Safety risks found in one-third of drugs approved by the FDA

❝ Almost a third of drugs cleared by the Food and Drug Administration pose safety risks that are identified only after their approval…

The researchers said the study, which appeared in JAMA, shows the need for ongoing monitoring of new treatments years after they hit the market.

❝ To win FDA approval, medications must be shown to be safe and effective. But many pivotal clinical trials used for approval involve fewer than 1,000 patients with follow-up of six months or less, according to the study. Safety problems often crop up years later after therapies have been used by much larger numbers of patients.

❝ The researchers reviewed 222 products approved between 2001 and 2010 and followed them through February of this year. With 32 percent of the medications, they found, the FDA took some kind of action to deal with safety issues that emerged after approval.

Three of the drugs were withdrawn from the market. The FDA also required 61 new black-box warnings — the agency’s most serious safety alert, included in the drug’s packaging — and issued 59 safety communications to inform doctors and consumers about newly identified concerns. Some products had more than one boxed warning added or safety communication issued over the time of the study.

The median time for an FDA action was 4.2 years after approval…

You, too, can be a beta tester for the FDA. Betting your life on it.

Surprised? NYC trans fat ban really did keep people out of the hospital

❝ In 2006, New York City passed a law banning artificial trans fats, also known as partially hydrogenated fats, in all restaurant foods. The law was first applied to fried foods — but not fried bread products like donuts — before taking effect for all restaurant foods in July 2008. A study released on Wednesday in the Journal of American Medical Association Cardiology found that the law, criticized by some as evidence of a “nanny state”, actually lead to a six percent decline in hospitalizations and strokes

❝ It’s been known since the 1950s that eating a lot of saturated fats is associated with heart attacks and poor cardiovascular health. Saturated fats are a kind of fat found primarily in animal products like lard and butter…and tend to be solid at room temperature. They get their name because, while all fats are made of long chains of carbon atoms, the carbon molecules that make up saturated fats share no double bonds—instead, they are “saturated” with hydrogen molecules…

Unsaturated fats, which tend to be liquid at room temperature, share double bonds between their carbon molecules and are often, but not exclusively, found in vegetables oils. Monounsaturated oils — like corn, peanut, and soy oil — have just one double carbon bond. Polyunsaturated fats (the so called ‘healthy fats’ like the omega-3 fats found in salmon or olive oil) have many double carbon bonds.

❝ The problem is that while unsaturated fats are healthier, they’re also tougher to use. They aren’t as versatile…And saturated fats, apart from being artery cloggers, also tend to go rancid…In the 1950s, researchers realized they could substitute animal fats with vegetable oils by using a hydrogen reaction to turn an unsaturated fat into a partially hydrogenated fat—one with many of the same properties as a saturated fat, but with less, well, saturated fat. Voila, they made margarine.

❝ Researchers didn’t invent trans fats—not exactly. Trans fats are naturally present in meat, but only in minuscule amounts. By finding a process to turn unsaturated fats into partially saturated fats, however, scientists set the stage for people to consume a lot of trans fats all at once for the first time…

❝ Artificial trans fats, as it turns out, are actually worse for humans than saturated fats. Not only do they raise our LDL (or “bad cholesterol”) just like saturated fats do, but unlike saturated fats, they also lower the HDL (“good cholesterol”), increasing the risk of heart disease. Trans fat consumption is also associated with development of diabetes and dementia.

❝ The JAMA study, which analyzed data from the New York State Department of Public Health from 2002-2013 and compared rates of hospitalization between the 11 New York State counties (five of which comprise New York City) which banned trans fat between 2007 and 2011, suggests that the research is right. Trans fats can be deadly.

Given the track record for our Federal Government in general and Congress in specific, we can expect them to climb on board with this science in, say, 8 or 10 years. Or more.

Even electing a reasonably sane government populated with a fair number of folks who comprehend as much science as a 6th grader – after we shove the Trumpkins and neo-cons out to pasture – it will take a few years just to undo the stupidity put in place during the reign of populist idiocracy.

