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Update July 2017


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Update July 22, 2017

FDA takes steps to boost generic competition, limit prices

In this Wednesday, April 5, 2017, file photo, Dr. Scott Gottlieb, President Donald Trump’s nominee to head the Food and Drug Administration, appears at his confirmation hearing before the Senate Committee on Health, Education, Labor, and Pensions, on Capitol Hill in Washington. (AP Photo/J. Scott Applewhite)

Linda A. Johnson

The Food and Drug Administration said it’s taking steps to boost the number of generic prescription drugs on the market in an effort to make medicines more affordable and to prevent price gouging.

Copycat pills generally have been much cheaper than original brand-name drugs. But recent high-profile cases have shown how lack of competition and medicine shortages allowed several drug companies to drastically increase prices for generics and some older brand-name products such as EpiPen emergency allergy injectors.

New FDA commissioner Dr. Scott Gottlieb made addressing prices a priority, saying that agency can help by increasing market competition. While the FDA reviews and approves medications, it doesn’t have the power to regulate prices.

“No patient should be priced out of the medicines they need, and as an agency dedicated to promoting public health, we must do our part to help patients get access to the treatments they require,” Gottlieb said in a statement.

On Tuesday, the FDA said it will now give priority reviews to new generic drugs until there are at least three on the market. That’s the level at which prices tend to drop sharply, up to 85 percent off the brand-name price.

The agency also published its first list of brand-name drugs that no longer have a patent’s protection but don’t yet have generic competition, a strategy to entice generic drugmakers to develop copycats.

The list includes an HIV medicine, a genetically engineered heart drug, prescription multivitamins and IV salt and sugar solutions. Some have been in short supply, sometimes for years, after quality problems shut down manufacturing lines or companies stopped making them to pursue more profitable products.

Among the best-known cases of dramatic price hikes: Mylan’s fivefold increase for EpiPen’s price and former pharmaceutical executive Martin Shkreli’s Turing Pharmaceuticals raising the price of an old drug for a deadly infection more than 5,000 percent, to $750 per pill.

Meanwhile, the FDA has scheduled a July 18 meeting to discuss possible changes to its rules for approving generics, which inadvertently have enabled some makers of brand-name medicines to prevent or delay generic rivals. (AP)


Merck says new type of cholesterol drug worked in big study

Linda A. Johnson

Trenton, N.J. (AP) - Merck & Co. said Tuesday that a new type of cholesterol drug reduced heart attacks, deaths and other complications of heart disease in a huge, late-stage study.

The positive result was a welcome surprise because three previous experimental drugs of the same type had failed.

Merck’s pill, anacetrapib, might eventually give high-risk heart patients a new option to add to cholesterol treatments that have helped prevent millions of heart attacks, strokes and deaths from heart disease. Cheap generics don’t cut those risks enough for many people, while two new cholesterol drugs cost $14,000 a year or more, so insurers have been restricting coverage.

The Merck drug works by blocking a protein called CETP. That’s a different way to control cholesterol than that of widely used, now-generic statins such as Lipitor and Crestor, and the newer injected drugs, Repatha and Praluent.

Anacetrapib was thought to benefit patients mainly by increasing HDL, or “good” cholesterol. Over time, Merck found it also significantly lowered “bad” cholesterol, or LDL, increasing the drug’s ability to prevent artery-clogging buildups of fatty plaques that can trigger heart attacks and strokes.

The company-funded study included 30,000 people, who were followed for more than four years. Half got the drug and the rest got dummy pills. Both groups also took atorvastatin pills, or generic Lipitor.

The size and duration of the study increased the chances that it would produce a positive result. Still, that might be just a modest improvement, Evercore ISI analyst Umer Raffat wrote to investors Tuesday.

Kenilworth, New Jersey-based Merck said it won’t release detailed study results until Aug. 29, at a European conference of heart specialists. That’s standard practice, but Merck raised questions about how well the medicine works by noting the company will consult with outside experts before deciding whether to seek regulatory approval to sell the drug.

Normally, when testing shows a drug is effective and fairly safe, drugmakers rush to apply for approval.

Merck’s apparent success with anacetrapib comes after three major rivals - Pfizer Inc., Eli Lilly and Co., and Roche Group - each saw drugs of the same type fail because of lack of effectiveness or dangerous side effects. Roche Group is starting a new test in heart patients with a particular genetic variation, Raffat noted.

In its brief statement, Merck said its initial analysis of study data found side effects were about the same as in earlier, smaller studies, with the most significant issue being that anacetrapib can accumulate and remain in fatty tissue long after taking the drug. It’s unclear whether that is harmful.


