Then, in a move striking at the very core of ethical scientific standards, the company’s senior director for medical research took the study results and, without giving credit to the UCSF researchers, published a misleading version in an obscure journal of which he was also an associate editor. The new version was used to support the company’s previous assertion of Synthroid’s superior reliability.
The reason that these 24 different drugs were chosen is that they all have a narrow therapeutic range. If it is not, the drug may too easily lose its effectiveness (if the dose is too low) or become toxic (if the dose is too high). This means that unlike with most kinds of drugs, for which there is a relatively large range of dosages that are both effective and relatively safe, the amount of these drugs that gets into the body must be more tightly controlled.
Since generics use the same active ingredients and are shown to work the same way in the body, they have the same risk-benefit profile as their brand-name counterparts. Fact: FDA requires that all drugs be safe and effective and that their benefits outweigh their risks.
Brand-name drug manufacturers have gone to extraordinary lengths to mislead doctors, pharmacists, and the public into believing that their products are produced to higher standards, and thus are safer and more effective than the same drugs produced by generic companies. These strategies have included setting up sham patient groups to lobby state legislatures to protect their brand-name drugs, and the suppression of scientific research by at least one brand-name company that showed their brand-name product was no better than those of generic companies.
Myth: Generics are not as safe as brand-name drugs.
The problems began in late 1990, when it became known that Synthroid and the other three levothyroxines were the same. The contract contained a clause giving Boots veto power over publication of the study’s results.
Many brand-name drug companies such as Warner-Lambert and its subsidiary, Parke-Davis, denigrate the quality of generic drugs in an attempt to hold market share from generics and protect profits. However, the facts about this brand-name manufacturer bear examining.
In this case, Warner-Lambert officials pleaded guilty to criminal charges for withholding important information about sloppy manufacturing practices from the FDA.
What Is Bioequivalence?. The FDA monitors reports of adverse drug reactions and has found no difference in the rates between generic and brand-name drugs. Fact: There is no evidence of this.
Some consumers have responded to drug company pricing double standards by hopping a bus and heading north to Canada, but for most people in the United States, this will not be feasible. But can you trust them?. A trip to your computer terminal, however, puts you instantly in touch with dozens of drug-selling operations, all eager for your business.
Boots Pharmaceuticals, which became the Knoll Pharmaceutical Company of Mt. Olive, New Jersey, in March 1995, suppressed publication of scientific research for more than two years in order to perpetuate the incorrect public impression that their brand-name version of levothyroxine (SYNTHROID) was more reliable than generic levothyroxine products from three competing companies. The cost to the American public in excessive charges for Synthroid over these two years has been estimated to be $800 million.
Internet Purchase (with Caution) of Drugs and Importing Drugs from Canada.
The GAO identified 13 drugs of particular interest and filed orders with 90 different pharmacies around the world; in the end, 68 drugs were received. The top-selling drugs, including Celebrex, Lipitor, and (of course!) Viagra, were generally widely available, but drugs requiring patient monitoring to protect patient safety (Accutane, Clozaril ) and narcotic pain relievers ( OxyContin, Percocet ) were tougher to find.
Fact: FDA requires generics to have the same quality, strength, purity, and stability as brand-name drugs.
Only five of the 29 United States sites required a prescription, with the remainder requiring the online questionnaire. Where the United States proved particularly inadequate was in requiring a prescription. Three of the non-Canadian foreign sites required a questionnaire, but the remaining 18 simply mailed the drugs. Most states consider the latter two options to constitute an improper practice of medicine but have generally failed to discipline those physicians lending their names to such schemes. Internet pharmacies are usually divided into three groups: (1) those to whom you have to mail a prescription; (2) those that have you fill out a questionnaire online and that, without ever examining you, dispense the drug; and (3) those that don’t even maintain the pretense of a questionnaire and simply provide the drugs. In contrast, every Canadian pharmacy required a prescription from the patient’s own physician, the most reputable option.
Because of the serious dangers of these 10 drugs, all were taken off the market. Examples of such disasters, which collectively have killed hundreds of Americans and injured thousands more, have involved the arthritis drugs or painkillers Oraflex, Suprol, and Zomax; the antidepressant Merital; the high blood pressure drug Selacryn; the diet drugs Pondimin, one-half of the once popular “fen/phen” combination, and its close chemical cousin Redux; Posicor, a drug for high blood pressure and chest pain; the diabetes drug Rezulin; and the painkiller Duract.
The United States government, at least, seems to suspect that illegal activity is rife in this industry. Fourteen of the 68 pharmacies (nine United States, one Canadian, and four from other foreign countries) were under investigation by either the United States FDA or the Drug Enforcement Administration for allegations including selling controlled substances without a prescription, lack of a doctor-patient relationship, selling adulterated or counterfeit drugs, smuggling, and mail fraud.
To sum it all up, generic drugs are just as effective and safe as brand-name drugs. 881 for some examples of generic savings. See the table on p. If the brand-name drug is not yet off patent, your pharmacist will advise you of this. Unless you want to waste quite a bit of money, ask your pharmacist to fill your prescription with a generic drug.
