In accordance with the FDA, generic drugs are identical or within an adequate bioequivalent range to the brand-name corresponding medicine with respect to the pharmacokinetic and pharmacodynamic properties. In the words of the FDA: “They are copies of brand-name drugs and are the same as those brand name drugs in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.”
Should anyone have heard of generic drugs before, one would know that they are a cheaper form of an original drug. What happens is that the main chemical substance which is meant to combat an ailment is the same. However, there must be some other chemical aspects of the drug which are different. Why then would one be more expensive than the other?
It is a fact that all types of medicine cause side effects. But the side-effects of the medicine that Karen Bartlett had to take sent her to a living hell. The woman’s ordeal began in 2004 when her doctor prescribed an anti-inflammatory medicine (Sulindac) for her shoulder pain. As a result, Bartlett was inflicted by a form of Stevens – Johnson syndrome (SJS/TEN)—a rare but known side effect.
What in fact happened was that it caused the external surface of her skin to deteriorate to the point of developing an open wound over more than 60% of her body. She spent months in a medically induced coma and underwent 12 eye surgeries (more pending). It has left her with lung damage and esophageal damage and she is now legally blind.
As was natural, the woman sued the company which manufactured the drug (Mutual Pharmaceutical) and the New Hampshire jury granted her $21 million. How did Mutual react? Its attorney pointed out that because Sulindac is the generic adaptation of the brand-name (Clinoril), the company had not been able to take the preventive actions the jury said it should have. In a quite conflicting and confusing back and forth argument on whether generic drugs are safe enough to prescribe, it is worth reading about other cases.
In a Washington Post article in 2011, Katherine Whipple, a clinical psychologist (Kensington) stated that it has been her experience where a patient who had been doing well suddenly regressed. After a series of questions to determine the cause of the regression, the outcome was that the patient’s medication had been changed from the name brand to a generic drug. Such an experience had been recurring with patients, thus it must be noted that not all generic drugs are created to equal their trademark counterparts.
It would be a dark age scenario should patients, who suffer such overwhelming side effects as Karen Bartlett, not have alternative action. It would be ideal, of course, for pharmaceutical companies to put forth a greater effort in formulating medicine with as few side effects as possible. Until then, however, it is up to the individual to discuss the possible side effects with his/her doctor and to seek alternative therapies should those side effects be too severe. And last but not least, pharmaceutical companies should be held accountable if it is proven without a doubt that their medicine is too harmful for the public.
And Karen Bartlett? Watch and listen to Karen herself describe her ordeal and what her life is like today and next time a doctor prescribes a drug, read the enclosed pamphlet more carefully.