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FDA Issues Dietary Supplements Final Rule

Byoliveridley

The FDA issues rules that will finally make dietary supplement manufacturers conform to some rules in the manufacturing of the products.

Which ones?

  1. Accurate potency and labeling – 30 mg glucosamine will now contain something close to 30mg
  2. Impurities Testing – All the raw materials will now be tested for impurities/contaminants. They will probably follow USP guidelines.
  3. Adverse event reporting – Manufacturers/sellers will need to report adverse events. This is after the fact safety testing, wholly inadequate, but better than what we had previously.

See something missing? Efficacy!! You do not have to prove that your product actually works! Basic safety? What is the overdose level? Interactions with other medicines/supplements? Is your dosing form actually bioavailable? Meaning, if you swallow a pill, will it actually get into your bloodstream and reach the intended target?

Who knows, but standardizing, cataloging and auditing manufacturing processes is a start, I guess. 1.5 cheers for the FDA!

I would be curious to find out how these companies are going to get audited by the FDA to prove that they’re following the quality control measures they’re supposed to implement. Guess I have to read the 815 pg bundle of joy that is the actual rule to find out more. A cursory word search on audits suggests that the manufacturers do audits on their suppliers, that the quality control unit of manufacturer perform audits on their manufacturing process, but nothing about the FDA conducting audits. Of course, calling yourself a GMP (good manufacturing processes) manufacturer is usually enough to trigger an FDA audit if you’re in pharma. I wonder how the FDA will deal with this one.

FDA Issues Dietary Supplements Final Rule

The U.S. Food and Drug Administration today announced a final rule establishing regulations to require current good manufacturing practices (cGMP) for dietary supplements. The rule ensures that dietary supplements are produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled.

“This rule helps to ensure the quality of dietary supplements so that consumers can be confident that the products they purchase contain what is on the label,” said Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. “In addition, as a result of recent amendments to the Federal Food, Drug, and Cosmetic Act, by the end of the year, industry will be required to report all serious dietary supplement related adverse events to FDA.”

The regulations establish the cGMP needed to ensure quality throughout the manufacturing, packaging, labeling, and storing of dietary supplements. The final rule includes requirements for establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and the finished product. It also includes requirements for recordkeeping and handling consumer product complaints.

“The final rule will help ensure that dietary supplements are manufactured with controls that result in a consistent product free of contamination, with accurate labeling,” said Robert E. Brackett, Ph.D., director of FDA’s Center for Food Safety and Applied Nutrition.

Under the final rule, manufacturers are required to evaluate the identity, purity, strength, and composition of their dietary supplements. If dietary supplements contain contaminants or do not contain the dietary ingredient they are represented to contain, FDA would consider those products to be adulterated or misbranded.

The aim of the final rule is to prevent inclusion of the wrong ingredients, too much or too little of a dietary ingredient, contamination by substances such as natural toxins, bacteria, pesticides, glass, lead and other heavy metals, as well as improper packaging and labeling.

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In Praise of Red Tape

Byoliveridley

In Praise of Red Tape

Is there any figure in American political discourse more reviled than the bureaucrat? Say the word and a potent caricature leaps to mind: the petty and shiftless paper pusher who wields his small amount of power with malice and caprice. Whatever the issue–from school reform to overhauling the nation’s intelligence apparatus–the bureaucrat is on the wrong side of it.

Hayes makes an argument that I try to make at mixed gatherings everywhere. Unfortunately, I do not make it as coherently as he does. The secret to any functioning government is a good mid-level bureaucracy that has enough technical experience to implement reasonably good policy, but isn’t overly politicized or corrupt. When I was growing up in India, one of the constant refrains was “Why can’t we be like the Americans? You can actually get a driver’s license without bribing someone!”

