Drug Patents | Alliance for Natural Health USA - Protecting Natural Health

FDA Proposes to Drop the Effectiveness Test for Alzheimer’s Drugs

Tue, 26 Mar 2013 18:00:16 +0000

OK. If they do, how about dropping the effectiveness test for food or supplements used to treat Alzheimer’s? Action Alert!

The US Food and Drug Administration was originally charged only with ensuring the safety of foods and drugs. But in 1962, Congress passed the Kefauver-Harris Amendment, also called the Drug Efficacy Amendment. It put the FDA in charge of also ensuring the effectiveness of the drugs they approve—a task the agency has never shown itself qualified to handle. It also caused the cost of approval to soar because of the requirement to prove effectiveness with double-blind random-controlled trials (RCTs). This in effect created the “Catch 22” we talk about so often, the fact that only drug companies with synthetic patented medicines can afford to pay as much as $1 billion for approval. This in turn makes the agency hostile to natural (and therefore unpatentable) medicines.
Now FDA is planning to loosen guidelines in approving new treatments for Alzheimer’s drugs. Companies would no longer have to show that the drugs improved daily, real-world functioning (such as dressing, feeding, etc.), which was an earlier requirement. FDA reasons that it has been too difficult for the pharmaceutical industry to test drugs meant for people either in the early stages of Alzheimer’s or at risk for it. Drug development for late-stage Alzheimer’s has also been very slow, as many drugs are failing to show improved real-world functioning in clinical trials.
Under the new proposal, drugs in controlled clinical trials can qualify for approval if people at very early stages of disease subtly improve performance on memory or reasoning tests, before they develop any obvious impairments. The FDA would then require companies to study the drugs after they are placed on the market, to check whether they are truly preventive in warding off Alzheimer’s in the long-term. However, these post-marketing studies might not require RCTs.
Critics note that it’s hard to test objectively for subtle cognitive changes. Billions may be spent on drugs that accomplish little or even do harm. It may take years to learn the safety, much less the effectiveness, of a drug.
The new proposal appears to be timed to benefit companies like Eli Lilly, which is currently conducting clinical trials for an early-stage Alzheimer’s drug called solanezumab. The drug failed to show any improvement for late stage- Alzheimer’s, but under the FDA’s proposed new rule, it will be easier to get approval for it. We recently told you about another product Eli Lilly was testing for Alzheimer’s diagnosis called Amyvid.
We aren’t comfortable with the timing of the FDA proposal, which is clearly intended to give drug companies a lucrative market monopoly for unproven but vastly expensive products created to take advantage of the widespread fear of developing Alzheimer’s. But we are not opposed at all to dropping the effectiveness requirement for FDA approval, in effect returning to the days before the Kafauver Act.
Once the FDA has decided that something is safe enough to introduce, it should be left to doctors to decide what is effective and what isn’t. It isn’t that there won’t be studies—in fact, doctors won’t be convinced without them. The plain reality is that FDA is simply not qualified to make these decisions, no matter how many billions they throw at the problem, billions they get from drugs companies they are supposed to be reviewing, in order to present evidence to panels in many cases composed of people paid by the same drug companies. The Kefauver Act system is broken; it needs major reform and change.
Meanwhile, if the FDA is going to lift the proof-of-effectiveness requirement for drugs, they need to do the same for supplements and food! Supplements cannot, according to FDA, claim to treat or prevent any disease unless they go through the full drug approval process and pay millions or hundreds of millions dollars to prove both safety and efficacy with new RCTs. No matter that humans and human ancestors have consumed vitamin C for millions of years and that we can’t live without it! It too would have to prove its safety and effectiveness as if it were a drug. Now, however, this standard is going to be lifted for certain drugs—no proof of effectiveness for real-world functioning needed before approval, with perhaps no RCTs required even after approval—and if so, at least let the same standard apply to natural foods and supplements!
The reason supplements can’t meet the safety test is not that they are unsafe, nor the proof-of-effectiveness test because they don’t work. It’s because without patent protection and the ability to charge exorbitant prices for their products, nutritional supplement companies can never recoup their investment in the clinical trials.
If the proposal for Alzheimer’s drugs were applied to natural foods and supplements, supplement manufacturers would be able to prove effectiveness without RCTs, while also having the opportunity to prove long-term effectiveness in post-marketing (i.e., observational) studies.
Whatever the FDA does, it is important to include natural supplements and foods in any Alzheimer’s prevention or treatment plan, such as

coconut oil to help prevent or halt the progression of Alzheimer’s;
nattokinase and niacinamide to halt or even reverse memory loss;
fish oil that is high in DHA together with PhosChol and Uridine-300, mixed with small amounts of selenium, B vitamins, and alpha-tocopherols; and
vitamin D for healthy brain function.

