Pharma news highlights: May

Ed Silverman

Pharmalot

This morning, Ed Silverman, shares his thoughts on some pharma industry news stories from throughout the month of May. From clinical trial results being announced at ASCO, to the sentencing of a lab employee in China for stealing compounds belonging to Merck, it’s fair to say a lot has been happening within the pharmaceutical and healthcare industries this month.

(Continued from “Pharma news highlights: April”)

The past few weeks have, in some ways, been dominated by news emanating from medical conferences, most notably, the American Society of Clinical Oncology annual gathering. As can be expected, these events are replete with results from clinical trials and follow-up discussions. But one particular study generated interest for reasons beyond the usual bottom-line findings.

A flurry of interest surrounded data for Zytiga, a prostate-cancer drug marketed by Johnson &amp, Johnson that was approved last year to treat advanced prostate cancer in patients who did not benefit from chemotherapy. Two months earlier, interim results were reported showing improved survival in patients who had not received chemo – the pill delayed cancer growth and helped patients live longer versus a placebo. As a result, an independent data monitoring committee suggested the study be halted.

The next shoe dropped at ASCO, where the results showed a 33 percent survival improvement, or about nine months compared with placebo. The benefit was better than expectations prior to the meeting, although fell shy of statistical significance. Nonetheless, Wall Street analysts believe the data suggests Zytiga is likely to be approved by the FDA to treat patients who have not been given chemotherapy.

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“Wall Street analysts believe the data suggests Zytiga is likely to be approved by the FDA to treat patients who have not been given chemotherapy.”

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But there were also chatter about the decision to halt the trial, given that statistical significance was supposedly close at hand. Although the trial demonstrated significant benefit in radiographic progression-free survival and secondary endpoints looked sufficient for FDA approval, there was criticism for ending the trial before statistical significance was achieved. The debate raised questions about the ethics of keeping some patients on placebo, the value of running a trial until all evidence is gathered and the composition of data monitoring committees that may be beholden to drug makers.

Shanghai lab employee sentenced for stealing

Another development that may have unnerved many multi-national drug makers was the sentencing of a WuXi Pharmatech employee in Shanghai for stealing compounds belonging to Merck. The lab employee pilfered compounds being developed into treatments for diabetes and hepatitis C, both of which are currently in Phase II testing, and attempted to sell them over the Internet by way of a middleman.

The move was soon detected by the drug maker and the employee was busted. Xiao Hao was given an 18-month sentence, including six months that were suspended, and ordered to pay $45,000 in restitution. The disclosure greatly embarrassed WuXi, which is one of the faster growing contract research organizations. The company vowed to improve operations and oversight.

Of course, thefts can happen anywhere. A former Sanofi chemist who worked in US headquarters in New Jersey was recently sentenced to 18 months in prison for stealing compounds and offering them for sale on the Internet. Nonetheless, the episode also served as a reminder that unfettered growth in Asia, particularly outsourcing crucial functions such as testing, comes with risks.

Vertex Pharmaceuticals’ embarrassment over study findings

One of the hottest drug makers, Vertex Pharmaceuticals, saw its reputation tarnished a bit recently thanks to an unexpected revision of interim study results for a combined cystic fibrosis treatment. A May 7 announcement mistakenly overstated the findings and, three weeks later, Vertex exec sheepishly disclosed the problem and blamed an unnamed contract research organization.

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“…drug makers are supposed to check the data before releasing it publicly.”

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Such gaffes are bad enough – drug makers are supposed to check the data before releasing it publicly. But then, there were reports that some Vertex execs and a board member sold chunks of stock during that three-week period when the stock rose 73 percent. The disclosure prompted US Senator Chuck Grassley, a pharma nemesis, to ask securities regulators to investigate.

The drug maker explained that the sales were permitted under a particular type of plan that allows execs to sell shares at pre-specified times. But the chain of events, nonetheless, raised questions about the timing of the disclosure for the revised results and to what extent, if any, this allowed the Vertex team to benefit.

US prescription painkillers debate

There was considerable handwringing in the US, where the US Senate Finance Committee launched a probe into drug makers that sell prescription painkillers as well as several patient advocacy groups and physicians due to “an epidemic of accidental deaths and addiction resulting from the increased sale and use of powerful narcotic painkillers.”

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“The debate over prescription painkillers has intensified each year.”

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Among the drug makers is Purdue Pharma, which sells OxyContin. Five years ago, a subsidiary pled guilty to felony misbranding in connection with a scheme to boost sales. The probe reflects “an epidemic of accidental deaths and addiction resulting from the increased sale and use of powerful narcotic painkillers,” according to the letters sent by the committee. They suggested there is growing evidence that drug makers “may be responsible, at least in part, for this epidemic by promoting misleading information about the drugs’ safety and effectiveness”.

The debate over prescription painkillers has intensified each year. A 2010 report from the US Centers for Disease Control and Prevention noted that the rise in overdose deaths in the US paralleled a 300 percent increase since 1999 in the sale of prescription painkillers. The drugs were involved in 14,800 overdose deaths in 2008, more than cocaine and heroin combined. And the misuse and abuse of prescription painkillers was responsible for more than 475,000 emergency department visits in 2009, a number that nearly doubled in just five years, according to the CDC.

In recent months, insurers have begun to take steps to thwart the rising abuse. In Massachusetts, for instance, the Blue Cross Blue Shield plan is about to restrict the ability of physicians to write new prescriptions for more than a 30-day supply of pills before a mandatory review by the insurer. However, patients with serious or chronic conditions, such as the terminally ill, will continue to receive opioids.

The next ‘Pharma news highlights’ can be viewed here.

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About the author:

Ed Silverman is a prize-winning journalist who has covered the pharmaceutical industry for the past 16 years. In addition to editing Pharmalot, he is currently an editor-at-large for Med Ad News.

Previously, he was a bureau chief for The Pink Sheet, the venerable industry newsletter, and a contributor to its sister publication, In Vivo magazine. Before that, Silverman worked as a business writer for The Star-Ledger of New Jersey, one of the nation’s largest daily newspapers, where he conceived and launched Pharmalot. During his 13-year tenure, he closely followed a variety of topics of concern to those who work for, and with, drug makers – drug development, mergers and acquisitions, regulatory oversight, safety and pricing controversies, and marketing issues.

Prior to joining The Star-Ledger, Silverman spent six years at New York Newsday and previously worked at Investor’s Business Daily, among other newspapers. He has a master’s degree in journalism from New York University and a bachelor’s degree in accounting from Binghamton University. Tethered to his laptop and Blackberry, Silverman lives in suburban New Jersey with his wife, three children, a sizeable Labrador retriever and a sneaky beagle.

What was your top pharma story from May?