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New drugs fail to align benefits, risks and costs

Serious Risks And Few New Benefits From FDA-Approved Drugs

By Donald W. Light
Health Affairs Blog, July 6, 2015

Over the past year, the U.S. Senate and The New York Times have been investigating the failure of the nation’s auto safety regulators to protect citizens from cars with occasionally dangerous faulty devices.

But neither august institution has paid attention to the Food and Drug Administration’s (FDA) failure to protect the 170 million Americans who take prescription drugs from adverse reactions that are killing more than 2,400 people every week. Annually, prescription drugs cause over 81 million adverse reactions and result in 2.7 million hospitalizations.

This epidemic of harm from medications makes our prescription drugs the fourth leading cause of death in the United States. Including hospitalizations and deaths from prescribing errors, overdosing, and self-medication, drugs move up to third place.

Below I describe the biases that appear throughout the drug development process, from initial research to FDA review and approval. I conclude with recommendations that would reduce drug development costs and ensure that drugs are only approved if they are safe and significantly more effective than already existing medications.

Figure 1. Few Clinical Advances in a Decade and Hundreds of Other Drugs Approved for Promotion
Number of New Drugs, 2002-2011
2 - Breakthrough
13 - Real Advance
61 - Some Advantage
918 - Little or No Improvement

(The exhibit focuses on France, a country whose consumer-oriented drug market features an array of products similar to the U.S.)

Flooding the market with hundreds of minor variations on existing drugs and technically innovative but clinically inconsequential new drugs, appears to be the de facto hidden business model of drug companies. In spite of its primary charge to protect the public, the FDA criteria for approval encourage that business model. The main products of pharmaceutical research are scores of clinically minor drugs that win patent protection for high prices, with only a few clinically important advances like Sovaldi or Gleevec.

This business model works. Despite producing drugs with few clinical advantages and significant health risks, industry sales and profits have grown substantially, at public expense. Companies spend 2-3 times less on research than on marketing to convince physicians to prescribe these minor variations.

The Center for Drug Evaluation and Research (CDER) is the FDA division responsible for determining whether new drugs should be approved. Its funding, however, now largely comes not from taxpayers but from the companies submitting their drugs to CDER for review.

This clear conflict of interest and approving so many new drugs with few clinical benefits serve corporate interests more than public interests, especially given the large risks of serious harm. Direct and indirect costs to society far exceed the cost of funding the FDA as a public, independent review body.

Peer-reviewed studies already demonstrate how pharmaceutical companies manipulate FDA rules to generate evidence that their new drugs are more effective and less harmful than unbiased studies would show. The industry then recruits teams of medical writers, editors, and statisticians to select and repackage trial results into peer-reviewed articles that become accepted as reliable medical knowledge.

Based on his investigations, Marc Rodwin concludes, “Scholarly studies have revealed that drug firms design trials that skew the results and that they distort the evidence by selective reporting or biased interpretation.”

New FDA policies to get more drugs reviewed faster so that they can reach patients sooner result ironically in even more drugs being approved with less evidence that they are either safer or more effective. Faster reviews mean the chance that a drug will generate an FDA warning of serious harm jumps from one in five to one in three.

To protect the public from unsafe and ineffective drugs and earn public trust, the FDA and Congress must acknowledge the biases described here that result from pharmaceutical corporations financing the public regulator. They should also require two changes: that new drugs demonstrate patient-based clinical advantages through comparative trials, and that these trials be based on the population that will actually take a drug.

These changes would reduce the flood of minor variations shown in Exhibit 1 and the subsequent billions spent on them.

http://healthaffairs.org/blog/2015/07/06/serious-risks-and-few-new-benef...

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Comment:

By Don McCanne, MD

Outrageously high pricing is not the only problem we face with new pharmaceutical products. We are inundated with new drugs that provide little or no improvement over existing products. This exposes us not only to the higher prices driven by new patents, but also to the potential of serious adverse effects that may not be recognized until the new drugs have been on the market for a period of time.

Under a single payer system, drug formularies should include only those products are reasonably effective, comparatively safe, and cost effective. Since the industry does not provide us with those assurances, it is the responsibility for the government to step in and do so.