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Merck Sues Over Law Empowering Medicare to Negotiate With Drugmakers

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Merck Sues Over Law Empowering Medicare to Negotiate With Drugmakers

The pharmaceutical company Merck on Tuesday sued the government over a federal law that empowers Medicare for the first time to negotiate prices directly with drugmakers.

Merck’s lawsuit, filed in federal court in Washington, is the drug industry’s most significant move so far to fight back against a substantial change to health policy, which will go into effect starting in 2026. Democrats pushed through the Medicare-negotiation program last summer as a provision of the Inflation Reduction Act, framing it as a way of lowering drug prices.

Only some drugs will be subject to negotiation with Medicare and only after they have been on the market without competition for years. But Merck, which generated $14.5 billion in profit last year, claimed in a statement on Tuesday that the law would stifle its ability and that of its peers to make risky investments in new cures.

Other drug companies have suggested that they will choose to cut certain drug development programs because of the projected dent to their revenue. Several have already said they were reassessing their research plans.

Merck said it was seeking a court order or another legal remedy that could exempt Merck from having to participate in the negotiation program.

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In the complaint filed Tuesday, the company’s lawyers at the law firm Jones Day claim that the Medicare-negotiation program is unconstitutional. They claim that the program would coerce Merck to provide its products at government-set prices, violating a clause of the Fifth Amendment that prohibits the government from taking private property for public use without just compensation. They also claim that the program would violate Merck’s free-speech rights by coercing the company to sign an agreement it did not agree with upon the conclusion of the negotiation.

But several experts who study the industry said the constitutionality arguments were weak and would face an uphill battle in court. “What Merck argues is ‘coercion’ is actually the establishment of a freer, more rational marketplace” that will address a crucial root cause of high drug prices, said Dr. Ameet Sarpatwari, an expert in pharmaceutical policy at Harvard Medical School.

Experts noted that the negotiation process gives drug makers leeway to reject Medicare’s final offer and walk away without a deal if they are not happy, subject to a tax.

In September, the government plans to announce the first 10 drugs that will be subject to negotiation in 2026. A widely used Merck drug for diabetes known as Januvia is likely to be on that list.

The program could also affect Merck’s long-term plans for its golden goose, the blockbuster cancer drug Keytruda. It could be among the first products targeted when negotiations begin in 2028 on drugs administered in a health care setting.

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The current version of Keytruda, administered as an infusion, will face its first competition that same year, so its sales are expected to erode regardless of whether it is targeted by the program. But Merck had been expecting to bring in significant revenue from a new formulation of Keytruda it is developing that can be more easily given under the skin. That could be subject to negotiation, too, under the government’s plans for the program.

The White House did not have any immediate comment on Merck’s lawsuit.

Sheryl Gay Stolberg contributed reporting.

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What threats lurk in the smoke and ash of L.A.-area fires? New health warnings

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What threats lurk in the smoke and ash of L.A.-area fires?  New health warnings

As Santa Ana wind conditions continue to stoke fears of resurgent wildfires across Los Angeles County, health officials are warning of yet another wind-borne threat: ash and dust from active fire zones and burn scars.

On Tuesday, the county Department of Public Health issued a windblown dust and ash advisory until 7 p.m. Wednesday.

During this time, ash may be dispersed from the Palisades and Eaton fire areas, as well as from the Hurst, Kenneth, Line, Airport and Bridge fire burn scars, according to the South Coast Air Quality Management District.

“Windblown ash particles may be too large to be detected by air quality instrumentation and will not influence Air Quality Index levels,” the advisory stated. “However, ash particles are typically visible to the naked eye either in the air or on outdoor surfaces.”

Experts say that wildfire smoke is unsafe for everyone and that all area residents should be worried about the potential health effects from this pollutant.

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The cause for concern is, “the main component of smoke is particulate matter and that can penetrate deep into the lungs, which directly causes respiratory issues, but it can also enter the bloodstream where it can cause a range of other health issues,” said Anne Kelsey Lamb, director of Regional Asthma Management and Prevention.

