Oxy-Morons: Congressional Prescribing Of Painkillers

05/18/2007 07:34 AM |

Members of Congress telling the FDA to relabel Oxy for only those with severe pain. No mention if having to endure lethal doses of stupidity from legislators and their staff qualifies. http://www.forbes.com  Read More & Comment...

Black Cloud at the FDA

05/17/2007 03:48 PM |

Oped this past Monday by CMPI board member Mark Thornton about the demise of the Office of Cancer Drugs at the FDA....When is the new commish going to inject some science and sanity into the agency?


http://online.wsj.com/article/SB117911315709601659.html  Read More & Comment...

Can Anyone Say Bulk Baloney: Private Sector Crowds Out Public Sector Rx Bulk Purchase Program

05/17/2007 10:14 AM |

Was the point to help the uninsured or simply stick it to the drug companies?

From http://www.fiercehealthcare.com

Arkansas Cancels Prescription Drug Discount Program Because of Lack of Interest
[May 16, 2007]

The Arkansas Department of Health and Human Services has decided to cancel Arkansas Rx, a state prescription drug discount program scheduled to begin enrolling uninsured state residents this year, according to department spokesperson Julie Munsell, the Arkansas Democrat-Gazette reports. Supporters of the program in 2005, when the program received funding approval, said that as many as 400,000 uninsured state residents would have qualified for the program.

However, only 2,800 uninsured Arkansas residents have expressed interest in the program, a number that would not have allowed the state to negotiate bulk discounts on prescription drugs, Munsell said. She attributed the lack of interest in the program, which the state promoted with a radio and newspaper advertising campaign, to the increased number of alternatives -- such as the Medicare prescription drug benefit, discounts on generic medications offered by Wal-Mart Stores pharmacies and discount programs sponsored by pharmaceutical companies. About 21 states have established or authorized prescription drug discount programs for low-income adults, according to Richard Cauchi, health program director for the National Conference of State Legislatures (Manthey, Arkansas Democrat-Gazette, 5/15).  Read More & Comment...

Comparative Effectiveness. Compare and Contrast.

05/16/2007 09:10 AM |

Effective for patients or effective for budgeteers?

When pols and pundits say that we need a system of comparative effectiveness measures "like the UK," it's important to understand what that means. Consider the following ...

An international study of patient access to cancer drugs has found that the UK is in the lowest category of 25 countries, which were measured on the uptake of 67 treatments. The study, by the Karolinska Institute and the Stockholm School of Economics, found that the overall performance was best in Austria, France, Switzerland and the USA.

The researchers noted that the biggest variations across the different national markets in the study were for bowel and lung cancer groups. In both cases, the UK ranked with Poland among the worst countries for patient access to drugs.

This is a system we want to adopt? When Representative Emerson, for example, points to saving "billions, maybe trillions, of dollars" what she means (whether or not she understands it) is that those savings come from denying care.

Yes -- even for cancer patients.

The Karolinska Institute and Stockholm School of Economics study was published in the Annals of Oncology.  Read More & Comment...

EBM: Regression to the Meanest

05/15/2007 05:07 PM |

As if we needed another example of the folly and bias of large studies, the following excerpt from http://www.scientificamerican.com says it all:

Gordon H. Guyatt, a professor of epidemiology and biostatistics at McMaster University in Hamilton, Ontario, who coined the term "evidence-based medicine," collaborated with 16 of his colleagues in an exhaustive survey of existing studies on the outcomes of various medical procedures in both the U.S. and Canada. Their work appears in the inaugural issue of the new Canadian journal Open Medicine, and comes at a time when many in Canada are debating whether or not to move that country's single-payer system toward for-profit delivery of care. The ultimate conclusion of the study is that the Canadian medical system is as good as the U.S. version, at least when measured by a single metric—the rate at which patients in either system died.

Here's what the authors left out to get to their conclusion:

"We included published and unpublished prospective or retrospective observational studies comparing health outcomes (mortality or morbidity) in Canada and the United States for patients of any age with the same diagnosis."

Unpublished? So we have no way of knowing if the study design or results are any good. Ok, next.


"We excluded randomized trials, studies that identified the patients on the basis of the occurrence of one of the adverse health outcomes of interest, and national disease-specific mortality studies that failed to define the population at risk (that is, those with the disease of interest)."

Translation: We excluded anyone who was sick.

"For instance, we excluded studies of national rates of death from cancers because lower mortality may be due either to a lower incidence of cancer or to better care for those with the disease."

