Frank S. David, MD, PhD leads the biopharma consulting firm Pharmagellan, where he advises drug companies and investors on R&D and business strategy. He is also an academic researcher on strategy, regulation, and policy in the drug industry; a member of the Harvard-MIT Center for Regulatory Science; and a former blogger at Forbes.com.
I wrote...
The Pharmagellan Guide to Analyzing Biotech Clinical Trials
This account of the early years of Vertex Pharmaceuticals, from its inception as a scrappy start-up to its early work in HIV, is a must-read classic for anyone interested in how science turns into new drugs. Barry Werth’s journalistic play-by-play is a cinematic, true-to-life picture of the strategic decisions, real-world challenges, and larger-than-life personalities that underlie modern drug development. His riveting follow-up, The Antidote, continues the saga by taking readers through Vertex’s pathbreaking work to transform the care of patients with hepatitis C and cystic fibrosis.
Since Nixon’s "War on Cancer," oncology treatment has seen some great advances, but also the approval of scores of over-priced drugs that do little to improve patients’ quality or quantity of life. Oncologist Vinay Prasad has written a broad, accessible overview of the flaws of modern cancer drug development that spans clinical trial design, conflicts of interest, regulatory policy, and more. His unabashedly anti-pharma stance gets preachy in places, but most of the challenges he identifies are spot-on and provide a thought-provoking roadmap for the future.
How hype, money, and bias can mislead the public into thinking that many worthless or unproven treatments are effective.
Each week, people read about new and exciting cancer drugs. Some of these drugs are truly transformative, offering major improvements in how long patients live or how they feel-but what is often missing from the popular narrative is that, far too often, these new drugs have marginal or minimal benefits. Some are even harmful. In Malignant, hematologist-oncologist Dr. Vinayak K. Prasad writes about the many sobering examples of how patients are too often failed by cancer policy and by how oncology…
What do we mean when we say “drug prices are too high” – and how can we fix them? In clear prose, Peter Kolchinsky, a successful biotech investor at RA Capital, clarifies the difference between list, net, and out-of-pocket drug costs, and explains how various parts of the system – drug companies, insurers, and pharmacy benefit managers (PBMs) – fit together to determine them. He also includes several detailed and timely suggestions for reform that would reduce the burden on patients and sustain biopharma innovation.
Developing life-changing drugs is risky and expensive—but that’s not what makes them unaffordable.Drug pricing is a staple of every news cycle and political debate. And while we’ve struggled for decades to agree on solutions that serve all patients without jeopardizing the invention of new medicines, many Americans suffer because they can’t afford the drugs they need.Do we really have to choose between affordability and innovation?In The Great American Drug Deal, scientist and industry expert Peter Kolchinsky answers this question with a decisive No. The pharmaceutical industry’s commitment to creating new lifesaving drugs destined to become inexpensive generics can be balanced…
A key issue about drug pricing not covered in Kolchinsky's book relates to value: even if a new therapy is affordable, is it "worth it"? Health economist Peter Neumann and his colleagues have written an authoritative, insightful, and extremely accessible history of efforts to align drugs' prices with their benefits to patients and society. This is a must-read guide for both insiders and non-experts to a topic that will be at the forefront of the drug pricing debate in the coming decade.
The US prescription drug business is a $500 billion industry whose rising prices carry profound consequences for patients, caregivers, employers and taxpayers across the nation. In the United States, average prices of leading brand-name drugs are two to four times higher than prices charged in other wealthy countries, raising questions as to what Americans are getting for the extra expense. On the other hand, healthy industry returns have arguably fueled life-saving innovation. With the advent of ever more targeted and powerful treatments, including cell- and gene-based therapies with multi-million-dollar price tags, the need for sensible drug pricing policies will only…
Reading was a childhood passion of mine. My mother was a librarian and got me interested in reading early in life. When John F. Kennedy was running for president and after his assassination, I became intensely interested in politics. In addition to reading history and political biographies, I consumed newspapers and television news. It is this background that I have drawn upon over the decades that has added value to my research.
It didn’t begin with Donald Trump. When the Republican Party lost five straight presidential elections during the 1930s and 1940s, three things happened: (1) Republicans came to believe that presidential elections are rigged; (2) Conspiracy theories arose and were believed; and (3) The presidency was elevated to cult-like status.
Long before Trump, each of these phenomena grew in importance. The John Birch Society and McCarthyism became powerful forces; Dwight D. Eisenhower was the first “personal president” to rise above the party; and the development of what Harry Truman called “the big lie,” where outrageous falsehoods came to be believed. Trump…
Grand Old Unraveling: The Republican Party, Donald Trump, and the Rise of Authoritarianism
It didn't begin with Donald Trump. The unraveling of the Grand Old Party has been decades in the making. Since the time of FDR, the Republican Party has been home to conspiracy thinking, including a belief that lost elections were rigged. And when Republicans later won the White House, the party elevated their presidents to heroic status-a predisposition that eventually posed a threat to democracy. Building on his esteemed 2016 book, What Happened to the Republican Party?, John Kenneth White proposes to explain why this happened-not just the election of Trump but the authoritarian shift in the party as a…
If you're a biotech executive, investor, adviser, or entrepreneur -- or aspire to be one -- you’re supposed to understand clinical trial results. But what if you’re not an expert in study design or biostatistics? The Pharmagellan Guide to Analyzing Biotech Clinical Trials will give you the foundation you need to analyze journal articles, press releases, and investor presentations about studies of new drugs with more confidence.