Wildfire smoke can be extremely harmful to the lungs of at-risk people, who include children whose lungs are still developing, pregnant women, older adults, and those with asthma, chronic obstructive pulmonary disease, chronic heart disease or diabetes, according to the American Lung Assn.

Exposure to air pollution such as wildfire smoke can also lead to the onset of asthma in otherwise healthy people, Lamb said.

As wildfires have become more common researchers have been learning that wildfire smoke, depending on what it consists of, can be even more dangerous to public health than other types of air pollution.

Last year the UCLA Luskin Center for Innovation published a study in the journal Science Advances that found an estimated total of more than 55,000 premature deaths in an 11-year span from inhaling fine particulate matter known as PM2.5, or soot, from wildfires.

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Air pollutants from wildfires are dangerous to the immediate fire zone and surrounding communities, but the harm can reach out farther.

Lamb noted that during the 2018 Camp fire in Butte County, researchers found smoke with lead in it 150 miles away from the fire zone.

“Even people who aren’t in the immediate vicinity of the fire are likely still facing some of the impacts of the smoke from it,” she said. “I encourage everyone in the broader area to take the same precautions that we would recommend for someone who’s really right there in the midst of it.”

What’s possibly in the air? In the ash?

We know that wildfire smoke can include toxic materials such as lead, asbestos and arsenic, which can lead to additional health harms, Lamb said.

Part of the reason wildfire smoke from the Los Angeles-area fires is particularly concerning is because — in addition to PM2.5 — the smoke from this disaster can include harmful components that were part of houses, items inside the home, buildings and cars that burned.

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Toxic chemicals from plastics, paint from the house and furniture are a few examples of what has been burned and is being released in the air, said Anthony Wexler, director of the Air Quality Research Center at UC Davis.

Researchers are still working to understand the relative toxicity of these specific chemical pollutants during a fire event.

“We’ve done some experiments, some early experiments in my lab showing that it’s more toxic, the building materials than burning wooded material,” Wexler said. “But again, we have just a little bit of data.”

In the face of uncertainty, he said, “people should protect themselves as much as they can.”

Local and regional public health officials are recommending that at-risk people stay indoors with the windows and doors closed — while keeping the indoor air clean.

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“You have permission to be a couch potato, as long as you have electricity so you can watch the tube,” Wexler said.

The more you do outside the more you’re going to expose yourself to all the harmful air pollutants.

Wexler advises you whip out the protective gear that you had for the pandemic: air purifiers, N95 masks, gloves and protective eyewear in case you have to go outside.

If I have to be outside, what can I do to stay safe?

If people need to be outside, experts recommend wearing an N95 mask.

That’s because those are really the only masks that are going to filter out the damaging fine particles, Lamb said.

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“The surgical masks allow too much air to get in, because it’s not the tight fit,” she said. “It doesn’t filter out as fine of particles as the N95 does.”

Researchers have looked into wearing cloth masks during wildfire smoke and found that it “led to more exposure because some of the smoke sort of settled in the material and then it was continuously breathed in,” Lamb said.

There are a lot of Los Angeles residents who are out in surrounding communities volunteering their time to local disaster relief efforts, providing essential services and working.

“We want people to volunteer and help out, because we need that,” Wexler said.

But there are further safety steps that men with beards should take, he said.

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Bearded men need to shave or at least cut back facial hair as much as possible so that a protective mask makes a firm seal around the face, keeping pollutants out.

Experts also urge everyone to remove clothes worn while working outside, including shoes, before entering home. Put the clothes in the wash right away, because some of the particulate they carry can come inside the home and affect other people, Lamb said.

One thing to remember, Lamb said, is that the components of the pollutants, including ash, will settle on the ground and can be aerosolized again when disturbed as part of the cleanup efforts.

“There may be no way to avoid that happening, but to avoid exposure, make sure you’re wearing a mask, and I would even have on eyewear, gloves and change clothes,” she said.

I have pets. How can I protect them?

As irritating as smoke can be for people, it can cause health problems for your pets too.

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Animals with cardiovascular or respiratory disease are especially at risk from smoke and should be closely watched during all periods of poor air quality, according to the American Veterinary Medical Assn.

