Modern Healthcare published an article by the Associated Press discussing the new heights reached by FDA approvals last year. An impressive forty-one first-of-a-kind drugs have been approved, the highest total since 1996 when the agency sanctioned fifty-three new drugs for public use. Strides in medical innovation are constantly made, but problems in the healthcare system remain.
In the article, two issues are touched upon briefly: cost and treatment of prevalent conditions. First, cost as a deterrent. Fifteen of the forty-one new drugs were for orphan diseases, "rare conditions and disorders that affect fewer than 200,000 people in the U.S." The number is significant and is said to reflect a shift in the drug industry's focus. It is now turning its eye towards rare conditions.
However, the problem lies with accessibility. Can people afford to use it? America's Health Insurance Plans, the national trade association representing the health insurance industry, according to the AP, "spent much of the last year speaking out against the costs for innovative new drugs, for both orphan conditions and more common diseases. AHIP and other groups took particular issue with the price of Sovaldi, a new hepatitis treatment which costs $94,500 for a 12-week supply."
That's $1,125 a pill. The treatment may be available but its cost may prove prohibitive. The second issue is the treatment of prevalent chronic conditions. The article mentions high cholesterol, heart disease and diabetes as some of the prevalent diseases and conditions that the industry considers as 'solved' as they already have 'effective' therapies available for the treatment of such ailments.
The terms 'solved' and 'effective' are problematic however, because they fail to address the underlying concerns when talking about these therapies - usually medication - that are available and most commonly prescribed. FDA approval doesn't preclude unwanted side effects.
"All medicines have benefits and risks. The risks of medicines are the chances that something unwanted or unexpected could happen to you when you use them. Risks could be less serious things, such as an upset stomach, or more serious things, such as liver damage. FDA approves a drug for marketing after determining that the drug's benefits outweigh its risks."
A recent article by Ed Silverman for the Wall Street Journal took note of the faulty system in place when it comes to reporting side effects caused by prescriptions drugs. Information about injuries accrued are incomplete and the reason, according to an analysis by the Institute for Safe Medicine Practices (ISMP), a nonprofit organization devoted entirely to medication error prevention and safe medication use, seems to be the shoddy reports filed by drug makers.
The FDA's Adverse Event Reporting System was put in place in order to gather information about side effects that prescription medicines may cause. "Consumers and physicians may voluntarily report problems to the agency or a drug maker, while drug makers must investigate and then report any side effect that may be attributable to one of their products," wrote Silverman.
"Drug makers, however, file the vast majority of reports. During the 12-month period through the first quarter of 2014, the pharmaceutical industry submitted nearly 97% of reports in the FDA system, according to ISMP. Consequently, the non-profit maintains the integrity of the reporting system rests largely with drug makers, but that drug makers too often file incomplete reports."
For a report to be reasonably complete, the ISMP notes that it should be dated and include patient age and gender. However, it was observed that in 36 percent of the reports filed by industry, the patient's age was not included and 44 percent of those reports were not dated.
"There were also questionable death reports. More than 28% of reported patient deaths did not have useful information about the cause of death or the possible role of a medicine," reported Silverman. "We have seen an increasing number of reports pointing to the dysfunctional healthcare system we have in place. Cleary, change is necessary," said Richard A. Kimball Jr., CEO of healthcare technology business HEXL, and an outspoken advocate of preventive medicine and telemedicine.
"A move towards a more proactive health care system geared towards preventive measures such as education, monitoring, and behavioral changes can potentially help preserve quality of life, not to mention save millions of dollars by avoiding the high costs resultant from poorly managed chronic conditions."
About the Author
Russell Benaroya, formerly of GoTo.com and REM Medical, is a major player in the health startup space. His most recent endeavor, social fitness & employer wellness platform EveryMove, is the result of a lifelong ambition to change the lives of others through physical activity.
