Your natural health products under illegal attack

Health Canada moves to put natural remedies in checkmate

by Shawn Buckley

We all have defining moments when it becomes clear that what we believe is simply not true. In the area of the regulation of natural health products (NHPs), I have had two defining moments that made it clear my beliefs were false. Prior to these two defining moments, I actually believed Health Canada wanted to protect us. I also believed the wishes of the people meant something to the government.

My first defining moment happened during a trial where I was defending an NHP company from Health Canada charges, such as selling their product without a licence. At the time, only the chemical drug regulations existed and such a product could not be licensed. A Health Canada inspector was in the witness box. I suggested to her that the purpose of Health Canada was to protect the health of Canadians. I thought this was a no-brainer suggestion. I fully expected her to say yes. She did not. Rather, she explained that the purpose of Health Canada was to enforce the Food and Drugs Act and Regulations. People in the courtroom were stunned. We all believed that the purpose of Health Canada was to protect us. This was a false belief.

The purpose of Health Canada is to enforce the law as it is currently written, not to protect our health. Fortunately, in that case, the court acquitted the company of all charges finding it was legally necessary for the company to protect people rather than be in strict compliance with the law. This was a case in which I asked the Court to rule that Health Canada caused deaths by restricting access to a natural remedy.

My second defining moment happened when I was lobbying in Washington DC concerning proposed changes to how their dietary supplements were regulated. We had just finished meeting with a Senator. While we were packing up, the Senator’s aid asked if he could speak to us. This aid was around 50 years old and had been an aid to senators and congressmen his entire working life. In short, he was a Washington insider. He explained to us that, at that time, there were one and a half full-time pharmaceutical lobbyists for every senator and congressman. He went on to explain that the influence of the pharmaceutical lobby is so great that most senators and congressmen are aware of the share prices of the pharmaceutical companies. He was, in effect, trying to make it clear to us that we would in no way have any influence on government policy, as we could not compete with the pharmaceutical lobby. I knew that there was a strong pharmaceutical lobby in both the US and Canada. I simply did not appreciate how pervasive it was. In my defence, this was before the release of Dr. Shiv Chopra’s book Corrupt to the Core, which gave an inside view of corruption within Health Canada. Dr. Chopra’s book should be required reading for anyone who thinks Health Canada can currently be trusted to protect us.

These two defining experiences made it clear to me that:

  • Health Canada is not there to protect my health. They are there to enforce the law (regardless of the flaws in the law) and
  • I could not count on the law being drafted to protect my health where my interest in health conflicted with the interests of the pharmaceutical lobby.

My dealings with Health Canada over the years have strengthened my belief that Health Canada is not there to protect us. In every instance where I have been involved as a lawyer and Health Canada is seeking to take an NHP away, Health Canada has never taken into account the risk of removing the NHP from Canadians who may depend on it. In the court case I referred to earlier, I led evidence of deaths caused by Health Canada restricting access to a NHP. Despite warnings that restricting access to the NHP could lead to deaths, Health Canada never took into account the danger of removing the product. Health Canada was only concerned with enforcing the law, regardless of the law causing harm and death. I have never seen Health Canada do a balanced risk analysis (i.e. one that balances a risk posed by a product against the risk of removing the product) to ensure that the safest course of action is taken. Health Canada is only concerned with strict compliance with the law, even if strict compliance will lead to harm.

Because Health Canada always demands strict compliance with the law, you should be very concerned about any moves to strengthen Health Canada’s ability to take natural remedies away.

Currently, Health Canada is signalling they want to change how natural remedies are regulated. These changes may signal the endgame for any practitioner or company that is more concerned with good health outcomes than the over-regulation of natural remedies.

Currently, NHPs are regulated as a special type of drug. Much of our knowledge of natural remedies comes from experience. For example, the British Navy learned that the vitamin C in limes prevented scurvy. Limes or lime extract could be licensed as an NHP based on this learned experience. It would not be necessary to run expensive clinical trials to prove limes treat scurvy. Indeed, if it were necessary to run expensive clinical trials for a lime scurvy remedy, we would never have access to limes to treat scurvy. This is because of our intellectual property right laws.

