AHRQ Comparative Effectiveness Studies: Depressing

02/01/2007 10:10 AM |

I get a kick out of politicians and policymakers who worship at the altar of evidence based medicine without knowing what the hell they are even talking about or even knowing the quality of the evidence. As if by default the information produced by a bunch of government paid contractors who punch up all the 'reliable' studies -- randomized clinical trials -- will come up with an objective answer that can be used to guide every doctor and every payment decision.

Under the Medicare Modernization Act, the Agency for Health Care Quality and Research was required to conduct comparative effectiveness studies of major classes of drugs. They have contracted out to places like RAND and the University of Oregon's Drug Evaluation Deathstar which was created by former Governor Kitzhaber who also came up with the idea of rationing care to Medicaid patients.

Anyways, here are the conclusions of the AHQR's panel comparing second generation antidepressants in treating major depression. I defy anyone to distill any message except: start out with what's cheapest and then switch if there are side effects:

"In general, the various second-generation antidepressants have similar rates of effectiveness. In controlled studies, about 38 percent of patients saw no improvement and 54 percent had only partial improvement.
According to the National Institute of Mental Health's Sequenced Treatment Alternative to Relieve Depression (STAR-D) trial, a substantial number (between about 25 percent and 33 percent) of patients will improve with the addition or substitution of a different drug."

Carol Clancy, who is smart and well intentioned, gave this piece of advice based on these findings:

"As with all medications, second-generation antidepressants should be used after careful consideration of benefits and risks. It's up to clinicians and patients to work closely together so the best possible results are achieved."

And we did the study because....? As Rosanna Danna used to say, "If it's not one thing, it's another."


The AHRQ called for future research to establish reliably the general efficacy of second-generation antidepressants for treating dysthymia and subsyndromal depression. Multiple-arm, head-to-head trials with placebo groups should be used.

Effectiveness studies with a high rate of applicability to primary care populations are generally lacking for most of the drugs. "Effectiveness trials with less stringent eligibility criteria, health outcomes, long study durations and a primary care population would be valuable to determine whether existing differences of second-generation antidepressants are clinically meaningful in 'real world' settings," the AHRQ said. Further research is needed on efficacy in population subgroups, such as the very elderly and patients with common comorbidities.

Recognising that approximately 40% of patients do not respond to initial treatment, the AHRQ said studies should explore whether combinations of antidepressants at initiation of therapy lead to better response rates than single agents.

Large, well-conducted observational studies are also needed to reliably assess the comparative risk of rare but serious adverse events, particularly for very elderly patients.



Hey, why don't we just enroll the entire world in a multiple arm, real world randomized clinical triall alongside a global well-conducted observational study to detect serious adverse events so we can stratify for every subpopulation. By the time we get done collecting and analyzing data - 20 years from now -- there will be a whole new class of targeted therapies based on disease mechanisms which will render the one size fits all approach to medicine will become increasingly outdated.

Of course, we need research on what works. But AHRQ approach and the outlandish proposal to enroll the entire world in eternal clinical trials for specific indications ignores the fact there are better ways to answers the thousands of clinical questions.

We are coming up with one size fits all answers at a time when we are producing personalized medicines. We need medical information that fits the era and its insights.  Read More & Comment...

Follow On Biologics....Weird Science and Fuzzy Math

01/31/2007 04:39 PM |

Follow-on biologics is a matter of when not if. But if it's introduction and explanation is left to the political hacks representing the managed care plans and the generic drug industry, Ben Affleck will have a hit movie many times over before a follow on biotech product is approved.

That's because in their greed and haste to appease the new Democrat overlords, the political spinmeisters are introducing assumptions about the ease with which one can produce therapeutic analogues and break patents that just don't exist in nature. A look at the good science a company like Momenta Pharmaceuticals is undertaking to improve characterization of complex proteins and their analogues underscores that follow on products are years in the making and will not be the function of just handing over data.

