WSJ Overlooks Stupak Stupor

02/20/2008 10:36 AM |

Anna Mathews puff piece on Bart Stupak paints him as a sometimes overzealous crusader seeking to right wrongs at an out of control FDA...Good thing she didn't include this stirring Stupak statement -- from an LA Times article -- about why Andy von Eschenbach, Sandy Kweder, Janet Woodcock and the FDA's cafeteria guy should resign...

"The drug companies know that this administration ... will do nothing to them. There is no fear of the FDA. With this culture with laissez faire oversight and regulation, I think they should be gone. If we get rid of them, it will put the drug companies on notice."



Is there such a thing as laissez faire regulation?

Last time I checked, drug approvals were at an all-time low and the percentage of IND getting through the FDA had gone from 11 percent to 8 percent over a ten year period. The percent of drugs withdrawn has remained the same over that same time period. Laissez faire?

Oh and has anyone given one tenth of the coverage to the fact that the NIH pulled the plug on the ACCORD study that killed people compared to the ENHANCE trial that did not? In both cases the protocols were changed midstream and ACCORD even had a data safety monitoring board.

I don't see Stupak holding a hearing on that. Maybe it's not a case of laissez faire regulation. Or maybe it's just that you get less media coverage.

http://online.wsj.com/article/SB120347636748679131.html?mod=home_health_right  Read More & Comment...

Dr. Bureaucracy vs.The Sustainable Individual

02/20/2008 07:03 AM |

No, not a new horror movie, a new op-ed from today's edition of The Detroit News:

Bureaucrats threaten personalized medical breakthroughs

American health care has come to a fork in the road.

On the one hand, science is opening up exciting possibilities. The booming field of "personalized" medicine recognizes that every one of us is unique -- not just in some sort of philosophical sense, but in the ways we get sick and the ways we get better.

Personalized medicine can size up our gene sequences to find out what ailments we're likely to get, and even prescribe preventative treatment.

Cancer doctors can now look for "biomarkers" on proteins to detect disease early and determine which treatments are most likely to work.

And this same science can help our doctors understand what medicines are wrong for us, avoiding unnecessary pain, suffering - and expense.

Unfortunately, just as these groundbreaking therapies are coming within reach of consumers, politicians and bureaucrats are threatening to make them off limits. As science makes ever-more-targeted treatment possible, politics could drag us right back to a one-size-fits-all system."

Here's the rest of the story:

http://www.detnews.com/apps/pbcs.dll/article?AID=/20080220/OPINION01/802200397/1008

And to further entice you, here's the concluding paragraph:

We hear a lot about sustainability these days. We want our ecosystem and our economy to be hale and hearty over the long term. But we also need a health care system that creates sustainable individuals. A market-driven system can do that, by bringing all the latest treatments to the public and letting competition drive down prices. Bureaucracies, by contrast, are mainly in the business of sustaining themselves. A move to government health care will take us down the wrong path.  Read More & Comment...

Partnerships? We Don't Need No Stinkin' Partnerships

02/19/2008 09:28 AM |

The Tufts Center for Drug Development -- enemy territory for drugwonks because of its concentration of RedSox rooters -- held a session on business models to improve R and D productivity recently...The takeaway point:

“No company – big, medium, or small pharma, or biotech – will develop new drugs entirely alone,” claimed the Center’s director, Kenneth Kaitin, at a recent panel meeting of industry executives in the US.

“Increasingly, R&D productivity gains will depend on developers focusing on what they contribute best to the drug development value chain and partnering with organisations that provide capabilities that are too expensive to develop or maintain internally, or are outside of the company’s core competence,” he added.
Read More

Meanwhile the Institute on Medicine as Profession, which is leading the purge of all contacts between industry and academia has a new program designed to cut the private sector out of drug development altogether. It is being lead by one of the leaders in drug discovery, David Rothman, PhD. ....Where would the government -- yes the government would be in charge -- get the money? What's in your wallet?
Read More

  Read More & Comment...

Parallel Trade? Don’t ask. Don’t tell.

02/19/2008 07:35 AM |

At a recent London policy conference on parallel trade, Heinz Kobelt (Secretary General of the European Association of Euro-Pharmaceutical Companies – EAEPC) discussed his association’s credo of “know your customer.” This was during a discussion of how parallel trade can actually help to enhance drug safety and security. (More on that absurd canard in a moment.)

