PRICES of generic drugs are rising almost twice as rapidly as prices of brand-name drugs, even as many insurers and the Bush administration are pressing Americans to switch in the name of saving money.
The trend is expected to continue over the next few years as a number of popular brand-name drugs lose their patent protection and drug makers introduce generic versions at high initial prices.
Prices of generic drugs are rising faster for several reasons.
First, a large number of patents on popular brand-name drugs expired last year, allowing makers of generics to enter the market. Makers of generic drugs typically charge higher prices when the first generic versions of expensive medicines reach pharmacy shelves.
In addition, the generic-drug industry is consolidating, leaving fewer companies to compete on the prices of older generic drugs. And wholesalers, drug plan managers and pharmacies have all found they can make higher profits on generic drugs than on brand-name medicines and still offer prices that are typically well below those of brand-name drugs.
The trend concerns those who saw in generic drugs a way to hold down medical costs for Americans without depriving them of necessary treatments.
“Generic drugs provide a considerable economic benefit to consumers,” said Ron Pollack, executive director of Families USA, a US national consumers' organisation.
But he added, “The benefit often turns out to be considerably less than it could be.”
The rapid price increases come on the heels of a proposal by President George W. Bush to help generic drugs reach the market faster, a plan that is vehemently opposed by makers of brand-name drugs.
The proposal would limit a brand-name drug maker to one automatic patent extension on any drug while it disputes the patent rights.
Generic drugs, chemical replicas of brand-name medicines, almost always cost less than the patented drugs they mimic, and until last year their prices were rising more slowly than prices of brand-name drugs.
But in 2001, generic prices rose nearly twice as fast as prices on all brand-name drugs. And in the first 10 months of last year, the pattern has continued.
The average price of a generic prescription drug rose 15%, to US$14.70 (RM55.86) from US$12.79 (RM48.60), from the corresponding period last year, according to IMS Health, a pharmaceutical information company.
Prices of all brand-name drugs, including those with no generic competition, rose 8.8%, on average, to $77.02 (RM292.67) from $70.79 (RM269), IMS said. The average prices represent total spending on generic drugs divided by the number of prescriptions written.
The price of one new generic drug, which replicates the ulcer drug Prilosec and is one of the best-selling drugs ever, is so close to the price of the brand-name medicine that at least one large insurer is not even trying to switch patients to the generic.
At the same time, manufacturers have raised the prices of some older generic drugs as much as 1,000% recently, albeit from low starting points.
In late November, Watson Pharmaceuticals, a large manufacturer of generic drugs, raised the price of the tranquilliser meprobamate by 725%. The drug is a generic version of Miltown, which lost patent protection more than 20 years ago.
Watson says its product is still a bargain. “Meprobamate still costs only 25% of the brand price” of Miltown, said Patty Eisenhauer, a Watson spokeswoman.
Virtually all the companies along the distribution chain, from wholesalers to managed-care drug distributors and pharmacies, are profiting handsomely before generic medicines reach patients.
Consumers spent US$19.4bil (RM73.72bil) on generic drugs from Jan 1 to Nov 1 last year, compared with US$98.6bil (RM374.68bil) on brand-name drugs. But almost half of all prescriptions filled last year were for generics, and that share is expected to grow to two-thirds over the next two years. – IHT
Growing' human kidneys
ISRAELI scientists have found a way to “grow” human kidneys from tiny grafts of tissue. The technique so far works only in mice, but the experiment could within a few years offer fresh hope for the tens of thousands awaiting kidney transplants.
The researchers used stem cells, those rare precursor cells that make such things as bone marrow, skin or heart tissue.
Yair Reisner of the Weizmann Institute reported that he and his colleagues transplanted human and pig kidney stem cells from foetal tissue into laboratory mice.
Both sets of transplanted tissue grew into perfectly formed, normal-sized mice kidneys. They accepted blood from the mice hosts, and they produced urine in the normal way.
The team calculated that if they timed the transplants carefully, there was less risk of rejection by the host's immune system. In normal transplants, tissue types have to be matched carefully, and even then there is a high risk of rejection. Some patients spend the rest of their lives taking immunosuppressive drugs.
Humans and other mammals start as a single fertilised egg and end as trillions of cells of 200 or more different kinds. Stem cells are the agents that create the new, specialised tissues.
American and European scientists are racing to find ways of using stem cells to repair damaged organs. There have been encouraging signs that cell transplants could lead to new growth or even repair of failing tissue. But nobody expected a tiny graft of alien tissue to turn into a fully formed organ.