The DMV (which is low level bureaucracy) still works well in the US (yes, my American friends, try getting a license in India!), but the mid level bureaucracy has gotten overly politicized in its top leadership over the years. This leads to that vicious cycle I have blogged about previously:

  1. Appoint lackey to head agency
  2. Appoint viceroy to oversee regulation
  3. Rewrite rules to increase power of executive over legislative
  4. Shift burden of proof away from the regulated to the regulators
  5. Slash budgets so regulating agencies cannot do the work adequately
  6. Hound competent employees out of the agency
  7. Routinely bash said agency as an example of “big government”

Repeat steps 4-7 as often as necessary to ensure “success”

Well, it appears that the mid-level bureaucrats pushed back, and Hayes catalogs the results.

I leave you with a good truism:

Red tape is what binds those in power to the mast of the law, what stands in the way of government by whim

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Let all residents vote in Canada

Byoliveridley

BC has municipal elections in October this year and I will be voting for the candidates whose policies, values and voting records on housing affordability, harm reduction, and walk/bike/transit friendliness match mine the closest. I might even have an endorsement or three up my sleeve. This year, I will also be asking Victoria’s municipal election candidates where they stand on letting permanent residents vote in our elections.

In the 2016 census, nearly 2.5 million people identified as non-citizen residents, out of which two million were permanent residents. The permanent residents live here, work here, play here, pay taxes, grow pensions, volunteer, commit crimes (yes, they’re like any other Canadian) and more, just like those with Canadian citizenship. However, they have no say in who represents them municipally, provincially or federally. I find this unfair, so do many people, including the Vancouver city council, who passed a resolution in 2018 (PDF) calling for the province to approve voting by permanent residents. This globe news article provides a good backgrounder.

In short, municipalities have run into the conservative buzzsaw that is the state of our (mostly) conservative or liberal provincial governments. This won’t change unless more people speak up.

The opposition is mainly that non-citizens are not sufficiently “invested” in the country, they’re too “new”. The more paranoid ones talk about divided loyalties, and bring up stories of foreigners being flown in to vote. Perhaps they should try getting a visitor visa to Canada (spoiler alert, difficult).  People who judge other people’s belonging or membership, however, usually have other items on their agenda. Let’s just leave it at that.

From my perspective, extending the vote is common sense, fair and just, and that’s that.

Permanent residents? The case is simple. They’re like citizens in all ways, except for voting, and having to renew every five years. If you want to make life difficult, you could ask them to renew voter registration every five years too, but really, you shouldn’t. Are you concerned about “loyalties”? If you are, then you should not be letting the thousands of dual British-Canadian passport holders vote.

How about residents without the permanent residency paperwork? Don’t see why not? If you’re concerned about timing of residency, put a time limit on the voting registration. There are very few non-permanent residents in Canada, half a million at last count, so, impact is small.

Undocumented? May be difficult, especially with visibility and its consequences. But, I would support it if we can find a solution that protects people while allowing for verifying identity for voting.

Of course, giving people a vote does not solve most problems, but that’s not the point. We see conservatives south of the boarder ceaselessly chipping away at the right of non-white people to vote. We need to be be going in the opposite direction on representation.

So, here are the questions on this issue I intend to ask Victoria’s municipal candidates in 2018:

  1. Do you support efforts to extend voting rights to all residents in Victoria?
  2. If you do, what are you willing/able to do to make this happen at the municipal level at least, then at the provincial level and federal levels?

A “no” on #1 is going to make it difficult to vote for you. A “yes” on #1 without some coherent plan on #2 means that you need to think about it some more.

Are you with me? Would you be willing to ask prospective candidates the same questions? Should there be additional questions? Do these questions make sense, or should they be reworked?

Cross-posted from interrobang

 

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Colonialism, Pharmaceutical style

Byoliveridley

Legal wrangle puts India’s generic drugs at risk – health – 29 January 2007 – New Scientist

Tens of thousands of people being treated for AIDS will suffer if Swiss pharmaceutical company Novartis succeeds in changing India’s patent law, the humanitarian agency Medecins Sans Frontieres warned on Monday. Novartis is challenging a specific provision of India’s patent law that, if overturned, would see patents being granted far more widely, heavily restricting the availability of affordable generic medicines, MSF says.

In 2000, antiretroviral (ARV) treatment cost was estimated at $10,000 per patient annually. But the availability of generic drugs produced mainly in India, allowed costs to plummet to about $70 per patient per year, Mwangi adds.

