Archive for the ‘Medicine’ Category

Service of Need to Know: If You’re in the Covid Trial Placebo Group, Do You Get a Vaccine ASAP?

Monday, December 7th, 2020

Photo: newatlas.com

I admire anyone who volunteers to test a potentially lifesaving drug. I was curious as to why piling on $billions from the US Government and Bill Gates Foundation, among many, helped speed up discovery of a vaccine by over three years. I guess it’s because the human guinea pigs are paid and to have the numbers injected to ensure efficacy and safety at $250 or more a pop requires deep pockets on the spot.

Carl Zimmer and Noah Weiland pose a dilemma in their New York Times article, “Many Trial Volunteers Got Placebo Vaccines. Do They Now Deserve the Real Ones?”  Seems it’s not an easy “yes” or “no.”   The tens of thousands injected with the placebo who thought they’d get a real shot in the arm after the vaccine was approved may wait as long as two years they reported.

Photo: savethestudent.org

Some scientists think these volunteers “should be moved toward the front of the line in exchange for [her] service for the greater good.” Last week “18 leading vaccine experts — including a top regulator at the Food and Drug Administration — argued that vaccinating placebo groups early would be disastrous for the integrity of the trials. If all of the volunteers who received placebo shots were to suddenly get vaccinated, scientists would no longer be able to compare the health of those who were vaccinated with those who were not.”

As background they explain that “It’s vital that neither the volunteers nor the staff running the trial know who is randomly assigned to get the vaccine or the placebo. This ‘blinding,’ as it’s called, eliminates the chance that people will behave differently depending on which treatment they get, potentially skewing the trial’s results.”

Pfizer “said it would propose to the F.D.A. that volunteers who got the placebo could get the real vaccine.” Richard Peto, a medical statistician at the University of Oxford and his colleagues argue that “once a placebo group disappears from a clinical trial, the chance to collect rigorous data about a coronavirus vaccine will vanish.”

Researchers claim they need to keep secret the placebo group to learn about how long the vaccine protects the recipients, how many get sick in subsequent months as compared to the placebo group.

Dr. Anthony Fauci Photo: businessinsider.com

Zimmer and Weiland reported that “If the companies were to encourage unblinding their trials, that could also harm their chances of receiving the F.D.A.’s full stamp of approval — a license. And allowing a trial to continue may also be good for their bottom line, because knowing when immunity from a vaccine begins to wane will dictate how frequently people will need their product.”

Dr. Anthony Fauci had a great solution: everyone gets an injection in reverse: Those who received the vaccine get a placebo and vice versa. Secret is preserved.

Assuming that there are fixed costs to discovering a vaccine and putting it through its approval paces, why else, other than the cost of assembling and paying sufficient numbers of human volunteer guinea pigs, would money be the answer to the record breaking time it took for discovery? Why wasn’t money used before to attack such pestilence as polio, cholera and AIDS? Do you know anyone who has volunteered to take a drug during a trial period? Do you agree that Dr. Fauci’s compromise, while costly, would be the solution to protecting the volunteers who received the placebo? Are you planning to be vaccinated?

Photo: theconversation.com

 

Service of Reporting to the Public New–Dire–Drug Side Effects When There Are No Alternatives for Chronic Ailments

Thursday, August 29th, 2019

Pill organizer Photo: tripsavvy.com

I get that people want to make smart decisions about their health, especially these days when many doctors don’t have time to explain the pros and cons of the meds they prescribe. And in spite of thorough vetting by the FDA before a drug is approved there often are discoveries of adverse side effects over time when patients take new drugs.

But when there are no alternatives the information we read and hear via consumer media can serve to frighten more than enlighten, and to what purpose?

Here’s the headline that inspired this post: “New Study Adds to Concern About Certain Drugs and Dementia Risk.”

Lisa Field wrote: “As people get older, they’re more likely to need medications on a regular basis to manage one or more chronic conditions. Some of these medications fall into a class known as anticholinergics and may not be ideal to take for long periods because they could increase the risk of dementia.” In an article on nextavenue.org Field highlighted results of a study published in a recent issue of JAMA Internal Medicine.

