Rahm Emanuel's Twisted Path to Price Controls

• 12.22.2006

Under his recycled piece of legislation, drug companies would be forced to sell as much of their old products at a government set price to foreign distributors or face criminal charges. At the same time, the FDA would be expanded to handle new duties, parcel inspection, warehouse inspection, pharmacy inspection and approving after the fact that drugs made for the European market -- though they vary in dosage form, formulation, coatings and packaging -- are equally safe and effective and bioavailable without any testing.

Meanwhile, our biotech and drug companies would still be barred and restricted and delayed from marketing products in foreign markets as they seek government -- I mean -- world market prices for the new medicines. All while the FDA is forced to spend more time handling the shipping and handling needs of European middlemen instead of drug safety and drug approval here at home.

Oh, and of course there would still be time to police the expanding array of internet drug sites that sell counterfeit meds or drain real meds from poor countries that would sold to us as well....

The John Grishams of Drug Importation

• 12.22.2006

The Fearsome Foursome of Emanuel, Dorgan, Snowe, and Emerson want drug importation and are going to try to Rahm it through Congress. That’s politics. But they’re confused. They don’t seem to understand (or they choose not to admit) that you can’t cherry-pick drugs from just Canada or one or two of the 25 European Union nations. They may only want drugs from Canada, Great Britain or France, but that’s impossible — because that’s already the law – in Europe. And that's a fact.

In Europe, parallel trade (what we call “importation”) is legal between all 25 EU member states. And last year 140 million individual drug packages were parallel imported throughout the European Union — and a wholesaler repackaged each and every one. This means that, literally, parallel traders open 140 million packets of drugs, remove their contents and repackage them. But these parallel profiteers are in the moneymaking business, not the safety business. And mistakes happen. For example, new labels incorrectly state the dosage strength; the new label says the box contains tablets, but inside are capsules; the expiration date and batch numbers on the medicine boxes don’t match the actual batch and dates of expiration of the medicines inside; and patient information materials are often in the wrong language or are out of date. Oops.

This means that drugs purchased from a British pharmacy to an unknowing American consumer (or a blissfully ignorant member of the United States Congress) could come from European Union nations such as Greece, Latvia, Poland, Malta, Cyprus, or Estonia. In fact, parallel traded medicines account for about 20% (one in five) of all prescriptions filled by the same British pharmacies that have had a record number of counterfeit recalls in 2006. And Pharmaceutish Weekblad, a respected pharmacy journal in the Netherlands, recently reported that counterfeit medicines found in the Netherlands at the end of last year entered the legitimate supply chain through parallel importers. Stubborn facts.

In the EU there is no requirement to record the batch numbers of parallel imported medicines, so if a batch of medicines originally intended for sale in Greece is recalled, tracing where the entire batch has gone (for example, from Athens to London through Canada to Indianapolis) is impossible. And all the large "legitimate" Canadian internet pharmacies already admit to getting their supplies from Europe. (An interesting and important side note is that these EU-sourced drugs aren't even legal for sale in Canada. So those folks who say we'll be getting "the same drugs as Canadians" are just plain wrong.) Caveat Emptor is bad health care practice and even worse health care policy. Safety cannot be compromised, even if the truth is inconvenient.

The World Health Organization (WHO) estimates that 8-10% of the global medicine supply chain is counterfeit — rising to 25% or higher in some countries. The largest counterfeit market with close proximity to the EU free trade zone is Russia, where the generally accepted estimate is that 12% of drugs are counterfeit. Now that the Baltic nations of Latvia, Lithuania, and Estonia have joined the European Union, WHO has warned that an increase in the risks of counterfeits entering the EU supply chain is “obvious.” Facts are stubborn things.

According to Sue Mitchell, editor of the British journal Epilepsy Today, “The parallel trade in medication is damaging people’s health and, at worse, putting lives at risk. Strong words, but when the discussion of the parallel importing of medication seems to revolve primarily around money, the reality of patient experience goes unheard all too often.”

Mr. Emanuel, Ms. Emerson, Senator Dorgan, Senator Snowe -- my 18-year old son has epilepsy. Please pay attention to the facts – and leave the fiction to John Grisham.

