Latest Drugwonks' Blog
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 email@example.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.