From the pensive pen of Dr. Sally Pipes:

“We are not prepared for a pandemic,” Health and Human Services Secretary Michael Leavitt said earlier this month. We do, however, face a significant risk of being hit by one. A new strain of the avian flu, known as H5N1, has killed at least 60 people in Asia since 2003. So far, humans cannot pass it to one another — virtually everyone infected caught the virus from a diseased bird.

The risk to people is nevertheless grave. The 1918 Spanish flu epidemic, blamed for 50 million deaths, also started among birds, but it mutated and spread to humans. Scientists fear the same thing could happen now. As an expert epidemiologist recently told the Wall Street Journal, “It龝 not a question of if, but when.” The Centers for Disease Control (CDC) estimates that an avian-flu pandemic could kill between 89,000 and 207,000 Americans. There is no publicly available vaccine for the new strain.

Now that the threat is upon us, the administration says it plans to bolster vaccine production in the United States and purchase huge quantities of antiviral drugs. But the question is: Why weren’t we ready in the first place?

The United States once had a large vaccine industry. In 1957, 26 companies supplied the market for standard children’s vaccines — but now only four companies do. Three decades ago, at least 10 U.S. firms manufactured vaccines to treat seasonal flu. By the late 1990s only five remained. And in 2004, the entire U.S. flu-vaccine market depended on just two companies — a French firm with a factory in Pennsylvania, and a California firm with a factory in Great Britain. Hence, our sense of crisis during last year’s flu season, when contamination at the British plant curtailed supply.

The only avian-flu vaccine likely to be available soon is made by the French company Sanofi-Aventis — the same firm we rely on for seasonal flu vaccines. The Sanofi-Aventis vaccine against H5N1 is undergoing preliminary U.S. government testing and showing early signs of success, but it’s not clear how soon it could be available. California-based Chiron — the one with the contaminated British plant — says it will have an H5N1 vaccine ready for testing by the end of the year.

To develop new and better flu vaccines is well within the reach of science. So why don’t U.S. drug companies, which dominate the global medicine market, make vaccines?

First, vaccines are subject to excessively strict screening by the Food and Drug Administration (FDA). So, for example, FluMist, a flu vaccine delivered via nasal spray, has only been approved for use for people aged between five and 49. It is our youngest and oldest, however, who run the greatest risk of catching the flu. This means that the cost of researching and developing new vaccines is needlessly expensive.

Second, vaccines are very expensive to produce. Using one older method of making flu vaccine, it costs about $300 million to build a factory and takes almost five years to get it completed and inspected. The company that makes FluMist, Maryland-based MedImmune Inc., could produce 20 million doses a year, but only about two million would get by the regulators. Because flu vaccine doesn’t keep, in 2003 MedImmune was forced to discard four million doses of its product.

Third, out-of-control lawsuits have scared companies away from developing and producing vaccines. For example, a researcher claimed in the 1970s that the whooping-cough vaccine caused brain damage. More than 800 lawsuits were subsequently filed in the U.S. against vaccine makers. Scientists later proved conclusively that there was no link between the vaccine and brain damage, but by that time the manufacturers were already out of business.

If companies stood a chance of recouping their investments, all these high costs of doing business might be manageable. Government price controls, though, make getting a return next to impossible. The Vaccines for Children Program was the final nail in the coffin of the American vaccine industry. Established by the Clinton administration in 1994, it established a single-buyer system for children’s vaccines. The government now buys 57 percent of all childhood vaccines, forcing steep discounts on manufacturers.

In short, litigation, regulation, and price controls have strangled our ability to prevent deadly diseases, among them avian flu. It doesn’t have to be this way. America leads the world in making medicine. Pharmaceuticals created by U.S. firms have made our lives longer, more comfortable, and more productive in ways our forefathers couldn’t have imagined. People everywhere clamor for AIDS and cancer medications invented in the United States. If we remove the red tape that has choked off vaccine production, we could have a healthy vaccine industry too.

Here’s another (prepublication) paper. We’re not called DrugWONKS for nothing.

Download file

Dan Carpenter, in the October 18, 2005 issue of Health Affairs, proposes financing post-marketing drug safety studies by augmenting FDA user fees. That’s just PDUFy. Why add (by Carpenter龝 own calculation) 25% increased cost to the process when a more expeditious route is to empower FDA with the enforcement authority required to compel post-market commitments made during the initial approval process. Carpenter’s modest proposal would certainly provide a lot of work for idle academics, but not much in the way of enhanced patient safety. Maybe its time that we kept our powder dry and kept sponsors to their NDA-phrase promises. For more thoughts on the Carpenter article, please click on “comments” below for a thoughtful response from Bob Goldberg of the Manhattan Institute.

