B12 Solipsism

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Archive for the ‘pharmaceutical’ tag

Diabetes and Low-Carb Diet

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Assembling Tian
Assembling Tian

Almost as if the healthcare industry (doctors, hospitals, pharmaceutical corporations, insurance corporations) have a vested interest in making profits before healing people. Not that they are trying to harm people, rather that making money is the first motive.

A low-carbohydrate diet was in fact standard treatment for diabetes throughout most of the 20th century, when the condition was recognized as one in which “the normal utilization of carbohydrate is impaired,” according to a 1923 medical text. When pharmaceutical insulin became available in 1922, the advice changed, allowing moderate amounts of carbohydrates in the diet.

Yet in the late 1970s, several organizations, including the Department of Agriculture and the diabetes association, began recommending a high-carb, low-fat diet, in line with the then growing (yet now refuted) concern that dietary fat causes coronary artery disease. That advice has continued for people with diabetes despite more than a dozen peer-reviewed clinical trials over the past 15 years showing that a diet low in carbohydrates is more effective than one low in fat for reducing both blood sugar and most cardiovascular risk factors.

The diabetes association has yet to acknowledge this sizable body of scientific evidence. Its current guidelines find “no conclusive evidence” to recommend a specific carbohydrate limit. The organization even tells people with diabetes to maintain carbohydrate consumption, so that patients on insulin don’t see their blood sugar fall too low. That condition, known as hypoglycemia, is indeed dangerous, yet it can better be avoided by restricting carbs and eliminating the need for excess insulin in the first place. Encouraging patients with diabetes to eat a high-carb diet is effectively a prescription for ensuring a lifelong dependence on medication.

At the annual diabetes association convention in New Orleans this summer, there wasn’t a single prominent reference to low-carb treatment among the hundreds of lectures and posters publicizing cutting-edge research. Instead, we saw scores of presentations on expensive medications for blood sugar, obesity and liver problems, as well as new medical procedures, including that stomach-draining system, temptingly named AspireAssist, and another involving “mucosal resurfacing” of the digestive tract by burning the inside of the duodenum with a hot balloon.

(click here to continue reading Before You Spend $26,000 on Weight-Loss Surgery, Do This – The New York Times.)

Whether or not you have health issues, I believe a diet consisting of as many vegetables and fruits as you can eat is the best for you. Avoid processed foods as much as possible, etc.

Written by Seth Anderson

September 12th, 2016 at 5:34 pm

Gilead Gouging Prices of Hepatitis C and H.I.V. Drugs

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Cut Rate Liquors and Real Drugs
Cut Rate Liquors and Real Drugs. 

Have we reached a tipping point for drug pricing yet? Seems close, at least, to a public consensus that pharmaceutical companies cannot set prices so high they shock the conscience. We have to weigh public health against private profits.

The attorney general of Massachusetts said on Wednesday that she had opened an inquiry into whether Gilead Sciences had violated state consumer protection laws by charging too much for its hepatitis C drugs.

The notification, which was contained in a letter to the company from the attorney general, Maura Healey, is the latest challenge to the practices of Gilead, which has become the largest and most profitable biotechnology company by dominating the market for drugs used to treat both H.I.V. and hepatitis C.

On Tuesday, the AIDS Healthcare Foundation, a nonprofit organization that treats patients with H.I.V. and AIDS, filed a lawsuit seeking to invalidate patents covering the new version of Gilead’s mainstay H.I.V. drug, tenofovir. The lawsuit also says that Gilead, to maximize product life span but to the detriment of patients, delayed the introduction of the new, safer version of tenofovir until the old version was about to lose patent protection.

The hepatitis C drugs, Sovaldi and Harvoni, are widely considered breakthroughs — curing most patients in 12 weeks with few side effects. But Sovaldi has a list price of $1,000 per daily pill, or $84,000 for 12 weeks, and Harvoni costs $94,500. Those prices, and the great demand for the drugs, have strained the budgets of state Medicaid programs and prison systems, forcing many of them to restrict treatment to those most seriously ill.