That's right folks, better care is not considered a factor in determining which health system is better. Can you say George Orwell?

In otherwords, if you are healthy and "use" the Canadian health system you die at a slower rate than in the US. Wow.

This, from the person who coined the term evidence based medicine.

For those fans of EBM here's the link. Steffie Woolhanler, Canadian health system symp is a co-conspirator on this piece of propaganda.

http://www.openmedicine.ca/article/view/8/1  Read More & Comment...

EBM: Evidence-Based Maybe

05/15/2007 01:20 PM |

Representatives Tom Allen (D-ME) and Jo Ann Emerson (R-MO) held a press conference this morning to announce the introduction of their Enhanced Health Care Value for All Act of 2007.

Representatives of interest groups supporting the legislation and congressional staff out-numbered reporters.

Allen and Emerson mentioned the $3 billion over five years that would be turned over to the Agency for Healthcare Research and Quality (AHRQ) to conduct comparative effectiveness studies.

They did not mention that only one third of this funding would be allocated from the federal budget; two-thirds of the money would come from taxes on health insurance policies.

Oops.

Emerson said the program is needed to combat pharmaceutical company marketing to physicians. She accused physicians of being on the take and encouraged patients to “challenge prescription decisions” made by their physicians.

Funny, last we encountered Representative Emerson, she was trying to limit the information that patients could get on their medicines.

Emerson claimed that the legislation is solely aimed at providing enhanced evidence, but also said it would save Medicare “billions and billions, maybe trillions of dollars.”

That's a boatload of "maybe."

David Helms, president of AcademyHealth said that the U.S. lags other countries in evidence-based medicine, and that it could learn a lot from countries like Australia and the U.K.

He didn’t say what the U.S. could learn from countries that routinely deny their citizens access to breakthrough life-saving and life-extending therapies.

That's why this piece of legislation should more appropriately be called "The Denial of Care Act."  Read More & Comment...

EPO: Blood Diamond Under Scrutiny At FDA and CMS

05/15/2007 09:56 AM |

A lot of coverage about the risks of using EPO -- the anti-anemia drug produced by Amgen and J and J mainly in the news. Much of the coverage is the typical "the drug companies pushed over and off-label use so people died" which is probably 5 percent accurate in that you can always find the cowboys and bad apples in any endeavor.

For the most part the use of EPO in treating patients with chronic kidney failure and patients at risk for anemia has been safe, sane and subject to study via observational and randomized clinical trials. Indeed, reading accounts of the cautions placed on the use of EPO you would think the companies were bribing docs to pump as much of the stuff into people as they could. Quite the contrary. Medical literature abounds with studies about what is the right dose to increase survival while not risk the lives of very sick patients. This research in turn is then evaluated, transparently and independently, into guidelines that are continuously adjusted. In some cases, physicians believed that super-corrective hemo-levels were preferable or tried, with very sick and anemic patients, to give them additional strength even through they were not receiving chemotherapy. It may be not be a perfect approach but patient concerns are and were front and center in most cases.

The most recent clinical trials are a culmination of this ongoing effort. That it might lead to a decline in sales should not be a consideration. Finding the right dose for the right patient should be.  Read More & Comment...

DSHEA is more than a stadium in Queens

05/15/2007 09:26 AM |

Absent in the debate over FDA reform is reform of DSHEA.

Yesterday, the Supreme Court rejected an appeal from a unit of Nutraceutical International Corp. to overturn a Food and Drug Administration ban on its ephedra dietary supplements.

Nutraceutical sued the FDA in 2004 to block the agency's action on ephedra, arguing it was abusing its authority and misusing federal regulations in order to take action on the dietary supplement, which is generally regulated more like a food than a drug.

A U.S. district court sided with Nutraceutical, Salt Lake City, but the 10th Circuit overturned that ruling.

"This case offers a key test of whether the FDA will be required to observe the statutory boundary between foods and drugs," Nutraceutical said in its appeal, arguing that the FDA never met the "burden of proof" necessary to force the supplements off the market. The company

This ruling is good news for the public health -- but it raises the issue of why so-called "supplements" are regulated as food in the first place.

The answer -- DSHEA. And it's time for a change.  Read More & Comment...