Update July 15, 2017

Drug shows promise against vision-robbing disease in seniors

This image provided by Roche, and manipulated by blurring the center of the image by the source, to illustrate how vision is affected by the so-called “dry” form of age-related macular degeneration. (Roche via AP)

Lauran Neergaard

Washington (AP) - An experimental drug is showing promise against an untreatable eye disease that blinds older adults - and intriguingly, it seems to work in patients who carry a particular gene flaw that fuels the damage to their vision.

This image provided by the National Eye Institute shows a microscopic image of a retina being damaged by the so-called “dry” form of age-related macular degeneration. (National Eye Institute via AP)

Age-related macular degeneration, or AMD, is the leading cause of vision loss among seniors, gradually eroding crucial central vision. There are different forms but more than 5 million people worldwide, and a million in the U.S., have an advanced type of so-called “dry” macular degeneration that has no treatment. At first patients may notice blurriness when they look straight ahead. Eventually many develop blank spots, becoming legally blind.

“These are seniors who are entering their golden years and now they’ve lost the ability to read, watch television, see their loved ones,” said Dr. Rahul Khurana, a retina specialist and spokesman for the American Academy of Ophthalmology.

The experimental drug, lampalizumab, aims to slow the destruction of light-sensing cells in the retina, creeping lesions that characterize the stage of dry AMD called “geographic atrophy.” When those cells die, they can’t grow back - the vision loss is irreversible.

What the research found

In an 18-month study of 129 patients, monthly eye injections of the drug modestly slowed worsening of the disease when compared with patients given dummy shots. What’s exciting for scientists came next, when researchers from drugmaker Genentech Inc. took a closer look at exactly who was being helped.

It turns out that nearly 6 in 10 of the study’s participants carry a gene variation that makes part of the immune system go awry - a genetic flaw already known to increase the risk of getting macular degeneration in the first place.

Those are the only patients who appeared to benefit from the drug; they had 44 percent less eye damage than the untreated patients, the Genentech team reported Wednesday in the journal Science Translational Medicine. While the study is too small to prove if lampalizumab really helps maintain vision, that’s a bigger difference than the overall results suggested.

Why would an immune-related gene affect aging eyes?

One arm of the immune system, the complement pathway, helps fight infections by attracting immune cells to attack bacteria.

Normally, there’s a barrier that keeps such cells away from the retina. But that barrier can break down with age, opening sensitive eye cells to harm from the spillover, explained Genentech immunologist Menno van Lookeren Campagne.

Now for the gene connection: Previous studies have linked macular degeneration to gene variations that remove some of that pathway’s natural brakes, so it can become too active.

The hypothesis: Genentech’s drug, lampalizumab, essentially offers a backup method for tamping down the immune reaction. An antibody, it works by inhibiting a particular enzyme named factor D that helps power the immune pathway.

“We try to reinsert the braking ability,” said study lead author Brian Yaspan, a Genentech senior scientist.

What’s next?

Wednesday’s study detected no safety concerns, clearing the way for Genentech and its parent company Roche to open two large-scale studies that aim to prove if the drug works. Results are expected later this year.

The current research sheds light on how that long-suspected immune culprit might be working, and is “the first suggestion that there may be a treatment for geographic atrophy coming up in the future,” said National Eye Institute retina specialist Dr. Wai Wong, who wasn’t involved in the study.

“It’s a very, very exciting study,” said Khurana, the ophthalmologist association’s spokesman, who also wasn’t part of the research. “From the basic science perspective, it makes a lot of sense.”

Health advice for now

Macular degeneration tends to occur after age 60, but it sometimes strikes earlier. According to the National Eye Institute, it’s less common in people who exercise regularly, avoid smoking, and eat a diet high in green leafy vegetables and fish.

Symptoms often aren’t noticeable early on. But several eye tests can detect signs of macular degeneration, including a dilated eye exam and a tool called an Amsler grid with straight lines that may look wavy if the macula, the center of the retina, is harmed.

Macular degeneration patients often are advised to take certain vitamin combinations that may help stave off advanced disease. And it’s important for patients to know what type they have. While there’s no treatment for the advanced dry form, the “wet” form occurs when leaky blood vessels grow under the retina - and there are several therapies that can help those patients preserve vision.


