Bioabsorbable stents

William O’Neill, MD of Henry Ford discusses bioabsorbable coronary stents, and the U.S. Abbott trials. They devices are approved in Europe and being well adopted. Because the stent goes away, long-term anticoagulation is not required, and aneurysms are possibly less of a problem.

The Weekly Summary

May 13^th – May 19^th  

In general news, Europe is entering a double-dip economic depression. In the U.S., triple scandals have paralyzed the Obama administration, ranging from the IRS targeting conservatives, to spying on AP journalists, to the growing Benghazi cover-up. In the rare good news category, the budget deficit is much smaller than last forecast, and the stock market bubble continues.

In healthcare mainstream news, actress Angelina Jolie underwent an elective double mastectomy because of her genetic risks. An abortion doctor in Philadelphia was found guilty of several counts of murder. The psychiatry bible DSM-5 was released. Lastly, former nurse, Marilyn Tavenner, became the first actual Director of CMS since 2006.

In healthcare business news, Ranbaxy shares fell after a $500 Million fine related to unsafe drug manufacturing and pleaded guilty to felony charges (but no human was arrested). Roche is exploring sales of diabetes blood glucose device unit. Aegerion (AEGR) stock was up 33% on hopes for Juxtapid, and MannKind (MNKD), left for dead, rebounded on rumors that Afrezza (inhaled insulin) might be approved and partnered.

On the data front, ASCO abstracts dominated the news. Bristol-Myers Squibb’s (BMY) Yervoy/anti-PD1 combo data were in-line with expectations in melanoma patients. Roche’s next-generation Rituxan (to fend off patent expiration) posted good data in CLL. Tesaro (TSRO) stock appreciated on good data for niraparib for breast and ovarian tumors. Halozyme (HALO) was up on ASCO data for pancreatic cancer drug PEGPH20. Puma (PBYI) stock spiked when data on Glaxo’s (GSK) drug Tykerb, that would compete with Puma’s neratinib, was disappointing. Sanofi (SNY) reported good data on JAK2 to treat myelofibrosis. Lastly, Gilead’s (GILD) idelalisib was effective for leukemia in Phase 1, as the company tries to enter oncology markets.

From the FDA, several new indications for existing drugs were approved, including Tarceva (Roche), and Simponi (JNJ). A Roche diagnostic test was approved for gene mutations in lung cancer, as a companion to Tarceva. Bayer’s Xofigo was approved for prostate cancer. Lastly, JNJ will stop all sales of metal-on-metal hip implants.

Reliable gun violence statistics

February 12, 2013 By Steven E. Greer, MD

In the wake of the Newtown, Connecticut massacre of 20 first graders and six brave adults, the debate over gun control is the main topic of the news. Consequently, both sides of the debate are using statistics to support their arguments. However, gun violence statistics are quite often inappropriately cited by untrained “pundits” or lobbyists.

A summary of some of the most important evidence and data: Read more »

Reasons for permanent slowdowns in healthcare spending growth

May 17, 2013- Interviewed by Steven E. Greer, MD

Since 2010, the rate of growth in healthcare spending has been the lowest in decades, even slower than the HMO era of the 1990′s. This had been attributed simply to the recession, but fundamental changes to Medicare and private insurance have taken place, as well as changes to costly new technology (e.g. medical imaging, prescription drugs, etc).

Analyzing all of this, David Cutler, PhD, Harvard economist and White House advisor, recently published a paper in Health Affairs. We interviewed him. In Part 1, he gives a general overview. In Part 2, we discuss in more detail bundling, high-deductible insurance, tiered drug formularies, and other specific changes that have been taking place.

Renal denervation devices to treat hypertension

William O’Neill, MD of Henry Ford Hospital discusses renal denervation devices used to treat refractory hypertension. He is involved with the Medtronic device trials.

