Archive: July, 2011
The Constitution’s commerce clause is 224 years old. It gives Congress its most important source of authority to regulate business. Over the years, the Supreme Court has been called upon to interpret it many times.
The legal challenges to health reform have now raised an interesting new issue. Not the one you’ve been hearing about concerning the scope of the commerce clause itself. The new question is whether the Court should be careful and deliberative - or quick and hurried - in making its interpretations.
The scope of the commerce clause is the central issue in the health reform challenges. Opponents of the law claim that Congress exceeded its authority under the clause in requiring that everyone have health insurance. When it ultimately rules on that claim, the Supreme Court may plow new ground, whatever it decides.
Evolutionary psychologist Paul Andrews has an unusual take on depression and anti-depressants.
Andrews, an assistant professor at McMaster University in Hamilton, Ont., thinks that depression, miserable as it is, serves a positive role, much as fever does in fighting infection.
He argues that the lethargy, lack of appetite, sleeplessness and rumination that accompany depression help people focus on and ultimately solve their problems.
Pharma is a diverse industry with hundreds of occupations and its own social structure. For that reason, people who work there pay attention to different storylines in the news.
Last week, we mentioned that people in our convenience sample who are involved with neuro-psychiatric products have been following an emerging story about a pattern of systemic fraud underlying the dangerous overuse of antipsychotic drugs. At the same time, people in the executive suites, together with their legal talent and other attendants, sense a growing concern over the federal government's efforts to hold fiduciary officers responsible for serious and repeated violations.
In particular, the Department of Health and Human Services's inspector general's office has grown frustrated that pharmas persist with off-label marketing and other transgressive patterns, despite settlements that imposed billion dollar fines on each of several companies. In cases involving repeat or flagrant offenders, the inspector general wants to hold senior executives accountable as a deterrent. Under that plan, the feds would bar pharmas from selling products to government agencies such as Medicare, Medicaid and the VA if the top officers retain their positions at the recidivist companies. Barring sales to the government amounts to virtual capital punishment for a pharma.
Donations totaling $10 million, mostly from a single anonymous donor, will allow the University of Pennsylvania's Perelman School of Medicine to create an interdisciplinary center focused on finding and disseminating treatments for orphan diseases, the school announced Tuesday.
Each "orphan" disease affects a relatively small number of people - fewer than 200,000 Americans - and that makes them less attractive targets for big pharmaceutical companies than more common maladies offering a bigger potential market.
Penn said there are 7,000 orphan diseases affecting 25 million Americans. Many are caused by genetic mutations and are diagnosed in children.
It took more than a week for doctors and nurses to get Pierre Trombert's congestive heart failure under control and send him home from Thomas Jefferson University Hospital.
But the trickier part, in some ways, was making sure he didn't come back.
Enter Joanne Heil, professional nudge.
The Food and Drug Administration recently alerted the public about reports of mix-ups between risperidone (Risperdal) and ropinirole (Requip). Some of the reported incidents involved patients who required hospitalization.
FDA evaluated 226 errors involving confusion between these drugs, all of which were reported either to FDA’s MedWatch adverse event reporting system or the National Medication Errors Reporting Program operated by my organization, the Institute for Safe Medication Practices.
Risperidone is a drug used for psychiatric conditions like schizophrenia or bipolar disorder. Ropinirole is used in Parkinson’s disease and a condition called restless legs syndrome, in which people can’t resist an urge to move their legs.
Any deal to tame the federal deficit will have to cut Medicare. Its costs keep growing like weeds in summer. Eventually, it could eat up more tax dollars than any other government program. And like a weed, it will start to crowd out everything else.
Most members of Congress on both sides of the aisle agree. The hard part is not whether to slice but how. Medicare cuts could affect our entire health care system.
And guess who could end up paying for Medicare savings, if they aren’t devised carefully. You and I.
Last week a small, unscientific sample of people working in pharma responded to our questions about which industry stories they've been following. Their comments may reflect the pervading mood in the industry these days.
No one mentioned scientific breakthroughs apt to hit the popular press this year or next. Likewise, no comments emerged about visible signs that the industry's economic fundamentals appear poised for a substantial upswing. Instead the news trends that appear to merit attention reflect a wariness or even a general apprehension.
For example, one group of middle managers, especially those involved with the neurology-psychiatry product classes, have been paying more attention to a slowly building story concerning the rampant overuse of antipsychotic medications.