Drug Policy Question of the Week – 6-5-11

As answered by Mary Jane Borden, Editor of Drug War Facts for the Drug Truth Network on 6-5-11. http://www.drugtruth.net/cms/node/3413

Question of the Week: What are adverse drug events?

An article in the Connecticut Law Review defines the U.S. Food and Drug Administration (FDA) as the agency that

“regulates both the safety and effectiveness of prescription pharmaceuticals and certain medical devices. In addition to ensuring that prescription drugs are safe and effective before they are sold in interstate commerce, the FDA approves all information a manufacturer plans to provide physicians on a drug’s recommended use, contraindications, risks, and side-effects.”

The FDA’s Center for Drug Evaluation and Research (CDER) is the regulatory body that oversees over-the-counter and prescription drugs, and biological therapeutics. This agency has produced several trendable reports, including a data briefing covering 1996 to 2006.

This paper overviews the CDER’s Adverse Event Reporting System that compiles

“voluntary adverse drug reaction reports from [healthcare practitioners] and required reports from manufacturers … this system forms “the basis of “signals” that there may be a potential for serious and unrecognized drug-associated events [or reactions].”

Drug reaction numbers from this FDA system are now displayed in two Drug War Facts Tables, one called “Prescription Drug Product Approvals, Recalls and Adverse Event Reports” and the other named “AERS Patient Outcomes by Year,” both sourced directly from the FDA.

Both of these tables reflect troubling statistics. The former table shows that Adverse Drug Event reports to the FDA concerning prescription drugs soared by almost +75% for the six years (2002-2007) compared to the prior six years (1996-2001). Further, and perhaps more disturbing, adverse reaction outcome “deaths” totaling over 370,000 and “serious outcomes” eclipsing 2,300,000 occurred during the ten years from 2000 to 2009 for the prescription drugs tracked by this FDA system.

These facts and others like them can be found in the Regulation of Prescription Drugs section of the United States chapter of Drug War Facts at www.drugwarfacts.org.

Drug Policy Question of the Week – 5-28-11

As answered by Mary Jane Borden, Editor of Drug War Facts for the Drug Truth Network on 5-28-11. http://www.drugtruth.net/cms/node/3403

Question of the Week: What are Clinical Trials?

Wikipedia defines clinical trials as,

“a set of procedures in medical research conducted to allow safety and efficacy data to be collected for health interventions such as drugs, diagnostics, devices, and therapy protocols.”

Clinical trials in the United States begin with the Food and Drug Administration or FDA that

“regulates both the safety and effectiveness of prescription pharmaceuticals and certain medical devices.”

The National Bureau of Economic Research overviews this process that,

“begins when a firm files an Investigational New Drug [IND] application, which requests permission from the FDA to conduct clinical trials on humans … Once the FDA gives its approval, the firm may begin conducting clinical trials for the drug, which proceed in three phases.”

“The goal of Phase I is to evaluate the drug’s safety and to obtain data on its pharmacologic properties. Typically, phase I trials enroll small numbers of healthy volunteers. Phase II trials then enroll slightly larger numbers of sick volunteers. The goal of these trials is to begin investigating a drug’s efficacy and optimal dosage, and to monitor the drug’s safety in diseased patents. Finally, Phase III testing typically involves larger numbers of sick patients and is the most costly stage of the approval process. Phase III testing seeks to establish more definitively the efficacy of a drug, as well as to discover any rare side effects. Upon the completion of Phase III testing, the firm submits a New Drug Application to the FDA, which is accompanied by the results of the clinical trials. The FDA may then reject the application, require further clinical testing, or approve the drug outright.”

These facts and others like them can be found Regulation of Prescription Drugs section of the United States Chapter of Drug War Facts at www.drugwarfacts.org.

Drug Policy Question of the Week – 4-20-11

As answered by Mary Jane Borden, Editor of Drug War Facts for the Drug Truth Network on 4-20-11.  http://www.drugtruth.net/cms/node/3355.

Question of the Week: Is Asset Forfeiture taxation?

According to the U.S. Justice Department,

“Civil forfeiture is a proceeding brought against the property rather than against the person who committed the offense. Civil forfeiture does not require either criminal charges against the owner of the property or a criminal conviction.”

“…forfeiture can be used to seize and forfeit the following:
• any amount of currency;
• personal property valued at $500,000 or less, including cars, guns, and boats;
• hauling conveyances of unlimited value.

Real property cannot be forfeited administratively.”

In 2009, U.S. Attorneys seized over one billion dollars in assets, roughly four times more than in 1989. During that 21 year span, the value of forfeited assets totaled 11 billion dollars, five billion short of the 2011 federal drug control budget.

The Justice Department readily admits that,

“… civil forfeiture expanded greatly during the early 1980s as governments at all levels stepped up the war on drugs.”

The department goes on to claim,

“… asset forfeiture can assist in the budgeting realm by helping to offset the costs associated with fighting crime. Doing what it takes to undermine the illicit drug trade is expensive and time-consuming. Forfeiture can help agencies target these difficult problems, sometimes without the need to seek additional outside resources to offset their costs.”

In its 2010 report, the Institute for Justice called asset forfeiture

“… legal fiction that enables law enforcement to take legal action against inanimate objects for participation in alleged criminal activity, regardless of whether the property owner is guilty or innocent—or even whether the owner is charged with a crime.”

I have to ask, is asset forfeiture for merely alleged drug crimes taxation without representation?

These facts and others like them can be found in the Asset Forfeiture Chapter of Drug War Facts at www.drugwarfacts.org.

Drug Policy Question of the Week – 4-12-11

As answered by Mary Jane Borden, Editor of Drug War Facts for the Drug Truth Network on 4-12-11.  http://www.drugtruth.net/cms/node/3343.

Question of the Week: Do drug courts work?

A new report called “Drug Courts Are Not the Answer” from the Drug Policy Alliance defines drug courts as,

“an application of therapeutic jurisprudence theories in which the judge does not ask whether the state has proven that a crime has been committed but instead whether the court can help to heal a perceived pathology.”

The report goes on to say,

“The judge is the ultimate arbiter of treatment and punishment decisions and holds a range of discretion unprecedented in the courtroom … The defense lawyer, no longer an advocate for the participant’s rights, assists the participant to comply with court rules.”

The National Association of Criminal Defense Lawyers asserts,

“Under the traditional drug court model, an individual must waive significant rights when entering drug court.”

“Most drug courts require a guilty plea as the price of admission.”

While drug courts have been praised for reducing recidivism and yielding positive cost/benefit ratios, the Congressional Research Service found,

“Drug court evaluations have been widely criticized for methodological weaknesses and data inconsistencies. … the majority of drug court program evaluations (1) have either no comparison group or a biased comparison group, … (2) report outcomes only for participants who complete the program, … and (3) use flawed data-collection methods, such as drug court participants’ self-reported surveys.”

District Judge Morris B. Hoffman concluded in the North Carolina Law Review,

“… drug courts are not satisfying either the legitimate and compassionate interests of the treatment community or the legitimate and rational interests of the law enforcement community. They are, instead, simply enabling our continued national schizophrenia about drugs.”

These facts and others like them can be found in the Drug Court Chapter of Drug War Facts at www.drugwarfacts.org.