Unintended Consequences of FDA Regulations

Eye surgeon Dr. Brian C. Joondeph described a crazy "unintended consequence" of FDA rules designed to "protect" patients.

Here's an extended excerpt from his blog post:

In my medical specialty of retina surgery, compounded and off-label Avastin is used in the treatment of macular degeneration, diabetic retinopathy, and other retinal conditions. At a cost of 40 times less than the FDA approved options, using compounded Avastin instead of the on-label expensive alternatives could save Medicare $3 billion per year. Studies have shown the lower cost Avastin is equivalent to the much more expensive Lucentis in treating macular degeneration. Many physicians will try Avastin as the first line of treatment in their patients and continue using it if it is working well.

As Avastin is being used “off-label” in a much smaller dose than used for its approved use in cancer treatment, it must be divided into extremely small doses suitable for injection into an eye. This is done by a compounding pharmacy. Most patients receive injections every four to six weeks for many years, with many physicians deciding at the time of the eye exam whether or not to give an injection. Most patients are elderly and/or visually impaired, meaning that a friend or family member brings them to their eye appointment.

Back to the FDA, which recently issued guidance in response to the new, compounding law. Specifically they “will require a patient-specific prescription for all drugs compounded.” While this may allow easier tracking of the rare cases when drugs are contaminated, it won’t alter the actual compounding process and won’t reduce the chance of contamination.

But once the retina surgeon examines the patient and determines that they need an injection, instead of using a preordered syringe from their inventory, they will instead have to send a prescription to the compounding pharmacy and have the patient return on a separate day for their injection. For a patient receiving monthly injections, this translates to 24 office visits rather than 12 each year. Depending on insurance, there may be a copayment for each visit. Not to mention the friend or family member doubling their driving duties and the physician further loading their already busy patient schedules. Imagine going to the family doctor for a flu shot and after a quick exam, having to return a week later for the shot after the doctor writes a prescription for it rather than simply pulling a vial of flu vaccine from the refrigerator and giving the injection.

The simple alternative for the surgeon is to abandon any intention of being a good steward of societal and patient monies by simply using the FDA approved, but far more expensive, drugs. This avoids the hassle of writing several hundred injection prescriptions each month and making patients return a week later for each injection. Good financial stewardship of government money loses appeal when the government complicates the physician’s business processes by such mandates. And when the government threatens physicians with a 30% cut in reimbursement via the SGR cuts, why should physicians jump through hoops to save Medicare a few dollars?

These FDA rules increase the "hassle factor" for patients and doctors. And cost more money in the long run.

Hsieh Forbes Column: "No, Gun Violence Is Not a 'Public Health' Issue"

My latest Forbes piece is now up: "No, Gun Violence Is Not a 'Public Health' Issue".

I discuss 4 reasons we shouldn't frame "gun violence" as a "public health" issue, including:

1) Gun violence is not an “epidemic”, except in a metaphorical sense.

2) If “public health” includes “gun violence”, then intellectual fairness demands that we consider pro-gun arguments as well as anti-gun arguments.

3) Expanding “public health” to include “gun violence” diverts us from genuine public health threats.

4) Guns are not the doctor’s “natural enemy.”

Although I think gun crime should not be shoehorned into the category "public health", I recognize that others may disagree. In that case, lives saved by allowing concealed carry should be just as much of the “public health” discussion as lives lost to gun violence.

For more details on each of the four points above, see the full text of "No, Gun Violence Is Not a 'Public Health' Issue".

Hiding Wrongdoing Behind "Privacy"

NPR has a good report on "When Federal Privacy Laws Protect Hospitals Instead Of Patients".

From the article:

In the name of patient privacy, a security guard at a hospital in Springfield, Mo., threatened a mother with jail for trying to take a photograph of her own son.

In the name of patient privacy, a Daytona Beach, Fla., nursing home said it couldn't cooperate with police investigating allegations of a possible rape against one of its residents.

In the name of patient privacy, the U.S. Department of Veterans Affairs allegedly threatened or retaliated against employees who were trying to blow the whistle on agency wrongdoing.

When the federal passed in 1996, its laudable provisions included preventing patients' medical information from being shared without their consent and other important privacy assurances.

But as a litany of recent examples show, HIPAA, as the law is commonly known, is open to misinterpretation — and sometimes provides cover for health institutions that are protecting their own interests, not patients'...

