Tag: "drugs"

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.

Hits and Misses

Avalere: ObamaCare Exchanges will only have 4.5 million signed up by end of 2014 open enrollment.

Australia scraps drug price controls to speed up access to new medicines.

The number of privately insured Americans taking drugs for attention deficit hyperactivity disorder rose by 4.8 million (36 percent), 2008 to 2012.

Aaron Carroll: You can’t trust the five second rule.

Health Wonk Review is up.

Headlines I Wish I Hadn’t Seen

1077More than a third of the U.S. population eligible for the Medicaid expansion are convicted criminals.

Kim Jong Un wins 100 percent of votes in North Korean election.

Wake me when it’s over: Prescriptions for sedatives up 12.5 percent annually for seven years.

“Scheduled ER visits” at New York’s Mount Sinai led to “obscene levels” of pay for cardiologists.

Why Do Terminally Ill Patients Have to Ask for Permission to Take a Live-Saving Drug?

Idiopathic pulmonary fibrosis is the scarring of lung tissue over time with no known cause, cure or approved therapy. Patients survive on average for only two to five years after diagnosis, and about 40,000 die of fibrosis-induced respiratory failure every year — roughly the same number as from breast cancer.

A drug called pirfenidone has been shown to delay the decline in lung function and even prolong life. But the FDA refused to approve pirfenidone when it was last reviewed in 2010 because the regulators claimed the evidence was insufficient, and now a new clinical trial shows how careless that decision really was. (WSJ)

Study: Drug Insurance Reduces the Cost of Other Therapies

Results indicate that obtaining prescription drug insurance through Medicare Part D was associated with an 8% decrease in the number of hospital admissions, a 7% decrease in Medicare expenditures, and a 12% decrease in total resource use. Gaining prescription drug insurance through Medicare Part D was not significantly associated with mortality. (NBER)

Headlines I Wish I Hadn’t Seen

Th2606-26345-1-SPere are more than 36,000 illegal (violating U.S. law) Internet pharmacies, mainly located abroad.

Obama: People can get subsidies outside the exchange. But is that legal?

HHS switch: Administration tells states to pay out ObamaCare subsidies now; verify later.

Members of Congress and their staffs have a way to opt out of ObamaCare: If they retire they can go back into the government subsidized, Federal Employee Health Benefits Program.

Life-Saving Drugs to Carry High Price Tag under ObamaCare Health Plans

Nov18DrugPricesResearchers with consulting firm Avalere Health found that 59 percent of silver-level plans on the new exchanges charge policyholders a percentage of the cost of specialty drugs rather than a fixed copay. Twenty-three percent of these plans have co-insurance rates of 30 percent or more of the cost of the drugs on the highest formulary tier, the analysis found. This rate increased to 60 percent among the lower-premium bronze plans, researchers said. The findings indicate that some patients will face higher or unexpected out-of-pocket costs on the exchanges when it comes to paying for specialty drugs. (The Hill)