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Drug companies have patient safety role

The U.S. House of Representatives on Friday overwhelmingly approved the 21st Century Cures Act, sending to the U.S. Senate bipartisan legislation which, if it works as intended, "accelerates the discovery, development and delivery of life-saving and life-improving therapies, and transforms the quest for faster cures," according to a House Energy and Commerce Committee summary of the bill. The measure, dubbed H.R. 6, passed by a vote of 344-77.

Some like it; some don't.

Here are just a few of the intentions behind the legislation, according to the House committee's summary:

  • Allow more "sharing and analyzing" of health data collected from research and clinical settings in order to expedite the development of cures and therapies.
  • Modernize clinical trials by expanding the use of "personalized medicine [to allow] researchers to design more targeted clinical trials that can produce results faster and cheaper. H.R. 6 will allow greater use of patient generated registries that speed the recruitment of participants."
  • Encourage the use of "biomarkers," rather than solely clinical trial data, to determine drug efficacy. (From the July 1 edition of the journal BMC Medical Genomics: "Biomarkers are defined as any molecule derived from a biological sample that can indicate current disease status, evaluate progression of the disease, or assess potential responsiveness to a particular medication. Biomarkers come in many forms including DNA mutations, proteins, and messenger RNA transcripts.")
  • Create in part from the receipts of sales from the strategic oil reserve "a dedicated and offset funding stream of $1.75 billion per year for five years for the NIH and $110 million per year for five years for the FDA."

The advocacy group Public Citizen said in a statement that it released on the day the bill passed, "At its core, this legislation is a horse trade: In exchange for increased funding for the world-renowned National Institutes of Health, lawmakers added perks for the pharmaceutical and medical device industries [such as lowering] standards for U.S. Food and Drug Administration approval of medical devices and medications (particularly with respect to antibiotics)..."

Physicians Dr. Jerry Avorn and Dr. Aaron S. Kesselheim, the latter also an attorney, critiqued the draft bill for a piece that the New England Journal of Medicine published June 3. They did not suggest the bill was all-bad. In fact, they saw a few encouraging points. But they found a few troubling aspects.

They wrote, "...as introduced, the 21st Century Cures Act instructs the FDA to consider nontraditional study designs and methods of data analysis to further speed approvals. Adaptive trial designs and the use of Bayesian methods hold promise in some kinds of evaluations, particularly in oncology. However, more problematic proposals include encouraging the use of 'shorter or smaller clinical trials' for devices and the request that the FDA develop criteria for relying on 'evidence from clinical experience,' including 'observational studies, registries, and therapeutic use' instead of randomized, controlled trials for approving new uses for existing drugs. Although such data can provide important information about drug utilization and safety once a medication is in use, there is considerable evidence that these approaches are not as rigorous or valid as randomized trials in assessing efficacy."

In regard to biomarkers, the physicians wrote, "Some biomarkers are accurate predictors of disease risk and can be useful measures of the efficacy of a new drug (such as low-density lipoprotein cholesterol for statins). But though a drug's effect on a biomarker can make approval quicker and less costly, especially if the comparator is placebo, it may not always predict the drug's capacity to improve patient outcomes."

We'll see whether this legislation is good, bad or a little of both, if it is enacted. Nevertheless, there is one thing that is indeed all-bad and should stop. No matter how fast the data is collected - and no matter how fast a drug is approved - when the findings show an incidence of serious side effects, the drug companies should not understate those side effects.

At the heart of Xarelto lawsuits is the contention that Janssen Pharmaceuticals disregarded in the anticoagulant's marketing materials important information about the risk of irreversible bleeding.

Moreover, an issue in Levaquin lawsuits is the alleged failure of Ortho-McNeil to warn consumers and their health care professionals through the fluoroquinolone antibiotic's label that peripheral neuropathy was not all that rare a side effect and that the nerve condition can be irreversible, even if the patient stops taking Levaquin.

When patients succumb to unreasonable risks to their health, there is a justice system in place to determine whether they should be compensated for their medical expenses, lost wages and other losses. Thank goodness there are attorneys who specialize in trying pharmaceutical injury cases and who know precisely what to do when a victim, no matter where he or she resides, calls for help.

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