Big Pharma, Bad Medicine

(Photo credit: Mike Licht, NotionsCapital.com)

Given the importance of rigorous, verifiable research in the practice of modern medicine, it seems a natural assumption that the doctors who treat us base their actions and recommendations on solid, irrefutable evidence. Evidence-based medicine, is, after all, the mantra that we as patients hear over and over again, especially when it comes to our inquiries into the implementation of alternative therapies that fall outside of the medical mainstream. More often than not we are told that there is simply no evidence for the effectiveness of this or that alternative therapy, and that rather than waste our time and energy on unproven and possibly dangerous unconventional remedies, we should stick to the tried-and-true, which almost always come in the form of pharmaceutical products produced by one of the giant multinational pharmaceutical firms, known collectively as “Big Pharma”.

The logic behind such thinking isn’t necessarily faulty. Untold millions of dollars are spent developing drugs and putting them through laborious clinical trials, the result of which is the evidence upon which “evidence-based medicine” thrives. Absent the data produced by this research model, the practice of medicine would be largely reduced to educated guesswork, based solely on the experiences and impressions of individual medical practitioners, which by definition would be limited in scope and might easily be skewed by subliminal prejudices and statistical aberrations physicians could encounter during the course of their careers. Relying instead on evidence amassed through years of rigid research encompassing thousands of patient hours makes deciding which medicine to prescribe or procedure to recommend an exercise in logic and intellectual reasoning, the cornerstones of all disciplines of modern science.

This all makes perfect sense, and indeed this very reasoning has fueled the rapid advances seen in many fields of medicine over the last half-century. However, if the evidence which is the foundation of evidence-based medicine becomes unreliable, or downright misleading, the entire edifice that is modern medicine stands in danger of collapse. To an extent that is almost incomprehensible, this is the very environment in which patients and physicians now find themselves operating, as the research published in scholarly journals and presented at medical symposiums appears to be increasingly biased in favor of the drugs being researched, to the point that physicians are now basing their treatment decisions on woefully incomplete data sets and trial results that conveniently leave out the negative while emphasizing the positive.

As is documented by British psychiatrist Dr. Ben Goldacre in his book “”Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients”, which was recently excerpted at Salon.com (click here), the trial evidence upon which doctors base their most important decisions is often misleading at best, and outright dishonest at worst. As more and more medical research is funded by the drug companies themselves, rather than by independent concerns such as foundations or government agencies, the results of that research appear to be becoming less and less reliable. Dr. Goldacre cites studies which show that research funded by pharmaceutical companies is far more likely to favor the drug being tested than studies funded by independent organizations.

One such study, conducted in 2007, looked at every published study investigating the effectiveness of statin drugs, which are commonly prescribed to lower cholesterol. The studies either compared an individual drug to another kind of treatment, or to a competing statin drug. In all, 192 studies were surveyed, and researchers found that pharmaceutical company funded studies were 20 times more likely to give results favoring the test drug than similar trials funded by independent concerns. Other studies looking at different bodies of research found discrepancies that weren’t quite so dramatic, but invariably found that industry funded studies were far more favorable to the drug being researched.

The reasons for this bias are many. Trial results can be manipulated by testing a drug against another drug given at a sub optimal dosage. Patient populations can be manipulated, so that only patients most likely to get better are used in the research. The researchers themselves, even those conducting studies that are properly designed, may be subconsciously biased by the knowledge that their paycheck is being funded by the pharmaceutical company whose drug is being tested. Whatever the reasons, the evidence appears to be irrefutable: the trial results upon which doctors base their treatment decisions are very often biased in favor of the treatment being tested.

To make matters worse – much worse – drug companies routinely fail to report negative research outcomes, never allowing them to see the light of day. The companies conduct many studies on a single drug, and only publish those studies whose findings are positive for the drug in question. Dr. Goldacre writes about a situation in which he did the very best he could as a doctor, only to later find that he had been misled by the very act of doing his due diligence. In deciding on an antidepressant drug on which to put a patient for whom other drugs had proven ineffective, Dr. Goldacre read every published study he could find on a new drug he was considering, which all showed it to be better than placebo, and as good if not better than competing antidepressant drugs. Later, Dr. Goldacre learned that, though he had read all of the available studies, he’d only received a tiny glimpse into the true research record of the drug he was investigating, Reboxetine.

