Results for “fda” 461 found
Our DNA, Our Selves
At the same time that the NSA is secretly and illegally obtaining information about Americans the FDA is making it illegal for Americans to obtain information about themselves.
In a warning letter the FDA has told Anne Wojcicki, The Most Daring CEO In America, that she “must immediately discontinue” selling 23andMe’s Personal Genome Service, more affectionately known as the spit kit.
As I wrote when this issue first surfaced in 2010:
The ability of genetic tests to predict diseases is currently limited; if the FDA were simply to require firms to acknowledge this point, say with a clear statement of probabilities, that would be one thing (although this task is better met by the FTC under advertising regulation). But the FDA is brazenly overreaching in trying to regulate genetic tests as medical devices. First, there is no question that these tests are safe–safer than brushing your teeth!–and also effective in identifying genetic markers. Thus,
there is no medical reason whatsoever for regulation.
Moreover, genetic tests provide information, personal information about our bodies and our selves. The FDA has no standing to interfere with the provision of such information.
Consider, I swab the inside of my cheek and send the sample to a firm. The idea that the FDA can rule on what the firm can and cannot tell me about my own genes is absurd–it’s no different than the FDA trying to regulate what my doctor can tell me after a physical examination or what my optometrist can tell me after an eye examination (Please read the first line. “G T A C C A…”).
The idea that the FDA can regulate and control what individuals may learn about their own bodies is deeply offensive and, in my view, plainly unconstitutional.
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.
Moreover, the FDA wants to judge not the analytic validity of the tests, whether the tests accurately read the genetic code as the firms promise (already regulated under the CLIA) but the clinical validity, whether particular identified alleles are causal for conditions or disease. The latter requirement is the death-knell for the products because of the expense and time it takes to prove specific genes are causal for diseases. Moreover, it means that firms like 23andMe will not be able to tell consumers about their own DNA but instead will only be allowed to offer a peek at the sections of code that the FDA has deemed it ok for consumers to see.
Alternatively, firms may be allowed to sequence a consumer’s genetic code and even report it to them but they will not be allowed to tell consumers what the letters mean. Here is why I think the FDA’s actions are unconstitutional. Reading an individual’s code is safe and effective. Interpreting the code and communicating opinions about it may or may not be safe–just like all communication–but it falls squarely under the First Amendment.
The FDA also has the relationship between testing and clinical validity ass-backward. The FDA wants to say no to testing until clinical validity is established but we are never going to discover clinical validity until we have mass testing. 23andMe is attempting to leverage individuals thirst for knowledge about themselves into a big data project that will discover entirely new connections between genotype and phenotype. But personalized medicine, just like personalized movie recommendations, only works with databases of millions. In the 20th century we took on many of our common diseases but it is now time to take on the uncommon diseases. There are some 7,000 known diseases and only about 500 have a treatment. Individual and disease heterogeneity is so large that even the diseases that we can treat are often not treated well. New approaches are necessary for progress. The collection of large amounts of DNA data is not the last step of personalized medicine but the first and by pushing back against the first steps the FDA is delaying the promise and progress of personalized medicine.
Full Disclosure: The FDA’s threat to regulate genetic tests in 2010 made me spitting mad so I put that spit to good use and became a 23andMe customer. Well worth it, if only to point out to my wife that contrary to all evidence I am in fact only 2.2% Neanderthal.
Getting rid of old regulations is much too hard
That is the topic of my latest New York Times column, which is entitled “More Freedom on the Airplane, if Nowhere Else.” It opens with this example:
It is sometimes the small events that reveal the really big problems lurking beneath the surface. That’s the case with the Federal Aviation Administration’s recent decision to grant airlines the liberty of allowing the use of electronic devices during takeoff and landing.
You still won’t be able to call on your cellphone during those times, but, if the airline allows it, you will be able to read on your Kindle or play Angry Birds throughout the flight.
That’s the good news. What’s the deeper problem? Our new Kindle freedoms, however minor they may seem, show how hard it is to clear away the old, unnecessary regulations that are impeding the economy.
