FEMALE condoms, which are selling around ¢500.00 per one, have been a mad rush for women since the early part of this year for a purpose the inventors would never have imagined.

They have proved handy as fashion accessories. Some use the flexible plastic rings on the tips of the condoms as bangles and seamstresses are using the rings for new embroidery designs.

Reports indicate that the female condom is getting increasingly popular at Tema, Ashiaman, Nima and Kanda. This reporter visited some leading pharmaceutical shops including Ernest Chemists, Vicdoris Pharmaceutical and Satea Pharmacy who confirmed the story that now, patronage has increased from two to ten pieces per lady.

According to Ben, a pharmacist at Satea Pharmacy in Tema, the patronage of female condoms was very low unlike its male counter part, but suddenly there has emerged a rush for it by ladies and he wondered what they use it for. "When I realized they were using it for bangles, I got infuriated and dedcided not to sell it again" adding that, in order not to think they are "spoilt girls" they open it and wear it right in front of you.

He said the female condom looks more cumbersome for its usage than the male condom which is much easier to use. "I will rather urge the promotion of male condoms so that producers of the female condom will stop producing for its wrong usage," he said.

"But let's not forget that this wrong usage has also served as a cover-up for ladies who intend actually using it for the right purpose: sexual intercourse" he added.

Sandra Ahiakonu, a lady, when interviewed on why she was wearing it, answered: "I saw it on other ladies and decided to wear them too; they are attractive and match anything you wear".

Mary's view was that, bangles which range from ¢5,000 to ¢ 25,000 are too expensive for her to buy; "I only need ¢2,000 and I will get four in a row to wear". She said when she removes the rings from the condom, she puts them in hot water to get rid of the oil after that she adds colour to them and wear.

Truly, until they tell you they got them from the female condom, you wouldn't know. "Education on the use of female condom should be intensified in order to create the right awareness among women", says Nancy Ocansey, a nurse. She continued that while the usefulness of the male condom is widely publicized in multi advertising campaigns, little is heard of the female condom.

She said those who have tried it also complain of having difficulties inserting it and that its size is intimidating.

Now, the question is: Who did the additional invention of making it an item of fashion?

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The 18th medicine price cut plan by the National Development and Reform Commission (NDRC) was issued on June 1, involving 67 cancer treatment drugs with more than 300 specifications. The average price decrease is 23 percent, and the biggest drop rate reached 57 percent.

Due to the frequent  cuts to antibiotics prices during recent years, the profit margin for cancer treatment drugs seems to be more lucrative. The number of domestic cancer treatment drug producers is nearing 100, and they are able to produce 40 out of the 49 commonly-used cancer treatment drugs approved by the World Health Organization (WHO).

The number of new cancer patients each year in China totals roughly 1.6 million, and the considerably large market potential for cancer treatment drugs is  well-known in the Chinese pharmaceutical industry.

According to hospital statistics, the purchase volume for cancer treatment drugs are climbing every year, and the purchase value accounts for about 13 percent of total hospital purchases, ranking  fourth in purchase value.

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We live in a time where the Government is getting us to think more about our health, how we can improve it and reduce obesity.

Therefore, its reassuring to know that a local pharmacy has become one of the first in the area to offer a professional Cardiac Risk Assesment Service.

Staveley Pharmacy now offer a range of specialist tests to help you establish where health improvements need to be made. These include tests for cholesterol, blood pressure, body fat composition, body mass index and diabetes.

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Advanced X-ray technology has helped scientists spot a new target that drug designers might use to attack the dreaded bird flu virus.

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For countries with little resources to fight AIDS, Thailand has become a beacon of hope on how to deliver drug treatments on a mass scale to those with the deadly disease, according to a report published by the World Bank on Wednesday.

 

The country has built a program that provides antiretroviral drugs for free or for a minimal amount.

 

Antiretroviral drugs work by inhibiting the replication of HIV. When antiretroviral drugs are given in combination, HIV replication and immune deterioration can be slowed and survival time boosted.