In her letter to Gilead’s chief executive, John C. Martin, Ms. Healey said her office was examining whether Gilead’s pricing would be an “unfair trade practice,” in violation of Massachusetts law.

“Because Gilead’s drugs offer a cure for a serious and life-threatening infectious disease, pricing the treatment in a manner that effectively allows H.C.V. to continue spreading through vulnerable populations, as opposed to eradicating the disease altogether, results in massive public harm,” she wrote, referring to the hepatitis C virus by its initials.

One motivation for Ms. Healey’s letter was a class-action lawsuit filed against Massachusetts’ Department of Correction asking for more inmates to be treated for hepatitis C. Ms. Healey’s letter said that treating everyone at the list price of Sovaldi would “easily exceed our entire budget for prisoner health care.”

(click here to continue reading Gilead Faces Fights Over Hepatitis C and H.I.V. Drugs – The New York Times]

More to come on this topic, I assume…

Written by Seth Anderson

January 29th, 2016 at 3:04 pm

THC Research continues

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Hard to imagine another pharmaceutical that receives so much resistance to even being studied. Perhaps the problem is that cannabis is not patented by Pfizer, anyone can grow their own, in pretty much the entire world. Hard for Big Pharma to realize profits on a medically significant weed.

Forest Of Asparagus

while the medical marijuana movement has been generating political news, some researchers have been quietly moving in new directions — testing cannabis and its derivatives against a host of diseases. The scientific literature now brims with potential uses for cannabis that extend beyond its well-known abilities to fend off nausea and block pain in people with cancer and AIDS. Cannabis derivatives may combat multiple sclerosis, Crohn’s disease and other inflammatory conditions, the new research finds. Cannabis may even kill cancerous tumors.

Many in the scientific community are now keen to see if this potential will be fulfilled, but they haven’t always been. Pharmacologist Roger Pertwee of the University of Aberdeen in Scotland recalls attending scientific conferences 30 years ago, eager to present his latest findings on the therapeutic effects of cannabis. It was a hard sell.

“Our talks would be scheduled at the end of the day, and our posters would be stuck in the corner somewhere,” he says. “That’s all changed.”

(click to continue reading Not Just A High – Science News.)

Let there be (vintage) light

and the mechanism of action:

A bigger revelation came in 1992: Mammals make their own compound that binds to, and switches on, the CB1 receptor. Scientists named the compound anandamide. Researchers soon found its counterpart that binds mainly to the CB2 receptor, calling that one 2AG, for 2-arachidonyl glycerol. The body routinely makes these compounds, called endocannabinoids, and sends them into action as needed.

“At that point, this became a very, very respectable field,” says Mechoulam, now at Hebrew University of Jerusalem, who along with Pertwee and others reported the anandamide discovery in Science. “THC just mimics the effects of these compounds in our bodies,” Mechoulam says. Although the receptors are abundant, anandamide and 2AG are short-acting compounds, so their effects are fleeting.

In contrast, when a person consumes cannabis, a flood of THC molecules bind to thousands of CB1 and CB2 receptors, with longer-lasting effects. The binding triggers so many internal changes that, decades after the receptors’ discovery, scientists are still sorting out the effects. From a biological standpoint, smoking pot to get high is like starting up a semitruck just to listen to the radio. There’s a lot more going on.

Though the psychoactive effect of THC has slowed approval for cannabis-based drugs, the high might also have brought on a serendipitous discovery, says neurologist Ethan Russo, senior medical adviser for GW Pharmaceuticals, which is based in Porton Down, England. “How much longer would it have taken us to figure out the endocannabinoid system if cannabis didn’t happen to have these unusual effects on human physiology?”

