ramanujan

  - When you cannot look at a screen (driving, working out)
  - When there are too many screens (control room)
  - In a very dark environment where visibility is impeded
  - If you are blind or vision-impaired

  [Submitted March 12]

  It's DanielTaylor again and I wanted to create a simple yet 
  intuitive post to explain the folks out there what happened  
  a couple of hours ago. This might also be useful for 
  bloggers or journalists who might be going to write about 
  it in the following hours.

  TL;DR

  The programs that read the blockchain, the bitcoin ledger, 
  disagree.

  Due to a bug in 0.7, it says that HIS is the correct 
  version of this ledger and 0.8 says that HIS is the correct 
  version.

  Miners (the people who add pages to the blockchain) are 
  told to switch to the 0.7 program so that this version 
  gains more support and the other one is discarded. 
  (orphaned).

  Regular users are not affected. Their transactions are 
  included in both ledgers and don't need to change any 
  programs.

  During that time, though, there is a slight chance of a 
  double-spend ocurring. That is why people recommended 
  merchants and exchanges to wait until there is one single 
  blockchain again before processing purchases and 
  merchandise.

  ...

  What's a double-spend?

  This is the reason why some merchants and exchanges stopped   
  processing incoming bitcoins for a couple of hours.

  The bitcoin network prevents people from spending the same 
  coins by mantaining this unique ledger, the blockchain. But 
  now that there were two of them, it was theoretically 
  possible to broadcast two different transactions with the 
  same coins and still get some confirmations.

  With some luck, someone could sneakily sneakily* buy a 
  television to a merchant who was reading the 0.8 ledger and 
  have the transaction confirmed. At the same time he could 
  have sent the same coins back to himself and, with some 
  luck, have the transaction confirmed on the 0.7 ledger.

  What happens is that, in the end when 0.7 wins, the thief 
  will have the television and his bitcoins. Remember that 
  there were two different versions of the same coins!

  This is not something easy to do and requires a lot of luck 
  because the blocks mined (the pages added to the ledger)  
  must be mined precisely in the correct order. But still, in 
  this situation it was easier to pull off and so it was 
  recommended for merchants and exchanges to temporarily stop 
  processing incoming transactions.

  Now the situation has resolved and the blockchain keeps 
  growing happily, page by page, block y block.

  People can inject just about anything they want into 
  themselves

  In Court, Plaintiff argued that he should have the right to 
  take whatever treatment he wishes due to his terminal 
  condition regardless of whether the FDA approves the 
  treatment as effective or safe, and that to prohibit him 
  from taking the treatment he wishes violates his rights 
  under the United States Constitution.4 The United States 
  Supreme Court previously addressed and rejected this  
  argument in Rutherford. In Rutherford, cancer patients 
  requested the right to use Laetrile, arguing, as does 
  Plaintiff, that for terminally ill patients the 
  effectiveness or safety of the proposed treatment is 
  irrelevant since such treatment is a last chance effort. 
  However, as identified by the Supreme Court in Rutherford, 
  to permit terminally ill patients to seek any type of 
  treatment regardless of the effectiveness of such treatment 
  would create a cottage industry existing solely to provide 
  potential panaceas to highly vulnerable patients. The 
  language of the Supreme Court in rejecting the Laetrile 
  argument is equally applicable here.

  "If history is any guide, this new market would not be long 
  overlooked. Since the turn of the century, resourceful 
  entrepreneurs have advertised a wide variety of purportedly 
  simple and painless cures for cancer, including liniments    
  of turpentine, mustard, oil, eggs, and ammonia; peat moss; 
  arrangements of colored floodlamps; pastes made from   
  glycerin and limburger cheese; mineral tablets; and 
  `Fountain of Youth' mixtures of spices, oil, and suet. In 
  citing these examples, we do not, of course, intend to 
  deprecate the sincerity of Laetrile's current proponents, 
  or to imply any opinion on whether that drug may ultimately 
  prove safe and effective for cancer treatment. But this 
  historical experience does suggest why Congress could 
  reasonably have determined to protect the terminally ill, 
  no less than other patients, from the vast range of self-
  styled panaceas that inventive minds can devise."

  The delay and large reduction in the total number of new 
  drugs has had terrible consequences. It is difficult to 
  estimate how many lives the post-1962 FDA controls have 
  cost, but the number is likely to be substantial; 
  Gieringer (1985) estimates the loss of life from delay 
  alone to be in the hundreds of thousands (not to mention 
  millions of patients who endured unnecessary morbidity). ... 

