Wednesday, February 8, 2017

Live Video: Claire Wineland and Cystic Fibrosis

While the advances in medicine have extended the lives of so many children into adulthood new challenges arise.  The numbers of fortunate people surviving places a new challenge for mental health, family relationships, and economic survival.  Family and personal relationships are important as well as support groups.

The people surrounding a patient with cystic fibrosis suffer emotionally more than the patieint.

Watch this video for an inspirational story from Claire.  Share the message and contribute to the Cystic Fibrosis Foundation.



The Vertex pharmaceutical company in a partnership with the Cystic Fibrosis Foundation have developed a program creating a "pipeline'  of genetic treatments for C.F.  Many are in Clinical Trials, and many have already been approved.  This is a major reason for long term survival of patients with cystic fibrosis.








Live Video: Claire Wineland and Cystic Fibrosis | The Mighty

Monday, February 6, 2017

A Guide To Budget Reconciliation: The Byzantine Rules For Disassembling The Health Law | Kaiser Health News

Repeal and/or amend the ACA ?  How it will take two years (2018).  Maybe.

If you thought constructing and passing the ACA was difficult...just you wait !

After capturing the White House, Republicans put repealing the health law at the top of their to-do list. But since they can’t get around a Democratic filibuster in the Senate, they are forced to use an arcane legislative tool called budget reconciliation to disassemble parts of the law. KHN’s Julie Rovnerand Francis Ying explain the process.

But Congress can’t use reconciliation to change parts of the health law like provisions requiring insurance companies to provide certain benefits or sell coverage to people with preexisting conditions. Those don’t directly affect federal spending.
That has led insurance companies to complain that they will go broke if they still have to sell to sick people, but healthy people won’t have any incentive to get covered. In that case, they say, only sick people will buy insurance, and premiums will skyrocket.
And the new Republican Congress seems set on using the technique to take apart the health law. Whether that’s a good idea may depend on whether you favor or oppose the Affordable Care Act.

Once again the tools that the Congress can use are inadequate and obsolete, leading to a further possible stalemate which only serves to hurt all.








Perhaps another reason to 'drain the swamp' . HHS Secretary, Tom Price, will have his hands full. Hopefully his medical judgments will prevail.  He also has the power of "Executive Order' something which President Trump has used already to meet his campaign promises.

But even as Congress spins its wheels. Price can push forward by using his discretion to undo crucial elements of Obamacare. That’s largely thanks to the Obama administration, which granted its health officials authority to write and implement hundreds of rules tied the law. The Trump administration now plans to use that same license to undo as much of Obamacare as it can.
“The statute itself gave [HHS] a lot of discretion,” said Edmund Haislmaier, a senior research fellow at the Heritage Foundation, who worked on health policy for the Trump transition team. “Live by the administrative state, die by the administrative state.”









A Guide To Budget Reconciliation: The Byzantine Rules For Disassembling The Health Law | Kaiser Health News

Friday, February 3, 2017

World's smallest MRI helps tiny babies - BBC News


Infants are not small people.  One size MRI does not fit for diagnostics.  MRI scanners have been specifically designed for shoulders,  arms, knees, and other smaller structures.  Smaller scanners expose patients to less irradiation.


The MRI images are more detailed and higher resolution.



Doctors in Sheffield are pioneering the use of a compact MRI scanner for imaging the brains of premature babies.
The machine, at the Royal Hallamshire Hospital, is one of only two purpose-built neonatal MRI scanners in the world.
At present, ultrasound is normally used to scan the brains of newborns.
Prof Paul Griffiths, of the University of Sheffield, said MRI was better at showing the structures of the brain and abnormalities more clearly.
So far about 40 babies have been imaged in the MRI scanner, which was built by GE Healthcare with funding by the Wellcome Trust.

MRI scans are rarely performed on severely premature babies because the risks involved in transferring and handling a sick infant can outweigh the benefits.

It is not known how much a neonatal MRI machine would cost, should the system eventually get commercialised, but full-size scanners are typically priced at several hundred thousand pounds.
Cincinnati Children's Hospital has a 1.5 Tesla neonatal MRI scanner that was adapted from adult orthopaedic use.