But because the spinmeisters and staff approach the biologicals sciences -- deliberately at times -- with the neuronal sophistication of single cell oceanic life forms -- it looks like producing follow on biologics (and milking money to pay for social programs) should be as easy as tapping a keg at a Moveon.org fundraiser.

As usual, Steve Usdin's Biocentury steers us into reality with his trenchant analysis and factual reporting. Can anyone say gold standard for reporting on pharmaceutical and biotech policy issues?





Download file  Read More & Comment...

Henry Waxman's Dangerous Political Science

01/30/2007 09:45 PM |

In his opening statement today on hearings about political interference with the work of government scientists (climate change) Henry Waxman said: I don't want politically correct science. I want the best science possible.

Here's Henry Waxman waxing on and off about non-inferiority trials less then four months ago:

“Permitting drug companies to take shortcuts in their clinical trials poses real risks to Americans,” said Rep. Waxman. “An antibiotic that is no better than a placebo can’t fight off an infection. Worse, it can subject you to serious, even life-threatening side effects without any compensating benefit. Americans deserve to have confidence that an FDA-approved drug will be both safe and effective.”

It's hard to know even where to begin. Non-inferiority trials are not short cuts. And asserting that an antibiotic that is no better than a placebo equals non-inferiority trials is scientifically wrong....

In any event, the fact that a member of Congress (along with Markey and Grassley) asking the GAO to investigate the FDA's use of trial designs is not politically correct science? How is this meddling any different than an OMB review of the methodology of climate change study methodology? It's worse.

Here's one effect of the Waxman peer review process...

Supposedly, FDA reviewers have sent signals that a drug intended to keep people alive whose transplanted organs are being rejected and have six hours to live on average should undergo placebo controlled trials to determine safety.

The best science possible? I would argue that Waxman's micromanagement -- if this FDA anecdote is even has a glint of truth to it -- borders on compromising the canons of science and the integrity of the entire drug evaluation process.  Read More & Comment...

Drugwonks Welcomes a New Pharma Blog

01/30/2007 05:53 PM |

It's called Pharmalot (no relation to Spamalot) but the guy producing it does live about five minutes away from me. He's Ed Silverman, who has covered the drug and biotech industry for the Star-Ledger of New Jersey for over a decade. Ed's reporting has been hard hitting and informative (full disclosure, we have bought each other a cup of Dunkin Donuts cover twice in the past eight years).

Ed will be a panelist at our Media and Medical Science conference by the way and I urge you to check out his new blog which is at http://pharmalot.com/ . We will be linking to it and encourage everyone to become a regular reader.

Best of luck, Ed!  Read More & Comment...

Annal-yze This!

01/30/2007 03:28 PM |

Advertising is really a fancy word for calling attention to yourself, which is what the "authors" of a study -- more of a review of TV commercials -- in that prestigious medical journal the Annals of Family Medicine really is.

The article is entitled "Creating Demand for Prescription Drugs: A Content Analysis of Television Direct to Consumer Advertising." Translation: we Tivo'd a lot episodes of 24, CSI Miami and American Idol as a pretext to make fun of those silly drug ads and get some media attention.

Here's what Dominick Frosch the lead (I am trying not to laugh when I write this ) author of this "study" concluded from his "content analysis":

All of the ads … contained elements that we considered problematic. I think consumers should be more skeptical of the pharmaceutical ads than some surveys find they are."

Ya think Dominick? You mean the fact that jokes about Viagra ads and the warnings about how drugs to certain urinary incontinence in man cause your breasts to swell isn't content analysis enough.

Here's what I consider problematic: Dominick's previous 'scholarship' on the subject of risk communication and what to tell patients who might have a serious disease. Dominick has devoted himself to exploring whether videos or the internet or discussion groups or talking to your doctor are more effective in getting people to stop smoking, get a prostate exam, lose weight, etc. Seems as though there is no clear answer and Dominick never compares advertising of any sort to these other approaches. So how does he know if, as he told Rita Rubin's USA Today: "they leave a lot to be desired in terms of providing useful educational information to consumers."

