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From today’s Washington Times…. The Vitter amendment is a shameful reflection on the political instincts of the Senator who sponsored it. But it also reflects poorly on the collective judgment of those members who voted for it without considering the signal it sends our enemies and more importantly, those courageous law enforcement agents who have risked their lives to make America and the medicines they take safer.

Counterfeit drugs and border security

The Washington Times


USA, 7/19/2006 - On March 29, the federal Joint Terrorism Task Force unsealed an indictment charging 19 persons with operating a global crime and terrorism ring spanning Lebanon, Canada, China, Brazil, Paraguay and the United States. The ring sold counterfeit drugs and other contraband materials, largely through direct consumer shipment from Canada, to Americans seeking cheaper drugs. It, in turn, directed its profits to support of the criminal terrorist group Hezbollah.

Less than four months later, as Hezbollah rockets rained down on Israel, the Senate voted for an amendment offered by David Vitter of Louisiana to ban U.S. Customs and Border Protection agents from seizing prescription drugs that Americans import from Canada. For Mr. Vitter, the passage was a defeat of sorts: He wanted to ban Customs agents from seizing medicines imported from anywhere, which suggests that the politicians who voted for the measure knew that dangerous people were trying to sell fake drugs in America.

How they deluded themselves into thinking that banning law enforcement from seizing drugs purchased from Canada would not be like creating a safe haven for terrorists is another question. Indeed, Canada is already the favorite port of call for fake medicines. According to customs, most of these drugs are not shipped through wholesale distribution channels but are shipped directly to consumers, with Canada being the major transshipment point because of its access to the U.S. market

In 2003, the FDA and Customs confiscated thousands of drug shipments headed for the United States. When opened, nearly half claimed to be of Canadian origin, but, according to FDA and Customs officials, 85 percent of them were from 27 other countries, such as China, Iran and Ecuador. And 30 percent of the drugs were counterfeit.

Banning Customs enforcement is tantamount to giving terrorists a free pass to flood America with fake and dangerous drugs. Customs and Border Protection is the largest investigative arm of the Department of Homeland Security. It plays the leading role in targeting criminal organizations that produce, smuggle and distribute counterfeit pharmaceuticals. Hence, Mr. Vitter and the Senate are handcuffing Customs from policing the very trafficking corridors that Hezbollah and gangsters use to penetrate our borders.

According the NY Times today, David Graham who is to rational evaluation of the risks and benefits of medicine what Hezbollah is to advancement of peace in the Middle East, called for the withdrawal of Ketek based on the fact that others in the FDA’s infectious disease division relied on post market data from Europe submitted by the company. That’s pretty funny considering Graham has called for the removal of Crestor, Celebrex, Accutane, Rice Krispies and tap water based on post market data.

Graham is not alone is his obsessive pursuit of Ketek. He is joined by an FDA staffer who wondered in a memo whether the risk of liver failure was worth one less ear infection in regards to a Ketek trial. Well, as I wrote before, if that is the benchmark, we shouldn’t give anyone tylenol for a fever.

“David Shlaes, an expert in infectious disease and antibiotic research with the development of a new medicine under his belt has sent this email to me in response to the recent articles about Ketek’s “dangers”


Recent press reports on the development, approval and subsesquent reports of toxicity of the antibiotic Ketek have me concerned. … The implicit (if not explicit) message was that the evil pharmaceutical company submitted flawed data to the FDA who, admitting the study was flawed, still approved the drug in spite of serious safety concerns. Now patients are dying because of the greed of Sanofi and incompetence or worse at the FDA.

.. Ketek, an antibiotic developed by Aventis, now Sanofi-Aventis, was reviewed by the FDA in 2001. They noted safety concerns, partly around the potential for liver toxicity, and requested additional safety data. Aventis then carried out an extremely large study of over 24,000 patients using more than 1800 different investigators worldwide. This was the study (no. 3014) where the FDA noted that the study was so flawed that they could not rely upon its data. Nevertheless, the FDA noted that in the post-marketing experience with Ketek worldwide during the intervening years until 2003, almost 4 million courses of therapy had been prescribed with no clear safety concern, plus there was a general lack of a safety signal in the 24,000 patients in the flawed study. Therefore, the FDA approved the antibiotic.

