Clinical Trial Deaths And Compensation In India // Pharmalot

An investigation by India’s health ministry has found that drugmakers running clinical trials in the country have not compensated survivors of most volunteers who died during their studies. Of 671 deaths that were reported last year, there is evidence that compensation was given in just three cases, The Business Standard writes.

And so, the health ministry has asked 44 drugmakers to explain why they have not provided compensation, which is mandatory under the current law. Among those queried were Eli Lilly, Novartis, Pfizer, Bayer, Merck, Johnson & Johnson and Sanofi-Aventis. For instance, data compiled by the ministry show there were 152 deaths reported during Sanofi trials and 138 took place in Bayer trials.

A Novartis spokesperson tells the paper that its clinical trial investigator insisted any deaths were not caused by a medication, but instead due to the progression of underlying diseases. And compensation is not required in such cases. Other drugmakers offered a similar argument. Ministry officials also say that most deaths, which were attributed to cancer or cardiovascular and cerebrovascular disorders, seemed to have occurred due to the advanced stage of illness among volunteers.

via pharmalot.com

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New Health Insurance Survey: 9 Million Adults Joined Ranks of Uninsured Due to Job Loss in 2010; Few Viable Health Insurance Options Exist for Unemployed - The Commonwealth Fund

An estimated nine million working-age adults—57 percent of people who had health insurance through a job that was lost—became uninsured in the last two years, according to the Commonwealth Fund 2010 Biennial Health Insurance Survey, released today. The survey paints a bleak picture for the 43 million adults under age 65 who reported that they or their spouse lost a job in the past two years, finding that job losses are often compounded by the loss of health insurance, leaving families vulnerable to catastrophic financial losses and bankruptcy in the event of a serious illness or accident.

According to the report, Help on the Horizon: How the Recession Has Left Millions of Workers Without Health Insurance, and How Health Reform Will Bring Relief, the unemployed have great difficulty finding affordable health care. Only 25 percent of people who lost employer health insurance were able to find another source of health insurance coverage, and only 14 percent continued their job-based coverage through COBRA. In addition, purchasing individual coverage was not a viable option for most people. Seventy-one percent of adults who tried to buy individual coverage in the past three years, or 19 million people, either found it difficult or impossible to find a plan that fit their needs; found it difficult or impossible to find a plan they could afford; or were turned down or charged a higher price for coverage because of a preexisting condition.

“This survey tells a story of millions of Americans who lost their jobs during the recession, lost their health benefits too, and had essentially no place to turn for affordable health care coverage—putting their health and financial security at risk,” said Commonwealth Fund President Karen Davis. “The silver lining is that the Affordable Care Act has already begun to bring relief to families. Once the new law is fully implemented, we can be confident that no future recession will have the power to strip so many Americans of their health security.”

via commonwealthfund.org

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'Dispense As Written' Prescriptions May Add $7.7 Billion To Annual Health Care Costs, Researchers Found

About 5% of prescriptions submitted by CVS Caremark Pharmacy Benefit Management (PBM) members in a 30-day period during 2009 included a "dispense as written" (DAW) designation.

This practice - whereby doctors or patients demand the dispensing of a specific brand-name drug and not a generic alternative - costs the health care system up to $7.7 billion annually, according to a new study by researchers at Harvard University, Brigham and Women's Hospital and CVS Caremark. Moreover, these requests reduce the likelihood that patients actually fill new prescriptions for essential chronic conditions.

In a study published this week in the American Journal of Medicine, the researchers demonstrate that DAW designations for prescriptions have important implications for medication adherence. They found that when starting new essential therapy, chronically ill patients with DAW prescriptions were 50 to 60 percent less likely to actually fill the more expensive brand name prescriptions than generics. "Although dispense as written requests would seem to reflect a conscious decision by patients or their physicians to use a specific agent, the increased cost sharing that results for the patient may decrease the likelihood that patients actually fill their prescriptions," the researchers said.

via medicalnewstoday.com

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Branded drug prices soar as generic pressure rises | Reuters

Pharmacists in Jordan-based Hikma Pharmaceuticals package generic versions of Ciprofloxacin hydrochloride 750 mg which will be exported to the U.S. and Western markets in Amman February 8, 2011.

Credit: Reuters/Ali Jarekji

By Deena Beasley

LOS ANGELES | Wed Mar 23, 2011 11:46am EDT

LOS ANGELES

(Reuters) - U.S. prices for brand-name drugs are rising faster than ever as patents expire on top-selling medicines and the pharmaceutical industry nervously eyes the future of healthcare reform.

Prices for the 15 best-selling drugs rose by much higher rates in 2010 than they did in each of the last five years, according to exclusive data from Thomson Reuters MarketScan, which measured the average cost of a daily dose as shown in medical claims data.

Two thirds of the drugs saw double-digit price hikes, well above inflation of 1.6 percent in 2010 measured by the consumer price index. The analysis indicates drug makers are scrambling to make as much money as possible from blockbuster drugs before their patents expire, while taking advantage of the fact that last year's healthcare reform bill did not cap drug prices.

According to MarketScan, payments for Pfizer Inc's Lipitor rose 11.4 percent last year, compared with 5 percent annually from 2005 to 2010. That meant the cost of a daily dose of the cholesterol drug rose from $3.17 at the end of 2009 to $3.53 at the end of 2010. Lipitor, which will soon lose patent protection, had 2010 global sales of $10.7 billion.

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$4 drug programs could save economy billions: study | Reuters

U.S. consumers could save billions of dollars by filling prescriptions for inexpensive generic drugs at stores such as Wal-Mart and Target, according to a new report.

A growing number of national chain pharmacies offer the generic form of a range of drugs - including anti-allergy medications, antidepressants, antibiotics and cholesterol-lowering drugs - for $4 for a 30 day supply. However, researchers found that less than 6 percent of people who could use such a program take advantage of it - costing both consumers and the government extra bucks.

All told, the US could save as much as $5.8 billion, according to the study

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