Photo: attorneygroup.com

She continued: “If there are no effective non-anticholinergic medications or other non-drug interventions, then I think whether the benefits of taking the medication outweigh the potential risks depends very much on the individual circumstances and the severity of the condition for which treatment is needed,” said the professor of medical statistics in primary care at the University of Nottingham’s School of Medicine.” Carol Coupland authored the study.

Tell me the point of worrying patients with this information if their chronic condition forces them to take an essential medicine for the rest of their lives which, one hopes, is longer than the time a dreaded side effect like dementia might set in? Should consumer editors and bloggers, TV and radio news producers table articles and programs that spotlight dire drug side effects until alternatives exist for these patients?

Photo: medshadow.org

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 What You Don’t Know CAN Hurt You: Essential Facts Relating to Health, Yours and the Country’s

Monday, December 18th, 2017

Donna Hammaker, Esq & Dr. Thomas M. Knadig, EdD

Did you know that:

  • Congress defines what “equivalent” means when it comes to generic drugs and that the therapeutic effectiveness of a generic might actually be half as that of the brand according to this definition? More below.
  • About 1/10th of the U.S. population has no health insurance; most of them are earning middleclass incomes and the lack of coverage causes two deaths every hour?

I learned this at an eye-opening program of the Healthcare Public Relations and Marketing Society of Greater New York [HPRMS]. Nancie Steinberg, president, introduced the speakers Donna K. Hammaker, Esq. and Dr. Thomas M. Knadig, EdD, who addressed representatives of some of New York City’s most prestigious hospitals and health organizations and the marketers and PR professionals who counsel them.

While some of what I heard was shocking, the takeaway as a consumer was nothing new: When it comes to your health, be informed and ask questions.

About the reference to generic drugs above, Hammaker said you could not pay her to take generic drugs from India or Israel. She mentioned “brand generics” by Novartis and Pfizer that seemed to pass muster.

The speakers, on the faculty of Saint Joseph’s University, Philadelphia, and authors of three textbooks for students and health care managers, the most recent of which is Health Care Management and the Law, shared data-driven facts and statistics gathered in the last two years.

Laced in the discussion were factoids about the Affordable Care Act, such as that much of it was first addressed during the Nixon administration and that many people are unaware of what’s in it. Healthcare has been Hammaker’s professional focus as a lawyer and yet even she was surprised by bits that she learned by studying it. [One wonders how many lawmakers are still in the dark and yet they call for changes.]

Photo: racolblegal.com

A caveat: I’ve posted sound bytes throughout this post. On just one of these topics alone, Clinical Trials, Hammaker gives a three hour lecture in which she addresses the differences between brand and generic drugs. There is similar backup in her latest 830 page book and hours-long lectures relating to her other contentions and conclusions. For example in Health Care Management and the Law the authors reference court decisions relating to the use of reprocessed medical devices which, in the interest of brevity, I don’t go into here.

Following are just a few highlights based on a list the authors handed out and subsequent discussion.

 

  • “Reprocessed medical devices are a cause for concern, as the FDA standards are not always strictly adhered to, patients are not necessarily informed they are receiving a reprocessed device, and such devices are often obtained from unregulated sources, such as the Internet.” Hammaker recommended that before undergoing a procedure that a patient specify on the hospital consent form that he/she wants a new device as well as the name of the manufacturer of the device. She explained, for example, that some hip replacement devices are made of cheaper metals that tend to break. In addition, she reported, the FDA is lifting restrictions in this area.
  • Photo: WebMD.com

    “Over 60 percent of the yearly $1.9 trillion employers spend on health care costs go toward treating tobacco-related illnesses.” We learned that it is legal for an employer to refuse employment to a smoker. In addition, an employer can charge current employees who smoke more for insurance; force them to take smoking cessation classes as a term of employment and conduct random tests [of hair] to identify smokers.

