Shouldn't the FDA know about
the real side effects of these drugs?
Not exact matches
These risks and uncertainties include, among others: the unfavorable outcome
of litigation, including so - called «Paragraph IV» litigation and other patent litigation, related to any
of our products or products using our proprietary technologies, which may lead to competition from generic
drug manufacturers; data from clinical trials may be interpreted by the FDA in different ways than we interpret it; the FDA may not agree with our regulatory approval strategies or components
of our filings for our products, including our clinical trial designs, conduct and methodologies and, for ALKS 5461, evidence
of efficacy and adequacy
of bridging to buprenorphine; clinical development activities may not be completed on time or at all; the results
of our clinical development activities may not be positive, or predictive
of real - world results or
of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to governmental payers; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights
of third parties, or have unintended
side effects, adverse reactions or incidents
of misuse; and those risks and uncertainties described under the heading «Risk Factors» in the company's most recent Annual Report on Form 10 - K and in subsequent filings made by the company with the U.S. Securities and Exchange Commission («SEC»), which are available on the SEC's website at www.sec.gov.
In June, Winfried Häuser at the Technical University
of Munich published a review paper showing that in many clinical trials, placebos produce fully half as many reported
side effects as
real drugs do.
Once the FDA green - lights a
drug and it is ushered into the hands (and IVs)
of patients, there is no
real incentive for a company to continue to collect information about
side effects in any systematic way.
You're body is used to all these endogenous artificial testosterone, you know, your testosterone to estrogen ratio is getting messed up and so you do have to use what's called post cycle therapy when you're on pro-hormones and we won't get into the post cycle therapy as much on this podcast «cause I know we're kinda pushing for time but the problem is that if you don't cycle pro hormones, it can be tough on your liver, it can be tough on your own endogenous production so it's something that you do wan na make sure that you do, that you understand how to cycle properly and I have to be careful
of course, giving out recommendations like that on this show just because so many people who are listening to this are competing in event like triathlons and marathons and thing
of that nature where they're gonna be
drug tested and stuff like this would be a big no - no anyways, you know, or they're going after more natural means and let's face it, prohormones can be kinda damaging to your body and the reason for that is because a lot
of these
side effects: acne and hair loss, breast tissue enlargement, or you know, what we affectionately call bitch tits in dudes, prostate swelling, you know, a lot
of these hormonal imbalances that get created from dumping exogenous sources
of hormones into your body and creating like a hormone milieu that can be a
real real issue from a health standpoint.
The
Drugs May be Worse than the Heart Attack Carl had a heart attack and then the real nightmare started with handfuls of prescription drugs and their side eff
Drugs May be Worse than the Heart Attack Carl had a heart attack and then the
real nightmare started with handfuls
of prescription
drugs and their side eff
drugs and their
side effects.
The delights in this edition include a whipping game (for
real), a blurry vertical shooter with gorillas in it, a game that features a jumping shark, a new release from the popular Flash game development team Nitrome, and an experimental project from Hempuli that explores the issue
of drug addiction and their
side effects.