Scientists locate the protein that will extend your life and figure out how to make it last longer

Lengthening Telomere, a DNA protein, may be a key to extending life to much older than 100 years.

Telomeres are DNA-protein complexes that protect the end of human chromosomes from DNA damage or fusion with neighboring chromosomes.  Nutritionists have long been interested in the dynamics of telomere length in the human body, and how telomeres factor into human health, lengthening life expectancy, and even have pondered the possibility of Immortality.   Research is showing that certain nutrients play a huge part in protecting telomere length, ultimately determining how long you live.

“The best analogy that we have for telomeres is that they’re like the little tabs on the end of shoelaces,” says Dr Adam Rutherford, a geneticist and author of Creation: The Origin of Life.

Just as the tabs, or “aglets”, hold the strands of the laces together, he says, telomeres – repetitive stretches of DNA on the end of each chromosome – perform the same function.

“Chromosomes are made up of a double helix, two strands of DNA, and they need an endpoint,” says Rutherford. “Without telomeres they’d unravel, like two bits of string that have been tied together.”

Studies have shown that certain Vitamins contribute to the length of a Telomere.  Scientists at the European Journal of Nutrition (EJON) found that the B vitamin folate also plays an important part in maintenance of DNA integrity and DNA methylation, which in turn influence telomere length. Researchers have found that women who use vitamin B12 supplements have longer telomeres than those who don’t. Vitamin D3, zinc, iron, omega-3 fatty acids, and vitamins C and E also influence telomere length.

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What You Need to Know About Human Organ Trafficking

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There’s that urban legend. You go to dinner with a good looking stranger, go back to their hotel room or yours, have a drink, and pass out. The next thing you know, you are in the bathtub, naked, covered in ice, with a poorly stitched side, and a phone nearby with a note attached. The note warns you to seek emergency medical care right away. According to medical anthropologist Nancy Scherper-Hughes, the truth is different, but is just as sinister and macabre, and tells us something about the state of global affairs today.

Nancy Scherper-Hughes has been working on the problem of human organ and tissue trafficking for a full decade. Yes, it is real, and it’s probably happening at a hospital near you. Encapsulated within is a travesty of justice, an argument over global equality, and the dark, secretive underbelly of medical science, which few of us have dared to peak at. Today, Scherper-Hughes is the director of Organ’s Watch, a nonprofit that keeps track of global organ trafficking. She is also the chair of Berkeley’s doctoral program in medical anthropology.

The truth is, organ trafficking is a reality in many parts of the world. Documented cases have shown up in Indonesia, China, India, South Africa, Brazil, and many other countries. The reason?The demand for organs is just so high. 123,000 men, women, and children are on the organ donor’s list right now. An average of 25 will die each day. As a result, there is a huge scramble to find organs, legitimate or otherwise.

11,000 organs were obtained on the black market in 2010, according to the WHO. That organization states that an organ is sold every hour, each day, every day of the year. Scheper-Hughes calls the demand for organs and tissues “insatiable.” According to her, it’s easier to trade in human body parts once they have been dehumanized through the processes of organ and tissue harvesting.

This high demand has set up a depressing yet all too familiar dynamic: organs going from poor to rich in the United States, and global South to global North. The poorest slums of the world supply kidneys, for instance, to donors in the U.S., Europe, Israel, and Canada. The UN is even looking into reports that ISIS, the wealthiest terrorist group ever, may be in the business of selling its victim’s organs. UN special envoy Nickolay Mladenov said that the matter is being investigated. Meanwhile, Scherper-Hughes says organ trafficking in wartime, particularly in dirty wars or those with undisciplined armies, is not uncommon.

Her life reads like that of a secret agent’s. The anthropologist has posed as a medical doctor in countries all over the world in order to investigate organ trafficking. She says, some of the U.S.’s topmost medical facilities have been caught with illegally trafficked organs. Scherper-Hughes has tracked organs to hospitals and medical centers in New York, Los Angeles, and Philadelphia, among other places. At one point, she found herself across the table from a group of organ transplant surgeons at a top Philadelphia hospital. The 60 year-old showed these physicians a sixty page report of interviews from a labyrinthine trail of buyers, sellers, and middle men, stretching across the world, showing just where the kidneys these doctors were implanting came from. The WHO estimates that one-fifth of all transplanted kidneys, or 70,000 of them, are trafficked each year.

