VEGF Trap-Eye yields positive DME Phase II data

VEGF Trap-Eye demonstrated a statistically significant improvement in visual acuity over 24 weeks compared to macular laser therapy in patients with diabetic macular edema (DME), said co-developers Regeneron Pharmaceuticals (Tarrytown, N.Y.) and Bayer Healthcare (Leuverkusen, Germany) in a joint press release.

In this study, visual acuity improvement was assessed by the mean number of letters gained over the initial 24 weeks of the study, the companies said. The double-masked, prospective, randomized, multi-center Phase II trial evaluated 219 patients with clinically significant DME with central macular involvement. The patients were randomized to five groups.

The control group was given macular laser therapy at week one, and these patients were eligible for repeat laser treatments, but these were available in limited frequency of no more than at 16-week intervals. A total of two groups received monthly doses of 0.5 or 2.0 mg VEGF Trap-Eye throughout the six-month dosing period, and two groups received three initial monthly doses of 2.0 mg of VEGF Trap-Eye (at baseline and weeks four and eight) followed through week 24 by either every eight-week dosing or “as needed” dosing with specific repeat dosing parameters. At week 24, the macular laser therapy group (N=44;1.7 treatments) had gained +2.5 letters; the VEGF Trap-Eye 0.5 mg monthly group (n=44; 5.6 injections) had gained +8.6 letters; the VEGF Trap-Eye 2 mg monthly group (N=44; 5.5 injections) had gained +11.4 letters; the group receiving VEGF Trap-Eye 2 mg every other month, following three monthly injections (N=42; 3.8 injections) gained +8.5 letters, and the group receiving VEGF Trap-Eye as needed following three monthly injections (N=45; 4.4 injections) gained +10.3 letters.

Regeneron said additional results will be available later this year.

RiskMetrics Group questions legality of Novartis merger proposal to Alcon

RiskMetrics Group, Inc. (Ann Arbor, Mich.), a risk management and corporate governance firm, has voiced concerns about the adequacy and legality of the merger proposal by Novartis (Basel, Switzerland) to minority shareholders of Alcon (Fort Worth, Texas), Alcon said in a press release.

The questions of legality pertain to any attempt by Novartis to “unilaterally impose a full takeover on Alcon,” Alcon said in the release. RiskMetrics also found that the proposal is in breach of best practices for mergers and acquisitions.

The findings of RiskMetrics group largely echoed those of the Alcon Independent Director Committee, which previously concluded that the Novartis proposal is “grossly inadequate,” Alcon said in the release.

On January 4, 2010, Novartis announced it would buy Alcon for about $180 a share from majority stockholder Nestle. Novartis already owned 25% of Alcon; with Nestle’s share, Novartis would then own about 77% and planned to buy the remaining 23% for about $147 a share, the companies reported.

RiskMetrics determined that premiums paid on standard squeeze-out transactions were on average 18.0% and 23.8% above the one-day and four-week target price, respectively, as compared to the Novartis proposal, which offered a discount of 7.0% and 5.0%, respectively.

RiskMetrics disputed Novartis’ claims that Alcon’s stock was trading with takeover speculation. The risk management firm also noted that the price Nestle negotiated for its stake two years ago is “to a large extent irrelevant to minority shareholders,” who are now faced with a different price.

Survey provides “snapshot” of health IT jobs

Health professionals believe that between 50,000 and 200,000 new jobs will be created in health IT by the year 2015, according to a recent survey.

The American Society of Health Informatics Managers (ASHIM), a nonprofit healthcare organization for health IT professionals, conducted the survey in response to data from the United States Bureau of Labor Statistics, which indicated a national deficit of qualified health IT workers. ASHIM officials said the survey’s purpose was to provide an early stage snapshot of the jobs activities taking place around health IT in the United States.

The Salt Lake City based organization surveyed 135 health professionals, 20 percent of which were beginners in health IT (one year: student), 30 percent of which were intermediate (one to five years: decision influencer, working level) and 50 percent of which where experts (five-plus years: decision maker, senior management).

According to the survey more than 10 percent of respondents believe that more than 200,000 new jobs will be created in health IT by the year 2015. Almost 30 percent think 50,000 to 100,000 new jobs will be created. And more than 40 percent believe there will be 50,000 new jobs created.

