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Saturday, February 2, 2019

FDA PDUFA Date for Evolus DWP-450 is February 2, 2019

https://thefly.com/landingPageNews.php?id=2857740

EU Panel Recommends Humira Biosimilars Idacio, Kromeya

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use has recommended granting marketing authorization for two biosimilars that are highly similar to Humira (adalimumab, AbbVie).
Humira is a tumor necrosis factor-alpha inhibitor that was authorized in the European Union on September 8, 2003. Both biosimilar products are indicated for certain inflammatory and autoimmune disorders, including rheumatoid arthritispsoriasispsoriatic arthritis, and Crohn’s disease. The committee proposes that both biosimilars be prescribed by clinicians with experience treating the conditions for which they are used.

Idacio

Idacio (Fresenius Kabi) will be sold as an injectable solution with 40 mg in a pre-filled syringe and a pre-filled pen and 40 mg/0.8 ml solution for use in children.
The 40-mg injectable solution is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasishidradenitis suppurativa, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitisuveitis, and pediatric uveitis.
The 40 mg/0.8 mL injectable solution is indicated for the treatment of juvenile idiopathic arthritis, pediatric plaque psoriasis, pediatric Crohn’s disease, adolescent hidradenitis suppurativa, and pediatric uveitis.

Kromeya

Kromeya (Fresenius Kabi) will also be available as an injectable solution with 40 mg in a prefilled syringe and a prefilled pen, and a 40 mg/0.8 mL solution for use in children.
The 40-mg injectable solution is indicated for rheumatoid arthritis, juvenile idiopathic arthritis, axial spondylarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, uveitis, and pediatric uveitis.
The 40 mg/0.8 mL injectable solution is intended for the treatment of juvenile idiopathic arthritis, pediatric plaque psoriasis, pediatric Crohn’s disease, and pediatric uveitis.
The summary of product characteristics for each biosimilar will include detailed recommendations for use of the product and be published in the European public assessment report, which will be made available in all official European Union languages after the European Commission grants marketing authorization.

White House Issues Its First National Drug Control Strategy

Soon after James W. Carroll was sworn in as the Trump administration’s new “drug czar” on Thursday, the White House issued its first national drug control strategy.
And already the heat is on.
The leader of the House Committee on Oversight and Reform is criticizing the Office of National Drug Control Policy’s (ONDCP’s) National Drug Control Strategy report, saying it does not appropriately address the ongoing opioid crisis.
Rep. Elijah Cummings (D-MD) said he would hold a hearing on February 12 to examine the strategy — the first-ever issued during President Donald J. Trump’s presidency.
“Although I am encouraged that the White House has finally put out its long overdue plan, I am very concerned that this strategy fails to identify additional resources to make treatment available for many who desperately need it, fails to identify quantifiable and measurable objectives and goals, and — in my opinion — fails to address the gravity of the generational crisis our nation now faces,” said Cummings, in a statement.
The 23-page National Drug Control Strategy‘s introduction states that the opioid overdoses have “resulted in more American deaths in just two years than in the course of the entire Vietnam War,” with 47,500 overdose deaths in 2017 attributable to an opioid. Half of those opioid deaths involved synthetic opioids such as fentanyl and its analogues.
The report also notes that overdose deaths involving heroin, cocaine, methamphetamine, and prescribed opioids have all increased since 2014.
The report describes the ease of synthetic opioid production and discusses strategies to block the entry of fentanyl and other illegal drugs into the United States as a means of reducing the number of new users.
Initiation can also be prevented with public awareness and education campaigns. “Studies show that addiction is a disease that can be prevented and treated through sound public health interventions,” the report states.