Written by Seth Anderson

June 21st, 2010 at 8:06 am

Posted in health

Tagged with , , ,

Glaxo Drug Faces More Scrutiny

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Follow up on the NYT article on GSK and their drug, Avandia that we blogged about recently

18th Street El Stop

A Senate report that revives concerns about a GlaxoSmithKline PLC diabetes drug’s link to heart attacks is putting pressure on the Food and Drug Administration to make changes to its drug-safety program.

People familiar with the situation say agency leaders held calls over the weekend to discuss how to address complaints from Sens. Max Baucus (D., Mont.) and Chuck Grassley (R., Iowa), who released a new report Saturday on the Glaxo drug, called Avandia.

The FDA is trying to assemble a timeline of what the FDA knew of risks associated with Avandia, these people say, and plans to call a meeting of an outside advisory committee in the next few months to look at recent information on the drug, which Glaxo reported as having global sales of £771 million ($1.2 billion) in 2009.

According to a two-year investigation by the Senate Finance Committee, Glaxo knew about data linking Avandia to elevated risk of cardiovascular events for several years, but played down the information and tried to suppress doctors who raised concerns. Starting in 1999, Glaxo executives complained to superiors about researchers who questioned Avandia’s safety, the report says.

[Click to continue reading Glaxo Drug Faces More Scrutiny – WSJ.com]

and the FDA is certainly not blameless in this mess

Some critics of the FDA cited the Avandia report in renewing calls for an independent safety unit at the agency to track problems with drugs after they go on the market. Currently the section that does “post-market surveillance” is subordinate to the division that approves new drugs. As a result, there is an inherent conflict of interest because the approval officers are judging their own previous decisions, critics say.

The question is: will public outrage be sufficiently heated to force some structural changes in the FDA? Jury is still out…

Written by Seth Anderson

February 22nd, 2010 at 8:27 am

Generic Drugs and the FDA

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In other corrupt-Washington-business-as-usual news, the pharmaceutical corporations have successfully protected their profits against generic drugs by convincing Washington to underfund the department of government regulators who approves generics. If they have no staff and no budget, generics can’t be brought to market, causing consumers and Medicare to spend more on non-generic drugs.

American consumers are waiting nearly a year longer for government regulators to approve new lower-priced generic drugs than they did in 2005.

The delays, caused by a growing backlog of applications at the Food and Drug Administration, may be costing consumers and the federal government hundreds of millions of dollars a year as they continue in some cases to pay for name-brand drugs even after their patents expire, industry analysts said.

[Click to continue reading New Generic Drugs Facing Longer Waits for Approval – NYTimes.com]

Currently, approvals are taking over 2 years to wade through. Obviously, this office of the FDA is not a priority.

With lawmakers preparing to meet at the White House next week to discuss ways to give more Americans access to health insurance, generic makers say that underfunding of the F.D.A.’s generics office is denying consumers access to more affordable drugs. The agency’s office of generic drugs has a budget of $51 million for fiscal year 2010, up from $41 million in fiscal 2009.

Executives at the generics meeting joked that government was spending less per year on reviewing applications for new generic drugs than the New York Yankees spend on the payroll of the left side of their infield. (Alex Rodriguez and Derek Jeter between them earned $54.6 million last year, according to ESPN).

but if Washington was serious about being cost-sensitive and fiscally responsible, they’d act already. Ultimately, delaying generic drugs ends up costing taxpayers more money

While accounting for the majority of drug prescriptions in the United States, generics represent just a fraction of the total cost of drugs. Generics accounted for 70.4 percent of the 2.9 billion prescriptions in the United States last year, according to IMS Health, a health information company. But they accounted for only about 15 percent of the $300 billion spent on prescription drugs in this country last year, IMS said.

The slowdown in new generic drug approvals ultimately hurts consumers — and government payers like Medicare — because prices stay higher when there are no or only a few generic alternatives to a branded drug, industry analysts said.

Sad state of affairs: almost as if pharmaceutical corporations like GlaxoSmithKline set national policy. Hmmm, maybe they do?

