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March 13, 2009
NEJM Publishes Results From The Landmark ATHENA Trial With Multaq(R) (dronedarone) In Atrial Fibrillation | www.medicalnewstoday.com
Dronedarone has the potential to be a major blockbuster for Sanofi (NYSE: SNY), given the magnitude of the problem it targets.
March 12, 2009
Hip deals put money in pocket | www.chicagotribune.com
The link between consultants and industry should not be stifled, lest it choke off innovation. However, accepting payment to buy loyalty to one product or drug probably goes too far.
Medicare - Carrot and the Stick!
July 15, 2008
Medicare Bil Includes e-Prescribing Bonus | www.modernhealthcare.com
Medicare will use a very small carrot to entice financially stressed physicians to employ electronic prescribing technology. Later on, Medicare will switch to the stick and penalize physicians who don't use such a system.
Access to physicians saved...for now!
July 14, 2008
Bill to Block Medicare-Fee Cuts | online.wsj.com
Cuts in Medicare put off for the time being, though only under substantial political pressure. This band-aid will last only so long; real reform of the flawed sustainable growth rate eludes us yet again! Bush and friends still favor the insurance lobby over senior's access to their physicians.
PhRMA wants to have their cake...then eat it too!
July 14, 2008
Drug Makers Say FDA Safety Focus Is Slowing New-Medicine Pipeline | online.wsj.com
Drug makers complain that the FDA's 'safety focus' slows down their development of new medications. They would love to see accelerated approvals; next they'll get the immunity from lawsuits that device makers have already received!
Lead In Toys/Contaminated Heparin vs Lower Cost Drugs!
May 22, 2008
China Muscles In On The Generics Industry | www.pharmalot.com
Any finished medication that a Chinese company tries to bring to the US (or European) market will face tremendous scrutiny. Look for Indian generic manufacturers (e.g. Ranbaxy, Dr Reddy's) to maintain their competitive edge due to their track record of safety. Eventually, lower cost generics may win the day if China allows stringent oversight of their production processes.
Beware the Unlicensed Practitioner!
May 22, 2008
Renal Failure Linked to Cosmetic Soft-Tissue Filler Injections | www.medscape.com
These 3 cases add to a number of others which have appeared in the news media, raising public awareness regarding procedures performed by unlicensed practitioners. Such cases are unlikely to impact the blooming market in FDA-approved fillers when administered by medical professionals.
May 20, 2008
Warning over drug trial’s effects on testing | www.ft.com
For too long big pharma has dictated which drugs will come to market and what they will cost. The entire American healthcare system is literally collapsing because of two costs: medications and bureacracy. Expect more payers to look for ways to bring down costs in the future.
Amgen: use an act to upstage science!
November 14, 2007
Amgen Spends Big Protesting Curbs On Anemia Drugs | online.wsj.com
Amgen, et al seeks to protect the lifeblood of their bottom line by recruiting a vulnerable patient group to do their lobbying for them. CMS is trying to follow the FDA in protecting patients and limiting inappropriate use of lifesaving but expensive (and sometimes dangerous) medicines.
Kaiser has problems (and has proposed reforms) with its quality assurance programs.
July 27, 2007
State fines Kaiser again | www.latimes.com
This article in the LA Times summarizes findings from an investigation by the Dept. of Managed Health Care in California. Quality assurance programs at a total of 8 Kaiser hospitals were the focus of state regulators; physician peer review seemed to garner the most attention. These types of programs are critical to a hospital's function since they serve to review and improve upon the care in question. Kaiser must be proactive in dealing with these findings, lest their reputation take a further beating.
Innovation? Not really, just an attempt to make money off of patients!
July 27, 2007
An Innovation in Health Care Opens at CVS/Pharmacy Stores in Knoxville and Chattanooga | money.cnn.com
MinuteClinic and the sundry of other retail clinics aren't providing any radical 'innovation' in patient care. All they're trying to do is make money off of patients by trying to meet what they perceive as a consumer demand: fast and easy access to the health care system. By getting patients to a provider in rapid fashion and with transparent pricing, they are delivering what patients want, not what patients really need. CVS (NYS:CVS) and the other companies that play host to these 'innovators' only have profit in mind. They lease space to the clinic with the belief that the patients will then fill their prescriptions their pharmacy. Any potential conflict of interest aside, the nurse practitioners at retail clinics are only able to diagnose and treat minor conditions; there is valid concern amongst those who have noted that these 'innovators' are in no way prepared to handle serious illnesses.
'New' (and expensive) doesn't necessarily equal better!
July 25, 2007
Older and cheaper pills just fine for diabetes | www.reuters.com
This article cited a comprehensive review from the Agency for Healthcare Research and Quality. The paper from AHRQ reviewed a litany of available clinical evidence on 10 commonly used medications for the treatment of diabetes. The investigators looked at a variety of clinically significant outcomes amongst the therapies (e.g. glycemic control, weight, cholesterol levels); there was insufficient evidence to draw conclusions on a number of important topics (e.g. all-cause and cardiovascular mortality). There was also a lack sufficient clinical evidence regarding some of the important 'newer' medications (e.g. DPP IV inhibitors), so these were not directly included.
Reduced healthcare costs or fatter insurance company profits?
