"Right To Try" Proposed In Oregon

Another good step in the right direction:

Diego Morris said he’s alive today because he used experimental drugs to treat his cancer even though they weren’t approved by the FDA.

In 2012, Morris was diagnosed with osteosarcoma. But because the medicine needed to treat it was not approved in the US, he traveled to Europe with his mother to get it.

Now he’s cancer-free and he flew to Oregon to join Rep. Knute Buehler to support the Right To Try bill...

Click through to see related video.

CO passed a similar law in 2014.  (Via Christina Sandefur.)

Catron: Still Not Working

David Catron discusses the latest snafus with ObamaCare in his latest AmSpec piece, "No, Mr. President, Obamacare Isn’t Working".

A couple of excerpts:

Last week, the White House took to Twitter for purposes of publicizing its latest Obamacare enrollment blarney. Far more informative than the tweet’s fictitious sign-up numbers was the schmaltzy video to which it was linked. Staged in the Oval Office, this one-act farce features a simpering HHS Secretary briefing our Thespian in Chief, who then delivers the following soliloquy: “The Affordable Care Act is working. It’s working better than we anticipated. It’s certainly working a lot better than many of the critics talked about early on.” In Obama’s 27-word script, “working” appears three times. The President doth protest too much, methinks.

And:

Ask the folks who learned last Friday that Obama’s bureaucrats sent them erroneous tax information relating to PPACA. AP reports, “Officials said the government sent the wrong tax information to about 800,000 HealthCare.gov customers, and they’re asking those affected to delay filing their 2014 returns.” And, as with most government blunders, the price will be paid by those who can least afford it. Robert Pear points out in the New York Times, “[T]housands of lower-income Americans who qualified for subsidized insurance had hoped for tax refunds and now must wait for weeks to file their taxes.”

For more, read the full text of  "No, Mr. President, Obamacare Isn’t Working".

FDA Hindering Promising Therapies Derived From Patient's Own Cells

Interesting update from the Winter 2015 issue of City Journal: "Patient, Heal Thyself".

Their teaser line: "Treatments from our own cells could cure many diseases -- if Washington will only allow it to happen."

They discuss how the current FDA regulatory paradigm stifles this promising research:

Unlike conventional drugs, these cell therapies are created from scratch, one patient at a time, and many of the tools used to create them are simple, compact, and cheap enough to land in laboratories that serve hospitals, small clinics, and doctors in private practice. They have been landing there in growing numbers in the last decade, and Washington has been trying to keep pace.

The Food and Drug Administration (FDA) has taken the position—upheld in February 2014 by a federal appellate court—that a patient’s cells become a “drug” when extracted and manipulated in a laboratory, and may not be used to treat the patient without FDA approval. But it is far from clear how the agency should set about approving a custom-made drug that will be prescribed to only one patient, in whom its safety and efficacy will be largely determined by how the patient’s molecular biology interacts with itself....

[R]igidly scripted trials remain the norm at the FDA. Responding to the advent of drugs precisely designed to modulate specific molecular targets, the FDA has gradually come to accept that the drug-approval process must take into account the relevant patient-side molecular factors as well.

The FDA has, however, been slow to accept trial protocols that systematically investigate those factors and incorporate them into prescription protocols that increase the likelihood that the drug will be effective. With rare exceptions, the agency requires that the molecular factors that might affect a drug’s efficacy be identified by studying the disease before a clinical trial begins, or by analyzing the drug’s performance in short, early-phase trials that involve few patients—far too few to provide a full understanding of how variations in patient chemistry may affect a drug’s performance. This has already been recognized as a serious problem in the testing of certain categories of conventional drugs...

The scientific aspects are fascinating. And the regulatory aspects are infuriating.

For more details on both, see the full text of "Patient, Heal Thyself".

(Link via Instapundit.)

(Image from the article, captioned: "Emily Whitehead, a child given cell therapy for acute leukemia; her family says that she shows no sign of the cancer today. Ed Cunicelli, The Children's Hospital Of Philadelphia/AP photo.")

BRI Debate at Georgetown

The Benjamin Rush Institute will be sponsoring a debate on 3/27/2015 at Georgetown University School of Medicine:

"Be It Resolved: Affordable, quality healthcare develops from maximizing freedom of choice – not government programs or mandates".

If you're in the Washington DC area, it looks like a great event!

From their announcement page:

When: March 27, 2015 @ 6:00 pm – 8:00 pm

Where: 

Georgetown U. School of Medicine - New Research Building Auditorium

Georgetown University
3900 Reservoir Road Northwest, Washington, DC 20007
USA

Cost:

Free, but RSVPs requested.

Contact:

John Grimsley

Email

Please RSVP through the green “Tickets” link on the announcement page.

The event is free but we want to plan the right amount of food! There is a parking garage located under the Leavey Center accessible from Reservoir Road, or there is the Southwest Parking garage accessible from Canal Road.

Debate Venue Details:

Date: Friday, March 27, 2015

Time: [Eastern]
6:00 PM Reception with soft drinks and hors d’oeuvres; Registration and initial voting
6:30 Debate Begins
7:45 Debate Ends. Final voting, tally.
8:00 Announcement of results.

