pharma malfeasance Archives

Profits Over People: Medication Risk and Drug Company Misconduct

Published on July 20, 2022

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If you haven’t read Chandler Marrs’ article on the safety of medications, take a moment to do so and understand that no medication is, as Marrs puts it, “perfectly safe.” I’m here to reaffirm this harsh pill to swallow (pun intended) through the telling of my own experience and the showcasing of research that reveals just how much sway Big Pharma has over the safety of medications.

I was 20 years old when I decided to take my doctor’s advice and go on hormonal birth control to help regulate my periods. I remember my mother, a registered nurse who worked in a local hospital, voicing her concerns about the oral contraceptive. At the time, she was seeing quite a few girls my age come in with clotting complications related to the pill.

Thinking I knew what was best for me, I ignored her advice to stay off of the medication. I was comforted in knowing that almost every single one of my close friends was taking some form of birth control, and they were fine. I’d be fine too.

I couldn’t have been more wrong.

Two months later, I was in the emergency room with a bilateral pulmonary embolism or multiple blood clots in my lungs. What I originally thought was a relatively safe medication turned out to be a life-threatening decision. Suddenly gone forever was my notion that any medications I was prescribed would be taken without risk.

After six months on blood thinners to dissolve the clots, I went back to living my life normally, both clot and birth control-free.

Fast forward four years, and I’m reading news stories discussing the thousands of lawsuits that have been filed against the makers of Xarelto, the same blood thinner I was prescribed to help me recover from my embolism. Although I suffered no complications from the medication, I was clearly one of the lucky ones this time. The anticoagulant, which is still on the market today, has no known antidote to reverse its blood-thinning effects, and it has caused so many severe internal bleeding incidents and deaths that legal action has been taken.

Prior to doing any research, my emergency room experience would have made me cast aside the lawsuits as frivolous. There’s a risk with any medication; I can’t deny that I knew the risks before I opted to take birth control. But, didn’t they also know the risks before agreeing to take the blood thinner just like I did?

Drug Company Misconduct

After digging deeper, I realized there was a bigger issue at hand. Drug companies wield an incredible amount of influence within the healthcare sphere that can lead to the approval of medications that should never find their way into patients’ hands in the first place. A major showcase of this influence is seen in Big Pharma’s ability to fund clinical trials.

These clinical trials must be conducted before a drug is approved for market, and funding has typically come from government sources like the National Institutes of Health. But in recent years, more and more industry-funded clinical trials are taking place, meaning that drug companies can sponsor their own medications studies. Critics of this funding allowance point to the fact that the potential for financial gain can lead to a conflict of interests. Companies that have a vested interest in a drug’s approval because it brings a boost in profits could favor positive outcomes while ignoring any negative results.

In the case of Xarelto’s industry-funded clinical trial, it was discovered that Johnson & Johnson withheld information from the FDA that would have highlighted the blood thinner’s inferiority to its comparison warfarin. During the study, 14,000 patients were given an overdose of the traditional anticoagulant due to the use of a faulty blood-testing device, decidedly skewing the results. The design of the company-sponsored trial also limited the distribution of Xarelto to once-a-day dosing that weakened the medication’s effects on participants. With less severe side effects being observed because of the smaller dose, Xarelto’s clinical trial looked favorable for the new experimental drug.

We see a similar story of clinical trial misconduct being told with another blood-thinning medication, Pradaxa. Pradaxa was put through an industry-funded study whose poor trial design led to FDA approval. Critics point out that there was probable cause for bias since it failed to be a double-blind study. Its trial participants were also made up of a demographic of people who were less likely to be prescribed the medication once it hit the market.

The FDA went on to approve the anticoagulant despite the lack of an antidote, but its decision was based on the fact that Pradaxa “wasn’t inferior” to traditional warfarin. This labeling could bring the drug to market, but it wouldn’t be able to give manufacturer Boehringer Ingelheim a leg up in its promotion of the medication. Therefore, the drug company requested that Pradaxa be labeled as “superior” to warfarin in its ability to reduce strokes so that it could make this claim in its marketing materials. The FDA granted the company’s request, decidedly ignoring its original concerns with the blood thinner.

Pradaxa hit the market without an antidote just like Xarelto, and I bet you can guess what happened next. Thousands of patients taking the medication suffered severe internal bleeding complications and even succumbed to the side effects. Like Johnson & Johnson, Boehringer Ingelheim faced a shocking number of Pradaxa lawsuits and created a $650 million settlement fund in 2014 to satisfy the claims.

Profits Over People

We cannot deny that every medication presented to us comes with some sort of risk to our overall health and well-being. I suffered the risks of birth control but miraculously avoided the complications associated with Xarelto. Costs and benefits are just a fact of the pharmaceutical industry.

But, the issue lies in the influence of Big Pharma. If drug companies, who are so clearly focused on boosting their profit margins, can impact clinical trials in such a way that it costs patients more than it benefits them, where do we draw the line?

It will take massive changes in the drug approval process and overall state of healthcare before we can start to see patient lives being placed above profits. But, what we can do is stay informed and educated on the prescriptions we’re taking. There is a lot going on behind the scenes before a medication makes its way into that little orange pill bottle, and it’s up to us as consumers to do our research, look into the possible complications, and voice any and all concerns with our doctors.