The trick seems to be in the timing.
Prof Reisner and his teams report that stem cells of a certain age – seven to eight weeks in humans – seem to be just right for making new kidneys.
If transplanted too early, the stem cells could grow into a mix of organ tissues, such as bone, cartilage and muscle, as well as kidney cells.
If the graft is too late, the foreign tissue will have developed a kind of identity badge that will guarantee its rejection.
Britain leads the world in research into embryo stem cells – the fount of all variety in the developing animal – but there has also been intense research into the use of more advanced stem cells to treat once-intractable illnesses. Even adult stem cells seem to be able to morph into different kinds of tissue.
One United States team turned fat left over from liposuction into bone, muscle and cartilage that could be used for transplant surgery. Two separate teams in New York have used bone marrow stem cells to repair heart damage in rats and mice.
A team at Hammersmith Hospital in London reported three years ago that they had grown liver cells from a patient's own bone marrow.
There are teams looking for ways to persuade damaged nerves to repair themselves, with the use of transplanted stem cells, offering new hope for people paralysed by injury, or crippled by stroke or neurodegenerative diseases. – Guardian Newspapers Limited
Acrylamide in food
THE Food and Drug Administration reported it had found high levels of the potentially cancer-causing substance acrylamide in a wide range of fried and baked products, particularly in French fries, potato chips and crackers.
The high levels discovered represent the first detailed American confirmation of earlier surprise findings from Europe, and have led to a broad FDA effort to determine whether acrylamide poses a cancer risk that requires changes in how foods are cooked and consumed.
So far, officials say, they have not found acrylamide risks great enough to recommend that consumers avoid any groups of food or specific products. It remains uncertain whether people consume enough acrylamide in their food for it to be harmful and whether the substance – which causes cancer in laboratory animals at high doses – is similarly hazardous to people, they said.
But Terry Troxell of the FDA's Center for Food Center and Applied Nutrition said that the agency agreed with the World Health Organization's conclusion that the discovery of acrylamide in many foods is a “major concern'' and needs to be aggressively researched.
The new FDA findings are included in a report on 300 common products the agency has tested for the chemical since Swedish researchers announced their discovery of acrylamide in many foods seven months ago. The FDA list showed predictably high acrylamide levels in most potato chips and French fries, but also significant levels in some breads, cocoas, almonds, coffees and crackers.
In almost all categories, however, the acrylamide levels highly varied. Popeyes french fries, for instance, had significantly higher levels than Burger King fries. The FDA also found great variations in acrylamide levels between bags of the same Lay's potato chips, even those produced on the same lines of the same factories.
FDA officials said their recommendations will come later, after more information is collected. They plan to test another 300 foods and want acrylamide to be deemed a “priority'' issue for the agency next year.
Troxell and other speakers stressed the complexity of the acrylamide situation, saying that researchers don't even know how acrylamide is formed in food or whether it has any biological effect on people who consume it. But they said that because it is a suspected carcinogen – the WHO's International Agency for Research on Cancer has determined that it is “probably carcinogenic to humans'' – its presence must be treated seriously, especially since it is sometimes found at levels considered quite high.
The FDA reported that acrylamide is most commonly produced in the cooking process of starchy foods, and that its levels increase as the cooking process gets longer and hotter. The FDA list, for instance, shows that Ore Ida Golden Fries contained 107 parts per billion (ppb) of acrylamide, while the same baked Ore Ida fries had 1,098 ppb.
The discovery of acrylamide in many foods was a major surprise to food researchers. The chemical has been used to purify drinking water and to produce plastics and dyes, and has been highly regulated because of its dangers. But it was never examined in food until Swedish scientists began testing for acrylamide in tunnel workers who had been exposed to it through water contaminated by an acrylamide-based solvent used to repair leaks. To their surprise, the researchers found high acrylamide levels in the red blood cells of both the tunnel crew and others with no known exposure to the chemical. That led the scientists to test common foods for acrylamide.
When Swedish official announced their results, they also reported that the acrylamide in food may be responsible for the deaths of several hundred Swedes annually. Other researchers in Europe quickly found similar acrylamide levels in their baked and fried starchy foods, but generally did not make similar assessments of possible deaths from the chemical. FDA officials said it was far too early to assess what, if any, harm acrylamide has caused in the United States. – LAT-WP