Sugar kills good cholesterol,

sugar

sugar

Scientists at the University of Warwick have discovered that ‘good’ cholesterol is turned ‘bad’ by a sugar-derived substance.

The substance, methylglyoxal – MG, was found to damage ‘good’ HDL cholesterol, which removes excess levels of bad cholesterol from the body.

Low levels of HDL, High Density Lipoprotein, are closely linked to heart disease, with increased levels of MG being common in the elderly and those with diabetes or kidney problems.

Supported by funding from the British Heart Foundation (BHF) and published in Nutrition and Diabetes, the researchers discovered that MG destabilises HDL and causes it to lose the properties which protect against heart disease.

HDL damaged by MG is rapidly cleared from the blood, reducing its HDL content, or remains in plasma having lost its beneficial function.

Lead researcher Dr Naila Rabbani, of the Warwick Medical School, says that: “MG damage to HDL is a new and likely important cause of low and dysfunctional HDL, and could count for up to a 10% risk of heart disease”.

There are currently no drugs that can reverse low levels of HDL, but the Warwick researchers argue that by discovering how MG damages HDL has provided new potential strategies for reducing MG levels.

Commenting on the research’s implications Dr Rabbani said:

“By understanding how MG damages HDL we can now focus on developing drugs that reduce the concentration of MG in the blood, but it not only be drugs that can help.

“We could now develop new food supplements that decrease MG by increasing the amount of a protein called glyoxalase 1, or Glo 1, which converts MG to harmless substances.

“This means that in future we have both new drugs and new foods that can help prevent and correct low HDL, all through the control of MG.”

A potentially damaging substance, MG is formed from glucose in the body. It is 40,000 times more reactive than glucose it damages arginine residue (amino acid) in HDL at functionally important site causing the particle to become unstable.

Glo1 converts MG to harmless substances and protects us. MG levels are normally kept low in the body to maintain good health but they slowly increase with ageing as Glo1 slowly becomes worn out and is only slowly replaced.

Dr Rabbani says: “We call abnormally high levels of MG ‘dicarbonyl stress’. This occurs in some diseases – particularly diabetes, kidney dialysis, heart disease and obesity. We need sufficient Glo1 to keep MG low and keep us in good health.”

Source:   eurekalert.org

New drug keeps you sober

New drug may keep you sober no matter how much you’ve had to drink:

 

New drug may keep you sober no matter how much you've had to drink

New drug may keep you sober no matter how much you’ve had to drink

 

Imagine a pill that could instantly sober you up no matter how much you’ve had to drink, or a hangover cure that worked minutes after swallowing it. Hardened drinkers rejoice: researchers are about to begin human trials on an “alcohol antidote” that may soon offer a cure to alcoholism.
The drug is a chemical called dihydromyricetin, or DHM, and is derived from a Chinese variety of the oriental raisin tree, which has been used for at least 500 years in China as an effective hangover cure. So far the extract has only been tested on boozing rats, but with promising results.
“DHM will reduce the degree of drunkenness for the amount of alcohol drunk and will definitely reduce the hangover symptoms,” said Jing Liang, lead researcher in the study. “In time, it will reduce [an alcoholic’s] desire for alcohol.”
Liang first tested how well DHM alleviated drunken rats’ clumsiness and loss of coordination by measuring how long it took them to right themselves after being laid on their backs. Rats were injected with an alcohol equivalent of a human drinking 15 to 20 beers in two hours to ensure that they were sufficiently wasted. As one would expect, it took the rats about 70 minutes just to get back up on their feet. After a milligram of DHM (per kilogram of rat body weight) was added to the mixture, however, the rats were able to right themselves in just five minutes.
The rats were next tested within a maze to see how well DHM neutralized hangover symptoms. Rats with a hangover typically react by cowering away in the corners of a maze, seemingly lacking motivation to seek an endpoint. But once those rats were given an appropriate dosage of DHM, their inquisitiveness was revived and they reacted just as rats that were given no alcohol at all.
Lastly, Liang tested whether DHM could cure alcohol addiction in rats. Boozy rodents were given a choice of drinking a sweetened solution of alcohol or sweetened water. Over a period of three months with DHM treatment, rats drank only a quarter the amount of alcohol that rats given no treatment drank.
Provided that the drug works as effectively in humans as it does in rats, DHM could be a breakthrough in the fight against alcoholism. But some researchers are concerned that it could eventually lead to more drinking rather than less. For instance, development of a similar compound called Ro15-4513 was abandoned several years ago due in part to such concerns.
“There was a lot of philosophical worry that an ‘alcohol antidote’ would entice people to consume alcohol and then count on being able to terminate the intoxicating effects on demand,” said Markus Heilig, clinical director of the U.S. National Institute on Alcohol Abuse and Alcoholism.
It’s certainly easy to imagine how such a drug could be abused. Drinkers could become intoxicated, then take a pill when it comes time to drive themselves home. Hangovers would also no longer be a deterrent to imbibing. But for those struggling to overcome an alcohol addiction — not to mention the 2.5 million people who are estimated to die every year due to alcoholism — the drug could be a godsend and well worth the risks.
Source:   mnn.com

