Tag: "drugs"

Scary Facts about Antibiotics

What is indisputable is that the status quo is untenable. An estimated 48,000 people die in Europe and the U.S. each year from infections caused by antibiotic-resistant bacteria, and this number is very likely to increase in years to come. “This is a global issue and a moral issue that needs to be dealt with in collaboration,” says Otto Cars, of the Swedish Institute for Communicable Disease Control in Solna.

From Nature Medicine via Kevin Outterson.

Headlines I Wish I Hadn’t Seen

Canvbnadian study: Almost one-third of patients never fill the prescriptions for the medicines they are told to take.

Jails house 10 times more mentally ill than state hospitals.

Doctor billed Medicare for $21 million in 2012; investigated by the FBI; makes large donations to Democrats.

Washington Post fact checks TV ad Barrack Obama ran against John McCain and finds that all the scary predictions actually came true — it’s called ObamaCare.

Most of the 4,000 doctors who received at least $1 million from Medicare in 2012 billed mainly for giving patients injections, infusions and other drug treatments.

Can States Overturn the FDA’s Limits on Compassionate Use?

At National Review Online, Jillian Kay Melchior, reports on a cancer patient who has run out of therapies. There are medicines under development that might help, but drug-makers won’t let her have them under the FDA’s “compassionate use” doctrine.

ClVariety of Medicine in Pill Bottlesinical trials accept only “typical” patients — Mikaela’s rare form of kidney cancer has ruled her out, but for others in her situation, complications as common as diabetes or high blood pressure could also be reason for ineligibility. And the Food and Drug Administration’s approval process for “compassionate use” of an experimental drug outside of clinical trials is extremely arduous.

First, a pharmaceutical company has to be willing to provide the experimental drug — a high-risk proposition, given that an atypical result in an atypical patient can prompt the FDA to delay approval or require significant and expensive additional testing…And approval from a pharmaceutical company is just the first step. Next, patients and doctors must fill out an exhaustive paperwork disclosure to submit to the FDA, which is estimated to take at least 100 hours to complete. The FDA then begins a review, which is supposed to take no longer than a month — but if the agency’s reviewers have any additional questions or need more information, that 30-day clock is reset. Finally, the hospital’s institutional review board has to give approval — and if a patient is being treated at a small hospital that lacks such an administrative panel, the case has to be reviewed by a bigger facility, often one unfamiliar with the patient.

Headlines I Wish I Hadn’t Seen

Blue Cross: 15% to 20% of enrollees aren’t paying premiums.

EPA tested deadly pollutants on humans.

Long-term antibiotics apparently work for lyme disease patients; but many doctors are afraid to prescribe them.

Hits and Misses

Pediatrician Examining ToddlerA medical student wants “to do the greatest good for the greatest number.” What kind of doctor should he/she become? Tyler Cowen answers. So does David Henderson.

The health co-ops are failing.

Can teledentistry actually work?

Eli Lilly’s answer to fake drugs: A $110 million bar code system with secret codes.

Are Foreign Drugs Safer Than You Think?

There are no reported examples of Americans dying by taking real, but F.D.A.-unapproved, medication bought online from a foreign pharmacy that requires valid prescriptions. This is after tens of millions of prescriptions have been filled online and internationally over the past 15 or so years, since online pharmacies were created. (NYT)

Henry Waxman Writes a Letter — Wipes Out $18 Billion of Biotech Market Value

The New York Times reports that Rep. Henry Waxman and three Democratic colleagues wrote a letter protesting the price of Gilead’s new hepatitis drug, Sovaldi. A twelve-week course of Sovaldi costs $84,000 — about $1,000 per pill.

iStock_000007047153XSmall“Our concern is that a treatment will not cure patients if they cannot afford it,” the congressmen said in their letter, which was sent on Thursday.

It was signed by Henry A. Waxman of California, the ranking Democrat on the committee, and Frank Pallone Jr. of New Jersey and Diana DeGette of Colorado.

Gilead’s stock fell 4.6 percent, to $72.07 on Friday. Nervous investors took down the shares of some other big biotechnology companies as well, worried that pressure on drug prices would increase. Biogen Idec and Alexion Pharmaceuticals both fell 8 percent, Vertex Pharmaceuticals 5 percent and Celgene nearly 4 percent.

So Why Don’t We Speed Up Approvals And Save More Lives?

This is from an NBER Working Paper by Frank Lichtenberg:

prescription-bottleWe investigate the effect of the vintage (year of FDA approval) of the prescription drugs used by an individual on his or her survival and medical expenditure. When we only control for age, sex, and interview year, we estimate that a one-year increase in drug vintage increases life expectancy by 0.52%. Controlling for other variables including activity limitations, race, education, family income as a percent of the poverty line, insurance coverage, Census region, BMI, smoking and over 100 medical conditions has virtually no effect on the estimate of the effect of drug vintage on life expectancy.

Are Antibiotics Making Us Fat?

…[D]ecades of agricultural research has shown that antibiotics seem to flip a switch in young animals’ bodies, helping them pack on pounds. Manufacturers brag about the miraculous effects of feeding antibiotics to chicks and nursing calves. Dusty agricultural journals attest to the ways in which the drugs can act like a kind of superfood to produce cheap meat.

Of course, while farm animals often eat a significant dose of antibiotics in food, the situation is different for human beings. By the time most meat reaches our table, it contains little or no antibiotics. So we receive our greatest exposure in the pills we take, rather than the food we eat. American kids are prescribed on average about one course of antibiotics every year, often for ear and chest infections. Could these intermittent high doses affect our metabolism?

In 2002 Americans were about an inch taller and 24 pounds heavier than they were in the 1960s, and more than a third are now classified as obese…

…New evidence shows that America’s obesity epidemic may be connected to our high consumption of these drugs… (NYT)

New FDA Rule on Generic Drugs Could Hike Costs $4 Billion per Year

seniors-and-prescriptionsA proposed FDA rule on labeling generic drugs could increase generic drug-makers’ exposure to product-liability lawsuits. This could add $4 billion a year to the cost of generic drugs, according to Scott Gottlieb, MD, and colleagues.

  • A new regulation proposed by the Food and Drug Administration will compel generic drug makers to update their drug labels to reflect purported “new” safety issues.
  • The regulation will result in increased drug prices and leave generic drug firms vulnerable to “failure to warn” tort suits, but produce no public health benefit.
  • It would be far more efficient and effective for the FDA to either review and update generic drug labels itself or adopt a more rational and logical oversight process, known as Prior Approval Supplements. Either approach would allow updating of drug labels without additional tort liability.