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The Bleeding Edge: Where Do We Go From Here?

Posted on October 2018

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The Bleeding Edge is a famous documentary that scrutinizes the side effects of implantable devices. Let’s offer an unbiased analysis of the benefits and drawbacks of devices, and discuss how biotech and pharma can do better.   

While the public often feels powerless to change large organizations the truth is that pharmaceutical companies are heavily regulated and subject to public opinion. In 2015, Turing Pharmaceutical reduced the price of a toxoplasmosis it had artificially elevated and publicly apologized after public outcry. Yale Law School offers a “primer for states” on how to advocate against pharmaceutical companies for fair drug prices.  And organizations such as Cancer Research UK gives clear information directly to patients on boycotting out-of-date drug trials. 

The question then becomes, what do we want our pharmaceutical companies to do? 

Pharma — the good and the bad

Pharmaceutical companies play a role in scaling the production of good ideas, as well as marketing bad ones. Recent initiatives for open science in Europe such as Britain's All Trials indicate that the public may play a greater role in determining future pharmaceutical R&D policies. So let’s take a look at what works and what doesn’t. 

Antibiotics can be considered an industry success story.  While penicillin was first noted to control the growth of bacteria in 1928 laboratory experiments, its production wasn’t scaled until 1945 in a US Government collaboration with industry.  As one 2013 history paper notes: 

“At the project’s inception, laboratory scientists could ferment minimal amounts of crude, unstable penicillin, and by January 1945 US production, through commercial-scale fermentation, had soared to 4 million sterile packages of the drug per month. Heralding a new phase in the history of the pharmaceutical industry, the WPB released penicillin for commercial distribution to the public in March 1945. ” 

In contrast, the widespread marketing of prescription pain medication is an industry failure.  In what has become termed the “opiod crisis”  pharmaceutical companies widely marketed prescription pain medication to the medical community as  “non-addictive” in the 1990s.  These drugs were addictive, and when widely used resulted in widespread diversion and misuse. Currently, the US National Institute of Health estimates that opioid addiction results in 116 deaths per day and costs the US $78.5 billion per year. As Sam Quinones, an investigative journalist and author of Dreamland: The True Tale of America's Opiate Epidemic documents: 

“A pill mill was a pain-management clinic, staffed by a doctor with little more than a prescription pad. A pill mill became a virtual ATM for dope as the doctor issued prescriptions to hundreds of people a day… Oxy prescriptions for chronic pain rose from 670,000 in 1997 to 6.2 million in 2002.” 

The Huffington post documented similar cases of Johnson & Johnson illegally marketing the antipsychotic Risperdal.  Despite the explicit FDA prohibitions against marketing the drug to children (side effects of Risperdal include diabetes, male breast growth, obesity, and brain shrinkage) the company promoted Risperdal to dozens of pediatric clinics — and even offered free samples.

We must conclude that pharmaceutical companies are large organizations and subject to the same limitations, as any collaborative human effort.  They can divert resources to solve unsolvable problems and reduce human suffering, or they can seek profit and inflict population-wide pain.

Implantables — the good and the bad

The Bleeding Edge documentary is about the device industry, so lets narrow the focus to devices. 

First, the body doesn’t like foreign objects.  When comparing against autograft, allograft, xenograft, and synthetic materials studies consistently show that synthetic materials have an increased infection, extrusion, and reoperation rate as compared to natural tissues. This is called a “foreign body reaction”. 

Artificial breasts, pacemakers, and artificial joints are among the most common implanted devices.  Let’s look at them a little closer:

  • Breast implants: Because breasts implants are a cosmetic procedure, they are under increased scrutiny by regulatory bodies, but despite years of study, they have remarkably few adverse immunologic effects.

  • Joint and bone replacement: Studies show that infection accounts for up to 12% of repeated hip replacements, and 22% of revision knee arthroplasties. Approximately 6% of prosthetic skull implants get infected but we still use them to reconstruct the skull in patients who have large cranial defects. 

  • Insulin pumps: Despite reports of allergic reactions in individuals we still use insulin pumps because they save lives — reducing cardiovascular disease and all-cause mortality in contrast to lifelong injections.
    Pacemakers: According to the British Heart Foundation approximately 25,000 people have a cardiac pacemaker fitted each year. This intervention has a complication rate of 15% but we still use it because it reduces morbidity and mortality among patients with heart disease. 

    Doctors and the device industry is well aware of the potential for reactions to implanted devices, and balances the risk of a reaction against the benefits of the device. 

How can pharma and biotech do better?

So how does a pharma company make these calculations in developing a device?

The short answer is they don’t.  Medical trials employ research ethics boards, an independent panel of experts who ascertain if the risk patients take in receiving experimental therapies are known and reasonable, patients are informed about them properly, and procedures are in place to deal with adverse effects. National health systems such as the US’s FDA and UK’s MHRA regulate device approval. Once a device is on the market there are adverse event reporting systems such as the UK’s Yellow Card Schema so that rare reactions can be tracked and a device recall issued if a trend is noticed. 

The Bleeding Edge documents the pain patients with nonspecific symptoms experience when their conditions are undiagnosed, and the betrayal patients feel when the products they buy from trusted vendors cause them harm. While systemic checks and balances may help at a population scale, they do not excuse the suffering of individuals.  

Unfortunately, good science on bad therapies can sometimes take a while to emerge. It takes courage for a patient to stand up for themselves and this advocacy is another check and balance on the system.  

Several innovations to big pharma may help reduce bias in clinical trials, mitigate risk, and make the process of drug delivery more effective. 

  • Open source clinical trials:  The open source science movement recommends registering all clinical trials so negative results are more obvious. 

  • Better clinical evidence for devices: Both the UK and the US have initiatives to increase the amount of clinical evidence needed for medical devices. 

  • Postmarket reform: Initiatives include better monitoring after a drug is launched, for early predictors of a bad therapy. 

  • Hospital-led non-profit drug companies: The Mayo Clinic has merged with seven other hospitals to create a not-for-profit generic drug company called Civica Rx which aims to provide steady prices and supplies on crucial drugs. 

In conclusion

All Trials is sponsored by Sense About Science, a UK organization that educates the public on the how science and evidence can be misrepresented in public life. A quote from their website summarizes the difficulty with device research and development: 

“Show me a drug with no side effects and I’ll show you a drug with no benefits. When you take a medicine you’re entering into a bargain. The prescriber, to the best of their knowledge, gives you a medicine that will do you more good than harm, but you have to accept the risk that it may do you more harm than good. For some medicines, we understand the risks and can mitigate them, but for others the knowledge is just not there yet.” - Martyn Lobley

Here at EPM Scientific, we like to think holistically.  We ensure the best talent is in the right place at the right time to ensure good medicine is available to patients in need.  But we are also aware that biotech and pharma are not simple industries, they impact individuals and can have unforeseen consequences.  We value partners who are altruistically motivated and aware of the gravity of their endeavors. 

While we respect the hard-won successes of existing systemic checks and balances on the pharmaceutical industry we can also do better.  We have hope that everyone involved in the device industry will seek to respond to the Bleeding Edge documentary with positive change. 

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