Playing God at the FDA

In about every presidential administration for the last three decades the vile underbelly of an Executive-Branch organization spills out into the open. Right now an implosion is in progress at the U.S. Food and Drug Administration (FDA) that could fully expose not only its phony pretense as a protector of the public's health but the agency as a dangerous and dictatorial handmaiden of a federally protected drug industry.

The most recent cracks in the FDA edifice began to show earlier this month on April 12 when the General and Plastic Surgery Devices Panel, an advisory body of the FDA, voted 5-4 against recommending that silicone-gel breast implants made by Inamed Corporation be sold since an effective ban was imposed on such devices in 1992. The decisive point with some panelists was that Inamed didn't provide data about the probability of its implants lasting ten years.

Where events started to get strange was the very next day, when the same panel voted 7-2 to recommend that the silicone breast implants made by another company (Mentor Corporation) be allowed on the market under certain conditions.1

Despite the pretense of meticulous deliberation, the two disparate votes were completely arbitrary. "They're two different devices," said FDA adviser Stephen Li, hardly clarifying anything. Mentor, like Inamed, had studied rupture rates for the devices for a three-year period. Yet Inamed's sample size was more than double that of Mentor's. The advisory panel made a show of being impressed by Mentor's presentation of evidence from a British study showing that 5% of Mentor's implants had ruptured within nine years. However, the FDA's own staff attacked this study, alleging that its sample was skewed toward volunteer subjects and excluded certain high-risk women.

The popular TV and print-news coverage of the disparate panel votes was typical. It implied that there was some sort of plausible significance to what was in reality a two-day charade by a body of capricious, pompous, and self-serving clowns. Glib answers by panel members to reporters' questions about the inconsistency of the two votes were accepted without much question. Not a single report raised the possibility of favoritism toward one company over another.2  The same panel (with some of the same advisers) in October 2003 voted in favor of Inamed when it had less data then it does today.3  In particular Stephen Li, the panel member who now grandstands as a meticulous champion for women's health in 2005, voted in favor of Inamed in October 2003. 

The panel's actions might be justified for devices that had been proven to be a significant threat to public health. The problem is that they weren't. 

The Anti-silicone Legend

The campaign against silicone implants began in 1978 when a woman received two of them after a double mastectomy.4  The following year she sued the manufacturer, Dow Corning Corporation, asserting that the implants were the source of health problems she had contracted. In 1984 she won almost $2 million. Buoyed by her victory, a deluge of suits began such that in 1992 the number of lawsuits against Dow Corning went from around 200 to about 10,000. 

That same year the FDA banned the devices claiming that they had not yet been proven safe. Maybe, but plaintiffs' attorneys and their "experts" had not scientifically proven that the devices were dangerous or that they were the cause of the connective-tissue diseases5  mentioned in the lawsuits. Despite this lack of evidence, plaintiffs went on to win as much as $20 million from their suits. In one memorable case, despite the fact that a woman's doctor conceded in court that her connective-tissue disease began before her implant surgery, the woman was still awarded more than $7 million by a jury.6  Studies7  debunking the alleged link between implants and connective-tissue diseases began to appear, but they didn't save Dow Corning from bankruptcy.

With the specter of connective-tissue disease now gone, the FDA's newest contrived danger became ruptures. Meanwhile in Europe, silicone-gel implants are not only available but much more popular than their saline counterparts because both patients and physicians agree that they look and feel more natural. 

What chain of events led to so many of our medical options getting usurped by a capricious government body?

Brief History

The first federal health effort was anything but impressive. It was the Act to Encourage Vaccination of 1813, which established a national agency for smallpox vaccine administered by James Smith, a Baltimore doctor who campaigned for passage of the Act. The Act was repealed in 1822 after Smith caused a smallpox epidemic in Tarboro, North Carolina. 

Smith had accidentally sent a Tarboro doctor samples of smallpox instead of the smallpox vaccine (made of cowpox).8  About 60 people contracted smallpox and 10 died. What eased repeal was the dispute over Smith's own competence at reducing smallpox in Baltimore. Baltimore's smallpox problem had grown worse since the passage of the Act.9   

The current FDA began as the Division of Chemistry10  in the Department of Agriculture in 1862. Harvey Washington Wiley, who arrived as chief chemist in 1883, worked assiduously to expand the federal government's power in food and drug markets. He organized a number of Progressive interests, mostly state-government bureaucrats and lay-activist busybodies, but also physician and pharmacist groups eager to restrict competition to redistribute wealth in their direction.