After all, the previous restriction on electronics during flights was broadly unpopular in a way that cut across partisan lines. Yet, for many years, the public’s complaints did not bring concrete change, mostly because of regulatory inertia. (If you’re worried about safety, by the way, the airlines can still, at their discretion, demand that these devices be turned off when deemed necessary.)
Here is another bit from the piece:
Many regulations, when initially presented, can sound desirable. The problem is that, taken in their entirety, excess rules divert attention from pressing issues like the need for innovation and new jobs.
Michael Mandel, an economist at the Progressive Policy Institute, compares many regulations to “pebbles in a stream.” Individually, they may not have a big impact. But if there are too many pebbles, a river’s flow can be thwarted. Similarly, too many regulations can limit business activity. When the number of rules mounts, it can become hard for a business to know whether it is operating within the law’s confines. The issue is all the more problematic when federal, state and local constraints all apply.
Our public sector is overregulated, too. For instance, the tangle known as government procurement has exacerbated problems with the Affordable Care Act’s health insurance exchanges. The required formal processes made it difficult to hire the best possible talent, led to nightmare organizational charts and resulted in blurred lines of accountability. It’s hard to turn on a dime and fix such problems overnight, no matter how pressing the need.
Read the whole thing.
Drug Shortages are Killing
The shortages of injectable drugs that I have been writing about since 2011 (e.g. here and here) are continuing and they are extending to ordinary nutrients needed by premature babies:
Because of nationwide shortages, Washington hospitals are rationing, hoarding, and bartering critical nutrients premature babies and other patients need to survive.
..At the time of this writing—some shortages come and go by the week—Atticus’s hospital is low on intravenous calcium, zinc, lipids (fat), protein, magnesium, multivitamins, and sodium phosphate; it’s completely out of copper, selenium, chromium, potassium phosphate, vitamin A, and potassium acetate. And so are many other hospitals and pharmacies in the country, leading to complications usually seen only in the developing world, if ever.
The article in the Washingtonian covers problems with GMP regulations and the FDA, as I did earlier. The article also makes the following point. Many of these products, especially the simpler ones, are available in Europe but it is illegal to import them to the United States.
Many doctors are pinning their immediate hopes on Congress’s forcing the FDA to form a global pipeline to import an emergency supply. “I have friends in other countries who could get me some, but that would be illegal,” one doctor says. In fact, pharmacists note that the phosphorous Europe uses is a better product than that in the US because it’s organic and doesn’t interact with calcium in the PN, meaning more phosphorous could be included in the IV bag.
When Miguel Sáenz de Pipaón, a neonatologist at a prominent hospital in Madrid, arrived in the US for a research visit, he was stunned by the nutrition shortages.
“It’s crazy,” he says. “That doesn’t happen in Europe.” He noted that the US relies on a 25-year-old lipid emulsion, which is in shortage, while European hospitals use a newer version that’s readily available. Rather than import the newer emulsion, the US has left many patients without any lipids at all.
Hat tip: Kurt Schuler.
From the comments
Rahul writes:
Just for the heck of it, I tried an alternative list:
1. Ramp up drastically the training output of new doctors and nurses: More med schools, larger intakes per school, elimination of 4 years of pre-med university etc. More med school student scholarships and subsidies?
2.Massively expand other lower tiers of the medical system: Physicians assistants, Nurse Practitioners etc.
3. Liberalize drug imports both commercial and personal. Allow direct import of any FDA-licensed drug sold in equivalent nations (western EU / Canada etc.). Mostly ignore Big Pharma’s opinions in this context.
4. Fully recognize all medical degrees from similarly developed nations (e.g. Canada / UK / Japan / Australia etc.) to the point that doctors from these nations can register and practice almost instantly in the US. Provide an almost limitless immigration quota for doctors from western nations. Even better, aggressively recruit doctors from abroad. Mostly ignore APA’s opinions in this context.
5. Allow and encourage Medicare / Insurance procedures to be carried out abroad where cheaper locales (Mexico? Canada? Argentina? ) exist. Incentivize recipients using these options. Premium rebates? Encourage private insurers to offer plans that economize on major procedures by treating abroad.