Unlike every other industrialized country, the United States refuses to negotiate drug prices or, as is done in Britain, negotiate a guaranteed profit margin for pharmaceuticals. As is well known, the only reason that United States residents have increasingly turned to the Internet or to Canada as a source for drugs is that drug prices are out of control at home. Drug prices in foreign countries are often half of what they are for identical drugs in the United States. In fact, we are in many respects going in the opposite direction; the recently passed Medicare prescription drug legislation actually prevents the Medicare program from using its massive purchasing power to negotiate lower drug prices.
You can get this information easily by asking your pharmacist. The table below was prepared by simply phoning a local pharmacy. Unless you want to waste a large amount of money—often hundreds of dollars a year—by using brand-name instead of generic drugs, you should ask for the generic version, especially if you are starting on a drug for the first time. (See table below.) One of the few bits of comparative information about prescription drugs readily accessible to consumers is the retail price of brand-name versus generic drugs.
Nine of these involved problems with dissolving of the drug, which can result in an insufficient amount being absorbed by the body. 4. For their brand of phenytoin (DILANTIN) alone—a drug used primarily for treating seizure disorders and one where the amount of drug in the blood is critical—there have been 12 recalls during this period. More than 975,000 bottles (some of which contained 1,000 capsules) and more than 30,000 injectable doses of Dilantin were affected by these recalls. From 1990 to the end of 1995, there were a total of 64 recalls of Warner-Lambert products as listed in FDA recall reports. In 1990, there were 3 recalls, 1 in 1991, 3 in 1992, 24 in 1993, 13 in 1994, and 20 in 1995.
Sixteen of 18 Canadian drugs did not comply with U.S. But the United States and Canadian sites were certainly not immune from problems. and all 18 Canadian drugs proved to have the proper amount of the active ingredient, while four of the other foreign drugs did not. regulations in that the packaging or labeling had not been approved by the FDA or the agency had not inspected the manufacturing plant. (These drugs may well have met the requirements of Canadian regulatory authorities, and Canadian labeling is quite similar to that in the United States.) However, all 29 U.S.
It found four generic and brand-name drugs—Synthroid and the three competing levothyroxines—to be bioequivalent by current FDA standards and interchangeable without loss of therapeutic efficacy in the majority of patients for treatment of hypothyroidism (low thyroid). Research that contradicted the Boots/Knoll superiority claim was finally published in the April 16, 1997, issue of the Journal of the American Medical Association. 7.
Both brand-name and generic drug companies are regulated by the FDA using the same standards for manufacturing facilities, quality and purity, and content of prescription drugs. The quality of prescription drugs, brand-name or generic, does not depend solely on the manufacturer but also on a strong and vigilant FDA.
Generics are not required to replicate the extensive clinical trials that have already been used in the development of the original, brand-name drug. Instead, generic applicants must scientifically demonstrate that their product is bioequivalent (i.e., performs in the same manner) to the pioneer drug. Since the safety and efficacy of the brand-name product has already been well established in clinical testing and frequently many years of patient use, it is scientifically unnecessary, and would be unethical, to require that such extensive testing be repeated in human subjects for each generic drug that a firm wishes to market. These tests usually involve a few hundred to a few thousand patients.
The classes of drugs tested included contraceptives, antibiotics, and medications prescribed for asthma, epilepsy, high blood pressure, and abnormal heart rhythms. A 1990 study by FDA laboratories from all over the country found that for those classes of prescription drugs that theoretically could be most likely to pose safety or effectiveness problems if they were not manufactured properly, the generic drug met the applicable standards in virtually all cases. Of the 429 samples of the 24 different drugs tested, including both brand-name and generic drugs, there were no samples tested that posed a health hazard to patients when examined for potency and, where applicable, dissolution rate and content uniformity.
Myth: Generics are not as potent as brand-name drugs.
Listed below are the names, both brand-name and generic, by therapeutic class, of all the drugs studied except for the birth control pill (because no generic version was studied) and aminophylline (AMOLINE, SOMOPHYLLIN, SOMOPHYLLIN-DF). As indicated in the table, many of these manufacturers have changed since the 1990 study because of mergers and acquisitions within the drug industry.
Over the years, there have been recalls because of these kinds of problems with both generic and brand-name drugs. But what about those drugs that have been on the market for a long enough time for the patents to have expired and that are available in both brand-name and generic versions? Which version is safer or more effective? It has always been our position that there is no difference between generic and brand-name drugs as far as the odds that there will be something found wrong with the amount of active ingredient or the purity.
The Question of Brand-Name Quality.
The Levothyroxine (SYNTHROID) Scandal.
Myths and Facts About Generic Drugs 6.
Myth: Generic drugs are likely to cause more side effects.
9. The results should give pause to anyone contemplating succumbing to the allure of the less expensive products on offer on the Web. The General Accounting Office (GAO), an investigative branch of Congress, recently conducted a study examining the practices of Internet pharmacy sales.
Fact: The firm seeking to sell a generic drug must show that its drug delivers the same amount of active ingredient in the same time frame as the original product.
