月別アーカイブ: 2014年3月

Pharmacy board’s actions with Walgreens raises questions about ethics, patient privacy, safety

pharmacy prescription drugs

A powerful member of the Indiana Board of Pharmacy was quietly involved in discussions with state pharmacy regulators about a $100 million project that benefited his employer — Walgreens pharmacies.

And now a government watchdog group and a labor federation say those actions not only violated state ethics laws, but have allowed Walgreen Co. to dramatically remodel dozens of stores across Indiana, compromising patient privacy and increasing the chance of errors in filling prescriptions.

One of the groups persuaded the U.S. Department of Health and Human Services to look into the matter. It recently launched an investigation into the patient privacy allegations at Walgreen.

Walgreen said it is cooperating with the investigation, and defended the store layout as safe and effective. “We presented this model to more than 30 boards of pharmacy around the country,” said Michael Polzin, a company spokesman in Illinois. “We’re very proud of the work we have done.”

In dozens of emails from 2011 reviewed by The Indianapolis Star, William J. Cover — then president of the state pharmacy board — played a key role in connecting state regulators with Walgreen officials months before the remodeling project became public.

During that time, Cover was corporate manager of pharmacy affairs for Walgreen — raising questions about whether he should have removed himself from any involvement with state officials concerning the project.

It seems clear he didn’t.

In one email, the executive director of the pharmacy board asked top state officials whether board members could travel to Illinois to visit Walgreen headquarters. “This is a specific request from my Board President,” wrote Phil Wickizer, referring to Cover.

In various emails spanning five months in 2011, Cover arranged two trips for the Board of Pharmacy to Walgreen sites in Illinois to meet company officials and inspect the new design. He sent information about the project to the Board of Pharmacy staff.

Walgreen was proposing a radical departure from most pharmacies, dubbed the “Well Experience.” The plan was to move pharmacists out from behind the counter to a workstation on the floor, where they could answer questions from the public and provide health counseling. Indiana was the pilot site.

Walgreen said it would spend about $100 million in infrastructure, hire 150 new employees and spend millions more in marketing and technology.

According to an email from Wickizer to the Indiana Professional Licensing Agency on May 11, 2011, “Walgreens wants to partner with the Board and get your buy-in before making such a commitment.” He said the company wanted to keep the plans confidential.

“I told them this would not be an issue,” Wickizer wrote.

The licensing association warned that the meeting in Chicago might violate Indiana’s open doors laws, and in a subsequent email, Wickizer reported to Walgreen officials that the board would go in two groups to avoid a quorum, which would require public notice.

Before the trips, Cover asked Wickizer whether other board members were supporting the project.

“Reaction so far?” Cover wrote on May 11, two months before the vote. Wickizer responded that three of the other six board members so far “have responded affirmatively.” An hour later, Cover followed up with Wickizer: “Thanks for all your hard work on this project. It is certainly appreciated.”

In an email three days before Walgreen’s project became public at a Board of Pharmacy meeting, Cover wrote to Wickizer: “Monday will be fun!!”

On Monday, July 11, 2011, Walgreen officials appeared before the board to explain the project. The board voted 6-0 to approve it, with Cover abstaining due to a conflict stemming from his employment at Walgreen.

Wickizer left Indiana government in 2012 to take a job as senior legal counsel at Express Scripts, a pharmaceutical mail-order operation based in St. Louis. He referred questions to the Indiana Professional Licensing Agency.

Cover, who is still on the board but no longer serves as president, did not return numerous phone calls to his office and home in Middlebury.

Sue Swayze, a spokeswoman for the Indiana Professional Licensing Agency, defended Cover’s conduct, saying he was merely coordinating logistical and scheduling issues, such as the trip to Chicago, while keeping himself out of substantive discussions of the project.

“We are sticklers about recusing ourselves from that discussion” when there are conflicts, she said.

She said it would be up to the state’s public access counselor or inspector general to making a legal ruling.

Two citizens groups say they plan to file a complaint Monday, with the Indiana inspector general’s office. Common Cause Indiana and Change to Win, a labor-supported activist group, say that Cover’s actions violated the Indiana ethics code. The emails were obtained by Change to Win under numerous open-records requests.

Julia Vaughn, director of Common Cause, a government watchdog group, said Cover should have removed himself completely from the matter.

“Under the circumstances, he should have kept himself at arm’s length,” she said. “Looking at the emails, I think more separation was needed, and that’s why we think an investigation is necessary.”

Change to Win said it has made more than 100 visits to Well Experience stores and has found widespread risks to patient privacy and public health. Pharmacists often leave their desks in a public area of the store to talk to patients in consulting rooms or to unlock a cabinet in the dispensing area.

When the pharmacist leaves, the public can look at the computer screens or at labeled bottles of medicine on their desk, the organization said. About 80 percent of the stores visited violated privacy laws in this way, the group alleged.

“No one wants to have their prescription for methadone or Viagra or their dependence on prescription painkillers sitting out on a desk for their neighbors or employees to see,” said Nell Geiser, an official with Change to Win in New York.

