Friday, April 25, 2014
Inquirer Daily News

POSTED: Thursday, March 6, 2014, 9:13 AM
Filed Under: Daniel Hoffman

Recently there's been some discussion in pharma's higher circles that biosimilars may not offer the road to riches along the lines touted by the industry's C-suite officers.  It is becoming increasingly clear that only a few companies may make substantial profits in that area and, in fact, biosimilars may actually represent a "fool's gold" for most pharmas.

Even as biosimilars aren't likely to be pharma's road to enormous profits, the recent events concerning Russia's incursion in the Ukraine open a light of reality into another of the industry’s illusions, this one involving the golden mountain of Emerging Markets.

It now appears that none of the BRIC countries that supposedly are the spearhead of pharma’s Emerging Markets strategy are meeting expectations.  China’s growth is slowing, the government is exercising price controls on drugs and they intend to grow their domestic pharma companies at the expense of foreign multinationals.  India and Brazil are even more aggressive at controlling prices, with India declaring compulsory licensing (i.e., breaking the patents) on several brands.  

POSTED: Wednesday, March 5, 2014, 9:24 AM
Filed Under: Michael Cohen

Medication safety in the home is an important public health issue. Almost half of all Americans have taken at least one prescription medication in the last month and more than three-quarters have taken an over-the-counter (OTC) drug. Most of these medications are taken in the consumer’s home or other residential or community setting. In these settings, the risk of medication errors is ever present as consumers with variable health literacy and unlicensed healthcare personnel undertake the complex processes associated with safe medication management. 

Our sister organization, the Institute for Safe Medication Practices (ISMP) Canada, recently collaborated with several provincial Offices of the Chief Coroner and Chief Medical Examiner in Canada to conduct an analysis of medication events associated with deaths in the community setting. The analysis uncovered clear themes and contributing factors that led to the fatal events. The findings are noteworthy since there is good reason to believe that the same issues are causing fatal medication errors in US homes. 

The overarching theme of the analysis was that of knowledge deficits leading to various patient safety risks. One of the key areas involved knowledge deficits related to people’s misperceptions or myths about medications, indicating their failure to appreciate general risks associated with prescription and OTC drug therapy. Most of the deaths involved an intentional therapeutic overdose, sharing of prescribed medications, and unsafe storage of medications.

POSTED: Wednesday, February 26, 2014, 6:00 AM
Filed Under: Daniel Hoffman

Last week the health care policy consultancy, Avalere Health, predicted that within a couple of years, most of the insurance plans obtained through the exchanges established by the Affordable Care Act will require consumers to pay a percentage of the costs—rather than fixed co-payments—for specialty medications (see here).  Termed “co-insurance,” these costs can amount to 50% of the costs for a drug to treat a rare or complex condition.

Given that these specialty drugs cost between $50,000 and $200,000 per patient per year, the amounts contemplated are well above the affordability level of most Americans.

In trying to assess what pharma companies plan to do as this situation develops, I spoke with a seasoned consultant who tries to coax his pharma clients into acknowledging the realities of the larger health care world in the belief that his listeners are rational and not obsessed with profit-making to the exclusion of all other motives.  He claimed, “Companies will need a two-step solution to address this challenge.”

POSTED: Tuesday, February 18, 2014, 6:00 AM
Filed Under: Daniel Hoffman

Over the last several years some widely discernible trends of the pharmaceutical industry's drug development process have emerged.  Much of this is driven by three factors.  The first is that a declining percentage of the drugs produced by research constitute genuine breakthroughs capable of substantially advancing the respective standards of care.  At the same time, both public and private payers have grown increasingly reluctant to pay constantly higher prices for the marginal, incremental improvements that characterize most of the new drugs coming to market.  Given the ceaseless demands of finance-driven pharma companies to maintain the profitability levels they enjoyed during the 1980s and '90s glory days, these factors have combined to shape the R&D pattern.

One prominent feature in the new R&D landscape is that many pharmas have withdrawn from therapeutic categories where clinical development is lengthy, expensive and fraught with regulatory hurdles.  So for example, some companies have reduced or entirely quit cardiovascular research where trials often need to enroll 20,000 or more patients in order to show a statistically meaningful improvement over existing medications.  Instead research budgets have flowed into oncology where regulators will often accept registration trials with only a few hundred test subjects. 

At the same time, favorable early results for an oncology compound can shorten the usual time needed to file because regulators know that the earlier availability of some new products will immediately save lives.  In such cases they will permit filing on the basis of Phase 2 results.  Moreover, the specter of imminent mortality in that area will generally make regulatory bodies more tolerant of debilitating side effects there than in other categories.

POSTED: Monday, February 17, 2014, 6:54 PM

It’s now February, and the Affordable Care Act, aka “Obamacare” is here. The law, as everyone knows, has become a political football, subject to endless spin and distortion. Yet many people, including some colleagues, do not know what the law entails. This week, I decided to take a closer look at how it could affect some of our patients …

The first is 18-year-old Mina, who just graduated from high school last year and has a part time job working, 20-30 hours a week at a pizza shop while she’s preparing to start college next fall. She makes about $10,000 a year. Mina (names have been changed to protect patient privacy) got dropped from the Pennsylvania Children’s Health Insurance Program (CHIP) when she turned 18 and her parents have no insurance, so she is uninsured.

