conflicts of interest

Can We Trust Government and Academic Scientists to Protect Us?

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Perhaps I’m naive, but I’ve always assumed that academic and government scientists were generally trustworthy, unbiased (or, at least as unbiased as possible given their humanity), and that they should be viewed as sources of truth. Academic and government scientists have minimal conflicts of interest, and they seek truth and the protection of the public, right? Every field has some bad-apples, but, as a general rule, I always assumed that government and academic scientists were the truth-seekers and protectors of the public. I assumed that they were objective, thoughtful public servants who were minimally swayed by corporate, political, or personal conflicts—because science is supposed to be a truth-finding method that isn’t supposed to be swayed by subjectivity, money, conflicts, or biases.

A Loss of Faith in Government and Academic Scientists

Those views have been shattered recently, and I’m left wondering, if I cannot trust government and academic scientists, who can I trust?

Some of the many reasons why I no longer trust the academic or government scientists are outlined in the (frankly, depressing) interview with Professor Marc Edwards that was published in The Chronicle of Higher Education, “The Water Next Time: Professor Who Helped Expose Crisis in Flint Says Public Science Is Broken.” In it, Professor Edwards notes that:

I am very concerned about the culture of academia in this country and the perverse incentives that are given to young faculty. The pressures to get funding are just extraordinary. We’re all on this hedonistic treadmill — pursuing funding, pursuing fame, pursuing h-index — and the idea of science as a public good is being lost.

When the most lucrative sources of funding for academic scientists are from pharmaceutical companies, agro-chemical corporations, the petroleum industry, and other big-moneyed interests—how are the academic scientists supposed to feel free to criticize those industries? Even if the financing sources are government agencies, academic scientists avoid criticizing them in order to keep the doors for future funding open. Edwards continues to iterate the problem:

You are your funding network as a professor. You can destroy that network that took you 25 years to build with one word. I’ve done it. When was the last time you heard anyone in academia publicly criticize a funding agency, no matter how outrageous their behavior? We just don’t do these things.

Edwards also notes the failures of the government scientists and regulatory agencies:

In Flint the agencies paid to protect these people weren’t solving the problem. They were the problem.

When the Government Agencies ARE the Problem

Unfortunately, the failure of government agencies to protect the public is not limited to the failure of the Michigan Department of Environmental Quality and the U.S. Environmental Protection Agency’s failure to recognize that the water in Flint, Michigan contained dangerously high levels of lead. The EPA also failed to recognize that DuPont was poisoning the water supply in Parkersburg, West Virginia with their production of Teflon and other perfluorooctanoic acid (PFOA or C8) products. (The New York Times Magazine article, “The Lawyer Who Became DuPont’s Worst Nightmare” and The Huffington Post article, “Welcome to Beautiful Parkersburg, West Virginia: Home to one of the most brazen, deadly corporate gambits in U.S. History” describe this environmental and health catastrophe.) The EPA not only failed to recognize and address the problems in Flint and Parkersburg, they actively hid the problems and even went so far as to blame the victims. Unfortunately, the situation in Flint (and the similar situation in Washington DC in 2010) and the situation in Parkersburg are not isolated incidents in an otherwise well-run and well-incentivized system. They are examples that illustrate systemic problems in academic and government “science.” The system is broken, and a broken system is not to be trusted.

“These people are unscientific.”

Says Edwards in his interview. He goes on to say:

I grew up worshiping at the altar of science, and in my wildest dreams I never thought scientists would behave this way. The only way I can construct a worldview that accommodates this is to say, these people are unscientific. Science should be about pursuing the truth and helping people. If you’re doing it for any other reason, you really ought to question your motives.

Amen to that.

I hope that other brave scientists, like Professor Edwards, start speaking up, and that the system changes—for the credibility of all academic and government scientists, and, more importantly, for our safety and health.

Who to Trust?

I am truly saddened to be left with the question of – if I cannot trust the government and academic scientists (I didn’t even consider trusting the corporate scientists) to give me and other members of the public accurate information about the safety of our water, food, medicines, consumer goods, etc., who can I trust?

Personally, I trust the victims and the whistle-blowers. I trust the people who are screaming about how they, or their loved ones, have been hurt by toxic pharmaceuticals, pesticides, food additives, poisoned water, and more. The victims and the whistle-blowers are screaming loudly despite having nothing to be gained, and often much to lose, from screaming. I trust the people who have no financial incentives shaping their views, who are reporting on what they experience and what they have researched. On the other hand, I don’t trust the people who are so blinded by their financing sources that they refuse to criticize them, and I’m saddened to hear that many academic scientists are in this category.