By reports, Wiley didn't accomplish much until the muckrakers arrived. Upton Sinclair's 1906 book The Jungle11  along with Wiley's and others' efforts worked to persuade Congress to pass the Federal Food and Drugs Act of 1906, eagerly signed by President Teddy Roosevelt. For the first time the new law gave national regulatory authority to the proto-FDA over food and drugs.12

The Progressives weren't content with the 1906 Act and wanted much more. They got their wish in 1937 from the elixir sulfanilamide tragedy. Sulfanilamide was used successfully in pill and powder form to treat strep infections. S.E. Massengill Company decided to meet frequent requests for sulfanilamide in liquid form. Unfortunately, the new product the company distributed contained diethylene glycol, an antifreeze and poison. More than 100 people died, quite a few of them children.

The Progressives milked the tragedy for all it was worth to give the government unprecedented new powers in the Food, Drug, and Cosmetic Act of 1938. The Act not only gave the FDA oversight over non-food, non-drug medical devices but cosmetics as well. Most important, it mandated FDA approval for safety for all new drugs coming to market.          

The Kefauver-Harris Amendments of 1962 were motivated by the thalidomide babies of Europe. Thalidomide was prescribed in the late 1950s as a sedative and treatment for morning sickness that was found to cause severe birth defects. The drug had never been approved for sale in the U.S.,13  but the birth-defects scare was a public motivating factor behind the passage of the Kefauver-Harris Amendments requiring each new drug be approved for "efficacy" as well as safety.

David "Robespierre" Kessler

The last fascinating and recent chapter in the FDA's history features one of the most despotic bureaucrats to ever head a federal agency. David Kessler was a Republican doctor appointed commissioner of the FDA in December 1990 by President George H.W. Bush. One of Kessler's proudest achievements was ordering U.S. Marshals in 1991 to seize and destroy 12,000 gallons of Proctor and Gamble's Citrus Hill Fresh Choice orange juice. Although a "Made from Concentrate" disclaimer was printed on the label, the word "fresh" was part of the product name and this, in Kessler's view, was a heinous crime of deception. Never mind that at the time the word "fresh" had 79 different uses by food processors and marketing surveys indicated that consumers didn't think that the phrase "Fresh Choice" necessarily implied fresh-squeezed juice.14

James Bovard revealed15  that Kessler timed the Proctor and Gamble raid to take place during his speech to a convention of food and drug attorneys where he announced the re-establishment of the FDA in the vigorous enforcement of food regulations. Weeks later one of Kessler's subordinates sent chills throughout the food industry by threatening similar action against any other food corporation that crossed Kessler's FDA.

Kessler's next target was supplements. In May 1992 sixteen armed FDA inspectors raided the Tahoma Clinic in Kent, Washington run by Jonathan Wright, M.D. Employees were held at gunpoint while FDA inspectors confiscated more than $100,000 worth of inventory and equipment because the clinic had been selling injectable B vitamins, a supplement that had harmed no users in the U.S. and had been safely used in Europe.16   Kessler also attempted to usurp regulation of tobacco products (a "nicotine delivery device" was his memorable reference to cigarettes). When that failed, he declared tobacco a "pediatric disease" and entreated a receptive Clinton White House to give him cover in bypassing Congress to grab control of the industry.17

One of Kessler's last major achievements at the FDA was of course his ban on silicone breast implants in 1992. Marcia Angell, former editor in chief of the New England Journal of Medicine and now a lecturer at Harvard Medical School, said there was "almost no reliable scientific information at the time of the ban" to support Kessler's decision.18

Treating Joint Pain With Heart Disease

This device has a 30-year history that, at best, is checkered. Given that history, it behooves us to have a higher standard—FDA adviser Stephen Li, explaining his disparate votes on silicone breast implants, April 13, 2005.

The above comment wouldn't be so laughable if the FDA wasn't in the middle of a COX-219  inhibitors scandal. Vioxx had been approved by the FDA in May 1999. In June 2000, Vioxx's maker Merck sent the FDA results of the VIGOR study which showed that Vioxx posed serious risks of heart attack, stroke, and sudden-cardiac death. Somehow the FDA didn't get around to changing the Vioxx label to warn about these risks until April 2002, almost two full years later. In September 2004 Merck was so alarmed by results it found in the APPROVe study it not only shut down the study early but pulled Vioxx from the market.