Food group choices linked to early deaths

❝ An estimated 45.4% of all deaths caused by heart disease, stroke and type 2 diabetes are associated with eating either too much or too little of just 10 food categories, according to research published in the Journal of the American Medical Association.

❝ The researchers based their estimates on a total of 318,656 deaths related to cardiometabolic causes — heart disease, stroke and diabetes — which occurred during 2012.

❝ A larger proportion of men than women died due to diet-related causes. This is consistent with generally unhealthier eating habits in men, say the researchers. Poor diet was also associated with a greater percentage of mortality among younger people vs. older people.

The biggest culprit? Too much salty food caused 9.5% of the total diet-related deaths. Red meat caused less than 1%.

RTFA. Well done. A pleasant surprise from CNN. Not trying to be snarky; but, frankly habit has me generally ignoring CNN since the downhill run with Time-Warner began.

Anyway – the article is useful and well-written, succinct and brief. Depending on when you click in, the article may or may not be broken into individual segments requiring arrow clicks to move on. I know, I know. That’s how they make their online income.

Gun control laws actually work – both ways, unfortunately

In this week’s obvious news, laws that allow people to kill other people with guns have led to more people killing other people with guns. According to two new research papers, stricter firearm laws are associated with fewer firearm homicides, and the implementation of Florida’s stand-your-ground law was associated with increased firearm homicides.

These findings, released today by the JAMA Internal Medicine, may sound obvious. But since Congress has essentially withheld all funding for gun violence research for the last 20 years, large-scale studies of this sort have been few and far between. As The Atlantic reported, “In the mid-1990s, Congress declared that funding at the Centers for Disease Control and Prevention shouldn’t be used to advocate for gun control, and it effectively blocked funding for the study of gun violence at the agency.” Despite studies showing that gun violence is a threat to human health and safety, the CDC, a federally funded public health agency with a seven billion dollar annual budget, still withholds support from gun research. Perhaps these new findings will bolster the case for federal funding.

Don’t hold your breath waiting for chickenshit Congress-critters to act.

One paper released today, first-authored by Lois K. Lee of Harvard Medical School, examined five types of gun laws: “those that (1) curb gun trafficking, (2) strengthen background checks, (3) improve child safety, (4) ban military-style assault weapons, and (5) restrict firearms in public places and leniency in firearm carrying.” The researchers found strong evidence that laws strengthening background checks and purchase permits helped decrease gun homicide rates. Interestingly, the researchers did not find strong evidence that laws focusing on trafficking, child safety and assault weapons decreased firearm homicides. The evidence for the effects of laws regarding guns in public places was not conclusive either way. On the whole, though, they found that, “stronger gun policies were associated with decreased rates of firearm homicide, even after adjusting for demographic and sociologic factors.”

Another paper released today, also in JAMA Internal Medicine, tracked the effects of Florida’s stand-your-ground law since its implementation in 2005. This law allows a person to use deadly force instead of retreating from what they believe to be a life-threatening encounter. To conduct this research, David K. Humphreys of University of Oxford and his colleagues examined gun death data for the years leading up to 2005 and the years after, then compared them to other states’ data for the same years. They found that gun homicides increased in the years following 2005, while prior to 2005 they had remained relatively stable. The comparison states (New York, New Jersey, Ohio, and Virginia) which don’t have stand-your-ground laws, did not have similar increases, strengthening the evidence that this is a Florida trend associated with stand-your-ground laws, not part of a national trend…

Informed discussion requires sound data. When public bodies, from the Republican Party and Blue Dog Democrats to the NRA oppose the collection of any data at all they only illuminate their cowardice, their fear of law and public practice reflecting conclusions about best practices. Ideology trumps evidence quite easily when evidence collection is forbidden.

The sugar industry paid for distorted health science for more than 50 years

❝ The sugar industry has a long history of shaping nutrition policy in the United States, working to mask the potential risks of consuming too much of the sweet stuff.

It wasn’t until this year, for instance, that the US Dietary Guidelines finally recommended people keep their consumption of added sugars below 10 percent of their total calorie intake — decades after health advocates began pressing for the measure. The sugar lobby had fended off this recommendation all the while.