Clinton's Global Health Hype

05/15/2007 06:50 AM |

My op-ed in today's Washington Times on how Bill Clinton legitimitized Brazil and Thailand self serving attack on pharma IP. The NGO's who give this exercise moral cover should be doubly ashamed...

http://washingtontimes.com/op-ed/20070514-093346-6396r.htm  Read More & Comment...

The Denial of Care Act

05/14/2007 02:05 PM |

Here we go again. Just got this via e-mail:

"Washington, D.C.-- U.S. Representatives Tom Allen (D-ME) and Jo Ann Emerson (R-MO) will hold a PRESS CONFERENCE TOMORROW (Tuesday, May 15th) at 11:15 a.m. at Cannon Terrace venue to announce the introduction of H.R. 2184, The Advanced Health Care Value for All Act of 2007.

This bipartisan legislation would authorize the investment of $3 billion in new research and syntheses of existing research by the Agency for Healthcare Research and Quality (AHRQ) within the Department of Health and Human Services on the comparative effectiveness of health care services (including prescription drugs, medical devices, procedures, and other treatments) to inform health care providers' decisions.

Joining Representatives Allen and Emerson will be representatives from organizations which support the bill, including AARP, AcademyHealth, Aetna, American Academy of Family Physicians, American Osteopathic Association, American Society of Health-System Pharmacists, Consumers Union, National Business Group on Health and United Health Group."

Folks, don't let the rhetoric fool you. This is legislation should really be named the Denial of Care Act -- because that is precisely what it will do and precisely what it is currently doing across Europe.

What about funding a study on the comparative effectiveness of insurance plans? Wonder how the AARP and AHIP would respond to that?  Read More & Comment...

Wrong-Way Rod Redux

05/14/2007 10:07 AM |

We've referred to the Illinois governor by the moniker "Wrong-Way Rod" because of his stance on drug importation -- the theory being that his compass on the issue of safety was broken.

But we were wrong.

The problem is that he's using the wrong compass. Rather than relying on the Compass of Public Health, Governor Blagojevich has been using the Compass of Political Calculation.

But it seems as though that, latter compass, is broken as well.

Witness Wrong-Way Rod's most recent gambit for attention -- a proposal to fund universal government health care in Illinois via a $7.6 billion "gross receipts tax" on Illinois businesses.

As the Wall Street Journal notes in an editorial, "... a funny thing happened on this road to Canadian health care. The state's more rational Democrats revolted, arguing it would drive businesses out of Illinois."

Aha.

The bigger issue is that, when it comes to health care, calls for "universal coverage," whether for insurance or medicines, sound good as soundbites -- but when people realize that "free" actually means "higher taxes" they think twice.

And this isn't even mentioning the chilling effect such schemes have on innovation.

The Democrat-controlled house in Springfield, voted down Wrong-Way Rod's proposal 107-0 ... after the Governor came out against his own idea.

It seems that Wrong-Way Rod is dealing with two compasses, both of which are broken .

As the Journal opinied, " 'Universal' government health care has once again returned as a political cause, with many Democrats believing it's the key to White House victory in 2008. They might want to study last week's news from Illinois, where Democratic Governor Rod Blagojevich's tax increase to finance health care became the political rout of the year."

Important to remember for many reasons, not the least of which is to see how the Governor's friend and ally, Representative Rahm Emanuel, reacts to Blago's Dilemma.  Read More & Comment...

Vetflix Nix Pix

05/14/2007 07:03 AM |

Check out this Hollywood-inspired look at the VA. It ran over the weekend in the Manchester Union Leader. (Yes, New Hampshire -- for all the obvious reasons).

If you like Medicare, you'll love Moviecare

Imagine turning 65 and finding a letter tucked in your mailbox offering unlimited movie tickets for just $25 a month. You read through the fine print, and amazingly, the offer isn't a scam. It's a new federal program called "MovieCare."

Not a bad deal. It's estimated that seniors spend between five and six percent of their income on entertainment, and this new program -- funded by the government -- would cover most of those expenses.

In some ways, Medicare Part D provides the same service, albeit for goods more important than movie tickets. Seniors used to spend about 3.2 percent of their total income on drugs. Thanks to Part D, those expenses have plummeted, and 20 million seniors who previously lacked prescription drug coverage now have it.

Not surprisingly, more than eight in ten beneficiaries are pleased with the drug benefit. If MovieCare were modeled on the Medicare drug benefit, more seniors than ever before would be able to go to the movies, the vast majority of movies would be available, and beneficiaries would likely enjoy the program as much as they enjoy Part D.