But the costs associated with the drugs have been a major barrier to access for those in the developing countries where a majority of those who have AIDS live. About 40 million people worldwide are believed to be infected with HIV.

 

At present, the cost of these drugs in developed countries ranges from $300 to $1,200 per year, according to the World Health Organization. Despite barriers to access, Thailand has managed to provide antiretroviral drugs to about 78,000 AIDS patients, which is more than 90 percent of those in need of the treatment.

About 6.8 million people living in low- and middle-income countries currently require antiretroviral therapy, according to the WHO. Yet the organization says only about 1.6 million of them are receiving the drugs.

 

Triple-Drug Combo

Thailand was able to deliver better treatment access due in part to an affordable domestically produced triple-drug combination, which costs about $30 per month.

 

The low price allowed the country's public health ministry to roll out a large-scale campaign to provide the drug combo as standard care.

 

The World Bank report also credited Thailand's success of widespread treatment to the country's vast network of district level hospitals and rural health clinics. The country also worked with NGOs to get the job done. Despite Thailand's success, it's still not enough to solve access problems to HIV therapies.

 

"In many ways we are still at the beginning of this effort," said WHO HIV/AIDS Director Kevin De Cock.

 

Dr. De Cock made the comment at the 16th International AIDS Conference, taking place this week in Toronto, where he announced the number of people receiving HIV antiretroviral therapy in sub-Saharan Africa had surpassed 1 million, a tenfold increase in treatment access in the region since December 2003.

 

Among the challenges to access will be funding the growing need in developing countries for second-line drug regimens, which are much higher in price in comparison to first-line treatments.

 

Health care and policy advocates have been taking the fight for improved access directly to the pharma industry.

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Sildenafil citrate, more commonly known as Viagra, is widely known as a treatment for erectile dysfunction (ED) in men. What many may not realize is the drug was not originally intended for sexual purposes, but rather for cardiovascular use. The help the drug provides for ED was merely a side effect recognized in a study. Viagra was previously believed to have no effect on the heart. However, in a recent study, the drug was tested on mice, and researchers found it deterred the short-term effects of hormonal stress on the heart. The mice whose hearts were larger due to stress remained a normal size when Viagra was used. The drug was also seen to be helpful in stopping and reversing the long-standing cardiac effects of high blood pressure. Furthermore, a study has been conducted on humans, and the outcome appears optimistic for the future of heart health.

PROMISING RESULTS: David Kass, M.D., and his team from Johns Hopkins observed the effects of Viagra in the heart via 35 study participants with no past or signs of heart disease. The patients were given two injections over a three-hour period of dobutamine -- a drug that increases heart rate and the strength with which the heart pumps. After the first injection, patients took either a dose of Viagra or a placebo. Those who took Viagra saw a slowdown of 50 percent from the increased heart rate induced by the dobutamine.

Dr. Kass says what researchers have recently discovered "is that the enzyme that Viagra and drugs like Viagra block acts kind of like a brake for the heart." He described the condition further saying if this "brake" is applied under normal conditions, nothing takes place, but if applied when stress is present, "you really can blunt stress response in the heart." Dr. Kass also noted that Viagra taken for cardiovascular purposes does not cause sexual stimulation, because that side effect requires the right environment.

FUTURE USE: Dr. Kass says if all goes well in the clinical trials, the drug could be used for cardiovascular treatment in about three to four years. This type of use for Viagra could have major positive implications for those who have heart disease.

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Barr Pharmaceuticals Inc.'s net income almost doubled in the fiscal fourth quarter, bolstered by revenue from a generic version of the allergy drug Allegra and contraceptives acquired during the past year.

Net income for the quarter ended June 30 climbed to $82.3 million, or 76 cents a share, from $42.1 million, or 40 cents, a year earlier, Woodcliff Lake, New Jersey-based Barr, the biggest U.S. maker of birth control pills, said today in a U.S. regulatory filing. Profit in the 2005 fourth quarter was reduced by $63 million because of a legal settlement.

