Tag Archives: FDA

Is Your Generic Medication Made In China and Is It Safe?

Last week the FDA recalled several versions of the generic blood pressure medication valsartan which were made in China and contained a carcinogen (see here.)

Since then I  have switched many patients from the bad valsartan to losartan or valsartan from presumably safe manufacturers.

It didn’t really occur to me that this could be just the tip of the iceberg until I received a reader comment which I will copy below.

As I thought about it, I realized that I have no idea where the generic ramipril I am taking is manufactured. It very well could be in China or India.

This recent article from The Epoch Times confirms that Americans are becoming more and more reliant on medications manufactured in China and that many researchers feel this poses a significant security threat.

The Food and Drug Administration (FDA) is inspecting only a small number of the Chinese companies that manufacture U.S. drugs, and those it does inspect are often found to have serious health violations. Meanwhile, the drugs that are making their way into the United States from China, either as finished products or as ingredients, are often falling far below U.S. safety standards. And some of these drugs are not being inspected at all.

The book, “China RX: Exposing the Risks of America’s Dependence on China for Medicine” by Rosemary Gibson and Janardan Prasad Singh,” details the problem.

It is very hard to find out how many US drugs come from China since drug companies don’t make their sources apparent. In addition, even if the drugs themselves aren’t manufactured in China, Gibson and Singh write

“China is the largest global supplier of the active ingredients and chemical building blocks needed to make many prescription drugs, over the counter products and vitamins.”

Below are the comments of my reader:


This is horrible. We have a problem in the U.S. It is the infiltration of Chinese generics. I had no idea that this generic was being supplied by a Chinese maker. In fact, the bottles I got said “SOLCO” which is based in New Jersey. Now I’m painfully aware that SOLCO Healthcare US which is based in New Jersey, is owned by Zhejiang Huahai Paarmaceutical based in China’s Zhejiang Province. So this is the Chinese company’s subsidiary distributing this drug in the U.S. China has a long history of selling tainted products in the U.S. Chinese drywall, lead-based paint on toys, tainted pet food, etc. Now it is important to understand that 85% of prescriptions filled in the U.S. are generic. And insurance companies will not pay for brand when generic is available. My valsartan was about $30 for 90 days. Diovan is $750. I get it. But when these companies cut corners and people are endangered, something is wrong. I will never ever take another generic drug without first finding out where the product comes from. I know this is not perfect, but it is something. I think the U.S. lawmakers need to do something to make this information more transparent. It baffles me as to how this drug could have been tainted with a highly toxic chemical for so many years (they now say 4 years). This chemical is known to cause liver damage and cancer. Apparently the manufacturer changed the way it made the active ingredient which created this poison by-product. And now who do we hold accountable? How do we get to the bottom of what went wrong, and how to prevent this going forward. We have no way to compel anything in China. All that said, thanks for your information here it is helpful. I worry that the losartan is made by the same company – I will surely investigate.


China is also flooding the American market with useless OTC medications. I realized this when I looked closely at this “motion sickness patch” which is highly rated on Amazon.

It has no active ingredient which could be realistically thought to treat motion sickness yet is featured on Amazon’s motion sickness treatment section and is favorably reviewed by over a thousand users.

 

Unfortunately, in the US now users of medications must be very aware of the source and quality of the products they put in their body. Generic prescription medications and OTC products are highly likely to be manufactured out of the US and with minimal oversight.

Skeptically Yours,

-ACP

Dear Dr. Gottlieb, Full Fat Dairy is “Healthy”. Why Are You Pushing Low-Fat Dairy?

By all accounts, Scott Gottlieb, the Trump appointed director of the FDA is doing a good job.

Vox points out, he has announced substantial FDA moves to reduce cigarette consumption and is committed to improving competition in generic drugs.

However, he gave a recent speech at the National Food Policy Conference  on “Reducing the Burden of Chronic Disease” which indicates he is misinformed on crucial aspects of nutritional science.

Gottlieb indicated he wanted the FDA to play a bigger role in guiding Americans to eat a healthier diet to reduce the burden of chronic disease.

To facilitate this he is looking to define what foods are “healthy”:

We’re keeping all these considerations in mind as we pursue rulemaking to update the definition of “healthy” so it’s based on nutrition criteria and food considerations that are more up-to-date than those being used for the current definition….

Once updating the definition, Gottlieb wants to label food as “healthy” In a way that makes it easier for consumers to understand:

To address this, we’ve had discussions about whether there should be a standard icon or symbol for the word “healthy” that everyone could use on food packages.

