'How do you feel about being a guinea pig?'

That's the question I ask my friends when they tell me they're on the latest medications to hit the market. As an aside, many of them have been on the NSAIDs (Non Steroidal Anti-Inflammatories) and, of course, the new COX-2 Inhibitors such as Celebrex,Vioxx, and Bextra, the latter two no longer on the market. This is the 'traditional' arthritis treatment, of course.

There's no doubt in my mind that they and the general public have placed too much faith in the regulatory authorities of Canada and the U.S - never mind the pharmaceutical companies - when it comes to trusting the efficacy of the medications they're taking. When I think of the U.S. Food and Drug Administration (FDA) and its record, and the extent to which Health Canada painfully follows their lead, I worry that the pharmaceutical industry has far too much influence on both country's regulatory systems. The FDA approval process is a de facto rubber stamp, and the Canadian approval process is veiled sufficiently to disguise any possible subjectivity. In Canada we have to use the U.S. Freedom of Information Act to access drug submission information. Processes like these make it difficult to get a handle on the issues surrounding the over 180,000 deaths annually from adverse drug reactions - the deadly tip of the 2 million hospital admission for adverse drug reactions iceberg..

Here's the Readers' Digest version of the drug approval process in North America: It's incomplete and admittedly inadequate, but the summary will give you a feel for the regulatory process.

The process, by the way, can take up to 12 years and a lot of money to be sure: $24 billion in R&D by the pharmaceutical companies in 1998. And while they are the most profitable companies in our economy, there's no doubt their industry is a high risk one.

Pre-Clinical research takes 1-3 years, averaging 18 months with research done on animals, followed by three phases of human testing followed by FDA review. Drug testing goes from the lab to animals to humans as one should expect. Animal testing is done on at least two species largely to assess how the drug gets absorbed and eliminated by organs. Of course, potential toxic effects are identified as well. Here the FDA conducts a safety review before allowing human testing to begin and New Drug Application (NDA) to be issued and controlled clinical trials can begin on humans.

Phase 1 Clinical trials identify how the new drug works on the human body and how the body gets rid of the drug. Phase 2 of the these clinical trials assesses effectiveness and safety of the drug, in addition to quantifying side effects. This phase involves a small number of people who may or may not have the disease or condition for which the drug is intended. Phase 3 is clearly the most important phase in the testing process and trials involve anywhere from several hundred to several thousand people to determine possible side effects and the overall effectiveness of the drug. However, there is no way these trials can identify all the possible side effects and adverse reactions that the drug would encounter in general use. Until 1992, the time period between NDA approval and FDA approval averaged just under two years. But that was then.

Today, in a period where many more drugs enter the market in the U.S first, pressures to speed up the approval process have begun to exert themselves. The pharmaceutical lobby, AIDS, and public demands for quicker drug approvals have led to a confluence of political compromises concerning the drug approval process. The FDA, first and foremost, has morphed into a partner of the pharmaceutical companies, a far cry from its original and truly regulatory function. Safety is now a secondary consideration. And while there are important exceptions requiring 'speed-up' for drug introduction and approval, public safety must remain paramount.

Today, regulatory systems are in crisis. Drug safety monitoring is minimal and cumbersome and the public is inured to the risks associated with drug use. Serious adverse drug reaction is simply a fact of life today and it shouldn't be. Today, most people taking medications are on multiple drugs, so now interactions are ostensibly studied when they are on the market. The trouble is it's the general population that's now the trial group.

Identifying reactions difficult and usually takes a few years to identify serious problems. A further complication is that less than 1% of adverse drug reactions are reported to the FDA's Office of Postmarketing Drug Risk Assessment because of US voluntary reporting system - Doctors see an adverse drug reaction and they have to fill out complicated forms if they want to report the reaction. Usually what happens to newly introduced drugs is this: if a serious adverse reaction is identified the product label is changed and an insert carries an advisory. The FDA rarely takes a drug off the market. After all, they approved it! This wasn't such a huge problem 15 years ago when, before 1990, only 3 or 4% of all new drugs into North America were first released into the the North American market. By 2002 it's 66% of drugs first released into North American market, so you can see how this has become a problem.

