Beware, genetically engineered and newer biological drugs

There is a rather well publicized issue surrounding multiple myeloma and the possibility of symptomatic treatment from a drug in this class that is approved for MS and Crohn's Disease. One of the serious side effects of the drug is that it can cause multiple myeloma and a very severe bacterial invasion of brain tissue that can be fatal. The drug is listed on the FDA's drug advisory information pages. These are reasons why the drug is so tightly controlled. Another may be that the effects of the drug really isn't known because no long term studies are completed before FDA approval and marketing.

Humira and other arthritis drugs have been worrisome for years, the risk of cancer has been raised, yet they are still plentifully prescribed.

Some forms of arthritis are well known to be associated with food allergy but this concept is absent or fleeting over (knee-jerk) consideration for promoting the drug.

Some cases of Chrohn's may be helped with more nutritional and natural approaches to revitlize the gut lining and function. Now this is a novel idea in MSM but its one I've seen work time and time again.

MS and multiply myeloma can be helped with more natural approaches too.

There just needs to be a better approach to health care.

Safety a problem for new generation drugs, tooBy LINDSEY TANNER, AP Medical Writer

He said the results simply show that doctors and patients should be aware that the drugs have many potential side effects that may not be listed on the label.

CHICAGO – Nearly a fourth of widely used new-generation biological drugs for several common diseases produce serious side effects that lead to safety warnings soon after they go on the market, the first major study of its kind found.

Included in the report released Tuesday were the arthritis drugs Humira and Remicade, cancer drugs Rituxan and Erbitux, and the heart failure drug Natrecor. All wound up being flagged for safety.

That might surprise some doctors who may have thought that these new treatments might be safer than traditional chemical-based medicines.

Researchers found that most of the warnings came within five years after these biologicals won government approval in the United States and Europe between 1995 and 2007.

Many traditional medicines wind up with safety warnings too after they go on the market. But experts said there were no similar studies of older medicines that made it possible to compare safety issues between the two groups of drugs.

The new study, by Dutch researchers, is the first comprehensive examination of these newer medicines, a driving part of the biotech revolution.

The drugs are known as biologicals because they're made from living material and they typically affect the body's disease-fighting immune system. Many relieve severe symptoms by suppressing that system.
It's that same mechanism that can result in side effects often not seen with traditional chemical-based medicines, said Dr. Charles Bennett, a Northwestern University drug safety expert. These can include brain and fungal infections and cancer.

Many are genetically engineered and Bennett said that because they typically resemble naturally occurring proteins, many doctors have assumed they were safer than traditional chemical-based medicines. But he said the study shows that's not necessarily true.

"They have an important role," Bennett said. "They're really the next generation of pharmaceuticals."

He said the results simply show that doctors and patients should be aware that the drugs have many potential side effects that may not be listed on the label.

Among the drugs under examination are Genentech Inc.'s psoriasis drug Raptiva, which just last week the Food and Drug Administration warned may contribute to a life-threatening brain illness and infections; and Exubera, an inhaled insulin product, linked with lung cancer risks. Exubera was approved by the FDA in 2006 but Pfizer Inc. stopped selling it last year.

The study appears in Wednesday's Journal of the American Medical Association.

It involved 136 biologics approved in the United States and 105 in the European Union between January 1995 and June 2007. A total of 41, or nearly 24 percent, got safety warnings issued through June 2008.

The results are a concern, and they underscore the need for closer scrutiny of drugs after their approval, said lead author Thijs Giezen of the University of Utrecht.

But he said the study also is reassuring because most problems showed up relatively soon after the drugs became available, which minimized the potential for widespread harm.

"If most issues are discovered within the first few years, then the system is working," Giezen said.

Bennett says it's unreasonable to think that the studied drugs' safety issues should have been discovered before they were marketed. That's because drug approval is based on relatively small studies with patients who generally are healthier than those in the general population. It often takes real-world experience for side effects to appear, he said.

Many biological drugs have advantages over conventional medicine, but the study shows their risks need to also be considered, said Thomas Moore of the Institute for Safe Medication Practices.

For example, non-steroid arthritis medicines including ibuprofen can reduce pain by decreasing inflammation, but they can cause stomach bleeding.

