People who buy prescription medications over the Internet, especially drugs purporting to treat erectile dysfunction, are playing Russian roulette with their lives, a new study contends.

At best the drugs won’t help you and at worst they could kill you, the review article said.

“You may be wasting your money or you may actually be hurting yourself,” said Dr. Margaret E. Wierman, professor of medicine at the University of Colorado at Denver and chief of endocrinology at the Denver VA Medical Center, who was not involved with the study.

Counterfeit Internet drugs are a mushrooming problem. Seizures of fake drugs in Europe quadrupled between 2005 and 2007. And the number of investigations undertaken by the U.S. Food and Drug Administration increased by a factor of eight between 2000 and 2006, according to the study, published in the International Journal of Clinical Practice.

The sale of counterfeit drugs has almost doubled in the last five years, and will hit $75 billion in 2010, according to one estimate, making it one of the more lucrative illicit drug markets.

As many as 2.5 million men in Europe may have taken counterfeit sildenafil (Viagra), the study authors stated.

“It’s a very significant problem and I think there are people who are being injured,” said Dr. Ira D. Sharlip, a spokesman for the American Urological Association and clinical professor of urology at the University of California, San Francisco. “The only way to avoid the problem is not to buy on the Internet.”

Viagra-like tablets bought on the Internet aren’t necessarily any cheaper than the real thing, but they do allow buyers to avoid the shame factor often associated with asking for this type of drug.

“The motivation is the anonymity of buying drugs on the Internet. It’s embarrassing to some men to go to a pharmacy and pick up his Viagra prescription, and it’s also embarrassing for some men to go to a doctor and say, ‘I have erectile dysfunction. I need some Viagra,’” Sharlip said.

The problem of fake drugs isn’t limited to impotence treatments. According to the study, two pregnant women died after they were given injections of a counterfeit iron preparation for anemia, and 51 children died in Bangladesh of kidney failure after taking paracetamol syrup that was contaminated with diethylene glycol, which is often used as antifreeze in cars.

So many things can go wrong with Internet purchases.

“The purity of the medication or the quality of the medication is under no sort of scrutiny or any type of oversight to determine if, first of all, it is the correct medication. And second, if it is correct is it in the correct dosage?” said Dr. Michael Chehval, chief of urology at St. Louis University.

Study author Dr. Graham Jackson, a cardiologist at London Bridge Hospital in the United Kingdom, said: “The first danger is people don’t know what’s in it. Some are just talcum powder or brick dust, while some have a bit of Viagra or Cialis and some chemicals that have nothing to do with it. One batch actually contained amphetamine, which is an addictive drug. Tablets are made shiny with road paint or shoe polish. The content of the medication could be anything.”

In 2008, four men in Singapore died after ingesting counterfeit impotence drugs that had been contaminated with a blood-sugar-lowering agent, the study reported.

And bypassing the involvement of a competent doctor means red flags could be missed.

“Erection problems can be an early warning sign of heart disease or diabetes,” Jackson said. “If you do have a problem and don’t see a doctor, diagnosis of those important conditions can be missed. Men with no symptoms at all who get an erection problem usually are an average of three to five years away from a heart attack. Instead of going to the Internet, they should be going to their doctors to find out if they are at risk and to do something about it.”

Problems also can occur when the impotence drugs actually do contain phosphodiesterase type 5 inhibitors (PDE5), the main ingredient in Viagra, as well as vardenafil (Levitra) and tadalafil (Cialis).

“People with underlying heart problems are at risk for cardiac events if they take this class of medication,” Chehval said.

According to the review article, about one-third of men reported sidestepping a health-care professional when buying erectile dysfunction drugs.

“This is a really serious issue. We can fix the erectile dysfunction and we can also fix the chances of getting a heart attack,” Jackson said.

Jackson is editor of the journal and reported multiple ties to pharmaceutical companies, including Pfizer, which makes Viagra. The review article covered more than fifty studies published between 1995 and 2009 and was conducted by British, Swedish and American researchers.

