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More than a quarter of the Food and Drug Administration employees who approved cancer and hematology drugs from 2001 through 2010 left the agency and now work or consult for pharmaceutical companies, according to research published by a prominent medical journal Tuesday.
Dr. Vinay Prasad, a hematologist-oncologist and assistant professor at Oregon Health and Science University, sought to understand the so-called “revolving door” between the FDA and the pharmaceutical industry, which he said is often discussed but hadn’t been quantified.
“We all know about these anecdotal cases” of a person who was “often a major player at the FDA, someone in an important role — and then they leave the FDA and go and work for industry,” Prasad said, but he couldn’t find anyone who knew whether this happened “5 percent or 60 percent” of the time.
Prasad and his colleague Dr. Jeffrey Bien, an internal medicine resident also at Oregon Health, tracked 55 FDA reviewers in the hematology-oncology field from 2001 through 2010, using LinkedIn, PubMed and other publicly available job data. They found that of the 26 reviewers who left the FDA during this period, 15 of them, or 57 percent, later worked or consulted for the biopharmaceutical industry. Put another way, about 27 percent of the total number of reviewers left their federal oversight posts to work for the industry they previously regulated. They published their findings in The BMJ as a research letter.
Going to work for industry after leaving the FDA is not inherently bad, but it does raise some questions.
“If you know in the back of your mind that your career goal may be to someday work on the other side of the table, I wonder whether that changes the way you regulate,” Prasad said. “Are you more likely to give [companies] the benefit of the doubt? Are you less likely to beat them up hard over [using bad comparisons in drug studies]?”
Prasad focused his research on his own field — hematology-oncology — because it spawns a large number of new drugs and reviewers have a lot of autonomy, he said.
“There’s a lot of room for interpretation in deciding whether or not a cancer drug should be approved,” he said, because so many studies of cancer drugs rely on what’s called a “surrogate endpoint,” meaning that something other than survival or quality of life was measured to determine whether a drug worked. For example, shrinking a tumor may be a stand-in for survival. But according to one of Prasad’s previous studies, there isn’t always evidence that surrogate endpoints are linked to better health outcomes, suggesting that some approved drugs aren’t as beneficial as they appear.
“Sometimes, the public needs [the FDA reviewers] to be firm. If they’re not, no one else in the health care sector is going to be,” Prasad said, adding that once the agency approves a drug, the Centers for Medicare & Medicaid Services has to cover it and can’t negotiate prices under current laws. “The FDA is often the only real wall between ineffective, harmful drugs and patients.”
He and Brien tracked reviewers instead of higher ranking officials because reviewers provided a larger sample size, Prasad said. They would have liked to include reviewers named on denials as well, but the denial documents are secret, making it impossible to identify the reviewers.
Although Prasad said FDA reviewers have a lot of power over approvals, Dr. Joshua Sharfstein, the FDA’s principal deputy commissioner until 2011, disagreed.
“There are just so many checks and balances within the review process that it’s really not up to one person by and large,” said Sharfstein, now an associate dean at the Johns Hopkins Bloomberg School of Public Health in Baltimore. “Key regulatory decisions are looked at from many different angles. I think it would be very difficult for an individual to do something inappropriate and not have that caught.”
Sharfstein said he has met with companies to offer advice, but was not compensated for it.
The revolving door is a fair topic to study, he said, but having former FDA officials on the pharmaceutical industry payroll can have a public health benefit. Former FDA employees with deep knowledge of the approval process help make it go smoother by ensuring all the relevant research is complete and the latest pathways to approval are understood.
“Companies are very nervous about the FDA,” he said. “So they need to have an understanding of how the FDA works.”
FDA spokesman Jason Young said employees leave the government to work for industry at various agencies, not just the FDA.
“The FDA has a strong set of rules in place to ensure that our employees are working in the public interest, not to advantage any company, organization or individual,” he said, adding that these include protecting confidential information they learned at the FDA and a “cooling-off” requirement for senior officials before they can work for industry.
