Latest Drugwonks' Blog
Now maybe people will start listenng.
Both campaigns, it seems, have come to their senses. The issue is safety.
And:
(1) It won’t save any money. Let’s not forget the non-partisan CBO study that showed that such policy would reduce our nation’s spending on prescription medicines a whopping 0.1% -- and that’s not including the millions of dollars the FDA would need to set up a monitoring system.
(2) The drugs being sent to U.S. customers from Canadian internet pharmacies are not “the same drugs Canadians get.” That bit of rhetoric is just plain wrong. Canadian internet pharmacies – by their own admission – are sourcing their drugs from the European Union. And while they may say their drugs come from the United Kingdom, let’s not conveniently forget that 20% of all the medicines sold in the UK are parallel imported from other nations in the EU – like Spain, Greece, Portugal, and Lithuania.
The important political point here is that when Americans are asked if they want drugs from nations other than Canada – the answer is a resounding “no thank you.”
(3) The state experience has been dismal and politically embarrassing. Remember the high profile “I-Save-RX”program? Over 19 months of operation, a grand total of 3,689 Illinois residents used the program -- which equals approximately .02% of the population. They don’t call him “Wrong Way” Rod Blagojevich for nothing.
And what of Minnesota and Governor Tim Pawlenty’s RxConnect program? According to its latest statistics, Minnesota RxConnect fills about 138 prescriptions a month. That's for the whole state. Minnesota population: 5,167,101.
And remember Springfield, MA and “the New Boston Tea Party?” Well the city of Springfield is now out of the drugs from Canada business.
(4) National Security concerns. According to a recent report from the federal Joint Terrorism Task Force, a global terrorist ring with ties to Hezbollah, is importing counterfeit drugs into America by way of Canada. They are doing so for profit today - but could just as easily do so for more nefarious and deadly purposes. And legalizing importation would only facilitate such actions.
The next canard, that of "universal" care is even more dangerous. It's government care -- and it ain't free.
"Universal" care is the new importation.
But we'll bask in the demise of importation until Monday.
(And, hopefully, reports of its death have not been greatly exaggerated.)
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)
In a consumer driven world, we could shift our dollars to what ails us most and find the best sources of care. But we are not there yet. In the meantime, the efforts of Congressmen Patrick Kennedy and Jim Ramstead should be commended along with those of Senator Pete Domenici to eliminate disparities in how mental illness is regarded by many health plans.
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:
--Roger Meyer, MD, listed on the brochure as "Clinical Professor of Psychiatry at Georgetown University and Adjunct Professor of Psychiatry at the University of Pennsylvania." Unfortunately, there just wasn't room to disclose the fact that he is actually the CEO of a company called Best Practice, which helps companies market their drugs via CME and provides a roster of "key opinion leaders" for hire.
I've only scratched the surface here, folks. There are many more speakers scheduled, all of whom are similarly dispassionate observers of the CME scene, and are equally scrupulous in their disclosures.
If you do go, I have a word of advice. Be careful around the speakers. Dinosaurs bite.
Mission accomplished.
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,
(1) He once worked at, among other places, Hudson Institute and (2) Because his brother is Dan Troy.
Well, I worked with Tevi at
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
From the Financial Times:
“A legal battle between GlaxoSmithKline and Greek wholesalers over parallel trade in drugs – which could have implications for the price of medicine - ended with a mixed result on Tuesday morning at
The European Court of Justice ruled that if a dominant company refused to meet “ordinary” orders for medicinal products, because it wanted to put a stop to parallel exports, it was breaching EU competition law.
But the judges said that it was up to individual countries’ courts to decide whether orders were “ordinary”. They would need to look at both the previous business relations between the drug company and the wholesalers concerned, and the size of the orders in relation to market needs in the country concerned.
Drug prices in
As a result, in 2000, GSK changed its Greek distribution system, and supplies to wholesalers were interrupted. The wholesalers complained that this amounted to anti-competitive conduct and an abuse of a dominant position.
In April, a senior legal adviser at the ECJ largely ruled against the company. Tuesday’s full court decision significantly qualifies that position.”
