If reports of bad side effects (e.g., death) surface after marketing has begun, these are suppressed if possible, denied, or obscured. Companies, when pressed, call for more extensive studies--that take years. Every effort is made to delay removal from the market. The FDA is virtually toothless, partly due to legislation and partly due to inadequate budget [5][6].
Sometimes, unpleasant or harmful side effect of a medication can be profitable. Consider atypical antipsychotic drugs such as Risperdal, used to treat such ailments such as schizophrenia, or anxiety. A common side effect is dystonia, which involves involuntary and uncontrollable muscle spasms that can force affected parts of the body into abnormal, sometimes painful, movements or postures. This ailment can be treated with another medication, trihexyphenidyl [7]. So, many profitable drugs contribute to the sales of other profitable drugs.
There are many cases where pharmaceutical companies have suppressed information about dangerous side effects of their products, and sometimes this has led to the deaths of thousands of people [8]. Altho such behavior has resulted in many law suits, and fines amounting to many millions of dollars, I know of no case where a corporate executive guilty of such behavior has been imprisoned. Even a very large fine is not much of a deterrent when the behavior penalized brings in several billion dollars in one year.
Selling the product
Physicians are central to sales, directly thru prescriptions, or indirectly thru recommendations. Recognizing this, the pharmaceutical industry, in addition to major advertising campaigns aimed directly at the general public, devotes a great deal of effort toward persuading physicians to prescribe and recommend their medications.
There is a large force of sales representatives (reps) who regularly visit physicians offices, distributing samples and literature. They ingratiate themselves with the physicians and their staffs by distributing small gifts such as T-shirts and coffee mugs. Doctors, and often nurses and secretaries, are taken to lunch, or meals are brought in to them [9].
Physicians are invited to attend "educational sessions" at luxurious resort hotels, all expenses paid, at which, among other things they learn about the latest pharmaceutical products. Prominent specialists are paid generously to give lectures to other doctors, or to sign ghost-written articles in prestigious medical journals, promoting medical products [10]. Other well known physicians who endorse certain products are paid as consultants. A company might buy, from a medical journal, tens of thousands of reprints of an article that views one of its products favorably.
When the FDA approves a medical product, it specifies the diseases, and the class of patients (e.g., adults over 18) for which it is appropriate. Physicians, however, are free to prescribe these drugs as they see fit. A common practice is for pharmaceutical companies to subtly encourage the use of their products to treat additional diseases and for broader classes of patients. Sometimes these so-called "off-label" uses exceed the specified use [11]. Occasionally, companies are fined when their encouraging of off-label use is too blatant. But, even when these fines are quite large, they generally don't exceed the added profits resulting from increased sales.
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