From those wonderful folks who brought you drug importation: “World Pricing”

• 12.22.2006

Having a slow morning? Today at 10:30 a.m., U.S. Representative Rahm Emanuel (D-IL) will announce bipartisan legislation aimed at “driving down the price of prescription drugs.” The Pharmaceutical Market Access and Drug Safety Act will be cosponsored in the House of Representatives by U.S. Representative Jo Ann Emerson (R-MO) and in the United States Senate by Senators Byron Dorgan (D-ND) and Olympia Snowe (R-ME).

So, you’d expect that these fine legislators to have a solid track record against protectionism, right? Nope.

Senator Olympia Snowe (R-ME) fiercely protects against cheap imports from foreign countries when they negatively affects constituencies in her backyard. She supported the US Government’s findings that softwood lumber imports from Canada were subsidized and unfairly priced. “The implementation of the softwood lumber agreement this morning brings a successful resolution to a long and often difficult dispute,” Senator Snowe said. “This agreement levels the playing field for the softwood lumber industry and brings an end to the unfair subsidizing of the Canadian lumber industry that had threatened thousands of softwood lumber industry jobs in Maine.”

What about unfairly negotiated foreign prices for on-patent pharmaceuticals. Nope.

Senator Byron Dorgan (D-ND) is normally a staunch protectionist. Similar to Senator Snowe, Senator Dorgan staunchly defended the wheat farmers in North Dakota against subsidized imports of wheat from Canada. He went as far as to give Prairie Home Companion-worthy testimony about a family farmer at a recent Congressional hearing. He said, “The question for the "government," it seems to me that is posed by Kevin Neece and others is will someone finally stand up for family producers, for family farmers in this country and insist and demand unfair trade and insist and demand that our trading partners, in this instance Canada, comply with fair trade rules and comply with the agreements that were reached.”

What about unfairly negotiated foreign prices for on-patent pharmaceuticals that unfairly place the financial burden of R&D on the American health care consumer? Nada.

And the leader of the pack, Rahm Emanuel (D-IL), supported the Byrd Amendment. When the Deficit Reduction Act of 2005 was passed, he co-wrote a dissenting opinion that stated: “Ensuring fair trade enables U.S. manufacturers and their workers to make continued investments to preserve their global competitiveness.”

What about unfair European trade practices that threaten pharmaceutical companies with patent expropriation if they don’t accept absurdly low “reference prices” for new and innovative products? Zilch.

But who needs consistency when you’ve got sound bites?

... but we try harder

• 12.22.2006

How about a little drugwonks self-congratulation.

According to Technorati (the folks who measure blog audience numbers) of the 55 million blogs out there, drugwonks.com has cracked the elite top 100,000. We're Number 92,165.

We try harder.

Thanks for being part of the ride. And stand by -- you ain't seen nothing yet.

No Biological Basis for Mental Illness?

• 12.21.2006

The rapid scientific movement towards a biomarker for AD reminds me of what some in the anti-psychiatry movement -- those who would discourage and destroy efforts to screen our young for mental illness -- state when they assert " that what is called mental illness such as depression, bipolar disorder, and other anxiety problems are caused by a “chemical imbalance” in the brain -- of unknown origin – is an unproven hypothesis and little more than mere conjecture. .... There is no way that we can quantitatively measure the serotonin (or any other neurotransmitter) level in a living human’s brain. Hence there can be no benchmark correct balance.

Right..

I guess all of the following are just PR efforts by BIG PHARMA

Genetics of emotional regulation: the role of the serotonin transporter in neural function. Trends Cogn Sci. 2006 Apr;10(4):182-91. Epub 2006 Mar 10

Imaging genetics: perspectives from studies of genetically driven variation in serotonin function and corticolimbic affective processing. Biol Psychiatry. 2006 May 15;59(10):888-97. Epub 2006 Jan 25.

Functional neuroimaging of genetic variation in serotonergic neurotransmission. Genes Brain Behav. 2003 Dec;2(6):341-9.

I could go on and on....but the point is the attack on Zyprexa, SSRIs or other medicines is based on a belief, a fervent one, that medicine is not necessary, that it only the perfect capitalist instrument, a form of control that keeps the consumer permanmently compliant. I am not entering the Mothership for that discussion. By the same token, while people are entitled to their opinions but they are not entitled to bully, threaten or intimidate me or anyone else.

