What to excpect in the Lame Duck: Cures and Creates?

 

The “Cures Act” would permit major new intrusions into private lives.  As the American Hospital Association told Politico Pro, the bill “is too broadly encompassing in allowing access to patient data for undefined research purposes; this undermines the trusted relationship between providers and their patients.” Specifically, section 1124 reclassifies research in the following subsections:

• Defining Health Data Research as Part of Health Care Operations

• Treating Disclosures of Protected Health Information for Research Similarly to Disclosures of Such Information for Public Health Purposes.

The details of your medical records will be available for any “research” related to public health (PH) or health care operations (HCO), including profiling, tracking, and analysis of patients and doctors. The federal definition of HCO is an astonishing 390 words long! And “public health” can be whatever the government says it is. HCO and PH could include experimentation at the bedside…without your consent. This is sometimes called Continuous Quality Improvement (CQI or QI). As the Hastings Center reports:

Federal agencies with responsibilities in this area have disagreed on where the interface between medical research and QI lies and how it should be handled. … The current state of uncertainty about what is ethically and legally required to safeguard participants in QI activities has already become a disincentive to engage in QI...

By reclassifying health data research, the “Cures Act” would make patient data available for undefined research purposes, including CQI, to more than 2.2 million entities plus government agencies.

This is a dramatic shift away from today’s protections for human subjects. Under today’s federal “HIPAA privacy rule,” researchers have specific de-identification requirements and limitations on access and use. However, HIPAA requires no patient consent for access or use under “health care operations” (HCO) or “public health activities.”

Only people living in states with true (anti-HIPAA) medical privacy laws would be protected – but those states are rare.

The “Cures Act” also prohibits barriers to outsider access. Section  3001 mandates that electronic health record (EHR) companies, under threat of penalties, provide transfer of and access to “the entirety of a patient’s data form any and all health information technology for authorized use under applicable law.” As stated above, Section 1124 expands “authorized use” to unspecified “research.”

H.R. 6 also specifically includes the use of patient data for controversial “comparative effectiveness research” (CER) as established by Obamacare.

A reporter from The Hill (Washington, D.C.) asked me yesterday about the dangers of allowing such broad access to private patient data. I included the following:

1. The end of the confidential patient-doctor relationship.
2. Health care rationing as outsiders profile patients and doctors and use patient data to dictate treatment and conduct rationing-based research.
3. Poor care as patients avoid the frank disclosures necessary for accurate and timely medical care.
4. Inaccurate research findings as patients falsify data to protect themselves.
5. Loss of public support for medical research and health care institutions as patients realize the research enterprise and the health care system do not respect their privacy rights, are interfering in treatment decisions, and are using their data for purpose they have no agreed to.

Read Twila's full analysis here.

Also read Twila'as 12 reason to oppose the 21 First Centrury Cures Act.

Rumors on Capitol Hill are that not only will Congress finish work on Cures Act in the lame duck, but it will make the bill worse by adding the "Creating and Restoring Equal Access to Equivalent Samples Act (CREATES Act) in order to pay for the CURES's acts new spending.

The CREATES Act (S. 3056) addresses what may be a legitimate problem with Food and Drug Administration (FDA) policies, but in a way that violates property rights.

Under current law, the FDA can require generic drug manufacturers to perform risk evaluation and mitigation strategies (REMS), in cases where the agency determines that the additional safety measures are needed before the generic version can be marketed. In order to develop these REMS, the companies holding the patients on drugs must turn over samples of their products to the generic manufacturers.

Concerns have been raised that some manufacturers are manipulating this requirement to make it difficult for generic drug manufactures to compete with their products by refusing to turn over samples of the drugs to their competitors.

These concerns are highlighted by the Turing Pharmaceuticals manipulation of the regulatory process to obtain and maintain a monopoly or the drug Daraprim. The company was able to charge a 500% mark-up.

Obviously, this system needs changing. The logical solution is to get the government out of their business of approving drugs and allowing free competition in pharmaceuticals.

Instead of moving in the direction of more freedom, the CREATES Act imposes new mandates and government-imposed costs on the drug development process.

Under CREATES a generic drug manufacturer has the power to sue a patent holder to force the holder to manufacture samples of their product for the use of their competitors. It also empowers courts to force companies to turn over safety protocols they have developed to their competitors.

No matter what one's views on the legitimacy of intellectual property, all libertarians should oppose giving any branch of government the power to force companies to turn over their product to their potential competitors. If government can force drug companies to share their products with their competitors, than why shouldn't I be able to force Coke to turn over their formulas to me for "Norm's Cola?"

I have heard that some are proposing to fix this problem by changing the FDA's rules. This is far from ideal. It is better than giving the federal courts new powers to violate property rights.

The best solution is to get rid of the unconstitutional FDA and let all drug manufacturers compete in a free-market.

Campaign for Liberty members who oppose further government spending, erosion of medial privacy, and "fixing" the problems with the FDA's regulations of pharmaceuticals should call their Senators and Representatives to tell them to oppose the CURES Act and the CREATES Act.

For more on how government regulations grants large pharmaceutical companies de facto monopoly powers that are responsible for the high prices of drugs like Daraprim, see here.