This just in …

STRASBOURG, France (AP) — Counterfeit Viagra, antibiotics and other drugs are on the rise in Europe, leading international pharmaceutical and health care experts said, blaming insufficient cross-border cooperation.

Meeting at a three-day conference organized by the Council of Europe, government officials, law enforcement officers, doctors and pharmaceutical experts from Europe and the United States called Thursday for tighter criminal legislation, better public awareness campaigns and a central point for collecting information on fake drugs.

They warned that the rise in counterfeit medicines could undermine patients’ confidence in public health care.

“It is worrying that there is no recognized central reference point in Europe entrusted with surveillance, trend analysis and policy recommendations in the field of counterfeit medicines,” said Maud de Boer-Buquicchio, deputy secretary general of the Council of Europe, the continent’s leading human rights body.

“This situation helps the counterfeiters, who can rely on international cooperation gaps in Europe,” she said. “Even when they are caught, they far too often get away with administrative fines with no deterrent effect.”

Counterfeit medicines make up approximately 10 percent of the European pharmaceutical market — up from close to zero 10 years ago — and often are supplied by international criminal rings, the World Health Organization says.

In Russia, some 20 percent of all drugs distributed are fake, while in Mexico it is 40 percent and in Nigeria as much as 80 percent, Council of Europe and WHO statistics show.

Counterfeit medicines often are packaged like the genuine product and are hard to detect. Lifestyle drugs, such as Viagra, and essential medicines such as antibiotics and insulin are particularly popular with counterfeiters, but there’s also an increasing number of fake contact lenses and even materials such as surgical mesh.

Experts warned that purchasing health products over the Internet poses a major health risk as such drugs often have not been approved by a competent health authority.

A study conducted by the U.S. General Accounting Office in 2004 showed that four out of 21 medicines ordered from Web sites outside the United States or Canada were fake.

“Patients using these services are at risk of receiving medicines which are counterfeit, out of date or unidentifiable for lack of proper packaging,” said Jean Parrot, President of the International Pharmaceutical Federation.

The conference, which runs through Friday, focuses on identifying ways to detect fake drugs, combating distribution and drawing up guidelines to protect the public. Representatives of the European Commission, the European Patent Office and the U.S. Food and Drug Administration were attending the meeting.

Fred Fricke, director of the Forensic Chemistry Center at the FDA, highlighted a recent case: Two former employees of pharmaceutical giant Johnson & Johnson set up their own business in India and were producing fake, non-sterile surgical mesh and distributing it to a number of hospitals in the United States.

Level-headed logic and sound advice from the editorial page of the Washington Post …

PROCEEDINGS began this week in the lawsuit filed by Frederick Humeston
of Boise, Idaho, against Merck and Co., the makers of the painkiller
Vioxx. Mr. Humeston wants compensation for the heart attack he suffered in 2001, two months after he began to take Vioxx. The facts of the case would seem to give Mr. Humeston little chance. Not only do studies of Vioxx show that the risk of heart attack is linked to use over a much longer term, but Mr. Humeston was, like many other middle-aged men, at risk of a heart attack for other reasons, too.
Unfortunately for Merck, scientific facts didn’t play much of a role in the first Vioxx trial, which ended on Aug. 19. The Texas jury in that case awarded $253.4 million to the widow of a man who died of a heart attack triggered by arrhythmia, which is not a condition Vioxx has been proven to cause. The jury, declaring that it wished to “send a message” to Merck, decided to make an enormous symbolic award anyway. Besides, said one juror afterward, the medical evidence was confusing: “We didn’t know what the heck they were talking about.” Because Texas law limits the size of jury awards, the final cost to Merck is likely to be closer to $2 million. But the precedent set by the jury is ominous. Merck is facing about 5,000 similar lawsuits. If every one of those costs the company $2 million, the total price will come to $10 billion — if, of course, a company called Merck is still around to pay it. Politicians and regulators should be asking themselves whether a system of massive cash awards to people who may or may not have been adversely affected by Vioxx is a logical, fair or efficient way to run a drug regulatory system. They should also be asking whether juries that scorn medical evidence are the right judges of what information should or should not have been on a prescription label. After all, Vioxx was produced and sold legally. The drug was approved by the Food and Drug Administration, and its label did warn of coronary side effects. It is possible, even probable, that Merck was negligent in its decision to ignore early warnings of the cardiovascular risks of Vioxx. But the company has already paid a price for that negligence, in the losses it has suffered after abruptly taking Vioxx off the market. Fair compensation for the injured needn’t entail disproportionate financial
punishment as well. In the long term, using the courts to “send a message” to Merck isn’t going to help consumers. If the result is an even more cautious FDA approval system and a more cautious pharmaceutical industry, that will keep innovative drugs off the market for much longer. More people will die waiting for new treatments. The cost of producing new drugs will rise dramatically. Already, there are whole areas of medicine — women’s health during pregnancy, for example — that are made so risky by liability issues that companies may stop doing research in them. The first principle of reforming this system should be that a company that follows the FDA’s rather extensive guidelines should be protected from punitive, if not compensatory, damages. At the very least, it is time for Congress to start considering whether a model such as the one set up for children’s vaccines — in which a fund is set up to cover the
costs incurred by children harmed by vaccines — should be constructed
for all drugs.

