The pharmaceutical industry has historically been a highly profitable business. Investors expect a big return on investment. Since 2000 the price increases for prescription drugs have far outpaced the cost of other consumer goods.
A Wall Street Journal article (April 15, 2009) noted that “The prices of a dozen top-selling drugs increased by double digits in the first quarter [of 2009] from a year earlier.”
This happened in the middle of the worst economic downturn in decades, when prices for other essentials remained flat or actually decreased.
In 2015 the Wall Street Journal (Oct. 5) noted that between 2010 and 2014 wholesale drug prices for 30 medications increased 76% over that five-year stretch: “That was more than eight times general inflation.”
Even when sales of a particular drug slow down, companies are likely to raise prices to keep profitability up. That is especially true when there is generic drug competition. As you can see in the table at the right, the “rules” of capitalism do not apply to the pharmaceutical industry. When a brand name drug loses its patent and has to compete with a generic drug, the company raises rather than lowers the price. Since insurance companies won’t pay, the patient is left holding the bag.
Pharmaceuticals used to be one of the best deals in medicine. Prices rarely rose from one year to the next. Some years they even dropped. Almost everyone looked on the pharmaceutical industry with respect because antibiotics, blood pressure medications, and epilepsy drugs saved lives at an affordable cost.
All that began to change in the 1980s. Prices started climbing, slowly at first and then much more rapidly. Companies began bumping prices every few months instead of once a year or less. Increases often outpaced inflation.
Once we hit the 21st century, the pharmaceutical industry lost any sense of shame. Prices began skyrocketing. Many of these medications have been on the market for decades (Premarin has been sold since 1942; Valium since 1963). If other consumer products followed big Pharma’s example, a car sold in 1975 at an average price of $5,000 might now cost as much as $500,000.
We’ve been tracking the costs of medications for 40 years. Here are a few examples of popular prescription medications.
* Prices are for 100 pills, from major drug chain stores
Drug* | 1975 | 1995 | 2015 |
---|---|---|---|
Coumadin (10 mg) | $9.40 | $86.19 | $346.61 |
Dyazide | $9.25 | $16.20 | $258.87 |
Lanoxin (0.25 mg) | $1.00 | $8.59 | $850.99 |
Lasix (40 mg) | $9.73 | $19.99 | $107.99 |
Premarin (1.25 mg) | $6.90 | $46.89 | $501.99 |
Valium (5 mg) | $8.99 | $62.29 | $546.99 |
When the Orphan Drug Act was passed by Congress in 1983, it was supposed to encourage drug companies to develop medicines most people assumed would not be profitable. That’s because such drugs treat rare diseases that affect a relatively small number of people. In fact the FDA initially referred to these medications as “significant drugs of limited commercial value.”
In those days, drug companies could not have imagined charging hundreds of dollars for a course of treatment, much less hundreds of thousands. The assumption was that the American public wouldn’t stand for price gouging. An executive within the pharmaceutical industry told us decades ago that if a cure for cancer were developed the company would have to virtually give it away. Otherwise drug company greed would be the undoing of the industry. Other Pharma execs were in agreement, but that was a long time ago.
Congress created incentives so companies would invest in rare diseases for which they might not break even. The government offered big tax breaks and in some cases subsidized clinical research. Patent and market exclusivity were also added bonuses for orphan drug development. One would have imagined that drug companies might have reciprocated by keeping prices affordable.
Sadly, the original intent of the humanitarian orphan drug initiative has been undermined by drug company greed. Major brand name manufacturers discovered that they could charge whatever they wanted and the public would not complain. When the hepatitis C drug Sovaldi was first marketed, the price was $1,000 a day. A full course of treatment requires 12 weeks of daily dosing. New melanoma drugs cost unimaginable amounts: treatment with Yervoy (ipilimumab) can run nearly $120,000 while a competitor, Keytruda (pembrolizumab), approaches $150,000 a year. The FDA has just approved the use of Yervoy and another immunotherapy drug called Opdivo (nivolumab) together to treat metastatic melanoma. This combination is substantially better than either drug alone. Opdivo costs roughly $150,000 a year. A patient receiving both Opdivo and Yervoy could face a bill of $270,000 a year. Even if insurance would cover this combination, the copay could be overwhelming.
Imagine if drug companies actually developed a real breakthrough drug against Alzheimer’s disease. If they charged $150,000 a year per patient (a real possibility) the economy might collapse.
Are drug companies killing the geese that lay their golden eggs?
In this ancient fable, a farmer and his wife discover that their goose is laying golden eggs. They become so greedy that they slaughter the goose hoping to retrieve the big lump of gold that they assume must be inside her. Instead, they find nothing special. Killing the goose meant no more golden eggs. Drug companies may soon discover that their pricing policies are unsustainable.
One example of drug company greed grabbed headlines because it was so shameless. A 62-year-old drug called pyrimethamine (Daraprim) is used to treat a potentially life-threatening parasitic infection called toxoplasmosis that can affect cancer and AIDS patients.
This medicine was originally developed by an acquaintance of ours, Gertrude Elion. She was working for the drug company Burroughs Wellcome at the time. Trudy went on to win the Nobel Prize for her many amazing drug discoveries. She would be turning over in her grave to know what has happened to the compound she developed for treating malaria and the parasite Toxoplasma gondii.
Rights to this very old medication were acquired in August, 2015, by the startup firm Turing Pharmaceuticals. The price shot up from a fairly high $13.50 per tablet to $750 per pill shortly after the drug was acquired by the new company. That brought the cost of treating a case of toxoplasmosis to as much as $73,500, an increase of more than 5,000 percent almost overnight.
This case stood out because the cost of manufacturing is low, estimated at less than $1 a pill. After all, this drug has been around for more than 60 years. Its research and development costs were amortized decades ago. There was no justifiable reason to hike the price so much. Imagine a cup of coffee going from $2.50 to $125 a cup overnight. No one would stand for it.