The survey found that most health professionals believe that health IT employers want both IT and healthcare experience and knowledge and that health IT certification is valuable in the hiring process.

According to a blog posted on InformationWeek, San Francisco EMR provider Practice Fusion is not worried about finding employees that have clinical experience when it comes to hiring new staff. As Ryan Howard, the company’s CEO, explained to InformationWeek, his firm “doesn’t want to hire people with preconceived mindsets about EMRs.”

According to the ASHIM survey half of survey respondents believe that IT professionals will be the more likely than healthcare industry professionals and new students to seek additional skills to work in the industry.

“While employers are ramping up to adopt electronic health records, IT workers are looking to augment their skills to meet those needs and to effectively communicate their qualifications,” said ASHIM Senior Vice President Stephanie L. Jones. “ASHIM believes it is important to understand and support the evolving needs of the healthcare community and will continue conducting this survey, adjusting questions, to inquire about them,” she said.

Respondents cited consultants and trainers as most likely to fill new positions (63 percent and 61 percent, respectively), with sales and IT positions following closely behind.

Generation crossover profitability

The full-service, general hospital is evolving to a new conception. The growing clinical complexity, the need of performance transparency to evaluate quality, the rising costs and the increasing competition are questioning the old paradigm that any hospital could excel across a broad spectrum of clinical service lines.

Most private hospitals have nowadays shrinking profit margins, and they are focusing on analyzing cost-accounting data to determine the profitability of patients and the different procedures they offer. This analysis is uncovering very profitable margins in certain activities, while pointing at other activities that are a clear loss to the center.

This is why new healthcare services, including specialty hospitals and outpatient centers with low-cost structures, limited complexity, and focused, high-quality service are emerging. Competitors like these are raising the performance bar for general acute-care hospitals.

Well, the old paradigm says “all volume is good volume”… and this is clearly nonsense from an economical point of view. When a hospital understands where its true profitability and expertise lies, it can be focused to generate value while cross-selling other hospital services to current patients.

Of course, there will always be procedures that are necessary while being not profitable, so, some procedures should continue operating at some level to help hospitals meet basic community needs and cover fixed costs. But my point is, in the private space we will see more and more specialization to achieve better efficiency. A new generation of healthcare services is on its way.

FDA issues warning letter to researcher about promoting Ipsens Dysport

The U.S. Food and Drug Administration (FDA) has issued a warning to Miami Beach-based researcher Leslie Baumann, M.D., regarding promotional statements she made about Ipsen Biopharm’s (Paris) injectable frown line treatment Dysport (abobotulinumtoxinA), the FDA said in a letter.

Dr. Baumann’s promotional statements about Dysport, which were made to two magazines and NBC’s “Today Show,” were reportedly made in 2006, prior to the drug’s FDA approval. The statements were therefore in violation of the FDA’s regulations on pre-approval promotion, the agency said in its letter.

Dr. Baumann was involved as a researcher in Phase III trials of Dysport, also known as Reloxin, at the time she made the promotional statements, the FDA stated.

Dr. Baumann’s statements about Dysport included claims that its effects “last a month longer than Botox (onabotulinumtoxinA, Allergan, Irvine, Calif.),” the FDA letter cited. The FDA approved Dysport for treating forehead wrinkles and frown lines last spring. Ipsen granted distribution rights for the drug’s cosmetic use to Medicis (Scottsdale, Ariz).

Intrapreneurship

I was in a meeting recently and a discussion was proposed as to whom should be the owner of an idea originated inside a hospital. The employee, the institution, both?

It is clear to me that when a physician is hired to do research, the output of this research should belong to the hospital, and the hospital should acknowledge his/her contribution by giving away part of the benefits obtained from it. In this case, the new idea would probably have been unthinkable outside the premises of the hospital, without its infrastructure and assets, so it makes sense.

But what happens if an employee has an idea, let’s say, related to his/her field of experience but not necessarily linked to research? Let’s take this example, if an OR Nurse perceives a need and thinks about a solution to this need while in the operating room, let’s say a new medical device, should the idea belong to the hospital? Well, yes, the idea came to them because they were working at the hospital, but can the hospital claim any ownership over it?

