Pharma

Public health officials continue to be concerned about public distrust of vaccines. In a study published in Lancet Infectious Diseases, the authors describe how a new public opinion surveillance application could help health experts quickly respond to and quash rumors and misinformation about vaccines.

The researchers found that of 10,380 global public opinion reports on vaccines identified during 2011 and 2012, 31 percent were negative. The researchers then categorized the concerns to determine which ones were most likely to disrupt citizen participation in vaccination programs and potentially contribute to disease outbreaks.

According to lead author Heidi Larson, London School of Hygiene & Tropical Medicine in the UK, "Recent measles outbreaks in the UK, stemming from children not-vaccinated due to fears prompted by now-discredited research over a decade ago, is one example of the long-term consequences of broken public trust in vaccines."

The application builds on the capabilities of HealthMap, an online surveillance tool that tracks disease outbreaks from electronic media in 144 countries. Boston Children's Hospital created HealthMap in 2006, using aggregated data from 11 governmental and commercial sources with funding from Google and Lifebouy.

The FDA approved GlaxoSmithKline's new combination chronic obstructive pulmonary disease (COPD) drug on May 10. Breo Ellipta is a dry powder inhaler that reduces inflammation in the lungs, increases airflow and reduces COPD exacerbations. The drug combines corticosteroid fluticasone furoate and vilanterol, a long-acting β2-adrenergic agonist (LABA).

GSK said the drug was tested in four primary COPD studies including two 6-month lung-function studies and two 1-year replicate exacerbation studies. One clinical trial involved 7,700 COPD patients.

Known side effects include headache, upper respiratory tract infection, inflammation of the nasopharynx and thrush. The drug also increases the risk for pneumonia and bone fractures, according to the FDA.

Breo Ellipta will carry a boxed warning about the increased risk for asthma-related death.

GSK developed the drug in collaboration with South San Francisco, Calif.-based Theravance. Under their agreement, Theravance will pay GSK $30 million upon FDA approval. GSK expects the drug will be available in the U.S. market by the 3rd quarter of 2013.

COPD is the third leading cause of death in the United States, according to the National Heart, Lung, and Blood Institute.

More information:

FDA Release

GSK Release

Theravance Release

In what is being described as a novel strategy that "blows up the drug industry's distribution model," Pfizer is making its blockbuster drug Viagra available online.

Pfizer says the move to sell the erectile dysfunction drug online is aimed at getting back some of the sales revenue going to online counterfeit pharmacies. According to Pfizer, Viagra is the most counterfeited drug in the United States. The company also believes being able to order online will save some men the embarrassment of going to the drug store. They're still required to have a doctor's prescription for the drug.

Being able to order Viagra online may make it more appealling than some competing products, including its main competitor, Eli Lilly's Cialis. At least until Lilly follows suit.

Online orders for the drug via viagra.com are fulfilled by CVS Caremark Corp.

After a federal judge ruled in April 2013 that the FDA must allow emergency contraception products to be available nationwide, the agency last week gave Teva Pharmaceuticals the go-ahead to market its Plan B One-Step emergency contraceptive via store shelves. Plan B will be available without a prescription to women 15 years old and older. A code embedded in the packaging will notify clerks to verify a consumer's age before purchase, according to the FDA.

Until now, emergency contraception products including Plan B and generic competitors have been kept behind the counter and have only been available by prescription to women 17 and older. The FDA had approved over-the-counter sales of Plan B for women of all ages in December 2011 but was overruled by Secretary of Health and Human Services Kathleen Sebelius.

In a written statement, Planned Parenthood called the approval "an important step forward" in allowing access to emergency contraception when its needed.

Are you curious about the history of medicine? Wonder about the most notable advancements in drug treatments?

Learn about ancient Egyptian medicine, Hippocrates, Marie Curie, Louis Pasteur and many other contributors to medical progress throughout history at the History of Medicine site. Chris Trueman launched his site in 2000 as a central resource for world history on the web. Trueman teaches history and British and American Politics at a secondary school in England.

The National Library of Medicine's History of Medicine website claims to have "one of the world's richest collections of historical material related to human health and disease."

The Science Museum of London's "Brought to Life" online resource is rich with photos and in-depth looks at key developments and their lasting impact on society.

State and city governments routinely given tax breaks and grants to companies as incentives to establish or expand local operations.

Recently, two healthcare powerhouses have encountered some resistance to proposed tax break scenarios being discussed in Minnesota.

Baxter International, the global drug-maker and medical device manufacturer with U.S. headquarters in Deerfield, Ill. is seeking a tax exemption from state sales tax on construction materials as it expands and retrofits a biopharmaceutical manufacturing facility in Brooklyn Park, a Twin Cities suburb. The first phase of the construction could employ about 190 and the second phase would add an additional 200 jobs, according to backers. The bill passed yesterday by the state Senate includes $15.4 million in incentives, including a retroactive tax exemption for the work Baxter has already done on the project. The deal, initiated by the city of Brooklyn Park and a government agency, has already been passed by the House. The proposal apparently included a confidentiallity agreement to keep Baxter's name hush-hush, and that's the cause of the rub.