If a chemical drug company invented a new drug they wanted to use to treat scurvy, they would have a patent on the new drug. Their patent would prevent any other company from selling a copy of the drug until the patent expired. The patent, in effect, creates a monopoly. Because there is a monopoly on the drug, the company can afford to go through the expensive clinical trial process. If they are successful, they can recover the costs of the clinical trials by charging a high price for the drug. They have a monopoly so the high price has to be paid. This is why new drugs are so expensive until after the patent expires.

An NHP company wanting to sell a lime extract for scurvy would not have a monopoly on their product. They did not invent limes and will have no intellectual property rights to limes or lime extract. In short, they cannot patent limes or lime extract. They would not be able to raise funds to go through the clinical trial process, as they would not be able to recover the cost by charging high prices. This is because they would not have a monopoly on the remedy. Any other company could copy the product and sell it at a lower price because there is no patent.

If you want to maintain your access to natural remedies, it is essential that NHPs are not subjected to the same types of evidence as is required for chemical drugs. Unfortunately, Health Canada is currently proposing subjecting NHPs to the same evidence standards imposed on chemical drugs. Not only does this ignore the differences in intellectual property rights, but it also ignores the risks of further restricting our access to natural remedies.

It is important to understand that there has never been a death caused by a NHP in Canada. Years ago, I made an Access to Information Act request of Health Canada asking for evidence of any deaths caused by NHPs going back to confederation in 1867. Health Canada could not point to a single death caused by a NHP. When our current NHP Regulations were introduced, the Regulatory Impact Statement made it clear it was inappropriate to regulate NHPs the same as chemical drugs because the NHPs had such a low risk profile.

Unfortunately chemical drugs do not share the low risk profile of natural remedies. Indeed, chemical drugs are one of the leading causes of death in Canada. Even over-the-counter chemical drugs like common painkillers and cold remedies cause a number of deaths each year. It is because chemical drugs are so dangerous that restricting our access to natural remedies will lead to death and harm.

Let me use nattokinase as an example. Nattokinase is a naturally occurring enzyme that can thin the blood. It is freely sold in the US. It used to be freely sold in Canada. Then Health Canada decided to restrict our access to nattokinase saying it was risky. I searched Health Canada’s Adverse Reaction Database and could not find a single harm event, let alone a death, caused by nattokinase in Canada. When I searched the same database for harm and death caused by the chemical drug blood thinners, there were many reports.

When Health Canada is demanding a natural product be removed and it is unsafe to follow Health Canada’s direction, the current penalties under the Food and Drugs Act are fines of up to $5,000 and/or three years of jail. Most persons or companies who have put a natural remedy on the market can survive such penalties. This enables them to act responsibly when following Health Canada’s direction would put Canadians at risk. If Health Canada’s directions are not followed, Health Canada can apply to a Superior Court for an injunction or other orders to ensure the law is followed. However, a Court will also have the opportunity to hear about the risk of removing a product, and will try to steer the safest course.

Health Canada is wanting to change the status quo. They want to be able to order recalls for NHPs without involving a Court. They also want to increase the penalties to fines of $5,000,000 a day for any violation, including for not following Health Canada recall orders. In addition, any management or employees involved in the violation could also be personally subjected to the $5,000,000 a day fines. I cannot think of a single NHP company that could withstand such fines. In effect, resisting Health Canada directions when it would be unsafe to follow them will be at an end.

Anyone who is concerned about giving a regulatory body the absolute say about what remedies are available should be concerned about the proposed changes. When new regulations and/or amendments to the Food and Drugs Act are introduced, we are all going to have to be ready for action. This is the most threatening proposal since the infamous Bill C-51. I am inviting all readers to do three things to prepare: 1) For a more thorough understanding of the proposed changes, visit www.nhppa.org and read my Discussion Paper on them; 2) Visit www.charterofhealthfreedom.org to familiarize yourself with the Charter of Health Freedom, which is a solution to the over-regulation of natural products, and 3) Financially support groups that will be resisting these changes. Advocacy for your health rights does not happen in a financial vacuum. You will either support groups such as the NHPPA or they will not have the resources to work on your behalf.

