Hard Evidence

• 09.18.2007

From The Times of London ...

Fake world of the Viagra plotters

For tens of thousands of men the medicines offered by Ashish Halai and his gang appeared to be the answer to two of their most worrying and embarrassing health concerns: impotence and baldness.

But the unsuspecting customers, buying what they thought were Viagra and Propecia, were victims of one of the most ambitious and elaborate of counterfeiting crimes. Halai and his associates were buying fake drugs from Chinese suppliers for as little as 25p a tablet and selling them for up to £20.

Details of their vast network – stretching from Britain to Hong Kong, Dubai, the US and the Bahamas – emerged yesterday as justice finally caught up with the conmen.

In the largest drug counterfeiting case in Britain, and after a trial lasting more than seven months, Halai, 33, was jailed at Kingston Crown Court for four and a half years as one of the key players in the plot.

From his £1 million home in Borehamwood, Hertfordshire, he helped to mastermind an operation in which fake pills were produced at secret factories in China and Pakistan and smuggled to the US and Europe. The rewards, the court was told, were “immense”.

The investigation, the largest conducted by the Medicines and Health-care products Regulatory Agency (MHRA), uncovered profits of more than £2 million. The agency said that this was the “tip of the iceberg”.

“The geographical spread was global and the financial rewards were immense,” Sandip Patel, for the prosecution, told the court.

The case dates back to 2003 and 2004, when counterfeit batches of Viagra and Cialis, impotence drugs made by Pfizer and Eli Lilly, were seized while being smuggled into Heathrow and Stansted airports.

The MHRA immediately launched an investigation which alerted them to a major manufacturing and smuggling operation. Samples showed that the medicines contained about 90 per cent of the active pharmaceutical ingredients found in genuine tablets. Most of the fake pills were sold via the In 2003 the MHRA contacted the US Food and Drug Administration, which seized 8,000 packages of Viagra in Miami. Then, in July 2003, MHRA officers seized more than 120,000 fake Viagra tablets. internet, but some found their way into chemists were they were sold as prescription medicines.

The full story can be found here:

http://www.timesonline.co.uk/tol/life_and_style/health/article2477868.ece?EMC-Bltn

Caveat emptor is not sound health care policy.

FDA Approves Genetic Test for Warfarin Dosing

• 09.18.2007

See what I mean?

This is a lot better than bureaucrats guessing...

http://ap.google.com/article/ALeqM5iX6mwtAXZaZ-NdJ3C9SQh4nOBrqQ

The Right Path for Optimal Dosing

• 09.18.2007

Genomas has lead the way to identifying the genetic links to painful side effects associated with statins. (I was honored to have been able to use their gene chip to guide my selection of statins.) This is the right and cost effective way of optimizing drug selection...


"Research by Genomas and collaborators at Hartford Hospital, University of California San Francisco and Yale has demonstrated a strong association between myalgia (muscle pain) arising during statin treatment and variability in genes related to pain perception. The research has been published in the September issue of the leading neurological journal Muscle and Nerve*, published by Wiley InterScience. The findings suggest that serotonergic neurotransmitter receptor function may contribute to the muscle pain induced by statins in some patients inheriting specific variants of the receptor genes. "

For more information go to http://www.genomas.net

Revlimid Runs a NICE Gauntlet, FDA Micromanaging ESA Dosing

• 09.18.2007

Steve Usdin makes the point in this week's Biocentury that companies who fail to come up with personalized algorithms for dosing and medicines will find themselves at the mercy of micromanagers and second-guessers at FDA panels, CMS and cost cutters generally. But the challenges, legal, economic, regulatory are great in this era of of no good deed going unpunished or sued. As Usdin writes "These studies, along with observational data, paint a complex, nuanced picture. Indeed, the panel members spent much of the meeting focused on an apparent paradox: attempting to increase Hb in kidney disease patients to levels approximating those in healthy individuals is harmful, but actually achieving higher Hb levels is usually beneficial.
The committee also grappled with the potential association between increased mortality risk and low response rates to ESAs, a circumstance that could affect as many as 40% of dialysis patients."

So much for the value of randomized trials in personalizing dosing regimens.


Meanwhile, as if we did not need another reminder that it won't stop at ESAs, Biocentury has a story about how patients waiting for Revlimid in the UK will have to wait years to produce comparative effectiveness data of the sort that Hillary's Best Practice Institute will generate.