World's smallest MRI helps tiny babies - BBC News

Wednesday, February 1, 2017

Who really wants to blow up the FDA? Not the drug industry

Health Train Express is following the issues that POTUS is addressing in regard to health care.

Following his not too surprising nomination of Tom Price for the head of HHS, he now turns his attention to another big player, the Food and Drug Administration.  While the FDA plays a major role in the safety of food products in the United States, not much is said about that during political campaigns or in decision making.  It's role in pharma, medical devices, and now mobile health applications draws headlines.

What most industry reporters usually mention is the length of time and the expense of developing new drugs, and how that contributes to increased drug costs.



President Trump has repeatedly said that the FDA needs to be overhauled. He’s talked about speeding up drug approvals and reducing regulations — he’s vetted possible FDA heads who want to put drugs to market before we know they are effective. But, outside the White House and Capitol Hill, is there anyone who agrees with this? STAT’s Damian Garde takes a look.


Trump has big plans to fix drug prices. Here’s your reality check

Eli Lilly has raised the price of insulin more than tenfold since 2001 and is now facing a class-action lawsuit and threats of a congressional investigation.
Amgen has repeatedly raised the price of Enbrel, a blockbuster anti-inflammatory treatment that has been on the market for nearly 20 years. The price of J&J’s competing Remicade rose by 63 percent between 2011 and 2016.Since 2010, Merck has raised its drug prices by more than 9 percent on average, and Novartis has increased the price of the cancer drug Gleevec from $26,400 in 2001 to more than $120,000 this year.
There have also been cases where drug prices have acutely skyrocketed, in come cases over 1,000 %.  drug for treating pinworm, an intestinal parasite was sold for $ 3.00 a dose, and now costs $ 300.00 dollars. Anthelmintics, such as mebendazole, pyrantel pamoate, and albendazole, are active against Enterobius vermicularis.
Mebendazole is now being studied as a drug to prevent cancer. (coincidence, or opportunistic ??
His pledges, which will need to be fleshed out, would likely require work from the Food and Drug Administration. Trump also said Tuesday that he would soon appoint a commissioner to lead the agency.
The industry, for its part, has rolled out an advertising campaign backed by tens of millions of dollars to burnish its public image. Industry officials described Tuesday’s meeting with Trump as a chance to get in the door with the new president after his incendiary comments. Depending on the time of the year, and politically expedient slogans pharma can change it's mantra.  
Late in 2014, the Amgen announced their original restructuring plans to reduce payroll was too modest, upping its goal on job cuts to 4,000. And the pharma giant followed up in the spring of 2015 by axing about 300 staffers after Bradway decided to shutter the Onyx campus obtained with its acquisition of Kyprolis.

Trump confronts big Pharma on Pricing


On Tuesday, though, Bradway became a job creator.
“We’ll be adding 1600 jobs at Amgen this year,” he told President Donald Trump, minutes after the president had finished a harangue about the new American jobs he expected in exchange for reduced regulations.
It may be unwise to paint the whole of pharma with the same accusations.  Politicians focus on the "outliers" to prove a point.  Readers should carefully consider the source and not take pronouncements at face value.
Follow Health Train Express daily by subscribing on the left sidebar.


Senate Finance Committee OKs Tom Price, MD, for HHS Chief



The Senate Finance Committee today approved the nomination of Rep. Tom Price, MD, (R-Ga), to head the Department of Health and Human Services (HHS) and serve as President Donald Trump's point person in repealing and replacing the Affordable Care Act (ACA).
 The 14 to 0 vote reflected the partisan tumult engulfing the nation's capital during Trump's first few weeks in office. All the votes came from Republican members of the committee because, for a second day in a row, the 12 Democratic members boycotted executive sessions to confirm both Dr Price and Steven Mnuchin, the president's nominee for Treasury secretary. Ranking member Sen. Ron Wyden (D-Ore) said the committee should not move forward on the nominations until it addresses "unanswered questions and misleading statements" by both men. Democrats contend that Dr Price has not come clean about alleged conflicts of interest regarding his investments in healthcare companies, which he has denied.
Dr Price's nomination now goes before the full Republican-controlled Senate for a vote. Because the Senate changed its rules when Democrats were in power to exempt cabinet-level appointments from a filibuster, Dr Price needs only a simple majority, or 51 votes, for confirmation. Republicans hold 52 seats.
Ignoring all the expected Republican/Democratic debate over ethics and politics, his confirmation will be unique in that he is the first physician in my memory to serve in this capacity.