Written by Seth Anderson

February 20th, 2010 at 1:47 pm

Diabetes Drug Avandia Harms the Heart

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Speaking of Racketeer Influenced and Corrupt Organizations, GlaxoSmithKline wants to protect its drug profits at the expense of hundreds of deaths a year.

Hundreds of people taking Avandia, a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports that recommend the drug be removed from the market.

The reports, obtained by The New York Times, say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart. Avandia, intended to treat Type 2 diabetes, is known as rosiglitazone and was linked to 304 deaths during the third quarter of 2009.

“Rosiglitazone should be removed from the market,” one report, by Dr. David Graham and Dr. Kate Gelperin of the Food and Drug Administration, concludes. Both authors recommended that Avandia be withdrawn.

The internal F.D.A. reports are part of a fierce debate within the agency over what to do about Avandia, manufactured by GlaxoSmithKline. Some agency officials want the drug withdrawn because they believe there is a safer alternative; others insist that studies of the drug provide contradictory information and that Avandia should continue to be an option for doctors and patients. GlaxoSmithKline said that it had studied Avandia extensively and that “scientific evidence simply does not establish that Avandia increases” the risk of heart attacks.

[Click to continue reading Diabetes Drug Avandia Harms the Heart, Studies Find – NYTimes.com]

Nancy Reagan - Just Say Yo

GSK is more interested in resurrecting their cash cow:

Driven in part by a multimillion-dollar advertising campaign, sales [of Avandia] were $3.2 billion in 2006

despite the US Senate suggesting the process itself was/is flawed:

Just Say No Drugs

In a letter sent Thursday to Dr. Hamburg, the Food and Drug Administration commissioner, Mr. Baucus and Mr. Grassley asked “what steps the F.D.A. has taken to protect patients in the TIDE trial” and said the trial’s patients had never been told about the concerns raised by the agency’s own safety officers.

Mr. Grassley said the internal agency battle showed that the agency needed to be restructured to give more power to safety officials like Dr. Graham and Dr. Gelperin over their counterparts who approve medicines and deal more directly with drug makers.

“It doesn’t make any sense to have these experts who study drugs after they have been on the market for several years under the thumb of the officials who approved the drug in the first place and have a natural interest in defending that decision,” Mr. Grassley said. “The Avandia case may be the most alarming example of the problem with this setup.”

The question of when and how to communicate possible drug risks has long bedeviled drug makers and regulators. Hints are common that drugs may cause injuries; thousands of drug injury reports pour into the Food and Drug Administration every week. For example, Avandia ranked first among all prescribed drugs in the number of serious, disabling and fatal problems — including 304 deaths — reported to the agency in the third quarter of 2009, according to an analysis done by the Institute for Safe Medication Practice, a drug safety oversight group.

The Senate investigation — the result of years of digging through more than 250,000 internal company documents — concludes that GlaxoSmithKline and by extension the F.D.A. delayed far too long in this process.

Don’t forget that the FDA’s coziness with the pharmaceutical corporations is part of the problem too. Unless there are some drastic structural changes in the FDA, these sorts of issues are going to come up repeatedly.

Written by Seth Anderson

February 20th, 2010 at 1:00 pm

Drug Chief at the FDA Is Accused

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Allegations of corruption and conflict of interest at the FDA? Really? How novel

Neon - NH Ballin Drugs Prescriptions

The inspector general of the Department of Health and Human Services is investigating a conflict-of-interest allegation involving the official in charge of drug approvals at the Food and Drug Administration, the FDA said.

The investigation of Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, stems from an ethics complaint filed by Amphastar Pharmaceuticals Inc., a California company that says it has been delayed in its six-year effort to win approval for a generic version of Lovenox, a multi-billion-dollar blood thinner.

In its complaint, Amphastar alleges that its competitor had special access to Dr. Woodcock at critical times in the prolonged approval process, which is ongoing. Amphastar points out that Dr. Woodcock co-authored a scientific paper with scientists at Momenta Pharmaceuticals Inc. while both companies were battling to win FDA approval of their generic blood thinners.