Maybe they do. But at least the guys in the gym remember the stupid Viagra ads and know what's Viagra's for. And if you want to promote prostate screening would you do it with Dominick Forsch with a video on PBS or Paris Hilton during halftime at the Superbowl.

That's the difference between PSA's (pun intended) and advertising.  Read More & Comment...

Kamp, Counselor

01/30/2007 07:11 AM |

Our good friend John Kamp, Executive Director of the Coalition for Healthcare Communication, begs to differ with the recent report in the Annals of Family Medicine on the future of DTC communications. And he takes particular umbrage at a sidebar editorial by Dr. David Kessler.

As do we here at Drugwonks. Kamp's right and his statement deserves to be shared.

We are proud to do so.

Coalition Responds to DTC Study, Editorial In Annals of Family Medicine, January/February 2007

The January/February 2007 edition of the Annals of Family Medicine contains a report on a DTC research study and an accompanying editorial co-authored by former FDA Commissioner David Kessler. Although the FDA needs to ground its DTC policy on the science of consumer behavior, the study and the editorial would lead policy makers in the wrong direction.

Either editorialists Kessler and Levy didn’t read the study carefully or chose to ignore its limits. Nothing in the research supports their opinions and conclusions that more stringent DTC rules are needed. Further, the research authors largely ignore the significant body of studies on the effects of advertising on consumer beliefs and behaviors, including the FDA's own studies, that demonstrate that exposure to advertising leads to more and better doctor-patient conversations.

The full text of the statement can be found by clicking on this link:

Download file

Remember -- it's the First Amendment for a reason.  Read More & Comment...

The Love that keeps on giving

01/29/2007 07:15 AM |

Jamie -- you still haven't explained why a country with no primary health care system, with a growth rate of 6 percent per quarter and a medical tourism industry has to rip off patents (and your interpetation of the Blackberry case is novel to say the least..but then you have way of leaving out the context of situations to assert that something was compulsory licensing -- more research for me--) For every case you cite there is another view or another ruling. And you -- as you often do -- mix up arguments.

My point about Gleevec was the availabiliy of competent oncologists. And in any event, once you start confiscating patents you kill innovation so there's no Gleevec like drugs...Your prize idea is nice if you want to reward an idea but you vastly underestimate the risk and unpredictabiity of drug development, the cost of PM surveillance, the investment of follow on research, the need for industry and VC support of pre-clinical work, investment in new genomic based tools....

A proliferation of AIDS drugs manufactured by Asian pharmaceutical companies and the lack of controls for quality or delivery could create drug-resistant strains of HIV, warns a Treat Asia report made available to the New York Times. Treat Asia is a network of clinics, hospitals and research institutions sponsored by the American Foundation for AIDS Research (AmfAR). Only three companies out of at least 27 Asian firms that are producing HIV drugs meet World Health Organization quality standards, though these drugs are increasingly available in Asia and abroad, said Treat Asia. The drugs made by the 24 other companies have either not been reviewed or have not met WHO standards.

In addition, there are too few qualified doctors trained to prescribe and monitor the use of the drugs, Treat Asia said. China has fewer than 200 doctors to treat its 840,000 people with HIV. In Thailand, 100 doctors are trained to treat AIDS - one for every 6,700 patients. Thailand has exported $3 million in HIV drugs, yet it has 84,000 HIV-positive citizens who are not receiving treatment.

When China offered free treatment to 5,000 HIV patients recently, 20-40 percent stopped taking the drugs due to a lack of counseling and combinations that caused side effects, said the group. Elsewhere, many patients are left with "little or no instruction on the safe and proper use of antiretroviral drugs," the report said.

"Our point is if there is proliferation of the generic drugs, as many are calling for, where is the
infrastructure to deliver them?" said Kevin Robert Frost, report co-author and a public health worker in Bangkok for Treat Asia.