The watchdog groups say officials’ haste in approving the project may have caused them to inadvertently violate the Indiana pharmacy laws that existed at that time. Indiana law required pharmacists to provide “immediate and personal supervision” to other pharmacy staff. Two years later, in 2013, the Indiana pharmacy regulations were amended to allow certain types of remote supervision.

Polzin, the Walgreen spokesman, declined to comment on the allegations against Cover, except to say the company expects all its employees to follow all laws.

Call Star reporter John Russell at (317) 444-6283. Follow him on Twitter: @johnrussell99. ___

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Pharmacy board’s actions with Walgreens raises questions about ethics, patient privacy, safety
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MEI Pharma (MEIP) Hits $10 a Share: Can It Continue?

MEI Pharma, Inc. (MEIP) just hit a fresh high moving above the psychologically-important $10 per share level for the first time. This mark is very close to the 52 week high for MEI Pharma which has added more than 46% in the last 12 weeks, suggesting that decent momentum is present in MEIP.

But after this fresh 52 week high and the positive price momentum, investors have to be wondering if MEI Pharma can continue to push higher or if a pullback is overdue. One place to find the answer could be in the recent earnings estimate revision activity that is taking place in MEIP.

Recent Estimates

Despite the move higher in MEI Pharma’s stock price, we have seen pretty negative earnings estimate revisions as of late, which means that analysts are becoming more bearish about MEIP’s prospects. In fact, 3 estimates have gone lower in the past two months compared to just x higher, while the consensus estimate has moved in the wrong direction over the same time frame too.

We actually give MEIP a Zacks Rank #4 (Sell) based on this information and think that the move higher for this company might be a bit overdone. So while trading has certainly been good lately, estimates suggest that this run could soon enter a consolidation period and that a pullback may be ahead for this ‘sell’ ranked stock in the near term.

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INNATE PHARMA : Start of cohort expansion of Phase I trial with lirilumab and nivolumab in selected solid tumors

Start of cohort expansion of Phase I clinical trial testing the combination of lirilumab and nivolumab in selected solid tumors

MARSEILLE, France, March 31, 2014 (GLOBE NEWSWIRE) — Innate Pharma SA (the “Company” – Euronext Paris: FR0010331421 – IPH), the innate immunity company developing first-in-class drug candidates for cancer and inflammatory diseases, today announced the start of the cohort expansion portion of the Phase I clinical trial testing the combination of the two investigational checkpoint inhibitors lirilumab (anti-KIR) and nivolumab (anti-PD-1) in selected solid tumors.

Additional details are available at clinicaltrials.gov.

Lirilumab is licensed to Bristol-Myers Squibb Company (BMY) and this Phase I trial is being conducted by Bristol-Myers Squibb.

About the Phase I trial with lirilumab (anti-KIR checkpoint inhibitor; BMS-986015) in combination with nivolumab (anti-PD-1 checkpoint inhibitor BMS-936558) in solid tumors:

The purpose of this Phase I open label study is to evaluate the safety of the combination of lirilumab and nivolumab and to provide preliminary information on the clinical activity of the combination. The primary outcome is safety. Secondary outcomes include a preliminary evaluation of efficacy, as measured by tumor assessment. It is conducted in two parts: dose escalation and cohort expansion. In the cohort expansion, patients will be dosed for up to two years.

About lirilumab:

Lirilumab is a fully human monoclonal antibody blocking interaction between Killer-cell immunoglobulin-like receptors (KIR) on natural killer (NK) cells and their ligands. Blocking these receptors facilitates activation of NK cells and, potentially, destruction of tumor cells by the latter.

Lirilumab is licensed to Bristol-Myers Squibb. As part of the agreement between Innate Pharma and Bristol-Myers Squibb, Bristol-Myers Squibb holds exclusive worldwide rights to develop, manufacture and commercialize lirilumab and related compounds blocking KIR receptors, for all indications. Under the agreement, Innate Pharma is conducting the development of lirilumab through Phase II in AML.

About Innate Pharma:

Innate Pharma S.A. is a biopharmaceutical company conducting research and development of innovative immunotherapy drug candidates for cancer and inflammatory diseases.

The company specializes in the development of first-in-class therapeutic antibodies targeting receptors and pathways controlling the activation of the innate immune system. Three product-candidates resulting from the company’s research platform are currently being tested in clinical trials, two of which by partners Bristol-Myers Squibb and Novo Nordisk A/S.

Listed on Euronext-Paris, Innate Pharma is based in Marseilles, France, and had 84 employees as at December 31, 2013.

Learn more about Innate Pharma at www.innate-pharma.com.

Practical Information about Innate Pharma shares:

Disclaimer:

This press release contains certain forward-looking statements. Although the company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. For a discussion of risks and uncertainties which could cause the company’s actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque”) section of the Document de Reference prospectus filed with the AMF, which is available on the AMF website (www.amf-france.org) or on Innate Pharma’s website.

This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country.

For additional information, please contact:

Cohort Expansion http://hugin.info/155662/R/1772746/604013.pdf

HUG#1772746

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INNATE PHARMA : Start of cohort expansion of Phase I trial with lirilumab and nivolumab in selected solid tumors
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