Sunday, November 28, 2004

Snakeoil?

A couple of weeks ago we received a letter from Darcy O'Neil, asking us to publish his story about a local London pharmacy's sale of unauthorized prescription drugs to people who did not know they were receiving them. He does not believe the public's interest is being served by the efforts of existing regulatory bodies to address the situation.

We here at the London Fog abhor governmental regulation in any form; and it seems to me that many of the problems that arise between regulatory boards and businesses wouldn't even be an issue if it weren't for the existence of unnecessary and monopolistic regulations in the first place. We must always be mindful of the government and the claims of its appointed bodies to know what is in our best interest when it comes to health.

However, in a regulated environment such as the pharmaceutical industry, people have come to expect that apothecaries will in fact sell the products that they claim to sell -- this is a matter of integrity that should be demanded of any business in a regulated or unregulated environment.

We present Mr. O'Neil's story along with a link to his website -- make of it what you will.

London Free Press is not currently reporting on this story. A free press can abet the process of helping people regulate their own transactions, but our local paper may not be so interested in this. However, we are not making any judgment here about the merits of this particular story or the Free Press' decision not to publish it at this time. Any comments?

On April 14, 2004 I presented the following story to the London Free Press. To date they have elected not to publish it, even though it concerns serious issues with the publics health. The only stated reason for not publishing is that their lawyers keep requesting revisions, but they are looking for a way to publish the story. Basically, their lawyers are concerned about potential legal threats if they publish the story.

The issue is with a local London pharmacy's sale of unauthorized prescription drugs to people who were unaware they were receiving them. They were marketed as "natural health products", but actually contain regulated (prescription) ingredients. The number of unauthorized products sold, that I am aware of, is 12,527 between 1999 and May 2003. This number could easily be doubled since many of the product sales were not tracked.

I was an employee at the company and after discovering the issues I "blew the whistle". I contacted Health Canada and the Ontario College of Pharmacists. The principals, both pharmacists, of the business admit to selling the products, but claimed ignorance. They stated they were unaware it was illegal to sell these products. That may work for some corner store vitamin shop, but these were licensed pharmacists.

The Ontario College of Pharmacists, after taking 282 days to investigate, decided that they should just receive a written warning! The sad thing is that this is the second time the company has faced discipline in the last three years. Membership has its privileges.

The London Free Press has refused to publish the story, even with the owners admitting to selling the unauthorized products. They are more worried about liability, even though there is a Health Canada document stating all of the above, and more. They have had all of the information on the story since April 2004. Chris Nixon, the city editor, has stated that the story is under review. Basically, it will be a historical article.

As for me, I was fired for insubordination in June 2003, for my complaining. I also received two lawsuit threats from my former employer. They never followed through since they were merit less. I also was threated with legal action by the Ontario College of Pharmacists since I recorded a number of phone conversations with their investigations department. Basically, the recording are embarrassing to them and they wanted them removed from my website. However, Canadian law clearly allows me to do this so I don't believe they will push forward with actual legal action.

The reason I am writing is that the mainstream media won't cover this story, for whatever reason, but there are thousands of people affected by this. I have a website, Snake Oil, that details the whole story. It includes a lot of evidence including pictures, legal documents, Health Canada docs, audio recordings and much more. The latest message I received from the London Free Press indicates that they are "still looking for a way to publish the story". Whatever that means. You either publish or you don't.

Self regulated organizations seem to be setup to protect their paying membership, not the public. This is a serious issue that needs public scrutiny, but without media coverage these pharmacists will be allowed to get away and keep their significant profits from the sale of all these unauthorized prescriptions. The people who were potentially harmed will never know.

It seems that the London Free Press has forgotten what "Free" means, and maybe a more appropriate name should be the London Not So Free Press.

Darcy O'Neil

15 comments:

Ian Scott said...

This guy's story is awfully fishy to me. He claims he was terminated for insubordination, yet in another account, he states that he goes into his boss' office, tells the boss that he is quitting, and wants some enormous amount of money for separation pay.

As well, he makes a big deal of one of his bosses surfing porn sites. So what? As well, some of the so called controlled substances were totally legal in Canada up to a few years ago, and are still legal in the U.S. Canada has weird controls over this sort of stuff, and just because something is against the law, doesn't mean it is bad for you.