Technorati Tags: buy prescription medications, cialis, erectile dysfunction drugs, fake drugs risks, Levitra, Viagra

As we all know purchasing anything on web has become actually simpler and faster but the issue is that’s it ok to buy even extremely popular drugs without prescription? Just take an example of a well-liked drug, Lipitor. Buy Lipitor online is simple. Lipitor ( Atorvastatin ) is a well-liked medication that’s widely prescribed to patients to stop strokes and coronaries by lowering the body’s production of LDL. this medication may also be used for some other purposes that may lead to harm.

You can order Lipitor online or can buy common Lipitor online but you should be aware of its complications too.

Besides buy meridia online from a web chemist ( nexium online chemist ) site, you may avail special online consultancy services to clear any questions about your medicine. The chief benefit that a Web dispensary offers over nearby community drugstores is the quantity of convenience, security and safety concerned in the whole exchange process. You’ll find that it is simpler for a sick person to send someone to the nearby pharmacy for purchasing universal cialis or to buy discount cialis, buy canada cialis or to get the prescription filled. Aside from that, many patients aren’t cushty disclosing their identities or the drugs taken by them to the community drugstores.

The ordered drugs and drugs ( lipitor pravachol, lipitor cost, lipitor zetia, pravachol Lipitor, lipitor pravachol ) are delivered inside a short period to the patients. The patients can maintain full privacy of their identity in this example. Another important point is that you aren’t ready to get correct and enough gratifying info with regard to a categorical medicine like lipitor pravachol, lipitor cost, lipitor zetia, pravachol Lipitor, lipitor pravachol for example. From your nearby community drug store which sell drugs over the counter. Online drug stores or web drugstores ( nexium online pharmacy ) offer detailed and correct info on varied drugs they’re working with. Not just that, this info is presented in an exceedingly straightforward language so a common person can understand the effects and side-effects of a selected drug and can use it correctly. Web pharmacies maintain a correct and complete record of all the small print of a client in a private way. This record history can’t be found with your nearby community medication store as they can not maintain it. Whether you have got to buy plavix or purchasing a common lipitor or other drugs like lipitor pravachol, lipitor cost, lipitor zetia, pravachol Lipitor, lipitor pravachol, all you are able to get simply by sitting at your personal computer in a convenient way.

Technorati Tags: Buying Drugs online, buying meds online, order Lipitor online

WASHINGTON (AFP) – The risks of taking anti-inflammatory drug Vioxx could have been detected nearly four years before the drug was pulled from the market, according to analysis of nearly 30 clinical trials.

The findings, published in the Archives of Internal Medicine on Monday, analyzed 30 Vioxx trials involving around 20,000 individuals and fund evidence of the drug’s risks from as early as 2000.

The Merck-made drug was pulled in 2004 after it was linked with serious cardiovascular problems, including heart attacks.

Much of trial data used in the meta-study has only become available because of litigation against the firm.

The study’s authors, including Joseph Ross of the Mount Sinai School of Medicine in New York, said the results showed the need for the open publication of clinical trials.

“Physicians and the public deserve to be in a position to make informed choices about risk and benefits (of pharmaceutical products),” the authors said.

Merck voluntarily withdrew Vioxx from sale in September 2004 after a company internal study in 2001 showed the drug doubled the risks of heart attack in patients who took it for 18 months or longer.

The company has since faced a slew of lawsuits and was forced to pay billions of dollars in damages.

Technorati Tags: antiinflammatory, cardiovascular, Vioxx, Vioxx risk

LONDON (AFP) – British health professionals have called for a change in the treatment of dementia patients after an official report warned that wrongly prescribed anti-psychotic medicines are causing the deaths of an estimated 1,800 each year.

As many as 144,000 out of an estimated 180,000 people suffering from the disease are unnecessarily given powerful “chemical cosh” drugs, the Department of Health-ordered review revealed.

The report also linked a significant number of strokes among elderly patients due to over prescription of the medication.

“We need to be sure that only the people who benefit from these drugs get them, and they get them at the lowest possible dose for the shortest period of time,” Sube Banerjee, the report’s author and professor of mental health at King?s College London Institute of Psychiatry, said in the report.

“It is clear that these medications are being prescribed to deal with behaviour and psychological symptoms in dementia rather than just for psychosis,” he added.

Banerjee urged social care services to develop a “different mindset” in tackling the issue.

There are presently 700,000 people in the country with the condition, but the numbers are expected to rise to one million in the next decade because of an ageing population.

