The Tainted History of the DPT Vaccine

In his article, "Study: Media Unintentionally Distorts Child Vaccine Risks," David Williamson reports on some of the controversy surrounding the safety of the Diphtheria, Pertussis, and Tetanus vaccination (DPT). The debate over the safety of this vaccine cocktail has raged for decades, not just in our country but around the globe.

There's no question that DPT vaccinations save lives; they have lowered the annual pertussis deaths from about 1000 annually to less than ten. Unfortunately, as reported by the National Vaccine Information Center (NVIC), the form of the vaccine used and sanctioned by the Centers for Disease Control also kills as many as 900 children per year, and leaves one of every 62,000 children immunized with permanent brain damage. Are those acceptable risks?

To add insult to injury, a purified vaccine is available that's virtually reaction-free, and has been produced and used in other countries for over 15 years, using technology the U.S. abandoned in the 1970's. The catch: it costs $9 more per injection.

While most parents would happily cough up the additional nine bucks to ensure their children's safety, drug companies have lobbied to delay the use of the purified vaccine (acellular) for as long as possible -- it might cut into their inflated 50 percent profit margins per vaccination.

Before digressing too far into the politics and economics of the public health system in this country, a brief world tour of DPT's tainted history is in order.

By 1972, six major US pharmaceutical companies had developed a purified (acellular) form of the pertussis vaccine which was virtually reaction-free. Unfortunately, the purification process yielded less of the active component necessary to confer immunity increasing the cost of production from cents to dollars per dosage. Acellular vaccine production was abandoned. In 1977, British researcher Dr. Gordon T. Stewart, of the Department of Community Medicine at the University of Glasgow, documented adverse reactions to DPT vaccine and evaluated the benefit to risk ratio for children in the United Kingdom. His research demonstrated that 1 of every 54,000 children receiving the vaccine suffered encephalopathy (brain disfunction) with rare instances of mental retardation ensuing. Other symptoms included fits of screaming, unresponsiveness, shock, vomiting, localized paralysis, and convulsions.

Of the 160 adverse cases he examined, 40 percent demonstrated hyperkinesis (increased muscle movements accompanying brain dysfunction), infantile spasms, flaccid paralysis, and partial or complete amentia (severe mental retardation).

He determined that adverse events were severely underreported or overlooked, that no protection from the disease was demonstrable in infants, and that claims by official bodies that risks of whooping-cough exceeded those of vaccination were very questionable. He estimated the risk of transient brain damage and mental defect to occur in 1 out of every 10,000 vaccinated, and risk for permanent brain damage to occur in 1 out of every 20,000 to 60,000 vaccinated.

Sweden banned the pertussis vaccine from its vaccination program in 1979, related to concerns of safety and its questionable effectiveness. This country decided it would rather endure the disease as opposed to the vaccine. (Mr. Williamson correctly points out that the United Kingdom experienced outbreaks of pertussis during this time period, however, 100,000 cases with only 36 deaths was viewed by many as minor compared to the potential loss from mass immunizations of millions of citizens with a defective vaccine -- do the math yourself -- a potential for 900 deaths annually in this country alone from the vaccine.)

In 1980, German researchers, Tonz and Bajc, compared incidences of seizures caused by the pertussis vaccine in Germany with those in America. German children suffered seizures at the rate of 1 per every 4800 infants immunized while American children demonstrated a rate of 1 seizure for every 600 infants immunized.

Concerns for safety prompted Japan to replace the traditional whole-cell pertussis vaccine with the purified, acellular vaccine. By 1983, studies indicated that the efficacy of Japanese acellular vaccines was equal that of the whole-cell vaccines, and complication rates had been cut by 83 percent.

In 1984 Austrian researcher, Dr. Gerhard Wiedermann, at the Institute for Environmental Medicine at the University of Vienna, evaluated the risks versus benefits of continuing the pertussis vaccination program and concluded pertussis vaccinations should be discontinued. His research team recommended that only DT vaccinations be given, and pointed out while no deaths from the vaccine had been confirmed in their country that, "pertussis offers many ailments, sufferings, and possibilities of damage."

That same year, Dr. Alan Hinman of the Division of Immunization at the Center for Prevention Services, along with Dr. Jeffrey Koplan of the Centers for Disease Control, produced a simulated model of 1 million children to examine the risks versus benefits of pertussis vaccine in the United States. These researchers concluded the over-all benefits outweighed the risks -- but they also documented the extent of damage this vaccine can cause. One minor reaction was predicted to occur with every 2.5 doses, one case of convulsions with every 1,750 doses, one child would collapse (shock) with every 1,750 doses, one case of encephalitis would occur with every 110,000 doses with a case of permanent brain damage with every 310,000 doses. Magnify these risks five times as each child receives 5 doses to complete the immunization schedule.

In 1992, Doctors Paul Fine and Robert Chen of the Communicable Disease Epidemiological Unit in London performed a re-analysis of studies on DPT which revealed previously under-reported complications. Their analysis of the British National Childhood Encephalopathy Study lead to a four-fold increase in the estimated risk of encephalopathy associated with DPT vaccinations. The investigators added that "(research) biases that underestimate risk have received less attention (than those over-estimating risks)," and "the fact that such biases do exist makes it difficult to demonstrate convincingly that a vaccine is not responsible for rare, severe, adverse reactions."

