The FDA and drug prices under the spotlight

drugpriceheadlinesAccording to the NY Times “a decision announced Thursday by the Food and Drug Administration to suspend sales of a leukemia drug, Iclusig, that was keeping patients alive but also significantly raising their odds of heart attacks, strokes, blindness, death and amputations” has led to concern that patients who are using the drug to stay alive may soon find it hard to refill their prescriptions.   “Despite the potential consequences, several doctors who treat people with the disease, chronic myeloid leukemia, said there were patients for whom nothing else works, and whose lives depend on the drug.” So who really should make the decision about treatment options ?Iclusig, also called ponatinib, was approved in December 2012 to treat patients who had chronic myeloid leukemia that did not respond to other drugs. The disease is a relatively uncommon form of leukemia, with about 5,000 cases a year and 600 deaths in the United States. The wholesale price of the drug was $115,000 a year.  In a bulletin on Thursday, the drug agency said that 24 percent of patients taking Iclusig who were studied for a median of 1.3 years, and 48 percent studied for a median of 2.7 years, had suffered “serious adverse vascular events.” Those figures are unusually high, and higher than what was reported from the initial studies done before the drug was approved.


In response physicians must fill out REMS paperwork to start or keep patients on the drug.  Instead of making the REMS paperwork easy to fill out the FDA, like any government agency, has made it a bureaucratic mess.  However beyond the paperwork the question arises as to ‘who should make the final decision as to what drug(s) are used to treat often fatal diseases ?  The answer to that of course is the patient in conjunction with their health care professional.  Patients need to be informed of the potential risks vs. benefits.  In this case this drug could hold the only key to survivability for this disease.  Rather than just slap a REMS on this drug perhaps the FDA should try a more patient focused approach to ensure that those already on therapy can still get the drug should they be willing to take the risk.

Here we go again…drug prices

Prescription drug use is the source of a significant amount of health care costs. Over the last decade, the percentage of Americans using five or more prescription drugs increased by 70 percent, according to a new infographic from  Why the disparity in drug prices in the US vs. other countries? It’s a question asked repeatedly, and the specific answers are multifarious and complex.  Politics. In other countries, where healthcare is the province of the state, governments negotiate lower drug prices. The U.K. has an agency, the National Institute for Health and Care Excellence (NICE), that assesses new drugs for cost-effectiveness and can reject them for routine use by the National Health Service. Other countries often follow NICE’s decisions. Still others have their own price-setting mechanisms; Germany’s new, strict assessment rules, for example, have frustrated drugmakers to the point that a few won’t launch new drugs there.


In the U.S., government health programs are forbidden from rejecting new drugs on cost grounds. Medicare is forbidden from negotiating drug prices; when the idea came up as part of the Affordable Care Act debate, it was summarily rejected in Congress. At the same time, a move toward comparative-effectiveness studies–which would put rival drugs or treatments through trials to determine which work better–was decried. That idea turned into the notorious “death panel” protest.

The costly cohorts battling multiple chronic illnesses consumed 21 percent of the nearly $1.3 trillion Americans spent on health care in 2010, at a cost of nearly $88,000 per person. Five percent of patients accounted for 50 percent of all healthcare expenditures. By contrast, the bottom 50 percent of patients accounted for just 2.8 percent of spending that year, according to a recent report by the federal Agency for Healthcare Research and Quality.

Then there costs associated with obesity.  Obesity is a big factor driving soaring rates of chronic disease in the United States, with many more Americans chronically ill than their European counterparts, a new study finds. It’s an expensive problem, too: According to researchers, chronic illnesses such asdiabetes and heart disease account for some $100 to $150 billion in health-care spending in the United States each year.


“The United States spends twice as much as European countries on health care,” noted lead researcher Kenneth Thorpe, chairman of the department of health policy and management at Emory University’s Rollins School of Public Health in Atlanta. “Seventy-five percent of what we spend in this country is associated with patients that have one or more chronic conditions and most of the growth is due to obesity.”

So maybe instead of focusing on drug costs, which are only 10% of every healthcare dollar spent, the authors should look at American’s who do a really bad job of managing their health and cost us so much money.




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