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’sfirst 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 Aveedwas 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 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 »
February 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 »
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.
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)acquiredLohmann 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.
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 »
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.” “
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 »
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 acquireForest (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.
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.
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 »
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.
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 »
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 »
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)acquiredCoStim. Mallinckrodt (MNK)acquiredCadence (CADX). Merck’s (MRK) planned sale of the consumer business could go for $10 Billion, according to reports, and Boehringeris 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.
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 Vyvansefailed 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.
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?
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 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.
In the general news, the State of the Union speech was uneventful. In Atlanta, a bumbling government allowed 2-inches of snow to strand thousands of cars on the freeways for days. In Wall Street, the stock markets finished down, with the worst January performance since 2009. Lastly, the Super Bowl was won by the Denver Broncos.
In healthcare business news, earnings seasons continued, with ALXNspiking onSoliris sales, and PFE continuing to struggle. STJ will stay in the renal denervation market. BIIB reported that drug pricing power is reducing as the numerous therapies for MS hit the market and cannibalize one another. AZN is cutting more jobs, and JNJ announced that it will hire Dr. Krumholz’s team at Yale for consulting on clinical data (Krumholz also heads up PCORI).
On the data front, new studies in PLOS added to NEJM reports that the popular “Low T” testosterone drugs double or triple the risk of heart attack in men over 65.
From the FDA, the agency will study the MI risk from topical testosterone replacement drugs, such as Axiron (LLY) and Androgel (ABBV). Also Vanda (VNDA)received approval for the new sleep aid drug Hetlioz.
In the general news, U.N. talks in Switzerland related to the Syrian civil war achieved little, as did the nearby Davos meeting of billionaires. In the U.S. record cold weather and snow pummeled the Midwest and Northeast.
In healthcare business news, earnings season began with JNJ, ISRG, BAX, STJ, BMY, and others reporting encouraging trends in revenue. In M&A, rumors of a takeover caused shares of Ariad (ARIA) to spike. Teva (TEVA)acquiredNuPathe for its migraine treatment Zecuity. Lastly, Covidien (COV)exited the renal denervation device business in the wake of Medtronic’s surprise failure of Ardian.
On the data front, Amgen’s (AMGN) cholesterol-lowering evolocumabmet endpoints in another trial. Also, Roche’s schizophrenia drug failed in two trials.
From the FDA, Amag (AMAG)was unable to convince the FDA to expand the label for its anemia drug Feraheme. India’s Ranbaxy products were banned from being used in medications meant for the U.S.. And in other regulatory news, CMS is cracking down on doctors who habitually over bill the system.
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.
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.
David P. Winchester MD, Medical Director of Cancer Programs for the American College of Surgeons, discusses recent data showing a more than a 100% increase in the rate that young women with early stage breast cancer are choosing double mastectomy, despite not having BRCA1 or BRCA2 mutations.
In the general news, in Europe, more terrorist threats were made against the Sochi Olympics coming up in February, and the President of France was caught having an affair. In the U.S., President Obama gave a speech addressing slight changes to the NSA spying program. Lastly, the stock markets finished the week down, and negative for the year.
In healthcare business news, the JP Morgan healthcare conference dominated, as usual. RNAi platform technology was a big theme, as Sanofi’s Genzyme unit acquired Alnylam’s(ALNY) platform. Few companies pre-announced Q4 earnings, indicating that bad news might be on the way for earnings season. One exception was Intuitive Surgical (ISRG) that released good Q4 numbers and 2014 guidance. Also, Actavis (ACT) joined other companies in exiting the China market due to the new onerous regulatory climate, in the wake of arrests for bribery, etc. In M&A, The Carlyle Group will buyJNJ‘s in vitro diagnostics business for $4.15 Billion. Lastly, Forest Labs (FRX)acquiredAptalis for $3 Billion.
On the data front, it was quiet. European cardiologists published a study on the significant amount of radiation delivered to patients from procedures.
From the FDA, Medtronic’s (MDT) CoreValvewas approved sooner than expected, sending shares of Edwards (EW) down. Chelsea (CHTP) spiked 100% on a surprise panel recommendation of approval for HTN drug droxidopa. Merck’s (MRK) Voraxapar also won a thumbs up from a panel, and Glaxo’s (GSK) Tafinlar to treat lung cancer was awarded “Breakthrough” pathway.
