Latest Drugwonks' Blog

The Letter "P"

  • 11.08.2006
So now what happens?

Post-election it’s all about the letter “P.”

I am concerned that, as far as FDA is concerned, we will lose whatever momentum there was towards an agency that was focusing on (as Andy von Eschenbach phrased it) “the three P's of prevention, predictive tools, and the participatory Critical Path” ...

… and we will move to a House of Representatives that is focused on payback and partisan politics. And that means hearings. Lots and lots of hearings couched in the word “oversight.” And that’s deleterious and particularly dangerous right now because of PDUFA.

On the broader health care front the Big P is certainly going to be a debate over whether or not Part D should be redesigned, specifically whether the non-interference clause should be revoked. Our new Speaker, Nancy Pelosi has this on her “First 100 Hours” to-do list. And that’s just a preliminary peroration towards a more frightening parley over price controls and intellectual property (aka: patents).

You can also bet we’ll see more rhetoric over plans for phony importation schemes.

It's very important to remember that this election wasn't fought on health care. And don't let anybody tell you different.

Which means we must redouble our efforts to advance the public health by being peppy, potent, proactive, persuasive, puissant – and most importantly – positive.

America's health is too important to be about partisanship or about profits. It must be about progress, about patients.

We must keep our eyes on the prize and persevere.
If the D's take control of both the House and Senate expect legislation to rollback Medicare reforms enacted in 2003 to pass with Republican support. If they do, they will find that such proposals will require robbing seniors of the choice of essential medicines now and in the future and starve biotech firms that are already losing money of markets. If the pharma and biotech industry were politically smart they would link the Democrat support of embryonic stem cell research with the fact funding for the enabling technologies comes from private firms that would be bled to death by Democrat part D proposals. That's a big if....
Gail Wilensky, who ran the Health Care Finance Administration under Bush I (that's CMS now) has an article today calling for a new public-private agency to evaluate the comparative-effectiveness of medical technologies.

Gail is smart and thoughful on health care matter so I can't figure out what she was thinking here. Maybe she thought she could tame the CE crowd which has an agenda.

http://

As the ALLHAT and CATIE studies show, even well funded comparative effectiveness studies will fall into dis-use for every good reasons. They are poorly designed, they are superceded by studies or personalized medicines that are based on a better mechanistic understanding of disease pathways. Applying ALLHAT recommendations to African Americans will kill them for example. And notice that people who promote C-E never talk about genetic testing to determine which medicine works best? That would be like Tower records talking about Itunes...

Indeed, since most C-E are underpowered they do not capture the genetic variations that explain and cause differences in response to medicines or other intereventions so of course "they all look alike" and regress to cheaper is better. Meta analysis only reinforces this one size fits all conclusion. Which is why for example, NICE has never caught an increased survival benefit from any new cancer drug since 1970. Then again, if you post your QALY at 50K survival doesn't mean very much either.

All of which translates into reimbursement decisions and the comparative effectiveness crowd knows it.

Take UK, Germany, Australia and Canada. All take their sweet time reviewing studies. All deny and limit access to new medicines and have fail first policies based on C-E. Have you read any of the VA off-formulary guidances? Take someone who has non-hodgkins's lymphoma. In the private sector, Rituxan is standard therapy. But not in the countries you cite and not in the VA.. Why? According to the comparative effectiveness studies, the reimbursing agencies want you to go through more painful and more toxic treatments first.


Finally, the entire field of medicine is moving toward the molecular and the personalized. Comparative effectiveness in the 21st century boils down to the right treatment for the right person at the right time. The agency Gail proposes is totally unsuited for arriving at that answer. I have read everyone of the AHQR comparative effectiveness studies...They are not usable in the clinical setting for docs because they are one size fits all and retrospective.

We need to invest in developing personalized treatment strategies that are preventive and prospective in nature. All this C-E will make the foundations and liberals that hate drug companies -- who by the way -- are not developing the next generation of new medicines (biotech firms that make no money are, ) happy. But it will hurt patients by delaying access and giving bureaucrats who know nothing about the practice or science of medicine control over care.
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
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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