Then came the story of an amazing cover-up. David Graham, M.D., a 20-year employee of the FDA along with other researchers found that Vioxx had caused as many as 140,000 cases of serious coronary heart disease, as many as 60,000 of them fatal. The study was slated for publication in the November 17, 2004 issue of the British medical journal The Lancet. The study didn't appear when scheduled because Graham says that he was threatened by superiors at the FDA. He told Newsweek,

What I believe they were trying to prevent from reaching the public was our estimates of the number of people who suffered heart attacks or died because of Vioxx use...I believe there were multiple levels of FDA management who wanted to keep the information of the magnitude of harm caused by Vioxx from the public and wanted to damage my credibility as a scientist...There's no question in my mind that, had Merck not withdrawn Vioxx, it would still be on the shelves today and Americans would still be dying from heart attacks because of it. And this would be with the FDA's full knowledge and complicity. When [Merck's] VIGOR study [which resulted in the addition of a warning label on the drug] came out in June 2000, it showed a fivefold increase in heart attack risk. What on earth was the benefit of Vioxx that the FDA thought was so great and so valuable that it outweighed this risk?20

When asked why doctors and patients weren't warned about Vioxx earlier, Graham said,

I would assume the reason this happened is because the FDA sees its mission primarily as one of serving the [pharmaceutical] industry...If the FDA really gave a high priority to safety, it's possible they never would have approved Vioxx when they did...The FDA's failure to ban high-dose Vioxx in 2000 is a mistake of monumental proportions, but it highlights the deficiencies in the FDA and its serious structural, cultural and scientific problems...I think the FDA is incapable of reforming itself, and it shouldn't be trusted to reform itself. The only way that things will change is if Congress imposes the changes. If it doesn't, it will have to accept some of the responsibility for the disasters that will follow. With Vioxx, the FDA looked the other way. And America paid a severe price for it.

Graham's study was eventually published in The Lancet in late January 2005,21  but amazingly, about three weeks later on February 18 an FDA advisory panel recommended returning Vioxx to the market. What should particularly haunt the panel was a vote in favor of Bextra,22  despite the panel's concern about limited long-term data on its safety.23

Then, lo and behold, on April 7, 2005—less than a month after the favorable advisory vote—Pfizer withdrew Bextra from the market at FDA request, citing not only heart attack, stroke, and sudden-cardiac death risks, but also potentially fatal skin reactions. It turns out that ten members of the FDA panel who voted February 18, 2005 for both Vioxx and Bextra not only had ties to their makers, but their votes were crucial for securing the favorable votes on the panel for both drugs.24

Government as Health Watchdog

If members of our society were empowered to make their own decisions...then the whole rationale for the [FDA] would cease to exist—David Kessler25

Given that governments around the world murdered about 170 million people last century,26  the notion of governments serving as vanguard protectors of their citizens' health seems to be an odd one to say the least. The sulfanilamide and thalidomide cases were certainly tragic, but thalidomide was never prescribed in the U.S., and while tainted sulfanilamide killed about 100, unfortunately that figure is dwarfed by the tens of thousands apparently killed by Vioxx. Especially note the latter figure in light of the FDA's recent ban on ephedra for being linked to the deaths of 155 people.27

Unfortunately those who want more health empowerment (to the horror of David Kessler and his ilk) have no choice but have their options limited by nothing more than a drug-company front that destroys safe orange juice and injectable B vitamins while providing cover for a joint-pain treatment linked to sudden-cardiac death. The probability of meaningful reform is about nil. In terms of economic interests, the Republicans are owned lock, stock, and barrel by the drug cartel, health-insurance companies, and physician interests such as the American Medical Association.28

For the left liberals and socialists, the FDA is their darling baby of the golden age of Progressivism, an age they yearn to revive while dreaming of both Hillary Clinton in the White House and the Democrats re-taking Congress in 2008. Convinced that the economy is nowhere close to being optimally regulated, it would be ideological suicide for them to concede that the public could be in more danger today then in the "bad old days" of laissez faire. Well informed when it suits their interest, their silence on the recent FDA scandals is no real surprise. They screamed bloody murder about Enron, although as corrupt and financially damaging as Enron was to many people, it certainly wasn't complicit in killing tens of thousands of people.    

While the public is still mostly in the dark about these matters, the rest of us can stay tuned for many more new installments in this protracted tale of horror.