At one point, during a telephone conversation, it sounds as if he is making an accusation that one of his bosses performed an illegal abortion using blach cohosh. Hmmm.. if Darcy is so principled as he claims, how come there is no documentation on this, and how come he didn't complain to the authorities immediately? I'm not saying abortion is right or wrong.. but Darcy sounds like one of those disgruntled former employee types that spends too much time on not improving himself, but pretending he is a martyr.

Darcy O'Neil said...

Just to clarify a couple of things about the post above. First, if it seems fishy that's fine, I attach my name to all of my work, I record my phone calls and publish them. As you can see, I'm not hiding anything. By the way for a Chemical Engineering Technologist, 3 months of severance pay is not an enourmous amount of money. You should check out what the London City Manager will get is he quites ($100,000).

As for whether these products are bad for you, I will state that many of them are, especially at the dosage levels given. I have no problem with some taking whatever they want, but when it comes to people taking stuff that they don't know, especially from a trusted source (pharmacist), then I have a problem.

And anyone who thinks someone would document an illegal procedure should rethink that statement. I am the one who contact Health Canada and I am the one who contacted the Ontario College of Pharmacists. Who else would you like me to contact?

I'm not a martyr, I'm just a person who tries to make the world an honest place.

Darcy O'Neil said...

Just an addition note for Mr. Scott. Take a look at your 12 year old and realize that when you need medication, you of all people, I expect, would demand only the best. Now if you didn't realize the products you purchased for hundreds of dollars, were expired and no longer active and could possible harm your child or not cure the disease, then wouldn't that cause you concern?

Attacking people like me, who do something instead of turning a blind eye to the unethical behaviour, isn't going to help your child.

Ian Scott said...

Darcy, I'm certainly not "attacking" you. I have no idea what you meant by that word. I pointed out that to me, your story sounds a bit fishy, and after spending an entire day, reading your complete website and listening to the recorded telephone conversations, I question your motives. I have no doubt that you are telling a version of the truth, but before I would ever come to any conclusions, I know that there are always two sides to a story, and I'd like to hear the other side.

There are some interesting inconsistencies in your story as well that just don't add up. In your letter, you say you were "fired for insubordination," however on your website, you give a slightly different account. You in fact, quit and asked for a large sum of money in order to quit. As far as what some mayor will receive is irrelevant. I disagree with mayors receiving huge sums.

As far as what is typical in your industry, typical just means that. It does not mean "deserved" or "always."

You also seemed to miss my point about the documentation. I was referring especially to the accusation regarding the "illegal abortion" using black cohosh. I could find nothing in your written complaints that alledged this; instead it was sort of a side comment during a telephone conversation. That really got me suspicious about your motivations. Why would you not "blow the whistle" so to speak, IMMEDIATELY, going right to the police, regarding this illegal abortion? Makes no sense, Darcy.

As far as expired product, you provided evidence that expired product was in the basement. I have expired product in my basement as well. I'd be very concerned if a disgruntled employee took pictures of my expired product, posted the images on a website, and insinuated that because I had this expired product, I also dispensed it.

I am not suggesting your story is false or fabricated. I'm just saying that to my mind, there are some inconsistencies that don't convince me completely.

As far as purchasing product from anyone, I always use the principle of caveat emptor, which all of us are free to adopt. I research my purchases in advance. I in fact have four children, and would never trust the word of just one person in their health or well being. I don't even trust the Government and it's regulations, Darcy. Do you?

Darcy O'Neil said...

Ian,

For your information, a pharmacist is not allowed to have expired products at the pharmacy. It is a safety measure designed to avoid errors.

As far as Mr. Polcz's side of the story, it is available in the May 2004 filing with the OCP which is available on the site.

I did decide that I couldn't work for an unethical employer anymore, and I was intent on leaving but it doesn't you can't ask for a severance. In the end I received nothing and "terminated" was what was put on my record of employment, not that I quit.

As for going to the police, they qoute I received from Inspector John Carson of the London police force was that "they didn't do vitamins or herbs". They dealt with crack and other serious drugs. It was recommended that I proceed through Health Canada and the OCP. Patient confidentiality is always an issues, that even the police cannot break without a court order. No evidence, no court order.

The Health Canada document clearly defines what was wrong at the pharmacy. Take what you will from this but pharmacists are suppose to be trusted and when they break that trust your family and my family are at risk.

Darcy

Ian Scott said...

Thanks for the information Darcy. Just want to point out to you that 100% of the time, me and my family are at risk for something. Risk can only be managed, never eliminated. Some folks rely on Government regulation to manage their risk. I prefer to rely on my own inquiries and judgements, as much as possible. Remember when the Government was telling us all that eggs were bad for us?