Trump has chosen a man who understands the medical system as a practicing physician. In the past, leaders have been from other sectors of government who in many cases were assessed on performance as heads of other departments.  Few physicians are confident in non clinicians when it comes to making medical decisions.  

Just recently chair of the House Budget Committee, Dr Price has been an adamant foe of the ACA and government regulation that he considers burdensome for physicians. Trump has said that once confirmed, Dr Price will work with the White House to introduce a plan to replace the healthcare reform law, one that will provide "insurance for everybody." If confirmed, the orthopedic surgeon would then help implement the replacement plan.



Senate Finance Committee OKs Tom Price, MD, for HHS Chief

Monday, January 30, 2017

Finally, mHealth is the winner : Software as a drug? - Health Files by Rajendra Pratap Gupta

The line between pharma and health information technology is blurring. SAAD (Software ad a drug stands alongside . of SAAS (Software as a Service)

The progress is punctuated by the FDA which will require vetting of health software when it is linked to treatments.  No such requirement has been proposed for electronic health records, but is now being required for mobile health applications and/or remote monitoring.

In the past the FDA (Food and Drug Administration) was responsible for the safety of food stuffs. It is also responsible for the safety and efficacy of pharmaceuticals, and medical devices.  The vetting of pharmaceuticals is complex and very expensive.  The cost of new drug development is quoted as between 450 million dollars and 900 million dollars.  Pharma uses these figures to justify the cost of new proprietary formulations. The patents are valid for 16 years.  When a new drug makes the 16 year mark it becomes available to other pharmaceutical companies to be sold as generic drugs,  and the cost drops significantly.

If and when SAAD becomes available for diagnosis and treatment it will require FDA approval. Usually this takes at least 12 to 24 months, unless there are urgent medical considerations.  I would expect a price increase for SAAS.

Therefore it is not at all a guaranteed win.







Finally, mHealth is the winner : Software as a drug? - Health Files by Rajendra Pratap Gupta | ET HealthWorld

Thursday, January 26, 2017

Here's what primary care doctors really think about Obamacare - LA Times



Conducted in December and January and published online Wednesday in the New England Journal of Medicine, the new survey shows that nearly three-quarters of general practitioners favored making changes to the Obama administration’s signature healthcare reform measure.
But in this nationally representative sample of primary care doctors, only 15% favored the law’s repeal. Among responding physicians who voted for Donald Trump, only 38% favored the law’s repeal.
That makes the repeal of the Affordable Care Ac, also known as Obamacare, far less popular among the physicians on the front lines of medicine than it is in the American body politic. A Kaiser Family Foundation poll taken after the November 2016 election found that 26% of Americans wanted to see Obamacare repealed.
Among the survey’s most striking findings was strong support for an extension of the Affordable Care Act that is absent from any GOP proposals: Two-thirds of primary care physicians endorsed the idea that any healthcare reform should include a public insurance option resembling Medicare that would compete with private plans.
Study coauthor Dr. Craig Evan Pollack, an internal medicine specialist at Johns Hopkins University School of Medicine, said he was struck by the strength of physicians’ opposition to measures that increased complexity and shifted costs toward patients. He suggested it was a direct result of doctors’ experience in caring for patients.
“As physicians, we see people struggle with out-of-pocket costs, deciding which types of care they’re able to afford and making very challenging decisions,” said Pollack. Primary care physicians, he added, “try to advocate for their patients.”
The new survey reflects the answers of 426 physicians drawn from a master file of the American Medical Assn. and is considered a nationally representative sample. Its findings appear to mark a significant shift in physicians’ opinions about the Affordable Care Act. In the opening months of 2015, 48% of primary care physicians had a favorable opinion of the Affordable Care Act and 52% viewed it unfavorably.
Dr. David Grande, an internal medicine physician at the University of Pennsylvania’s Perelman School of Medicine, said that as the Affordable Care Act got up and running, virtually all of his colleagues have treated new patients who had previously been uninsured or who struggled to hold on to insurance.