Vitamins Take Another Health Hit

CBS News asked the US government’s top authority on supplements, Paul M. Coates, director of the Office of Dietary Supplements for the National Institutes of Health, for the bottom line on:

• Vitamin E: “We have exhausted the possibilities for its role in chronic disease prevention.”
• Vitamin C: “No effect for cancer prevention.”
• Vitamin B: “For the prevention of chronic diseases like heart disease and cancer, the evidence does not point to a benefit of B vitamins.”

Nonetheless, there are some useful supplements.  For example: folic acid during pregnancy, Vitamin B12 for patients who can’t absorb it and calcium when dietary sources aren’t enough.

Selenium, Vitamins E and C Won’t Prevent Prostate Cancer

In findings that were released early because of the public health implications, the results of two large randomized, controlled clinical trials showed that selenium, vitamin E and vitamin C won’t prevent men from getting prostate cancer.  Previous findings seemed to indicate great promise, but the supplements failed to provide a cancer-prevention benefit.

Andrew Shao, vice president of scientific and regulatory affairs for the Center for Responsible Nutrition in Washington, D.C., was quoted in the HealthDay article as saying that he thought researchers need to “redefine our expectations for nutrients. They’re not magic bullets, though they do have tangible effects.”

Selenium, Vitamins E and C Won’t Prevent Prostate Cancer
Large trials fail to confirm suspected benefit

TUESDAY, Dec. 9 (HealthDay News) — Selenium, vitamin E and vitamin C won’t prevent men from getting prostate cancer.

In findings that were released early because of the public health implications, the results of two large randomized, controlled clinical trials showed the supplements failed to provide a cancer-prevention benefit, despite past findings that seemed to indicate great promise — particularly for selenium. Both studies were expected to be published in the Jan. 7 print issue of the Journal of the American Medical Association.

“Our results showed no evidence of benefit from selenium and vitamin E on prostate cancer and other cancers,” said the lead author of one of the studies, Dr. Scott Lippman, a professor of medicine in the division of cancer medicine at M.D. Anderson Cancer Center, in Houston.

Lippman’s study, known as the SELECT trial, included more than 35,000 men. Black men included in the study were all over 50, and men from other races were all over 55. (Blacks have a higher risk of developing prostate cancer than do men of other races, according to the American Cancer Society.)

The men were randomly assigned to one of four groups: selenium; vitamin E; selenium and vitamin E; or a placebo. The average follow-up time was more than five years.

The researchers found no statistically significant difference between the groups, and the trial was ended early, because there was no convincing evidence of efficacy.

The second study, done by Harvard researchers, included almost 15,000 male physicians over 50 who were randomly assigned to receive vitamin E, vitamin C, or a placebo. The average follow-up time for this trial was eight years.

Again, no statistically significant benefits were found from either vitamin C or E when it came to preventing prostate and other cancers.

These studies are just the latest in a long list of recent research that’s been discounting the use of individual vitamins and supplements for chemoprevention. Other recent studies have suggested that vitamins, B, C, D, E, folic acid and calcium taken alone, or in various combinations, aren’t effective for cancer prevention.

“Single-agent interventions, even in combinations, may be an ineffective approach to primary prevention in average-risk populations,” wrote Dr. Peter Gann, the author of an accompanying editorial in the same issue of the journal.

Andrew Shao, vice president of scientific and regulatory affairs for the Center for Responsible Nutrition in Washington, D.C., said he thought researchers need to “redefine our expectations for nutrients. They’re not magic bullets, though they do have tangible effects.”

Shao said studies that look at vitamins and cancer prevention tend to treat vitamins the same way they would a targeted pharmaceutical agent. But, he said, “the whole body is affected by nutrients, while pharmaceuticals are highly specialized and targeted to specific cells.”

“It would be a mistake to look at one trial that answers a very specific question and say these nutrients don’t work at all,” said Shao.

Lippman, however, said he doesn’t recommend the use of supplements for cancer prevention. “There’s no evidence to support taking these,” he said.

Leading Canadian natural health product manufacturer calls for better industry regulation

One of Canada’s leading natural health product manufacturers issued a public call for stricter regulations yesterday.  While some natural health product manufacturers have been leading the fight against industry regulation, Vic Neufeld (Jamieson’s president and CEO) stated that Federal regulation has “been too slow and did not go far enough.  The Canadian consumer has to be protected.”

He argues that current rules are so lax that Ottawa can’t even order harmful products off store shelves and is only able to issue toothless health advisories.  Tougher standards are needed to protect public health from tainted materials in supplements.

While natural health products are regularly used by many Canadians, this may change if consumers aren’t adequately protected.  The numerous health advisories and product warnings risk damaging consumer confidence.

Globe and Mail
The pressing need for more oversight was highlighted on Tuesday when Health Canada issued an advisory saying that a company inadvertently sold a product labelled as containing vitamin C that was improperly manufactured using vitamin A instead. The products were sold under the brand names of New Roots Herbal Vitamin C8 and Vitazan Professional Vitamin C Advanced Ascorbate.

Health Canada warned the pills may contain high doses of vitamin A, exposing users “to potential risks of adverse events.” It urged consumers, particularly pregnant women, not to use them.

The warning is the latest in a long string of advisories Health Canada has made during the past two years over undeclared drugs, heavy metals and steroid hormones, among other deleterious substances, that have been found in some natural health products.

Mr. Neufeld said one weakness in Canada is that a company importing a health product ingredient only has to conduct safety tests on one shipment from offshore suppliers each year. In South Korea, by contrast, the government requires every batch that Jamieson sends there to be tested.