Some time after Goldacre prescribed Reboxetine for his patient, researchers did a comprehensive survey of all the trials that had ever been conducted on the drug, including those that had not been submitted for publication in academic journals by the drug company, collecting their data through numerous requests to manufacturers and regulating agencies. They found that seven studies had compared Reboxetine to placebo. Of those seven studies, only one found the drug had a positive result, the other six found Reboxetine to be no better than a dummy sugar pill. Only the positive study was published for review by physicians. The six failed studies were never submitted for publication. Trials comparing the drug to competing drugs showed a similar pattern. Three trials, totaling 507 patients, found Reboxetine to be more effective than a rival drug. However, other trials, which used data derived from 1657 patients, found that Reboxetine treated patients fared worse than those on other drugs. These findings were again left unpublished, shielded from the view of the physicians.

Tragically, this situation is typical of the industry. The fact that pharmaceutical companies can fund their own studies and decide to only publish positive data is unfathomable. Would we let, say, automobile manufacturers conduct their own safety tests, and without question accept their claims that the cars they make are the safest in the land? Of course not, yet this same practice has been allowed to flourish in an industry upon which the health of the world has come to rely. The situation is outrageous, but is so endemic that remedies are difficult to come by.

The British Medical Journal, a highly respected academic journal better known these days as BMJ, has, as of January of this year, announced that it will only publish studies that allow access to patient data from all of the studies conducted on the drug in question. The editors of the BMJ lay out their case for this action in a hard-hitting editorial published last October (click here). If only other academic journals would follow suit. The pharmaceutical giant GlaxoSmithKline announced in October 2012 that it will open up all research data for investigation by physicians and scientists (click here). While this is an admirable step, it comes only after GlaxoSmithKline was forced to pay $3 billion to the Federal Drug Administration to settle three charges of fraud levied against it (click here), one of which included holding back data and making unsupported claims regarding its diabetes drug Avandia.

Another of the charges in the GlaxoSmithKline settlement was that the pharmaceutical giant used inappropriate tactics to influence physicians to prescribe their drugs, tactics which included paying large speaking fees to doctors and providing them free access to high-priced entertainment. Couple the reality that pharmaceutical companies have been allowed to bury negative trial data with the fact that these companies routinely use their huge sales forces to court practicing physicians with offers of all-expenses-paid trips to “educational symposiums” in exotic locales, free gifts and lunches, and sponsored lectures, and we have what some cases amounts to a completely rigged system.

As circumstances currently stand, physicians find themselves faced with a situation in which they can’t trust the research published in academic journals (often their only resource for such vital information), and many find themselves subject to conflicting influences offered by pharmaceutical companies, the success of whose products lies completely in the hands of these same physicians. The end result can only be that patients in general, who trust their very lives to doctors, can only wonder about the motivation and correctness of the treatment decisions made on their behalf. For MS patients, whose drugs can cost tens of thousands of dollars a year and some of which carry potentially deadly side effects, the gravity of these questions is only multiplied.

It’s a situation that truly boggles the mind.

The below video is a presentation given by Dr. Ben Goldacre on some of these very same issues. It's really a must watch…
 

Related articles

• 5 prescription drugs doctors had no idea could hurt their patients (ted.com)
• What is known - and not known - about your flu medication (macleans.ca)
• Profits over your dead body (arstechnica.com)

Our System for Treating the Sick Is Sick Itself; No Cure In Sight

Hippocrates: a conventionalized image in a Roman "portrait" bust (19th century engraving) (Photo credit: Wikipedia)

I’ve recently come across a spate of news pieces that illustrate just how far our health care system has gone astray. Most of the folks reading this blog are themselves chronically ill, or have a personal connection to the chronically ill. As such, Wheelchair Kamikaze readers are unfortunately more familiar than the average Jane or Joe with the inner workings of the world of modern medicine.

For the healthy, from the outside looking in, modern medicine can often appear to be a sleek and technically sophisticated miracle machine, using high-tech wizardry and groundbreaking research to treat and tame diseases that have been the scourge of mankind for millennia. This image is carefully cultivated, through public relations, advertising, and a news media that loves a good story about astonishing advances made in the battle against disease. Those of us who are forced to enter the belly of the beast, though, often find something quite different: a confusing, frustrating, and often dysfunctional world in which reliable answers are heartbreakingly few and where patients are too often seen as consumers rather than sick human beings. Though individual healthcare practitioners themselves are, for the most part, good men and women, the system within which they operate has evolved to put profit before patient, and the subtle and not-so-subtle pressures this framework exerts can warp even the best intentioned souls among them.

