The Food and Drug Administration is the advocate for public health. Critics, however, charge the agency is substituting politics for science. Now, the FBI and a House subcommittee have launched probes.
The FDA has come under attack from both Republicans and Democrats for heavy-handed behavior ranging from seizure of concentrated orange juice because it was labeled "fresh" to threatening a mother with criminal sanctions for selling a home drug testing kit for kids. Thirty-five years after an FDA reviewer was awarded a presidential medal for blocking thalidomide, a drug linked to birth defects, a growing number of critics are pointing out that delaying an effective drug or medical device can be just as harmful as approving an unsafe drug.
The FDA's delays often have been attributed to bureaucratic caution and overzealousness. But its defenders were able to defeat reform bills in the last Congress that would have required the agency to speed approval times. Now, as Congress debates funding for the FDA, a disturbing pattern of possible ethical violations is coming to lighjt that could undermine the agency's credibility and force fundamental reform. Both the FBI and a congressional subcommittee are looking into allegations that the FDA has shown favoritism to certain companies and politicians in its decisions to approve or deny drugs.
Rep. Joe Barton of Texas, chairman of the House Commerce subcommittee on Oversight and Investigations, tells Insight "the possibility exists" that the FDA could be facing a scandal as big as when agency officials were found to have taken bribes from generic-drug companies during the late eighties.
"I'll give you an example," Barton says. "A lot of Americans today are getting their eyes corrected by using a laser-surgery technique that the FDA has approved. It has been on the market approximately two years now. Before it was available, competing applications were submitted to the FDA. The first process submitted was by a company in California called BISX. Well, its competitor [Summit Technology] submitted an application and, during the review process, lo and behold, the BISX application showed up in an envelope in the mailbox of the personal residence of the president of the competitor. Obviously that document came from somebody in the FDA.... It goes to the very integrity of the review process if a competing application is given b somebody within the FDA to a competitor." According to a company statement sent to the subcommittee, Summit President David Muller received "an unsolicited anonymous package that apparently included confidential FDA documents" with other maio at his home on Nov. 24, 1995, opened the package and threw away the envelope at the airport and didn't realize what the documents were until after he arrived a his destination. The statement said that after ereviewing the documents, Muller sent them to his attorney on Nov. 27, who "promptly returned the documents to the FDA, except for one copy" that for a reason the statement did not explain was "temporarily placed in a locked safe" and "was later provided to the FDA under the terms of a written agreement." The statement emphasized that"[n]either Dr. Muller nor anyone at Summit know who sent the documents." Barton is disturbed that he has heard from the FBI that FDA officials are stonewalling the investigation. "The FDA is just hiding its head under a rock on this," Barton says. "The FBI has sent an agent apparently to ask a few questions, but nobody within the management of the agency is forcing anybody to talk.... My guess is there's at least one and maybe several people who are guilty as sin, and they're just keeping their mouths shut." FDA Deputy Associate Commissioner Larry Bachorik inadvertently may have confirmed the status of the FBI investigation when he told Insight, "We don't comment on open investigations." FDA officials also cited the active investigation as their reason for not testifying at Barton's hearing. But the subcommittee did hear revealing testimony from former FDA employee Mark Stern, who said he was forced out after trying to report ethical lapses to top officials. "I think he's credible," Barton says of Stern. "He testified under oath, and he appeared to me to be knowledgeable and truthful in what he was saying." Stern testified that he noticed unusual things after he was assigned to review the BISX excimer laser for FDA approval. He recalled tha in November 1995, a month after Summit Technology became the first company to receive approval to sell its excimer lasers to eye doctors, a coworker informed him that an employee who had reviewed the Summit application but since had been transferred out of the opthalmic division had requested and received a copy of a letter written to VISX regarding its approval status.
When news hit in early December of Summit President Muller receiving confidential documents concerning the BISX application, Stern reported what he knew to an investigator at the FDA's Office of Internal Affairs.
Stern said under oath that on Dec. 28, Susan Alpert, director of the Office of Device Evaluation, told him to resign or he would be fired. Stern said he was "shocked" because his performance had been highly praised before this meeting. Stern recalled that in January, when he tried to contact then-Commissioner David Kessler, who had promised personally to meet with any employee who had an ethical concern, he promptly was refused, put on administrative leave and ordered to vacate the FDA premises immediately by Bruce Burlington, director of the FDA's Center for Devices and Radiological Health.
Stern explains to Insight that he resigned in lieu of termination the next day because "the alternative was that, if I didn't resign, I would have to pay back my $8,000 of physician-compensation allowance ... and I wouldn't get a letter of recommendation -- so that I wouldn't be able to work anywhere." Within two weeks, he went to see Alan Slobodin, general counsel of the House Oversight and Investigations subcommittee, which launched an investigation. FDA spokeswoman Sharon Snider turned down Insight's requests to interview Burlington and Alpert about the reason for Stern's departure.