Another issue is that patients are often being told they can't get a copy of their own medical records, in the name of "privacy"(!)

Armstrong on Halbig

Ari Armstrong takes a deeper look at the Halbig ruling in his latest post for The Objective Standard, "ObamaCare, Nonobjective Law, and Brothers' Keepers".

Money quote:

That ObamaCare pervasively violates the rights of individuals to control their own wealth and to freely negotiate terms of health insurance and health care on a free market is bad enough; that ObamaCare does so via ambiguous, nonobjective statutes is even worse. Not only through its ambiguous wording but through its deliberate deference to the whims of bureaucrats, ObamaCare substantially empowers the executive branch and hordes of bureaucrats to create whatever health policies they wish.

The basic problem is not that the Supreme Court will substantially decide how ObamaCare is interpreted. On the legal front, the basic problem is that Congress breached its Constitutional authority by ignoring its legally enumerated powers. On the moral front, the basic problem is that many American politicians—along with the Americans who voted for them—accepted the premise that, in health care, “we are our brothers’ keepers,” which now means, in practice, that elected officials, appointed judges, and unaccountable bureaucrats are to a substantial degree the keepers of each of us when it comes to health care. If Americans don’t want their health care controlled by bureaucrats, they must reject the premise that we are our brothers’ keepers and vote accordingly in the future.

Catron Vs. Roy On Halbig Rulig

Here are a few more responses to the recent federal court ruling on ObamaCare.

David Catron: "Obamacare Slowly Succumbs to Its Birth Defects" (PJ Media, 7/23/2014)

Avik Roy: "Halbig Court Opinion: A Victory For The Rule Of Law, But Merely A Speed Bump For Obamacare" (Forbes, 7/23/2014)

At this time, I think reports of ObamaCare's demise are premature.  But it's not a slam-dunk that it will survive intact either.

Halbig Ruling

Big legal news on ObamaCare. Here's a good description from Jonathan Adler, "D.C. Circuit strikes down tax credits in federal exchanges":

This morning the U.S. Court of Appeals for the D.C. Circuit released its much awaited opinion in Halbig v. Burwell.  In a 2-1 opinion, the Court held that the Internal Revenue Service regulation authorizing tax credits in federal exchanges was invalid.

Judge Griffith, writing for the court, concluded, “the ACA unambiguously restricts the section 36B subsidy to insurance purchased on Exchanges ‘established by the State.”  In other words, the court reaffirmed the principle that the law is what Congress enacts — the text of the statute itself — and not the unexpressed intentions or hopes of legislators or a bill’s proponents...

Although this decision is faithful to the text of the PPACA – that is, faithful to the text Congress actually enacted, as opposed to the health care reform some wanted or now wish they had gotten — it will provoke howls of outrage from ACA supporters.

On the other hand, William Jacobson notes: "4th Circuit upholds Obamacare federal exchange subsidy after D.C. Circuit rejects".  And related thoughts from Adler.

Given this split, the issue will almost certainly end up in the US Supreme Court.

(I also expect that many on the political Left to argue that this shows why the patchwork kludge of ObamaCare should be replaced by a simpler "single-payer" system.)

Bad Science, Bad Medicine

Forbes contributor Bill Frezza recently discussed the growth of bad science in his piece, "Bad Science Muckrakers Question the Big Science Status Quo".

In particular, he notes how a combination of publish-or-perish job pressures and the race for government grants produces an enormous amount of sloppy (and sometimes outright fradulent) science.

Fortunately, there are websites like RetractionWatch that keep on eye on scientific fraud and misconduct.

Another issue Frezza points out is the bias against privately-funded research.  One excerpt:

To make matters worse, private research dollars are being choked off by ill-conceived regulations, making researchers even more dependent on government grants, as Dr. Thomas Stossel at Harvard Medical School points out.

Stossel calls overly restrictive conflict of interest regulations “a damaging solution in search of a problem.” A self-described “typical academic socialist, totally living on grants for the first third of my career,” Stossel says his eyes were opened in 1987, when he was asked to serve on the scientific advisory board of Biogen (now Biogen IDEC), a fledgling biotech startup that went on to become a tremendous success. “I realized how fundamentally honest business people are compared to my academic colleagues, who’d run their grandmothers over for recognition.”

While working with Biogen, Stossel learned how difficult it was to translate academic research into products that actually help people. “It was during that time that conflict of interest mania emerged.” In 1988 Harvard Medical School instituted the first conflict of interest rules, largely as a result of an incident at the Mass Eye and Ear infirmary that was sensationalized by The Boston Globe.

