The Weekly Summary

easter-parade-new-york-cityApril 7th – April 13th

In the general news, a “diplomatic solution” to the Russia-Ukraine standoff was announced. In Korea, hundreds were killed when a ferry boat capsized. In the U.S., Easter came and went without incident.

In healthcare business news, it is rumored that Pfizer (PFE) wants to merge with AstraZeneca (AZN). Both companies have been struggling mightily. Medtronic (MDT) was set back by a court that granted Edwards (EW) an injunction against marketing CoreValve. In earnings, JNJ sales were weak in medical devices, as were ABT‘s. The reason being that the ACA-ObamaCare law has reduced hospital visits and surgical procedures. One bright spot in JNJ’s earnings was the newly marketed HCV drug, Olysio, which posted good launch revenue.

From the FDA, GlaxoSmithKline’s (GSK) diabetes drug Tanzeum was approved. In medical devices, the agency is also cracking down on the gratuitous use of live cases beamed into medical meeting halls.

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

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.

Interview with Simon Townshend about the Daltrey/Townshend Teen Cancer Program

The Daltrey Townshend teenage and young adult cancer center at UCLA

 

The Weekly Summary

BubbaApril 7th – April 13th

In the general news, the most prominent journalists reporting on the Ed Snowden NSA spying scandal were allowed to return to The United States. Also, the HHS Secretary, Kathleen Sebelius, finally “resigned”. In sports, Bubba Watson won the Masters golf tournament again, defeating 20-yo Jordan Spieth.

In healthcare business news, Mallinckrodt (MNK) acquired Questor for $5.6 Billion. Kicking off earnings season, Intuitive Surgical (ISRG) pre-announced and lowered revenue estimates.

On the data front, data from the EASL dominated the news, with Merck’s (MRK) HCV drugs (MK-5172 and MK-8742) posted strong results, sending shares of GILD down. Also hurting GILD were more essays in the NEJM about the high cost of Sovaldi. Intercept’s (ICPT) drug obeticholic acid was also effective in primary biliary cirrhosis. In cancer, the Puma (PUMA) drug neratinib was better than Herceptin in HER2 patients. Alkermes’ (ALKS) schizophrenia drug aripiprazole lauroxil met endpoints. Boston Scientific’s (BSX) registry data on their S-ICD was positive. Lastly, spine stimulation device somehow allowed all paraplegics in a small study to begin to move their legs again, using their own brain, bypassing the spinal lesion.

From the FDA, MannKind’s (MNKD) Afrezza was set back by a 3-month delay in the PDUFA date. Also, Celladon’s (CLDN) gene therapy “drug” Mydicare for CHF received Breakthrough status.

How many stent cases does it take to bill Medicare for $18 Million?

Melgen with Obama and MendezApril 9, 2014- By Steven E. Greer, MD

The release of data by Medicare showing what each doctor earns from billing CMS is making news for the outlier doctors who billed for millions. One Miami ophthalmologist, for example, billed for $21 Million in 2012 alone. Also catching our eye was another Florida interventional cardiologist who billed for $18.1 Million.

Just how many stent cases per day would he have had to have performed to bill for $18.1 Million? We asked Dr. William O’Neill of Henry Ford Hospital. Read more »

Catheter approaches for mitral replacement

March 23, 2014- interviewed by Steven E. Greer, MD

With catheter based methods for replacing the aorta valve not being adopted as expected, the medical device industry is now looking to the mitral valve for hope. Doctors in London and Canada performed the first human implants of the Neovasc and Edwards Lifesciences mitral valves.

We interviewed Dr. William O’Neill of Henry Ford Hospital about the various attempts to repair and replace the mitral valve without cracking the chest. Dr. O’Neill is an equity owner in Neovasc, and works with Edwards Lifesciences for the aortic valve studies.

Occluding the left atrial appendage to prevent stroke in A-fib

Thromboembolic stroke caused by atrial fibrillation is the primary reason patients are placed on anticoagulation. However, those blood thinners also carry significant bleeding risks. As a result, various mechanical surgical approaches have been tried to prevent stroke, and obviate the blood thinners.

The newly approved Boston Scientific Watchman left atrial appendage occlusion device aims to prevent clots from forming and migrating to the brain. We interviewed Dr. William O’Neill of Henry Ford Hospital, a leading interventional cardiologist, about the Watchman, and whether it will truly allow patients with A-fib to stop warfarin or other blood thinners.