Senator Charles Schumer (R, NY) weighs in on the Tamiflu issue with the following perspective; “The problem is not the expense of the drug but rather the shortage of supply, which would immediately be rectified if other companies were able to produce it.” Well, kind of. “If” only it were as simple as gearing up mass production of Tamiflu the problem would indeed be helped, if not “immediately rectified.” But, unfortunately, it’s not so simple. Mark Twain said that for every complicated problem there is usually a simple solution — and it’s usually wrong. And Tamiflu production is extraordinarily complicated. We’re not talking about a toaster that can be mass-produced by anyone, anywhere in the world at any time. The Senator went on to say that the manufacturer of the drug, Roche, should be compensated fairly for giving up its rights over the drug. “I deeply respect the investment Roche has made in order to bring Tamiflu to market, but am confident that there is a way to both serve the public need and ensure that your company receives compensation,” he said in a letter to the company. Glad to hear that a well-respected United States Senator respects intellectual property rights. That’s a good point of departure. I wish the same could be said for rogue Indian patent thieves, the World Health Organization, and the Secretary-General of the United Nations.

Representatives Waxman and Slaughter just announced their co-sponsorship of HR 839, the “Restore Scientific Integrity to Federal Research & Policymaking Act.” Now, while I certainly object to the “restore” bit — I do agree with much of the verbiage, to wit: “Appointments to scientific advisory committees shall be made without regard to political affiliation, unless required by federal statute.” Also, that federal agencies would be required to ensure that “no individual appointed to serve on a federal advisory has a conflict of interest that is relevant to the functions to be performed, unless such conflict is promptly and publicly disclosed and the agency determines that the conflict is unavoidable.” During my tenure at the FDA I was the senior official in charge of advisory committees and I’m here to tell you that what Henry and Louise are advocating is already status quo ante Grassley. But there is one conflict that I need to make known — my wife and Representative Slaughter’s daughter roomed together in college.

It is time to take off the gloves and prosecute stupidity. Looking at it from a different, more proactive angle, it’s time for tort reform. After all, as Forrest Gump so aptly put it, “stupid is as stupid does.”

Our courts are over-crowded and under-funded. Auto insurance and professional liability rates are too high. And, unfortunately, our personal responsibility levels are too low. A New York man sued McDonald’s, Burger King, Wendy’s, and Kentucky Fried Chicken for contributing to both his obesity and his related health problems. I wonder if he took Vioxx?

The man may be fat, but his attorney is a fathead, a very wealthy fathead. If we are going to prosecute stupidity, we will have to make it a misdemeanor (since our courts and jails are already over-burdened), but let us make enabling it a felony.

Keeping in mind the immortal words of former congressman and convicted felon James Trafficant, “Beam me up, Scotty,” consider this editorial from the 10/16/05 edition of the Business Review of Western Michigan:

Contraindicative Rx

If some state lawmakers have their way, drug makers in Michigan will lose their shield against consumer lawsuits. That’s a tough pill to swallow. The bills, which last month passed the House on an 89-17 vote, would repeal a 1996 state law that protects drug makers from liability if their products meet U.S. Food and Drug Administration safety and labeling standards. The bills’ Democratic sponsors are emboldened by last month’s Texas jury verdict against Merck and Co., which marketed the pain killer Vioxx. The jury awarded the widow of a Vioxx user $253.4 million. But here’s one fact to remember: The Michigan protection does not apply if a company intentionally withholds information or makes misrepresentations to federal regulators. While we worry that a lawsuit shield prevents a drug’s users from seeking every angle of recourse against a company that brings to market a drug with unintended ill consequences, the process of researching, developing and receiving approval to market a drug takes several years. What Michigan may do while trying to provide recourse for consumers is erode business protections against meritless lawsuits. What’s more, eliminating the drug-company immunity sends the wrong message as the state seeks to keep what remains of Pfizer’s facilities in western Michigan and elsewhere in the state and attract investments from life-sciences companies — a topic that came up in Business Review’s May 25 quarterly forum in Kalamazoo and Sept. 14 forum in Grand Rapids. After all, life sciences is a logical extension for protection. “We’ve got to protect the rights of consumers and make sure people who are negligent, and wantonly negligent, are punished,” state Rep. Bill Huizenga, (R, Holland),told Business Review. “On the flip side of that, we need to make sure companies are able to be innovative.” Huizenga, chairman of the House Commerce Committee, said removing immunity tells the pharmaceutical industry — and life sciences, too, we say — that Michigan business law is going backward. Here’s our prescription for lawmakers — take a dose of reality, give it a rest and call us in the morning.