Look Darcy, I don't you from Jesus Christ.

And I still say it seems a bit fishy. But that's just my opinion, and remember, I don't know who you are, so don't take it personally. I have no personal interest in the case other than one of curiousity. So, from that perspective, it's my own objective (at least objective in the sense that I'm a complete outsider to the whole thing.. don't even live anywhere close to London for that matter). As well, I used to investigate many crimes and allegations of crime. I know there is always two sides, and often, reporters of crime have motivations that need to be examined as well. It's a fact, man.

I have no knowledge of the regulations regarding pharmacies. You know more about than I do, I am sure. But I do know that regulations get broken everyday. Often, many regulations are not considered "absolutely required" and are more of a guideline. Take even the Highway Traffic Act for example. When was the last time you saw the police out enforcing stopping behind white lines? I mean.. some are worded in such a way, it is almost impossible to not break a law or regulation, but we all know that it would be silly to enforce them. On the other hand, some people, not aware of our traffic, might find it just terrible that the police don't enforce this white line law.. look at all the pedestrians that might get put at risk!! they might say. But reality is different.

I appreciate you letting me know about the regulation regarding expired product. But not knowing enough about the industy, I don't know if that is one of those 'serious' regulations - or just one that is a "guideline" kinda thing. I could see how impossible it could be to enforce it except in extreme situations - and even then, does it require anything more than a warning really? If a product expires on June 30, 2004, does that mean on July 1, 2004, inspectors should charge the owner for having expired product?

Yes, you're case suggests product that was far more than one day expired. But my example above illustrates a point - that just because there is a regulation in place, even most investigators know that not all regulations are worth while in prosecuting for non-compliance.

I just learned what black cohosh was today. Had no idea when I heard your taped phone call. Correct me if I am wrong, you say something like, "do you know he HAS PERFORMED ILLEGAL ABORTIONS using black cohosh?"

When I heard that, I assumed, by the way you had worded the allegation, that black cohosh was something like a coat hanger, and that you were alleging that the guy actually "DID" something to the woman and fetus.

But my research now leads me to believe that he probably just sold the stuff to someone. That's a big difference than alleging he actually PERFORMED an abortion, don't you think? Mind telling us how this abortion was performed, exactly?

Darcy O'Neil said...

Ian,

True your family is at risk most of the time, but there are laws designed to minimize that risk. If those laws are followed then it works better. If everyone does what they want, then there are going to be issues. In this case all of your inquiries would have been met with assurances like "I'm a pharmacist and I use my own products" or we have a state of the art manufacturing facilities". I atteneded that site about 4 times and it was a hole. Everything was sold in a capsule so you couldn't tell the difference whether something was good or bad. But the sales pitch was very slick.

One thing I've noticed over the past 18 months is people don't beleive there are actually good people doing good things anymore. It's truly a sad statement on the state of this country. What I can tell you about myself is, and this may not help, I am an Ontario Government employee and work at a local casino. To work at a casino you have to pass a very thorough background check, including criminal. I do not have a criminal record. I also contacted Health Canada three months prior to quiting / being terminated. Health Canada recommended I contact the OCP to complete the process.

With regards to the seriousness of the issues, I think when over 13,078 unauthorized prescription products are sold then it's serious and not "silly". These are not minor infractions that can be overlooked. The fact that many of these customers had serious diseases and were fleeced for $50 to $100 per bottle of unproven medicine caused me some concern. You may not be aware but you can't market products with Schedule A claims (i.e. cancer). Otherwise everyone would have a cure and people who are facing death would take any chance to help themselves. Hence snakeoil and the easy sale (a sucker's born every minute). Expired products have a number of issues surrounding them that I won't go into, but I have an article on my website about it.

By the way Pharmacies are self-regulated according to legislation. i.e. the pharmacists run themselves. This is generally a bad idea. Why not have the inmates run the asylum.

As for the Black Cohosh procedure, it is done in combination with another herb called Penny Royal (yes the tea of the same name but far more concentrated). The user takes these two herbs early in the pregnancy. The reason it works is that these two herbs cause blood vessel damage, i.e. they rupture them. The fetus is very small and the blood vessels are very easily destroyed, terminating the fetus.

Aside from the legal issues around penny royal there is a significant danger to the user (it will burst blood vessels in the eyes and other organs). Black Cohosh in high does can do the same. If the procedure doesn't work (generally 40% chance) then the unborn child will have sever disabilities.