All schizophrenics react to medicines the same way. So says the New York Times. According to the Gray Lady, “The nation is wasting billions of dollars on heavily marketed drugs that have never proved themselves in head-to-head competition against cheaper competitors.” But have these medicines proved themselves where it counts — in the bodies and biochemistries of schizophrenics? For many patients (although clearly not enough for the New York Times) a new therapeutic option often provides the chance to live their lives outside the horrible fog of schizophrenia The plain fact is that some medicines work better for some patients than for others. Some marginally so, others more significantly. One size does not fit all and nowhere is this more true than in patients suffering from severe mental illness. It’s time that the good folks at the Times editorial board stop listening to the better (Marcia) angels of their nature and reserve judgment before speaking with mental health professionals, patients and families thereof.

Seems as though there’s more to Switzerland than chocolate, Heidi, and precision watches. We now, unfortunately, must add a problem with counterfeit prescription drugs. The problem will get it’s most high-profile airing at a three-day Council of Europe meeting instigated by the Swiss Agency for Therapeutic Products, Swissmedic.There have been two high-profile cases of counterfeit drug trafficking in Switzerland in the past three years. In 2002 a wholesaler in the Basel region was caught selling repackaged drugs to Germany worth SFr23 million ($18 million). And two years later Swiss customs seized HIV medicines that had been stolen from a batch sent to Africa by the World Health Organization. Swissmedic is also concerned about the quantity of fake drugs available on the internet.
The Swiss regulatory authority proposed the Council of Europe meeting two years ago because the problem is not just confined to individual countries. “This is a Europe-wide problem, which means we have to collaborate,” said spokesman Paul Dietschy. “Some countries need to change their laws because this is not illegal in all countries. We also need to solve problems with data protection that stops us getting information.” Dietschy hopes the programme of workshops and presentations at the Council of Europe headquarters in Strasbourg will lead to a coordinated effort to combat the problem. The event will be attended by representatives of all 46 Council of Europe member states together with healthcare professionals, patients’ organisations and representatives from the pharmaceutical industry.”We need a collaboration between customs, justice authorities and police on the one hand and the drugs industry, including manufacturers, wholesalers and medicine agencies on the other,” said Dietschy. “We must educate doctors and pharmacists and connect the industry to the authorities.” He added that the problem of counterfeit drugs was relatively new in Europe, but has been growing steadily over the past five years. “This has been going on in developing countries for many years, but it is a new problem in Europe since the beginning of the 21st century. There have been about 15 big cases in Europe that we know of. There is big money involved.”The Council of Europe estimates that drugs that have been deliberately and fraudulently mislabelled are on the rise. “They present substantial health risks to Europe’s citizens, including potential fatalities,” the council said in a statement ahead of this week’s meeting.

Here’s an idea — how about sending Sentors Dorgan and Vitter on a fact-finding mission?

Every potential government action yields a reaction, and nowhere is that eternal truth clearer than in the ongoing debate over the importation of pharmaceuticals subject to foreign price controls. Such legalized importation would be one way for those favoring price controls on pharmaceuticals—a blatant wealth transfer from the future to the present—to have that cake without actually having to vote for it, and thus having to bear responsibility for the ensuing adverse effects on future human suffering.

In any event, all the importation talk some months ago led the authorities and others in Canada and elsewhere to make it clear that they could not be viewed as America’s pharmacy; the Canadian market simply is too small to supply America’s pharmaceutical demands even at current prices. And the pharmaceutical producers themselves, like all good capitalists attempting to do well by doing good, would have incentives to limit sales into the various foreign markets, so that foreign governments in effect would not take on the role of determining pharmaceutical prices in the U.S.