[Click to continue reading Drug Chief at the FDA Is Accused Of Conflict – WSJ.com]

Big Pharma owns the regulating process, makes sense they own the regulators themselves as well.

Written by Seth Anderson

August 12th, 2009 at 9:47 am

Conflicts of Interest Ensare Journalists, Too

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Just a little corruption, nothing to pay attention to

Health reporters may become entangled in the same kinds of ethical conflicts they often expose when accepting industry-sponsored awards and relying on corporate public relations offices, three researchers warn.

Journalism awards consisting of cash prizes and all-expense-paid trips given out by drug companies are among the more “astonishing” financial ties between journalists and drug companies, the authors said. The paper appears in the online edition of the British medical journal BMJ.

Among the prizes cited are the Embrace Award for reporting on urinary incontinence — consisting of trips to Washington, D.C., and Paris — offered by pharmaceutical firms Eli Lilly and Boehringer Ingelheim, as well as another Eli Lilly award for cancer treatment stories that includes a weeklong international trip for two.

The authors also point a finger at journalism training and education programs sponsored by the health care industry and to professorships funded by drug company grants. The writers go on to criticize reporters’ reliance on drug company press officers for referrals to experts or to patients, whose views may have been carefully screened.

[Click to continue reading Conflicts of Interest May Ensnare Journalists, Too – NYTimes.com]

Written by Seth Anderson

May 17th, 2009 at 8:01 pm

Posted in Business

Tagged with , , ,

Lobbying vs Good Policy

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Drug companies are fretting that their huge advertising budgets won’t be large enough to sell their expensive drugs at the expense of cheaper generics, so are ramping up lobbying efforts.

Crack in your Bridge

U.S. drugmakers led by Merck & Co. and Biogen Idec Inc. are stepping up their fight against President Barack Obama’s move to encourage cheaper medical care.

Already the biggest spender on influencing policy, the drug industry is hiring well-known individuals, some with stories of personal battles against disease. They include Tony Coelho, a former House Democratic leader who has epilepsy; Andrea LaRue, counsel to Tom Daschle when he was Senate Democratic leader; and the firm of Democratic fundraiser Tony Podesta, brother of Obama adviser John Podesta.

The firepower shows the drug industry’s resolve to stop Obama from using comparisons of medical treatments to force cuts in health costs. More than half of medical care may be based on insufficient evidence of effectiveness, the Congressional Budget Office said in March. Meantime, the Health and Human Services Department says all medical spending will probably rise this year to $2.5 trillion, or 18 percent of the economy.

“The companies fear that older generic drugs might very well turn out to be better than the newer advertised drugs, which bring in much more of a profit,” said Julian Zelizer, a history and public affairs professor at Princeton University in Princeton, New Jersey. “In difficult economic times, the drug companies don’t want to take any risks, so they are bringing out the biggest lobbyists in the business.”

[Click to continue reading Merck, Biogen Boost Lobbying to Defy Obama’s Drug Comparisons – Bloomberg.com ]

Pathetic, but will undoubtedly be effective. In these sorts of matters, money usually trumps good policy. Would be surprised if the Obama administration (and 111th Congress) would be any different.

Written by Seth Anderson

April 17th, 2009 at 9:39 am

Nigerians can sue US drugs firm

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Is it really better to litigate in the US?

Nigerian families can sue the Pfizer drugs giant in the US over its alleged role in the deaths of children, a US appeals court has ruled. The decision overturns ruling by a lower court that the case must be heard in Nigeria.

Pfizer is accused of killing 11 children and injuring 181 others when an antibiotic was tested on them during a meningitis epidemic in 1996.

Pfizer denies the claims, saying they were victims of the outbreak.
The epidemic killed 12,000 children in Nigerian in six months.

