RUTHFULLY YOURS

Marty Makary’s “One Pharm Fix: Limit the ‘Orphan Drug’ Incentives” (op-ed, Dec. 21) addresses shortcomings of the Orphan Drug Act that lead to increased costs to consumers and insurers. While better controls of financial oversight of orphan drugs might lead to lower medical costs and reduce patient expectations for some of the unsupported off-label claims, I would argue that the Orphan Drug Act does not provide enough incentive for the development of drugs to treat low- and mid-grade cancers such as primary brain gliomas and medulloblastoma tumors that I have treated for 43 years.

The drugs needed may take many preclinical years to develop and 12 years to do the clinical trial required by the FDA. In addition, one drug is likely to be insufficient for tumor control and two to three drugs targeted to specific pathways may be needed. Complicating this is the likelihood that one drug may provide limited antitumor efficacy and two to three drugs together may be needed to control tumor growth and future transformation to a more malignant glioblastoma. In this case, Orphan Drug 7-year exclusivity is an inadequate incentive as the drugs may easily take 15-17 years to develop and test and hundreds of millions of dollars in cost, leaving insufficient time to recover costs associated with this risky undertaking to develop chemotherapy for these rare tumors. This argument is also true for many other low- and mid-grade solid cancers.

California has a powerful economy, with 14 million private-sector jobs. It also has burdens: welfare recipients (12.6 million), generously paid government employees (2.1 million) and people collecting government pensions (1.3 million).

Add up the numbers. There are 114 clients drawing from the government for every 100 people chipping in by working outside the government and paying taxes. We’re calling this the Feedme Ratio. Six states have a number over 100.

These states are at risk of going into a downward spiral in the next recession. The burdens will remain but too many of the providers—employers in the private sector—might shrink or decamp. Why add jobs in a state that asks each productive worker to carry not just his or her own weight but also the weight of one other person?

New York is on the list of at-risk states, with a Feedme Ratio of 108. New Mexico is in the worst shape, with 143 government clients for every 100 private-sector workers.

The three other states with Feedme Ratios over 100: West Virginia at 116, Mississippi at 111 and Arkansas at 103. You can check your state on this map.

Barack Obama entered office in 2009 with overwhelming popular goodwill and solid majorities in both houses of Congress. He chose not to translate that political heft into passing “comprehensive immigration reform” (i.e., open borders and amnesties) or more gun control.

He opposed gay marriage. He warned that he could not use presidential fiats to grant amnesty, close down Guantanamo, or remake the EPA in his own image. He borrowed as never before, in vain hopes of kick-starting a natural recovery that he would soon abort through his own anti-business jawboning, more regulations, growth in government, and tax increases.

So far Obama’s legacy is a sudden crash in energy prices and an unforeseen huge expansion in U.S. oil and gas production that came despite — not because of — his efforts.

Indeed, Obama scarcely succeeded in ramming through Obamacare — and only through untruths that it would lower costs and premiums, expand coverage, and ensure continuance of existing plans and patient doctors — and then wisely quit trying to strong-arm other legislation that could have cost him the 2012 election.