Kidney Conscription in Iran
Al Roth points us to this story in Farsi about Iran’s plan to exempt kidney donors from military service. Google Translate reports:
Donate one of your kidneys to be exempted from military service
Acting Human Resources department Stadkl Armed Forces exemptions from military service the soldiers announced the donor organ. According to ISNA, General Moussa Kamali on donor exemption from military service, said the donor organ to make it happen efficiency, We’ll exempt him from military service. According to him, for example, people who donate one of his kidneys has been the inclusion of medical waivers are exempt from military service. Stadkl Armed Forces Acting Human Resources department stating Srfdashtn donation card member, was not the reason for exemption from military service, said those who donate their organ, even during military service are exempt from military service.
No doubt some people will find this unjust. Indeed it is but certainly less unjust than conscription without such an option.
Daniel Klein views the rise of government through Ngram
Here is the abstract:
In this very casual paper, I reproduce results from the Google Ngram Viewer. The main thrust is to show that around 1880 governmentalization of society and culture began to set in — a great transformation, as Karl Polanyi called it. But that great transformation came as a reaction to liberalism, the first great transformation. The Ngrams shown include liberty, constitutional liberty, faith, eternity, God, social gospel, college professors, psychology, economics, sociology, anthropology, political science, criminology, new liberalism, old liberalism, public school system, Pledge of Allegiance, income tax, government control, run the country, lead the country, lead the nation, national unity, priorities, social justice, equal opportunity, economic inequality, forced to work, living wage, social needs, our society, bundle of rights, property rights, capitalism, right-wing, left-wing, virtue, wisdom, prudence, benevolence, diligence, fortitude, propriety, ought, good conduct, bad conduct, good works, evil, sentiments, impartial, objective, subjective, normative, values, preferences, beliefs, and information.
The paper is here. Here is one example:
Assorted links
Acemoglu and Robinson on the great stagnation
Two things are absent in this debate, however.
First, much evidence shows that what determines technological innovations isn’t some sort of “exogenous innovation capacity,” but incentives…
Schmookler illustrated these ideas vividly with the example of the horseshoe. He documented that there was a very high rate of innovation leading to improvements in the horseshoe throughout the late 19th and early 20th centuries because the increased demand for transport meant increased demand for better and cheaper horseshoes. It didn’t look like there was any sort of limit to the improvements or any evidence of an “exogenous innovation capacity” in this ancient technology, which had been around since 2nd century BC. Then suddenly, innovations came to an end, but this had nothing to do with running out of low hanging fruit. Instead, as Schmookler put it (p. 93), it was because the incentives to innovate in this technology disappeared because “the steam traction engine and, later, internal combustion engine began to displace the horse… “
Their full post is here.
I have changed my mind on this issue quite a bit over the last four to five years. Yes incentives matter, but outside of extreme environments are changes in incentives explaining the changes in what we observe? I now think it is of critical importance where a sector or economy is on “the innovation curve.” It was easier to innovate in game theory in the 1980s than it is today, even though the salaries of top economists have risen significantly. The pharmaceuticals market is larger than ever before, and yet the pipeline is largely dry. We are simply at a point where further breakthroughs are hard (and it is not obvious that FDA innovation taxes are getting worse over this period of change.) Weren’t so many inventors of the 19th century largely “yahoos,” with no fancy degrees, relatively low pay, little or no peer review, not at the peak of the Flynn effect, and so on, and yet they were on a fruitful part of the innovation curve and performed wonders.
I think in terms of general purpose technologies and platform-like breakthroughs. Once you get them, innovation runs wild, otherwise it is tough sledding, with incentives still accounting for some of the variation within a particular place on the innovation curve.
Medical Self Defense
Americans have historically put great weight on the right of self-defense which is one reason why many people support the 2nd Amendment, as the Supreme Court noted explicitly in District of Columbia v. Heller. But what about medical self-defense? John Robertson argues:
A person can buy a handgun for self-defense but cannot pay for an organ donation to save her life because of the National Organ Transplantation Act’s (NOTA) total ban on paying “valuable consideration” for an organ donation. This article analyzes whether the need for an organ transplant, and thus the paid organ donations that might make them possible, falls within the constitutional protection of the life and liberty clauses of the 5th and 14th amendments. If so, government would have to show more than a rational basis to uphold NOTA’s ban on paid donations.