  If the U.S. system resulted in appreciably safer drugs, we 
  would expect to see far fewer postmarket safety 
  withdrawals in the United States than in other countries. 
  Bakke et al. (1995) compared safety withdrawals in the 
  United States with those in Great Britain and Spain, each 
  of which approved more drugs than the United States during 
  the same time period. Yet, approximately 3 percent of all 
  drug approvals were withdrawn for safety reasons in the 
  United States, approximately 3 percent in Spain, and 
  approximately 4 percent in Great Britain. There is no 
  evidence that the U.S. drug lag brings greater safety.

  Plaintiff requests that Dr. Davis be authorized to inject 
  Plaintiff with the with the experimental goat neutralizing 
  antibody drug [1] and that the FDA be enjoined from 
  interfering with Dr. Davis' treatment of Plaintiff. ...

  The Court is sympathetic to Plaintiff's situation. 
  However, the law is very clear, and under the current 
  statutes and regulations, Plaintiff's physician may not 
  administer the goat neutralizing antibody drug absent 
  prior approval of the FDA. In Court, Plaintiff argued that 
  he should have the right to take whatever treatment he 
  wishes due to his terminal condition regardless of whether 
  the FDA approves the treatment as effective or safe, and 
  that to prohibit him from taking the treatment he wishes 
  violates his rights under the US Constitution. ...

  This Court is in no way criticizing the intentions of 
  Plaintiff and his physician or the potential effectiveness 
  of the proposed treatment. Plaintiff's physician should 
  pursue approval of his Investigational New Drug 
  application as quickly as possible. Plaintiff's doctor 
  must obtain appropriate approval through the proper 
  regulatory authorities. As much as this Court may 
  empathize with Plaintiff, the authority to provide some 
  type of exemptions for individuals such as Plaintiff rests 
  with Congress and not with this Court.

  “We did a safety review, consulted with experts on PML, 
  and worked closely with FDA to come up with a risk 
  management program that allowed us to bring it back on the 
  market in a way that limited its use,” a Biogen 
  spokeswoman told the Law Blog. The plan prohibits giving 
  Tysabri for unapproved uses.

  Biogen Idec is running an early-stage trial of the drug in 
  multiple myeloma, but Baron doesn’t meet the criteria to 
  participate.

  Baron’s a prominent donor to the Democratic party, and 
  many of his powerful friends, including Lance Armstrong 
  and Bill Clinton, made appeals on his behalf. And the 
  family agreed not to sue if anything goes wrong.

  Ultimately, his doctors at the Mayo Clinic worked directly 
  with the FDA to find a “legal basis” for giving Baron 
  Tysabri. The deal was announced on Baron’s son’s blog late 
  yesterday.

  I remember reading an academic article that showed how the 
  real cost was almost always 1/20 of that

  It's faster to run experiments on animals than people. 

  I think you are vastly overestimating what society has to 
  gain by deregulating medicine. You'll get a one-time gain 
  of 10 years of progress at the cost of an unknown number of 
  lives.

  - 0 die from testing
  - cure appears at end of 10 years
  - 10 million people die over those 10 years
  - 10 million deaths

  - 1000 die from testing over 3 years
  - 3 million die from disease over those yeers
  - cure appears in year 3
  - no further deaths
  - 3 million + 1000 total deaths

  Dr. Holdren passed the letter on to the Food and Drug 
  Administration for review. But, in the FDA's response, the 
  agency gave the issues little more than a data-driven brush 
  off. They cite five studies in response to the professors' 
  request for independent verification of the safety of these 
  X-rays; however, three are more than a decade old, and none 
  of them deal specifically with the low-energy X-rays the 
  professors are concerned about. The letter also doesn't 
  mention the FDA's own classification of X-rays as 
  carcinogens in 2005.

  By law, FDA must respond to your 510(k) within 90 days, and 
  typically they do. The thing you have to understand is that 
  FDA measures 90 days about the same way the NFL measures 
  the 60 minutes in a football game. It's not unusual for the 
  clock to spend more time stopped than running.

