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September 2017 Newsletter

 Recent Project News 

  • Our 2016 Impacts Report on the Promotion of Diabetes Drugs in Washington DC was featured in an interview with Susan Wood in Medscape Today. "We only had about a 15% increase in [diabetes] prevalence, and a 350% increase in costs for diabetes drugs," said Dr. Wood. 

  • Dr. Fugh-Berman was quoted in an August 17th Chicago Tribune article on pharmaceutical company payments to physicians. She said, "Drug reps do not see physicians unless they are affecting their prescribing, and pharmaceutical companies do not pay physicians unless they are affecting their prescribing."

  • Alkermes continues its aggressive marketing tactics by lobbying drug court judges to make Vivitrol the only drug offered in medication-assisted treatment. On August 3, Dr. Fugh-Berman was quoted in an NPR story about this strategy, "It would be great if the [FDA] went after this," she says. "I think it does fall under their jurisdiction, but I wouldn't rely on that being enough." 

Joy's Favorite Article of the Month

This month I want to highlight an article by Huseyin Naci, Katelyn Smalley, and Aaron Kesselheim called Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration. The accelerated approval pathway allows the FDA to approve products based on surrogate measures that may serve as indicators of clinical outcomes.

The authors explored the characteristics of trials for drugs in the accelerated approval pathway. Between 2009 and 2013, the authors found 22 drugs with 24 indications that the FDA granted accelerated approval, a majority of which were oncology drugs. The FDA required 38 postapproval studies for these 24 indications to confirm the efficacy that was shown in the preapproval trials. As of April 2017, 19 of the 38 studies were completed. Of the 24 indications, 42% had efficacy confirmed in the postapproval trials. The authors also highlighted the high percentage of accelerated approvals that relied on nonrandomized trials and surrogate endpoints.

Drugs granted accelerated approval often become standard treatment, but should practitioners be relying on them when we really don't know about the long-term efficacy of these drugs?

Joy Eckert is the Project Manager of DCRx and AccessRx at the George Washington University Milken Institute School of Public Health.

RxFiles

Drugs as Innocent Bystanders

by Andrea Sikora Newsome, PharmD


“The patient is thrombocytopenic at 134, so I think we should switch off the Pepcid to a PPI,” the resident says to the team.

A wince briefly passes over my face. The attending catches my expression knowingly, and when the resident finishes, he speaks. “What are this patient’s risk factors for thrombocytopenia? Why don’t we have the students go around in a circle until we can’t anymore.”

Sepsis.
Critical illness.
Infection.
Fungal infections.
HIT.
CRRT.
Cardiac bypass.
Hemodilution. 
Liver disease.

The students are able to go around three times before they start grasping at straws and this was a question just focused on this one patient. If the question had been opened up to any risk factor or cause, we may have been there all morning. Patients in the intensive care unit (ICU) have multiple risk factors for thrombocytopenia and this patient was no exception.

This is an example of what I have started calling the “drugs as innocent bystanders” phenomenon that can occur in the intensive care unit. This is where we blame a drug for something that it probably has nothing to do with and then switch to a less optimal therapy to avoid this purported interaction.

Thrombocytopenia is one of the most common laboratory abnormalities observed in the ICU; by some estimates, more than half of patients are thrombocytopenic at some point in their ICU stay. Indeed, it is so common that once, as a resident, a pharmacist asked me what a “normal” platelet count was. I guessed, “Over 100?” They chuckled at my answer, “I guess for the ICU that is normal.”

Thrombocytopenia is generally defined as a platelet count less than 150 x 103 /µL. Critically ill patients will frequently dip below 100 x 103 /µL. Severe thrombocytopenia, less than 50 x 103 /µL, occurs in about 5-20% of patients; at that level, many surgeries are deferred and thromboprophylaxis with heparin is withheld. Histamine-2 blockers – especially cimetidine – have been associated with thrombocytopenia. However, the numbers are extremely low and most reports are individual case reports in which patients had multiple other risk factors in addition to drug therapy.

Thus, we are faced with a risk-benefit analysis. Should we switch from famotidine, a H2 blocker, to pantoprazole, a proton pump inhibitor (PPI)? Stress ulcer prophylaxis (SUP), previously discussed in this column, is such a rich example of evidence-based medicine (or lack thereof) it is worth revisiting. PPIs have demonstrated superiority in the treatment of gastrointestinal bleeding due to their superior acid inhibition properties; however, this benefit has not translated to SUP in the unit. When it comes to SUP, there is a goldilocks effect. Too little acid suppression (as with antacids) is not as effective in prevention of bleeding. However, too much acid suppression (as with PPIs) is associated with increased infection because the stomach can no longer neutralize bacterial threats.

H2 blockers seem to have the “just right” amount of acid suppression that minimizes bleeding but causes fewer infections. However, an aggressive marketing campaign, among other factors, has led many prescribers to believe that PPIs are superior - despite increased adverse effects and higher costs. As a result, everyone looks for a reason not to use famotidine and thrombocytopenia is an easy target. Ironically, PPIs also have thrombocytopenia listed as an adverse effect but somehow have avoided this bad rap.

“So tell me why you’re making our pharmacist make that face?” The attending jokes with the resident. He has heard my speech on this before and takes the lead.
“Because it is probably all those things and not the famotidine?” The resident replies.
“Exactly,” I say, “famotidine is probably just an innocent bystander in all this.”

Andrea Sikora Newsome, PharmD, is a Clinical Faculty Member at the University of Georgia in Augusta, Georgia.

News Round-Up

(For more, follow @Pharmed_Out on Twitter!)

Aug 28

FDA cracks down on stem-cell clinics, including one using smallpox vaccine in cancer patients by Laurie McGinley (Washington Post)

Aug 23

Patients Not Always Informed of Study's Purpose in Noninferiority Trials by Michael Mezher (Regulatory Affairs Professionals Society)

Aug 20

Big Pharma Can Be Beaten: This Union Proved It by Fran Quigley (Truthout)

Aug 15

South Carolina sues OxyContin maker Purdue over opioid marketing by Nate Raymond (Reuters)

Aug 14

Climbing cost of decades-old drugs threaten to break medicaid bank by Sydney Lupkin (Kaiser Health News)

Aug 12

A Cancer Conundrum: Too Many Drug Trials, Too Few Patients by Gina Kolata (New York Times)

Aug 11

The cost of treating opioid overdose victims is skyrocketing by Casey Ross (STAT News)

Aug 9

Study: Doctors received more than $46 million from drug companies marketing opioids by Katie Zezima (Washington Post)

Critics slam Trump's 'Substance-Free' Plan to Address Opioid Crisis by Julia Conley (Common Dreams)

Aug 8

Pharma Phantasy: The $30 Billion PCSK9 Inhibitor Market by Larry Husten (CardioBrief)

Deaths from drug overdoses soared in the first nine months of 2016 by Lenny Bernstein (Washington Post)

Generic Drug Prices are Declining, But Many Consumers Aren't Benefiting by Charles Ornstein, Katie Thomas (ProPublica) 

Aug 1

The generic drug industry has brought huge cost savings. That may be changing. by Carolyn Johnson (Washington Post)

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