Anyone worried about Alzheimer’s should be taking such natural preventive approaches—not taking hugely expensive, new-to-nature, and potentially toxic synthetic drugs even before they have the disease.
Action Alert! There is a sixty-day comment period on the FDA’s proposal. Write to the FDA and tell them if they’re going to allow Alzheimer’s drugs to be approved without being able to prove their effectiveness, they need to follow the same standards for food and supplements that treat Alzheimer’s. Allow natural substances to make disease claims without having to spend a billion dollars to prove their effectiveness! Please send your message today!

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Private Companies Are Trying to Patent Your Genes!

Tue, 14 Aug 2012 17:00:54 +0000

Not only that, but a federal court has now ruled that FDA can regulate your cells as drugs.

We reported in January that the US Food and Drug Administration wants to treat your body’s stem cells as drugs—cells taken from our own bodies and then re-implanted with the purpose of treating medical problems, usually to renew damaged body parts.
And now, as reported by the Wall Street Journal, a DC district court has ruled that these adult stem cells are in fact “drugs” (and therefore fall under FDA jurisdiction), even when the cells are taken from a patient and then re-inserted into him or her. In other words, the court ruled that you don’t have the right to stem cell treatment even when you’re using your own stem cells to treat your own injury!
The court’s ruling extends FDA oversight, at least in principle, into things as common as in-vitro fertilization. In other words, reproductive cells would also become “drugs” under the law.
Now a private company, Myriad Genetics, is arguing that they own the patent for two genes, BRAC1 and BRAC2, which account for most inherited forms of breast and ovarian cancer.
Women who are at high risk for inheriting breast cancer can test for mutations in these two genes. Under the Myriad gene test, called the BRACAnalysis, women who test positive have 82% higher risk of breast cancer and 44% higher risk of ovarian cancer. The results of the test are instrumental in determining a woman’s treatment options.
If Myriad’s patent claims are upheld, it means they have ownership over particular genes in the human body. They can charge whatever dollar amount they dream up to access those genes via the test—which is currently $4,000. Women concerned about their risk of breast or ovarian cancer wouldn’t be able to have anyone but Myriad look at their genes. And such a high price means a woman who might need the test the most might not be able to afford it.
The patents would keep competitors from offering tests, which restricts market competition to decrease prices, increase access, and improve the tests themselves. It would also cut off scientific research: scientists outside Myriad couldn’t study these genes without Myriad’s permission. Think of that: no new breast cancer therapies could be developed using these genes, because someone holds a patent on them and won’t give others access to them.
The American Civil Liberties Union and the Public Patent Foundation filed lawsuit against Myriad, the University of Utah Research Foundation, and the US Patent and Trademark Office. They said the patent restricts scientific research and patient access to medical care, and violates the First Amendment and patent law because genes are part of nature and therefore cannot be patented.
ACLU and PPF won in the lower court, but lost on appeal in federal court. Two of the judges said genes can be patented because testing looks for distinctive chemical forms of the genes and not as they appear naturally in the body. The dissenting judge argued that “plucking a leaf from a tree does not turn it into a human-made invention.”
However, in March the Supreme Court vacated the decision. They instructed the appeals court revisit the case, and arguments will begin on July 20. ACLU will be arguing that genes are natural and therefore cannot be patented.
Dietary supplements have long been denied patent protection because they are considered natural. The same standards should apply to the pharmaceutical industry. The system shouldn’t create loopholes to allow them patent protections on our own bodies just to increase their profits and deny consumer access.

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FDA Advisory Panel Green-Lights Toxic Weight Loss Pill

Tue, 28 Feb 2012 18:00:36 +0000

The FDA had previously rejected this very same drug for safety reasons. So how do they explain the sudden flip-flop?

