The Weekly Summary

Virgin Galactic

April 29th – May 5th

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.

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

5 living presidents

April 22nd – April 28th  

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.

 

Jennifer Temel, MD, Vicki Jackson, MD: Early palliative care improves outcomes in lung cancer patients

Produced and interviewed by Steven Greer, MD

A group from Harvard published a paper in The NEJM that showed early initiation of palliative care in a group of lung cancer patients resulted in improved outcomes and a survival benefit comparable to chemotherapy studies. The trial was randomized. Both cohorts received chemotherapy, with one group having the additional palliative care. Interestingly, although the palliative care group had nearly a three-month longer median survival, the patients opted for less aggressive chemotherapy at the end of life.

In Part 1, medical oncologist Dr. Temel summarizes the paper.

In Part 2, Dr. Jackson, acting Director of Palliative Care at the Massachusetts General Hospital elaborates on the specific procedures and counseling provided.

TAVR collaboration: William O’Neill, MD

Interviewed by Steven E. Greer, MD

William O’Neill, MD, Director of the Structural Heart Disease Center at Henry Ford Hospital, discusses how the new Transcatheter Aortic Valve Replacement (TAVR) procedures are creating productive collaborations between cardiac surgeons and interventional cardiologists. As a result, more traditional open heart valve replacements are also happening. He then discusses the CMS reimbursement policy that makes TAVR cases money losers for the medical centers.

FDA official, William Maisel, pleads guilty to crime, keeps job

April 24, 2013 By Steven E. Greer, MD

In July of 2012, the New York Times reported on an FDA scandal of the agency spying on internal whistleblowers, by hacking into their work and personal emails. The FDA employees who were the victims filed lawsuits, and The Healthcare Channel interviewed the plaintiff’s lawyer, Stephen Kohn.

One month later, a senior FDA official who was named as a defendant in the lawsuit above, William Maisel, MD, PhD (a former Harvard cardiologist), was a arrested in a Maryland suburb on five counts relating to soliciting a prostitute. The story was not reported well in the national press and the fate of Dr. Maisel at the FDA had been unknown. Read more »

The Weekly Summary

Bomb

April 15th – April 21st  

In general news, it was a week of mayhem, with the Boston Marathon terrorist bombings on the news 24/7, making mailings of ricin to The White House and congress ignored news. Then, a huge fertilizer plant explosion in Waco, Texas killed more than a dozen first responders and local residents.

In healthcare business news, earnings season revealed that surgical procedure volume continues to decline, hurt the medical device divisions of JNJ and Abbott (ABT). Amgen (AMGN) agreed to pay an insignificant $25 Million to settle kickback charges. An Illinois court ruled in favor of JNJ in a metal hip lawsuit, perhaps boding well for further cases. Vivus (VVUS) announced that it would begin selling weight loss drug Qsymia through retail pharmacies. Lastly, Life Technologies (LIFE) could be acquired by Thermo Fisher (TMO).

On the data front, Vertex (VRTX) shot up 62% on Friday when the cystic fibrosis drug Kalydeco met endpoints in a phase 2 trial.

From the FDA, an AdCom recommended approval for GlaxoSmithKline (GSK) and Theravance’s (THRX) COPD drug Breo Ellipta. Discovery Labs (DSCO) shares were up on rumors over the FDA and long-delayed Surfaxin. ABT received approval for the Tecnis Toric lens implant. Sarepta (SRPT) shares were down when it appeared that the muscular dystrophy drug eteplirsen would not win Breakthrough status. Lastly, the agency rejected Allergan’s (AGN) migraine drug Levadex and a generic version of oxycontin, which was a boost for Purdue Pharma.

FDA CDER Director on Benlysta for lupus and adaptive clinical trials.

(In 108iHD)

Janet Woodcock, MD, Director of the FDAs new drug division, CDER, discusses with Steven Greer, MD the first drug approved to treat lupus in 50 years, Benlysta (belimumab). The BLISS trials were somewhat innovative in that the second trial was adapted to use seropositive markers to ensure that true-lupus patients were enrolled, thereby decreasing the chances of a non-responder. This led to a discussion of adaptive clinical trials that change during the enrollment after interim looks.