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OpEdNews Op Eds    H3'ed 11/3/09

Big Pharma's Biologic Bonanza

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Message Marcy Winograd
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Blogger and breast cancer survivor Jane Hamsher rightfully and righteously laments the 12-year monopoly protection on biologics — miracle drugs made from living matter - folded into the current health insurance reform bill. Conversely, Big Pharma must be clinking its Martini glasses, passing the Sherry, and luxuriating in guaranteed profits.

While it's clear, as Rep. Eshoo points out in her counter-blog, that the Eshoo amendment, limits for the first time licensure protection for exorbitant cancer and HIV drugs, it's also true that a minimum12-year monopoly that allows Roche-Genentech to charge cancer patients with breast or brain tumors $185,000 per year for Avastin or Abbot Labs to suddenly increase its prices five-fold for Norvir, a key ingredient in the AIDS-HIV cocktail, constitutes an excessive stranglehold on access to medicine desperately needed, not only here but worldwide where AIDS leaves a trail of tears throughout Africa.

CALPERS, California's 1.4 million employee pension plan, and AARP, the senior insurance group, both opposed the 12-year protection as unsustainable.

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Congressman Waxman (D-Santa Monica), Chair of the Energy and Commerce Committee wanted a five-year patent; President Obama supported a seven-year compromise exclusivity on biologics.

"Many members are looking for so-called game changers that would bring more competition and lower costs" in the health-care sector, said Mr. Waxman. "But if we do what the drug companies want and add on long periods of monopoly protection...we will not only lose that opportunity, but guarantee higher drug prices for the foreseeable future."

Waxman lost. Eshoo won.

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So did Big Pharma with a dozen years of patent protection.

The Federal Trade Commission concluded twelve years is too long. In an FTC June 10, 2009 report, "Follow-On Biologic Drug Competition," the commission supports a shorter patent period, lest pharmaceutical giants rest on their laurels, confident a generic cannot be introduced any time soon..

"The report states that the 12- to 14-year regulatory exclusivity period is too long to promote innovation by these firms, particularly since they likely will retain substantial market share after FOB (generics) entry."

How unfortunate that my opponent Jane Harman (whose 2008 stock portfolio included investments in three biologic manufacturers: Pfizer, Abbot Labs, and Johnson & Johnson) joined committee Republicans and other Democrats to side with Eshoo to override their committee chair when Waxman, the genius behind the 1984 generic drug bill that has saved taxpayers hundreds of billions of dollars, proudly introduced legislation to limit patent protection on biologics to five years, a more reasonable time period in which manufacturers can recoup their investment and turn a fat profit for shareholders.

In Time Magazine's (Nov. 2, 2009) "You don't know him (he's a lobbyist) but he may be the biggest winner in health-care reform. So who loses?" writers Karen Tumulty and Michael Scherer describe the fatal committee blow on July 31, 2009.

"Waxman's fellow California Democrat Anna Esho offered a last-minute amendment that Waxman opposed. Knowing he would lose, Waxman decided to save face with a quick voice vote. But Eshoo insisted on a roll call, which put every member on record. ..... It is understandable the drug makers would want a roll-call accounting of who their friends and enemies are, considering the size of the investment they are making on Capitol Hill: in the first six months of this year alone, drug and biotech companies and their trade associations spent more than 110 million — that's about $609,000 a day — to influence lawmakers, according to figures compiled by the non-partisan watchdog group Center for Responsive Politics."

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Shortly after the committee vote to extend the patents 12 years, Air America broadcast commercials in Los Angeles thanking Jane Harman for her support of drug research. Friends called me to complain. Why is Air America airing these commercials? My question was — Why is Big Pharma thanking Harman?

Now I know.

Not long after that — this came in the mail.

Big Pharma now wants Harman to support a bill that will funnel taxpayer dollars into Big Pharma's drug comparison effectiveness research.

The real question on biologics, however, reflects deeper issues also mirrored in the single-payer debate. Just as single-payer advocates object to for-profit insurance companies whose first responsibility is a fiduciary one, to make money for shareholders, health care activists who challenge Big Pharma question whether for-profit corporations, often reliant on partnership money from the taxpayer-supported National Institute of Health, should be allowed to own the rights to life-saving medicine now out of reach to some 90-million Americans who are uninsured or under-insured, millions more whose insurance companies refuse to cover the costs, as well as much of the Third World living in poverty.

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Marcy Winograd is a high school English teacher in the Los Angeles Unified School District. In 2010, she mobilized 41% of the Democratic Party primary vote when she ran as a congressional peace candidate challenging Blue Dog incumbent Jane Harman.
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