At today’s BioCentury Summit, FDA Deputy Commissioner Scott Gottlieb issued a blunt broadside to the medical journal mandarins …

“Too much important medical information remains shielded behind strict embargo policies and too long peer-review cycles that mostly serve the interests of enterprising journal editors rather than patients.

Medical journal embargo policies are the C-Section of Journalism — you can report on something at the date, and time, of your choosing. And the medical journals such as the New England Journal of Medicine and Science are pressuring everyone, including the FDA, to release information more quickly.

They are right. Information that could influence clinical medical practice needs to be made available more quickly, and more widely, after it has gone through a deliberative scientific process that firms up its meaning and the magnitude and the veracity of its conclusions.

But why should the medical journals alone have the luxury of bottling up information behind longwinded peer review processes that can wind on for months and embargo policies that serve no useful purpose?”

Let’s see what Time Magazine has to say about that!

Senator Charles Grassley is so smart! Reading his recent statements and press releases (yes — they are hard to differentiate) you’d think he was smarter than all the career scientists at the FDA (well, except for one), the combined R&D staffs of every global pharmaceutical company, Dr. Elias Zerhouni — and now we can add to that illustrious list Dr. Andrew von Eschenbach. That being the case, and for the good of the country, maybe the senator should ask President Bush consider him to head the FDA? Then again, maybe not.

One of the reasons President Bush tapped Andy von Eschenbach to take hold of the suddenly rudderless FDA is because von Eschenbach thinks big. Now he must also think broadly. His oft-repeated (and unfairly ridiculed) challenge to make cancer a chronic disease by 2015 raised a lot of eyebrows — but it focused attention on the task at hand. His management style at the NCI challenged a lot of entrenched interests, but succeeded in making the federal government once again relevant in driving an aggressive agenda — one based on the foundation that the best kind of research is of the applied variety. A victor over cancer three-times over, von Eschenbach will now face a different kind of tripartite battle — political, bureaucratic, and scientific. He’s a known quantity at FDA, having led collaborative efforts on both NCI’s and FDA’s Critical Path efforts — rising above internecine rivalries to provide an unfortunately rare example of government agencies working together for the common good. He’s a man of energy, action and integrity. He’s a survivor. Good luck Andy.

The following is excerpted from a forthcoming article by CMPI Board of Advisory member Henry Miller …

Ideally, the nominee for FDA commissioner should be equal parts consummate manager, technocrat, and Lord High Executioner. Realistically, he must have several attributes:

Superior management skills and experience. The agency’s scope is so
sweeping — encompassing cardiac pacemakers, x-ray machines, condoms, home pregnancy-testing kits, drugs, vaccines, artificial sweeteners and fat substitutes — that a single person cannot be expected to master the body of science, medicine, pharmacology and engineering (to say nothing of the law and “regulatory science”) involved. The FDA’s own professional staff can frame the issues and options; the function of the agency head is chiefly to manage the far-flung empire, craft appropriate incentives for moving products through the pipeline more efficiently, and make the final decision on difficult policy questions. Also, the commissioner needs to be competent to perform reality checks for the senior staff. An excellent example is the agency’s oversight of food biotechnology: FDA regulators have in place a scientific and workable policy, but at UN-based negotiations on food standards, they have proposed and supported unscientific approaches to biotech foods that conflict with their own domestic policy.

Unassailable integrity and honesty. The Commissioner’s decision-making must meld law, science, medicine and regulatory precedents, in a way that maximizes the public interest. The incumbent needs to earn the respect of those who have a stake in FDA’s policies and decisions — that is, patient groups, individual consumers and drug companies — with candor, consistency and rectitude. The FDA Commissioner’s job should not be awarded as a political plum, as are cabinet posts and many ambassadorships. Politics should be banished insofar as that is possible, with the commissioner doing what is in the public interest and then taking the heat from all quarters for unpopular decisions. A corollary is that the commissioner should probably not aspire to higher political positions in government Doing the job right makes plenty of enemies.

There’s a new white paper worth reading. It comes from Alberto Mingardi of the Bruno Leoni Institute in Italy and leverages the current American debate over drug importation to address some more fundamental and troubling issues — sustainability of global pharmaceutical development. Heres a sample. The full paper can be found at http://brunoleoni.servingfreedom.net/BP/

Free-riding (on drug discovery and development) by European countries does appear a markedly unsustainable course: ironically, the price controls in force in almost every development economies endangers the American exception. Pressures on the United States to take the course of socialized medicine come from many quarters and some steps in that directions have already been taken. The prospect of a “globalization” of socialized medicine emphasizes all the flaws of a situation in which Europe is content with living off the American golden eggs goose. When the fact is taken into account that in 1998 as much as 33 of the best-selling (and, therefore, most appreciated) drugs were of American origin, it is clear that the very future of an innovative healthcare industry depends on that goose. Beyond any moral issues, the danger exists that, if the United States will achieve further European-style legislative “progress,” that overstretched goose might lay her last egg.

I am proud to have served with Les Crawford at the FDA. I am prouder to consider him my friend.

The DC Council has approved legislation (which Mayor Anthony Williams has said he will sign) that would make it illegal for pharmaceutical companies to sell prescription drugs at an “excessive price” in the District of Columbia. And, of course, if companies don’t comply there is a civil penalties clause. In medical terms, the Council needs to have their collective heads examined. But their mental health isn’t the issue. The real question is, what aspects of drug pricing do pharmaceutical company’s control? Pfizer doesn’t own a chain of pharmacies. Eli Lilly doesn’t have a stake in CVS. And, in case you didn’t know, there is no such thing as MSRP (manufacturer’s suggested retail price) for prescription medicines. Here’s how it works — a drug company sells its products to a wholesaler who sells it to a pharmacy (often with multiple re-sellers and re-packagers in-between). And everyone along the supply chain marks up the price to make a profit. In fact, by the time you receive your prescription at the pharmacy, the price can be upwards of 40% over the initial price charged by the pharmaceutical company. But, since the DC Council is made up mostly of lawyers (including the genius who introduced the legislation, David Catania — a lawyer at the mega-DC firm of Akin, Gump, Strauss, Hauer, Feld) it’s not surprising they’ve chosen to focus on the deepest pockets — the pharmaceutical industry. It wouldn’t look good, after all, if their legislation forced local pharmacies (who enjoy a sizable profit on their sale of medicines) to close in Anacostia. What does “DC” stand for? Based on the current disposition of the DC City Council, it stands for “Drug Catastrophe.”

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.