The Weekly Summary

Michael Lewis on 60 Minutes and HFT

Michael Lewis on 60 Minutes and HFT

March 31st – April 6th

In the general news, two western journalists were shot by an Afghanistan police officer, killing one. In the U.S., author Michael Lewis dominated the news by giving “60Minutes” an exclusive on his new book about how high speed trading that “rigs the market”, prompting the FBI to investigate. On the markets, a good March jobs number increased the chance that the Fed would raise interest rates, spooking traders (i.e. computer algorithms).

In healthcare business news, IMS Health (IMS) raised $1.3 Billion in an IPO. Cardinal Health (CAH) diversified further into medical devices with an acquisition of AccessClosure for $320M. Lastly, Rite Aid (RAD) acquired Health Dialog Services Corporation, a leading provider of health coaching.

On the data front, Novartis’ (NVS) Angiotensin Receptor Neprilysin Inhibitor trial was stopped early, ostensibly due to exceptional efficacy. Medtronic (MDT) posted good data on drug coated balloons for the peripheral vessels. Also, bariatric surgery was shown to reverse diabetes.

From the FDA, MannKind’s (MNKD) inhaled insulin Afrezza won approval from the advisory committee, sending shares up 80%. Two antibiotics were advanced when committees voted in favor of Cubist’s (CBST) tedizolid and Durata Therapeutics’ (DRTX) dalbavancin, and Curis (CRIS) was allowed to resume trials on CUDC-427 for breast cancer.

Interview with MannKind’s CEO, Al Mann, and CFO, Matt Pfeffer.

October 23, 2013- Interviewed by Steven E. Greer, MD

The Healthcare Channel interviewed the CEO of MannKind, Al Mann, and the CFO, Matt Pfeffer. Topics discussed include the latest clinical trial data on inhaled insulin Afrezza and the cash situation. We also discuss Mr. Mann’s other company, Second Sight, which has a Medicare and FDA-approved bionic eye to treat diseases that damage the nerves in the retina.

Super rapid acting insulin and inhaled insulin

Robotic surgery and controversies

January 24, 2014- Dr. Dutson gives an update on the referral patterns and safety concerns over the Da Vinci system.

Produced, Interviewed by Steven E. Greer, MD

We interviewed UCLA’s Erik Dutson, MD, surgeon and Director of UCLA’s Center for Advanced Surgical and Interventional Technology (CASIT), about the Intuitive Surgical da Vinci robotic system, and recent safety controversies.

Violent video games and aggressive behavior

March 30, 2014- Interviewed by Steven E. Greer, MD

A recent JAMA paper connects the dots between violent video games and aggressive behavior. Author Craig Anderson, PhD, from Iowa State, reviews the findings.

The Weekly Summary

Northwestern football players winning a battle to be labeled as union employees

Northwestern football players winning a battle to be labeled as union employees

March 24th – March 30th

In the general news, Russia was ousted from the G8 for its aggression in Ukraine. In the U.S., President Obama announced more details on his plan to phase out the NSA metadata collection. The IRS ruled that Bitcoin is taxable property, but not currency, allowing it to exist. The IPO window has closed, with yet more IPO’s tanking, such as ticker KING. Lastly, colleges took a blow as Northwestern players were allowed to unionize, with payment of layers the next logical step.

In healthcare business news, the biotech bubble seems to be deflating. The Everyday Health (EVDY) IPO traded lower on the first day. Medtronic (MDT) surprised by announcing it was continuing the renal denervation program despite the failure of the Phase 3. Baxter (BAX) is spinning off the vaccine business. Lastly, Gilead (GILD) responds to the bad press and discounted Sovaldi in some insurance plans.

On the data front, MDT’s CoreValve study was published in the NEJM and presented at the ACC showing a rare survival superiority to open heart surgery. Also, Amgen’s (AMGN) monoclonal antibody that inhibits PCSK9, evolocumab, lowered LDL. Pfizer’s (PFE) Genotropin met endpoints in premature babies. BG Medicine’s (BGMD) Galectin-3 test met endpoints in a study to predict patients at risk of hospitalization for hear failure. Lastly, Exelixis’ (EXEL) cabozantinib failed in a prostate cancer indication, cutting the stock valuation by half.

From the FDA, Biogen’s (BIIB) Alprolix was approved for hemophilia. JNJ’s Topamax was approved for migraines, and Quest Diagnostics (DGX) received approval for an encephalitis test. Also, Idera (IDRA) shares spiked when their drug, IMO-8400, was safe in a Phase 2.