High IQ and drug use

People that use drugs, are generally smarter than their counter parts:

High IQ linked to drug use

High IQ linked to drug use

The “Just Say No” generation was often told by parents and teachers that intelligent people didn’t use drugs.   Turns out, the adults may have been wrong.

A new British study finds children with high IQs are more likely to use drugs as adults than people who score low on IQ tests as children.  The data come from the 1970 British Cohort Study, which has been following thousands of people over decades.  The kids’ IQs were tested at the ages of 5, 10 and 16.  The study also asked about drug use and looked at education and other socioeconomic factors.  Then when participants turned 30, they were asked whether they had used drugs such as marijuana, cocaine and heroin in the past year.

Researchers discovered men with high childhood IQs were up to two times more likely to use illegal drugs than their lower-scoring counterparts.  Girls with high IQs were up to three times more likely to use drugs as adults.  A high IQ is defined as a score between 107 and 158.  An average IQ is 100. The study appears in the Journal of Epidemiology and Community Health.

The lead researcher says he isn’t surprised by the findings.  “Previous research found for the most part people with high IQs lead a healthy life, but that they are more likely to drink to excess as adults,” says James White a psychologist at Cardiff University in the United Kingdom.

It’s not clear why people with high childhood IQs are more likely to use illegal drugs.  “We suspect they may be more open to new experiences and are more sensation seeking,” says White.  In the paper, White and his co-author also mention other studies that find high IQ kids may use drugs because they are bored or to cope with being different.

That seems to ring true for one of my childhood classmates. Tracey Helton Mitchell was one of the smartest kids in my middle school. But, by the time she was in her early 20’s, Tracey was a heroin addict. I found out while flipping channels one sleepless night and stumbled upon the documentary “Black Tar Heroin.”

“I was confident in my abilities but there was a dissonance,” says Tracey, with whom I recently reconnected.  “No matter what I did, what I said, where I went, I was never comfortable with the shell I carried called myself.”

 

Source: CNN.Com

Protein Drug mimic’s food deprivation

A Drug That Can Extend Life as Effectively As Dieting:

A Drug That Can Extend Life as Effectively As Dieting

A Drug That Can Extend Life as Effectively As Dieting

Many studies have shown that rigorous caloric restriction, or strict dieting, can increase longevity dramatically in lifeforms from yeast to humans. But a study released today shows one way to mimic the life-extending effects of food deprivation – using drugs.

A team of researchers in the UK explored the role of a protein known as S6K1, which turns out to play an extraordinary role in aging and age-related disease. When the researchers grew mice lacking the gene to produce S6K1, their mice lived significantly longer (see chart – the red lines are mice without S6K1). They also developed fewer age-related debilitating conditions.

A Drug That Can Extend Life as Effectively As Dieting

Female mice without S6K1 lived slightly longer than their male counterparts, and over 160 days longer than the control group. That means the female mouse lifespan increased by twenty percent.

Mice without S6K1 also lost weight, even if they ate more than ordinary mice. In other words, a substance that could block the expression of S6K1 would trick the body into thinking that you’d gone on a very rigorous diet. And it would make you healthier into an older age. The best part?

In their paper, the researchers conclude:

It might be possible to develop drug treatments that manipulate S6K1 and AMPK to achieve improved overall health in later life. Indeed, short-term rapamycin treatment reduces adiposity in mice, and metformin treatment [often used against type 2 diabetes] extends lifespan in short-lived mice.