According to Biocentury:

"Multiple myeloma patients in the U.K. will have only limited
access to one of the newer drugs for the disease, Velcade bortezomib, as a result of NICE’s recent recommendation to shave the number of patients who would be indicated for the drug. And they will have limited access in the foreseeable future
to another new drug, Revlimid lenalidomide from Celgene Corp., which is in no hurry to undergo the NICE process..."

Who can blame them, because it takes at least a year and, in the case of the UK, years to get reimbursement approval.

The pace is going to be slower in the U.K. Although Revlimid is available to patients who have private insurance, going through the country’s reimbursement
process is not near the top of CELG’s list because NICE takes such a long time.
Indeed, Gill said the company does not even have a timeline for when it will begin the process. “We will work with NICE as expeditiously as possible, but historically it takes years.”

Best Practice Indeed

Watch How the Fearmongers Manhandle This Mound of Information

• 09.17.2007

Two U.S. Department of Health and Human Services agencies will collaborate in the most comprehensive study to date of prescription medications used to treat attention deficit hyperactivity disorder (ADHD) and the potential for increased risk of heart attack, stroke or other cardiovascular problems.

Thank you Dr. Nissen and Dr. Furberg....

AHRQ and FDA to Collaborate in Largest Study Ever of Possible Heart Risks With ADHD Medications

Researchers supported by the Agency for Healthcare Research and Quality and the U.S. Food and Drug Administration will examine the clinical data of about 500,000 children and adults who have taken medications used to treat ADHD, to determine whether those drugs increase cardiovascular risks.

Because medications used to treat ADHD can increase heart rate and blood pressure, there are concerns about the drugs' potential to increase cardiac risks. It is also thought these risks may be different for adults and children, but more evidence is needed about the long-term effects of using ADHD medications.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01700.html

What Nissen is Missin'

• 09.17.2007

The attack on Avandia is really an attack on the FDa's authority wrapped up in a bogus concern about the risk of cardiovascular death associated with diabetes. Treatment of type 2 diabetes requires management of many diseases that contribute to heart attacks. That includes managing high cholesterol which of course Avandia is associated with. So it would seem logical to identify which patients on Avandia who had heart attacks were not on statins (something the FDA numbers crunchers did). Nissen and co simply gloss over this issue. But good diabetes management with respect to MI requires it. So why not make this an issue of improving CV outcomes instead of Avandia and the FDA?

See Gina Kolata's excellent article in the NYT from Aug 2007 to see how it can be done:

http://www.nytimes.com/2007/08/20/health/20diabetes.html?pagewanted=3&ei=5070&en=f729f5b46fa2a74d&ex=1190174400

Worst Best Practice

• 09.17.2007

The Washington Times editorializes on the stupid coverage decision CMS made on ESAs. Hillary has made her Best Practice Institute a cornerstone of her new "American Health Choices Plan" (has anyone been more manipulative in the use of the English language than Hillary) Yes, you will have choices, much like the choices you get from a elementary school cafeteria. The Best Practice Institute will tell which drugs at which dose at which time without regard to individual variation because that's what is required to cut $100 billion from health care spending. That and price controls on new drugs. You think a one size fits all dose for ESAs is a one shot deal (that ignores the impact of cost effectiveness or quality of life relative to transfusions). Think again. If CMS gets the power to impose a dose specific criteria on one drug, it can do it on ALL medicines.

That's Hillary's plan for Health Care Choices....

http://washingtontimes.com/article/20070916/EDITORIAL/109160019/1013/EDITORIAL

Copping a Plea

• 09.17.2007

In April of 2006 James Copping (Principal Administrator, European Commission Enterprise & Industry Directorate-General) had this to say about rethinking the EU Commission’s position on information-to-patients:

“From the Commission’s point of view, we want a system where patients can be empowered to take an equal part in health care decisions. To do that, they need more information and we all want to make high-quality information available as soon as possible. We believe that all stakeholders have a role to play to provide this information, but the tricky issue for us is to find the appropriate framework which national regulatory authorities can live with.”

Copping continued as to possible ways to achieve that goal:

“The pharmaceutical industry has a lot to contribute because of their resources, skills and expertise and we have seen in the working group that the industry plays a constructive part. It’s amazing to me that an industry which plays such an important part of our health care is often seen on par with the tobacco or the oil industry. It’s not clear to me why this is the case, but we need to develop good working relationships between all of us. We all agree that we need good quality information, but none of us can do it alone.”

