Tag: pharmaceuticals

Should the FDA relax in the search for new cures?

Jan 9, 2009• 1

By Matthew Holt

Over at DiabetesMine #1 health blogger Amy Tenderich has very important post. She and several fellow travelers are appealing to the FDA to strike a balance between safety and progress in allowing new diabetes treatments.

The FDA of course has been beaten to a pulp these last few years because it’s played footsie with the drug industry and ignored several potentially damning studies, with the result that the number of drugs withdrawn from the market has been much higher than in previous years.(Vioxx, Phen-Fen, Baycol, et al).

I’ve always felt that the FDA’s role should not to be a black/white (dangerous/safe) stamp of approval, but instead it should be the honest broker of getting all the data out there. As Amy and her crew point out, some diabetics may be prepared to take a risk of higher long-term cardiac complications in return for a medium term gain from a new medication. Something similar is certainly true in terms of hormone replacement therapy.

Global 2.0: A lesson from Indian pharmacies

Sep 6, 2008• 4

By Sarah Arnquist

MedPlus Pharmacies is arguably one of India’s fastest growing health companies. Since its launch in 2006, the retail pharmacy chain has opened 500 stores in several Indian cities and serves roughly 25,000 customers daily.

Medplus In a space no larger than a walk-in closet tucked into neighborhoods, local MedPlus pharmacists dispense low-cost but guaranteed high quality medications and track customer orders with a sophisticated electronic record system.

In many respects, the MedPlus business model could not be more different than that of U.S. retail pharmacy chains. I spoke recently with Apu Gupta, MedPlus COO, who explained to me that the business’ success is rooted in its uniquely Indian model developed by founder and CEO Dr. Madhukar Gangadi while he was a student at Penn’s Wharton School of Business.

MedPlus’ business model would likely not work outside India, and the Walgreens or CVS model would likely not work in India, Gupta said. This got me to thinking about a term I first heard last spring: Global 2.0.

Personalities drive prescribing

Aug 14, 2008• 4

By Merrill Goozner

PharmaLive, the website that bills itself as the "Pulse of the Pharmaceutical Industry," recently ran this press release from PeopleMetrics, a marketing research firm. The group surveyed physicians to measure the effectiveness of sales representatives pushing atypical antipsychotics for five leading US-based pharmaceutical companies: AstraZeneca, Bristol Myers Squibb, Janssen, Lilly and Pfizer.

The survey’s questions measured physicians’ response to the salespersons who visit their offices. Depending on the answers, the docs were categorized as either Fully Engaged, Engaged, On The Fence and Disengaged. "Overall, 31% of physicians were Fully Engaged or Engaged, while the largest proportion of physicians (53%) were On The Fence," the research showed.

"Sales representatives must develop personal relationships with their
physicians to achieve the highest levels of engagement," the survey
concluded. "In fact, emotional components such as friendship with the
reps are the strongest indicators of Fully Engaged physicians. . . We
find that this emotional dimension is key in understanding physicians’
perceptions toward their reps and the pharmaceutical company as a
whole" and will be "the most impactful drivers of physicians’
prescribing behaviors."

Gee, and I thought it was the peer-reviewed literature they dropped off showing how well the drugs work. Silly me.

This post first appeared on Merrill Goozner’s blog, Gooznews.

Viagra prescribed more safely online than in regular practice?

Aug 8, 2008• 9

By Matthew Holt

Really? Can this be true? Well so says a bunch of academics writing in the Mayo Clinic’s journal.

They looked at records of questionnaires taken and prescribing decisions made by a licensed, regulated online pharmacy called KwikMed — that is trying very hard to establish itself as ethically and legally different from those fly by night guys whose spam comments will rapidly attach to this post! They looked at the various outcomes and end points including safety and level of counseling and found that the online system produced results as good as or better as those found from a big records review in an unnamed (not surprisingly!) large multi-specialty clinic in Salt Lake City, UT.

Now obviously the ability to create an online questionnaire for specific conditions with clear inclusion/exclusion criteria (like ED or hair loss) means that as clear a picture can be gained in most cases from a good history taken online–and probably the history will be given more honestly by the patient. Plus the rigor of the history is probably better than one taken in a rushed office visit. And then it gets reviewed by a doctor who may recommend another approach but most times agrees and sends the Rx on to be filled.

CollabRX aims to make drug development faster and cheaper with power of Internet

Aug 1, 2008• 3

By Sarah Arnquist

Harnessing the collective power of patients needing new treatments and therapies to speed up and lessen the cost of the development process drives a new venture called CollabRX. Callobrx

Jay M. Tenenbaum, Collab RX founder, learned he had melanoma in 1998 and had a recurrence five years ago. He found many patient advocacy groups working to raise awareness of the deadly skin cancer and to raise money for research, but felt they lacked collaboration.

Tenenbaum saw a business opportunity in that lack of collaboration and founded CollabRX with $2 million of his own money.

The Wall Street Journal profiled Tenenbaum and his new company this week. An excerpt from the Journal:

CollabRx aims to expand patient-funded research
further by connecting individuals or small numbers of patients with the
tools and services they need. Each CollabRx client is assigned a
project manager, a specialist who works with patients to devise a
research strategy, interpret the results and later steer any promising
prospects toward development of possible treatments.

CollabRx calls such integrated projects virtual
biotechs because they aim to replicate many of the steps typically
taken as part of a pharmaceutical or biotech company’s search for a new
drug. As the number of private labs available to do sophisticated
research grows, many parts of the drug-development process can now be
contracted separately. Researchers in various locations can share
information and material by means of a Web-based network created by
CollabRx software engineers.

Stealth marketing: doctors and public radio

May 11, 2008• 3

By Sarah Arnquist

Over at Slate, veteran health care journalists Shannon Brownlee and Jeanne Lenzer raise tough questions about the lack of disclosure regarging four doctors’ ties to the makers of antidepressants, while they told audiences of public radio stations nationwide that the connections between suicide and antidepressants were largely overblown.

The radio program, Infinite Mind, produced the show in April titled Prozac Nation: Revisited.

Here is writers’ nutgraph:

"The radio show, which was broadcast nationwide and paid for in part by
the John D. and Catherine T. MacArthur Foundation, had the air of
quiet, authoritative credibility. Host Dr. Fred Goodwin, a former
director of the National Institute of Mental Health, interviewed three
prominent guests, and any radio producer would be hard-pressed to find
a more seemingly credible quartet. Credible, that is, except for a
crucial detail that was never revealed to listeners: All four of the
experts on the show, including Goodwin, have financial ties to the
makers of antidepressants. Also unmentioned were the "unrestricted
grants" that The Infinite Mind has received from drug makers, including Eli Lilly, the manufacturer of the antidepressant Prozac."