You’ve got to love the friendly multinational arguing to make extra billions while people die. But I don’t think any Indian judge will overthrow Indian patent law. And there is a national interest  exemption built into most patent statutes, per the TRIPs agreements.

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India Rejects Obvious Patents

Byoliveridley

Would have been my headline. Apparently, the New York Times byline writer was more concerned about a multi billion dollar company losing a small amount of money than the fact that a different ruling in this case would have made life saving drugs unaffordable for millions of people. When did American newspapers become shills for the elite?

Setback for Novartis in India Over Drug Patent – New York Times

Indian companies will be free to continue making less expensive generic drugs, much of which flow to the developing world, after a court rejected a challenge to the patent law on Monday.

Aid organizations declared the ruling a victory for the “rights of patients over patents,” but the Swiss drug company Novartis, which filed the case, warned that the ruling would discourage investments in innovation and would undermine drug companies’ efforts to improve their products.

At issue is the degree of innovation required for a drug to be regarded as truly “new”, where there is a significant enough chance for failure that the company would never develop it unless afforded monopoly rights for 10 years. A very well known tactic by drug companies is to make a slightly different formulation of an existing drug, say an extended release form of a drug which takes a little longer to dissolve, and hence is available to the body at a different time. Under US patent law, this qualifies for full patent protection on the extended release form. By now, the science of making an extended release tablet is well known, it’s just a question of formulating the drug with a different set of inactive ingredients that take longer to dissolve, or sometimes, through a differently engineered tablet. The chemistry of this change is predictable, published and not really innovative. Why should these small changes have patent protection?

Bonus Note: Madras is my home city, so I’m glad it was decided there!

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What can the U.S learn from homeopathy?

Byoliveridley

Homeopathy was all around me growing up in India, so I read this article with interest as it jogged many memories of visiting the family homeopath with my parents.

Faith Healing with Homeopathy — In These Times

Homeopathy rests on three unproven tenets: First, “Like treats like.” Because arsenic causes shortness of breath, for example, homeopaths prescribe its “spirit” to treat diseases such as asthma. Second, the arsenic or other active ingredient is diluted in water and then that dilution is diluted again and so on, dozens of times, guaranteeing—for better and worse—that even if the dose has no therapeutic value, it does no harm. And third, the potion is shaken vigorously so that it retains a “memory” of the allegedly curative ingredient, a spirit-like essence that revives the body’s “vital force.”

Fooey, the description of the science is hilariously pseudoscientific, but homeopathy is no laughing matter in India. It is estimated to be a Rs. 250 Crore (that is 2.5 billion rupees or about $58 million) industry as of 2002-2003.  I do not think this includes doctors and clinics. This website lists 158 colleges in India offering the  valid (it is like an MD!) degree of Bachelor of Homeopathic Medicine and Surgery, or BHMS. My parents swear by it, most of my family living in India has either visited, or regularly visit one. It is hugely popular for hepatitis and liver disease, more so than conventional medicine in India.

What’s the deal? Why is it so popular? I think Terry Allen is on the right track, this sentence here, buried in the middle, hits the nail on the head…

Part of the effect comes from the ritual of consultation with a practitioner who treats the patient like a person rather than a body part on an assembly line.

Allen does not quite grasp the significance of this sentence and tracks away into placebo effects and evil pharma. But here’s the deal: A lot of Indians (who can afford $4-$5 consultation fee) visit their homeopath every month. When I tagged along with my parents, we would go on a Sunday afternoon at 2 PM to this homeopath’s office, which was a wing of his house (a big house, I might add!). It was a relaxed and leisurely time, he spent 10-15 minutes with each of us (yes, my parents made me!) talking about the previous month, what we were up to, how stressed we’d been, how our ailments from the previous month were doing, had we noticed any changes to our health over the month, etc. We would be interrupted occasionally by his little kid, or his assistant relaying a message from his wife, it was as far removed from a doctor’s visit as possible. And yes, he would take your blood pressure, run simple blood tests, etc. At the end of it, he would give you little sugar pills/sugar coated powder formulations to take home. The formulations were individually dosed, it was all categorized and labeled for you.

