VIOXX and Vaccines: Vive La Difference

By RFD Columnist, Dr. F. Edward Yazbak
tlautstudy@aol.com

On September 30th, Merck and Company announced the “Voluntary Worldwide Withdrawal of VIOXX®” (1). By now, everyone has obviously heard that VIOXX has been withdrawn, that thousands of people may have suffered heart attacks or strokes and that the FDA may have been aware of problems with the drug for sometime.

What seems to have been less noticed is the fact that the withdrawal of VIOXX was “worldwide” and that is where the difference between drugs and vaccines is so evident. When a drug is found to have caused problems, it is just withdrawn from the shelves and returned to the manufacturer. In the case of VIOXX, printed forms were made available in doctors’ offices that patients can complete and return to the manufacturer with any and all unused pills in their original package and the sales slip, for a partial refund. More importantly, the company stopped manufacturing the product all together.

With vaccines on the other hand, things are very different. Though pediatric vaccines with Thimerosal were slowly withdrawn from the US market starting in 1999, many years after Japan and Scandinavia, their production was not interrupted. The vaccines were simply sent to countries that were willing and often begging, to use them. Obviously the “margin of profit” decreased because WHO and UNESCO could buy similar products from India at a fraction of the price that the US market allowed, but even the reduced returns represented millions of dollars in sales. 

According to the CDC, the last case of “wild” polio in the US was in 1979. Rare and isolated cases of VIPP (vaccine induced paralytic polio) caused by the oral polio vaccine (OPV) had been recorded for years and compensated by the Federal Government. In the late nineties, the OPV was withdrawn from the US market and replaced by an improved inactivated vaccine (IPV). The production of OPV did not stop and the product was and still is exported in huge quantities, mostly to Africa and South America, where more serious problems have appeared due to local factors and conditions.

In Uganda, many children became paralyzed and many died. In a moving presentation at the NVIC Second International Conference on Vaccination (November 2002), Kihura Nkuba, the founder of the Greater Africa Radio, described how parents in Uganda who were aware of the risks of the OVP, actually hid their strongest children in the forests, when they knew that the vaccination teams were coming. When Mr. Nkuba tried to question why a vaccine banned in the US was being used in his Country, the retaliation was swift and quite scary. The fact that a live virus vaccine was being administered repeatedly to children and adults, whose immune status was not usually known, in an area where HIV was epidemic, had simply been overlooked. 

The Americas were declared free of wild polio virus in 1999, just as a polio outbreak was identified in Hispaniola, an island shared by Haiti and the Dominican Republic. (2) Two children died and at least 19 others were paralyzed. A brilliant review by the CDC field investigators revealed that the deadly virus that caused the outbreak came from a single dose of OPV given to a single child who was probably Haitian. The CDC explained that genes crucial to the virulence of the live vaccine are switched off in the OPV. For reasons unknown and possibly through random mutation, they were switched back on in the Hispaniola virus. Another intriguing thing also happened. Genes not belonging to the polio virus showed up. The offending virus had borrowed genetic information from enteroviruses in the children it infected. Nothing similar had ever happened in the United States but again, conditions in Hispaniola were different. The situation prompted Bruce Aylward, Head of the WHO Polio Eradication Program to caution: "It reminds us that we need to be very careful in our development of a post-eradication policy."

In Japan, hundreds of reports of aseptic meningitis following the administration of an MMR vaccine containing the Urabe strain of live mumps vaccine forced the Government to ban the product. This did not deter France and the United Kingdom from using it until the early nineties when, under pressure, they decided to issue their own ban. Even then, the manufacturer who could have switched to another triple vaccine with a less virulent mumps vaccine strain decided not to change their product and simply targeted the South American market.

In September 1997, there were 74 cases of aseptic meningitis admitted to a single infectious disease hospital, the Couto Maia Hospital (3), following a mass vaccination program that began in August in the Province of Bahia (Brazil). In the city of Salvador in northeastern Brazil, 58 cases of aseptic meningitis were recorded, during the three weeks following the vaccination program. The MMR vaccine administered contained the Urabe strain. (4)

The double standard between drugs and vaccines is flagrant in the United States.

While it is recommended that every health care provider (HCP) discuss in detail with patients and guardians the adverse effects of the vaccine (s) to be administered, this is not always done. Rarely indeed does the HCP give the patient or parent enough time to read the VIS (Vaccine Information Statement) provided by the CDC, suggest that the office be advised of adverse events immediately, report said complications to VAERS (Vaccine Adverse Event Reporting System) in a timely fashion or mention that a compensation program is available, as recommended by the CDC.

A package of chewable fever-reducing tablets or a 4-oz (now 3-oz) bottle of Cough syrup has some ten lines, in minuscule print, describing every remotely possible side effect. Yet a parent whose infant is receiving 5 vaccines (7 antigens) is lucky to have heard 10 words about what is being administered and what to expect.

Is it possible that the nonchalant attitude about vaccination is due to the fact that the physician is immune from litigation in the United States? Certainly surgeons, prior to surgery, seem more careful to discuss all possible complications and options with the patient, who is then sent home with a video or a neat folder containing even more details and drawings.

In the United States, prescription drug manufacturers can appeal directly to their customers on TV,   describe how beneficial their product is and tell them to ask their doctor for a prescription. Sometimes, they even offer a coupon for a week’s supply.

The doctors can hardly refuse to comply in fear of antagonizing their patients, who had been totally convinced by the ad that featured another fellow with a “white coat.”

The exorbitant price is not a deterrent because the patient usually has a prescription plan that will cover most of it. The fact that a similar, possibly safer drug is available over the counter and costs less than the co-pay seems totally irrelevant.

The specter of litigation ensures that all possible side-effects, even if they are disagreeable to hear about just before or after dinner, are always enumerated. The listing of drug inter-actions using complicated generic names or chemical formulae seems to be intended more to protect the manufacturer than to inform the patient. 

 So what is in the future?

No one will probably miss VIOXX.

Many will miss seeing Dorothy Hamill pirouetting into their homes.

Huge advertisement budgets will increase sales and profits and guarantee that criticism of drugs and vaccines will remain muted.

Doctors will need to talk about vaccination even less frequently as the 5 in 1 vaccine is replaced by its 7, 9 or 11 in 1 successor.  

References:

1. Link
2. Link
3. Lucena R, Gomes I, Nunes L, Cunha S, Dourado I, Teixeira Mda G, Goes J, Cardoso E, Rodrigues B, Cardoso A, Barreto ML, Melo A. Clinical and laboratory features of aseptic meningitis associated with measles-mumps-rubella vaccine. Rev Panam Salud Publica. 2002 Oct;12(4):258-61.
4. Dourado I, Cunha S, Teixeira MG, Farrington CP, Melo A, Lucena R, Barreto ML. Outbreak of aseptic meningitis associated with mass vaccination with a urabe-containing measles-mumps-rubella vaccine: implications for immunization programs. Am J Epidemiol. 2000 Mar 1;151(5):524-30.