Experts share the following information to keep your beloved animals safe during a poor or unhealthy air quality event:

  • Keep pets indoors as much as possible, and keep your windows shut.
  • Smoke is especially tough on your pet birds. Keep them inside when smoke is present.
  • Let dogs and cats outside only for brief bathroom breaks if air quality alerts are in effect.
  • Avoid intense outdoor exercise during periods of poor air quality. Exercise pets when dust and smoke have settled.

When can I stop wearing a mask and safely open my windows?

In regards to the current windblown advisory, experts advise you check for updates from local officials and follow their safety guidance.

How can I check the air quality in my area?

Even though windblown ash particles may be too large to be detected by air quality instrumentation and officials warn it will not influence Air Quality Index levels, you should still keep an eye on the air quality in your area.

When you are looking at the air quality reading, keep in mind the harmful particles that are not being recorded.

You can do so with the following tools:

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  • AirNow, the website and the app, created by the U.S. Environmental Protection Agency includes information from its permanent air quality monitors as well as temporary air quality monitors that will be put in place in incidents like this. It has an updated “Fire and Smoke” map, or you can enter your ZIP Code and check the air in your community.
  • Purple Air is a company that helps monitor air quality by selling easy-to-install sensors with real-time data on various particulate matter levels. Purple Air has a free online map with real-time air quality data.
  • The South Coast Air Quality Management District issues advisories, guidance and warnings in regards to air quality impacts. It has a current hourly air quality index map and a dedicated webpage to news releases of such advisories.

All resources will provide a number for the air quality index. If it’s greater than 100, that is considered unhealthy for sensitive and at-risk groups. If it’s greater than 150, it is considered unhealthy for all people.

Where can I find free N95 masks in Los Angeles County?

Here is a list of locations where you can pick up free N95 masks.

This list will be updated as more organizations, local agencies and others post their offerings.

  • L.A. Care Health community resource centers. There is an extended list of locations and contact information online.
  • All Los Angeles Public Library branches. The branches will be offering free masks while supplies last. Check online for branch address and hours; it’s encouraged you call ahead to check on supply inventory.
  • Los Angeles city recreation and senior centers, aquatic facilities, golf courses, museums, and the Cabrillo Marine Aquarium will all be providing free masks. A complete list of locations and contact information is online.

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Moderate Drinking Raises Cancer Risks While Offering Few Benefits

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Moderate Drinking Raises Cancer Risks While Offering Few Benefits

Among both men and women, drinking just one alcoholic beverage a day increases the risk of liver cirrhosis, esophageal cancer, oral cancer and various types of injuries, according to a federal analysis of alcohol’s health effects issued on Tuesday.

Women face a higher risk of developing liver cancer at this level of drinking, but a lower risk of diabetes. And while one alcoholic drink daily also reduces the likelihood of strokes caused by blood clots among both men and women, the report found, even occasional heavy drinking negates the benefits.

The report, prepared by an outside scientific review panel under the auspices of the Department of Health and Human Services, is one of two competing assessments that will be used to shape the influential U.S. Dietary Guidelines, which are to be updated this year.

The government has for several decades recommended a limit of two standard alcoholic drinks per day for men and one for women.

In December, a review of the data by the National Academies of Sciences, Engineering and Medicine supported this advice, finding that moderate drinking was linked to fewer heart attack and stroke deaths, and fewer deaths overall, compared with no drinking.

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But some experts fear that the harms of moderate drinking have been understated, particularly the risk of cancer, which is the leading cause of death among people under 85, according to the American Cancer Society.

In 2020, the last time the dietary guidelines came up for review, scientific advisers suggested lowering the recommendation to one drink daily for both men and women. That advice did not appear in the final guidelines.

The analysis from the National Academies tied moderate drinking in women to a small but significant increase in breast cancer, but said there was insufficient evidence to tie alcohol to other cancers.

This month, however, the U.S. Surgeon General, citing mounting scientific evidence, called for labeling alcohol with cancer warnings similar to those that appear on cigarettes. The report issued on Tuesday found that the increased cancer risk comes with any amount of alcohol consumption and rises with higher levels of drinking.

