Federal regulators have warned Johnson & Johnson that it could face fines and other sanctions for selling faulty insulin pumps and delaying disclosures of serious injuries to diabetics who were using its OneTouch Ping and 2020 pumps. The FDA ordered the Animas Corp. unit of J&J to explain why it kept selling pumps known to fail and also to submit a plan to rectify a failure to promptly report cases in which its device might have caused or contributed to death or serious injury....
In the issue with the Animas insulin pumps, some pump keypads for controlling how much insulin is injected were deteriorating prematurely, leading to failures. "We decided to go with a new keypad because it's more durable," [spokesperson Caoline] Pavis said.
But while Animas was lining up the new keypad supplier, it was still selling the older ones. The FDA demanded documents about the company's decision to do that.

Unlike most of the windbags currently roaming Capitol Hill, this was a case of the federal government doing its job. And it wasn't only the FCC, it was the Department of Justice and some well-reasoned state attorneys general.
This is what effective regulation of corporate greed is supposed to look like. Not all mergers are a good idea because you say that they are. This was one of them.
[CEO Stephenson invoked the ruling to justify raising prices....] Because AT&T can't get more spectrum, and because it pursued an ill-advised and destructive method for pursuing more spectrum, it has to raise your prices. Do you feel that on your face? That's AT&T spitting on it....Customers should not pay for your mistakes, AT&T, nor should they pay for ineffective politicians who care more about disagreeing than they do about getting something done....
[Stephenson implied] that the FCC's inaction on spectrum also means that AT&T won't be able to create jobs through capital investment projects...AT&T used a similar "It will create jobs!" line when promoting the merger.
How AT&T got some civil rights groups and labor unions to mouth that same promise will remain one of my life's deeper mysteries, especially since the consolidation of two major carriers (and two major GSM carriers) would likely have resulted in job losses through the elimination of redundancies.

Asked to address the concerns of naysayers, who argue that there is little proof that reducing salt in the diet will have an effect on health outcomes and who say that the administration should not get involved in "nanny-state" activities like regulating the amount of sodium people consume, Bakris said that government-backed salt-reduction campaigns "have been very effective in the UK, in Finland (with a dramatic improvement in mortality) and in Japan, and there is absolutely no reason we should not do this.

"The reality is that there needs to be some guidance to the general public about this—most people do not read labels, most people don't pay attention, and they don't know how much salt is too much... Clearly, the FDA does have a role as a regulatory body to adjust sodium standards in foods so that they are in keeping with the current guidelines."

"It's certainly true that people who are in their 20's and teens don't need salt restriction for blood-pressure control, [but it is an acquired taste. If] you don't learn from a young age, it's going to catch up with you in your 40's, 50's, and 60's, when you actually will need some salt restriction..."

In response to what Bakris calls the "outcomes mafia, who say that unless we have an outcomes study it's impossible to make any conclusions," he remarked, "[C]ommon sense has to prevail. The FDA as a regulatory body has accepted the notion that lowering of blood pressure is a validated surrogate for a reduction in cardiovascular mortality and morbidity... To do an [outcomes] clinical trial...you would need well over 100 000 people, so it's not feasible. Let's be reasonable."

"If you are telling me that reducing BP by 5 to 7 mm Hg, which is what most of these salt restrictions will do, is not going to translate into a benefit, then I think we have to throw out all the clinical trials we have to date...[No meta-analysis of any clinical trials] fails to show that a reasonable reduction in blood pressure has not [sic] been associated with a benefit, certainly on stroke and to a lesser degree on coronary events...[T]he data are very consistent."

"I think the conflict of interest here needs to be established,...With all due respect, many of the people who are saying this are also consultants to the Salt Institute, they are lobbyists in their own right. They spin the data to make it suit what their needs are."

You might think drugs only get on the market if they've been shown to be useful. But "useful" can mean many different things: for FDA approval, for example, you only need trials to show your drug is better than a placebo. That's nice, but with most medical problems, we've already got some kind of treatment. We're not interested in whether your drug is better than nothing. We're interested in whether it's better than the best currently available option.

So it turns out that, out of all the 197 new drugs approved in the past decade, only 70% had data to show they were better than other treatments (and that's after you ignore drugs for conditions where there was no current treatment).

But the problems go beyond just using the wrong comparator: most of the trials we rely on to make real-world decisions also study drugs on highly unrepresentative, freakishly ideal patients. These patients are younger, with perfect single diagnoses, fewer other health problems, and so on.

Isabelle Boutron and colleagues...took every trial published over one month that had a negative result – 72 in total – and then went through each trial report to look for evidence of “spin”: people trying to present the results in a positive light, or distract the reader from the fact that the trial was negative....
Sometimes the [original] researchers found some other positive result in the spreadsheets and pretended that this was what they intended to count as a positive result all along. Sometimes they reported a dodgy subgroup analysis. Sometimes they claimed to have found that their treatment was “non-inferior” to the comparison treatment (when in reality a “non-inferiority” trial requires a bigger sample of people, because you might have missed a true difference simply by chance). Sometimes they just brazenly banged on about how great the treatment was, despite the evidence.
There a lots of things in place to stop this kind of stuff from happening. Trials are supposed to be registered, before they begin, with their protocol described in full, so that highly motivated individuals can go back and check if researchers changed their minds about what constituted a positive result, retrospectively, after the results came in. There are also reporting guidelines, such as CONSORT, which formalise the information that is supposed to appear in any scientific paper resulting from a trial.
But there is no enforcement for any of this, everyone is free to ignore it, and commonly enough – as with newspapers, politicians, and quacks – uncomfortable facts are cheerfully spun away.

