why bother?…

Posted on Sunday 18 May 2014

So what’s a nice guy like me doing in a place like this? PhRMA.org? Google got me there when I was looking up something with Insel’s name in the search. But this is what greeted me:
by Thomas Insel

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.

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…

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.
A better question is what was Tom Insel, Director of the NIMH, 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 was a clone of this next PhRMA post. So the Director not only posts on PhRMA, he makes their arguments for them:

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] 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.

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.

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.

How and Why IP Protection Works

There are three key elements for an effective intellectual property system:
    It must provide fair and effective incentives for innovation
    It must provide innovators certainty regarding their rights
    It must offer patent holders strong enforcement tools for defending infringed patents
Without intellectual property rights, competitors could simply copy biopharmaceutical innovations as soon as they were proven safe and effective, offering their own versions without investing the time and money to develop the medicines. Innovators in the biopharmaceutical industry could lose the ability to recoup their substantial investment in new drug development, making it more challenging to find funding.

Reasonable intellectual property protection is essential to sustain the U.S. biopharmaceutical sector’s continuing investments in new research and development. At the most fundamental level, IP rights give America’s biopharmaceutical research companies a chance to fund research into new treatments for our most costly and challenging diseases.

Read More
    PhRMA 2014 Special 301 Submission — PhRMA has submitted it’s 2014 Special 301 Submission with the aim of protecting innovation and intellectual property around the world
    Note to Media on Elected Officials Support for 12 Years of Data Protection in TPP –Read letters from various members of Congress supporting intellectual property protections in TPP
But this post about intellectual property was also familiar from another place, the notorious presentation by AbbeVie lawyer, Neal Parker, at the meeting last Fall in Brussels, arguing for confidentiality [a deal-breaker?…]. The Association of Clinical Research Organizations [ACRO] makes a similar argument. And the APA‘s Jeffrey Lieberman’s make-nice-with-PHARMA article [Time to Re-Engage With Pharma?] rounds out the chorus.

There was a time when the pharmaceutical industry would have been seen as a support industry for doctors and patients in their quest for improved health. The same for the medical device makers, medical insurance providers, and hospital corporations. But now things seem to have become reversed, with doctors being seen as the distribution system for these industries’ products and patients as consumers. Likewise, organizations like the NIMH and the APA were to assist doctors and patients in their quest for health – but now they have taken on the role of defining how doctors practice, what diagnostic system to use, and have generated guidelines for treatment – paying homage to and dependent on the makers of treatments and the purveyors of medical care with a lousy track record by any standard.

So perhaps, in lieu of these future undiscovered medications, we might consider what the best treatment for the mental illnesses is right now, and readjust things when we have something else in hand. We might consider the fact that data confidentiality is a major reason why these drugs that were so highly touted are now considered so inadequate – they used the confidentiality to hide the truth about safety and efficacy. The quickie overseas Clinical Trials haven’t served us well nor have the expert-derived diagnostic categories and guidelines. Put succinctly, these industries and organizations have done very little to help maintain a high standard of medical care. They blew it. Why bother helping them to continue the same practices that exploit our medical care systems and add no value?
    Bernard Carroll
    May 19, 2014 | 12:45 AM

    Count the numbing, anodyne buzzwords in that piece from the Director of NIMH: new generation; public health need (twice); needless suffering; progress in genomics; define the biology; tune specific brain circuits; opportunity for progress; networked solutions. How many times to we need to tell Dr. Insel that original science can’t be ginned up from the top down? And since when is it in his job description to act chummy with PhRMA – on its record the most corrupt industry in modern times? Glaxo Study 329 of Paxil in kids (lead ghost author Martin Keller), anybody? Glaxo Study 352 of Paxil in bipolar depression (lead ghost author Charles Nemeroff), anybody? Did Thomas Insel, NIMH Director, ever come out in public as distancing the agency from such scandals? Silly me to even ask. Thus do Federal bureaucrats glide their way through the ethical shoals.

    May 19, 2014 | 5:41 PM

    I don’t understand why the 6 weeks or so it takes psychiatric drugs to “work” (meaning, overcome the body’s hormonal homeostasis) is considered such a terrible disadvantage.

    Instead of throwing in the kitchen sink medication-wise, clinicians can use this time to build relationships with patients and teach them techniques such as mindfulness and self-soothing as they deal with side effects together.

    Or is the lag such a drawback because answering questions about side effects is so time-consuming? Or, even when they do “work,” the drugs don’t work very well? That patients are still complaining?

    May 19, 2014 | 5:47 PM

    or it justifies more research or maybe “ketamine” parlors…

    May 19, 2014 | 9:27 PM

    Heh heh heh, I scried “ketamine” in Insel’s statement, too.

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