In the FDA bad news category, JNJ’s Xareltowas rejected by a panel for the acute coronary syndrome indication. Lastly, the agency had more problems with Ranbaxy plants in India.
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.
To Senators Dick Durbin, Richard Blumenthal, Sherrod Brown, and Edward Markey
cc: Margaret Hamburg, Commissioner of the U.S. Food and Drug Administration
cc: Ari Emanuel, CEO, William Morris Endeavor
January 20, 2014
Recently, two people at the Golden Globes awards show (Leonardo DiCaprio and Julia Louis-Dreyfus) were photographedsmoking e-cigarettes. Then, your group of senators (i.e. Durbin, Blumenthal, Brown, and Markey) wrote a letter to NBC and the Golden Globes producers expressing concern that the images would help promote real cigarette smoking.
With such outrage over two obscure glimpses of e-cigarettes, why then is nothing being said about this pervasive film directing style that shows close-ups of actors smoking real cigarettes?
The latest example of this cinematic style is the new HBO drama “True Detectives”. Every single scene (no exaggeration) of Matthew McConaughey shows him with a cigarette in his mouth. It is repulsive. I have to look away.
More concerning than my discomfort is that this show now encourages smoking by associating one of the most admired leading men in Hollywood with chain smoking. I could list dozens of other films and TV dramas that also portray smoking the same way.
Hollywood violence, in film and video games, encourages violence. Now, Hollywood portrayals of cigarette smokers is promoting cancer.
In Part 1, Sammy Saab, MD, MPH, liver disease and GI doctor from UCLA, discusses the standard of care for hepatitis C, which is 48-weeks of interferon with ribavirin. He then discusses the new protease inhibitor drugs, Incivek and Victrelis, and why their bad side effect profile limited usage despite higher cure rates.
In Part 2, Dr. Saab discusses the data on the new all-oral therapies that do not require the toxic interferon injections, are only 12-weeks of therapy, and have much higher cure rates approaching 100% SVR. He mentions Gilead’s sofosbuvir, the Abbvie cocktail of drugs, and others.
How did our ancient ancestors evolve from being pure meat eating carnivore hunters into grain fed farmers, and which diet is healthier? With nearly 7 Billion people on planet earth, how did obesity become a bigger problem than malnourishment? Did humans suddenly become undisciplined glutton sloths, or is modern processed food toxic and addictive? These are the questions answered by Robert Lustig, MD, pediatric endocrinologist at the University of California, San Francisco, in his new book “Fat Chance: Beating the odds against sugar, processed food, obesity, and disease“.
The book is really three books in one. Book 1 is an excellent scientific summary of the physiology of hormones that control hunger and fat production, and also the foods and environmental factors that alter the energy regulation of the body leading to obesity. Book 2 is a refreshingly credible assessment of the various diets and fads that have been tried and studied over the decades, and a guide to buying healthy real food. Book 3 then discusses the politics and policy that have led to the rise of the processed food industry and subsequent global obesity pandemic. Most importantly, this book is not another “new diet” scheme concocted by a greedy quack doctor trying to sell books and paraphernalia.
In the first part of “Fat chance”, Dr. Lustig explains why the dogma of “All calories are equal” is false. Some foods are turned into fat by the liver, become toxic, and cause the brain to crave more food, while other foods nourish the body and give a sense of being full (satiety). He also makes the case against obesity being the fault of the patient. Obese people do not simply “eat too much” and are not “too lazy to exercise”. In fact, he points out that strict diets and ample exercise are doomed to fail if the food eaten is the modern processed sugary food so ubiquitous in the modern world.
Since 2001, the number of obese children in America has tripled, Read more »
The Wall Street Journal published an article explaining how the pharmaceutical industry data mines credit card records, Internet traffic patterns, and other personal data on individuals, then forms educated guesses about the diseases those people might have. Locating actual people with specific diseases is valuable for companies that recruit patients into clinical trials, and also for drug companies trying to sell products via Direct-To-Consumer advertising.
What if there were a much better way to not only know exactly the diseases a person has, but also what diseases they are likely to develop? There is, and it is found in one’s human genome, or their DNA.
The Holy Grail for marketing companies and the healthcare industry would be to know the DNA of people. Of course, that information is strictly confidential and it would be illegal to snoop and collect DNA from people, unless people are tricked into giving it away with contractual consent.
23andMe, a small company that sells genetic screening kits based on saliva samples, recently got into trouble for illegally marketing genetic screening tests that were not validated and approved by the FDA. The company has since stopped marketing the tests.