Former FDA Chief Dr. Margaret Hamburg, who left the administration last year, told Stat News in March that she would wait before jumping into an industry job, adding that “this perception of the revolving door is damaging to everyone” and that she would not consider “any boards of any company big or small that was regulated by the FDA for a couple of years.” She also is quoted as saying it is “unfortunate” that people think “a complete division” is necessary between the agency and the industry.
The FDA Alumni Association, whose slogan is “serving those who have served,” currently lists four job openings for former FDA employees. Three are at consulting firms and one is at a law firm seeking an “FDA compliance paralegal.” Of the consulting jobs posted, one is for a regulatory scientist and the other is for a regulatory toxicologist. The third is a food and cosmetic consulting job.
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Think for a moment the length of time you’ve spent playing along with eye glasses. No matter whether you’re focused on replacing these, cleaning them, as well as finding them all. What you ought to comprehend is the fact that there are more alternatives. If this sounds like something which will be useful to discover more about, invest time to put together a scheduled appointment along with your doctor today. He understands what should be completed and then he will almost certainly work hard to make sure that you are able to contain a far better daily life while not having to handle eyeglasses on a daily basis.
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The actual move for you to portable vapes provides been developing rapidly these days. Vaporizers get been all-around for some sort of long period, but generally. Since with every thing, technological innovation offers finally produced its technique through for you to the planet of water lines and documents. A person may now quickly vape when traveling and also you rarely have for you to break the actual bank for you to do this. You may want to look at aromatherapy recipes too.
Now that will you can easily get your own personal hands upon a lightweight vaporizer and so easily, typically the question right now is, the reason why should folks vape? Typical cigarette smoking methods burn up the dried herbs and also turn these people. When the particular herbs burn off, the chemical substance composition produces toxins. Vaping, on the actual other side, evenly warms the dried out herbs simply enough for you to release their own aromas with no breaking along the genuine herbs on their own. After vaporization, the herbal products will become a soothing color.
When making use of a vape, instead regarding huge fumes clouds, you will experience any barely apparent, light water vapor that goes away quickly. Actually in the actual short moment the watery vapor is about, the aroma is certainly not pungent or maybe familiar. The actual actual vape unit alone adds for you to the acumen. Most devices can become mistaken intended for an e-cig and ignored quite very easily. They could also end up being easily stashed and taken off from some sort of pocket or maybe bag with a events notice. Click here for herbal vapes for aromatherapy.
It has happened to the finest of women. One bright and early morning, just after you end cleaning your teeth you peek inside the hand mirror, scowl, peek once again, and after that lean in to be able to investigate the skin involving your face yet a third time. You possess a line. Unluckily, if you don’t take terrific care, it will probably be the earliest involving quite a few. The particular manner in which you react to that very first faint wrinkle. could very well determine how you will look pertaining to most of the rest of your existence. Precisely what can you carry out to give your skin the opportunity to look and feel its best for your next handful of decades? Thankfully, there are quite a lot of natural aging tips that when started quickly and practiced conscientiously, will guarantee you’ve got young plus desirable face for a lifetime.
The actual golden rule of younger looking complexion is always to steer clear of the sunshine without exceptions. Wear sun block, (both moisturizing lotion and even foundation can be obtained having sun screen lotion) whenever you’ll be in the sun, even when it is just out shopping. Turn it into a constant part of your current daily routine, not necessarily an action you save pertaining to the beach. Any time dealing with crows feet around the eyes, try and avoid squinting, as it is the primary cause and also aggravator involving crows feet. Through putting on sunglasses plus a hat having a brim you will not simply steer clear of lines and wrinkles around your eye area, but you will be safe guarding your personal sight, likewise. In addition, try and avoid smoking cigarettes. As outlined by betterafter50.com, smoking is probably the primary reasons ladies often look more aged as compared to their particular real age.