But before long, it's also likely that some congressional lawmakers would decide that MovieCare -- despite its enormous popularity -- was costing taxpayers too much because of heartless movie studio bosses.

We'd see speeches vilifying studio moguls and their "massive" profits. We'd see breathless reports of seniors who went to to see Flags of Our Fathers on a Friday night but ended up trapped in a showing of Man of the Year -- the horror!

Here's a link to the rest of the screenplay:

Download file

And we'll see you at the movies.  Read More & Comment...

proper use of anti-depressants

05/13/2007 05:55 AM |

here's my piece in yesterday's NY Post about the patrolling of anti-depressants and the larger issue of FDA pressures and responsibilities:

DANGEROUS WARNINGS
By MARC K. SIEGEL
May 12, 2007 -- CONGRESS may soon increase the Food and Drug Administration's oversight of pharmeceuticals. I certainly don't think we should simply trust what drug companies tell us, but I have my worries about the FDA, too.
Why? Consider one of my patients. Last year, the teen was in trouble - fighting with both parents during an ugly divorce and becoming severely depressed and violent. He'd had a fistfight with a relative and been expelled from his school

This year, he is not dead or in prison, but back in school. He's a much happier person who has been helped greatly by psychotherapy, time to heal his emotional wounds - and the anti-depressant Zoloft.

I can't say that he would have committed suicide without the medication, but the chances of his downhill spiral continuing would have been much greater. And the pill most certainly did not increase his chances of taking his own life.

Yet the FDA recently opted to impose its most serious "black box" warning on the prescription of anti-depressants to those aged 18 to 24. This sends the wrong message about drugs that are often life-saving.

What has led to these new warnings? An analysis of the use of 11 anti-depressants in 77,000 patients in this age group - which found an increased risk not of suicide but of suicidal thoughts for one patient in a thousand.

This number is quite small - and the FDA has a history of overestimating this kind of risk. It instituted a black-box warning against use of anti-depressants in children and younger adolescents in 2004. But a recent study in The Journal of the American Medical Association showed that the presence of "suicidal thoughts" in this group is less than half what the FDA had thought.

Is there any science behind the fears of these useful meds? Dr. John Mann, director of neuroscience at the New York State Psychiatric Institute and an expert on suicide, notes that starting an anti-depressant can occasionally remove inhibition and fear of death - "the person is no longer indecisive, and suicide may ensue."

But this theory is really a justification for careful observation by a trained professional like a psychiatrist, not for irrational fear of the drug. Any patient taking a drug for the first time may experience unexpected side effects, so early surveillance is always warranted.

And, while some caution about tiny theoretical risks may be in order, a growing fear of these drugs is hurting actual patients.

The pediatric warnings were instituted in March 2004; since then, the number of prescriptions of the common SSRI anti-depressants written for those under 19 has dropped by more than 10 percent. Meanwhile, childhood and adolescent suicides rose by nearly 20 percent in 2004 over the prior year. Fewer anti-depressants, that is, were followed by more suicides.

I worry that we'll now see that trend continue with the extension of the warnings to older patients. Worse, suicide grows more common among older teens, so the loss of life with the new warnings could be that much greater.

Warnings are only useful when they protect us against something dangerous. With untreated depression, the danger of suicide is far greater than the risk of the drugs that prevent it.

Dr. Marc K. Siegel is author of "False Alarm."  Read More & Comment...

There'll always be an England, but ...

05/11/2007 10:13 AM |

There may very well "always be an England," but there won't always be the drugs you need to survive if you live there. Welcome to the world of heathcare technology assessment aka comparative effectiveness aka evidence-based medicine.

When it comes down to brass tacks, what all these fancy phrases means for patients is "sorry -- no medicines for you." So much for "universal" health care. "Government" health care is more like it.

It's reached such a state in the UK that the following appears in today's edition of The Telegraph:

The drugs the NHS won't give you

Suninitib (Sutent)
For kidney cancer.
Licensed, but the Department of Health has yet to refer it to Nice for a recommendation.

John Quance, 57

The former fireman was told he could not have the drug Sutent because the NHS would not pay for it.

Mr Quance, who has been diagnosed with kidney cancer, cashed in his pension and remortgaged his house to pay for it privately, but fears that he may have to sell his home unless the NHS steps in. Cornwall Primary Care Trust said it was not prepared to pay the £22,000-a-year cost of the drug until it was approved by Nice.