The Senate hearing on Monday focused on transparency and the cloak of secrecy placed around the project.

The deal could represent "a dangerous precedent," according to Rep. Greg Davids, because of limited public vetting and legislative scrutiny.

Baxter acquired the 235,000 square-foot facility from the Danish biotech Genmab. According to Baxter's website, about 60 percent of the company's sales and workforce were outside the United States in 2012. "With manufacturing facilities located throughout the world, Baxter's philosophy of manufacturing locally allows the company to better manage production, costs and pricing," states Baxter.

The Mayo Clinic, the crown jewel of Minnesota's substantial healthcare industry, also encountered some resistance in its special bid for tax breaks and public spending to aid its expansion in Rochester, Minn.

Both bills are are expected to be passed as part of an omnibus tax bill that was sent to a conference committee last night.

Actavis, one of the world's largest generic drug makers, announced April 26 that it has settled its patent litigation with Purdue Pharma over generic OxyContin. Under the agreement, Actavis gains a license to begin marketing its generic version of the pain medicine in January 2014, pending FDA approval of Actavis's Abbreviated New Drug Application (ANDA) for the drug.

The company said it expects to earn more than more than $100 million in combined gross profit in 2014 and 2015 through sales of the generic.

According to IMS Health, 2012 U.S. sales of OxyContin were $2.8 billion.

In at least two instances, the Food and Drug Administration (FDA) failed to notify doctors and patients that some drugs were approved based on faulty research, according to an investigation by Pro Publica, a non-profit investigative journalism group.

In one instance, the FDA left medicines on the market even after the agency was informed by a inside whistleblower that studies conducted by Cetero Research, an international drug testing company based in Houston, Texas, were fraudulent. The FDA often bases its approval of new drugs at least partially on research conducted by Cetero and other testing labs.

In another case uncovered by Pro Publica, the FDA found that studies produced by Quebec, Canada-based MDS Pharma Services between 2000 and 2004, were "questionable."

FDA announced it was requiring drug manufacturers to redo many of the MDS studies conducted during the five-year problem period. And, just as in the Cetero case, the agency declined to make public a list of 217 generic drugs, both on the shelves and awaiting approval, that it said could be affected by MDS' potentially faulty research.

Instead, the FDA assured the public that all affected drugs were safe and effective, even as it was requiring re-testing of many of those medicines.

Both Cetero Research and MDS Pharma Services are now operating under different names.

Cetero filed for Chapter 11 bankruptcy in 2012 and adopted PRACS Institute as its new name. PRACS Institute filed for bankruptcy on March 22, 2013. MDS Pharma Services has been renamed Nordion.

Newfoundland and Labrador predict a savings of $17 million this year on prescription generic drugs, following enactment of a joint provincial bulk-buying plan to lower generic drug costs. Saskatchewan predicts a savings of about $10 million under the plan which took effect this month.

So far, provincial health departments have lowered the cost of six commonly used generics, with more to fall under the price reduction plan throughout the year.

The health care component of the Council of the Federation, a collaboration of premiers from Canadian provinces and territories, agreed in January 2013 to reduce the cost of generic drugs, without federal help. The initial price cuts took effect April 1.

The six drugs, for common ailments like high cholesterol, high blood pressure, depression and gastrointestinal conditions, represent "20 percent of the publicly funded spending on generic drugs in Canada," according to the Federation.

Swiss pharma Novartis lost a 7-year patent dispute over a cancer drug April 1 when the Indian Supreme Court upheld that nation's patent office decision to deny a patent for Glivec, a cancer drug. The drug is called Gleevec in the United States and is an often effective treatment for chronic myeloid leukemia and some other cancers.

The court ruled that under India's patent law, Novartis could not be granted a patent for an existing drug, even if the drug was an improved version. Glivec was first introduced in India prior to 2005, when India adopted its patent law.

In a statement following the ruling, Novartis said it had concerns with India's "growing non-recognition of intellectual property rights that sustain research and development for innovative medicines." Novartis' managing director in India Ranjit Shahani said, "We brought this case because we strongly believe patents safeguard innovation and encourage medical progress, particularly for unmet medical needs. This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment."

However, the company said it intends to continue providing Glivec free of charge to most of the 16,000 patients currently receiving Glivec in India through a donation program. The remaining patients -- about 5 percent -- are covered through insurance or reimbursement programs.

Novartis said it has donated more than $1.7 billion worth of Glivec to patients in India since 2002.

Generic versions of Glivec are currently available for about $175 a month, while the original drug costs about $2,600 a month.