Treat Asia - which called for the creation of a regional database to help determine which drugs are available where - will make the report available beginning Sunday on its Web site: www.treatasia.org.

I also provide the link to the US Pharmacopeia report on the poor quality of generic version of drugs in Thailand...produced at the request of the President's AIDS program, the one you and I support...

http://www.uspdqi.org/pubs/other/ANEReview.pdf

You are living in the 1980s... and you have cast your lot with the parasites as opposed to the producers of better health.  Read More & Comment...

James Love Response to My Blog

01/28/2007 03:10 PM |

Robert, several points on this blog.

1. Countries can issue compulsory licenses for all sorts of reasons, not even limited to health, such as, for example, the recent US compulsory licenses for the Blackberry device, Microsoft DRM patents (held by Z4), Toyota, DirectTV and Johnson and Johnson.

2. Thailand has one of the best medical infrastructures in the world, which is one reason why it is becoming a common destination for European or US citizens, as a place for surgery. But this is besides the point. Since when do you need "infusion centers and trained technicians" to take Gleevec or Plavix?

3. Your claim that "The generic makers have developed unworkable and unsafe meds that have contributed to drug resistant HIV strains" is supported by what evidence? The WHO and the US FDA are both approving the quality of generic medicines for HIV. Is the Bush administration too "pro-generics" for you?

4. Your are free to have your own view of the Leavitt exchange. True, Leavitt did not issue a compulsory license to allow generic supplies. However, Leavitt has told Roche they must manufacture Tamiflu locally (a local working requirement on the patent), to protect US access and so the US can seize supplies in the case of an emergency. If Roche had refused this request? If they had refused, Leavitt was in the position to issue the compulsory license. The testimony has read by many as a unilateral demand by the US for local production, made at the very time the US Congress was asking for the compulsory license. As you noted, Leavett told the Congress, that if Roche did not expand production, "its important for Americans to know that the federal government will do everything necessary to protect people in this country." What exactly does that mean to you? Canceling Christmas cards for Roche?  Read More & Comment...

Jamie Love: Not a Bad Dancer

01/25/2007 10:48 PM |

In his blog in today's Huffington Post, Jamie Love implies it's ok to seize patents for all sorts of reasons. The fact is, there is only one reason, one measurable objective -- two actually -- that any nation can undertake to seize a patent before it expires and license to another manufacturer. First, it must demonstrate that their is an observable public health benefit that will be derived by that action as opposed to purely political gain. It's one thing to have a cheaper drug on a market. Another thing to have the infrastructure to deliver high-tech products. For instance, it would be nice to have Avastin available at discount prices in developing countries but you need infusion centers and trained technicians. Ditto Gleevec or Plavix.

Similarly, the whole HIV compulsory license thing has been a big fat joke on the developing world. The only people who have really benefit -- apart from those who are involved in the President's Global HIV plan and Gates activities -- are the profiteers in and out of the governments and the counterfeiters, those who mark up products fake or otherwise. The generic makers have developed unworkable and unsafe meds that have contributed to drug resistant HIV strains.

Now to top it all off, in his latest round of blogging...he misrepresents the truth. What a shock. He claims that Secretary Mike Leavitt testified he supported compulsory licensing. Here's the actual exchange between Congressman Tom Allen from Maine and Leavitt who just finished telling the House Commerce subcomm on Health that the prez wants to spend $7 billion to boost production of avian flu vaccine and anti-viral production

This video clip begins with Leavitt saying that Roche has promised not to let intellectual property be a barrier to generic production - Roche is willing to work with other companies that are able and prepared to produce the drug. He stresses that the drug is very difficult to produce, involving complicated steps, sometime dangerous - explosions are required in some of them. The Secretary concludes "It is not likely… that we will see any other manufacturers of Tamiflu certainly in a year and more likely two years. And that would be true in this country or any other country."