Here, then, is a smattering of examples that each serve as windows into the often enigmatic environment in which patients are forced to tread. Think of the following snippets as flashbulb lit snapshots taken in a pitch black room, briefly illuminating nooks and crannies that can only hint at the whole of a much larger setting. Each example is in itself maddening, but strung together they portray a system of treating the sick (and healthy) that has drastically gone off the rails.

♦ HCA, the largest for-profit hospital chain in the United States, is revealed in this article (click here) to have played host to a disturbingly high number of cardiac procedures (mostly angioplasties) that were found to be medically unnecessary, and apparently performed to drive profit and increase both the company’s and the treating physicians’ financial bottom lines. At Lawnwood Regional Medical Center, in Fort Pierce, Florida, a confidential review revealed that about half of the diagnostic cardiac catheterizations done at the facility were performed on patients without significant heart disease. A review of HCA internal documents indicated that “rather than asking whether patients had been harmed or whether regulators needed to be contacted, hospital officials asked for information on how the physicians’ activities affected the hospitals’ bottom line.”

Driven by the need to show steadily increasing profits in the face of the company’s impending Initial Public Offering, it seems that HCA turned to cardiac care to provide a reliable pipeline of revenue. A 2003 review of procedures done at Regional Medical Center Bayonet Point, in Hudson, Florida, revealed that a disturbing 43% of 355 angioplasty cases “were outside reasonable and expected medical practice”, and that treating physicians routinely overstated the degree of coronary blockage found in the treated patients. As a result of this internal review, Bayonet Point suspended the privileges of nine physicians. These cardiac procedures were a financial boon to the company, as Medicare reimburses hospitals about $10,000 for each stent used in angioplasties, and $3000 for diagnostic catheterizations.

One would hope that instances of such rampant malfeasance are extremely rare, but although this report concentrated on one large hospital chain, the unnecessary procedures were performed in a number of different facilities, and by a shockingly high number of physicians. As is evidenced by this account, the institutional and personal pursuit of profit within the healthcare system would appear to be a potent inducement for some of those who took the Hippocratic oath to turn their backs on that solemn text.

♦ The headline of this article shouts that “Diabetes May Be Reversed by Long Used Vaccine for TB” (click here). Great news, right? Well, not so fast. In a small study the 90-year-old vaccine, called BCG, was shown to induce the completely nonfunctioning pancreases of some type I diabetics to once again start producing insulin. “These patients have been told their pancreases were dead… We can take those people, give them a very low dose twice and see their pancreases kick in and start to make small amounts of insulin.”

So, what’s the problem? Sounds like widespread research should be undertaken posthaste. The vaccine already exists, and has been in use for almost a century to treat not only tuberculosis but also bladder cancer. But therein lays the problem. A 90-year-old vaccine cannot be patented, and is readily available as a cheap generic. Therefore, huge heaps of cash cannot be generated by finding new uses for it. Soon after the lead researchers made their initial discoveries using mice, “they tried to interest every major drugmaker in developing the vaccine as a possible cure for diabetes. All told her there wasn’t enough money to be made in a cure that used an inexpensive, generically available vaccine.” The researchers are currently undertaking fundraising from private donors, and thus far have $11 million of the $25 million needed to proceed to the next stage of research.

As disturbing as the story is, with its seemingly blatant disregard for the well-being of millions of people worldwide suffering from type I diabetes, the hard truth is that the major pharmaceutical companies were actually fulfilling their legal mandate in turning down research that had very little, if any, profit potential. All of the major pharmaceutical companies are public companies, their stock traded openly on world markets. Publicly traded companies are mandated by law to be beholden to their shareholders, not to the customers who eventually consume their products. The job of pharmaceutical company CEOs is not to produce the most beneficent concoctions their researchers can come up with, but rather the most profitable ones. In declining to fund further research into the BCG vaccine’s role in potentially eradicating type I diabetes, drug company executives were not only fulfilling the responsibilities of their office – doing their jobs, so to speak – but also following the letter of the law. Not to go all gutter on you, but how fucked up is that?

♦ As patients afflicted with a horrible disease that has no cure, we often vent our frustrations about those who are the face of this medical universe we have unwillingly been sucked into, the physicians who regularly treat us. A quick sampling of the online conversations being held on Internet MS forums soon reveals that many patients openly revile their neurologists, some of whom I’m sure deserve all the reviling they can get. I count myself as one of the extremely lucky ones, as I feel an actual affection for my neuro, despite his inability to stop the relentless progression of my disease. He’s simply an empathetic man, and his frustrations with trying to treat this repugnant illness are evidenced by his obsession with trying to unravel its mysteries. We don’t always agree on treatment options, but I know in my heart that my neurologist has my best interests in mind. I say this not only because of my own personal sense of the man, but also for some far more tangible reasons: he doesn’t accept insurance, and doesn’t allow pharma sales reps to enter his clinic.