The media attention and public outcry were so great that eventually the company announced it would “modestly lower” the price for Daraprim, perhaps by 10%. Once the media outcry died down, however, the company decided not to lower the price after all.
Pyrimethamine isn’t the only old drug to have its price boosted suddenly. A medicine for tuberculosis called cycloserine jumped over 2,000 percent almost overnight. This medication was first marketed in 1955. More recently, the price went from $15 a pill to $360. The drug is used to treat a rare form of multi-drug resistant TB that could pose a public health hazard if not controlled.
Because outraged physicians spoke up, the deal that gave Rodelis Therapeutics rights to the drug were reversed. The nonprofit that now owns the license to cycloserine will reportedly “only” charge $35 per capsule.
Turing isn’t the only company to acquire old drugs and then dramatically boost prices. Valeant Pharmaceuticals also jacked up drug prices on some old pharmaceutical products. Isoproterenol (Isuprel) is a very old drug that is crucial for certain kinds of life-threatening heart rhythm problems. It is also essential when a patient develops serious breathing problems during general anesthesia. According to the Wall Street Journal, Valeant increased the price of Isuprel by 525 percent to $1,347 a vial.
Time magazine (May 30, 2016) noted that Valeant “would buy patents for unique, lifesaving drugs, hike their prices and then watch the profits roll in.” Over a dozen other drug companies “had made similar price hikes in recent years. The difference is in degree. While Valeant doubled and tripled the prices of its new drugs overnight, other drugmakers have arrived at similar results but with smaller price hikes, imposed over longer periods of time. Last year, drugmakers increased the prices of their brand-name drugs in the U.S. by an average of 16.2%…” That is way over inflation.
An article in JAMA Dermatology (Feb., 2016) documented price changes for dermatologic drugs between 2009 and 2015. During this time the authors report that the consumer price index inflation rate was 11%. They note that the cost for 50 capsules of Valeant’s psoriasis drug Oxsoralen-Ultra went from $1,227.32 in 2009 to $5,204.31 in 2015 (a 424% increase). During the same time, Valeant’s Targretin gel, for cutaneous T-cell lymphoma, reportedly went from $1,686.78 a tube to $30,320.12 a tube. Patients with this cancer may need more than a tube a month.
A rare genetic condition called Gaucher disease causes untold suffering. Without treatment, patients develop cognitive impairment, seizures, broken bones and many other life-threatening complications.
Because it is an uncommon condition, any medicine developed for Gaucher disease is by definition an orphan drug. A biotech drug that can help control this disorder, Cerdelga, has been reported to cost over $300,000 a year.
If the medication allows a patient with Gaucher to have a decent quality of life for 20 or 30 years the cost could exceed $5 million for an orphan drug.
Perhaps you are asking the question, “why should I care? No one I know has Gaucher disease. I’m not taking Daraprim, Keytruda, Opdivo, Targretin or doxycycline.“
You should care because someday you may need a cutting edge cancer drug that could cost $150,000 a year. Right now, your insurance premiums are probably going up, in part because of sky-high drug prices. This affects every American right now!
What We Spend on Rx Drugs
Americans spend more on prescription medications than any other country in the world. According to an article published in Consumer Reports titled “Is There A Cure for High Drug Prices?” (August, 2016):
“America spends a tremendous amount of money for prescription drugs—$424 billion last year alone before discounts…”
A Wall Street Journal article titled “Why the U.S. Pays More Than Other Countries for Drugs” (Dec 1, 2015) points out:
“Drug prices in the U.S. are shrouded in mystery, obscured by confidential rebates, multiple middlemen and the strict guarding of trade secrets.”
Other countries arm wrestle drug companies over prices. In the U.S. drug companies charge whatever they want.
Once upon a time most generic medications sold in the U.S. were made in the U.S. Unannounced visits by FDA inspectors were relatively easy to carry out because the agency had boots on the ground and everyone spoke English.
Now, the overwhelming majority of the ingredients in generic drugs (over 80%) are made in foreign countries like Thailand, Turkey, Brazil, Mexico, Bangladesh, Slovakia, China and India. Inspections of these foreign plants are far less frequent than in the U.S. and the FDA must announce that it is coming well in advance, especially in countries like India and China.
Just about the time we began hearing from substantial numbers of patients that they were having problems with their generic drugs, India and China were becoming key suppliers to the U.S. generic drug market.
There is simply no way for the agency to inspect all the plants in China, India, and elsewhere that are producing medications that land on American drugstore shelves.
For more than 25 years we were among the country’s most enthusiastic supporters of generic drugs. After all, the difference in price between some brand name products and their generic equivalents is almost unbelievable. At the time of this writing the beta blocker heart medicine Coreg (12.5 mg) costs over $350 for a 90-day supply at a chain pharmacy. The generic carvedilol costs $10 for the same amount at a big-box discount drug store.
A three-month supply of the anti-anxiety agent Valium will cost you close to $500 in some pharmacies. The same amount of the generic diazepam will run around $10 at a discount drug store. A related drug, Ativan, would cost around $2,500 for a month’s supply, while the generic lorazepam costs between $10 and $12.
Why wouldn’t we love generic drugs? Insurance companies do! It saves them tons of money. All big payers embrace generic drugs, from the government (think the Department of Veterans Affairs, Medicare and Medicaid) to big businesses that provide health coverage to employees. Even the FDA loves generic drugs. Here’s what this watchdog agency has to say:
“FACT: When it comes to price, there is a big difference between generic and brand name drugs. On average, the cost of a generic drug is 80 to 85 percent lower than the brand name product.
In 2010 alone, the use of FDA-approved generics saved $158 billion, an average of $3 billion every week.”