Most women find that they inevitably end up getting at the very least several creases. Among the best ways to treat facial wrinkles will be to buff away all the exterior layer of the skin on a regular basis, unveiling the beautiful and smooth, brand-new skin beneath. This may become attained with an exfoliation wash cloth, a microdermabrasion device, as well as from chemical peels from your current skin specialist as well as cosmetic surgeon. A good reason a person’s skin looks older as the lady ages is a result of the gradual loss of collagen that takes place with time. By ingesting a packet of unsweetened gelatin each day, you are going to give your body all the raw supplies it needs to reconstruct your skin’s collagen the natural way.
Folks who possess never in fact walked into a good AA appointment might believe it’s the actual most demoralizing place in earth. Videos tend for you to show the gatherings while a location where shattered people sit down slumped about coffee, speaking about their errors. So when you carry out end way up at the alcohol rehab conference, an individual might become surprised to be able to find your self actually savoring it. It may be common with regard to a presenter to help make everyone chuckle with a great absurd aged drinking tale or humorous observation.
Meetings are usually often total of radiant people who also are make an effort to enjoying currently being present within their individual lives along with in the particular lives regarding others. As well as, AA will be the core for numerous social outings. One particular of the particular biggest doubts many involving us get about acquiring sober will be that individuals won’t need to suspend out together with us ever again. Specialists from this site here mastered to connect socializing using drinking. However in truth, when our own drinking received to their worst, the majority of of us all were really isolating significantly of the particular time. We all may have got ditched several friends who else thought many of us boozed also much-or many of us may possess been cast off because involving your conduct. Staying sober offers anyone many possibilities to help to make new buddies.
Professionals have gathered some sort of list regarding what they believe are usually the most essential reasons why people need to get fit, or perhaps stay in shape. Exactly what this signifies is a person have some sort of baseline regarding durability, muscle endurance, cardiovascular ability, and flexibility for you to lead the fuller, better life. When you are usually weak inside one regarding these several areas, read on or read online!
Regular exercising has recently been proven in order to lessen “bad” cholesterol ranges along with improve “good” cholesterol. Exercising could help a person sleep much better. Folks who else exercise have a tendency to sleep a lot quicker and keep asleep lengthier.
Irregardless of your current body physical appearance, normal exercise helps boost your self-pride. Physical exercise not simply reduces excessive blood strain, it will help prevent the idea. Simply by increasing muscles strength, staying power, and enhancing flexibility and also posture, standard exercise aids to stop back discomfort. Studies display that physical exercise is a good successful cure for repeated back pain. See more online at this page.
Exercise not really only will certainly improve the particular total quantity of unhealthy calories that anyone burn, nevertheless also may increase your current resting metabolic rate, and so you lose more calories from fat while from rest. A great increase inside flexibility may decreases tightness in important joints, and can easily decrease ache and infection associated along with arthritis.
In five states this fall — California, Arizona, Nevada, Maine and Massachusetts — voters will be deciding whether marijuana should be legal for recreational use. And any of those states that do legalize marijuana will have to wrestle with the question of how to enforce laws against stoned drivers.
It has been legal to smoke pot for fun in Colorado since January 2014, and the state modeled its marijuana driving-under-the-influence law on the one for alcohol. If a blood test shows a certain level of THC, the mind-altering compound in marijuana, the law says you shouldn’t be driving.
It sounds straightforward, but consider the case of Abby McLean, a stay-at-home-mom from the Denver suburbs.
McLean, 30, was driving home from a late dinner with a friend two years ago when she came upon a DUI roadside checkpoint.
“I hadn’t drank or smoked anything, so I was like, ‘Let’s go through the checkpoint,'” she recalled.
McLean is a regular marijuana user but she insists she never drives while high.
Still, the officer at the checkpoint told her he smelled marijuana and that her eyes were bloodshot. Eventually he whipped out handcuffs, and McLean said she started to panic: “Like, massive panic attack. And, ‘Oh, my God, I have babies at home. I need to get home. I can’t go to jail!’ ”
She didn’t go to jail that night, but she got home hours late. A blood test later revealed McLean had five times the legal limit of THC allowed in Colorado, which is five nanograms of THC per milliliter of blood.
