Fake Sildenafil: Raising the Flag

Those who buy erectile dysfunction drugs (or any other drugs, for that matter) over the internet need to read this Pfizer-sponsored research. If your attitude is "It's worth a try - what harm can it do?" the answer is plenty.

The research details how many counterfeits are out there and just how substandard almost all of them are. Only around 10% of all sampes tested were within 10% of the stated dosage strength for the active ingredient sildenafil. About 25% had no sildenafil at all. Remember, these are counterfeits labelled as genuine Viagra(R), not herbal remedies sold as cheaper alternatives.

Talcum powder, commercial-grade paints, paracetamol (acetaminophen) and metronidazole, an antiprotozoal/anti-infective, have been found in counterfeit Viagra(R), as well as large quantities of other unidentified impurities . Metronidazole has significant adverse effects when combined with alcohol, whereas overdose of paracetamol can cause potentially fatal liver damage. Printer ink has been found in some samples - it is used to colour the tablets their distinctive blue.

The low quality of counterfeit products is not surprising - that's one of the reasons why they are so profitable for criminals - but this report puts alarming numbers on the problem.  Even allowing for potential conflicts of interest, since this report is from Pfizer, it should act as a further red flag to those who buy their medicines from internet.

Fat Profits For Counterfeit Victoza?

The newly approved Novo Nordisk product, Victoza(R) is set to be a blockbuster. Indicated for type II diabetes, in conjunction with exercise and diet control, it addresses a huge and growing global market. As we collectively get fatter and the prevalence of type II diabetes goes up, there will be a rising demand for products like Victoza(R) and this looks like a good step forward in treatment.

However, the internet buzz about Victoza(R) giving more effective weight loss than existing therapies such as GSK's Alli(R) will also drive demand for "off-label" use - by people who don't have type II diabetes but want a more effective diet pill. Since physicians are not supposed to prescribe Victoza(R) for weght loss alone, there is a danger that people will look for it in unofficial channels such as internet pharmacies. 

New "lifestyle drugs" always attract counterfeiters into the market, eager to exploit the embarrassed and the unwary. Don't get Victoza(R) from anyone except your regular physician. If you need it, you'll get it, but if she won't prescribe it, that's for good medical reasons. Don't risk your health by looking elsewhere.

Tips for Avoiding Fake Drugs

Don't fall victim to counterfeit drugs.  Here are some of the things to think about when buying and consuming drugs.

• Do I need this particular medication?
Many medical conditions are accompanied by internet myths and legends regarding supposed new treatments or cures. Aimed at the desperate, these can lure the incautious into putting faith in untried remedies. The first step in avoiding counterfeits is to seek the advice and endorsement of a qualified medical practitioner for any medication you wish to take.

• Is my desired medication approved and available in my country?
If you live in a developed country, and your national regulator has not approved the medication you want, there is likely a very good reason. If you live in the United States, you are part of the world’s most commercially attractive and profitable medical marketplace. Manufacturers usually want FDA to approve their drugs so they can gain access to the US market. If the drug doesn’t appear on the FDA approved drugs database, known as “Drugs@FDA” then this is a major warning sign.

• Is my source and method of purchase a safe one?

There are reputable internet pharmacies, but unfortunately on a global basis these are in the minority. There are a large number of bogus sites which may be involved with various criminal activities including money laundering, selling counterfeit products, credit card fraud and identity theft. Order drugs via the internet only with extreme caution. Unless the identity of the site is known and can be fully verified (by making a call to a pharmacist, for example) then it is safer to assume that it is not a genuine site.

Beware: counterfeiters will also fake their online accreditations. Take nothing at face value and check everything out until you are satisfied. Has the site asked you for a medical prescription or other documentation? If you are asking for medication which requires a medical prescription in the jurisdiction in which you live, and you have not been asked to provide any paperwork, then ask yourself why not?

• What does the packaging look like?