We are entering a time where unless we stand up and be counted, we will forever lose the right to decide for ourselves how we will treat ourselves or our loved ones when we/they are sick. Will you be counted?

Shawn BuckleyOriginally published in Vitality magazine, December 2016 (www.vitalitymagazine.com) Excerpted from the article “Freedom of choice threatened – again.” Shawn Buckley is president of the National Health Products Protection Association (www.nhppa.org).

Junk Economics

financial magician

Realities of a deceptive system

Sharmini Peries of The Real News Network interviews Michael Hudson

Michael Hudson, author of the newly released J is for Junk Economics, says the media and academia use well-crafted euphemisms to hide fictitious capital, debt deflation and the global economic crisis.

Sharmini Peries: Why did you write J is for Junk Economics: A Guide to Reality in the Age of Greed and Deception?

J is for Junk EconomicsMichael Hudson: I originally wrote it as an appendix to a book to have been called The Fictitious Economy. That draft was written before the 2008 crisis. My point was that the way the economy is described in the press and in university courses has very little to do with how the economy really works. The press and journalistic reports use a terminology made of well-crafted euphemisms to confuse understanding of how the economy works.

In addition to giving key words to explain what’s positive and how to understand the economy, I discuss the misleading vocabulary, the Orwellian double-think used by the media, bank lobbyists and corporate lobbyists to persuade people that austerity and running into debt is the key to wealth, not its antithesis. The aim is to make them act against their own interests, by drawing a fictitious picture of the economy as if it’s a parallel universe.

If you can make people use a vocabulary and concepts that make it appear that when the 1% gets richer, the whole economy is getting richer – or when GDP goes up, everybody is improving – then the people, the 95% who did not improve their position from 2008 to 2016 somehow can be made to suffer from the Stockholm syndrome. They’ll think, “Gee, it must be my fault. If the whole economy is growing, why am I so worse off? If only we can give more money to the top 5% or the 1%, it’ll all trickle down. We’ve got to cut taxes and help them so they can give me a job because as Trump and other people said, Well, I never met a poor person who gave me a job.”

I’ve met a lot of rich people, and instead of giving people jobs when they buy a company, they usually make money for themselves by firing people, downsizing and outsourcing labour. So you’re not going to get the rich necessarily giving you jobs. But if people can somehow think that there’s an association between wealth at the top and more employment, and that you have to cut the taxes on the wealthy because it’ll all trickle down, then they have an upside-down view of how the economy works.

I had written an appendix to the book and that took on a life of its own. If you have a vocabulary that describes how the world and the economy actually work, then one word will lead to another and soon you build up a more realistic picture of the economy. So I not only discuss words and vocabulary, I discuss some of the key individuals and the key economists who’ve made contributions that don’t appear in the neoliberal academic curriculum.

There’s a reason the history of economic thought is not taught anymore in the universities. If people really read what Adam Smith wrote and what John Stewart Mill wrote, they’d see that Smith criticized the landlords. He said that you’ve got to tax away their rents because it’s a free lunch. Mill defined rent as what landlords make in their sleep, without working. Adam Smith said that whenever businessmen get together, they’re going to conspire as to how to get money from the public at large – how to do a deal and mislead people that it’s all for society’s good.

This is not the kind of free enterprise that people who talk about Adam Smith explain when they depict him as if he were a tax cutter, an Austrian economist or a neoliberal. They don’t want to hear what he actually wrote. So my book is really about reality economics. I found that to discuss reality economics, we have to take back control of the language or economic methodology, not use the logic that they use.