Last week, the FDA’s Endocrinologic and Metabolic Drug Advisory Committee voted 20 to 2 to recommend approval of Qnexa, a diet pill that has documented risks of causing birth defects and heart problems. The committee’s approval pretty much paves the way for full FDA approval. If approved, Qnexa would be the first new prescription weight-loss medication since 1999. There is only one other diet prescription medication currently on the market: Orlistat (marketed under the trade name Xenical), which tends to cause loose, oily stools, along with a host of other possible side effects, some of which may be serious.
Qnexa was rejected twice, once in October 2010 over heart risk concerns, and again in January 2011 because one of its ingredients can cause cleft lips in the children of women who take it. Qnexa is a combination of two existing drugs, the appetite suppressant phentermine and the anti-seizure medication topiramate. Both have serious risks.
PubMed Health lists 63 side effects for topiramate. It can prevent you from sweating and make it harder for your body to cool down when it gets very hot. It can also harm fetuses and cause birth defects, cause kidney stones and osteoporosis, and alter your mental health “in unexpected ways” and cause you to become suicidal. Last year, the FDA reclassified topiramate as a class D drug, meaning that it carries risks to a fetus but may still be acceptable for use in pregnant women despite the risks!
Side effects of phentermine include cardiovascular adverse effects (heart palpitations, dizziness, chest pain, edema, and increased blood pressure), not to mention vomiting and diarrhea. Other reported adverse effects include convulsions, hallucinations, hostility with urge to attack, mania followed by depression, and panic.
Put the two together and you have a real winner of a diet drug! What’s more, diet drugs often exert their weight loss effects only while the drug is being taken. This promotes “yo-yo dieting,” which leads to more weight gain and is more likely to increase the risk of heart attack, metabolic syndrome, diabetes, and other serious health problems.
Does anyone imagine that the average overweight patient who is prescribed this drug will have a clue what’s in it, or what they could be letting themselves in for?
Officials for Vivus Inc., Qnexa’s manufacturer, have proposed a “tightly controlled system” for prescribing Qnexa to prevent birth defects, including “limits on which pharmacies can dispense the medication, such as registered mail-order pharmacies.” Of course, we can think of another way to prevent birth defects or cardiovascular problems from Qnexa: don’t approve it in the first place! As Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen, points out, “Diet drug history is littered with those banned only after they found out about cardiovascular risk areas.”
What is causing the reckless and irrational approval of such an obviously dangerous drug? One of the driving forces is the pharmaceutical industry’s sense of panic. The patents on their biggest money-making drugs are expiring, which will cause drug prices (and profits) to plummet when generic versions become available. So Big Pharma is desperate for new blockbuster drugs—and FDA is beholden to the pharmaceutical industry. The drug industry, having been exposed for over-hyping the “cholesterol problem” for the sake of its own profit, now sees the obesity epidemic as the next opportunity for exploitation.
Predictably, according to investment experts, Qnexa is poised to become “the next Lipitor” (as if that’s a good thing!). The cholesterol drug Lipitor had $10.7 billion in sales in 2010 before losing patent protection last year. Analysts say Qnexa, if approved, may generate $448 million in sales in 2015.
With so few weight loss medications on the market and obesity at epidemic levels in America, the panel felt that the risks posed by obesity outweighed the drug’s side effects. Dr. David Katz, of the Yale Prevention Research Center, said, “This is far from a great drug. The FDA panel recommended approval of Qnexa only because the ranks of useful weight loss drugs are so thin, and desperate times call for desperate measures. Approval of Qnexa would reflect that…desperation.”
The irony, of course, is that healthy, natural solutions for weight loss and management are being ignored, as we explained in our popular article on the subject. And just last week, natural health expert Dr. Joseph A. Mercola explained how eating fat does not make a person fat—but the overconsumption of carbohydrates does: “Overeating carbohydrates can prevent a higher percentage of fats from being used for energy, and lead to an increase in fat production and storage. It also raises your insulin levels, which in short order can cause insulin resistance, followed by diabetes. Insulin resistance is also at the heart of virtually every chronic disease known to modern man.”
The FDA is expected to decide by April 17 whether or not to accept the advisory panel’s recommendation to approve Qnexa. The agency usually follows the recommendations of its advisory panels but is not required to do so.
How outrageous is it that FDA will consider green-lighting an incredibly toxic drug, but won’t let supplement producers make weight loss claims for safe, natural products? FDA has created a situation where consumers cannot be told about the health benefits of nutritional supplements and natural foods because FDA is censoring the manufacturers. This forces consumers into a situation where they only hear the endless advertisements from drug makers and major media—something that will increase dramatically if Qnexa gets approved.