Multiple Goals

The strategy also calls for increased use of Prescription Drug Monitoring Programs, better guidelines for clinicians on the use of opioids for acute and postsurgical pain, and an exploration of alternatives to opioids to treat pain.
The report basically follows the recommendations of The President’s Commission on Combating Drug Addiction and the Opioid Crisis, issued in November 2017. It includes urging greater awareness and use of naloxone, wider use of evidence-based treatments such as medication-assisted treatment, and removing barriers to treatment for substance use disorders.
The report did set some goals in terms of gauging the strategy’s effectiveness:
  • A significant reduction in the number of Americans dying from a drug overdose within 5 years
  • A one-third reduction in nationwide opioid prescriptions within 3 years, and that all healthcare providers have adopted best practices for opioid prescribing within 5 years
  • To make evidence-based addiction treatment, particularly medication-assisted treatment for opioid addiction, more accessible nationwide
  • A significant reduction in the production of plant-based and synthetic drugs outside the United States
  • To make illicit drugs less available, reflected in increased price and decreased purity
  • To realize an increase each year in drug seizures at all US ports of entry
The drug control strategy was long-time in coming. Typically, the ONDCP releases a strategy each year, but the Trump administration had not previously issued one. That may be in part because the ONDCP has suffered from a lack of confidence from the president and no permanent leadership of the drug office during his presidency.
The White House has periodically threatened to strip all funding from the ONDCP.
Carroll, who had been leading the ONDCP on an interim basis, was eventually nominated as the permanent drug czar — after the previous nominee, former Rep. Tom Marino (R-PA), had to withdraw in the wake of reports that he’d spearheaded an effort to essentially stop policing opioid manufacturers.
Carroll, an attorney, was confirmed by the Senate on January 2.
He was enthusiastic about the new drug control strategy. “This comprehensive plan reaffirms President Trump’s commitment to addressing the opioid crisis aggressively and in partnership with our partners across the nation,” he said, in a statement.
“The Strategy builds upon our current whole-of-government approach that educates Americans about the dangers of drug abuse, ensures those struggling with addiction get the help they need, and stops the flow of illegal drugs across our borders,” Carroll said.

Friday, February 1, 2019

McKinsey Advised Purdue Pharma How to ‘Turbocharge’ Opioid Sales, Lawsuit Says

The world’s most prestigious management-consulting firm, McKinsey & Company, has been drawn into a national reckoning over who bears responsibility for the opioid crisis that has devastated families and communities across America.
In legal papers released in unredacted form on Thursday, the Massachusetts attorney general said McKinsey had helped the maker of OxyContin fan the flames of the opioid epidemic. McKinsey’s consultants, the attorney general revealed, had instructed the drug company, Purdue Pharma, on how to “turbocharge” sales of OxyContin, how to counter efforts by drug enforcement agents to reduce opioid use, and were part of a team that looked at how “to counter the emotional messages from mothers with teenagers that overdosed” on the drug.
The McKinsey disclosures are part of a lawsuit Massachusetts filed against Purdue Pharma, accusing the company of misleading doctors and patients about the safety of opioid use. Even when the company knew patients were addicted and dying, it still tried to boost sales of opioids, the lawsuit alleges, adding, “All the while, Purdue peddled falsehoods to keep patients away from safer alternatives.”
Purdue Pharma helped plant the seeds of the opioid epidemic through its aggressive marketing of OxyContin. More than 130 people die each day in the United States — 47,000 in 2017 — after overdosing on opioids, according to the National Institute on Drug Abuse.

As the death toll from opioid abuse has climbed, the cast of those who are alleged to have contributed to the crisis — manufacturers, distributors, doctors, pharmacists, hospitals and regulatory agencies — has grown. McKinsey is the newest and perhaps most surprising actor in this drama.
“From our initial review of the complaint, it appears that some of the references to McKinsey’s work lack context, including references to McKinsey that appear to be second- or third-hand,” McKinsey said in a statement, adding that it was continuing to review the document.
The suit, filed last year, names several Purdue executives and board members as well as members of the Sackler family, which controls the privately held company. McKinsey is mentioned 71 times in the 275-page complaint. The unredacted version was first reported by ProPublica and the medical news website Stat.
In 2009, McKinsey wrote a report for Purdue Pharma saying that new sales tactics would increase sales of OxyContin by $200 million to $400 million annually and “suggested sales ‘drivers’ based on the ideas that opioids reduce stress and make patients more optimistic and less isolated,” according to the lawsuit.
It was that year that Craig Landau, then Purdue’s chief medical officer and now its chief executive, had an email exchange that included a McKinsey consultant about how to counter mothers whose teenagers had overdosed on OxyContin. The solution: bring in patients to emphasize how the drug helps to relieve pain.

