The changing face of the pharmaceutical industry in the US

10 April 2018

13:58

As pharma encounters massive shifts in public perception, which is seemingly negative in the current climate, Nick Johns, technology & digital safety investigator, ConsumerSafety.org, looks at the focus of pharma in the US and how shifting this could benefit public perception and more importantly health.

Changing face

As the pharmaceutical industry has grown and evolved, its perception in the public eye has undergone a number of dramatic shifts. The massive surge in marketing¹and prescriptions of opioid pain relievers starting in the late 1990s contributed to what is now the worst public health crisis in American history,²and much of the news surrounding big pharma today is overwhelmingly negative.

The pharmaceutical industry has brought us some of the most impactful innovations in history, and in this climate it can be hard to distinguish it as the same industry that brought us drugs like Aspirin, Insulin and Penicillin. Problems in the system became apparent as profitability became a more prominent motivator for drug research and development, but regulations are still skewed in favour of drug manufacturers.

The FDA has developed a number of programmes over the last few decades designed to expedite the drug approval process in order to more quickly deliver promising new medications to suffering patients. The ‘fast track’ programme included in the 1997 Food and Drug Administration Modernization Act allowed qualifying drugs to shorten their development timeline by approximately one year.³The benefit of lessening the time it takes for new medications to make their way to patients is clear, but shortening the review process can potentially lead to less rigorous trials and shorter observation periods to check for possible side effects and interactions.

One prominent example is Xarelto, initially considered a groundbreaking anticoagulant prescribed in order to prevent blood clots and reduce the risk of stroke or deep vein thrombosis (DVT). Praised by researchers for its effectiveness with only a single pill taken once daily, Xarelto was approved for a number of conditions and prescribed to millions. Since there is no antidote to its effects, patients taking Xarelto can experience irreversible and potentially fatal bleeding⁴from small injuries that would normally clot quickly. Patients have suffered from severe internal haemorrhaging or brain bleeding, and since Xarelto does not require blood monitoring when used, it can be more difficult to detect these side effects before they become problematic.

Legal complaints about the drug often cite the lack of clarity around the absence of an antidote for the drug and the omission of results from some clinical trials on its warning label, but in spite of this the drug quickly became an important aspect of Janssen Pharmaceuticals (a division of Johnson & Johnson) and Bayer revenue year after year. Accounting for over $2 billion in sales in 2016. By September 2017, reports showed Xarelto earned its manufacturer $1.8 billion in the nine months, despite so many health risks and more emerging lawsuits.

As George W. Merck famously posited, medicine is for the people — not for the profits. Safely treating patients should always be at the core of any healthcare system, but recently the focus appears to be elsewhere. Lobbying in the pharmaceutical industry has been on a sharp incline. The pharmaceutical and health products industry spent a total of $78 million in lobbying in the first quarter of 2017, an increase of $10 million from the same period in 2016.⁵While there is nothing inherently unlawful about lobbying, this vast spend has allowed large pharmaceutical companies to influence drug policies.⁶Efforts to pass laws that would limit opioid prescribing efforts have received dramatic pushback from the drug industry. The Pain Care Forum, funded by Big Pharma, spent upwards of $740 million to curb legislation that would have put limits on opioid prescribing habits.⁷

The importance of the pharmaceutical industry’s original mission of research into new and safer solutions to a growing list of healthcare concerns is paramount, but the priorities of our current system seem to have deviated from their initial purpose. The current focus on speed and profitability over safety and efficacy makes it clear that regulations need to change.

A shift focusing on transparency in quality testing and legislation, as well as the elimination of exploitable policies or loopholes that allow larger companies to stifle the generation of affordable generics, has the potential to not only lower our rising healthcare costs but to improve the overall quality and accessibility of medication to the public.

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