In the bad news category, the Novartis (NVS) drug serelaxin was voted down by an AdCom despite having “Breakthrough” status. Lastly, Zogenix (ZGNX) was hot when state regulators in Massachusetts banned the newly approved, highly controversial, strong pain pill Zohydro.

TAVI: Comparing CoreValve to Sapien

Interviewed by Steven E. Greer, MD

William O’Neill, MD of Henry Ford discusses the recent pivotal data for the Medtronic CoreValve device, soon to be approved, and how this new device will compete in the clinical arena with the Edwards Lifesciences Sapien valve.

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.

Serelaxin to treat acute heart failure

The FDA granted Novartis the coveted “Breakthrough” status for drug serelaxin to treat acute heart failure. If approved, it will be the first drug in decades to address AHF. Also, early data suggest that serelaxin might have a survival benefit, which would be unprecedented.

To learn more, we interviewed Gregg Fonarow, MD, Director, Ahmanson-UCLA Cardiomyopathy Center and Co-Chief of Clinical Cardiology. He discusses the strengths and weaknesses of the Phase 3 trial upon which the FDA based the decision to grant Breakthrough status.

The Weekly Summary

YellenMarch 17th – March 23rd

In the general news, Russia continue to aggress toward sovereign Ukraine after it annexed southern Crimea. The US and Europe responded with economic sanctions. In the U.S., Fed Chair Yellen gave her first news conference, and spooked the markets with talk of raising interest rates. In sports, Northwestern University football players filed a class action against the NCAA claiming that they are not students, but rather employees, and want to start a union.

In healthcare business news, small deals were announced, such as Bristol-Myers (BMY) partnering with Five Prime for immunotherapies, and Elbit Imaging (EMITF) acquiring Gamida Cell. In earnings, BGMD shares spiked on good numbers. Elsewhere, WellPoint (WLP) joined the bandwagon griping that Gilead (GILD) Sovaldi prices are too high.

On the data front, a study indicates that colon cancer rates have dropped by 30% since the year 2000. Related, Exact Science’s (EXAS) stool test for cancer mutations met endpoints. Intercept’s (ICPT) obeticholic acid (OCA) to treat primary biliary cirrhosis met endpoints, but the stock sold off over safety concerns. Amgen (AMGN) met endpoints with Evolocumab (AMG 145) in patients With homozygous familial hypercholesterolemia. Lastly, Glaxo’s (GSK) MAGE-A3 therapeutic vaccine did not help patients with non-small cell lung cancer.

From the FDA, Geron (GERN) stock rebounded 40% when the clinical trial hold that clobbered the stock was announced as “temporary”. Paladin Therapeutics’ Impavido was approved to treat the tropical disease leishmaniasis, as was Celgene’s (CELG) apremilast to treat psoriatic arthritis.

In other regulatory news, congress spooked the entire biotech sector by announcing hearings about GILD‘s high prices for HIV and HCV drugs. Also, an SEC probe hurt Galena Biopharma (GALE) stock.

Oh my god, I have a disease!

March 21, 2014- This DTC TV drug ad medicalizing a non-disease really struck us as egregious

Google’s Larry Page wants your medical records to be public for “research”

March 20, 2014-By Steven E. Greer, MD

Charlie Rose interviewed Google founder Larry Page at the 2014 TED conference. During the talk, Mr. Page unabashedly announces that he thinks your most sensitive of information, your medical records, should be made public for “research”. He naively believes that these records can be “anonymous”.

Google wants your medical records

Google wants your DNA now (Not just with 23andMe)

Beware The Google

Google wants your medical records

Interviewed by Steven E. Greer, MD

In Part 3 of our interview with Robert Klitzman, MD, ethics professor at Columbia University, we discuss how Google and other companies want to get into the business of managing sensitive data found in electronic medical records. Google Health failed in 2001, but they have other companies in the works. How might the data be abused and resold?

Book review: “ADHD Does Not Exist” By Richard Saul, MD

March 20, 2014- By Steven E. Greer, MDadhd-does-not-exist-richard-saul1

Richard Saul, MD strived to be provocative with his new book ADHD Does Not Exist. He not only succeeded, but also backed up his bold assertion with ample sound logic and supporting data.

This is an important book because ADHD, as defined by the psychiatry guidelines in the DSM-V, can now be diagnosed in 5% of the United States population. Up to 11% of all children have been diagnosed. Up to 20% of high-school-age boys have been diagnosed with ADHD: a 40% rise in just ten years.