Barr added an intrauterine device called ParaGard, the contraceptive pill Mircette and copies of Sanofi-Aventis SA's Allegra to its portfolio in the past year. Generic Allegra and some of the company's oral contraceptives are facing increasing competition, which will probably reduce sales, said Robert Uhl, an analyst with Friedman Billings Ramsey in Arlington, Virginia.

``They're vulnerable on a few big money-makers, and at the moment the question is how to get those replaced or offset so the company grows faster than the erosion,'' Uhl said in a telephone interview before earnings were released.

In the fourth quarter, Barr's revenue rose 25 percent to $351.7 million from a year earlier.

Barr, which derives about two-thirds of its sales from generic medicines, is trying to acquire Zagreb, Croatia-based Pliva d.d., a generic drugmaker. The acquisition would give Barr access to Pliva's generic drug markets in Russia, the U.K., Germany, Spain and Italy.

Barr shares fell 68 cents, or 1.3 percent, to $52.32 yesterday in New York Stock Exchange composite trading. The stock has lost 16 percent this year, underperforming a 6 percent gain in the 14-member Standard & Poor's 500 Pharmaceuticals Index.

Barr, which makes the ``morning after'' emergency contraceptive called Plan B, said last week it may be close to resolving with the Food and Drug Administration a longstanding request to make the drug available without a prescription. The contraceptive has been available with a prescription since 1999.

Plan B had $17.7 million in U.S. sales last year, according to IMS Health Inc., a Fairfield, Connecticut-based company that tracks prescription trends. Sales may double if Plan B is made available over the counter, Barr's Chief Executive Officer Bruce Downey has said.

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A federal prescription drug directory fails to list more than 9,000 medications but catalogs tens of thousands more that are no longer on the market, according to a report Monday.

The Food and Drug Administration directory is neither complete nor accurate, according to the inspector general of the Department of Health and Human Services.

The omissions and errors limit the usefulness of the directory, which is meant to help the FDA and other government agencies in handling recalls, identifying medication errors and controlling imports, the IG's report said.

The FDA said it generally agreed with the report and is working to fix the problems it identified, including by making it easier for companies to submit listing information.

Federal law requires pharmaceutical companies to list with the FDA the prescription drugs they make. As of February 2005, the FDA's National Drug Code Directory listed 123,856 prescription drug products.

However, the review found it missed about 9,200 prescription drugs, while continuing to include about 34,200 other drugs either no longer sold or listed in error.

Most of the omissions and inaccuracies are related to the failure of drug companies to comply with mandatory listing requirements, the report found. While unlisted drugs are considered"misbranded"as of August 2005, the FDA had not subjected any manufacturer to criminal or regulatory action solely because it failed to list a product, according to the report.

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One of the nation's largest respiratory therapy companies on Monday said it would stop making unapproved copies of drugs and distributing them to patients, days after receiving a warning from the FDA.

Rotech (ROHI) health care, while saying it disagreed with the Food and Drug Administration's stance, said in a release that it will no longer accept new prescriptions for some of its pharmacy-made drugs and begin switching 30,000 patients to brand-name formulations.

At issue are drugs used by asthmatics and others with respiratory conditions. The drugs are inhaled using a table-top device called a nebulizer.

The company was one of three targeted by the FDA for scrutiny last week, with the agency saying the pharmacies were mass-producing respiratory drugs in violation of federal law. The FDA says some pharmacies are making large amounts of unapproved copies of brand-name drugs. Drugs made in pharmacies are held to less-stringent safety and sterility rules than the agency sets for drugmakers.

The FDA allows pharmacies to make drugs for patients, a process called compounding, but only if they have valid individual prescriptions from doctors saying their patients need treatments, dosages or formulations that aren't made by commercial manufacturers.

Last week, the FDA said the three — Rotech, CCS Medical and Reliant Pharmacy Services, owned by home oxygen company Lincare (LNCR)— had crossed into mass-producing their own versions of the drugs.

"There is no demonstrated medical need for your compounding of these products that are essentially copies of commercially available drugs," the FDA said in a warning Wednesday to Orlando-based Rotech.