Organized crime syndicates work behind the scenes. Their methods are varied. Sometimes they trick the person into giving up the organ. For instance, there are cases where the so-called patient is treated for a sickness they don’t have, and the traffickers make off with the organ. Or they force the person into giving it. But oftentimes, it is a cash payout that draws people out. There are cases where the person decides to sell their organ, say a kidney or a section of liver, but gets cheated, ending up with a much lower amount than what they were promised beforehand.

From there, the kidney, or whatever it is, goes to organ brokers, who can get $150,000 per transplant or more. $200,000 is not uncommon. Meanwhile, the donor usually only gets around $5,000. These brokers cross international lines to find “broker-friendly” hospitals in the U.S. and other developed nations. Two surgeons in the room with Scherper-Hughes in Philadelphia were implicated. The meeting ended poorly. The medical anthropologist was tossed out. The follow-up internal investigation turned up nothing. Scherper-Hughes believes many doctors are either involved, ignore where the organ came from, don’t ask questions, or are in denial. Let’s look at a few documented cases of organ trafficking.

In China in 2006, a state run hospital was exposed for trafficking the organs of prisoners of conscience. 10,000 transplantable organs are sold out of China each year, a market worth $1 billion, despite the fact that few donors are on official lists. This has become the subject of a documentary: “Human Harvest: China’s Organ Trafficking.” International investigators cite evidence that tens of thousands have been killed in China to support illegal organ trafficking by the government.

Al Jazeera, in February of this year, helped break up a three person trafficking ring in Indonesia. Here villagers in West Java, around 30 individuals, had sold their kidneys to the tune of $5,000 apiece. Other stories include a child in China who had his eyes cut out, possibly for the corneas, an African girl who was kidnapped and rescued in the UK before her organs could be harvested, and in America, the dizzying case of Kendrick Johnson. His death was deemed a freak accident in the school gym — they said the boy suffocated in a rolled up gym mat. Loved ones remained skeptical, however. After a protracted fight, his parents finally got a court order. They had the body exhumed and independently autopsied. During the autopsy, the medical examiner discovered something terrifying. The Georgia teen was found to have had all his organs removed and replaced with newspaper.

Though organ donation is regulated in the U.S., there are ways to beat the system. Corruptible funeral home directors forge death certificates and consent forms before the human remains are disposed of. In the developing world, people are kidnapped and used for their organs. Children sold into sexual slavery sometimes have their organs sold. And there are those in slums who give up their tissues, a piece of their liver, or their kidney, just to get their hands on a few hundred American dollars.

Scheper-Hughes has seen advertisements requesting organs in newspapers in Brazil, Moldova, and parts of Africa. She has also witnessed middlemen trawling the streets for donors in some countries holding wads of $100 bills. In China, one ad stated a kidney would get you $4,000 and a new iPad. Organ transplant tourism is a growing field, and here black market organs are often supplied.

The UN HUB or Global Initiative to Fight Human Trafficking, has listed the organ trade as one of their top priorities. Someday 3D printed organs using stem cells will make donation obsolete. But human organ trafficking will continue to be a serious, global problem as long as global inequality remains unchanged, desperate people of affluence and those just as desperate financially tight — tight regulations or not — believe there are huge profits to be had. The urban legend is scary, if not a bit melodramatic. The reality, however, as it often is, is in some sense even more horrifying.


Groundbreaking Research Links Autism with Histamine, Inflammation and Mast Cell Activation.

The study of histamine has been attracting quite a bit of attention over the last few years — and not just in relation to seasonal allergies or insect bites. The compound is also associated with a variety of other health complaints, from migraines and depression to schizophrenia. And now scientists have discovered another surprising connection to the naturally occurring chemical: autism.

The Role Histamine Plays in Immune Response

When we come in contact with an allergen that we have a sensitivity to — like pollen or we’re stung by an insect — the body releases histamine to overcome the threat. A series of physiological reactions occur: blood vessels dilate, while mast cells (a type of white blood cell) are activated to attack the invader.