Gottlieb goes on to bemoan a focus on nutrients rather than foods but in the very  next sentence recommends a food, dairy, in a form that has one important nutrient stripped from it-fat.

Traditionally, we’ve focused primarily on the nutrients contained in food in considering what is healthy. But people eat foods, not nutrients.

This is why we’re asking the important question of whether a modernized definition of “healthy” should go beyond nutrients to better reflect dietary patterns and food groups, like whole grains, low fat dairy, fruits and vegetables and healthy oils?

Obviously, the first step in getting Americans to eat healthier is to make sure you are doling out the correct advise and in his speech Dr. Gottlieb indicates he has bought into  long-standing fundamental errors. I wrote him the following letter hoping to correct these errors.


Dear Dr. Gottlieb,

Congratulations on your recent appointment as FDA director and kudos for your fine work to date. I read your recent comments on developing an updated definition of “healthy” and the importance of  conveying that information to American consumers  I applaud your efforts in this area as well as your ongoing efforts to limit cigarette smoking and improve generic competition.

I am fine with guiding consumers to healthy foods but I beg of you, let this determination of what is healthy be guided by the actual science, not prior dogma.

In your recent speech you indicate that Americans are not consuming enough dairy and you recommend low-fat dairy which implies that you and the FDA believe that scientific studies have demonstrated that dairy fat is unhealthy.

Five years ago I, too , thought dairy fat was unhealthy and recommended my patients avoid butter, full-fat yogurt and cheese. However, when challenged on this belief, I reviewed the scientific literature on dairy fat and cardiovascular disease.

It turns out when objectively analyzed (as I have written about here and here ) there is no scientific evidence that supports the concept that dairy processed to remove dairy fat is healthier than the original unadulterated product.

In fact, evidence suggests full fat dairy reduces central obesity, diabetes, cardiovascular disease and atherosclerosis in general.

As a result of misguided recommendations to avoid dairy fat, it is virtually impossible in most grocery stores to find full fat yogurt or milk. The vast majority of the dairy aisle is devoted to various low or non fat concoctions which have had loads of sugar and chemicals added and are arguably worse than a Snickers bar.

Dr. Gottlieb ,I am not cherry-picking the data here or relying on out of date studies. I’ve reviewed everything I can find on this issue and reviewed it without bias. Evidence continues to accumulate supporting the healthiness of full fat dairy.

For example, here’s a 2018 review from researchers totally unaffiliated with the dairy industry which asks the question “Dairy Fats and Cardiovascular Disease: Do We Really Need to Be Concerned?”

After a exhaustive review they conclude the answer is no.

recent research and meta-analyses have demonstrated the benefits of full-fat dairy consumption, based on higher bioavailability of high-value nutrients and anti-inflammatory properties. … In general, evidence suggests that milk has a neutral effect on cardiovascular outcomes but fermented dairy products, such as yoghurt, kefir and cheese may have a positive or neutral effect.

Flawed Reasons for Low Fat Dairy Recommendations

As I have written previously, I believe there are three reasons for the failure of major nutritional recommendations such as the 2015  Dietary Guidelines For Americans  to correct previously  flawed advice to choose  non or low-fat dairy over full fat:

1. In  few randomized dietary studies showing benefits of a particular diet over another, non fat or low fat dairy was recommended along with a portfolio of other healthy dietary changes.

The overall benefit of the superior diet had nothing to do with lowering the dairy fat but was due to multiple other changes.

2. The dairy industry has no motivation to promote full fat dairy. In fact, they do better financially when they can take the fat out of milk and sell it for other purposes such as butter, cheese, and cream. (Please read my interview with a plastic surgeon dairy farmer on the skim milk scam here.)

3. Saturated fat is still mistakenly being treated as a monolithic nutritional element.  Although dairy fat is mostly saturated, the individual saturated fats vary widely in their effects on atherogenic lipids and atherosclerosis. In addition, the nature of the saturated fat changes depending on the diet of the cow.

4. Since authorities have been making this low fat dairy recommendation for so long they are extremely reluctant to reverse their advice. It lowers their credibility.

There Is No Scientific Consensus On What Constitutes A Healthy Oil

Finallly, Dr. Gottlieb, I would like to briefly point out that there is considerable ongoing scientific debate about what constitutes a “healthy oil.”

I summarized this last year on a post on coconut oil (which I fear you will also pronounce “unhealthy”).