In 2013, amid the rapidly intensifying opioid crisis, the federal Drug Enforcement Administration and the Justice Department reached a settlement with Walgreens, the second-biggest American pharmacy chain. Walgreens agreed to new procedures to crack down on illegal prescriptions. In a report to Purdue Pharma, McKinsey said that “deep examination of Purdue’s available pharmacy purchasing data shows that Walgreens has reduced its units by 18%.”
According to the lawsuit, McKinsey recommended that Purdue “lobby Walgreens’ leaders to loosen up.”
McKinsey also recommended that Purdue redirect its sales force to focus on doctors who were especially prolific prescribers of OxyContin, according to the suit. One slide made public by the attorney general’s office, attributed to McKinsey, focused on one doctor in the town of Wareham, Mass., who almost doubled his annual output of OxyContin prescriptions after a big increase in visits from Purdue sales representatives.
If doctors resisted, McKinsey recommended that Purdue employ “patient pushback,” getting patients to lobby for OxyContin, according to the suit.
In a statement, Purdue said that the Massachusetts attorney general’s office “offers little evidence to support its sweeping legal claims.” The company also said that the lawsuit mischaracterized McKinsey’s work with Purdue.
On a chat site where participants must have a McKinsey email address to register for the company’s discussion room, several expletive-laced expressions of outrage over the revelations of McKinsey’s work with Purdue were mixed with comments about the responsibility to serve the client’s bottom line within moral and ethical boundaries.
“Then, of course it’s ok to maximize shareholder value, seek profits!,” one person wrote. “But not at all costs, not at the cost of our moral values and our society’s well being.”
Another person’s post — like all 42 entries about Purdue and McKinsey posted by midday Friday, it was anonymous — reproduced a bullet point from McKinsey’s values statement stating that the company will “observe high ethical standards.”

That is the second bullet point printed on the framed poster listing McKinsey’s mission and values that graces the 21st-floor lobby of McKinsey’s home office in Midtown Manhattan. The first reads: “put client interests ahead of the Firm’s.”
In 2018, after it spent years advising Purdue Pharma on how to increase sales of OxyContin, McKinsey published a report titled: “Why we need bolder action to combat the opioid epidemic.”

Everything You Need to Know About Giving Up Cigarettes

So you have decided to give up smoking. That is undoubtedly a great decision, but the difficulties start from day one.
Cigarettes truly are addictive, and smoking does reliably and quickly relieve stress and enhance the positivity in one’s outlook. Therefore, quitting is accompanied by the pains of withdrawal and resulting emotional downs.
Yet it is still possible to keep on track to achieve successful quitting. The first step is to have a clear personalized plan in place. This should help you firstly to resist the immediate urge to smoke, and secondly, to successfully resist the repeated temptation to start again.
Quit smoking. Image Credit: Marc Bruxelle / Shutterstock
Quit smoking. Image Credit: Marc Bruxelle / Shutterstock

Identifying triggers and cues

What makes you crave cigarettes? Thinking this through will help you avoid the triggers, such as the morning cup of coffee or evening glass of wine which makes you reach for the cigarettes. Instead, for instance, take a walk or have a warm bath at the designated time of the day.
This change will help break this habitual association. A journal is crucial in identifying the cravings, their intensity and the setting. This way both light and strong triggers can be identified and successfully tackled by lifestyle modifications.

Quit day

Set a date when you are going to stop smoking and make it soon, and on a peaceful day. Prepare for known difficulties, like withdrawal symptoms and cravings. Let others know your plans so they can help keep smokers away from you and encourage you.
Moreover, throw out all the cigarettes and even the smell of cigarette smoke. If necessary, get over-the-counter or prescription nicotine release products. Stress management may be useful as well; thus instead of smoking, try different relaxation methods.

Reasons for relapse

Nicotine produces physical and psychological addiction because of the effects it has on the brain. Once nicotine levels drop in the body, this produces aforementioned feelings of cravings, as well as physical withdrawal symptoms. To deal with these, a twofold approach is needed.