Though diagnosis is not perfect, marketing is often mangled and manipulative, and medicines do have risks to describe medication as "drugging" and claiming schizophrenia is not a true disorder discourages effective treatment.

An Increasingly Randy FDA

• 12.21.2006

First Andy. Now Randy. And that's just dandy.

Randall Lutter Appointed Acting Deputy Commissioner for Policy

Dr. Andrew von Eschenbach, Commissioner of Food and Drugs (FDA), today announced that Randall Lutter, Ph.D., will serve as Acting Deputy Commissioner for Policy. Lutter will be replacing Dr. Scott Gottlieb who recently announced his resignation, effective late January 2007.

In this role, Lutter will provide guidance and input on all agency matters and serve as lead advisor to the Commissioner on agency policy.

“Randy has played a key role in the development and implementation of many of the agency’s highest priority initiatives,” said Dr. von Eschenbach. “The leadership he has shown in his current position as Associate Commissioner for Policy and Planning will ensure not only a smooth transition but also continued success in carrying out this agency’s mission.”

Lutter joined FDA in 2003 as Chief Economist in the Office of Planning and has most recently served as the Associate Commissioner of Policy and Planning where he coordinated the agency’s regulatory and administrative policies aimed at protecting and advancing the health of the public. In this capacity he has also served as a lead advocate for Administration, Department, and FDA policies and programs before the Congress and to the public, especially with respect to health risks associated with importation of drugs and challenges controlling counterfeit drugs.

Before joining FDA Lutter was a resident scholar with the American Enterprise Institute and fellow with the AEI-Brookings Joint Center for Regulatory Studies. From 1991 to 1997 he served at the Office of Management and Budget in the Office of Information and Regulatory Affairs and from 1997 to 1998 he was senior economist for regulation and the environment at the President’s Council of Economic Advisers.

Lutter is a graduate of Cornell University where he earned a Ph.D. and M.A. in Economics.

Gene Genie

• 12.21.2006

And there are still people out there who say that "personalized medicine" and pharmacogenomics are science fiction. Well, fact trumps fiction.

New Chemical Is Said to Provide Early Sign of Alzheimer’s Disease
By REUTERS

A chemical designed by doctors in Los Angeles could give earlier signals of Alzheimer’s disease and provide a new way to test treatments, a study has shown.

Currently, the only way to diagnose the disease is to remove brain tissue or to perform an autopsy.

The new study, to be published today in the New England Journal of Medicine, is by doctors at the University of California, Los Angeles, and is part of a larger quest to find a better method to diagnose the condition using tracers that can be detected with a positron emission tomography, or PET, scan.

The new chemical, called FDDNP, attaches to abnormal clumps of proteins called amyloid plaques and nerve cell tangles that develop in Alzheimer’s sufferers and inhibit messages being processed by the brain.

In the study, Dr. Gary Small and his colleagues discovered that the chemical allowed doctors to pick out which of 83 volunteers had Alzheimer’s, which had mild memory problems and which were functioning normally for their age.

It was 98 percent accurate in determining the difference between Alzheimer’s and mild cognitive impairment, which surpassed the 87 percent success rate for a PET scan test that measured sugar metabolism in the brain, and the 62 percent accuracy rate when doctors used a magnetic resonance imaging.

The FDDNP signal can be seen in people years before they develop Alzheimer’s disease, Dr. Small said.

Finding an easier way to track brain deterioration would also make it easier to assess experimental treatments, as researchers try to prevent or reduce the accumulation of plaques and tangles.

Dr. Small and 4 of the other 15 authors named in the research paper have a financial interest in FDDNP, which has been licensed to the German conglomerate Siemens AG. He said he hoped to see it on the market in three years.

About 4.5 million people in the United States have Alzheimer’s, a number that is expected to grow as the population ages. About 15 million to 20 million more have the mild cognitive impairment that often leads to the disease.

Where are the Haldol and Aspirin Lawsuits and Hearings?

• 12.21.2006

In the wake of sensationalist articles about Zyprexa and weight gain you would think that the next big story would be all those horrible side effects caused by typical antipsychotics like Haldol - which people like Robert Rosenheck and his cheerleaders inthe NY Times claim are just as good -- and cheaper -- than Zyprexa.