This is good news, because often when researchers make discoveries related to longevity there is no immediate pathway to manufacturing a life-extending drug. For all of us who want to stay healthy in old age while still eating sugar and fat once in a while, let’s hope this research team starts testing a drug based on their S6K1 discovery – and soon.

Drugs Create Super-Soldier

5 Drugs Used to Create a Super-Soldier:

 

5 Drugs Used to Create a Super-Soldier

5 Drugs Used to Create a Super-Soldier

Even though Super-Soldiers might sound like a bad narrative from a sci-fi film, they are more real than ever in a world obsessed with technological and biological advancement. Forget about crazy scientists in abandoned castlesthese drugs are real and they really work too. These drugs aren’t locked away in Area 51 type secret government bases either, a lot of these drugs are actually available right now for anyone to buy.

 

1. XBD173 : Anxiety Killer

Shell shock, post traumatic stress, different names but the same meaning. XBD173 is a drug that can not only eradicate anxiety and fear but it can do it instantly without any side effects or withdrawal symptoms. In total 1 in 8 soldiers, who’ve fought in the Iraq war, suffer from post traumatic stress disorder which is over 10% of the armed forces. Removing anxiety would create fearless and unstoppable soldiers who wouldn’t be affected by any of war’s brutalities or cruelties.

2. Provigil : No More Sleep

Imagine a soldier that didn’t need to sleep or rest half as much as a ‘normal’ soldier did? Completely possible with Provigil (AKA Modafinil) which was initially created to deal with narcolepsy, shift work sleep disorder and excessive daytime sleepiness. The drug radically improves work rate and alertness which means even with less sleep or rest, a soldier can work harder and more effectively.

3. D-IX : Nazi Cocaine

D-IX is a cocaine based drug originally created by the Nazis under Hitler’s evil reign. Criminologist and expert Wolf Kemper said “It was Hitler’s last secret weapon to win a war he had already lost long ago”. The drug was initially tested on prisoners at the Sachsenhausen concentration camp, they were given 20kg packs to carry and which marched with for 90km without rest.

4. Valproic Acid : Super Survivors

When a soldier suffers an injury that causes rapid blood loss, the body’s reaction is to go into shock which will sustain life for a short time however, if the body stays in shock for more than a short time, it can lead to organ failure, and death can soon follow. Valproic acid causes 87% of blood loss victims to survive (well in cows at least) which means that it could be possible to survive for prolonged hours after a bad injury.

5. Select Androgen Receptor Modulators : Instant Muscle Mass

Anabolic steroids are simply concentrated amounts of testosterone that rapidly build muscle mass but scientists have never been able to completely rid undesired side effects, until now. SARMs are a new and improved version of anabolic steroids that allows huge muscle growth without any side effects, whilst a potential super soldier wouldn’t be the size of the Incredible Hulk or nearly as green, this almost overnight treatment could turn a scrawny bunch of boys into a bulky troop of men.

Anti-CD47 eliminates all cancer cells

One Drug to Shrink All Tumors:

 anti-CD47 in addition to chemotherapy

anti-CD47 in addition to chemotherapy

A single drug can shrink or cure human breast, ovary, colon, bladder, brain, liver, and prostate tumors that have been transplanted into mice, researchers have found. The treatment, an antibody that blocks a “do not eat” signal normally displayed on tumor cells, coaxes the immune system to destroy the cancer cells. A decade ago, biologist Irving Weissman of the Stanford University School of Medicine in Palo Alto, California, discovered that leukemia cells produce higher levels of a protein called CD47 than do healthy cells. CD47, he and other scientists found, is also displayed on healthy blood cells; it’s a marker that blocks the immune system from destroying them as they circulate. Cancers take advantage of this flag to trick the immune system into ignoring them. In the past few years, Weissman’s lab showed that blocking CD47 with an antibody cured some cases of lymphomas and leukemias in mice by stimulating the immune system to recognize the cancer cells as invaders. Now, he and colleagues have shown that the CD47-blocking antibody may have a far wider impact than just blood cancers. “What we’ve shown is that CD47 isn’t just important on leukemias and lymphomas,” says Weissman. “It’s on every single human primary tumor that we tested.” Moreover, Weissman’s lab found that cancer cells always had higher levels of CD47 than did healthy cells. How much CD47 a tumor made could predict the survival odds of a patient. To determine whether blocking CD47 was beneficial, the scientists exposed tumor cells to macrophages, a type of immune cell, and anti-CD47 molecules in petri dishes. Without the drug, the macrophages ignored the cancerous cells. But when the CD47 was present, the macrophages engulfed and destroyed cancer cells from all tumor types. Next, the team transplanted human tumors into the feet of mice, where tumors can be easily monitored. When they treated the rodents with anti-CD47, the tumors shrank and did not spread to the rest of the body. In mice given human bladder cancer tumors, for example, 10 of 10 untreated mice had cancer that spread to their lymph nodes. Only one of 10 mice treated with anti-CD47 had a lymph node with signs of cancer. Moreover, the implanted tumor often got smaller after treatment — colon cancers transplanted into the mice shrank to less than one-third of their original size, on average. And in five mice with breast cancer tumors, anti-CD47 eliminated all signs of the cancer cells, and the animals remained cancer-free 4 months after the treatment stopped. “We showed that even after the tumor has taken hold, the antibody can either cure the tumor or slow its growth and prevent metastasis,” says Weissman. Although macrophages also attacked blood cells expressing CD47 when mice were given the antibody, the researchers found that the decrease in blood cells was short-lived; the animals turned up production of new blood cells to replace those they lost from the treatment, the team reports online today in the Proceedings of the National Academy of Sciences. Cancer researcher Tyler Jacks of the Massachusetts Institute of Technology in Cambridge says that although the new study is promising, more research is needed to see whether the results hold true in humans. “The microenvironment of a real tumor is quite a bit more complicated than the microenvironment of a transplanted tumor,” he notes, “and it’s possible that a real tumor has additional immune suppressing effects.” Another important question, Jacks says, is how CD47 antibodies would complement existing treatments. “In what ways might they work together and in what ways might they be antagonistic?” Using anti-CD47 in addition to chemotherapy, for example, could be counterproductive if the stress from chemotherapy causes normal cells to produce more CD47 than usual. Weissman’s team has received a $20 million grant from the California Institute for Regenerative Medicine to move the findings from mouse studies to human safety tests. “We have enough data already,” says Weissman, “that I can say I’m confident that this will move to phase I human trials.”

 

Russian Narcotics expert Olga Zelenina Jailed

Outcry over jailed Russian chemist:

Olga Zelenina

Olga Zelenina

Narcotics expert Olga Zelenina falsely accused of aiding drug trafficking, say supporters. A Russian chemist stands accused of complicity in organized drug trafficking, and is currently imprisoned in Moscow’s detention centre number 6, where she shares a cell with Nadezhda Tolokonnikova, a member of the prominent activist punk band Pussy Riot. But Zelenina’s supporters say she is the victim of a monstrous miscarriage of justice, and has done nothing more than provide an expert opinion on the opiate content of a consignment of poppy seeds. They are pessimistic that a court hearing scheduled for 24 September will result in her immediate release. Zelenina heads a laboratory at the Penza Agricultural Institute, some 600 kilometres southeast of Moscow, one of the best-equipped chemical-analysis labs in Russia. She is a specialist in the biology of hemp and poppy, and is a sought-after expert in legal cases involving narcotics produced from these plants.

“Surely you cannot put a scientist in jail just because you don’t like her opinion?”