In April of 2007 the Director of the Enterprise and Industry Directorate General of the European Commission released its report for consultation on "current practice with regard to provision of information to patients on medicinal products." The report focuses on information publicly available on the internet from regulatory bodies or official sources in member states -- mostly of information on package leaflets, databases of approved drugs and regulatory reports, and other sources of information from regulatory bodies on approved drugs.

The report concludes, "Member States may not be in a position to fully address patients' needs in terms of the substance of information and the access via different means. In turn, the pharmaceutical industry possesses the key information on their medicines but this information can currently not be made available to patients and healthcare professionals through Europe."

The idea of a public-private partnership stems from the recent second progress report of the European Commission's High Level Pharmaceutical Forum that proposes "to organise a platform to bring together relevant stakeholders to explore ways to exchange good practices and on ways to overcome barriers to accessing information." Although the Commission does not support direct to consumer advertising, they are clearly suggesting that reliable information could come jointly from both industry and regulatory bodies.

Indeed, efforts that include industry (and their proven ability to communicate health care information to patients – aka consumers – in partnership with governments (with their ability to use the bully pulpit on behalf of the public health) is a potent alliance and the right way to proceed.

But not everyone agrees.

Here’s what the British Medical Journal has to say in a recent editorial:

“We think that a partnership between drug companies and drug regulatory authorities in the area of information … would be confusing. Therefore, we propose two areas of real partnership with the drug industry that would reinforce public trust in the system.

The first would entail a real commitment to waive confidentiality and give full access to data on the effectiveness and safety of drugs. Giving full access to all clinical trial protocols (not just those that are registered for publication purposes) and to the periodic safety update reports available to regulatory agencies would enhance transparency.”

Does the BMJ really think that practicing physicians have the time or inclination to plow through thousands of pages of clinical trial data? And, anyway, isn’t that besides the point?

If “more information” is good for physicians – why isn’t it equally good for patients?

Or does the BMJ believe that only medical professionals should have access to information?

The BMJ editorial concludes by saying that"

“The most sensible way to protect public health would be to identify sources of unbiased and systematically reviewed information and maintain the current European legislation on drug promotion, while reinforcing the role of the European Medicines Evaluation Agency.”

Here’s a link to the complete BMJ editorial:

http://www.ifpma.org/PressReviewEmail/PressReviewDetail.aspx?nID=8133&SD=LoB8AhN%2fJP9w%3d%3d

Is more government control and a continued policy of information denied to patients the BMJ’s idea of progress?

I left my heart (medicine) in San Francisco

• 09.14.2007

What? No "drugs from Canada" as the great panacea? How times change. Attention members of Congress who are still beating the dead horse of foreign drug importation ...

Healthy San Francisco is a new program that offers free or subsidized health care to all 82,000 San Francisco adults without insurance. It is financed mostly by the city which, according to the New York Times, “is gambling that it can provide universal and sensibly managed care to the uninsured for about the amount being spent on their treatment now, often in emergency rooms.”

The Times reports that “Healthy San Francisco provides uninsured San Franciscans with access to 14 city health clinics and 8 affiliated community clinics, with an emphasis on prevention and managing chronic disease. It is, however, not the same as insurance because it does not cover residents once they leave the city.”

Until November, enrollment will be limited to those living below the federal poverty line ($10,210 for a single person; $20,650 for a family of four). Then it will open to any resident who has been uninsured for at least 90 days, regardless of income or immigration status.

The coverage is not portable and city officials believe that people with private insurance will have little incentive to drop their policies to take advantage of the city’s cut-rate services.

Patients are asked to contribute nominal amounts through membership fees and co-payments that vary by income. Those from families with incomes below the federal poverty line pay nothing. Those who earn more pay quarterly fees that range from $60 to $675, which is the rate for those with incomes above 500 percent of the poverty level ($51,050 for a single; $103,250 for a family of four). That is where the subsidy ends. The co-payments range from $10 to $20 for a clinic visit and from $200 to $350 for an inpatient stay.

A final financing mechanism has placed the program in legal jeopardy. To make sure the new safety net does not encourage businesses to drop their private insurance, the city in January will begin requiring employers with more than 20 workers to contribute a set amount to health care. The Healthy San Francisco program is one of several possible destinations for that money, with others being private insurance or health savings accounts.