  • “Estimates indicate 90 million people in the US live with a preventable chronic disease [such as diabetes and hypertension often caused by such factors as smoking and obesity], the ongoing care for which amounts to 75 percent of the annual $3.3 trillion health care budget.” As health insurers are no longer covering illnesses and disease that could have been prevented, Hammaker asked, “Is this a direction we want to take?”
  • “While the biggest burdens to the U.S. health care system are depression and gun violence, they receive scant attention in the health care reform debates; yet the cost of gun violence in the US is equal to the cost of smoking, obesity and other preventable health care illnesses combined. Estimates of civilian gun ownership have been as high as 330 million vs. the U.S. military and law enforcement that possess approximately 4 million guns. The nation’s risk pools absorb $1.4 billion yearly to cover anticipated costs of treating victims of fatal firearm assaults.”

There are a lot of hot topics here and no doubt people who disagree with some conclusions. [We know people who suffer from a disease–chronic Lyme–that many physicians and insurance companies don’t recognize.] Were you surprised by any of this information? Are you more assertive in dealing with your health issues and those of family members today than you were in the past? Are you concerned that information like this is not readily available making it hard to protect yourself appropriately?

Photo: techlicious.com

Service of Greed: Will it Get You One or Another Way?

Monday, July 3rd, 2017

Photo: linkedin.com

Martin Shkreli is on trial for federal securities fraud, but regardless of how the judge instructs the jury to forget his arrogance in another high profile example of greed, it may nevertheless impact his destiny. Well over 100 potential jurors were already excused because they had nasty things to say about the man.

Photo: drugs.com

I previously wrote about Shkreli in “Service of Side Effects of Drug Prices.” He earned the rights to a life-saving drug, Daraprim, that for decades saved lives of those with a potentially fatal parasitic infection, when he bought a drug company, Turing Pharmaceuticals AG. He raised the price of a pill to $750 from $13.50 because, as Wall Street Journal reporter Rebecca Davis O’Brien quoted him, “he had an obligation to ‘maximize our profit.’”

Let the jury decide his fate.

Speaking of drugs and greed, the EpiPen price-gouging saga comes close, but there’s hope. Read on.

Photo: capitalwired.com

Heather Bresch, CEO of Mylan, led the charge on the price of the emergency allergy medicine from $94 for a pair when her company purchased the product, to $700, for those without insurance, or $630 with. Further, the pens need to be replaced every year. Under pressure, the company subsequently introduced a generic version that cost $225-$425 wrote Linda A. Johnson, ABC News.

“Analysts and others have estimated that it costs less than $20 to produce a pair of EpiPens,” she reported.

This was background to the real focus of Johnson’s news: The FDA “approved Adamis Pharmaceuticals Corp.’s product, which should go on sale later this year. Symjepi is a syringe prefilled with the hormone epinephrine, which helps stop life-threatening allergic reactions from insect stings and bites, foods such as nuts and eggs, or certain medications.”

She continued: “Adamis spokesman Mark Flather said Symjepi is intended to be a “low-cost alternative” to EpiPen and similar products, and the company is aiming to sell it for less than generic EpiPens.” Claims about Symjepi range from being easier to use than EpiPen and because the syringe is smaller, it fits more easily in pockets and handbags.

Here’s hoping Symjepi [what a name] will represent healthy competition to EpiPen, serving to adjust the prices of all antidotes to severe allergies. “Adamis said it is still lining up a distributor so it hasn’t set the exact price for its product, which will be sold in pairs like EpiPen,” wrote Johnson.

I believe in profits but really.

  • How can a manufacturer of life-saving medicines gouge to such an extent and sleep at night?
  • How can investors stand silent?
  • Is this approach standard practice with pharmaceuticals?
  • Are there any benevolent CEOs?
  • Are these manufacturers encouraged by the climate in which 217 House members and at least 43 Senators don’t blink at tossing 22 million off health insurance while lowering taxes for the wealthy?
  • And last, public pressure has put an end to careers of corporate and religious sexual abusers and loudmouth public figures who use inappropriate language. Will it impact flagrant examples of corporate greed?