Biologic rheumatoid arthritis medicines Remicade, Enbrel and Humira are designed to ease painful joints by keeping the body's immune system from attacking itself, the underlying problem in the disease. But they are much more expensive and have been linked with higher risks for potentially fatal infections. Also, the FDA is investigating possible cancer risks.

"My message to patients is that these biological products often can treat very difficult to treat diseases but may have very substantial risks and that you need to take extra care to educate yourself as to what those risks might be," Moore said.

And in another report on this timely topic -

Reports of serious drug reactions hit recordBy RICARDO ALONSO-ZALDIVAR, Associated Press Writer

WASHINGTON – The number of serious drug reactions and deaths reported to the government shot up in the first three months of this year to set a new record, a health industry watchdog group said Wednesday.

The Food and Drug Administration received nearly 21,000 reports of serious drug reactions, including more than 4,800 deaths, said an analysis of federal data by the Institute for Safe Medication Practices.

Two drugs accounted for a large share of the latest reports. One was the blood thinner heparin. Most of the drug's problems were prompted by tainted heparin imported from China. The other was Chantix, a new kind of anti-smoking drug from Pfizer.

Chantix, which had the most reports of any medication, works directly in a smoker's brain to ease withdrawal symptoms. It also blocks the pleasurable effects of nicotine if the patient is tempted to light up again. Earlier this year, the FDA warned that Chantix may be linked to psychiatric problems, including suicidal behavior and vivid dreams. Pfizer said Wednesday it stands by Chantix, and that the volume of reports might be linked to publicity about the side effects.

"The FDA is aware of the increasing number of reports, and we take them seriously," said spokesman Christopher DiFrancesco. But officials are not sure whether reports are up because problems are getting worse, or simply due to greater awareness about drug safety issues.

The watchdog group that prepared the analysis has served hospitals and pharmacists for years as a clearinghouse for information on medication errors. Known as ISMP, the organization is now trying to reach consumers with regular reports on drug safety trends.

"We believe that one of the most important tools to promote is to monitor trends on a regular basis," said Thomas J. Moore, a senior scientist with ISMP. "Knowing which drugs are causing injuries and how many people are being hurt is the raw material we need to fashion sound measures to promote patient safety."

The FDA defines serious drug reactions as ones that cause hospitalization, require medical intervention, or place a life in jeopardy. The agency's monitoring system relies on voluntary reports from doctors and is only believed to capture a fraction of overall problems.

The 20,745 cases reported from January through March was 38 percent higher than the average for the previous four calendar quarters, and the highest for any quarter, the report said.

The number of deaths, 4,824, was a nearly threefold increase from the last calendar quarter of 2007. The FDA said heparin was largely to blame.

Previous ISMP research has shown that reports of serious drug safety problems had increased markedly since the late 1990s.

The FDA case reports provide a signal of possible problems with a drug, but a cause-and-effect connection can only be established through painstaking investigation. If the FDA were a police agency, the reports would indicate "probable cause," but not necessarily "guilt beyond a reasonable doubt."

The ISMP study found that heparin accounted for 779 reports of serious problems, including 102 deaths. The FDA, using data that covers a longer time period, has reported 238 deaths possibly linked to heparin.

Heparin "illustrates an example of a significant drug safety problem that was promptly and effectively resolved by the drug manufacturers and the FDA once the issue was detected and understood," the report said.

Not so with Chantix, it concluded.

The FDA should forcefully warn patients taking Chantix that they may have blackouts that could lead to accidents, the report said. Current warnings say patients may be too impaired to drive or operate heavy machinery, but such language is standard for many medications. The government has banned the drug for pilots.

The report found 15 cases of Chantix patients who appeared to have been involved in traffic accidents, and 52 additional cases involving blackouts or loss of consciousness. The FDA said it taking a second look at the Chantix warnings.

The agency received 1,001 reports of serious injuries linked to Chantix, more than for the 10 best-selling brand name drugs combined.

Chantix "continued to provide a striking signal of safety issues that require investigation and action," the report said. The authors acknowledged Pfizer's concern that publicity may be driving up the number of reports, but concluded there's enough evidence to warrant stronger FDA action.

Pfizer said the total sum of its Chantix data, including results from clinical trials, show the drug's benefits clearly outweigh its risks.

