Archive for the ‘Pharmaceutical’ Category

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 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

Service of Cost vs. Benefit in Healthcare: Who Decides?

Monday, July 6th, 2015

Photo rinehartclinic.org

Photo rinehartclinic.org

This New York Times article, “Cancer Doctors Offer Way to Compare Medicines, Including by Cost,” made significant—if terrifying–points in addition to how cost impacts what drugs a patient may get. Given their ineffectiveness, I wondered why those given as examples are prescribed in the first place.

If you or a loved one has a heart condition, don’t click away just yet: Reporter Andrew Pollack noted that cardiology societies are following in oncologists’ footsteps. And I wouldn’t be surprised if this trend soon affects patients with any and all conditions if it effectively cuts costs for insurers. 

Actor Robert Young playing Marcus Welby, MD

Actor Robert Young playing Marcus Welby, MD

Pollack wrote “Roche’s Avastin, when added to chemotherapy, had a net health benefit of 16 out of 130 possible points when used as an initial treatment for advanced lung cancer. Its monthly cost was $11,907.87, compared to $182.09 for the chemotherapy alone.

“Eli Lilly’s Alimta for that same use had a net health benefit of zero with a cost exceeding $9,000 a month compared to about $800 a month for the drugs it was compared to in the clinical trial.”

Later in the article Pollack spelled out the rating system: “Drugs for advanced cancer are given a score from 0 to 130. Up to 80 of the points are based on a drug’s effectiveness in prolonging lives, delaying the worsening of cancer or shrinking tumors. Then up to 20 points can be added or subtracted based on side effects. And up to 30 bonus points can be granted if the drug relieves cancer symptoms or allows a patient to go without treatment for a period of time.” 

Actor Hugh Laurie who plays Dr. House

Actor Hugh Laurie who plays Dr. House

Regardless of cost why would anyone prescribe a drug that benefits a patient from zero to 16 “points” out of 130?

Other news that was unsettling: “The release by the American Society of Clinical Oncology of what it calls its ‘value framework,’ is part of a change in thinking among doctors, who once largely chose drugs based on their medical attributes alone.” [The underline is mine.] Silly me: and I thought doctors still prescribe what they do according to how a drug helps a patient.

According to Pollack the average cost of cancer drugs runs $10,000/month and some as much as $30,000/month. This is information, Dr. Richard Schilsky said at a news conference, that some doctors don’t know nor do patients. Schilsky is chief medical officer of the American Society of Clinical Oncology. [Why is this significant? Even if you’ve been paying for health insurance for eons and have hardly used a cent until you need to, you can reach the ceiling when off goes the insurance spigot.]

Pollack wrote that this value framework considers the cost to the patient and the health system.  I assume “health system” translates to government supported Medicare and Medicaid plans. 

Ingrid Bergman playing Dr. Constance Petersen

Ingrid Bergman playing Dr. Constance Petersen

As a result, Pollack observed, doctors are now put in the role of “being stewards of societal resources.” He continued, “That is somewhat of a controversial role for doctors, since it might conflict with their duty to the patient in front of them. But the oncology society said it did not see those roles as being in conflict.”

Other points Pollack made include:

  • A rep for the Pharmaceutical Research and Manufacturers of America said the cost of drugs represents only 20 percent of treatment.
  • The cost of drugs is unrelated to how “novel it is or whether it prolonged life versus just shrinking tumors.”
  • In Britain, a drug is rated according to its “cost per extra year of life they provide adjusted by side effects and symptoms.”
  • Starting in June United Healthcare requires “oncologists to get prior approval from the insurance company for every cancer drug they administer. The company will then track what happens to patients and eventually provide information to doctors about how well each drug works.”

Summarizing the questions:

  • Why prescribe a drug that does little if anything to better a patient’s health or length of life?
  • Is a doctor who chooses a drug for a patient based solely on its medical attributes old fashioned and out of step and will he/she soon be forced out of work by insurance companies?
  • If a patient can scrape together the co-pay of a super expensive drug, can an insurance company refuse to pay its part? Then what?
  • Will United Healthcare only use its approval to track drug effectiveness, as Pollack suggests, or eventually will it control costs by refusing to pay?
  • Is the American Society of Clinical Oncology correct when it asserts that there is no conflict for doctors who are now made responsible for the country’s medical resources and their responsibility to their patients?
  • Unless people have unlimited incomes, most adults are aware of what they pay for food, beverages, clothing, shelter and only recently have they become aware of the cost of healthcare. Isn’t this a good thing?

  pills 2

Service of Did You Get the Message?

Thursday, March 7th, 2013

Megaphone

With all the technology at our fingertips, I wonder how well we have learned to effectively communicate, absorb and act on information, especially in giant organizations and companies.

Oh what a tangled web we weave….