“We know there are situations where anti-psychotic drug use is necessary - we’re not calling for a ban, but we do want to see a significant reduction in use,” said care services minister Phil Hope.

Neil Hunt, chief executive of Britain’s Alzheimer’s Society, welcomed the review saying the recognition of the scale of the problem was long overdue.

“This goes beyond quality of care. It is a fundamental rights issue. Our members tell us of enormous worry and distress over what is happening to their loved ones,” he added.

Technorati Tags: anti-psychotic medicines, dementia drug, psychological symptoms, treatment of dementia

Analysis of a dozen published studies testing possible new uses for a Pfizer Inc. epilepsy drug found that reporting of the results was often misleading, indicating the medicine worked better than internal company documents showed.

According to the report, when a company-funded study’s primary finding wasn’t favorable, that result was usually buried and something else positive was highlighted, without disclosing the switch.

The documents used in the review were obtained by lawyers suing Pfizer for refunds on prescriptions paid for by insurers and consumers. The lawyers, who are seeking class action status for the cases, claim Pfizer concealed evidence the epilepsy drug Neurontin didn’t work for those unapproved uses, including nerve pain, migraines and bipolar disorder.

One of the report’s authors is an expert witness for the plaintiffs; another has received fees from the lawyers.

Pfizer disputes the report’s conclusions, saying the company never “attempted to mislead the medical community about the effectiveness” of the drug for certain uses.

“We believe the review suffers from significant bias, insufficient data, poor methodology, and cannot pass the threshold of credible scientific research,” Pfizer said in a statement.

The report, by researchers at the University of California at San Francisco and the Johns Hopkins Bloomberg School of Public Health, comes two months after Pfizer was fined a record $2.3 billion — including an unprecedented $1.2 billion criminal fine — for illegally marketing other blockbuster drugs.

The report appears in Thursday’s New England Journal of Medicine.

Dr. Sidney Wolfe, head of health research at consumer group Public Citizen, called it the first comprehensive look “at studies in which a company and people working for it so maliciously manipulated the data to make a drug look more effective than it actually was.”

“In every instance, the published article made the drug look better than it would have,” said Wolfe, a member of the Food and Drug Administration’s drug safety advisory committee. “This results in harm.”

Neurontin was approved by the FDA a decade ago for treating seizures and later for pain caused by shingles — but not for other conditions. Its potential side effects include suicidal tendencies and depression.

While doctors can prescribe drugs for unapproved, or off-label uses, drug companies are legally barred from promoting their products for such uses. Drugmakers often test drugs for additional conditions and publicize the results. But they don’t always seek approval for those new uses, particularly if the new findings aren’t convincing.

Experts believe most Neurontin sales were for off-label uses — the ones in the reviewed studies. Sales peaked at $2.7 billion in 2004, when Pfizer paid $430 million in government fines to settle allegations it improperly marketed the epilepsy drug for unapproved uses. By last year, Neurontin sales fell to $387 million due to cheaper generic versions sold as gabapentin.

For the new review, the researchers examined 20 patient studies funded by New York-based Pfizer and its Parke-Davis unit on use of Neurontin for preventing migraines or treating nerve pain or bipolar disorder. The studies were published in medical journals or presented at conferences, mostly over the last decade.

In eight of the 12 published studies, the main outcome listed in internal documents differs from the one later given in the published report. In half the cases, a new primary outcome was substituted and in others, the original main outcome was instead reported as a secondary measure or wasn’t disclosed at all.

The authors cited some limitations to their review, including not knowing who made the changes.

“We cannot be certain that selective reporting was a decision made by employees of Pfizer and Parke-Davis, since the authors of the published reports included nonemployees,” the researchers wrote.

Arthur Caplan, director of the University of Pennsylvania’s Center for Bioethics, called the report “one of the most ethically disturbing papers I’ve read in some time” and “an indication that people have been playing fast and loose with studies,” particularly industry ones.

Caplan said the FDA should have the power to audit industry drug studies. Wolfe said there should be bigger fines and jail terms for manipulating study data, plus tougher rules for studies being published in journals.

Medical journals in recent years have required that studies be listed on a federal Web site, http://www.clinicaltrials.gov, to be eligible for publication. That move was made partly to make it harder for industry to hide studies on products that don’t pan out and only publish those with good results. The study descriptions also list their primary and secondary outcomes.