Unfortunately, the Supreme Court has rejected medical self-defense arguments for physician assisted suicide and let stand an appeals court ruling that patients do not have a right to access drugs which have not yet been permitted for sale by the FDA (fyi, I was part of an Amici Curiae brief for this case). Robertson argues, however, that these cases can be distinguished. Physician assisted-suicide doesn’t fall within a long-American tradition necessary to receive due-process rights and organ transplants are not untested or experimental. It’s a good argument although it’s disappointing that the medical self-defense principle must be unjustly delimited.
Hat tip: Law, Economic and Cycling.
Whither Fashion Copyright?
The Innovative Design Protection Act (S.3523) would extend copyright protection for three years to fashion designs, including “undergarments, outerwear, gloves, footwear, and headgear; handbags, purses, wallets, tote bags, and belts; and eyeglass frames.” (Bill text.) Despite being introduced in every Congress since 2006, the bill has barely eked out of committee and no version has been brought to a floor vote.
On the surface, it seems that Congress should have done more with this proposal. It would make U.S. law commensurate with designer protections in France, Canada, and other countries. Supporters argue this would save U.S. jobs and constrain foreign pirates from stealing American ingenuity. Congress has previously carved out copyright protections for other useful articles. And there is a popular industry lobby behind the proposal. What’s more, the courts have recently protected fashion designs. So why haven’t the authors of the bill celebrated yet?
Bad politics?
1. Because fashion design in the U.S. is centered in a relatively few locales, it doesn’t yield political gains to a sufficient number of congressional districts or states. But this explanation is a false start because legislation like this gets logrolled all the time.
2. It is simply a bad idea and doesn’t pass even Washington’s sniff test. This ascribes much credit to Congress in sifting good ideas from bad.
3. The lobby, while part of it is popular and noticeable, is not unified behind the idea. High-end designers have been backing the idea from the start, but clothing and shoe makers dug in their heels early and later came on board nominally (they prefer reducing import tariffs).
Bad timing?
4. A version of the fashion copyright bill was first introduced in the House in 2006, just as the housing bubble was going pop. With Washington focused on the financial crisis, terrorism, and unemployment, and with a growing public furor over economic inequality, the deck has been stacked against distributing rents to high-end designers.
5. Increased party polarization over the past decade has made it difficult to establish winning coalitions for bills like these. A few days ago I asked Chris Sprigman (co-author of “The Piracy Paradox”) about this. He said, “That’s generally true, but hasn’t been true of copyright. Copyright has mostly been bipartisan.” While he and Kal Raustiala predicted after the recent election that the GOP could potentially take a more reluctant stance on copyright: “then as if on cue, the whole Republican Study Committee fracas over the “anti-copyright” report erupted.” Chris elaborates here.
In sum: It’s conceivable the bill could just hang around long enough and a political opportunity will emerge. Yet having barely made it out of committee, and with no floor vote in either chamber, the proposal hasn’t been put to a serious political test. So it could just be too politically risky. Everyone buys clothes and shoes, and they presumably like that they’re spending less and less on apparel. Plus, through their regular shopping experiences, they can also see vividly that knockoffs are the reason they have inexpensive options. Do elected officials really want to test those waters? It’s difficult to see a winning coalition forming against the potential backlash that fashion copyright would generate.
More on these issues from MR:
Alex covered the rapid cameo of the Republican Study Committee’s “radical but sensible position paper on copyright.”
Tyler covered “The Piracy Paradox” in his February 2006 entry, “How does the fashion industry work without copyright?” See also his: “Can we do without digital rights management?” and why the economics of food recipes resists copyright (“Food relies so much on execution…”); and why the French prioritize copyright.
India, India, India!
Today at MRUniversity we release the first of our country sections, India. In nearly 50 videos we cover key aspects of India’s history, economics, politics and culture from the viewpoint of development economics. Among the topics are India’s Early Growth History, Gandhi and the Salt March, the Green Revolution, Food Crises and the Media, the Rise of Private Education in India, and the Economics of Bollywood.