Place: Georgetown University School of Medicine
Room — New Research Building Auditorium
3900 Reservoir Road Northwest,Washington, DC 20007

Moderator: Michael Ramlet (Morning Consult)

Arguing the Affirmative:
Dr. Josh Umbehr MD (AtlasMD)
Dr. Lee Gross, MD (Epiphany Health, Inc.)

Arguing in Opposition:
Dr. Dennis McIntyre, MD
Dr. Adriane Fugh-Berman, MD

WSJ On Records and Regulators

Two quick links to recent Wall Street Journal pieces worth reading.

Singer: "ObamaCare's Electronic-Records Debacle".

He highlights both the obvious and hidden costs of mandated electronic medical records, and how they harm patients in the real world.

Huber and Howard: ''What Failed, the new Cancer Treatment or Regulators?"

They discuss how rigid FDA testing guidelines hinder the approval of drugs that might work well for one subpopulation of patients, even if they have minimal effect on the general population.  In essence, this means stifling the development of "personalized medicine" and "precision oncology" based on an individual's unique genetic traits.

(As always, if these direct links only show the preview page, you can often read the full text for free by typing the article title into a Google search box, and getting the "Free Day Pass" version of the article.)

ICD-10 Costs

From the Daily Signal: "How This New Regulation Will Drive Up Your Health Care Costs".

Our own medical practice is already undergoing ICD-10 training as well as upgrading our business office software.  I don't know how much money it is costing, but it sure is taking a lot of man-hours!

(Via Benjamin Rush Institute.)

Hsieh Forbes Column: Why You Should Record Your Doctor Visits

My latest Forbes piece is now out: "Why You Should Record Your Doctor Visits".

Here is the opening:

NBC's Brian Williams has gone from being a respected news anchor to the butt of Internet jokes after he recanted a false story about being shot down in a helicopter over Iraq. As a result of the subsequent controversy, NBC has suspended Williams without pay for 6 months -- essentially costing him $5 million.

But whether or not Williams' story was an innocent "false memory" or a deliberate lie, it is the case that false or unreliable memories are a surprisingly common phenomenon. In a health care setting, patients' false memories of medical conversations might cost them more than money -- it might even endanger their lives. Hence, patients may wish to record their doctors' visits to protect themselves...

During my research for this piece, I learned that "40-80% of medical information provided by healthcare practitioners is forgotten immediately" and "almost half of the information that is remembered is incorrect" (!)

Fortunately, modern technology now makes it easier for patients to record these important discussions with physicians, for instance with a smartphone.

For more information on the benefits of this practice, read the full text of "Why You Should Record Your Doctor Visits".

Coverage But No Care in NJ, CA

Two recent news stories from New Jersey and California again highlight the fact that "coverage" does not equal medical care.

From the New Jersey Star-Ledger (2/5/2015): "Who will treat the flood of Obamacare Medicaid patients?"

From the San Jose Mercury News (2/7/2015): "Obamacare: Medi-Cal a waiting game for many low-income Californians".

In New Jersey, patient Justin Holstein said:

"You have a card saying you have health insurance, but if no doctors take it, it's almost like having one of those fake IDs," he said. "Your medication is all paid for, but if you can't get the pills, it's worthless."

Richard Holstein, his father, is a Long Branch psychologist who has watched his son struggle to get care. Yet he no longer accepts Medicaid in his own practice because the managed care payment of about $40 is half of what regular insurance pays, and a quarter of his full fee, he said.

Similarly, in California:

"We had a shortage of primary care doctors before this flood (of Medi-Cal enrollees) came about," said Dr. Steven Harrison, a veteran primary care doctor who directs a residency program for such physicians at Natividad Medical Center in Salinas. "Now we have a dire shortage."

A common theme in both stories: Patients were promised "coverage" under ObamaCare.  But they have a very difficult time finding a physician willing to see them, especially at the low rates that Medicaid pays.  Doctors essentially lose money on these patients, which means there is no way they can "make it up in volume".

The government even forbids Medicaid patients and doctors from reaching their own mutually-acceptable contractual arrangement to supplement Medicaid fees.  From the Star-Ledger piece:

Joanna DeProspero was desperate to find a pain management doctor for her adult daughter, who works part-time at Home Depot despite back pain. When she proposed paying cash, she learned it's illegal for a doctor to accept such a payment. Doctors who participate in Medicaid cannot bill a patient anything extra, said Downs, of the medical society -- even if that payment is freely offered by the patient.

 "I've literally cried at the end of the day after six or eight phone calls," said DeProspero...

One unfortunate side effect is that the patients end up going to the local emergency rooms instead (for care that isn't strictly an emergency), thus worsening the overcrowding situation in the ERs.

Supporters of the Affordable Care Act trumpet the increased "coverage" numbers provided by the law. But much of that increase is due to an expansion of Medicaid rolls, where the benefits are increasingly illusory for patients.

As we've seen throughout history, central planning and government fiats cannot create supplies of goods and services from thin air.  Instead, they merely create (or worsen) shortages.  Sadly, patients in New Jersey and California are paying the price for their lawmakers' ignorance of this lesson.

(New Jersey link via M.L.)