But, during the ensuing Q&A it turns out that “know your customer” actually means “don’t ask/don’t tell” when it comes to one of their most important and largest category of customers – wholesalers, specifically those shady entrepreneurs who go beyond legal EU parallel trade into the clearly illegal realm of marketing non-approved drugs to North America.

Case in point: Rimonabant.

Licensed and legally marketed in the EU under the brand name “Acomplia,” this medicine is not approved for use in the United States. But type “Acomplia” into any US search engine and you’ll find no shortage of Canadian internet pharmacies ready, willing, and able to sell it to any American with a credit card.

How is this possible? Because these pharmacies are buying their supplies from European wholesalers – wholesalers who are getting their supplies (legally) from within the EU and then selling them (illegally) outside the confines of the Treaty of Rome.

When confronted with this shady behavior, Mr. Kobelt was at a loss for words, finally saying that it was an issue that should be brought up with the wholesalers.

Heinz – you can’t have 57 flavors of “know your customer,” choosing to "know them" only when it's convenient is a policy that is neither sound nor honest.

As to parallel trade enhancing safety and security, here’s how Heinz spins that one.

During his presentation he pointed out (correctly) that the recent spate of counterfeit drugs that had infiltrated legitimate UK pharmacies had been discovered by a parallel trader. And that’s true. But what he didn’t mention is that those same products had already passed through three other parallel traders without being found.

Some victory for drug safety and parallel trade.

Something else that Heinz didn’t share was that, when the parallel trader found the counterfeits, rather than calling the UK authorities as required (the MHRA in this instance), he called the company whose drug had been counterfeited – so that he could get his supplies replaced.

Parallel trade and altruistic commitment to drug safety? Sure.  Read More & Comment...

Courageous Sanity Triumphs Over Political Inanity

02/16/2008 09:11 AM |

Despite those who believe that the government should control what medical journal articles doctors can read, some courageous sanity from the FDA.

FDA to Guide Off-Label Drug Marketing

By MATTHEW PERRONE AP Business Writer
© 2008 The Associated Press

WASHINGTON — The government on Friday proposed guidelines for how pharmaceutical companies can use medical journal articles to market drugs for unapproved uses.

The Food and Drug Administration guidelines, criticized by some lawmakers as too lenient, have been eagerly anticipated by drug and device companies like Pfizer Inc. and Medtronic Inc. that often use medical literature for marketing.

Companies are not allowed to market products for "off-label" uses, or those that have not been cleared by the FDA as safe and effective. However, under a law that expired in 2006, the agency made an exception for reprints of medical journal articles, which sales people often give to physicians.

Off-label prescriptions account for an estimated 21 percent of overall drug use, according to a 2006 analysis in the Annals of Internal Medicine. The practice is common in treating conditions such as cancer, where doctors will prescribe drugs approved for one type of cancer for another.
"This guidance should reinforce the point that FDA has no business interposing itself between a doctor and scientific information," said Peter Pitts, president of the Center for Medicine in the Public Interest.

Rep. Henry Waxman released an earlier draft of the guidelines in November without FDA's permission. The California Democrat, who chairs the committee on oversight, said Friday FDA should not issue final guidelines until Congress makes sure the new standards will not jeopardize patients.

"This ill-advised guidance is great news for the drug industry but terrible for public health," Waxman said Friday.

But former FDA Deputy Commissioner Scott Gottlieb said getting the latest medical research to physicians is critical for the patients, since it can take months or even years to update drug labels.

Gottlieb points out that Genentech's breast cancer drug Herceptin showed breakthrough results in early-stage tumors as early as 2005, but wasn't approved for that use until late 2006.

Here’s a link to the FDA statement:

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01798.html

And here’s a link to the complete AP story:

http://www.chron.com/disp/story.mpl/ap/fn/5545881.html

Knowledge is power. And information saves lives.   Read More & Comment...

Dr. Stupak on SSRIs and Suicide

02/15/2008 07:18 PM |

Here's Bart Stupak, head of the Health subcommittee on Energy Commerce, who is running the series of show trials on the FDA and the pharmaceutical industry (only anti-industry and FDA malcontents need testify) on the "link" between SSRIs and suicide:

"SSRI’s have not been proven effective in treating adolescent
depression. To the contrary their use may actually increase the suicide rate of its young
patients. In response to these reports of increased suicide rates with SSRI use, FDA
officials suppressed their own post marketing surveillance, prohibited FDA employees
from discussing the report, and launched an investigation to find the person who leaked information to the press. Today, SSRI remain on the market without a clear medical benefit to the patient."

