The week in review, January 27-February 3, 2013
medwireNews: This week's stories include: guidelines to brain amyloid PET scanning make a debut; CDC's wagging of the finger to noninfluenza vaccination trends; the cautious road to available generic biologics; expert panel opts for tightening of the leash on hydrocodone drugs; lawmaker acts to put kidney dialysis drugs in their place.
Until recently, a conclusive diagnosis of Alzheimer's disease (AD) has been a retrospective assessment made postmortem. But AD verdicts are bound to change with the advent of high-quality positron emission tomography images of the most studied offender in AD, brain amyloid (Aß) plaques, in living people.
Yet the question remains as to how the scanning technology should be used to best guide diagnostic and treatment approaches to AD. The issue becomes a bit of a conundrum when the presence of plaques does not necessarily lead to AD while other health issues can elicit dementia.
To pave a clearer path concerning the appropriate use of this tool, the Society of Nuclear Medicine and Molecular Imaging and the Alzheimer's Association jointly produced the first ever guidelines.
Not with the program
The latest influenza scourge garnered much attention while vaccination coverage levels for other threatening infections seem to have been marginalized from general concern.
That is, until the Centers for Disease Control and Prevention (CDC) found vaccination coverage for infectious diseases such as tetanus and herpes zoster were "unacceptably low," as stated in the department's Morbidity and Mortality Report (MMWR).
The CDC called for more initiatives to get people on track in getting vaccinated that would demand greater vigilance from healthcare providers.
Wariness of the knockoff
The complexity of biologic drugs reaches the point where only a living cell is able to manufacture it. The involvement that is required to produce biologics is such that various manufacturers are likely to end up with a slightly different end product by harnessing the cellular factories - not to mention storage and handling - in diverse ways.
Until recently, generic competition to brand name drugs has concentrated on drugs that are chemically manufactured. But thanks to the 2010 Biologics Act, follow-on biologics are now able to enter the playing field.
But with potential variances of biologics possibly leading to harmful results such as unwanted immune response, some biotech companies of brand name drugs are urging state policymakers to be extremely prudent in not rushing to give the OK to cheaper biosimilar alternatives.
Voting for restraint
At a recent Food and Drug Administration (FDA) meeting to address the rampant abuse of drugs containing hydrocodone, the deputy assistant administrator in the Drug Enforcement Agency, Joseph Rannazzisi, pointed out that the dire stats reflect physicians' failure to take the problem seriously.
Ultimately, an advisory panel of 29 experts also present at the gathering voted to place more stringent regulatory rules on the painkiller by changing its Schedule ranking - which the FDA heeded and has yet to determine how to proceed.
Numerous advocates pointed out foreseeable issues arising from this alteration, such as reduced access to those who truly need the drug.
Not so fast
Much to the surprise of many lawmakers as the 11th hour American Tax Payer Relief Act was hammered out to end the "fiscal cliff" standoff, legislation was included that exempted a class of oral drugs to treat kidney dialysis patients from Medicare price controls.
Vermont's Congressional Representative Peter Welch decided he would have none of what he described as a "backroom deal" that ultimately would "feed at the public trough" by filing legislation that would eliminate the exemption.
The incident is part of a continuing effort since 2008 to alter reimbursement protocol for dialysis treatment that arguably motivates profit-driven overprescribing.
By Peter Sergo, medwireNews Reporter