Mike Adams, the Health Ranger
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 Yet another clever way to boost Big Pharma profits
Always pondering ways to make the drug market more lucrative for large pharmaceutical corporations, the FDA is now floating the idea of charging application fees to manufacturers of generic drugs. This, in turn, would make it more expensive for generic drugs to receive approval, hiking their price and limiting their price advantage vs. brand-name drugs. The end result? Greater brand-name drug sales (which, of course, is what the FDA is ultimately after). |
| The agency, of course, is spinning this whole proposal as a huge benefit to consumers, saying it would help them approve generic drugs more quickly, thereby saving U.S. employers hundreds of millions of dollars in lower drug costs. Of course, those same corporations could save BILLIONS if they invested in nutrition, prevention and natural health instead of drugs and surgery, but that's another story.
Clearly what we need is genuine FDA reform, not making the FDA even more addicted to industry money. |
Bottom Line Health
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| Participants who took generic drugs showed 12.6% greater therapy adherence than patients who took brand-name third-tier drugs, the study authors report. Patients who took second-tier drugs had 8% greater adherence than those who used third-tier drugs.
These findings are another reason why "generic drugs should be prescribed for patients beginning chronic therapy, as long as there are no specific clinical reasons why a branded drug may be more appropriate," says Shrank.
"Physicians commonly prescribe chronic medications for important medical problems. |
| Patients who are prescribed generic drugs are more likely to continue taking them than patients who take brand-name drugs, a new study has found.
THE STUDY
Dr. William Shrank, of Brigham and Women's Hospital and Harvard Medical School, both in Boston, analyzed how well 6,755 patients who were enrolled in a three-tier pharmacy benefit plan stuck to their drug regimens. Under this plan, the patients had the highest copayment for nonpreferred brand-name drugs (third tier), smaller copayments for preferred brand-name drugs (second tier) and the smallest or no copayment for generic drugs. |
| These findings are another reason why "generic drugs should be prescribed for patients beginning chronic therapy, as long as there are no specific clinical reasons why a branded drug may be more appropriate," says Shrank.
"Physicians commonly prescribe chronic medications for important medical problems. Both physicians and patients should be aware of how the medication choice directly influences the patient's ability to follow the prescribed treatment," he says.
. - The Center for Drug Evaluation and Re-— search has more information about generic drugs at www.fda. |
Mike Adams
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 Creates obstacles for the introduction of generic drugs that would compete with brand-name drug sales. For example, the FDA now supports charging generic drug companies to conduct safety reviews on chemicals that have already been approved by the FDA and are currently sold under brand names.
Attempts to modify intellectual property laws for its own gain, such as promoting proposals that would extend patent protection on drugs by several more years, thereby guaranteeing years of additional profits (at the expense of consumers) before competing generic drugs can be introduced. |
Bottom Line Health
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| The Center for Drug Evaluation and Re-— search has more information about generic drugs at www.fda.gov/cder/consumerinfo/ generics_q&a.btm.
How to Save Big on Drugs
Americans spend an average of $885 annually on prescription and over-the-counter (OTC) medications. But when it comes to cost, you have more options than you might think.
Example: An average daily dose of the popular cholesterol-lowering statin Lipitor costs approximately $98 per month. Lovastatin, a generic of the statin Mevacor that is used in lower-risk patients, is available for $37 a month. |
| Under this plan, the patients had the highest copayment for nonpreferred brand-name drugs (third tier), smaller copayments for preferred brand-name drugs (second tier) and the smallest or no copayment for generic drugs.
There were six classes of drugs included in the study: cholesterol-lowering statins, oral contraceptives, orally inhaled corticosteroids (used to treat asthma) and three types of antihypertensives (calcium-channel blockers, angiotensin receptor blockers as well as angiotensin converting enzyme inhibitors). The group received 7,532 new prescriptions during the study. |
Shannon Brownlee
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 Drug patent laws granted a company seventeen years of exclusive rights to develop and sell its product before the patent expired and generic drugs horned in on the market. (Today, drug patents have been extended to twenty years.) Three to six years of that patent were eaten up by testing the drug and getting it through the FDA approval process. If advertising only to doctors meant that a drug took another four or five years to reach its sales potential, that left less than a decade before the patent ran out and cheap generic competitors marched in. |
Craig Pepin-Donat
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 In 2005, there were only 78 drugs approved, of which 18 were actually "new" while 344 generic drugs were approved and another 108 received "tentative" approval.21 At the FDA's Center for Drug Evaluation and Research (CDER) Web site you will find that drug applications are broken down into seven categories based on the chemical type. Only one type is really a new drug, which is defined as a "new molecular entity." The others are new because they feature new formulations or new combinations of
When New Doesn't Mean New drugs that have already been approved. From 1994 to 2004, only 13. |
Andreas Moritz
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 Some generic drugs were marked up as much as 3,000 percent or more.