Does it look as though it has been opened or tampered with? If there is a plastic “shrink sleeve” around the neck of the bottle, check that it looks like an original and has not been re-sealed in any way. If it is a liquid product with a rubber seal, look for needle holes or damage to the aluminium collar. Does the package or bottle look scuffed or dirty, like it has been recycled? Criminals sometimes re-use medical trash. If you’ve used this drug before, does the packaging you received this time look exactly the same as previous ones? Look for small differences – different fonts, changes in text size, mis-spellings, colour changes, logo not quite right etc. Is the manufacturer’s label on straight, as it should be for machine-labelled genuine drugs? If not, it may have been re-labelled by hand.

• What does the product itself look like?

Does the shape and size of the pill look right? Is it the same as last time? Do the pills all look the same as each other? Genuine drugs have a consistent appearance.  Are the pills cracked or chipped or crumbling?Has the pill colour changed compared to previous prescriptions? Manufacturing of genuine medicines is highly controlled and they should look the same every time. Even subtle changes from the usual appearance can indicate fake product

• When taking the drug:

Does it smell or taste different? Does it behave unexpectedly (e.g. dissolve differently)?

• After taking the drug:

Did you experience any adverse effects? Minor but unexpected effects (headache, nausea, dizziness etc) from a new batch of a medication, which you have taken regularly without previous problems, may be a sign of fake or sub-standard drugs. More major adverse events should always be followed up with a medical consultation. Often, these events are explainable by other factors, but in some cases fake drugs may be to blame. If you have an adverse event, keep all drug packaging and tell your medical practitioner of your concerns.

Photo: zimpenfish

Fake Drugs in Africa - A Local Perspective

For an African perspective on the fake drug problem, see a very interesting and professional video called "If Symptoms Persist" at http://www.mpedigree.org/home/symptoms.php. This isn't brand new but provides a great local viewpoint (especially the first two-thirds of the 30 minute show) on the counterfeit problem in Ghana and its impact on issues such as malaria and public health. In my experience, the concerns, attitudes and priorities expressed are true of all African states. China is highlighted as the main source of the fake goods.

We need to address the counterfeiting problem now where it hits home hardest (in Africa, Latin America, Southeast Asia) and at its main sources (in China and elsewhere) or it will spread like a virus. Like a new infectious disease, fake drugs have the potential to kill millions unless we take quick action. 

Two Silent Pandemics

A Reuters article discusses plans by global drug companies to reduce their prices for some drugs in developing countries - particularly those drugs aimed at chronic diseases.  The World Economic Forum thinks that conditions like diabetes, cancer, obesity will become a "silent pandemic" in developing countries as life expectancy improves.

Unless we are really careful, the second, unintended effect of price reductions in developing countries could be to set up a very profitable criminal arbitrage.  The conversion of low priced but genuine product, intended for third world markets, into higher-priced, identical products for the USA (for example) is a fantastic profit opportunity for organised crime and a potential second silent (but deadly) pandemic.

I support price reductions for the developing world - it will help to reduce the level of counterfeit drugs there and bring better healthcare to millions - but we must think through the consequences as well.

Maybe the global drug industry will become a much lower margin business.  That would please some, but it runs the risk of stifling investment and the killing the creativity of the pharmaceutical industry - love them or hate them, we all need "big pharma" if the cures of tomorrow are to be developed.

Better to make sure that governments and the drug industry invest in strong anti-counterfeiting and anti-diversion measures to accompany any price differentials, to minimise  easy profits for the criminals.

Photo: tobyotter

Alli Money

The FDA issued a warning recently about fakes of the GSK weight loss product Alli in the US, apparently bought online.  The weight loss market is a prime target for counterfeiters because many people would prefer to buy online rather than have the embarrassment of a visit to the doctor.

It seems that the counterfeit product contains sibutramine, a potentially dangerous controlled substance.  The outer packaging of the fake Alli was pretty accurate, with only a couple of minor differences to the real thing: a missing lot code and a wrongly formatted expiry date. The other differences were a very slightly different thread on the bottle neck, and a different sealing foil. 