If we experience an angry rash, itchy eyes or swelling, that’s histamine at work. Usually, the reaction subsides quickly once the threat is over. But sometimes, when the body is exposed to an excess of histamine — either through the ingestion of high-histamine foods or with excessive production by the body — an intolerance to the chemical may develop, which can lead to asthma, anxiety, digestive disorders, mood swings, aggression, fatigue and much more. In fact, Dr. Theoharis Theoharides, a mast cell researcher and head of the Molecular Immunopharmacology and Drug Discovery Laboratory at Tufts University, has even found mast cell activation may be the root cause of autism in many children.

The Connection Between Autism and Brain Inflammation

Autism spectrum disorders (ASDs) now affect as many as 1 in 45 children — and the numbers are rising. Considered a neurodevelopment disorder, autism is characterized by varying degrees of dysfunctional communication and social interactions, repetitive and stereotypic behaviors, as well as learning and sensory deficits. [source] Researchers are scrambling to pinpoint the reason for this disturbing trend, but the disorder has proven to be incredibly complex and treatment options are limited.

A promising study published during the summer of 2016 in Translational Psychiatry may shed some much needed light on the root cause of the disorder — and how to address it.

Dr. Theoharides and his colleagues — in collaboration with Tufts University School of Medicine, Sackler School of Graduate Biomedical Sciences, and the Department of Child Psychiatry at Harvard Medical School — believe they may have uncovered a significant cause of the core symptoms of ASD. Dr. Theoharides is considered an expert in his field and is within the top five percent of most quoted authors in scientific papers.

According to the study:

“Recent epidemiological studies have shown a strong statistical correlation between risk for ASD and either maternal or infantile atopic diseases, such as asthma, eczema, food allergies and food intolerance, all of which involve activation of mast cells (MCs). These unique tissue immune cells are located perivascularly in all tissues, including the thalamus and hypothalamus, which regulate emotions. MC-derived inflammatory and vasoactive mediators increase BBB [blood brain barrier] permeability.”

The findings indicate that levels of pro-inflammatory molecules interleukin (IL-1B, IL-6, IL-17) and tutor necrosis factor (TNF) are elevated in the brain, spinal fluid and blood of autistic patients and increase when the individual is under stress. These molecules are produced directly by mast cells.

Another paper published by Dr. Theoharides in the journal Biochimica et Biophysica Acta (BBA) – Molecular Basis of Disease found a similar correlation between mast cell activation and neurodevelopment issues:

“A number of papers, mostly based on parental reporting on their children’s health problems, suggest that ASD children may present with “allergic-like” problems in the absence of elevated serum IgE and chronic urticaria. These findings suggest non-allergic mast cell activation, probably in response to environmental and stress triggers that could contribute to inflammation. In utero inflammation can lead to preterm labor and has itself been strongly associated with adverse neurodevelopmental outcomes. Premature babies have about four times higher risk of developing ASD and are also more vulnerable to infections, while delayed development of their gut–blood–brain barriers makes exposure to potential neurotoxins likely. Perinatal mast cell activation by infectious, stress-related, environmental or allergic triggers can lead to release of pro-inflammatory and neurotoxic molecules, thus contributing to brain inflammation and ASD pathogenesis, at least in a subgroup of ASD patients.”

Likewise, this study study in Cellular and Molecular Neurobiologydiscovered that “Histamine is one of the few central nervous system neurotransmitters found to cause consistent blood–brain barrier opening” which is a factor in inflammation, cerebral edema and what Dr. Theoharides calls “allergy of the brain” in ASD patients.

Moreover, when large amounts of histamine are present, the body triggers the production of epinephrine (adrenaline) to correct the imbalance. Adrenaline then sparks a flight or fight response within the body. If this heightened state of stress becomes chronic, it interferes with stomach acid production and overall digestion — leading to parasites, pathogenic bacteria and food sensitivities. The body also dumps magnesium and zinc into the muscles to prepare for a quick reaction. This in turn creates deficiencies of these important minerals, which are crucial for the immune system and neurological development. Disruption of sleep, anxiety, learning disabilities and malabsorption issues soon follow.

Reducing Mast Cell Activation

To reduce mast cell activation and subsequent inflammation, several approaches are effective. One is to consume a low-histamine diet. Another is to use carnosine and methylated B vitamins. To breakdown histamine in the digestive tract, supplementing with diamine oxidase (DAO) may be necessary if the individual is susceptible to low DAO levels through genetic heritage or diet. Many times, people who are deficient in DAO also suffer from allergies and auto-immune disorders, both of which are common in ASD individuals.