Now here's the worst part, pharmacists are not doctors and do not have any rights to diagnose and treat disease. This person asked specifically if she could take something that might terminate the pregnancy. She didn't want to go to a doctor because it was against her religion to have an abortion. But if she happened to take something that worke then it wasn't meant to be. That was her rational.

If someone comes to a pharmacy requesting the procedure then the pharmacist should direct the patient to their doctor and get proper counselling and if after that, a proper medical procedure. This pharmacy was putting a person's life at risk. Coat hanger or chemical it's all the same.

Anyway, it's a difficult issue to persue. There are at least three other witnesses but getting them to speak, and end up like me, isn't much of a motivation.

Here's a question for you. Doesn't it seem odd that a pharmacist can plead ignorance to selling hundreds of products that required a prescription? They have, by law, a required set of books to have at the pharmacy. One is called the Compendium of Pharmaceuticals, that lists all prescription drugs in Canada. Didn't he ever think about opening that book? The fact that they had a 10,000+ sq ft building that housed one million dollars in manufacturing equipment and nver bother to look into whether it required a license or not?

You can say there are two sides, and there always is, but he did many things very wrong and I contacted the appropriate authorities and got my ass kicked in doing so. Three lawsuit threats are no fun. But the odd thing is that of all the threats, neither my former employer or the OCP ever followed through, because they would be slaughtered. I have too much evidence in my favour.

Anyway, no good deed goes unpunished seems to hold true.

Darcy O'Neil said...
This comment has been removed by a blog administrator.
Darcy O'Neil said...
This comment has been removed by a blog administrator.
Lisa said...

I removed these last two comments because they were duplicates of the preceeding entry.

Ian Scott said...

Darcy.. there's a lot in your comments that I would love to respond to, from a philosophical point of view. But I'm too tired to do that right now.

You speak of issues that are dear to my heart. And I fear if I respond to them, I will wax far too philosophically, and pollute The London Fog's blog.

But I do have a question for you. Do not answer this right away. Be totally honest. I hope it even causes you to search your own self.

If the pharmacy had given you the 30,000 dollar severance that you asked for, would you be doing all of this?

You don't even have to answer the question. The question however, is legitimate. Don't answer right away. don't answer in some fit of "of course I would, as I believe in values" sort of thing.

But think about it for a long time, before you answer. Question yourself about that. Three days. Meditate upon that question. Get personal with yourself.

"If I, Darcy, had received the 30 grand I asked for, would I be going to all this work to prosecute my former employee?"

I dunno.. maybe you would. But if you would, why didn't you just stay, until the issues were resolved when you probably would have been able to do more "good"?

Why did asking for severance seem so important to you? Why not just quit on principle?

Think long and hard about this question. Please. I will be very disapponted in you if you offer a reply immediately. I want you to think about this for a day or two, or more.

And come back with an honest answer. An answer that only you can provide.

I'll get to your other ponts later. When I am more wide awake.

Best,

Ian

Darcy O'Neil said...

I don't really have to add more thought to it or get "person with myself", because I spend everyday thinking about how my actions affect me and my family. I'm not some anarchist.

First, like I said before, I contacted Health Canada in Feb. 2003, knowing that my complaint specified stuff that someone in my position would only know about. My boss would have terminated me had he discovered I filed the complaint. My concience is clear based on the fact I did the right thing by filing this complaint.

Would 30K and not be refered to as disgruntled, have made me not pursue this case so far? Probably not. But I still would have filed the OCP complaint and let them handle it without so much followup. In June 2003 I figured Health Canada was doing a good job and changes were being made. It was in the authorities hands. As for staying, I reason that if I wasn't part of the solution, I was part of the problem. I spent 16 months trying to help and I only increased sales while allowing the owners to continue their illegal actions. Greed is powerful. The cost of running a pharmaceutical company is high, quality control, cleanliness, traceability, etc all cost money. My former boss would rather buy a Lexus and stereo equipment than put money into quality control. But, if you are into beating your head against a wall, maybe you would have stayed longer than I did.

Now why have I pursued this so much? Because I've been threatened with three lawsuits, have terminated with cause on my record of employment, Mr. Polcz is stating I'm disgruntled to everyone, accused me of criminal actions, the OCP has violateded legislation that requires them to complete all investigations in 120 days. I've also been lied to by the OCP on many occassions, a government mandated organization.