Pfizer said it now has 1,245 company-sponsored studies listed on the Web site.

Technorati Tags: epilepsy drug, Neurontin, New England Journal of Medicine, Pfizer, Pfizer drug studies, preventing migraines

Medication overdoses send one in every 180 US 2-year-olds to the emergency department every year, researchers from the Centers for Disease Control and Prevention report. Such overdoses are responsible for more than two-thirds of all childhood poisonings.

Most of the time, these cases occur when a child finds a medicine and eats or drinks it without adult supervision, Dr. Daniel S. Budnitz, who directs the Medication Safety Program at the CDC’s Division of Healthcare Quality and Promotion and led the study, told Reuters Health.

“Although there have been some great stride in preventing deaths from overdoses with the traditional child-resistant caps…it might be time to kind of take the next step,” Budnitz said. He said the CDC is working with manufacturers and other agencies to come up with innovative packaging that reduces the likelihood that a child can take too much of a medication.

While the number of calls to poison control centers nationwide is declining, Budnitz and his team note in the American Journal of Preventive Medicine, the percentage of those calls that involve medicines rather than household products such as cleaners and pesticides jumped from 34% to 44% from 2002 to 2006.

It’s not clear why, Budnitz said in an interview, but the fact that people are simply taking more medicines these days could be a factor.

To better understand how to prevent unintentional medication overdoses in children, the researchers looked at data from the National Electronic Injury Surveillance System for 2004-2005 on visits to emergency departments for unintentional poisoning by patients 18 and under.

Medication accounted for 68.9% of these visits, or an estimated 71,224 visits every year, Budnitz and his team found. Over-the-counter products were responsible for a third of the medication-related poisonings.

The most common medications involved were acetaminophen (Tylenol), representing 9.3% of cases; cough and cold medicines, 7.3%; antidepressants, 6.1%; and non-steroidal anti-inflammatory drugs such as ibuprofen (Advil), 5.3%.

Four out of five visits were due to children ingesting medications on their own, while 14.3% involved misuse of medications, for example a child being given too large a dose by an adult, or being dosed too frequently.

The youngest children were most at risk, with kids 5 and under accounting for 81.3% of the medication-related poisonings. As children got older their likelihood of unintentional medication overdose decreased, but rose again during adolescence, possibly because parents were allowing them to take medications on their own, Budnitz and his team note.

“These are not teens who are trying to get high or kill themselves,” Budnitz noted, but who simply may not understand how to use medicines. “Really you can only take medicines as directed. If the bottle says take two for pain it doesn’t mean that taking eight will be even better.”

Parents should know, he added, that teens may still need guidance in using medications properly.

And it’s also crucial for parents to tightly close the caps of medicine bottles and put them up out of the reach of children, he added. Putting medicines in a place that’s “convenient” for parents, he said, may also mean that it’s easy for kids to reach too.

Technorati Tags: accidental poisoning, Medication overdose, medicine overdose, misuse of medications, unintentional medication overdoses, using medications properly

A drug used to help prevent recurring breast cancer appears to hold promise as a treatment for deadly fungal infections, new research has found.

University of Rochester Medical Center researchers found that tamoxifen kills yeast in mice with Candida infections, which can be fatal to people with compromised immune systems, including people with cancer or HIV and those taking immunosuppressants for chronic conditions.

At extremely high levels, tamoxifen slashed yeast levels by 150-fold, causing most fungus cells to break up and die while halting surviving cells from progressing into a disease-causing state, their study found.

“It’s still early, but if tamoxifen, or molecules like it, turns out to be an effective treatment against serious fungal infections, it’ll be a welcome addition to our arsenal,” Dr. Damian Krysan, an assistant professor of pediatrics at the university and an author of the study, said in a university news release.

The results are published in the August issue of Antimicrobial Agents and Chemotherapy.

Available antifungal medications pose some issues for people who need them the most, according to background information in the news release. The only new class of antifungals approved for use in the past two decades is generally effective, but they can only be taken intravenously, which poses logistic and other problems for some patients. And the most common oral antifungal medication only slows fungus cell growth, making it difficult for immune-compromised patients to completely shake their infections.