Mr Quance said: "I have worked all my life, I have been in the forces, the prison service and the fire service for 30-odd years and I feel a little bit abandoned.

"The staff and the hospital have been excellent but it is a little disappointing not to get funding when it has been proved [the drug] is working."


--------------------------------------------------------------------------------

Bevacizumab (Avastin)
For bowel cancer.
Licensed for colon cancer in January 2005, but turned down on the grounds of cost-effectiveness in January.

Victoria Otley, 56

Miss Otley was diagnosed with bowel cancer at the end of 2005. She had complained of being in pain but doctors told her that it was nothing to worry about.

By the time her cancer was diagnosed it had spread. She took other drugs and later asked about getting Avastin after her sister read about it on the internet. Yesterday, Miss Otley, a former hairdresser from Dagenham, said: "I asked my consultant but he said it wasn't available on the NHS."

She and her sister paid £15,000 for a course of Avastin and the cancer shrunk, however they cannot afford to pay for any more. "You work all your life and pay your taxes and this is what you get. I think it's disgusting."


--------------------------------------------------------------------------------

Cetuximab (Erbitux)
For bowel cancer.
Licensed in June 2004 and turned down by Nice in January this year.

Ian MacDonald

The former bridge inspector's doctor told him that he would have liked to have prescribed Erbitux, but that he could not because it was not available on the NHS.

Mr Macdonald has tried various drugs and radiotherapy since being diagnosed with bowel cancer in the year 2000.

His wife Catherine, who has given up work to care for him full-time, said yesterday: "My husband has worked all his life in this country and never had a day off sick and yet he is refused a drug that might stabilise or shrink his tumour.

"I can't understand why it is not available here but it is in other countries. It's awful."


--------------------------------------------------------------------------------

Erlotinib (Tarceva)
For non-small cell lung cancer.
Licensed in Sept 2005, approved by the Scottish Medicines Consortium in June last year and rejected by Nice in March on the grounds that it was not clinically or cost effective. Manufacturers Roche are appealing against the decision.

Susan Allen, 43

She was told she had ten months to live after being diagnosed with lung cancer in December 2005.

A non-smoker, whose hobbies include cycling and running, the mother-of-one underwent chemotherapy and radiotherapy and was prescribed Tarceva by her oncologist in October last year. She had to pay for the daily pills herself initially, at a cost of £70 per day, until her local health authority eventually changed its mind.

She said: "Denying the drug is condemning patients to death."


--------------------------------------------------------------------------------

(Bortezomib) Velcade
For bone marrow cancer patients who have had at least one earlier therapy or are unsuitable for a bone marrow transplant.
Nice has agreed to review its rejection of the drug in March. Patients in Scotland, Wales and Northern Ireland have been able to get it since last year.

George King, 57

Mr King, who is terminally ill with bone marrow cancer was forced to consider moving to Scotland to get access to Velcade in an attempt to prolong his life.

Mr King, an electrical engineer from Teesside, said earlier this year: "People with terminal illnesses shouldn't have to fight for treatment. It's so frustrating. This drug is available not only in Europe, but just a few miles north of where I live. I don't have any option but to move away from my family, friends and the people who have helped me through the cancer until now."


--------------------------------------------------------------------------------

Pemetrexed (Alimta)
For mesothelioma, a cancer caused by exposure to asbestos, and small-cell lung cancer.
Patient groups are waiting for the results of an appeal against Nice's rejection of the treatment in February for lung cancer. A decision on funding for mesothelioma is expected in September.

Bernard Hoyland

The retired mechanical fitter spent the last years of his life fighting to make Alimta available for patients in his area.

After he was diagnosed with mesothelioma he was told his primary care trust would not pay for him to receive Alimta because it was too expensive. He launched a legal attempt for compensation against his former employers, began travelling to London every three weeks to receive cancer treatment and joined a campaign to force NHS bosses in Teesside to fund Alimta. Six months after funding was agreed, Nice ruled that it was too costly.

Mr Hoyland, who called the decision "simply unacceptable", died last November.

His son Paul said: "He ended up having to travel to central London after finding he could get the chemotherapy down there. He was a victim of the postcode lottery."  Read More & Comment...

Here Comes the Sun

05/11/2007 08:34 AM |

The New York Sun, that is.

