By Siegfried Othmer, PhD

The National Academies Press has just published a volume on the topic of the huge unmet burden of neurological disorders. The report covers a recent workshop dedicated to this topic. Appraising the state of affairs is the relatively easy part of the task:

”…malfunctions in the central nervous system (CNS) instigate a wide range of devastating symptoms. The associated illnesses include developmental, psychiatric, and neurodegenerative illnesses, many of which are chronic and cause serious and long-lasting disabilities. Together, they are extremely prevalent and have an enormous impact from cradle to grave.”

“ These conditions generate great human suffering and impose a tremendous economic load. According to 2014 estimates from the Society for Neuroscience, nearly 100 million Americans suffer from nervous system disorders, and associated annual expenses exceed $760 billion. Furthermore, falls and road injuries, both of which rank high in causes of disability, can arise from various brain disorders and are not included in the numbers above. Real costs include not only the price of treatments, but also lost productivity of patients and their caregivers. Between 2011 and 2030, mental health conditions will account for 35 percent of projected loss of global economic output from non-communicable diseases.”

Already mental and behavioral disorders account for nearly a quarter of all years lived with disability in the US, and that percentage is slated to increase. One reason is the aging of the population. Presently the cost of care that shows up in the marketplace comes to about $110B for dementia alone. The impact is expected to rise to some $250B by 2040 in current dollars.

Insurance company data reveals that patients with a mental or substance use disorder accounted for 30% of all medical expenditures, and their cost of care was two to three times as high as for those without a behavioral condition. The American Psychological Association estimates that “patients with behavioral health conditions cost an estimated $525B in health care expenditures annually.”

In the face of this escalating demand for services, it is noted that the pharmaceutical industry is broadly de-escalating its investment in brain-based disorders. Six of the ten largest have cut back dramatically, on the order of 50 percent just since 2009. Venture funding devoted to drug research is declining majorly as well. The withdrawal from the domain of neuroscience seems to be disproportional.

“The objective of this workshop was for participants to discuss approaches for incentivizing R&D that will produce therapies that target unmet medical needs and significantly improve lives in the area of CNS diseases by strengthening market protections and regulatory processes.

Unfortunately the discussion at the workshop tended along the lines of just getting the system we have working better. If companies are flagging in their research efforts, then perhaps they need to be incentivized. Several participants argued that rebalancing the underlying risk/reward calculus could help keep companies engaged in making CNS drugs. For example, increased market protections might help increase CNS drug investment.

This is a strange preoccupation, since we are dealing with a pharmaceutical industry that is by far the most profitable in our society. Increasing their incentives even further does not seem to be of the greatest urgency. Matters are also out of scale. Pharmaceutical company revenues come to over $300B per year, whereas the total NIH budget is barely larger than $30B.

Drug companies see the handwriting on the wall. The mainline approach of impinging on neuromodulator systems is maturing, and its objectives have not been met. The appraisal by Thomas Insel, head of NIMH is sobering: “Outcomes from traditional approaches have not improved over decades of assessment and treatment as usual for depression, schizophrenia, bipolar disorder, ADHD, etc., despite decades of research and billions of dollars.” (2009)

Of course there will still be new departures and radical new discoveries, but the costs of innovative research at the front end tend to be light on the budget. If the drug companies were to see an opportunity here, they would not lack the resources to pursue it. The costs of drug approvals are high toward the end of the journey, not at the beginning. So the NAS group of advisers are on a fool’s errand.

One also has to wonder how they can take such an uncritical attitude toward the industry they are trying to help, at a time when a solid chorus of criticism is arising even from within its ranks. Here’s the judgment of Marcia Angell, former editor of the New England Journal of Medicine, who has been sounding the alarm for some time:

“ [The pharmaceutical industry] has moved very far from its original high purpose of discovering and producing useful new drugs. Now primarily a marketing machine to sell drugs of dubious benefit, this industry uses its wealth and power to co-opt every institution that might stand in its way, including the U.S. Congress, the Food and Drug Administration, academic medical centers, and the medical profession itself.”

She is not alone: Even back in 2004 Richard Horton, editor-in-chief of the British Lancet, said “Journals have devolved into information laundering operations for the pharmaceutical industry.” Up to one-half of the published pharmaceutical literature may simply be untrue, and the responsible research establishment has “taken a turn toward the dark side.”

“There is increasing concern that most current published research findings are false,” added Dr. John P.A. Ioannidis, a professor of disease prevention at Stanford University, in a PLoS One paper entitled “Why Most Published Research Findings Are False.”

Studies sponsored by drug companies are four times as likely to show results favorable to the sponsor than studies funded independently. Dr. Peter Rost, former VP of Pfizer, illustrates how this is done in his book “The Whistleblower, Confessions of a Healthcare Hitman” (a title that mirrors the earlier ‘Confessions of an Economic Hitman’, by John Perkins). The money flowing to academia via narrowly targeted funding streams shapes the research that is done, and when the outcomes are not favorable to the funder, the money is likely to flow elsewhere. Everyone implicitly understands how the system works.

The marketing expenditures of drug companies come to more than $10,000 per doctor per year, yielding a total of more than $15B/year even back as far as 2000. Jerry Kassirer, former editor of the New England Journal of Medicine, laments the consequences. In the book “On the Take” he argues that the onslaught of industry money has deflected many a physician’s moral compass, and has impacted the everyday care that we receive from our doctors.

“It is frightening how many similarities there are between the industry and the mafia,” Dr. Rost once wrote. “The only difference is that all those people in the pharmaceutical industry see themselves as decent citizens.”

This is the industry that the NAS consultants wish to shore up with even more public funding, and furnish with even more legal protections. In their mental universe, neurofeedback does not even exist. The society suffers for their ignorance.

Reference:
Financial Incentives to Encourage Development of Therapies That Address Unmet Medical Needs for Nervous System Disorders: Workshop Summary (2015), National Academies Press

Sheena M. Posey Norris, Evelyn Strauss, Christopher DeFeo, and Clare Stroud, Rapporteurs; Forum on Neuroscience and Nervous System Disorders; Forum on Drug Discovery, Development, and Translation; Board on Health Sciences Policy; Institute of Medicine

Siegfried Othmer, PhD
drothmer.com

This entry was posted on Thursday, September 10th, 2015 at 9:48 am and is filed under Clinical Symptoms. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.