Antoni Ribas, MD discusses cancer drugs targeting the PD1 signaling pathways

Interviewed by Steven E. Greer, MD

March 19, 2013

The upcoming ASCO meeting will be dominated by numerous presentations relating to new cancer drugs targeting the cell surface molecule called PD-L1, and the immune cell receptors PD1. Early Phase 1 data in non-small cell lung cancer, renal cancer, and melanoma demonstrated such impressive sustained tumor responses that they papers were published in the New England Journal of Medicine. Antoni Ribas, MD of the UCLA Jonsson Comprehensive Cancer Center is involved in trials testing some of these new molecules. In the video interview, he explains the mechanisms of action, reviews data published so far, and previews new data to be seen at ASCO.

UCLA’s Dr. Edward Garon discusses anti-PD1 and anti-PD-L1 drugs treating NSCLC

March 26, 2013 Interviewed By Steven E. Greer, MD

UCLA’s Dr. Edward Garon discusses anti-PD1 and anti-PD-L1 drugs treating NSCLC in early trials, with remarkable tumor response rates.

The Damon Runyon Cancer Research Foundation panel

March 8, 2013  By Steven E. Greer, MD

We interviewed three of the oncologists and industry executives who spoke at the Damon Runyon Cancer Research Foundation in Cambridge, Massachusetts in March. They were:

• Richard B. Gaynor, MD, Chair, Accelerating Cancer Cures; Vice President, Cancer Research/Clinical Investigation, Eli Lilly
• Michael J. Vasconcelles, MD, Senior Vice President, Oncology Clinical Development Millennium; The Takeda Oncology Company
• Catherine Wu, MD, Dana-Farber Cancer Institute

The first topic of discussion was Read more »

The Weekly Summary

Benghazi

May 6^th – May 12^th  

In general news, a study showed that environmental levels of CO2 are the highest in human history. The investigation into whether Hillary Clinton and the State Department covered up the death of the American ambassador in Benghazi, Libya, picked up momentum. New Jersey Governor Christie received a Lap-Band procedure for his obesity, and Iron Man 3 earned $700 Million in the box office, worldwide.

In healthcare business news, Actavis (ACT) might acquire Warner Chilcott (WCRX), following the failed attempt to merge with Valeant (VRX).  Eli Lilly’s (LLY) CEO underwent CABG surgery. The WebMD CEO announced his departure after only a year. Lastly, struggling Vivus (VVUS) announced plans to possibly partner with a Big Pharma to market weight loss drug Qsymia.

On the data front, LLY’s lymphoma drug, enzastaurin, failed. Also, Baxter’s (BAX) Alzheimer’s drug, Gammagard, failed.

From the FDA, AbbVie (ABBV) was the latest to receive Breakthrough status, and also for an HCV drug regimen. Recall, BMY received breakthrough for its HCV regimen last week. GlaxoSmithKline (GSK) received approval for COPD drug Breo Ellipta. Medtronic (MDT) had a new ICD approved. Lastly, Impax (IPXL) and Actavis received approval to make a generic version of Endo’s (ENDP) Opana opioid pain pill.

President Obama forced to campaign for ACA law as 2014 nears

The slowdown in elective procedures and reduced demand for costly drugs

Updated May 7, 2013- The demand for prescription drugs and medical devices is continuing to slow down, as new forms of employer-provided health insurance require greater out-of-pocket expenses for costly drugs or procedures. After the first quarter of earnings, almost all drug companies reported slower than expected sales. The Healthcare Channel was the first to bring up this issue back in 2010.

October 29, 2010

In Part 5 of the Weekly Summary show, Frank Eismont, MD, Chairman of The Department of Orthopaedics at The University of Miami Miller School of Medicine, leads the roundtable discussion on the slowdown in elective procedures such as orthopedic implants and spine fusion caused by the high unemployment and fewer insured. The same factors are also causing reductions in what would seem to be non-elective therapies, such as branded diabetes drugs and coronary stenting.

Will healthcare spending really continue at its current pace?

Interviewed by Steven Greer, MD

The consensus among government budget forecasters such as the CBO is that the current growth rate of healthcare spending will continue and result in healthcare becoming 30% of the GDP. It is not well appreciated that the CBO is often very inaccurate because the models their staff use incorporate past or current growth estimates in perpetuity. In contrast, Wall Street financial analysts are paid to make the tough judgment calls that tweak future-year growth estimates based on fundamental analysis.

