Posts Tagged ‘FDA’

Service of 5 Plus 2 Equals 10: A Hard Pill to Swallow

Thursday, March 7th, 2019

Photo: mathspig.wordpress.com

Of course the math in the headline is wrong. I’m writing about drug prices in this country and nothing about what they cost and why computes either.

Did you see the alarming New York Times editorial, “Getting Answers on Drug Prices,” published the day before last week’s hearing at which seven heads of pharmaceutical companies were to meet the Senate Finance Committee? They represented Pfizer, Sanofi, Janssen, Bristol-Myers Squibb, AstraZeneca, Merck and AbbVie.

Photo: Microsoft.com

Between DJT’s trip to Vietnam and the Michael Cohen hearing, the results of the big pharma exec hearings were largely buried, at least on the news shows I hear/see. What I found didn’t really answer one eye-opening fact—why drugs cost so much more here than elsewhere. According to the editorial, a month’s worth of Actimmune to treat malignant osteoporosis costs under $350 in Britain versus $26,000 here. The editorial contends that drug prices have skyrocketed to the point that many who take them for such ailments as high blood pressure, cancers, allergies and more ration them “at great peril.”

NBC News politial reporter Leigh Ann Caldwell reported that the top exexs “could not commit to lower the price of commonly used prescription drugs even as they admitted that they control those prices. And one executive acknowledged that the high cost of medicines hits poorest patients the hardest.” That executive was Kenneth Frazier, Merck Chairman and CEO. Note: According to Caldwell the pharma industry spent a record $28 million on lobbying last year.

Photo cnn.com

The execs blame Medicare regulations. “‘The system itself is complex and it is interdependent, and no one company could unilaterally lower list prices without running into financial and operating disadvantages,’ Frazier said.” He suggested that by sitting all parties around a table “‘I think we can come up with a system that works for all Americans.’

“They pointed to a statistic that consumers on Medicare pay 13 percent out-of-pocket for prescription medication, compared to just 3 percent for a hospital stay. Some senators connected the large salaries of executives or the profitability of the company to drug costs.” In 2016, Medicare Rx drug spending, according to the Kaiser Family Foundation, accounted for 30 percent of all.

In a Wall Street Journal analysis of the hearings, Peter Loftus summarized questions directed at AbbVie CEO Richard Gonzalez, responsible for “about the biggest-selling medicine in the world, Humira, a treatment for rheumatoid arthritis and gut disorders. Humira generated $19.9 billion in global sales for AbbVie in 2018, up 8% from the year before.” In 10 years list price for a box of two pre-filled syringes went from $1,524 to $5,174 today. The company has maintained exclusivity on the drug by taking patents out on the nine or 10 diseases the drug addresses.

People—and companies that pay for their health care—are desperate to find reasonable alternatives not always with acceptable success. Sheila Kaplan wrote about the F.D.A. accusation against Canadian drug distributor CanaRx. According to her New York Times article the F.D.A. claimed that the company was selling “unapproved and mislabeled medicines to unsuspecting Americans looking to save money on prescriptions, and warned it to stop.”

Photo: fda.gov

F.D.A. commissioner Dr. Scott Gottlieb “was especially concerned about CanaRx’s sale of drugs with special safety requirements because they were high-risk and needed to be carefully managed to protect vulnerable patients.” Tracleer, for pulmonary arterial hypertension and CellCept, for transplant patients, were two on the agency’s warning list.

Through its attorney Joseph Morris, CanaRx denies the charge. He told Kaplan “Every prescription that is dispensed through a CanaRx program is dispensed directly to the patient from a licensed, regulated, brick-and-mortar pharmacy in Canada, Britain or Australia, and the patient can be sure that medicine she receives is the medicine that her doctor ordered.” Morris explained that CanaRx “serves as a broker between the companies’ employees and pharmacies and physicians in Canada, Australia or Britain.” The employees are encouraged to buy their meds to save their employer money by sending their Rx to CanaRx “which finds a foreign doctor to reissue it, and have it filed locally.”

The Times editorial began by comparing the promise of these hearings with one in 1994 in which the heads of seven of the country’s biggest tobacco companies admitted the truth about cigarettes. “The hearing ushered in a public health victory for the ages.” I fear nothing like this will result from last week’s hearings with big pharma.