And via Bloomberg, this add:
“The court ``has confirmed that companies must be able to take reasonable and proportionate steps to protect their own commercial interests, even if they hold a dominant position and such steps must be assessed in the light of the ordinary requirements of the markets,'' London-based Glaxo said in a e-mailed statement.”
Is this the beginning of the end of pharmaceutical parallel trade in the EU? It depends. But one thing is certain, if nations such as the
No matter -- if the EU decides to act in its own best interests perhaps the next Congress can design a plan where we import cheaper drugs from ... India.
The House Energy & Commerce Committee needs to help fix the problem, not the blame.
Statements coming out of the committee like -- “The FDA has refused to take meaningful regulatory action despite the fact that, for the past three years, it possessed credible information that Ranbaxy had engaged in a pattern of fraudulent behavior regarding its generic drug applications and records pertaining to good manufacturing practices.” -- is not being fair to an agency that at the time under debate and yet today is under-funded and under-staffed.
But when the committee says -- “The FDA, for example, conducted preapproval inspections for only 17 percent of the Ranbaxy applications approved since January 2005. It also allowed Ranbaxy to perform the key bioequivalence studies for generic drug approvals in facilities owned by the firm and conducted by clinicians employed by the firm.” – they’re right. The same rule that holds true for innovator companies must also applied to generic drug manufacturers – otherwise the public’s queasiness about the quality and character of generic drugs will continue.
But Representative John Dingell, who chairs the committee, goes to far when he says, “The heparin fiasco made it clear that the FDA had compromised the policies that were put in place during the last generic drug scandal to protect the public from fraud. This latest Ranbaxy announcement further confirms that those protective policies are in shambles. The FDA is not doing its best to protect the medicines that Americans depend on for their health.”
That’s not true. It’s not fair. And it’s not helpful.
FDA backs BPA as study links it to heart disease, diabetes
Really, and I thought it was the all the junk food the corporations put in the plastic bottles that were the cause of those diseases. I guess the evil corporations are just hell bent on killing people...and the FDA, which is "backing" BPA is just doing the bidding of it's corporate masters..
And most important a study in JAMA by David Melzer and crew that ostensibly links high levels of BPA with increased incidence of heart disease and diabetes supposedly proves that BPA causes these illnesses. The study found "that higher BPA concentrations were associated with diagnoses of cardiovascular disease and diabetes. We also found associations between higher BPA concentrations and clinically abnormal concentrations of the 3 liver enzymes examined, namely GGT, alkaline phosphatase, and lactate dehydrogenase. Importantly, we observed no associations with the other common conditions examined, suggesting specificity of the associations. A series of sensitivity analyses provided further support for the specificity of the associations found."
Which lead a BPA expert named John Peterson Myers to invoke THE PRECAUTIONARY PRINCIPLE in a side-by-side editorial in JAMA:
"It's impossible to say that BPA is safe,"
http://www.usatoday.com/news/health/2008-09-16-bpa-heart_N.htm
The problem is that the 2003-2004 National Health and Nutrition Examination Survey (NHANES) which were used to estimate daily intake of BPA, shows that most Americans, regardless of age, have a median intake have approximately three orders of magnitude below health-based guidance values of 50 mug/kg-day....
So Melzer et. al stacked the deck with respect to the BPA levels to demonstrate a correlation with self reported claims of having been diagnosed with diabetes or heart disease and snap shots of insulin and C-reactive protein levels...
http://www.ncbi.nlm.nih.gov/pubmed/18414515?ordinalpos=27&\
http://jama.ama-assn.org/cgi/content/full/300.11.1303#SEC5
http://jama.ama-assn.org/cgi/content/full/300.11.1353
Are we all on the same page now?
All good things.
The issue of companion diagnostics is particularly crucial or, more appropriately, critical (yes -- like in Critical Path) -- and not just for existing medications (warfarin and Herceptin come to mind) -- but also for pipeline programs. Are we approaching a time when the FDA might consider asking for companion diagnostics to be developed as part of the approval process for some products? That would be a 21st century personalized partnership, adding a whole different dimension to both safety and efficacy.
The FDA/Penn agreement also will faciliate interaction between the FDA and Penn students -- an important next step in the agency's urgent need to expand its recruitment efforts.
Particular congrats go out to Mary Poos, the FDA's Sultana of MOUs, for yet another job well done.
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.