Allen responds that today the U.S. has insufficient manufacturing capacity for antiflu drugs, and Leavitt agrees. Allen tells Leavitt that on August 30, 2003 the WTO agreed on a set of rules under which countries with insufficient manufacturing capacity could import needed pharmaceuticals produced under compulsory license, but we opted out and persuaded other countries to opt out as well. The question from Allen: was this a wise decision? Leavitt answered that in times of a pandemic each country will only have access to what it can produce domestically, because each country will want to keep and use whatever it has inside its borders.

"Finally, Allen asks Leavitt if he would be prepared to issue a compulsory license if Roche failed to adequately expand production? Leavitt said that he did not think this would be needed, but he thinks its important for Americans to know that the federal government will do everything necessary to protect people in this country."

From this Jamie deduces that Leavitt is for compulsory licensing. What some people will do for America....  Read More & Comment...

Bill Clinton to Dems: We Were Right on Drug Price Controls

01/25/2007 10:22 PM |

Telling 100 Democrat strategists to expect aggressive health care proposals from his wife (would we expect shy ones) ex-President Bill Clinton -- who has not stopped spinning and legacy seaching (among other things) since he left office -- proclaimed that the recent Democrat retreat from imposing the VA formulary on seniors was a....(ready for this) vindication of HIS administration's effort to impose price controls on prescription drugs (including the Biotechnology Price Inquisition which caused biotech stocks to tank 40 percent and venture capital investment to hit the lowest point in the industry's history).

Yeah and the slaughter in Rwanda that happened under his watch and the hasty retreat from Somalia (also a Clinton production) was a roadmap for how to win in Iraq and send the right messages to Islamic fanatics.

Why does Newt Gingrich keep calling him the smartest man in American politics? Is that supposed to be a good thing?  Read More & Comment...

It ain't Shakespeare, but ...

01/25/2007 07:06 AM |

What? You haven't already read CBO's just released "The Budget and Economic Outlook: Fiscal Years 2008 to 2017!

Great prose? Certainly not. Great news? Absolutely (if you know where to look).

Consider this snippet which appears on pages 58-59 ...

"The current estimate for Part D spending is significantly lower than CBO's 2006 estimates, for two reasons. First, Medicare's payments for prescription drugs under Part D are largely based on competitive bids that drug plans submit to provide coverage. The bids submitted for calendar year 2007 are much lower than expected-about 15 percent below the 2006 bids, on average. As a result, CBO reduced its projection of the per capita costs of providing drug coverage. In addition, recent information from the Department of Health and Human Services' Centers for Medicare and Medicaid Services indicates that a larger-than-expected number of the Medicare beneficiaries who are not enrolled in Part D have some other form of drug coverage that is comparable to Part D. Because CBO expects that many of those beneficiaries will retain their existing coverage rather than enroll in Part D, it has lowered its estimate of the ultimate participation rate from 87 percent to 78 percent of Medicare beneficiaries."

"In its estimate for the Medicare Modernization Act, which established Part D benefits, CBO projected net spending for Part D at $32 billion for 2006 and $518 billion for 2007 to 2013. (CBO's overall estimate that the legislation would cost $395 billion from 2004 to 2013 included savings that would occur elsewhere in the budget that would be attributable to the creation of Part D and to the effects of other provisions unrelated to the drug benefit.) CBO's current estimate of net spending for Part D for 2007 to 2013 is $136 billion lower than the original forecast, a difference of about 26 percent."

Amazing as that news is, I do not predict a movie deal for the book.  Read More & Comment...

When is a Drug Risk not a Drug Risk?

01/24/2007 11:38 AM |

When is a drug risk not a drug risk? When you don't understand it. I refer, of course, to the so-called "Brief Summary" which, as some say, is like the Holy Roman Empire -- neither brief nor a summary.

A new paper (of which I am a co-author), in the January edition of Drug Information Journal, relates new research demonstrating that as the number of listed side effects increases, patient recall decreases.

