On December 18, 2003 Thomas Menino, Mayor of Boston, came to the FDA for a discussion of drug importation.  I was there.

I was there to hear the mayor lecture us on internet pharmacy safety.  I thought he was there to engage in a dialogue.  I was wrong.  He was there to grandstand.

Here’s how our meeting was covered in the Boston Globe on December 19^th:

And again a few days later on “Your World With Neil Cavuto.” 

How times change. According to a story in last week’s Boston Globe, “Four years after Mayor Thomas M. Menino bucked federal regulators and made Boston the biggest city nationally to offer low-cost Canadian prescription drugs to employees and retirees, the program has fizzled, never having attracted more than a few dozen participants.”

In late July of 2008, the Canadian supplier for the program, Winnipeg-based Total Care Pharmacy, sent a letter to city officials saying the firm was terminating its agreement because there were so few participants. In 2006, Boston saved $4,300 on a total of 73 prescriptions. When Total Care decided to end its relationship with the city, only 16 Boston retirees were still participating.

But, as they say, denial is more than just a river in Egypt.  As the Globe reports, “Boston City Council member Michael Ross said he believes the city was forced to abandon the program because of federal pressure. The Food and Drug Administration strongly opposed efforts by cities and states to offer Canadian prescription drugs, saying the suppliers were not regulated by the United States and that the safety of the drugs could not be guaranteed.”

Yes – we did say all those things.  And that remains the position of the FDA.  And it's the correct position.  As to the reason Mayor Menino's program failed you can, as the Ol’ Perfessor used to say, look it up  -- only 16 participants.

Some tea party.

Why worry about whether the proposed bail out of Wall Street will give consumers the shaft when you can....well,  see below: 

ntidepressants may damage male fertility

Last Updated: 2008-09-24 15:19:18 -0400 (Reuters Health)

LONDON (Reuters) - Common antidepressant drugs may reduce some men's fertility by damaging the DNA in their sperm, according to scientists.

A study of 35 healthy men given paroxetine - sold as Paxil or Seroxat by GlaxoSmithKline - found that, on average, the proportion of sperm cells with fragmented DNA rose from 13.8 percent before treatment to 30.3 percent after just four weeks.

Similar levels of sperm DNA damage have been linked to problems with embryo viability in couples trying to have children. The research by Peter Schlegel and Cigdem Tanrikut of the Cornell Medical Center in New York was reported in New Scientist magazine and is due to be presented in November at a meeting of the American Society for Reproductive Medicine.

A copy of the study abstract was made available to Reuters.

"The fertility potential of a substantial proportion of men on paroxetine may be adversely affected by these changes in sperm DNA integrity," the experts concluded.

There are three words you never thought you would see strung together....

The study adds to concerns voiced by the same doctors in 2006, after finding that two men had developed low counts of healthy sperm following treatment with two different selective serotonin-reuptake inhibitors (SSRIs).

The article goes on...

Allan Pacey, Senior Lecturer in Andrology at the University of Sheffield, said the apparent increase in sperm DNA damage was "alarming", although he noted the level at which damage becomes clinically significant was open to debate.

"It is a shame that the authors appear not to have conducted a randomised controlled trial which would be the most scientific way to investigate the drugs effects, but I agree that the results are of concern and need to be investigated further," he said.

Drugwonks is open to suggestions for an appropriate study design. 

http://www.reutershealth.com/archive/2008/09/24/eline/links/20080924elin019.html

Is CMS using the process of National Coverage Determination to sneak comparative effectiveness into the back door?  That might be an overstatement.  Probably fairer to say that CMS is putting it right on the table.  It will control the methodologies and when it will be used and under what conditions unless a more transparent and consumer focused approach is quickly developed.   And CMS, much like NICE is aiming straight for the most innovative technologies that allow more personalized and preventive treatment of diseases such as cancer.  Here's an example of a technology CMS worries might not be comparatively effective:

"A limited body of evidence informs gene expression profiling tests to inform cancer therapy decisions.  It is unclear if the widespread addition of such testing to the evaluation of patients with would result in a meaningful change in disease management and improved health outcomes."