Dr. Saul estimates that the monetary cost of this epidemic of ADHD is as high as $50 Billion. $14 Billion, or 27% of that $52 Billion, was spent on families related to the ADHD “patient”. Another $12 Billion was spent on schools and other health related costs. Read more »

The subcutaneous ICD

The concept of applying high voltage to shock a heart out of ventricular tachycardia or fibrillation has been known to be effective long before modern implantable cardiovert defibrillators (ICDs) were invented several decades ago. Over the last ten years, the ICD components, such as the wires that go through the large veins and into the heart, have broken, resulting in recalls by the FDA, lawsuits, and deaths. The national press has caused many patients and doctors to opt out of having an ICD implanted.

To address those design flaws, Cameron health developed an ICD with electrode wires that tunnel under the skin, but not inside the heart. Now owned by Boston Scientific, the FDA approved the S-ICD device in 2012.

We interviewed the director of electrophysiology labs at UCLA, Noel Boyle, MD, to learn more about the launch of the product and gauge the level of interest amongst doctors.

The Weekly Summary

Malaysian pilotMarch 10th – March 16th

In the general news, The missing Malaysian Boeing 777 jet continued to dominate news, as it turned into a hijacking investigation. Russia continue to invade Ukraine, seeming to have won the battle for Crimea. In the U.S., President Obama’s record low approval helped fuel a special election win for the GOP in congress: an election viewed as a referendum against Obamacare. In the senate, Senator Feinstein openly accused the CIA of spying on senate staff computers.

In healthcare business news, Charles River (CRL) acquire Galapagos (GLPG). A court invalidated Pfizer’s (PFE) Celebrex patent. Also, Gilead’s (GILD) CEO cashed in more than $160 Million worth of stock options last year, amidst critics who claim that Solvadi for HPC is too costly.

On the data front, Oxigene (OXGN) shares spiked more than 130% after drug Zybrestat, combined with Roche’s Avastin, to treat ovarian cancer met endpoints.

From the FDA, Geron (GERN) shares sank when the agency put a hold on trials for Imetelstat in Essential Thrombocythemia and Multiple Myeloma. Lastly, Regado’s (RGDO) anticoagulant REG1 was classified as Fast Track.

Atul Gawande’s surgical checklist fails in real world study

March 15, 2014- By Steven E. Greer, MD

In 2009, Atul Gawande, MD, MPH and his large international team published in the New England Journal of Medicine (NEJM) an observational study that showed a significant reduction of death and “complications” after non-cardiac surgery. The World Health Organization (WHO) created the checklist used in the NEJM paper. After this non-randomized, non-controlled, observational study was published, entire nations adopted the surgical checklist system.

Now, in 2014, a population study drawing from Ontario surgical patient data, published in the NEJM, showed no significant benefit from the widespread adoption of the same WHO surgical safety checklist that Dr. Gawande popularized. This study was also observational, but it was stronger than the 2009 Gawande study in that it included the entire population within a region.

What went wrong? Read more »

Medical Tip: How to get special glasses for computer screen distances, for cheap

presbyopiaMarch 14, 2014- By Steven E. Greer, MD

With remarkable regularity across all populations, the inner lens of the eye loses flexibility after age 45 and people begin to have trouble reading up close (presbyopia). So, to compensate, people push the book or computer screen away. Then, as the eyes worsen, people start to have trouble reading computer screens even when they are three feet away.

The solution is Read more »

Current weight loss surgical therapies

January 24, 2014- Interviewed by Steven E. Greer, MD

Erik Dutson, MD, weight loss surgeon at UCLA, explains why his medical center does not implant the Lap-Band, and how the “sleeve” bypass is the main procedure of choice now for weight loss surgery.

William Abraham, MD: The CardioMEMS’ heart failure pressure measurement system

By Steven Greer, MD

The CardioMEMS’ heart failure pressure measurement system will be evaluated by an FDA advisory committee next month. The CHAMPION trial, led by Dr. Abraham at Ohio State, demonstrated that the constant pressure monitor implanted in the pulmonary artery can reduce hospitalization rates for congestive heart failure patients, increasing quality of life and decreasing cost.

The device is powered by energy sources outside the body and has no moving parts. Therefore, the device does not need to be replaced and has a low chance of fracturing or causing bodily harm once implanted.