This commentary (click here) provides some insight into the phenomenon of physician burnout, a condition brought on by the restrictions and edicts of a system that would seem to sometimes be as frustrating for the doctors trying to operate within it as it is for patients seeking reliable and compassionate treatment. A recent survey of 7000 doctors “found that almost half complained of being emotionally exhausted, feeling detached from their patients and work or suffering from a low sense of accomplishment.” Doctors suffering from such burnout are obviously more prone to make mistakes, have an inability to establish any kind of real relationship with their patients, and generally perform below the expectations of the sick people who are so reliant on them.

The cause of this physician malaise is often invisible to those of us under a doctor’s care, who may only see an insensitive and mechanical being who exhibits little or no empathy towards our plight. Indeed, that’s the way I viewed my first MS neuro, and why I sought out the services of the man who is now my doctor.

According to the commentary, “The study casts a grim light on what it is like to practice medicine in the current health care system. A significant proportion of doctors feel trapped, thwarted by the limited time they are allowed to spend with patients, stymied by the ever-changing rules set by insurers and other payers on what they can prescribe or offer as treatment and frustrated by the fact that any gains in efficiency offered by electronic medical records are so soon offset by numerous, newly devised administrative tasks that must also be completed on the computer.

In this setting, “doctors are losing their inspiration… and that is a very frightening thing.”

While this certainly does not excuse all of the bad behavior by physicians recounted by patients in conversation after conversation, it certainly makes some strides towards explaining it. Indeed, many doctors feel so frustrated by the factory like approach dictated by insurance companies, with daily quotas to see X number of patients and restrictions placed on the treatments they can offer, that they are leaving the practice of medicine entirely.

This of course does not excuse the behavior of physicians who blatantly order unneeded tests and perform unnecessary procedures simply to run up bloated billing, or who view their patients as vehicles for their own financial advancement. Such doctors do exist, and in unacceptable numbers, but can we expect more from a healthcare system that has evolved into a moneymaking Goliath, under the direction of huge corporations that routinely squeeze the humanity out of the medical equation? A system increasingly dominated by publicly traded companies whose calculations are based more on stock price than on patient care? From research labs to clinic examination rooms, the well-being of patients, and sometimes of the doctors who treat them, is being sacrificed at the altar of the Almighty dollar.

Is it any wonder that diseases seem never to be cured, but instead turned into lifelong “manageable” conditions, those suffering from them forced into a state of perpetual reliance on obscenely expensive pharmaceutical products to maintain some semblance of wellness, and sometimes even to just maintain life?

If only there was some evil cabal to blame, some sadistic brethren of money grabbers to be tarred and feathered and run out of town. But no, what we are faced with is a systemic dysfunction, a misguided medical colossus that requires only decent people doing their jobs to maintain it, even as its course runs further and further astray. It is an engine with a wicked momentum, dragging all of those in its tow to a place where everyone, eventually, will be unwitting passengers. Very few make it through this life without finally suffering serious illness, and this universal fate is what ultimately fuels the system, driving it ever forward.

Do no harm, indeed…

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Big Pharma Behaving Badly (And Making Me Want to Vomit)

Image by BlueRobot via Flickr

Sorry about the nauseatingly graphic nature of the title of this post, but the following info makes my head explode.

Pharmaceutical industry giant Merck Serano this week paid $44.3 million to settle a lawsuit alleging that the company paid kickbacks to MS neurologists for prescribing its blockbuster MS drug, Rebif (click here). The scam allegedly included hundreds of doctors, and seems to have been centered on the Consortium of Multiple Sclerosis Clinics (CMSC), a nonprofit corporation that is supposed to help educate patients. Among its other activities, the CMSC administers the quarterly NARCOMS surveys, designed to build an ever growing database on MS and its effects on patients, which are diligently filled out by thousands of multiple sclerosis patients, including, until now, yours truly.

The lawsuit was brought by a former Merck Serano employee turned whistleblower, who was fired by the company after expressing disbelief that such underhanded and blatant misdeeds were going on with the company’s full knowledge and participation. The entire lawsuit document is available online (click here), and to save you the trouble, the good stuff starts on page 6.