The families say that Pfizer tested out an oral antibiotic called Trovan on some 200 ill children in hospital in Kano, without first getting the consent of their parents.

They say the drug killed 11 children and caused blindness, deformities and brain damage in others

[From BBC NEWS | Americas | Nigerians can sue US drugs firm]

Pfizer’s lawyers will be working overtime this weekend.1

Footnotes:
  1. I removed my lame Nigerian scam jokes, they really aren’t relevant, nor were they that funny. If they made me laugh, maybe I’d keep them. Do you have any good Nigerian scam email jokes? []

Written by swanksalot

January 30th, 2009 at 9:58 pm

Posted in health

Tagged with ,

No Social Networking for Big Pharma

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No social networking for Big Pharma, probably because they are worried that people might realize that the latest and greatest new pharmaceutical has some nasty side effects, or worse, is just ineffective.

Although a majority of marketers have embraced online social media and user-generated content efforts, one industry is conspicuously not taking advantage of the gold rush: pharmaceuticals.

Drug brand Web sites almost never carry the features that marketers usually are desperate to give their customers: bulletin boards, chat rooms, blogs and Web-page hosting.

The reason: Marketers fear that user-generated content will include complaints about injuries caused by their drugs’ side effects. The law requires these “adverse events” to be reported to the FDA. The FDA’s adverse-event databases are regularly combed by lawyers looking for potential class-action suits

[From Why Pharma Fears Social Networking]

and this just boggles the mind:

On the other side are brand managers, whose every published word must survive a thicket of in-house lawyers, some of whom aren’t Internet savvy.

Dori Stowe, chief digital strategist at Grey Healthcare Group, New York, recalls speaking with a pharma company’s legal team about a campaign, “and somebody raised their hand and asked, ‘What’s Google?

Anecdotal, sure, but how McCain-esque to you have to be to have avoided learning the name of Google? I’ve been using Google as my web search tool since 1998, so that’s ten years, plus Google is a hugely successful publicly traded company.

Written by swanksalot

December 1st, 2008 at 10:34 am

Posted in Advertising

Tagged with ,

Marijuana is a Powerful Medicine

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Aron Rowe of Wired points out one of the biggest problems with our healthcare system: if a drug was not created in a laboratory, by a pharmaceutical corporation, and subsequently approved by the FDA, then no matter how effective the drug might be, the drug will have an immense barrier to entry.

Marijuana contains an amazing chemical, beta-caryophyllene, and scientists have thoroughly proven that it could be used to treat pain, inflammation, atherosclerosis, and osteoporosis.

Jürg Gertsch, of ETH Zürich, and his collaborators from three other universities learned that the natural molecule can activate a protein called cannabinoid receptor type 2. When that biological button is pushed, it soothes the immune system, increases bone mass, and blocks pain signals — without causing euphoria or interfering with the central nervous system.

Gertsch and his team published their findings on June 23 in the Proceedings of the National Academy of Sciences.They focused on the anti-inflammatory properties of the impressive substance — testing it on immune cells called monocytes and also in mice.

Since beta-caryophyllene seems to be powerful, occurs naturally in many foods, and does not get people high, it could turn out to be a nearly ideal medication. The organic compound is also phenomenally cheap. Sigma Aldrich sells it, in kosher form, for forty-two dollars per kilogram.

Unfortunately, big pharmaceutical companies tend not to seek FDA approval for natural chemicals, and most doctors are reluctant to prescribe drugs that have not received a green light from the regulatory agency. Thus, it would require a heroic effort by academic researchers to prove that beta-caryophyllene is safe and effective in humans.

[From Some Proof that Marijuana is a Powerful Medicine | Wired Science from Wired.com]

A real shame. In a fair world, natural remedies would be the first option, not an option only available to law-breakers.