In their house editorial, the Sun supports the Senate's vote on the FDA Revitalization Act and makes the point that:

"The thing to remember in all this is that when it comes to innovative medicines, safety is rarely an "either/or" question, as Peter Pitts, a former FDA associate commissioner and president of the market-oriented Center for Medicine in the Public Interest, pointed out recently in the Journal of Life Sciences. On a net basis, people are living longer and healthier than ever before, thanks in good part to the availability of remarkable new drugs. Keeping the innovations coming will only become more critical now that the first baby boomers are senior citizens. The Senate has demonstrated a willingness to do that, no help from our own senators."

Here's a link to the complete editorial:

http://www.nysun.com/article/54294  Read More & Comment...

Kim Possible

05/11/2007 08:01 AM |

We've said it before, but Kim Strassel says is best. Here's her excellent piece from today's edition of the Wall Street Journal.

Canadian Drugs, Eh?

Listen to Maine Sen. Olympia Snowe discuss importing drugs from Canada, and you'll hear endless happy talk about "more competitive prices," "substantial savings" and how "crucial" reimportation is to "the American consumer." What you won't hear Ms. Snowe mention much is the drug-import program of Portland, Maine.

Interesting that, since Portland was one of those cities that gained notoriety a few years back for defying federal law and setting up a Canada import program that it promised would save its thousands of city employees and their dependents a bundle on drugs. Three years in, it has attracted all of 350 participants.

That was also the flame-out fate of a statewide plan by Gov. John Baldacci to empower the Penobscot Indian Nation to build a distribution center to import price-controlled Canadian drugs for some 325,000 uninsured and underinsured Mainers. The tribe in February unceremoniously closed the program (which never got its hands on Canadian drugs, but morphed into a domestic mail-order business), having attracted just 3,000 Medicaid recipients.

Ditto, all across America. Three years ago, grandstanding governors and mayors vowed to break federal law and set up state-run drug import programs, giving millions of citizens the "opportunity" to buy cheap Canadian drugs. The media showered these souls with headlines, praised them for being on the side of poor, strapped U.S. consumers -- then forgot all about it. Today, most state-import programs are on life support, while some have closed completely. Never mind all Washington's hifalutin arguments about intellectual property, free trade and safety; the overwhelming majority of Americans appear to have little use for import programs that offer few drugs at long wait times, under suspect safety conditions and with minimal savings.

All of which helps explain this week's bizarre, and highly cynical, Senate votes on drug imports. Many of the very senators who supported or co-sponsored Ms. Snowe's amendment to change federal law and allow Canadian imports hail from states that have seen their own high-profile programs wither or die. That includes Wisconsin's Herb Kohl and Russ Feingold, Missouri's Claire McCaskill and Dick Durbin of Illinois.

These folks know firsthand that Canadian imports aren't really that popular and won't save much, if any, money. But they do like what this debate offers, namely the chance to bash U.S. pharma companies and to stand with "overcharged" U.S. consumers. The votes are more a sideshow, and it explains why some senators, who publicly support the easing of drug-import laws, also voted for a poison pill that gutted Ms. Snowe's amendment on safety concerns. It isn't as if masses of Canadian drug fans will come storming down their doors.

If anything, Portland is a success compared to the more high-profile state programs that got rolling in 2004. When Illinois Gov. Rod Blagojevich introduced his I-Save-RX program, which was initially joined by neighboring Wisconsin, he dramatically declared that "the nearly 13 million people who live in Illinois and the more than five million people who live in Wisconsin will have the opportunity to save hundreds -- and in some cases even thousands -- of dollars each year on the high cost of their medicine." Mr. Blagoevich spent nearly $1 million in taxpayer dollars developing it, including some 500 state workers from two dozen agencies who spent 5,600 hours flacking the program.

All this caused Illinois Auditor General William Holland to get curious about just how much benefit this wonder program was producing, and last fall he issued a stunning report. Over 19 months of operation, a grand total of 3,689 Illinois residents had used the program, which equals approximately 0.02% of the population. Results from the four other participating states were even more laughably dismal. Wisconsin had 321 people use the program; Kansas 267; Missouri 460; and Vermont 217. Mr. Holland also noted that the program was, er, illegal, and that the state had failed to implement quality control.

Things haven't been much rosier for Minnesota Gov. Tim Pawlenty, a Republican who felt it expedient to throw over the U.S. drug industry in favor of a few populist headlines. Mr. Pawlenty promised in 2003 that his Minnesota RxConnect program would serve some 700,000 people. A representative from Minnesota's department of human services explained to me this week that the state (conveniently) does not break out the number of people who use its program. But according to its latest statistics, Minnesota RxConnect last month filled a total of 138 prescriptions. That's for the whole state. Programs like those in Springfield, Mass., have simply closed.

