Tag: drugs

When “Zero Tolerance” Is Deadly

In his testimony before Congress advocating for the legalization of medicinal marijuana, National Review senior editor Richard Brookhiser argued that “the law disgraces itself when it harasses the sick.” How much more so when a school’s absurd “zero tolerance” drugs policy prevents a child with asthma from reaching his life-saving inhaler in time:

Ryan Gibbons was only 12 years old when he died from a severe asthma attack during recess at school. He would have simply reached for the prescription inhaler that he always carried with him, but his school took it away and locked it in the principal’s office.

As Ryan gasped for air, his friends picked him up and carried him to the office where his inhaler was held. But they couldn’t get there in time. Ryan passed out before they reached his potentially life-saving medicine. He never recovered. The date was Oct. 9, 2012.

The tragedy took place at Elgin County School in Straffordville, Ontario, Canada. Now Ryan’s grieving mom, Sarah Gibbons, is leading a campaign to get schools to change their senseless policy of keeping essential inhalers away from asthmatic children — by law.

The bill that she wants lawmakers to pass is dubbed “Ryan’s Law,” in honor of her son’s memory. The proposed law would force schools to let kids who have a doctor’s okay carry inhalers in school, in a pocket or backpack.

It’s too often the case that would-be laws named after deceased children are hastily conceived with little thought given to unintended consequences, but here it is the policy that the law seeks to overturn that was implemented without enough forethought. Schools certainly have a legitimate interest in keeping even legal drugs like alcohol and tobacco off its premises and preventing potentially-harmful prescription drugs from falling into the wrong hands. But inhalers are different than antibiotics or other prescription drugs that are taken at regularly scheduled intervals. The risk that some non-asthmatic students might abuse the inhalers is dwarfed by the risk of blocking access to inhalers. According to the Asthma and Allergy Foundation of America, nearly 25 million Americans suffer from asthma, including over 9 percent of children, and there are about 3,300 deaths resulting from asthma each year, “many of which are avoidable with proper treatment and care.”

This isn’t the first time a school policy came between a student with asthma and his inhaler. Last year, a student with asthma experiencing breathing difficulties passed out when a school nurse and school dean refused to allow him to use his inhaler – which was “still in its original packaging, complete with his name and directions for its use” – because his mother hadn’t filled out the proper form. The school did not call 911 and insisted even after the fact that it had done the right thing by following its policy to the letter.

Overregulation: The View From a Helicopter Cockpit

Philip Greenspun discovers that an FAA inspector is happy to march a little helicopter charter outfit run by a single owner/pilot through the same paperwork slog that a much busier operation would face:

Finally, the FAA inspector looked at my random drug testing program to make sure that everything was in place. I’m subject to the same drug testing requirements as United Airlines. I am the drug testing coordinator for our company, so I am responsible for scheduling drug tests and surprising employees when it is their turn to be tested. As it happens, I’m also the only “safety-sensitive employee” subject to drug testing, so basically I’m responsible for periodically surprising myself with a random drug test. As a supervisor, I need to take training so that I can recognize when an employee is on drugs. But I’m also the only employee, so really this is training so that I can figure out if I myself am on drugs. As an employee, I need to take a second training course so that I learn about all of the ways that my employer might surprise me with a random drug test and find out about drug use. But I’m also the employer so really I’m learning about how I might trap myself. … Five minutes after the FAA inspector left, I received a phone call. “I’m from the FAA and we’d like to schedule an audit of your drug testing program.”

Things proceed to get crazier from there. And none of the craziness is likely to change so long as being worried about regulatory overkill is construed in Washington as being Against Air (or Food or Toy or Drug) Safety.

A Hospital Drug Shortage Made In Washington

As readers may know, I’ve been beating the drum for a while on the increasingly dangerous shortages that doctors are encountering in the availability of common, off-patent drugs used in hospital and clinical settings, including drugs that are important in chemotherapy, anesthesia, and infection control. Among the reasons for the shortages: the Food and Drug Administration has toughened its regulation of pharmaceutical makers in ways that lead to manufacturing line shutdowns and withdrawals from production.

John Goodman has a must-read blog post at Health Affairs Blog on the mounting crisis, amplified by a post by George Mason economist Alex Tabarrok at Marginal Revolution, getting into further specifics. In particular:

• 246 drugs are now considered to be in shortage, a record high, and the number has been rising for years. Rationing of scarce chemotherapy drugs is now making a difference in which patients have a chance at survival. In the absence of familiar compounds, doctors are falling back on inexact substitutes, sometimes more dangerous and less effective.

• After “tainted drugs” scares a few years ago, the FDA stepped up its Good Manufacturing Practice regulations, which control the production of pharmaceuticals. In particular, it now proclaims zero tolerance, barbed by tough fines, for many technical infractions whose actual impact on patient risk is at best doubtful, and it is unafraid of shutting down production lines again and again for retooling until its regulations are satisfied to the letter. It also changes its formulation and manufacturing requirements often, with scant forgiveness for makers who have trouble retooling to the new specifications quickly.

• Remarkably, the feds have inserted themselves into the role of central planners of drug output. Goodman:

For example, a drug manufacturer must get approval for how much of a drug it plans to produce, as well as the timeframe. If a shortage develops (because, say, the FDA shuts down a competitor’s plant), a drug manufacturer cannot increase its output of that drug without another round of approvals. Nor can it alter its timetable production (producing a shortage drug earlier than planned) without FDA approval.