Photo: addictedtocostco.com

Service of Court Rulings that Thin Consumers’ Ability to Sue

Monday, June 26th, 2017

Photo: history.com

The California law suit against Bristol-Myers Squibb and the blood thinner Plavix involved almost 700 plaintiffs because the drug “allegedly created a substantial risk of heart attack, stroke and other injuries,” wrote Jess Bravin in The Wall Street Journal. But only 86 plaintiffs were from California and according to a new Supreme Court 8-1 ruling, only those cases can be heard in that state. Justice Sonia Sotomayor dissented.

Photo: drugsdb.com

“The ruling was one of a series this term limiting so-called forum shopping, where plaintiffs’ attorneys file suit in a state or federal court they believe will be sympathetic to their claims,” Bravin reported.

California’s Supreme Court argued that all should be considered because the claims were similar; Bristol-Myers Squibb sales reached $900+million in the state and the drug was sold around the country. Justice Sotomayor wrote: “There is nothing unfair about subjecting a massive corporation to suit in a state for a nationwide course of conduct that injures both forum residents and nonresidents alike.”

The winning argument went that “Companies have long complained that plaintiffs in certain cases seek out venues where they believe they are most likely to receive favorable rulings, even when the cases involved may have only a tenuous connection to the area.”

Supreme Court Justice Sonia Sotomayor. Photo: biography.com

According to Bravin, Justice Samuel Alito wrote: “The nonresidents were not prescribed Plavix in California, did not purchase Plavix in California, did not ingest Plavix in California, and were not injured by Plavix in California. The mere fact that other plaintiffs were prescribed, obtained, and ingested Plavix in California—and allegedly sustained the same injuries as did the nonresidents—does not allow the state to assert specific jurisdiction over the nonresidents’ claims.”

Bravin added: “Consumers groups, however, have warned that cutting back too sharply on plaintiffs’ ability to sue could give big companies more ways to avoid responsibility for harm they cause.”

Had you heard of forum-shopping before? Do you agree with the Supreme Court—that the court in a state can hear only about plaintiffs from that state? Or does that help corporations “avoid responsibility for harm they cause,” that consumer groups fear?

US Supreme Court building. Photo: en.wikipedia.org

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 Potential Typos: New York State’s Electronic Prescription Drug Law

Thursday, April 7th, 2016

Typo

The new law in New York State that makes it mandatory for physicians to order drugs electronically immediately made me think of a few things. 

  • I worked in an office where if one person chronically left open a window midwinter potentially causing frozen pipes and other calamities or did some other thing management frowned upon, everyone got a memo—not just the offender. The alleged major reason for ordering prescriptions online is to cut down on doctor shopping for pain killers like Vicodin or Percocet. So why make doctors go through the rigmarole for all doctor shoppingprescriptions?
  • An ace editor reporting on product introductions in a trade magazine mistyped one digit in a client’s toll free number, [prior to websites]. Readers calling the number got an earful of porn. We laughed, she was embarrassed, errors happen when you juggle work and are rushed. I predict that when a doctor types a bunch of digits while listening to a patient’s complaints and questions he/she either won’t hear important information or is set up to make mistakes in the order.

Say you’re the receptionist tasked with the pill ordering chore. As you take messages, make appointments, greet patients and mishear the name of the drug the boss yelled in from another room, do you think you’ll get right all the codes for meds and pharmacies? What the patient gets may be a surprise. 

I feel that the more personal information we are forced to put in easily hackable places the worse for all. In a recent comment about a previous post “hb” wrote: “Given that the internet is now totally insecure as to confidentiality… if you catch syphilis cavorting with a prostitute, not just your wife/husband and children/parents, but also all your friends and neighbors are going to know about it within weeks. Maybe the young just don’t care, but I do!” My thoughts precisely.

Drs John LaPook and Holly PhillipsI heard Jon LaPook, MD, chief medical correspondent for CBS News with Holly Phillips, MD, [Photos, Left], on the “Morning Rounds” segment of CBS This Morning Saturday on April 2. Dr. Phillips admitted it’s faster for her to call in a prescription and doesn’t think the electronic logon and pharmacy search is time-effective but she seemed resigned as all NY docs must be. If they don’t comply, they are subject to fines, loss of license—even jail time. 

