Did you notice any change in the popularity and kinds of performance enhancing drugs available during the length of your career? Do you think this has affected your company’s manufacture and marketing of these products?

During my career, the sales of pseudoephedrine (PSE) containing drugs rose dramatically. Given that this active ingredient had been on the market for many years in cough and cold medications, the sudden increase was exceptional and primarily due to the abuse of pseudoephedrine as a stimulant but more particularly as a precursor for the illegal manufacture of amphetamines.

The company introduced alternative formulations using phenylephrine (PE) instead of PSE. Meanwhile the regulatory authorities up-scheduled PSE containing medications to Pharmacist Only and requiring personal identification.

By its very nature, the abuse of prescription medications and controlled substances is difficult to quantify due to the ‘sharing’ of prescriptions, internet purchases and the illicit diversion of prescription drugs.

Only doctors can legally supply prescription drugs for off-label indications but only if there is an established medical need. Furthermore, it is illegal for drug manufacturers to promote the off-label use of prescription drugs, even if they have clinical support.

The off-label use of drugs is primarily driven by doctors who access the medical literature to seek effective therapies for their patients. Doctors will use orthodox pharmacology in the first instance but in the event of an unresponsive condition, may try off-label options.

Doctors can seek information from pharmaceutical manufacturers eg unpublished studies, but the company cannot distribute these in an unsolicited manner. The interests of the patient is paramount and the company would provide the doctor with the best available information.

While promoting off-label use of drugs is illegal, a company can always seek to formalize off label use by seeking regulatory approval for new indications with appropriate clinical support. This would naturally form part of the marketing development plans for relevant drugs.

Where do you see the development, manufacture, and marketing of performance enhancing drugs 20 years from now?

Scientific progress is unstoppable. The is no doubt that nootropic drugs that truly earn the descriptor ‘smart drugs’ will be developed with impressive benefits and safety profiles. The pricing of these novel drugs will eventually reduce as patents expire and generic copies enter the market, creating a much larger pool of potential users.

While the unknown long-term effects will still be an issue for some, the competitive nature of an increasingly knowledge/intellect driven workforce will pressure most people to conform.

This will provide huge opportunities for pharmaceutical companies to develop, manufacture and market products for a potentially massive new ‘performance enhancement’ market.

I believe the regulatory authorities will adapt to these developments by allowing the sale and marketing of drugs for non-medical, physical and cognitive performance enhancement.

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Note from Martin Lancaster – ‘the opinions expressed above are mine alone and should not be attributed to any other individuals or entities.’