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

Weekly Roundup: Media Hits and Misses

• 11.03.2006

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.

AP reports. Drugwonks translates

• 11.02.2006

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.

Families USA Has a Strange Way of Showing Concern for Seniors

• 11.02.2006

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.

The Washington Post said it so it must be true

• 11.02.2006

The Washington Post gets it.

Big Time.

And just in time.

Here's the first paragraph of an editorial from today's paper:

An Election on Drugs
The Democrats oversell a Medicare solution.
Thursday, November 2, 2006; Page A16

ONE OF the Democrats' election talking points is a promise to revamp the Medicare prescription drug benefit. They paint the 2003 legislation as a sellout to pharmaceutical firms: Rather than having Medicare officials use the government's bargaining power to keep drug prices down, the law left the job of negotiating prices to private insurers. The Medicare drug benefit has actually turned out to be cheaper than projected, and most beneficiaries say they are satisfied with it. But the House Democratic leader, Nancy Pelosi (Calif.), nonetheless accuses Republicans of "putting pharmaceutical companies and HMOs first at the expense of America's seniors."

And here's the last graph:

It's fair to object that consumers may not be equipped to make smart decisions; the market signals they send may reflect the success of gauzy drug commercials rather than clinical evidence. The attraction of the market-based model depends on consumers being guided more by science-based Web sites created by universities or other groups. It's an open question whether consumers, led perhaps by their insurers, will learn to make sophisticated drug choices, but the fact that Medicare patients already buy more generic medications than other Americans is an encouraging sign of the capacity for smart purchasing. A switch to government purchasing of Medicare drugs would choke off this experiment before it had a chance to play out, and it would usher in its own problems. For the moment, the Democrats would do better to invest their health-care energy elsewhere.

To read the entire editorial, go to http://www.washingtonpost.com

Will someone with Nancy Pelosi's e-mail address please forward this article to her office ASAP.

Joseph Mercola: Pharmaceutical Fraud

• 11.02.2006

I find it incredible that the media slams drug companies for marketing medicines that undergo years of rigorous clinical testing yet fail to investigate schlockmeister's like Kevin Trudeau or the most recent peddler of pharmaceutical porn, Joseph Mercola. Mercola is supposedly an osteopath who has a book entitled the Great Bird Flu Hoax on the NY Times Best seller list. The book claims that world wide concern about avian flu was concocted to gin up huge profits for companies that Rumsfeld and Cheney had ties to. I guess that means the WHO and UN were also on the take but no matter.

Ironically, the way Mercola got the book onto the best seller list was by getting people to preorder the book in massive enough quantities to qualify as a best seller. You might say that's a way of manufacturing a hoax to generate massive profits as well but perhaps that is too fine a distinction.

In fairness to Mercola, some of the products he peddles -- krill oil tablets -- have a modicum of clinical research to support claims that they help reduce cholesterol or alleviate PMS. But he hypes them endlessly, asserting without substantial evidence beyond smaller clinical studies that products such as coconut oil or krill oil can prevent infections, arthritis, etc. And he promotes a study claiming that neptune krill oil "alleviate symptoms caused by rheumatoid arthritis and osteoarthritis, including joint pain, stiffness and functional impairment and significantly inhibit inflammation as shown by a decrease in C-Reactive Protein (CRP) -- a biomarker for inflammation." There is no such study in the medical literature...

Mercola has also been cited by the FDA on a couple of occasions for making medical claims for products without any evidence.

All the while he flogs drugs and vaccines as dangerous and deadly, using newspaper accounts for he source material.

Despite overwhelming evidence that mercury does not cause neurological damage he continues to whip up conspiracy sentiment that it does. And now, though scientific evidence overwhelmingly demonstrates that aspartame is extremely safe for the vast majority of consumers, Mercola is about to come out with a book called "Sweet Deception" that -- of course -- will conclude that the government and corporations colludes to cover up the TRUTH about artificial sweeteners and the mind numbering and cancer causing effects they have.

And of course Mercola will have a NY Times best seller ready to be pre-sold.

Along with a sugar alternative that he will be hawking as well.

Sometimes coincidences are sweet too.

The Cancer Kooks Respond

• 11.02.2006

Here is the official response to my article in the Daily News. It does not address the substance of my concerns: that Breast Cancer Action discourages women from obtaining mammograms and from using medicines that can actually treat breast cancer when detecting and instead urges women to wait till we identify and eliminate every evironmental toxin that in the judgement of Breast Cancer Action causes breast cancer to get well....

http://www.nydailynews.com/news/ideas_opinions/story/466935p-392909c.html
Cancer research
San Francisco: Robert Goldberg's Op-Ed, "End sick crusade against breast cancer research" (Oct. 29), was full of factual errors. It also mischaracterized Breast Cancer Action and our 16 years of supporting the voices of those affected by the disease. We encourage pink-ribbon consumers to get informed, provide women with the facts so they can make informed choices about their health and organize people to do something about breast cancer besides worry. We also call for research to focus on key unanswered questions about breast cancer. We value transparency and are highly regarded in the cancer world, Goldberg's diatribe notwithstanding.
Barbara A. Brenner Executive Director

That Giant Sucking Sound

• 11.02.2006

Should Representative Pelosi become Speaker Pelosi we can almost certainly expect another round of absurdity surrounding the issue of drugs "from Canada." (Again and as always, please note the quotation marks.)

I had dinner last night with some Canadian policy wonks who are very concerned about the sanctity of their own legitimate supply of pharmaceuticals -- and rightly so. Legalized importation would create a giant sucking sound, the end result being the Great White North being drug-free -- and not in a good way.

There is, at present at least one private member's bill that I know of in Ottawa that would ban bulk exports of pharmaceuticals to the US (thus making it illegal for whole states -- like California and Illinois -- and programs -- like Part D -- to source their medicines supply from Canada). But it's an opposition member and not likely to go anywhere.

Prime Minister Harper had better wake up to the reality that, should Mrs. Pelosi's 100 Hour Reign of Terror become reality it won't be "Just say no to drugs," it'll be "Just say no drugs."

Oh Canada!