Donut Hole Defined

• 09.08.2008

 A new Kaiser Foundation sponsored study uses an IMS data set to look at how many seniors hit the donut hole and what happens when they do.  It turns about about 14 percent go through the point where seniors have to spend up to $3850 of their own money on drugs.  That's about the same as in 2006 according an independent study conducted by IMS itself if you take away seniors who did not spend anyting on prescription.  Adding in seniors that spent nothing you get about 6 percent hitting the donut hole. 

The Kaiser folks wiped out the seniors who spent nothing to plump up the bottom line figure.   Why is one level of spending any less or more important than any other.  Indeed, when doing weighing of distributions you have to add those folks in so that decision was a political one to say the least, not a methodological imperative.  Six percent is still 3 million people.  And it doesn't take away from the fact that both studies found people who hit the hole -- up to one in 10 -- stopped taking their meds for diabetes, depression, Alzheimer's, hypertension and that more than half did not restart after getting catastrophic coverage.  

The biggest problem with the Kaiser study is that it does not compare the behavior of seniors with and without gap coverage indeed the authors admit:

"The IMS database does not provide sufficient information about Part D plans (in particular, it does not distinguish among the multiple plan offerings of a single sponsor) to allow for identification of the small share of enrollees in plans with gap coverage, which prevents us from excluding them from the analysis." 

http://www.forbes.com/forbeslife/health/feeds/hscout/2008/08/21/hscout618675.html

Small share?  Actually over 60 percent are enrolled in plans in gap coverage. 

The interesting policy question is what aren't more seniors choosing plans with gap coverage over the lowball premium plans? 

A further policy question is whether encouraging seniors to switch from an existing medicine in a class -- generic or not -- to another drug is wise.   Gail Shearer of Consumer Union sent a letter to the NY Times arguing that "taking the cholesterol-lowering drug simvastatin (the generic of Zocor) instead of Lipitor saves about $60 to $70 a month. Likewise, many people with acid reflux disease can save $150 to $200 a month by taking nonprescription omeprazole (the generic of former best-selling Prilosec) instead of the much-advertised Nexium. People should raise the issue of drug prices with their doctors to make sure they get prescriptions for medicines they can afford."

http://www.nytimes.com/2008/09/07/opinion/l07Medicare.html?scp=1&sq=gail%20shearer&st=cse

I am glad she urged people to raise the issue with doctors because switching drugs is something people should not do on their own.  Direct to consumer information -- from any source -- should start with patient VALUE in the long term and work from there.   Off the cuff money saving comments can be dangerously expensive otherwise. 

WSJ Goes Into the Gutter on Sarah Palin

• 09.08.2008

Here's the WSJ's June Kronholz looking into the soul of Sarah Palin and concluding that her newborn Trig is, well, just a cynical political prop:

"Little Trig Palin prompted more than delegate coos when he joined his mother on stage at the Republican convention. He also raised new questions among parents whose children have disabilities.

Was Alaska Gov. Sarah Palin simply including her 5-month-old son, who has Down syndrome, in a big family moment, or was she exploiting him in a tight presidential campaign? Would he help break down social barriers facing children with Down syndrome, or would those children now be drawn into the right-to-life debate?"

Wasn't it the media and the left wing blogosphere who raised all these questions and invaded her family's privacy?  Of course it was and that's where Krumholz went for her "sources."

"Among bloggers' top concerns is a Bush administration measure that would trim Medicaid funding for community services for people with disabilities. Democrats have so far stalled the cuts, which advocates for the disabled said would force the disabled back into institutions.

Blogs also were filled with questions about Gov. Palin's record on services to the disabled during her two years in state office. This spring, Alaska agreed to almost triple its spending on special-needs children, to $73,840 each beginning in 2011. But Gov. Palin didn't help draft the legislation."

She didn't help draft the legislation??  Obviously a sign of neglect!!

..http://online.wsj.com/article/SB122083992345509015.html

Lies. Damn Lies. And Statistics (about cancer).

• 09.08.2008

A new article in NewsWeek is titled, “We Fought Cancer…And Cancer Won.”

According to the article, “In 2008, cancer will take the lives of about 230,000 more Americans—69 percent more—than it did in 1971.”

That’s true.

The article continues, “Of course, since the population is older and 50 percent larger, that raw number is misleading. A fairer way to examine progress is to look at age-adjusted rates. Those statistics are hardly more encouraging. In 1975, the first year for which the National Cancer Institute has solid age-adjusted data, 199 of every 100,000 Americans died of cancer. That rate, mercifully, topped out at 215 in 1991. In 2005 the mortality rate fell to 184 per 100,000, seemingly a real improvement over 1975."