Mainstream economists talk as if any status quo is in equilibrium. The subliminal trick here is that if you think of the economy as always being in equilibrium, it implies that if you’re poor or you can’t pay your debt, or you have problems sending your kids to school, that’s just part of nature. As if there isn’t an alternative. That is what Margaret Thatcher said: “There is no alternative.” My book is all about how, of course, there’s an alternative. But to make an alternative, you need an alternative way of looking at the world. And to do that you, as George Orwell said, you need a different vocabulary.

To make an alternative, you need an alternative way of looking at the world. And to do that you, as George Orwell said, you need a different vocabulary.

SP: You also talked about how businessmen use these terminologies in order to mislead us. We have a businessman in office, as president of the United States, who is proposing all kinds of economic reforms supposedly in our favour, in terms of workers. And you know, the big infrastructure projects he is proposing that are supposed to elevate and lift people out of poverty and give them jobs and so on. What is the mythology there?

MH: Well, you just used the word “reform.” When I grew up, and for the past century, “reform” meant you unionize labour, you protect consumers and you regulate the economy so there’s less fraud against consumers. But the word “reform” today, as used by the International Monetary Fund in Greece when it insists on Greek reforms, means just the opposite: You’re supposed to lower wages by 10 or 20%. You cut back the pensions by about 50%. Ideally, you stop paying pensions in order to pay the IMF and other foreign creditors. You stop social spending. So, what you have is an inversion of the traditional vocabulary. Reform now means the opposite of what it meant early in the 20th century. It’s no longer Social Democratic. It’s right wing, anti-labour, pro-financial “reform” to cut back social spending and leave everything in a privatized way to the wealthy, and to the corporate sector.

So reform is the first word that I’d use to illustrate how the meaning has changed as it’s used in the mainstream press. Basically, what the right wing has done in this country is hijack the vocabulary that was developed by the labour movement and by socialist economists for a century. They’ve appropriated it and turned it to mean the opposite.

There are 400 words that I deal with. Many of these words show how the meaning has been turned upside down, to get people to have an upside-down view of how the economy works.

Michael Hudson
Michael Hudson

Michael Hudson is a distinguished research professor of economics at the University of Missouri, Kansas City, and author of many books including: The Bubble and Beyond and Finance Capitalism and Its Discontents, and Killing the Host: How Financial Parasites and Debt Destroy the Global Economy. Hudson’s most recent book J is for Junk Economics: A Guide to Reality in the Age of Greed and Deception is an A-to-Z guide that explains how the world economy really works – and who the winners and losers are. The book includes 400 concise acerbic entries, essays, and full topic index. Junk Economics covers contemporary terms that are misleading or poorly understood, and important concepts that have been abandoned – many on purpose – from the long history of political economy. Two key concepts are Rent Theory and Debt, which explain how Unearned Income and the Financial Sector impoverish governments and populations the world over as power and riches flow upward into the hands of the few. Several additional essays provide background for key points and explore today’s uncertain political and economic environment.     

To understand what’s really going on, it’s not necessary to re-invent the wheel; the major issues that guide healthy economies were known to the Ancients and were expanded upon by the classical economists of the 18th and 19th centuries, including Adam Smith, David Ricardo, John Stuart Mill, E. Peshine Smith, Simon Patten, Karl Marx, Thorstein Veblen, and others of many political stripes whose aim was to leave the brutal legacy of feudalism behind. Their ideas and principles are brought back into the spotlight here. His book will deconstruct today’s “value-free,” watered-down and deceptive economics that favor the wealthy. This knowledge empowers the next generation to create a successful economy with proper checks and balances for the social benefit of all. www.michael-hudson.com www.therealnews.com


EVENT: Michael Hudson, in person

April 11, Rio Theatre
1660 East Broadway (at Commercial), Vancouver
Doors 6:30, Starts 7:00 PM.