The full New York Times story can be found here:

http://www.nytimes.com/2007/09/14/us/14health.html?_r=1&hporef=slogin

Little cable cars riding half-way to the stars not included.

20/20 Foresight

• 09.13.2007

From today's WSJ ...

Sick Sob Stories

By JOHN STOSSEL
September 13, 2007

In Michael Moore's movie "Sicko," a widow named Julie Pierce tells a tearful story: Her husband died of kidney cancer after their health-insurance company denied payment for a bone-marrow transplant that might have saved his life. Ms. Pierce's rage is palpable as she repeats the word her insurers used in response to her husband's request. "They denied it," she sneers. "Said it was 'experimental.'"

Viewers of the documentary are meant to understand that "experimental" is health-insurance code for "expensive," and that Ms. Pierce's husband was left to die for the sake of profit. According to Mr. Moore's movie, "Any payment for a claim is referred to as a medical loss," and when a claim is denied, "it's a savings to the company."

But Mr. Moore is so busy following the money that he doesn't take the time to follow the science. Treating cancer patients with bone-marrow transplants has a dubious history.

Twenty years ago, many oncologists believed that bone-marrow transplants, along with high doses of chemotherapy, might offer a cure for breast cancer. Insurance companies refused to pay, calling the treatment experimental and unproven. Breast-cancer sufferers went to court: In one case, a jury awarded $77 million to the family of a woman who was denied payment for the treatment. Wives and mothers told heart-rending stories in newspapers and on TV. Politicians quickly moved to guarantee the treatment to all breast-cancer patients. Ten state legislatures mandated that every insurance policy cover bone-marrow transplantation for breast-cancer patients. Amid the media circus and political self-congratulation, the question of whether bone-marrow transplants are medically effective faded into the background.

The sad truth is that the treatment isn't effective. When researchers released the results of their clinical trials to the American Society of Clinical Oncology in 1999, they showed that the treatment offered no benefit. Worse, it often killed women faster than their cancer, and caused them unnecessary pain. At a time when their health was at its greatest risk, more than 30,000 women were exposed to an invasive, harmful and ultimately useless treatment that the National Institutes of Health no longer recommends. But only one state legislature has repealed its law requiring insurance companies to pay for the treatment. Some doctors believe bone-marrow transplants might help kidney cancer patients, and the NIH is conducting clinical trials to find out. Until the treatment has been shown to do more good than harm, insurers are reluctant to pay for it.

Mr. Moore claims that because private insurance companies are driven by profit, they will always deny care to deserving patients. For this reason, he argues, profit-making health-insurance companies should be abolished, our health- care dollars turned over to the government, and the U.S. should institute a health-care system like the ones in Canada, Britain or France. But does Mr. Moore think, even for a second, that any of the government systems he touts in his movie would have provided a bone-marrow transplant to Ms. Pierce's husband? Fat chance.

When government is in charge of health care, the result is not that everyone gets access to experimental treatments, but that people get less of the care that is absolutely necessary. At any given time, just under a million Canadians are on waiting lists to receive care, and one in eight British patients must wait more than a year for hospital treatment. Canadian Karen Jepp, who gave birth to quadruplets last month, had to fly to Montana for the delivery: neonatal units in her own country had no room.

Rationing in Britain is so severe that one hospital recently tried saving money by not changing bed-sheets between patients. Instead of washing sheets, the staff was encouraged to just turn them over, British papers report. The wait for an appointment with a dentist is so long that people are using pliers to pull out their own rotting teeth.

Patients in countries with government-run health care can't get timely access to many basic medical treatments, never mind experimental treatments. That's why, if you suffer from cancer, you're better off in the U.S., which is home to the newest treatments and where patients have access to the best diagnostic equipment. People diagnosed with cancer in America have a better chance of living a full life than people in countries with socialized systems. Among women diagnosed with breast cancer, only one-quarter die in the U.S., compared to one-third in France and nearly half in the United Kingdom.

Mr. Moore thinks that profit is the enemy and government is the answer. The opposite is true. Profit is what has created the amazing scientific innovations that the U.S. offers to the world. If government takes over, innovation slows, health care is rationed, and spending is controlled by politicians more influenced by the sob story of the moment than by medical science.