A small drug company has won an early fight in its case against the FDA, which will allow it to promote its fish-oil pill for treatments not explicitly approved by the agency. The federal case has huge implications for the future of prescription drugs in the US and could weaken the FDA’s power to regulate how drugs are marketed.
The ruling has nothing to do with consumer focused advertising. It has to do with informing and promoting off label uses of the drug to doctors. Pharmaceutical companies are free to share any research with doctors that support uses of the drug not specifically approved by the FDA.
Also, the ruling is incredibly specific to Amarin and outlines exactly what is a truthful and non-misleading in the context of Vascepa only. So in response to the article headline, yes this could change how the FDA regulates drugs but in reality it hasn’t and won’t.
Tourism isn’t the only industry eager to benefit from the relaxing of the decades-long trade embargo against Cuba. Medical researchers on both of sides of the Straits of Florida now have the chance to collaborate with previously off-limits colleagues. Of particular interest to the U.S. is a Cuban lung cancer drug that took 25 years to develop.
People rarely get addicted to these things because they want to get high – they get addicted because it’s the only thing that allows them to cope with their issues. Removing the reward certainly allows them to come off the meds but you need to be sure that the illness can be dealt with without those meds.
Correlation does not imply causation! This doesn’t seem to rule out other factors, like whether apple eaters have healthier diets and lifestyles in general (which seems likely).
Also, “An apple a day keeps the doctor away” isn’t an aphorism, it’s an old advertising slogan created by the apple industry. And it’s about as credible as any other slogan. Apples aren’t particularly healthy compared to other fruits like berries or tomatoes – they just had good PR.
A new study suggests that people should regularly eat apples not necessarily to keep the doctor away, but as a means to reduce national health care spending.
This is a somewhat unsatisfying article. The first way that apple eaters might differ from the rest of the population is simply that they are more likely to be eating more fresh fruit, which we already know has health benefits above a certain level.
Unfortunately, I don’t have access to JAMA, so I can’t access the original paper to see if they controlled for this.
I’ve only ever gotten warfarin/coumadin in pill bottles, which has an expiration date on it. It’s roughly two (2) years, assuming storage at below 25 C/77 F in the original packaging. It’s never been an issue to me – a prescription lasts me roughly three months.
The expiration date has almost nothing to do with the content of the pills. To get a drug approved, the manufacturer must show a minimum shelf life. Obviously they do not want to put some on a shelf and wait 5 years to see if they decompose. So experts utilize “accelerated aging” tests to simulate shelf life. The pills are exposed to more heat and humidity than normal, and then these surrogate markers are extrapolated to a shelf life. It is also obvious that manufacturers do not want to put a long expiry date on the pills because people would keep them forever.
Is something still good after say two months past “stated expiry”? It depends on how they were stored. If they were in a place where they got direct sunlight – probably not. If they were in a refrigerator and were opened occasionally, they probably got moisture in the bottle and probably are no good. If they are in a pill bottle for a pharmacy, kept in a medicine cabinet and only opened occasionally – they are probably good. If they are in a sample pack from the manufacturer and were not exposed to excessive heat, they are probably still good. Drugs typically do not “go sour” (like milk) to give you a good indication of when they have turned bad. Aging for most drugs is pretty linear. Meaning, the compounds break down at a regular rate over time and the potency of the entire pill gradually diminishes. Therefore, a pill taken during the expiration month has virtually the same potency as it would one month after expiration.
There is another component of shelf life that is worth mentioning: marketing. If generic warfarin had a shelf life of 2 months, and the brand-name coumadin had a shelf life of 4 years, would anyone buy the generic? Also, what’s the benefit for the makers of coumadin showing that their drug has a shelf life of 5 years instead of 4 years? If you leave it at 4 years, most people will clear out whatever they have when it expires and buy a new bottle. All of these things and more are discussed when a company decides the shelf life of a drug.
TLDR: If there is doubt, there is no doubt. Please do not risk another DVT, pulmonary embolism, heart attack, stroke, aneurysm… If you decide to take blood thinner medication after expiry, depending on frequency I’d recommend testing an INR earlier and more often. And potentially expect to be told to increase the dose if the drug is less potent.
Researchers from the University of California have developed acid-fueled micro-machines capable of traveling and delivering cargo directly inside a living creature. It’s a breakthrough that’s expected to significantly advance the field of medical nano-robotics.
Scientists have developed drug-delivering micro-machines before, but these systems were only tested under in vitro conditions (i.e., cell cultures outside the body). But in this latest breakthrough, Wei Gao and colleagues have shown that artificial micromotors can travel inside a live mouse, deliver its cargo, and produce no toxic effects.
This is definitely an important proof-of-concept. Nanotechnology has the potential to reshape the way medicine is done. In the future, scaled-up versions of this rudimentary micro-machine could deliver important medicines to previously inaccessible parts of the body (e.g., to treat peptic ulcers and other illnesses), fight infectious diseases, or even perform complex tasks like direct cellular manipulation and repair.
In a recent study, an “expensive” salt solution was shown to to be significantly more effective at managing the symptoms of patients with Parkinson’s disease than an “inexpensive” one. The salt solutions were identical placebos.
Placebo effects mostly operate on highly subjective symptoms like pain, nausea, mental performance (i.e. coordination, mental acuity, alertness, mood etc). It also has some effect in temporarily boosting immunity, as it has long been determined that stress influences it. And when the patients have been told that they are on placebos, the effect rapidly reverses.