A few news reports did mention that 23andMe is a Google-backed genetic testing company, run by the ex-wife of Google Founder Sergey Brin. But Google has far more ambitious plans than just 23andMe. Read more »
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.
CBS’s “60 Minutes” interviewed the man, Anthony Bosch, claiming to have been the pseudo-doctor who administered MLB’s Alex Rodriguez’s PED schedule. Mr. Bosch is not a doctor, but went to a foreign medical school for a short period.
The number of daily injected drugs is alarming. The sublingual oral steroids taken before games is also very unusual. A-Rod was told to pop a “Troche” minutes before a game. Mr. Bosch seems to think that testosterone has a rapid onset of action of just minutes. That is not the case.
The dosages and unusual scheduling indicate that A-rod might have been receiving ineffective therapies from a quack, which would be ironic, indeed. Was A-rod merely boosted by the placebo effect of these “Troche’s”?
In the general news, Fallujah and other accomplishments of the Iraq war are falling back into control of the Taliban as the U.S. military departs. The NYT Op-Ed supported clemency for Ed Snowden. Record cold Artic air dipped into the Lower 48, and the December jobs report was dismal, creating only 74,000 new jobs. In sports, A-Rod was banned for a year from MLB.
In healthcare business news, The HHS canceled the contract with CGI, the creator of the infamous Obamacare website. Mylan (MYL) announced numerous new generic drug launches. Lilly (LLY)cut back on in-house R&D even more. Lastly, and Biogen (BIIB)partnered withSangamo (SGMO) to develop drugs for hemoglobinopathies, staying with the trend in the industry to target orphan diseases with orphan drug status and great pricing.
On the data front, it was busy ahead of the JPMorgan conference next week. Intercept Pharma (ICPT)spiked 450% after a trial for obeticholic acid in patients with non-alcoholic steatohepatitis was stopped early. Epizyme (EPZM) spiked more than 80% on news that drug EPZ-5676 met proof of concept in leukemia, triggering Celgene (CELG) payments. The JNJ and Pharmacyclics (PCYC) drug Resonate to treat CLL was also stopped early, sending shares higher by 30%. Amgen’s (AMGN) Sclerostin (romosozumab) was effective in PMO. Lastly, the big negative news of the week was the surprise failure ofMedtronic’s (MDT) renal nerve ablation device in the pivotal trial (MDT paid $800 Million to acquire Ardian).
From the FDA, Glaxo’s (GSK) received approval for approved Mekinist(trametinib) and Tafinlar (dabrafenib) for melanoma. Bristol (BMY) and AstraZeneca (AZN) received approval for new diabetes drug Farxiga. The hold was lifted on Cell Therapeutics (CTIC)trial fortosedostat. Lastly, Neurocrine (NBIX) was reprimanded for poor trial design of drug NBI-98854.
Disgraced Wall Street sell-side technology sector analyst, Henry Blodget, who was banned for life by the SEC from working in Wall Street, is making a comeback in tech by running a news aggregation site called Business Insider. It has funding from Tech Titans, such as Jeff Bezos of Amazon.com, The Huffington Post, and others.
Mr. Blodget was interviewed by Charlie Rose, and Charlie asked him whether the tech stocks are in a bubble again, ala 1999. He dodged the question, but then went on to claim to be a current prognosticator of an overall stock market bubble yet to burst. Perhaps hoping to vindicate his “pump and dump” reputation earned in the last tech bubble, he bemoaned to Charlie Rose that he wish he had called it a bubble at the top in 1999.
Meanwhile, Mr. Blodget refused to label tech stocks, such as Twitter (TWTR), as being bubble-valuation equities, despite Twitter having a market cap of $40 Billion in December of 2013 (it has already fallen 25% in valuation to $30 Billion, in less than a month).
We decided to seek some answers from Mr. Blodget via the Twitter venue. After a 12-hour delay, he did engage us in an interview, see below: Read more »
Many medical devices cause a far greater clinical impact than pharmaceutical therapies such as statins and chemotherapies. For example, ICDs have a dramatic life-saving capability, but for only a small portion of the patients receiving an ICD. Likewise, coronary stents improvement survival in patients with acute MI, but merely alleviate angina in most other patients.
A new device, unknown to most doctors, currently being investigated in Australia, Europe, and South America, could confer the most dramatic clinical benefit to the largest group of patients in the history of medical devices. That device is the Ardian renal artery/nerve ablation catheter to treat essential hypertension, recently acquired by Medtronic.