Dr. Theoharides has also examined the possible use of luteolin and other bioflavonoids such as quercetin for their calming properties in relation to mast cell activation and brain inflammation.

In the paper Atopic diseases and inflammation of the brain in the pathogenesis of autism spectrum disorders, Dr. Theoharides concludes:

“Atopic diseases may create a phenotype susceptible to ASD and formulations targeting focal inflammation of the brain could have great promise in the treatment of ASD.”

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Umbilical cord blood could slow brain’s ageing, study suggests.

Scientists hope protein infusion which rejuvenated brains of aged mice could combat mental decline in older people

CT scans of a patient with Alzheimer’s disease. If the protein therapy is effective in humans it could be a potent weapon against neurodegenerative diseases such as Alzheimer’s.
CT scans of a patient with Alzheimer’s disease. If the protein therapy is effective in humans it could be a potent weapon against neurodegenerative diseases such as Alzheimer’s. 

Scientists have reversed memory and learning problems in aged mice with infusions of a protein found in human umbilical cord blood.

The striking results have raised hopes for a treatment that staves off mental decline in old age, but researchers stressed that more studies, including human trials, are needed before the therapy can be considered for clinical use.

Tests on frail rodents found that the protein therapy rejuvenated an area of the brain called the hippocampus, which is crucial for memory formation, and one of the first and most important regions to deteriorate in old age.

Older mice that received the treatment reacted like younger animals in a series of behavioural tests, according to researchers at Stanford University in California. They escaped from a maze faster than before, had better memories, and started building nests again, a skill the animals tend to lose in old age.

Researchers led by Tony Wyss-Coray made the discovery after they noticed that human umbilical cord blood had unusually high levels of a protein called TIMP2 when compared with blood from older people. When injected into mice, the protein ramped up the activity of a group of genes that revitalised the hippocampus, and made it more able to adapt to new information. Details of the study are reported in Nature.

The work is the latest in a string of studies that suggest molecules found in young blood may be able to rejuvenate old brains and other tissues. If the therapies are effective in humans, they could become a potent weapon against the cognitive decline that comes with old age, and also neurodegenerative diseases such as Alzheimer’s.

But until the treatment has proved itself in humans, scientists are roundly cautious of the work. The lesson from Alzheimer’s research on mice is that almost everything works in the animals, and so far nothing works in humans, said Rob Howard, professor of old age psychiatry at University College London. “Having taken that on on board, this is a really interesting way to understand how we might help people who are aged or in the early stages of the disease,” he said. The protein therapy might not reverse brain ageing, or halt Alzheimer’s, but it might boost what remains of the healthy brain to at least offset some of the decline that accompanies old age.

Jennifer Wild, a clinical psychologist at Oxford University, said that while the results were interesting, it was too early to consider it as a therapy for humans. “It’s exciting for mice who have cognitive ageing, but it’s way too early to start extrapolating that to say we can help humans,”, she said.

Early Clinical Trial Shows ‘Cancer Vaccines’ Can Protect Humans From Tumours 

Cancer comes in many different forms, and it is not unusual for diagnosed patients to endure multiple kinds of treatments before one that is effective against their particular form of cancer is found.

If it takes too long for doctors to find the right treatment, the consequences can be fatal.


The severity of cancer has fuelled physicians and scientists from all walks of life to explore any possible solution, including those that seem natural to those that may at times seem unconventional.

Well, researchers are now taking vaccines, which typically target viruses and bacteria, and reworking them to zero in on the patient’s specific cancer cells.

Physicians and scientists led by Catherine Wu at the Dana-Farber Cancer Institute in Boston just presented their results of their new cancer therapy to the American Association for Cancer Research (AACR) in Washington, DC.

Their personalised vaccines have prevented early relapse in 12 patients with skin cancer, while also boosting patient immunity when combined with a cancer drug.

While earlier cancer vaccines targeted a singular cancer protein found ubiquitously among patients, these personalised vaccines contain neoantigens, which are mutated proteins specific to an individual patient’s tumour.

 These neoantigens are identified once a patient’s tumour is genomically sequenced, providing physicians with the information they need to pinpoint unique mutations.

Once a patient’s immune system is provided a dose of the tumour neoantigens, it can activate the patient’s T cells to attack cancer cells.