“Even the state’s experts will say that number alone is something, but generally not enough, and we really hammered that home,” he said. Aschner got a hung jury and McLean pleaded to a lesser offense.
Still, McLean’s trip through the criminal justice system is emblematic of numbers that suggest a sharp increase in marijuana DUI arrests in Colorado. So far this year, State Patrol data show that total DUI citations this year rose to 398 through early July, compared with 316 in for the same period 2015.
It turns out, measuring a person’s THC is actually a poor indicator of intoxication. Unlike alcohol, THC gets stored in your fat cells, and isn’t water-soluble like alcohol, said Thomas Marcotte, co-director of the Center for Medicinal Cannabis Research at the University of California, San Diego.
“Unlike alcohol, which has a generally linear relationship between the amount of alcohol you consume, your breath alcohol content and driving performance, the THC route of metabolism is very different,” Marcotte said.
That’s why adapting drunk driving laws to marijuana makes for bad policy, said Mark Kleiman, a professor of public policy at New York University. “You can be positive for THC a week after the last time you used cannabis,” he said. “Not subjectively impaired at all, not impaired at all by any objective measure, but still positive.”
Still, Colorado and five other states have such laws on the books because pretty much everyone agrees that driving stoned can be dangerous, especially when combined with alcohol.
What police say they really need is a simple roadside sobriety test. Scientists at UCSD are among researchers working on several apps that could measure how impaired a driver is. One has a person follow a square moving around a tablet screen with a finger, which measures something called “critical tracking.” Another app measures time distortion, because things can slow way down when a person is high.
The THC route of metabolism is very different.
Those tests are still experimental.
Denver District Attorney Mitch Morrissey said the uncertainty doesn’t mean Colorado should throw out its THC blood test. He said it may not be perfect, but it gives juries another piece of evidence to consider at trial.
“I think that putting in a nanogram level makes sense,” said Morrissey. “I can’t tell you what level it should be. I don’t think Colorado’s is right. I don’t think it should be as high as it is. I think it should be lower.”
Morrissey remembers trying alcohol DUI cases as a young prosecutor. The science wasn’t settled then either, the blood alcohol standard was about twice as high as it is now, and it took years for it to be lowered.
“I think that has to do with better testing better technology,” which Morrissey said will improve eventually for marijuana too.
In the meantime, some regular marijuana users, like Abby McLean, are scared to drive for fear of failed blood tests.
“I haven’t gone out really since then, because I’m paranoid to run into the same surprise, ‘Oh oh, there’s a DUI checkpoint.'”
The list of preventive services that women can receive without paying anything out of pocket under the health law could grow if proposed recommendations by a group of mostly medical providers are adopted by federal officials later this year.
The draft recommendations, which are open for public comment until Sept. 30, update the eight recommended preventive services for women. That list was developed by the Institute of Medicine — now called the National Academies of Sciences, Engineering, and Medicine — to build on existing recommendations and fill in gaps that weren’t addressed in the health law. Under the IOM list, which took effect in 2012, most health plans are required to cover well-woman visits, screening and/or counseling for sexually transmitted infections, domestic violence and gestational diabetes as well as breastfeeding support and supplies.
In addition, most health plans must cover, without cost sharing, all methods of contraception that have been approved by the Food and Drug Administration. That controversial requirement led to numerous lawsuits by religious institutions and employers that object to providing such coverage, including several cases that reached the Supreme Court.
When it developed the initial list, the IOM advised that the guidelines be reviewed and updated at least every five years in order to stay current with scientific evidence. This year, the review panel also weighed in on breast cancer screening, coverage of follow-up testing or procedures as part of the preventive services and male methods of birth control.