We're not talking nickels and dimes here, but huge chunks of cash, on the order of $25,000 a pop. The CMSC allegedly funneled over $500,000 to various doctors, effectively operating as a money-laundering outfit for Merck Serano, and the fact that the company settled for $44 million indicates this disgusting scam went far deeper than what is apparent in the legal document. Unfortunately, by settling the lawsuit, Merck Serano has effectively prevented all of the gory details from coming to light, as would've been the case if the suit had been brought to trial, and thus become public record. The settlement covers fraud charges regarding Medicare and Medicaid, but what of the patients that may have been steered into injecting themselves with a drug that might not have been their best choice by scoundrels in white lab coats more intent on stuffing their pockets than following the Hippocratic oath? Where is their justice?

Coming at a time when trust between neurologists and their patients has become frayed due to the CCSVI controversy, the revelations provided by the lawsuit and subsequent settlement are especially revolting. It is simply outrageous that a drug company can get away with paying physicians kickbacks for prescribing drugs with what amounts to a slap on the wrist. The terms of the settlement, $44.3 million might sound like a sizable sum, but considering that sales of Rebif exceed $1 billion a year, the penalty is miniscule. Additionally, this is most likely only a quick peek under a very big rock, and it is just a glimpse at goings-on that would shock and dismay the legions of desperate patients who are the real victims of these disgusting, dishonest, and deceitful practices.

Before being forced out of work due to disability, I was employed by one of the huge worldwide entertainment conglomerates, which included in its portfolio some of the biggest record labels on the planet. In the music industry, what Merck Serano is guilty of is referred to as "payola". Simply put, payola is the practice of paying disc jockeys, radio station program managers, and other "hit makers" to play and promote the songs of a music company's artists. Back in the 50s, payola brought down the careers of some of America's top DJs, and to this day people go to jail when found guilty of the crime.

Now, what's more harmful to society, a music company paying radio stations to play the latest Beyoncé single (I'm just pulling an example out of thin air here, not accusing Beyoncé or her record company of anything) or a drug company paying doctors to prescribe their products to desperately ill patients? The rancid stench of greed and avarice has infected many of our most important societal institutions. After reading the above allegations, can any patient truly trust that their doctor has no ulterior motive as he scribbles the name of some drug on his prescription pad, very often in an office whose walls and shelves are filled with posters and promotional products handed out like shiny trinkets by pharmaceutical company representatives? That swirling sound you hear is the ethics of an entire society going straight down the toilet.

The fact that this case was settled, and not brought to court, ensures that the names of most of the players will not be revealed. I'm tempted to reveal those named in the lawsuit here, but as a settlement was reached, and no verdict of guilt ever handed down, they remain simply accused, not convicted. My personal ethics therefore prevent me from slandering those who might not be guilty as charged, however unlikely that may be. That's not to say that you shouldn't click the link (here it is again), read the lawsuit, and find those names for yourself. In fact, I wholeheartedly encourage you to do so.

Every single doctor and medical professional who received any of these tainted funds, or participated in distributing them, should be named, shamed, stripped of their licenses, and thrown in jail. They're a disgrace, each a pustule on the ass of humanity, and deserve nothing more than humiliation and degradation. Unfortunately, thanks to the niceties of a system that too often protects those in positions of power at the expense of the regular folks who rely on them, the scoundrels involved will remain anonymous, free to enjoy the fruits of their despicable actions. Despite our high-minded ideals of justice for all, far too often there is justice for none.

As for those involved in this medical and legal debacle, and the many other similar cons we will likely never hear about, may their eyes fall out. Bastards.

Related articles

• Merck Serono pays $44M to settle kickback charge (seattletimes.nwsource.com)
• PRESS RELEASE: Pharmaceutical Giant, Serono, Agrees to Pay $44.3 Million to Settle False Claims Act Case (fredericacade.wordpress.com)
• Georgia joins $44.3 million pharmaceutical settlement (ajc.com)

The Medical Industrial Complex: Sick People Required

Image by Getty Images via Daylife

Living life with a chronic illness such as Multiple Sclerosis gives one an inside view of the medical establishment, a view that healthy people rarely glimpse. In the blissful ignorance of good health, modern medicine appears to be bright and shiny, a miracle machine complete with magical elixirs, futuristic technology, and a sophisticated understanding of the maladies that strike human beings. Headlines and television news anchors shout about the latest medical breakthroughs, and a stream of television commercials assure us that there are pharmaceutical remedies for everything from cancer to osteoporosis to erectile dysfunction. Once sick and thrust into the belly of the beast, though, this illusion starts to fall away, and a different reality emerges.

