publication bias

Most Medical Treatments have Limited Evidence

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evidence-based-medicine

The journal Clinical Evidence, a project of the British Medical Journal, reports that at least 50% of common therapeutic interventions are completely unproven – meaning neither doctors nor researchers have any idea if they work or not. Worse yet, only 35% of treatments are known to be beneficial (11%) or likely beneficial (24%).

Recall, a few years ago the journal Obstetrics and Gynecology published a story reporting that only 30% of Ob/Gyn clinical practice guidelines were evidence based. When combined with the flurry of recent data on publication bias, fraud in scientific publishing and a more recent report that the Majority of Landmark Cancer Studies cannot be Replicated (to be clear, this study is paywalled and we can only access the abstract), the evidence base, in supposedly evidence-based practices, is crumbling quickly.

To address the lack of evidence the clinical practice, Congress authorized the Patient Centered Outcomes Research Institute (PCORI) along side the Affordable Care Act. Per their website, PCORIs mandate is:

to conduct research to provide information about the best available evidence to help patients and their health care providers make more informed decisions. PCORI’s research is intended to give patients a better understanding of the prevention, treatment and care options available, and the science that supports those options.

A laudable goal to be sure, bringing patients to the table in medical decision-making and research is long overdue. However, given the breadth and depth of the lack of evidence and the astronomical costs of adverse events and poor medical outcomes, educating patients about non-evidence based therapeutic options or comparing treatment A to treatment B as seems to be the focus, might not be enough to solve this problem. And given the billions of dollars at stake in pharmaceutical sales, it seems unlikely that bringing patients to the table will have any impact on product safety.

Indeed, if product pharmaceutical marketing is any indication about the direction the industry continues to pursue, it is clear that product safety and efficacy concerns are minimal at best.

John Oliver’s: Marketing to Doctors

Beyond the shenanigans on the front lines of pharmaceutical marketing noted by John Oliver, everything from the initial research (and definitions of the disease itself), peer review and publication, through FDA approval, CDC and other agency marketing, to the clinical guidelines to which physicians must practice, is influenced by pharmaceutical industry funding that sways evidence favorably. So much so, that recent reports have suggested there most medical research is utterly flawed.

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How I Lost my Faith in Scientists

On December 21, 2013, The Huffington Post published an article entitled “Americans Have Little Faith in Scientists, Science Journalists: Poll.” 

How I Lost my Faith in Scientists

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Lisa Bloomquist flouroquinolone antibiotics

On December 21, 2013, The Huffington Post published an article entitled “Americans Have Little Faith in Scientists, Science Journalists: Poll.”  The article noted that, according to a HuffPost/YouGov poll, “only 36 percent of Americans reported having ‘a lot’ of trust that information they get from scientists is accurate and reliable. Fifty-one percent said they trust that information only a little, and another 6 percent said they don’t trust it at all.”

People trust science journalists even less, with only “12 percent of respondents said (saying) that they had a lot of trust in journalists to get the facts right in their stories about scientific studies.”

I was raised by an engineer with a science background.  I don’t have any religious beliefs that keep me from believing what scientists say about human or earth history.  My political and ideological beliefs don’t conflict with those of scientists, generally.  I believe that science is the best method of seeking the truth that humans have found thus far.  I believe in the efficacy of the scientific method.

But I am one of the people in the 51 percent who only trust the information provided by scientists “a little” and one of the 88 percent who doesn’t trust science journalists to get the facts right. I haven’t fully lost my faith that scientists will eventually get to the right answers, but I have lost my trust that they are on the right path. Here are a few reasons why:

  1. I know more about my mysterious condition than they do.  I had an adverse reaction to Cipro, a fluoroquinolone antibiotic, and that triggered Fluoroquinolone Toxicity Syndrome – a syndrome that is more similar to an autoimmune disease than an allergic reaction to a drug.  There are hundreds of reputable, peer-reviewed journal articles about the effects of fluoroquinolones on human cells.  I am thankful for those articles (and the scientists that did the research and wrote the articles), as they have given me much of the information that I have.  But there is no consensus among research scientists about how fluoroquinolones affect humans, or even human cells.  Fluoroquinolones are chemical creations of humans.  Their effects on human cells should be testable, verifiable and known (they have been on the market for more than 30 years), but they’re not. The effects of fluoroquinolones on human cells are complex and multifaceted. But there are causes and effects and truths to be found, yet victims of these drugs are left to do the research about how these drugs work and put together the pieces as to why they are ill, because the experts, the scientists and researchers, aren’t. This isn’t okay.
  2. Rise in chronic mysterious illness.  People are sick with “diseases of modernity.”  Doctors and scientists don’t seem to have any answers as to what diseases like fibromyalgia, chronic fatigue syndrome, adverse reactions to drugs (including vaccines), autoimmune diseases, allergies, and others are caused by, or how to fix them. When you, or a family member, become ill, and there is nothing that your doctor can do to help you, yet your pain and suffering are definitely real; the natural and reasonable tendency is to lose trust in those who are failing to give you answers. We expect answers to medical, biological, and chemical problems from doctors and scientists, and when they fail to give us those answers, we lose faith in them.
  3. Publication bias.  Publication bias is “the practice of selectively publishing (drug) trial results that serve an agenda.” It’s an ethically disgusting practice and most scientists agree that it should be eliminated, somehow. Yet it continues. The Huffington Post article noted that many people distrusted scientists and science journalists because they believed that the scientist’s findings were influenced by political ideology or the influence of the companies sponsoring them. No system has yet been put into place to minimize or eliminate bias.
  4. Scientists aren’t seeing the big picture.  There is a struggle between specialization and detail, and the so-called “big picture.”  Journal articles will point out details of a problem, then fail to link those details to the big picture.  For example, there are journal articles that note that fluoroquinolones deplete mitochondrial DNA.  What that means for human health and how that affects the person who takes those drugs, is not noted.
  5. Scientists aren’t taking a stand.  There are journal articles about the disastrous effects of some drugs on human health, but there seems to be little screaming about the limiting of the use of those drugs based on the findings. Rather, the warning label is simply updated, and people continue to be hurt, when their pain, suffering and death could have been prevented.
  6. Nonsense explanations.  In an article in The Atlantic entitled “Living Sick and Dying Young in Rich America” about how an increasing number of young people are coming down with chronic illnesses, especially autoimmune diseases, the explanations put forth by the doctors and scientists interviewed as to why young people are sick with autoimmune diseases bordered on ridiculous.  Junk food and a lack of exercise were asserted to be the main culprits. Junk food and lack of exercise will certainly make a person fat and they may cause some chronic illnesses like obesity and diabetes, but they aren’t likely to trigger an over-expression or over-stimulation of immune system cells (unless the junk food is made from GMOs and immune-system altering chemicals, in which case it’s possible), which is what causes autoimmune diseases. Perhaps pharmaceuticals that have been shown to stimulate immune system cells should be looked at as a culprit, instead of the victim’s diet and exercise habits.
  7. Faith-based assertions.  Almost every journal article I read about the safety of the drugs that hurt me, fluorouquinolones, has a faith-based, incorrect statement that they are “generally regarded as safe.”  Many of the articles then go on to note deleterious effects of fluoroquinolones on human cells, but those truthful findings don’t seem to inspire revision of the presumptive statement that they are “safe.”
  8. Faith-based following.  To be accused of being anti-science is a huge insult.  If you question the safety of a drug or vaccine you risk being accused of being anti-science, and the assumption is that you must be irrational, dangerous, or opposed to the progress that has been made with other pharmaceuticals or vaccines.  The demonizing of those who question scientists is, ironically, anti-science, as science is built on questioning assumptions and faith-based beliefs.
  9. Conflicting results.  When questions are asked that should have a yes or no answer, and those questions can be verified in a laboratory setting, different groups of scientists should be able to get consistent results.  Replicability is a tenet of science. Yet there are conflicting results to many important, answerable questions throughout scientific journals.  It’s frustrating and it decreases the credibility of scientists that questions that should be answerable aren’t being answered.
  10. Changing stories.  Is butter good for us or bad for us?  How about coffee?  How about fluoride?  What about statins?  The story changes constantly. This destroys the credibility of the people telling the story – doctors, scientists, nutritionists, and others.
  11. Disbelief of patient reports.  If one patient comes forward asserting that a pharmaceutical or vaccine hurt him in an unusual way, it is reasonable to think that the patient might be mistaken, that there might be another explanation for his pain.  However, if hundreds or thousands of patients come forward with the same, or similar stories, their assertions should be listened to. Unfortunately, their stories are being systematically disregarded and denied by doctors and scientists alike. Hurt patients have no reason to lie, they have no conflicts of interest (generally), so they should be listened to and believed. In systematically ignoring them and their pain, doctors and scientists are being callous and un-curious, and they are losing credibility.
  12. Not asking the right questions.  Mitochondrial dysfunction is related to many diseases including, “schizophrenia, bipolar disease, dementia, Alzheimer’s disease, epilepsy, migraine headaches, strokes, neuropathic pain, Parkinson’s disease, ataxia, transient ischemic attack, cardiomyopathy, coronary artery disease, chronic fatigue syndrome, fibromyalgia, retinitis pigmentosa, diabetes, hepatitis C, and primary biliary cirrhosis” (source) and others.  Many pharmaceuticals, including statin drugs, synthetic antibiotics, antidepressants and others, adversely affect mitochondria.  Yet the affects of drugs on mitochondria are not systematically examined before drugs are put onto the market.  If mitochondria are not being looked at, the right questions are not being asked, and if they’re not asked, they won’t be answered.  We count on scientists to ask the right questions.  When they don’t, they lose credibility.