Stossel characterizes this rationale as, “If I am paid by a corporation to do research, I am going to lie, cheat and steal.” Based on his experience at Biogen, he calls this a “total inversion of reality.” He notes that, “95 percent of the scientific papers retracted for falsification, fabrication, or plagiarism have no commercial connection.” And yet, conflict of interest rules continue to proliferate, choking off what could be a critical alternative to taxpayer funding...

In other words, "privately funded" is presumed to be corrupt whereas "government funded" is presumed noble and pure.

It's bad enough when taxpayers are obliged to fund sketchy science.  The problem gets worse when sketchy science is used to set "clinical guidelines" for physicians to follow -- guidelines that may be harmful to patients.

Dr. Robert McNutt and Dr. Nortin Hadler discuss this issue in more detail in, "How Clinical Guidelines Can Fail Both Doctors and Patients":

At best, these guidelines are recommendations based on scientific studies with results that pertain to the average among us. They do not adequately incorporate the personal differences and preferences of each of us as individuals. Furthermore, while these recommendations are based on clinical science, rarely is the science complete or incontrovertible.

Hence, the recommendations are consensus statements reflecting the perspectives of those charged with the production of the guideline. Of the thousands of clinical practice guidelines that have been produced, the majority is based on inadequate science and therefore reflects the conjecture of the “thought leaders” recruited to the task.

Unfortunately, under the new health law physician pay is going to be increasingly tied to various "quality measures" including adherence to clinical guidelines of dubious reliability. 

Do you want your physician to be rewarded for putting patients on anti-cholesterol drugs based on population guidelines that might not apply to you as an individual?  Or do you want your physician to be able to freely exercise his or her best individual discretion on your behalf? 

Physicians will be facing these sorts of questions in coming years.  You'd better hope your physician will stay loyal to you as a patient.

(National Institutes of Health; photo credit Wikipedia)

Hiding Misdeeds Behind Privacy Laws

Stewart Baker asks an interesting question in the Washington Post: "Who is protected by patient privacy laws? Hint: not patients."

He quoted from this recent Washington Post story, "VA uses patient privacy to go after whistleblowers, critics say":

Citing patient privacy, managers have threatened VA employees or retaliated against those who complain about agency misconduct, according to a key congressman and the union that represents most of the department’s employees.

“VA routinely uses HIPAA as an excuse to punish into submission employees who dare to speak out,” said Rep. Jeff Miller (R-Fla.), chairman of the House Committee on Veterans’ Affairs. He is leading a probe into the coverup of long wait times for VA patients.

David Borer, the American Federation of Government Employees’ top lawyer, listed a number of cases involving a VA claim of patient privacy used to stifle whistleblowers in a June letter to the department.

The Office of Special Counsel (OSC), which investigates whistleblower retaliation cases, is “very concerned about the misuse of HIPAA,” said Eric Bachman, an OSC deputy special counsel. “The potential chilling effect of even a small number of these HIPAA retaliation cases is a serious issue and one that should be addressed by the VA in short order.”…

Valerie Riviello is one VA employee who felt the lash of the department’s culture of retaliation.

A registered nurse at the Albany Stratton VA Medical Center in Upstate New York, Riviello said she was threatened with suspension and stripped of managerial duties after she complained last November about how a veteran was treated.

Riviello said the vet was unnecessarily restrained, with an arm and leg strapped to bedposts.

“They scared the hell out of me,” Riviello said with worry clear in her voice. “They sent me a letter saying I could go to jail.”

That threat came in the form of an e-mail to Riviello’s lawyer, Cheri L. Cannon, a partner with the Tully Rinckey law firm. The VA e-mail said that information Riviello provided Cannon “unlawfully includes medical records of a VA patient” and noted that violating HIPAA “is a felony offense subject to imprisonment and a fine of up to $250,000.”

If the government punishes whistleblowers, it's all the more remarkable that they are still willing to speak out.  Which is all the more reason to punish those covering-up misdeeds, not those doing the right thing.

Physician Autonomy Under Siege

Steve Jacob recently reported on how, "Physician Autonomy Is Under Siege".

One excerpt from a physician in the trenches:

Dr. Robert Monteiro, an internist in New Bern, N.C., said, "There is a huge amount of interference into the doctor-patient relationship, and that has a large impact on your professional satisfaction. You want to come to treatment decisions without someone telling you what to do and how to do it."

