Monday, July 29, 2019
Surescripts-Amazon PillPack battle over patient data heats up
Surescripts has terminated its contract with a vendor it claims fraudulently requested patient medication history to give to Amazon’s online pharmacy PillPack and will turn the matter over to the FBI, according to CNBC. It is the latest move in a battle over patient data between Amazon and the largest e-prescribing company in the U.S.
Six things to know:
1. The dispute centers on how PillPack accessed patient prescription data. Until recently, PillPack received its data from a third-party entity, ReMyHealth, which compiles raw data from Surescripts, cleans it up and offers it to clients. PillPack’s service relied on this data to maintain an accurate list of patient medications to keep up with refills and uncover duplicate subscriptions. ReMyHealth recently said it would stop working with PillPack.
2. Earlier in July, PillPack was warned that Surescripts might cut off its access to the data through ReMyHealth. Amazon threatened to sue Surescripts to prevent the e-prescribing company from ending its access to the data. One person familiar with the legal dispute told CNBC that PillPack has sent a cease-and-desist letter to Surescripts.
3. Now the battle is heating up again. Surescripts is accusing the vendor, ReMyHealth, of breaking the terms of their contract by giving “fraudulent information” to Surescipts to get the prescription data. In particular, Surescripts said that ReMyHealth asked for data to send to “providers caring for patients in hospitals,” when instead it was sending that information to PillPack.
4. Surescripts said it has alerted the FBI and stopped ReMyHealth from accessing its network of data.
5. “We are still investigating the full scope of these improper activities, but today are taking immediate steps to protect the data our partners entrusted to us and the privacy of our patients they serve,” Surescripts told CNBC. “Specifically, we have suspended ReMy Health from our network and our terminating their contract and are turning the matter over to the FBI for further investigation.”
6. An unnamed PillPack spokesperson told CNBC, “Given that Surescripts is, to our knowledge, the sole clearinghouse for medication history in the U.S., the core question is whether Surescripts will allow customers to share their medication history with pharmacies. And if not, why not?”
McKinsey under fire for consulting on opioid sales
Global consulting firm McKinsey & Co. is facing criticism for its role in opioid marketing for Johnson & Johnson and Purdue Pharmaceuticals, The New York Times reports.
The consulting firm’s work has been cited in cases against pharmaceutical companies in Oklahoma, Massachusetts and New Jersey. The Oklahoma case cites its work for Johnson & Johnson on how to better influence prescription behavior. In Massachusetts, the company is named for helping Purdue Pharma “turbocharge” OxyContin sales, according to the report.
McKinsey is not a defendant in the lawsuits.
In a statement to The New York Times, McKinsey said: “Our historical work for clients in this industry was designed to support the legal prescription and use of our clients’ products. Opioids have had a devastating impact on our communities, however, and we are no longer advising clients on any opioid-specific business on a global basis.”
Johnson & Johnson said it still uses McKinsey for projects not related to opioids.
Wave Life Sciences EPS misses by $0.09, misses on revenue
Wave Life Sciences (NASDAQ:WVE): Q2 GAAP EPS of -$1.22 misses by $0.09.
Revenue of $7.63M (+56.4% Y/Y) misses by $8.13M.
Cash and cash equivalents of $252.9M
Rhythm Pharmaceuticals EPS misses by $0.36
Rhythm Pharmaceuticals (NASDAQ:RYTM): Q2 GAAP EPS of -$1.24 misses by $0.36.
Cash, cash equivalents and short-term investments of $195.2M
Gilead Sciences Q2 2019 Earnings Preview
Gilead Sciences (NASDAQ:GILD) is scheduled to announce Q2 earnings results on Tuesday, July 30th, after market close.
The consensus EPS Estimate is $1.71 (-10.5% Y/Y) and the consensus Revenue Estimate is $5.54B (-1.9% Y/Y).
Over the last 2 years, gild has beaten EPS estimates 75% of the time and has beaten revenue estimates 75% of the time.
Over the last 3 months, EPS estimates have seen 13 upward revisions and 6 downward. Revenue estimates have seen 10 upward revisions and 8 downward.
Trial reveals potential for treating larger strokes with thrombectomy
Building on research results published today in JAMA Neurology showing patients with larger ischemic strokes could benefit from endovascular thrombectomy, an international, multicenter Phase III clinical trial will be starting at The University of Texas Health Science Center at Houston (UTHealth).
The trial, called SELECT2 (Optimizing Patient Selection for Endovascular Treatment in Acute Ischemic Stroke), is a randomized, controlled, open-label, assessor-blinded trial assessing efficacy and safety of thrombectomy procedure in patients with larger ischemic stroke.
While multiple previous clinical trials showed that endovascular thrombectomy was safe and beneficial for patients with smaller areas of damage from an ischemic stroke, potential safety and benefits for larger strokes are still unknown.
Ischemia refers to blood supply restriction to tissue. In an ischemic stroke, a clot blocks blood flow in a cerebral artery, preventing oxygen from reaching the surrounding brain tissue and resulting in cell death. That area of cell death is called an ischemic core.
In endovascular thrombectomy, a small catheter is guided through an artery, usually a femoral artery, through the body to the site of the blockage in the brain. A blood clot removal device is deployed, which captures the clot. The catheter is then retracted.
The earlier Phase II clinical trial (SELECT), which enrolled patients in nine U.S. comprehensive stroke centers, included 105 patients with large ischemic cores. It showed potential benefits: 31% of patients who were treated with endovascular thrombectomy achieved functional independence, compared to 14% of patients who received medical management only.
“It is unclear now if thrombectomy is safe and efficacious in patients with a large ischemic core stroke. Treating physicians face a dilemma on whether to intervene in these patients,” said Amrou Sarraj, MD, first and corresponding author and associate professor of neurology at McGovern Medical School at UTHealth. “Our results represent very good preliminary data that thrombectomy may be safe and efficacious in this population. It’s time to test those results in a randomized trial.”
The results of SELECT showed reasonable safety outcomes with thrombectomy in patients with larger strokes. The risk of secondary bleeding with thrombectomy did not increase significantly compared to medical management. Mortality rate decreased with thrombectomy (29%) as compared to medical management (42%).
The Phase III trial, which begins in August, will enroll 560 patients at 30 comprehensive stroke centers in the U.S., Canada, and Europe.
“If proven to be safe and effective, SELECT2 will extend thrombectomy indications to improve clinical outcomes in a large group of patients that does not have many treatment options at this point,” said Sarraj, who is a member of UTHealth Institute for Stroke and Cerebrovascular Disease.
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McGovern Medical School co-authors on the JAMA publication were Sean I. Savitz, MD; Clark Sitton, MD; Peng R. Chen, MD; Chunyan Cai, PhD; Bita Imam, PhD; Sujan Reddy, MD; Kaushik Parsha, MD; Deep Pujara, MD; Roy F. Riascos-Casteneda, MD; Haris Kamal, MD; and Andrew Barreto, MD. James C. Grotta, MD, director of stroke research at Memorial Hermann-Texas Medical Center, was also a co-author.
The upcoming trial sites include Cleveland Clinic, Stanford University, Rush University, Vall d’Hebron University Hospital at Barcelona, Toronto Western Hospital, and Oslo University Hospital, among others. McGovern Medical School is the coordinating center for the study, and the global principal investigator is Sarraj.
The new trial is supported by Stryker Neurovascular and McGovern Medical School.
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