Historically, generic drugs have been a bargain. And you can still buy hundreds of generic drugs at bargain basement prices in discount drugstores. But the few examples we have shared demonstrate that just because a drug has lost its patent does not mean it will be inexpensive. We are not prepared to say there has been collusion among generic drug manufacturers, but recent price hikes are hard to explain.
Even some common generic drugs have increased dramatically in price in recent years. Take the antibiotic doxycycline, for example. It was first approved under the brand name Vibramycin in 1967. This broad-spectrum tetracycline-type drug has been used for decades to treat a wide range of infections, from chlamydia and cholera to Lyme disease and Rocky Mountain Spotted Fever. Doctors also use it for urinary and respiratory tract infections.
Doxycycline used to be dirt cheap. One analysis from Pembroke Consulting (reported in the Star-Telegram) found that the price of this antibiotic has gone from $.06 per pill to $3.65. That is an increase of over 6,000 percent in a relatively short period of time. In other words, doxy actually increased more than Daraprim (which went up 5,000 percent). Because the antibiotic was so inexpensive to start with, most people were not outraged by the breathtaking price increase.
The same analysis found that clomipramine, a drug prescribed for obsessive-compulsive disorder, has gone up more than 3,000 percent, from $0.27 per pill to $8.57. According to our research, the price is now more than $10 per pill.
No one has a good explanation for the kinds of price hikes that have occurred in the generic drug marketplace. In theory, capitalism is supposed to prevent this sort of thing thanks to a competitive marketplace. That does not seem to be working.
One explanation is that consolidation within the generic pharmaceutical industry means that fewer companies are making generic medications. Just three companies, Mylan, Teva and Actavis, generated 44 percent of generic drug revenue around the world. If a company has a monopoly on a product it can charge whatever it wants.
If profits aren’t considered substantial for a given drug, a company can stop manufacturing it on a moment’s notice. That has led to potentially life-threatening drug shortages. A number of companies have stopped making certain generic drugs. Decreased supply and increased demand has led to price gouging.
Dozens of large generic drug makers have gotten into trouble with the FDA because of bad manufacturing practices. As a result, some key products from abroad have been banned, contributing to shortages and higher prices. What is puzzling to us is the lack of interest by other generic manufacturers. Why isn’t there a willingness to compete? We hope there isn’t skullduggery going on.
Even when generic drug prices are low, they are not always a deal.
Like everyone else, we had accepted the FDA’s assertion that generic drugs were “identical” to their brand name counterparts. We were told that the FDA had stringent guidelines and that generic manufacturers had to prove that their “copycat” products were absorbed into the body at the same rate and to the same extent as the originator compound. This was supposed to guarantee that the generic drug was “bioequivalent” to the brand name, ie, absolutely equal but just a lot less expensive.
We believed what we were told and did not question the FDA’s ability to approve generic drugs and monitor the manufacturing of such products. We assumed that the FDA knew what it was doing even though the process was and remains surprisingly secretive. Most health professionals–doctors, pharmacists and nurses–also believe that the FDA has perfected its oversight of generic drug approvals and quality control.
Drug buyers at wholesalers, hospitals, large health systems, nursing homes, chain drugs stores and mom and pop pharmacies are delighted to take the FDA’s word that it has everything under control. But the data the FDA relies upon and the bioequivalence curves that the generic manufacturers submit are considered “proprietary.” As a result, no one but the FDA can see and interpret the results of the tests. Most pharmaceutical purchasers for health systems, nursing homes, and the like are happy to take the FDA’s word that the system is working perfectly. We think everyone should see the data!
After promoting generic drugs and defending the FDA for decades, we began to question the agency’s oversight by the late 1990s. In increasing numbers, readers of our syndicated newspaper column began reporting problems with generic drugs. At first we didn’t believe them. We accepted the FDA argument that people just imagined that their generic medications weren’t working, either because they were less expensive or had a different color. But eventually the reports convinced us there was a problem.
As the FDA began increasing the number of inspectors it had in India from a handful to over a dozen, problems in manufacturing began emerging. Over the last several years the FDA has banned products from 44 different Indian drug-making facilities.
Among the companies that ran into trouble with the FDA were some of the largest generic manufacturers in India such as Sun Pharmaceutical Industries, Dr. Reddy’s Laboratories, Wockhardt, Aurobindo and Ranbaxy. Other companies that have faced FDA challenges include Zydus, Cadila, Amsal Chem, RPG, Kamud Drugs, Post Chemicals and Yag Mag Labs.
Indian drug firms have been accused of deleting unfavorable data, faking test results and improper manufacturing procedures. One company, Ranbaxy Laboratories, pleaded guilty to felony charges after being accused of falsifying data. The company paid $500 million in fines.
Chinese drug companies have also come under fire. In some cases there were violations of good manufacturing practices. In others there were “data integrity problems.” Can we trust foreign manufacturers? Can the FDA guarantee quality? We have our doubts.
On May 18, 1998, we published this account in our column:
“I have been treated for hypothyroidism for over thirty years, and have been on Synthroid 0.125 mg for the past ten. This year my doctor wrote the prescription for a generic at the same dose.
“By the fourth day on the generic, I felt as though I was on the end of a tightly coiled spring. I couldn’t sleep; I had a slight case of diarrhea; I was sweating more than usual and my heart felt as though it would pound out of my chest. “When I finally realized all this might be due to the change in medication, I had the pharmacist give me Synthroid instead. Almost immediately I calmed down, my heart stopped pounding so hard and I was back to my normal self. Why should this drug have affected me so?”
Another reader reported:
“My mother was switched from Lasix to a generic furosemide for heart failure. Her feet started to swell and she had trouble breathing. As soon as we got her back on Lasix she got better.”
