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Gastroparing forms of naproxen and an awakening FDA

December 9, 2008

Analysis of:PN 400 Phase III Studies Show Clinically Meaningful Benefit in Reducing Gastric Ulcers Compared to Enteric-Coated Naproxen | www.astrazeneca.com

We first reported NSAID gastropathy over a quarter century ago when naproxen was first being introduced. At that distant time the FDA did not accept endoscopic lesions as a surrogate endpoint for the silent clinical ulcers and bleeds associated with about 2 per cent of those on sustainded NSAID therapy, such as naproxen. And as the same 2 per cent of elderly NSAID users continue to bleed and die gastrosparing combinations of proton pump or nitrous oxide donors are added to naproxen to mitigate this. But to prove the success of such preventative measures endoscopy is still required to antedate any dangerous bleed. Flash forward 25 years and the FDA is about to finally accept the endoscopic evidence of thousands of reports submitted to date.Thus, we might be ready to cast aside the black box warning for truly safer new combined therapy. That is progress even if too long delayed.

Personalized Medicine: Find a Target Disease Marker and Streamline the Drug Approval Process

November 26, 2008

Analysis of:Report: Novartis Could Cut Drug Development By a Year | www.therapeuticsdaily.com

In the era of pharmacogenomics and specific disease outcome surrogate markers a new opportunity exists to greatly shorten the drug approval process and provide advanced positioning of the newly approved agent based upon specificity of target. However, it will still take time to sort out serious adverse event data based upon host risk population issues. Yet that could partially be addressed with conditional approval pending rigorous post-marketing safety monitoring. Overall, not a bad trade-off.

A Formula for Cardiovascular Toxicity: Dose/Duration Therapy in the Elderly

November 26, 2008

Analysis of:FDA to examine CV side effects of several meds | www.fiercepharma.com

Whether an NSAID or Avantis, if you dose the sick elderly long enough and fully the recipe for CV toxicity awaits. Since so many co-therapies (10 or more) are common in long term elderly pharmacotherapy and so much pre-existing cardiovascular brews in this cohort, it is no surprise that heart attacks, strokes and other CV complications become part of the numbers game of serious adverse events of so many agents. For the reality is that these agents do not primarily prevent such common events over time in this high risk population and become confounded with inevitabe events as a "side effect" when in realigy they may simply represent an associated event instead. The ideal is to treat healthier, younger subpopulations if you hope for the safest outcomes. Otherwise face reality with a better acceptance of inevitable risk-benefit trade offs.

Cheating Generic Competition Invites Big Brother and Oversight

November 24, 2008

Analysis of:How a Drug Maker Tries to Outwit Generics | online.wsj.com

Cephalon brazenly distorting generic competition by overpricing its existing Provigil prior to introduction of a generic successor mimics the notorious example of the successful introduction of Nexium as a costly optic isomer of its parent Prilosec without pharmacological justification of the trumped up charges of its successor product beyond pure profit. Hiowever, that was then and this is now: a new administration determined to control pharmaceutical costs through head to head competition...not price fixing. Thus, costly power plays to distort the impact of generics on run-away profits can very well invite a cost-control Oversight Commission to penalize such sleight-of-hands and restore fairness to the intended market mechanisms that generic competition properly exemplifies in the face of health care cost over-runs.

Pain Relief with Ulcers, Strokes or Heart Attacks: Pick your poison!

November 19, 2008

Analysis of:Painkiller Risk Found for Heart Patients | www.nytimes.com

Nsaids are the most common therapy for arthritis and related pain problems. But in all forms they have up to a 2% risk of fatal GI bleeds. COX2 Nsaids such a Celebrex and COX2 related Voltaren have the lower risk of GI bleeds but a higher risk of cardiovascular complications. Proton pump acid suppressants such as Nexium mitigate the GI risk when used with Nsaids but increase the risk of cardiovascular complications and are associated with osteoposis fracture problems. All of this is amplified in the elderly. So how do you "pick your poison" when seeking pain relief:1.Do not take NSAIDs in full dose for any prolonged period of time.2.Ask your doctor if you even should be taking Nsaids instead of other analgesics such as Tylenol or weak opioids.3.Be sure you always understand the trade-off between benefit and risk based on your health profile.

Outsourcing clinical trials is outsourcing ethical standards as the price for global profits

January 31, 2008

Analysis of:New lease on life? The ethics of offshoring clinical trials | www.ft.com

Outsourcing at all levels of the global economy is a reality of today's marketplace. Medical economics is a huge slice of that pie. U.S. and European standards have provided the highest basis for judging quality clinical research and development at great cost and careful effort. Thus no surprise that multinational pharma now pushes the envelope while regulatory oversight remains mired in the bureacracy of past practices. As usual, deaths and serious side effects with attendant media frenzy will provide an uncertain rudder on this massive boat to future drug development masking future technological progress in the mire research on the cheap.