Setting aside the recent tragedy in Northern Illinois where the gunmen went off his meds, went on a shooting spree and killed himself. ...Stupak's statement is not only scientifically incorrect, it is downright misleading and dangerous. There should be a black box warning around everything Stupak says regarding medicines, particularly SSRIs which have been shown to benefit patients and are associated with a decline in suicides. And again, there is no link to SSRIs and in increase in suicides, rather some unclear evidence based on an unvalidated measure called suicidality that includes just talking about self harm in general.

Stupak held several fear-drenched hearing about antidepressants in 2003-2004. He is partially responsible for the decline in SSRI prescription use and the corresponding increase in adolescent suicide. So the question is:

And this guy is head of the Health subcommittee? Why is he being taken seriously? Why isn't he being held accountable?

Here's Bart Stupak on the "link" between SSRI's and suicide

  Read More & Comment...

Importation a "done deal? Don't bet on it.

02/15/2008 06:08 PM |

Like they say, everything you read in the newspaper is true – except for those things you know about personally.

Case in point: the Wall Street Journal reporting that, regardless of which of the remaining three amigos gets elected in November, “drugs from Canada” is a done deal.

Nope. Here’s why not:

(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.

And 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.

So while the candidates may opt for “drugs from Canada” as a useful political talking point – a way to say “look how tough I can be on those bad drug companies. The real issue lies elsewhere.

When it comes to health care reform, there’s one major policy difference that sets Senator McCain apart from Senators Obama and Clinton – Senator McCain believes in the strengths of a market economy. He sees drug importation as an access issue. The other side sees it as a way to import price controls and a first step towards government-run health care.

Don’t get fooled by the importation rhetoric. It’s nothing but a side-show. And it ain’t gonna happen. It's more dangerous as a smoke screen.  Read More & Comment...

Rhetorical Question

02/14/2008 12:21 PM |

Rhetoric counts.

People seem to like the idea of "universal care" but don't much cotton to "government care." That's why you don't hear any of the remaining presidential candidates talking about the latter. But here's one term that nobody seems to like -- health care rationing.

Unfortunately, though, health care rationing is a direct consequence of government-run health care throughout Europe. It's a truth that's, well, universal -- although entirely absent from SiCKO and stump speeches.

Consider the recent report by the British House of Commons Health Committee. They made a total of 38 recommendations -- here are two:

* Wider debate on rationing in the healthcare system across all stakeholders: in particular, NICE must communicate more clearly the reasons for a negative appraisal to patients and clinicians. The Committee also highlighted the scope for disinvestment in some areas to free up resources for more "cost-effective" treatments.

Typical centralized approach -- costs first, patients last. That's one thing that is universal about top-down government-run health care.

But here's some good news. The Committee also recognized the need for additional research into a more "societal-friendly" (aka: long-term and patient-centric) view of HTA. Specifically, the Committee wants to know more about the Swedish Pharmaceutical Benefits Board (LFN) and its wider societal perspective on reimbursement assessments.

Maybe there's something to be said for the Stockholm Syndrome after all.

All things considered, a free-market approach to health care is the best solution since, by definition, it combines the needs of the consumer (aka: the patient) with those of the service provider (in this instance, payers). Part D is only the most recent manifestation of this Economics 101 phenomenon.

And amazingly (if not surprisingly) discussion of Part D seems to have evaporated from the presidential debate. Why? Because it reinforces the proposition that free-market health care (in the case of Part D in combination with a behemoth government program) gets the job done with excellence and under budget.

There's a lesson there not only our transatlantic cousins -- but for our presidential candidates.

Will reality triumph over rhetoric? Stay tuned.  Read More & Comment...

Parallel Universe

02/13/2008 12:30 PM |

I'm in London at a conference on the European parallel trade experience. And it is, indeed, quite an expereince.

Consider first the topic I have been assigned to address: "What a potential Democratic victory will mean for parallel trade in the USA." Well, first of off, I certainly intend to share with my European colleagues my belief that ALL elections in the United States are democratic ones. And next I will tell them why, when it comes to parallel trade (aka "drug importation") it won't make any difference whatsoever.