In the first case, it was apparent that the generic was supplying way too much active drug, leading to classic symptoms of hyperthyroidism. In the second case, the generic form of the diuretic furosemide did not appear to be supplying enough medicine. For a patient with heart failure this could be a life-threatening situation.
The more we shared such stories with our readers, the more we heard of other generic drug problems. People with epilepsy who were well controlled on brand name medication reported breakthrough seizures shortly after being switched to a generic form.
A mother told us that her son’s ADHD symptoms were well controlled on Ritalin. When she sent him off to school on the generic methylphenidate he would have a bad day. The teacher, who didn’t know about the switch, complained about his behavior and the mom could see for herself that the generic formulation was not helping his attention span or controlling his hyperactivity adequately. Such stories made us wonder what could be going on. The more we searched for answers the more concerned we became.
I need more information about the generic for the epilepsy drug Keppra. I understand that the generic is relatively new. Is it safe to take, and does it have the same active ingredient as Keppra?
Generic drugs are supposed to be identical to their brand name counterparts. We have received troubling reports about this generic epilepsy medicine (levetiracetam), however. One reader wrote,
“I take Keppra and recently I was switched to a generic version. Several days after I began taking the generic pills, I suffered multiple seizures. I had to go back on name-brand Keppra.”
When we asked the FDA about this problem, we were told that the generic formulation was unlikely to be responsible for seizures. Despite this reassurance from the FDA we have continued to receive numerous complaints about generic levetiracetam.
We consider this a potentially life-threatening problem. If someone has a seizure while driving or operating machinery it could be a disaster. We do not understand why the FDA has not taken these concerns more seriously.
We upset the entire FDA apple cart when we discovered that the FDA mistakenly approved a generic bupropion version of the antidepressant Wellbutrin XL 300. Shortly after Budeprion XL 300 became available at the end of 2006, we started hearing complaints from readers. [The distributor of this drug (Teva) decided to give its generic formula of bupropion a special name, hence the “branded generic” Budeprion. It was the first long-acting 300 mg generic version of Wellbutrin XL 300, a billion dollar antidepressant.]
Hundreds of people eventually reported that they were experiencing side effects from this bupropion formulation (headaches, sleep disturbances, anxiety, agitation, nausea, crying attacks, tremors, etc.). Despair and depression returned and some people became suicidal, like this reader:
“The pharmacy gave me Budeprion instead of brand name Wellbutrin. I steadily deteriorated into a suicidal crisis. I had never been suicidal before! My therapist gave me a new prescription for Wellbutrin and within a week, I was better.”
What made stories like this one especially convincing—and disturbing—was the frequency with which people who reported them insisted that even in their darkest days of depression, they had never had thoughts of killing themselves before being switched over to the generic for Wellbutrin. Upon resuming the brand medication, they felt fine again, and the suicidal thoughts disappeared.
Those Wellbutrin stories scared us, and we bombarded the FDA with them starting in early 2007. We also published a report with ConsumerLab.com to draw attention to the problem. The FDA pretty much dismissed our concerns, reverting to the old “it’s all in their heads” argument. For five long years we badgered the agency until finally the FDA admitted that Budeprion XL 300 was not bioequivalent and asked the manufacturer to remove this generic drug from the market. Read the whole sad story at this link.
The FDA would like the public to believe that this was a simple mistake. What it revealed to us, however, was that the entire FDA generic drug approval process is suspect. The FDA does not actually assess rate of drug absorption over time as required by law. We think it violates the generic drug bioequivalence legislation.
Health professionals and insurance companies that insist generic drugs are “identical” to their brand name equivalents take the FDA’s word for it. What we discovered, however, is that the FDA has violated its own guidelines for decades.
For as long as we can remember, the FDA defined bioequivalence between a generic knock-off and the brand name drug as having the “same rate and extent of absorption.” That is what officials in FDA’s Office of Generic Drugs have been saying for a very long time (AAPS J, March 5, 2008).
The reality, however, is that the FDA wasn’t paying much attention to “rate.” Instead of comparing hour by hour absorption, the agency looked at one number, the maximum blood concentration known as C-Max. Most health professionals are clueless about this mysterious FDA generic drug approval process.
There were other signs of problems with generic drugs that were difficult for the FDA and the public to ignore. There was a huge scare from January 2007 to May 2008 involving the blood thinner heparin. The FDA reported hundreds of allergic reactions and deaths linked to impure heparin. The raw ingredients for heparin come from pig intestines often processed in factories in China.
Investigations revealed that some plants were processing heparin as a sideline to their sausage-casing business. These firms weren’t registered as pharmaceutical companies and were exempt from regulation by the Chinese equivalent of the FDA. This led to dangerous practices by some of the companies producing heparin, and many people got sick as a result. To this day we have not seen a clear explanation regarding who was responsible for this disaster and how it could be prevented in the future.
The same motivation to keep costs down drove pet food manufacturers to buy wheat gluten contaminated with melamine from China. Adulterated Chinese baby formula, which is illegal in the U.S., has led to the tragic deaths of many Chinese infants.
The generic drug market is also a cutthroat business. Because large buyers are told that all FDA approved generics are acceptable, the only factor they need to consider is price. Foreign manufacturers must deliver the lowest cost products in order to compete successfully in the U.S. marketplace. That has apparently led to some shady practices that have compromised quality.
Because the FDA relies entirely on data submitted by generic drug companies, it has no good way of telling whether someone cooked the books. Over the last decade there have been examples of testing companies that have done just that. One in the United States, Cetero, falsified clinical trial data on a number of generic drugs. The largest clinical research organization in India, GVK Biosciences, also got into trouble testing generic drugs in human subjects. The European Medicines Agency accused the company of faking data on roughly 700 different generic drugs from dozens of generic drug companies over a five-year period. Hundreds of generic drugs were banned. Although we think the FDA relied on GVK data to approve Indian generic drugs, the agency has been very secretive about which drugs might have been affected. In many cases the FDA seems more concerned about secrecy than truth.