FDA conducted a thorough review of adverse events related to Ketek in the post-market setting. They were able to identify 12 cases of acute liver failure of which four were fatal among 10 million prescriptions. There were 23 cases of liver toxicity overall in the data set. As a result of these findings, the FDA approved label for Ketek has been changed to note in bold letters the possibility of severe liver toxicity â a reasonable approach based on the data.

Congress, specifically representatives Markey and Waxman, both democrats, and Senator Charles Grassley, a republican, have sent inquiries to the FDA regarding the approval of Ketek. Apparently, they believe that Ketek should never have been approved, and that the FDAâs approach to the entire problem has been flawed. Some have demanded that Ketek be withdrawn.

I would like to try and put all this in some perspective. To me, Ketekâs story is one of risk and benefit and the risk tolerance of American society and the FDA. Let us take an old reliable antibiotic or even two or three â penicillin, amoxicillin and augmentin. These antibiotics are very closely related, generic, inexpensive and are taken by many more millions of patients, including and especially children, than take Ketek. Augmentin, a combination of two penicillin-like drugs, had peak year sales of well over $2B at one point and may be the biggest blockbuster antibiotic in the history of the pharmaceutical industry. Penicillin is thought by most physicians to be the most safe and effective antibiotic ever to be developed and marketed. Yet the penicillin drugs can be expected to cause a fatal allergic reaction once in every 35-100,000 courses of therapy. Therefore, among the 10 million courses of therapy as surveyed for Ketek and for which 4 fatal cases of liver toxicity were identified, we could expect 100 to 285 deaths if the prescriptions had been for any of these penicillin drugs. In the FDA approved labeling for the penicillin drugs, the possibility of serious or even fatal allergic reactions is noted, just like the possibility of liver toxicity is noted in the Ketek label. Aspirin probably causes 7,000 deaths and 76,000 hospitalizations a year in the United Sates.

I wonder if, given our concern over Ketek, penicillin would even make it to the marketplace today, or if it were approved, whether it would be withdrawn shortly afterwards as reports of fatal anaphylactic reactions started to arrive at the FDA. Could we register asprin? Or, would we rely on the information already included in the approved product label noting a risk of rare but serious allergic reactions? Is Ketek different from penicillin? Would there be congressional hearings pillorying the FDA for approving or not forcing the withdrawal of penicillin?

I think its time for all of us, the press, Congress and the American public to take a step back from this brink â for the brink it is. More large pharmaceutical companies have halted their antibiotic research efforts than the number that still continue working in the area. Among a large number of reasons for this pullback is the increasing stringency and cost of clinical trials required for registration â of which Ketek is an example. If we want to have continued new and beneficial therapies from the pharmaceutical industry, in particular, if we want to have new antibiotics that fight infections resistant to the old antibiotics, we need come to a realistic understanding of the risk we are willing to accept.”

Covering less effective drugs

USA TODAY’s story implies that because most new drugs don’t “cure” cancer for most patients, they shouldn’t be so expensive. In fact, from 1975 to 1995, new cancer drugs increased the life expectancy of people diagnosed with cancer by about one year. From 1995 until today, death from cancer has been declining faster than at any other time in history.
USA TODAY bases its assertion that most new drugs don’t extend life on studies that tested drugs designed for specific groups from the results of one-size-fits-all studies. But lives are extended and enhanced by matching the right drug to the right patient well before the disease advances.
Maybe someone should have looked at an earlier USA TODAY story titled “Experimental drug stuns cancer doctors” (News, May 16, 2005). It describes Revlimid, which costs thousands a month and is a drug that targets a certain genetic mutation that causes a hitherto incurable blood disorder more common than leukemia is. Revlimid is nearly 100% effective in two-thirds of patients with the disease. It eliminates ineffective, equally expensive and debilitating blood transfusions.
USA TODAY wonders why people have to shell out money for cancer drugs. It should have asked why health plans cover the entire cost of cheaper and less effective drugs but not Avastin.
Robert Goldberg, Vice President
Center for Medicine in the Public Interest New York

William Tucker today has a great column in OpinionJournal discussing an interview with Andy Kessler, the author of The End of Medicine, with a particular emphasis on the amazing impact of advancing technology in terms of early diagnosis of disease and chronic conditions. Not emphasized heavily—-but clearly implicit within the topic—-is the complementary role of pharmaceuticals in the early treatment and cure of such diseases and conditions discovered early. It does not take a rocket scientist to foresee a large component of medical care as early diagnosis and then cure by pharmocology. Nor does it take a genius to see the dark clouds hovering over that bright landscape as a result of price controls, bureaucratic footdragging, and other such policy impediments, yet another shining achievement of Beltway magic.

