Over a year ago Tom Perez, president of the Montgomery County, MD County Council (and better known as the David Catania of Silver Spring) introduced a resolution that would allow the county to purchase “drugs from Canada.” According to The Washington Post, Perez “anticipated offering the benefit to 85,000 employees and retirees, including 27,000 affiliated with the school system. But the plan suffered a setback last month when the county school board declined to pursue a contract with Canusa, a privately held health benefits company based in Windsor, Ontario, largely because of concerns that the program would violate federal law. So now, Perez is focusing on the county government, with 12,500 workers and retirees, in part because it is the entity over which the council has direct control.” Now Mr. Perez is going to make the local police and fire forces and the other hard working members of the Montgomery County civil service guinea pigs in his lab experiment designed for blatant political ambitions. And, as far as the county retirees are concerned, I wonder how much time (oops — times up) he’s spent educating them on the Medicare Part D benefits to which they are entitled. Meanwhile, the Canadian Health Minister has made it clear that he will not allow his nation to become America’s drug store. That’s why Canadian internet marketers — profiteers masquerading as pharmacists — now need to get their drugs from Europe. And that means Latvia as well as Great Britain and Portugal as well as Germany. Mr. Perez’s plan would not deliver “the same” drugs that Canadians get at their local pharmacies. That’s a fallacy proven 100 times over and conveniently and irresponsibly ignored by the County Council president. And since the Council of Europe just released a new study revealing the bad news about the European Union’s fast growing problem of counterfeit drugs — it’s good news that the Montgomery County school board did their homework and sent Mr. Perez and his foolish notions to detention.

Just read the NY Times interview with Thomas Ryan, the CEO of CVS. The topics he discussed were interesting — the impact of generic drugs on his bottom line, legal liability, and his acquisition strategy. What was even more interesting (and disturbing) was what he didn’t discuss — anything to do with health care affordability, access, or Medicare Part D. And the article was in the health section. Sounds disturbingly familiar.

This is a story of two prime numbers. The first prime number is 779. That’s the number of Google “news” hits for today’s announcement that final-stage testing shows Merck’s Gardasil vaccine to be 100% effective over the short term in preventing infection with two strains of human papillomavirus, a sexually transmitted disease that is the leading cause of cervical cancer, during a Phase III study of more than 12,000 young women in 13 countries. The drug was genetically engineered to block HPV types 16 and 18, which cause 70% of cervical cancers. 779 hits for an announcement of truly global significance. Coming in a distant second is the second prime number, 219. That’s the number of Google hits for the headline, “Merck opens its defense in Vioxx trial.” My rough math shows, therefore, that the media feels that an almost complete defeat of cervical cancer is about three and a half times more newsworthy than Merck’s defense in the second Vioxx trial. TGIF.

A new WHO study reports that India, China and Russia will suffer losses of billions of dollars in national income over the next decade unless investments are made to prevent rising levels of chronic diseases. A March 2005 research synthesis from HHS’ Agency for Healthcare Research and Quality estimates that the United States could save nearly $2.5 billion a year by preventing hospitalizations due to severe diabetes complications. But the global debate shouldn’t be primarily about the money — it should (indeed must!) be about saving lives. And the debate needs to begin at home.

In 1979, 31,691 Americans had a foot amputated because of undiagnosed and untreated diabetes. Last year that number grew to over 80,000. And hundreds of thousands of heart attacks and strokes, caused by high blood pressure and high cholesterol, cost the American health care system billions of dollars. The cost in terms of human suffering cannot even begin to be measured.

The argument that health care is “too expensive” is too broad. The proper argument is that waiting for Americans to get seriously ill and then intervening is too expensive. Earlier diagnosis and earlier, continuing care is crucial to the future health of both Americans and of the American health care system.

We cannot afford, in terms of either dollars or lives, to continue playing the health care “blame game” — because disease is the enemy and the cost of disease is staggering. One part of the blame game is about health care prices — for hospitals, insurance, drugs, and doctors. Rather than looking for a villain, it’s time to start asking the hard questions and finding the right answers — and focusing on how to reduce the price of a diabetic amputation is the wrong approach. We need to do the things that can be done to prevent it in the first place, because that’s the best way to save money and improve lives. And we need to do this now, because we also want to be able to invest in and afford better treatments for other conditions — cancer, Parkinson’s, etc. that are so desperately needed and that hold so much promise.

The first step in this process is an honest, broad-based dialogue. In order to revitalize our health care system we must refocus the debate about health care. In order to save lives, reduce costs, enhance quality and deliver on the promise of robust health to all groups of Americans, all of the players in the health care debate — including government must work together as a team, as a unit, as a public health defense force armed and ready to advance the pubic health.