Update July 8, 2017

FDA approves quicker-to-administer drug for blood cancers

This photo provided by Genentech, the Roche Group’s biologic drug unit, shows vials of Rituxan Hycela. On Thursday, June 22, 2017, the Food and Drug Administration approved Rituxan Hycela, a more convenient version of a blockbuster drug for treating three common blood cancers. (Genentech via AP)

U.S. regulators have approved a more convenient version of a blockbuster drug for treating three common blood cancers.

The Roche Group’s Rituxan, on the market for 20 years, is administered in a hospital or clinic through an intravenous drip that can take several hours.

On Thursday, the Food and Drug Administration approved the Swiss drugmaker’s new version, Rituxan Hycela (RIH’-tux-en HEYE’-cell-uh). It’s injected in about six minutes, shortening clinic visits.

It’s given every three weeks for six months to treat diffuse large B-cell lymphoma, for a total cost of about $48,600 without insurance - the same as for Rituxan.

Rituxan Hycela also was approved for treating follicular lymphoma and chronic lymphocytic leukemia.

Rituxan, which will still be available, is Roche’s top seller. It had 2016 sales of $7.5 billion. (AP)


Hints of some steps that may boost brain health in old age

 Lauran Neergaard

Washington (AP) - Are you seeking steps to keep your brain healthy in old age?

There are no proven ways to stave off mental decline or dementia, but a new report says there are hints that exercise, controlling blood pressure and some forms of brain training might offer help.

Without proof, the government should not begin a public health campaign pushing strategies for aging brain health, the National Academies of Sciences, Engineering and Medicine said in a report released Thursday.

But the public should be told the evidence is “encouraging,” though inconclusive, the report concluded. That way, people can use the information in deciding whether to invest time and money on different interventions.

The three highlighted strategies “do no harm,” said neuroscientist Alan Leshner, chairman of the National Academies committee. “At least two of them are really good for you” even if the brain link doesn’t pan out.

Scientists know that risky changes in the brain begin decades before symptoms of Alzheimer’s and other dementias become apparent, suggesting there’s a window when people might bolster their cognitive health. But the report says Americans face a “bewildering” array of products and strategies promoted for brain health despite little if any rigorous science to back them up.

The National Institute on Aging asked the prestigious National Academies to review the field. The committee said three interventions should be more closely studied to prove if they really can help:

- Getting high blood pressure under control, especially in middle age. People with hypertension need treatment anyway to prevent heart disease and strokes.

- Increased physical activity. Similar to the blood pressure advice, what’s good for the heart has long been deemed good for the brain.

- Cognitive training, specific techniques aimed at enhancing reasoning, problem solving, memory and speed of mental processing. While immediate task performance may improve, the committee said it’s not clear whether there’s lasting, meaningful benefit.

This is not merely “brain games” on your computer, Leshner said. The committee isn’t backing those costly computer-based programs. Indeed, the government fined one brain training company last year for misleading consumers.

Instead, the best study to date included training done in groups, providing social engagement too. And cognitively stimulating activities include such things as learning a new language, the report noted.

“Since generally keeping intellectually active appears to be good for you, do that,” Leshner advised, and if you’re considering a commercial program, ask the company to see studies backing it.

The Alzheimer’s Association had been awaiting the recommendations, and agreed that “more research is needed to determine what the optimal interventions should be,” said chief medical officer Maria Carrillo. “In the meantime, we recommend that people challenge their brains to maintain brain health.”


Update July 1, 2017

Drones carrying defibrillators could aid heart emergencies

An experimental study in Sweden suggests drones equipped with heart defibrillators could help with response times for out-of-hospital cardiac arrest. (AP Photo/Nati Harnik, File)

Lindsey Tanner

Chicago (AP) - It sounds futuristic: drones carrying heart defibrillators swooping in to help bystanders revive people stricken by cardiac arrest.

Researchers tested the idea and found drones arrived at the scene of 18 cardiac arrests within about 5 minutes of launch. That was almost 17 minutes faster on average than ambulances - a big deal for a condition where minutes mean life or death.

Drone-delivered devices weren’t used on patients in the preliminary study, but the results are “pretty remarkable” and proof that the idea is worth exploring, said Dr. Clyde Yancy, a former American Heart Association president who was not involved in the study.

Cardiac arrest is a leading cause of death worldwide, killing more than 6 million people each year. Most happen at home or in other nonmedical settings and most patients don’t survive.

“Ninety percent of people who collapse outside of a hospital don’t make it. This is a crisis and it’s time we do something different to address it,” said Yancy, cardiology chief at Northwestern University’s medical school in Chicago.

