Seemingly, the US Centers for Disease Control and Prevention (CDC) could not have picked a better week to issue advice on how to prepare for a zombie apocalypse, with political headlines yelping about a much-predicted 16 May crash of the US economy, a 21 May doomsday prophecy and a scandal involving former California Republican Governor Arnold Schwarzenegger, who, coincidentally, starred in the 1991 "Terminator" sequel "Judgment Day".

Indeed, a top CDC official on 16 May issued advice on his blog about what Americans need to do before a zombie invasion occurs.

Dr Ali S Khan, US assistant surgeon general and head of the CDC's Office of Public Health Preparedness and Response, used the deadpan comedic zombie tactic to draw more attention to the more serious topic of emergency preparedness as the US gears up for its 2011 hurricane season, which got underway on 15 May in the Pacific region and starts 1 June for the Atlantic.

Health officials were hoping the zombie hook would get more Americans interested in disaster planning – something that generally only catches US residents' attention after a major catastrophic event, such as Hurricane Katrina, which struck the US Gulf Coast on 29 August 2005, killing more than 1,800 people and costing the nation an estimated $81 billion in damages – with lessons learned often forgotten until the next event, like the ongoing flooding and tornadoes that have been hitting much of southern US this spring.

"There are all kinds of emergencies out there that we can prepare for," Dr Khan started off his 16 May "Public Health Matters" blog, Social Media: Preparedness 101: Zombie Apocalypse. "Take a zombie apocalypse for example. That's right, I said z-o-m-b-i-e a-p-o-c-a-l-y-p-s-e. You may laugh now, but when it happens you'll be happy you read this, and hey, maybe you'll even learn a thing or two about how to prepare for a real emergency."

Within the first day, Dr Khan's zombie posting got about 30,000 hits, with nearly 1 million by the end of the week – even reportedly crashing the website at one point, with the CDC scrambling to find more server space.

After describing a brief history of zombies for his audience, Dr Khan noted that the rise of the brain-eating, reanimated walking-dead corpses in pop culture "has given credence to the idea that a zombie apocalypse could happen," leading many people to wonder "How do I prepare" for such an event – because after all, how different could that occurrence be from a hurricane, earthquake, pandemic or nuclear attack?

As part of an emergency kit, which the CDC advised is the first step to any disaster preparedness planning, Dr Khan insisted that along with water, batteries and other supplies, ensuring prescription and nonprescription medications are included is vital – items whose importance became critically clear in the wake of the 2005 Katrina storm, when US Gulf Coast pharmacies and hospitals were knocked out of commission, leaving diabetes, heart, asthma and other patients with chronic conditions without their needed medicines for days before the government came to the rescue with drugs from the Strategic National Stockpile.

Dr Khan assured his blog readers that if zombies did start roaming US streets, the CDC would conduct an investigation, much like any other disease outbreak, and provide technical assistance to cities, states and even international partners dealing with a zombie infestation, with that assistance including consultation, lab testing and analysis, patient management and care, tracking of contacts and infection control.

"Not only would scientists be working to identify the cause and cure of the zombie outbreak, but CDC and other federal agencies would send medical teams and first responders to help those in affected areas," Dr Khan said, adding that he personally would be volunteering the agency's "young nameless disease detectives for the field work".

Meanwhile, US Treasury Secretary Timothy Geithner has implemented additional measures to allow continued funding of the federal government's obligations after the $14.29 trillion debt ceiling had been reached on 16 May – extending the US borrowing authority to 2 August, which President Barack Obama said averted, for now, an unraveling of the global economy. And, if you are reading this article from planet earth, obviously, the "Judgment Day" declaration was a bust, leaving the "governator" to face the realities of his disgrace.

CDC recaps 10 'great' public health successes

Taking a much more serious tone, the CDC in its 20 May Morbidity and Mortality Weekly Report (MMWR) outlined the US government’s advances in public health during the first 10 years of the 21st century, with the agency declaring there have been "tremendous improvements" in preparedness and response since the 2001 terrorist attacks on the US.

Atop the MMWR's list was the US market entrance of new vaccines for preventing hospitalizations, deaths and the spread of diseases, such as rotavirus, meningitis, herpes zoster, pneumococcal disease and the human papillomavirus.

Health officials noted that a 2011 economic analysis indicated that vaccination of each US birth cohort with the current childhood immunization schedule prevented about 42,000 deaths and 20 million cases of disease, with net savings of nearly $14 billion in direct costs and $69 billion in total societal costs.

Indeed, the implications and outcomes for use of two vaccines – pneumococcal conjugate and rotavirus – have been "particularly striking," the CDC said.