The list above saddens me.  If I can’t trust scientists to give me answers, who can I trust?  Is there an alternative?  I’m not the type to start an alternate belief system, and I truly do believe that the scientific method is the best way of finding truth that we have.  But scientists are failing to find the answers as to why, for example, an increasing number of young people are suffering from chronic autoimmune ailments than at earlier times, or appalling autism rates keep getting worse and worse, and people are suffering because of the lack of answers provided.  So I have lost trust in them.  Sadly, I have more trust in personal reports (which are, of course, anecdotal) that I read on the internet than I do in scientific studies.  At least I know that the people screaming about their pain, their struggles, their need for answers, etc. aren’t subject to publication bias with their screams.

The only way to find answers to chemical, biological and medical problems is through science.  Scientists must be the ones to step up to do the science. They must be the people to find the answers.  Substantive, reliable, replicable, truthful information cannot be gained without them and their methods.  We are at their mercy in finding answers to many of life’s problems, especially those having to do with human health.  I trust that some brave scientists will step up to rectify some of the criticisms that I listed above.  I certainly hope so.

I don’t expect scientists to be perfect.  I don’t expect them to have all the answers.  I don’t expect them to be infallible.  But I do expect them to be curious, humble, truth-seekers who minimize bias and conflicts of interest to the best of their abilities. I expect them to be ethical and moral. I expect them to take responsibility for the bad that comes along with the good of their creations. I expect them to be prudent and careful when dealing with chemicals that can mess things (human bodies and the environment) up in ways that can’t be fixed.  I expect them to be honest.  I expect them to be outraged.  I expect them to be curious.  I expect them to seek answers to the real problems and dilemmas that people face.  Perhaps I’m naïve.  Perhaps I’m expecting too much from my fellow humans who happen to have the title of Scientist.  Perhaps I’m not being fair.  I apologize if that is the case.  We are all just people trying to do the best we can to make the world a better place.  I just wish that I was still sure that, collectively, scientists were making progress toward making the world a better, not worse, place.  Until I gain some reassurance, consider me one of the doubtful and untrusting.  I am truly, deeply saddened by this.

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 Lisa Bloomquist’s site, www.floxiehope.com.

Participate in Research

Hormones MatterTM is conducting research on the side effects and adverse events associated with the fluoroquinolone antibiotics, Cipro, Levaquin, Avelox and others: The Fluoroquinolone Antibiotics Side Effects Study. The study is anonymous, takes 20-30 minutes to complete and is open to anyone who has used a fluoroquinolone antibiotic. Please complete the study and help us understand the scope of fluoroquinolone reactions.