But I'll report on my own remarks tomorrow. For now, let me share with you some insights from Mr. W. Neil Palmer of RTI Health Solutions. (By way of bona fides, Neil has served as a senior official with the Canadian Patented Medicine Prices Review Board -- the dreaded PMPRB -- as well as with the Health Division of Health Canada, and the Kellogg Centre for Advanced Studies in Primary Care in Montreal.)

His take on the European experience with parallel trade:

* It is not the policy of EU governments to use parallel trade to deliver savings to their individual health care systems.

* Because savings are not passed on to consumers and payers.

* Patient care may be jeopardized because of quality, supply chain integrity and reguatory compliance issues -- as well as potential shortages occuring in exporting nations.

* Increased parallel trade results in decreased competitivenes of the pharmaceutical industry in local markets. And, since the profits of the parallel traders aren't reinvested into R&D, opportunities are lost for the patient, the local health care system, and the economy.

Other than that, it's been a terrific experience.  Read More & Comment...

Something Fierce in Healthcare Finance

02/13/2008 09:22 AM |

Fiercemarket publishing adds another publication to its lineup today. Along with it's excellent coverage of the business and science of pharma and biotech it will now follow the money in FierceHealthcareFinance. The newsletter will cover managed care reimbursement policies,state and federal regulation, medical billing and coding and IT solutions for finance along with other issues.

Go to fiercehealthcarefinance.com for more information and subscription links.

Best of luck!  Read More & Comment...

Health Care For All

02/12/2008 10:23 PM |

But not if the special interests, single payer types, stick-in-the-muds get their way...

Here's Benjamin Brewer's column on how he could deliver cheap primary care for $20 a month per person, but can't because of the usual collection of regulations and organized resistance. Reminds me of the obstructionist stance of doctors groups and protectionist fault finding of Health Care Renewal when it comes to retail health clinics..

But it makes sense to me that there be fair payment for primary care services that require a lot of what is now largely uncompensated work beyond an office visit. The cost would be peanuts, and the benefits of improved care could be enormous. What's missing in the debate over our nation's health-care crisis is that primary care is cheap. Cheaper than your cellphone bill. Cheaper than a tank of gas. Cheaper than dinner and a movie. It's so cheap the average person doesn't value it properly. I could have covered my salary for 2007 and the costs of all my staff and overhead for less than $20 per patient per month, including maternity and hospital care. My practice covers 80% to 90% of what the average person would ever need a doctor for. Compare that to what you or your employer is paying for health coverage, and you'll find that the high costs are due largely to catastrophic illnesses, hospital charges and money going to middlemen.

"....Even though I'd like to, I can't offer comprehensive primary care on a subscription basis for $20 per month. The Illinois Department of Insurance would send me to the slammer for running an unlicensed insurance company.

But most Americans could afford a package that combined $20-per-month primary care, $4 generic pharmacy prescriptions and some catastrophic coverage. If the combination was tax-deductible for the individual, then I think it would be a slam dunk. Netflix can rent you 4 movies a month for $23.99, but I'm not allowed to rent you a medical home for less than you'd spend to watch a movie each week. Before we're saddled with an unaffordable national health plan, we should consider renting an affordable medical home...."

But that's the point Dr. Brewer. Screw the fact that you can deliver an affordable and quality product to people who would buy it an open market that you are proud to deliver. It's all about saddling us with national health care. Ideology uber alles...

Oh, and did you disclose your conflicts. The folks at Health Care Renewal -- the arbiters of politically correct speech in the health care arena -- demand to know before you are allowed to give your opinions again.
http://online.wsj.com/article/SB120277184155560513.html  Read More & Comment...

Step Up to Debar

02/12/2008 11:31 AM |

According to the Pink Sheet:

"The integrity of FDA's drug approval process is being undermined by the agency's failure to actively and consistently prohibit participation by companies and individuals previously convicted of crimes associated with drug approval, the House Energy and Commerce Committee's minority staff concludes in a report released Feb. 11 by Rep. Joe Barton, R-Texas."

Does Mr. Barton have any evidence that folks who should have been disbarred haven't been? Does a lack of disbarments equal a lack of enforcement?

"FDA's debarment authority comes from the Generic Drug Enforcement Act of 1992, which was enacted in response to the generic drug scandal of the late 1980s. It allows debarment of generic drug companies, but FDA has failed to take action against even one firm, the report says."

"The report also notes deficiencies in the law and suggests FDA be given authority to debar brand-name and biologics companies, as well as those that make animal drugs and medical devices, that debarment be allowed for misconduct that occurs after a drug is approved and that incentives be devised to encourage FDA to start and complete debarments more quickly and efficiently."

