RUTHFULLY YOURS

Flint, Mich., has been poisoning its residents.

The city, in an attempt to save money, planned to stop buying water from Detroit and sign up with a regional water system; in the interim, it was getting its municipal water from the Flint River, which is as much a garbage dump as it is a body of water. Residents complained that the water smells of chemicals, that it isn’t the right color, etc. Children’s lead levels are dangerously high, and an outbreak of Legionnaires’ disease may also be linked to city water. The city knew about this, and did approximately nothing in response until the problem was well advanced.

A word that is curiously scarce in coverage of this disaster: Democrat.

Flint, like big brother Detroit down the way, has a long history of political dominance by the Democratic party. Its current mayor is a Democrat; so was her predecessor; the mayor before him, Don Williamson, was a career criminal (he did time for various scams some years back) and a Democrat who resigned under threat of recall; his immediate predecessor, Democrat James W. Rutherford, is a longtime politico and was elected to finish out the term of Woodrow Stanley, who was recalled because of the financial state in which he left the city.

Stanley was in effect replaced by — Democrat — Darnell Earley, former director of the Democratic legislative caucus’s research-and-policy team, who became the city’s emergency manager. Earley is the Democrat the other Democrats blame for changing the city’s water supply, and the Michigan Democratic party has demanded his termination.

The Obama administration knew about this, too, and had known for a long time, since February of last year at least — but it chose to keep quiet on the matter.

Can a drug company be held liable for following the directions of federal regulators on warning labels? Johnson & Johnson did exactly that, only to be slapped with a $63 million jury verdict in Massachusetts for inadequate warnings. The Supreme Court is being asked to hear J&J’s appeal in a case with major implications for uniform national business regulation.

In 2003 Richard Reckis treated his seven-year-old daughter Samantha with over-the-counter Children’s Motrin for a fever. Samantha developed a rare and advanced case of Stevens-Johnson syndrome called toxic epidermal necrolysis which caused skin blistering, as well as lung, liver and vision damage. Her parents sued Johnson & Johnson in state court for failing to alert buyers to the potential side effects, and the Massachusetts Supreme Judicial Court affirmed the jury verdict.

The legal problem is that the federal Food and Drug Administration had rejected the specific labelling enhancement that lawyers for the Reckis family say should have been applied. In 2005 what’s known as a Citizen Petition to the FDA suggested that Motrin should include language on “serious skin reactions” and “potentially life-threatening diseases” and specify the names of some of the conditions.

The FDA agreed on the need for improved warnings about skin reactions, but it said it would not be helpful to include a mention of “life-threatening” conditions or the names of the conditions, which most people were unfamiliar with. Instead, the agency said, “a description of symptoms” was more appropriate for the over-the-counter medication. J&J would have been defying federal regulatory guidelines if it had included the warning that the Reckis lawsuit claims should have been on the bottle.

The legal doctrine at issue is federal pre-emption, and in 2009 the U.S. Supreme Court ruled (Wyeth v. Levine) that some state court lawsuits against drug companies over warning labels are pre-empted by federal law if the FDA has made its opinion on labelling clear. While some cases might require guessing about FDA directions, in this case the FDA was asked to consider a specific warning and rejected it.

Dr. Coburn is a physician and former Republican senator from Oklahoma. He serves as an adviser to Project FDA at the Manhattan Institute.

In his State of the Union address on Tuesday, President Obama called for America to become “the country that cures cancer once and for all.” As a three-time cancer survivor (metastatic colon, metastatic melanoma and metastatic prostate), I can tell you that this “moonshot,” as Vice President Joe Biden first called it, is a bold goal—but one within our grasp.

Last week’s report from the American Cancer Society shows that cancer mortality is down more than 20% over the past 20 years. Many patients are living longer thanks to better treatments and earlier detection. Science is tipping the odds of survival in favor of patients.
Ironically, we’re handicapping ourselves in the war on cancer, in part because of a web of privacy regulations like the Health Insurance Portability and Accountability Act. HIPAA makes it difficult for researchers to tap into large caches of clinical and genomic data shared across multiple institutions or firms, and then share their findings more broadly.

The law allows some research uses, but only if the uses (and informed patient consent) are specified in advance. As one analyst put it, “because obtaining [consent] from huge numbers of people or [institutional review board] waivers ranges from the impracticable to the impossible, important research has gone undone and important findings unshared.”

Harnessing that information—“big data”—would allow us to personalize prevention and treatment based on the genetic characteristics of a patient’s tumor, family history and personal preferences, while minimizing unwanted side effects. But today cancers are often fought “off the grid.” Patients whose cancers resist standard treatment, or whose tumors reappear years later, are medical puzzles. Their doctors cobble together treatments through intuition, experience and case studies scattered in the medical literature.

The clinical trials that pharmaceutical companies rely on for FDA approval and drug labeling capture too little of the information patients and physicians need. The trials only enroll 3% of cancer patients and can take years and tens of millions of dollars to finish. Many trials never enroll enough patients to get off the ground.