The proposed new recommendation would allow women at average risk for breast cancer to begin screening as early as age 40 and receive a mammogram every one or two years. That is a more liberal standard than the guidelines that insurers rely on for free screening from the U.S. Preventive Services Task Force, which recommends women generally be screened every other year starting at age 50.
“We have really confused the heck out of women,” said Dr. Hal Lawrence, executive vice president and chief executive officer of the American Congress of Obstetricians and Gynecologists. “Do I start at age 40, do I start at 50, do I do it every year or do I do it every other year? We wanted to get some uniformity.”
ACOG was awarded a 5-year grant to manage the review process, working in conjunction with a steering committee of nearly two dozen provider groups from different women’s health disciplines.
In addition to the breast cancer screening itself, the ACOG working group proposes that if imaging tests, biopsies or other interventions are required to evaluate the mammogram findings that those be considered an integral part of the screening, which would mean they would be provided without charge to women.
Such follow-up care emerged as a theme from the panel: If additional testing or procedures are necessary following a preventive service, it should be covered as part of the service. The recommendations also clarify that some of the preventive services may require more than one visit and provide other specifics on coverage requirements.
“It’s critically important for plans and people to recognize that the well-woman visit [required under the current guidelines] could happen in multiple places and require multiple visits,” said Mara Gandal-Powers, senior counsel at the National Women’s Law Center, which participated in the ACOG working group. “If you’re a woman who needs a Pap test and a colonoscopy, you’re probably not getting them from the same providers and you’re hopefully not getting them at the same time.”
The recommendations’ specificity is important: The original IOM guidelines left implementation details vague, leading to scuffles between patient advocates and insurers over precisely what was covered, and that ambiguity required ongoing guidance from the federal government. For example, if a plan covers oral contraceptives without cost sharing, could it charge for other hormonal methods such as the contraceptive patch? Answer: No.
“It’s helpful to get the real-world piece,” said Dania Palanker, assistant research professor at Georgetown University’s Center on Health Insurance Reforms. “For insurers, what do we mean when we say you have to cover a service?”
A spokesperson for America’s Health Insurance Plans said that the trade group will likely submit comments on the proposed recommendations and declined to comment before then.
The working group recommended expanding the scope of what’s covered without cost sharing in some important ways. The contraceptive coverage requirement, for example, would cover over-the-counter methods of birth control without a prescription and allow women to receive a full-year supply of contraceptives all at once, which has been shown to improve adherence.
The ACOG group also proposes covering contraception methods used by men, including condoms and vasectomy.
“The best contraceptive method for a woman at a particular time may be her partner,” said Adam Sonfield, a senior policy manager at the Guttmacher Institute, a reproductive health research and policy organization.
The working group will submit its final recommendations to the Health Resources and Services Administration, part of the Department of Health and Human Services, by Dec. 1, and HRSA will make the final decision on adoption of the recommendations. If adopted before the end of the year, they would go into effect for most plans at the beginning of 2018.
Please visit khn.org/columnists to send comments or ideas for future topics for the Insuring Your Health column.
The summer months is the best time of year to be outside the house and benefit from the outside air. Several parents take their annual trip throughout the summer months, during the time their children happen to be away from classes, to allow them to hang out with them and avoid a lot of the costs of day care. It can be really challenging to remain inside your home when the weather is so wonderful outdoors. There is a bit of great info out there regarding activities to do during the summer that could increase the whole family members’ wellness. Bicycling, playing in the recreation area and fishing are good ways to get physical exercise. It is crucial that you avoid dehydration and utilize sun block frequently. An alternative choice you’ll be able to see here is usually to barbecue lean healthy proteins and take in much more refreshing vegetables and fruit since they will be in season. A more healthy diet program will assist you to feel far more motivated and may make good behavior for kids. Kids often model the way in which their moms and dads eat in addition to play so make sure you set up a good model for them. Far more sunshine indicates more time for being together as a family group. Hanging out collectively having a great time and lounging helps to reduce pressure, which will help boost your state of health. Maintain a few of these practices running while the conditions starts to become colder in the springtime and winter time.