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Dispatch: Biologics; Tobacco vs. H1N1; Pop-Tarts vs. Brownies; Black-Market Food
By Curtis Porter
Unclear Fate of Biologics
President Obama's recently released healthcare reform proposal “creates a pathway for the creation of generic versions of biological drugs so that doctors and patients have access to effective and lower-cost alternatives.” The White House has discussed this strategy before, having previously proposed a reduction in the period of patent protection against generic or “follow-on” biologics from twelve years to seven.
“Both the House and Senate bills would have allotted the current twelve years of protection for biologics, but they haven't said yet if the President's plan will reduce that,” says ACSH's Jeff Stier. “That's something most people won't pay attention to, since it is complex and not among the top few issues in healthcare reform. But if the period of patent protection were reduced, it would have a huge negative impact on development of innovative biotech drugs, since the companies which invest millions in research would not be able to reap the exclusive reward of their innovative therapies for as long. It would also be likely to increase costs over the short term, since companies would have to get more revenue in a shorter time period, so they would raise the price of the drugs to recoup the costs of research. This is one example of how little-known provisions can have a big impact on your healthcare.”
Tobacco Better Than Eggs?
The Department of Defense, chagrined by the slow response time to the H1N1 pandemic, is supporting research to develop vaccines using tobacco plants instead of the time-consuming process using eggs.
“It just so happens that of all plants, it had to be a tobacco plant,” says Stier. “It's just such an interesting plant. You would think that there is potential that those in the tobacco industry may want to invest in this research. Well, the PLoS Medicine journal decided they can't publish research that is funded by the tobacco industry. How ironic. This illustrates why their new policy is unhelpful. All they have to do is say whether the science is good or bad, but they've removed themselves from the conversation.” You can see Stier's comment on the PLoS Medicine editorial here.
ACSH's Dr. Elizabeth Whelan adds, “With all this chatter about how there's no evidence that e-cigarettes and non-combustible tobacco products are safer than smoking cigarettes, the only people who would want to fund research to prove that they are safer are those working for tobacco and e-cigarette companies, and now they won't bother because no one will consider publishing their work in a peer reviewed journal, if other journals follow suit.
“The American Legacy Foundation does all kinds of tobacco research -- and they are published widely -- and they are, in essence, funded by tobacco money, since their initial funding came from the Master Settlement agreement with tobacco companies. This is not to understate the deviousness and maliciousness of cigarette companies -- particularly decades ago -- in trying to downplay the dangers of smoking. We're not trying to wipe that history out, but we're in a new age now, and we need to look at things scientifically, not based on funding.”
“It is indeed ironic that the poor, abused tobacco leaf is now a potential powerhouse of vaccine manufacturing,” says ACSH's Dr. Gilbert Ross. “Yet I wonder if vaccines -- and other medications in the future -- would be subject to new FDA tobacco law if made in a tobacco plant? This is another unintended consequence of that terrible law.”
Probably Should Have Seen This Coming
A New York Times blog reports, “Nine months after effectively banning most fundraising food sales in city schools, a city panel will vote Wednesday on an amended regulation that will allow student groups to sell items like Pop-Tarts and Doritos during the school day but not brownies, zucchini bread, or anything else homemade.”
“Essentially, the reason for it is that they don't want any homemade products because they don't know how much fat is in them,” says Stier. “It just goes to show you the path you go down when you demonize certain foods in schools.”
Dr. Ross adds, “Take note of this item, which clearly illustrates the lack of scientific basis for these new regulations: Also banned from approved school snacks are 'artificial sweeteners.' Now where did that one come from?”
Black Market Junk Food
According to FoodNavigator.com, “The Romanian food industry association Romalimenta Federation believes the proposed junk food tax will boost the black market and stimulate fiscal fraud, and in the worst case could harm food safety.”
“This is an example of the unintended consequences that can come with taxing specific foods,” says Dr. Whelan.
Curtis Porter is a research intern at the American Council on Science and Health (ACSH.org).
Michael P. Elston, MD (February 24, 2010)
Regarding Biologics: The concomitant problem with simplistic solutions, such as that offered by the Obama administration, is that the cost of many complex agents is not solely dependent upon years of patent protection afforded them. Often more importantly, the sophisticated production processes required constitute the majority of ultimate product cost and therefore even generic production cannot achieve substantial cost-savings. You are absolutely correct in assessing the consequences to society, should the Administration prevail in reducing patent protections currently afforded to pharmaceutical manufacture.
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