Latest Drugwonks' Blog

Today the New York Times invokes the myth that drug prices went up an average of 6 percent last year. I think that number comes from an AARP study conducted by the PRIME Institute which used manufacturer prices posted from July 2005 and June 2006.

Well, a little research goes a long way. Going to plans in my home state of NJ, If you look at some of the changes in Medicare part D prices for the Top 25 Brand Name Prescription Products over the same time period, you find that the retail prices have actually gone up slower (4.5 percent) under the AARP than manufacturer prices reported by its own study and out out of pocket share during the initial coverage level has declined by 12 percent! That suggests actual price concessions were deep and that therefore the 6 percent manufacturer price increase (the sticker price) was wishful thinking at best. Prices during the gap under the Humana plan decreased by 4 percent a year and the out of pocket costs during coverage have dropped as well.

And in all cases the retail price of the drug is cheaper than what seniors could get a drugstore.com.

Moving over to the VA model is to see that drugs such as Aricept, Abilify, Evista, Fosamax, Lipitor and Xalatan are not on the VA formulary while they are on the Medicare Part D formulary.

That's just for starters. Which explains why nearly 35 percent of VA seniors tried to join Medicare part D.

Today's Pop Quiz

  • 11.06.2006
Good morning class and I hope you had a relaxing and refreshing weekend.

To welcome you back, Professor Drugwonk has decided on a pop quiz. Please do not turn over your paper until I say "go!"

Question: Which article appeared in today's New York Times?

As drug prices climb, Democrats find fault with Medicare plan

For big drug companies, the new Medicare prescription benefit is proving to be a financial windfall larger than even the most optimistic Wall Street analysts had predicted. But those gains may come back to haunt drug makers if Democrats take control of Congress this week.

or ...

Antidepressants tied to lower suicide rates in kids

In US counties with the highest rates of prescriptions for selective serotonin reuptake inhibitors (SSRI), a type of antidepressant, the rate of suicide among children ages 5 to 14 is lower than that observed in counties with lower rates, according to a new report.

First person to get the answer correct wins the new edition of Sid Wolfe's "Worst Pills, Best Pills."

Second person to get the correct answer wins two copies.
Yawn?

According to today's edition of the Wall Street Journal, The U.S. Centers for Disease Control and Prevention is aiming to boost awareness of chronic fatigue syndrome.

Chronic fatigue syndrome "is a terrible illness that prevents many people from taking part in everyday activities and participating in the things they enjoy," CDC Director Dr. Julie Gerberding said at a news conference Friday. Early diagnosis and treatment of the disease are important for recovery -- even though it isn't clear what the best treatments are, CDC officials said.

Currently, there is no cure for the syndrome, which is estimated to affect around one million Americans.

Symptoms of the illness, including fatigue, short-term memory impairment, joint and muscle pain, are treated with medications that target the pain or fatigue. Antidepressants are also used.

Although the syndrome was officially recognized by the government in the late 1980s as a medical condition, many people still question whether the condition is a true physical illness.

The lack of knowledge on the causes and treatment of the disease has caused drug companies to stay away from research in the area. Information on the disease can be found at the CDC's Web site, www.cdc.gov/cfs/.

Philadelphia-based Hemispherx Biopharma Inc. plans to seek Food and Drug Administration approval to market Ampligen as a chronic fatigue treatment by the end of the year. If approved, it would be the first drug directly targeted to treat the syndrome.
Important new paper by, among others, my friend and former colleague, Randy Lutter, FDA's Associate Commissioner for Policy & Planning, on why personalized medicine saves lives and saves money.

Here's the executive summary:

Progress towards realizing a vision of personalized medicine—drugs and drug doses that are safer and more effective because they are chosen based on an individual’s genetic makeup—has been slower than once forecast. The Food and Drug Administration has a key role to play in facilitating the use of genetic information in drug therapies because it approves labels, and labels influence how doctors use drugs. Here we evaluate one example of how using genetic information in drug therapy may improve public health and lower health care costs.