Medications to treat high blood pressure deliver tens of billions in revenue to the pharmaceutical companies, yet the magnitude of effect is just a few millimeters of mercury reduction in hypertension. In a small, but well designed, trial of the Ardian device, improvements in blood pressure of the magnitude of 30 mmHg were seen in almost all patients. If these data hold up, and safety concerns do not arise, this device would turn the hypertension market upside down, to the dismay of Big Pharma. Total medical costs could be reduced as well if damage to the kidneys, eyes, and hearts of millions of patients are avoided.
Matthews Chacko, MD, Director of Peripheral Vascular Intervention at Johns Hopkins, discusses this device, the data in The Lancet, and his thoughts on safety and efficacy.
The ARBITER 6-HALTS study investigating Zetia and Niaspan was stopped early, confounding the outcome and likely inflating the efficacy of Niaspan. There was no ethical reason to stop the trial early. It is quite possible that there would have been no benefit to Niaspan whatsoever if the trial were carried out to completion.
Dr. Gordon Guyatt discusses the statistical reasons that clinical trials should not be stopped early, in most cases. Early stoppage has been a growing problem in the cardiology and oncology trials.
Gordon Guyatt, MD, epidemiologist, internist, and biostatistician at McMaster University updates us on the progress being made against the problem of clinical trials being stopped early to inflate efficacy of drugs. Since our first coverage of the topic two years ago, the FDA, the Cochrane group, and other agencies have implemented changes in policy. Dr. Guyatt discusses the Crestor JUPITER trial as an example of a trial that was stopped early and inflated efficacy.
Dr. Guyatt explained in a previous post why early stoppage of clinical trials results in falsely inflated efficacy of the therapy being studied. The April 16, 2009 edition of The New England Journal of Medicine has a great example how Kaplan curves tend to converge with time and erase early efficacy differences. The study looked at the drug valsartan for the treatment of atrial fibrillation and failed to show a benefit over the comparator cohort(see graph). If it were stopped early, it would have shown that the drug was effective. Note the curves touching, or converging, as time progresses.
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?
In the general news, Russia suffered two suicide bomber attacks near Sochi, ahead of the February Olympics. In the U.S., the stock markets ended in bubble-esque fashion, with TWTR having a market cap of $40 B. In the courts, two different federal rulings conflicted over the legality of the NSA spying efforts, setting the stage for the Supreme Curt to rule.
In healthcare business news, Myriad Genetics (MYGN)shares fell when CMS cut reimbursement by 50% for the BRCA breast cancer tests.
On the data front, all was quiet in the house, not a creature was stirring, not even a mouse.
From the FDA, Novo Nordik’s Trettenwas approved to treat a are form of hemophilia, known as congenital Factor XIII A-subunit deficiency. Also, Sanofi’sLemtrada was surprisingly rejected to treat MS. The agency cited poor Phase 3 trial design.
Like a broken record, 2013 was yet another tough year for healthcare companies. Several forces are currently changing the supply and demand curve for therapeutics, resulting in fewer hospitalizations and visits to the doctor. Effective new drugs that could once be priced arbitrarily in the six-figures and still sell well are now meeting pushback. Also, patients are putting off surgical procedures, hurting sales of medical devices.
Even before the ACA law (Obamacare) was enacted, the cost of healthcare coverage for employers was driving a trend to provide insurance policies with higher and higher out-of-pocket costs. A new form of healthcare delivery arose to meet the demand of people with ailments who either did not have insurance or desired to pay in cash. Walk-in cash clinics unaffiliated with tertiary care medical centers sprouted up in shopping malls across America.
With tens of millions still unemployed and without insurance, and the rest with the new forms of pseudo-insurance, overall healthcare spending growth in the United States slowed to levels not seen since the HMO days on the 90′s. The White House, desperate to spin the unpopular ACA law, took credit for the reduction in spending, and no letup seems likely in store for 2014.
With that as a depressing overview, we reviewed the events of the year to attempt to come up with a list of the most important healthcare stories for 2013. This is what we came up with. The most important stories of 2013 were: Read more »
Which smartphone apps will the FDA label as a medical device making them taxable tax under the ACA Obamacare law? The final FDA guidelines will be issued this year, and Republicans in the House have held oversight hearings on the matter. We discussed the matter on Fox Business. the full House hearing can be viewed below.