Yes, and it was unclear if the widespread addition of taxol to breast cancer patients would result in a meaningful change either.  But it did.  But only after we had a widespread addition through clinical use. 

The larger issue is how  CMS  sticks approaches to evaluation that are outdated and fail to incorporate the same science used to develop the technologies they want to measure.  This includes biological m markers of disease, disease progression, differences in treatment response and effects.  This was and is the rate limiting factor that led the FDA to launch the Critical Path.  

The Personalized Medicine Coalition has offered to meet with CMS to encourage a more patient-centered approach in evaluation, which is a great first step.  But we need a Critical Path for Personalized Medicine to insure that the old tools and methods of evaluation are not used to exclude and delay access to innovations but instead help guide appropriate use from the outset and learn from how clinicians optimize care. 

Here's a laundry list of some of the new technologies (and a few old ones) that CMS wants to apply outdated comparative effectiveness evaluation as NICE does in the UK
http://www.cms.hhs.gov/mcd/ncpc_view_document.asp?id=19

Contact PMC for a copy of the letter it sent to CMS.  It lays out a set of common sense set of patient-centered principles for evaluating new medical technologies.  
http://www.personalizedmedicinecoalition.org/

Britain’s National Health Service is preparing to allow its loyal subjects to pay for some top-up drugs.  

“Topping off” is when a patient pays for drugs that the NHS will not provide because NICE (The National Institute for Health and Clinical Excellence) has determined that a given medicine’s “cost-effectiveness” isn’t up to snuff.

Key point – the government is getting ready to allow private citizens to spend their own money on healthcare. 

According to an article in the Times of London, opponents of this reform feel it will  “spell the end of the National Health Service.”

The complete Times story can be found here.

Further reforms are planned to the system under which local NHS committees decide which patients are exceptional cases and can receive drugs not yet approved by NICE.

If you are not “exceptional,” please take two steps forward … over the cliff.

Ministers were forced to review the ban after an outcry over the death in March of Linda O’Boyle, a grandmother who was denied free NHS treatment after buying a drug to treat her bowel cancer.

According to some at the NHS, patients must be made to understand what might happen if they ran out of cash before finishing their treatment.

Indeed.  But what about never getting a chance at treatment in the first place?

Attention must be paid -- particularly by those who deem "health care like in England," as the "universal" solution to health care reform in the United States.

Yesterday’s CMPI conference on the current state of continuing medical education addressed the single most important issue relative to industry-sponsorship of CME – it works.

It’s really telling that this is the great unspoken secret.

Well, yesterday it was spoken about – a lot.

George Lundberg, MD (editor-in-chief of the Medscape Journal and former JAMA editor) spoke of “government by consent of the governed” – his point being that physicians overwhelmingly support industry support of CME. Lundberg commented that, "As we say in LA (that's Lower Alabama), if it ain't broke, don't fix it."

Tom Stossel, MD (Professor of Medicine, Harvard Medical School) spoke of “an inquisition of disclosure.”  Tom is always so subtle.

Jack Lewin, MD (President, American College of Cardiology) reassured the audience that none of the members of Congress he’s spoken with are considering an industry tithe for CME (which would then be distributed by some high-minded and entirely conflict-free government-anointed body).

Jack's pretty plugged in, but if such a legislative program ever was enacted, perhaps it could be dubebd “PDUFuss."

Dr. Lewin also spoke of the current “run-and-hide” environment of the CME sponsorship debate.  How helpful. The denizens of conflict of interest (the so-called “COI-Polloi”) have once again put their own private/political interests in front of the public health.  And the result may very well be devastating.

At the end of the day, the most important message coming out of this event was that there are two sides to every story (often more) -- and that all the current  binary/good guy-bad guy debate achieves is is to hide the tremendous nuances in how physicians learn (and, ultimately, how patients benefit) from industry-sponsored CME.

The full proceedings of this event (full audio and video, along with all PowerPoint presentations) will be available shortly at www.cmpi.org.

Jack Lewin’s opening slide really summed everything up. Here’s what it said:

 “The best interest of the patient is the only interest to be considered.”