One of the beauties of the scientific method is that it removes a lot of subjectivity and personal bias from the equation. Victims, and sometimes whistle-blowers, are reporting on their personal experience, and thus, there is always a certain amount of subjectivity in what they report. However, I’ll take a little subjectivity and transparent bias when listening to a victim or whistle-blower over a person who has scientific credentials but who is swayed against reporting the truth by “enormous pressure” to please their funding sources.

In both Flint and Parkersburg, the EPA actively covered-up corporate and government malfeasance that was hurting the citizens of those communities, and a large number of academic scientists stood by and didn’t question the corporations or government’s actions because they didn’t want their funding to be jeopardized. I don’t trust the people who think that way.

I hope that the recognition that Professor Edwards and his Virginia Tech team receive for their work in Flint makes other academic (and government) scientists think, and that some mechanisms are put into place that will ensure that government and academic science is credible, minimally biased, trustworthy, etc. Government regulators and funders, as well as those in academia, have important roles to play. They need to play their roles well, or we will all lose faith in them, or worse, get hurt by their negligence.

Until systemic changes are put into place to encourage government and academic scientists to be more driven by truth and public service than money, I’m going to continue to believe the victims and whistle-blowers over the government and academic officials. Sure, subjective reporting has its problems, but there is more value in a personal anecdote than there is in greed-driven “science” where the goal is funding rather than truth.

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This article was published originally on February 15, 2016.

 

The Healthcare System Collapse: Lessons From the Housing Market Crash and “The Big Short”

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The book (and movie) The Big Short got me thinking: What will be the next bubble to pop? I am certainly not a financial expert, and I have no idea what is involved in stocks or bonds, but I would venture to guess that at some point in the near future the healthcare system, and the pharmaceutical companies in particular, are going to crash.

The 21st Century Cures Act

As is pointed out in The Big Short, all people and institutions respond to incentives. The 21st Century Cures Act, which is passing through Congress right now, incentivizes pharmaceutical companies to produce ineffective drugs that are no better than snake-oils.

The 21st Century Cures Act will allow drug approvals to be based on biomarkers and surrogate measures rather than health outcomes. This means that drugs will not need to be shown to treat effectively or cure diseases or even symptoms—rather, they will only need to demonstrate that they change a particular biomarker.

A New England Journal of Medicine (NEJM) article, “The 21st Century Cures Act — Will It Take Us Back in Time?” notes that:

..though a drug’s effect on a biomarker can make approval quicker and less costly, especially if the comparator is placebo, it may not always predict the drug’s capacity to improve patient outcomes.

If a drug doesn’t need to improve patient outcomes, how, exactly, is it effective? And how is it any better than snake-oil?

All pharmaceuticals come with side-effects and risks. The 21st Century Cures Act’s encouragement of drugs to be approved based on biomarkers rather than patient outcomes will enable pharmaceutical companies to produce and market drugs that have risks but no benefits.

A current example of biomarkers being used instead of health outcomes that is currently working out poorly is the HPV vaccine, which hasn’t changed cervical cancer rates at all, while leading to debilitating adverse-effects for thousands of people (mainly young women).

Additionally, the 21st Century Cure act “could substantially lower the standards for approval of many medical products, potentially placing patients at unnecessary risk of injury or death.” (New York Times, “Don’t Weaken the F.D.A.’s Drug Approval Process”). The Act will decrease the standards that must be met for clinical testing, and will rush new drugs, especially antibiotics, to the market without conventional clinical trials.

I suspect that the 21st Century Cures Act will initially inflate the healthcare system and its stocks—after all, it will remove many of the regulatory barriers that keep drugs from being rushed to market. However, when people realize that they are being hurt by ineffective, dangerous drugs, they will lose faith in the medical system as a whole, and eventually the system will collapse. Confidence in the safety and efficacy of pharmaceuticals is necessary for people to continue to consume them. The pharmaceutical industry is foregoing their credibility in exchange for short-term gains. They do so at their own risk.

Inept Regulatory Agencies

Just as the ineptitude of Moody’s, Standard and Poor’s and other rating and regulatory agencies contributed to the collapse of the housing market, the failure of the FDA to properly regulate pharmaceuticals is likely (in my opinion) to contribute to a collapse in the healthcare market.

The FDA is not adequately regulating drugs to protect the public. More than 124,800 people die each year because of direct adverse drug reactions and medical mistakes—and that’s not even counting those who die indirectly from adverse drug reactions that lead to chronic illness. This situation is unacceptable, and it shows that the FDA is not doing its job of protecting the public from dangerous drugs.

Pharmaceutical companies with large amounts of money, power and lobbying influence, are writing the rules of the game, and neither the FDA nor anyone else is stopping them from putting dangerous drugs onto the market. Any system that lacks checks and balances will eventually destroy itself—the medical system is no exception.