Hormones MatterTM conducts other crowdsourced surveys on medication reactions. To take one of our other surveys, click here.

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Will the Sunshine Act Curb Pharma Payments to Doctors?

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Healthcare and Money

Just two weeks ago, as part of the Affordable Care Act, the Centers for Medicare and Medicade Services published its final rule on the reporting mandates for physician payments from pharmaceutical and medical device makers. Called the Physician Payment Sunshine Act, this law requires:

applicable manufacturers of drugs, devices, biologicals, or medical supplies covered by Medicare, Medicaid or the Children’s Health Insurance Program (CHIP) to report annually to the Secretary certain payments or transfers of value provided to physicians or teaching hospitals (“covered recipients”).

Why Is This Important?

For too many physicians, the medications they choose to prescribe are influenced by these payments. A case control study at a university hospital found that physicians who requested a new drug be added to the formalary were 19X more likely to have received money or gifts from the drug company. According to the New England Journal of Medicine as of 2007 fully 94% of all physicians accepted gifts from pharma, although by 2009, only 84% of physicians accepted gifts from pharma.

In their Dollars for Docs series, Propublica not only detailed the trail of money from the pharmaceutical industry to physicians and the changes in prescribing practices that ensued, but also, found that over 250 of the physicians receiving these payments had been disciplined by their state’s medical boards with the public never the wiser.

Wouldn’t you want to know if your physician was receiving payments to ‘consult’ on a particular drug or medical device? What if that drug or device turned out to be dangerous like, Avandia or Vioxx or in the case of women’s health Yasmin, Yaz or Ocella or even the vaginal mesh implants?  I would. And soon, you will be able to find this information, at least for those physicians that accept medicare or medicade. For the remaining physicians, we’ll have to rely on the stellar, investigative reporting of organizations like Propublica.

What Is the Physician Payment Sunshine Act?

The Physician Payment Sunshine Act mandates payments or ‘transfer of value’ to physicians be reported to the Secretary of Health and Human Services. Collection of this information is set to begin in August with full compliance and reporting expected in 2014.

The cool thing about this act, if it is implemented correctly, is that payment or transfer of value includes money for marketing activities, such as promotional or conference talks and consultation services. It also will include research grants and “charitable” contributions (which usually come with some promotional strings attached), funding to attend conferences, honoraria and royalties and license fees. The pharmaceutical and device companies making these payments will be required to list names, address, amount of payment, date of payment(s) and describe the service for the payment made for anything over $10. The database will be searchable so that patients can determine what monies their physicians received from pharma or device companies.

Where the Sunshine Act Fails

From the original to the final regulations, a work-around for paying physicians to speak at pharma sponsored continuing medical education (CME) events was added. According to the regulations, so long as the sponsoring company doesn’t pay the physician/speaker directly, those fees are acceptable and need not be listed publicly. Instead, the pharma company must pay a third party vendor to arrange and pay the speakers. CME conferences are where most physicians learn the latest drug therapy, device or medical technique. It is unlikely that speakers at these conferences will speak against the sponsor’s product. Funneling the payments through a third party vendor, who is also paid by the sponsor, is no more than a quick pass at laundering the fees.

What Do Physicians Think About the Sunshine Act?

The opinions are mixed, at least publicly. Some physicians are fully behind the new efforts in transparency and have begun their own campaigns to disentangle the marketing relationships between pharma and physicians. The National Physicians Alliance sponsors the Unbranded Doctor campaign:

The National Physicians Alliance’s Unbranded Doctor is unmasking the pharmaceutical industry’s bogus claim that its marketing efforts are just educational ventures for physicians. By signing up physicians to renounce gifts, lecture fees, and “education” from companies, the Alliance is championing objectivity, integrity, and professionalism.

—Jerome Kassirer, MD
former Editor-in-Chief, New England Journal of Medicine

Similarly, the British Medical Journal (BMJ) has positioned itself as a lead proponent of transparency and open data. On the other hand, CME released a survey of over 500 physicians asking if the new regulations to list publicly whether industry sponsored their attendance at CMEs would curtail their attendance. The result was a resounding – yes.