                                                            William Mayo, MD

I wonder if Rahm Emanauel or Charles Grassley have any second thoughts....

http://www.reuters.com/article/politicsNews/idUSN1842642120080918

McCain, Obama rethink drug reimportation: aides

Thu Sep 18, 2008 3:26pm EDT

By Susan Heavey

WASHINGTON (Reuters) - U.S. presidential candidates Barack Obama and John McCain are reviewing their support for allowing individuals to import cheaper prescription drugs in light of tainted medicines and other goods made in other countries, their advisers said on Thursday.

Reimportation, as the practice is known, has been controversial for years, even as some supporters have arranged trips to Canada and Mexico for patients to stock up on cheaper medications.

But recent scares involving chemical-laced batches of baby formula and the blood thinner heparin -- both made in China -- have raised new concerns that safely bringing in additional medical products from overseas could be tougher than expected.

"Both candidates were in favor of reimportation and sort of subsequent to the heparin incident (there's) a lot less enthusiasm," said Dora Hughes, a health policy adviser to Democratic candidate Obama.

"We have a better understanding of the challenges that go along to support the importation," she said, speaking before the Generic Pharmaceutical Association's (GPhA) annual conference in Washington .

Neither adviser said their candidate had abandoned reimportation, but had realized it would be more difficult.

"We now realize the challenges for doing that are greater than before," Douglas Holtz-Eakin, a senior policy adviser to Republican candidate McCain, told reporters at the conference.

Groups representing brand-name and generic drugmakers, including GPhA, oppose reimportation, saying it could allow more unsafe products into the country.

Canada and some other countries have lower prices for many prescription drug because of government price controls. Several U.S. bills have proposed allowing some importation for personal use but have never become law.

Since then, problems with numerous foreign products have raised new questions about how to import medications safely.

Most recently, more than 6,000 infants in China have fallen ill and at least three have died so far from milk powder contaminated with the chemical melamine, in a widening scandal that erupted earlier this month.

Sales of Chinese-made formula are banned in the United States , but U.S. officials have said some formula may have slipped into the country.

In February, the U.S. Food and Drug Administration reported the first deaths in U.S. patients given heparin made by Baxter International Inc. The agency later acknowledged it had failed to inspect the Chinese facility where the drug's raw ingredient was made.

Pet food, toothpaste and other Chinese-made products have also drawn U.S. warnings. Critics have chided the FDA for its inability to properly inspect overseas manufacturers.

FDA officials have said they lack enough staff and money to regularly inspect such facilities.

(Reporting by Susan Heavey; Editing by Tim Dobbyn)

 

Danny Carlat, the self-annointed, holier than the rest of , high priest of what passes for bias and conflict of interest in medicine doesn't like it when someone suggests that the assertion that pharmaceutical support for CME is corrupting is simply an biased assertion that survives only in an evidence free zone.... This exchange, which shows the practicing psychiatrist becoming unhinged by my fairly mild post, shows what happens when a self-righteous gasbag is punctured:

Getting Slimed by the Slime Specialists

"I must be doing something right. Yesterday, after I provided some free publicity for an upcoming "evidence-based" evaluation of industry funding of CME, I received the following comment from the Vice President of CMPI, Robert Goldberg:

Apparently you are the only pure one left on the planet. You have no biases or opinions that color your judgment or clinical practice. And of course your opinion about the negative pharmaceutical industry's impact on research -- none of which can be demonstrated through the traditional scientific methods but only appeals to emotion -- are right and everyone else is wrong. But that's not bias. Apart from the fact that the Sourcewatch material is three years old and outdated (which means you didn't even bother to check the facts since our 990 is readily available) you don't even have the intellectual or moral courage to engage on the merits of the issue CME or more generally the relationship between industry and academia. Rather, you resort to the oldest rhetorical trick in the book: attacking the character or motives of a person who has stated an idea, rather than the idea itself. That's the sign of a bully and a coward. If you had any integrity or guts at all you would show up at our session (the very thought of it must give be keeping you up nights!!) engage in reasoned discussion. But I doubt you will.