A drug manufacturer has petitioned FDA to stop supplement producers from even mentioning the words “weight” or “weight loss” in ads. If the FDA agrees, food or supplement competition for weight loss drugs will be wiped out in one stroke. Don’t let them think we’ve fallen asleep on this issue—take action now!

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The Little Purple Pill Problem

Tue, 27 Jul 2010 13:29:20 +0000

Forbes magazine calls it “a parable of what’s wrong with health care [costs].” We think that the popular drug Nexium is a scandal for a different reason – what it does to your digestion.

AstraZenica, the international pharmaceutical company worth $46.8 billion, began selling a drug called omeprazole in 1989 under the brand name Prilosec. It is a proton pump inhibitor, and it was marketed as a treatment for heartburn, peptic ulcer disease, and GERD (gastroesophageal reflux disease). Two years before the patent expired, AstraZeneca changed the formulation slightly and started selling it as a new patented drug, Nexium. What the drug company did not want was for consumers to stay with Prilosec, essentially identical to the new drug, once the old drug came off patent and the price collapsed.
This strategy worked. Nexium is easily AstraZeneca biggest seller, bringing in $5 billion so far. And part of that is its cost: $2,000 for a year’s supply. While the drug company says an average consumer only pays a $30 co-pay for Nexium, a recent Forbes article points out that the rest of us are paying for it with higher health insurance rates.
The article also provided more details about how the company managed the switch from Prilosec to Nexium: “Intense marketing around Nexium coincided with price increases for Prilosec, pushing many patients to Nexium. Doctors, easy to woo with drug sales reps bearing samples and company-commissioned research reports, were happy to write scripts for the new drug—and oblivious of the economic implications. Insurers and their corporate clients mostly wimped out, paying full freight for Nexium. Nobody wants to be the bad guy with employees’ health coverage. But the sum of many dubious coverage decisions adds up; the nation’s health spending keeps rising at 5% to 6% a year.” Prescription drug spending accounts for about 10% of the total health pie—which is estimated to be around $260 billion for 2010.
This is scandalous in a number of ways. First, Nexium is little different from Prilosec, which can be purchased for $13.50 for a month’s supply at Costco. The difference is, one version is patented and the other is not. The company has always justified the drug by pointing to a single study that found Nexium was three percentage points better at preventing a rare form of esophageal damage than Prilosec.
But even worse, as we reported last year, acid blockers like Prilosec and Nexium incorrectly treat most people’s stomach problems, including heartburn and GERD, by turning off acid production.
While it seems counterintuitive, recent studies suggest that the problem for most stomach sufferers is not too much stomach acid, but too little! Other maladies—bloating, belching, constipation, indigestion, and even thinning hair or breaking fingernails in women—may also be the result of too little acid. So antacids may actually be making the problem worse.
If antacids and acid blockers are a cause rather than a cure for stomach problems, this would rank as one of the major medical errors of history. For more information about why most stomach sufferers may need more stomach acid, not less, see Your Stomach by Dr. Jonathan Wright.

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Another Great Vitamin B Raid?

Tue, 19 Aug 2008 19:09:39 +0000

Newspapers in 1992 proclaimed it The Great B Vitamin Raid. Armed agents stormed into the office of Jonathan Wright, MD taking hostage the clinic’s supply of Vitamin B-12 and B-complex along with the clinic’s computers, books, files, mailing list, and office equipment.
No charges were ever filed against Dr. Wright (details available in the issue of AAHF Pulse of Health Freedom). But the FDA’s action to retaliate against him was telling in three ways. First, the FDA admitted it did not have the evidence required for a search warrant. Second, the raid was clearly in retaliation for a suit filed by Wright after an earlier raid targeting the common amino acid l-tryptophan at Wright’s facility. And third, the FDA’s bias against supplements and in favor of the prescription drug industry continues to this day. This bias is what connects the dots in a variety of recent FDA actions that might otherwise seem unrelated.