And so we have yet another example of government grasping ever-more power so as to circumvent the problems created by previous (or other proposed) power grabs: Current proposals to allow the importation of pharmaceuticals subject to foreign price controls include provisions forcing the producers to sell to the foreign governments all the drugs demanded at the controlled prices, thus transforming the foreign markets into the central middleman suppliers for the U.S. market.

Where to begin? This means that foreign governments—or more specifically, the foreign governments imposing the tightest price constraints—will be given the power to set prices in the U.S. Do we want the future of U.S. medical technology to be determined by political pressures overseas and/or by bureaucrats in Ottawa or Brussels or elsewhere? Apparently, some in the U.S. Congress do indeed. And precisely what is the economic value of any given pharmaceutical patent when that economic value in the U.S. can be confiscated by foreign politicians, whether elected democratically or not? So much for the future of pharmaceutical investment and innovation—the research and development process takes over a decade, and what investor wants to bet on political outcomes not only in the U.S., but anywhere in the world?— and thus for the future development of cures.

And let us have no nonsense about the importation of pharmaceuticals subject to price controls as a manifestation of “free trade.” Forced sales at controlled prices—prices not approved even by We the People, that is, Congress—are no more consistent with the principles of free trade than the purchase of stolen merchandise from the back of a truck would be consistent with the principles of free enterprise. Thus is the forced sales approach a blatant violation of the Takings Clause of the 5th Amendment, as the price controls would transfer the property rights (i.e., real wealth) inherent in patents from pharmaceutical producers and future patients to current interest groups without any compensation whatever, whether just or not.

The last time I read the 13th Amendment to the Constitution, it said something rather sharply unfavorable about involuntary servitude. The forced sales proposals would mandate that pharmaceutical producers sell all that is demanded at the prices dictated overseas, without recourse to the ordinary processes of negotiation, let alone legal institutions. Thus would American firms be forced to serve foreign masters—literally—on terms dictated by foreigners. And let us not forget the “nondiscrimination” dimension of the forced sales gambit: If the German government buys, say, 30 million doses of a drug at a given price, would the pharmaceutical firm be forced to sell an identical quantity at the same price to anyone in Germany? That the answer is not clear—it might very well be “Yes”—reveals a good deal more about the forced sales idea than its proponents would like us to know.

And is there any reason to believe that such forced sales would be limited to drugs? If U.S. politicians can transfer wealth to their constituencies in the form of “cheap” pharmaceuticals, why not a myriad of other goods that require massive up-front investments?

So there we have it. Fewer medicines. U.S. markets held hostage to foreign political pressures. A wholesale destruction of the Bill of Rights. Government of, by, and for the People—Sovereignty—cast to the winds. Such are the inexorable outcomes yielded by politicians and bureaucrats in hot pursuit of wealth redistribution, the larger adverse implications be damned.

Breaking news story from Canada — the Royal Canadian Mounted Police (the RCMP is Canada’s FBI) has admitted there are three or four counterfeit pharmaceutical investigations in the Greater Toronto area, but they won’t say anything else — including what drugs are involved. According to Ken Hansen, head of the RCMP’s federal enforcement unit and the co-chair of an Interpol committee on counterfeiting, the government has known about the threat of fake pharmaceuticals for some time — it was flagged in a 2000 RCMP report — but the rate at which it is growing is why it’s suddenly on the radar screens across the world. “You’ve got to evolve to meet the crime. Status quo isn’t an option. The problem will just get worse,” said Hansen. “Virtually every organized crime group in Canada is involved in counterfeit goods because it turns a high profit and comes with limited punishment and little enforcement.” That sounds ominously familiar to what’s going on in the U.S., Europe, Africa, and Asia. Health Canada and the U.S. Food and Drug Administration signed a memorandum of understanding to communicate and cooperate on issues of drug safety. I wonder if Health Canada has picked up the phone?

For more information on CMPI’s September 20th Washington, DC gathering of many of the world’s top counterfeit drug experts (including a free audio webcast) please visit www.rxcmpi.org.

The Council of Europe is launching a program to combat counterfeit medicines with a seminar in Strasbourg from 21 to 23 September 2005. It will bring together all Council of Europe member states, European associations of trade and industry, healthcare professionals and patients’ organizations, institutions of the European Union and international organizations to draw up measures against counterfeiting that will work. Counterfeit medicines are deliberately and fraudulently mislabelled, and they are on the increase in Europe, with estimates ranging from 6% to 20% of market shares in certain regions. They present substantial health risks to Europe’s citizens, including potential fatalities.