Tyler and I will both be in Delhi on Thursday December the 20th to talk to students of MRUniversity and others about economics, development and the future of online education. Information on times and places to follow.
By the way, for those of you taking the Development Economics course the India material is bonus to be sampled at will – this won’t be on the exam!
MRU also introduces new features this week including user contributions of links, videos and other materials directly from the video pages, ordering of questions by votes or recency and easier ways to see and access related materials and user contributions.
Marcia Angell’s Mistaken View of Pharmaceutical Innovation
At Econ Talk, Marcia Angell discusses big Pharma with Russ Roberts. I think she gets a lot wrong. Here is one exchange on innovation.
Angell: The question of innovation–you said that some people feel, economists feel, [the FDA] slows up innovation: The drug companies do almost no innovation nowadays. Since the Bayh-Dole Act was enacted in 1980 they don’t have to do any innovation….
Roberts: But let’s just get a couple of facts on the table…[The] research and development budget of the pharmaceutical industry is, in 2009, was about $70 billion. That’s a very large sum of money. Are you suggesting that they don’t do anything–that that’s mostly or all marketing? That they are not trying to discover new applications of the basic research? It seems to me basic research is an important part. Putting that research into a form that can make us healthier seems to be a nontrivial thing. You think they are–what are they doing with that money?
Angell: If you look at the budgets of the major drug companies–just go to their annual reports, their Security and Exchange Commission (SEC) filings, you see that Research and Development (R&D) is really the smallest part of their budget. If you look at the big companies you can divide their budget into 4 big categories. One is R&D, one is marketing and administration; the other is profits, and the other is just the cost of making the pills and putting them in the bottles and distributing them. The smallest of those is R&D.
Notice that Angell first claims the pharmaceutical companies do almost no innovation then, when presented with a figure of $70 billion spent on R&D, she switches to an entirely different and irrelevant claim, namely that spending on marketing is even larger. Apple spends more on marketing than on R&D but this doesn’t make Apple any less innovative. Angell’s idea of splitting up company spending into a “budget” is also deeply confused. The budget metaphor suggests firms choose among R&D, marketing, profits and manufacturing costs just like a household chooses between fine dining or cable TV. In fact, if the marketing budget were cut, revenues would fall. Marketing drives sales and (expected) sales drives R&D. Angell is like the financial expert who recommends that a family save money by selling its car forgetting that without a car it makes it much harder to get to work.
Later Angell tries a third claim namely that pharma companies do no innovation because their R&D budget is mostly spent on clinical trials and, “it’s no secret how to do a clinical trial.” I find this line of reasoning bizarre. I define an innovation as the novel creation of value, in this case the novel creation of valuable knowledge. Is Angell claiming that clinical trials do not provide novel and valuable knowledge? (FYI, I have argued that the FDA is overly safety conscious and requires too many trials but Angell breezily and nastily dismisses this argument). In point of fact, most new chemical entities die in clinical trial because what we thought would work in theory doesn’t work in practice. Moreover, the information generated in the clinical trials feeds back into basic research. Angell’s understanding of innovation is cramped and limited, she thinks it begins and ends with basic science in a university lab. Edison was right, however, when he said that genius is one percent inspiration and ninety-nine percent perspiration–both parts are required and there is no one-way line of causation, perspiration can lead to inspiration as well as vice-versa. Read Derek Lowe on the reality of the drug discovery process.
Angell infuses normative claims to the industrial organization of the pharmaceutical industry. Over the past two decades there has been an increase in the number of small biotechnology companies, often funded by venture capital. Most of the small biotechs are failures, they never produce a new molecular entity (NME). But a large number of small, diverse, entrepreneurial firms can explore a big space and individual failure has been good for the small-firm industry which collectively has increased its discovery of NMEs. The small biotechs, however, are not well placed to deal with the FDA and run large clinical trials–the same is also true of university labs. So the industry as a whole is evolving towards a network model in which the smaller firms explore a wide space of targets and those that hit gold partner with one of the larger firms to pursue development. Angell focuses in on one part of the system, the larger firms and denounces them for not being innovative. Innovation, however, should be ascribed not to any single node but to the network, to the system as a whole.