In The Big Short it is noted that, “His (Steve Eisman’s) experience with household finance had disabused him of any hope that the government would intercede to prevent rich corporations from doing bad things to poor people.” I suggest that the American people likewise disabuse themselves of the notion that the FDA is protecting patients from pharmaceutical corporation malfeasance. Dangerous drugs are killing and maiming millions of people, and the FDA—a large branch of the American government, is doing nothing to fix the situation.

Complicated Instruments

The housing market crash was due, in part, to the fact that CDOs and other financial instruments, were so complicated, and so poorly understood, that few people (and certainly not those in the regulatory agencies) realized that they were enabling malfeasance, foolishness, and fraud.

Likewise, pharmaceuticals are so complicated that few people, and certainly not those at the FDA, know how they work. For example, it is well-known that fluoroquinolone antibiotics (Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin and Floxin/ofloxacin) damage tendons and other connective tissues (there is a black box warning on all fluoroquinolones noting that they have this adverse effect). However, it is not known HOW fluoroquinolones damage tendons and other connective tissues, or what factors put an individual at risk for experiencing tendon ruptures after exposure to fluoroquinolones. Additionally, the delayed adverse-effects and the tolerance thresholds for fluoroquinolones are not understood at all—by anybody. There are a lot of very smart biochemists in the world who try to understand drugs, but even (maybe especially) they understand that the complex feedback and feed-forward loops in our biochemistry are poorly understood. Our biochemistry is so complex that consequences of disrupting one system, or one interaction, are unknown.

Most people assume that someone understands how drugs work. Understanding is necessary for proper regulation and most people assume that the FDA knows how each drug works well enough to properly regulate them. This is a false assumption, and when people realize that their assumptions about the FDA understanding the consequences of the drugs they are supposed to regulate don’t hold, they will lose faith in the medical system.

Loss of Credibility

When people are hurt by the medical system, they tend to opt out of it entirely. There are certainly some exceptions to that statement, but if you look at patient groups for people who have been hurt by medical devices (like Essure), psychiatric drugs (like benzodiazepines), other pharmaceuticals (like fluoroquinolones), or vaccines (like Gardasil), you will find people who are highly suspicious of the medical system as a whole. They opt out of the system and avoid consuming pharmaceuticals entirely after they have been hurt by a medical device, pharmaceutical, or vaccine. Most of them trusted the medical system before they were hurt by it, but after being grievously injured by a medical device or pharmaceutical, they no longer trust the medical system and opt out of using it whenever possible.

For people to trust the medical system and for it to maintain credibility, medicine must truly be evidence-based science. If it is not based in science, it is no better than the snake-oils of the past. If it is no better than snake-oils, will people trust it as much as they currently trust snake-oils?

When enough people are hurt by the medical system, and enough people opt out of it, it will collapse. I have no idea when that will happen, or even if it will happen. I believe that the 21st Century Cures Act will increase the likelihood of a healthcare system collapse, and that a medical system that seeks profits over health for the American (or any other nation) public, is not sustainable.

I suspect that, at some point in the future, people will look back at the medical system of the early 21st century and think that we were all fools for letting the pharmaceutical companies hurt and kill so many people. People will look back at this time and wonder why we trusted profit-motivated corporations with chemical concoctions that can permanently damage our cells, and even our DNA.

We trusted the pharmaceutical companies based on faith in the system. We had faith that medicine was evidence-based. We had faith that the regulatory agencies were protecting us. We had faith that proper tests were being done. We had faith in the notion that side-effects were “rare.” But when people get hurt, and they become one of the “rare” people injured by pharmaceutical company greed, their perspective changes—and many people lose faith in the system entirely. If enough people lose faith in the system, and if the system destroys its credibility, it will collapse.

We saw the collapse of the subprime housing market in 2008 and The Big Short explained the collapse in easy-to-understand terms. A similar stage is being set in the healthcare industry—with legislation that abolishes safety standards, incompetent regulatory agencies, and complexity that is mind-boggling. Just as people woke up to the fact that subprime mortgage bonds were not worth anything, eventually they will wake up to the fact that there are too many drugs that are doing more harm than good—and once the medical system loses credibility, it will crash. This anticipated crash can be prevented, but I don’t see any systemic movement toward that. We shall see.

Information About Fluoroquinolone Toxicity

Information about the author, and adverse reactions to fluoroquinolone antibiotics (Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin and Floxin/ofloxacin) can be found on www.floxiehope.com.

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More people than ever are reading Hormones Matter, a testament to the need for independent voices in health and medicine. We are not funded and accept limited advertising. Unlike many health sites, we don’t force you to purchase a subscription. We believe health information should be open to all. If you read Hormones Matter, like it, please help support it. Contribute now.

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