Vitamin B-6 Now Under Assault

Recently, Medicure Pharma submitted a citizen’s petition to the FDA asserting the all dietary supplements containing pyridoxal 5’-phosphate (the natural bioactive form of Vitamin B6 known as P5P supplements) should be banned. As discussed in the July 7, 2008 issue of AAHF Pulse of Freedom, Medicure Pharma wanted to see this natural form of Vitamin B-6 banned from the dietary supplement industry in order to ensure the exclusivity of its drug product, MC-1.
There are prescription forms of various natural nutrients including potassium, coenzyme Q-10, and bromelain, among others. But this hasn’t been used as justification to ban the natural form.
B vitamins — some of our most basic vitamins — seem especially at risk at the moment. The law states clearly that natural substances may not be patented. But Merck holds a patent on a natural form of folate, the calcium salt of 5-methyl tetrahydrofolate, considered by many to be the best natural form of folate.
Dr. Steven W. Bailey, a researcher, was able to get five patents issued on the basis of his work with this form of folate. Merck Eprova acquired license to more than one patent covering the use of 5-methyl tetrahydrofolate, selling it under the trade name Metafolin.
Merck has since only sold this supplement in large bulk quantities and imposed stringent restrictions of the use of Metafolin in dietary supplements that include what formulas and dosages can and cannot be used. Bristol Myers Squibb also obtained a patent in 1999 for the treatment of Alzheimer’s disease using folate.

What This Means For All Of Us

B vitamins are essential nutrients. Dr. Kilmer McCully showed us that key B-vitamin nutrients help control the enzyme homocysteine, a known risk factor for heart disease as well as other conditions.
There is another reason why all of us need vitamins and other supplements and why it is essential to be able to buy them at normal prices, not patented drug prices. A British study by physician Dr. Dave Thomas (using The Chemical Composition of Food in the years 1940 through 1990) showed that most if not all fruits and vegetables have had declining nutrients over that 50-year span. Recent USDA research confirms this fact.
Factory farming has changed the nutrient composition of soil and brought unripened products to the marketplace. The emphasis now is on size, appearance, and a longer shelf-life to sell the product, not on nutritional content.
This analysis was triggered by a British physician’s curiosity. His patients had a myriad of chronic diseases yet all claimed to ‘eat well’. Indeed, government analyses in the US continue to confirm that there is a correlation between a nutrient poor diet and chronic degenerative disease.
Americans are well fed, and in many cases overfed, yet undernourished. Arizona university research has revealed that most American children get key nutrients only from their morning breakfast cereal. Additional Arizona university research has shown that most Americans get their daily vitamin C from their morning orange juice.
Fewer than ten percent of Americans get the right amount of fruits and vegetables, key sources of nutrients. And a growing number of academia-based experts indicate it is impossible to get the nutrients we need from diet alone. Under these circumstances, supplementation is essential.
May 2005 research published in the Journal of the American Medical Association (as analyzed by Jeffrey Bland, Ph.D. in the Functional Medicine Monthly notes the fact that 78% of our nation’s health care dollars go to the treatment of chronic diseases. A diet rich in processed foods, nutrient depleted foods, and a sedentary lifestyle are correlated with our nation’s alarming rates of type II diabetes, heart disease, asthma, allergies, and a host of other chronic diseases.
Combine this with the concept of drug-induced nutrient depletion. For example, oral contraceptives result in lower levels of vitamins that include B-6 as well as other B-vitamins. Steroids deplete the body of more nutrients than any other single classification of drugs.
Magnesium deficiency is widespread thanks to the generous use of certain heart disease related medications including diuretics for high blood pressure and congestive heart failure. According to some, we are now in the midst of a potential crisis of coenzyme Q-10 deficiency because statin drugs deplete this vital nutrient and statin drug use is at an all time high. Most recently, pediatricians have been told by medical authorities to give statins to children as young as age 8.
The sale of statins has also led to the demonization of cholesterol, a substance that our bodies and especially our brains need, and an effort by drug companies to redefine normal levels of total cholesterol down.
At time when Americans get far too little of key nutrients such as folic acid (B-3) because of their consumption of processed grain products, we cannot afford to ignore the move by drug companies either to ban natural vitamins or to patent them. This will restrict our use of these key nutrients and raise the costs of healthcare at a time when those costs have already spiraled out of control, in part because of drug prices. Protecting our access to key natural nutrients is good medicine, for you and me and for this nation.

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