Pfizer's Chantix (varenicline), already under fire for safety issues, was targeted again late last week when the Institute for Safe Medication Practices, a nonprofit best known for its work in preventing medication errors, reported that the smoking cessation product was associated with more serious adverse event (SAE) reports than any other drug.

 looked at US adverse event reports received by FDA in the fourth quarter of 2007. During that period, only 35 drugs accounted for 100 or more SAE reports. (FDA received reports on 769 drugs in the period; the median number of SAE reports per drug was five.)

Chantix logged 998 reports, followed by interferon beta (640), etanercept (555), infliximab (554), fentanyl (404), and oxycodone (372). The list of events Chantix has been associated with since launch is strikingly diverse, including hyperglycemia/new-onset diabetes, convulsions, embolic and thrombotic events, hostility/aggression, psychosis, and vision disturbance. In all, there were 78 deaths, including 28 suicides, in which varenicline was suspected of playing a role.

The good and bad features of the data, according to ISMP:

On the plus side: "Because of the large numbers of patients exposed to the drug, these data are capable of detecting events that might not show clearly in relatively small, relatively short clinical trials. A large share of these reports were investigated and submitted by the drug manufacturer, presumably with consistent procedures, and potential events were selected using criteria that had previously undergone validation testing. In addition, these events occurred under real world conditions, and not the narrowly selected patient population in the clinical trials."

On the minus side: "[T]hese reports do not establish causality; most patients were taking multiple drugs; the event classification tool is limited to identifying potential cases, and is not definitive. Reporting is voluntary for consumers and health professionals, and little is known about reporting rates. Crude published estimates show that from 1 percent to 10 percent of all serious events are reported, but with wide variation among drugs, event times and over time."

What's more, the study's authors point out that it is possible that the number of reports was artificially boosted by adverse publicity surrounding Chantix or some other non-medical cause.

The challenge in sorting out Chantix's effects is that a number of the events might be accounted for, in part, by nicotine withdrawal. Nicotine, of course, has been linked in various ways with depression, schizophrenia, ADHD, and other psychiatric maladies, and it is thought that many potential patients use tobacco as a form of self-medication to help control their symptoms. These kinds of patients, as well as patients with recent cardiac disease and those taking a wide variety of drugs, were excluded from Pfizer's Phase III trials.

"We have concern about the use of varenicline by persons in settings where the risk of accident is high," the study concludes. "We recommend doctors and patients exercise caution in the use of varenicline, and consider alternative methods of smoking cessation. The FDA and the manufacturer should on a priority basis assess the information available and conduct additional research where current data are insufficient to resolve questions about the safety of varenicline."

Articles

A new study ranks Pfizer's anti-smoking drug as number one in generating adverse event reports. That's bad news for Pfizer-but in the long run, what does it really mean?

Chantix Under Fire

This year, hundreds of pharma employees have found themselves on the chopping block, and there seems to be no end in sight to the layoffs. However, one employment-consulting firm took a closer look at where displaced pharma workers are ending up, and the results were actually positive.

According to Lynn Brown, marketing vice president for Right Management, many of the industry's laid off workers are finding jobs at other pharma companies, or in jobs related to the industry, such as contract sales, research organizations, or the biotech sector.Between January 2007 and March 2008, Right Management interviewed 1,282 pharma employees who were displaced from their jobs, and found that:

73 percent found new jobs at the same or higher pay scale

84 percent did not have to relocate to find new jobs

43 percent found new positions through networking

15 percent found new opportunities through the Internet

12 percent landed new careers through employment agencies or search firms

8 percent obtained new jobs by applying directly with their new employers

Data was taken from satisfaction surveys completed by Right Management's clients; the firm did not break down the survey by job title or segment, so it's uncertain how many positions were sales, research and development, or executive level. But according to Brown, much of the downsizing comes from strategic change.

"One of the big things we find in the pharma industry is that when a company announces they're downsizing, other pharmas call us right away to say, 'If you are servicing the out-placing work for X company, could you make those candidates available to us, or set up a job fair'" said Brown.

Brown also noted that the number of former pharma employees reaching out for assistance is no bigger this year than in the last couple of years, but she said that the number of layoffs are expected to increase in the next few years. Pharma compares to the financial segment, which Right Management also covers. Both verticals have seen a major crunch in the last year, but employees in both fields are landing jobs in the same industry.

"These numbers are strong," Brown said. "It shows that people do find jobs pretty easily in pharma."

News Analysis

While pharma groans at the endless stream of layoffs, one headhunting firm has some encouraging news: Pharma might be cutting costs, but it's also hiring.

Survey: Pharma Layoffs Finding Jobs

Microsoft may have gotten a jump on the competition with the 

 last October, but now Google has entered the race with its own medical Web offering-Google Health.

Launched last week in an early beta mode, Google Health offers users a personal Web site to store their medical records and personal health information. They can also access third party services to learn about particular medical conditions, and relay up-to-date health information to their physicians.

So why is a search engine interested in healthcare?

"Google Health is an extension of Google's mission to organize the world's information, and make it universally accessible and useful," said Missy Krasner, product marketing manager for Google Health. "It puts the user in charge of his or her personal health information, allows them to decide who they want to share it with, and gives them the ability to take their data with them wherever they go," said Krasner.

Under the Google Health privacy policy, personally identifiable information is kept in private user accounts. User-specific, de-identified information such as anonymous log data is restricted, and cannot be shared with third parties. Google may use aggregate, de-identified data to publish trend statistics and associations (similar to what is published in Google Trends)-for example, Google Health users with diabetes who have received flu shot this year.


While many in the pharma industry are watching the Google Health launch closely, some are curious as to how pharma can partner with the search giant. ZDNet writer 

 on his blog that if pharma used Google's keyword advertising program to target Google Health, it would reach its most captive audience yet. "Pharma and the rest of the healthcare business is a massive business opportunity for Google," wrote Foremski.

 that it has no plans to run ads in Google Health at this time. Much like its other products-such as Google Earth-Google Health is free to anyone who uses it.

According to Krasner, once Google Health launches, its APIs will be made public, and any company with a value-add service can review the documentation to integrate. "We will ask, however, that services be transparent to our users about how they use personal health information, and how they comply or align with the Google Health privacy policy," said Krasner.


One of the biggest challenges will be how to put decades of medical information online. Inputting by hand could be tedious and off-putting to novices and tech-savvy users alike. To make data entry a bit simpler, Google has partnered with a handful of doctors, hospitals, and retail pharmacy chains that will allow users to download information directly from their healthcare provider to Google Health.

The initial list includes: Beth Israel Deaconess Medical Center, Cleveland Clinic MyChart, Longs Drugs, Medco, MinuteClinic from CVS Caremark, Quest Diagnostics, RxAmerica, and Walgreens Pharmacy.

"Healthcare today has many challenges and problems," Krasner said. "Google Health is not the solution to all of the problems, but this is a good start. We intend to keep growing our interests in health, and we will continue to listen and learn."

Can pharma take advantage of new healthcare data storage sites such as Google Health and Microsoft?s Health vault? Everyone?s curious, but no one?s talking.

Pharmaceutical Executive-05-28-2008

Chantix Under Fire

Survey: Pharma Layoffs Finding Jobs

Google Launches Health Site