The second is the Bankole family. The parents are immigrants from Africa and recently became citizens. They clean offices at night in Center City and as contractors have no health insurance. Policies that they would have purchased on their own were expensive and would not have covered expenses due to Mrs. Bankole’s diabetes, a pre-existing condition. Their two children are insured through CHIP.  Their income, through a lot of overtime is about $60,000. They are both worried that Mrs. Bankole will need to cut back her hours because she has been feeling unwell from the untreated diabetes. 

POSTED: Monday, February 17, 2014, 9:23 AM
Filed Under: Michael Cohen

Two recently published studies of one of the newer blood thinners, Pradaxa, point the way to reducing the risk of its major drawback—high rates of bleeding of 16% a year.  

Pradaxa was approved in October 2010 as an alternative to the standby blood thinner Coumadin (warfarin). Both are effective in reducing the risk of disabling strokes in people with a condition known as atrial fibrillation, a heart disorder affecting about 2.5 million mostly older patients in the U.S.

Pradaxa’s marketing advantage was that it was easier to use than Coumadin, which requires careful monitoring of its blood clotting effects and often a dose adjustment.  The FDA approved Pradaxa with only a single standard therapeutic dose of 150 mg, taken twice a day. The laboratory test for Coumadin, called INR, was not useful or accurate with Pradaxa for determining whether blood clotting was inhibited too much—leading to bleeding—or not enough, which might increase stroke risk. However, unlike Coumadin, no antidote exists for Pradaxa to halt bleeding quickly should it occur.

POSTED: Tuesday, February 11, 2014, 12:05 PM
Filed Under: Michael Cohen

Rotavirus is a virus that causes a type of gastroenteritis (inflammation of the lining of the stomach and intestines) that can lead to severe watery diarrhea, vomiting, fever, and abdominal pain. According to the CDC, rotavirus gastroenteritis can also lead to dehydration (loss of body fluids) in babies and young children. This is a serious complication that may require hospitalization for administration of IV fluids. The virus is a major cause of death in children around the world.

Fortunately there are two oral live rotavirus vaccines available in the US that can protect children against rotavirus gastroenteritis. But since the use of live oral poliovirus vaccine was discontinued in the United States in 2000, other than rotavirus vaccines, no other oral vaccines are routinely given to children in the U.S. Therefore, providers now have less experience administering oral vaccines and, on occasion, by mistake they’ve accidentally injected oral rotavirus vaccine, making it completely ineffective.

Recently the Centers for Disease Control and Prevention (CDC) examined reports of accidental injection submitted to the Vaccine Adverse Event Reporting System (VAERS), operated jointly by CDC and FDA. There were 39 reports of injection overall. A Merck product, RotaTeq, is available as a liquid in a squeeze applicator. This was involved in only 6 out of 39 errors reported by CDC. Most cases (33 out of 39) happened with the Glaxo SmithKline (GSK) product, Rotarix, which requires mixing a dried out form of the vaccine into a liquid before giving it.

POSTED: Thursday, January 30, 2014, 11:59 AM
Filed Under: Daniel Hoffman

In an effort save money on continually rising drug costs, the Germans passed the Reform of the Market for Medicinal Products act in 2010 to assess whether newly approved brands in that country justify their higher prices with greater benefits than older products.  Germany's Federal Joint Committee, composed of physicians, hospital administrators and health insurers was charged with assessing the comparative benefits of new products.  Their findings then form the basis for price negotiations between the manufacturers and the statutory health insurance funds.  New brands that offer no added benefits cannot receive prices higher than what existing products charge.

The Federal Joint Committee started its work in 2012 and, to date, 60% of the new drugs they analyzed failed to show additional therapeutic benefits beyond those of older medications.  Despite this cost saving to payers and consumers, the German government of Conservative Chancellor Angela Merkel, in a bow to pharma pressure, is set to scrap the Reform system.

Interestingly, physicians in Germany do not fall into the typical pattern of their American counterparts.  In most cases, American practitioners remain eager to prescribe pharma's newest offerings, even though their only knowledge of the costs and benefits of new medications is generally limited to what sales reps spoon feed them.  German physicians and their organizations, by contrast, are now urging the country's new coalition government not to discontinue the drug review process.  For example, the chairman of the German Medical Association's Drug Commission publicly stated that scrapping the review will make it more difficult for physicians and others to obtain independent information about new drugs (see here).

About this blog

Check Up covers major health events in our region and offers everything from personal health advice to an expert look at health reform. Read about some of our bloggers here.

For Portions of this blog may also be found in the Inquirer's Sunday Health Section

Michael Cohen id the president of the Institute for Safe Medication Practices in Horsham.

Daniel Hoffman is the president of Pharmaceutical Business Research Associates (PBRA) in Glenmoore, Pennsylvania, a healthcare research and consulting company specializing in key account positioning and messaging.

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