July 16, 2007
Insurer offers healthy bonus | www.denverpost.com
Individual consumers have begun to shoulder increasing percentages of healthcare costs. As costs continue to rise, healthy consumers will become increasingly disillusioned with paying for the consequences of others' unhealthy lifestyles. If programs exist that reward consumers for making good choices, the insurance companies that offer them may grow in popularity. Consumers who fail to make good lifestyle choices may face higher premiums and in the end have an added incentive to change. These incentives and preventive measures can reduce the incidence of a number of diseases, in turn lowering insurance company costs.
Good news for generic manufacturers!
July 16, 2007
FDA Approves First Generic Versions Of Lamisil Tablets - Agency Also Approves Over-the-counter Terbinafine Cream To Treat Athlete's Foot | www.medicalnewstoday.com
Onychomycosis is a widespread and common condition, affecting up to 30% of the US population older than 60 (and 20% of people aged 40 to 60). Onychomycosis results in disfigured, often painful nails which many patients would like to have treated. None of the approved treatments for onychomycosis have particularly high success rates, though terbinafine seems to be the most effective in a number of comparison trials. Itraconazole is terbinafine's main competitor; griseofulvin and ketoconazole have fallen out of favor and topical ciclopirox isn't very effective.
ALKS 29 could boost the bottom line!
July 11, 2007
Alkermes Announces Positive Results from Phase 1/2 Clinical Study of ALKS 29 | www.pipelinereview.com
Psychosocial support in combination with drug therapy is key to the successful treatment of patients with alcohol dependence. Naltrexone is effective from a number of clinical standpoints, but nausea and hepatocellular injury are two of its side effects. Acamprosate can cause diarrhea and was no more effective than placebo in the COMBINE study, which limits its usability. Topiramate, ondansetron, and nalmefene may be other possible treatments, but further studies will be required before they gain acceptance. From a pharmacological standpoint, there is room for improvement when it comes to treatment of a problem which causes significant morbidity and mortality.
July 9, 2007
Lexicon Develops Antibodies that Lower Triglycerides and Cholesterol as Potential New Therapy for Heart Disease | www.pipelinereview.com
ANGPTL4 knockout mice were shown to have lower triglyceride and cholesterol levels than their counterparts, but an important question to ask is how this correlates to human subjects. If ANGPTL4 has a human correlate then this may be a novel therapeutic avenue which is still untapped. The buildup of atherosclerotic plaque is the result of an inflammatory process, and cholesterol is a major player in its pathogenesis. A monoclonal antibody against the right target (ANGPTL4?) could be a blockbuster drug if it were shown to stem (or reverse) such a disease. Lowering cholesterol levels and triglycerides via a biological drug could be a promising modality, but it would have to compete against a host of other effective options.
A new revenue stream or more Medicare frustration?
June 5, 2007
Quality reporting initiative may be too cumbersome | modernhealthcare.com
Depending on the practice, the PQRI may turn out to be a valuable new stream of dollars or just another frustrating part of Medicare. The difference between the two is the amount of work required to attach the PQRI code to each particular claim. For practices already invested in electronic medical records it shouldn't be a terrible burden, especially if those EMR's have integrated billing software. If a physicians' practice is not yet invested in an EMR, then the PQRI represents a substantial investment of time in exchange for only a 1.5% bonus payment.
The wrong solution for a vexing problem
June 5, 2007
Hospital-borne ailments face Medicare budget ax | www.indystar.com
Most healthcare professionals readily admit that the current error and infection rates in hospitals is far too high. Iatrogenic complications and nosocomial infections increase morbidity and mortality, as well as driving up healthcare costs; eliminating them entirely is probably not feasible. Therefore, CMS would be better off focusing on rewarding practitioners for good outcomes and hospitals for shorter lengths of stay. Taking the punitive approach simply engenders resentment towards Medicare and will likely result in trade groups lobbying Congress to prevent the enactment of such measures.
Bad news for Avandia and Glaxo
June 4, 2007
Heart Attack Risk Seen in Drug for Diabetes -- Avandia | www.nytimes.com
Even though the study in the NEJM was a meta-analysis, just the possibility of an association between Avandia and increased cardiovascular risk spells bad news for Glaxo. Physicians will be inclined to fear that Avandia will be looked upon as another Vioxx, and thus will be inclined to change therapies post haste. Even the potential for harm, whether or not it truly exists in a prospective, randomized trial, will hurt sales. Physicians have a duty to first do no harm, so many will utilize options with proven safety.
June 4, 2007
Insulins - Inhalable insulins unlikely to become blockbusters | www.pipelinereview.com
Inhaled insulin has a slim chance of making a big impact in the U.S. market for a number of reasons. There are questions regarding long-term safety that remain unanswered, especially amongst those with underlying pulmonary disease. Injectable insulin has a track record of proven efficacy, safety and is known to have a reliable pharmacokinetic profile.
Mobile Advertising Set To Soar ? Yes, But What Is The Engine For Growth
November 17, 2009
Roche Receives H1N1 FDA Emergency Use Authorization
November 16, 2009
From a physician point of view
November 16, 2009
Zetia Now Off Best Practices List for MI Prevention, But is Niaspan > Diet?
November 15, 2009
November 15, 2009
www.medscape.com
Rapid DNA Test to Detect Clostridium difficile Infection Approved by FDA Today
www.medicalnewstoday.com
Abbott To Acquire Evalve, Inc., A Leader In Minimally Invasive Cardiac Valve Repair Technology
www.pipelinereview.com
www.nytimes.com
www.docguide.com
FDA: Ongoing Omalizumab Study Shows Increased Number of Cardiovascular Events