Warfarin, an anticoagulant commonly used to prevent and control blood clots, is complicated to use because the optimal dose varies greatly among patients. If the dose is too strong the risk of serious bleeding increases and if the dose is too weak, the risk of stroke increases. We estimate the health benefits and the resulting savings in health care costs by using personalized warfarin dosing decisions based on appropriate genetic testing. We estimate that formally integrating genetic testing into routine warfarin therapy could allow American warfarin users to avoid 85,000 serious bleeding events and 17,000 strokes annually. We estimate the reduced health care spending from integrating genetic testing into warfarin therapy to be $1.1 billion annually, with a range of about $100 million to $2 billion.

Did that last bit get your attention? Good! Here's a link to the entire paper:

http://www.aei-brookings.org/admin/authorpdfs/page.php?id=1337&PHPSESSIS=2b0284fa8e8d5t08bd4e1515ac971482

PD3

  • 11.03.2006
Since there's a general belief that the pharmaceutical industry invents new diseases, we thought we'd get in on the fun with Part D Denial Disorder or PD3.

The unfortunate symptoms of PD3 are easy to spot: feelings of inadequacy when it comes to the private sector, the irrational belief that senior citizens have no cognitive abilities and, non-dietary aversion to donut holes. A less severe but related condition has been identified as Pelosian Ideation Syndrome (PIS) -- which can manifest itself through both disorientation and lack of balance.

If you feel you may suffer from PD3 stop reading this blog immediately and log onto the Public Citizen website for immediate relief.

A new study, funded by PhRMA and conducted by the Amundson Group, shows (among other interesting things) that in 2005 the average Medicare beneficiary filled 2.5 prescriptions per month -- but in 2006 (and with Part D coverage) that number jumped to 4.0 prescriptions per month. (The study found that the increase was consistent across all ages.)

The study also measured the average out-of-pocket cost for each day's supply of medication. And to those PD3-free readers, the findings should come as no surprise -- a per unit measure shows a 74% reduction in patients' out-of-pocket costs from $1.58 BPD (Before Part D) to 40 cents APD (After Part D).

More access at lower cost. Pretty sweet double play.

As for positive patient outcomes, the study measured the impact of Part D on access to drugs for specific chronic conditions that are highly prevalent in the Medicare population: Alzheimer's disease, high cholesterol, diabetes, hypertension, and osteoporosis -- all conditions that are often undertreated.

For each of these chronic conditions, the study found that there was a significant increase in the number of prescriptions filled per month -- suggesting that patients with these conditions are getting treatment under Part D that they were not previously receiving.

Note: In rare but advanced cases of PD3, symptoms can also include the belief that chronic disease should not be treated early and aggressively and the inability to differentiate between Santa Claus and the Non-Interference Clause.

If, after reading this blog, you are experiencing feelings of guilt and inadequacy, please consult a specialist -- Dr. Mark McClellan.

To view the complete study, click on the link below:

http://www.phrma.org/files/Amundsen_Study.pdf
I know that lots of reporters are on leave or had very little time to go through the Family USA report. And FUSA knows that. The media was manipulated and used by FUSA and reporters should not be happy about it....The Family USA report continues to astound me...Here's a group that has been in favor of generic drug approvals and use and then turns around and claims that generic coverage is not meaningful, which is a weasel word for not having 100 percent of all drug costs covered for all seniors regardless of income or ability to pay. So much for means testing, right?

Another weasel word....generic equivalent instead of generic alternative. FUSA claims that most of the commonly used drugs have no generic equivalent, which means an exact copy. There are however, generic alternatives which might be cheaper and as effective (or not depending on the person) for all but 6 of the drugs FUSA lists. There are generic beta blockers, calcium channel blockers, pain relievers, anti-depressants, proton pump inhibitors, etc that FUSA ignored to paint a dire picture.

Finally, FUSA ignored the fact that many of the drugs on the Medicare formulary they regard as meaningul such as Aricept, Lipitor, Nexium, Prevacid, Evista, Celebrex...are not on the wonderful VA formulary it would use instead of the horrible private sector PBM model which by the way FUSA endorsed in 2000 when proposed by President Clinton and the Dems.