Shortly after he left the FDA, Stern's hepatitis C worsened; "It's only a matter of time," he says. He now spends what he believes are his last days enjoying the company of his wife and children and pondering nagging qyestions about the FDA. "Any approvals that come out of the FDA until this is solved have to be viewed as possible tainted, because you don't klnow what went into the decision," he says.
One disapproval that Stern and other FDA critics believe is tainted involves a noninvasive glucose monitor for diabetics and some of the same FDA officials Stern dealt with in the medical device division.
Today, 16 million diabetics prick their fingers at least four times a day to measure the glucose levels in their blood. But if the Diasensor 1000 -- a device that uses low levels of infrared light to read glucose levels without drawing blood -- proves effective for even one-sixteenth of these, 1 million diabetics no longer would have to suffer this painful ritual.
The success of the Diasensor 1000 also would mean huge losses for companies that make finger-prick kits. That's why executives at Biocontrol Technology Inc., the small Indiana, Pa., medical-device company that manufactures the Diasensor, were suspicious when the FDA allowed an outside expert who had been employed as a consultant by companies that make finger-prick kits to serve as a voting member of the advisory panel that decided the Diasensor's fate. FDA medical-device chief Burlington -- the man Sten says kicked him off the FDA premises for voicing ethical concerns (and who again declined comment to Insight) -- signed a waiver exempting Julio Santiago, a professor of pediatrics at Washington University School of Medicine in St. Louis, from rules that prohibit special government employees from participating in matters in which they have a financial interest. Santiago turned out to be one of the only panel members with knowledge of the Clarke error grid, the statistical technique Biocontrol used in its studies to measure the effectiveness of the Diasensor.
In 1988, Santiago had coauthored a medical-journal article that used the error grid, confidently descried as "a new method for determining the clinical accuracy of patient-determined blood glucose results," to evaluate a glucose-monitoring system. Yet, in the FDA's panel meeting on the Diasensor, Santiago described the error grid as "dangerous" and "not an accpeted way of measuring the accuracy of anything." Santiago and most of the members then recommended against approving the device because of insufficient data.
About a week after the meeting took place Biocontrol Chief Executive Officer Fred Cooper received a letter from one of his investors who had attended. The investor described a conversation he and another investor had with Santiago when they ran into him at the airport. "Dr. Santiago asked us a very unusual question," the investor recalled: " 'If someone knew in advance that the Diasensor 1000 would be declined for marketing approval, could he make a lot of money shorting the stock?' Dr. Santiago suddenly laughed out loud, and then with a serious voice asked, 'Would that be considered inside information?' " The investor wrote that Santiago also told him that the Diasensoir would never receive approval from the FDA, but that for a $20,000 consulting fee he would design a study that would lead to a successful understanding of the data Biocontrol submitted to the FDA. Biocontrol gave the letter to both the FDA and Barton's subcommittee, which raised the conflict-of-interest issue at a hearing but didn't subpoena Santiago or the investors to testify under oath.
Both the Diasensor and the laser issues arose in a period in which former FDA employees say the agency became more politicized than ever. Henry Miller, the former director of the FDA's Office of Biotechnology, recalls that in staff meetings shortly after Bill Clinton took office, Jerold Mande, executive assistant to the commissioner and a former Al Gore staffer, would say, "I just got off the phone with the White House. This is what they want the agency to do." Jim Phillips, Kessler's special assistant for investigations from 1991-94, tells Insight that around the time Clinton took office, Kessler -- a Bush appointee who promised ethical reform in the wake of the generic-drug scandal -- began to pursue only sound-bite issues such as regulating tobacco and "let everything fester" at the agency. "He foold\ed America and dropped the ball," Phillips says, citing the fact that Kessler would mock him when he tried to discuss issues such as inadequate foreign inspections.
Some are charging wholesale politicization of the agency. The Senate ethics committee looked into allegations that MAssachusetts Democrat Ted Kennedy assisted the Waltham, Mass.-based Summit Corp. in getting approval for its laser device. An FDA memo obtained by Insight says, "Summit has apparently complained a lot in the past to Ted Kennedy." Investor's Business Daily reported that, since 1992, Summit and its employees gave at least $186,103 to Democratic groups and candidates. In May, the committee cleared Kennedy -- apparently satisfied with his answer that his staff urged prompt consideration of Summit as it would for any Massachusetts constituent. Kennedy did tell the ethics committee that Muller hosted a Kennedy fund-raiser at Muller's home.