Monteiro said preauthorization for medications, imaging, and treatments requires increasing amounts of time. He said the uncompensated time required to complete paperwork associated with patient care limits patient access, because physicians run out of hours. He added that the constantly shifting insurance-plan changes and requirements can be overwhelming.

"It's as if you are playing a game and don't know the rules. Then rules constantly change and maybe you get penalized for new rules, even if you don’t know what they are. As doctors, we have no problem justifying how we take care of patients. But having to fill out a three-page form to get a generic blood thinner is ridiculous," he said.

He also linked to an article in JAMA (Journal of the American Medical Association) detailing the new pressures on physicians.

In particular, the JAMA article notes: "Clinicians increasingly are expected to substitute social and economic goals for the needs of a single patient."

Patients may want to start asking: Is my doctor really working for me?

(Link via Dr. Matthew Bowdish.)

Interview on 3 Languages of Politics

Philosopher (and my wife) Dr. Diana Hsieh recently interviewed me about "Understanding the Three Languages of Politics" on her live internet radio show, Philosophy in Action. You can listen to or download the podcast any time. You'll find the podcast on the episode's archive page, as well as below. About the Interview:

How many times have you been in political discussions with friends where you find you're talking past one another? You'll make points they consider irrelevant, whereas they'll focus on issues you consider nonessential. Such problems can be overcome, at least in part, using Arnold Kling's concept of the "Three Languages of Politics."

Paul Hsieh will explain how freedom advocates (e.g., Objectivists and better libertarians), conservatives, and liberals tend to use three vastly different metaphors in political discussions, which can create unintentional misunderstandings and miscommunications. He will also discuss how to frame discussion points so they better resonate with those speaking the other "languages" without compromising on principles.

Listen or Download:

• Duration: [51:15]]
• Download: Standard MP3 File (17.6 MB)

Topics: Topics:

• About the "three languages of politics"
• The differences in the three languages
• The difference that the three languages make
• Examples of the three languages
• Conflict between camps
• Alliances between camps
• Political argument between camps
• The debates over the Hobby Lobby decision
• Using the three languages to become more persuasive
• Caveats and cautions
• Three take-home points

Links:

• The Three Languages of Politics by Arnold Kling
• EconTalk: Arnold Kling Interview

For more about Philosophy in Action Radio, visit the Episodes on Tap and Podcast Archives.

Volokh on Hobby Lobby

Of course the big news from yesterday was the SCOTUS ruling on the Hobby Lobby case. Here's a nice summary from UCLA law professor Eugene Volokh: "The Hobby Lobby majority, summarized in (relatively) plain English".

The decision was clearly a win for Hobby Lobby.  However, I don't know what wider ramifications (if any) it will have on the ObamaCare law.

And if you ever wondered how and why health insurance became coupled to employment in the US, here is an excerpt from a piece I wrote in November 2013, "The Only Obamacare Fix Is For Obama To Legalize Real Health Insurance":

The current system of employer-based health “insurance” is an artifact of federal tax rules from World War II. When the U.S. government imposed wartime wage and price controls, employers could no longer compete for workers by offering higher salaries. Instead, they competed by offering more generous fringe benefits such as health insurance. In 1943, the IRS ruled that employees did not have to pay taxes on health insurance paid for by employers; in 1954, the IRS made this rule permanent.

This law permanently distorted the health insurance market in favor of employer-based plans. If an employer pays $100 for health insurance with pre-tax dollars, the employee enjoys the full benefit. But if the employer pays that $100 as salary, the worker will only be able to purchase $50-70 of insurance after taxes. The law also created perverse incentives for insurers to shift as many services as possible into pre-tax plans. Gradually, they started covering not just major expenses but minor routine expenses such as immunizations and well-baby checks. (Think of what would happen to the market for car oil changes if they were offered as a tax-free benefit through your workplace.)

Over time, this tax disparity helped employer-based health insurance dominate the private insurance market. Hence, most workers don’t own their own health insurance in the same way that they own their auto or homeowners insurance. When workers change jobs, they almost always must also change health plans...

The battles over what benefits should be provided by employers would evaporate if we uncoupled health insurance from employment.  No one expects their employer to provide their car insurance or homeowner's insurance.

For some specific reform proposals, read the full text of "The Only Obamacare Fix Is For Obama To Legalize Real Health Insurance".