Is “The Day” (the daily newspaper of New London, CT) on your morning “must read” list? Well if it’s not, you missed the report that Pfizer has a new public Web site with information from hundreds of clinical trials. According to the story, Pfizer now has data posted on the site from 314 studies for its drugs that subsequently reached the market. Beyond “The Day,” not one Google hit. Why no media interest on the clinical trials database of the world’s largest pharmaceutical company? There was certainly an ocean of ink spilled excoriating Big Pharma over the black cloak of secrecy previously surrounding such data. Sadly, it’s another case of Anorexia Newvosa — a disease evidenced by a media feeding frenzy (aided and abetted by self-serving politicians and special interest groups) over perceived misdeeds, followed by a total lack of interest in how the problem is addressed. There’s a Japanese proverb that is relevant here — “Don’t fix the blame, fix the problem.” Those members of the media and Congress suffering from Anorexia Newvosa, binge on the bad news and then purge themselves of interest in the solution. But this is, fortuantely, a treatable disease and the front-line therapy is intellectual honesty. Unfortunately, this treatment is currently considered off-label for too many elected officials and members of the Fourth Estate.

Because of the sincere desire of Senator Charles Grassley and others to play a more active role in health care, an article of possible career interest —

Oct 3, 2005 — CHICAGO (Reuters) — A clown in the operating room may relax anxious children who are about to undergo surgery, but the entertainer has to learn to keep out of the way, Italian researchers said on Monday. A study of 40 children between 4 months and 3 years old who were accompanied by at least one parent prior to minor surgery found having a clown present significantly reduced anxiety levels for both child and parent. Three out of five children suffer anxiety before surgery, according to the report published in the journal Pediatrics. Clowns succeeded in distracting the children until the administration of anesthesia, but apparently annoyed doctors and nurses.

Here’s a piece from today’s (October 3, 2005) Wall Street Journal. As we ponder drugs from foreign nations and increasingly aggressive counterfeiters, we would do well to remember what life was like before “safe and effective” was the order of the day.

How Elixir Deaths Led U.S. to Require Proof of New Drugs’ Safety

Only 70 years ago, American companies could legally sell poison in a medicine bottle.

Obviously, no drug maker would knowingly kill its customers — the free market would punish that kind of bad business. But a company that inadvertently sold a drug resulting in multiple deaths faced no legal penalties.

In 1937, however, the consequences of Americans’ unfettered right to buy and sell medicine became disastrously clear. An antibacterial syrup called Elixir Sulfanilamide killed at least 75 people, some of them young children who had been suffering from nothing more serious than a sore throat. “Even the memory [of our 6-year-old daughter, Joan] is mixed with sorrow, for we can see her little body tossing to and fro and hear that little voice screaming with pain,” wrote a grief-stricken Tulsa, Okla., mother to President Franklin Roosevelt.

The elixir’s manufacturer, S.E. Massengill of Bristol, Tenn., wasn’t expected to test its drugs for safety, and it didn’t. The company’s owner later said he and his chemists “regret the fatal results,” but “do not feel there was any responsibility on our part.” The company eventually paid a fine, but only for misbranding: Under existing federal law, the term “elixir” was restricted to solutions containing alcohol.

Massengill, like other drug companies of the time, had been doing a brisk business in the newly discovered miracle drugs known as sulfa, which were manufactured in tablets or powder. But many of Massengill’s customers, particularly young children, preferred their medicine in liquid form. A Massengill chemist found that sulfa could be suspended in water, raspberry flavoring and diethylene glycol, an industrial chemical sometimes used to make antifreeze.

The company’s laboratory “tested the mixture for flavor, appearance and fragrance and found it satisfactory,” wrote Carol Ballentine in a 1981 article in FDA Consumer magazine. Some 240 gallons of the syrup were shipped across the country. Even if customers had wanted to check the ingredients, they couldn’t. The drug companies had the right to keep their formulas secret.

At the time of the elixir debacle, the food and drug industries were still regulated by a 1906 law that was stuffed with loopholes and mostly unenforceable. In 1933, a new bill was introduced in Congress. Among other provisions, it proposed to outlaw the sale of medicines that might kill someone who ingested them. For the next five years, the bill and its successors were stalled and gutted by the brawny proprietary-medicine lobby, with help from friends in the newspaper industry, which had become addicted to advertising revenue from wonder drugs like Paw-Paw Pills and Cherry Pectoral.

“Your pocketbook is about to be filched,” wrote a medicine maker to newspapers in which he had placed advertising. “We ask you to take an active, aggressive stand against this bill, not as a matter of cooperation to us but for your own business interests … An isolated editorial or two will not suffice in this matter.”

The opponents of new drug and cosmetic regulation, nicknamed the “pain and beauty boys” by the press, argued that Americans’ belief in their right to self-medicate was as deeply held as their belief in the right to free speech or worship. People wanted the convenience of buying their medicines over the counter, the critics argued. Under the new law, a simple headache would mean a costly trip to the doctor. And why should the federal government play gatekeeper to private citizens’ medicine cabinets?