“We don’t have vaccines against fungal infections, and the few drugs we do have aren’t always effective,” Krysan said. “We’ve got a lot more work to do to figure out whether tamoxifen could be used in high doses or whether it could be used in combination with other treatments, but we’re excited about the possibility of giving doctors another way to help these critically ill patients.”

Technorati Tags: antifungal, Breast Cancer Drug, Candida infections, Fungal Infection, tamoxifen

NEW YORK (Reuters Health) – People with high blood pressure that isn’t controlled by multiple medications are likely eating too much salt, new findings in the journal Hypertension show.

Individuals with so-called resistant hypertension showed sharp reductions in their blood pressure when they dramatically cut their salt intake, Dr. Eduardo Pimenta of the University of Queensland School of Medicine in Brisbane, Australia and his colleagues found.

“It was an amazingly large reduction in blood pressure,” Dr. Lawrence J. Appel of Johns Hopkins University in Baltimore, who wrote an editorial accompanying the study, told Reuters Health. Appel estimated that 10% to 20% of people have resistant hypertension, meaning they are taking three or more blood pressure medications but their blood pressure is still too high.

But the reductions in sodium intake in Pimenta’s study-down to 1.15 grams per day-would be very tough for people to achieve in a real-world setting, Appel added. (Sodium levels in food are correlated with salt levels.) “You can advise people to reduce sodium but the food supply has so much sodium it’s very difficult for individuals to do this on their own.”

Pimenta and his team had 12 people with resistant hypertension alternate between low and high sodium diets for a week each, with a two-week “washout” period between the diets.

Study participants’ initial average systolic blood pressure, the top number in a blood pressure reading, was 145.8 millimeters of mercury (mm Hg), while diastolic pressure, the lower reading, was 83.9 mm Hg. They were taking an average of 3.4 antihypertensive medications each.

On the high sodium diet, they were consuming 5.7 grams of sodium daily, while the low-sodium diet contained 1.15 grams of sodium daily.

US and UK guidelines recommend people consume less than 6 grams of sodium daily, while the World Health Organization recommends reducing intake even further, to less than 5 grams. But people in the developed world typically consume 9 to 12 grams of sodium a day.

In the study by Pimenta and his team, going on the low-salt diet reduced people’s systolic blood pressure by 22.7 mm Hg, on average, and their diastolic pressure by 9.1 mm Hg.

“The current results suggest that patients with resistant hypertension are exquisitely salt-sensitive,” the researchers suggest. These individuals’ salt intake is probably causing them to retain so much fluid that standard…treatments for reducing blood pressure aren’t helping them, they add.

In the other study, Dr. Feng J. He of the University of London and her colleagues tested a less dramatic sodium reduction in 71 whites, 69 blacks, and 29 Asians. All spent two weeks on a low-sodium diet, and were then randomly assigned to take sodium pills or a placebo for six weeks, after which they were switched to the opposite treatment for another six weeks.

Being on placebo versus taking sodium was equivalent to consuming 6.5 grams per day of salt versus 9.7 grams daily.

In He’s study, participants’ blood pressure averaged 146/91 while they were taking the sodium tablets, but fell to 141/88 when they were on placebo. The differences were significant among whites, blacks, and Asians-which is important, He noted in an interview, because most studies to date have been done in whites, while blacks and Asians are at particularly high risk of complications from high blood pressure.

Cutting salt also led to changes in the urine that suggested the change might be producing additional benefits for the kidneys and heart and circulatory system beyond the effects on blood pressure, He and her team found. Study participants were also losing less calcium in their urine, so reducing salt could be helping to protect their bones, too.

The UK has been working with the food industry to gradually reduce the amount of sodium added to food, He noted. This is crucial, she pointed out, because 80% of the sodium intake for a typical person in the developed world comes from salt added to foods by industry. The beauty of the UK plan, she added, is that the consumer doesn’t have to do anything to reduce their salt intake. Since the effort began, the researcher noted, average salt intake in the UK has fallen from 9.5 to 8.6 grams daily. “You can see it’s already working,” she said.

The US is working on a similar effort, Appel noted, but “the UK is ahead of us right now.” In the meantime, he writes, instead of focusing on the next drug or the next device for controlling blood pressure, “a renewed and aggressive emphasis on lifestyle modification, specifically sodium reduction, is warranted in patients with resistant hypertension and uncontrolled blood pressure.”