Although there have been some incredible advances made in our efforts to heal sick humans over the last 50 years, there are still vast swathes of patient populations whose illnesses remain poorly understood, insufficiently and ineffectively treated, and ultimately incurable. Problematically, many of these patient populations generate billions and billions of dollars for the modern medical hierarchy, a situation that sets up a paradox within our profit driven medical establishment. Cure these patients, and vast sums of money and an elaborate infrastructure would simply evaporate; keep them perpetually reliant on hyper expensive medicines and medical procedures, and reap the fruits of an unending money machine.

Before I am accused of being a conspiracy nut, let me state outright that I do not believe that there is a cabal of evil, mustache twisting, demonic connivers assembled around a huge flaming conference table, snacking on deep-fried baby’s arms while plotting to keep cures and remedies hidden and out of reach from the desperately ill. If this were the case, the solution would be fairly straightforward; simply "out" the conspirators, and the walls would come tumbling down. Rather, the problem has become incorporated into the system itself, insidious and inherent, the logical outcome of the evolution of a medical industrial establishment that has come to view sick people as consumers and horrendous illnesses as opportunities for tremendous financial gain. This system does not require people with malicious intent to keep it functioning; it only needs decent people doing their appointed jobs to the best of their abilities to keep the gears turning.

As previously stated, the past 40 or 50 years have seen some incredible medical advances, most of them in the fields of surgery and in the treatment of traumatic injuries and infectious illnesses. Organ transplants, less invasive surgical techniques, and an ever increasing understanding of human physiology have combined to put a shine on many facets of modern medicine. A patient's chances of surviving a heart attack, or avoiding having one in the first place, are much better now than in 1950. Knee injuries that in decades past would have necessitated complex and sometimes crippling surgery can now be done using arthroscopic techniques requiring only tiny incisions, with recovery times measured in a few short weeks rather than many grueling months.

The treatment of some of our most dreadful illnesses, though, have not seen such advances. Ask the average person about the chances of surviving cancer today vs. 1950, and I would expect that most would tell you that your odds of beating the disease are much better now than they were 60 years ago, a belief driven largely by the almost relentless marketing done on behalf of the medical profession. The New York Times, though, reports that "the death rate for cancer, adjusted for the size and age of the population, dropped only 5 percent from 1950 to 2005." (Click here for article). Headlines blaring about the latest advance in cancer drugs rarely mention that the studies cited often declare a cancer drug "effective" even if it increases the lifespan of the patients taking it by only a handful of weeks. The fight against some forms of cancer has indeed benefited from modern medical advances, but for many cancers, little real headway has been made.

Since the vaccine for polio was found in the mid-1950s, very few if any diseases have actually been eradicated. Instead, the trend is towards turning diseases such as diabetes, AIDS, some cancers, and multiple sclerosis into treatable chronic illnesses, their patients heavily reliant on fantastically expensive medications and interventions. The reason for this lies largely in the fact that over 70% of our medical research is carried out by pharmaceutical companies, whose primary mandate is to generate financial profit.

The job of a publicly traded pharmaceutical company CEO is to constantly drive up the price of his company's stock, not to facilitate the creation of drugs that would be of the most benefit to the patients taking them. This isn't a question of morality, but of economics. The drug companies, and those who manage them, are merely doing what every other business endeavors to do in our free-market capitalist system, to constantly increase profit. I'm all for free-market capitalism; in recorded history there has been no better economic driver and creator of wealth. Unfortunately, when applied to healthcare, in many cases good economics has led to very bad medicine. The corroding influence of big money, in addition to an environment of lax regulation, has led to some shocking abuses of the system, such as the marketing of drugs that are known to be dangerous (click here for info), and the suppression of studies whose results are unfavorable to the drug being tested (click here for info).

Over the past three decades, pharmaceutical companies have discovered that the best way to increase profit is to market "blockbuster" drugs that patients must stay on for the rest of their lives. In the case of multiple sclerosis, this has led almost all research to concentrate on compounds that alter or suppress the human immune system, based on the "autoimmune model" of the disease, which states that MS is the result of an immune system gone awry. In reality, it's becoming more and more clear that the aberrant immune response seen in MS patients is more a symptom than a cause of the disease. Some unknown agent is driving the immune system to attack the central nervous system, the latest and hottest theory being that the vascular abnormalities collectively known as CCSVI (click here for info) might be the cause.