It was frightening, said the head of an advertising agency that specialized in patent medicines, to see “such a sweeping grant of autocratic power being placed in the hands of any bureau or department of government.”

Added the general counsel of a drug industry trade group in congressional testimony, “I have never in my life read a bill or heard of a bill so grotesque in its terms, evil in its purpose and vicious in its possible consequences.”

Elixir Sulfanilamide provided the emotionally wrenching case history the bill’s supporters needed to mobilize public opinion. By the time anyone realized the elixir was poison, it had been distributed in at least 15 states and bought over the counter by many customers unknown to the pharmacists.

The Food and Drug Administration put almost its entire staff of 240 agents on the trail of the elixir, and their attempts to trace every pint provided a dramatic running narrative for the press. Based on the death rate of those who took the medicine, if all 240 gallons had been consumed, more than 4,000 people would have died.

In 1938, Congress passed the Food, Drug and Cosmetic Act, under which, for the first time, pharmaceutical manufacturers would have to prove the safety of their products before putting them on the market. That year, the FDA also decided that sulfanilamide, among other powerful drugs, should be taken only under the direction of a doctor, putting another nail in the coffin of some pain and beauty boys.

Write to Cynthia Crossen at cynthia.crossen@wsj.com

The following verbatim quote is from a story in today’s Washington Post, not as you may think, from the pages of the National Lampoon —

“Von Eschenbach also faces potential conflict-of-interest issues because of his ongoing role as vice chairman of the board of C-Change, a nonprofit organization headed by George H.W. and Barbara Bush.” Now, you-ve probably never head of C-Change. Me neither. So I looked it up. “C,” in case you were wondering, doesn’t stand for “conservative” or “cabal” or “callous” — it stands for “cancer.” And Dr. von Eschenbach serves on the board with other well-known super-conservatives like Senator Diane Feinstein. Since you won’t find out more about the mysterious “C-Change” anywhere in the Post article, here is some verbiage direct from the organization’s website. First, their mission statement:

“C-Change is comprised of the nation’s key cancer leaders from government, business, and nonprofit sectors. These cancer leaders share the vision of a future where cancer is prevented, detected early, and cured or is managed successfully as a chronic illness.”

And do these folks gather in secret to further the vast right-wing conspiracy? No? Then what do they do? Thanks for asking, it’s more than the Post did. “One of the underlying principles of C-Change is to leverage the leadership and expertise of all sectors of society to eliminate cancer as a major public health problem at the earliest possible time. C-Change is both a forum and a catalyst for identifying issues and major challenges facing the cancer community and for initiating collaborative actions to complement the efforts of individual.”

Members of C-Change include representatives from:

* Governmental agencies with federal funding devoted to cancer research and/or applications
* Academic cancer centers
* Private, for-profit companies
* Nonprofit advocacy/consumer organizations
* Professional organizations representing groups of individuals and/or organizations with a common interest in cancer
* Congressional, administration, and state government officials
* The media

Yep. Sure sounds like a conflict of interest to me.

Looks like the Wall Street Journal struck a nerve. Senator Charles Grassley, in a letter published today in the WSJ, says some pretty interesting things that scream out to be memorialized both for future reference and for reference in the Orwellian Dictionary of Newspeak. Here’s the first, “I’ve not argued that faster drug approvals increase the risk of unsafe drugs making it to market.” And another, “Your editorial underscores my strong belief that the FDA’s relationship with drug makers is too cozy. My view is based on evidence that FDA leaders have gone out of their way to accommodate drug makers when drug safety questions come up.” Maybe the Senator should attend the occasional advisory committee to see how absurd this comment is. And by the way, evidence? What evidence? Here’s a third, “My criticism of the close relationship is not based on the fact that pharmaceutical companies pay user fees to the FDA. I’ve said repeatedly that those fees don’t account for the problem and eliminating them would not be a solution.” There you have it folks, Senator Grassley supports PDUFA reauthorization. Well, we’ll see about that. I always thought he believed user fees were (as Mr. Orwell might say) “doubleplusungood.” You can look it up.

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.

Impressive investigative reporting by Robert Pear and Stephanie Saul of the New York Times into Les Crawford’s resignation turned sour in the very last sentence of their story. Quoting Dr. Crawford’s brother-in-law, the article ends with the comment that Dr. and Mrs. Crawford will get through these trying times “because they’re very strong Christians.” Now, let’s be honest, Robert Pear doesn’t include quotes to capture the folksy tone of the American South. He and Ms. Saul intended it as a put-down, as a way to position Dr. Crawford and his family as redneck chuckleheads who either don’t have the wherewithal to understand a federal financial disclosure form or as snake oil Billy Sunday Chautauqua charlatans. The South shall rise again.

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.