December 4, 2013
We are at a turning point in medicine. Knowledge of the individual\’s genetic makeup will soon allow molecular medicine to reach deep inside each of us to cure most of the maladies that afflict us—and perhaps even slow the rate at which we age. First we will learn to understand each person\’s genome; then we will learn to craft treatments tailored to his or her genetic constitution.
But it may not be so easy—and not for purely scientific reasons. Consider 23andMe, a commercial enterprise launched in 2006 that was merely looking to inform Americans about their potential genetic vulnerability to certain diseases. Regulators from the Food and Drug Administration have dropped the hammer on the company, citing baseless fears that its customers will do something dangerously stupid in reaction to the information that the tests provide. The FDA\’s regulatory labyrinth is not only slow to digest the science behind the genetic testing involved in 23andMe. It also can\’t quite figure out what to do with the proliferation of molecular biomarkers that can predict treatment efficacy more quickly than the conventional clinical trials the agency relies upon.
All this is just the tip of the iceberg, Peter Huber argues in \”The Cure in the Code,\” his urgent, compelling account of how 21st-century medicine is being hampered by a regulatory regime built for the science of the 20th century.
via Review: The Cure in the Code – WSJ.com.
December 2, 2013
Through one man\’s story, Project FDA\’s new video shows how new technology can enable us to triumph over once-intractable diseases –if the FDA can adapt outdated regulations to fit a new medical reality. The video features interviews with Manhattan Institute senior fellow Peter Huber, author of CURE IN THE CODE: HOW 20TH CENTURY LAW IS UNDERMINING 21ST CENTURY MEDICINE, 23andMe co- founder Linda Avey, and others.
via Building a 21st Century FDA: Advancing Science, Saving Lives – YouTube.
November 28, 2013
But as the FDA frets about the accuracy of 23andMe’s tests, it is missing their true function, and consequently the agency has no clue about the real dangers they pose. The Personal Genome Service isn’t primarily intended to be a medical device. It is a mechanism meant to be a front end for a massive information-gathering operation against an unwitting public.
Sound paranoid? Consider the case of Google. (One of the founders of 23andMe, Anne Wojcicki, is presently married to Sergei Brin, the founder of Google.) When it first launched, Google billed itself as a faithful servant of the consumer, a company devoted only to building the best tool to help us satisfy our cravings for information on the web. And Google’s search engine did just that. But as we now know, the fundamental purpose of the company wasn’t to help us search, but to hoard information. Every search query entered into its computers is stored indefinitely. Joined with information gleaned from cookies that Google plants in our browsers, along with personally identifiable data that dribbles from our computer hardware and from our networks, and with the amazing volumes of information that we always seem willing to share with perfect strangers—even corporate ones—that data store has become Google’s real asset. By parceling out that information to help advertisers target you, with or without your consent, Google makes more than $10 billion every quarter.
via 23andMe Is Terrifying, But Not for the Reasons the FDA Thinks: Scientific American.
November 28, 2013
Aggravating the conflict is a cultural clash between Silicon Valley, with its devotion to libertarianism and self-knowledge, and a ponderous old-school bureaucracy. But as the veteran journalist and F.D.A. watchdog Matthew Herper notes in one of the sharpest pieces written on this debacle, the agency’s investment into at least four years of negotiations suggests that it was trying to be accommodating. Herper reluctantly concluded that 23andMe is “either … deliberately trying to force a battle with the F.D.A., which I think would potentially win points for the movement the company represents but kill the company itself, or it is simply guilty of the single dumbest regulatory strategy I have seen in 13 years” of covering the F.D.A.
via How 23andMe Broke the Rules: The F.D.A. Versus Personal Genetic Testing : The New Yorker.
