Trends to Watch

Drug Development System Needs Private Industry Support Report Finds

Contrary to the beliefs of some in the medical research arena, private industry drugmakers and device manufacturers make critical contributions to the development of new drugs and devices and that NIH-sponsored and private-sector pharmaceutical research are crucial in the pursuit of medical innovation.  The column from Dr. Benjamin Zycher, a senior fellow at Manhattan Institute’s Center for Medical Progress, was published in the June 28 edition of the Wall Street Journal.  He writes that “private-sector contribution to pharmaceutical science is immense and indispensable” and criticism to the contrary is wrong.  He also notes that new policy proposals such as federal negotiation of drug prices, and drug reimportation would actually diminish private investment and harm the complementary balance of public and private research investment.

Dr. Zycher’s article for the paper was adapted from a new report  and his two colleagues at the Manhattan Institute also have published on this topic.  The study,  "The Truth About Drug Innovation", examines 35 drugs and drug classes and finds that private-sector research was responsible for “central advances in basic science for seven, in applied science for thirty-four, and in the development of drugs yielding improved clinical performance or manufacturing processes for twenty-eight.”  He mentions that publicly funded research tends to focus upon basic science of disease biology, biochemistry and disease processes, while private research is more applied science whereby these new scientific discoveries can be used in pursuit of new treatments and cures.  “Because public and private investments in pharmaceutical research are strongly complementary, a reduction in private research and development would erode, perhaps sharply, the economic benefits of NIH research efforts as well,” Zycher writes.

Senator Asks Congressional Leaders, NIHs’ Aid in Research Conflicts Probe

The Ranking Member of the Senate Finance Committee asked Congressional leaders and leaders at the National Institutes of Health (NIH) to assist in his efforts to identify and track potential conflicts of interest in taxpayer funded medical research.  Senator Charles Grassley (R-IA) asked on June 25 that  Members of Congress who sit on the relevant appropriations subcommittees to “step in to establish penalties for grantees who fail to report financial conflicts and to bring transparency to taxpayer funded medical research.”  He also called upon NIH leaders to more aggressively monitor these conflicts and “send a clear message that hiding conflicts of interest due to either sloppiness or sneakiness will not be tolerated.” 

Sen. Grassley’s statement notes his ongoing efforts on this subject including a bill he introduced in September 2007 which would create a process for drug and medical device manufacturers to report all payments and gifts of value which they make to physicians to the federal government.  Current federal law requires the NIH to monitor financial conflicts of interest by requiring the institutions who receive grants who receive grants to collect and manage information on the money that their researchers receive from drug and device makers and others in industry, but recent news reports seem to indicate that this is not happening in individual cases like that of three Harvard researchers involved in research into psychiatric medicine use in children.  Sen. Grassley believes that these examples call the integrity of the research into question and the resulting public concerns give Congress “plenty of reasons” to establish new penalties for grantees who fail to report their financial conflicts. 

CNN Asks 'Do You Want to Be A Guinea Pig' In News Report

A news report on CNN delved into the issue of volunteers participating in clinical trials and gave readers a number of questions that they should ask prior to getting involved.  The June 26 story in their network’s “Empowered Patient” section noted that both healthy people and patients with specific illness can get involved with clinical trials, volunteers can receive free medical care and are often compensated for participation, and the positives of helping expand medical research.  However, it also noted that volunteers should ask questions about the trial, what the side effects of the treatment might be, continued access to the drugs being tested after the trial concludes and how the doctors are being compensated for the research.  On the subject of compensation, one bioethicist quoted in the story said patient should inquire whether trial doctors and professionals are “"likely to be influenced in their judgments by money or professional connections to the study sponsor."

You may want to review the CNN story to be prepared to answer these questions raised there.  You may also wish to contact ACRP about obtaining any specific materials or documentation related to professional certification and policy standards which will help you work with current patients and possible volunteers to help them understand the benefits and risks of clinical trial participation.  

FDA Group Turns Up Spotlight on Safety of Pediatric Trials at Meeting

A federal review of pediatric trials on drugs began on June 9 with concerns about the safety and need of these types of trials on the front burner.  The two day meeting of the Food and Drug Administration’s Pediatric Ethics Subcommittee of the Pediatric Advisory Committee in suburban Washington DC will review how to do pediatric studies on drugs for disorders such as asthma, on potential AIDS vaccines and for the medical use of stem cells according to Bloomberg News.  Congress passed the Best Pharmaceuticals for Children Act in 2002 that grant companies extended patents on drugs that have been tested in children.  However, concerns remain that there is an insufficient number of clinical trials involving children because of safety concerns.

In fact, the FDA’s own pediatric ethicist, who works to increase the amount of safe medical research in children, asked that the two-day session be held.  The meeting may lead to guidance documents for the institutional review boards (IRBs).  Observers note that the FDA guidelines permit some research that poses more than minimal risk when children stand to benefit and IRB's should consider the standard risks of children's daily living as including activities like bicycling and snowboarding.