Angell makes some good points about publication bias in clinical trials and the sometimes too-close-for-comfort connections between the FDA, pharmaceutical firms, and researchers. But in making these points she misses the truly important picture. Namely that new pharmaceuticals have driven increases in life expectancy but pharmaceutical productivity is declining as the costs of discovering and bringing a new drug to market are rising rapidly (on average ~1.8 billion per each NME to reach market). In my view, the network model pursued on a global scale and a more flexible and responsive FDA, both of which Angell castigates, are among the best prospects for an increase in pharmaceutical productivity and thus for increases in future life expectancy. Nevertheless, whatever the solutions are, we need to focus on the big problem of productivity if we are to translate scientific breakthroughs into improvements in human welfare.
Marijuana, Prescription Requirements and the Doctrine of Informed Consent
It used to be common for physicians to withhold information and even to misinform patients “for their own good.” Authorities as venerable as Hippocrates advocated that some information be concealed from patients. Today, most of us would find it outrageous if a physician misinformed his patient to perform surgery regardless of the reasons. Changes in public opinion and a series of court cases have overruled medical paternalism. In the 1914 case Schloendorff v. Society of New York Hospital, Benjamin Cardozo wrote:
Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits an assault for which he is liable in damages. This is true except in cases of emergency where the patient is unconscious and where it is necessary to operate before consent can be obtained.
It wasn’t until the late 1950s and in particular the 1957 case Salgo v. Leland Stanford, however, that the doctrine of informed consent (DIC) became well accepted in practice and in medical ethics. The doctrine of informed consent has both consequentialist and deontological justifications. On the consequentialist side, informed consent generally leads to better medical outcomes. Patients are also better able to understand their own overall interests than are others so the DIC leads to better overall welfare. On the deontological side, it is today widely accepted that all patients have a right to autonomy and that physicians cannot justly abrogate that right even in the patient’s own interest. It would be wrong to require someone to undergo surgery even if such surgery was necessary to save their life.
In an interesting paper in the Journal of Medical Ethics Jessica Flanigan argues that the same reasons which support the doctrine of informed consent also support a patient’s right to use pharmaceuticals without a doctor’s prescription. Based on Peltzman and Temin she argues that the consequential outcomes of prescription-only have not been good, at least not overwhelmingly so. Most importantly, patient autonomy applies just as much to the choice to medicate as to the refusal to medicate:
Citizens have rights of self-medication for the same reasons that they have rights of informed consent. The prescription drug system has bad consequences and it privileges regulators’ and physicians’ judgements about a patient’s health over the patient’s judgement about her overall well-being. Most troublingly, the prescription drug system violates patients’ rights.
Instead, I propose that prohibitive pharmaceutical policies, which are a kind of strong paternalism, be replaced by nonprohibitive policies that enable patients to obtain whatever medicines they choose while promoting informed consumer choices by making expert advice readily available.
Notice that the argument is not simply that prescription only requirements are against social welfare but rather that support for the doctrine of informed consent also supports the right to use pharmaceuticals without getting the consent of an official.
I am pleased that the voters in Colorado and Washington approved adults to use marijuana for any purpose. In the future people will be shocked that we arrested millions for marijuana use in the same way that we are shocked that doctors used to perform surgeries without a patient’s informed consent.
Should there be required labeling of GMOs?
Here is one on-the-mark take (of many):
…there have been more than 300 independent medical studies on the health and safety of genetically modified foods. The World Health Organization, the National Academy of Sciences, the American Medical Association and many others have reached the same determination that foods made using GM ingredients are safe, and in fact are substantially equivalent to conventional alternatives. As a result, the FDA does not require labels on foods with genetically modified ingredients because it acknowledges they may mislead consumers into thinking there could be adverse health effects, which has no basis in scientific evidence.