Despite the problems that some people have reported in using generic drugs, these low-cost alternatives are still one of the best ways to save money and many people use them without trouble.
Here is a summary of why we have lost confidence in the FDA’s ability to guarantee the quality of generic drugs in America.
1) The FDA’s approval process does not really measure “rate of absorption” between brand and generic drugs over time. We see this as a fundamental flaw in the FDA’s system and a violation of the law.
2) Some clinical testing organizations in the U.S. and abroad have been caught fudging data that was used in generic drug applications to the FDA. Inspectors from the agency have missed important clues. Whistleblowers revealed the problems after FDA inspectors gave the companies a clean bill of health. This undermines our confidence in the FDA’s ability to catch serious problems.
3) Manufacturing facilities in China, India and other foreign countries have repeatedly been found in violation of good manufacturing practices. In numerous cases, monitoring data has been mishandled, deleted or falsified.
4) The FDA relies largely on the honor system. It does very little testing of its own but relies on electronic or paper submissions from generic drug companies. If data is faked, the FDA has a hard time uncovering it. Whistleblowers are few and far between.
5) The FDA is secretive in its handling of generic drug data. Health professionals and patients do not have access to bioequivalence curves, so we must take the FDA’s word for its generic drug approvals. Even when foreign manufacturers are found in violation and their products are banned from U.S. pharmacies we are rarely told which drugs are under suspicion and should be avoided.
6) The FDA’s system for collecting complaints about generic drugs is flawed. The FDA allows people to submit complaints at its MedWatch website. There are problems, however. The FDA requires a complaint to specify the manufacturer/labeler, but pharmacies may not always put this information on the drug label. If they do, it is often in hard-to-read tiny print. The expiration date is also required, but pharmacists almost never put the actual expiration date on the label. Lot number is also required, but again, your generic drug label rarely, if ever, comes with a lot number. The NDC# must be included but most people have no idea what that is.
Generic | Brand |
---|---|
amiodarone | Cordarone |
carbamazepine | Tegretol |
clindamycin | Cleocin |
clonidine | Catapres |
cyclosporine | Sandimmune |
digoxin | Lanoxin |
divalproex | Depakote |
ethosuximide | Zarontin |
isoproterenol | Isuprel |
levothyroxine | Levothroid, Levoxyl, Synthroid |
lithium | Eskalith |
phenytoin | Dilantin |
prazosin | Minipress |
primidone | Mysoline |
procainamide | Pronestyl |
quinidine gluconate | Quinaglute |
quinidine sulfate | Quinidex |
theophylline | Theo-24, Theolair, Uniphyl |
valproic acid | Depakene |
warfarin | Coumadin, Jantoven |
This list of Narrow Therapeutic Index (NTI) drugs is more comprehensive than many, but there are dozens of other drugs that could be added. We recommend using the brands for these drugs when possible. If you must use a generic form, try to stick with one manufacturer. Monitor your reactions carefully, and report anything unusual to your doctor immediately.
Slight variability in the way a drug is released in your body may not be a really big deal with some medications. For example, if you are taking diazepam (Valium) for anxiety, getting a bit more or less over six hours is not likely to make much of a difference to your wellbeing. Ditto for ibuprofen. Doctors sometimes prescribe this pain reliever in doses ranging from 300 to 800 mg three or four times a day up to a total of 3200 mg. That is such a wide dosing schedule that a modest variation in absorption should not have a great impact on health.
But there are some medications with a Narrow Therapeutic Index (NTI), which means that the difference between an effective dose and a toxic dose is very small. If you are taking a NTI drug (see list at left), we advise you to consider shelling out for the brand version. If that is impossible, then try to stick to a generic formulation that seems to work well for you, and keep careful track of your reactions. Monitor your side effects and subjective responses, but also keep careful records of your lab results and your numbers (blood pressure, blood sugar, etc., depending on what medication you’re taking).
We understand that buying a brand name is not an option in many cases. Seniors especially have been slammed by the high cost of prescription drugs. Insurance companies often offer incentives for generics and disincentives for brand. They might not pay for them at all. You will need to enlist your physician as an ally. Doctors understand the importance of dosing and absorption for NTI drugs. Neurologists and cardiologists know that too much or too little medicine can mean the difference between life and death.
“I’m an RN working full time in a Coumadin clinic. We monitor and adjust the blood thinner Coumadin for over 3,000 patients and I can assure you generics make a difference. We had patients who had been in target range literally for years as long as they were on Coumadin. When they started taking generic warfarin we found they needed 20 to 30 percent more drug and were much harder to keep in range. Those who went back to Coumadin went right back on their previous dose and stayed in target. Generics may be ‘equivalent’ but in a drug with a narrow therapeutic index they sure are not equal.”
We have received hundreds of complaints about generic formulations of Celebrex (celecoxib). John in California wrote:
“I’ve been taking Celebrex for arthritis in my spine for years. Upon switching to generic celecoxib pain relief disappeared and I have been in agony ever since.”
Another reader shared a solution:
“You wrote about someone whose insurance refused to pay for Celebrex and was switched to the generic celecoxib. The person had begun to experience swollen joints and the other symptoms Celebrex treats.
“I had the same reaction when I got switched but had read in your column about others with the same problem. I talked to my pharmacist, who said it was the most common complaint he heard but that there was a solution.
“He said to ask specifically for celecoxib made by Greenstone. It is identical to Celebrex and is manufactured by the same company. Because it is a generic, insurance will pay for it and most pharmacies will order it for you every month.
“Within a week I was able to use my hands again. They had gotten so bad I could not even grip my steering wheel. I’m back to doing the things I enjoy.”