Unlike previous attempts towards cancer vaccines, which did not produce conclusive evidence in halting cancer growth, Wu’s team made their personal vaccine much more specific to each patient’s cancer, targeting about 20 neoantigens per patient.

The vaccines were injected under the patients’ skin for a period of five months and indicated no side effects and a strong T cell response.

All of Wu’s patients who were administered the personal vaccine are still cancer-free more than 2.5 years after the trial.

However, some patients with an advanced forms of cancer also needed an some extra punching power to fend off their diseases.

Two of Wu’s patients who did relapse were administered an immunotherapy drug, PD-1 checkpoint inhibitor, in addition to the personalised vaccine.

Working in conjunction with the enhanced T cell response from the vaccine, the drug makes it difficult for the tumour to evade the immune cells. The fusion of the two therapies eliminated the new tumours from both patients.

But we can’t get too excited yet. While these results are promising, the therapies are relatively new and require much more clinical testing.

Many physicians around the world are working together to test the potency of neoantigens in order to verify if the vaccine works better than current immunotherapy drugs over a sustainable period of time.

Personalised vaccines are costly and take months to create, a limiting factor in providing care to patients with progressing cancers.

Still, this study is an encouraging sign for many oncologists who are interested in using the immune system to fight cancer.

More than a million new patients are diagnosed with cancer each year in the U.S. alone, and even in situations where the cancer is treatable, the available chemotherapy agents themselves can be very toxic.

If proven safe and effective, this personalised cancer vaccine could give patients around the world hope for powerful treatment with fewer side effects.

Male contraceptive jab almost 100 per cent effective… and it can increase libido

A contraceptive injection for men has been shown to be almost 100 per cent effective, and may also increase libido.

The hormone-based jab is designed to lower sperm counts by acting on the brain’s pituitary gland.

Over a year-long trial, nearly 96 per cent of couples relying on the injection to prevent unplanned pregnancies found it to be effective. During this time, only four pregnancies occurred among the men’s partners.

 However, researchers said more work was needed to address the treatment’s reported side effects, which included depression and other mood disorders, muscle pain and acne. However it did also increase libido.

Dr Mario Festin, from the World Health Organisation in Geneva, Switzerland, said: “The study found it is possible to have a hormonal contraceptive for men that reduces the risk of unplanned pregnancies in the partners of men who use it.

“Our findings confirmed the efficacy of this contraceptive method previously seen in small studies.”

The contraceptive was found to be 96 per cent effective during 12 month trials 
The contraceptive was found to be 96 per cent effective during 12 month trials 

The injections contained a long-acting form of progestogen, a hormone that has the effect of blocking sperm production controlled by the pituitary gland.

Nearly 300 men were given injections every two months, which reduced sperm count to one million per millilitre or fewer within 24 weeks. At the end of the trial, three-quarters of the men said they would be willing to continue using the contraceptive jab.

Prof Allan Pacey at the University of Sheffield said: “There is certainly an unmet need for an effective reversible contraceptive for men, along the lines of the hormonal contraceptive for women.

“However, none of the preparations that have been developed and tested to date have managed to become a commercial reality for one reason or another.

“In this latest study, the authors used a combination of hormones (progesterone and testosterone) to try and take the science forward. Using long-acting injectable forms of these hormones they were able to suppress the production of sperm to a remarkable degree. As such, this contraceptive was extremely effective and therefore certainly has promise.

“However, the fact that so many side effects were observed in the men who were taking part in the trial is of concern. For a male contraceptive to be accepted by men (or women) then it has to be well tolerated and not cause further problems.”

Source: Journal of Clinical Endocrinology & Metabolism

Cyanide suicide of Oxford academic after she revealed she was transgender

An Oxford University chemist poisoned herself with cyanide after telling her family and friends she was transgender, an inquest heard.

Erin Shepherd took her own life despite being apparently pleased with her transition from man to woman, Oxford Coroner’s Court was told.


Erin Shepherd, an Oxford University researcher, was found by firemen who forced their way into her flat

The 27-year-old was found dead in her flat in East Oxford after sending a suicide note via email to her parents and two sisters.

The researcher was found by firemen who forced their way into her flat, after shutting down the whole street alongside police and paramedics.

She was discovered near a container of white powder, which was confirmed as cyanide.