Frivolous lawsuits do nothing to educate the American public about better health care. In fact, they trivialize such important efforts. What’s most disturbing, however, are the effects such lawsuits have on our diminishing view of personal responsibility and warped perspective on blame. Blame is what people do when they find themselves on the wrong end of the risk/reward equation. Blame supposes fault and as Plutarch wrote, “to find a fault is easy, to do better may be difficult.”

If we do not stand up for what’s right and what’s needed, then we will live to see a thousand Michigan’s bloom.

Disconcerting news from the subcontinent. “Right or wrong, we’re going to commercialize and make oseltamivir,” (Oseltamivir is the generic name of Tamiflu) said Dr. Yusuf K. Hamied, chairman of Cipla of Bombay. Well, since you asked, it’s wrong. It’s IP theft. It’s trading profit today for health care innovations tomorrow. It’s profiteering. According to Roche, making the drug involves 10 complex steps and would take another company “two to three years, starting from scratch,” to produce it. Dr. Hamied dismissed that claim, saying that he initially thought it would be too hard but that his scientists had finished reverse-engineering the drug in his laboratories two weeks ago. Dr. Hamied said he would sell generic Tamiflu “at a humanitarian price” in developing nations and not aim at the American or European market. I wonder if this includes Illinois?

Here’s a new and insightful piece by Benjamin Zycher, Ph.D.

The greater the power to redistribute wealth wielded by government, the stronger the private-sector incentive to circumvent it, and so ever-expanding is the power that government must grasp. Nowhere is that eternal truth clearer than in the ongoing debate over the importation of pharmaceuticals subject to price controls overseas. Such legalized importation would be one way for those favoring such price controls — 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 current and future human suffering.

Under a system of reimportation of price-controlled medicines, the pharmaceutical producers, understandably seeking to protect the economic value of their investments and thus their ability to develop new medicines for the future, would have incentives to limit sales into the various foreign markets, so that foreign governments in effect would not determine pharmaceutical prices in the U.S. And the foreign governments, interested in preserving adequate supplies of medicines for their own populations, have made it clear that they cannot serve as pharmacies for Americans.

And so having shunted aside both the serious counterfeiting/safety issues attendant upon the drug importation system now contemplated, as well as the implicit, but huge, erosion of intellectual property rights inherent in the price controls, the Congressional proponents of such importation now must confront the unwillingness of the foreigners to serve as the price control middlemen for the U.S. market.

And confront it they have. The 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.

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 Brasilia? 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 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 inherent in patents from pharmaceutical producers and future patients to current interest groups (a blatantly private use) 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, say, the German Sickness Funds buy 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 else 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 do the same for 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.

Having just returned from Geneva, all I can say is that, as far as health care policy is concerned, it’s HQ for EuroDisney. During my brief sojourn in the city of chocolate, private banks, fine watch movements and Jean-Jacques Rousseau, UN Secretary-General Kofi Annan dropped in for a surprise visit at the World Health Organization. While at WHO he said that the UN would be “encouraging pharmaceutical companies and others to be helpful, making sure that we do not allow intellectual property to get in the way of access of the poor to medication.” Since there is unanimous global agreement that every corner of the globe deserves access to avian flu vaccine, what about a statement from the UN chief reminding the world that it is precisely because of IP protection that we have a treatment at all? It’s truly frightening that the SecGen, his fellow travelers at WHO and the other bureaucratic ticket-takers at acronym-laden EuroDisney/Geneva are willing to not only condone attacks on IP as the great divide of the 21st century, but to promote a siphoning off of the fuel that drives the engine of pharmaceutical innovation for a few column inches. It is short-term thinking of the most dangerous kind — the kind with consequences. Perhaps it’s time for Kofi Annan to take a refresher Econ101 course. Perhaps it’s time that he talks to the invisible hand.

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.