Is the FDA looking after your Medical Safety?

Research shows there are 2,000 deaths/year from unnecessary surgery; 7000 deaths/year from medication errors in hospitals; 20,000 deaths/year from other errors in hospitals; 80,000 deaths/year from infections in hospitals; 106,000 deaths/year from non-error, adverse effects of medications – these total up to 225,000 deaths per year in the US from iatrogenic causes which ranks these deaths as the # 3 killer. Iatrogenic is a term used when a patient dies as a direct result of treatments by a physician, whether it is from misdiagnosis of the ailment or from adverse drug reactions used to treat the illness. (drug reactions are the most common cause).

Based on the findings of one major study, medical errors kill some 44,000 people in U.S. hospitals each year. Another study puts the number much higher, at 98,000. Even using the lower estimate, more people die from medical mistakes each year than from highway accidents, breast cancer, or AIDS. And deaths from medication errors that take place both in and out of hospitals are aid to be more than 7,000 annually.

A statistical study of hospital deaths in the U.S. conducted at the University of Toronto revealed that pharmaceutical drugs kill more people every year than are killed in traffic accidents.

The study is said to show that more than two million American hospitalized patients suffered a serious adverse drug reaction (ADR) within the 12-month period of the study and, of these, over 100,000 died as a result. The researchers found that over 75 per cent of these ADRs were dose-dependent, which suggests they were due to the inherent toxicity of the drugs rather than to allergic reactions.

The data did not include fatal reactions caused by accidental overdoses or errors in administration of the drugs. If these had been included, it is estimated that another 100,000 deaths would be added to the total every year.

The researchers concluded that ADRs are now the fourth leading cause of death in the United States after heart disease, cancer, and stroke.

According to a USA Today (Dennis Cauchon, Sept 25,200) study, more than half of the experts hired to advise the government on the safety and effectiveness of medicine have financial relationships with the pharmaceutical companies that will be helped or hurt by their decisions. These experts are hired to advise the Food and Drug Administration on which medicines should be approved for sale, what the warning labels should say and how studies of drugs should be designed. The experts are supposed to be independent, but USA TODAY found that 54% of the time, they have a direct financial interest in the drug or topic they are asked to evaluate. These conflicts include helping a pharmaceutical company develop a medicine, then serving on an FDA advisory committee that judges the drug.

The conflicts typically include stock ownership, consulting fees or research grants.

Federal law generally prohibits the FDA from using experts with financial conflicts of interest, but according to the article, the FDA has waived the restriction more than 800 times since 1998. These pharmaceutical experts, about 300 on 18 advisory committees, make decisions that affect the health of millions of Americans and billions of dollars in drugs sales. With few exceptions, the FDA follows the committees’ advice.

The FDA reveals when financial conflicts exist, but it has kept details secret since 1992, so it is not possible to determine the amount of money or the drug company involved.

A USA Today analysis of financial conflicts at 159 FDA advisory committee meetings from Jan. 1, 1998, through last June 30 found:

• At 92% of the meetings, at least one member had a financial conflict of interest.
• At 55% of meetings, half or more of the FDA advisers had conflicts of interest.
• Conflicts were most frequent at the 57 meetings when broader issues were discussed: 92% of members had conflicts.
• At the 102 meetings dealing with the fate of a specific drug, 33% of the experts had a financial conflict.

“The best experts for the FDA are often the best experts to consult with industry,” says FDA senior associate commissioner Linda Suydam, who is in charge of waiving conflict-of-interest restrictions. But Larry Sasich of Public Citizen, an advocacy group, says, “The industry has more influence on the process than people realize.”

In an article written by Andrea Knox for Knight Ridder Newspapers appeared on January 7, 2001 in “The Star,” a Ventura County Newspaper.

“In the past four years, 10 prescription drugs and a vaccine have been taken off the market after killing and injuring thousands. According to the article, it is estimated that US drug fatalities runs 100,000 a year. There is no way of confirming the numbers because there is no reliable way to track and investigate problems with drugs. Doctors are not even required to report bad drug interactions.”

It also doesn’t help that the FDA has cut the time for routine drug approvals, making the real-life test for drugs coming after it has actually been approved. Without a proper monitoring system, it takes longer to discover what drugs could be causing problems.

The above is to show that unless as an informed consumer to take responsibility for your own health, nobody else out there in terms of a regulatory body is looking after the safety of drugs. While nutritional and natural medicine products are being stringently regulated in nearly all first world countries, drugs which are infinitely more deadly are not regulated to the same degree.

For example in Singapore, there was a scare about skullcap. Based on adverse drug reports on a handful of individuals in Germany and Switzerland, the drug was banned in Singapore. Compare this with the drug Vioxx. Dr. Graham told the Senate Finance Committee (US) that Vioxx may have caused 55000 deaths alone, more than the 28000 projected by the FDA. Only then did Merck take it off the shelves.

So the next time the next wonder drug comes up, let someone else check it our first. The FDA is too busy doing things other than safeguarding the medical safety of America and the world.

Be well

Dr Sundardas