With the various healthcare reform proposals being “scored” by the CBO now, the issue of whether healthcare will indeed balloon out of control is of vital importance. The HCC interviewed Harvard economics professor David Cutler who takes a contrarian view that healthcare spending will slow and perhaps decrease due to a variety of factors.

The Miami Summit on Healthcare Spending Reduction

June 29, 2010

Produced and interviewed by Steven Greer, MD

CurrentMedicine.TV and The University of Miami Health System hosted a roundtable discussion on the general topic of ways to reduce the growth of healthcare spending. With the passage of the healthcare insurance coverage expansion law, or Affordable Care Act  (ACA), in order to make the plan budget neutral, at least $500 Billion in healthcare spending will need to be trimmed just to reduce the growth rate. Nothing like that has ever been accomplished by the Federal government.

The panel of experts were:

• Donna Shalala, PhD, President of The University of Miami and former Secretary of the Health and Human Services Department for eight years under the Clinton administration.
• Pascal Goldschmidt, MD, Dean of The Miller School of Medicine, The University of Miami, and CEO of the UM health System
• Ralph Sacco, MD, Chair of the Department of Neurology, The Miller School of Medicine, The University of Miami
• David Cutler, PhD, Professor of Applied Economics, Department of Economics and Kennedy School of Government, Harvard University, and senior adviser to President Obama on health policy
• Steven Greer, MD, moderator

In Part 1, The following topics were discussed:

• Pharmaceutical price negotiations by Medicare, the VA, and other Federal agencies
• How PBM’s do not pass along to the payer the rebates they negotiate on drug prices
• Durable medical goods pricing
• The increase in the Medicaid population under the ACA and the stresses to State budgets
• The Medicare “Doctor Fix”
• Cuts to Medicare Advantage
• Cuts to oncology practices
• How the ACA healthcare reform will not decrease spending overall, but rather slow growth

If you do not see the embedded video below, click here

The Weekly Summary

April 29^th – May 5^th

In general news, Israel made an air strike into neighboring Syria, as the Syrian civil war escalates. In the U.S., the monthly jobs report was better than expected, adding 165,000 jobs, and unemployment dipped to 7.5%. Also, Richard Branson fired the rocket engines on his Virgin Galactic passenger spaceship, in a low altitude test, making commercial space flight closer.

In healthcare business, earnings seasons continued, with more signs of lower demand for drugs and devices. PFE lowered guidance, and sales of HCV drugs for MRK and VRTX were down. AUXL continues to be unable to launch Xiaflex, and MDT cut 230 jobs in the spine divisions. In banking M&A, Bayer will buy Conceptus (CPTS) for $1.1 B, to get into the contraceptive business. Lastly, MRK and PFE entered into a partnership to market ertugliflozin for Type 2 DM.

On the data front, Gilead (GILD) announced important news with the success of the LONESTAR trial of sofosbuvir (7977) and ledipasvir, which cured 95% of HCV patients after 8 weeks of therapy. GILD earnings were strong as well. Regeneron (REGN) stock was up on bad news for rival drug DARP-in made by Allergan (AGN). AGN’s bimatoprost to treat baldness also failed.

From the FDA, the “morning after” birth control pill was approved to be sold without a prescription to 15-yo girls. Merck’s (MRK) combo-cholesterol drug, Liptruzet (Generic Lipitor plus Merck’s Zetia), was approved. Raptor Pharmaceutical’s (RPTP) Procysbi was approved for orphan disease nephropathic cystinosis. Bristol-Myers (BMY) received Breakthrough status for their three-drug regimen (daclatasvir, asunaprevir,  BMS-791325) to treat HCV, giving it a possible time advantage over Gilead’s sofosbuvir (7977). Also, JNJ’s Sedasys system that delivers anesthesia during colonoscopies was approved.