Bridge of Smoke

Written by Seth Anderson

July 1st, 2008 at 7:46 am

Posted in health

Tagged with , , , ,

Red Wine May Slow Aging

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Breakfast drinks self-portrait
[Breakfast drinks self-portrait – click to embiggen]

Is it too early to have a sip? I could pretend we lived in 17th C.E. France…

Red wine may be much more potent than was thought in extending human lifespan, researchers say in a new report that is likely to give impetus to the rapidly growing search for longevity drugs.

The study is based on dosing mice with resveratrol, an ingredient of some red wines. Some scientists are already taking resveratrol in capsule form, but others believe it is far too early to take the drug, especially using wine as its source, until there is better data on its safety and effectiveness.

[From New Hints Seen That Red Wine May Slow Aging – NYTimes.com]

What every meal needs
[What every meal needs – click to embiggen]

Far too early to take in drug form, but not too early to drink red wine in its natural state – a glass on the way to my mouth!

Oh wait, there isn’t much resveratrol in each glass:

the door has now been opened to drugs that exploit an ancient biological survival mechanism, that of switching the body’s resources from fertility to tissue maintenance. The improved tissue maintenance seems to extend life by cutting down on the degenerative diseases of aging.

The reflex can be prompted by a faminelike diet, known as caloric restriction, which extends the life of laboratory rodents by up to 30 percent but is far too hard for most people to keep to and in any case has not been proven to work in humans.

Research started nearly 20 years ago by Dr. Leonard Guarente of the Massachusetts Institute of Technology showed recently that the famine-induced switch to tissue preservation might be triggered by activating the body’s sirtuins. Dr. Sinclair, a former student of Dr. Guarente, then found in 2003 that sirtuins could be activated by some natural compounds, including resveratrol, previously known as just an ingredient of certain red wines.

Dr. Sinclair’s finding led in several directions. He and others have tested resveratrol’s effects in mice, mostly at doses far higher than the minuscule amounts in red wine. One of the more spectacular results was obtained last year by Dr. John Auwerx of the Institute of Genetics and Molecular and Cellular Biology in Illkirch, France. He showed that resveratrol could turn plain vanilla, couch-potato mice into champion athletes, making them run twice as far on a treadmill before collapsing.

Seriously, even I would be challenged if I had to drink 100 bottles of wine a day. However, a glass or two? No problem, no problem at all. Clinical trials always start from a higher dosage – easier to see results that way – and then work back down to lesser dosages.

Separately from Sirtris’s investigations, a research team led by Tomas A. Prolla and Richard Weindruch, of the University of Wisconsin, reports in the journal PLoS One on Wednesday that resveratrol may be effective in mice and people in much lower doses than previously thought necessary. In earlier studies, like Dr. Auwerx’s of mice on treadmills, the animals were fed such large amounts of resveratrol that to gain equivalent dosages people would have to drink more than 100 bottles of red wine a day.

The Wisconsin scientists used a dose on mice equivalent to just 35 bottles a day. But red wine contains many other resveratrol-like compounds that may also be beneficial. Taking these into account, as well as mice’s higher metabolic rate, a mere four, five-ounce glasses of wine “starts getting close” to the amount of resveratrol they found effective, Dr. Weindruch said.

Ode to Dionysus
[Ode to Dionysus – click to embiggen]

Written by Seth Anderson

June 4th, 2008 at 9:15 am

Drugs Dollars and Doctors

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Got to pay for that house in Aspen somehow….

Benjamins

Suit Details How J&J Pushed Sales of Procrit – WSJ.com

Documents in a lawsuit filed against Johnson & Johnson by two former salesmen show how the pharmaceutical giant sought to boost sales of its blockbuster anti-anemia drug Procrit by offering contracts that fattened doctors’ profits and urging its salespeople to push higher-than-approved doses.

Some of Mr. [Dean] McClellan’s documents [a drug salesman for 12 years] reviewed by The Wall Street Journal indicate that Ortho Biotech created complex purchasing programs offering doctors discounts and cash rebates on Procrit, which would increase the doctors’ profits.