Drinking is linked to a higher risk of death for seven types of cancer, including breast cancer, colorectal cancer, liver cancer as well as cancers of the oral cavity, pharynx and larynx and esophagus.

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Men and women are both vulnerable to these health harms, but women are much more likely to develop a cancer linked to drinking, the report said.

“Among the U.S. population, the risk of dying from alcohol use begins at low levels of average use,” the report said. “Higher levels of alcohol consumption are linked with progressively higher mortality risk.”

Those who consume more than seven drinks per week have a one in 1,000 risk of dying from a condition related to alcohol. The risk increases to one in 100 if consumption is more than nine drinks a week.

This article will be updated.

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What to do if you have to evacuate without your medications

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What to do if you have to evacuate without your medications

The Los Angeles fires have forced thousands to evacuate indefinitely from their homes, often without necessary medications or medical devices. Here’s what to do if you find yourself without access to the things you need to stay on top of chronic conditions.

Go directly to the pharmacy

If the fire has closed your doctor’s office, or if wait times will keep you from getting your medicine when you need it, you can go directly to a pharmacy to replace needed medications, said Dr. Richard Dang, assistant professor of clinical pharmacy at the USC Mann School of Pharmacy and Pharmaceutical Sciences.

“We definitely don’t want patients to wait days without medication, and physicians are probably slammed as well with the requests that are coming in on top of their regular patient load,” he said.

If you typically get prescriptions from a chain pharmacy like CVS or Walgreens and your usual branch is closed or otherwise inaccessible due to the fires, you can request a refill from any other pharmacy in that chain.

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If you’ve evacuated to an area without a branch of your usual pharmacy nearby, you can go to any nearby pharmacy and request to have your prescriptions transferred to that location. If, for example, you typically get prescriptions from Rite Aid but have evacuated to an area with only a Walgreens nearby, you can go to Walgreens and ask to have your prescription transferred there.

If neither your pharmacy nor your physician is reachable because of the disaster, California law allows pharmacists to dispense a “reasonable amount” of medication without a prescription at their discretion to see patients through until they can get a regular supply.

Don’t worry about what’s in-network for now

The California Department of Managed Health Care on Jan. 9 ordered all insurance providers licensed to operate in the state to suspend prescription refill limits for members affected by the fires who need to replace necessary medications.

The order also allows consumers to fill existing prescriptions or obtain new ones at out-of-network pharmacies without any additional costs beyond what they would have paid at in-network outlets.

“There are so many barriers to getting meds. Patients don’t need any more right now, given the situation,” said Dr. Rita Shane, vice president and chief pharmacy officer at Cedars-Sinai Medical Center.

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If you are having trouble contacting or getting the services you need from your health insurer, you can contact the DMHC Help Center at www.DMHC.ca.gov or 888-466-2219 (TDD: 1-877-688-9891) for free assistance.

Call your insurance provider to replace devices and equipment

The state order also mandates that insurance companies replace medical equipment or supplies for people who have lost or can’t access theirs because of the fires.

Call your healthcare plan provider to figure out the best way to replace any necessary equipment. Every healthcare plan is required to have a toll-free number prominently displayed on its website to assist fire disaster victims.

Organizations can help

If you’re not sure where to start or don’t typically have health insurance, you can dial 211 or visit 211LA.org for community organizations that can help with emergency medication access and other services in a disaster.

Don’t wait

The fires have upended thousands of lives in Los Angeles County. While there are a dizzying number of things to take care of in the wake of an evacuation, your health should be a priority, Shane said.

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“The most important thing is to tell people to get their refills sooner rather than later,” she said.

Insurers, pharmacies and doctors offices will likely be dealing with high caseloads and may have longer wait times than usual. Sorting out prescriptions and device replacement without the documents you’d typically have on hand may take longer.

“The last thing we want is for people to end up in the emergency departments,” Shane said. “They could be in a situation of having to wait for a long time, and we wouldn’t want people to miss doses of medications that are really important for their well-being.”

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