  • 75% of physicians said the disclosure rules would affect their decision to attend at least somewhat.
  • 47%  of physicians said the disclosure rules would affect their decision to attend to a great extent.
  • 46% of CME speakers said the disclosure rule would affect their decision to participate as a panelist or presenter to a great extent
  • 25% percent said it would somewhat affect their participation

Will the Sunshine Act Curb Pharma Payments to Doctors?

Probably not. Unless and until full transparency about medical research, clinical trials and adverse events are made open and accessible to patients and physicians, medical marketing, fabricated data or omitted data, publication bias, and conflicts of interest will continue to pervade our healthcare system. Dangerous medications like the Yasmin suite of birth control pills and unsafe medical devices like J&J’s Gynecare Prolift will remain on the marketplace long after any reasonable person could vouch for their safety.

The Sunshine Act will, however, give patients one more tool to evaluate their physicians and give researchers, investigators and others a way to identify and publicize bad behavior. Who knows, maybe it will even save some money.

To find out if your physician receives money from the pharmaceutical industry go to Dollars for Docs.

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5 Health and Science Trends to Watch in 2013

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As the New Year beckons several trends that emerged in  2011-2012 are certain to explode in 2013. Here is a look at the trends I’ll be watching.

Trend 1: Open Science

Although open source and collaborative software development have been the norm for decades, the notion of open science has only recently gained a foothold.  Bolstered by recent access to large data sets from government entities, an array of mobile health applications, an explosion of data-hackers, and a growing mistrust of industry sponsored research, scientific research, especially health and medical research, is about to move from the lab to the social sphere.

Trend 2: Citizen Science

From volunteer classifiers and armchair tinkerers to full-fledged data analytics and engineering, the next decade is sure to see an explosion of scientific discovery coming from the most unlikely places.  In health and medical research, the tools to measure and analyze one’s own health are becoming more readily available to consumers.  Every person is potentially his or her own science experiment.  Every social network a data set. How we choose to utilize that information, who we share it with and how we share it will likely determine the next major corporate players in the marketplace.  At the very least, this new found access to health data, whether it be our own or others with similar diseases and health issues, is changing the very dynamic of the doctor-patient and patient-industry relationship.

Trend 3: The End of Academic Publishing

Peer-reviewed, industry-sponsored, closed-sourced publishing has been the gold-standard for scientific publishing for decades, but the model is broken and everyone knows it.  In much the same way that the internet and blogosphere have damaged traditional media, open access to data and information has made the closed nature of academic publishing an all-but obsolete model for the dissemination of information.  Add to the mix the growing problem of significant publishing biases, fraudulent and errant data, the once vaulted anonymous, peer-review process – the process that arguable defines academic publishing – is crumbling.

Perhaps the final straw of what will ultimately be the sector’s unraveling (lest the model change quickly) was Elsevier’s unsuccessful attempt to privatize and profit from taxpayer funded research through shady legislation called the Research Works Act (RWA). Coming on the heels of the failed Stop Internet Piracy Act (SOPA), scientists and major universities loudly protested RWA and succeeded in blocking the bill. Elsevier suffered and continues to suffer significant economic losses.

As a result, open access publishing which had been growing quietly over the last decade, exploded in 2012. Even more interesting, a bevy of new collaborative and open source research and publication sites (ResearchGate, for example) emerged heralding a complete shift in the control and dissemination of scientific and medical information.

Trend 4: The Rise of the Social Entrepreneur and the B Corporation

One of the most innovative trends in recent decades is the emergence a new corporate structure, called the B-Corporation that will codify social goals alongside corporate profits.  The B Corp is a hybrid of sorts that combines the social intentions of the non-profit with the fundraising and profit potential of a C corporation. Though the B Corp has no teeth or tax benefit per the federal tax code and is only recognized in 16 states thus far, it has legs. There is a real hunger to create pragmatic business solutions for social problems. Social entrepreneurism is on the rise and B Corps may provide the structure to help them succeed.

Currently, B-Corps are focused primarily on social and environmental problems. Should the B-Corp gain traction in the healthcare industry, it could usher an entirely new class of innovation in traditionally ignored and underfunded areas of the healthcare sector- orphan diseases/drugs or maybe even women’s health.