Procrit is an infused drug, which is administered by a doctor. Unlike pills sold by pharmacies, infused drugs offer profit opportunities for doctors, who can buy the drugs, administer the infusions in their offices, and collect the payments from insurers or the government. Drug companies can fatten the doctor’s margin using discounts and rebates to lower the price.

How are these doctors any different than a street corner drug dealer? Why doesn’t the DEA spend some time investigating these pushers too? Reminds me of Glenn Greenwald’s question as to why doctors can over-rule patients.

Mr. McClellan’s documents on the marketing of Procrit show that in 2004 — after Amgen Inc.’s competing drug Aranesp came on the market — J&J made offers that would allow buyers of Procrit to receive discounts off an already-reduced price as well as rebates. For example, an internal company memo calculates that a physician who bought nearly $1 million of Procrit over 15 months would get a check for $237,885 back, or 24%.

Another J&J program offered hospitals an incentive to buy Procrit and shun Aranesp: discounts on purchases from across Johnson & Johnson’s product line — including some huge-selling drugs and medical devices sold by different subsidiaries — if the hospital used Procrit at least 75% of the time when prescribing anti-anemia drugs.

In addition, J&J created a “Right of First Refusal” contract for doctors, requiring them to allow Ortho Biotech to make a counteroffer if Amgen’s Aranesp price undercut Procrit.

Mr. McClellan also alleges the company pushed doctors to prescribe a higher dose years before it was approved as safe and effective by the FDA. For years, the company focused on educating health care providers on Procrit’s medical benefits, he says. But in the mid-1990s at a national sales force meeting, an Ortho executive announced that the division was moving to promote what it called “QW dosing,” switching patients from three, 10,000-unit doses a week to a single, 40,000-unit dose in cancer patients, Mr. McClellan says.

Written by Seth Anderson

May 30th, 2008 at 1:24 pm

Posted in News-esque

Tagged with ,

Adults and Prescription Drugs

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This has long bothered me as well. Why are doctors (and governments) given such vast powers over which drugs are ok for a patient? Seems like a capricious system. Competent adults should be allowed to treat themselves as they see fit (which of course they often do by resorting to other means, or alternative medicine, etc.), and not strictly as their doctor sees fit. No other profession has quite as much power as doctors do in this instance.

Glenn Greenwald – Salon

I’ve always been interested in the topic of prescription drug laws because — even more than laws which prohibit adults from using recreational drugs — it seems absolutely unjustifiable for the government to prevent adult citizens from deciding for themselves which pharmaceutical products they want to use. Put another way, it seems unfathomable that competent adults are first required to obtain the “permission” of a doctor before being “allowed” to obtain and consume the medications they think they need — and that they are committing crimes if they do not first obtain that permission (or, worse, if they try to obtain that permission and are unable to do so).
….
Why should the doctor have the ability to override the decisions of the patient? Why should the doctor’s permission be required before the patient undergoes the pharmaceutical treatment he chooses? That really makes no sense to me, and for that reason, I am vehemently opposed to these prescription laws.

Beyond all of that, there is even less reason for the Federal government to be monitoring what substances anyone takes. In addition to all the other reasons I listed in the post and commenters have added, I am also convinced — reading around everywhere today on this topic — that there are substantial numbers of people foregoing pharmaceutical treatments that they think they should have (and which even their physicians recommend) because they fear having that information registered in data bases with the government.

Adults have the right to do all sorts of things that other people, including experts in a particular field, think are stupid and self-destructive, even when the person’s livelihood or even life are at stake. That is, more or less, a defining attribute of being an adult.

What is the difference between the attorney-client and doctor-patient relationship, where the former is purely advisory but the latter becomes parental? And other than consumption of medicine which can actually affect the public health (such as excessive consumption of antibiotics), why should an adult be deemed a criminal for using a particular medicine all because a doctor (for whatever reasons, including self-interest) will not give permission?

Written by Seth Anderson

April 17th, 2007 at 7:00 pm

Posted in government

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