Only when the capsules are broken open does the difference become obvious to the casual observer - the GSK product has neat globules and the fake is powder.  How many of us would have spotted that? Most of the time we just swallow our pills or capsules without a second thought.

This incident highlights, once again, the need for vigilance in rooting out fake medicines.  If it looks wrong, or different from last time, take it back to your pharmacist or report it to the authorities.  FDA has a mechanism for doing just that on their website, as does MHRA in the UK.

And if you are thinking of buying medicines over the internet, my advice is simple. Don't.  There are some legitimate online pharmacies but they are heavily outnumbered by people who would sell you anything to make a buck.

Deep Thought

In a few weeks time, I will be forty-two. By my reckoning, that's about 50% of the way through my life expectancy if I'm lucky.  I'll be exactly half my grandmother's age and probably almost twice her height. Scientifically, using tabloid newspaper statistical methods, that means by the time I die I'll be huge.

Elvis died at 42.  Maybe, if he'd lived, the King would be still be cool at seventy five this year, or maybe he'd be turning out embarassing elevator muzak, but sadly we'll never know.

As all Douglas Adams aficionados know, "42" is also the answer - after 7.5 million years of calculation by a specially built supercomputer - to the Ultimate Question of Life, The Universe and Everything.  So I'm hoping for big things in the next twelve months. 

Unfortunately, as in the book, the Ultimate Question itself remains frustratingly unknown for most people.  Maybe this is why many men have a mid-life crisis at around my age. But a Porsche 911 doesn't fit my new (and largely bogus) green image and the current Mrs Davison has also put her foot down firmly and pre-emptively on the notion of a trophy wife.

Photo

Swallowing Your Medicine

There is an interesting article in this week's Economist  about smart pills - intelligent, ingestible devices which can can relay data to other devices outside the body, and thus onwards to medical practitioners. Eventually all pills and capsules might be tracked this way.(http://www.economist.com/businessfinance/displaystory.cfm?story_id=15276730, subscription may be required).

The pill technology has been thoroughly developed, but it looks like the budget for the receiver device was sacrificed (see left).  Photo: aeu04117

On a serious note, this stuff could be a step forward. It is thought that at least a third of prescription drugs are not taken correctly, or at all.  This leads to revenue losses for drug companies but also, more importantly, to sub-optimal treatment for the patient. Any device that can aid timely administration of medicines should help to improve treatment outcomes and thus lower healthcare costs overall.

Positive benefits:
Closer medical supervision; better patient compliance with dosage regimens; easier identification of adverse events

Negatives:
Potential for privacy intrusion; repeated texts and emails from MegaCorp/your doctor/your mother, asking you why you haven't taken your dose of PanaceaRx today.

One of the applications mentioned in the article is a service launched by a telco in Mexico which allows customers to determine whether they have influenza by using their mobile phone. Barring any eye-watering iPhone rectal thermometer app, I 'm not sure how this works.  Having had H1N1 flu this summer, I can confirm that a four dollar digital thermometer (sub-lingual) is all you need.

If this were a drug would you develop it?

Try Googling "live longer" and you will get so many hits that you'd need a very long life just to view them all.  Clearly there is a lot of interest in health and longevity and all sorts of people, from the well-meaning to quacks and charlatans, are lining up to take advantage of it. Diet, lifestyle, exercise, faith, alternative medicine - all are staking a claim to help us live a better and longer life.  But do any of these things stack up?  What if I were leading a pharmaceutical industry research team, and we examined the evidence for each claim as if it were a drug candidate? Would I recommend any of these approaches to the CEO for further investment?

For another project, I am doing some research into nutrition and alternative medicines.  I'll check out the claims for anything that one can swallow and digest, basically.  I'll be looking to see what, if any, scientific basis these claims may have, based on scientific literature evidence.   I'm leaving out psychological, exercise and faith-based life extension, to keep the project manageable. 