In our video interview, Dr. Abraham answers these questions:

  • Can you please summarize the CHAMPION trial?
  • What unmet clinical need does the CardioMEMs device meet?
  • Which heart failure sub-classes will benefit the most from this device if it is approved by the FDA?
  • What might be some reasons this technology would not be adopted by cardiologists?
  • Which type of cardiologist will likely care for the patient after the CardioMEMs monitor is implanted?
  • Are reimbursement codes established already for the device and procedure?
  • Will mortality data be required or will hospitalization be adequate for the FDA and CMS?
  • Is too much information a problem? Will the CardioMEMs PA pressure data cause interventions that otherwise would not have been delivered?
  • Will new data be presented at the TCT or other upcoming meetings?

The Weekly Summay

Rand-Paul

 

Rand Paul winning the CPAC poll

March 3rd – March 9th

In the general news, Russia continues to occupy the Crimea region of Ukraine. In the states, the February jobs report indicated 175,000 new jobs created.

In healthcare business news, earnings season wound down, with little news other than lawsuits being initiated against Medtronic (MDT) over InFuse.

On the data front, again there was little news other than Carmat’s first patient implanted with their artificial heart died.

From the FDA, Oxygen Bio (OXBT) shares spiked after the agency lifted a hold on Oxycyte to treat ischemic brain injury. Endo Pharmaceuticals (ENDP) long-acting injection testosterone drug Aveed was approved. Topical gel testosterones carry the added risk of infection others who come in contact with the user. In India, troubled Ranbaxy recalled its generic Lipitor. Lastly, Regeneron (REGN) shares sank as neurocognitive safety signals flared for large molecule cholesterol drug PCSK9, and the FDA asked for the companies to investigate.

The ACC seems to support dangerous energy drinks

March 6, 2014- By Steven E. Greer, MD

The Maryland State Assembly will begin debate on a bill to regulate “energy drinks”, such as those made by Monster Beverage, just as tobacco is regulated. Data from poison control centers directly link at least 20,000 emergency room visits to energy drink overdoses. From 2003 to 2011, ER visits caused by energy drinks quadrupled, according to Dr. Stacy Fisher who testified before the Maryland State Assembly. Read more »

We need intelligent doctors, not memory savants

Man with Doctor laughingFebruary 15, 2014- Opinion, By Steven E. Greer, MD

The ability to get a joke, or comprehend that a sarcastic comment was meant as humor, requires high-level abstract thinking. Memorization does not.

In social media venues, people with low intelligence are on full display every day. On Twitter, for example, I often make sarcastic comments that are obvious jokes. Most people “get it”. However, invariably, some random yahoo will reply angrily misinterpreting my sarcasm as a straight comment.

It occurred to me recently that perhaps being able to detect sarcasm, irony, and other complex components of human intelligence would be a better screening tool for pre-med student aptitude than the MCAT and GPA. Maybe all medical school interviews should involve some sort of comedy club session, with the admission board secretly watching the applicants on video monitors. Read more »

The 23andMe home genetics test kit controversy

Interviewed by Steven E. Greer, MD

In Part 1 of our interview with Robert Klitzman, MD, ethics professor at Columbia University, we discuss the 23andMe genetic test kit company and why the FDA made them stop marketing the tests.

Is cath lab fluoroscopy radiation exposure dangerous?

Interviewed by Steven E. Greer, MD

With former President George W. Bush receiving a coronary stent and cardiac chest CT-scan, the topic of cath lab radiation, and whether it is dangerous, has been discussed within small circles, but not not widely in the mainstream press. Coincidentally, Emory cardiologist Reza Fazel published the first analysis of cath lab fluoroscopy time distributions from a  database of more than 1,000 hospitals. We interviewed Dr. Fazel to learn the factors associated with unnecessarily long fluoroscopy times, and the associated dangers.

Comparing radiation leaks from major nuclear events

CBS discusses Physician Payment Sunshine Act

The serious adverse events caused by Axiron

Do topical testosterone gels harm others?

The Weekly Summary

Russi in UkraineFebruary 24th – March 2nd

In the general news, Russia seems to be edging toward a war with NATO and the U.S. by sending troops into sovereign Ukraine. In the States, the stock markets finish up 5% for the month, offsetting January losses. Meanwhile, the record cold winter continues, hurting the economy.

In healthcare business news, Endologix (ELGX) stock sank 25% on bad revenue guidance for its AAA stent graft. Medivation (MDVN) also sank on lowered revenue guidance for prostate cancer drug Xtandi drug. Elsewhere, Eli Lilly (LLY) acquired Lohmann for animal health, and Bayer acquired Dihon for its traditional herbal Chinese medication products.