Trend 5: The Power of Women

Hell hath no fury like a woman scorned was proved over and over again during this last election season. Though narrowly framed as the abortion debate, the fight over women’s reproductive healthcare rights goes much deeper. It is a battle over fundamental human equality under the law and spans every aspect of the modern economy, but most especially the healthcare sector.

We have yet to see the full backlash of the political attempts to limit women’s healthcare decision-making, but make no mistake, fail to recognize the power of millions of angry women, and your business, your political career will be over (how many local and federal legislators were voted out of office by women’s groups?).  Sorry guys but you wouldn’t stand for a bunch old women regulating your seminal excursions, why would you expect women to forfeit their healthcare choices, safety and survival to a bunch of old men with less than honorable motivations. As 2013 beckons, expect women to wield much more political and economic power. The companies and politicians that recognize this will unseat those that do not.

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How I Lost my Faith in Scientists

On December 21, 2013, The Huffington Post published an article entitled “Americans Have Little Faith in Scientists, Science Journalists: Poll.” 

Fabricated Data: What Happened to Peer Review?

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Two independent reports published just this month call in to question the integrity of medical research publishing and the effectiveness of the peer review process.

Publish or Perish and Peer Review

Academic careers are made or destroyed on the number of publications one has in high ranking peer-reviewed journals. In many cases, it’s not the quality of the research but the quantity of publications. The industry insists that peer review is the gold standard that ensures only quality research is published. More and more, however, we are finding that this may not be the case and that economic interests often override ethical behavior.

Conflicts of Interest

Just last week, a report in the Archives of Internal Medicine found that 71% of committee chairpersons responsible for instituting clinical guidelines had significant conflicts of interest with industry. In many ways, those clinical guidelines set the tone for what will be accepted in leading medical journals. As we and others have reported before, publication bias, the tendency to publish only those studies that present positive results (e.g. support accepted clinical guidelines) in scientific journals is rampant and can seriously jeopardize patient care.

Even Worse: Fraud and Misconduct in Medical Publishing

Earlier this month a report published in the Proceedings of the National Academy of Sciences  found that in 2012, one in every 10,000 medical articles published is retracted. This is compared to one in every 100,000 articles that was retracted in 1975, a ten-fold increase. Strikingly, 67% of the retractions were due to misconduct and the vast majority (43%) for fraud or suspected fraud (fabricated or falsified data, plagiarism).

Information Laundering

The increased rate of fraudulent research retraction, combined with the high publication bias, the industry sponsored ghostwriting scandals, the recognized conflicts of interest on many peer review panels, and the overall lack of transparency in medical publishing make it very difficult for physicians or patients to trust the veracity of ‘clinical evidence’.  The lines between science and profit have been blurred so much that the integrity of the once revered peer review process is questionable.  According to the Richard Horton, editor of the Lancet:

“journals have devolved into information laundering operations for the pharmaceutical industry.”

A New Model

Much like the broken healthcare system where physicians are rewarded for the number of services and tests they provide rather than the quality of care or positive outcomes, medical publishing and by association medical research are tangled in skewed economic model; one that rewards quantity over quality and positive results over negative. If peer review is no longer the stopgap to medical information fraud that it once was, we need a new model. Some suggest open data and crowd-review are the answers.  We’ll explore the open data debate in subsequent posts. What do you think? Should raw, health or clinical trials data be open to all, presuming personal identity can be concealed?

 

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How I Lost my Faith in Scientists

On December 21, 2013, The Huffington Post published an article entitled “Americans Have Little Faith in Scientists, Science Journalists: Poll.” 

Data Matter

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A dirty little secret in medical literature, systematic reviews are only as strong as the individual studies they examine. And when negative data are not published in the major medical or scientific journals, as is commonly the case, these reviews cannot help but be skewed.  A report by the British Medical Journal found that when outcome data were re-analyzed to include the unpublished data for 42 previously FDA-approved drugs, a whopping 93% of the outcomes changed.

All data matter, especially in medicine.  With systematic reviews and meta analyses, the gold standard in scientific publishing, researchers seek to make claims about a particular drug or health event based upon the totality of the published research. Physicians and other scientists use these systematic reviews to guide decision-making. Prescribing a drug based upon the positive findings of a systematic review gives one considerably more confidence than doing so based upon a few unrelated studies. When the systematic reviews are based upon insufficient reporting of negative or null results, the review is likely inaccurate.

