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

Bausch + Lomb Names Robert Steffen, O.D., M.S., Director of Clinical Affairs, Vision Care

Bausch + Lomb announces the appointment of Robert Steffen, O.D., M.S., to director, Clinical Affairs, Vision Care. In his new role, Dr. Steffen will provide clinical support for new product development.

Perfect Healthcare startups

Some months ago, an entrepreneur asked me which were the “qualities” that I valued the most in a healthcare start-up. It is really a fair question, but it has no easy answer. Investing is both a science and an art, and therefore it is difficult to categorize “qualities” that add up to the perfect company. There is no such thing as a “perfect” healthcare start-up.

However, I will give it a try (this is highly personal, different investors may provide very different answers). These are the qualities I value the most:

1. Compelling product or service that brings something new to the market, something different to what competitors are doing. An improvement over the current “gold standard” of practice, suggesting market uptake of the technology/service could be fast.
2. Strong intellectual property or at least solid barriers of entry ready to be built and not easily replicable by competitors
3. Target a big “niche” market, the bigger, the better.
4. High quality team, a team that can be trusted to accomplish its goals. Investors do no invest in ideas, but in the execution of ideas, therefore, the people behind the execution must be the most appropriate to the task
5. Smooth path to market, meaning the start-up should have definable and visible regulatory and clinical paths. This is mandatory in an extremely regulated market such as healthcare.
6. Be clear and focused, with a well thought business model.

To those “present” qualities I would add a “future” final one: the investor should be able to imagine who would be willing to buy the company in the future, and under what circumstances.

Abbott Enhances Pharmaceutical Pipeline with Acquisition of Facet Biotech

Abbott Enhances Pharmaceutical Pipeline with Acquisition of Facet Biotech

Bausch + Lomb Announces Ongoing Grant Support to Cornea and Contact Lens Residents

Bausch + Lomb today announced its ongoing support of North American cornea and contact lens residents who attended the Global Specialty Lens Symposium (GSLS), as well as the 2009 American Academy of Optometry (AAO) Meeting.

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