Tuesday, 7 August 2012

Can You Trust Your Drugs?

It’s not uncommon to hear of a food item recall—a bit of glass or metal is found in your jar of instant coffee and supermarket shelves are cleared of that “batch”[i]. Everything from eggs[ii] to pet food[iii] is “recalled” when salmonella contamination is detected. Chinese parents are still reluctant to buy Chinese-made baby formula after the 2008 melamine-in-dairy foods scandal[iv]. Yet when it comes to the drugs we take, self-monitoring by producers and overseeing bodies such as the US FDA seems to be disturbingly lax.

Although 60 Minutes apparently ran this story a year ago in the U.S., I just came across it the other day on the net. Drug manufacturer Glaxo-Smith Kline had serious breaches of protocol in a major manufacturing plant in Puerto Rico. Without insider Cheryl Ekhart’s brave whistleblowing, the plant could still be putting out adulterated and mislabelled drugs, including medications like diabetes drug Avandia, antidepressant Paxil (paroxetine), and non-prescription antacid medication Tagament being put in each other’s bottles, with each other’s labels, and with dosages mislabelled. In one case, an 8-year-old boy prescribed 10mg of Paxil was actually getting 25mg Paxil CR. Watch the story here.

Glaxo pleaded guilty to fraud charges and settled out of court with a $750 million dollar fine. Sadly, this sort of practice is “business as usual” for pharmaceutical companies, and Glaxo is one of the worst. This year (2012) they agreed to pay a record-breaking US$3 billion in fraud settlements[v] for promoting off-label use[vi] of their drugs (such as Paxil for children!) and failing to report detrimental safety data on their drugs. Abbott Laboratories settled for $1.6 billion (misleading marketing of anti-seizure med Depakote), and Johnson & Johnson may be fined up to $2 billion over off-label marketing of their antipsychotic Risperdalv.

The fines keep going up, but drug sale profits more than compensate for the fines. In a 2009 article by David Evans[vii], he reported that the total of US$2.75 billion paid by drug giant Pfizer in fines up to that point accounted for just a little over 1% of the company’s $245 billion revenue generated between 2004 and 2008.

Pharmaceutical companies are big businesses. Although improving your health is their stated goal, keep in mind that if you are healthy, you are no longer their customer. Ultimately, a pharmaceutical company's primary loyalty is not to you the consumer, but to shareholders who want the company to generate good returns for their investment.  To make top profits, drug companies have to sell as much product as they can for the highest possible price to as many people as possible. In the business world, that's good business.

Can you trust your drugs? I dunno. It seems to me that if a company wants to be a trusted name, they have to produce a pure and reliable product. But if the 60 Minutes story is any indication, it sounds like Glaxo, at least, is more interested in keeping problems quiet than alerting the public and fixing problems when they occur. So just as important as whether you can trust your drug, can you trust your drug company?

[vi] “Off label” means it hasn’t been approved for us for that particular condition or age group. Doctors can prescribe drugs off-label, and it is presumed that they will tell their patients they are doing so. However, many doctors often rely on information from pharmaceutical manufacturers regarding the suitability of particular drugs for their patients, and if marketing promotion does not indicate that a particular use has not been approved, doctors may  not realize it’s an “off label” treatment.

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