The problems I have described are not new, and they have been described on many previous occasions. They could be fixed, without taking research out of the hands of industry altogether, but to do so would require that the drug companies recognised the scale of this scandal, and campaigned themselves for more effective regulation: demanding full mandatory publication of all trial data from themselves and their competitors, for example.
Instead we see inertia, and the failure of regulators to engage adequately with these serious problems. In medicine, bad information leads to bad decisions: we prescribe one drug where an alternative would have been more effective, or had fewer side effects; or we prescribe an expensive drug, unnecessarily, when a cheaper alternative was equally effective, and so we deprive the community of limited healthcare resources. This is dangerous and absurd. Doctors who are making treatment decisions need access to good quality trial data, presented transparently, and all of it, not just the positive findings that drug companies choose to share.

There is no excuse for companies witholding data from academics and doctors. But most revealing, as ever, are the deeprooted flaws this story exposes in our rather ad hoc systems for gathering, analysing, and disseminating evidence on risks and benefits of treatments.
This drug has been on the market since 1999, and it has seen billions of dollars of sales every year. There has been plenty of real patient experience of this treatment, but we have failed to capture it for analysis. Most of the trials included in these meta-analyses weren’t specifically designed to look at heart problems, and so the data on these, collected incidentally, is unpredictably inaccurate.
In an ideal world, for every patient, wherever possible, we could be gathering anonymised outcome data and comparing this against medication history, making exceptions only for those who put their anxieties about privacy above the lives of others (I will have this argument with you any time). In an ideal world, wherever a patient is given any treatment, and there is genuine uncertainty about which treatment is best, they would be simply and efficiently randomised to one treatment, and their progress monitored. In an ideal world, these notions would be so routinely embedded in our notion of what healthcare looks like that no patient would be bothered by it.
This isn’t fanciful, or difficult, or disproportionately expensive. Instead we have unsatisfactory hotchpotch of incomplete monitoring systems and unforgivable secrecy.

Few of us would want to live in a society without rules that keep our air and water clean; that give consumers the confidence to [invest in financial markets or to buy groceries. When new standards are proposed, opponents often claim an assault on business and free enterprise. Drug companies argued the bill creating the FDA would "destroy the sale of patent remedies." Automakers predicted a seatbelt mandate would destroy the] industry....The President of the American Bar Association denounced child labor laws as "a communistic effort to nationalize children"....

Companies adapt and standards often spark competition and innovation...[Steve Chu, my Secretary of Energy, reminded me how the government set modest, gradual energy efficiency targets a couple decades ago. Companies competed to hit these markers, and] hit them every time, and then exceeded them. [A] typical fridge now costs half as much and uses a quarter of the energy...It saves families and businesses billions of dollars.

The treatment goals for patients with diabetes have evolved significantly over the last 80 years, from preventing imminent mortality, to alleviating symptoms, to the now recognized objective of normalization or near normalization of glucose levels with the intent of forestalling diabetic complications....

Margaret Darst Corbett [teacher of the Bates method, stated,] "the optic nerve is really part of the brain, and vision is nine-tenths mental and one-tenth only physical." <br />
In [1940, Corbett was charged with violating] the Medical Practice Act of California for treating eyes without a licence. [M]any of her students testified on her behalf, describing...how she had enabled them to discard their glasses. One witness testified that he had been almost blind from cataracts, but that...his vision had improved to such an extent that for the first time he could read for 8 hours at a stretch without glasses. Corbett explained in court that she was practicing neither optometry nor ophthalmology and represented herself not as a doctor but only as an “instructor of eye training”.....<br />
The trial attracted widespread interest, as did the “not guilty” verdict. [The California State Legislature rejected a bill that would have] made such vision education illegal without an optometric or medical licence.

Eliminating all violence by the mentally ill leaves 95-97% of the baseline level of violence intact.

Other drug companies, though...are undaunted by the FDA’s warnings and are continuing to use social media without even linking directly to adverse effect warnings,...Rather than having risks one click away, some ads require a click and then a scroll to the bottom of the page, where a viewer then has to follow another link to get the warnings. “Industry is probably trying to ride this wave” of unregulated social media...As services like Twitter and Facebook keep growing, companies feel increasingly compelled to use them to interact directly with consumers or to market their brands.
“They’re falling all over themselves to get into the game. If you’re not in it, you can’t win it,” says Mack, who is also a blogger at Pharma Marketing Blog. But with looming FDA regulations, “that game will soon be over.”

Certain common herbicides and lipid-lowering fibrate drugs act in humans to block T1R3, a nutrient-sensing taste receptor also present in intestine and pancreas.Commonly used in agriculture and medicine, these chemical compounds were not previously known to act on the T1R3 receptor. The T1R3 receptor is a critical component of both the sweet taste receptor and the umami (amino acid) taste receptor. First identified on the tongue, emerging evidence indicates that T1R3 and related taste receptors also are located on hormone-producing cells in the intestine and pancreas[; they] detect nutrients in the gut and trigger the release of hormones involved in the regulation of glucose homeostasis and energy metabolism. "Compounds that either activate or block T1R3 receptors could [potentially influence] diseases such as obesity, type II diabetes and metabolic syndrome," noted Monell geneticist and study leader Bedrich Mosinger, M.D., Ph.D.