Retrospective analysis of claims data to evaluate outcomes. Comparative evaluation of similar treatments to determine which approach cost-effective Shifting public and private dollars to the lowest-cost providers to reign in health care spending. That’s the gist of the so-called “evidence-based” medicine movement which has spread like the Hanta virus through hospital, managed care and state policy circles to create price-based prescription drug formularies that limit or encourage the use of lower priced medicines based on these sorts of exercises described above. Managed care and liberal thinks have been particularly aggressive in supporting EBM and has helped fund the Oregan center that is cranking out studies demonstrating that no one medicine is any better than any other for most people.

Now these same groups are howling now that they Medicare is giving them a taste of their own medicine. According to the NY Times (and I have will have to come to my own conclusion after further research) Medicare is developing a a new system of payment “… based on hospital costs, rather than on charges, and would be adjusted to reflect the severity of a patient’s illness. ” But the data for doing so will be based on a retrospective analysis of claims data which by definition cannot keep up with changes in technology. Hospitals and managed care plans are complaining — and so are some member of Congress probably prompted by the same interests — because they are afraid it will cut reimbursement for many procedures and technologies. A sample of the comments:

J. Brian Munroe, vice president of WellPoint, one of the largest private plans, said he feared that the Medicare changes “will introduce a significant amount of disruption to the commercial health insurance marketplace, driving up health care costs and causing marketplace confusion.”

Dr. Alan D. Guerci, president of St. Francis Hospital in Roslyn, N.Y., said the new formula would cut Medicare payments to his hospital by $21 million, or 12 percent. “It will significantly reduce payments for cardiac care and will force many hospitals to reduce the number of cardiac procedures they perform,” Dr. Guerci said.

According to the NYT…”drug and device makers have been lobbying Congress and the Bush administration to delay the changes to allow further analysis. Device makers are scheduled to meet with top White House officials this week. More than 200 members of Congress have signed letters supporting a one-year delay. “

But I thought evidenced based medicine was a good thing. Wellpoint was leading the way in integrated EBM into its formulary. Ditto Medicaid and many hospitals. Now, when the same interests who were using it to swing an axe at drug companies see that EBM is a double edge sword they are screaming for help and wringing their hands about horrible it is.

What’s the DRG for hypocrisy?


A hospital now receives the same amount for a patient with a particular condition, like pneumonia, regardless of whether the illness is mild or severe.

Against the backdrop of a war which is an obvious test of the Westâs will to stand up to terror, writing about medical innovation or health care seems insignificant. But if it wasnât clear what the shaping impulse of CMPI and drugwonks is , maybe this is a good time to state or restate it now.

Medical progress has many enemies because many people regard the drug companies and biotech firms â because they are American, multinational, profitable and founded on patent protection â as evil. So therefore, many fail to separate out the benefits of progress from those that produce it. No different from the anarchists and communists that destroyed and appropriated the means of production and took the step of killing or diagnosing those who engaged in genetic research as insane because it conflicted with the Partyâs view that all equal in all respect. So therefore today governments push the notion of one size fits all medicine and cost-effectiveness for the group at time when effectiveness is a function of genetic differences that determine response to environment, lifestyle, medicines and disease.

There are those that twist science for their own political agenda. Some counterfeit medicines for profit. Some aid and abet counterfeiters â who are usually gangsters and terrorists working together — by giving them a clear path to sell fake medicines to Americans by barring law enforcement from inspecting packages that in the past have been shown to be laden with adulterated pills. Thatâs our Congress folks! And the scientific stupidity extends to the stem cell debate, to those who shade and overstate studies on one side or the other not to advance discussion but to slam the other side. Moreover, it extends to the media that canât take five minutes to do a Google search to determine if the expert they have on speed dial has any scientific substance behind them.

We have the tools and know-how to more effectively protect people against infectious diseases, bioterrorist threats. We have the capacity to eliminate inappropriate medical care. We have the ability to increase the value of health care by investing in information systems, medicines and decisionmaking tools that promote the prevention and prediction of disease. What we lack is the leadership and coalition of the wiling to accelerate a shift to the use of these advanced technologies and approaches.

