“Right to Try” Bill Sits on Gov. Brown’s Desk

Pills health careDavid Huntley was the picture of health. A San Diego State University professor and a triathlete, he never expected to face a disease that would stop him in his tracks in his 60s. But that’s what ALS does. It comes on fast and there’s no way to stop it.

We met David and his wife Linda earlier this year when they came to Sacramento to support a bill we had sponsored, AB159 the California Right To Try Act.

Right To Try allows doctors to prescribe to terminally ill patients medicines being used safely in clinical trials. The goal of this legislation is to get promising new medications into the hands of people who have exhausted all their options and need one more chance to try to save or extend their life.

David was already wheel-chair bound and had to use a machine to talk, but his testimony was extremely powerful and helped lead to the passage of this bill in both the State Assembly and State Senate with overwhelming bipartisan support.

Sadly, David passed away just a few short weeks later. David’s tragic story has been repeated too many times in the United States. Medical researchers who develop promising new treatments typically spend a decade and $1 billion to maneuver through the FDA’s approval process. While a promising medicine is under review, only a tiny fraction of all patients who could benefit ever gain access through a clinical trial.

The FDA does have a process that allows patients to seek permission to access investigational medicines. But this “Compassionate Use” process requires a massive amount of paperwork and hundreds of hours to navigate. There are dozens of documented cases of people dying while waiting for approval.

But Americans shouldn’t have to ask the government for permission to try to save their own lives. They should be able to work with their doctors directly to decide what potential treatments they are willing to try.

Right To Try is an effort to help sick and dying Californians get access to the medications that could save them more quickly. Under the law, terminally ill patients would be able to work with their doctors and companies with promising new drugs that have already passed FDA safety tests to take those drugs without having to enroll in a clinical trial.

California wouldn’t be acting alone. Twenty-four other states have adopted Right To Try laws. In every state where the law has been considered it has been approved by wide margins by both Republicans and Democrats. This is a rare non-partisan issue in today’s fractured political climate.

But what could be partisan about giving a dying person the right to try to save his own life?

Right To Try is also having an impact on Washington. Earlier this year, in response to this national movement, the FDA announced plans to revise the paperwork that doctors must submit to request permission to treat a terminally ill patient with an investigational medicine. The FDA said its goal is reduce a doctor’s time to apply from 100 hours to 45 minutes.

That’s a great move in the right direction, but it’s not enough. Even though the forms in the first step of the process will be shorter, patients will still be required to submit an application asking the federal government for permission to try to save their own lives.

We need to remove barriers that prevent doctors from providing the care they are trained to give. And that’s exactly what Right To Try will do. People should have access to the medications that could save them with no exceptions and no permission slip required.

AB159 is on Gov. Brown’s desk, waiting for his signature. David Huntley didn’t live to see him sign it. But let’s hope every other terminally ill Californian has the chance to benefit from the new options this law will provide. If this law has the potential to save even one person’s life, we should let them try.

Originally published by Fox and Hounds Daily

Senator Jeff Stone represents the 28th Senate District. Assemblyman Ian Calderon represents the 57th Assembly District.

James Lacy: Coated plastic balls spawning bacteria in L.A. reservoirs

James Lacy discusses with Fox’s Stuart Varney L.A.’s latest attempt to alleviate the drought by reducing evaporation in reservoirs. Their attempts, however, may be actually be increasing evaporation and spawning bacteria contamination.

Jim is the principal author and editor of the new book “Taxifornia 2016: 14 Essays on the Future of California” which is available at the CreateSpace eStore now here: https://www.createspace.com/5497002, and at Amazon and other outlets after Labor Day.

FDA Regulations Could Wipe Out 99 Percent Of E-Cigarette Industry

e-cigaretteThe e-cigarette industry could be all but wiped out thanks to regulations coming down the pipeline from the Food and Drug Administration.

Most damaging of all, e-cigarette makers will have to retroactively submit marketing applications for all their products, with the costs running into the millions.

Manufacturers of e-cigarettes could also be banned from advertising the reduced risk from substituting smoking for vaping unless they can convince the FDA otherwise.

In 2009, e-cigarettes came under the purview of the FDA and may face many of the restrictions placed on the tobacco industry, such as issuing health warnings and stopping sales to minors.

The e-cig industry is still relatively young, with the first e-cigarette invented in China in 2007. Despite there being close to 20 million Americans regularly using e-cigarettes, the FDA’s regulations could bankrupt the vast majority of producers.

Speaking to The Hill, Jan Verleur, co-founder and CEO of VMR Products, said as much as 99 percent of the industry could be wiped out. “This makes it so any product released after the grandfather date would require premarket approval,” said Verleur.

He added that ”the process could cost us half a million to million dollars,” per individual product. With more than 500 e-cigarette products, VMR Products would have to pay five times the company’s revenue.

His comments echo those of the president of the American Vaping Association Greg Conley who told the L.A. Times Monday that 99 percent of the small businesses in the industry could close their doors.

There is as of yet no fixed date for when the rules come into force. The FDA has said it will give companies two years to submit their applications and they will be able to sell the products under review during that time.