CBS's famous Sixty Minutes national TV show (aired 1st April 2007), revealed the biggest ever health scandal, which so far cost the American public nearly $1.5 trillion. The scam is orchestrated by the pharmaceutical companies, which through powerful lobbying in the American Congress, helped pass a prescription drug bill that prevents Medicare from buying prescription drugs at a discounted rate for their members. Other institutions, such as the U.S. |
Peter J. Whitehouse and Daniel George
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 Add to their expense accounts all the lawyers they pay to defend intellectual property rights and to attack generic drugs, and it is a wonder that they have any money left to pay for actual research.
Ten years ago I founded a group called the International Working Group for the Harmonization of Dementia Drug Guidelines. We succeeded in bringing together academics, industry leaders, and government regulators to discuss Alzheimer's and related disorders and helped craft guidelines necessary to demonstrate that a drug should be approved for the treatment of Alzheimer's disease. |
J. Douglas Bremner
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 I accepted that the high price of drugs was justified by the need to pay for the research to develop new ones, and that generic drugs were bad because they drained money away from research for new life-saving drugs.
However, being a physician scientist, I am naturally inclined to question the evidence for any particular statement of fact. For most of my career this has been limited to specific questions related to my area of research, which is mainly focused on the brain and, more recently, heart disease. |
Joe Graedon, M.S. and Teresa Graedon, Ph.D.
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 Williams, MD, executive vice president and chief executive officer of the United States Pharmacopeia (USP), what he thought about generic drugs. The USP is the organization that has been setting US pharmaceutical standards for more than 185 years, before there even was an FDA.6 Before taking over the top job at USP, Dr. Williams worked at the FDA (from 1990 to 2000). There, he was deputy director for pharmaceutical science at the Center for Drug Evaluation and Research. He oversaw the division that reviews generic drug approval for the FDA.
Dr. |
Greg Critser
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 For CEOs, it became a competitive issue not unlike that of generic drugs. A company's ability to recruit patients became a highly visible indicator — to investors, Wall Street, and board members — of a pharma firm's viability. If a lack of such ability ate into the company's production of a steady stream of blockbuster drugs, it could depress stock prices and create intense pressure by stockholders and board members. The issue was becoming an obstacle in the path of innovation and profits, at least as seen by top executives in all major pharmaceutical companies. |
Joe Graedon, M.S. and Teresa Graedon, Ph.D.
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| My health insurance provider decided to save money and switched me to generic drugs. The result was an overnight increase in glucose level to over 140 mg/dl with no change in eating behavior.
2. Keep lab records. Make sure your physician always provides you with a record of your laboratory results. Track these numbers in a diary or on a computer. Anyone with lipid problems should track cholesterol and triglyceride levels. People taking Coumadin (warfarin) must be scrupulous about monitoring lab values like INR or PT. Those who are hypothyroid should be notified about TSH, T3, and T4 readings. |
Peter Rost
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 He also calls for a doubling of drug patent life [185] which would result in a drastic reduction of new, low-priced generic drugs.
Dr. McKinnell starts his book with the surprising confession that he doesn't always believe in what he's saying. "They listened to my logic, but I could tell they weren't convinced, and to tell you the truth, I wasn't either." [11]
He also doesn't shy away from embarrassing facts, "Branded drug prices are anywhere from 25-100 percent more expensive in the United States. |
| Additionally, the physician's group agreed that they wouldn't prescribe Pfizer drugs if suitable generic drugs were available.
Pfizer is a very sales oriented company and these events shook them up. Their worst nightmare would be a national boycott of their products. According to the Albuquerque Journal, Pfizer said the company had "several products of great value to patients" for problems such as high cholesterol, cancer, high blood pressure, and glaucoma. |
Mike Adams, the Health Ranger
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 The really good doctors will first see if they can get patients to make healthy lifestyle changes on their own, and if they can't, they'll prescribe generic drugs instead of the overpriced brand-name drugs. But really good doctors, sadly, are also really rare. I happen to know a few, but they are the exception, not the rule.
Nevertheless, nearly all doctors -- the good ones, the bad ones and the downright corrupt ones -- take money and gifts from drug companies. Walk into any doctor's office, and you'll be hard pressed to find a single object (mugs, paper pads, pens, etc. |
Joe Graedon, M.S. and Teresa Graedon, Ph.D.
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| Anyone without insurance will likely opt for generic drugs just to survive. We used to think that was a very good idea.