I’d accept a difference of a few hundred dollars between medicine sold in the UK and here to make up for our complex Medicare and Medicaid pricing regulations and rules, but isn’t a difference of $25,650, in the instance of Actimmune, a bit of a stretch? With technology on the side of efficiency and cost-savings, why does a vial of insulin cost $1,500 today vs. $200 a decade ago? Could the paucity of TV news coverage about these hearings be related to the enormity of pharma ads on these shows? Will anything rattle the industry sufficiently so it becomes more responsible and less greedy?

Service of Dodgy Supplement Manufacturers: Know What You’re Swallowing

Thursday, November 1st, 2018

Photo: self.com

I don’t always read labels and instructions on over the counter remedies. After dousing my poison ivy-inflamed arms and face with the tonic recommended by a pharmacist my husband asked, “Did you read the instructions?” I hadn’t and I was using it incorrectly. I just popped in my mouth an Airborne lozenge that belongs in a cup of water. With my label reading record, lucky I don’t take fancy supplements—just vitamins and calcium.

A surgeon, Sreek Cherukuri, in Sumathi Reddy’s Wall Street Journal article said “Avoid supplements marketed for sexual health, weight loss and muscle building, which are most frequently tainted with illegal ingredients.” He added “The majority of products are unproven. Even if they aren’t dangerous, they could be a waste of money.”

Photo: today.com

Reddy reported findings from JAMA Internal Medicine in “The Illegal Ingredients in Your Dietary Supplements.” Even after the FDA warned about experimental stimulants that increase blood pressure and heart rate that are not approved for use by humans in dietary stimulants, they remain in some. DMAA, oxilofrine, BMPEA and DMBA can cause heart attacks and strokes. “By 2017, researchers found DMAA in two supplements, oxilofrine in nine, BMPEA in one and DMBA, previously found in none, in four.”

Reddy wrote that no manufacturers were identified. “The researchers looked at nine weight-loss supplements, two sports supplements and one cognitive-function one and tested them for the stimulants in 2014 and 2017.”

Photo: nowloss.com

An earlier California Department of Public Health study also published by JAMA analyzed FDA warnings between 2007 and 2016 mostly in sexual enhancement, weight loss and muscle building supplements, wrote Reddy. It “found that prescription-drug ingredients were in 776 dietary supplements, many even after the FDA issued public warnings about the products. There were 157 products containing more than one unapproved ingredient.” Reddy reported that “The analysis found that the FDA recalled the products less than half the time.”

FDA Spokesperson Jeremy Kahn wrote this in an email to Reddy: “The FDA is committed to doing everything within its resources and authorities to identify and remove unsafe products from the market, and we continue to work collaboratively with all of our stakeholders to help ensure that products marketed as dietary supplements are safe, well-manufactured and accurately labeled.” According to Kahn, “Even when the FDA issues a recall or takes enforcement action against a distributor, other distributors often continue to sell the recalled product, or distributors relabel products to evade detection.”

Pieter Cohen, an associate professor at Harvard Medical School and general internist at Cambridge Health Alliance told Reddy: “Whatever the FDA is doing to try to eliminate these experimental stimulants from supplements is not working and consumers are going to continue to be exposed to this if the FDA doesn’t step up and become much more aggressive in its enforcement.”

Do you take supplements? Do you know what is in them? Were you aware that they are not vigorously regulated? Do you tell all your doctors about what you take as some might impact surgery and/or interact with prescribed drugs?

Photo: marketwatch.com

Service of Genetic Tests: Do You Want to Know or Not?

Monday, April 17th, 2017

Photo Brockpress.com

Photo Brockpress.com

Most of my friends and colleagues present themselves for medical tests and checkups when they should while I drag my feet attending to only the most essential. My philosophy: Who wants to know?

So it would be very unlikely for me to send away to 23andMe at any time in my life to learn whether one or more of the 10 diseases the company tests for, such as late-onset Alzheimer’s or Parkinson’s, will afflict me.

There are many chomping at the bit to find out and now the FDA says that they can: No more need to pass by a genetic counselor or through a doctor for the privilege. Spit into a receptacle to provide a sample of saliva; send $199 and voila—you’ll soon know about how or if you relate to any of the 10.

Jessica Boddy, NPR summarized info on an FDA press release: “The testsBlood pressure test assess genetic risk for the conditions but don’t diagnose them, the FDA says. The agency urges consumers to use their results to ‘help to make decisions about lifestyle choices or to inform discussions with a health care professional.’”