Recently Henry Miller (a member of the Center for Medicines in the Public Interest board of advisors — the parent of this blog site and a fellow FDA alum) published an op-ed in The Washington Times titled “FDA’s Short Dose of Reality.” While I don’t agree with a lot of what Henry writes, I certainly feel he raises some critical points — one of which is that the health policy community is a tightly knit fraternity. Or should I say “sorority?” I mention this gender question because, in his piece, Henry points out that the senior vice president of the Association of American Medical Colleges (David Korn) is married to a former FDA Deputy Commissioner (Carol Scheman). (Note: Henry did not use her name in the article.) Dr. Miller received a scathing e-mail in response and their dialogue — completely unedited — can be seen below. Here’s the question — why the hubbub?

To: Henry Miller
From: Carol Scheman

Dear Henry,

Your recent “Washington Times” piece was forwarded to me and while I am not particularly interested in debating the opinions you express, I am surprised that you think it pertinent to note that “David Korn, is one of the two authors and happens to be married to a former FDA deputy commissioner.” I think this reference is not simply silly and gratuitous, it is also sexist and offensive and an artifact of a time when some people found two career couples and the idea of women working somehow odd and complicating. I am not sure what point you were trying to make so I decided to ask you. Was this simply a random thought that your editors neglected to excise or are you making a point? And if you are making a point, exactly what is it? And with this issue aside, I do hope you are well.

Sincerely,
Carol

To: Carol Scheman
From: Henry I. Miller

Dear Carol:

Nice to hear from you; I hope all goes well. The point of my article to which you took offense was merely to point out that there’s an obscure connection between one of the authors of the AAMC
report (which I found to be less than complete and too kind to FDA) and the agency that most readers of the report wouldn’t know about. I would also have drawn attention to the connection if David had been, say, the father or brother of a former FDA deputy commissioner.

With best regards,

Henry

Is this the first confirmed case of Karl Rove Syndrome?

From CMPI blogisto, Dr. Henry Miller …

In recent years, the costs of drug development have skyrocketed, with
direct and indirect expenses now exceeding $800 million to bring an average drug to market; and fewer than one in three drugs that are approved for marketing ever recoup their development costs. Even more ominous, the number of applications to FDA by industry for permission to market drugs has been steadily decreasing since 1995.
But drug and biotech companies spend more than $30 billion a year on
research, so how can that be? The reason is that regulators are
continually raising the bar for approval. For example, in just the past few years FDA officials have arbitrarily and unexpectedly directed clinical investigators to begin trials at inappropriately low dosages; limited approval of early stage studies only to single-dose, instead of dose-ranging, studies; demanded unnecessary, invasive procedures on patients; and even required that foreign trials be completed and the results submitted before the U.S. trials could begin. It’s bad enough that such an overly cautious mindset delays the availability of new drugs, but regulators’ increasing preoccupation with safety concerns may have become contagious: Drug manufacturers, too, seem to have begun to “err on the side of safety” to a degree that causes safe and effective drugs to be taken off the market voluntarily. An example is Tysabri, only the sixth medication approved — and the first in several years — for the treatment of Multiple Sclerosis (MS), a debilitating autoimmune disease that affects the central nervous system. The stunning results of the drug’s testing in clinical trials — which showed improvement in the quality of life and a reduction by more than half in the frequency of clinical relapses — induced FDA to grant accelerated approval last fall. MS patients eagerly put their names on waiting lists to get the medicine. But this ray of hope for MS sufferers was short-lived. By the time that several thousand patients were being treated with Tysabri, three deaths from a rare neurological disorder caused by a virus were reported. (Because the drug suppresses certain aspects of the immune response, regulators, clinicians and the drug’s developers had from the beginning been sensitive to the possibility of infections as a side effect.) Immediately — some would say prematurely — the manufacturers of the medicine voluntarily halted production and distribution, withdrew Tysabri from the market, and immediately initiated a full review of all patient data. MS victims and many neurologists were bitterly disappointed. Data obtained since the withdrawal have confirmed the drug’s efficacy and shown no additional drug-related deaths, so as a scientist, physician and
policy wonk, I wonder why Tysabri isn’t back on the market. Surely, this is a product that patients (with the approval of their physicians) should have the right to choose.

