deserve to know about the safety risks of medicines that they buy. It’s time Health Canada took back the regulation of OTC advertising.

This article was originally published on The Conversation. Read the original article, including his disclosure statement.

What Big Pharma pays your doctor: ��ֱ�� expert

Christopher.Sorensen — Thu, 05 Jul 2018 15:56:26 +0000

What Big Pharma pays your doctor: ��ֱ�� expert Christopher.Sorensen Thu, 07/05/2018 - 11:56

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Research shows that money and meals from the pharmaceutical industry do increase the amount doctors prescribe the drugs being marketed (photo via Shutterstock)

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University Health Network

Members of Innovative Medicines Canada (IMC), the lobby group for the large pharmaceutical companies, recently released their voluntary reports of payments to health-care professionals and health-care organizations.

Altogether, the 10 reporting companies paid out more than $75 million in 2017.

This is the second year of these disclosures. When they started, Russell Williams, then the IMC president, said on CBC’s The Current: “We’re open to continually improving and monitoring” the disclosures. According to the new president, Pamela Fralick, the 2016 revelations were only a first step and she expected more companies to disclose payments in 2017.

Come the 2017 disclosures, and there are still the same 10 companies. Moreover, the disclosures are actually not on the IMC website, they are on the individual companies’ websites and are not easy to find. It takes at least a couple of mouse clicks to locate the material. Nor is there any more detail this year than last year about how the money is used.

IMC touts these disclosures as “part of our commitment to high ethical standards and enhancing trust.”

But all that the companies have disclosed are gross figures — with no information about what they paid for.

Paid to promote opioids?

Why did Purdue Pharma, makers of OxyContin and a host of other opioid products, give almost $1.9 million to health-care professionals in 2017?

All Purdue’s website says is that the money was for “services.” Were some of those services speeches made by doctors on behalf of Purdue? In the past Purdue has paid doctors $2,000 a talk.

Amgen Canada gave more than $6 million to health-care organizations, but we don’t know what these organizations did with that money.

Novartis spent $350,000 on travel expenses so that doctors and possibly other professionals could go to international congresses and/or global stand-alone meetings.

Who were these health-care professionals? What meetings did they go to? Where were the meetings?

Canada lags behind

Big Pharma here in Canada is far behind the curve when it comes to disclosing where the money is going. The federal government doesn’t seem to be in any hurry to force the companies to make more information public either.

Just over a year ago, then Health Minister Jane Philpott’s position was that forcing the disclosure of payments to individual doctors was, “in principle…an important concept” but should be left to the provinces.

In the United States, companies have had to disclose any payment of more than $10 to a doctor since 2013. The doctors are named.

In Australia, an analysis of information that companies must disclose found that, from October 2011 to September 2015, 42 companies sponsored 116,845 events for health professionals.

In nine European countries, disclosure is either mandatory or voluntary. Many of the European voluntary codes allow doctors to opt out of having their names disclosed.

IMC justified not linking doctors’ names to payments on the grounds of Canadian privacy laws, but Ontario’s recently passed legislation will require disclosures to include the names of all health-care professionals who receive money or any other “transfer of value.”

Later this summer, British Columbia will hold public consultations about the same type of legislation.

Free meals increase prescriptions

Disclosure is only the first step. Payments made to doctors can be linked to how they prescribe.

In the U.S., this has been analyzed using the Medicare database. The links show an association between the amount of money doctors get and their prescription of brand-name statins (cholesterol-lowering drugs) rather than much less expensive generic versions.

Receipt of industry-sponsored meals with a value of less than $20 is associated with an increased rate of prescribing the brand-name medication that is being promoted.

Receiving money from opioid makers in one year is associated with prescribing more opioids the next year.

Perhaps this is why IMC doesn’t want to take disclosures any further. This lobby group is afraid that Canadians will realize the perverse effects of all the payments its member companies make.

This article was originally published on The Conversation. Read the original article.

��ֱ�� expert on pharmacare and the 'chaotic world' of Canadian drug prices

noreen.rasbach — Mon, 19 Mar 2018 20:30:27 +0000

��ֱ�� expert on pharmacare and the 'chaotic world' of Canadian drug prices

noreen.rasbach Mon, 03/19/2018 - 16:30

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Could universal pharmacare reduce excessive drug price hikes in Canada? Eric Hoskins, former Ontario minister of health, will chair a federal advisory council to implement a national pharmacare plan (photo by Andrew Francis Wallace/Toronto Star)

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The cost of a life-saving drug to treat cystinosis – a rare disease affecting probably 100 people across Canada – is soon to rise from $10,000 per year to more than $300,000 annually.

The new form of the drug, Procysbi, contains the same active ingredient as the old form of the drug, Cystagon. It differs only in that it contains a new coating, enabling a slower release of chemicals into the body.

Reforms to the Patented Medicine Prices Review Board (PMPRB), a federal agency that sets a maximum introductory price for new patented drugs, could help rein in this type of increase.

But a coalition of patient groups, some partially funded by drug companies, want Canada’s health minister and Health Canada to stop this reform process. They argue that lowering drug prices in the manner proposed could limit access to new drugs.

The drug companies are backing them up.