On the data front, InterMune (ITMN) spiked 155% on new clinical data for pirfenidone to treat treating idiopathic pulmonary fibrosis (IPF). Previous studies failed. Also, the CDC updated the obesity study, reporting that the epidemic of obesity is waning.

From the FDA, Anika Therapeutics’ (ANIK) received approval for arthritis therapy Monovisc. Bristol-Myers Squibb (BMY) won approval for Myalept to treat generalized lipodystrophy. Also, Dexcom (DXCM) won approval for the G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System.

Book Review: Dragnet Nation by Julia Angwin

Dragnet-Nation-UpdatedMarch 2, 2014- By Steven E. Greer, MD

Author of Dragnet Nation, Julia Angwin, won her Pulitzer Prize while working for the Wall Street Journal. She is now is an investigative reporter for ProPublica. Her new book builds upon her years of work while at the WSJ that detailed how our privacy has been eroded by the modern digital age, updated for the Ed Snowden NSA revelations. Read more »

FDA investigated by congress for spying on whistleblowers

Update February 26, 2014- Senator Grassley convened an oversight hearing in the senate, and also testified before the House today. He issued this press release, “Sen. Chuck Grassley of Iowa today testified before a House committee on the Food and Drug Administration’s aggressive email monitoring of employees who were concerned about the safety of certain medical devices and released an investigative report on the monitoring with Rep. Darrell Issa, chairman of the House Committee on Oversight and Government Reform, which convened the hearing.  Grassley made the following statement on FDA comments in media reports on the agency’s actions in the case.

“An FDA official is quoted as saying the agency did not target, intercept or prevent any communications to Congress.  That’s false.   The FDA may not have begun the email monitoring to try to capture privileged communications with attorneys, the Office of Special Counsel and Congress, but senior managers certainly knew early on that it was happening and they kept doing it.  Emails with two Senate committees’ staff and a House member’s staff were all intercepted, stored, and summarized for senior managers by the FDA contractors conducting the monitoring.  The FDA is trying to deny the facts rather than own up and take responsibility for what it did.” “

The serious adverse events caused by antipsychotics

Christoph Correll, MD: antipsychotics in children

Op-Ed: A disease called ‘childhood’

Is JNJ illegally promoting deadly drugs to the elderly?

Tenets of the Palo Alto business model

Tech lineup 500February 24, 2014- By Steven E. Greer, MD

With so many young kids becoming billionaires overnight in Silicon Valley, you might be thinking how you too can cash in. The chances are that you will fail, because you do not know the secrets to becoming a Palo Alto billionaire. If you want to have any hope with your new “app” company, you have to reboot your morals.

Well, you are in luck. We happen to have seen the secret playbook that is circulated around amongst the tech VCs. These are golden. Here they are: Read more »

The Weekly Summary

Shiffrin and KievFebruary 18th – February 23rd

In the general news, Western-friendly civilian protestors fight off a military attack in Kiev, Ukraine, and seems to have prevented a dictatorship that was forming an alliance with Russia. Nearby, the Winter Olympics in Sochi, Russia ended. In the U.S., Facebook acquired an unknown app company, WhatsApp, for $19 B to mostly kill a threat to its business model of offering “free” software in exchange for spying on users.

In healthcare business news, Medtronic (MDT) reported earnings, taking a large write-off for the failed Ardian renal denervation line. Stryker (SYK) acquired yet another company, Berchtold. Also, Actavis (ACT) plans to acquire Forest (FRX) for $25 Billion.

On the data front, Eli Lilly’s (LLY) lung cancer drug, ramucirumab, met endpoints. Also, “Low-T” testosterone drugs, such as Axiron (LLY) and Androgel (ABBV),  continue to get bad press with studies showing safety concerns.

From the FDA, Chelsea Therapeutics (CHTP) won approval for Northera (droxidopa) to treat hypotension caused by Parkinson’s. Also, it was announced that the regulatory pathway for OTC drugs will be revamped.

Laws governing genetic tests

Interviewed by Steven E. Greer, MD

In Part 2 of our interview with Robert Klitzman, MD, from Columbia University, he discusses the laws protecting the data gathered during genetic tests, whether insurance companies can use the data to deny coverage, and the how for-profit companies can sell those data for product marketing.