ADVANCED EOA is not so advanced...Revisiting a common old condition with new answers.

January 28, 2008

Analysis of:Advanced Erosive Osteoarthritis (EOA) | www.medscape.com

EOA has been well described and well known for over a half century. It is symptomatic in its inflammatory DIP/PIP erosive presentation and clinically has an end stage indistinguishable from common variety OA. Simple treatment with NSAIDs or hydroxychloroquin and contrast baths is uniformly suppressive of symptoms and signs of local inflammation without reversing erosions. So why the fuss? Simply because of ignorance, it has been confused with any variety of coincidental co-existing clinical conditions common to the elderly leading to wastful testing and overtreatment. And systemic therapy leads to unwanted toxicities.

Synvisc-One Could Be a Blockbuster: Bet on it!

December 17, 2007

Analysis of:Genzyme Receives FDA Response Letter on Synvisc-One (TM) | www.pipelinereview.com

Synvisc and other short-acting hyaluronate substances are classified for their "viscosupplementation" of compromised osteoarthritis synovial fluid allowing them to be regulated in the simpler device section of FDA. The biologically active immunomodulating activities of hyaluronates, however, is well known but require sustained exposure. Synvisc-One now provides this sustained exposure to the chronic osteoarthritis compromised joint and with six month repeat injects may reverse a debilitating disease process without risky, costly surgery afflicting multimillions.

4SC pyrimadine-acting agent in RA: too little info, too soon to interpret!

December 3, 2007

Analysis of:4SC announces initial results from its Phase IIa clinical study with SC12267 | www.pipelinereview.com

Initial report does not define any numbers, demographics, inclusions and exclusions related to co-therapies, co-disease, morbidities, compliance, intent-to-treat versus per-protocol outcomes differences. We are left with some marketing type observations about RA therapy and possible positive results without regards to statistical significance versus placebo. Requires much more detailed analysis of ADE's and SSE's, drop-out and much more complete pharmacology on this new agent in order to assess.

HOLD ON TO YOUR WALLETS BABY BOOMERS. Looking through a prism darkly.

November 30, 2007

Analysis of:Osiris Therapeutics Announces Positive One Year Data from Chondrogen Trial for Knee Repair | www.pipelinereview.com

First of all, this is not a hypothesis generating study but a fishing expedition after an orthopedic procedure intervention. Maybe that's what happens when you let orthopedists loose with statistical analysis. Patients entered the study without any baseline osteoarthritis (OA) required...just a torn meniscus. Meaning no level playing field to even judge the normally slow advance of OA by defined critical X ray changes. Absent controls for quad exercises, weight control, weight bearing activities and other analgesics we seem to have a mish-mash to judge even clinical outcomes. Since 2/3 of symptomatic OA patients do not respond predictably to intra-articular hyaluron it is a lousy control absent usual placebo group.

Betting on bone density and not osteosarcoma

November 20, 2007

Analysis of:FORTEO(R) Increased Spine Bone Mineral Density in Patients with Glucocorticoid-Induced Osteoporosis | www.pipelinereview.com

Bone density loss a known risk with exogenous corticosteroid therapy...but also sex, age, disuse, catabolic disease should factor into outcome risk for fractures as the feared outcome. Forteo(R) is currently a second line therapy for osteoporosis issues based on  cost and osteosarcoma theoretical fears from substantial animal data. For an elderly invalid with corticosteroid dependancy this data is encouraging with known osteopenia as a back-up to oral alternatives. But final trade off will be theoretical prevention of fracture potential versus unproven malignancy fears.

Massive statin market misfits waiting for safe alternative!

November 9, 2007

Analysis of:Health Canada Approves Natural Supplement for Management of Cholesterol | www.therapeuticsdaily.com

Block buster statins have captured major hypercholesterolemia market but many canniot tolerate them. Till now good alternatives lacking till recent Canadian regulatory approval of this chitin product of crustacian exoskeleton (sounds good enough to eat). Called Cholestol and available unofficially in U.S., it is cheap, safe (rare G.I. irritation only) and lowers LDL (bad cholesterol) as well as total serum cholesterol. 200 patient 4 month study basis of approval will lead to other comparisons but no drug interactions noted.

First of many topical NSAIDs can revolutionize safer treatment of common Osteoarthritis!

November 8, 2007

Analysis of:Voltaren Gel Receives US Regulatory Approval As The First Approved Topical Prescription Treatment For Pain Associated With Osteoarthritis | www.medicalnewstoday.com

Decades of world-wide use (outside of U.S.) of topical NSAIDs in common OA has demonstrated huge market with local efficacy on multi-product testing. Topical nsaids have been spared significant toxicity because of fractional bioavailability while achieving local pain and anti-inflammatory relief equal to oral NSAIDs on corroborating large meta-anaylysis surveys. Experience with topical NSAIDs has demonstratead that efficacy/safety in local OA will find successful use extended to all accessible joints (i.e. mcp, pip, and knees) regardless of initial listed indication for knees only.