The following list contains the authorized generic drug name followed by the brand name inside the parenthesis followed by the manufacturer inside brackets. With this information your pharmacist should be able to locate the precise authorized generic drug that you seek.
To give you some idea of the cost of these brand name drugs, a month’s supply of Lovaza at the time of this writing would be over $500. The asthma drug Singular would be over $250. A tube of MetroGel for acne rosacea would cost $446 and the heart medicine Rythmol SR would be $753. Getting the authorized generics would provide quality assurance at a dramatically lower price.
No doubt we have created a lot of uncertainty about the quality of many generic drugs. This puts many people in a terrible double bind. They cannot afford hundreds of dollars a month for brand name drugs but their insurance company will only allow generics. What to do?
Authorized generics may be a solution to the dilemma of mistrust surrounding some generic drugs. Many physicians, pharmacists and patients are unaware that this option exists. The brand name manufacturer makes a deal with a specific generic company to supply its drug directly or provides the generic maker with exact instructions on how to duplicate the brand name product.
Although the FDA says that all generic drugs are identical to the brand name, that is not accurate if by identical they mean exactly the same. Generic drug companies can use different excipients (the compounds that give the pill color, strength and texture). The generic manufacturer may also have to come up with a completely different drug delivery system (the Budeprion XL 300 debacle).
No one else has access to the precise process of manufacture or the origins of both the active and so-called inactive ingredients. The delivery system (the way the brand name drug releases its active ingredients) may remain under patent by the originator company. An authorized generic is theoretically made on the same production line with the same release technology or in a facility that is allowed to use the process exactly as it was developed by the brand name company. The cost, however, is far less than the original brand name drug. In practice, the authorized generic is usually made by the original brand-name manufacturer although it may be sold by a generic drug firm through a licensing arrangement.
In the story on the left you will read about Celebrex and some problems people have reported with the generic formulation celecoxib. The generic manufacturer Greenstone is a subsidiary of the drug giant Pfizer. It is hardly any wonder that Pfizer, the maker of Celebrex, would provide its own company the right to market an authorized generic.
The FDA probably has mixed feelings about authorized generics. That’s because the agency asserts that all FDA-approved generic drugs are identical to their brand name counterparts. Admitting that there might be special generic drugs that are sanctioned by the brand name manufacturer and may be made on the same production line using identical ingredients might undermine confidence in other generic products, something the FDA is loathe to do.
That said, the FDA has a web page devoted to authorized generic drugs. The agency is required by law to list “all authorized generic drugs, including (1) the drug trade name, (2) the brand company manufacturer, and (3) the date the authorized generic drug entered the market.”
Sadly, the feds don’t tell you the company that is actually making the specific authorized generic drug for your brand name medicine. Leave it to the FDA to omit this critical piece of information. This is a huge flaw in the authorized generic system.
Until the FDA solves its generic drug problems, patients may wish to ask their pharmacist for an authorized generic. Do not assume your pharmacist will know what an authorized generic drug actually is. You may need to print this article and take it with you to the pharmacy. When such an alternative exists, it may be worth paying a bit more for the extra reassurance such a designation provides. Generic drug companies that specialize in authorized generics include Greenstone, Par Pharmaceuticals, Patriot Pharmaceuticals and Prasco. We cannot guarantee that all the generic products listed in the catalogs of these companies are made on the same production line as the brand name company, but if they are selling a truly authorized generic it should have the identical active and inactive ingredients and a similar formulation.
You may have to pay a bit more for for an authorized generic compared to a standard generic drug. But if it is a higher quality product, it may be worth the extra cost and your insurance company should be happy that it is a generic instead of a really high-priced brand name medicine. Your pharmacist will need to go to bat for you and possibly even special order an authorized generic. That could create challenges in a busy chain pharmacy. You may also need to enlist your physician to insist the insurance company cover your authorized generic. It should be worth the hassle.
Pharmaceuticals are now made all over the world. That includes both brand name products as well as generics. The pills you buy at your local drugstore or get in your mail box could easily have been manufactured in India, Israel or Ireland. That’s why we find it so hypocritical of the Food and Drug Administration and the pharmaceutical industry to warn Americans that drugs purchased outside the United States may not be trustworthy.
If it’s OK for chain stores like CVS, Walgreens and Walmart to buy pills made in India or China, we do not understand why Americans cannot buy brand name medications from Canada that were manufactured in facilities run by Novartis, Pfizer, Roche, Merck or AstraZeneca. That’s right, the FDA fails to mention that many of the medicines Americans are buying from Canadian pharmacies, online or in person, have been manufactured by the same pharmaceutical rms on the same production lines as those sold in the U.S. The really big difference: they cost a lot less in Canada!
Citizens of the United States pay far more for their medicines than the people of any other nation on earth. That’s because drug companies have no constraints here. They can literally charge what they want. A brand name medicine that costs hundreds of dollars a month in the U.S. can be dramatically less in Canada, even if it was made in the same facility.
Take the heart drug Lanoxin (digoxin). This is a narrow therapeutic index (NTI) medicine, which means that the difference between a safe dose and a toxic dose is quite close. There is no room for error with this medicine, which is why some doctors specify the brand rather than the generic. The last time we checked, 100 pills of Lanoxin (0.25 mg) cost over $800 in the U.S. In Canada, the same quantity of Lanoxin (brand, not generic) would be less than a tenth as much (about $75). The blood thinner Coumadin (warfarin) is another NTI drug with little room for variability. In the U.S. the 10 mg brand name product could cost as much as $350 for 100 pills. In Canada the same amount of the brand name Coumadin would be less than a third as much ($97 from one online Canadian pharmacy).