Is Mr. Barton recommending that "crimes" be broadened to include "misconduct?" What does this mean -- and what does "misconduct" include?

"The report was released the day before the House Energy and Commerce Oversight and Investigations Subcommittee hearings on a fraudulent clinical trial conducted for Sanofi-Aventis' antibiotic Ketek."

Clearly the timing of the report is coincidental.  Read More & Comment...

CMS Unmoved By Clinicians But Persuaded by Paper

02/11/2008 01:31 PM |

Here's CMS Medical Director on the CMS policy to restrict ESAs in a one size fits all way:

The American Society of Clinical Oncology, which represents cancer doctors, and the drugs' makers, are continuing to submit new evidence to bolster their argument that the restrictions will boost the risk of blood transfusions, he said.

FERVENT REACTION

Straube said he has seen no convincing evidence to support reversing the decision. A recent poll released by cancer and blood doctors suggesting doctors believe the policy is leading to more blood transfusions will have little sway, he said.

That survey of about 500 oncologists and blood doctors asked about views on Medicare policy and its impact on care.

Straube said there is no evidence in properly controlled trials that blood transfusions could rise based on the policy.

"People don't use surveys to make national coverage decisions," he said. "These were opinions."

Straube said he was "disappointed" and surprised by the fervent reaction of the cancer doctor community.

"Our staff looked at over 800 evidenced-based articles published in the literature," he said. "I doubt seriously whether most clinicians read all 800."


Lest I incur the righteous wrath of Healthcare Renewal, let me restate what I found after going through all the evidence-based articles...

There is no evidence in properly controlled trials that blood transfusions won't rise nor that blood transfusions are safer or could be associated with less cancer. So why is the burden of proof on clinicians and patients? Similarly, where is the evidence that the additional risk of cancer -- the relative risk of which must be established in the context of the existing cancer under treatment and with the recognition that in all the properly conrolled trials excess mortality was not always associated with higher hemoglobin levels -- is not worth the benefit from the patient perspective?

According to Straube, the opinion of a patient or physician no longer counts. Only the judgement of staff who look at evidence-based articles matter. And as for those studies, there is no consistency in trial design, population size, tumor stage, etc. There is a lot of mixing and matching and none of those studies look at the safery and effectiveness of blood transfusions.

Is this how we want medicine to be paid for and practiced in the United States? Should we ignore individual differences in response to drugs and disease in favor of population based studies.

It's a pretty straightforward question. Let me know. Leave the ad hominem attacks out.


http://www.reuters.com/article/Regulation08/idUSN0850178720080208  Read More & Comment...

Hoosier Daddy?

02/11/2008 01:04 PM |

Oh well, so much for, um, pulling one's own weight.

According to a story in the Chicago Tribune, “Executives at an Indianapolis health-care system, frustrated by rising benefit costs, proposed a new program to get employees fired up about staying healthy.

Rather than offering incentives, Clarian Health Partners would fine employees who didn't try to quit smoking or lower their cholesterol or blood pressure. The threat of hiking their medical premiums by as much as $30 per paycheck surely would get their attention, executives reasoned.

They were right, but the proposal also generated so much resentment that Clarian Health never rolled out the program.”

Here’s a link to the complete article:

http://www.chicagotribune.com/business/chi-sun_health_0210feb10,0,1758041.story

Wonder how these folks in the Circle City feel about another type of health care mandate – government-run health care?  Read More & Comment...

Insta-Americans: Now Cancer

02/11/2008 12:04 PM |

According to a story on the Forbes website, “Just 5 percent of Web pages devoted to breast cancer contain inaccurate information. But pages focused on complementary or alternative medicine are 15 times more likely to make misleading claims and contain other false information, a new study says.

Moreover, standard measures of quality developed to assess the accuracy of Web pages don't really work, said the authors of the study, published in the March 15 issue of the journal Cancer.

According to the study, 44 percent of women recently diagnosed with breast cancer search the Internet for relevant information about the disease. Many visit the Internet before seeing a physician, which means they may be forming opinions and making treatment choices without professional input, the study authors said.”

Here’s a link to the complete article:

http://www.forbes.com/forbeslife/health/feeds/hscout/2008/02/11/hscout612512.html

When it comes to breast cancer or any cancer – or any health condition – caveat emptor is dangerous practice.  Read More & Comment...