❝ New research, published…in JAMA Internal Medicine, shows that Big Sugar may have done more than just advocate for favorable policies. Going back more than 50 years, the industry has been distorting scientific research by dictating what questions get asked about sugar, particularly questions around sugar’s role in promoting heart disease.

❝ The paper focuses on a debate that first popped up in the 1950s, when the rate of heart disease started to shoot up in the United States. Scientists began searching for answers, and zeroed in on dietary saturated fat as the leading contributor. The energy we get from food comes in three kinds of nutrients: fats, carbohydrates, and protein…

Today, scientific consensus related to the role specific macronutrients play in the diet has shifted. Researchers have come around to the view that a person’s overall eating habits probably matter more for health than the particular percentages of carbs, fats, and proteins taken in. But they also generally agree that some kinds of fats are less damaging to health than others. (In particular, unsaturated fats appear to be better for one’s cardiovascular disease risk than saturated and trans fats.) And that too much sugar can be just as bad as too much fat for the heart.

❝ The new JAMA paper reveals why the public may know less about the sugar-heart link than it ought to…

Beginning in the 1950s, notes the JAMA paper, led by Cristin Kearns of UC San Francisco, a trade group called the Sugar Research Foundation was concerned about evidence showing that a low-fat diet high in sugar might raise cholesterol levels in the blood.

If sugar turned out to be a major driver of heart issues, the group surmised, that could be devastating for sugar producers…So the Sugar Research Foundation aligned itself with leading Harvard nutrition professors, and paid them the equivalent of $48,900 (in 2016 dollars) for a two-part research review, later published in the New England Journal of Medicine, that would discredit the link between sugar and heart disease.

It ain’t just ancient history. A couple generations of nutritionist were taught to believe the skewed analysis was holy writ, a premise so well established it must serve as the starting point for all following work.

RTFA for details. Yes, there’s nothing new about money buying results. Sometimes in science, though more rarely, say, than in American politics.

Live in the US? Rejoice! You’re free to pay too much for prescription drugs

Why does the US pay more for prescription drugs than any other country? Monopolies and a government that can’t negotiate, scientists said in a paper that may provide ammunition for lawmakers aiming to lower drug costs.

Researchers from Harvard Medical School dug through medical and health policy papers published in the last 10 years to figure out why people in the US spent almost twice as much on prescription drugs in 2013 compared to 19 other industrialized nations — and why prices are still going up. They found that FDA regulations and patents protect drug companies from competition, and federal law prevents Medicare from negotiating drug prices. All of which work together to allow drug companies to set their own prices…

Aaron Kesselheim and his colleagues propose a number of solutions. Those include giving Medicare the power to negotiate prices, as well as removing some of the regulations that keep generics from speedily entering the market. The authors also suggest educating payers, providers, and patients about how effective competing treatments are, and having pharmacies automatically substitute cheaper generic drugs for pricey brand name prescriptions…

But Kesselheim thinks allowing Medicare to negotiate is small potatoes compared to making sure there’s competition in the pharmaceutical marketplace.

The JAMA paper describes two forms of legal protection that give brand name pharmaceuticals an effective monopoly. The first is exclusivity granted by the FDA that gives new small molecule drugs and biologics windows of five to seven years and 12 years, respectively, before generic versions can be sold. And patents can protect the active ingredient and chemical structure of a drug — as well as less fundamental aspects like its formulation and coating — for 20 years or more. Generic manufacturers can sue to challenge these patents, but in a practice called pay for delay, big name pharma companies settle the suits and pay generics manufacturers to wait it out until the patent expires…

Along those lines, Amy Klobuchar — the senator who called for an investigation into EpiPen price hikes — is co-sponsoring several bills that could, if they passed, help increase competition in the pharmaceutical marketplace by enabling Medicare price negotiation, allowing patients to import pharmaceuticals from Canada, and preventing pharmaceutical companies from blocking generics entering the marketplace.

And as the final healthcare professional interviewed for the article noted – all these remedies can and should be applied to the whole range of price-gouging we face as captive consumers in a nation where our politicians are owned by lobbyists.

OK. I added that last phrase.