But committee members did not talk to former Summit employee James Fallon, who in a sworn affidavit says a former Summit executive told him in 1993 that Kennedy promised approval to Summit President Muller [since fired from the company] in exchange for $1 million for his reelection campaign and another $500,000 for the general Democratic cause. Kennedy's press secretary Kathleen McKiernan calls Fallon's statement "patently false and absurd." Muller told Insight "there is no basis" for claims of FDA preferential treatment.
How serious is all of this? "Even the appearance of substituting politics for science compromises the FDA's position of being an advocate for othe public health," observes Robert Goldberg, an FDA scholar at the Washington-based American Enterprises Institute.
It's a lot easier to scare people than it is to unscare them. When guilt is added to fear, the task is even tougher. Americans have been convinced that environmental tobacco smoke, or ETS, is dangerous. Of course they're frightened, and smokers have been made to feel guilty. They fear they are hurting, maybe killing others -- maybe even their own children. Media-mediated and neighbor-reinforced, this scary message about ETS gets even wetter Pavlovian slaver when the alarm-bell ringers are top goivernment officials or those with names followed by lots of letters and fancy affiliations. But these highly publicized claims from seemingly trustworthy sources don't hold up under close scrutiny.
"Ridiculous!" you say, "Why would our own government (or the New York Times) want to lie about this?" Let's look.
The Centers for Disease Control and Prevention issued a warning rivaling a surgeon general's: "Mothers who smoke 10 or more cigarettes a day actually can cause as many as 26,000 new cases of asthma among their children each year." The origins of this phantom statistic are tucked away in back sections of the Environmental Protection Agency's unreadable tome on ETS -- a near guarantee that no one actually will get to it. From my reading of it, however, I detected a postmodern evolution of Darwinian selectivity. The EPA carefully picked a subset of 10 existing studies on childhood asthma and ETS to review. Then, it fished within these studies to find the shark bait.
They decided to highlight only four of the 10 to base their assessment of increased risk of childhood asthma from ETS. Then the agency completely dismissed the one study showing absolutely no effect. Next, from the numerous results contained in the remaining three studies, the EPA considered only those they liked. After cherry-picking findings from the cherry-picked subset of their cherry-picked set of studies, the EPA number crunchers pronounced it "reasonable" to use a range of 75 percent to 125 percent as their estimated increased risk for developing asthma in children whose mothers smoke 10 or more cigarettes per day. They then creatively projected this increased risk to the entire population.
Suddenly, between 8,000 to 26,000 new cases of childhood asthma could be attributable to mothers smoking 10 or more cigarettes a day, or so reads the government's report. And with another pass of the federal government's magic wand, another 26,000 new cases of childhood asthma could be seen as caused by moms who smoke half a pack.
Moving as if ETS were even more deadly than sarin gas, the Occupational Safety and Health Administration, or OSHA, in April 1994 proposed new regulations tantamount to a total ban on workplace smoking in the United States. For employers willing to foot the bill, the proposed rule would permit smoking areas only if "enclosed and exhausted directly to the outside, and maintained under negative pressure sufficient to contain the tobacco smoke." Additionally, no work of any kind is allowed in this smoking area. The only people permitted to enter this area to do any work would be cleaning staff.
How did OSHA come up with a rationale for this sweeping prohibition? First , they looked at all the 13 studies with findings on occupational ETS and lung-cancer risk. From these, OSHA chose only one on which to base its estimate of increased risk from workplace ETS. OSHA's reasoning: This particular study was large and well designed. But so were others in this group! This was the only study among the 13 with a result to OSH's liking.
Opposed by a range of individuals and groups, OSHA's proposed rule generated more than 100,000 letters; the required public hearing lasted an unprecedented six months. The prohibition plan still seems alive and stubbornly kicking within the halls of Palace OSHA.
In an amazing feat of federal legerdemain, the Department of Transportastion, or DOT, managed to convince the International Civil Aviation Organization (a UN agency) to pass a resolution that airliners should absolutely and universally prohibit smoking. DOT created its very own fat research report to reinforce its point.
This ban was scheduled for July 1996, but there's been a lot of foot-dragging. Do the foot-draggers know something others don't? Perhaps they actually read DOT's research report about ETS in airliner cabins, and after they stopped laughing, they tossed it.