TenTripTktI buy a 10-trip web ticket on the Internet—have been doing so for years.  When I handed mine to the conductor, she said, “It’s expired.” I said, “I just got it in the mail!” She pointed to a date on the ticket which must have been the date the ticket was processed. She took it as the date the ticket expires. I explained the situation and convincingly as she didn’t make me pay, but the confrontation was heated and I didn’t like all the fuss.

The next conductor punched my ticket without a word so I asked him what the deal was and he said that scads of tickets were mailed with the distribution rather than the expiration date and not to worry about it—the conductors all received a directive about the glitch.

ConductorPunchingTktThe ticket-collecting conductor for my third ride on the web ticket had not read the directive as I had to again explain the situation, with pairs of rider’s eyes staring at me suspiciously from behind Kindles and newspapers as I argued for my cause.

So it got me to ponder how, when you run something as big as Metro-North and there’s a mistake like this one, a company gets out the word effectively.

Metro-North has the email addresses of all the web ticket buyers. Why not send a copy of the directive to carry in our wallets at minimal cost in time and none in out of pocket.

Sticker shock

CarRegisinWindowI thought of this when a friend told me about the letter she received from the New York State Department of Motor Vehicles. It explained that the department “has identified a defect in the registration documents supplied by our vendor that has prevented the printing of most registrations and window stickers that were ordered starting January 1.”

The letter went on to say that her registration is processed and everything is in order and if kept in the vehicle, the letter should serve as proof should she need to show it to law enforcement officials. Further, all police agencies and courts were notified.

Since then, she got the sticker. In the interim, this friend, who lives in Westchester, had received no summons for an expired registration.

The police and traffic staff in NYC have an easier time checking registration dates on parked cars in city streets to fulfill their ticket quota and I wonder: Did they all get and retain the message? Recipients of the letter wouldn’t put it in their car windows because both name and address are clearly typed in a bigger font than the body of the letter. My parents, parked on a city street, once got a ticket for being one day overdue.

Drug test

PharmacyI renewed a prescription on the phone via press one press two, punch in your Rx number, for an ordinary drug from a store that asks you for the date and time you expect to pick up your order. When I got there an hour or two after the time I’d noted, the pharmacy attendant said that the meds were on back order and asked if I could return the next day. The next day I got a call to tell me my prescription was waiting for me.

To save me a fruitless trip, shouldn’t they have also called to tell me when it wasn’t?

Are my expectations too high? Do you have examples where someone didn’t get the message and instances of a company or organization communicating them flawlessly, where everyone involved heard and remembered?

ShorttallBasketballPlayers

Service of Trust

Thursday, February 21st, 2013

trust2

This blog doesn’t usually pinion a brand by name, but when it is number five in a list of most trusted, and when its executives have done something dastardly and incomprehensible, I make an exception to my blog’s policy.

I read in David Reich’s post, “Who do we trust,” on his “my 2 cents blog,” about a Harris poll of 19,000 people at random who felt that Amazon was the most trusted brand and the rest were, in order, Apple, Disney, Google, Johnson & Johnson, Coca-Cola, Whole Foods, Sony, Procter & Gamble and Costco.

caneI am shocked as much by the deed as by the cavalier attitude by management about something that takes so long to gain and a second to lose: Trust. I am appalled by yet another heartless business decision made by people who obviously have zero empathy about the pain and suffering they cause others.

Here’s the story:

“The note sent by a doctor to several executives at Johnson & Johnson was blunt: an artificial hip sold by the company was so poorly designed that the company should slow its marketing until it understood why patients were getting hurt,” Barry Meier wrote in a February News Analysis piece The New York Times. This was a follow-up to his January front page Business Day story, “Maker Hid Data About Design Flaw in Hip Implant, Records Show.”

Continued Meier in the analysis, “The doctor, who also worked as a consultant to Johnson & Johnson, wrote the note nearly two years before the company recalled the device in 2010. And it was far from the only early warning those executives got from doctors who were paid consultants. Still, the company’s DePuy orthopedic unit plowed ahead, and those consultants never sounded a public alarm to other doctors, who kept implanting the device.”

I recommend that you read the analysis for the reasons/excuses he posits that more doctors didn’t make a fuss as well as his earlier piece where I first read about this nightmare.

hip-replacementI take such a decision personally and feel enraged by it. An operation is scary for most and things can go wrong such as infections or heart failure or unforeseen reactions to the anesthesia.  And now and again there might be a kink in a device–mistakes happen. But a manufacturer that lets doctors use something its executives know doesn’t have a chance of working boils my blood.

Draconian as it sounds, I think that in future executives who know about  flaws in the devices they manufacture should have one of them implanted in their body or if they sell lousy medicine be forced to take it. It may be the only way to stop such conduct. Fining is useless.

How have we allowed companies to succeed without being expected to exhibit an iota of social responsibility? How do we protect ourselves from such a device being implanted in a friend, family member or ourselves?

old-hands

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