Shaken – not Stirred

02/11/2008 08:35 AM |

My eldest son has Juvenile Myoclonic Epilepsy that is marvelously under control due to the golden combination of the right medication in the proper dose, along with strict and compliant adherence.

So it came as somewhat of a shock at the end of last month when the FDA issued an altert to health care providers on the “Risk of Suicidal Thoughts and Behavior with Antiepileptic Medications.”

Here is a link to the FDA alert:

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01786.html

As with many recent FDA risk communications initiatives, the unintended consequences may very well outweigh the need for the communication.

To that end I recommend to you an article from the New York Times, “Making Sense of the Great Suicide Debate.”

According to the article, “Many doctors who treat epilepsy patients said they were bewildered by the recent reports and concerned that regulators were scaring patients away from valuable medications based on limited evidence ... In the case of the epilepsy drugs, the F.D.A. found 4 suicides among some 44,000 people taking the drug in 199 studies, and none among some 28,000 on placebo.”

Here is a link to the complete article:

http://www.nytimes.com/2008/02/10/weekinreview/10carey.html?_r=1&ref=health&oref=slogin

The regulatory policy issue at play here is FDA risk communications and the important (and mostly unaddressed) question of unintended consequences.

Is it important for the FDA to communicate with health care providers and patients (and parents of patients) when relevant safety data becomes available? Yes. But is the agency weighing the risks and benefits of such communications with the appropriate finesse – as they do when they review a drug application – that’s the question.

And it’s a good question for the FDA’s new Risk Communications Advisory Committee to consider when they meet for the first time on February 28.  Read More & Comment...

Make Mine a Rubin

02/09/2008 11:02 AM |

By way of Forbes, a real "call it like I see it" piece by Paul H. Rubin, Professor of Law and Economics at Emory University and former Chief Advertising Economist at the Federal Trade Commission and Chief Economist at the U.S. Consumer Product Safety Commission. The topic is the important role of drug reps and, more broady, drug marketing> Rubin's article is both important and timely -- and should serve as an education for those who opt for soundbites rather than sound public health policy.

On My Mind: A Free Lunch
Paul H. Rubin

There's nothing wrong with letting drug reps schmooze with doctors. What's the matter with Americans? They think there is something incestuous about the connection between drug companies and doctors.

Politicians tell them that the drugmakers wine and dine physicians while pushing the latest antibiotic or statin. Utterly corrupted, doctors impose those medications on patients, whether or not the drugs are better than cheaper alternatives.

A pending U.S. Senate bill would require drug companies to report gifts to doctors of more than $25; the House is investigating marketing practices. New York State's legislature plans to hold hearings this year on the relationship between doctors and drug companies. One congressional critic has even compared the drug industry with the tobacco industry, and Senator John McCain has called drugmakers the "bad guys."

What drugs are these legislators taking? Drug company reps offer overworked doctors useful, lifesaving information in an efficient manner. The drug companies are of course motivated by profit, but economists have known since Adam Smith that the profit motive is the best way to induce someone to do something useful. (Disclosure: I consult for the drug industry from time to time, most recently for Pfizer.)

Marketing and research are both information activities; they work together to get effective drugs to patients. The two activities are not in competition for resources. The denouncers of drug companies don't understand this. One of the senators sponsoring the bill suggests that "the millions of dollars these companies spend on marketing ... could be put into research." In fact, drug companies would not switch money from marketing to research. If they cannot market drugs in the best way, they will reduce spending on research. What's the point of inventing a new drug if doctors and patients don't know about it?

Academic physicians think that doctors should obtain information by reading medical journals. Practicing doctors do not have time to comb through the International Journal of Medical Sciences or the Annals of Internal Medicine. A meal with a pharmaceutical salesperson is a time-efficient way for a busy doctor to learn about new drugs, or perhaps a better therapeutic alternative, or a drug with easier dosing or fewer side effects than the old drug. Physicians interact with more than one drug rep, so they have competing sources of information.

Another argument made by supporters of the Senate bill is that promotion leads physicians "to prescribe the expensive new drugs that are being marketed to them when a more affordable generic would do," in the words of one senator. There are three things wrong with this argument. First, manufacturers of generics do not promote those drugs, so it might be
difficult for the physician to learn about generics at all. Second, new drugs lead to better health outcomes. They keep people out of the hospital. A 2007 study by business professor Frank Lichtenberg of Columbia University estimated that a prescription for a new drug (5 years from FDA approval) costs an average $18 more than an older one (15 years on the market) but reduces other medical costs, including hospital and office visits, by $129. Finally, by leading consumers to purchase newer drugs, marketing increases investment in innovation and thus makes research more likely.