Generally, states oversee the practice of pharmacies, but the FDA steps in when problems arise, such as product contamination or when pharmacies cross into manufacturing. Rotech's statement Monday that it supplies 30,000 patients with compounded respiratory drugs is a rare look at the size of some drugmaking pharmacies. Generally, the number of customers or doses supplied is kept secret by the FDA and the companies.

A Rotech subsidiary, Pulmo-Dose, makes the drugs for asthma and other respiratory conditions.

Lincare had no comment about any decisions it might make on its compounding efforts, said spokesman Joe Grillo. CCS Medical did not return calls.

Rotech is of the nation's largest respiratory therapy and home medical equipment firms, with $533 million in revenue last year. But it is struggling, particularly after Medicare lowered payments in the past two years for oxygen and some inhalation drugs. Moody's downgraded the credit ratings of Rotech last week.

For just one product, a pharmacy-made drug called budesonide, the company said in a recent Securities & Exchange Commission filing, the lower payments may result in a $30 million drop in revenue this year. Medicare now pays about $4.40 a 0.5 milligram dose for the commercially prepared drug, the SEC filing says, but dropped payment to 29 cents for a pharmacy-made product.

Rotech on Monday said its decision to switch patients back to commercially prepared products, which it said would take several months, would increase its annual revenue by about $60 million and its projected annual pretax profit to about $10 million.

Washington D.C.-based attorney David Adams, a former FDA policy director now in private practice representing pharmaceutical companies and patient groups, says it appears that Rotech has decided it would rather change than fight.

"For now, it appears they don't want to take on the FDA in what's almost certain to be a significant enforcement action," says Adams.

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Make sure the medicine comes with the patient safety information printed in English.

Ask for the product in the manufacturer's original package.

Report suspected counterfeiting to the FDA MedWatch Program at 800-332-1088 and to the manufacturer.

Check medicine or its packaging. If it appears different from usual, check with your pharmacist and the manufacturer to see if they've changed the packaging.

Avoid medicines in foreign packaging because unregulated imports have been one way for counterfeits to enter the U.S. market.

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Q: Now that Mel Gibson's alcohol problem is out in the open, perhaps there will be more discussion about treating alcoholism. Why don't rehab centers use naltrexone or acamprosate for this disease?

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The National Institute for Health and Clinical Excellence (Nice) have been given final draft approval by a Government watchdog.

The drugs Arimidex (anastrozole), Femara (letrozole) and Aromasin (exemestane) reduce the risk of tumors spreading following surgery and could help thousands of women with early stage breast cancer.

Although there is still a chance of appeal, it is unlikely to be stopped at this point in the process.

The drugs will stop the natural production of the hormone, ostrogen - which is responsible for the growth and recurrence of several types of breast cancers.

In a 2004 study, researchers found that patients who switched from tamoxifen to Aromasin halfway through treatment reduced the risk of the disease returning by a third.

The Government has made clear that doctors should not wait for Nice guidance to complete all its stages before prescribing such drugs to women.

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A new study says a cholesterol drug may help stroke survivors. The study in the "New England Journal of Medicine" found that giving stroke patients high doses of statins like Lipitor reduced the risk of a second stroke. Experts say the results could change the treatment guidelines for some stroke patients. The study was paid for by Pfizer, the maker of Lipitor.

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Americans love to argue about the line that separates church and state. But what about science and state?

Congressional Democrats, including Washington Sen. Patty Murray, have accused fellow politicians of meddling in Food and Drug Administration affairs - namely, the pending over-the-counter availability of emergency contraception.

Leading scientists agree that women should have non-prescription access to emergency contraception. And scientists know best.

Washington, along with nine other states, allows pharmacists to dispense emergency contraception, also known as the "morning after pill," without a prescription - although the state pharmacy board has called for pharmacist discretion. In June, the board proposed and endorsed a rule that would allow pharmacists to refuse to dispense emergency contraception. On Monday, nine Washington women filed official complaints in Olympia. The board meets again Aug. 31, and should use the opportunity to drop the proposal.

