Suzanne Ward, senior director of medical strategy at Boston Scientific, examines supply chains in 2020 and why patients should be aware of what's really in the medicines they take.
Medicines
If you want to see the future of medicine in the US, check out Trader Joe’s, or even Whole Foods in that country.
Trader Joe’s aisles are lined with store brand grocery products that many people are very happy to buy at a premium compared to generic options. Prior to their acquisition by Amazon, Whole Foods was sometimes called “Whole Paycheck,” but here again shoppers showed a willingness to pay a premium for groceries that they deemed of higher quality based on sourcing or ingredients.
You should look closely at the labels and signs at these stores. They tell you the simplicity and purity of the ingredients, where they were derived from, where it was made, and the measures taken that provide clarity and alleviate worries about what might be hidden.
Certainly, groceries are not medicine. But consumers seem much more focused on investigating the ingredients and methods behind their food than in the medicines they ingest. Medicine is different – but why?
Is it that patients don’t care where their medicine comes from or that cost outweighs everything else -- possibly including quality? Some experts believe that, and the thinking has even found its way into the political arena. Recently, US secretary of Health and Human Services Alex M. Azar penned a column about president Trump’s executive order “to take major steps to deliver American patients the affordability they need, the options and control they want, and the quality they deserve.”
The debate can be simplified to “good enough,” and “buyer beware.” Author Katherine Eban has exposed the lengths to which some foreign generic drug manufactures will go to cut corners to save money on the manufacture of medications prescribed to US patients in her book “Bottle of Lies.” Regulators are pressured to introduce more competition and reduce intellectual property protections in order to force prices down. This is aided by the belief that if a drug price goes up, investors are pocketing the profit -- and the investment isn’t going to scientists and new breakthroughs.
In part, we have unscrupulous companies to thank for this perception; they raise prices several times over while cutting research and development, and failing to contribute to the advances in science that made their therapy possible. They may even reduce investment in their manufacturing processes, trying to reduce the cost of manufacturing so they can increase profits as a means to growth.
But competition is best when it’s not just based on price, but also quality. The trouble is, how can you see a difference in quality. It’s not like picking up a shirt at the store, or comparing two melons at the grocer.
It’s often assumed there is no major difference between two drugs claiming to do the same thing, as long as they are FDA approved for the same condition. However, it’s useful to understand that the FDA standard is a minimum standard.
As with grocery store product labels, pharmaceutical labels and how something is made are important – such differences are often hidden from physicians, patients and insurance companies because they are not necessarily disclosed on the label. But these differences are critical because peoples' actual lives depend on it.
That’s where something called Good Manufacturing Practice comes into play. Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimise the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
GMP covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff. Detailed written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made.
But few patients are aware of these. They are taken for granted in the healthcare process.
The medical field needs to take a page from the retail sector. It’s not enough to provide quality in the final product, and not even enough to invest in science or work to address potentially deadly medical conditions.
We have to advocate for a model that provides more information to consumers on how their medicine is made, where it is made, and what measures are taken to ensure that the medicine you are provided will perform just as the medicine provided to patients in a clinical trial performed. A “good enough” approach is no longer sufficient– not in an era in which we’re seeing increasing cynicism about science and the companies who provide medical products.