Facing nicotine withdrawal

The physical symptoms of nicotine withdrawal start within an hour of quitting, and may be at their worst in two or three days. They may last for up to a few weeks. However, bear in mind that they always pass. You just need to last them out, and to alert others to the chances that you may struggle emotionally for some time.
The symptoms include:
  • Cigarette cravings
  • Mood changes such as anxiety or nervousness, tiredness, lack of concentration, depression, irritability and restlessness
  • Physical symptoms such as increased appetite, insomnia, headaches, tremor, constipation, low heart rate or increased coughing
To handle these, new coping strategies are ideal to disarm the triggers, whether stress, boredom, or anxiety.
Secondly, avoid trigger habits or cue routines to weaken the brain link between smoking and that cue. For instance, you could end a meal with a piece of cheese or dark chocolate, fruit, or just walk in a green no-smoking zone.
The plus point is that vegetables, fruit and cheese don’t go well with cigarettes, making it easier for you. Water is preferable to an alcoholic drink, a cola, tea or coffee, or soft drink, for the same reason. In addition, water may ease certain discomforts that arise as a result of nicotine withdrawal (such as coughing, constipation and urge to eat).
Remind yourself that nicotine withdrawal cravings will cease in about 5-10 minutes, so distract yourself till then. For instance, you could watch that video you have been planning to watch for the last couple of days, catch up with a friend, manipulate some modelling clay, or almost anything that will need your attention and catch your interest. Another good way is to enter a no-smoking zone.
The four Ds summarize a winning strategy in this situation:
  • Delay for 10 minutes
  • Deep breathing – or breathe through a straw
  • Drink water in sips
  • Do something else to distract yourself
Write down a list of the top five reasons for quitting in your case, and have it ready to reinforce your motivation. And always, always, get support – either online or face to face.

How long till I feel better?

Nicotine withdrawal symptoms will last for only a few weeks at most. The physical symptoms recover much faster. The following table may be helpful:
TIME SINCE QUITTINGBENEFIT
Six hoursStable heart rate and blood pressure
One dayAlmost nicotine-free blood
One weekBetter taste and smell, better removal of external dust, tar and mucus by the lungs
Three monthsLess respiratory symptoms, better immunity, better circulation to limbs
Six monthsLess stress
One year anniversaryBetter lung function
Five yearsHeart disease risk lower, cervical cancer risk normal
Ten yearsLung cancer risk lower
Fifteen yearsNormal risk for stroke or heart attack

What other benefits are there for me?

You will obviously no longer have to make sure you do not smell of smoke, or that you have access to cigarettes wherever you go. Furthermore, you no longer endanger others by your second-hand smoke. Other benefits are that you will save a huge amount of money, and your self-esteem will rise, while you can now run or climb stairs without wheezing.

Will I gain weight if I quit smoking?

Smoking cigarettes suppresses the appetite. However, most people put on only a couple of kilograms in the first six months after quitting, and this also goes down over time. Of course, food tastes better once your taste buds are refreshed, but this should not make you turn to food instead of tobacco as your coping strategy.
Instead, adopt other healthy pleasures, such as a walking, listening to music or reading a good book. Additional advice is to avoid processed and sweet/fatty foods, eat mindfully and drink a lot of water.

Do medications help?

Several medications are successfully used to help smokers quit the habit, especially in a physician-monitored program. Some prescription medications can help smokers quit, but should be used for as short as possible.
Nicotine replacement gums, patches, lozenges, inhalation or nasal sprays all aim at relieving the physical symptoms by steadily releasing small amounts of nicotine over a period of time. This avoids tar and smoke inhalation.
Vaping, or e-cigarettes, prevents the intake of tar and toxic gases from cigarette smoking. However, they are associated with:
  • Negative health effects from nicotine in the cartridge liquid
  • Chronic lung disease from the flavorants in e-cigarette liquids
  • Occasional formaldehyde from the e-cigarette vaporizers

Are there any alternative therapies to help quit successfully?

Some methods used to stop smoking without nicotine replacement or vaping include:
  • Hypnosis that induces a state of deep mind relaxation where suggestions that help create an aversion to cigarettes and a stronger determination to stop smoking can be introduced
  • Behavioral therapy helps learn new ways to cope and breaks the habits and associations related to smoking
  • Motivational therapies which focus on the gains from quitting

What about smokeless tobacco?

Smokeless tobacco is tobacco designed for chewing and is high in nicotine. In fact, it may release 3-4 times more nicotine than you would get from a cigarette. However, albeit the adverse effects of smokeless tobacco on cardiovascular system are lower when compared to smoking per se, but are still higher than those in non-smokers.