The technique used by DOT was to measure the amount of "bad stuff" from tobacco smoke in the cabins' air. They expected to find higher concentrations in planes with smoking sections than in those without. Since smoking bans already were enforced on domestic flights, no-smoking planes readily were available for comparison. Their state-of-the-art measurements were surprising: Once past the "boundary rows" (the first three next to the smoking section), average levels of respirable particles and carbon dioxide actually were lower on smoking flights than on no-smoking flights. Average levels of nicotine were low enough to be undetectable past the boundary rows on the majority of flights. On the minority with detectable nicotine levels, the difference, measured in micrograms (1 billionth of 2.2 popunds) per cubic meter (3 1/3 feet) of air was a minuscule 1/20 of 1 microgram. Average carbon-monoxide levels were a rousing 0.2 micrograms per cubic meter higher on smoking flights! There were, however, 200 fewer parts per million of headache-making carbon dioxide on the smoking flights than on the nonsmoking.
But DOT had a mission. So their crystal ball predicted over a span of 20 years, four excess lung cancer deaths among the entire U.S. cabin-crew population. Shazam! Then DOT declared that smoking should be extinguished from the skies, since it would be too expensive sufficiently to improve the ventilation and filtration of airline-cabin air. The expense? Twenty dollars per flight, max, or a big 36 cents per smoker on a full Boeing 747, or 93 cents on a 727. Incidentally, smoking isn't the only reason to improve airline ventilation.
Publicity about a recent study on ETS and acute or chronic respiratory illnesses in children admonishes, "Children exposed to tobacco smoke ... suffer over 10 million days of restricted activities ... 21 percent more than unexposed kids." Ten million is a catchy, scary number, but where does it come from? The study appeared in the May 13-18 1996 issue of the "scientific" journal, Tobacco Control, the very title of which should raise questions about scientific objectivity. The authors show right up front that they failed to find a "statistically significant" relationship between the children's exposure to tobacco smoke and any respiratory illnesses.
But then they reported that the parents in their sample were asked how many days the children missed school or had their activities restricted. Somehow, the researchers "found" here the relationship they wanted -- albeit small. No attempt was made to determine if other factors could account for this, nor was there any attempt to account for the contradiction.
The authors took their preferred finding, extrapolated it to the whole U.S. population and, eureka!, 10 million. Note: This number signifies only that, for unknown reasons, parents who smoked recalled keeping their kids home slightly more than parents who didn't , but it doesn't mean that the smokers' offspring were sicker. The researchers did not publicize the fact that the number of childhood illnesses linked to ETS exposure was negligible. This is misleading reporting.
If the prohibitionists could make a convincing case that ETS causes heart disease (the leading killer in the United States) in nonsmokers, they'd be in clover. Even with a small excess risk from ETS, really big death estimates could balloon. The lack of hard evidence doesn't stop tobacco prhibitionists and their scientific allies from trying. Witness a front-page story in the New York Times on May 20; A team of Harvard researchers released the results of a 10-year study which claimed that regular exposure to other people's smoke at home or at work almos doubled the risk of heart disease. Case closed? Not according to Steve Milloy, executive director of The Advancement of Sound Science Coalition, who called the study another case of "epidemiologists trying to pass off junk science as Nobel prize work." A day after the Harvard report was issued Milloy issued the following statement: "The new study uses statistics -- not science-- to claim that secondhand smoke increases the risk of heart attack by 91 percent. This abuse of statistics is such a problem that the National Cancer Institute issued a press release in 1994 advising that increases in risk of less than 100 percent were not to be trusted. And for good reason. In the new study, there was no measurement of even one person's exposure to secondhand smoke. The researchers relied on unverified questionnaires. Also, it is likely the researchers did not adequately consider other competing causes for heart disease such as smoking, lack of exercise, poor diet and so forth." Is there a pattern here? An Aug. 15, 1996, an Associated Press bulletin claimed that the results of a huge study showed that never-smokers married to smokers had about a 20 percent higher risk of dying from heart disease than with nonsmoking mates. Actually, this result only applied to the never-smoking men married to current smokers. No excess risk was found for never-smoking women married to current smokers. Oops! They forgot to mention that part of it. And wouldn't there be more heart disease in the husbands of heavy smokers than of light smokers if, in fact, ETS exposure had something to do with it? But in this study, the finding was upside-down; the more the wife smoked, the lower the husbands' risk. Hmmm! This piece of information also failed to appear in the AP story.
Since the 1960s, our government, aided by an assortment of do-gooders, has been trying to get everyone to quit smoking. It started out reasonably by disseminating information that smoking was linked to some nasty diseases. Having our best interests at heart, concerned professionals and government officials apparently felt compelled to devise stronger arguments to make us do the right thing. The government funded research in order to confirm the idea that ETS is harmful. But, the research results came in mostly indeterminate and, in some cases, negative. What to do? Well, since it's for a good cause, ignore the reality. Claim lots of dire findings. Divide, scare and intimidate.
[ Ed. Note: Sound familiar folks? One more set of lies to add to a very long list!!! ]
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