People should pay particular attention to the sodium content of breads and cereals, Appel said. Even though individual products aren’t excessively high in sodium, he added, because people tend to eat a lot of these products, they can add up.

For the population at large, He said, the advice is clear: stop adding salt during cooking, stop adding salt at the table, and pay attention to food labels. Most important, according to He, is cooperation from the food industry in gradually lowering the amount of salt added to foods over time. “That would make it actually much easier for the general public.”

SOURCE: Hypertension, September 2009.

Technorati Tags: blood pressure medications, high blood pressure, Hypertension, sodium, systolic blood pressure

LOS ANGELES (AFP) – Michael Jackson’s death has lifted a veil on the sinister underbelly of fame, with associates of the pop icon hitting out at celebrity-dazzled doctors who funnel powerful narcotics to the stars.

Jackson, who died Thursday aged 50 after collapsing at his home in Beverly Hills, had a long history of prescription drug use, stretching back to 1993 when allegations of child abuse were leveled against him.

Reports that Jackson had been injected with a powerful painkiller by a personal physician shortly before his death triggered speculation that the star had a ready supply of prescription medications.

According to Jackson’s close friend and confidante, new age guru and trained cardiologist Deepak Chopra, the entertainment world is rife with doctors who trade their access to drugs for celebrity.

“There’s a plethora of doctors in Hollywood that are drug peddlers, they are drug pushers,” Chopra told CNN. “They just happen to have a medical license.”

Chopra spoke of a “huge problem” Hollywood had with “celebrity doctors who not only initiate people into the drug experience but then they perpetuate it so that people become dependent on them.

“I think this is something that really should be investigated because it’s a disease,” Chopra added.

“The number-one cause of drug addiction in the world, and particularly in the United States, is not street drugs but medical prescriptions given legally by physicians.”

The fatal alliance of drugs and celebrity has been one of Hollywood’s longest-running narratives, whether the decades-long addiction battle fought by Judy Garland before her death in 1969 aged 47 or recent cases, such as the accidental overdose of Australian actor Heath Ledger in New York in 2008.

The circumstances surrounding Jackson’s demise have meanwhile evoked eerie comparisons with the 2007 death of former Playboy model Anna Nicole Smith.

Smith died of an accidental drug overdose in a hotel in Florida. An autopsy subsequently found a lethal cocktail of several prescription drugs in her body.

Her boyfriend and two doctors are currently facing trial in California, accused of conspiring to provide the platinum blonde sex symbol with prescription drugs.

“These individuals repeatedly and excessively furnished thousands of prescription pills to Anna Nicole Smith, often for no legitimate medical purpose,” California Attorney General Edmund Brown said in March.

The US Drug Enforcement Administration on Friday renewed concerns about rising deaths from misuse of prescription pills.

“Diversion and abuse of prescription drugs are a threat to our public health and safety similar to the threat posed by illicit drugs such as heroin and cocaine,” said Gil Kerlikowske, director of national drug control policy.

Chopra meanwhile revealed he first had an inkling Jackson was receiving drugs from multiple sources following his 2005 acquittal on child-sex charges when the star had stayed at his home.

“At one point, he started asking me for a prescription. He knew I was a physician. I had a license. He asked me for a prescription for a narcotic. And I said what the heck do you want a narcotic prescription for?” Chopra said.

“It suddenly dawned on me that he was already taking these and that he had probably a number of doctors who were giving him these prescriptions.”

Chopra’s concerns appeared to be supported by the former nanny of Jackson’s three children, Grace Rwaramba, who was quoted in British newspapers on Sunday as saying she regularly had to pump the star’s stomach.

The star was addicted to narcotic painkillers, she said in comments reported by The Sunday Times.

“I had to pump his stomach many times. He always mixed so much of it,” said Rwaramba, 42.

“There was one period that it was so bad that I didn’t let the children see him… He always ate too little and mixed too much.”

Technorati Tags: celebrity doctors, drug addiction, medical prescriptions, painkillers, prescription drug, prescription drugs, prescription pills

I’m the first to admire the strengths and virtues of the free-enterprise model as it applies to drug development and sales. This model encourages drug companies to employ talented people and to take risks in developing new drugs for serious medical problems. But let’s face it, current practices also produce undesirable effects.