Another Media Miss....

Anti-Depressants Linked to Lower Suicide Rates

Researchers report an inverse relationship between antidepressant prescriptions and the rates of suicide in children and adolescents -- a finding that contradicts the Food and Drug Administration's "black box" warning for selective serotonin reuptake inhibitor medications, also known as SSRI drugs.

The University of Illinois at Chicago epidemiologic study appears in the November issue of the American Journal of Psychiatry.

The researchers examined suicide rates of children ages 5-14 in each county of the United States from 1996 to 1998 and county-level data on SSRI prescriptions. The results were adjusted for sex, race, income, access to quality mental health care and variations in county-to-county suicide rates.

"We found that counties with the highest prescription rates for SSRI drugs had the lowest suicide rates in children and adolescents," said the lead author Robert Gibbons, director of the Center for Health Statistics and professor of biostatistics and psychiatry at UIC. "This is just the opposite of what you would predict if SSRI's were producing suicide."


Yeah, which comports with meta-analyses of randomized clinical trials and other epidemiological studies. So in light of the media's reporting on the opposite -- based on a handful of questionably conducted small studies -- where's the coverage?

So what are reporters looking at? Drug marketing practices...what a shock.

Med schools warn of drug sales pitches
By David Caruso (AP)

No point giving you the whole article since it is such a time worn theme....the pizza, the prizes, it corrupts.

The punchline of course is delivered once again by Jerome Kassirer who of course is beyond reproach on all things medical....


"Dr. Jerome Kassirer, a professor at the Tufts School of Medicine and a frequent critic of the doctor-pharmaceutical relationship, said schools need to do more than just lecture.

"The question to ask yourself about these programs is: What are the faculty doing? Because if the students walk away from those sessions and find out their faculty are off speaking for Pfizer, what are they going to think?"

My answer: I can't wait till I get a crack at that too.....

Or better yet how about a universal ban on speaking fees for everyone. Why should Kassirer get paid to spout his views. Isn't that a conflict? If he was really comitted to his cause, he would do it for nothing. How do I know that the money given to him by a group is causing him to shade or shape his view?

Similarly, reporters give talks for money on their views of the world? Doesn't that make them appear less objective and blur the distinction between their obligation as journalists to inform and simply being paid to give their opinion. How do I know that a reporter is truly being objective when they are receiving outside income to provide their opinion?

Sorry, no hits this week. Let's see what election week brings.

PS. Here's a photo of my son Zach doing urban combat training in the Negev.. (He is the one on the left) Can I repeat again how proud I am of him? Anyone who knows John Kerry's email please forward...

AARPeeved

  • 11.03.2006
Anybody else had enough of the AARP’s regular “Trends” reports on prescription drug pricing? I’d been tuning them out since the only difference from one report to the next was the date -- but Henry Waxman has reignited both my interest and my ire.

Let’s start with the actual report.

The first thing to note is that the AARP report relies on a measure of wholesale cost from a proprietary dataset – not the actual prices paid by cash customers. Patients with insurance (yes – like Part D) don’t ever see these prices. America’s insured focus their attention and anger on ever-rising co-pays (which increase many times-fold the price of the prescription medicines they are, in theory, linked to).

I think the folks over at Big Insurance (yes – like the AARP) have some ‘splaining to do.

Here's a link to the rest of the story ...

http://www.pharmexec.com/pharmexec/article/articleDetail.jsp?id=382532

Unhappy Birthday

  • 11.03.2006
One hundred years ago today, on November 3 1906, Alois Alzheimer, psychiatrist and pathologist, presented the first case of the disease that later came to bear his name in Tubingen Germany. The patient, Auguste D, developed dementia in her 50s and was so restless and confused that doctors prescribed balneotherapy - day long immersion in a lukewarm bath - to soothe her. When she was at her worst they knocked her out with chloroform.

According to an article in today's edition of The Independent (London), "A cure remains a distant dream."