Ask program administrators why so few people use Canadian imports, and they'll give you a frank, and long, list. Many consumers are wary about safety issues. They like having a relationship with a local pharmacist, and like knowing their drugs have undergone a U.S. quality check. Many drugs aren't available: that includes anything that needs to be taken immediately (antibiotics, for instance), or specialty drugs (such as injections for diabetics, which are hard to ship). It's also the case that many chronic diseases are today managed with generics, which remain cheaper in the U.S. Those that do use import programs tend to be a very small population that take maintenance drugs, say for high blood pressure, or cholesterol.

Perhaps an even bigger point is that huge numbers of Americans don't even pay for their drugs, but rather farm out their bills to an insurer. That's even more the case now that seniors are getting their drugs through Medicare. Joseph Bruno, the former Republican minority leader in Maine's legislature and now full-time CEO of a chain of pharmacies in that state, points out that 94.5% of his customers get prescriptions paid by a third party and so aren't price-sensitive.

"This is nothing but political posturing," he says of the U.S. Senate debate. He also notes that many of the infamous "bus trips" from Maine to Canada were in fact ginned up by labor unions that wanted to elevate drug prices into a political issue, and that successfully left the false impression that Americans were falling all over themselves for Canadian meds. "If you look at the numbers, that's just not the case."

Still, don't expect the political caterwauling over imports to go away any time soon. There's still too much political upside to talking up a program that few Americans really want to use.  Read More & Comment...

Where's the BEMS?

05/11/2007 07:51 AM |

Assuming that Kenzi is passed without amendments that make medicines less safe -- meaning importation or follow-on biologics -- the current bill will give FDA tons of money for new tools to monitor drug risks post market.

That should put the pressure on the agency and its overlords in Congress to allow medicines with targeted risk benefit profiles on the market right? (We know who is running the show absent real leadership at the FDA.) After all if we put REMS in place because all risks are unknown during and after a clinical trial, the same can and is true about benefits, nes pa? And who is to say whether the collective benefits are less important than the collective risks? Shouldn't patients in a subpopulation make that decision or do FDAers, the media, Hill staffers, etc in their infinite wisdom know in advance for everyone who will benefit and who will be harmed with such precision that they should be entrusted with making decisions for everyone else. Or are these REMS tools just for show?  Read More & Comment...

Dogmatic Day Afternoon

05/10/2007 03:59 PM |

Many opinions out there on Kenzi.

Here's mine: Don't be dogmatic.

Change is not an all-or-nothing proposition. Small movement in the right direction is the beginning of momentum. (And small victories are better than explosive defeats.)

And remember the words of Plutarch, "Time is the wisest of all counselors."  Read More & Comment...

Save money -- and hold the evidence

05/10/2007 12:24 PM |

When developing "evidence-based" guidelines, the World Health Organization routinely forgets one key ingredient: evidence. That is the verdict from a study published in The Lancet.

"This is a pretty seismic event," Lancet editor Dr. Richard Horton, who was not involved in the research for the article. "It undermines the very purpose of WHO."

Seismic, indeed. (But is it seismic enough to make the pages of Consumer Reports?)

WHO's Director of Research Policy Dr. Tikki Pang said that some of his WHO colleagues were shocked by The Lancet's study, but he acknowledged the criticism had merit, and explained that time pressures and a lack of both information and money sometimes compromised WHO work.

Gevalt!

"We know our credibility is at stake," Pang said, "and we are now going to get our act together."

Who's in charge over there? The Great Ballantine?

Here's the rest of the story:

http://www.miamiherald.com/852/story/99331.html

Evidence? We don't need no stinking evidence -- as long as our results provide back-up for evermore restrictive national formularies.  Read More & Comment...

Is It Safe?

05/10/2007 10:31 AM |

Here are two new publications (one from the new Journal of Life Sciences by yours truly and the other from Health Affairs by Scott Gottlieb, MD) that discuss the pharmaceutical risk/benefit equation.

Both articles ask and address the same question: Has "safety" become deliterious to the public health?

Here's a link to the Scott's Health Affairs paper:

Download file

And the link to my article in the Journal of Life Sciences:

http://www.tjols.com/commentary/may8_is_it_safe.jsp  Read More & Comment...