The Los Angeles Times has once again published an extensive report in response to claims made by drug manufacturer Purdue Pharma. In a press release published this month, the pharmaceutical giant claimed that contrary to what was written in the newspaper, the company has resisted efforts to change dosage recommendations for their potentially addictive opioid drug, OxyContin.

OxyContin, the best-selling US painkiller, claimed 12 hours of relief from pain with a daily dosage of twice a day to ensure the best pain control. In 1996, the drug helped Purdue Pharma generate $31 billion in revenue.

Like morphine, the drug contains oxycodone — an opioid often referred to as a narcotic. The drug is used to treat pain which is unmanageable by other means. The Food and Drug Administration (FDA) has approved the drug for usage amongst children as old as eleven.

The drug was first created for curbing prescription opiate addiction by using time-release pain relief. Interestingly, according to the data from the National Survey on Drug Use and Health (NSDUH), since its release two decades ago more than 7 million people have abused the drug.

The Arguments

If the newspaper’s claims are accurate, the FDA can order the company to conduct new studies into the dosage regiment of OxyContin, which could take a huge chunk out of the company’s resources.

Ever since the newspaper’s report was first published, both sides have been embroiled in a bitter dispute.

According to Purdue Pharma, the report claims that the drug has a 12-hour dosage problem which puts patients at a risk of addiction. But an FDA report published several decades ago rejects the premise that frequent OxyContin increases the risk of adverse reactions and side effects. The medical company states that this reinforced the dosage recommendations and the LA Times did not include this in the report.

In response, the LA Times stated that the FDA was ordered to add warnings on the drug label prohibiting use at least less than 12 hours by the state of Connecticut in order to prevent any unsafe practices and stop black market drug sales. Purdue Pharma lawyers opposed the order at the time and thought the dosage should be allowed to be modified according to particular patient needs. The FDA rejected the order in 2008 and claimed that physicians should retain the right to prescribe the drug at less than twelve hour intervals.

Purdue Pharma also mentions that the newspaper claims OxyContin to be an eight-hour drug, according to clinical data. Additionally, 20 years of data including several controlled clinical trials, supports 12-hour dosages for the FDA-approved drug.

The FDA approved label for the drug, which has been updated more than 30 times, states that no significant studies show efficacy and safety at less than recommended dosage intervals. The LA Times, in response, remains firm on its statement that its first report included clinical data from the trials conducted by the company in which patients needed medication before the 12-hours were up. The first trial had more than one-third patients complaining of pain within 8-hours of dosage and nearly half of the participants asked for more medication.

Purdue Pharma claims that OxyContin’s use with 8-hour intervals is appropriate and physicians should be allowed to prescribe the drug. However, the FDA does not allow companies that manufacture drugs to promote their unapproved use.

The LA Times bites back by saying that the article simply reports that the drug does not work for 12 hours in many patients and can therefore lead to withdrawal symptoms which potentially increase addiction risk. The article also observes that Purdue did not check the efficacy of the drug at different schedules.

According to the Purdue, the LA Times claimed that patients rarely take extended release drugs at different intervals. However, the FDA has noted that there might be significant patient variability and recommends individualized treatment. The newspaper added weight to their previous statements by claiming the article makes the opposite claim and that the drug works differently in each patient.

Purdue Pharma stated that the newspaper claims to have unearthed new information but the article fails to provide key facts to the public and diminishes a complex and difficult issue, creating mass confusion.

The LA Times responded that the newspaper has worked through thousands of internal company records and court documents, some of which were sealed by the courts at the company’s request. All steps taken by the company to fight abuse were mentioned in the article.

Purdue also claimed that the newspaper disregarded information that the company provided in several meetings with the paper. The LA Times claimed that the company executives refused to talk on the record. Furthermore, the two phone briefings arranged by the company itself, on the condition of anonymity by the relevant company executive, were added in the article where they seemed relevant.

FDA And Drug Regulations

FDA allows the company to change labeling and drug dose recommendations if new information comes to light, even after market release of the drug. The agency can also take action by investigating particular dosage issues and ordering the companies to lower the current recommended dosages. An example includes the FDA requiring drug companies to “lower recommended dose for certain sleep drugs containing zolpidem” when they were found to hinder patient activity in the morning.

Currently, the FDA has not announced any investigations into the claims made by the newspaper nor have they asked the company to produce any evidence to contradict the newspaper’s findings

The 1906 Foods and Drugs Act expanded the FDA authority to regulate drugs in which the FDA approves, regulates and ensures safety and effectiveness of drugs through two steps — pre-approval (pre-market release) and post-approval (post-market release).

Initially, a company develops a prototype, which is then approved by the FDA after an investigational new drug (IND) application. The company then carries out clinical trials, including human trials. The data collected is submitted in the form of a non-disclosure agreement (NDA). Finally, the FDA reviews the data for safety and effectiveness of the drug use, appropriateness of the proposed labels and the adequacy of the manufacturing method of the drug.

After the drug’s market release, the FDA continues to ensure effective and efficient drug production, distribution, and use. Thereafter, the FDA continuously monitors the company activities through on-site visits, official documents and surveys.