A widely cited 2000 article in the Journal of the American Medical Association summarized 29 published studies critiquing the interaction between doctors and drug reps. Notable feature of these articles, as quoted in the summary paper: "No study used patient outcome measures."
That is, in all of the medical literature on drug sales, there was no evidence of harm to patients caused by doctors and drug reps breaking bread. These articles were written by physicians who by their oaths put patient welfare at the top of the list, but they were critical of the industry based on analyses that totally ignore this measure.

A recent report shows that the life expectancy of Americans is at its highest level ever and will continue to increase. It is truly amazing that this society keeps coming up with ways to demonize and penalize an industry that has provided us with so many benefits.  Read More & Comment...

Crazy Eddies

02/08/2008 11:33 AM |

Here’s an (audio-only) link to last night’s NewsHour with Jim Lehrer, where I debated Gail Shearer of Consumer’s Union on the topic of pharmaceutical DTC advertising – and the specific debate swirling around Dr. Robert Jarvik’s inability to scull.

http://www-tc.pbs.org/newshour/rss/media/2008/02/07/20080207_jarvik28.mp3

Feedback, as always, welcome.  Read More & Comment...

WHO to WIPO: Having wonderful time. Glad you're not here.

02/08/2008 10:06 AM |

According to reports in the Bangkok Post, the World Health Organization led a mission (at the request of the new Thai government) to Bangkok to formulate a report on compulsory licensing and to provide technical advice on various aspects of TRIPS.

But the WHO team is likely to provide more than just “technical” assistance considering that the WHO’s new chief IP official is anti-industry ideologue German Velasquez.

Consider the article Velasquez penned in Le Monde diplomatique not so diplomatically entitled “Unhealthy Profits,”

“After Doha, it is clear that if drugs are considered as goods, health will remain an extension of the market, with remedies and treatments available only to those with enough purchasing power.”

Here’s a link to the complete article (in English):

http://mondediplo.com/2003/07/10velasquez

And here’s another reason to consider the WHO Bangkok mission as slanted -- there wasn’t a single representative from WIPO (the World Intellectual Property Organization).

Hello?

This is Geneva bureaucratic politics at its worst – and blatant disregard for the spirit of international cooperation in both protecting intellectual property rights and advancing public health.  Read More & Comment...

Hypocrisy is Prejudice With a Halo

02/08/2008 09:51 AM |

I find the hypocrisy on the Victoria Hampshire case amusing, predictable and disgusting. But it's just symptomatic of a larger trend fueled largely by hypocrisy.

Let's grant that Dr. Hampshire did find a serious problem with Pro-Heart and that Wyeth responded not by addressing the facts of the matter instead challenged Dr. Hampshire because she received $160 for prescribing a competitor's products through a website that gave her a cut of the drug sales.

Once the supposed "conflict" was identified, all the alarms went off at the FDA. Senator Grassley and the media depicted this as some sort of intimidation of a whistleblower.

How is Wyeth's behavior and the hell that Dr. Hampshire went through any different than when the roles reversed on any well meaning physician or researcher who follows the data but then is undercut by the COI canard? Is it only a COI when a drug company is involved?

How about this...recently the Josiah Macy Foundation released a report demanding that industry funded CME must end and that any academic who receives industry funding should be barred from participating in CME events because of this COI stuff.

Turns out that the report, was prepared as thecarlatblog.com notes by the brightest minds in medicine "The report was the product of a conference attended by many of the brightest minds in medicine", including Catherine DeAngelis, editor-in-chief of JAMA, David Blumenthal of Mass General and head of the Soros funded Institute on Medicine as a Profession which is leading the purge of academics who deign to work with industry; Harvey Fineberg, president of the Institute of Medicine, and David Leach, recent executive director of the Accreditation Council for Graduate Medical Education. Dan Duffy a senior adviser to the ABIM Foundation is a spin-off of the American Board of Internal Medicine, which profits from compulsory certification by internists and internal medicine subspecialists. As of 2005, the ABIM Foundation had over $60 million in its reserves, and its leadership has declared “professionalism,” as it defines it, as its mission.It was chaired by Suzanne Fletcher, emeritus primary care professor at Harvard Medical School

The conference was held in lovely Bermuda not in downtown Baltimore.