It’s hardly any wonder that U.S. citizens are paying attention to Canadian prices, especially if they have to take outrageously expensive brand name medications. If you travel to Canada to buy your medicines in person, you can verify that a pharmacy is legitimate. But most Americans can’t afford to go to Canada every time they need a refill. Many are relying on the Internet for convenience and affordability. But if consumers aren’t careful, they could end up buying online medicines from Dandong, China, or Mumbai, India, instead of Canada. Just because a website says “Canada” does not guarantee that you will be dealing with a genuine Canadian online pharmacy. There are some precautions you can take to reduce the likelihood that you will be fooled by an organization that is posing as a Canadian pharmacy.
The Canadian International Pharmacy Association (CIPA) is a group of licensed retail pharmacies in Canada (www.cipa.com). The organization recommends the following precautions if you decide to buy your drugs from a Canadian online pharmacy:
The Food and Drug Administration frowns upon the idea of U.S. citizens purchasing medicine from Canada. A former FDA Commissioner, Lester Crawford, went so far as to suggest that buying medications from Canada was tantamount to aiding and abetting terrorism.
Health Canada took a dim view of this argument. As for counterfeit pills, there’s no evidence that tainted drugs are more of a problem in Canada than in the U.S. In fact, one could argue that Health Canada protects its citizens more effectively from counterfeit or substandard drugs than the FDA. That’s because repackaging, which involves putting pills from large bottles into smaller containers, is common in the U.S. but not allowed in Canada. This is one way in which diluted or counterfeit medicines have made their way into the supply stream in the U.S.
Strictly speaking, it is illegal to import prescription drugs into the U.S. from Canada or any other country unless they are unavailable here. That said, neither the FDA nor U.S. Customs is anxious to arrest seniors who are trying to save money on their blood pressure pills. It is possible that a shipment might be held up or refused, so it would be smart not to leave ordering until the last minute.
This online pharmacy states that the medications it sells are “sourced only from Canada.”
https://www.youdrugstore.com
1-855-968-6337
This pharmacy with a brick and mortar home in Vancouver, BC, claims to sell only medications from Canada. Not listed as a member of CIPA
https://www.canadacloudpharmacy.com
1-800-901-0041
DrugMartDirect is CIPA certified and on the PharmacyChecker.com list. It is a “prescription referral service,” referring to pharmacies in Winnipeg, Manitoba, as well as Australia, New Zealand, Singapore and the UK.
https://www.drugmartdirect.com
1-855-402-2022
This Canadian online pharmacy partners with stores in Singapore and Turkey as well as New Zealand and the UK.
https://www.qualityprescriptiondrugs.com/?affiliate=1157
1-877-244-0429
This online Canadian pharmacy gets 5 star consumer ratings from PharmacyChecker.com. It is not CIPA certi ed. It sources drugs from Canada and the UK.
http://www.advpharmacy.com/homepea
1-888-471-4721
This pharmacy based in Winnipeg, Manitoba, has affiliate pharmacies in New Zealand, Singapore and the UK. It is recommended by PharmacyChecker.com and is CIPA certified.
https://www.planetdrugsdirect.com/
1-888-791-3784
PharmacyChecker.com is a United States website that also verifies Canadian pharmacies. We have met the founders (Tod Cooperman, MD and Gabriel Levitt, MA). They have impressed us with their commitment to helping U.S. citizens obtain affordable and reliable medications. Even more helpful than the list of pharmacies are the PharmacyChecker.com price comparisons. You can go to the website, put in your medication and find out how much it will cost from several different Canadian pharmacies.
Take the example of Crestor (rosuvastatin). This cholesterol-lowering drug could cost over $600 for a three-month supply of the 10 mg tablets in the U.S. About the same three-month amount (84 pills) would run around $150 from a Canadian pharmacy. The antipsychotic drug Abilify (5 mg) could cost over $600 for a one month supply. From Canada, Abilify would be less than a third as much.
If you go to PharmacyChecker.com you will discover that many Canadian pharmacies partner with other countries such as Australia, New Zealand, Barbados, United Kingdom and Singapore. According to PharmacyChecker.com, these are legitimate pharmacies shipping brand name medications made in the major manufacturing plants of the originator company. Should you prefer only Canadian products, you can request them from the online Canadian pharmacy, but in some cases the brand name companies have made it hard for the pharmacies to obtain medications for export.
Here are some Canadian online pharmacies that meet both CIPA verification and PharmacyChecker.com standards. We have no horse in this race and no relationship with any company. We make no endorsements and merely list these options for your consideration.
We have received a number of comments from people who have purchased drugs from Canadian pharmacies. Joe in New England wrote:
“During a period of time that I was unemployed Lipitor was $3 a pill in the U.S. The same drug from the same supplier was running $0.75 to $1.00 a pill from a Canadian online drugstore. It even came in the same packaging from Pfizer production facilities in Northern Ireland and the Bahamas. There was NO DIFFERENCE from the American purchased pills.”
Marilyn in Illinois wrote:
“PharmacyChecker.com will tell you the source of your pills, something your local drugstore may not reveal. Ordering my brand name drugs from Canada saved me a bundle. One drug was shipped from Minnesota, as the US facility had a contract to provide pills for the Canadian citizens.
“The DOJ (Department of Justice) has said they will not arrest grandpas [if they buy drugs from Canada].”
Susan in Dallas adds:
“I have been buying ALL my drugs from Canada for 12 years and have saved thousands of dollars. Many of my friends do the same. The pharma companies in the U.S. are making millions of dollars because of their ridiculous prices.”
For many Americans, Canada represents a cost-effective solution to the outrageous cost of brand name drugs in the United States. As long as the pharmacy is legitimate, there is a very good likelihood that medications will arrive in a timely manor. If they are lost or stopped at Customs, most legitimate Canadian pharmacies will make good on the shipment at no extra cost to the consumer.