Tickets: www.real-estate-crisis-vancouver.eventbrite.com


photo montage by Tom Voidh | source photos © Scott Hancock © Ljupco

Mayday! Abandon the Christy Clark ship of fools

There is no money to help the most vulnerable citizens, but Clark’s Liberals spend billions to help their friends and financial supporters. It is a greedy, hateful style of government.
– Norman Farrell

by Bruce Mason

Let’s cut the crap and cut to the chase. Let’s quit cutting fake bait and wasting more precious time chucking good money after bad. We’ve tossed more than enough of our precious legacy and life-blood overboard, feeding the insatiably greedy sharks and their minions that float at the top of the financial food chain. Truly fed-up, it’s past time for a reset; it’s time to change course, right here, right now.

Make no mistake about it; we’re at the epicentre, caught in a perfect tsunami storm of hot air and tidal waves – the greenhouse gas regression or green revolution – on a collision course. The eyes and hopes of much of this planet are pinned on us in BC where Greenpeace first set sail. We are not only up to the task, but we also don’t have any real choice.

After 16 years hosting The Daily Show, Jon Stewart observed, “Bullshit is everywhere. The good news is bullshitters have gotten pretty lazy and their work is easily detected. So I say to you tonight, friends, the best defence against bullshit is vigilance. So if you smell something, say something.” And may we add, be somebody, do something?

One of my most trusted and vigilant sources is Norman Farrell, a long-time accountant with a well-developed, keen sense of smell. Dubbed “master researcher” by one of my mentors, Rafe Mair, Farrell’s outstanding blog, https://in-sights.ca/, has several thousand posts on everything from “Accountability” to “Wilderness Committee.” He told me, “People have questioned my opinion, but never my facts.” It’s well worth bookmarking and supporting.

Just before this issue of Common Ground went to press, Farrell posted “Pull down the veil of lies” (February 26), utilizing Ministry of Finance numbers to show how the record and promises of Christy Clark (Neo)Liberals are “egregious dishonesty,” in conflict with basic truth and common sense.

In the recently released 2017 Budget and Fiscal Plan, the government that got elected by promising a “Debt-Free BC” forecasted the provincial debt will grow $11 billion to a total of $78 billion over the next three years. But that last number doesn’t include $100 billion-worth of contractual obligations, as if non-existent and without impact.

BC Debt including Contractual Obligatons“Contractual obligations became a major financial commitment in the mid-2000s when BC Liberals privatized public services and moved major capital projects off balance sheets,” Farrell reports. “Schools, healthcare facilities, bridges, highways and power installations – although commissioned by and for the public and paid for by the public – were financed by private organizations and therefore excluded from direct provincial debt.

“People in need of social assistance have had benefits frozen for a decade,” he adds. “There is no money to help the most vulnerable citizens, but Clark’s Liberals spend billions to help their friends and financial supporters. It is a greedy, hateful style of government.”

To wit, Rich Coleman, the second most powerful politician in BC – he’s deputy premier, minister of natural gas and minister responsible for housing – boasted on behalf of his government’s record on poverty: “We have to remember that a person on social assistance, a single person on social assistance in British Columbia, gets double the annual income of a person in the Third World,” he huffed, adding a Trump-like insult-to-injury: “I know you don’t like it when I tell you how good this country is, but that’s fine. All I ever hear is negative, negative, negative, destructive, pessimistic attitude.”

No doubt, Big Rich would include Farrell’s honest, meticulous facts. Here’s something else to mull: if I gave you $1 every second, in one minute you would pocket 60 dollars. After 12 days, you’d be a millionaire, beyond the wildest dreams of most of us. At that rate – to hand over a billion – for you to bank the kind of numbers our politicians toss around would take almost 32 years.

Let’s get serious. Rather than investing in public retrofits, renewables, transit and care giving sectors of health and education to stimulate a rush of well-paying jobs, and instead of improving the lives of hard-working British Columbians – especially First Nations and others receiving a raw deal in an unequal economy (the highest in Canada and growing exponentially) – the BC (Neo)Liberals are attempting to bribe voters with tax money taken during Christy Clark’s term and dating back an unrelenting 16 years in office.