On September 20th, the Pacific Research Institute’s Center for Medicines in the Public Interest (the parent site of DrugWonks.com) is holding a conference on the urgent issue of international prescription drug counterfeiting. For more information on the event — which will feature leading international experts as well as senior U.S. government officials from the FDA and the Department of Justice — please visit www.politicalcap.com/pri. The event is being held in Washington, DC. If you are unable to be there you can still attend virtually via our audio weblink. To register for the audio weblink (at no charge) please visit www.videonewswire.com/event.asp?id=30518.

The following from the meek and mild mind of Bob Goldberg, PhD …

Only in the NY Times can a recusal to avoid even the appearance of a conflict of interest be treated as evidence as malfeasance of a sort. The Times, like most of the media never places its j’accuse in any context. So for instance, its story about the BMS diabetes drugs ignores the fact that the treatment targets a particular receptor (PPAR) that increases insulin sensitivity. It was only confirmed as a target by showing that people with a certain mutation of a gene regulating the PPAR receptor. Thus down the road it will be likely that for people with this variation, the BMS drug will be one of the best medicines for diabetes since it is the only one correcting for the genetic defect. This will be millions of patients who will get their insulin levels right when they could not with other drugs. All this is somehow over the heads of the great journalistic minds at the NYT. Perhaps this is why the writer only focuses on the ‘serious cardiovascular risks’ as opposed to trying to draw a nefarious link between and Vioxx. And perhaps this is why it ignored the fact that the risk is rare (less than 1 percent of all patients) which makes it as risky as other diabetes drugs on the market. Witholding that information probably had nothing to do with the goal of trying to explain the approval of the drug as a product of the ethically compromised panel. Interestingly, the NY Times failed to have either Gardiner Harris or Stephanie Saul cover advisory committee REJECTIONS of high profile drugs put forth by Johnson and Johnson, Abbott and Pfizer for cancer and osteoporosis respectively. Why? Because the votes don’t square with the conspiratorial model of drug approval they advance. Nor can the NY Times explain why it failed to mention the industry consulting of one advisory committee member, gastroenterologist Bryan Cryer, when quoting him in an article that the blood thinner Plavix might cause stomach ulcers but does note his financial ties in a piece alleging his vote to keep Celebrex on the market was bought and paid for. All this underscores the fact that ideology, pursued without regard to the truth or accuracy, turns people into idiots. No better example is that of Maurice Hinchey a congressman who would bar Nobel Prize winners in medicine from advising the FDA if they consulted for drug companies. Since all of them have, the Nobel Laureates are to be considered bias and compromised, according to the twisted logic of Hinchey and the NY Times. By extension which should disregard Pasteur’s path breaking insights into the role bacteria play in causing disease and his vaccine developments because he was largely funded by the French beer and wine industry. Sadly, based on the NY Times articles, Hinchey was able to get an amendment passed that would ban every researcher of any note from helping the FDA if they had done any consulting with companies. My thinking is that we should apply this thinking to all fields. Accordingly, Hinchey should recuse himself from making any statement or voting on any bill that involves tort reform since he receives so much PAC money from the trial. And NY Times reporters who receive a $500 bonus for writing such articles should disclose as such. Ironically, FDA advisory committee members have asked for more disclosure of their financial holdings in an effort to ally concerns. But view this too has not been disclosed by Hinchey or the New York Times. That alone underscores an important consideration which we should weigh in evaluating their claims: Intellectual or ideological bias may be more difficult to ferret out than financial conflicts, but they can be politically more destructive.