American patients have had enough. Ann in Florida relates the following experience:
“I was changed from brand name Cymbalta to the generic duloxetine. My depression started coming back. My doctor told my insurance company that the brand name antidepressant was medically necessary but the insurance company still denied it. I appealed the decision but they still denied it.
“My neurologist told me to order from Canada as I could continue to get the brand name Cymbalta at a more affordable price. He faxed a prescription to a reputable online Canadian pharmacy. I now get 90 days of the brand name Cymbalta for less than my co-pay here in the United States.
“It is sad that we have to get our brand name medicine from another country because our insurance won’t pay for it. The prices for brand name medications in the U.S. are ridiculously high. The USA is the only country that allows these high prices for brand name meds. It is shameful that we are forced to take generics that do not work and are not equivalent.”
For patients who do not want to take their chances with a Canadian pharmacy because it is illegal or who cannot get their physicians to fax a prescription to an online Canadian drugstore, there are a number of other strategies for saving money on medicine. First and foremost, let your doctor know you are concerned about price and that you do not necessarily expect a prescription. Some doctors admit that they write prescriptions partly because they think their patients want them. It also serves as a convenient way of ending an office visit. If your doctor says that lifestyle changes could solve a health problem, make those changes. They will be far cheaper and healthier in the long run. Find a health coach who can help you maintain the changes.
Whenever you can, make changes to your lifestyle that may help reduce the number of prescription drugs you need to take. Exercise, weight loss, real food and relaxation techniques are all very effective for helping to reduce blood pressure, cholesterol, anxiety, depression, and insomnia.
Consider non-drug alternatives such as home remedies and dietary supplements. You may find that vinegar and Listerine soaks or topical Vicks VapoRub are as good for fighting toenail fungus as prescription Jublia, with the added virtue of being much cheaper. Coconut water, almonds, chewing gum, fennel, yellow mustard or DGL (deglycyrrhizinated licorice) may ease heartburn without the cost or side effects of PPI drugs.
Talk to your doctor and pharmacist about over-the-counter drugs, which are often far less expensive than prescription medications, and frequently equally as effective. For example, there are now many effective OTC allergy medicines available.
Discuss your cost concerns with your doctor, and ask her to consider prescribing the most cost-effective medication for your condition. There may be several options available to you. Also talk to your doctor and pharmacist about whether or not it is safe for you to split your pills. Sometimes the difference in price between 5-milligram, 10-milligram, and 20-milligram tablets is negligible, and simply buying larger doses and splitting them at home can help save money. But not all pills can be split safely.
Find out if you qualify for free medicine. The pharmaceutical industry has a program for helping those in serious financial need get their prescription medications. To see if you’re eligible, visit www.helpingpatients.org or call 888-477-2669.
Shop around! Prices vary between pharmacies and online services. Secret shoppers for Consumer Reports surveyed over 200 pharmacies around the country. What they found was shocking: “In short, prices can vary widely from retailer to retailer, even within the same ZIP code. Drugs could cost as much as 10 times more at one retailer vs. another.”
Haggle! Americans negotiate the price of a new or used car. What they don’t realize is that it is also possible to negotiate with a pharmacist about the price of medicine. Consumer Reports suggests asking, “Is this your lowest price?” This is especially true if you pay out of pocket. Do not rule out independent pharmacies. They may beat the chains and are more likely to negotiate.
If your insurance company requires that you take a generic drug, ask your pharmacist to seek out the authorized generic which should be identical to the brand name. It may even be made on the same production line. Though it might be a bit pricier than other generics, it will be far less than the brand name. Authorized generics are especially important if your medicine has a narrow therapeutic index. When taking a generic drug always monitor your reactions (both lab records and subjective responses).
Control your quantity. See if you can try a free sample when you start a new drug to make sure that you can tolerate it and that it works for you. If you can’t get a sample, ask your pharmacist to dispense a trial dose. If you decide to go ahead with the prescription, you might save money by buying in bulk from big-box pharmacies like Costco. Consumer Reports found that Costco offered great prices and you don’t have to be a member to buy Rx drugs there. During the open enrollment time period of your insurance plan make sure your medications are covered. Plans change drug coverage from year to year.
Shop online. Consumer Reports suggests GoodRx.com to “learn a drug’s ‘fair price.’” Visit PharmacyChecker.com and CIPA.com to find verified Canadian pharmacies (see page 16). This may be especially important if you need to take a brand name medicine that is prohibitively expensive in the U.S. and is a narrow therapeutic index drug.
According to the Arthritis Foundation, 70 million Americans (one in three adults) suffer from arthritis. Prescribed and OTC NSAID medications may have serious side effects, from high blood pressure, heart attacks and strokes to bleeding ulcers and kidney damage.There are ways to cope with the pain.
The various medicines used to treat blood pressure all have pros and cons. They are outlined in this guide, which also includes nondrug approaches such as exercise, diet, supplements and special foods such as beet juice and chocolate.
Get the straight and skinny on statins, and learn about nondrug approaches to lowering cholesterol. What other factors are critical for maintaining heart health?
Learn about the pros and cons of popular antidepressants and get advice on how to get off drugs like Cymbalta, Effexor or Paxil. Find out what nondrug approaches can help depression.
Popular heartburn medicines have disturbing side effects. Get information on how to manage heartburn without powerful acid-suppressing drugs. Learn ways to reduce the discomfort of discontinuing PPIs.
Get tips for beating insomnia without expensive sleeping pills. This guide includes a list of drugs that can cause insomnia. It also discusses the pros and cons of commonly prescribed sleep aids.
Read the details on various medicines prescribed to lower blood sugar for people with type 2 diabetes. Get advice on nondrug approaches such as diet, supplements and special foods.
Published on: March 11, 2024
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Last Updated: May 03, 2024
Publisher: The People's Pharmacy
© 2024 The People's Pharmacy