Who is the owner of the idea, then? It may seem a futile discussion, but to me it represents the most important barrier to innovation in our healthcare systems, so it is far from trivial. Sometimes employees don’t engage in innovation because they perceive the ownership issue as unfair. If we want to foster innovation in healthcare, this question needs to have a clear answer. At the end of the day, it all goes down to how the hospital sees healthcare professionals: Do employees work for the hospital, or do they work at the hospital?

Are hospitals really willing to encourage innovation and intrapreneurship inside their premises? Are hospitals willing to create a culture of reward for those entrepreneurs? There is a lot to be gained here: if the hospital succeeds in fostering innovation, it can create a great environment to attract talent, lead, and generate economic value and social impact.

People do respond to incentives. That’s something I learned very early when dealing with innovators and entrepreneurs. Innovation should not trigger a war between the healthcare facility and the employee. It should always be a win-win scenario where both parties can create a lot of value if they cooperate. So, in my opinion this is not about claiming ownership, but about both parties acknowledging how far can they go and how better they will be if they work together, and share the ownership. That’s the answer that makes sense to me.

 

Gov. Paterson proposes bill to require disclosure from PBM

New York Governor David A. Paterson has proposed legislation that would increase transparency and promote competition among pharmacy benefit managers (PBMs) by requiring them to disclose additional drug information to health plans, doctors, and patients.
“PBMs perform a valuable service, but there is little oversight of their practices and little competition,” said New York State Health Commissioner Richard Daines, M.D., in the release. “The three largest PBMs—Medco, Caremark, and Express Scripts—manage pharmacy benefits for 200 million Americans, 95% of those who have prescription drug coverage.”

Under Paterson’s bill, PBMs would be required to disclose the actual use of drugs by the health plan’s participants, any conflict of interest that the PBM might have with the health plan, any increase in the net price to the health plan for a covered drug and the reason for the increase, and all contracts entered into by the PBM with a network pharmacy or pharmaceutical manufacturer. The bill would also notify patients and disclose any relevant clinical and financial information to prescribers before a PBM could switch a patient to a more expensive drug, the governor said in the press release.

Gene expression may be linked to retinoblastoma progression

The inactivation of the 16INK4A gene may play a key role in the progression of retinoblastoma, said researchers at Thomas Jefferson University’s Sbarro Institute for Cancer Research and Molecular Medicine (Philadelphia, Pa.) in a press release.

In a recent study, published in the Journal of Cellular Physiology, researchers focused on the 16INK4A due to its suspected role in retinoblastoma progression and its link to familial cancer predisposition.

In the study, Marco G. Paggi, M.D., Ph.D., and colleagues assessed blood samples taken from 29 patients and their parents. They found low to moderate 16INK4A protein expression in five of 11 (45%) retinoblastoma tumor specimens. They also found reduced p16INK4a RNA expression in blood in 16 of 29 (55%) retinoblastoma patients compared to normal controls. This reduction was associated with the depletion of the p16INK4a gene, the researchers said in the release.

The researchers also found reduced expression in at least one parent among nine of the 16 (56%) patients with reduced p16INK4a RNA expression. This suggests a heritable susceptibility to retinoblastoma, the researchers said.

Lead-based eye makeup may have fought infection in ancient Egypt

Lead-based eye makeup used by ancient Egyptians appears to have had antibacterial mechanisms that may have helped prevent common infections, said researchers from Paris’ École Normale Supérieure in a news report.

In a study originally published in Analytical Chemistry, Christian Amatore, Ph.D., and colleagues used electron microscopy and X-ray diffraction to assess 52 samples from containers of preserved makeup at the Louvre.

The makeup consisted primarily of four lead-based chemicals: galena, cerussite, laurionite, and phosgenite, the researchers said in the news report. Due to deterioration of the makeup samples over the centuries, the researchers were unable to identify what percent of the makeup was lead. The researchers contend that during periods in which the Nile River flooded, the population was particularly vulnerable to infections caused by particles that entered the eye, causing inflammation.

The dosage of lead in the makeup was a key factor in its potential benefits, Dr. Amatore said in the news report.

Abbott Receives U.S. FDA Approval for New Cataract Multifocal Intraocular Lens

Abbott Receives U.S. FDA Approval for New Cataract Multifocal Intraocular Lens

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