Once again into the abyss. This time the issue is Guidant defibrillators. Solid reporting by Barry Meier of the New York Times raises some troubling and important matters. The first, of course, is what did Guidant know, when did they know it, and why did they delay reporting important adverse events to the FDA? The second, more troubling question, isn’t when the FDA knew — it’s why didn’t they act sooner. Or, to be more precise, how long did the report reside in a CDRH in-box before it was read and acted on. The first set of questions raise the specter of disquieting corporate shenanigans. But the issue of CDRH timeliness is, in the broader scope of the public health, more important, more troubling and, believe it or not, easier to address and remediate. The “front end” of CDRH functions well enough. The “back end,” the part that deals with post-market surveillance issues, not as well. The dedicated career staff at CDRH, under the respected leadership of Dan Schultz work hard — but they (like the rest of FDA) are under-funded and under-staffed. Let me be clear. There is no excuse for delay — but human beings can only do so much. Minus an increase in funding (which doesn’t seem to be in the cards any time soon) something else must be done, from a process perspective, to eradicate delays of potentially life-saving information. Even if Guidant had submitted its report on time, it’s likely the FDA would have taken the same amount of time to read it, digest the implications and issue the same public health advisory. The question isn’t confidentiality. That’s not even relevant. The issue is timeliness. And the answer is for the FDA to take a hard look at its existing processes and make them better. The New York Times, editorializing on its own report, recommends an interesting option — separate the wheat from the chaff. Ask device companies to provide a separate “hot sheet” that directs the FDA’s attention to the most crucial information — rather than burying it deep within the bowels of a more lengthy report. Drugs have risks and devices fail — that’s the world in which we live. And it’s all the more reason for device manufacturers to step up to the plate and be a more senior partner in protecting the public health. But corporate behavior is no excuse for an FDA process issue. A problem has been identified and a solution suggested. Now it’s time for the dedicated public servants at the FDA to solve it — and fast.

In 2006 the Center for Medicine in the Public Interest (www.cmpi.org), estimated that counterfeit drug commerce will grow 13% annually through 2010.  The CMPI study is cited by the WHO on its updated counterfeit pharmaceuticals fact sheet.

Counterfeit sales are increasing at nearly twice the rate of legitimate pharmaceutical sales and they are a money machine.  In 2010 CMPI estimates that fake drugs will generate $75 billion in revenues — a 92% increase from 2005.  And the risks of detection and prosecution are low.

Our original estimates were made based on conservative projections of counterfeit medicines manufacture and sales issued by the WHO, the FDA, the EU Commission and other global bodies. 

But we now feel these numbers are too low – because an entirely new criminal enterprise has emerged – counterfeit ingredients.  While counterfeit API (active pharmaceutical ingredient) isn’t a new issue, there is a new and frightening manifestation.  In the past, counterfeit API was purchased by criminals making counterfeit drugs.  Today a new, significantly more dangerous and difficult to fight enterprise is underway – the sale of counterfeit (“tainted”) ingredients to legitimate pharmaceutical manufacturers.  The most high profile example of this is the deadly case of Heparin.

It is impossible to believe that the case of Heparin was an unfortunate mistake – a quality lapse, a one-time and unique circumstance. The facts speak otherwise.  This was a case of fraud.  Criminal fraud.  So let’s call it by its proper name -- counterfeiting.

Counterfeit medicines, according to the WHO are “deliberately and fraudulently mislabeled with respect to identity or source. Counterfeiting occurs both with branded and generic products and counterfeit medicines may include products with the correct ingredients but fake packaging, with the wrong ingredients, without active ingredients or with insufficient active ingredients.”

It’s time to rethink and broaden that definition to include the potential for fake ingredients (“tainted” is both too polite and too inaccurate a term) that insidiously find their way into legitimate pharmaceutical manufacturing.

And, unfortunately, it means that CMPI must recalculate its global estimates for counterfeit medicines and their profits upwards.

When asked why he robbed banks, Willy Sutton, the depression-era desperado replied, “because that’s where the money is.” And, as my former boss Mark McClellan used to say, if Sutton were alive today he’d be selling counterfeit prescription drugs. The bad news is that international prescription drug counterfeiting is on the rise. The worse news is that pending US legislation could make it even worse. Two news items crossed the wire late this week that illustrate this growing problem — and its truly global nature. The first story, from China, tells of eleven Chinese nationals and one American arrested in a counterfeit medicine scheme that spanned eleven countries, 440,000 bogus pills and $4.3 million US dollars. The drugs being peddled were Lipitor, Viagra, Cialis and Levitra. The nations involved were the US, Great Britain, Switzerland and Israel. (Note to Senators Dorgan and Vitter: Drug importation from the EU is dangerous.) The second, more frightening news item comes from Hamilton, Ontario where a registered pharmacist, Abadir Nasr, was charged with selling counterfeit Norvasc (a medicine used for the chronic treatment of hypertension and angina). Congressman Bernie Sanders (I, VT) and others, when asked about the dangers of drug importation are fond of quipping, “Show me the dead Canadians.” Well, the regional coroner in Hamilton is currently investigating the deaths of five people who filled prescriptions for Norvasc at Mr. Nasr’s pharmacy. All five died of a heart attack or stroke. (Note to Governors Pawlenty, Blagoevich and Doyle — and a big red warning to Governor Perry: Drug importation from Canada is dangerous.) Attention must be paid to this very serious problem and the way to make it better is not to make it worse by opening up American borders to medicines not under the jurisdiction of the FDA. Here’s another question — why haven’t either of these news stories been reported by any major American media. (Note to The Washington Post and the New York Times: Google “Hamilton, Ontario.”)

