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Patients at risk: the gamble of clinical trials

10/13/2016

 
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Often I wish for simpler times. As a medical writer, I considered published clinical trials, especially randomized-controlled trials and meta-analyses as the highest level of clinical evidence. That was before listening to John Ioannidis Professor of Medicine and Health Research and Policy at Stanford University School of Medicine and Professor of Statistics speak at the Lown Conferences.

The timing was perfect. Writing projects were becoming less collaborative and more administrative. Research was left on the table in favor of honed objectives aligned with a client brand strategy, publication plan, or marketing plan. Let me clarify less you envision babies being tossed out with bath water--not all pharmaceutical companies, academic centers, medical societies or healthcare stakeholders follow their own special interests right down a rabbit hole--but to quote Lewis Carroll--“Which way you ought to go depends on where you want to get to...” 

When working with smaller budgets for clients lacking the infrastructure of industry, a large academic center, or medical society--data quality and scalability are critical. What is the saying? Garbage in, garbage out? What do you do when results of half of the clinical trials are hidden. How do we know? Try looking up a few clinical trials--go ahead--we will wait. The bad news is that the information you need could be in one in over a hundreds places. 

Health and Human Services recently published the Final Rule requiring guidance for registration and submission of clinical trials and their findings. Head over to clinicaltrials.gov to observe how many studies fail to provide data within the 1 year requirement. Approximately twice as many positive trials are published vs. negative findings--statistically 4 out of 5 trials are indeed breaking the law.

Universities, charities, governments, industry all conduct trials--what unites them? The culture of secrecy. 

How do we fix it?

AllTrials is a movement led by patients to provide information--historic data as well as evolving clinical data. Pass it on.

​AllTrials is an international initiative of 
Ben Goldacre, BMJ, Centre for Evidence-based Medicine, Cochrane Collaboration, James Lind Initiative, PLOS and Sense About Science and is being led in the US by Sense About Science USA, Dartmouth’s Geisel School of Medicine and the Dartmouth Institute for Health Policy & Clinical Practice. The AllTrials petition has been signed by 89138 people and 682 organisations.

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Click on the image or Clinical Trial Publication Game from the Economist to test your new drug! 
The "game" is a publication bias simulator and allows perspective to see how decisions to withhold results skews medical evidence.

I recommend following OpenTrials for progress in creating transparency in clinical trials. Recently launched in beta and with Ben Goldacre, MD as a founding member, the goal is providing a
 “comprehensive picture of the data and documents on clinical trials conducted on medicines and other treatments around the world.”

When a new drug gets tested, the results of the trials should be published for the rest of the medical world -- except much of the time, negative or inconclusive findings go unreported, leaving doctors and researchers in the dark. In this impassioned talk, Ben Goldacre explains why these unreported instances of negative data are especially misleading and dangerous.
The AllTrials website provides real time solutions for all stakeholders--all you need to do is click a button. Here is the information for Pharmaceutical companies. GSK and LEO Pharma are already actively participating...
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I attended a webinar on predictive analytics sponsored by a large clinical research organization. I use predictive analytics methods for clients and like to collect algorithms for addressing complicated data questions--such as adherence.

For example, you need to consider that injections are typically prescribed for the experienced patient--who are typically more adherent. If we compared adherence based on all patients with out regard for formulation we would be introducing bias. Looking at data with deeper granularity we now observe the influence of drug delivery and adjust our analyses.

Obviously if we all could access QuintilesIMS data resources or other proprietary databases the playing field would be level--but we can't--and it isn't. Not enough of us any way. As a journalist I have been granted access to several proprietary databases. Learned by trial and error, meeting by meeting, and connection by connection--once we access the data--what we have is information.

On the other hand--if you need a collaborative partner--lets chat. 
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Thoughtful discussions about content development and outcomes analytics that apply the principles and frameworks of health policy and economics to persistent and perplexing health and health care problems...

Public interest, the future of healthcare?

10/3/2016

 
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Attempts to regulate capitalistic forces impacting the public interest go back a ways--think Civil War and earlier. If we think like a paleontologist examining a rock formation--the marker of interest would definitely identify the advent of the railroad and The Granger Laws as an important discovery.