Often the obstacle is the pessimism engendered by the tired old debate or critique advanced by the enemies of medical progress â and the enemies of America and capitalism â that profit motives are whatâs wrong with health care. This critique is simply a political tactic designed by those who want to exert their own control over the course and shape of medicine. They want to control the means of production. They want less profitable companies, different research agendas, different products, and different people in control over institutions critical to progress and ultimately want the government to make major decisions in health care.

The first strike of the anti-globalists and al Qaeda alike is the suppression of the creative energies of men and women wherever they seek to organize their energies to advance and enrich themselves, their families, and communities outside of authoritarian control. Without protection of intellectual rights and free markets therefore, the human condition diminishes.

A world that does not dare to defeat tyranny and evil when the opportunity arises â or gives up, in the elusive quest for redistribution, the individual freedom to compete with and control what one creates will cease to exist.

Terrorists everywhere win by sowing fear. They achieve victory by getting people to give up and by believing there is no hope. The same goes for enemies of medical progress who seek to scare us into believing that only a purge of private sector research, government run health care and limits on patent protection with a goal of redistribution will save us from financial ruin and exploitation.

The enemies of medical progress ultimately have no vision of a better, healthier world. We at drugwonks hope to offer one by providing courageous examples and aggressively challenging lazy, unthinking and manipulative efforts to undermine the efforts of individuals to advance and commercialize medical insights. We are at the beginning of a new revolution in human health and productivity and we aim to support those involved in making it happen.

Major findings published this week in the Proceedings of the National Academy of Science. : A so-called “me-too” beta-blocker works best for people with a particular genetic mutation. The drug, called bucindolol doesn’t have much benefit to most people with high blood pressure. But for people whose blood pressure is channeled through a specific pathway affected by the Arg 389 gene and have a specific mutation also have a 40 percent higher reduction in mortality from heart failure. People who carry an entirely different gene would do worse on the drug.

The research — carried out and sustained over a decade by Mike Bristow of the University of Colorado and Steve Liggett, now of the University of Maryland — has been translated into both a drug and diagnostic. Media reports (The Washington Post) have stated that “it is unknown, for example, whether even those patients with the responsive gene would do better on bucindolol than on the two beta blockers already on the market for heart failure — a serious disease that kills half its victims within five years.” In fact, to the extent that the expression of the gene and disease is pathway specific — and the Bristow-Liggett research suggests that it is — no other drug would work better. Thus, CV treatments would follow the path taken by targeted cancer drugs.

So much for the effort to shove everyone into the cheapest drug based upon average response. Sometimes an older drug will have spectacular benefits for specific patients as a result of combining it with a diagnostic and sometimes the new medicine designed with a diagnostic in tandem will work better for another group. Evidence based medicine is being replaced by genomic-based medicine. The problem is policymakers and pundits still act and think as if the technology and informatics of healthcare is mired in the 20th century. It’s changing. And if ways of paying for and organizing and choosing healthcare don’t change in response, they become obstacles to better health.

You can read the publication online at the PNAS website: “A polymorphism within a conserved B1-adrenergic receptor motif alters cardiac function and a B-blocker response in human heart failure.

The Vitter Twitter

  • 07.12.2006

Now that the AARP has said that the Part D benefit offers better discounts than unsafe and unregulated drugs from foreign websites, you’d think that the sideshow known as “drug importation” would find its rightful place deep within the dustbin of history. But, sadly, no. Alas some of our elected officials (in this case led by Senator David Vitter, R, LA) are still beating that particular drum.

“I don’t think … taking away small amounts of prescription drugs from seniors crossing back from Canada, et cetera, is the right thing do,” said Sen. David Vitter, a Louisiana Republican who sponsored the amendment to a Department of Homeland Security funding bill.

Senator Vitter doesn’t want a discussion he wants a soapbox, because he knows the facts — that uninspected, unregulated foreign drugs are unsafe and illegal — make his oratory vacuous. If he doesn’t know then he’s deaf, dumb, and blind.

This is a recording.

Unfortunately his is a chorus backed by a supportive media echo chamber. But the music is out of tune and increasingly out of touch.

Here’s what Senator Vitter is complaining about — recently the FDA launched an investigation confiscating thousands of drug shipments headed for the U.S. When opened, nearly half claimed to be of Canadian origin but, according to FDA investigators, 85 percent of them were from 27 other countries such as China, Iran, and Ecuador. And 30 of the drugs were counterfeit.

Facts are stubborn things.

If you are looking for media attention, please leave your name at the sound of the beep.