The researchers reached the same conclusion after analyzing cardiac arrest data in Sweden, focusing on towns near Stockholm that don’t have enough emergency medical resources to serve summer vacationers. The analysis found an emergency response time of almost 30 minutes and a survival rate of zero, said lead author Andreas Claesson, a researcher at the Center for Resuscitation Science at Karolinska Institute in Stockholm.

To see if care could be improved, Claesson’s team turned to drones.

Drones are increasingly being tested or used in a variety of settings, including to deliver retail goods to consumers in remote areas, search for lost hikers and help police monitor traffic or crowds. Using them to speed medical care seemed like a logical next step, Claesson said.

The study was done last October and was published Tuesday in the Journal of the American Medical Association.

More than 350,000 Americans had a cardiac arrest in a nonmedical setting last year, the American Heart Association says. The condition is often confused with heart attacks but they’re different.

Heart attacks occur when a clot or other blockage stops blood flow to the heart. Cardiac arrest occurs when electrical impulses controlling the heart’s rhythmic pumping action suddenly malfunction. The heartbeat becomes very irregular or stops, preventing blood from reaching vital organs. Death can occur within minutes without treatment to restore a normal heartbeat, ideally CPR and use of a defibrillator.

The researchers used a small heart defibrillator weighing less than two pounds, featuring an electronic voice that gives instructions on how to use the device. It was attached to a small drone equipped with four small propeller-like rotors, a global positioning device and camera.

They launched the drone from a fire station within about 10 kilometers from homes where people had previous cardiac arrests.

In the study’s video footage simulating a rescue, a drone soars over residential rooftops and then lands gently in a backyard. A man dashes out of the house, grabs the defibrillator and carries it inside.

There were no crashes or other mishaps during the study, Claesson said. He plans a follow-up study to test drone-delivered defibrillators for bystanders to use in real-life cardiac arrests.

The test results show “a great potential for saving lives,” he said.


Obesity rising in nations rich and poor, especially in kids

Mike Stobbe

New York (AP) - The global obesity problem now affects 1 in 10 people in the world, it is rising in countries rich and poor, and in many countries it is increasing faster in children than adults, according to a new study.

The researchers estimated more than 107 million children and 603 million adults are obese.

The research found obesity has tripled in children and young adults in countries like China, Brazil and Indonesia. Those numbers are particularly troubling because it means more young people are on track to become obese adults and develop problems like diabetes, heart disease and a range of cancers, some experts said.

The study was led by a team at the University of Washington in Seattle. It was published online by the New England Journal of Medicine and presented at a food science and policy meeting in Stockholm.

Researchers reported on 195 countries, although data was incomplete or nonexistent for many of them. They made assumptions and used mathematical modeling to fill in gaps.

Despite the limitations, “this is the best picture that’s out there for global obesity,” said Edward Gregg, a diabetes expert at the U.S. Centers for Disease Control and Prevention. He wrote an editorial that accompanied the study.

Some of the findings:

- Obesity rates doubled in 73 countries between 1980 and 2015. Countries where obesity did not increase significantly included Afghanistan, Bulgaria, and the Democratic Republic of the Congo.

- Worldwide, about 5 percent of children and 12 percent of adults were obese in 2015. In the U.S. about 17 percent of children and 38 percent of adults are obese, according to earlier CDC estimates.

- Among the 20 largest countries, the United States had the highest level of obesity among children and young adults. Bangladesh had the lowest.

- Egypt had the highest rate of obese adults. Vietnam had the lowest.

- But the United States had the largest number of obese adults in 2015, with 79 million. China came in second with 57 million obese adults - even though China has more than four times as many people as the U.S.

- China had the largest number of obese children, with 15 million. India had 14 million.

- Globally, about 4 million deaths were attributed to being overweight or obese in 2014, from causes like heart disease and diabetes.

Some good news is that improvements in medications and other kinds of health-care seem to be helping people survive longer even if they have weight-related health problems. Researchers did not find an increase in weight-related rates of death and disability, Gregg observed.

But with obesity levels rising, there is a pressing need for better nutrition and other efforts to prevent unhealthy weight gain, said Dr. Ashkan Afshin, the study’s lead author.

Unfortunately, “there is no single simple solution for the problem of overweight and obesity,” he said.
 


DAILY UPDATEE

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HEADLINES [click on headline to view story]

FDA takes steps to boost generic competition, limit prices

Merck says new type of cholesterol drug worked in big study


Drug shows promise against vision-robbing disease in seniors


FDA approves quicker-to-administer drug for blood cancers

Hints of some steps that may boost brain health in old age


Drones carrying defibrillators could aid heart emergencies

Obesity rising in nations rich and poor, especially in kids


 



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