  This guidance is intended to provide industry with 
  information on how the Food and Drug Administration (FDA) 
  is applying the 180-day generic drug exclusivity provisions 
  of the Federal Food, Drug, and Cosmetic Act (the Act) in 
  light of recent court decisions. The guidance
  addresses the issue of the elimination of the "successful 
  defense" requirement, which required an abbreviated new 
  application (ANDA) applicant to be sued for patent 
  infringement and to prevail in the litigation to receive 
  the 180-day period of marketing exclusivity.

  approved treatments in humans often lag 10 years or so 
  behind what's known to work in animal models

  Early in 1921, Banting took his idea to Professor John    
  Macleod at the University of Toronto, who was a leading 
  figure in the study of diabetes in Canada. 

  Banting and Best began their experiments by removing the 
  pancreas from a dog. ... By giving the diabetic dog a few 
  injections a day, Banting and Best could keep it healthy 
  and free of symptoms.

  The team was eager to start testing on humans. But on whom 
  should they test? Banting and Best began by injecting 
  themselves with the extract. They felt weak and dizzy, but 
  they were not harmed.

  In January 1922 in Toronto, Canada, a 14-year-old boy, 
  Leonard Thompson, was chosen as the first person with 
  diabetes to receive insulin. The test was a success. 
  Leonard, who before the insulin shots was near death, 
  rapidly regained his strength and appetite. The team now 
  expanded their testing to other volunteer diabetics, who 
  reacted just as positively as Leonard to the insulin 
  extract.

  The news of the successful treatment of diabetes with 
  insulin rapidly spread outside of Toronto, and in 1923 the 
  Nobel Committee decided to award Banting and Macleod the 
  Nobel Prize in Physiology or Medicine.

  I don't think removing the FDA is going to find a cure for 
  diabetes.

  Early in 1921, Banting took his idea to Professor John 
  Macleod at the University of Toronto, who was a leading 
  figure in the study of diabetes in Canada. Macleod didn't 
  think much of Banting's theories. Despite this, Banting 
  managed to convince him that his idea was worth trying.

  In January 1922 in Toronto, Canada, a 14-year-old boy, 
  Leonard Thompson, was chosen as the first person with 
  diabetes to receive insulin. The test was a success. 
  Leonard, who before the insulin shots was near death, 
  rapidly regained his strength and appetite. The team now 
  expanded their testing to other volunteer diabetics, who 
  reacted just as positively as Leonard to the insulin 
  extract.

  The news of the successful treatment of diabetes with 
  insulin rapidly spread outside of Toronto, and in 1923 the 
  Nobel Committee decided to award Banting and Macleod the 
  Nobel Prize in Physiology or Medicine.
  

  We need the FDA to regulate drugs and medical devices.   
  There's too much potential for quackery. 

  The extreme skepticism of my colleagues led me to believe   
  that I might never be funded to perform the crucial trial 
  of antibiotics...  I realized then that the medical 
  understanding of ulcer disease was akin to a religion. No 
  amount of logical reasoning could budge what people knew in 
  their hearts to be true. Ulcers were caused by stress, bad 
  diet, smoking, alcohol and susceptible genes. A bacterial 
  cause was preposterous.

  We should be paying medical researchers similar incomes to 
  engineers at Silicon Valley tech firms.

  California taxes are funding one of the biggest research 
  efforts into stem cells.

  Last September, Nature predicted a stem cell showdown in 
  Texas, between the FDA and a company providing unproven 
  stem cell treatments, and that seems to be happening. In a 
  severe “warning letter” posted on the agency’s website this 
  week (but dated September 24, 2012), the FDA told 
  Sugarland, Texas-based Celltex Therapeutics Corporation 
  that its stem cell products fall under FDA regulation and 
  need to be approved before use in patients.

  The letter is a challenge to new regulations that the Texas 
  Medical Board put in place in April, which had made FDA 
  approval an option, not a requirement. Those regulations 
  state that doctors injecting stem cells into patients need 
  FDA approval or the approval of a local institutional 
  review board (IRB). The warning letter makes clear that the 
  FDA expects its approval to be mandatory—effectively 
  replacing the “or” with an “and”.

  In recent court filings, the Food and Drug Administration 
  has asserted that stem cells—you know, the ones our bodies 
  produce naturally—are in fact drugs and subject to its 
  regulatory oversight. So does that make me a controlled 
  substance? The bizarre controversy revolves around the 
  FDA's attempt to regulate the Centeno-Schultz Clinic in 
  Colorado that performs a nonsurgical stem-cell therapy 
  called Regenexx-C.

  We need the FDA