Generic Paxil Suicide Lawsuit

Citizens Commission on Human Rights Award Recipient (Twice)
Humanist, humorist

Saturday, February 28, 2009

Priorities of Drug Regulators

Regulation: A rule designed to control the conduct of those to whom it applies. Regulations are official rules, and have to be followed...

Unless of course you are part of the team at Health Canada, the FDA or the MHRA, it seems.

Exactly what 'regulations' are put in to place at the three regulatory drug bodies above?

One would assume that they regulate the drugs people take but are they merely regulating the drugs that people make as opposed to regulating the pharmaceutical companies that make them?

Quite a bold question but all will become apparent in this latest rant of mine.

A story has just surfaced on CBC News, Canada, that is quite alarming. Although it centres strongly on Health Canada and the FDA it is quite conceivable to rope the MHRA in too.

The story centres around the sale of cheap drugs on the Internet and how online Canadian pharmacies are cashing in on this booming trade. One has to question Health Canada for overseeing this. Basically, drugs are cheaper in Canada than the US, so they make an awful amount of money by selling drugs online to the Americans. Paxil, Zoloft, you name it, they are all there.

Now things are at a delicate stage where the whole SSRi withdrawal protocol is concerned. As I understand proposals have been put forward to the BNF to amend the wording regarding withdrawal from SSRi's and the MHRA did promise me that they would meet with David Healy to discuss a tapering programme. As yet, no meeting has been secured. Anyway, I did tell the MHRA, or at least their former communications officer, that just because I had met with them it would not mean that I would stop writing about them if something niggled me and I thought it was newsworthy. I'm beyond lambasting individuals that work at the MHRA but will call Kent Woods, the CEO, to task if I think they are not doing their job properly. The buck, after all, stops at the head honcho does it not?

Anyway, I digress.

Today's rant sees me homing in on online pharmacies and how they are regulated. These, however, are not the pharmacies selling obesity, anti-baldness or erectile dysfunction drugs. These are online pharmacies that are selling popular drugs such as Paxil and Zoloft.

Late last year the MHRA teamed up with pharma giants Pfizer and made a special advertisement that was aired throughout cinemas here in the UK. The crux of the message was don't buy your drugs online. It was plainly obvious that Pfizer's Viagra was the subliminal message behind this footage.

I'm all for stamping out fake drugs but I am also all for regulating the 'proper' drugs we take too. It seems the MHRA, FDA and Health Canada much prefer to home in on the illegal sale of drugs over the Internet rather than the regulation of pharmaceutical drugs... that is after all their primary role is it not? They may argue that stamping out fake drugs is also a role of theirs - my argument is that it seems to be taking precedence over a much bigger problem!

The U.S. Food and Drug Administration's [FDA] official line on buying drugs over the Internet is if you're an American buying drugs online, you could be paying for:

Counterfeit drugs.

Medicine that's too strong or two weak.

Drugs made in unsafe conditions.

Drugs that are beyond their best-before date.


Two arguments that are both feasible here:

1. The regulators have to protect the public safety so monitor fake drugs over the Internet, coming down hard on those that are caught.


2. The regulators are merely protecting the pharmaceutical industry who see small online businesses as competition.

The regulatory authorities are funded by pharmaceutical companies, in other words, any drug that comes through the door needs investigation by the regulator to see if it is safe and effective. Pharma pay for that investigation process. Unfortunately, many bad drugs have slipped through the system and onto pharmacy shelves because the regulators have had the most important data kept from them... by the very same people who have paid them to 'investigate the data!'

There is no conspiracy here. This is fact.

Two stories highlighted on this blog only yesterday is testament to that fact. [1] [2]

The FDA says there's nothing wrong with buying online, as long as the website is located in the United States, is licensed by the state board of pharmacy where the site is operating, has a licensed pharmacist on hand to answer your questions and requires a prescription from a doctor who is licensed to practice in the United States.

So, in essence, if any website meets the above criteria then it's okay to order... or at least be diagnosed with an illness that they just happen to have the cure for.

Question I have for the regulators - Why is this allowed to happen and why are you not making waves to stamp out this problem?

One would have thought that pharma would have been right behind you financially?

One has to take a step back and look at the bigger picture here.

Online pharmacies that are selling the likes of Paxil and Zoloft are, in the main, making money for pharma. Online pharmacies that sell anti-baldness, obesity and erectile dysfunction pills [of which there are many] are fleecing the pharmaceutical companies because they are much harder to regulate.

The FDA, MHRA and Health Canada should get their priorities in order if they want us to believe that they are looking after the welfare of the public. Too many drugs are slipping through their own 'robust' regulatory system and into the mouths of men, women and children. These same drugs [granted a licence by the regulators] are causing heart attacks, severe adverse withdrawal reactions and in some cases death! Far more than any online 'entrepreneur/s' who is/are selling fake tablets.

Yes, it's wrong to sell bad drugs. It is also wrong to grant a licence to bad drugs. Something Health Canada, the FDA and MHRA have done time and time again.

Face it, their reporting systems are out of date and largely ignored because to actually believe that a drug that they licenced in the first place is causing harm to an individual or individuals would show how flawed the regulatory system is.

Meantime, doctors prescribe us drugs such as Paxil [Seroxat], Zoloft, Vioxx, Seroquel, Lexapro and a whole host of others. Drugs that have been 'investigated' with money given to the investigators by the very same people who manufactured the drugs!

The regulatory systems in the USA, UK and Canada ARE NOT robust. Far from it.

Just ask the parents of any child who has died as a result of the regulators granting a licence to a drug that killed them, ask the grieving widow of a husband who killed himself as a result of SSRi use.

I get no satisfaction out of pulling up regulators for their failures, I just get a sense that they might one day listen to what the patients have to say rather than protect what pharma have to sell.

The Industry [pharma] commit the crime, the regulators aid and abet it.

It really is as simple as that.


Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal



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