Some of Haldol's side effects.
The risk of tardive dyskinesia is around 4% per year in younger patients, higher than with most other antipsychotic drugs. In patients over the age of 45, the percentage of those afflicted can be even higher. Other predispositive factors may be female gender, prexisting affective disorder and cerebral dysfunction. See chlorpromazine for further details.
Other side effects include dry mouth, lethargy, muscle-stiffness, muscle-cramping, restlessness, tremors, and weight-gain; side effects like these are more likely to occur when the drug is given in high doses and/or during long-term treatment. Depression, severe enough to result in suicide, is quite often seen during long-term treatment.

Oh, and then there's the 'revelation' that painkillers like aspirin cause more liver injury than, say, Ketek, Senator Grassley's drug of choice.

Where are the Haldol and aspirin lawsuits? Or at least where are they in proportion to lawsuits against Lilly for weight gain associated with Zyprexa or Sanofi for 12 cases of liver injury?

Slip and fall litigation is pursued without regard to public health risk but with respect to profit.

So for those of you who commented about our earlier posts regarding the source of legal documents (and more on that later) it does matter. As long as journalists think its kosher to report the sources of income of respected academic researchers in the same sentence as they report what they say about a subject, we believe it is kosher to request that they report the source of everyone's income, particularly if that information source has a vested interest in the outcome of the case or decision that the reporter is writing about.

Democrats are Disconnected.....

• 12.20.2006

A recent WSJ poll shows that 70 percent of Democrats favor having the government 'negotiate directly with drug companies' (price controls) while only half favor cutting tax breaks for oil companies.

Drugwonks is not in favor of either. But did anyone ask real questions as in "price limits like those in Europe, Australia, Canada or the VA that limit the access of new medicines to millions of patients and delays access by 3-5 years." Or what if the "cost-effectiveness criteria used to negotiate prices meant that new drugs that delay progression of Alzheimer's by five years were never developed costing our nation $10 trillion causing 2 million additional cases of the disease that might not have occured?"

Maybe a new poll is needed. One that reflects that public policy, like all of life, is a series of tradeoffs.

GAO tell it on the Mountain

• 12.20.2006

Or, more to the point, the Hill.

A report released yesterday by the Government Accountability Office reports that annual research and development spending by the pharmaceutical industry increased 147 percent, to $60 billion, between 1993 and 2004. At the same time, the number of new drug applications to the Food and Drug Administration grew by only 38 percent and about two-thirds of the new applications were for drugs that represent modifications to existing medicines, while 32 percent were for potentially innovative new drugs.

This is yet another example of the GAO “reporting” something that is widely known, widely reported, and widely debated. But it’s worth repeating because it focuses the spotlight on the crucial need for better drug development tools – precisely the remit of the FDA’s Critical Path program.

Please refer to our report, “Prescription for Progress” which can be found at http://www.cmpi.org At that link you’ll also find video of the conference we held to discuss the future of drug development, with speakers including FDA Commissioner Andy von Eschenbach and FDA Deputy Commissioner Janet Woodcock.

But, alas, rather than using the GAO report to focus attention on the real issue, politicians are using it to pick up some cheap headlines by bashing Big Pharma.

Consider this comment by Senator Dick Durbin (D, IL), "The findings . . . raise serious questions about the pharmaceutical industry claims that there is a connection between new drug development and the soaring price of drugs already on the market … Most troubling is the notion that pharmaceutical industry profits are coming at the expense of consumers in the form of higher prices and fewer new drugs."

Here’s a fact that you won’t find under Durbin’s Turban – over the last 50 years the average American lifespan has increased by 10 years – a full decade, due largely to the impact of pharmaceutical research and development.

And the scary part is that 21st drug development is more complex and complicated as we move from small to large molecules and begin to aggressively research practical and personalized applications of the human genome.

But, as far as Senator Durbin is concerned, the beatings will continue until morale improves.

Step One: Give the FDA the tools it needs to help industry expedite 21st century drug development. Far too many drugs fail in Phase III. That’s not economically smart or sustainable – and it’s certainly not the best way to advance the public health. The FDA Critical Path program can help industry better understand which investigatory new drugs have the best chance for success – and which ones should be abandoned – far earlier in the process.

When asked why he was so successful, Thomas Edison replied, “Because I fail faster than everyone else.”

GAO figure.