Since the mission of pharmaceutical companies is to generate the most bang for their research bucks, they direct their research dollars to projects that have the best possibility of leading to substantial profit. This, in turn, influences the behavior of even the most well-meaning medical researchers, who, just like everybody else, need to feed their families and pay their bills, and who naturally seek to advance their careers. Thus, they are drawn to investigations that will most likely win hotly contested research dollars. That funding, the vast majority of which comes from the big pharmaceutical companies, goes almost exclusively into researching novel compounds that can be patented and remain the sole property of the company that discovers them for many profitable years.

This same dynamic inherently underfunds research seeking to eradicate diseases that have each, in effect, become multibillion dollar a year industries. This is not because of evil or malicious intent, but instead is the result of the economic engine that drives what can be called the "medical industrial complex", the misguided marriage between profit-seeking corporations and the healthcare industry, which requires a perpetual supply of sick people to keep the money flowing. This need for patients is so intense that it can sometimes lead previously untreated and relatively benign conditions to be deemed diseases that require pharmaceutical intervention, as in the case of osteopenia (click here for details).

This same drive also leaves many potentially effective but unprofitable remedies untested and relatively ignored. Drugs such as Low Dose Naltrexone (LDN) and the effects of diet and natural remedies have barely been studied for their impact on MS, simply because there is no profit to be made from them. Recently, a cheap blood pressure medication, Lisinopril, has been shown to have some promise as an MS drug. This discovery wasn't made by any run-of-the-mill research scientist, but by Dr. Jim Steinman, one of the inventors of Tysabri, a very expensive and controversial MS medication that is very effective but also carries with it the possibilities of very serious side effects. Dr. Steinman would like to see a full scale human study of the effects of Lisinopril, but says that "Lisinopril is as inexpensive as any prescription drug at this time, so pharmaceutical companies won't see any profits from financing a study" (click here for article). Thus, the drug remains unstudied in its effectiveness against MS, for now and probably forever.

It's hard to see a solution to this disheartening status quo, other than a significant increase in the government funding of medical research. Unfortunately, the trends are heading in the opposite direction, with more and more funding coming from the private sector, as public dollars become scarcer and scarcer in this age of soaring deficits and cries for smaller government.

As a patient suffering from MS, the situation is incredibly frustrating, as it's clear to me that much of the research now being done on the disease is not conducted with patient benefit as its primary underlying goal, but rather with the profit potential and market share that each patient represents as the target. The recent CCSVI controversy has brought this situation into focus for thousands of MS patients, because if relatively simple vascular surgery can indeed treat MS effectively, the multibillion dollar a year treasure chest that is MS will be wrested from the grasp of the pharmaceutical companies, whose financial influence within the medical and political sectors cannot be overstated. The medical industrial complex is a self-perpetuating entity that will not easily be shut down, the sheer force of its financial weight creating an almost irresistible momentum.

I'll let my final words on the subject be these: As a just and honorable society, please, view me first as a patient, not as a consumer. Human suffering should never be treated as a commodity, regardless of the considerable economic incentives to do so.

Don't Believe Everything That You Read

Unless you read it here, of course...

As somebody who keeps a close eye on MS related news, literally each and every day I come across news articles and press releases touting some amazing new medical breakthrough or groundbreaking drug therapy that promises to smite the MS beast. These bits of news are quickly gobbled up by the various Internet MS message boards, and generate all kinds of excited chatter in the virtual MS world.

The e-mail inboxes of MS patients are often filled with notes sent by well-meaning family members and friends, breathlessly announcing these findings. Now, there's nothing wrong with hope and optimism, as we'd be doomed without them, but it's important that patients learn to keep things in perspective, if only just to keep from suffering repeated disappointments.

The truth of the matter is that most of the breakthroughs generating these headlines amount to far less than meets the eye. Just today, there is news about a group of scientists who have identified two genes that seem to be vital in determining the severity of MS. Reading a little bit deeper, though, reveals that this discovery was made on mice, and the genes in question are mouse genes. I like mice as much as the next guy (as long as they stay the hell out of my house), but the simple fact is that MICE DON'T GET MS.

Scientists induce mice to get diseases that kind of resemble MS (most often, an allergic reaction called EAE), and then test all kinds of things on these mice to see if they'll affect the phony MS that the mice have been given. Quite often, the drugs and therapies being tested prove to have a dramatic effect on the mouse MS imposter. So often, in fact, that I've come to believe that staring intently at a stricken mouse, or talking lovingly to it, will cure it of this MS pretender (note to self: get some mice, make them gimpy, apply for MS research grant, tell mice that you love them, schedule press conference). Unfortunately, the same benefits rarely carry over to humans, because, as I mentioned before, MICE DON'T GET MS.

