This article is more than 5 years old. Information may no longer be current.
Farewell to 2012: The year of new drugs and new regulations
Click Here to Manage Email Alerts
The past year saw a continuing trend in the erosion of control of medical practice by medical practitioners. The dictates of officials and bureaucrats of both government and insurance companies continue to increase physician workload, practice expense and diminish the time available for patient visits.
In the name of increased quality, many innovations such as meaningful use of the EHR have become the means by which the payers assess the compliance by practitioners with their complicated reimbursement formulas. Thus, there is no benefit to the patient and, perhaps, net loss depending upon the distraction and lost time by each practitioner as they laboriously fill out electronic pages rather than converse directly with their patients. The taking of a history, once one of the two crown jewels in the universe of physical diagnosis, is no longer a discretionary and subtle tool for elucidation of diagnostic possibilities, but rather has become a routine tool for the assessment of the level of an office visit. Where once upon a time, long, long ago, in a universe far, far away, skilled physicians were able to delicately dissect away confusing and irrelevant diagnostic possibilities while discerning undiscovered clues to the nature of the true illness, now there is only routine processes of “hitting the marks” to satisfy the payers. Predictably, this leads to overutilization of diagnostic testing to fill the gap and provide a bulwark against unjustified malpractice claims. All of this leads only to increased, rather than decreased, costs for medical care. But never mind addressing the true origins of these increases, let us press forward with our imaginary solutions for those increases while we continue to deny the underlying true causes and therefore need never address effective solutions such as tort reform and the regulatory actions interfering with real health care delivery.
As I have noted previously in these columns, all of these developments were completely expected following the continuing shift of the costs of medical care from patients to employers (insurance companies and government) which began under Roosevelt during WWII. As every child has learned long ago, he who pays the Piper calls the tune. While insurers were once extensions of employer-provided health care, increasingly government has come to see itself as the grand determiner of appropriate health care, as it now pays for large chunks of such care through Medicare and Medicaid. Although both programs substantially underpay for the care which they mandate, we physicians have chosen to dance to their tune. In the long run, we are rewarded by an SGR payment reduction yearly and by the need for authorization of care already decided as necessary by licensed, qualified physicians caring for the patient firsthand. The whole process is insulting and emblematic of governmental arrogance. But, since we do not object, we continue to get more of the same. This will continue until we choke on these programs or rebel, hopefully the latter.
Alan J. Garber
Finally, this year past did produce some gifts in the form of new medications approved for use in endocrine diseases, especially diabetes. Of course, with these approvals come new regulatory impediments to the approval process. Approximately one-third of the 27 million patients with diabetes in the US are treated with insulin. There is now a rapidly developing class of ultra-long acting basal insulins beginning to appear at the FDA. The first of these – insulin degludec – was voted for approval by the FDA Advisory Committee in November 2012. Naturally, the whole process was complicated by the interjection of an entirely new requirement for insulin approval, namely measures of excess cardiovascular risk exactly analogous to those requirements already imposed after the rosiglitazone controversy. These required demonstrations of a lack of excess CHD risk using post facto analyses of regulatory trials designed for drug registration have crept into the approval process for virtually every agent in the endocrine and metabolic division at FDA. They are now required for evaluations of anti-obesity drugs and now even for insulin, a naturally occurring human protein without known atherogenicity. The thoughtless extension of such regulatory hurdles slows drug development and raises considerably the cost of such development, ultimately impacting drug prices at the consumer level. Yet, no one comments negatively about these growing barriers to new drug approvals.
Yet another barrier to diabetes drug approval seems to be gaining strength in the approval process. We know that patients with obesity have an increased risk for certain soft tissue malignancies, and that diabetes seems to further enhance the degree of underlying risk. It is therefore not surprising to see imbalances from time to time in the number of such malignancies in regulatory trials of anti-diabetic agents. Toxicology and carcinogenicity studies in animals are required for all such agents. Yet, even where no excess risk of cancer was noted in the pre-clinical studies, agents with imbalances in numbers of malignancies between active agent and control groups are held up for further study as these findings may be signals of potential human problems with the agent in the future. Such delays are applied not even when the imbalances are judged to be insignificant by the Agency’s own statistical methods. Thus, it seems unclear how an insignificant difference can become even more insignificant when more cases are accumulated. But such is the logic in Washington these days, in the year past; thank goodness!
For more information:
- Alan J. Garber, MD, PhD, is the Chief Medical Editor of Endocrine Today.