Public Law 96-517 – The Most Important Law You Never Heard About. What it Does, and Why Things Need to Change…

By Peter McCarthy ND – Chairman Texas Health Freedom Coalition

 

If you pay regular attention to virtually any media organization in this country, from time to time (very infrequently!) you may encounter an obscure story about how the influence of money has negatively impacted the quality of scientific research in virtually every field of science.

Those of us who are chronologically advantaged (read that: old!) can remember when that was not the case.  In the 1970s and before, much scientific research was conducted in government laboratories.  Perhaps more important, regardless of where government-funded research was conducted, none of the researchers or their organizations could profit from the results of that research.

All that changed on December 12, 1980 with the passage of Public Law (P.L.) 96-517.  Officially titled the Patent and Trademark Law Amendments Act, it became better known as the Bayh-Dole Act, after its co-authors, then-Senators Birch Bayh (D-IN) and Bob Dole (R-KS).

According to Wikipedia, “Before the Bayh–Dole Act, federal research funding contracts and grants obligated inventors (where ever they worked) to assign inventions they made using federal funding to the federal government. Bayh–Dole permits a university, small business, or non-profit institution to elect to pursue ownership of an invention in preference to the government.”

A companion piece of legislation, Public Law 98-620, further facilitated the ability of government contractors to profit from their research.

At the same time, a concerted effort was initiated to transfer much of the research conducted in all scientific disciplines from government research facilities to academic institutions and/or corporations.  The result in the health care field has been that, today, only 36% of medical research is funded by the government.

The Consequences…

A friend of mine who has been a very influential senior staff member in the Texas legislature for many years once cautioned me that every piece of legislation enacted at any level of government, no matter how well intentioned, has unintended consequences.  P.L. 96-517 is no exception.  The stated intent of the authors was to stimulate innovation in, and expansion of, U.S. scientific research.  That has certainly occurred, but not without unintended cost.

The collective unintended consequence of P.L. 96-517 has been that the U.S. scientific community has essentially become a for-sale enterprise.  With the exception of basic research, much of which is still conducted in government laboratories, virtually any scientific study, in any field of endeavor, supporting any scientific conclusion, can be purchased from a willing university, private think tank, or corporation.

Unfortunately, the mainstream media has not kept up with this story, due in large part to the influence of sponsorship dollars flowing directly from those companies who benefit directly from the research status quo.  This is demonstrated by the nature of the coverage of science in general by most media organizations, which consists mainly of parroting the text of a press release without any additional scrutiny.

A Disaster…

The result of this state of affairs has been nothing short of disastrous for the U.S. health care system, and you don’t have to take my word for it.  For example, Marcia Angell, MD, former Editor-In-Chief of the New England Journal of Medicine, and author of The Truth About Drug Companies, has this to say about the situation:

“It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine.” 

John P. A. Ioannidis, a Professor of Medicine and of Health Research and Policy at Stanford University School of Medicine, and a Professor of Statistics at Stanford University School of Humanities and Sciences, published a scathing critique of the current state of U.S. scientific research that concluded:

“It can be proven that most claimed research findings are false.”

And Dr. Richard Horton, the current editor-in-chief of the Lancet – considered to be one of the most well respected peer-reviewed medical journals in the world – published a statement in May of 2015 declaring that a lot of published research is in fact unreliable at best, if not completely false.

“The case against science is straightforward: much of the scientific literature, perhaps half, may simply be untrue. Afflicted by studies with small sample sizes, tiny effects, invalid exploratory analyses, and flagrant conflicts of interest, together with an obsession for pursuing fashionable trends of dubious importance, science has taken a turn towards darkness.”

One would think that, given the nature and sources of these critiques, alarms would sound all across the health care research field.

Well, not so much.  So many now benefit from the status quo that few, if any, voices for change are being heard, much less heeded.  It would simply upset the gravy train for too many.

What Do We Do?

Given the status quo (and the benefits that accrue to so many), realistic, achievable solutions are limited at best.  Perhaps the most direct and eventually influential remedy will be for those of us in the health freedom movement to highlight, again and again, the financial connections between the researchers and those who profit from the research.  This will require some additional collective detective work on our parts, but in the long run it will be worth it.

Eventually, as is always the case, mainstream media will catch up with what our community already knows.  In the meantime, let’s agree to more aggressively “follow the money” as it affects scientific research and its beneficiaries and, equally important, spread the word about it widely.  The results will benefit us all.

 

By Peter McCarthy ND – Chairman Texas Health Freedom Coalition

6 thoughts on “Public Law 96-517 – The Most Important Law You Never Heard About. What it Does, and Why Things Need to Change…”

  1. While crony corporate corruption is rampant in government in general, and “scientific research” in particular, I’d like to take a contrarian position and suggest that it is because we have such an interventionist government when it comes to matters of health especially that we have such corrupted science. The conflicts of interest in, for example, the CDC committee that “recommends” vaccines that one crony (Dr. Paul Offitt the Profit) was allowed to vote for a vaccine recommendation that put millions in his pocket. There are simple no dis-interested experts available, apparently.

    As we look for solutions, I suggest a libertarian approach. Let us abolish taxes, bureaus and regulations, so there is less political power over health care for the politicians and cronies to buy and sell. If there were no corrupt govt agency providing a bureaucratic fig leaf to big pharma, the public and competition just might demand transparency before voting with their consumer dollars.

    When it costs a billion dollars, literally, to get FDA drug approval, a monopoly right that is worth many hundreds of billions, the money will flow and the corruption will degrade science and health.

    The solution is not a return to the alleged “good old days” of govt science (well, I suppose the Manhattan Project was “successful”); the solution is to abolish the system of political control that engenders the corruption in the first place.

  2. Hmmm… apparently, nobody on that gravy train will go to jail, just fade into oblivion or re-emerge in different offices.. sorta like the evil creatures slain in video games?? poof! and no clean up… uh, yeah!

    Oh so neat and tidy, just a big misunderstanding. Whitewash opportunity deluxe.. No corrective measures needed… ttyl

  3. Ah, yes. Pharmaceuticals, agrochemicals, vaccines.
    Backed by the best science money can buy.

  4. It’s nice to see this posted. There has been too much libertarian thinking on this blog. On this issue, the solution is NOT “throw everything into capitalism.” (I refuse to call it “the free market” because it is not “free” – how “free” am I to give up any and all money?) On this issue, the solution IS to take a bad system of regulation – the one we have now – and replace it with a good one – one that is similar, at least, to the one that existed back in the 1970s.

    Also, though Ioannidis might be right, be careful about him. I believe that he has worked with a pseudoskeptic named Steven Novella, (carpet head) in the past. (Remember him?)

  5. This was a careful measured and well writted piece and the author is to be congratulated. We should always follow the money trail but at some point there should be consequences for those responsible and at present there is not. Quite what the answer is I do not know.

  6. That’s right Ralph, spoken like a true Dark Money, Koch Brothers crony. The Libertarian cabal wishes to do away with any checks and balances, so corporations can do whatever they want without consequences. After all Wall Street has shown us how well removing regulations works. How about fixing the corruption? Starting with campaign finance reform, so big corporations can’t buy lawmakers. Or here’s an idea, what about prosecuting corporations and trade organizations for racketeering and breach of the Antitrust Act, when they buy laws to exclude competitive industries. Why don’t we keep the elite and Big Corp from having financial influence over Universities and research? And what about respecting an individual’s right to bodily integrity? May be if we passed a Health Bill of Rights that protects an individual’s inalienable right, as a sovereign entity, to do what one chooses with one’s own body. Great article Peter. Thanks

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