Here is a link to that article:

http://news.independent.co.uk/world/science_technology/article1951233.ece

We must not allow the walls that stymie progress towards finding better treatments (and, ultimately, cures) to stand. President Bush, Dr. von Eschenbach, Dr. Zerhouni, members of Congress: Tear down these walls.

Aggressive measures are required and one important way we can help advance this agenda is to forcefully support, fund, debate, and participate in the FDA's Critical Path agenda. This is a core function of the Center for Medicine in the Public Interest (CMPI), the think tank home of drugwonks.com.

We invite you to join our crusade.
Medical schools train doctors to resist marketers' siren songs
The Associated Press By David B. Caruso
2 November 2006

NEW YORK (AP) - Medical schools in several states are strengthening programs that warn doctors and students not to be dazzled by drug company marketing practices.

DRUGWONKS TRANSLATION: Put on these sunglasses and place a wreath of garlic cloves in all examination rooms.

The Mount Sinai School of Medicine announced Wednesday that it would use a $400,000 grant to remind doctors to question sophisticated sales presentations and rely on solid science when deciding which medications to give patients.

DRUGWONKS TRANSLATION: So tell me, is your new product really more effective? Wow – did you see that shot! These are great seats.

The program is one of five receiving $1.9 million from the Attorney General Consumer and Prescriber Education Grant Program, which has awarded $11 million to 28 institutions interested in cautioning health care workers about pharmaceutical sales techniques.

DRUGWONKS TRANSLATION: Pharmaceutical sales representatives are really minions of Satan.

The Center for Evidence Based Policy at Oregon Health & Science University administers the grants.

DRUGWONKS TRANSLATION: When it comes to “evidence-based policy” we don’t really need evidence – and if you don’t agree you can give us back the check. That’s our policy.

One of the programs being implemented at Mount Sinai will be a new type of class at its Morchand Education Center, famous for training exercises in which actors play patients. For these new sessions, though, the actors will be playing pharmaceutical company sales representatives.

DRUGWONKS TRANSLATION: STELLAAAAA!!!!!!

Another part of Mount Sinai's program will advise health care providers how to tactfully deal with patients who see a drug on television and demand a prescription.

DRUGWONKS TRANSLATION: Hey – did you go to medical school too?

Money for the education programs comes from a $430 million settlement that resolved charges that pharmaceutical giant Pfizer Inc. illegally paid doctors to prescribe its drug Neurontin for uses that had not been approved by the U.S. Food and Drug Administration.

DRUGWONKS TRANSLATION: Providing better medical education is Job One. Actually, that’s wrong, sorry – demonizing the pharmaceutical industry is Job One. My bad.

The next $6.5 million in grants will be used to inform consumers on how drugs are prescribed and marketed, said the Center for Evidence Based Policy

DRUGWONKS TRANSLATION: And the third traunch will be used to fund a program on better health outcomes through collective farming.
The Families USA report claims to demonstrate that fewer seniors will have to stand alone drug plans that offer meaningful coverage through the doughnut hole. In fact, the report either deliberately ignores or fails to acknowledge a fundamental shift in the design of stand-alone plans for 2007. Namely, lower out of pocket spending for a larger number of medicines for seniors. And the number of plans who offer such an approach has actually doubled from last year.

Most plans actually fill the doughnut hole and eliminate the coverage gap before it even starts by encouraging seniors to use generic medicines instead of brand drugs when available. In turn, most plans have added more drugs to their formularies and kept co-pays for newer medicines low. As a result, more seniors – most of whom never had drug coverage before – will have a wider choice of drugs and lower out of pocket expenses.

Ironically, for all its concern about providing seniors with meaningful doughnut hole coverage the FUSA proposal to use the VA system of price controls and drug formularies would create another kind of drug donught hole. It would create a gap in essential medicines. Only 38% of the drugs approved in the 1990s, and 19% of the drugs approved by the FDA since 2000, are on the VA National Formulary. Only 22% (17) of the 77 priority-review drugs approved since 1997 are on the 2005 National Formulary. By comparison, 100 percent of both types of FDA approved medicines are on the AARP Medicare formulary.
CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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