My Son Is An Autistic Disorder Therapeutic Market Opportunity?

Pharma view of my son 

My view of my son

Apparently when pharmaceutical company executives contemplate the Autistic Disorder which limits the life of my son,  and the lives of many who suffer from the limitations imposed by Autistic Disorder, they see Autistic Disorder Therapeutic Market Opportunities, as described in thepharmaletter:

"The autism spectrum disorder (ASD) therapeutics market was valued at $3.1 billion in 2010 and is forecast to grow at a compound annual growth rate (CAGR) of 7.5% over the next eight years to reach $5.5 billion by 2018, finds GlobalData’s new report titled Autistic Disorder Therapeutics.

This market growth is primarily attributed to the high prevalence (0.6% to 1%) and prevalence growth rate (10-17%) of ASD in the US and in certain European countries. Co-morbidities such as anxiety, epilepsy and depression associated with ASD also contribute to the growth of the ASD therapeutics market.

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Preference for educational/behavioral therapy over medication

GlobalData’s analysis suggests that educational/behavioral therapies such as Applied Behavioral Analysis (ABA) through environmental changes and behavior modification are the preferred treatment options for ASD patients. There are two approved drugs available on the market for the treatment of irritability associated with autistic disorder; while off-label drugs are prescribed to provide symptomatic relief only.

Therefore, behavioral therapy is the preferred treatment option over drug therapy. However, drug treatment is still required in certain physiatric disorders and with certain challenging behavior associated with ASD. Approximately 50%-70% people are prescribed drug therapy as behavior therapies alone are not always sufficient for managing the disease."

Translating from Pharma Speak ($$$) into one of the known human languages (English): pharmaceutical corporate profits should continue to rise with increases in Autism Spectrum Disorder diagnoses. Not to worry about ABA and other behavioral interventions ... "preferred" options ... depriving "pharma" (their expression not mine) of profits.

I hope pharma will forgive me. When I see my son I do not see an Autistic Disorder Market Opportunity I see a wonderful and amazing boy who has enriched my life in a way not contemplated in pharma newsletters.  I don't see $$$ when I see my son.  I see his amazing smile, his laughter, the joy he brings us each day.

Whooda Thunk It? CNN: Study Raises Bias, Timely Disclosure Questions About Pharma Funded Drug Trials

Whooda Thunk It?

CNN reports that a recent study has disclosed evidence of bias in pharmaceutical company funded drug trials. The study found evidence of an inherent bias in favor of the drug being studies with such studies being 4 times more likely to report outcomes that favored the drug of the sponsoring pharmaceutical company. Industry funded drug trials were also less timely in providing public information about the trial results:

Researchers from the United States and Canada looked at 546 drug trials registered in ClinicalTrials.gov, a registry of both federal and private trials in the United States and abroad. 346 of them, or 63 percen, were funded by the drug industry. The remaining 200 were paid for by government or non-profit organizations. Study authors found that more than 85 percent of industry-funded trials in their sample posted favorable outcomes and were 4 times more likely to report findings that favored their drug.

"We did this study in order to determine whether there is an inherent bias because pharmaceutical companies fund trials on products in which they have a financial interest," said study co-author Dr. Kenneth Mandl of Children's Hospital, Boston. "The most reassuring result would have been that the rate of favorable outcomes would be the same regardless of funding sources. In a very dramatic way that was not the case and what we need to ascertain is if the cause of this shift toward favorable findings among trials funded by pharmaceutical companies is related to the details of the protocols and study design."

Dr. Florence Bourgeois, also of Children's Hospital, Boston and lead author of the study says typically trials sponsored by drug companies are more efficient and well funded. Still, she found the result stunning. "The implications of these findings are that we need more oversight in the way clinical trials are designed as well as in the analysis and reporting of the results. One option may be to make study protocols directly available on clinicatrials.gov as well as the comprehensive reviews complied by the FDA on trial results." She continued, "While we cannot specifically point to which factors contribute to the association between funding source and positive results reporting, our findings speak to the need for more disclosure of all elements of a study."

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According to Mandl, industry funded trials also were less timely in terms of providing public information including trial results. He says even though drug trials are overseen by the Food and Drug Administration, there are still some variables that could favor pharmaceutical companies, including placebo comparisons, dosing and duration. "The concern is the pharmaceutical industry is funding the studies of the drugs in which they have a vested financial interest."

The influence of pharmaceutical companies in last years widely criticized H1N1 pandemic was examined by the Parliamentary Assembly of the Council of Europe (PACE). In its March 23 2010 report The handling of the H1N1 pandemic: more transparency needed the PACE expressed concern over the connections between World Health Organization (WHO) science advisors and pharmaceutical company interests:

11. Independent experts from the medical community mainly criticised the agenda setting and governance process concerning the H1N1 flu in terms of the criteria used for declaring a pandemic, the lack of empirical evidence justifying such a step and the clearance to use certain medicines and vaccines. They also repeatedly raised the issue of the influence that private stakeholders from the pharmaceutical industry might have had on major decisions taken by international and national authorities. For the purpose of this memorandum the rapporteur has compiled the main issues raised in a critical perspective. All arguments presented seem to have one common reference point: the disparity between the relatively mild unfolding of the influenza and the actions taken at European and national level.2

None of this, of course, is to suggest that there is any  unhealthy pharmaceutical company influence on public health authorities involved with autism issues ... right Dr. Gerberding?   Maybe Dr. Julie Gerberding, President of Merck Vaccines  can put to rest fears of pharma conflicts of interest by pushing for a comparative study of autism rates in vaccinated and unvaccinated populations as once called for by  former CDC  Director Dr. Julie Gerberding who once said that "such studies could be done and should be done".