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ello, everyone, and welcome to the middle of the week. Yet another steamy day is on the way, and we are trying to stay cool with cups of iced stimulation. We hope you are doing the same. We should note that we will be taking an extended break starting later today and will return next week. So we hope you survive the next few days. Meanwhile, here are some tidbits. Hope all goes well …

A new type of injectable cholesterol drug may save the health system from paying for heart attacks and strokes, but the high list price would still mean an increase total health care spending by 4 percent, according to a study in the Journal of the American Medical Association. In order to be cost-effective, the PCSK9 inhibitors should cost just over $4,500 per year. The roughly $14,000 list price, however, does not include manufacturer rebates. The companies selling these drugs disputed the findings.

The Alli weight-loss pill has been supported by problematic clinical studies that “systematically understated” its potential harms, according to STAT, citing a study in PLOS Medicine. The study compared published journal articles with data summaries submitted to European regulators and found the publications disclosed just 14 percent to 33 percent of adverse events compared with the data summaries.

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ViiV Healthcare started Phase 3 trials of a two-drug regimen for HIV that might simplify treatment for patients who receive therapy for the first time, PMLive tells us.

Drug makers that change hard gelatin capsule suppliers do not need to seek approval beforehand under a policy introduced by the Food and Drug Administration, InPharma Technologist says.

Zhejiang Medicine, which makes antibiotics sold in the US, hid quality testing results that may have indicated the products were contaminated, according to a warning letter issued by the FDA.

Carl Icahn bought 3.4 million shares in Allergan valued at $785.7 million, Reuters reports. Icahn began acquiring shares in the drug maker last spring after its $160 billion buyout deal with Pfizer fell through.

A new study falls far short of showing that mothers taking acetaminophen during pregnancy increases their child’s risk of behavioral problems, writes STAT.

Roche signed a licensing deal worth up to $270 million with Eleven Biotherapeutics to develop a monoclonal antibody for ocular conditions such as diabetic macular edema, PharmaTimes reports.

An issue at a GlaxoSmithKline ingredients plant will limit supplies of the Avycaz antibiotic sold by Allergen for the next six months, according to InPharma Technologist.

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  • To The Editor:

    The August 17 article “Another analysis finds new cholesterol drugs are not cost-effective” highlights a cost-effectiveness model published in JAMA that threatens to make it even more difficult for patients with high cholesterol to access new medicines called PCSK9 inhibitors.

    Statins work extremely well for most patients with high cholesterol. Currently, PCSK9 inhibitors are intended for high-risk patients who have already had a cardiovascular event and those with genetic pre-dispositions to very high cholesterol who are already on an optimal statin dose and cannot reach their desired LDL goals.
    Cardiovascular disease (CVD) takes an American life every 40 seconds and costs the U.S. $600 billion. Driving down the cost of CVD complications is imperative and innovative therapeutics like PCSK9 inhibitors are our best hope. Unfortunately, nearly a year after the FDA approved these medicines, approximately two-thirds of patients prescribed a PCSK9 inhibitor continue to struggle to get these medicines from their insurer.

    The study asserts that these drugs would add $120 billion to U.S. health care spending, but arrived at this conclusion by exaggerating the number of patients who would actually use the drugs and underestimating their risk. In addition, the authors used the list prices for these medications – rather than the net price payers actually pay for them – to arrive at an inflated cost estimate.

    As new drug treatments are made available, a balanced discussion about value is critical to inform complex decisions – as long as they are based on realistic assumptions. Health experts must focus on collaborating to both assess and unlock the value of innovation, while ensuring patients get access to the medicines they need.

    Sincerely,
    Raymond C. Jordan
    Senior Vice President, Corporate Affairs
    Amgen

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