In 1997, FDA researchers concluded that oral contraceptive pills, taken correctly, are safe for emergency use. In 1999, the FDA approved Plan B, an emergency contraceptive pill also marketed under the name Levonorgestrel. In 2000, the American Medical Association announced its support for over-the-counter emergency contraception.

In 2003, members of an FDA independent joint advisory committee voted 23-4 to recommend Plan B for over-the-counter sale. They also decided - in a 27-1 vote - that Plan B could be safely used, even by adolescents.

In 2005, the Journal of the American Medical Association reported that increased access to emergency contraception does not lead to increases in pregnancy rates or unprotected sex, or cause women to give up regular birth control. Also in 2005, the American Academy of Pediatrics published a statement in support of making emergency contraception available over the counter to teens and young adults.

Despite overwhelming evidence that emergency contraception is safe and effective, the FDA approval process has stalled again and again. Agency administrators and their political allies have likened emergency contraception to abortion. The morning-after pill contains hormones, like those in birth-control pills, and prevents pregnancy a short time after unprotected intercourse. It inhibits or delays ovulation and/or interferes with implantation.

That's very different from the "abortion pill," mifepristone, which is given within 49 days of con. It blocks progesterone receptors in the lining of the uterus, cutting off support to an already-formed embryo.

Neither morality nor politics should cloud FDA approval. According to scientists, the drug is safe, effective and suitable for over-the-counter distribution. It should be made available.

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After previously forecasting 7 percent to 9 percent sales growth for 2006, management now expects results in the lower end of that range. That's due in part to disappointing sales of its insulin drugs.

It also faces increased competition for its Zyprexa antipsychotic medication, its top-selling drug that has seen its sales slip slightly in the U.S. It loses patent protection in 2011.

Shares of Eli Lilly (LLY) are down 4 percent this year, following a small dip last year and a 19 percent drop in 2004.

Sales were up 5 percent in its recent quarter on gains in treatments for depression and lung cancer. The new Medicare drug benefit that offers prescription-drug coverage to elderly and disabled people has generally helped earnings of drug companies this year.

Lilly is committed to research and development. Big pharma is, after all, a battle of products. Lilly's Cialis drug for erectile dysfunction had worldwide sales of $750 million last year, though Pfizer is suing Lilly with a claim that Cialis infringes on Viagra patents. Lilly ranks as the third-largest maker of biotechnology-based drugs, behind Amgen Inc. and Genentech Inc.

Consensus rating on stock of Lilly is a "buy," according to Thomson Financial. That consists of five "strong buys," seven "buys," 13 "holds" and one "underperform."

Earnings are expected to increase 9 percent this year, in line with the major drug manufacturing industry. Next year's projected 8 percent rise compares to 12 percent forecast industrywide. The five-year annualized return of 10 percent is slightly better than the 9 percent projected for its peers.

The U.S. Food and Drug Administration has approved use of Lilly's drug Gemzar to treat recurrent ovarian cancer when used in combination with carboplatin chemotherapy.

Lilly is awaiting a ruling from U.S. regulators on approval of Arxxant, a drug to combat eye damage in diabetics that could become a big seller. The company is testing an anti-cancer pill that could shrink brain tumors and potentially other forms of cancer.

A federal jury recently ruled Lilly infringed the patent of Ariad Pharmaceuticals with its drugs Evista and Xigris, ordering it to pay $65.2 million.

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Dying of lung cancer, Carolyn Hobbs tried a new biotechnology drug that produced an unanticipated side effect: acute sticker shock. She was waiting for her second treatment in a hospital near Denver less than two years ago, when someone from the business office marched in to warn that her share would cost more than $18,000, since the drug wasn't insured for her type of cancer.

In her six decades, she had shared in a long marriage, raised three children, worked in a nursing home, painted as a hobby — and wasn't ready to leave it all behind. But she was also a careful spender who sometimes returned new clothes to the store, deciding she didn't really need them.

So she refused the treatment.

Extraordinary care for dying patients can make for inspiring medicine, but its extraordinary costs make it an increasingly debated choice to promote public health. Many economists, doctors, and ethicists say this care too often buys too little for too much — and that its expanding share of medical resources might better pay for screening and treating diseases in earlier stages.