The paper, "A New Model for Communicating Risk Information in Direct-to-Consumer Print Advertisements" can be found at http://www.cmpi.org

Not rocket science. Social science  Read More & Comment...

A Chronic Achievement

01/24/2007 08:08 AM |

President Bush's State of the Union discussion of tax credits for health insurance should remind us all that the goal of health care shouldn't be, exclusively, to deal with acute medical problems -- but rather to provide patients with both the opportunity and the incentive to pursue care for chronic conditions (such as hypertension). Because, even with all of the advances in hospital care, it's still a much better deal -- both financially and personally -- to address a condition (such as hypertension) before it results in an acute, life-threatening event.

It's the same logic that propels Part D. Keep seniors healthy by providing low-cost access to the medicines they need and they (1) will be healthier, more productive citizens, and (2) will not need far more costly health care interventions (i.e., hospital procedures).

Eureka -- it works. Part D has propelled millions of seniors, for the first time, to seek out and receive appropriate treatment for their chronic conditions (such as hypertension).

And that's a success that demands greater attention. It's a success that goes a long way to improving the State of the Union.  Read More & Comment...

Drug Development Summit: Good News From the Pipeline

01/23/2007 06:49 PM |

I was both an attendee and speaker at the MedAdNews Drug Development Summit.

Two important takeaway points. Make that three. Ok four.

1. Companies are refilling their pipelines with new drugs that will hit new targets for unmet medical needs in areas like Alzheimer's, cancer, schizophrenia, Parkinson's, respiratory infections and stroke.

2. Companies are doing a better job of weeding out medicines that won't work or would "fail" because of toxicity issues earlier than ever. Drug development is becoming more predictive.

3. Many of the Critical Path recommendations are being adopted. Adaptive trial designs, bio-imaging, exploratory INDs are all being used.

4. Companies are interested in doing more collaborative work to identify biomarkers, both efficacy and safety. Creating the framework for doing so is difficult.

The takeaway: this is an industry furiously seeking to change. It probably should be more transparent and collaborative and find a better way to market its medicines but that will happen too.

The question is, why do some many people still believe that drug companies are sitting on cures for diseases so they can make money? I can't tell you how many otherwise intelligent people have actually asked me if this is true.... Another reason that biotech and drug companies need to tell the public what they do.  Read More & Comment...

The Left Wing Response to Bush Health Care Tax Cut: Medicaid Uber Alles

01/23/2007 06:07 PM |

The left has been complaining for years about how the tax system is unfair to the poor and working class. So when the president comes along with a plan level the playing field where it really counts -- a tax cut that makes health care affordable no matter where you are or whether you are working -- their reaction is predictable: spend money (either directly or in the form of tax credits) to shove people into Medicaid.

Here's Ron Pollack's predictable response to the tax cut:

“Instead of this ill-advised proposal, the President should expand health coverage for the 9 million children who are uninsured when Congress reauthorizes the State Children’s Health Insurance Program (SCHIP) later this year.”

Right. The same 9 million kids who have not been enrolled since SCHIP started in 1997. Hey Ron, Families USA has been shoveled millions of bucks to do outreach and enrollment over the past decade.
Wonder why people didn't sign up despite your winning personality?

Because SCHIP equals Medicaid. Pollack and other child "advocates" call SCHIP a medical home for uninsured kids but that's like calling public housing as good as a private home. People want to buy into the real thing, something they can own, not some government assistance they have to apply for.

But the Left hates giving people control over health care dollars because that means they lose control over them. I once debated one of the advocates and asked them why they opposed just giving people money to buy health care. Did she think the same people they believe should have the choice about abortion were too stupid to choose which health plan to have the abortion in? She had no answer.  Read More & Comment...

AIDS Activists Sue Pfizer For Making People Party Harder

01/23/2007 05:57 PM |

We are not making this up.