This was a great shock. Those closest to her did not foresee this.Oxfordshire coroner Darren Salter

Oxfordshire coroner Darren Salter described her suicide in January as a “tragic case'”, adding: “This was a great shock.

“Those closest to her did not foresee this. Things seemed to be going in the right direction. Very sadly, something caused her to decide to take her own life.”

Mr Salter read evidence from Miss Shepherd’s doctor, Richard Baskerville, who said she registered in 2015 under her former name, David Shepherd.

Mr Baskerville’s statement added: “She had recently come out as transgender. She had an extensive circle of friends and was pleased with her progress in transitioning. Her death was a sudden and tragic event.”

Miss Shepherd had completed her DPhil in chemistry at Corpus Christi College and had recently started as a paid academic in the chemistry department.

She had changed her name and was taking speech therapy to adopt a new identity.

Oxford cyanide
The property in Oxford where Erin Shepherd  was found. CREDIT: INS

Detective Sergeant Kevin Parsons, of Oxford CID, said Miss Shepherd accessed the university labs at 6am on the day she died, and it was likely to be around that time that she took the cyanide. At the inquest, he said: “She had struggled with her gender identity for most of her life.

 “She was doing well and showing no signs of unhappiness.”

He told the court how Miss Shepherd was unable to attend school as a teenager after being diagnosed with chronic fatigue syndrome, but worked hard to achieve.

Police were called to Miss Shepherd’s home by her sister Sophie Shepherd, after she received an email entitled ‘I am so sorry’.

The court heard she rang her sister urging her to flush the cyanide down the toilet, to no avail.

The university released a statement that said Miss Shepherd was “an outstanding chemist” whose death “greatly saddened” her friends.

Mr Salter concluded Miss Shepherd died of suicide.


How the trauma of life is passed down in SPERM, affecting the mental health of future generations

  • The changes are so strong they can even influence a man’s grandchildren
  • They make the offspring more prone to conditions like bipolar disorder

The children of people who have experienced extremely traumatic events are more likely to develop mental health problems.

And new research shows this is because experiencing trauma leads to changes in the sperm.

These changes can cause a man’s children to develop bipolar disorder and are so strong they can even influence the man’s grandchildren.

Psychologists have long known that traumatic experiences can induce behavioural disorders that are passed down from one generation to the next.

However, they are only just beginning to understand how this happens.

Researchers at the University of Zurich and ETH Zurich now think they have come one step closer to understanding how the effects of traumas can be passed down the generations.

The researchers found that short RNA molecules – molecules that perform a wide range of vital roles in the body – are made from DNA by enzymes that read specific sections of the DNA and use them as template to produce corresponding RNAs.

Other enzymes then trim these RNAs into mature forms.

Cells naturally contain a large number of different short RNA molecules called microRNAs.

They have regulatory functions, such as controlling how many copies of a particular protein are made.

The researchers studied the number and kind of microRNAs expressed by adult mice exposed to traumatic conditions in early life and compared them with non-traumatised mice.

They discovered that traumatic stress alters the amount of several microRNAs in the blood, brain and sperm – while some microRNAs were produced in excess, others were lower than in the corresponding tissues or cells of control animals.

These alterations resulted in misregulation of cellular processes normally controlled by these microRNAs.

After traumatic experiences, the mice behaved markedly differently – they partly lost their natural aversion to open spaces and bright light and showed symptoms of depression.

Men who have experienced traumatic events are more likely to have children with mental health problems

Men who have experienced traumatic events are more likely to have children with mental health problems

 These behavioural symptoms were also transferred to the next generation via sperm, even though the offspring were not exposed to any traumatic stress themselves.

The metabolisms of the offspring of stressed mice were also impaired – their insulin and blood sugar levels were lower than in the offspring of non-traumatised parents.

‘We were able to demonstrate for the first time that traumatic experiences affect metabolism in the long-term and that these changes are hereditary,’ said Professor Isabelle Mansuy.

‘With the imbalance in microRNAs in sperm, we have discovered a key factor through which trauma can be passed on.’

However, certain questions remain open, such as how the dysregulation in short RNAs comes about.

Professor Mansuy said: ‘Most likely, it is part of a chain of events that begins with the body producing too many stress hormones.’

Importantly, acquired traits other than those induced by trauma could also be inherited through similar mechanisms, the researcher suspects.