November 26, 2013
Let me be clear, I am not offended by all regulation of genetic tests. Indeed, genetic tests are already regulated. To be precise, the labs that perform genetic tests are regulated by the Clinical Laboratory Improvement Amendments (CLIA) as overseen by the CMS (here is an excellent primer). The CLIA requires all labs, including the labs used by 23andMe, to be inspected for quality control, record keeping and the qualifications of their personnel. The goal is to ensure that the tests are accurate, reliable, timely, confidential and not risky to patients. I am not offended when the goal of regulation is to help consumers buy the product that they have contracted to buy.
What the FDA wants to do is categorically different. The FDA wants to regulate genetic tests as a high-risk medical device that cannot be sold until and unless the FDA permits it be sold.
via Our DNA, Our Selves.
November 25, 2013
The Food and Drug Administration (FDA) is ordering the biotechnology firm 23andMe to immediately stop selling its heralded DNA test kits.
23andMe never proved that its tests are effective and never received clearance to market them from the FDA, the agency said in a letter sent on Friday. That’s a violation of the Federal Food, Drug and Cosmetic Act.
The company’s kit tests saliva samples, sells for $99 and claims to help diagnose risks of health conditions and possible negative reactions to certain medications.
“The more you know about your DNA, the more you know about yourself,” 23andMe says in its online marketing materials.
But according to the FDA, the firm never affirmed that it works as a diagnosis device.
via FDA orders halt to DNA test sales | TheHill.
October 9, 2013
The hunt for cheaper prescription drugs long has led consumers to reach beyond U.S. borders, but under a Maine law set to take effect Wednesday, their search now will have the state\’s blessing.
The law, the first of its kind, sanctions the direct purchase of mail-order drugs from some foreign pharmacies. It has ignited a court battle with the pharmaceutical industry and set the stage for a broader fight over access to less-costly medication.
\”If Maine can do this, other states will do this. It could have a big impact on pharmaceutical companies\’ long-term profits and desire to invent new medications,\” said Boston University economics professor Laurence Kotlikoff, who researches drug imports. \”On the other hand, in some areas, they [drug makers] need to be brought back in line.\”
via Maine to Allow Prescription-Drug Imports – WSJ.com.
July 31, 2013
President Obama promised to mend the failings in the American health-care system, and yet for cancer treatment, ObamaCare is taking a rotten feature of the old system and making it worse.The Affordable Care Act expands a program called 340B, which siphons money from drug makers and insurers to subsidize certain hospitals. The program has been expanded as a way to offset some of the cuts that the law imposes on hospitals. One significant side effect: 340B is increasing the cost of cancer care—and harming its quality.When the program began in 1992, its aim was to support hospitals that cared for many uninsured, indigent patients. Over the years, the program was radically broadened, gradually morphing into a government cash cow that hospitals of every description have learned to exploit.
via Scott Gottlieb: How ObamaCare Hurts Patients – WSJ.com.
July 15, 2013
The White House Office of Management and Budget on July 12 finished reviewing a long-awaited regulation on the 340B drug discount program, a regulation that CMS first proposed two years ago and that drug makers and hospitals serving a disproportionate share (DSH) of the poor have been fighting over since.
May 16, 2013
This article studies how well International Nonproprietary Names (INNs), the “generic” names for pharmaceuticals, address the problems of imperfect information. Left in private hands, the identification of medicines leads to confusion and errors. Developed in the 1950s by the World Health Organization, INNs are a common, global, scientific nomenclature designed to overcome this failure. Taking stock after sixty years, we argue that the contribution of INNs to social welfare is paramount. They enhance public health by reducing errors and improving patient safety. They also contribute to economic efficiency by creating transparency as the foundation of competitive generic drug markets, reducing transaction costs, and favoring trade. The law in most countries requires manufacturers to designate pharmaceuticals with INNs in labeling and advertising. Generic substitution is also permitted or mandatory in many countries. But not all the benefits of INNs are fully realized because prescribers may not use them. We advocate strong incentives or even legally binding provisions to extend the use of INNs by prescribing physicians and dispensing pharmacists, but we do not recommend replacing brand names entirely with INNs. Instead, we propose dual use of brand names and INNs in prescribing, as in drug labeling.
via Generic Drug Names and Social Welfare.