• by: Peter Pitts |
  • 10/11/2017
From the pages of the Wall Street Journal …

A Flawed Study Depicts Drug Companies as Profiteers
Peter J. Pitts

Even the authors admit their selection criteria are a ‘critical limitation.’ That’s an understatement.

Are drug companies ripping off cancer patients? Of course they are, suggests a much-hyped study published last month in the journal JAMA Internal Medicine. The truth is more complicated.

Drug companies receive a staggering return on investment “not seen in other sectors of the economy,” write Vinay Prasad of Oregon Health and Science University and Sham Mailankody of Memorial Sloan Kettering Cancer Center. They estimate that pharmaceutical firms spend $720 million on average to develop a single cancer drug, while the average cancer therapy generates sales of $6.7 billion.

The editors at JAMA are brilliant physicians, but they could use a refresher on the economics of drug development. Several methodological flaws in the study lead the authors to underestimate drug-development costs. 
Messrs. Prasad and Mailankody examined 10 publicly traded companies that secured their first-ever Food and Drug Administration approval between 2006 and 2015. They pulled data on companies’ research spending and revenues from annual financial reports filed with the Securities and Exchange Commission. These selection criteria are a joke. By looking at 10 companies that produced only one cancer drug each, the authors screened out big multinational corporations that had previously secured FDA approval for one or more drugs. Small biotech firms that hadn’t secured FDA approval for any treatments were also excluded. 
The authors admit that the selection criteria are a “critical limitation.” No kidding: They only looked at 15% of all cancer drugs approved from 2006 to 2015, ignoring the other 85% of cancer therapies introduced that decade. This helped them “prove” their hypothesis.
The analysis also overlooks hundreds of millions of dollars of research spending at companies that never develop an FDA-approved medicine. Nine of every 10 publicly traded drug companies lost money in 2014, according to a 2016 International Trade Administration report. Most therapies don’t make it out of the lab and into clinical trials. Of those that do, only 12% are brought to market.
Those that defy the odds and win FDA approval don’t accurately represent the broader biopharmaceutical industry. Consider the success of these 10 drugs against those that are still going through clinical trials. Even if all of these companies’ other experimental drugs in the development pipeline failed, the success of this study’s 10 drugs would have resulted in an overall clinical approval success rate of 23%, twice the industry average.
Worse, five of the companies in question had purchased their drugs from smaller biotech firms. The authors didn’t count any of the research-and-development spending of these “nurturer” firms, only by the acquiring firm.
The other five drugs were developed entirely in-house—and the authors lowballed cost estimates for developing these drugs. Messrs. Prasad and Mailankody counted only two years of development costs before the first mention of the drugs in the medical literature. They figured this would accurately reflect preclinical costs, such as lab tests. 
Their assumption is wrong. In reality, the initial, preclinical research period often lasts four years or more. And for four of the 10 drugs examined, companies started lab research at least seven years before the first mention of the drug in any published medical studies. 
Drug development is much more expensive than the JAMA study suggests. More reliable is a November 2014 study from the Tufts Center for the Study of Drug Development. This more thorough examination estimates total research costs are about $2.6 billion for new cancer drugs. Politicians who advocate price controls undoubtedly will cite the JAMA study anyway. Never mind that government-imposed price caps would hamstring researchers and prevent the development of new treatments and cures.
In the past 17 years, biopharmaceutical companies have invented more than 550 FDA-approved medications. More than 800 experimental cancer drugs are currently under development at companies of all sizes, from tiny biotechs to giant multinationals. By misinforming readers, the JAMA study undermined the great work that drug companies are doing today.
Mr. Pitts, a former FDA associate commissioner (2002-04), is president of the Center for Medicine in the Public Interest

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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