That the results might include many unpleasant surprises will surprise only those unfamiliar with the record of a century of central planning failure.

• Pre-1938 drugs are suffering particular disruptions because of a separate FDA program, long demanded by consumer groups, to subject these “grandfathered” compounds to regulatory oversight just as tough as newer drugs. The dictates of the Drug Enforcement Administration also contribute to problems with some controlled substances.

• Several leading professional organizations, including the American Society of Anesthesiologists and the American Society of Clinical Oncology, collaborated on a meeting last November to raise the visibility of the issue and seek possible solutions. You can read its summary report here. Objectively, it’s a damning indictment, but be warned that — rather typically in a field where many key players live in fear of offending the FDA — the report refrains from outspoken criticism of the agency and in fact proposes widening the agency’s funding and powers.

Wouldn’t this make a good subject for hearings at the newly Waxman-liberated House Commerce Committee?

Drug Violence in Mexico

The apparent drug gang killings of U.S. consular employees this weekend in Juarez, Mexico are a bloody reminder that President Obama is getting the United States involved in yet another war it cannot win. Drug gang killings also occurred in Acapulco, with a total of 50 such fatalities nationwide over the weekend.

Unfortunately, Obama has responded to the latest incident by following the same failed strategy as his predecessors when confronted with drug war losses: a stronger fight against drugs.

Though the deaths are the first in which Mexican drug cartels appear to have so brazenly targeted and killed individuals linked to the U.S. government, illicit drug trade violence has killed some 18,000 people in Mexico since President Calderon came to power in December 2006—more than three times the number of American military personnel deaths in the Iraq and Afghanistan wars combined.

The carnage only shot up after Calderon declared an all-out war on drug trafficking upon taking office. After more than three years, the policy has failed to reduce drug trafficking or production, but it is weakening the institutions of Mexican democracy and civil society through corruption and bloodshed, which are the predictable products of prohibition.

The 29 people killed in drug-related violence this weekend in a 24 hour period in the state of Guerrero sets a dubious record for a Mexican state. And an increasing number of Mexicans, including former Mexican Foreign Minister Jorge Castañeda, are calling for a thorough rethinking of anti-drug policy in Mexico and the United States that includes legalization. Legalization would significantly reduce drug cartel revenue and put an end to an enormous black market and the social pathologies that it creates.

Thursday Links

  • How Obama’s plan for health care will affect medical innovation in America: “Imposing price controls on drugs and treatments–or indirectly forcing their prices down by means of a ‘public option’ or expanded public insurance programs–would reduce the incentive for innovators to develop new treatments.”
  • Register now for the upcoming Cato forum featuring author Tim Carney and his new book, Obamanomics: How Barack Obama Is Bankrupting You and Enriching His Wall Street Friends, Corporate Lobbyists, and Union Bosses. Buy the book, here.

ObamaCare Threatens Innovation

That’s the conclusion of economist Glen Whitman and physician Raymond Raad, who write in Forbes:

Unfortunately, the health care bills moving through Congress could curtail medical innovation. Imposing price controls on drugs and treatments–or indirectly forcing their prices down by means of a “public option” or expanded public insurance programs–would reduce the incentive for innovators to develop new treatments.

Proposed reforms could also retard business model innovation–an area where innovation is weak. Congress has already used its control of Medicare to limit the growth of specialty hospitals. A nationally mandated insurance package would severely curtail innovation in payment methods and insurance products, which have the potential to improve the coordination and delivery of health care services.

The health care debate should address more than just covering the uninsured and controlling costs. When the U.S. generates medical innovations, the whole world benefits. That is a virtue of the American system that is not reflected in comparative life expectancy and mortality statistics.

The op-ed is based on the authors’ Cato Institute policy analysis, “Bending the Productivity Curve: Why America Leads the World in Medical Innovation.”

ObamaCare’s ‘Sweetheart Deal’ for PhRMA

The New Republic’s Jonathan Cohn reports that back in March, IMS Health projected slightly negative revenue growth for the pharmaceutical industry but recently changed that projection to 3.5-percent annual growth from 2008 through 2013.

“What changed?” Cohn asks. “A major factor, according to IMS, was the emerging details of health care reform … Put it all together, and you have more demand for name-brand drugs … enough to boost revenue significantly.” And:

“If this bill is implemented,” the report concludes on page 138, “an increase in prices on new drugs can be expected.”

How could this be happening?  Oh yeah:

That brings us back to the deal that the Pharmaceutical Researchers and Manufacturers of America, which represents those companies, made with the White House and Senate Finance Committee …

The industry agreed to embrace health care reform and, later on, launched a massive advertising campaign to promote the cause. In exchange, the White House and Senate Finance–which had been asking various industries to pledge concessions that would help pay for the cost of coverage expansions–promised not to seek more than $80 in reduced payments to drug makers.

To an industry as big and profitable as the drug makers, giving up $80 billion over ten years wouldn’t seem like much of a sacrifice–a point critics started making right away. But if IMS is right, the drug industry wouldn’t even be giving up $80 billion, in any meaningful sense of the term. If anything, it’d be making more money. Maybe quite a lot of it.

Which is what I predicted, both here and here.

Cohn concludes, “the drug industry has enormous leverage in Congress.” But Cohn still supports the president’s health care takeover. Or is it PhRMA’s health care takeover?

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