Also accurate.

Further, “Perhaps the most sobering statistic has nothing to do with cancer, but with the nation's leading killer, cardiovascular disease. Thanks to a decline in smoking, better ways to control hypertension and cholesterol and better acute care, its age-adjusted mortality has fallen 70 percent in the same period when the overall mortality rate from cancer has fallen 7.5 percent.  No wonder cancer "is commonly viewed as, at best, minimally controlled by modern medicine, especially when compared with other major diseases," wrote Harold Varmus, former director of NCI and now president of MemorialSloan-KetteringCancerCenter in New York, in 2006."

Yep.  But what's implicit in what Dr. Varmus says is -- since we're not dying of heart attacks and strokes (thanks largely to pharmaceutical interventions) -- we're living long enough to get cancer.  (Also -- NewsWeek fact-checkers please note --  Varmus wasn't the "former director of NCI," he was the former director of the NIH.)

So, are more people getting cancer?  Yes.  Are more people dying of cancer?  Yes.  Does that mean that we are "losing" the war on cancer?  Not necessarily.

“The meager progress,” according to NewsWeek, “has not been for lack of trying. Since 1971, the federal government, private foundations and companies have spent roughly $200 billion on the quest for cures."

Meager?  Really?

The often ignored reality is that 5-year relative survival rates, for all cancer sites, have increased from 50.1% in 1975 to 65.9% in 2000.

Is cancer close to being “cured?”  No.  Is cancer close to becoming a chronic disease?  It depends.  Is there much work to be done?  Certainly.  Is there need for even more financial investment on the part of both public and private sectors?  Of course.

Is there cause for hope?  Absolutely. And no better reason to embrace and fund the Critical Path program.

Response to FDA Early "Warning" of Drug Problems is So Predictable

• 09.08.2008

The really, really early warning requirement for new drugs has prompted the predictable response from the usual suspects. The goal of course is to focus post market detective work on which groups of people respond best to which drugs.  But that's not how it's playing out. PhRMA fears people will worry unnecessarily and safety-uber-alles zealots like Diane Zuckerman, president of the National Research Center for Women and Families, worries "It's not going to say how many reports there were. It's not going to say how many died and how many were hospitalized."  

Oh.  And just how high a body count would Diane like?  I have a clue.

Diane, has also said that  anti-depressants don't work and that she knew better than I did because she is an epidemiologist,  When I told her that certain members of my family had responded well to SSRIs she said, "Well, good for you. "   I could feel the love. 

http://ap.google.com/article/ALeqM5jLeef2T5nlybcAAzF3Fe1qqDEaqgD930MUEG0

Like I said, predictable.

AERS Apparent II

• 09.05.2008

Per the earlier question, "Will the FDA advise a pharmaceutical company in advance if one of their products is to be be included in a quarterly AERS report?" -- the answer is "yes."

According to my source inside the agency, "For all our communications we endeavored to communicate 24-48 hours in advance."

As far as today's inaugural report, sponsors were notified yesterday.

Question:  why not sooner?

AERS Apparent

• 09.05.2008

The FDA announced today that it will post, quarterly, a report of drugs that are being evaluated for potential safety problems.  The FDA will base this list on adverse events reported through the agency’s Adverse Event Reporting System (AERS). The first report will be posted today.

This reporting mechanism is a requirement of FDAAA.

Ultimately, based on these evaluations, the FDA can require next steps ranging from (1) nothing – if the adverse events are determined not to be drug-related, (2) a risk management plan (REMS), (3) a label change, up to and including (4) a Phase IV clinical trial. It's important to note that all of these options can now, per FDAAA, be mandated by the agency.

This news was presented by Paul Seligman, MD (Associate Director of Safety Policy and Communication, CDER) and Gerald Dal Pan, MD (Director, Office of Surveillance and Epidemiology).  Both commented on the need to keep these warnings in perspective and both spoke to the issue of unintended consequences and that the agency would strive to communicate the information in the manner designed to avoid misinterpretation by patients and overreaction by the media.

(If you disagree that the media overreacts, let's see what happens tomorrow.)

One way to help modulate the unintended consequences (aka, "general hysteria") these things tend to generate is to make sure drug companies have some advance warning of these postings so they can be prepared to communicate their perspectives to patients, physicians and payers.  Will the FDA be advising companies that a given product will be included in the report?  It wasn't discussed during the press briefing.