The FDA’s Center for Devices and Radiological Health director Jeffrey Shuren said “‘it is important that people understand that genetic risk is just one piece of the bigger puzzle, it does not mean they will or won’t ultimately develop a disease.’ Other known factors that can play into the development of disease include diet, environment and tobacco use.” 

Photo: thefactfile.org

Photo: thefactfile.org

We already know about the importance of a healthy diet and the risks of tobacco use as they relate to all sorts of diseases–so nothing new here–and I can’t do much about my environment. Loosening regulations on power plants and reducing fuel efficiency standards for cars is going to impact everyone in a bad way. I wonder if people in 45’s administration realize that they, their children and grandchildren might suffer as a result?

Referring to test results Boddy quoted a Harvard Medical School professor who warned that the “information is complicated.”

Nobody in the article spoke up for those who don’t want to know. Do you want to learn what your genetic makeup indicates might happen? Would you be irritated if at 68 you sold your house and all your belongings to move into an adult care facility and found yourself at 95 in great form still with no signs of late-onset Alzheimer’s? Would knowing spoil what’s left of your life be it 20 or 70 years? Would you cancel your marriage plans if you wanted to have children and you learned that both you and your intended had similar genetic indicators for a nasty disease?

 

Photo: reference.com

Photo: reference.com

 

Service of a Glacial Pace When it Comes to Food Safety: Key Word–Preventable

Thursday, September 24th, 2015

Sloth

Even advocates of the Slow Movement might agree that it’s taken far too long for the Food and Drug Administration to create and implement rules for the five year old Food Safety Modernization Act. Congress passed the act, wrote Jesse Newman, “after a wave of deadly outbreaks in the past decade stemming from contaminated fruit, spinach, peanut butter and other products.”

So hurry up, already, before someone else gets sick and/or dies!

With the new rules, the feds can take action before—not after—foods are found to be tainted. Newman added that manufacturers will have to “detail in writing” their food-safety steps. But don’t breathe sighs of relief just yet. According to Newman, food companies large and small have until 2018 to comply, though the larger ones must move more quickly.

And then there’s insufficient funding. More about that later.

Food safetyIn “FDA Tightens Its Food-Safety Rules,” Newman wrote: “About 48 million people, or one in six Americans, get sick each year from foodborne diseases, according to the Centers for Disease Control and Prevention. About 128,000 people are hospitalized, and 3,000 die annually.”

Those made ill from tainted peanut butter who are still alive might find solace in this week’s Associated Press [AP] headline “Ex-Peanut Exec gets 28 Years in Prison for Deadly Salmonella Outbreak.” The executive, Stewart Parnell, was the owner of Peanut Corporation of America. According to the AP, this was “the stiffest punishment ever handed out to a producer in a foodborne illness case. The outbreak in 2008 and 2009 killed nine Americans and sickened hundreds more, and triggered one of the largest food recalls in U.S. history.”

PeanutsParnell knew that he’d shipped contaminated peanut butter, the federal jury determined. The AP reported that Judge W. Louis Sands said, “‘These acts were driven simply by the desire to profit and to protect profits notwithstanding the known risks.”

The killer is that these incidents needn’t happen. “Largely preventable” were the words the FDA deputy commissioner for food and veterinary medicine used in Newman’s article. The reporter mentioned the latest listeria outbreak in ice cream that killed three people and the fact that “Blue Bell neglected practices that might have prevented listeria contamination.” And then there were the Mexican cucumbers that contained salmonella and lately made people sick in 30 states.

PreventableBut there’s another snag: Insufficient funding. The FDA says it needs $260 million to implement the rules but House and Senate appropriations bills for 2016 are under $100 million. Maybe they can take some money from health insurers who have to pay the hospital and medical bills of people who didn’t have to get sick in the first place.

Given that members of Congress and the FDA and their families eat food, and we clearly can’t depend on manufacturers to take the right steps on their own, I’m puzzled at the sluggish pace they’ve agreed to to avert preventable, potentially life-threatening measures. And you? Is there a better way? Have you ever been made sick by tainted food? Isn’t it incredible that due to lack of responsibility of so many we even need such regulations?

vintage family eating dinner

Get This Blog Emailed to You:
Enter your Email


Preview | Powered by FeedBlitz

Clicky Web Analytics