Chronic Hepatitis C therapy huge target:new monotherapy role pre-mature

November 6, 2007

Analysis of:Pharmasset Presents R7128 14-Day Monotherapy Study Results for the Treatment of Chronic Hepatitis C | www.therapeuticsdaily.com

Massive need for chronic hepatis C therapy: think major chunk of population endemic in China alone. Target audience in U.S. significant, alone. FDA demands for safety and efficacy will take years beyond this early phase dose trial. If monotherapy works well, impact will be enormous. Nothing to match it yet.

Double or nothing: the host decides!

October 26, 2007

Analysis of:Abbott Scientists Create One Molecule With Two Antibody Functions | www.pipelinereview.com

Antibody specificity in complex autoimmune diseases as RA and SLE is not a zero sum game. Host responces can disease reactive versus suppressive. Introducing multiple reactive sites is "doubling down" on a more comprehensive mitigation of targets or opening a Pandora's box of new autoimmune expression. Far more clinically controlled focused research sensitive to exquisite individual variation in responces in these diseases of still unknown etiology lies ahead before realistic appraisal is possible.

Consider host-risk issue witth Remicade first!

October 26, 2007

Analysis of:Clinical Studies Show REMICADE® Reduces Incidence Of Bowel Surgeries In Ulcerative Colitis Patients | www.medicalnewstoday.com

Remicade is potent immunosuppressive effective in ulerative colitis and rheumatoid arthritis disease suppression. However, serious infection or sepsis past history, and strong cancer history should mitigate against its use as there are other non-immunosuppressive choices absent those specific risks. Apheresis is now available in those high risk host situations as an alternative in both ulcerative colitis and RA. In RA penacillamine, Placquinil, gold salts and various other non-immunosuppressive choice are alternatives, also.

Evotec: happy dreams?: TOO EARLY TO TELL

October 22, 2007

Analysis of:Evotec Reports Positive Top-Line Results in Phase II Study with EVT 201 in Elderly Insomniacs with Daytime Sleepiness | www.pipelinereview.com

Multiple hypnotics have come and gone so that issues of quality of initial sleep, undisturbed sleep and absence of hang over were all addressed in this small initial trial. Evotec based upon the GABA nuerotransmiter with partial agonist features is chemically attractive and the results support good efficacy but headaches and dizzyness at the higher dose may prove a potential problem. Hypnotic dependancy potential is not addressed by such  short term experience and can seal the ultimate acceptability and important labeling issues that are important to product survival in this competative market.

The Medicare straight jacket: logos over ethos.

October 18, 2007

Analysis of:Nonpayment for Performance? Medicare's New Reimbursement Rule | content.nejm.org

It had to happen. Under any guise a socialized medical schema survives by erecting rigid barriers through rigid rules designed with the efficiency of a cookie-cutter. Performance is determined by a committee absent the individual variations that clinical medicine presents through the variable expression of disease (with co-diseases), with drug outcomes (with co-drugs) in a patient who is more often not young, not healthy and usually suffering. Through such stereotyped interventions you supposedly save money, relieve suffering and reverse variable health threats...good luck, because everyone else loses and everything else is penalized.

Failed stomatitis biological dramatiizes simplicity over "super-science".

October 15, 2007

Analysis of:CuraGen Announces Top-Line Phase II Results on Velafermin | www.pipelinereview.com

*Severe stomatitis more than just a cancer therapy experience; common to various virus and medication reactions. *The simple generic "cure" has long been frequent, direct applications of vitamin E: cheap, safe and readily available and it works! *Looking for dramatic specific answers at the sub-cellular level of histone receptors and expensive biologicals may be scientifically interesting but meddling in a complex multi-receptor array of targets that may require sophisticated pharmacogenomic answers not justified for an already accessible objective.

COX 2's Are Not the Future! Same Issues/Same Hosts.

October 10, 2007

Analysis of:Prexige, Anti-inflammatory Drug, Withdrawn In Canada | www.medicalnewstoday.com

ASA was replaced by Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) as "better tolerated" and as simpler to take until G.I. ulcers and deadly bleeds became a real threat (that later Prilosec-type agents were able to mitigate). An iso-enzyme of NSAIDs (COX 2) proved to have reduced ulcer danger but has been found to be specifically associated with cardiovascular complications, renal and liver dysfunction The host population at risk is the elderly who use all forms of NSAIDs most and so often have so many other co-drugs (interactions) and co-diseases (complication prone) that expensive COX 2 drugs have proven to fail their safety limits.

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