Again, in the last few years we've experienced. 2 million hospital submissions due '*solely* to adverse drug reactions, and 180,000 of them result in death.

I earlier alluded to the U.S. FDA - Canada Health relationship. Both are now in lockstep with the pharmaceutical companies now given the FDA's 'partnership' role with U.S. industry. The Canadian Medical Association Journal (CMAJ) reported on a joint review under the terms of a memorandum of understanding that Canada and the United States signed in April 2004 concerning their intention to reduce 'bureaucratic hurdles' - read 'impediments and critical scrutiny' - "for manufacturers applying to have new drugs approved in both jurisdictions, and to bring new drugs to market faster." (CMAJ 2004; 171:121). We boomers are an unhealthy lot and there certainly are pressures to introduce drugs to alleviate all those aches and pains associated with chronic degenerative diseases that will afflict almost 90% of us - if you buy into the 'attack medicine paradigm'.

Here are two articles that give you a feel for what the regulatory landscape looks like.

Women's Health Protection Groups have called for more transparency in the Canadian drug approval process.
http://whp-apsf.ca/en/documents/transparency.html

Canada's drug approval process too hasty says Mary Wiktorowicz, a York University professor who recently conducted a study comparing drug approval and recall rates in Canada with those of the United States and several countries in the European Union.

Her study is reported in an article by Christine Maki at http://media.www.thevarsity.ca/media/storage/paper285/news/2003/10/30/Science/Canadas.Drug.Approval.Too.Hasty.Says.Prof-543377.shtml

So remember, the next time you get that prescription for that miracle drug you saw advertised on TV, remember, only 50% of the problems remain unidentified. Dr. Ray Strand wisely suggests that you should wait 5 years before you take any OTC medication to reduce your chances of next being in a hospital bed.

On that last note, for an easy and informative read, I recommend Dr. Ray D. Strand, M.D., Death By Prescription: The Shocking Truth behind An Overmedicated Nation. 2003 Thomas Nelson Publishers.

Advertising Prescription Drugs!

I'm sure you've noticed the marked increase in direct to consumer (DTC) pharmaceutical advertising on TV. I'm sure many of you are like me when I wondered why they were advertising drugs I couldn't buy without a doctor's prescription. Well, it just so happens pharmaceutical companies like making money. That's not a bad thing in principle, of course. Nor is it a bad thing that they want to advertise and market their products. They are good at what they do and they are the most profitable companies around- more profitable than banks; more profitable than the oil companies! No mistake about it, their advertising helps them sell their products in a very competitive marketplace. After all, there are usually many alternative therapeutic strategies available to consumers. But just because you have the bucks shouldn't mean 'anything goes', especially if you consider that the #3 cause of mortality in the US and Canada is death by doctor prescribed drugs and misuse of drugs, running behind only heart disease and cancer as causes of death.

Some highlights:

* The latest advertising figures show the industry is now spending over $3 billion, doubling and tripling their advertising budgets. In 1991 the drug companies spent a measly $55 million. And you wondered why you were seeing more ads lately!

* Prescription drug advertising is now a major force in North American medicine, directly impacting consumer behaviour.

* Americans spend $500 billion on drugs. I know in Canada, provincial health spending is overwhelmed by increases drug costs - particularly drug costs associated with providing medical services to people suffering from chronic degenerative diseases. Those medical services account for 60% of their annual expenditures. I'm sure that's a similar total in the US, albeit one privatized to some extent..

* The average number of prescriptions per person has increased from 7.3 in 1992 to 10.4 per person in 2000.

* Doctors prescribe the brand name the patient names 70% of the time!

Dani Veracity has written an informative article for NewsTarget.com describing this startling trend in marketing prescription drugs. It's here at http://www.newstarget.com/010315.html I hope you get a chance to read it. Lot's of great information there.

