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By Agnes Shanley, Editor in Chief
Pharmaceutical manufacturers can’t be blamed for doing all they can to extend the life cycles of the drugs they invent and produce. After all, each new drug requires, on average, 10 years and over $800 million to get to market, plus an incalculable amount of dedication, sacrifice, paperwork and frustration.
The growth of generic drug manufacturing operations has challenged the pharmaceutical industry, legally, technologically and ethically. Generics manufacturers have injected some healthy competition into the industry, but they also have drug inventors scrambling to protect their hard-won intellectual property.
In this issue’s cover story, Contributing Editor Angelo De Palma examines the techniques that pharmaceutical innovators are using to cheat patent death and hold off the advances of generics. Some of these techniques are truly innovative — PEGylation, for example, which not only changes a drug’s form, but can improve some of its properties. Other techniques are definitely crafty. And legal. But are they always ethical? Should an existing drug in a new form be considered truly novel?
Amendments to Hatch-Waxman have limited options for extending patent life, and cut down on frivolous lawsuits. Litigation, once an automatic response to generic competition, is now a last resort. Instead of focusing on the back end, more companies are working at the front end, and reducing time to market, to extend drug life cycle.
In addition, more drug companies appear to realize that there’s a need to balance legitimate concerns for intellectual property, profits and shareholder value with ethics and humanism. Consider the industry’s initial response four years ago, when generic versions of antiretroviral therapies for HIV were first announced. These generics cost less than $600 per year per patient, a fraction of the $13,000 per year that similar name brand therapies cost in the U.S., and were launched by countries that had no tradition of patent protection. Understandably, drug makers felt threatened.
Activists focused more attention on this issue, and the industry backed down. Now, pharmaceutical innovators are even supporting some of these efforts.
As a result, a tiny but growing generic antiretroviral HIV drug market is taking root in the developing world, where only a few hundred thousand of the millions of people affected with HIV actually receive adequate treatment. Thailand, for example, now makes a number of AIDS drugs thanks to the pioneering work of Dr. Krisana Kraisintu.
Originally, Bristol-Myers Squibb sued Kraisintu over antiretroviral drug patents, although she argued that the intellectual property came from the National Institutes of Health. Ultimately, BMS withdrew the suit, voicing its support for the people of Thailand.
Kraisintu is now embarking on a project that would produce cheap antiretrovirals in the continent most devastated by HIV and AIDS: Africa. Starting in Tanzania, she has applied for funding to upgrade a 40-year-old manufacturing facility and is also scoping out projects in the Democratic Republic of Congo and Eritrea. This is truly missionary work—inspirational and worthy of support. It’s more significant than merely donating drugs; as the old adage goes, “Give a man a fish and he’ll eat one meal; enable him to fish and he’ll eat for a lifetime.”
The same drug companies that fought to block generics overseas are now supporting efforts like these (and, as Managing Editor Paul Thomas notes in "The Relief Tsunami," several have also donated generously to regions devastated by December’s tsunami).
Late last month, the FDA approved the first generic AIDS antiretroviral treatment, which will be manufactured by Aspen Pharmacare, South Africa’s largest generic drug firm. The drug will cost less than a dollar a day per patient. BMS, Glaxo and Boehringer Ingelheim have all licensed their antiretroviral technologies voluntarily to the project. And the U.S. government requested over $3 billion to fund antiretroviral drug procurement and distribution.
What about the generics manufacturers at home? Given the cost of medication and the number of uninsured people in the U.S., generics serve a vital function. Isn’t there room enough for everyone, the innovators and those who turn yesterday’s cutting edge into tomorrow’s commodity?
As more companies realize, focusing on the “back end” to extend drug life cycles and shut out generics is, at best, short-sighted. As more companies embrace new IT, process analytical technologies, and concepts like Lean and Six Sigma, development and manufacturing teams are working more closely together, weeding out discoveries that only look good on paper, and streamlining costs and adding years to their products’ saleable lives.
Closed industries that stifle competition are often changed from without. Consider telecommunications. Generics, both here and abroad, offer big pharma the opportunity to change from within, to become more agile, and to “do the right thing.”
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