Publication bias, as it is called in research circles, is a well known problem to many. By nature, scientific journals gravitate toward positive and novel results, in much the same way TV news reporting tends toward negative, salacious events. Both are clamoring for market share. Unlike in TV news, bias in the research industry can and does have serious consequences when medical-decision making rely on those results. Noted physician and medical blogger Harlan Krumholz, contends that medicine’s biggest threat is not some exotic virus, but missing data.

Case and point, when data about adverse events are withheld from publication, bad drugs, such as Vioxx are released into the market place and presumed safer than they actually are.  A similar scenario is emerging for Yaz/Yasmin. These birth control pills are currently facing a bevy of lawsuits  for some serious adverse events.

So what is one to do, who does one trust?  I don’t know the answer to that question, but I think that good first steps include transparency and open access to data and research. As a patient, this includes access to scientific and medical research as well as access to our own medical data. As we report in the stories below, access to research is at risk if the Research Works Act passes.

A next step is to demand all data be published in drug studies, the good, the bad and the ugly. The British Medical Journal reports, those data are available in many, but not all cases, through FDA and other repositories. However, culling and analyzing those data along side the published reports is no easy task.

Perhaps a third option, is post-market crowdsourcing. Granted, not the best option when dealing with potentially dangerous therapeutics, but in this new environment of empowered patients and big data, crowdsourced research is becoming more common. The organization adverseevents.com is aggregating patient-reported adverse reactions to medications. It’s freely available to patients and physicians globally. A myriad of other companies have come on the market in recent years to crowdsource the research for all sorts of medical conditions. These companies offer patients the opportunity to participate and learn directly from the research conducted. Unlike traditional clinical research, the data and results are not cloistered, but are open and readily accessible.

In the end it all comes down to data and how we use it to make decisions about our health.  I believe data matter. I believe data ought be open and accessible. What do you think?

Participate in Crowdsourced, Post-Market, Adverse Events Research

Take a few minutes to complete a survey about the medications and surgical procedures you have utilized. Take as many health surveys as are applicable and share the surveys with your friends. All surveys are anonymous and completely voluntary. We’re adding more surveys every month, so check back frequently or sign up for our weekly newsletter to keep abreast of the latest research news.

Take one of our health surveys:

Crowdfund Research on Medications that Matter to You

Lucine Health Sciences and Hormones Matter, are unfunded and run by Dr. Chandler Marrs along with a cadre of dedicated volunteers. We know the work we do is important and needed and so we’re doing it anyway, despite the lack of funding. We’re bootstrapped to the nth degree, but determined to fill the critical data void in healthcare, one study at a time.

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We Cannot Manage What We Do Not Measure

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Pay attention to the whimper or be forced to cry uncle. Those are your choices. Those were the choices that faced the nation ten and twenty years ago as naysayers to the economic policies certain to bankrupt our country became evident, but they were ignored or lambasted as fringe. The collective wisdom forged forward with derivatives, with the merging of investment and saving banks, against the whimpers of many, only to cry uncle in 2008 as the catastrophe loomed.

As the ‘other 99%’ seek to realign our political and economic situations, women must lead the changes in the health industry. We must pay attention to the whimpers, to the evidence that something is off, and more importantly, we must take heed before uncle is cried. How do we do that within such a flawed system of industrialized, profit-based medicine? Education, measurement, transparency and responsibility.

Education. The number one factor contributing to health is education. The more educated women (and men) are the better health they experience. Why? Better decision-making. Although there are clear associations between income and health, the association between education and health is stronger.

Education allows one to navigate the morass of medical marketing, cut to the truth, and identify the untruth in advertising. Education permits women the confidence to seek alternate directions in health and not simply take what is prescribed to them as gospel. Quite simply, education permits responsibility in health choices. It doesn’t necessarily lead to taking responsibility or making the right choices; we’ve all seen really smart, highly educated people do really stupid things. Rather, education creates the environment where those choices can be made.
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