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Originally published by the Daily Caller News Foundation

Soda Wars: Business Groups Sue San Francisco To Defend First Amendment

Soda pourA trio of business groups is suing San Francisco to protect the First Amendment rights of companies that sell and market sugary drinks.

On 24 July, the California Retailers Association, the American Beverage Association and the California State Outdoor Advertising Association filed a lawsuit to prevent mandatory warning labels on soda ads. The San Francisco ordinance, which was passed in June by nine votes to zero would cover soda ads on billboards, buses, transit shelters, posters and stadiums.

The plaintiffs argue “the city is trying to ensure that there is no free marketplace of ideas, but instead only a government-imposed, one-sided public ‘dialogue’ on the topic — in violation of the First Amendment.” They hope the District Court will overturn the city government’s decision.

The label, which must cover 20 percent of the ad, reads “WARNING: Drinking beverages with added sugar(s) contributes to obesity, diabetes and tooth decay.” The labels mimic warning signs placed on cigarette packs.

Drink manufacturers will not only have to comply with producing warning labels but will be subject to a wave of new restrictions. Baylen Linnekin, chief executive of Keep Food Legal, writes, “the law would prohibit soda makers from identifying the products they sell while protesting against the law on public space. It bars ads advertising soda, Frappuccinos, or some Jamba juices on public property.”

Linnekin identifies two violations of the First Amendment in the city ordinance. One being the government preventing speech with which it disagrees and two, compelling the speaker to switch their language to that preferred by the government.

Government efforts to label certain products with health warnings have taken a knock in recent years. The California plaintiffs may draw hope from the 2012 case where tobacco companies won a major victory after a federal appeals court struck down requirements for cigarette packs to display graphic health warnings.

Judge Janice Rogers Brown of the District of Columbia Circuit, who voted with the majority in the case, wrote ”this case raises novel questions about the scope of the government’s authority to force the manufacturer of a product to go beyond making purely factual and accurate commercial disclosures and undermine its own economic interest — in this case, by making ‘every single pack of cigarettes in the country a mini billboard’ for the government’s antismoking message.”

The Food and Drug Administration which was pursuing the policy has not attempted to reintroduce the graphic labels.

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Originally published by the Daily Caller News Foundation

California Senate votes to raise smoking age to 21

As reported by the Los Angeles Times:

The state Senate on Tuesday approved a bill that would raise the minimum legal age for buying cigarettes and other tobacco products from 18 to 21 as part of an effort to reduce smoking by young people.

Sen. Ed Hernandez (D-West Covina) said he introduced the bill, SB 151, out of concern that an estimated 90% of tobacco users start before age 21. Raising the minimum age will mean that fewer teenagers pick up the habit, said Hernandez, an optometrist.

He cited a study done by the Institute of Medicine for the federal Food and Drug Administration that concluded that raising the smoking age to 21 would cut smoking by 12% more than existing control policies. …

Click here to read the full article

California Chemical Laws Fail Science Test

Every day, we make choices that carry a degree of risk. Car crashes are the leading cause of death for those under 44, but that doesn’t stop us from getting behind the wheel. While we can’t completely reduce our risk of a crash, we can lower it by avoiding risky behaviors like speeding recklessly or texting.

Yet despite the potential deadliness of an automobile crash, car makers aren’t required to put a safety label on vehicles. And even if they did, it’s unlikely that we’d see a dramatic decline in the number of car crashes. It’s curious then that California law requires warning labels on products that pose dramatically less risk.

When California citizens went to the polls in 1986, it probably seemed like a no-brainer to vote for a law that required manufacturers and businesses to warn consumers when they might be exposed to chemicals that could cause cancer or developmental defects. The law, known as Proposition 65, sounds like an excellent public health initiative in theory. In execution, however, the law has created warning label overload.

There are myriad problems with the law. But in a new paper on Proposition 65, I’ve identified two fatal flaws with Proposition 65’s procedures: the threshold for determining whether a chemical poses a health risk is incredibly low, with no way of explaining to consumers the degree of risk exposure to the chemical poses, and the process for determining which chemicals require warning labels is alarmingly unstandardized.

For starters, a chemical earns a place on the state’s list of dangerous chemicals if California regulators find that exposure causes one excess case of cancer in 100,000 individuals over a 70 year period.

To put that in perspective, roughly one in 100,000 people will die from running or playing soccer. At the same time, research has shown that exercise can lower the risk of heart disease, cancer, diabetes, and a number of deadly health ailments.

This is precisely why Proposition 65 warning labels are ridiculous — there’s no context for what level of exposure poses an actual risk and when a chemical might actually have health benefits.

Take seafood for example. Researchers have suggested that consuming fish and shellfish has numerous health benefits. They contain a number of essential nutrients, including omega-3 fatty acids, but almost all fish contains at least a small amount of mercury. In fact, recent research suggests that consumption of fish by pregnant mothers might actually boost brain development and has no impact on prenatal development.

Mercury is listed as a carcinogen under Proposition 65. Therefore fish in California comes with a warning label.