"People still have an underlying belief that there's an infinite amount of resources that can be invested in health care," says Dr. Harlan Krumholz, a Yale University heart specialist who studies quality of care. "But I think we're coming to a realization that we're going to need to confront these issues explicitly."

___

• Cancer drugs manufactured in living cells, instead of beakers. These biotech drugs target just diseased tissue, unlike chemotherapy. Thanks to these drugs, some late-stage colon and blood cancers are no longer hopeless.

Some of these therapies, like the biotech drug Gleevec for leukemia or implanted defibrillators for some heart problems, work wonders in many patients. The trouble with many treatments, though, is that average patients gain only several more months of life, studies have found. A lucky few may survive for years, so many seek treatment in the hope of beating the odds.

Whoever pays, costs are up. This care costs several times more than the older treatments it supplements or replaces. A last-resort cancer drug can cost up to $50,000 a year — if patients survive that long — with insurance typically picking up at least two-thirds. A mechanical heart pump can cost more than $200,000, with hospital care.

"I have two small children, and dying right now is not an option," colon cancer patient Rebecca Dague, of Medina, Ohio, said recently.

Faced with such a disease, more than a third of Americans now would want "everything possible" done to save their lives, up from just over a fifth in 1990, according to a poll by the Pew Research Center for the People and the Press.

For many on the brink of death, the choice of desperate measures is hardly a choice at all. "It's better to pay the money than sleeping with the worms," said Jake Rogers, 62, of Chicago, of his implanted left-ventricular assist device. His doctors implanted a second one in June, when his first wore out after 15 months.

From their first day of medical school, doctors are trained to do their utmost for patients like Rogers. "I think probably there's more tolerance for high cost at the end of life, when all the options have been exhausted," says cost analyst Milton Weinstein, at the Harvard School of Public Health. "I think there's a moral force that causes us to want to do anything we can, irrespective of the cost."

While doctors advocate for the interest of dying patients, they may also be subtly swayed by earning their livings partly from providing this care. And many patients don't fret, because they are insulated from huge payouts by insurance.

Robert Graham, 73, of East Brandywine, Pa., chuckled when he heard the high price — up to $250,000 — of heart pumps like the one implanted in him last November. It was covered by insurance.

"I got to live a long time to be worth that!" he said. Yet the average patient in the best medical test so far lived less than nine more months.

Federal safety regulators do not regulate the price of end-of-life treatments. They evaluate only if drugs or devices work, not how well they work for their prices.

Medicare, which insures about 80 percent of dying Americans, makes no acknowledged evaluation of cost in deciding what to cover. It is not allowed to negotiate for lower drug prices. Its coverage umbrella sets a standard for private insurers.

Under such pressures, the $1.9 trillion spent on U.S. health care in 2004 will balloon to $4 trillion by 2015, federal forecasters project. In that year, health spending, which claimed 16 percent of the economy in 2004, would consume 20 percent and cost the average American $12,400.

Some believe the country can afford to spend even more — and that it's worth it. Others fear a crash, with insurance perhaps turning into a luxury item. Nearly everyone, though, agrees there's an upper limit somewhere on the horizon.

"So far, we've given everything to everybody," says economist Lester Thurow of the Massachusetts Institute of Technology. "We haven't made the tough choices yet."

___

Yet choices are being made every day, case by case.

Some insurers refuse to cover a treatment. Doctors send patients home to die, sometimes out of mercy. Some patients say enough is enough.

Dr. David Johnson, at Nashville's Vanderbilt-Ingram Cancer Center in Tennessee, pitched Erbitux to his brother-in-law, a 57-year-old married truck driver with advanced colon cancer. However, the drug has barely been proven to extend average survival at all.

The doctor remembers his brother-in-law refusing and saying: "Are you stupid? I'm not giving up my limited resources."

The drug's marketer, Bristol-Myers Squibb, did not reply to repeated requests for comment.

