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Ethically Speaking: Governments should lead, not follow on prioritizing drug development

By Charlie Craig
Staff Columnist

A major problem facing people sickened or threatened by neglected diseases is that the for-profit global biopharmaceutical industry sets the agenda for new drug development, and their suffering is not considered worth the investment.

While biopharmaceutical companies follow their fiscal responsibilities, many others rightly argue human suffering should not be obscured by balance sheet calculations of profit and loss.

The debate over attending to neglected diseases, such as tuberculosis and other communicable infections, is intensifying and it increasingly involves ethical justification for governments taking more aggressive action.

Governments typically try to entice biopharmas with financial incentives. But the strategy has not succeeded and the health of people in developed and undeveloped nations remains dangerously at risk.

One solution may lie with governments addressing what Tufts University experts describe as the "disparity dilemma" with the same intensity expended for defending against bioterrorism.

The Tufts Center for the Study of Drug Development examined the dilemma in the U.S. and found that "neglected diseases" includes chronic illnesses as well as infections.

In a 2015 essay, "Meeting Unmet Medical Needs: The Disparity Dilemma," the centers' experts noted that while the FDA controls drug approvals, the biopharmaceutical industry decides what drug candidates enter clinical development.

Tufts Professor Christopher-Paul Milne, co-author of the essay, told BioWorld Today no one group coordinates priorities. "You have the payers doing one thing, patients calling for other things and pharma considering what's going to make the best profits," he said. "Then all of a sudden the government comes in and starts throwing out money because they want to see something for Ebola."

THE WILD WEST

Milne added, "It's a wild, wild West out there, and that's a problem because you have major diseases, like heart failure, that is still a major killer, and nobody wants to work on them because they can make more money in cancer."

He and his colleagues proposed creating a national commission to identify the nation's health needs and an FDA program to reward companies with fast track reviews when their drug development aligns with commission priorities. Although the plan likely would advance public debate on disparities, more dramatic change is needed.

This disparity dilemma is a global concern, of course, and was front and center at the recent 2016 International AIDS Conference in South Africa with respect to tuberculosis (TB).

Although TB can be cured, it is responsible for more deaths each year worldwide than any other infectious disease and with the bacteria's growing resistance to existing treatments, new drugs and vaccines are needed. (See BioWorld Today, July 21, 2016).

But because TB affects economically disadvantaged people disproportionately, the disease does not represent a profitable market for the private sector.

The discourse at the 2016 AIDS conference focused on a seldom-discussed ethical notion that the private sector's profit motives should not trump a human right to benefit from scientific progress.

There is ample evidence many nations, including the U.S., recognize this right. A 2012 United Nation's Human Rights Council report cited international laws, such as the Universal Declaration of Human Rights, and regional treaties, such as the Charter of the Organization of American States, as guaranteeing the right of all people to benefit from scientific progress.

Consequently, the obligation for enforcing such a right falls on governments. Many are trying to cope with TB, for example, but so far waving incentives at biopharmaceutical companies still dominates the strategy.

"It's like a dance," explained Christine Sizemore, TB section chief at the National Institute of Allergy and Infectious Diseases (NIAID). The institute and universities, along with small biotech and big pharmaceutical companies, choreograph different parts.

"All the pieces are theoretically available," she said, "but we haven't had specific entities or compounds that have been able to navigate through the pipeline."

However, even if there were new treatments, Sizemore told BioWorld Today, "The reality is right now we're stuck, and if we had a drug that were to make it through phase II and phase III, who's going to end up manufacturing it?

"NIAID's mission," she said, "is not to pay for manufacturing products but to bring entities to a stage someone else can do something with them and market them."

ONE SOLUTION: EXPAND, REPLICATE BARDA

One solution may be an expansion of the U.S. strategy for responding to bioterrorist attacks and natural infectious disease outbreaks. The Biomedical Advanced Research and Development Authority (BARDA) contracts with private sector drug developers and manufacturers to make sure the nation has the medical countermeasures to protect people from these public health threats. (See BioWorld Today, Aug. 25, 2014.)

Why not apply this model more broadly for TB and other neglected infectious and tropical diseases as well as for chronic diseases that fall within Milne's U.S. disparity dilemma?

Rather than relying on research and marketing incentives, the U.S. government could contract with companies for medicines, distribute them at affordable prices at home and abroad, and save lives and health care dollars associated with expensive hospital care. In the process, new drug industry subsectors may emerge.

TB is not as prevalent in the U.S. as other countries, Sizemore said, and allocating resources to manufacture drugs would be difficult to justify. But, she said, "If South Africa or India had a model like this where they would agree to a pre-purchase concept of a drug, creating a market for the product as a buyer, in theory that would work. But theory is a little easier than the reality of what drives priorities."

Such a theory may be a long way from becoming practice anywhere. But with rapid advances in biology making drug development more precise, a human right to scientific progress should not take a back seat to private sector profit margins in setting health priorities and saving lives.

Charles Craig is a writer, editor and lecturer on bioethics and biotechnology issues with a master of arts in bioethics and master of journalism degree. He has more than 20 years of experience in the biotech industry as the former president of Georgia Bio, author and editor of Ernst & Young's annual Global Biotechnology Report (2001-05), director of publications with the Biotechnology Innovation Organization (1998-2001) and writer and editor with BioWorld Today (1994-98).

Introducing Ethically Speaking, a new column from BioWorld, exploring the intersection of patients' needs with advances in medicine. The views expressed in this column are solely those of the author and do not reflect the views of BioWorld Today or Thomson Reuters.