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    Generics vs branded drugs: get what you believe

    Like many people, you may be hesitant to buy less expensive alternatives to brand-name drugs, despite legislation allowing pharmacists to substitute original medications with generic alternatives.

    You may feel that you would compromise your health to do so, or you may feel you have little say in which drugs you buy. Or it may just be that like many people in this country, you do not understand what generics are all about.

    Research shows that South Africans are far behind when it comes to consumer savvy at the pharmacy counter. Generics use in countries such as the US and UK account for 75% and 70% of the medicine uptake respectively. In SA, it only accounts for 19%.

    But just what is the difference generics and other drugs?

    "Originals" or brand-name medicines are manufactured by the company that originally designed or developed the drug, and registered the patent for it. These patents are usually granted for 20 years, and help to ensure market exclusivity so that the pharmaceutical companies can recoup the costs of research.

    While the patent may be active for 20 years, the drug itself will often only become available years after the registration. This makes the period of "exclusive marketing" even more limited.

    "Generics" are drugs which are for all intents and purposes exactly the same as the "original" drug. They are produced by a different manufacturer once the original's patent has expired.

    In most cases, generics not only contain the same active ingredient as the original drug, but are required to go through studies prior to registration to prove the chemical structure and absorption are the same as the original. So provided the dosage and frequency of taking the medication are the same, there should be no change in treatment outcome whether using an "original" or a "generic".

    All about the money

    The difference usually lies in the cost. Companies manufacturing generic drugs do not need to invest in the research resources of originating companies. They can sell drugs anywhere from 25% to 50% less than the original product's pricing.

    Brand manufacturers do fight back, often radically reducing the cost of their drug at the time of patent expiry, in order to compete. Others, like Pfizer Pharmaceutical, decide to compete in the generic space by buying and developing their own generic-producing company - like Pharmacia in Pfizer's case. This meant that as soon as the patent for Pfizer's blockbuster cholesterol-lowering drug Lipitor expired in SA in 2006, Pharmacia was able to move in competitively to sell generic alternatives, produced essentially by the same company.

    It can be seen as a case of innovation versus cost, because generics substitution is one of the primary ways to minimise the escalating costs of healthcare across the globe. Medications account for around 16% of our total medical costs. In the US and UK, growing use of generic substitution has seen increased numbers of people accessing medicine at a lower overall cost.

    Substitution

    Following this trend, in 2001 SA passed a law which allowed pharmacists to offer their clients substitution of branded medicine with a generic alternative.

    Certain drugs are considered "non-substitutable", and the pharmacist cannot offer the swop if the doctor has specified that generic substitution is not permitted.

    "Our pharmacists do routinely offer clients generic substitution," says Dis-Chem director Niall Hegarty.

    "The response from consumers to generics is mixed. We find in some areas of the country, people are more willing to substitute with generics; in others they are quite opposed to them."

    Drive down costs

    Yet experts say generics are an important part of the solution to driving down healthcare costs, especially in developing nations. The downside is they don't stimulate pharmaceutical innovation.

    Only one in every 10000 molecules investigated ultimately becomes a marketable product. So while there is a need to drive down the costs of healthcare, there is also a need to provide an incentive for the costly innovation required.

    The question is whether that innovation can be afforded.

    So why don't South Africans believe in generics?

    Cost is not the only driver of medication usage. If it were, there would be higher uptake of generics.

    Instead, when it comes to healthcare, many consumers believe that a lower cost equates to substandard treatment.

    Same ingredients

    Yet generic drugs that contain the same active ingredients and properties are proven to be as effective and safe as originals.

    In many cases, such as with the Lipitor/aspavor example, the generic is even manufactured by the same company. The generic is in effect a clone of the original.

    And yet, some healthcare providers and people continue strongly to believe that generics are inferior products.

    "In both public and private sectors, we routinely make use of generic medications," says Dr Eric Klug, a Johannesburg-based cardiologist.

    "We really find no difference between 'generic' and 'original' medications, so it's not clear why some practitioners refuse to use generics."

    He says that in cardiology, measures of whether a drug is working or not, such as cholesterol levels and blood pressure, are objectively quantified, making the evidence irrefutable as to whether a treatment is effective or not.

    "In other areas of practice, it's perhaps not as apparent to practitioners that they can achieve the same treatment outcomes with generic substitutes."

    In essence then, you get what you believe.

    Reverse placebo effect

    Dr Andrea Sapano, from the Molecular Toxicology Unit at the University of Bologne, in her research in the Journal of Biomedical Biotechnology in 2009, notes that generic substitution invokes a "reverse placebo" effect. This might explain why for some people they could be less effective.

    In controlled double-blind trials where individuals have no knowledge of whether they are taking a generic or brand name product, there is no significant difference in their efficacy.

    But in studies where participants are told they are being given "discounted" medication, it has shown to be genuinely less effective than "full price" alternatives.

    The only plausible explanation is the placebo effect.

    "Even the term 'generic' versus 'branded' makes us think of designer clothing compared to discount store substitutes," Sapano says.

    "Consumers see 'branded' as the gold standard of treatment."

    The placebo effect is an incontrovertible influence of our expectations, attitudes and beliefs on the outcome of medical intervention. In essence, the placebo effect "wires" your system for a positive (or negative) outcome based on two factors: the "expectancy" that a product will work and previous experiences (known as "classic conditioning") that a product has historically worked for you.

    Each of these influences ultimately shapes your response to medication.

    Sapano believes that when an original medication (prescribed by the doctor) is substituted with a generic alternative, the expectations and classic conditioning of the person's interaction with the drug is altered, rendering it genuinely less effective.

    Trusting generics

    According to Hegarty, the line between generic and branded medications for the consumer is becoming more blurred.

    "We are seeing a trend where generics alternatives are becoming trusted brands in their own right. Clients are asking for generics by name which they've used and found to be effective."

    MBA research by Clicks manager Matthew Igbinovia, through the Gordon Institute of Business, revealed interesting correlations that influence South Africans' medicine choices.

    He found that being on a medical aid, being younger or having a lower education level made people more likely to opt for original medications, while higher education levels economic or hardship made generic options more favourable.

    While people did cite safety as an important concern when buying medication, they could not translate this into realistic input.

    Perception

    As Igbinovia puts it: "Safety becomes a thing of the perception that people have of a particular medicine, rather than reality."

    We all do put a price on our health, it seems, and when it comes to rational thinking, cost is a serious consideration.

    "The research showed that people are three times more likely to use generics than branded medicines simply based on cost," says Igbinovia.

    Perhaps the most insightful of his findings was that 14% of consumers did not know if they were using generics.

    Consumers are too often caught between the recommendations of their doctor or pharmacist, say researchers, and ultimately are not deciding for themselves whether or not to use generics.

    So, while the ultimate solution lies in more education and incentives for doctors and pharmacists to prescribe generics, consumers do need to take more of an active role in decision-making when it comes to medication.

    With the escalating price of healthcare, it's clear that South Africans need to make more use of generic drugs. And if they are determined not to be "generic believers", they will have to be prepared to pay the price.

    Source: Business Day

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    About Dr Karen Koch

    Dr Karen Koch is a Johannesburg medical doctor and health writer.
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