{"id":46302,"date":"2014-05-18T23:59:21","date_gmt":"2014-05-19T03:59:21","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=46302"},"modified":"2014-05-18T23:59:21","modified_gmt":"2014-05-19T03:59:21","slug":"why-bother","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2014\/05\/18\/why-bother\/","title":{"rendered":"why bother?…"},"content":{"rendered":"
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So what’s a nice guy like me doing in a place like this? Ph<\/em><\/strong><\/font>RMA<\/strong><\/font>.org<\/font>? Google got me there when I was looking up something with Insel’s name in the search. But this is what greeted me:<\/div>\n
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What needs to happen to ensure that ‘treatment’ is front and center in america’s ongoing conversation on mental illness<\/a><\/div>\n
PhRMA<\/font><\/strong><\/div>\n
by Thomas Insel<\/div>\n

We need a new generation of treatments for mental disorders. With current medications for schizophrenia, bipolar disorder, and depression, many people get better, but too few get well. And for many mental disorders, such as post traumatic stress disorder [PTSD], anorexia nervosa, and the core symptoms of autism, we lack effective medications altogether. The public health need is undeniable: neuropsychiatric disorders are the largest source of medical disability in the U.S. with onset before age 25 in 75% of affected people. <\/p>\n

In the absence of predictably effective treatments, trial and error with current medications remains the standard of care. Since it takes several weeks for antidepressant and antipsychotic medications to reduce symptoms, trial and error often means weeks of needless suffering. In the absence of compelling evidence for choosing a specific treatment, polypharmacy, for better or worse, is now the norm for treating mental disorders. Unfortunately, multiple medications increase the risk for adverse events, and this approach has generally not been proven more effective than giving a single medication…<\/p>\n

But we also need better therapeutics. The recent progress in genomics [common variants found in schizophrenia and rare variants in autism] is beginning to define the biology of mental disorders. The discovery of rapidly acting antidepressants [treating depression in 6 hours instead of 6 weeks] reveals unexpected opportunities for treatment. And results from clinical trials with both psychosocial and neuromodulatory treatments demonstrate that psychiatric symptoms are, in fact, highly responsive to intervention, including interventions that tune specific brain circuits. The public health need is great and the opportunity for progress is clear. But it is equally clear that there will not be a magic bullet for schizophrenia or autism or anorexia nervosa. The future for treating mental disorders belongs to networked solutions that combine medications, technology, and psychosocial treatments.<\/div>\n<\/blockquote>\n
A better question is what was Tom Insel, Director of the NIMH<\/font><\/strong>, doing in a place like this? I guess I shouldn’t be surprised. One of Dr. Insel’s blogs from June 2012 called Experimental Medicine<\/a> was a clone of this next Ph<\/em><\/strong><\/font>RMA <\/strong><\/font>post. So the Director not only posts on Ph<\/em><\/strong><\/font>RMA<\/strong><\/font>, he makes their arguments for them:<\/div>\n
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Intellectual Property Protections Are Vital to Continuing Innovation in the Biopharmaceutical Industry<\/a><\/div>\n
PhRMA<\/font><\/strong><\/div>\n

Biopharmaceutical research companies operate under a challenging business model: For every 5,000 to 10,000 experimental compounds considered, typically only one will gain Food and Drug Administration [FDA<\/font><\/strong>] approval, after 10 to 15 years of research and development costing an average of $1.2 billion, based on a 2007 study. The few successes must make up for the many failures. In fact, only two out of every 10 medicines will recoup the money spent on their development.<\/p>\n

Drug research and development leads to the discovery of tomorrow’s life-changing and life-saving new medicines. Biopharmaceutical intellectual property [IP] protections, such as patents and data protection, provide the incentives that spur research and development. They help ensure that the innovative biopharmaceutical companies that have invested in life-saving medicines have an opportunity to justify their investments. Intellectual property protections also help companies secure the resources for future investments in research, giving hope to patients who await tomorrow’s innovative medicines. <\/p>\n

The existing framework of intellectual property policies—including the recently amended patent law and the inclusion of 12 years of data protection for innovative biologics in the health reform law—are necessary to support future R&D investment . These policies provide incentives that spur biopharmaceutical innovation, leading to new treatments and eventually generics—and biosimilars.<\/p>\n

How and Why IP Protection Works<\/p>\n

There are three key elements for an effective intellectual property system:<\/div>\n