 

Paul Gigot’s Op-Ed section disgraces the Wall Street Journal, yet again

gigot-Edit_0February 21, 2014- By Steven E. Greer, MD

On February 20th, Paul Gigot, the editor in charge of gatekeeping the letters published in the prestigious Wall Street Journal, allowed two men to criticize Secretary of State John Kerry’s remarks about climate change. Read more »

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

November 13, 2013- By Steven E. Greer, MD

The AHA released the long-awaited new guidelines that recommend which patients should be on a cholesterol-lowering statin, such as Lipitor or Crestor. The panel of experts incorporated evidence-based medicine into the guidelines, perhaps better than any other medical society guideline panel has done previously. However, the panel also used some very dubious statistical tools as well.

According to Read more »

NY Times reports that CMMI “research” is junk science

February 3, 2014- By Steven E. Greer, MD

The Healthcare Channel was the first to report in 2012 that the new CMMI, created by the ACA “Obamacare” law, was nothing but a pork project designed to deliver funds to political cronies. Subsequent to our reporting, the senate convened oversight hearings, and the director of CMMI was fired.

Today, the New York Times reports that the quality of “research” coming out of CMMI is suspect. Gina Kolata writes, ” The idea seemed transformative. The Affordable Care Act would fund a new research outfit evocatively named the Innovation Center to discover how to most effectively deliver health care, with $10 billion to spend over a decade. But now that the center has gotten started, many researchers and economists are disturbed that it is not using randomized clinical trials, the rigorous method that is widely considered the gold standard in medical and social science research. Such trials have long been required to prove the efficacy of medicines, and similarly designed studies have guided efforts to reform welfare-to-work, education and criminal justice programs.” Read more »

Industry conflicts arise at PCORI threatening any real comparative effectiveness research

February 7, 2014- By Steven E. Greer, MD

The Patient Centered Outcome Research Institute (PCORI) was created by the PPACA “ObamaCare” law in 2010. Well-funded with approximately $3 Billion over ten years,  the mission was, among other things, supposed to be to conduct comparative effectiveness research (CER) that would determine whether costly therapies are any better than cheaper alternatives.

The rise of CER has been one of the most feared developments by the drug and device industries. To avoid powerful lobbying efforts that could have resulted in de-funding and the death of PCORI before it got started, the institute steered away from even hinting at conducting CER. Now, almost four years later, PCORI is finally funding CER research. However, critics, such as former White House Director of Office of Management and Budget, Peter Orzag, say that the money spent by PCORI on CER is still not enough.

Meanwhile, a leading doctor in charge of PCORI research strategies, Harlan Krumholz, MD, Read more »

The Weekly Summary

Hamburg IndiaFebruary 10th – February 17th

In the general news, the U.S. hockey team defeated the Russians at the Olympics. In the U.S., Comcast plans to acquire Time Warner cable for more than $40 Billion, as the cable industry loses subscribers.

In healthcare business news, more biotech IPO’s launched, with Concert Pharma (CNCE). Novartis (NVS) acquired CoStim. Mallinckrodt (MNK) acquired Cadence (CADX). Merck’s (MRK) planned sale of the consumer business could go for $10 Billion, according to reports, and Boehringer is facing lawsuits over Pradaxa bleeding. Impacting HMO’s, The White House delayed yet another implementation of the ACA law.

On the data front, yet another non-randomized study of mammograms cast doubt on the effectiveness of reducing cancer.

From the FDA, Commissioner Hamburg personally visited India drug manufactures, in the wake of the numerous serious manufacturing problems found at Ranbaxy. The Medicines Company (MDCO) drug Cangrelor was rejected by an advisory committee. Another voted that Bayer’s Aleve (naproxen) is no safer than the other NSAIDs, which all have a black box warning. Durect (DRRX) was rejected on its third attempt to get the post-op pain drug Posidur approved. Lastly, JNJ and Pharmacyclics (PCYC) received approval for Imbruvica to treat CLL.

The Weekly Summary

tonight-show-jay-leno-tears.jpgFebruary 3rd – February 9th

In the general news, The Winter Olympics began in Sochi, Russia, without any drama. In the U.S., the January job report was weak. The stock markets sank more. Microsoft named a new CEO as the company struggles to deal with the demise of PCs, and Twitter (TWTR) became the latest tech stock to implode. In entertainment, Jay Leno  unwillingly ended his 22-years at the helm of the Tonight Show.