Researchers find no benefit from chemotherapy at end of life

Chemotherapy near death failed to improve quality of life (QOL) for patients with cancer, even those who otherwise were in good health, a review of end-of-life care showed.

Quality of life near death (QOD) deteriorated in patients who had good performance status when they started chemotherapy. Palliative chemotherapy had no impact on QOL among sicker patients, Holly Prigerson, PhD,…and colleagues reported online in JAMA Oncology.

…”Thus, chemotherapy appears to contribute directly to worse QOD, presumably through adverse and toxic effects that impair the QOL of those who are initially feelling well.”

Organizations that have clinical guidelines addressing end-of-life chemotherapy, such as the American Society of Clinical Oncology (ASCO), might need to rethink their recommendations, Prigerson and colleagues added.

Even an accompanying editorial expressing some disagreement…acknowledged that “if an oncologist suspects the death of a patient in the next 6 months, the default should be no active treatment.”…

Three years ago, ASCO’s expert panel for the “Choosing Wisely” campaign identified use of chemotherapy in patients for whom no proven benefit existed as one of the most widespread, wasteful, and unnecessary practices in oncology. ASCO recommends against the use of chemotherapy for patients who have not benefited from prior therapy…

Prigerson and colleagues examined the association among ECOG performance status, chemotherapy, and QOL in the last week of life…They hypothesized that patients with good performance status would have worse QOL if they received additional chemotherapy, and that patients with poor performance status would not have an improvement in quality of life with chemotherapy…

Beyond the data, the study suggests that “equating treatment with hope is inappropriate,” Blanke and Fromme said.

“Even when oncologists communicate clearly about prognosis and are honest about the limitations of treatment, many patients feel immense pressure to continue treatment,” they said. “Patients with end-stage cancer are encouraged by friends and family to keep fighting, but the battle analogy itself can portray the dying patient as a loser and should be discouraged. Costs aside, we fell the last 6 months of life are not best spent in an oncology traetment unit or at home suffering the toxic effects of largely ineffectual therapies for the majority of patients.”

Time to turn away from the greed-centric portion of the medical-industrial complex, folks. Pay attention to the folks who say, as did these researchers, “This is a clarion call…to take the lead in curtailing the use of ineffective therapy and ensuring a focus on palliative care and relief of symptoms throughout the course of illness.

Overdue.

Painkiller deaths reduced by 25% in states with medical marijuana

States that have legalized medical marijuana tend to experience an unexpected benefit — fewer overdose deaths from narcotic painkillers…

Access to medical marijuana is associated with 25 percent fewer prescription drug overdose deaths each year compared to states where medical pot is illegal, according to findings published Aug. 25 in JAMA Internal Medicine.

What’s more, states that pass medical marijuana laws see their overdose death rates decrease dramatically in the years immediately afterward…

The study authors believe that people suffering from chronic pain tend to rely on medical marijuana when they have that option, which reduces the risk of addiction and overdose that accompanies use of narcotic medications.

The study used data from the U.S. Centers for Disease Control and Prevention to determine the prescription painkiller overdose death rate for each state between 1999 and 2010, and then took into account whether and when each state had passed a medical marijuana law…

Critics are trying hard to come up with rationales that support continued reliance on the profitable trade in prescription painkillers – and don’t confront idjit ideology that says cannabis is the Antichrist.

Overdose deaths from prescription painkillers have skyrocketed over the past two decades, increasing 118 percent between 1999 and 2011, according to the CDC.

The agency estimates that every day 113 people die from drug overdoses in the United States, and another 6,700 land in the emergency room from an overdose…

States’ overdose death rates decline an average 20 percent in the first year following the passage of a medical marijuana law, the researchers found. By the second year, overdose death rates on average decline 25 percent, and as much as 33 percent by five years after legalization of medical pot.

Medical marijuana laws also are associated with a more dramatic decrease in overdose death rates than other means commonly used to tackle prescription drug abuse, the study noted.

There is no reason for Congressional opposition to medical marijuana other than it may cut down contributions from amoral corporations chartered to profit from pain and illness.

Creeps like Mitch McConnell and Erik Paulsen may as well take their contributions directly from the drug cartels instead of the painkiller producers. Cut out the middleman.