In many respects, the vilification of coconut oil by federal dietary guidelines and the AHA resembles the inappropriate attack on dairy fat and is emblematic of the whole misguided war on dietary fat. In fact, the new AHA advisory  after singling out coconut oil goes on to cherry-pick the data on dairy fat and cardiovascular disease in order to  support their faulty recommendations for choosing low or nonfat dairy.

Canola and corn oil, the products of extensive factory processing techniques, contain mostly mono or polyunsaturated fats which have been deemed “heart-healthy” on the flimsiest of evidence.

The most recent data we have on replacing saturated fat in the diet with polyunsaturated fat comes from the Minnesota Coronary Experiment performed from 1968 to 1973, but published in 2016 in the BMJ.

Data from this study, which substituted liquid corn oil in place of the usual hospital cooking fats, replaced corn oil margarine for butter and added corn oil to numerous food items, showed no overall benefit in reducing mortality. In fact, individuals over age 65 were more likely to die from cardiovascular disease if they got the corn oil diet.

So, Dr. Gottlieb, please continue your efforts to make Americans healthier but make sure the current scientific evidence actually supports your recommendations. Keep in mind, the disastrous public health experiments of previous decades.


Skeptically Yours,

-ACP

N.B. Some of my posts on dairy fat are below.

Dairy Fat Makes You Thinner

The Skim Milk Scam

More Evidence That Diary Fat is associated with a lower risk of heart disease

What happens to cholesterol levels when you switch to low or non fat dairy?

Dietary Guidelines 2015: Why Lift Fat and cholesterol limits but still promote low fat dairy?

In defense of real cheese.


h/t to the always excellent Conscien Health for bringing Gottlieb’s speech to my attention.


Credit for the featured image of dairy cows from the wonderful Trader’s Point Creamery

Death Knell For Niacin For Lipids Sounded by FDA?

The skeptical cardiologist stopped writing new prescriptions for niacin extended release tablets in 2011. For any patient who was taking niacin, I recommended stopping it.

Because niacin had favorable effects on the cholesterol profile, physicians had been utilizing it for many years in high risk patients on statins who had low HDL  (good cholesterol) and/or high triglycerides.

The rationale was that, since high HDL was associated with lower risk of heart attacks, raising the HDL would lower that risk. Similarly, lowering the triglycerides would improve cardiovascular risks.

While niacin certainly improved the cholesterol profile, there was no good evidence that starting it in a patient already on statin would improve cardiovascular outcomes. The cholesterol profile is a surrogate endpoint: the actual treatment goal is reducing cardiovascular disease.

In 2011, the AIM-HIGH study proved there was no benefit to adding niacin to good statin therapy despite increasing HDL from 35 to 42 mg/dl, lowering triglycerides and lowering LDL. This and other studies showing no benefit of niacin therapy (and worrisome adverse effects) should have resulted in the total cessation of niacin prescriptions, especially  in patients on statins.

Unfortunately, old habits die hard amongst physicians, and the allure of raising HDL and lowering triglycerides with niacin persisted despite a lack of evidence of any benefit in lowering cardiovacular risk.

Yesterday, the FDA announced it was removing from the market two  drugs made by Abbvie, Advicor and Simcor, which are combinations of extended release niacin plus lovastatin or simvastatin, and removed its approved indication for niacin ER plus statin for lowering CHD risk stating:

“Based on the collective evidence from several large cardiovascular outcome trials (Refs. 1-3), the Agency has concluded that the totality of the scientific evidence no longer supports the conclusion that a drug-induced reduction in triglyceride levels and/or increase in HDL-cholesterol levels in statin-treated patients results in a reduction in the risk of cardiovascular events. Consistent with this conclusion, FDA has determined that the benefits of niacin ER tablets and fenofibric acid DR capsules for coadministration with statins no longer outweigh the risks, and the approvals for this indication should be withdrawn.”

This is good news for patients whose physicians were keeping them on the unproven brand name combination drugs, Advicor and Simcor.

There are still legitimate uses of niacin to prevent vitamin deficiencies but If you are still taking some form of niacin ER for the purpose of preventing heart disease with or without a statin I recommend presenting your doctor with the link to the FDA pronouncement above and having a good discussion with him about the rationale for staying on it.

The other drug mentioned in the announcement, fenofibric acid,  is far less often prescribed and is not available as a combination. It is the most effective drug we have for extremely high triglyceride levels over 500 mg/dl which can cause pancreatitis. I have a few patients on the generic fenofibric acid strictly for the purpose of lowering their dangerously high triglycerides but not for the indication of lowering their cardiovascular risk.

Nonsurrogateingly Yours

-ACP