We have been scrutinizing drug prices carefully for 30 years. When we began this journey we were unabashedly pro-generics. We were swimming against the tide. The overwhelming majority of prescriptions filled in American pharmacies were for brand-name products. In those days, pharmacists and physicians frequently defended branded drugs as being superior in quality and worth every extra dime because they represented an investment in future pharmaceutical development. |
| We began to have doubts about generic drugs several years ago, prompted by a mother who insisted that when she substituted generic methylphenidate for the brand-name Ritalin, it didn't work as well to control her son's attention-deficit/hyperactivity disorder (ADHD). She would send him off to school on the generic drug and he wouldn't perform as well. The teacher complained about his behavior and the mom could see for herself that the methylphenidate was not helping his attention span or controlling his hyperactivity adequately. |
Mike Adams, the Health Ranger
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 And there are no signs of change, as the FDA seems wholly committed to protecting Big Pharma's profits by making it more difficult for generic drugs to receive approval (for example), and by continuing to discredit or outlaw herbs and natural medicines that actually prevent disease and make people healthier.
But elsewhere in the world, outright corruption in the health industry simply does not reach such extremes. Citizens of countries throughout Europe, Asia, South America and even New Zealand have far greater access to herbal medicine that really works. |
Jacky Law
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 February 2005, making it the world's largest manufacturer of generic drugs overnight.33
But the EU's refusal to bend its rules so its citizens might pay more for the latest drugs would seem to express the nub of the problem from pharma's global perspective. 'It is within the countries of old Europe, which house 250 million people, that the problems lie,' says pro-industry commentator Philip Brown. 'Here, personal enterprise, self-sufficiency and drive have been squeezed out like juice from an orange, leaving just the pith and the peel. |
Joe Graedon, M.S. and Teresa Graedon, Ph.D.
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| The FDA was adamant that generic drugs were identical to their brand-name counterparts. Congress passed legislation to speed approval of generics in anticipation of a tidal wave of blockbuster brand-name drugs that were on the verge of losing patent protection, like the cholesterol-lowering drug Zocor (simvastatin) and the antidepressant Zoloft (sertraline).
Insurance companies and HMOs were doing everything in their power to switch people from pricey brands to generic alternatives. They created three- and four-tier co-payment schedules. |
Death by MedicineGary Null PhD, Carolyn Dean MD ND, Martin Feldman MD, Debora Rasio MD, Dorothy Smith PhD.
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| Instead of choosing between drugs and a diet-lifestyle change, seniors are given the choiceless option of either high-cost patented drugs or low-cost generic drugs. Drug companies are attempting to keep the most expensive drugs on the shelves and to suppress access to generic drugs, in spite of stiff fines of hundreds of millions of dollars from the government.140'141 In 2001 some of the world's biggest drug companies, including Roche, were fined a record £523 million ($871 million) for conspiring to increase the price of vitamins. |
Mike Adams
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| Attempts to modify intellectual property laws for its own gain, such as promoting proposals that would extend patent protection on drugs by several more years, thereby guaranteeing years of additional profits (at the expense of consumers) before competing generic drugs can be introduced.
Suppresses free speech on the internet by pressuring search engines like Google to require "pharmacy licenses" from advertisers before they can post online ads for medications of any kind. |
Joe Graedon, M.S. and Teresa Graedon, Ph.D.
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| As the stories began accumulating, though, we were gradually beginning to question our steadfast faith in generic drugs' invincibility.
/ have taken Prozac for approximately 10 years with wonderful results. Approximately 1 to 2 weeks after a recent renewal I was aware that I was feeling withdrawn, depressed, and slightly anxious. My husband and co-workers also noted a change in me. While taking my morning dose, I happened to glance at the label and noticed that I was given the generic equivalent without my knowledge. |
H. Winter Griffith, M.D.
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 A doctor may specify a brand name because he or she trusts a known source more than an unknown manufacturer of generic drugs. You and your doctor should decide together whether you should buy a medicine by generic name or brand name.
Generic drugs manufactured in other countries are not subject to regulation by the U.S. Food and Drug Administration. All drugs manufactured in the United States are subject to regulation.
6—Drug Class
Drugs that possess similar chemical structures or similar therapeutic effects are grouped into classes. |
Kelly Patricia O'Meara
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 TMAP concluded that the patented bi-polar drugs were superior to generic drugs.14
Jones concludes his nearly 70-page report with a damning assessment of the unholy alliance between the pharmaceutical industry and political entities, saying: "The pharmaceutical industry has methodically compromised our political system at all levels and has systematically infiltrated the mental health service delivery system of this nation. They are poised to consolidate their grip via the New Freedom Commission and the Texas Medication Algorithm Project. |
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