Senators Stabenow (D, MI) and Vitter (R, LA) both need better staff work and a remedial course in patent law. Both are offering up H.R. 2862 (aka the Northup amendment). Purpose — “To prevent the United States Trade Representative from negotiating future trade agreements that prevent the United States from changing United States patent law to allow the importation of pharmaceutical products.” It’s a familiar canard — and a dangerous one, as intellectual property rights of US companies are under attack across the globe. Their position, that the USTR shouldn’t have the authority to negotiate agreements that enshrine US patent law, is half-baked and benighted since that’s precisely what Congress instructed the USTR to do in the Bipartisan Trade Promotion Authority Act! Debbie and David are fixated on the recent agreements USTR negotiated with Australia, Singapore and Morocco — and name these three accords specifically in their loony legislation. But the truth is that the provisions in these agreements apply to ALL patented products. It’s also especial peculiar since Australia already has its own law prohibiting the export of pharmaceuticals (Hello Byron!) and neither Senator Stabenow nor Senator Vitter have included Singapore or Morocco as recommended nations of export on drug importation bills they’ve either authored or co-sponsored. H.R. 2862 is a clear choice between truth or consequnces. And,as the saying goes, results are what you expect, and consequences are what you get.

Huh? Jerry Avorn raises some interesting and valid arguments in his September 8th Perspective in the NEJM. But, unfortunately, he swiftly devolves into the bizarro world of Marcia Angell. In discussing FDA’s clinical measurements of “safe and effective” he posits that the public health would be better served if the agency also required, “consideration of a drugs efficacy and safety as compared with alternative therapies.” Dr. Avorn argues that such clinical evidence would make better prescribing information more readily available. But since every patient is unique, how relevant is this really? Just as there is no such thing as a “me-too” medicine (as any sober chemist will tell you), neither is there such a thing as a “me-too” patient. Patients (otherwise known as “people”) respond differently to different drugs — even drugs within the same therapeutic category. Asking FDA to recalibrate “safe and effective” to “as safe mostly but not as effective in some circumstances but somewhat more effective in others” is a poor public health course. Dr. Avorn, chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital should know better. There are a lot of places that FDA belongs — but subjective intermediary between patient and doctor is not one of them.

Well, my wife prevailed upon me to see The Constant Gardener this weekend. How can I say this gently: Don’t waste your money. A new tuberculosis strain is wreaking havoc across Africa, you see, and a corrupt pharmaceutical firm has developed an effective treatment that, sadly, has the unfortunate side effect of killing many of those taking the drug. We know this because UN aid workers in Kenya, using only the most rigorous of statistical analytic tools, say so. And so the poor Africans killed by this drug are secretly buried in lime pits, while the official records of their lives are expunged. Only Soviet-style airbrushing of photos failed to have been included. Meanwhile, the starlet—-Ms. Rachel Weisz, aka Tessa Quayle in the film—-learns that the evil pharmaceutical firm, aided by some corrupt British officials, is covering up the obvious evidence of the drug’s deadly effects because fixing the formula would cost millions and take considerable time during which the firm’s competitors could create their own effective drugs that would not kill people, thus cutting into the corrupt firm’s profits, etc., etc. And this perfidy makes sense because the epidemic is likely to spread worldwide, creating a large demand for the drug, and suppression of the deadly side effects will guarantee a huge market in Asia and the West. It’s all about the money, you see.

Got that? Anyway, the evil pharmaceutical firm through its allies in Kenya arranges for the murder of the fair Tessa and her ally, a Kenyan doctor both humanitarian and seemingly the only man in the country both unpoor and uncorrupt, before they can expose the plot. After all, that is not the kind of direct-to-consumer advertising that sells medicine. And so Tessa’s loving husband Justin picks up the torch, exposes the evildoers for what they are, and then allows himself to be murdered by the same nefarious forces so that he can be together again with his beloved Tessa in heaven. Who says that Hollywood is not religious?