Inquiring minds want to know (1) if "yes," how far in advance will a company be notified and, (2) if "no," why not?

More as more develops.

Copy of Capitol Hill Event

• 09.05.2008

Center for Medicine in the Public Interest presents:

"Industry Support for Continuing Education of Healthcare Professionals"
Monday September 22, 2008
8:00am-12:00pm
121 Cannon House Office Building, Washington, DC

CLICK HERE to view the Capitol Hill event invitation

This file requires Adobe Reader. Click Here to download Adobe PDF Reader.

Capitol Hill Event

• 09.05.2008

Center for Medicine in the Public Interest presents:

"Industry Support for Continuing Education of Healthcare Professionals"
Monday September 22, 2008
8:00am-12:00pm
121 Cannon House Office Building, Washington, DC

CLICK HERE to view the Capitol Hill event invitation

This file requires Adobe Reader. Click Here to download Adobe PDF Reader.

Will Mr. Ross be home for Christmas?

• 09.05.2008

Last night John McCain came out strongly against healthcare reform that would have  “bureaucrats” telling doctors how to practice medicine. 

And he’s right. 

Many people, who disagree with the GOP nominee, echo the empty rhetoric of SiCKO and are calling for healthcare “like in Europe – where it’s free.” 

Well, it ain’t free.  Government-controlled healthcare is funded through (gasp!) taxes.

Consider Canada, while the percentage of taxes used to provide healthcare varies, it is estimated that 22 percent of taxes collected go towards funding of their health system.

Then consider the United Kingdom, so often held up by advocates of "universal" healthcare.

Citizens of the UK pay 11 percent of each pound they make in weekly income between £100 - £670 for the NHS, plus an addition 1 percent of income over £670 a week.

But it’s not only what you pay – it’s what you get (or don’t get) for the money. Consider this story from today’s edition of the British newspaper, The Independent:

“A cancer sufferer whose primary care trust refused to pay for a drug which could extend his life by up to three years has launched an 'end of the road' legal challenge to the decision. If Colin Ross continues to be denied the drug, Revlimid, he will die within a few months, experts say.

Mr. Ross, 55, said his doctors had requested funding for up to four courses of Revlimid at £5,000 a time. "If I don't win and I get no further treatment, I won't be here for Christmas. It's as simple as that," he said.

He was diagnosed with multiple myeloma, a cancer of the blood cells, in May 2004. Doctors at the Royal Marsden Hospital in London deemed Revlimid to be his last chance after side-effects forced him to give up the other life-prolonging drugs he was taking.

Revlimid is readily available to patients in Europe and the US but has yet to be approved by the National Institute of Clinical Excellence. 

In May, West Sussex Primary Care Trust blocked an emergency application for NHS funding for Revlimid for Mr. Ross, saying it was too expensive and his circumstances were not sufficiently exceptional for him to qualify.”

Yes – that’s what the “bureaucrat” said – “his circumstances were not sufficiently exceptional …” 

Yes, by all means, let’s put bureaucrats in control of health care.

Is this the sort of healthcare “reform” we want? 

Is that the sort of “change” we want?

For those who call for “free and universal” healthcare, remember the words of Benjamin Franklin, who said:

"All human situations have their inconveniences.  We feel those of the present but neither see nor feel those of the future; and hence we often make troublesome changes without amendment, and frequently for the worse."

CME: An Evidence-Based Evaluation

• 09.04.2008

On September 22 in Washington DC, the Center for Medicine in the Public Interest is hosting a half-day conference on pharmaceutical industry support of continuing medical education.  We'll address some key questions such as:

* Is it "true" that industry-sponsored CME helps neither physicians nor patients because it is "biased?"

* Would CME be "better" if industry just gave the same dollars to academic medical centers and hospitals?

* Does barring industry support dampen intellectual freedom and drive talented people out of academic medicine?

We'll be joined by experts such as Tom Stossel, MD (Professor of Medicine, Harvard Medical School), Roger Meyer, MD (Clinical Professor of Psychiatry, Georgetown University), Jack Lewin, MD (President, American College of Cardiology), Gary Puckrein (National Minority Quality Forum), Michael Weber, MD (Professor of Medicine, Downstate Medical Center) and others.

We hope to see you there.  Here's a copy of the complete agenda. 

If you would like to attend (there is no cost), please contact Mario Coluccio at (212) 417-9169 or mario.coluccio@cmpi.org