AIDS group sues over Viagra ads



Andrew Bridges

The Associated Press


Tuesday, January 23, 2007



WASHINGTON -- An AIDS organization sued Pfizer Inc. on yesterday over ads the group says encourage use of Viagra as a party drug. The nonprofit group said such recreational use furthers the spread of HIV and other sexually transmitted diseases.

The suit, filed in Los Angeles by the AIDS Healthcare Foundation, calls Pfizer's ads for the impotence drug false and misleading. The suit echoes allegations made in an ad campaign announced by the group last month.

The nonprofit group alleges the marketing of Viagra has fostered an increase in the spread of STDs. Studies have found the drug is used -- illegally -- in conjunction with crystal methamphetamine to form a party drug "cocktail."



Drugwonks believes that the combo of crystal meth and Viagra is an off-label use that Pfizer has never promoted. There is no truth to the rumor that the company sought product placement in episodes of Six Feet Under, Entourage or Queer as Folk....  Read More & Comment...

Pharma is too profitable?

01/23/2007 07:48 AM |

Ask the 10,000 people at Pfizer who are losing their jobs.  Read More & Comment...

The other Emerson

01/22/2007 11:49 PM |

After hearing from Representative Emerson, perhaps it's time to listen to the other famous American of the same name -- Ralph Waldo Emerson -- who said:

"No one cares how much you know until they know how much you care."

Words to remember as we fight for the future of America's health and health care system.  Read More & Comment...

The Wyden-Snowe Stem Cell Disinvestment Bill

01/19/2007 06:42 PM |

Story Landis, director of the NIH's National Institute of Neurological Disorders and Stroke testified before a Senate committee today that need for federal funding for embyronic stem cell research was compelling:

"Science works best when scientists can pursue all avenues of research," Landis said. "If the cure for Parkinson's disease or juvenile diabetes lay behind one of four doors, wouldn't you want the option to open all four doors at once instead of one door?"

That's fine. Everyone's in favor of funding one form of stem cell research or another. But why then support a bill that would kill private sector funding of stem cell research or undermine private sector investment that complements or builds on federal funding. Namely the Wyden-Snowe bill requiring direct government negotiation -- meaning price controls, restricting/delaying access to new medicines -- under the following circumstances --

Under the Snowe-Wyden proposal, that ban would be lifted and the HHS Secretary would be required to negotiate if:

* A drug is a single source drug, which means there is only one brand name of the drug available;

* A drug was created with substantial taxpayer funding for its research and development;

* A private insurance plan requests help; and

* For any fallback plan for which the Secretary must provide.

A cure for Parkinson's would definitely pull a hat trick under this ingenious piece of legislation. Why not just hang out a sign that says: "Companies that successfully invest in stem cell research will be punished for doing so?"  Read More & Comment...

A Scanner Darkly

01/19/2007 11:25 AM |

Here's a story right out of the movie "The Barbarian Invasions" and it can be summed up in two words, "Hello Plattsburgh."

For those who think that we should adopt the Canadian health care model this should serve as yet another cold shower of reality or, in the words of Stephen Colbert, a "Truth Mitzvah."

MDs forced abroad for scanner training
Limited access to cancer-detecting machines spurs Ontario university to look elsewhere

LISA PRIEST
Toronto Globe and Mail
January 19, 2007

The use of crucial cancer-detecting PET machines is so restricted in Ontario that one university must send its medical residents to the United States and elsewhere for training. The low number of cancer patients eligible for PET screening means University of Western Ontario residents cannot obtain the experience they require. St. Joseph's Health Care in London scans as few as four patients a week, sometimes none. The rest of the time it experiments on laboratory-bred dogs and pigs.

Of all the provinces that have Positron Emission Tomography scanners, Ontario has the most restrictive access. That's because it is running clinical trials to determine how best to use them on cancer patients.