• 1The conditions were that patients sign consent forms stating that they understand the risks of the devices, the implants be sold by Mentor only to surgeons who complete "special hands-on training," and Mentor begin a registry to determine the probability of implants leaking within a decade.
• 2Not that there necessarily was in this particular case, but favoritism is a valid issue worthy of far more exploration than it is currently given. The February 18, 2005 advisory vote in favor of Vioxx was almost certainly influenced by panel members' close ties to Merck.
• 3The FDA ignored this recommendation.
• 4A nice, albeit sketchy account of the anti-silicone implant campaign can be found in Steve Milloy's Junk Science Judo, pp. 14–15.
• 5Connective-tissue diseases include lupus, scleroderma, vasculitis, as well as poly- and dermatomyositis.
• 6Milloy, p. 14.
• 7A study in the June 16, 1994 issue of the New England Journal of Medicine, found "no association between breast implants and the connective-tissue diseases and other disorders."  See Gabriel et al. "Risk of Connective Tissue Diseases and Other Disorders after Breast Implantation."  NEJM. 330:1697–1702. An analysis in the same journal published six years later concluded that from "a public health perspective, breast implants appear to have a minimal effect on the number of women in whom connective-tissue diseases develop, and the elimination of implants would not be likely to reduce the incidence of connective-tissue diseases."  See Janowski et al. "Meta-Analyses of the Relation between Silicone Breast Implants and the Risk of Connective-Tissue Diseases."  NEJM. 342:  781–790.
• 8A favorable account of the Act is Singla, Rohit. "Missed Opportunities:  The Vaccine Act of 1813."  1998.
• 9Earle, W.E. Pox Americana. Baltimore City Paper. February 5, 2003.
• 10This was changed to the Bureau of Chemistry in August 1901.
• 11A nice, short debunking of Sinclair's The Jungle is Lawrence Reed's "Of Meat and Myth."  Here.
• 12Interestingly Wiley's power ended up being limited after the Act's passage, not by federalist concerns in the courts but by a bureaucratic war with Secretary of Agriculture James Wilson. Wilson created a Board of Food and Drug Inspection in 1907 to counter any differences in enforcement protocol he had with Wiley and he created an advisory board in 1908 of outside scientists to counter Wiley's scientific authority. Wiley's resignation in 1912 ended up being a mixed blessing in that he was a more ardent food cop than drug cop. The focus of the Bureau turned much more toward drugs after Wiley's departure.
• 13One view, right or wrong, is that the drug would probably have been approved but luckily for the FDA its application was bottled up in layers of bureaucracy.
• 14A detailed account of Kessler's anti-orange juice, anti-vitamin, and anti-tobacco crusades can be found in Bovard, James. "Double-Crossing to Safety."  American Spectator. January 1995.
• 15ibid.
• 16ibid.
• 17See here for an account of the FDA's anti-tobacco activities.
• 18Bandow, Doug. "Winding Up a Decade of Junk Science."  Washington Times, 8 May 1999.
• 19COX-2 is short for cyclooxygenase-2.
• 20Vioxx Woes May Reveal FDA's Flaws. Newsweek. Web Exclusive. Jan. 28, 2005.
• 21Risk of acute myocardial infarction and sudden cardiac death in patients treated with cyclo-oxygenase 2 selective and non-selective non-steroidal anti-inflammatory drugs: nested case-control study. The Lancet. Volume 365, Issue 9458, Page 475.
• 22Most interesting of all were the questions, raised incidentally by the panel's defensiveness over the embarrassing COX-2 situation, about non-COX-2 painkillers such as naproxen, ibuprofen, diclofenac and others linked to bleeding, stomach ailments, and problems with blood pressure. Not surprisingly, there wasn't much in the way of long-term data on these drugs as well.
• 23Again, notice the vote in favor of Bextra despite concerns about a lack of long-term data, and just three weeks before it was pulled off the market by the FDA. Recall that the vote against Inamed's silicone implants was due to a lack of long-term data. Obviously there's no consistency on the issue of long-term data across FDA advisory panels.
• 24Associated Press. "10 on FDA Vioxx Panel Had Ties to Companies."  February 25, 2005.
• 25Bovard, James. "First Step To an FDA Cure:  Dump Kessler."  Wall Street Journal. December 8, 1994.
• 26Rummel, R.J. Death by Government. New Brunswick:  Transaction, 1994. Here for statistics.
• 27On April 14, 2005 a federal judge struck down the FDA ban on ephedra and the FDA's regulation of the substance as a drug and not a supplement. Although pre-Kessler, the George H.W. Bush FDA also banned L-Tryptophan in March 1990 due to a toxic version of the supplement produced by a Japanese company that was linked to 37 U.S. deaths and 1,500 cases of EMS. Dean Manders states that the supplement has been widely used in Canada and Europe and suggests the FDA ban had more to do with advancing the interest of Eli Lilly and its drug Prozac.
• 28This report reveals how drug-company perks to physicians to prescribe new drugs can lead to the over-prescribing of medication or prescribing of expensive medications when cheaper and similarly effective ones are available.