In regard to rate setting, the Granger cases were argued before the Supreme Court in 1876 and 1877. Railroad companies were in the habit of  charging preferential freight rates and storage rates to their larger customers. The Supreme Court declared that railroads were businesses "affected with a public interest" and as such, "must submit to be controlled by the public for the common good". 


U.S. Supreme CourtMunn v. Illinois, 94 U.S. 113 (1876)Munn v. Illinois
94 U.S. 113



ERROR TO THE SUPREME COURT OF THE STATE OF ILLINOIS
Syllabus
1. Under the powers inherent in every sovereignty, a government may regulate the conduct of its citizens toward each other, and, when necessary for the public good, the manner in which each shall use his own property.

2. It has, in the exercise of these powers, been customary in England from time immemorial, and in this country from its first colonization, to regulate ferries, common carriers, hackmen, bakers, millers, wharfingers, innkeepers, &c., and, in so doing, to fix a maximum of charge to be made for services rendered, accommodations furnished, and articles sold.

3. Down to the time of the adoption of the fourteenth amendment of the Constitution of the United States, it was not supposed that statutes regulating the use, or even the price of the use, of private property necessarily deprived an owner of his property without due process of law. Under some circumstances, they may, but not under all. The amendment does not change the law in this particular; it simply prevents the States from doing that which will operate as such deprivation.

4. When the owner of property devotes it to a use in which the public has an interest, he in effect grants to the public an interest in such use, and must, to the extent of that interest, submit to be controlled by the public, for the common good, as long as he maintains the use. He may withdraw his grant by discontinuing the use.

5. Rights of property, and to a reasonable compensation for its use, created by the common law cannot be taken away without due process; but the law itself, as a rule of conduct, may, unless constitutional limitations forbid, be changed at the will of the legislature. The great office of statutes is to remedy defects in the common law as they are developed, and to adapt it to the changes of time and circumstances.
Laws were written to protect the consumer or public from discriminatory rates establishing a precedent for private businesses that served the public interest. What protection are we granted from Pay for Delay Laws that allow pharmaceutical companies to delay access to generic drugs--as just one example.

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You can see parallels between the escalating costs of healthcare where profit leads the debate. We lose much when we fail to reflect on history and potential solutions for the long-term.
The Interstate Commerce Act of 1887 was made law with the support of both major political parties and of pressure groups in all regions of the country. The main provisions of the law, all of which applied only to railroads, were these:
  1. Mandating of "just and reasonable" rate changes. (This was the traditional language of the Anglo-American common law).
  2. Prohibition of discrimination in the form of either special rates or rebates for individual shippers.
  3. Prohibition of discrimination or unjustified "preference" in rates for any particular localities or shippers or products.
  4. Forbidding of long-haul / short-haul discrimination. Unless an exception was allowed by the Interstate Commerce Commission, no company might charge more for a shorter than for a longer distance on the same route (and in the same direction).
  5. Prohibition of pooling of traffic or markets.
  6. Establishment of a five-member Interstate Commerce Commission.
The ICC was empowered to investigate railroad operations, to call witnesses, and to hand down decisions on all aspects of rates and other matters covered by the act. Thus it became the first federal independent regulatory commission, a hybrid agency with elements of judicial, legislative, and executive powers.
There is a long rich history of establishing public interest and allowing the federal government to come to the aid of the public even when dealing in the corporate or private enterprise framework. How long will the public be subjected to capitalistic "whatever the market will bear" pricing of their health and ultimately their quality of life? Perhaps what we need is a "lightbulb moment". 
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Is Public Utility Model The Ultimate Direction Healthcare Reform Will Take?

"The public utility idea is one that has worked before," I said. My grandmother lives in the middle of nowhere. Do you think the power company wanted to run powerlines out to her house? Do you know how much it cost for them to put electricity in rural America?
It was the government, with the Rural Electrification Act who made them do it. And she pays the same for electricity as everybody else, even though it cost way more to get power to her house than it does to get it to their urban and suburban customers."
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    I am a medical/health economics writer/ data analyst, ultra-runner, and mom. 

    In a world of "evidence-based" medicine I am a bigger fan of practice-based evidence.

    Question the quality of the evidence. The motivation for disseminating the evidence.

    Who stands to benefit the most from its uptake?

    ​Remember the quote by Upton Sinclair...


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