Following the introduction of pneumococcal conjugate vaccine, an estimated 211,000 serious pneumococcal infections and 13,000 deaths were prevented during 2000 to 2008, the CDC said. And, routine rotavirus vaccination, implemented in 2006, now prevents up to 60,000 rotavirus hospitalizations each year, the agency added.

The CDC noted that advances also were made in the use of older vaccines, with reported cases of hepatitis A, hepatitis B and varicella at record lows by the end of the decade.

Another major success over the past decade included the decline of deaths from coronary heart disease and stroke – dropping from 195 to 126 per 100,000 people and from 61.6 to 42.2 per 100,000, respectively, with new medications playing a key role in those reductions.

Other public health successes over the past decade included better cancer prevention due to more efficient screenings, significant progress in controlling infectious diseases because of innovative and targeted prevention efforts and a reduction in tobacco use attributed in part to the US FDA gaining new regulatory powers and establishing new restrictions.

According to the CDC, the advances in public health over the past decade contributed "significantly" to the sharp decline in the overall age-adjusted US death rate from 881.9 per 100,000 people to 741 – a record low and a continuation of a steady downward trend that began during the last century.

In other Washington news:

FDA advisers back adding weight-based dosing on OTC acetaminophen labels

An US FDA advisory panel on 18 May unanimously recommended adding dosing information to the labels and packaging of over-the-counter (OTC) acetaminophen for toddlers and babies 6 months to 2 years.

At the end of a two-day joint meeting of the FDA's Nonprescription Drugs and Pediatric Advisory Committees, panelists also unanimously recommended that liquid acetaminophen-containing products carry weight-based dosing charts on the labels.

Current labels and packages for OTC acetaminophen products, such as Johnson & Johnson's Children's Tylenol, only include dosing directions for children age 2 years and up, with a statement to "Consult a doctor" before giving the drug to toddlers and babies younger than 2.

But regulators said parents, nonetheless, give the drugs to children younger than 2 often without consulting a physician. The FDA noted that errors involving acetaminophen use in children commonly are caused by parents' confusion about how much to dose.

The agency's outside advisers also said makers of OTC acetaminophen should no longer promote their drugs as pain relievers for children under 2 years, since toddlers and babies cannot verbalize if the drugs are actually reducing their pain.

Earlier this month, makers of OTC liquid pediatric acetaminophen, including J&J and Perrigo, agreed to stop making and selling concentrated infant drops of the medicine in an effort to reduce dosing confusion and errors with the drugs. The 160mg/5mL of acetaminophen will now be the only liquid concentration available for all children 11 years and under, with the infants' strengths of 80mg/0.8/mL and 80mg/1mL no longer sold in the US. The infants' products also will come with syringes and flow restrictors, while the products intended for ages 2 to 11 years will continue to come with dosing cups.

The FDA also issued new guidelines about OTC liquid pain relievers, cold medicine, cough syrups and digestion aids packaged with cups, droppers, syringes or spoons intended to ensure correct measuring (scripintelligence, 6 May 2011).

FDA panel supports use of Abbott's Trilipix with a statin, but wants new study

An FDA advisory panel on 19 May voted 9-4 in favor of permitting Abbott to continue marketing Trilipix (fenofibric acid) for use with a statin in the US, despite a study that found an increased risk of a major adverse cardiac event in women using the combination therapy approach, with no added efficacy benefit.

The advisers said there was not sufficient evidence to remove the combination indication from Trilipix's labeling. The FDA's Endocrinologic and Metabolic Drugs Advisory Committee, however, unanimously recommended US regulators require Abbott to conduct a new long-term trial to study the safety and effectiveness of the combination of Trilipix and a statin.

Trilipix is approved in the US in combination with a statin to reduce triglycerides (TG) and increase high-density lipoprotein cholesterol (HDL-C) in patients with mixed dyslipidemia and coronary heart disease (CHD) or a CHD-risk equivalent who are on optimal statin therapy to achieve their low-density lipoprotein cholesterol (LDL-C) goal.

Trilipix also is approved as a monotherapy to reduce TG in patients with severe hypertriglyceridemia and as monotherapy to reduce elevated LDL-C, total cholesterol, TG and apolipoprotein (Apo) B, and to increase HDL-C in patients with primary hyperlipidemia or mixed dyslipidemia.

The FDA convened its panel of outside advisers to help it decipher the meaning of data from the Action to Control Cardiovascular Risk in Diabetes-Lipid (ACCORD-Lipid) trial as they relate to the efficacy and safety for statin use with Trilipix (scripintelligence, 17 May 2011).

The randomized, double-blind, placebo-controlled ACCORD-Lipid study evaluated the efficacy and safety of adding fenofibrate – a drug similar to Trilipix – to Merck's Zocor (simvastatin) in patients with Type II diabetes.