Consumers are conditioned to want results and doctors are more easily manipulated than you think. She argues doctors are 'seduced' by the advertising. And so too is the media. Witness the power of the pharmaceutical advertisers as clearly illustrated by JAMA's publishing of a specious meta-study on antioxidant efficacy as mentioned in my previous post. Media bias and 'scientific independence' are skewed by their economic clout. This subtle type of bias sometimes becomes more blatant. Criticism of their products carries a price.For example, as Veracity notes in her article, a former editor of the Journal of the American Medical Association (JAMA) alleged that Pfizer, a major pharmaceutical company, had withdrawn $250,000 worth of advertising because an article appeared there had been critical of one of their new drugs.

Canada doesn't allow direct-to-consumer drug advertising. In fact, only the US and New Zealand allow this. It hardly matters though to us Canadians because we are exposed to virtually the same amount of US based adverising as the average American. Those regulations are in place throughout the world for good reasons and they have more to do with protecting the public interest than worrying about the profits of drug companies. I look forward to the day when the US authorities take their public responsibilites more seriously and regulate this type of advertising. I think the average person would agree if they knew how these products got into the marketplace in the first place. But that's another story.

JAMA Meta-Analysis Attack on AntiOxidants

You may have heard about a recent Feb. 28th, 2007 article published in the Journal of the American Medical Association (JAMA) on the apparent dangers of antioxidant supplementation. It's no surprise these kinds articles and news reports surface spectacularly from time to time given the nature of the media and the economic imperatives of those whose interests it serves to publicize any article or comment that even so much as hints at problems associated with nutritional products as a whole. The media clearly served as an ally of those interests in this case.

We need to remind ourselves that these kinds of products are blamed for one or two deaths every year. Of course, these same products are often in direct competition with doctor-prescribed drugs, which also happen to be the 4th leading cause of mortality in the U.S. Actually, they are the 3rd leading cause of death when you include misuse of drugs with those deaths. There's a rich irony there somewhere on the old 'negative publicity' spectrum.

What shouldn't be too big of a surprise is that the shot was fired by JAMA - a publication and organization that not long ago took the bold step of renouncing its long-standing opposition to supplementation - actually recommending supplementation to its readership. You had the feeling it did so only because it wanted to maintain a minimum of credibility. But remember, JAMAs main source of revenues is from paid pharmaceutical advertisements, and he who pays the piper plays the tune. And so there it is: one more specious report and one more feeble attack on the idea that there are alternatives to their drugs in the fight against degenerative disease.

Here's a great editorial response to the article by Bill Sardi of Knowledge of Health Inc.
http://www.knowledgeofhealth.com/report.asp?story=What%20Was%20the%20Message%20from%20the%20Antioxidant%20Meta%20Analysis&catagory=Health%20Agencies

The Council for Responsible Nutrition (CRN) also responded to new meta-analysis examining the effect of anti-oxidant supplements on all-cause mortality. Here's their response:
http://www.crnusa.org/PR07_JAMA_antioxidant_metaanalysis_022707.html

Bad science will always be used to argue a point. Sadly, JAMA, by publishing this egregious article, has allowed itself be used as a vehicle for pharmaceutical industry propaganda. Advertisers, it seems, must be tended to, and JAMA has shown that it's not above entering the fray from time to time to score some 'customer points'. The timing is always good when you can supplement - sorry for the pun - pharmaceutical industry 'direct-to-customer' ad campaigns with news stories supporting the false notion that antioxidants will help you die sooner. After all, that's where the big money is, isn't it?

The NutraBlog

Welcome to my first attempt at blogging!

Why 'NutraBlog'?

I have a passion for nutrition; its benefits, its potential, and its politics.

What I'd like to do here is post my comments on news of the day in nutrition and interesting articles I've come across. I'd also like to take this opportunity to invite others interested in this fascinating area to post their comments as well. Your comments and participation are most welcome.

A brief note about me - a disclaimer if you will. I make no claims to expertise on nutrition in the traditional sense. I have no formal training in nutrition or suffer from any chronic degenerative disease. So far as I know I am perfectly healthy! What I do have is a point of view, and I would like to use this blog as a vehicle of expression for myself and others interested in the potential of nutrition in battling chronic degenerative diseases and maintaining people's general health.

There. I hope I haven't been too wordy! So here we go....