RUTHFULLY YOURS

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.

Janet Levy,Los Angeles writes

“More Pakistanis and Afghans (including 4 know Islamic State operatives) on the terror watch carrying American passports entered the United States in October than in the prior 12 month period. These potential jihadists are being transported on remote farm roads instead of interstates and being stashed in Acala, Texas, a ghost town outside of El Paso within easy access of a state highway.Judicial Watch (JW) reports the existence of an ISIS camp within a few miles from El Paso and another camp within proximity of Deming and Columbus, New Mexico.Reportedly, Texas Congressman (Beto O’Rourke) contacted local FBI, Homeland Security Investigations and Border Patrol officers in an effort to identify and possibly intimidate sources that may have been used by JW to break the story of the nearby ISIS camps.There is growing cooperation at our southern border between organized crime and terrorist groups, including Hezbollah, to finance terrorism, launder money and smuggle people and drugs into the U.S.See the report below from New York Analysis of Policy and Government. ”

More Pakistanis and Afghans, including those of military age, carrying U.S. passports, and on the terror watch list illegally entered the United States in the first month of this fiscal year (October) than in all of FY2015 (September 2014 to October 2015), According to a San Diego Reader report.

Rep. Duncan Hunter (R-California) in a recent letter to Homeland Security Secretary Jeh Johnson, stated:
“It is routinely said that there is no ‘specific and credible information about an attack on the homeland.’ Despite this assertion, the Southern land border remains vulnerable to intrusion and exists as a point of vulnerability. And evidently there are criminal organizations and individuals with the networks and the knowhow to facilitate illegal entry into the United States without regard for one’s intentions or status on a terror watch list. The detention of two Pakistani nationals underscores the fact that any serious effort to secure our homeland must include effective border security and immigration enforcement.”
According to the San Diego Reader, “Muhammad Azeem and Muktar Ahmad, both in their 20s, surrendered to U.S. Border Patrol agents in September, according to Immigration and Customs Enforcement. One was listed on the Terrorist Screening Database for ‘associations with a known or suspected terrorist. The other was a positive match for derogatory information in an alternative database,’ according to Hunter’s letter. Azeem and Ahmad are among dozens of men – described by Border Patrol agents as “military age and carrying U.S. cash” who began entering the U.S. through a Tijuana-based human-smuggling pipeline in September.”