In this response, Mr. Goldberg demonstrates exactly why his organization and his blog have become notorious for perfecting the art of personal-attack-as-policy-discussion. Those who want to find example after example of Mr. Goldberg's and Mr. Pitt's inimitable rhetorical style should read this expose recently published in opednews.com.    Here Danny links to the ravings of Evelyn Pringle....a most reliable and objective source of information...

Some of their pit bull (sans lipstick) pronouncements:

--"Sidney Wolfe, Public Citizen’s General Secretary of Junk Science..."

--"Not the real FDA - a Grahamatization" (referring the David Graham, the FDA analyst who revealed the extent of the Vioxx health risks)

--"That's the sign of a bully and a coward," describing me. We've descended to that level of name-calling now?

If Mr. Goldberg would like to engage in the merits of the CME discussion, he merely has to read dozens of my prior postings, in which I comment ad nauseum on the innumerable developments, debates, and policy pronouncements in the world of CME. If he would like concrete examples of commercially biased CME, I have provided them in spades.

Unlike the speakers at his conference, I don't have Fortune 500 companies standing in line ready to pony up for a trip to Washington D.C. at a moment's notice. If CMPI really wanted to engage in an "evidence-based" discussion, they would have invited speakers with alternative points of view, but they didn't, and because of that, the conference is a charade and is merely an opportunity for networking among those who profit mightily from industry-sponsored CME. "


And here's the psychiatrist's temperate posting of the previous day....

Wednesday, September 17, 2008

Jurassic CME Park comes to Capitol Hill

Look out, congressmen and senators. The dinosaurs are stampeding the Hill.

That reactionary unthink tank, Center for Medicine in the Public Interest (CMPI), is sponsoring what they are calling an "Evidence-Based Evaluation" of industry support of continuing medical eduation. You can view their invitation here.

For those who have not yet learned about CMPI, go to Sourcewatch for as much information about them as you can stomach. Essentially, they are a front group for the pharmaceutical industry, the CME industry, and whatever other stakeholding company is willing to fund them according to this menu of donating options. For example, $10,000 buys you a "corporate sponsorship" and up to four meals with "CMPI research scholars," $25,000 nets you a seat in the "Chairman's Circle" and an invitation to a "summit," and big spenders can go whole hog with a $100,000 membership in the "President's Club," and a "personal briefing."

Joining with this den of integrity will be none other than George Lundberg, M.D., editor-in-chief of Medscape. Dr. Lundberg embarrassed Medscape and the entire medical community recently with this video editorial in which he responded to the CME concerns of the nation's top medical organizations by saying: "We are just going to keep doing what we are doing. It is good. We are clean. Our work is transparent.”

Other participants, all of whom will examine the issue from a balanced and "evidence-based" perspective, are:

 

A question I get asked a lot these days is – Who should be on the short-list for FDA Commissioner?

Henry Waxman isn’t on my list – but he sure sounds like he wants the job.

According to Alicia Mundy at the Wall Street Journal, “In a letter sent today, Waxman, a California Dem who chairs the House oversight committee, demanded that the agency explain its priorities and accused it of carrying water for the drug and device industry."

His specific accusations surround the issues of pre-emption and the dissemination of medical journal articles that discuss off-label use. (For more on pre-emption, see here and here. And on the issue of off-label, see here and here.)

This most recent episode of the Waxman Inquisition really goes beyond the pale. In his letter, America’s Oversighter-in-Chief comments that Deputy HHS Secretary Tevi Troy isn’t to be trusted because:

(1) He once worked at, among other places, Hudson Institute and (2) Because his brother is Dan Troy.

Well, I worked with Tevi at Hudson – and during our joint tenure there we received exactly zero funding from the pharmaceutical industry. But, hey, why let the facts get in the way when the rhetoric of personal attack provides such florid opportunity? Did Mr. Waxman’s office even bother to check the facts? Facts? Facts? Who needs facts when you’ve got friction.

As to Dan Troy, I can personally attest from confidential knowledge that they are, in truth and in fact, brothers. So what? What is Mr. Waxman implying?

Shameful. Cowardly.

It’s also disappointing (but not surprising) that Mr. Waxman chose to release the letter to the media before it arrived at the FDA.

Maybe next time Mr. Waxman should ask one of his interns to hand-deliver the letter – since it’s so urgent.