Working for the Greater Good

The reputation of the pharmaceutical industry has taken a number of hits in recent years, with most negativity a result of its own creation. Recent news stories have not done much to encourage optimism.

For example, recalls of angiotensin II receptor blocker (ARB) drug products-triggered by the identification of a suspected carcinogen in the widely used blood pressure medication-continued. To help clarify the status of drugs in the class, FDA developed a list that reports the results of the agency’s testing for the presence of nitrosamine and indicates those drugs that are still to be tested (1).

Perhaps the two most egregious issues in the eyes of patients, policymakers, and the public, however, are high drug prices and the opioid epidemic.

The discourse about the high cost of drugs in recent years can be characterized as a low simmer, with occasional outbursts from elected officials, a lot of finger pointing, and little progress. The topic should erupt to a fever pitch in the coming months as the 2020 presidential election gains steam.

Finger pointing has also been the response from various sectors of the healthcare and pharma industries in response to the opioid crisis. Recent media attention upped the scrutiny of business practices of companies manufacturing and distributing the drugs. For example, a recent article detailed how drug distributors had previously been cited and fined for lax monitoring of suspicious orders or circumventing guidelines (2).

Although civil lawsuits have been filed in multiple states, the first criminal charges related to improper opioid distribution were filed in late April 2019 against executives at a New York drug distributor. The US Attorney’s office charged two executives at the Rochester Drug Cooperative with unlawfully distributing oxycodone and fentanyl and conspiring to defraud the Drug Enforcement Administration (3). Time will tell if criminal penalties will be more a deterrence than previous civil fines.

Pharma does good

There is some promising news in the fight to eradicate or reduce the effects of malaria, one of the world’s oldest and deadliest diseases. The World Health Organization reported 219 million cases and 435,000 deaths worldwide in 2017, with no significant progress in reducing the number of cases in 2015–2017 (4).

World Malaria Day (April 25, 2019) was marked with the launch of a pilot program in Malawi of the first malaria vaccine for children up to two years old. The RTS,S vaccine, in development for 30 years, was demonstrated in clinical trials to prevent approximately 4 in 10 malaria cases, including 3 in 10 cases of life-threatening severe malaria, WHO reports. The pilot program will be extended to Ghana and Kenya in coming weeks (5). GlaxoSmithKline will donate up to 10 million vaccine doses for the pilot (6).

Another recent therapy, Krintafel (tafenoquine) was approved by FDA in July 2018 as the first new treatment for Plasmodium vivax (P. vivax) malaria in more than 60 years. Developed by GlaxoSmithKline in collaboration with Medicines for Malaria Venture, the drug was approved for the radical cure (prevention of relapse) of P. vivax malaria in patients aged 16 years and older who are receiving appropriate antimalarial therapy for acute P. vivax infection (7).

References

1.  FDA, FDA’s Assessment of Currently Marketed ARB Drug Products, accessed April 22, 2019.
2.  D. Hakim, W. K. Rashbaum, R. C. Rabin, “The Giants at the Heart of the Opioid Crisis,” www.nytimes.com, April 22, 2019.
3. US Dept. of Justice, “Manhattan U.S. Attorney and DEA Announce Charges Against Rochester Drug Co-Operative and Two Executives for Unlawfully Distributing Controlled Substances,” Press Release, April 23, 2019.
4. WHO, World Malaria Report, November 2018.
5. WHO, “Malaria Vaccine Pilot Launched in Malawi,” Press Release, April 23, 2019.|
6. GSK, “Fighting Malaria in the Lab and on the Ground,” www.gsk.com, April 18, 2019.
7. GSK, “US FDA Approves Krintafel (tafenoquine) for the Radical Cure of P. vivax Malaria,” Press Release, July 20, 2018.

Article Details 

Pharmaceutical Technology
Vol. 43, No. 5
May 2019
Page: 10

Citation 

When referring to this article, please cite it as R. Peters, “Working for the Greater Good,” Pharmaceutical Technology 43 (5) 2019.