Results of the study indicated there was no statistically significant difference in the proportion of study participants treated with Zocor plus placebo verus Zocor plus fenofibrate who experienced a major adverse cardiac event, 11.3% versus 10.5%.

In a prespecified subgroup analysis from the ACCORD-Lipid trial, however, there was an increase in the proportion of women treated with Zocor plus fenofibrate versus Zocor plus placebo who experienced a major adverse cardiac event. 9.1% versus 6.6%.

"Abbott appreciates the committee's recognition that the totality of data, including ACCORD-Lipid, supports retaining the co-administration indication for Trilipix in appropriate patients," Dr Eugene Sun, vice president of global pharmaceutical clinical development at Abbott, said in a statement.

Abbott noted that the National Cholesterol Education Program treatment guidelines recommend consideration of the use of a fibrate with a statin in patients with TG at or above 200 mg/dL who are at LDL-C goal, but not at non-HDL-C goal.

Abbott pointed out, however, that two-thirds of patients in the ACCORD-Lipid study would not qualify for treatment with fibrates under current guidelines.

Senate panel adopts bill seeking to unseal pharma settlement docs

The US Senate Judiciary Committee on 19 May adopted legislation in a 12-6 vote aimed at ensuring courts consider public safety implications before judges decide to seal documents in settlement agreements that could hide information, such as defects in products, which could potentially put consumers at risk.

Court-sanctioned secrecy agreements prevent government officials or consumer groups from learning about defective and dangerous products that can stay on the US market unchallenged, said Senators Herb Kohn (Democrat-Wisconsin), Lindsey Graham (Republican-South Carolina) and Patrick Leahy (Democrat-Vermont), who sponsored the legislation, known as the Sunshine in Litigation Act.

A federal judge in Orlando, Florida, currently is deciding whether AstraZeneca can keep under seal adverse effect data related to its antipsychotic Seroquel (quetiapine fumarate).

Plaintiffs' lawyers and Bloomberg News sued to force the London-based drug maker to make public documents discovered in dismissed lawsuits.

In 2009, the court unsealed some documents, but denied requests to release AstraZeneca's submissions to foreign regulators and sales representatives' notes on physicians' meetings. "This is exactly the sort of case where judges should consider public health and safety when deciding whether to allow a secrecy order," Senator Kohl said in a 19 May statement.

The senators also pointed to a 2005 settlement involving Lilly's schizophrenia and bipolar disorder drug Zyprexa (olanzapine), in which plaintiffs in the case are forbidden from communicating or publishing any statements about the specific events, facts or circumstances giving rise to their claims.

US Senate bill seeks to halt sales of black-market drugs

Senators Chuck Schumer (Democrat-New York), Jon Kyl (Republican-Arizona) and Michael Bennet (Democrat-Colorado) on 16 May introduced legislation seeking to stop stolen prescription medications from entering the US drug supply chain.

If enacted, the bill, known as the Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhanced Safety Act, or the SAFE DOSES Act, would modernize and strengthen laws related to stolen prescription drugs and increase sentences for the theft, transportation and storage of the products. The legislation also would enhance penalties for anyone who knowingly obtains stolen medical products, especially when someone is harmed or dies from the drugs.

The bill also aims to make theft of medical products a predicate for US federal racketeering and wire-tapping laws.

Under the legislation, criminals also would be required to pay restitution for any victims harmed by the stolen products.

FDA: Pfizer failed to properly report adverse Chantix effects

The FDA on 19 May disclosed on its website that Pfizer had failed to properly report serious adverse neuropsychiatric events related to the New York pharma's smoking cessation aid Chantix (varenicline).

The FDA said it asked Pfizer in July 2010 to resubmit to the agency "thousands" of reports of potential adverse events spread over a number of years, which regulators said were initially submitted in a "way that did not allow for comprehensive evaluation".

The agency said it became aware last year that a few manufacturers had submitted adverse events reports to FDA through "improper channels". The agency said it clarified its instructions to drug manufacturers, including Pfizer, to submit adverse event reports through a channel that would allow for the adverse event reports to be entered into FDA's adverse event reporting system (AERS), a database that tracks postmarketing reports.

The FDA said the resubmitted reports from Pfizer "confirm what we already knew about Chantix and would not have changed the agency's position on the drug's risks and benefits, given that the data in these reports were consistent with those that led to the 2009 labeling change".

The FDA said, at this point, it does not have any new safety concerns with Chantix, though those that have been established remain under active review.

But the US-based nonprofit Institute for Safe Medication Practices (ISMP), which tracks adverse event reports, argued that because the Chantix reports had not been promptly included in the FDA's AERS database, the agency's analysts could not evaluate 150 completed suicides reported to the company, along with hundreds of other cases indicating psychosis, depression or attempted suicide.

Regulators said they are continuing to monitor the postmarketing safety of Chantix.