1. When their drug that was wonderful last month is suddenly no good.

It’s been entertaining to watch the drug companies suddenly come up with new, patentable variations of their drugs just when their old patents are expiring. For example, since the 1970s, the Abbott company has been doing a dance with different formulations of valproic acid (used for seizures, migraines and bipolar disorder). At first, the brand name was Depakene, but when that patent ran out, Depakene was suddenly no good any more, and Depakote (just barely different enough to be patentable) was the only drug one should think of. Then when Depakote’s patent ran out, suddenly it wasn’t any good, either. Now Depakote ER (extended release) is the only way to fly.

This approach of reworking the old drug into longer-acting formats has worked for other drug companies, too. For example, GlaxoSmithKline has gone through the same dance with their formulations of bupropion for depression, evolving from Wellbutrin to Wellbutrin SR (sustained release) to Wellbutrin XL (extended release). Wyeth, seeing a good thing, followed the same path with venlafaxine antidepressant, going from Effexor to Effexor XR (extended release). It’s just an amazing coincidence how these new, suddenly-better drugs emerge just when the old drugs expire and face generic competition.

2. When they make us forget that the older drugs work just fine.

Since 1954 we’ve had effective anti-psychotic drugs to treat schizophrenia, but beginning in the 1990s a series of new anti-psychotics emerged, now called the “atypical” or “novel” anti-psychotics. Suddenly, the older drugs — all generic and therefore reasonably priced — were no good. Only the new, patented anti-psychotics were any good and one might even be guilty of malpractice if one prescribed an older drug (or continued prescribing one to a patient who seemed to be doing fine). Indeed, a generation of new psychiatrists cycled through training programs with this concept in mind, rarely writing a prescription for an older drug.

The alleged superiority of the newer drugs was tested in the recently completed CATIE (Clinical Antipsychotic Trials in Intervention Effectiveness) study and found to be absent. The study compared four newer drugs to an older drug, perphenazine, and the differences in outcome were minimal to none.

3. When they hook us on samples.

Doctors’ offices receive samples of patented (high mark-up) drugs and not of unpatented (low mark-up) drugs. Therefore, patients are steered toward the expensive drugs by means of these “loss-leaders.”

4. When they draw attention away from non-medication treatments.

Drug companies sell drugs. Therefore, when it comes to marketing their products, they have no interest in promoting — or even mentioning — non-drug treatments. There are no salespeople making the rounds of doctors’ offices to remind physicians of the rigorously proved benefits of stress management training for migraine and tension-type headaches, or of cognitive-behavioral counseling for depression.

5. When the sales reps push unapproved uses.

Recently, a Pfizer sales rep told me that his company’s drug, pregabalin, is effective in preventing migraine. He shouldn’t have said that. Pregabalin is FDA-approved for treatment of epilepsy and nerve-pain, but not migraine. Although physicians in the U.S. are allowed to prescribe drugs for “off-label” uses, drug companies are prohibited from advertising their drugs for non-approved uses. In fact, Pfizer got in trouble for pushing another drug, gabapentin, for unapproved uses.

6. When they shape medical practice.

Drug companies aggressively court the thought-leaders, like faculty members at medical schools, with financial perks such as impressive fees for speaking engagements. They also subsidize medical publications. The effects of these marketing activities on medical practice are not necessarily beneficial to patients.

For example, tissue plasminogen activator (tPA) is an expensive clot-dissolving drug approved for use in stroke patients. Its benefits are modest and its risks are real (brain hemorrhage and death). Thoughtful clinicians might reasonably conclude that the benefits of administering tPA do not outweigh the risks. But this is not the message that comes from many thought-leaders and publications. Instead, the implication is that administering this drug is a standard of care, and omitting it constitutes malpractice.

7. When doctors don’t think critically about what they’re doing.

This, strictly speaking, isn’t a deficiency of the drug companies. But because the only salespeople that doctors see are for expensive, branded drugs, the names of less expensive (or more effective) alternatives may not come to mind when prescriptions are written.

Technorati Tags: drug development, drug development companies, drug sales, drugs medical problems, new drug development, new drugs development