"We stand by the efficacy and safety profile of Chantix," the company said in a statement. "There are few things that provide greater health benefits than quitting smoking. Pfizer is committed to reducing the prevalence of smoking globally. As part of that mission, we want to increase peoples' understanding of the dangers of smoking and the benefits of quitting."

But then again we've mentioned Chantix in several other posts herein.
And if you've queries regarding more natural ways to approach stopping smoking, contact us.

Food Allergy on the Rise

The increase in food allergy is good to make note of because of several factors.

One of course is the ever increasing level of environmental toxicity in air, water and food.

Food coloring, additives and flavorings also are known to contribute to this health concern. Over processed foods (including cereals and dairy) and the increased use of highly allergenic or GMO soy in formula, pesticide use and other GMO foods must be considered.

One issue that for the most part that is overlooked is the effect of the myriad of vaccines forced on children from birth to the teen years, on GI problems and allergy.

Over and over again I am amazed at just how the gut issues in infants and small children become more prevalent, how troubling acid antagonist drugs are thrown at them (leading to many more serious problems over time), and how the use of simple remedies like real food, enzymes and probiotics are ignored.

Even children's prescription drugs include many colorings, flavorings and artificial sweeteners - all known to impact developing gastrointestinal and immune systems.

I wonder when common sense will return to health care and mainstream medicine.

Food allergies increasing in US kids, study says By MIKE STOBBE, AP Medical Writer

ATLANTA – Food allergies in American children seem to be on the rise, now affecting about 3 million kids, according to the first federal study of the problem.

But experts said that might be because parents are more aware and quicker to have their kids checked out by a doctor.

About 1 in 26 children had food allergies last year, the Centers for Disease Control and Prevention reported Wednesday. That's up from 1 in 29 kids in 1997.

The 18 percent increase is significant enough to be considered more than a statistical blip, said Amy Branum of the CDC, the study's lead author.

Nobody knows for sure what's driving the increase. A doubling in peanut allergies — noted in earlier studies — is one factor, some experts said. Also, children seems to be taking longer to outgrow milk and egg allergies than they did in decades past.

But also figuring into the equation are parents and doctors who are more likely to consider food as the trigger for symptoms like vomiting, skin rashes and breathing problems.

"A couple of decades ago, it was not uncommon to have kids sick all the time and we just said 'They have a weak stomach' or 'They're sickly,'" said Anne Munoz-Furlong, chief executive of the Food Allergy & Anaphylaxis Network, a Virginia-based advocacy organization.

Parents today are quicker to take their kids to specialists to check out the possibility of food allergies, said Munoz-Furlong, who founded the nonprofit in 1991.

The CDC results came from an in-person, door-to-door survey in 2007 of the households of 9,500 U.S. children under age 18.

When asked if a child in the house had any kind of food allergy in the previous 12 months, about 4 percent said yes. The parents were not asked if a doctor had made the diagnosis, and no medical records were checked. Some parents may not know the difference between immune system-based food allergies and digestive disorders like lactose intolerance, so it's possible the study's findings are a bit off, Branum said.

However, the study's results mirror older national estimates that were extrapolated from smaller, more intensive studies, said Dr. Hugh Sampson, a food allergy researcher at the Mount Sinai School of medicine.

"This tells us those earlier extrapolations were fairly close," Sampson said.

The CDC study did not give a breakdown of which foods were to blame for the allergies. Other research suggests that about 1 in 40 Americans will have a milk allergy at some point in their lives, and 1 in 50 percent will be allergic to eggs. Most people outgrow these allergies in childhood.

About 1 in 50 are allergic to shellfish and nearly 1 in 100 react to peanuts, allergies that generally persist for a lifetime, according to Sampson.

Some people have more than one food allergy, he said, explaining why the overall food allergy prevalence is about 4 percent.

Children with food allergies also were more likely to have asthma, eczema and respiratory problems than kids without food allergies, the CDC study found, confirming previous research.

The study also found that the number of children hospitalized for food allergies was up. The number of hospital discharges jumped from about 2,600 a year in the late 1990s to more than 9,500 annually in recent years, the CDC results showed.

Also, Hispanic children had lower rates of food allergies than white or black children — the first such racial/ethnic breakdown in a national study.

The reason for that last finding may not be genetics, said Munoz-Furlong. She is Hispanic and said people in her own family have been unwilling to consider food allergies as the reason for children's illnesses. "It's a question of awareness," she said.