In healthcare business news, earnings season continued with few good stories. St Jude (STJ) hosted the annual analyst day. Myriad (MYGN) acquired diagnostic Crescendo Bioscience for $270 Million. AbbVie (ABBV) picked Singapore to be the new location biologics manufacturing, following a wave of many others, such as Roche. Gilead (GILD) is getting pressure to lower to price of HCV drug Solvadi in Asia. Lastly, a wave of new biotech IPOs are hitting the market, with Revance Therapeutics (RVNC) spiking on the first day.

On the data front, Shire’s (SHPG) ADHD drug Vyvanse failed in a depression trial.

From the FDA, Covidien’s (COV) newly acquired Given Imaging PillCam was approved for colonoscopies. Lastly, Prima Biomed (PBMD) spiked on news that a key trial change for CVac was agreed upon.

Prepare for Comparative Effectiveness Research

February 8, 2014- By Steven E. Greer, MD

The HCC hosted a healthcare reform summit in 2009, after the ACA law was first announced by the new Obama administration. In the proposed legislation, the PCORI was created.

Properly administered, comparative effectiveness (CER) can be effective at reducing wasteful ineffective healthcare spending. Therefore, CER is a big fear of the industry, and politics will always have a heavy influence.

Now that the ACA “Obamacare” law has been implemented, the PCORI-funded wave of new studies will start to impact commonly used drugs and devices. Will it be quality research or junk science?

One segment from our 2009 summit featured Sir Michael Rawlins, who runs the UK’s comparative effectiveness agency called NICE (see video). It is worth re-watching. Even in the socialized British healthcare system, the healthcare industry muted much of the impact of British NICE decisions, and Mr. Rawlins was shy to even mention CER in our discussion.

Will the powerful industry lobbyists in the United States take the teeth out of American PCORI CER? Will the big bucks of industry infiltrate PCORI staff and created biasing conflicts of interest?

Industry conflicts arise at PCORI threatening any real comparative effectiveness research

The FDA discusses Brilinta

February 4, 2014- The WSJ is reporting today on a Johns Hopkins doctor who filed a federal court complaint, using the Federal False Claims Act. The WSJ reports, “In July 2011, the Food and Drug Administration approved AstraZeneca PLC’s anticlotting drug Brilinta for patients with certain severe coronary conditions. A study had shown the pill saved lives and reduced heart attacks—a real eye-opener in medicine.

But behind the scenes, a drama is unfolding over whether the drug should have been approved. In a sealed complaint filed in U.S. district court in the District of Columbia, Victor Serebruany, an adjunct medical professor at Johns Hopkins Hospital who specializes in such drugs, contends the study numbers may have been manipulated.

Dr. Serebruany has told federal investigators that the number of deaths in the study’s control group—those taking a competing drug—was unusually high compared with earlier trials. He also has questioned the tabulation of heart attacks in the study, alleging it was skewed in Brilinta’s favor, according to people familiar with the matter and documents reviewed by The Wall Street Journal. The study measured cardiovascular deaths, heart attacks and strokes.

Dr. Serebruany filed his complaint under the federal False Claims Act. Under that law, the U.S. government has the option of joining the lawsuit to recover money.”

July 20, 2011-In a somewhat surprising move, the FDA approved AstraZeneca’s anticoagulation drug branded as Brilinta (ticagrelor). This drug had the PDUFA date delayed as the FDA wrangled with the messy clinical data that failed to show any benefit in the North American cohorts. It had become a case study in the bigger problem of Big Pharma relying on CRO’s to conduct their clinical trials.  Steven Greer, MD spoke with Janet Woodcock, Director of the FDA’s CDER, about the label. In addition, Pradaxa and Xarelto, two other new anticoagulation drugs, were discussed.

The only 5 minutes of the Edwards Sapien AdCom you need to watch

(best viewed in full-screen)

Update: June 11, 2012

The FDA briefing documents for the June 13 advisory committee to review the PARTNER-A label expansion indicate that the trial was biased by the fact that 7% of the patients randomized to open heart surgery never received surgery. Meanwhile, the stroke rate was 100% greater in the Sapien valve, and the valve function was inferior with aortic regurgitation.

July 22, 2011

Steven Greer, MD gave a 5-minute slide presentation to the July 20th FDA advisory committee that was convened to evaluate the possible approval of the new Edwards Lifesciences (EW) percutaneous aortic valve. He drew comparisons to the now infamous JNJ Cypher coronary stent, pioneered by Dr. Marty Leon and his CRF crew, and the new Edwards Sapien valve, also being led in development clinically by Dr. Leon, et al. and urged caution before approving the valve without adequate safety data.

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