Canadians pay the price

According to Pamela Fralick, the CEO of Innovative Medicines Canada (IMC), the lobby group representing the multinational drug company subsidiaries operating in Canada: “The proposed changes would negatively affect patients by slowing and limiting access to new, life-saving medicines and vaccines, and will have consequences for investment and employment in Canada’s life science sector.”

IMC and its predecessors have been making the same type of veiled threat since the early 1970s, when Manitoba introduced its public drug formulary, a list of drugs the province would cover.

With a national pharmacare plan, all Canadians would benefit from lower drug prices (photo by Shutterstock)

While there are drugs that are not sold in Canada, the reason is the relatively small Canadian market, not the price.

In fact, when it comes to paying for prescription drugs, only the United States and Switzerland outspend Canada on a per capita basis out of 31 industrialized countries in the Organization for Economic Co-operation and Development.

There are now 19 drugs on the Canadian market that cost $50,000 or more per year, compared to just six a decade ago.

And, contrary to what IMC claims and what the patient groups seem to believe, only one in 10 new drugs are actually major therapeutic improvements.

Increase of 3,000 per cent

The dramatic rise in the cost of treating cystinosis – a genetic disease that causes kidney damage – reflects the dysfunctional nature of the way Canada controls drug prices.

Up until now, the treatment has been a product called Cystagon that must be vetted by Health Canada on a patient-by-patient basis since it’s not approved for sale in Canada. Now the newer version of the drug, Procysbi, made by Horizon Pharma – and taken twice instead of four times daily – is being marketed in Canada.

With the advent of Procysbi, the cheaper Cystagon will no longer be available to Canadian patients. Under the current rules enforced by the PMPRB, Procysbi is treated as a “breakthrough drug,” which is why the 3,000-per-cent price increase was permitted.

Again, the only difference between Cystagon and Procysbi is the latter has a special coating enabling its release into the body more slowly.

All of the basic research and development of Procysbi was financed by patient groups, not drug companies. Horizon Pharma has not publicly offered any reason for the price it plans to charge. The company is going to offer the drug for free for a limited time, but what happens when that option ends?

This isn’t the first time there’s been sticker shock about drug prices in Canada. In September 2017, the PMPRB ordered Alexion Pharmaceuticals to lower the $700,000 annual cost of Soliris, used in the treatment of rare blood disorders.

The pan-Canadian Pharmaceutical Alliance, a coalition of provincial and federal drug plans, bargains with companies for lower prices and is in negotiations with Horizon Pharma. But even if it can secure a discount, that will only apply to what provincial drug plans pay.

Private drug plans and people paying out of pocket, assuming anyone could actually afford Procysbi, will not get the discount.

National pharmacare a solution

A national pharmacare plan could help to bring some order to the chaotic world of Canadian drug prices. Everyone in the country would be covered under a public plan and benefit from the lower drug prices that would be achieved.

Pharmacare doesn’t necessarily mean that drugs will sell for pennies. But based on the experience in other countries, we will be much better off.

If companies don’t like the price being offered, then they could still try to sell their drugs to those who could afford them, but the market would typically be very small, encouraging the companies to lower prices.

However, Finance Minister Bill Morneau doesn’t seem interested in a universal pharmacare plan, preferring to try to fill gaps and add to the patchwork in the existing system, although now he seems to be backing off from his initial comments.

Perhaps people with cystinosis should ask Morneau to cover their costs.

Joel Lexchin is a board member of Canadian Doctors for Medicare, professor emeritus of health policy and management at York University, and associate professor of family and community medicine at the University of Toronto.

This article was originally published on The Conversation. Read the original article.

Joel Lexchin

Health Canada committees risk financial conflicts of interest: ����ֱ�� expert

Troubling lack of information

Canadians need unbiased advice

Why Big Pharma must disclose payments to patient groups: ����ֱ�� expert

Advocacy groups echo corporate interest

All payments should be disclosed

����ֱ�� expert on why we need answers to the thalidomide tragedy to ensure drug safety now

Canada slow to act

Drug safety blamed on patients

More than 400 babies affected

NAFTA negotiations may threaten pharmacare: ����ֱ�� expert

Generic drugs essential to pharmacare

Ten years of data exclusivity

Big money spent on biologics

����ֱ�� expert on how drug ads leave Canadians in the dark about safety risks

Health Canada relinquished responsibility

Agencies regulate themselves

Virtually unreadable messages

What Big Pharma pays your doctor: ����ֱ�� expert

Paid to promote opioids?

Canada lags behind

Free meals increase prescriptions

����ֱ�� expert on pharmacare and the 'chaotic world' of Canadian drug prices

Canadians pay the price

Increase of 3,000 per cent

National pharmacare a solution

Health Canada committees risk financial conflicts of interest: ��ֱ�� expert

Why Big Pharma must disclose payments to patient groups: ��ֱ�� expert

��ֱ�� expert on why we need answers to the thalidomide tragedy to ensure drug safety now

NAFTA negotiations may threaten pharmacare: ��ֱ�� expert

��ֱ�� expert on how drug ads leave Canadians in the dark about safety risks

What Big Pharma pays your doctor: ��ֱ�� expert

��ֱ�� expert on pharmacare and the 'chaotic world' of Canadian drug prices