Next month, the IOM is holding a meeting on the issue of COI in CME as part of a study funded in part by...the Josiah Macy Foundation and the ABIM Foundation.

Last year the IOM held a meeting, also paid for, in part, by Macy and ABIM. Here were some of the participants:

Suzanne Fletcher
Dan Duffy
David Korn, VP for Research, AAMC and colleague of David A. Davis
Eric Campbell, Phd who works under David Blumenthal at the Massachusetts General Hospital -- and is also associated with the Soros funded IMAP -- where he regularly compiles based on surveys what physicians have what financial connections with industry. These surveys are also paid for by IMAP. High profile medical journals publish the data. The New England Journal of Medicine appropriately prevents him from interpreting the results, but in response to press inquiries he clearly imparts that these relationships are dangerous and was quoted comparing company gifts to physicians to baseball umpires being wined and dined by team management. The JAMA let him conclude that

“financial relationships are prevalent and therefore must be disclosed and managed.”

Who is on the IOM Conflict of Interest Committee?

Eric Campbell for one.

Here is the sampling of the orientation of others on this supposedly objective panel:

Bernard Lo, MD, Chair. He is an ethicist from UCSF who participated in the 1990s Clinton health plan. He has not published extensively on FCOI, although he published a survey of FCOI policies in The New England Journal of Medicine in 2000 (“Conflict of interest policies for investigators in clinical trials” volume 343, pp 1617-1620). In that publication he states:

“We suggest that university-based investigators and research staff be prohibited from holding stock, stock options, or decision-making positions in a company that may reasonably appear to be affected by the results of their clinical research.”

Robert P Kelch, MD, Executive VP, University of Michigan Health System whose last publication listed on Pub Med is entitled: “Maintaining the public trust in clinical research,” a summary in the New England Journal of Medicine in 2002 of the AAMC COI guidelines. Its conclusion states:

“One cannot work simultaneously as an inventor-entrepreneur and a physician or other health care provider and maintain the trust of patients and the public.”

And my favorite:

George Lowenstein, PhD, Professor of psychology at Carnegie Mellon University and in the vanguard of the “social science research” that concludes physicians, contrary to their beliefs, do not know when they are being manipulated by sales techniques. At the AAMC symposium on “The scientific basis of influence and reciprocity” Loewenstein “stressed the following conclusions (pp. 23-24):”

“Conflicts of interest will inevitably bias physician behavior, however honorable and well-intentioned specific physicians may be. Bias may distort their choices, or they may look for and unconsciously emphasize data that support their personal interests.

The only viable remedy is to eliminate COIs whenever possible – e.g. eliminate gifts from pharmaceutical companies to physicians. This should include gifts of any size, because even small gifts can result in unconscious bias."

So perhaps Dr. Hampshire was likewise suffering from unconscious bias or false consciousness. Or more generally, does that transcendent property only adhere to cash from drug firms and not trips to Bermuda from the same Foundation that is underwriting both the study designed to influence the IOM study and the IOM study itself?

As I have written before, the issue of COI is largely a red herring. COI is all about the Left's discomfort with perceived corporate influence in medicine. The giveaway of course is this absurd idea that doctors don't know when a pen will corrupt them psychobabble that is the scaffolding of this purge.

The compiling of gift and speaking registries, the movement to centralize all commercial support of research and education, conduiting it through central AHC administrations instead of to individual faculty members, ban all corporate samples and gifts to physicians and prohibit company sales representatives from visiting AHC faculty are all assaults on the free exchange of information and a threat to very canons of science. This assault on the free speech of academics -- which as I will show is nothing more than a thinly veiled and funded effort by trial attorneys to make it easier to sue doctors and overturn the FDA pre-emption doctrine with respect to what is on a drug label -- will not stand.

The Academic Senate of the University of California System, recently rejected such proposals (“Proposed Guidelines Regarding Vendor Relations”), declaring them “vague, overbroad, addressing perceived rather than real concerns and in violation of academic freedom” (reported in Nature 448: 394, 2007). So to did the University of Medicine and Dentistry of NJ.

This is just the beginning of a fight to take back medicine from the ideologues and tort lawyers.

Ambrose Bierce defined hypocrisy as "prejudice with a halo." Exactly. Time to knock that halo off.  Read More & Comment...