This is a watershed moment for medicine. Biopharmaceutical companies are working to develop treatments and immunizations to combat Covid-19 in an unprecedented mobilization that shines a light on the drug industry's agility and heroic deployment of resources. On Thursday, the Food and Drug Administration takes a major step forward in that effort by gathering its first advisory panel to track the progress made in creating a vaccine. Yet despite this extraordinary response, the prevailing reputation of Big Pharma remains largely negative.
An attitude adjustment is warranted and will be essential to ensure that Americans reap the full potential of lifesaving therapies and beneficial treatments.
For well over a decade, the public has more often associated drug companies not with dedication to noble endeavors like vaccines to combat a deadly virus but with greed, price-gouging and its role in the opioid crisis. At the very same time, we can expect to hopefully have lifesaving treatments within a year of a global pandemic only because of the ingenuity and audacious accomplishments of U.S. pharmaceutical companies and the decades of scientific and clinical research that preceded our current crisis. As CEO of one of those companies, I hope there will be a greater public appreciation of the pharmaceutical industry accompanied by a reset of expectations after the Covid-19 pandemic has been tamed.
To be clear, some of the criticism that certain drug companies have received is justified. But only some — and the criticism should be focused on a few bad actors, not an entire industry. Instead, an attitude adjustment is warranted and will be essential to ensure that Americans reap the full potential of lifesaving therapies and beneficial treatments that only the pharmaceutical industry can deliver, and only if afforded proper support and resources after the coronavirus crisis has passed.
Many often ask why drugs are so expensive, and the perceived overcharging for medications is a frequent focus of consumer ire. The simple answer is that major medical discoveries take an astonishing amount of time and money, as well as other resources. Most pharmaceutical researchers spend the entirety of their professional careers — often driving down dead-end paths — before they hopefully discover what could be a viable medicine. Only then, in that unlikely scenario, does the much longer and expensive process of clinical testing begin.
Our company, as just one example, has spent over 20 years developing a potential medicine for heart failure, a disease of epidemic consequence that is growing in prevalence with our aging population. Only now, after extensive dedication, persistence and resilience, have we proceeded through dozens of clinical trials that may hopefully result in our investigational medicine advancing to FDA review and approval so doctors can prescribe it to patients. Even then, it could take us years to recoup the well over $1 billion invested, let alone start to make a commercial profit.
And yes, a profit motive matters. Profits are reinvested in research and attract other capital. Leading pharmaceutical companies reinvest around a quarter of their total sales — not profits — into beginning the low-yield research all over again, and depend on the rare medications that do succeed to cover the costs of those that don’t. It’s that very circle of life that enables our American pharmaceutical companies to achieve medical breakthroughs like the ones a global population is anxiously awaiting in the fight against Covid-19.
A nation, and frankly a world, expect not only fruitful research and development, but also manufacturing and distribution on very short notice and on an unprecedented scale. Vast infrastructure promptly mobilized is only possible when resources are invested in capacity long before they are marshaled.
That’s not to say, of course, that Big Pharma does everything right. In addition to the issues that make headlines, a more insidious problem is that too many drugmakers — to borrow from the baseball lexicon — become satisfied with hitting a steady string of singles. All too often, even the best biopharmaceutical companies let investors with short attention spans dictate their research priorities. As a result, too many drug companies target new medicines that afford only incremental gains and work within already validated clinical and regulatory frameworks.
Between 2006 and 2014, the number of annual applications filed for new drugs in the United States averaged 35, only a fraction of which were truly novel. The fact is, developing an innovative drug therapy and shepherding it through the approval process is far riskier and more expensive than making marginal improvements on proven medications. Novel drugs have a less than 10 percent chance of earning FDA approval.
The ambition shown by pharmaceutical companies to eradicate Covid-19 should not end when a vaccine is discovered. It's time for more of them to again and again swing for the fences. If others in our biopharmaceutical industry were willing to take bigger, long-term risks, they could better deliver cutting-edge medicines patients will increasingly need beyond the pandemic — and also meaningfully increase their own bottom lines.
There are a few simple steps that can catalyze the process. First, pharmaceutical companies need to centrally anchor the needs of patients more pivotally in their corporate strategies. Patients and their advocates should be centrally involved at all stages of drug discovery and development, not just post-marketing, and patient voices should reverberate in laboratories and boardrooms alike.
Second, drug companies and their investors should adopt longer-term outlooks that assign more intrinsic value to future medical impact rather than Wall Street’s fixation on momentum, volatility and short-term profit swings. Sources of investment capital should better align with the anatomy of an industry that may take longer to deliver on the promise of science and, as such, can ultimately reward more bold undertakings.
Finally, drug companies should focus on areas where their expertise can make the biggest difference, instead of letting what is trending in science dictate their research agendas. We are seeing this play out during the pandemic, in which many companies without a legitimate platform relevant to combating coronaviruses have rushed in. This situation will inevitably lead to confusion and subtract from our shared interests in breakthrough medicines.
The more reports of issues during trials, the more skeptical people will be about taking the most evidence-based treatments when they become available. As Clint Eastwood aptly said, “A man’s got to know his limitations,” and so, too, should pharma companies realize that what seems like an interesting economic opportunity can quickly backfire into societal backlash.
A nation, and frankly a world, expect not only fruitful research and development, but also manufacturing and distribution on very short notice and on an unprecedented scale.
With that said, the moonshot mentality and momentum toward solving public health crises should be maintained. We are undoubtedly going to face massive medical problems after Covid-19 from diseases associated with our aging demographics. These challenges will require similarly courageous calls to action on the frontiers of health innovation. Strong public support along with significant private sector investment are necessary to deliver new medicines with the speed and scale needed to adequately confront these complex health care challenges.
The world has learned hard lessons in 2020, since there is no lottery ticket or fast pass to protect us from deadly diseases. We need to invest more, not less. We need to take the long view on those investments. And we need to champion and reward heroic biopharmaceutical researchers and patients who take risks to find and test treatments that lie beyond our most ambitious reach.