Employers and insurers are discreetly controlling costs through premiums, deductibles, co-payments, caps, and even outright exclusions. "Benefit costs would go through the roof if there were no considerations given to the costs," says Karen Ignagni, president of the trade group America's Health Insurance Plans.

Despite official denials, the federal Medicare program makes subtle cost evaluations, says Dr. William Maisel, a Boston heart specialist who chairs a federal committee on cardiac devices. "I think they are concerned about people using the term

rationing' or

withholding therapies,'" says Maisel, at Beth Israel Deaconess Medical Center.

One way to control costs, without saying "no," is to keep reimbursements low. For example, Medicare's $140,000 reimbursement last year for heart pumps is widely acknowledged as below-market.

"We can't say,

No,' explicitly. We say,

Yes, but,'" explains Peter Neumann, who runs a Tufts University center on medical cost-effectiveness in Boston.

Yes, but start with a cheaper drug, get prior authorization, or make a bigger co-payment.

Or, for the 45 million uninsured: Yes, but go to the emergency room and rely on charity for extended care. The nonprofit Patient Advocate Foundation reports that nearly half of its cases or requests for help involved co-payments last year, up from just 5 percent in 2002.

"If you've got a thick wallet or a full purse, you can get any care you want. If you don't, there's rationing for you," says former U.S. Health Secretary Joseph Califano, who later dealt with escalating health costs as a board member at Chrysler Corp.

"We're going to have to think very hard about how to provide some of these truly exotic treatments," he adds.

___

Many now press for more systematic thinking about cost controls applied by insurers, hospitals, and policy makers. They say medical guidelines should more strongly steer older, sicker patients — and other inappropriate candidates — away from the most expensive treatments.

Cost-effectiveness analyses should be applied, they say. One common approach calculates the cost of a treatment for each year of life it saves. Many health economists view $50,000-to-$100,000 as a reasonable upper limit for what public and private insurers should pay.

Such calculations include adjustments for lost quality of life. For example, a heart pump is clearly less valuable if it puts a patient in the hospital for three of his last five months with a miserable infection.

Heart pumps were first used as a temporary bridge to a heart transplant and only approved as regular implants in 2003. About 1,000 were implanted last year, but the ultimate annual market is estimated in the tens of thousands. Yet an analysis last year put their cost-effectiveness at between $500,000 and $1.4 million per year.

Even one of their pioneers, Dr. Eric Rose at Columbia University, concedes that would make their value "more than challengeable," but he expects improvements.

"It's hard for me to justify in a society that's falling short in basic health care," adds heart doctor Steven Nissen, at the Cleveland Clinic, a federal adviser who voted against expanding use of heart pumps beyond patients waiting for a transplant.

Dr. Barry Straube, who heads the Medicare unit that decides what to cover, believes "it would be helpful in setting priorities when we have limited budgets to look at cost-effectiveness."

Take also the example of the new biotech drug Avastin, which treats colon cancer for about $4,400 a month. Effectiveness? It is proven to extend average life by up to five months. In a survey this year, only one-fourth of 139 cancer doctors felt that represents "good value."

Genentech, which makes Avastin, believes its drug prices provide reasonable value to patients and powerful financial motivation in-house to improve treatments for a terrible disease, says Walter Moore, a company vice president. However, he says Genentech may impose its own lifetime cap on a patient's charges for Avastin.

For now, many hospitals partner with drug companies to treat dying patients for free, especially in the early stages of testing. Dr. Roy Herbst, at the M.D. Anderson Cancer Center in Houston, says the price of biotech drugs has forced the subject of cost into his discussions with colleagues for the first time.

"If we lost $30 million a year on Avastin, those are things that couldn't go into research and support programs," he says.

Others, too, question the current priorities of U.S. medicine.

"We've prioritized end-of-life care as more important than preventive care or chronic care," says Dr. John Santa, medical director for the Center for Evidence-based Policy in Portland, Ore.

Doctors, says University of Pennsylvania heart surgeon Dr. Michael Acker, should keep away from "high-tech, expensive technology just to postpone the inevitable."