Another flavor of MS news item that often creates a frenzy are early-stage drug trial results, typically released by the pharmaceutical company developing the drug in question. In order to meet FDA approval, experimental drugs must go through a three stage trial process. Each of these phases are usually double blinded, placebo-controlled trials, in which one group of patients is given the actual test drug, and the other a placebo. The trial process generally takes about 8 to 10 years.

Very often, the results of successful early Phase 1 or Phase 2 trials are loudly announced to the world, setting off a wave of excitement among MS patients starving for optimistic news. Tellingly, these announcements are usually found in the financial or business pages of newspapers or Internet news sites. Why is that, you might ask? The answer is simple, but somewhat disheartening. The primary motivation behind the release of such results is not to give MS patients hope that they can hang their hats on, but rather to pump up stock prices (in the case of the big public pharmaceutical companies) or generate investor cash (in the case of smaller, startup firms). Very early in my MS career, my neurologist, Dr. Big Brain, warned me to not take any of these reports too seriously, as the primary motivation behind them is financial.

One must never forget that the pharmaceutical business is a mega-industry in this country, and that the fortunes, both literally and figuratively, of pharmaceutical company executives rise and fall with the stock prices of the companies they run. In fact, as public companies, the big pharmaceutical companies are mandated to place the interests of their stockholders before the interests of the patients taking the drugs they produce. These companies must generate ever-increasing profits, or risk the calamity of falling stock prices.

There have been recent revelations of pharmaceutical companies burying unfavorable trial results data, and sometimes even misrepresenting such data (in other words, lying about it). Even when data is not actually misrepresented, the methods used to statistically analyze it can influence the favorability of the data one way or another. Naturally, drug companies choose to analyze the data in the fashion most favorable to the outcomes they desire, but very often, this does not result in the most accurate assessment of a drug's effectiveness and/or risk to patients. Unfortunately, the reported results of these giant shell games often toy with the emotions of desperately ill patients hungering for a little good news.

All in all, it's best to take much of the news generated about MS with several grains of salt. Between mice that don't get MS, and the financial wheelings and dealings of the pharmaceutical industry, much of the information out there just isn't very reliable. Don't get me wrong, I believe that there are great strides being made in battling the disease, but if even one quarter of the positive news reported about MS were true, the illness would have been cured years ago...

Please, Check Your Meds!

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As a patient dealing with chronic illness, I regularly visit a number of doctors, each of whom prescribes for me a variety of pharmaceutical concoctions. Along with my primary neurologist, I see a primary care physician, a urologist, a neuro ophthalmologist, an endocrinologist, and a pain management specialist. Each of these MDs makes good use of their prescription pads, and subsequently I have enough pharmaceuticals in my bathroom to open my own apothecary.

I'm sure this delights the hell out of the big pharmaceutical companies, who rival insurance companies and the New York Yankees on my list of most detested entities on Earth (one of these days, I'll post a long and barely coherent rant about Big Pharma and its rancid influence on the healing professions), but it's left me with literally handfuls of pills to take each day.

As I'm chugging down these little vessels of wonderfulness, in their dizzying array of different shapes, sizes, and colors, I often wonder if they might be doing me more harm than good. I mean, here I am, in possession of a finely balanced symphony of physiology, a body that has taken millions of years of evolution to develop, and I'm two or three times daily ingesting substances that profoundly manipulate the workings of many of its systems. Of course, in my case, evolution as provided me with a body that probably should have been recalled, but that's besides the point. A little research into many pharmaceuticals reveals that their mechanisms of action are poorly understood, other than the fact that they appear to work. Kind of like magic; here's a quarter, now it's gone, except it's not really gone, now is it?

On their own, each of the pills we take may be beneficial, or at least not harmful, but when taken in addition to other medications, serious consequences can result. Drug interactions are a significant cause of death in this country, and as responsible patients we shouldn't rely on our doctors to keep track of each and every prescription that has been given to us.

There is a terrific website, provided by drugs.com, which allows you to enter the names of all of the prescription medications you're taking, and then alerts you to any possible problems with drug interactions. The site even allows you to save your list of drugs, so you can add to it the next time you're given a prescription. I urge everybody reading this post to please, please visit this website and check your medications. I did so yesterday, and was alerted to a possibly severe interaction between two of the drugs I'm currently taking.

So, if not for yourself, do it for the Wheelchair Kamikaze. I can't afford to lose any readers. Click this link and check all of your medications.

Really, do it now.