Interesting times. Frustrating as hell, as well, as we fall further behind, as summed up in a recent email from another former high-level politician and talk show host, Rafe Mair: ‘’Thank God for a business oriented govt. BC Hydro bankrupt – debt doubles under Christy – LNG a huge and very bad joke – Budget surplus from kids dying, ignored mentally ill, abandoned homeless – Phoney, ‘balanced budget’ – LNG at Squamish into the atmosphere, shit in Howe Sound to kill restored fish runs, whales, porpoise and dolphins, tankers to keep us all rich and dead – Kinder Morgan to pollute Burrard Inlet, Salish Sea, Gulf Islands and Straits of Juan de Fuca with bitumen leaks and spills.

Now, ICBC’s massive losses from their monopoly insurance company. And to top it all off, a self-styled beauty queen for a premier, who keeps airlines and photographers prosperous with our money, never answers questions and is incapable of telling the truth. BC is in the very best of hands, don’t you think?”

A last word from Norm Farrell: “Because corporate media does not report the above figures, it is up to citizens to correct the record. Do so at every opportunity during the election campaign. Blow up the myth that Liberals, while pandering to special interests, are competent financial managers.”

Do more than just vote, which is every citizen’s right and enviable responsibility. Google the platforms and join the campaigns of the optional parties: the opposition and our best chance, NDP, the Green Party and even the Conservatives. Ask questions, become informed, talk it up. Be able to honestly look anyone in the eye, including future generations, and say, “This is what I did, up to, and including, May 9th, 2017.”

Bookmark Norman Farrell’s site, in-sights.ca, sign-up for his emails and support IN-SIGHTS through donations, a wise investment in your/BC future.

Bruce Mason is a Vancouver and Gabriola-Island based five-string banjo player, gardener, freelance writer and author of Our Clinic. brucemason@shaw.ca

Relationship skills for today’s complex world

by John Gray

Both men and women require a new kind of emotional support that embraces greater authenticity, intimacy and personal expression. Gone are the days when a woman was required to be submissive and dependent on men and a man had to carry the burden of providing for his family alone.

This change has created incredible new opportunities, both for relationships and individuals. People have the opportunity to be themselves in ways they never could before and to embrace characteristics beyond those of their traditional gender roles, allowing for relationships of more profound intimacy than ever before.

But these changes also bring significant new challenges. We must learn to successfully express our masculine and feminine qualities in ways that reduce, rather than increase, our stress. And we must learn how to support our partners’ new needs as they do the same for us.

Just because women today work side by side with men in the workplace and men participate more in raising their children, it does not mean men and women are the same. Our roles are certainly changing but our biology is still very different. And because men and women are different, we react to the changes in our roles in different ways, ways that are often misunderstood and misinterpreted by our partners.

These challenges relate to single people as much as to couples because the changes in our modern relationships are a reflection of the changes that are currently happening within us as individuals. The new insights we receive by going beyond Mars and Venus are necessary not just for romantic relationships but also for our own happiness as well as that of our children.

What we are witnessing is a dramatic shift in the context of our relationships. Trying to have successful relationships today while using the skills and insights developed for traditional relationships over thousands of years is simply not enough and does not work.

For both men and women, providing each other the new support necessary to create a fulfilling relationship is a tall order. Most men have no role models for providing this kind of support. I know I certainly didn’t. Our relationship training came from watching our fathers, who may have been skilled in the old model but not in this new one. By going to work every day to provide for their families, our fathers could fulfill most of our mothers’ relationship expectations.

This journey of transformation into someone who knows their own needs and is able to support their partner’s is not immediate. But you can begin this journey now; you don’t have to wait for your current partner or a future partner to join you. All it takes is for one partner to change and the relationship will change. Eventually, as one person becomes a better partner, the other comes along.

When you are coming from a place of fulfillment, you have more to give. When your heart is fully open, and you have new gender-specific insights regarding your partner’s new needs, not only will you experience a higher level of fulfillment but also, with your help, your partner will be able to respond better to your own new needs. It rarely works to ask for more when you are dissatisfied with what you are getting. But even more important, it never works to ask for more when your partner is not getting what they need.