"It breaks our hearts to have to send them [students] away," said Damien Maharaj, program director of nuclear medicine at Western's Schulich School of Medicine & Dentistry. “We simply have to meet their [Royal College of Physicians and Surgeons of Canada] guidelines. Failure to do so would be noted and the potential to go on probation exists."

The development follows an evaluation conducted by the Royal College of Physicians and Surgeons of Canada, a body that accredits postgraduate medical programs in addition to certifying specialists. The college told the university that the lack of resident training in PET scanning was a weakness that required a remedy.

The university was asked to put in writing its plan for ensuring that nuclear-medicine residents receive the necessary PET training elsewhere, Dr. Maharaj confirmed. He stressed the program remains fully accredited and that London produces some of the best nuclear-medicine specialists in Canada. Ultimately, though, Dr. Maharaj said: "PET is not a research tool, it's a clinical tool. We really should be offering it to people."

Cancer patients can access Ontario's nine PET scanners under five clinical trials or through a patient registry introduced a year ago. The registry is limited to suspected recurrent colorectal, thyroid or germ-cell cancer and patients with certain solitary pulmonary nodules. As of Oct. 31, 408 Ontario patients had obtained PET scans through the registry and 926 patients had scans as part of the clinical trials.

Compare that to Quebec, a province that provides the broadest access to PET scans; this year, it plans to do 21,000 scans. Patients can access PET scans in British Columbia, Alberta, Manitoba and New Brunswick. Nova Scotia also plans to purchase a scanner and expects to have it operating by the fall.

"It's terrible," said Christopher O'Brien, vice-president of the Canadian Association of Nuclear Medicine. "You have one of the major teaching programs that can't meet the Royal College standards because of a government moratorium on access to PET scanning."

Though Dr. Maharaj said the university will try to help defray the costs, ultimately it is a "financial hardship" for the residents who will have to pay rent in two cities, in addition to covering transportation and food costs for three months. Potential training spots include Duke University in North Carolina, Harvard in Boston and centres in Canada, possibly Winnipeg or Sherbrooke, he said.

Training in the United States poses a particular problem: malpractice insurance does not cover the residents so they can act only as observers and cannot interpret the scans. That is why J. C. Warrington, the chief nuclear-medicine resident at the University of Western Ontario, is hoping to relocate to another Canadian city. "We would prefer to not to have to go further than is absolutely required because of our expenses required with travel," said Dr. Warrington, a fourth-year nuclear-medicine resident, one of two who will have to relocate this July.

All other nuclear-medicine residents training at Western will also have to relocate for three months in their final year of training, until the hospital is able to provide more PET scans to patients, Dr. Maharaj said.

A PET scan can find a lung cancer that has spread, preventing a futile operation. Colorectal cancer patients may discover tumours on their liver can be safely removed. A scan can also help determine when chemotherapy is not working, prompting doctors to change a drug cocktail. It costs about $2,500.

Whatever the case, the results need to be carefully interpreted as non-cancerous conditions can resemble cancer; only a biopsy can confirm the presence of cancer.

Dr. Warrington said though relocating may pose an imposition, it is a far greater imposition for cancer patients to travel out of province or country to obtain PET scans. In 2005-2006, 82 Ontarians were sent out of country for PET scans at a cost of $653,255, while 42 others were denied, according to Health Ministry figures provided by John Letherby. However, the process of sending patients to the United States has been winding down since late August.

Figures obtained under a Freedom of Information and Protection of Privacy Act request reveals that Ontario has sent cancer patients to 20 different U.S. hospitals for PET scans for 18 different conditions, many of them cancers or suspected cases of cancer since April 1, 2002.
They include Duke University -- the very institution to which nuclear-medicine residents may be sent for training. As well, patients have been sent to Johns Hopkins in Baltimore; the Mayo Clinic in Rochester, Minn., and Scottsdale, Ariz.; Detroit Medical Centre; and Cleveland Clinic Foundation.

Of those sent to the United States, the patients had lymphoma and cancers of the breast, brain, esophagus, testes and lung.  Read More & Comment...