Also, my former employer knew I was getting married and took these actions with malice. He never intended to follow through, just wanted to "scare" me. Well, I don't find that funny nor do I appreciate it. He hurt my wife and caused her a lot of worrying before the wedding. You probably don't know what it feels like to receive a legal threat where everything you worked for could be gone based on a court decision in their favour. Even though I did the right thing.

At this point I'm not really fighting my former employer. My issues are with the OCP and London Free Press. I'm sure by this point my employer is clean as a whistle. However, the OCP shouldn't be allowed to get away with their action. Much like your pursuit of poor government, I pursue the OCP to ensure that they run their organization properly. The London Free Press uses the "Free" in their name without realizing what it means. They're not so free if their lawyers won't allow them to publish Health Canada documents.

I'm not unlike you. You fight about the governments actions all the time. Why? Should government organization be allowed to send frivolous lawsuits to you. to get you to stop blogging? I doubt you would put up with that. Should the government officials be allowed to make millions of dollars through illegal activities and keep it? Should we forfit our rights and freedoms, specifically free speech, because a lawyer tells you that you might be liable if you speak the truth (tortious interference). You should look into this legal issue, it will destroy your right to free speech if you don't fight it. Have you ever seen the movie "The Insider"? Same issue with publishing the story in this case.

You seem to beleive I'm still fighting my former employer, but it's only a small part of the overall action. The OCP misbehaviour, mismanagement, poor decisions and inaction is my main cause right now.

Second, is the London Free Press, and their inaction. This is/was news, but because of lawyers it will never get out, unless I fight for it. Do you want a repressed media? The government will only be a small irritant compared to money grubbing lawyers who protect their clients with aggressive tactics. I've seen it three times in the last year. You may fight, I definately fight, but the majority of people will not fight. That's when our freedoms go down the toilet.

Like I said before, the Polcz are probably clean now. Health Canada conducted an additional followup a few months ago and the OCP will be conducting an unannounced inspection within a year. I have done my part. Now I fight for the principal.

Darcy

Ian Scott said...

Ok. But.. still trying to figure out the abortion assertion you made. Would you explain more about that, and how this illegal abortion was actually performed?

Darcy O'Neil said...

First, pharmacists are not allowed to perform any medical procedures. A procedure doesn't mean cutting or stitching. Most of the time it's prescribing drugs to treat a disease, like cancer and chemotherapy, no cutting just chemicals.

In this case the lady asked for a specific procedure and the owner of the pharmacy willingly provided the chemicals to do so, without authorization from a medical practioner. It's against the law and ethically very poor judgement. You may say that people can do whatever they want, and it's true no-one can stop them. But, a pharmacist has accepted the Code of Ethics required to practice and this goes against the code.

You are looking at one very small issue that isn't really involved in this whole case. My concern is the thousands of people in London who received unauthorized drugs without knowing it. And a pharmacist who claims to be ignorant of the laws that govern his business. That seems a little fishy to me.

Anyway, this is my last comment. Everything being debates is philosophical and this has nothing to do with philosophy. These pharmacists broke the law, admitted to doing so and are being allowed to keep the millions of dollars they made and continue to practice. The people who were harmed or fleeced will never know. Doesn't make sense.

Ian Scott said...

Your last comment huh? Ok. Philosophical? Ok. What is the law based on, Darcy?

I break the law every day. I bet you do too, when it is a law that isn't convenient for you. And it's minor. I bet you don't come to a complete stop at the white line ALL the time. I bet you exceed the speed limits sometimes. I bet if some narrow minded cop pulled you over for doing 1 Km over the speed limit, you'd be pissed off. Philosophical? Perhaps. Philosophy and reality do meet at times.

As i said, i don't know enough about the Pharmaceutical industry. But it seems to me that there are probably many regulations that aren't enforced stringently, just like most cops won't pull you over for 1 KM/hour over the speed limit. Would you like them to do that? It IS THE LAW, you know.

As well, your definition of "procedure" with regard to abortion is odd, in my books. You say I am looking at one very small issue. Sorry bud.. but you're wrong. Illegal abortions are CRIMINAL. That is far more serious, in the eyes of most people, than any other law or regulation. In fact, I am focusing in on your most serious allegation, Darcy. You alleged a criminal act occurred. And not just summary conviction, either. But an indictable offence!!

But for some reason, you want to say that I'm focussing on a minor issue?? I'm sorry, but I have a problem with that.