Generic Drugs: Questions and Answers

What are generic drugs?

A generic drug is identical — or bioequivalent — to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price. According to the Congressional Budget Office, generic drugs save consumers an estimated $8 to $10 billion a year at retail pharmacies. Even more billions are saved when hospitals use generics.

Generic vs Brand: Same Quality and Performance

Is there a generic equivalent for my brand-name drug?

To find out if there is a generic equivalent for your brand-name drug, use Drugs@FDA, a catalog of FDA-approved drug products, as well as drug labeling.

You can also search for generic equivalents by using the “Electronic Orange Book.” Search by proprietary “brand” name,” then search again by using the active ingredient name. If other manufacturers are listed besides the “brand name” manufacturer when searching by the “active ingredient,” they are the generic product manufacturers.

Since there is a lag time after generic products are approved and they appear in the “Orange Book,” you should also consult the most recent monthly approvals for “First Generics“.

Are generic drugs as effective as brand-name drugs?

Yes. A generic drug is the same as a brand-name drug in dosage, safety, strength, quality, the way it works, the way it is taken and the way it should be used.

FDA requires generic drugs have the same high quality, strength, purity and stability as brand-name drugs.

Not every brand-name drug has a generic drug. When new drugs are first made they have drug patents. Most drug patents are protected for 20 years. The patent, which protects the company that made the drug first, doesn’t allow anyone else to make and sell the drug. When the patent expires, other drug companies can start selling a generic version of the drug. But, first, they must test the drug and the FDA must approve it.

Creating a drug costs lots of money. Since generic drug makers do not develop a drug from scratch, the costs to bring the drug to market are less; therefore, generic drugs are usually less expensive than brand-name drugs. But, generic drug makers must show that their product performs in the same way as the brand-name drug.

How are generic drugs approved?

Drug companies must submit an abbreviated new drug application (ANDA) for approval to market a generic product. The Drug Price Competition and Patent Term Restoration Act of 1984, more commonly known as the Hatch-Waxman Act, made ANDAs possible by creating a compromise in the drug industry. Generic drug companies gained greater access to the market for prescription drugs, and innovator companies gained restoration of patent life of their products lost during FDA’s approval process.

New drugs, like other new products, are developed under patent protection. The patent protects the investment in the drug’s development by giving the company the sole right to sell the drug while the patent is in effect. When patents or other periods of exclusivity expire, manufacturers can apply to the FDA to sell generic versions.

The ANDA process does not require the drug sponsor to repeat costly animal and clinical research on ingredients or dosage forms already approved for safety and effectiveness. This applies to drugs first marketed after 1962.

What standards do generic drugs have to meet?

Health professionals and consumers can be assured that FDA approved generic drugs have met the same rigid standards as the innovator drug. To gain FDA approval, a generic drug must:

  • contain the same active ingredients as the innovator drug(inactive ingredients may vary)
  • be identical in strength, dosage form, and route of administration
  • have the same use indications
  • be bioequivalent
  • meet the same batch requirements for identity, strength, purity, and quality
  • be manufactured under the same strict standards of FDA’s good manufacturing practice regulations required for innovator products.

Are generics really the same as branded drugs?

In October the Food and Drug Administration took a highly unusual step: It declared that a generic drug it had previously approved — a version of the popular antidepressant Wellbutrin — was not in fact “bioequivalent” to the name-brand version. The FDA withdrew its approval.

If you’re a layperson, this is the way you probably think of generics: They’re the exact same products in different packaging; generics companies can sell such medications for a fraction of the cost of the originals because they don’t have to spend huge sums on drug development and marketing.

That apparent miracle explains why more than 80% of all U.S. prescriptions dispensed in 2012 were generic. Using nonbranded medications saved Americans $193 billion this past year, according to the Generic Pharmaceutical Association.

The FDA’s rules effectively acknowledge that. The agency’s definition of bioequivalence is surprisingly broad: A generic’s maximum concentration of active ingredient in the blood must not fall more than 20% below or 25% above that of the brand name. This means a potential range of 45%, by that measure, among generics labeled as being the same.