To improve your relationship, your first step is to find your way back to opening your heart without depending on your partner to change. Your second step is to feel, say, or do what you can to help them. By giving them what they need, they will be way more inclined to give you what you need in return. Your third step is to ask for more in small increments while giving your partner big rewards for giving more. This is your formula for success; expecting more without giving more first is a formula for failure. In addition, expecting too much too soon will also sabotage all your efforts.

By understanding what is most important
to your partner’s fulfillment, you can
more successfully target your energies and love. Both men and women in relationships need to find their own happiness first without depending on their partner changing. Likewise, a single person must find their happiness without depending on finding the perfect partner for them.

To be happy and fulfilled in our relationships, we first need to be happy and fulfilled in our lives. It is unrealistic to depend on our intimate relationships as the sole source of fulfillment. When we create a life rich in friendships, family, exercise, good food, meaningful work or service to the world and have plenty of opportunities for fun, entertainment, education, personal growth, and spiritual devotion, then having a loving relationship can make us even happier. To experience lasting love in relationships today, you must find a baseline of happiness by fulfilling your other needs separate from your needs for an intimate relationship.

It is much easier to drop a bomb than to drop our egos and find love. It is much easier to escape the pain of our broken hearts by running away from love. But those who continue to try are the most noble and deserve more love and encouragement, even – especially –when they make mistakes.

Today we all want more – from our lives and from our relationships. The good news is that we can have more. But first, we must learn how to get it.

Excerpted from the introduction to Beyond Mars and Venus: Relationship Skills for Today’s Complex World by John Gray. (BenBella Books)

EVENT March 25

Women’s Health Show 9:30am – 6pm
Fairmont Hotel Vancouver, 900 W. Georgia.
Bestselling author John Gray is a special guest.
Talk: Beyond Mars & Venus (his new book).
Full details at www.womensvoicehealthshow.com

The hero behind the thalidomide exposé

Frances-Oldham-Kelsey

Dr. Frances Oldham Kelsey 1914 – 2015

by Roxanne Davies

When Dr. Frances Oldham Kelsey (photo, above) applied for post-doctoral work at the University of Chicago, the employer mistook her name for that of a man’s. Sharing with a professor she thought she might be accused of depriving a man of his capacity to support a wife and child, her professor replied, “Don’t be stupid, accept the job. Sign your name and put ‘Miss’ in brackets.”

Thankfully, Dr. Kelsey followed the advice and accepted the job. With an outstanding combination of character and career skills, she would eventually save countless pregnant women and their babies in the US from the thalidomide disaster. Tragically, Canada allowed the drug to be prescribed to Canadian women between 1960 and 1962.

In 1959, the American Food and Drug Agency (FDA) tasked Dr. Kelsey with reviewing thalidomide, a new drug synthesized in 1954 by the German drug manufacturer Chemie Grünenthal. Touted as a wonder drug in Europe to treat insomnia and alleviate morning sickness, which, in some severe cases can last for hours, thalidomide was available over-the-counter in at least 46 countries under many different brand names, from October 1, 1957 into the early 1960s.

Skeptical about the manufacturer’s clinical studies, Dr. Kelsey refused to authorize it for market in the US, noting the company’s arguments for safety were not convincing. Executives from the drug manufacturer wrote, phoned and showed up at her lab to try and persuade her to approve their application, but she would not budge. They called her an obstructionist nitpicker.

In early 1961, Dr. Kelsey spotted a letter in the British Medical Journal written by a Scottish physician who cited incidents of nerve damage among his patients taking thalidomide. Dr. Kelsey asked why the drug’s manufacturer had never mentioned the troubling side effect; she also began to press company officials about the effects of thalidomide on a fetus, for which the drug makers had not done any testing. By November 1961, she was vindicated when the full scope of the thalidomide tragedy began to unfold. News from Europe linked the drug to birth defects, including stunted or missing limbs, heart malformations, deafness and blindness.