"In the highest-benefit patient, you don't get that much benefit, and it costs a lot," adds Alan Garber, a Stanford University doctor and economist who chairs a Medicare coverage advisory panel and questions the value of both heart pumps and Erbitux.

Carolyn Hobbs' husband disagrees, at least in her case.

Though she initially refused Erbitux because of cost, she ultimately arranged to get that drug and three other biotech drugs for free, with help from her doctor, hospital, Medicare and the drug industry. Her husband says she managed to keep a reasonable quality of life, even through most of her final months.

She died in November. To this day, her husband isn't quite sure how much was spent.

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 LOOPHOLE in regulation has fostered a rise in potentially unsafe drug-making in pharmacies, prompting calls for urgent intervention.

Regulators and experts have called on the Therapeutic Goods Administration (TGA) to develop a national policy to protect patients from the risks associated with medicines prepared by "compounding chemists".

Stephen Marty, registrar of the Pharmacy Board of Victoria, said it was up to the Commonwealth to regulate the practice. "There should be nationally consistent regulation in place," he said. "Snake oil is very much alive and well."

The Therapeutic Goods Act, established in 1989, includes exemptions for compounding, the traditional role of pharmacists to make medicines for individual patients when no commercial product was available. At the time, compounding was rare and public health risks were deemed very small.

But a small nexus of pharmacists, doctors and marketers used the loophole to sell expensive "hand-made" drugs, which are promoted as natural. The drugs are made by chemists in their own pharmacies. The process is legal but poorly regulated.

According to a report commissioned by the TGA, the practice "has grown out of all proportion" in a small number of pharmacies in Australia. "This is part of an international trend and appears to be accelerating rapidly." While exact numbers are not known, the report estimates a small number of specialty pharmacies in each jurisdiction and up to 50 others with some level of involvement.

So-called natural hormone replacement therapy is one of the biggest sectors of the emerging industry, riding on the wave of fear caused by contested claims in 2002 that conventional hormone therapies increased the risk of cancer. Anti-ageing formulations are also booming.

As they are not classified as manufacturers, compounding pharmacists do not have to comply with safety standards set by the TGA or the professional pharmaceutical body, Medicines Australia. And as they operate within professional standards, state and territory pharmacy boards cannot intervene.

Last year the Australian Health Ministers Advisory Council and the TGA agreed tighter regulation was necessary. However, a TGA spokeswoman said a decision on future regulation would be postponed until after the administration merged with the New Zealand authority, expected late next year.

Associate Professor John Gullotta, chairman of the Australian Medical Association's therapeutics committee, said the TGA must act urgently. "They can't put it off any longer because it's been going on far too long," he said.


Patients can pay thousands of dollars for diagnostic tests and hundreds more for expensive medications made by compounding pharmacists.

The sector is led by the Professional Compounding Chemists of Australia, a commercial subsidiary of the powerful US lobby, Professional Compounding Centers of America, and a supplier of drug ingredients.

To attract customers, compounding pharmacists use websites, newspaper advertisements and customer loyalty programs, and some lobby GPs directly. At least one pharmacist has offered GPs up to $11,000 a year in extra income and company shares if they wrote just three prescriptions for compounded products a day.

Mr Marty, from the Pharmacy Board of Victoria, said most pharmacists practised in good faith and further regulation must allow for legitimate compounding. "I don't want to see pharmacists prohibited from dispensing unique, one-off products. It's fine for them to do so provided they have got the evidence-base (to prove its) safety and efficacy," he said.

Vital difference in therapies ■ Natural hormone replacement therapy (NHRT or bio-identicals) is a hormone preparation made by select pharmacists with inadequate regulation, scientific research or quality control, and is not approved for use.



■ Conventional hormone replacement therapy (HRT) is a hormone preparation made by pharmaceutical companies. It is strictly regulated, based on extensive research and approved for use.
SOURCE: PROFESSOR HELENA TEEDE

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For the next week, we will be bombarded with news about HIV/AIDS as thousands of scientists, researchers, specialists, health-care workers and activists gather in Toronto for the XVI International AIDS Conference, which has as its theme: "Time To Deliver.

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