There are other differences. The generic must contain the same active ingredient as the original. But the additional ingredients, known as excipients, can be different and are often of lower quality. Those differences can affect what’s called bioavailability — the amount of drug that could potentially be absorbed into the bloodstream. As the American Heart Association recently noted, “Some additives traditionally thought to be inert, such as alcohol sugars, cyclodextrans, and polysorbate-80, may alter a drug’s dissolution, thereby impacting its bioavailability.”

That can result in drugs that release active ingredients into the blood far more quickly, leaving patients feeling dizzy or nauseated. Barbara Davit, director of the division of bioequivalence II in the FDA’s Office of Generic Drugs, acknowledges that the agency does not apply “formal statistics” to measuring Tmax, the time it takes for a drug to reach maximum concentration. But reviewers do informally consider it, she says, asserting that applications have been rejected because of Tmax results.

Much of the credit for the FDA’s decision to withdraw its approval for Teva’s version of Wellbutrin goes to Joe Graedon, a pharmacologist, advocate, and co-host, with his wife, Terry, of an NPR radio program called The People’s Pharmacy. Prompted in large part by a deluge of critical reports from listeners who felt sickened by generics or found them ineffective, he undertook his own research. In 2008 he encouraged an independent laboratory to test the generic equivalent of Wellbutrin 300 mg after listeners complained that Teva’s version, Budeprion XL, had made them feel woozy, sick to their stomach, or even suicidal.

Joe Graedon, a pharmacologist and radio host, has pushed for transparency on nonbranded drugs.

He was stunned to learn that the generic’s active ingredient dissolved four times more quickly in the first two hours than that of the brand name because of a different time-release mechanism. Graedon began pushing the FDA to release more results from generic-drug companies’ pharmacologic studies. (The FDA generally relies on company tests rather than conduct its own.)

The FDA refused to divulge the data, deeming it proprietary. For five years the agency dismissed complaints from Graedon and others that the generic Wellbutrin wasn’t the same as the original. Eventually, however, patient advocates pressured the regulators to conduct their own tests. The results revealed that on average Teva’s product achieved a 75% concentration within the blood — below the 80% minimum — and in some cases delivered as little as 40%. (This episode is extremely unusual, argues Gordon Johnston, a representative for the Generic Pharmaceutical Association, who says the FDA’s standard “has been demonstrated to assure bioequivalence between brand and generic drugs.” Johnston notes that the agency occasionally withdraws approval for name-brand drugs too.)

At a meeting of the FDA’s advisory committee for pharmaceutical science and clinical pharmacology in 2011, Dr. James Hennessey, clinical director of the division of endocrinology at Beth Israel Deaconess Medical Center in Boston, presented evidence of three different generic formulations of levothyroxine (used to treat hypothyroidism). All were more potent than the branded version and varied from one another. One was 12.5% above, another 9% above, and another 3% above the brand name’s potency. All had been approved as bioequivalent. Noting that “less than 10% dose intervals make clinical differences,” Hennessey told the advisory committee meeting, “These differences are too large.”

The committee voted to support the tightening of bioequivalence standards for narrow therapeutic index drugs. The FDA’s Davit says the agency is working on a proposal to “narrow the acceptance criteria.”

Those are the questions that hover over generics when manufacturers follow the rules. Then there are the issues that occur when they don’t.

With an estimated 80% of active drug ingredients and 40% of finished medications coming from overseas — in some cases from manufacturing plants that the FDA has not yet inspected — quality can be significantly compromised. In November the maker of generic Lipitor, Ranbaxy Pharmaceuticals, recalled 480,000 bottles after tiny shards of glass were found inside pills. (The FDA granted Ranbaxy, India’s largest generics company, permission to produce a version of the anticholesterol medication, a process Fortunechronicled in a 2011 article titled “The War Over Lipitor.” The approval came after a seven-year investigation in which the Justice Department concluded that, among other misbehavior, Ranbaxy had fabricated drug-approval data. The company agreed to pay $500 million and entered into a consent decree.)

The FDA’s position that generics are safe and therapeutically identical has rarely varied. But in October 2010, Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, acknowledged in a speech to the Generic Pharmaceutical Association, “I’ve heard it enough times from enough people to believe that there are a few products that aren’t meeting quality standards.”

Such admissions have done little to slow the drive toward generics. As Graedon points out, patients, insurers, and the government all benefit from the massive cost savings of using generics. Few have wanted to ask questions. Now, in the wake of the FDA’s action in the Teva case, that may begin to change.


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