This is like having a mini physical every month. Surely, just the act of talking to someone made you feel better, the act of ritually opening up little packets of “medicine” and following detailed instructions for 5 days helped, surely the homely and relaxing atmosphere of visiting a family friend helped, I don’t know.

Metrics? both my parents occasionally had their hypertension treated with homeopathy. This worked as long as they were borderline, and simple stress management would get the numbers down. This doctor was/is very good at stress management because he talked calmly, yet firmly, he would listen and tease their little everyday stressors out of them and that was probably good for a 10 point reduction. But I remember the homeopath sending mom off to a doctor for a more conventional treatment regimen as soon as she hit 160.

It never ever worked for me because I was way too sceptical to buy into the process, so I would not listen, or relax enough to talk. I would take my pills, but it would make absolutely no difference whatsoever. Of course, he was trying to treat me for severe sinus related issues probably brought on by pollution, and by sleepless nights spent on a beach looking for turtles!

I am sure that for every good homeopath, there were two bad ones who just handed out pills of sugar. But my parents’ homeopath was, and continues to be part Dr. Phil, part candyman, part cheerleader!

Homeopathy probably “works” because it makes people take the time to think about their life and what’s ailing them. It’s a lesson that American primary care providers could do well to learn.

Photo of a button which says push to cross, with an added hashtag DontMakeMeBeg

Retire the Beg Button

Byoliveridley

Photo of a button which says push to cross, with an added hashtag DontMakeMeBegBiking down the Galloping Goose Sunday on my way to the excellent Panama Flats park, I came up on the intersection of the Goose with Tillicum Road, and traffic on Highway 1 (running parallel to the Goose) was flowing. It was in the middle of a minutes long traffic cycle, the appropriate time for people on foot and on bikes to be moving through unimpeded.

Except, that orange stick figure was telling me I should not go, which meant I had to push the “Beg” button first. Voila, the orange stick figure was replaced by the white one telling me I could cross. Of course I could cross, I was moving in the same direction as traffic and it was logical! Why was this even an issue?

I abhor beg buttons, and here’s why, this has been documented repeatedly.

It’s annoying for walkers: have you ever tried to walk a few blocks, stopping to hit the button at every single intersection? Or hit the button just a few seconds too late and had to wait a whole additional cycle? But it also illustrates the backwardness of our street design: pedestrians, who are supposed to have the right-of-way, are required to press a button at an intersection in order to get a walk signal, which should happen automatically

I’ve written many an unpublished diatribe that had those exact same words!

Especially here in Victoria, pedestrians take first priority, then people on bikes (pdf), all prioritized above car traffic in the official community plan. This is true in Saanich as well. If that is the case, and our municipalities were serious about improving the non car driver’s experience, then they need to aggressively retire all beg buttons. Remove them, or note that they are not to be used. I’ve of course heard anecdotal information from people in engineering/planning that they are disabled in some places. That’s not good enough. If you are going to disable a button, you need to label it as so, say DO NOT PRESS! And, while you’re at it, time your pedestrian crossing signs to maximize crossing time. I’m tired of seeing “Do not Walk” signs come up a good twenty seconds before car traffic stops, this is not necessary, and harkens back to a car first mentality that needed to have gone away with the 20th century. Why, I crossed a 3 lane (+ wide turning cuts) in Sidney at a deliberate saunter starting after the “Do not walk” (not the warning) had come on and still had a good few seconds before the car light changed to red.

Victoria is getting better, but there are still too many intersections where cars are prioritized. Take Fairfield and Moss, corners are two shopping/office blocks, a church and a busy community center/child care. But, guess what, there’s beg buttons still, and certain times of the day when crossing Fairfield is something you have to accomplish in 10 seconds or less. Completely unnecessary.

Time for a campaign to Retire the Beg Button at traffic lights and move them all to mid block crosswalks where we can cross the road by pressing a button that will make cars stop for a few seconds.

Originally posted on Interrobang on 17-May-2016

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