In September 2011, the defence attorneys of Sergey Shilov, a Russian businessman under investigation by the Russian Federal Drug Control Service (FDCS), asked her to provide an expert opinion on the amount of opiates that could possibly be extracted from 42 metric tonnes of food poppy seeds that Shilov had imported from Spain in 2010. Cultivation of the opium poppy (Papaver somniferum) has been banned in Russia since 1987. But the import of poppy seeds for use in foods, such as cakes and bread, is legal — as long as they are 100% free of narcotic opium alkaloids such as morphine and codeine. Poppy seeds do not contain these alkaloids, but other parts of the plant that do, such as poppy straw, can become mixed into shipments as a result of poor harvesting practices. In her expert report, Zelenina stated that it is technically impossible to fully eliminate such impurities from poppy seeds, as Russian laws require. She also wrote that the seized seeds did not contain any deliberately added narcotic compounds, says Natalia Andreeva, Zelenina’s Moscow-based lawyer. On the basis of gas-chromatography and mass-spectrometry measurements of samples analysed in her lab, Zelenina calculated the overall morphine and codeine content in the poppy-seed consignment in question to be 0.00069% and 0.00049%, respectively. In such low concentrations, opiates can only be identified or extracted in well-equipped analytical chemistry labs, she wrote. This opinion apparently failed to satisfy the prosecutors,” says Irina Levontina, a linguist at the Russian Language Institute in Moscow, who is frequently heard as an expert in libel and drug lawsuits. “It has become quite common for Russian prosecutors to accuse independent experts if they don’t like their opinions. It can be downright dangerous for experts to appear in court.” In the early morning of 15 August, a group of FDCS officials accompanied by masked and armed members of a special police unit entered Zelenina’s home in Lunino, a town in the district of Penza. They arrested her and took her to Moscow, where she was charged with aiding and abetting attempted drug trafficking by an organized group. On 20 August, a judge at Moscow’s Zyuzino District Court ordered her detention until 15 October, says Andreeva. “Olga Zelenina has been asked for her honest scientific expert opinion and is now kept in jail for no reason other than having provided just that,” says Mikhail Gelfand, a biologist at the Institute for Information Transmission Problems in Moscow. “I have read her report, and to me it looks absolutely reasonable. There is no justification at all to keep her in detention.” Olga has done nothing else than her duty as a scientist and as a citizen,” adds Andreeva. “Surely you cannot put a scientist in jail just because you don’t like her opinion?” A Moscow city court will decide on Monday whether she will be released from detention until an as-yet unscheduled trial date.

 

Drugs companies profiting from Innovation crisis

Drugs companies putting profit ahead of medical discoveries, warn scientists:

 Drugs companies putting profit ahead of medical discoveries, warn scientists


Drugs companies putting profit ahead of medical discoveries, warn scientists

The multi-billion pound pharmaceutical industry has spent the last decade developing new drugs which have produced little benefit and caused considerable harm, experts say today. The claim that there is an “innovation crisis” in pharmaceuticals because of the difficulty and expense of discovering new drugs is a myth fostered by an industry whose chief focus is on marketing, they add. Counter to drug industry claims that the pipeline of new drugs is running dry, the number of new drugs being licensed each year has remained at between 15 and 25. But most involve minor tweaks to existing drugs, designed to grab a slice of an existing market rather than offering genuine therapeutic innovation. Independent reviews suggest that 85 to 90 per cent provide little benefit over existing treatments with some, such as Vioxx the painkiller and Avandia, the diabetes drug, causing serious side effects which led to their withdrawal, the latter’s in Europe. Writing in the British Medical Journal, Professor Donald Light from the University of Medicine of New Jersey and Joel Lexchin from York University in Toronto say the situation has remained the same for 50 years. The incentives for drug development are wrong and have skewed the behaviour of the industry. “This is the real innovation crisis: pharmaceutical research and development turns out mostly minor variations on existing drugs and most new drugs are not superior on clinical measures. [They] have also produced an epidemic of serious adverse reactions that have added to national healthcare costs,” they say. More is spent on marketing (25 per cent of revenues) than on discovering new molecules (1.3 per cent). Drug industry claims that the cost of bringing a new drug to market is £1bn and is unsustainable are exaggerated, they claim. Research and development costs did rise substantially between 1995 and 2010 by $34.2bn (£21.9bn), they concluded, but revenues increased six times faster – by $200.4bn. Companies avoid mentioning this “extraordinary revenue return”, they said, adding that up to 80 per cent of drug spending is used by the industry on promotion. The authors call for licensing authorities around the world to stop approving new drugs of little therapeutic value. They suggest large cash prizes should be awarded for genuinely new therapeutic agents in lieu of patent protection. The European Medicines Agency, which licenses drugs in the UK and Europe, keeps certain data about their safety and efficacy secret. Yet 29 per cent of new biological agents approved by the EMA received safety warnings within the first 10 years. In a second paper, researchers from the London School of Economics in the UK argue that drug manufacturers should be made to demonstrate that their products are superior to existing treatments before being granted a licence, rather than, as now, superior only to a placebo. “Changing the nature of regulation could encourage manufacturers to concentrate on the development of new drugs in therapeutic areas with few alternatives,” they say. “Supplementing regulation with scientific advice and guidance can steer manufacturer’s interest and efforts into key research priorities.” Stephen Whitehead, chief executive of the Association of the British Pharmaceutical Industry, said: “We strongly disagree with the claims made in these papers. Medical research has always rested on iterative and gradual innovation rather than breakthrough advances which are very rare. If it were not for the incremental improvements made in the treatment of HIV, the disease would still be terminal rather than a manageable condition.”