Scaring consumers away from fish flies directly in the face of U.S. Food and Drug Administration’s advice that “Fish and shellfish are an important part of a healthy diet.” According to the FDA, “for most people, the risk from mercury by eating fish and shellfish is not a health concern.” Yet California’s Proposition 65 warnings indicate otherwise to consumers — research suggests the prominent warning labels in restaurants and markets where fish is sold have resulted in a dramatic decline in fish consumption.

This begs the question: How are California’s regulators determining which chemicals are harmful? Unfortunately, as I’ve explained in my new paper, there appears to be no consistent or standardized testing protocols for what constitutes sufficient evidence to label a chemical as either carcinogenic or causing developmental harm. That’s why the state’s chemical decisions can contradict opinions rendered by the FDA, EPA, and other regulatory agencies across the globe. Chemicals are listed even if the scientific consensus isn’t on the state’s side.

To truly make Californians healthier, the state needs to develop a standardized process, ideally with input from outside experts, for determining which chemicals should be listed and explaining the actual risk to consumers. After all, it’s more likely that taking car rides will have you swimming with the fishes than eating fish will put you six feet under.

Dr. Joseph Perrone, Sc.D., is the Chief Science Officer at the Center for Accountability in Science, a project of the nonprofit Center for Organizational Research and Education. CORE is supported by a wide variety of businesses and foundations, including those in the hospitality, agriculture, and energy industries.

Pain-Pill Abuse Can Be Curbed Through Private-Sector Innovation

Picking the proper medication for our patients is a delicate nuance that is part of the art of medicine.  Cook book medicine does not often make a very good cake. Of late, government regulations have made it more difficult to find the right recipe for our patients particularly when they need pain relief.

Pain is a common problem.  Pain may be chronic or acute and may take on a life of its own particularly if it is not managed properly   I have seen patients with the kind of pain that makes living a normal life nearly, if not completely, impossible. Simple daily functions that most of us take for granted, such as walking or sleeping, can become insurmountable tasks.  Many of these patients unquestionably require the use of pain medication.  For them it is not a choice, it is a necessity.

Opioid pain relievers are almost never a first choice. The side effects are overwhelming particularly for the elderly. But, they can literally be lifesaving for these patients.  Unfortunately, the opioid abuse is a billion dollar industry and the government has decided to come in with an iron fist and impose regulations that neither curb the abuse or establish a means of reasonable accessibility for those who need the medication.

More than 60 people die every day in the United States from prescription drug overdoses.  6.5 million people abused prescription drugs in 2013, more than double that of heroin, cocaine and hallucinogens, combined.

According to a 2010-2011 government survey almost 1.5 million Californians, ages 12 and over, were estimated to have abused painkillers in the previous year. Seven percent of adolescents ages 12 to 17 in California used pain relievers for nonmedical reasons in the previous year, according to 2009-2010 figures.

Taxpayers are left on the hook for increased medical and policing costs, and abuse can also wreak economic devastation by reducing productivity.  Misuse and abuse of opioids is estimated to cost the U.S. $56 billion annually.

The opportunity to find a better means of administering opiods opened the door to the American entrepreneurial spirit and private industry has answers. By utilizing “abuse deterrent formulations” for opioid painkillers, we can significantly reduce the abuse of these drugs.

Breakthrough abuse deterrent formulations provide patients with the same pain relief as conventional opioid medications, but protect against abuse by making crushing, cutting and dissolving for injection extremely difficult and blocking the euphoric effect of the pills when manipulated.

While there are many contentious issues among those in the healthcare field, the facts in this situation are clear: pain management is a necessity for millions of people and non-medical use of these drugs is a medical, ethical and public safety problem that must be addressed.

The Food and Drug Administration considers the development of abuse deterrent formulations a high public health priority, and those of us in the medical community, along with policymakers in the Capitol, should as well.

Research on the relatively new abuse deterrent formulation of OxyContin, the first opioid approved by the FDA to make abuse deterrent claims, found that inhalation and injection abuse dropped from 70 percent to 40 percent, and poison control center calls declined by 32 percent.

It is estimated that utilizing abuse deterrent formulas can save hundreds of millions of dollars in medical and criminal justice costs.   These are dollars that would be far better spent elsewhere, as we struggle to rebound from the worst economic downturn most of us have ever seen.

Abuse deterrent formulations have received widespread support as part of a comprehensive effort to combat prescription drug abuse and promote appropriate pain management, including from the Office of National Drug Control Policy, the Community Anti-Drug Coalitions of America, members of Congress and the National Association of Attorneys General.

The California Medical Association approved a resolution in December 2014, supporting the FDA’s ongoing efforts to evaluate and label abuse deterrent technology and opposing the imposition of administrative deterrents that decrease access to and coverage of prescription drugs with abuse deterrent properties.

Our regulators need to open the doors for these new formulations rather than developing regulations that only hurt those patients who legitimately need these meds.  It is time that healthcare professionals, patient advocates, stakeholders and policymakers move forward to improve access to this new technology.  I welcome this rare opportunity where private industry can work productively with government to help America’s patient find a productive pain-free day.

Marcy Zwelling, MD, is Vice Chair, American College of Private Physicians