What if I slip?

A slip does not mean you have failed. Instead, try to analyze the situation so you can observe what went wrong, and adjust your smoking plan to avoid the same thing next time around. The most important thing is to always get up if you fall. Throw away the remaining cigarettes so they cannot tempt you.
Reinforce your resolve by keeping track of the number of no-smoking days you racked up so far. If a friend or family member is trying to quit, support them in all these ways. Encouragement, talking them through difficult times, and avoiding smoking situations are all helpful. Finally, do not preach or threaten, as it may just worsen the situation.

Further Reading

Infrared Therapy: Health Benefits and Risks

Infrared therapy is a new and innovative light-based method to treat pain and inflammation in various parts of the body. Unlike ultraviolet light, which can damage the skin, infrared light enhances cell regeneration. Infrared light is delivered to the site of injury or inflammation at certain wavelengths, promoting cell repair.
The key characteristic of infrared light is its ability to penetrate even the deep layers of the skin, providing better pain relief. Also, infrared light is safe, natural, non-invasive, and painless. Thus it may be able to provide a broad range of health benefits.
Infrared treatment for rehabilitation orthopedic medical care. Image Credit: VP Photo Studio / Shutterstock
Infrared treatment for rehabilitation orthopedic medical care. Image Credit: VP Photo Studio / Shutterstock

Why is Infrared Therapy Widely Used Today?

Infrared therapy is widely used in the fields of medicine, dentistry, veterinary medicine, and in autoimmune diseases, to name a few. The therapy is safe and natural, which enables it to be offered as an alternative treatment for various health conditions like muscle pain, joint stiffness, and arthritis, to name a few.
Infrared therapy has many roles in the human body. These include detoxification, pain relief, reduction of muscle tension, relaxation, improved circulation, weight loss, skin purification, lowered side effects of diabetes, boosting of the immune system and lowering of blood pressure.

What are the Health Benefits of Infrared Therapy?

Cardiovascular Health

One of the key health benefits of infrared therapy is improvement in cardiovascular health. Infrared light increases the production of nitric oxide, a vital signaling molecule that is important for the health of blood vessels. This molecule helps relax the arteries and prevents blood from clotting and clumping in the vessels. Aside from these, it also combats free radicals to prevent oxidative stress and regulate blood pressure.
Nitric oxide is essential in improving blood circulation, which provides more oxygen and nutrients to injured tissues. Thus, infrared light hastens wound healing and stimulates the regeneration of injured tissues, reducing inflammation and pain.

Pain and Inflammation

Infrared therapy is an effective and safe remedy for pain and inflammation. It can penetrate deep through the layers of the skin, to the muscles and bones. Since infrared therapy enhances and improves circulation in the skin and other parts of the body, it can bring oxygen and nutrients to injured tissues, promoting healing. It helps ease pain, relieve inflammation, and protect against oxidative stress.

Muscular Injuries

Infrared therapy improves the action of the mitochondria within cells, thus triggering the growth and repair of new muscles cells and tissues. In other words, infrared light can hasten the repair process after a muscle injury.

Detoxification

Infrared therapy can be applied through saunas. Detoxifications are important since they may strengthen the immune system. At the same time, detoxification aid biochemical processes to function properly, improving food digestion. In infrared saunas, the body’s core temperature increases, leading to detoxification at the cellular level.

Potential Cancer Cure

Infrared therapy is a potentially viable cancer treatment. Studies show significant activation of nanoparticles when they are exposed to infrared radiation, rendering them highly toxic to surrounding cancer cells. One such modality is photoimmunotherapy, using a conjugated antibody- photoabsorber complex that binds to cancer cells.

What are the Risks Linked to Infrared Therapy?

Each day, humans are immersed in infrared radiation from the sun in the form of heat. In fact, infrared saunas are in-demand today, but experts warn of possible health risks. Thermal or heat injuries can happen, depending on the wavelength of the infrared light. Thermal injury can occur even without pain. Also, pregnant women, people with heart diseases, and those who are sick should never undergo infrared therapy.
Moreover, experts warn against using infrared therapy to treat chronic diseases while neglecting the use of medications and recommended treatment procedures. Though infrared therapy promises many health benefits, its study is far from complete. At present, therefore, it should be considered an adjunct to medical treatment, and other regimens should be continued as prescribed.