Well, if Big Pharma is motivated only by money, why would they expose themselves so crudely to the plaintiff’s bar in the West? After all, people would start dying in the West also; can we even imagine the sums that the juries would award in such cases? And would the FDA and the other regulatory agencies in Europe simply accept the results of such African “clinical trials?” And what about the brand name capital of the offending pharmaceutical firm? Does it not have a profit motive to protect it by marketing only drugs the benefits of which justify the downside risks?

This flick is so silly—-so Michael Moore-like in its excess and mendacity—-that the pharmaceutical industry has little to fear from it in terms of adverse p.r. It’s good thing, as Martha might put it, when those out to destroy capitalism prove themselves so crude.

Just for a minute put aside your feelings about emergency contraception and rather than thinking about Plan B, consider Plan E. That’s E like in Ephedra. During my tenure at FDA, one of the agency actions I was most proud of was the banning of dietary supplements containing Ephedra. All the scientific evidence supported the decision. Politicians and the media were laudatory. There was broad public support — especially among parents of high school athletes — some of whom had tragically died because of these dangerous snake oil supplements. I am convinced that lives were saved because of the FDA’s decision. And then, in April of this year, a federal judge in Utah — Ground Zero for the dietary supplement industry, overturned the agency’s ban. The judge’s ruling was based on the legal argument that FDA hadn’t really proven Ephedra was dangerous. Yes, that is absurd. But sometimes the law really is an ass. That’s why it’s so important that FDA decisions be based not only on sound science but also on a sound legal foundation.

Which brings me to Plan B. Considering the highly charged environment surrounding female reproductive issues, legal maneuvering to overturn a potential “behind the counter” decision wouldn’t be based on science, but rather on the agency’s authority to make such a split decision. And making public health decisions through litigation is not in the best interests of the public health. An action on Plan B, absent a definitive and public rule making process would, rather than making emergency contraception more widely available, very likely delay OTC availability due to prolonged and protracted legal actions. And if legal action is the most effective route, you can be sure it will be pursued.

Almost every year during Sweeps Week (when networks try to boost viewership for their annual Nielson ratings) there is a health-related horror story. This year almost every network news program, both local and national, ran stories on how FDA-approved vaccines are causing autism in previously normal, happy, healthy young children. One the one side (the side with about 95% of the airtime) are parents (mostly mothers) whose children developed autism after being vaccinated for childhood diseases. On the other side (and for only the briefest of sound bites) is a nerdy looking doctor saying that every single third-party research study over the past ten years shows absolutely no correlation between autism and childhood vaccines. Who do you think the average viewer believes? And this fear-over-facts tabloid journalism was even more effective this year than usual with the FDA on its heels over drug safety. And to prove to us, once again, that irresponsible actions often have dire unintended consequences, Governor Pataki just signed into law a bill that (effective in 2009) would prohibit children three years of age or younger from being inoculated with vaccines that contain the mercury preservative thimerosal. Another action in the growing litany of public opinion rather than hard science driving public health policy. According to the American Academy of Pediatrics, “This legislation represents very bad public health policy that is based on junk science and mass hysteria, not on the evidence of science.” The AAP continues to say that such a ban has the very real danger of scaring parents away from getting their children vaccinated. Whenever a child develops a horrible condition parents want someone to blame. But the hard truth is that bad things do happen to good people for reasons that cannot be determined. But a worse fate is to reintroduce into society childhood diseases that were the scourge of previous generations. Governor Pataki has incautiously adopted the Precautionary Principle — and put at risk the youngest generation of the Empire State.

Attention Senators Dorgan and Vitter: Here’s some info from a recent AP story that you might find interesting …

MEXICO CITY. In just eight years Farmacias Similares, or Similar Pharmacies, has grown from a single store in Mexico City to 3,329 across Mexico and is spreading throughout Central America as well as Argentina, Ecuador and Chile. A pharmacy opened in the Peruvian capital of Lima on July 29. Colombia is next. And it’s made Victor Gonzalez a rich man.

His catchy advertising — a cartoon doctor and an army of scantily clad models — has made 58-year-old Gonzalez a household name. His slogan is “The Same, Only Cheaper.”

Now the recovering alcoholic and self-professed womanizer wants to translate his popularity into a run for president, though the law is against him, as is most conventional wisdom.

Gonzalez refuses to divulge his net worth, joking in an interview, “If I tell you, they’ll come kidnap me.” But his eight companies, manufacturing, transporting or selling pharmaceuticals, generated around $400 million in sales last year. His group claims to control one-quarter of Mexico’s $9 billion drug industry.