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This article was first published in January 2018.

Another Day, Another Death

by Chandler Marrs, PhD

Published on July 25, 2017

3212 views

Another Gardasil girl died last month. I didn’t know her, but her mother had written for us a few years back. My heart aches for her family and for all of the other families who have lost loved ones to pharmaceutical industry malfeasance. Sadly, her death is just one more in a long line of deaths attributable to this vaccine. For the industry that profits from this vaccine, her death means nothing.

No one, except her family and friends will suffer for her death. There will be no culpability from the industry that manufactures and distributes this vaccine, none from the governmental agencies that fail to address the safety issues of these medications, none from the doctors who push this and others vaccines and then dismiss the side effects outright leaving parents to navigate the resultant complex illnesses on their own. No one will admit responsibility. How can they? We have all have been fed a heavy diet of ‘vaccines are always perfectly safe’, that injuries and deaths are due to random chance, not the cocktail of toxicants proffered under the guise of herd immunity. Just unlucky I guess, the price to pay for the safety of others.

Vaccines are perfectly safe.

Really?

Forget, of course, that this is foolhardy and that nothing is perfectly safe.

Forget also that industry knows these vaccines are neither safe nor effective, having fudged the trials and post market research, spent billions on marketing to promote the faulty research, and no small sum on astroturfing campaigns, replete with vitriolic trolls and an echo chamber of paid ‘thought leaders‘.

Forget that 70% of major media budgets are funded by the pharmaceutical industry advertising, as are most medical associations, medical education, university and continuing, medical journals, and patient support groups. Health journalism too, receives its fair share of pharma funding.

Forget that the pharmaceutical industry spends more in lobbying politicians than any other industry, including defense.

Forget that the FDA is a revolving door to cushy industry jobs. Approve this or that drug and one is set for life once one’s government affiliation is over.

Forget too that FDA review panels are staffed with industry insiders and that FDA approves 96% of all applications. Can’t imagine how bad a drug has to be in order the FDA to reject it.

Forget that when vaccine side effects began to be recognized en masse during the Reagan administration, industry quickly colluded with governmental agencies to force vaccination and eliminate any liability for themselves. Enter the vaccine courts, where no matter the injury, no matter the negligence or malfeasance, the government foots the bill for industry. What an ideal business model; all products are always safe and if they aren’t someone else covers those costs. Liability? Responsibility? Nope.

Forget all of these things, and yes, vaccines can be considered perfectly safe, side effects ignored, and deaths considered unfortunate matters of coincidence.

Except they aren’t and we shouldn’t forget.

Young women are dying and/or are debilitated to the point of wanting to die, thousands of them, with this one vaccine alone. This is on top of the skyrocketing number of vaccine and pharmaceutical injured children. Did you know that 1 in every 68 children suffers with neurodevelopmental disorders; 1 in 68. That is a staggering statistic that should give us all pause, but mostly, it doesn’t. Neither does the fact that 70% of adults take at least one medication chronically, 50% take two or more, and 20% take five or more medications, or that toddlers represent the largest growing market for psychotropic medications – toddlers! Admittedly, toddlers can be a bit crazy, but do we really, truly believe that toddlers need antidepressants, stimulants, or worse yet, antipsychotics?

With all of these medications and vaccines, are we healthier?

Nope.

In fact, for the first time in generations, we are living sicker and dying younger. But no, we hold tight to the belief that pharmaceutical medicine is working and all of these injuries, illnesses, and deaths are flukes attributable to the vagaries of random chance.

It was a convenient dissonance while it lasted; still is for many. It allowed us to avoid the much starker reality of modern pharmaceutical medicine or modern living in general: that chemistry matters, that toxicants don’t just magically disappear once they enter the body (or the oceans), and that for all of our technological brilliance, we really have no frickin clue what the compound effects of all of these chemicals are. We really don’t. Heck, we don’t even know what most medications do. A study in the British Medical Journal found that only 50% of medications have sufficient data to suggest that they are likely effective. And since we don’t test most medications on women, we really have no idea whether any medications work or induce serious side effects in women.

Pharmaceuticals are chemical toxicants, plain and simple. They are poisons, albeit sometimes necessary poisons, but poisons nevertheless. We don’t call them poisons though. We call them medicines, but the fact remains, poisons don’t become less poisonous simply because we rename them.

Poisons, by their very nature, are designed to kill things, to block things, and otherwise usurp normal biological functions. Poisons do not ‘heal’. They supplant and they override. Neither do they become less poisonous simply because we take them in small doses. In fact, in many cases, it’s with the smaller doses, particularly when taken chronically, that we see the most devastating side effects, the complex multi-system ones that do everything but kill the individual outright. We are dissonant from these concepts, sometimes willfully. The chemistry is complicated, the disinformation dense, and if we’re truthful with ourselves, it’s easier not to know. Until it isn’t.

Knowing all of this, what do we say to the families who have lost love ones to vaccine injury or death or medication injury or death? How do we go about our daily lives knowing the science is corrupted, arguably with intention, and that more will suffer as a result?

I don’t know the answer to either of these questions. All I know is that as a mom, I feel your loss and I am sorry.

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