Further Reading

Targeting Opioid Prescriptions May Have Little Effect on Epidemic

Dose limits, prescribing guidelines, prescription drug monitoring programs, and similar interventions will have a “modest effect, at best” on the number of opioid overdose deaths in the future, a mathematical model projected.
Lowering the incidence of prescription opioid misuse from 2015 levels would decrease overdose deaths only 3% to 5% by 2025, according to Jagpreet Chhatwal, PhD, of Massachusetts General Hospital in Boston, and colleagues, writing in JAMA Network Open.
“If our aim is to bend the overdose death curve and fix the opioid overdose crisis in the near future, we will fail miserably by relying solely on controlling the supply of prescription opioids,” Chhatwal told MedPage Today.
Because deaths from illicit opioids appear to be rising, additional policy interventions are needed urgently, he added: “While initiatives designed to reduce exposure to prescription opioids are useful for preventing people from misusing opioids in the first place, these initiatives, in isolation, will not have much impact on opioid overdose deaths.”
“We’re currently in a very dynamic environment with many laws, regulations, and initiatives to address the opioid crisis,” observed Mark Bicket, MD, of the Johns Hopkins University School of Medicine in Baltimore, who was not involved with the study.
While making predictions that control for these elements is challenging, “it’s clear we need to focus on more than one strategy to make a meaningful impact on overdose deaths,” Bicket told MedPage Today: “Overdose deaths from opioids appear to be reaching a plateau, but deaths from synthetic opioids like illicit fentanyl appear to be rising, based on the most recent data from the CDC.”
In their analysis, Chhatwal and colleagues used data from the National Survey on Drug Use and Health (NSDUH) and the CDC from 2002 to 2015 to calibrate a systems dynamic model to project probable opioid outcomes to 2025. They analyzed the trajectory of the opioid epidemic based on four scenarios: if prescription opioid misuse remained at 2015 levels (reference); if it fell by 7.5%, per year, based on patterns from 2011 to 2015; if it fell even faster at 11.3%; and a hypothetical situation of no new incidence of misuse after 2015.
Under all scenarios, reducing the incidence of prescription opioid misuse decreased overdose deaths by 3.0% to 5.3%.
Based on 2015 levels, the annual number of opioid overdose deaths would increase from 33,100 in 2015 to 81,700 (95% uncertainty interval [UI], 63,600-101,700) in 2025, according to the model — a 147% increase. A total of 704,000 people (95% UI 590,200-817,100) would die from an opioid overdose during those years, with 80% of the deaths attributable to illicit opioids. Illicit opioids would be used by 61% more people, and about half of all new opioid users would begin with illicit rather than prescription drugs.
The projections echoed ones last year by Stanford University researchers, which showed that no single policy is likely to substantially reduce opioid deaths over 5 to 10 years. “Reducing opioid prescriptions will save lives, but this cannot be the nation’s only policy tool,” Keith Humphreys, PhD, of the Stanford School of Medicine, told MedPage Today.
“A big caveat with these forecasting studies is that they are very sensitive to the data you use and the assumptions made,” added Michael Barnett, MD, MS, of the Harvard T. H. Chan School of Public Health in Boston.
“Even if the exact magnitude and trends in opioid overdose may be different, I think the important point in this study is that reducing medical opioid prescribing will only have a modest impact on the national burden of overdose deaths,” Barnett told MedPage Today.“The largest challenge right now is how can we prevent overdoses and treat addiction in individuals who transition to heroin or fentanyl.”
The study has other limitations, Chhatwal and co-authors noted. The model was calibrated to data sources that underestimated outcomes: NSDUH, for example, excluded homeless and incarcerated populations. And interventions and opioid epidemic dynamics may have substantial variations at the local level, which the researchers could not include in their model.
The researchers reported relationships with the National Institute on Drug Abuse, Optum Labs, the National Center for Advancing Translational Sciences/Boston University Clinical & Translational Science Institute, the Centers for Disease Control and Prevention, the University of Maryland Baltimore/Office of National Drug Control Policy, and the Medical Imaging and Technology Alliance.