Dr. Kelsey was instrumental in ensuring that thalidomide was never prescribed to any pregnant woman in the US. Although thalidomide was withdrawn from the West German and UK markets by December 2, 1961, it is shameful it remained legally available in some Canadian pharmacies until mid-May 1962.

It has been estimated that thalidomide maimed 20,000 babies and killed upwards of 80,000 worldwide. Many families with surviving children filed civil suits, but all the victims had to wait years without support because the criminal trial took precedence. When the criminal trial of employees of Chemie Grünenthal opened in the town of Alsdorf, in the district of Aachen, on May 27, 1968, it promised to be comparable in scale and emotional intensity to the post-war Nuremberg trials. Nearly 700 people crowded the biggest space in the region: a casino. Every day, the judges, lawyers, scientists, press and witnesses passed by three deformed children nursed by Red Cross sisters while their mothers waited inside hoping to learn the cause of their children’s affliction. The trial lasted two and a half years. The trial ended in April 1970 when proceedings were halted because it was deemed there was little public interest in securing a conviction.

More than half a century after the pill’s threat to an embryo was proven, the company that produced the first disaster continued to sell the drug in parts of Latin America, through prescription only, and babies continued to be born with malformations similar to the survivors from the 1960s. Initially Grünenthal had insisted that it was blameless, claiming the thousands of abnormal births were an act of God. The company now admits its role in the drug disaster and that the thalidomide tragedy will forever be part of their history. Grünenthal would eventually provide approximately 100 million marks as compensation for the victims.

Thalidomide is making a comeback as a strictly regulated drug prescribed by doctors to combat serious skin conditions such as leprosy and is being explored as an HIV/AIDS or cancer drug. Celgene Canada, based in Mississauga, Ontario, provides biotech therapies and has rebranded thalidomide as Nightmare Drug to Celgene Blockbuster.

In 2010, the British government officially apologized to people hurt by the drug, after earlier agreeing to pay £20m (US$31m) to thalidomide’s victims. In 2013, a class action suit by Australian and New Zealand victims of thalidomide against the drug’s British distributor Diageo Scotland Ltd. was settled for $89m.

It is unknown how many Canadian women and children were harmed by thalidomide, but in 1991 there were 109 Canadians who could prove they were thalidomide damaged. In May 2015, the Canadian Conservative federal government announced details of the compensation package for the 92 remaining Canadian survivors. They would receive annual pensions of up to $100,000 depending on the severity of their disability for the remainder of their lives. An additional $500,000 was placed in in a medical assistance fund to be accessed by individuals to help with mobility and adaptive tools as required. Prior to the government compensation package, the average thalidomide survivor “survived” on $14,000 a year.

I was humbled by the personal stories and photographs of our Canadian survivors who showed tremendous grit and grace in their daily struggles. It is a sad irony that Dr. Kelsey was not able to save her fellow Canadians, however, remaining survivors have graciously thanked her for her life’s work. Mercedes Benegbi, executive director of the Thalidomide Victims Association of Canada, said the tribute to Dr. Kelsey is deeply deserved: “To us, she was always our heroine even if what she did was in another country.” Dr. Kelsey was born in Shawnigan Lake on Vancouver Island and was a dual citizen for most of her professional life, visiting often, but returning to Canada in her late 90s.

Compassionate, courageous truth-tellers often are responding to a higher calling, a sense of duty and justice. Sadly, many of these men and women end up experiencing long-lasting problems. An Australian study looked at 35 men and women from various occupational backgrounds, who had uncovered harms to the public. “Although whistleblowing is important in protecting society,” the report reads, “the typical organizational response causes severe and long-lasting health, financial and personal problems for whistleblowers and their families.”

Dr. Kelsey showed strength and courage by refusing to bend to pressure from drug company officials and her actions saved countless American women and their babies. Hailed as a hero, she was the second woman only to be honoured by president John F. Kennedy for distinguished federal civilian service.

On her 101th birthday in 2015, Dr. Kelsey received the Order of Canada in a private ceremony in her daughter’s home in London, Ontario. She died less than 24 hours after receiving the award.