There are so many important issues surrounding drug safety — better labels, more transparent clinical trial results, e-prescribing, compliance, to name only a few. Drug advertising just isn’t one of them. The pickle is that it’s the most visible. The continuing debate over whether or not consumer advertising for prescription drugs is “good” or “bad” misses the point — the genie (as Janet Woodcock has said) cannot be put back in the bottle. Certain segments of our already over-regulated society are suffering from a severe Washington-induced over-dose of self-righteousness. And that includes many members of Congress.

By no stretch of the imagination should government be in the business of controlling either the message or the medium.

What would you think if the Federal Communications Commission and the Food and Drug Administration got together and decided that too many sound bites of Charles Grassley or Maurice Hinchley were hazardous to the health of the American television viewer? Why you’d be upset, right? I would. (Really, I would.)

There are, of course, some things that should be regulated. That’s what living in a civilized, modern society is all about. The Pursuit of Happiness means that, even though we live in a free society, you can’t yell “fire” in a crowded movie theater. Factories aren’t allowed to poison the air and water, and consumer products must advertise themselves truthfully. That’s the 21st century Social Contract.

And pharmaceutical advertisements must be accurate, fair and balanced — as defined and reviewed by the FDA. Most people (and I think it’s fair to say most legislators) don’t understand that the brief summary (otherwise known as the “small print”) and the fair balance and adequate provision (more frequently referred to as the part of the TV ads where they talk about all the bad stuff that can happen) is dictated by the FDA. And I mean “dictated” like in “take this down verbatim and use it.”

At a Senate hearing Senator Debbie Stabenow asked Janet Woodcock (who was Director of CDER at the time — the center that contains the division that reviews pharmaceutical promotional materials including consumer ads) why FDA approved so many ads. Dr. Woodcock paused and then reminded the Senator that FDA doesn’t approve ads, they review them. And that ain’t just a rhetorical finesse.

DTC ads aren’t perfect, but they do provide significant benefits to the public health. There’s plenty of information and opinion on this topic on this vey blog site. But the big issue is free speech. It’s the first amendment — and for a reason.

If we pursue restrictions on pharmaceutical DTC advertising and promotion, can a total prohibition be far behind? It’s certainly possible — then watch for steroid-injected special interests going after …

* Big Macs and Whoppers. After all, cholesterol kills.
* Hummers and SUVs. An insidious plot by the oil industry to promote irresponsible petroleum consumption.
* Disposable Diapers. A real biohazard. Banning them is more than a job — it’s a doody.
* M&M candies. All of the colors are not equally represented.

Sound absurd? When you hear people talk about banning, restricting or limiting any type of speech don’t be passive. Make no mistake — advertising is on the cutting edge of free speech.

The same people who would restrict and then ban pharmaceutical ads would fight to the bitter end for other people’s right to publish pornography and produce films containing the most violent and vile acts conceivable. Don’t doubt it for a minute.

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!

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.

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.

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.”

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.

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?

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.

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?

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.