Or try the National Academy of Sciences from 2010:
Many U.S. farmers who grow genetically engineered (GE) crops are realizing substantial economic and environmental benefits — such as lower production costs, fewer pest problems, reduced use of pesticides, and better yields — compared with conventional crops, says a new report from the National Research Council.
Here is a good NYT summary Op-Ed on that report. There is not the scientific evidence for Mark Bittman’s recent evaluation that:
G.M.O.’s, to date, have neither become a panacea — far from it — nor created Frankenfoods, though by most estimates the evidence is far more damning than it is supportive.
It’s the tag there that is problematic. He doesn’t offer a citation, nor has he in past columns offered convincing material to back this evaluation (you can read here for a somewhat more detailed account from Bittman; it simply minimizes benefits and does not support “by most estimates the evidence is far more damning than it is supportive”). This earlier critique of Bittman is on the mark on virtually every point.
The standards of evidence being applied here are extremely weak. In that last Bittman link he wrote that:
…The surge in suicides among Indian farmers has been attributed by some, at least in part, to G.E. crops…
The link is to a sensationalistic Daily Mail (tabloid) story, yet that gets translated into “has been attributed by some.” In that story, the suicides were caused by indebtedness and supposedly the debts were in part caused by a desire by farmers to buy GMO crops. In comparable terms one could write that anything one spends money on could cause suicide through the medium of indebtedness.
By the way, the Wikipedia treatment gives some more detailed citations suggesting that GMO crops are not a significant cause of farmer suicides in India. The most careful study of the matter reports this:
We first show that there is no evidence in available data of a “resurgence” of farmer suicides in India in the last five years. Second, we find that Bt cotton technology has been very effective overall in India. However, the context in which Bt cotton was introduced has generated disappointing results in some particular districts and seasons. Third, our analysis clearly shows that Bt cotton is neither a necessary nor a sufficient condition for the occurrence of farmer suicides. In contrast, many other factors have likely played a prominent role.
I would in fact be more supportive of the GMO labeling idea if renowned food writers such as Bittman, and many others including left-wing economists, would come out and boldly proclaim the science about GMOs to their readers. Too often the tendency is to use a “I’ll try not to say anything literally incorrect, while insinuating there are big problems” method of scoring points against big agriculture. (Another common trope is to switch the discussion to “distribution” and to suggest, either explicitly or implicitly, that a net benefit technology such as GMOs is somehow unnecessary or undesirable; dare I utter the words “mood affiliation“?) GMO labeling is the one issue which has gained legal traction, so critics of “Big Ag” just can’t bring themselves to give it up.
Bittman’s whole column is about GMOs, but he gets at the important point only in his final sentence:
[With better information] We’d be able to make saner choices, and those choices would greatly affect Big Food’s ability to freely use genetically manipulated materials, an almost unlimited assortment of drugs and inhumane and environmentally destructive animal-production methods.
Overuse of antibiotics and animal treatment (both cruelty and environmental issues) — now those are two very real problems, backed by overwhelming scientific evidence. The fact that the California referendum is instead about GMOs — which have overwhelming scientific evidence for net benefit and minimal risks — is the real scandal.
It’s time that our most renowned food writers woke up to that difference. In the meantime, they are doing both us and themselves a deep disservice.
Rand Paul Wants to Bring European Medicine to the United States
From a Rand Paul press release:
Today the U.S. Senate voted to pass the Food and Drug Administration Safety and Innovation Act (S.3187), which included language inserted by Sen. Rand Paul. This language would force the FDA to accept data from clinical investigations conducted outside the United States, including the European Union, to speed the process of getting life-saving drugs on the market by the FDA.
“Innovation in clinical drug trials should not be confined to the data received from trials in the United States. Findings from countries that incorporate the same rigorous requirements as we do when developing life-saving drugs and devices should be accepted by the FDA as well,” Sen. Paul said.
I agree but I would go further: Any drug or medical device introduced into say the EU, Japan, Canada or Australia ought to be automatically approved in the United States within 90 days. Such a procedure would reduce delay, eliminate needless duplication and cut costs.
Think about it this way: Europeans don’t regard the FDA as the best or final arbiter of safety and efficacy so why should we?
See FDAReview.org, especially the section on reform options, for more.