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October 15, 2007

First Sign of a Sinking Ship -- Political Expediency

by Peter Pitts

John McCain demonstrates his ignorance of health care while on the hustings in Iowa -- or maybe it's just political pandering -- you be the judge:

“Pharmaceutical companies must worry less about squeezing additional profits from old medicines by copying the last successful drug and insisting on additional patent protections and focus more on new and innovative medicine.”

Attention Senator McCain:

America’s pharmaceutical and biotechnology research companies set a new record for biopharmaceutical research spending last year with an investment of $55.2 billion to develop new medicines and vaccines. That's $3.4 billion higher than the previous record of $51.8 billion spent by U.S. companies in 2005.

The research spending of all of America’s biopharmaceutical companies is much higher than the amount spent on biomedical research by the National Institutes of Health and pharmaceutical research companies in other countries.

It may not be popular or politically expedient to admit the truth. But we expect better from Senator McCain.

Posted by peterpitts at 02:13 PM
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October 08, 2007

Plan B(TC)

by Peter Pitts

The FDA has announced, via the Federal Register, a November 14 hearing to explore "the public health benefit of drugs being available without a prescription but only after intervention by a pharmacist."

The agency wants input on issues such as whether there should be a behind-the-counter status for certain drugs and whether the status should be a transitional way for prescription products to eventually move to over-the-counter status, where consumers can purchase products on store shelves. Other questions include the impact on patient safety and whether it would improve access to medications.

A BTC category would almost certainly reopen the conversation about the “statin quo.”

In 2005, an FDA advisory panel voted down a bid by Merck & Co. and Johnson & Johnson to sell Mevacor, a cholesterol-lowering drug, without a prescription. Several panel members said the FDA should consider establishing a behind-the-counter system that would allow consumers to purchase Mevacor from pharmacists much like the British are allowed to purchase Merck's Zocor, another cholesterol-lowering drug. Most panel members said that, if such a system existed in the U.S., they would have voted to allow Mevacor to be sold without a prescription.

The FDA noted that other countries with behind-the-counter status include Australia, Canada, New Zealand, Denmark, Germany, Italy, the Netherlands, Sweden and Switzerland.

This is an important debate as well as a "teaching moment" for American pharmacists to communicate the crucial role they play in 21st century American health care.

Posted by peterpitts at 09:24 AM
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October 03, 2007

No-Part Harmony

by Peter Pitts

The Patent Reform Act of 2007 (S. 1145) seeks to “harmonize” the American patent system with those of other nations. But, as Kevin Kearns of the U.S. Business and Industry Council has written, “do we really need to be "harmonized" with a calcified European system or the impossibly unfair Japanese system, not to mention the Chinese system, where intellectual property theft is a way of life?”

Bottom line is that the pending legislation would make it harder for patent holders to enforce their rights or win just compensation from those who infringe their rights. It would be harder to prove "willful" infringement, which entails punitive damages. The bill also includes a mandatory apportionment test that would lessen the value assigned to patents in most products.

Not only would the bill reduce the value of patents, but it would facilitate patent theft.

Under our current system, inventors can "opt-out" of having their application published by filing "only" in the United States and not in another country where it can be ripped off. The current bill would eliminate the opt-out provision.

Think “health care innovation.” Then think “India.”

According to the Center for the Study of Drug Development at Tufts University, only 1 in every 5,000 compounds screened becomes an approved medicine. This means of every 5,000-10,000 compounds tested, only 250 enter pre-clinical testing, five into clinical testing and only one achieves FDA approval. Without robust intellectual property protection, no company, even ones with the most benevolent motivations, would find it feasible to develop new, innovative, lifesaving and life enhancing-products for consumers.

There are precious few “Eureka!” occasions in healthcare. Progress is made step-by-step, one incremental innovation at a time. And those incremental innovations require extensive research and are expensive. But, that’s how health care progress is made – not through Hollywood-style “Aha!” moments so popular with politicians and pundits.

Does our patent system need reform? That’s a question for patent experts. Should we facilitate a patent system that disincentivizes pharmaceutical innovation? That’s a no-brainer.

Posted by peterpitts at 09:26 AM
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