FDA loss of drug control

Drug data reveal sneaky side effects:

Pills

Pills

 

An algorithm designed by US scientists to trawl through a plethora of drug interactions has yielded thousands of previously unknown side effects caused by taking drugs in combination.  The work, published today in Science Translational Medicine1, provides a way to sort through the hundreds of thousands of ‘adverse events’ reported to the US Food and Drug Administration (FDA) each year. “It’s a step in the direction of a complete catalogue of drug–drug interactions,” says the study’s lead author, Russ Altman, a bioengineer at Stanford University in California.  Pills in pill boxes.  A program predicts the potential side-effects of mixing different pills.  Although clinical trials are often designed to assess the safety of a drug in addition to how well it works, the size of the trials needed to detect the full range of drug interactions would surpass even the large, late-stage clinical trials sometimes required for drug approval. Furthermore, clinical trials are often done in controlled settings, using carefully defined criteria to determine which patients are eligible for enrollment — including other conditions they might have and which medicines they can take alongside the trial drug.  Once a drug hits the market, however, things can get messy as unknown side-effects pop up. And that’s where Altman’s algorithm comes in.  “Even if you show a drug is safe in a clinical trial, that doesn’t mean it’s going to be safe in the real world,” says Paul Watkins, director of the Hamner–University of North Carolina Institute for Drug Safety Sciences in Research Triangle Park, North Carolina, who was not involved in the work. “This approach is addressing a better way to rapidly assess a drug’s safety in the real world once it is approved.”

More related stories

Altman and his colleagues have been studying drug–drug interactions as a way to understand how a person’s genes influence their response to pharmaceuticals. To do that, he says, you must first have a good picture of the molecular mechanisms that underlie drug responses.  “Adverse events are incredibly valuable clues to what these drugs are doing in the body,” Altman says. “They can tell you the other pathways in the cell that are being tickled by these drugs.”  But reports of adverse drug events are notoriously prone to bias. For example, cholesterol-lowering treatments are more often taken by older patients, and so conditions associated with ageing, such as heart attack, could be wrongly linked to a drug as a side effect.  Altman and his colleagues reduced this bias by adopting an approach sometimes used in observational clinical trials. They developed an algorithm that would match data from each drug-exposed patient to a nonexposed control patient with the same condition. The approach automatically corrected for several known sources of bias, including those linked to gender, age and disease1.  The team then used this method to compile a database of 1,332 drugs and possible side effects that were not listed on the labels of those drugs. The algorithm came up with an average of 329 previously unknown adverse events for each drug — far surpassing the average of 69 side effects listed on most drug labels.  The team also compiled a similar database looking at interactions between pairs of drugs, which yielded many more possible side effects than could be attributed to either drug alone. When the data were broken down by drug class, the most striking effect was seen when diuretics called thiazides, often prescribed to treat high blood pressure and edema, were used in combination with a class of drugs called selective serotonin reuptake inhibitors, used to treat depression. Compared with people who used either drug alone, patients who used both drugs were significantly more likely to experience a heart condition known as prolonged QT, which is associated with an increased risk of irregular heartbeats and sudden death.  A search of electronic medical records from Stanford University Hospital confirmed the relationship between these two drug classes, revealing at roughly 1.5-fold increase in the likelihood of prolonged QT when the drugs were combined, compared to when either drug was taken alone. Altman says that the next step will be to test this finding further, possibly by conducting a clinical trial in which patients are given both drugs and then monitored for prolonged QT.  What should the drug regulators do with the thousands of possible side effects Altman and his team uncovered? That is a complex problem, says Watkins, who adds that regulators will have to factor in the availability of alternative treatments and the magnitude and seriousness of the side effect, among other considerations.  Altman, who serves as an adviser on the FDA’s Science Board, says that he plans to present his results to the agency. He suggests that the algorithm could be used with the FDA’s existing drug-surveillance programs to remove bias. However, he points out the enormity of the task: “We’ve just released a database with 10,000 or more adverse events,” he says. “I do not expect the FDA to uncritically take these results and add them to every drug label.”