I won't be doing any amateur clinical trials on human guinea pigs because (a) it is generally frowned upon by most of the worlds regulatory and judicial systems and (b) lifespan research takes a long time (the clue is in the name) and you and I have short attention spans.

Personally, I am a fan of walnuts after meeting an academic who raved about their positive nutritional benefits. I have them every day on my breakfast cereal. I will either live forever or die choking with an ironic expression on my face and milk on my trousers. If you have any personal favourites (with or without evidence of efficacy) please pass them on and I'll take a look.

Picture: steffenz

How Not To Be A Dumb Slog Millionaire*

Sometimes you need to step back and examine your motives.  Why do I run around doing stuff that doesn't really need doing and isn't fun?   Am I working to live or living to work? 

I have been reading "The 4-Hour Work Week" by Timothy Ferris - see http://www.fourhourworkweek.com/ for details and a great blog. I bought it on a random whim from a bargain bookshop (sorry Tim). The title did its job and hooked me in, but I confess that my first thought was the quote from Wayne's World: "Yeah, and monkeys might fly out of my butt".

Tim's concept of lifestyle design is very thought-provoking.  Even if you are happily cruising in the fast lane of the rat race, I recommend you check it out. Many of the streamlining techniques can be applied even if you don't want to quit your job.

The basic thesis is that stuff you don't enjoy doing should be eliminated or outsourced.  You should focus on your personal "core business", in MBA-speak. This doesn't mean you hang out in your pyjamas and watch Countdown / Days of Our Lives / Neighbours - delete as appropriate. It means freeing your time to do what you want to do, not what you have to do, by making cash creation a much more efficient part of your life. If you don't enjoy your job, why are you spending ten, twelve, sixteen hours a day on it?

Should you wait for the pot of gold at the end of the rainbow, or make time to enjoy the beautiful spectrum of vivid colours along the way? Since I live in rainy England, I will likely get many chances for rainbow examination.  I'll let you know how it goes.

*The "Dumb Slog Millionaire" nickname was originally coined for English cricket's star batsman, Kevin Pietersen, after some spectacularly ill-advised shots at critical moments.

Large decarb, to stay, please

Since changing my job at Christmas my carbon footprint has reduced, by my estimation, to around 15% of its previous value.  The carbon contribution of the two flights (or more) per week of my business development job was huge, dwarfing all other activities. 

I'm not exactly a tree-hugging vegan, but I've tried to do my bit for the environment over the years.  Nobody has recycled more whales than me.  It was, relatively speaking, a total waste of time trying to be green while I was flying around everywhere. Hopefully, now that I have a more sensible existence I can make a smaller impact on climate change.  Sorry, Earth, for my previous behaviour.

The carbon calculator on http://www.carbonfootprint.com/ is very easy to use and quick and takes into account most of the main carbon sources. 
(Photo: Francois Roche from Flickr)

Fake Drugs, Real Lives

Fake drugs have never been so prevalent, but we rarely hear about the true cost in lost and damaged lives. The news media usually fits fake drug stories into other pigeonholes: sex and health for erectile dysfunction drugs, foreign trade for counterfeits from India or China. When we get a personal angle to these stories it is usually from the white world.

The true cost of fake drugs is measured not by bedroom disappointment or boardroom dollars but by lives unlived. These tragedies are occurring mostly in Africa, Asia, and Latin America, away from the Western media spotlight.

Malaria is a mostly-curable disease that disproportionately afflicts the young. Effective drugs exist but are widely counterfeited. How many children in developing countries die needlessly of malaria because the drugs that should save them are fake? No-one knows, but my bet is that if it was American kids that were dying then we would know more about it and something would have been done about it by now.

It's time for a global initiative to stamp out fake drugs. Yes, I know that various pilot programs are under way and data standards are under discussion and the supply chain is complex and blah blah blah. This problem is solvable. We should do it now.

Photo: ephotography from Flickr