Dr. Kathleen Stratton and her colleagues at the Institute of Medicine reported in 1994 the Diphtheria and Tetanus (DT) portions of the DPT cocktail had been causally related to anaphylactic reactions (severe allergic reactions), Guillain-Barre Syndrome (numbness of the extremities with severe forms producing various degrees of paralysis), and brachial neuritis (inflammation of the brachial nerve). It remains inconclusive as to whether or not these portions of the vaccine cause residual seizure disorders, demyelinating diseases of the central nervous system (infections of nerve cell linings causing muscle weakness and visual disturbances), mononeuropathy (single nerve inflammation), and arthritis. As of last year, the Institute reported that no controlled clinical trials had been conducted to rule out a causal link between DPT and encephalopathy, demyelinating diseases, Guillain-Barre syndrome, and anaphylaxis!

When the major vaccine manufacturers lobbied Congress in 1986 to pass the National Childhood Vaccine Injury Act (NCVIA) to absolve them of all liability related to adverse reactions caused by their products, they obviously had plenty to worry about. With this Act, the National Vaccine Injury Fund was established by levying a user tax against citizens for immunizing their children. Since its creation the fund has compensated 579 vaccine induced deaths adjudicated through the Federal Court of Claims to the tune of $700 million dollars. Forty percent (227) of these vaccine induced deaths were originally misdiagnosed as Sudden Infant Death Syndrome (SIDS). Mind you, the American taxpayer now compensates the victims of these defective products, while the major manufacturer and supplier of DPT in the U.S., Wyeth-Lederle, watched its profits soar 300 percent since the passage of this Act. Wyeth-Lederle earned $350 million in sales of DPT last year.

Mr. Williamson's figures on the malpractice damage suits are somewhat misleading as well. There is a great difference between filing a malpractice case and having damages awarded to the victims of medical malpractice. All told, the dollar amount associated with litigation for negligent practice totals up to only one percent, or $10 billion dollars, of the total annual healthcare tab. (This is for all malpractice litigation, and vaccine litigation is but a small portion of this amount.)

The Congressional Budget Office (CBO) confirms these figures which include all malpractice settlements, all malpractice insurance premiums, all legal fees, and all court costs. Furthermore, the Harvard Medical Practice Study revealed that of the one percent of patients estimated to be injured as a result of negligence only one-eighth ever discovered they were victimized and filed suit, and only one-sixteenth of those filing suits ever recovered any monetary damages. The damage awards themselves have been on a steady decline over the past ten years, and out of court settlements plummeted from an average of $2 million in 1993 to $1 million in 1994. Jury awards have decreased even further to an average of $500,000 per case.

It is probably correct that some 250 lawsuits were being brought against the manufacturers of vaccines by 1986 prior to the legislative relief granted to these companies. Problem is, there most probably should have been more -- many more.

Most people don't realize when they have been victimized by negligent practice or by defective products. Very few file suit, and when the cause of many of these deaths and disabilities are misdiagnosed it becomes very easy for this industry to write off its adverse reactions by saying they just happen to be a coincidence of normal childhood neurological disorders.

As pointed out earlier, 40 percent of the victims compensated after passage of the NCVIA had been misdiagnosed originally. This figure is consistent with many studies by pathologists documenting rates of misdiagnosis at 35 to 40 percent as to the cause of death in all range of ailments. An increase in autopsies appears to be indicated if one is to discount or subscribe to the coincidence theory.

While some argue the damage caused by these vaccines is rare, and over just how many have suffered these negative side-effects, it is clear that many adverse reactions go unreported, over-looked, or misdiagnosed.

(In one 20 month period alone, the National Vaccine Information Center documented 54,000 adverse vaccine reactions which included 700 deaths. Dr. David Kessler, now retiring commissioner of the FDA added that only 1 of every 10 adverse events associated with vaccines are reported.)

I personally can't image too many crimes worse than destroying the life of a child with a product which is known to have negative side effects when there is a safer product available but simply not being pursued because there is not enough profit motive in it for the manufacturer -- this is public health, not toasters which are being sold!

In 1996, the CDC approved using the acellular (purified form) of the DPT vaccine for use in 15 month-old children in the U.S., and it is now being evaluated in controlled trials. It is interesting to note that up until 1995, five of the nine representatives of the Centers for Disease Control Immunization Advisory Panel had financial ties to the industry. The Chairman, Dr. James Cherry, acknowledged the risks of severe brain damage and death from the DPT vaccinations in 1979, but by 1990 he had done an about face and declared these known dangers as being "myths." Between the years 1980 through 1992, Dr. Cherry had received over a million dollars in unrestricted DPT research grants from Lederle -- DPT's largest manufacturer.

Some twenty-four years after the development of the purified vaccine, with the U.S. pursuing it once again, all that remains are the questions of the discarded victims and the fears of parents who must chose whether or not to immunize their children.