Lastly, in the bad news category, Titan’s (TTNP) Probuphine was rejected, as were Gilead’s two HIV drugs. A panel advised against approval of AVEO’s tivozanib and the stock imploded 50% and a panel also advised against Delcath’s (DCTH) chemo system, the Melblez Kit.

The Massachusetts General trauma response to the Boston bombings

Interviewed by Steven E. Greer, MD

Paul Biddinger, MD, Medical Director for Emergency Preparedness, Massachusetts General Hospital and also Chairman of the Massachusetts Medical Society’s Committee on Preparedness, discusses how his hospital, and all of Boston, responded to the several hundred severely injured patients after the Boston terrorist bombs. Lesson from the battlefield helped saves lives, as did the fact that Boston possibly has more Level 1 trauma centers than any other city in the world.

How Boston medical centers prepare for unconventional weapon attacks

Interviewed by Steven E. Greer, MD

Paul Biddinger, MD, Medical Director for Emergency Preparedness, Massachusetts General Hospital and also Chairman of the Massachusetts Medical Society’s Committee on Preparedness, discusses how his hospital prepares and trains for the event of chemical and nuclear (dirty bomb) attacks.

Also

TAVR Finances: William O’Neill, MD

Interviewed by Steven E. Greer, MD

The clinical adoption of  Transcatheter Aortic Valve Replacement (TAVR) has been slower than expected due to reimbursement rates that cause most cases to be financial losses for the medical centers. We discussed the issue with TAVR pioneer, William O’Neill, MD, of the Henry Ford Hospital.

The Weekly Summary

5 living presidents

April 22^nd – April 28^th  

In general news, the price of gold crashed and computers problems caused trading irregularities at the CME. Also, a hacked Twitter account of the AP with a bogus comment about a threat to the U.S. caused yet anther flash crash in the stock markets.

In the general news, earnings season continued, with both the drug and medical device stocks indicating that consumption of pharmaceuticals and medical devices are down. Edwards Lifesciences (EW) imploded 23% the day after it lowered full-year guidance. Elsewhere, counterfeit versions of Allergan’s (AGN) Botox were found in the supply chain, similar to counterfeit Avastin previously. The merger of Valeant (VRX) and Actavis (ACT) is stalling. Theravance (THRX) plans to split into two companies. Roche is cutting 170 US jobs. Novartis (NVA) is being sued a second time for alleged kickbacks to doctors. Glaxo (GSK) is the latest company to outsource R&D. Lastly, cash-strapped states are suing drug companies over deceptive drug advertising.

On the data front, high stroke rates in the HeartWare (HTWR) LVAD raised eyebrows. Also, a link between the use of anti-depressants in pregnancies and subsequent autism was suggested.

From the FDA, Merck’s (MRK) anti-PD1 drug in the melanoma indication won a coveted Breakthrough status. Cook Medical recalled the peripheral Zilver stent. Lastly, another black box warning was added to codeine drugs used in the pediatric population

The other casualty from Boston: Old-school TV news

April 27, 2013 By Steven E. Greer, MD

On April 15, 2013, at 2:49 PM, two terrorist bombs exploded at the finish line of the Boston Marathon, killing three, and blowing off the legs of many others. The other casualty of the event was TV news. Already hanging on to life by a thread as ratings decline double-digits, year after year, and as few people under the age of 30 pay for cable TV, the broadcast TV news suffered mortal wounds in the aftermath of the Boston bombings.

In vain attempts to be relevant in the world of the Internet with instant posts on Twitter and news blogs, Read more »

The IOM report on counterfeit and substandard drugs

Prashant Yadav, PhD, Director, Health Care Research Initiative, University of Michigan, discusses the IOM report he helped author that investigated the extent of the problem of counterfeit and substandard drugs. The FDA commissioned the report in the wake of high profile problems, such as counterfeit Avastin and the meningitis outbreak caused by substandard drugs.

Since 80% of the active ingredients of medicinal drugs consumed by Americans come from Chine, India, and other countries, the supply chain is complex. He explains that no adequate tracking system exists for all of the components of the drug, from start to completion to the store shelves. In fact, the tracking of FedEx or UPS packages is far more sophisticated than the tracking of drugs.