Dr. LaPook said he loved the system. A patient contacted him while he was on a flight and he was able to submit a prescription from the plane. However, the only additional benefit he could point to, in addition to controlling access to painkillers, was that there will be no mistakes made by bad handwriting where the pharmacist “reads quinine when the doctor meant Quinidine.” He admitted that the checking part of the process—to confirm that the patient isn’t getting painkillers elsewhere–is clunky but predicted that the system will eventually be great.

A young friend, who can fix any computer and is more tech-savvy than most, told me that the only winners in this new arrangement are the people who sold the programs to physicians and pharmacies. Do you agree?

Tech savvy

Service of Side Effects of Drug Prices

Monday, October 19th, 2015

 

High prices 2

I read about the fallout of dodgy if legal pricing practices by big pharma from three viewpoints in recent weeks causing both curious and predictable side effects.

James Surowiecki wrote “Taking on the Drug Profiteers,” in The New Yorker, about the infamous Martin Shkreli and concluded that the problem with Shkreli’s exploiting loopholes in the pricing of drugs is “not with the man but the system that has let him thrive.” Shkreli, who owns Turin Pharmaceuticals, raised the price of Daraprim from $13.50 to $750 a pill because he could. This is “rent seeking,” that Surowiecki defined as “increasing profits not by adding real value for customers but by exploiting loopholes.” Daraprim, first sold in 1953, treats toxoplasmosis. After public uproar Shkreli lowered the price of the drug that among other things treats AIDS and malaria. 

Big pharma 1It’s not the only example of the rent-seeking model, he wrote, adding to the list Thiola, to treat kidney disease. The company that makes it is also owned by Shkreli. Last year the price increased “twenty fold.” A company called K-V Pharmaceutical increased the price for a shot that thwarts preterm births from $15 to $1,500. “There have also been alarming increases in the pries of common drugs like doxycyclene. Generic-drug makers have been merging with each other, leaving fewer competitors.”

Innocent people who are sick aren’t the only victims according to Michelle Celarier’s article, “Stuck in the Mud,” in the New York Post last week. She wrote about battered portfolios of some “hotshot hedge fund activists” and big pharma accounted for one of the headaches. She reported Bill Ackman of Pershing Fund’s “5.7 percent stake in Canadian pharmaceutical giant Valeant, which announced late Wednesday that it is under investigation by federal prosecutors in New York and Massachusetts regarding pricing of drugs,” as one of the problems. “Valeant has lost 36 percent of its value since Aug. 1.” Pershing Fund is down $600 million as a result.

big pharma 3The Wall Street Journal dug a bit deeper into drug pricing. In “Valeant Probe Reprises Focus on Drug Pricing,” Jonathan D. Rockoff reported that pharmaceutical companies paid $3 billion + in fines in the last 10 years “to resolve pricing cases.” I can hear Jackie Gleason in his role in the “Honeymooners” referring to “a mere bag of shells.” According to Google, the global industry represents $300 billion a year.

The fines are largely due to overcharges to Medicare and Medicaid. According to the law, a company must offer Medicaid its best rate. Merck didn’t do that.with Zocor–a cholesterol lowering drug and a painkiller no longer on the market, Vioxx. Merck settled at $650 million. [But how much did it make?] Rockoff listed other examples in the past but you get the idea. Pfizer’s Wyeth division is currently being investigated for overcharging Medicaid for heartburn medicine Protonix.

That’s not all. Big pharma gives money to charities that in turn pay for the prescriptions of needy patients. Valeant spent $544 million in 2014 and anticipates $630 million this year. That’s legal. What’s not is when the charity directs the patient to a certain drug. That’s considered a kickback. Let’s get real: Who wouldn’t promote the products of a company that supports your charity/your job?

What do you think of a corporate model that takes advantage of loopholes to raise prices dramatically to make money to the detriment of its often desperate customers? Do you think relatively tiny fees act as the slightest deterrent to a corporation intent on making a profit by skirting the law? What about Valeant giving $millions to charity that comes back in business for its products?

loopholes

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