Generic firms have facilities comparable to those of brand-name firms. Fact: The FDA won’t permit drugs to be made in substandard facilities. In fact, brand-name firms account for an estimated 50% of generic drug production. They frequently make copies of their own or other brand-name drugs but sell them without the brand name. The FDA conducts about 3,500 inspections a year in all firms to ensure standards are met.
Myth: Brand-name drugs are made in modern manufacturing facilities, and generics are often made in substandard facilities.
The FDA also has an obligation to make known to health care professionals and to the public its conclusions that false or misleading reports are being generated. The FDA has a public obligation to investigate thoroughly all allegations of drug product defects or failures. The agency has not found any of the allegations raised thus far in the brand-name versus generic drug controversy to be valid.
All six pharmacies that accepted payments for the drug and then failed to fill the order were located outside of the United States or Canada. Not one of the 21 drugs obtained from outside the United States or Canada included a product label and only six contained warning information. Most improperly shipped drugs came from these countries as well: insulin that was not refrigerated, moisture-sensitive drugs that were not sealed, drugs hidden in compact disc cases, and drugs labeled as “dye and stain remover wax.”.
FDA Repels Attacks on Generic Drugs.
Brand-name drugs are subject to the same bioequivalency tests as generics when their manufacturers reformulate them. Using bioequivalence as the basis for approving generic copies of drug products was established by the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act.
As discussed above, it is in the first seven years after approval—when there is never any generic equivalent available because the patent has not yet expired, that most drugs are found to cause serious problems, not infrequently leading to their removal from the market.
Myth: Generics take longer to act in the body.
One way scientists demonstrate bioequivalence is to measure the time it takes the generic drug to reach the bloodstream and its concentration in the bloodstream in 24 to 36 healthy, normal volunteers. This gives them the rate and extent of absorption—or bioavailability—of the generic drug, which they then compare to that of the pioneer drug. The generic version must deliver the same amount of active ingredients into a patient’s bloodstream in the same amount of time as the pioneer drug.
As can be seen in the above table, over the course of a year, for drugs such as the high blood pressure drug lisinopril, which must be taken daily, the savings—365 times $.57 per day—are a hefty $208 in one year; and the savings are hundreds more for others that many people may be using.
That much of this industry has its sights trained on the United States should be no surprise: Americans use prescription drugs heavily and, thanks to the failure of the government to restrict prices or profits (as is done in most developed countries), we pay more for them. Among its billions of pages, the Web contains a minigrowth industry in prescription drug sales.
The results of the study were submitted to the Journal of the American Medical Association in April 1994. The study was sent to five experts for peer review and was accepted for publication in November 1994, with its publication scheduled for the January 25, 1995, issue of the journal. 8. against UCSF and the investigators.” Because of the clause in the contract giving the company veto power over publication, UCSF said it would not defend the researchers if the study was printed without the company’s permission. On January 13, 1995, the researchers suddenly withdrew the study from publication, citing as the reason “impending legal action by Boots Pharmaceuticals, Inc.
5. For aminophylline, an asthma drug that we do not recommend as a first-line treatment, five batches from two manufacturers failed to meet the FDA standards. For 23 of the 24 different drugs, there was no difference between the brand-name and the generic versions in the FDA laboratory tests for purity or quality. Although none of these five batches posed a health hazard, all were recalled.
In six categories of drugs, both brand-name and generic versions were tested. The drugs that tested included six asthma drugs, four for treating epilepsy, four high blood pressure drugs, four drugs for treating heart arrhythmias, a birth control pill, one antibiotic, a drug for treating depression, and a so-called blood-thinning drug. In the case of the birth control pill, all of the major brand names, but no generic version, were tested.
3. 2 Today there are more than 7,800 generic versions of the approximay 10,668 FDA-approved pharmaceuticals. In 1984, generic drugs accounted for less than 19% of all prescriptions filled. In addition, even though generics account for more than half of prescriptions dispensed, generics account for less than 16 cents of every dollar spent on prescription drugs. Today, generic drugs represent more than 54% of all prescriptions dispensed in the United States.
The company paid the researchers $250,000 to do the study. Boots’s expectation was that the study would find Synthroid to be superior to the generics. In this case, a finding of bioequivalence would justify the use of less-expensive, equally effective generic products instead of Synthroid. Knoll’s predecessor, Boots, contracted with a faculty member and researchers at the University of California at San Francisco (UCSF) in 1987 for a bioequivalence study comparing Synthroid with three competitors’ levothyroxine products.
The university conducted an investigation of how the research was done and found only minor and easily correctable problems. Once it was clear that the study would not support the claim of Synthroid’s superiority, Boots alleged scores of deficiencies and errors in the study. Over the next four years, Boots waged a calculated campaign to discredit the researchers and their work. 8. Some members of the investigating panel found Boots’s interactions with the researchers to be “harassment” and characterized the company’s actions as “deceptive and self-serving.” The university concluded that the study was carefully done and complied fully with the terms of the contract.
Six years after it was known that there was no difference between Synthroid and generic levothyroxine products, and more than two years after the UCSF research should have been published, the Journal of the American Medical Association published the research just as it would have appeared in January 1995, had it not been for Boots’s interference.Oxycodone brand and generic names