Here was the Headline:

Drug Interactions
Financial Ties to Industry
Cloud Major Depression Study

At Issue: Whether It’s Safe
For Pregnant Women
To Stay on Medication
JAMA Asks Authors to Explain

The article, by David Armstrong of the WSJ, dramatically begins:

“For pregnant women considering whether to continue taking antidepressant drugs, a study in a February issue of the Journal of the American Medical Association, or JAMA, contained a sobering warning: Stopping the medication greatly increases the risk of relapsing into depression……But the study, and resulting television and newspaper reports of the research, failed to note that most of the 13 authors are paid as consultants or lecturers by the makers of antidepressants.”

But the article, and the endless tongue wagging that followed, failed to note that most of drugs mentioned in the study are now available in generic form.

Oh.

That’s right folks. Big pharma and their hacks had nothing better to do than conduct research to advance the well-being of pregnant women suffering from depression knowing that the drugs in question were either off-patent or about to be. How is THAT possible?

The WSJ and Mr. Armstrong ignored the extensive literature looking at the genuine risks of treating depression to the fetus as well as the risks of not doing so. Not only are such women more likely to commit suicide or do harm to others, untreated depression during pregnancy itself is associated with impaired feto-placental function, premature delivery, miscarriage, low fetal growth and perinatal unwanted effects. Armstrong never looked at any other studies or cared to, just as he never looked at expiration dates on patents.

This article is nothing short of disgusting. It’s basis thesis is not even warranted by the facts but Armstrong goes along and eggs people into making comments that prejudge the research and researchers. Armstrong claims the study is clouded by financial ties to industry. But his article is devoid of even a nanobyte of objectivity. Whose judgement is clouded?


I am receiving lots of interesting emails from patients and groups who take exception to the piece in USA Today about the price of cancer drugs: The article, written by Elizabeth Szabo, parrots the approach formulated by Geete Anand at the WSJ both in terms of bias and sloppiness. It is of the “these drugs are hugely expensive and don’t add much to survival and these drugs are too pricey and people who are dying can’t afford them.” I have yet to figure out how drugs can be both ineffective and essential at the same time, but from Szabo’s rushed perspective being both just adds to the drama and criminality of having to spend, on average $1600 a year on cancer therapy.

The US spends about $24 billion on cancer drugs, less than is spent on cholesterol drugs and slightly more than ulcer medication. Total spending on cancer in the US is $75 billion. That means 32 percent of total spending on cancer is drugs, about average for chronic illness. Meanwhile the total cost of cancer to the US, including lost productivity due to death and illness is approximately $210 billion. By 2010, cancer drug spending will rise to about $55 billion. If we can limit use to those who can benefit the most and increase survival we save billions in productivity costs and quaity of life. Where was Szabo on all this?

1. The claim that most new drugs don’t “cure” cancer but just add a few months of life is meritless. To be sure the recent Tarceva and Gemzar trials showed no survival advantage, but they were genetically non-selective studies. There is no average cancer so there is no average response or survival rate. Many new targeted therapies increase survival signfiicantly for subpopulations precisely because they hit a specific pathway unique to a particular group. The substantial increase in life expectancy is masked by large clinical trials that include non-responders. For many, being disease free for five years with no tumor progression amounts to a cure. And that doesn’t include the cervical cancer vaccine.

2. Doesn’t quality of life matter? If you can life for two years without the horrible effects of cancer or chemotherapy and thereby stay at work, be in school, remain a parent, isn’t that worth something. Revilimid eliminates the terrible trauma associated with extensive and repeated blood transfusions which cost $60000 a year. What about the value of being able to treat the disease without such complications and disabling approaches.

3. Where is the responsibility of insurance companies to cover the cost of cancer medications. Why would it cover the cost of cheaper and less effective drugs but not Avastin or Herceptin? Indeed, tiered copays have been shown to discourage appropriate and cost-effectiveness use of medicines for diabetes and heart disease. Cancer is no exception. Companies should not have to shelling out money for medicines that insurance companies should be paying for.

4. Reducing cancer mortality by even 10 percent would generate over a trillion in productivity in America. Insurance companies might not gain, but we would.

Here’s the real question: Why doesn’t the media analyze the issue of new medical technology from this broader perspective and be more thorough in its investigation of clinical evidence prior to making such assertions as “higher prices but little added benefit.” And why does it focus on the price of medicines rather than the way in which price is used to ration access by health plans when the drugs themselves add significant value to the lives and wellbeing of Americans.

CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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