Watchman shot dead

March 10, 2013 By Steven E. Greer, MD  The Healthcare ChannelF1.medium

PREVAIL, the much anticipated second major trial of the Boston Scientific device called Watchman was a bust. The trial endpoints were changed in midstream of the trial, but it still did not help. The efficacy endpoint was not met this time, contradicting the first major trial, PROTECT, where a small efficacy was found. (Even if the statistical endpoints were met, the primary endpoint was a clinically meaningless composite of stroke, systemic embolization, and cardiovascular caused death.)

The safety of the device has always been the show stopper. Read more »

The Weekly Summary

nelson-mandelaDecember 2nd – December 8th

In the general news, South Africa’s leader and icon, Nelson Mandela, died of natural causes at the age of 95. In the U.S., President Obama declared the ACA health insurance exchange website to be repaired, mostly. In the economy, unemployment continues to decline, leading many to expect the Fed to taper the bond buying “QE”.

In healthcare business news, Forest Labs (FRX) announced $500 Million in cuts and layoffs. JNJ was dealt bad press on the Daily Show over the bribery charges related to Risperdal. Also, OncoMed (OMED) stock doubled when a deal was struck with Celgene (CELG) to develop six anti-cancer stem cell therapies.

On the data front, the meetings season picked up with ASH the venue for good data on JNJ and Pharmacyclics (PCYC) leukemia drug ibrutinib. AbbVie (ABBV) also posted data on its leukemia drug, ABT-199. In the failed category, LLY‘s depression drug, edivoxetine, failed. Also, Lexicon’s (LXRX) irritable bowel syndrome drug, LX1033, failed.

From the FDA, presents were handed out galore. For the “Nice” companies, Gilead’s (GILD) Sovaldi was approved as the first HCV drug not requiring interferon, and was priced at $1,000 per pill. Also, Auxilium’s (AUXL) Xiaflex was approved to treat Peyronie’s curvature of the penis (The DTC TV ads should be interesting). In the “Naughty” category, components of the Intuitive Surgical (ISRG) robotic surgery systems were recalled. Biogen Idec’s (BIIB) hemophilia B drug, Alprolix, was delayed.

Over at CMS, Scrooge came to Myriad (MYGN) by lowering reimbursement on the BRCA breast cancer tests, and also to Edwards (EW) by lowering rates for TAVI.

Don Berwick, MD: Waste in the American Healthcare System

Dr. Berwick, former Director of CMS and former President and CEO of IHI, discusses the percentage of waste in the American Healthcare System. He also mentions the new proposals by nine specialties recommending that 45 procedures and tests be performed less often as they are almost always unnecessary.

The Weekly Summary

Macys balloonNovember 25th – December 1st  

In the general news, China stirred up trouble by claiming a larger airspace near Japan as their own. In the U.S., Thanksgiving passed by without trouble, despite a Midwest storm, and Obamacare was set back again, with another delay. Small business will be given until 2015 to fully comply.

In healthcare business news, Thanksgiving caused a near blackout of news. Bayer did bid $2.4 B for Norwegian cancer company Algeta.

On the data front, Orexigen (OREX) shares soared on Phase 3 data for weight loss drug Contrave.

From the FDA, the Google-backed genetic test company, 23andMe, run by the former wife of Google co-founder Sergey Brin, was shut down by the FDA for marketing the human genome tests before FDA approval. Restriction on GSK’s Avandia. Lastly, another drug won “Breakthrough” status, Portola Pharmaceuticals’ Factor Xa inhibitor “antidote”, PRT4445, to reverse drugs, such as Xarelto, Eliquis, and Lovenox.

CBS allows TV doctor to make egregious claims about statins

Can a “calculator” really tell doctors who should be on Lipitor?

Nortin Hadler, MD: lack of evidence for widespread statin use

The risk of diabetes associated with statin drugs

“You’re telling me this now?” Why the news is suddenly critical of statins and antidepressants

 Sanjay Kaul, MD: The Crestor JUPITER indication label expansion

Don Berwick, MD: Changing from fee-for-service to bundled payments in Medicare and Medicaid

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 »

Double arm transplantation

Gerald Brandacher, MD, Scientific Director of the  Composite Tissue Allotransplantation (Reconstructive Transplant) Program at Johns Hopkins discusses the first double arm transplant.

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.

Benjamin Sommers, MD PhD: Expansion of Medicaid and impact on mortality rates

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