doing would wrest control away from the âshadow governmentâ 16 that runs health care and would restore it to patients and doctors.
PATENTS ON DRUGS
When Senator Estes Kefauver attempted to come to grips with the pharmaceutical industry in the early 1960s, his bill ended up mandating randomized controlled trials without being aware he had done so, as one of his aides slipped these into the 1962 act. Kefauver maintained support for the prescription-only status of new drugs, despite expressing compelling doubts about arrangements in which one person orders what another will have to consume. But he couldn't muster the votes for the one thing he actively sought to change, the system of patenting drugs. Changing this system, he thought, was crucial to bringing down the prices of drugs.
The Americanâand now worldwideâsystem enables companies to take out product patents on drugs. A patent of this type offers companies a monopoly on a new drug for twenty years, effectively on a worldwide basis. We grant this privilege to companies in return for novel and truly beneficial compounds. But the system was put in place at a time when patents were restricted to a national territory and when the idea of a blockbuster drug was inconceivable.
The current arrangements have failed usâalthough they work wonderfully well for companies. They have failed in that companies are not producing novel drugs of the type we desperately need. We do not have the breakthroughs for cancers, dementia disorders, or for the neurological and rheumatoid conditions that still cripple and kill usâoften from quite a young age. 17 In fact we now have a situation, brought about in part by product patents, where, in principle, it is not in the interest of companies to improve our therapiesâcertainly not to the extent that would eliminate disorders. Treatments that cure rather than maintain disorders risk leading to a fall in company revenues and, as the example of using antibiotics to cure ulcers shows, companies will make efforts to block the adoption of cures that appear on the horizon. Getting rid of the incentive to develop a blockbuster that product patents offer would reorient drug development back to what most people think both medicine and pharmaceutical companies are trying to do, which is to eliminate the scourge of disease.
Furthermore, the ability to have an exclusive patent on a drug creates conditions suitable to blockbuster marketing. As drugs have increased in celebrity status in the 1990s and 2000s, any independent assessments made of the therapeutic advantages offered by new drugs have consistently indicated that these have been minimal at best. Indeed, pharmaceutical companies now seem to be able to make blockbusters out of drugs that are virtual carbon copies of already available and cheaper drugsâNexium out of Prilosec, Lexapro out of Celexa, Lyrica out of Neurontin. These are companies who are masters at generating and maintaining wants rather than companies who are any good at making drugs. Indian and Chinese pharmaceutical companies are today more innovative when it comes to producing novel and needed drugs than are the Western pharmaceutical manufacturers. As long as our companies can make their money from our wants there is no need for them to meet our needs.
It is far from clear that we need any patents on medicines. Asian companies have produced innovative compounds profitably without the protections of a product patent system. And as the makers of generic drugs show, a great deal of money can be made from drugs that are offpatent or sold over the counter. If patents are needed, one option is to reduce the length of protected time companies get for their patentsâthis was the option favored by Kefauver in 1962. Another option is to return to a system that offers patents on processes rather than productsâa system that worked well in Germany for a century and led to the greatest rate of