R.I.P. – Medical Innovation

Medical innovation could be the latest casualty of the global economic crisis, according to Professor David Wield, Director of the Economic and Social Research Council’s (ESRC) Edinburgh-based Innogen Centre.  He warns that investment into research for new drugs – which globally runs into the billions – is now seriously at threat as investors shy away.

Is this prediction alarmist?  Let’s hope so, since continued medical innovation is essential to the health and welfare of people around the world.

New Medicines Threatened By Credit Crunch

The global financial crisis could seriously delay the discovery and production of many new life-saving medicines, warns a major international conference today.

Investment into research for new drugs – which globally runs into the billions – is now seriously at threat as former investors in the drug companies shy away as a result of the economic meltdown.

Professor David Wield, Director of the Economic and Social Research Council’s (ESRC) Edinburgh-based Innogen Centre, and chair of the ‘Genomics and Society: Reinventing Life?’ conference, delivered a stark warning prior to the gathering of over 200 experts at conference in London.

Professor Wield said: “Investing in biotech companies is now seen as risk taking, and will not be for the timid. What will happen to investment in biotech research if finance cannot even be found for relatively everyday expenses which are increasingly becoming more of a struggle?

“Drug discovery depends on long-term finance with high risk of failure – and lots of it. Financing of biotechnology companies hit $50bn in 2007. And overall, these biotechs only made profits for the very first time last year, amounting to $1bn on revenues of $59bn.”

According to Professor Wield, in addition to the impact on the basic research performed at biotechnology companies, development of medicines by pharmaceutical companies has also been hit by the credit crunch.

In recognition of the significant long term and immediate challenges faced by the pharmaceutical sector the UK Research Councils are working to help underpin future development of the sector for example to find new ways of enabling effective drug trials that enjoy public confidence; and building new research partnership with the sector.

Cell phones — the newest weapon in the battle against counterfeit drugs?

I came across this interesting article from Wired magazine about two young entrepreneurs who may have come across a way to help tackle the problem of counterfeit drugs.  By using cellphones to connect the people who produce drugs with the people taking them, they hope to reduce the amount of counterfeit drugs in the world by 25%.

“Using their cellphones to check identifying numbers on the drugs with the manufacturer, sick people in the developing world will be able to authenticate that the drugs they are using don’t come from shady operations that often neglect to include the actual medicine in the pill.”

Regardless of whether or not cell phones become the newest weapon in the battle against counterfeit medicines, the intentions of these entrepreneurs are commendable.

PopTech: 20-Somethings Take On $50 Billion Counterfeit-Drug Biz

If you get malaria, you take medicine, and you get better.

At least, that’s how the process should work, but a flood of counterfeit medications is threatening the doctors’ ability to treat sick people in the developing world. A 2006 study found that more than half the anti-malarials in southeast Asia contained no actual medicine.

While public health officials fret, the increasingly sophisticated shadowy network of fake-drug producers will rake in an estimated $75 billion by 2010, according to a pharmaceutical industry research group. Despite rapid growth in counterfeiting over the last decade, no one has quite figured out how to stop handbag knockoffs, let alone ersatz pills that the FDA admits, “can be difficult, if not impossible” to tell apart from the real thing.

Sounds just like the kind of problem that a couple of scrappy twenty-somethings with a dream can solve, right?

Maybe not, but that’s just what N. Taylor Thompson and Nathan Sigworth, the youngest members of PopTech’s new fellows program, are trying to do. Using cellphones to connect the people who produce drugs with the people taking them, the Dartmouth-schooled duo’s big goal is to reduce the amount of counterfeit pharmaceuticals in the world by 25 percent.

“Not only are we doing something that has a positive benefit for consumers who are sick, but it’s something that actually takes away from the profits of people making money on fake medicines,” Sigworth told Wired.com.

Thompson and Sigworth are excellent examples of the post-internet social entrepreneurs that PopTech is trying to attract. Comfortable with the digital world, they can bring youthful vigor and tech know-how to the occasionally stodgy world of nonprofit development causes. Perhaps most importantly, they remain optimistic that new technological and business models can overcome daunting challenges that have defeated their elders.

“How do you tackle a problem like this yourself at 22 or 23?” Sigworth asked. “From the beginning, we’ve tried to surround ourselves with people from pharma and other organizations that could really help make this happen.”

And it wasn’t as if they chose this problem at random from the huge-world problem bin. Sigworth said that he and his partner saw a unique opportunity to fight counterfeit drugs because Big Pharma’s needs match up with the needs of poor, sick people in the developing world. Like a Yahoo Pipe, they could connect corporate money to social needs.

“It really is the nexus of where public health concerns and private concerns come together,” Sigworth said.

The entrepreneurs’ nascent company, Pharmasecure, has developed a business model to drop the cost of authenticating drugs low enough that supply-chain security can be extended into countries like China and India.

Using their cellphones to check identifying numbers on the drugs with the manufacturer, sick people in the developing world will be able to authenticate that the drugs they are using don’t come from shady operations that often neglect to include the actual medicine in the pill. The innovation isn’t the technology, it’s the business model that will allow the poorest people on earth access to the technology.

They’ve gotten support from C. Everett Koop, former surgeon general of the United States, and fellow Dartmouth alum, and are in the process of raising capital to take their ideas from the prototype to the people who need them.

As you might expect, people working to fight counterfeit drugs don’t make a lot of friends among the illegal racket, so some of Sigworth and Thompson’s plans — and their whereabouts — remain secret, but they are planning to be operating in eight countries across Asia and Africa over the next few years.

Drug safety in the global market

The following article from the International Herald Tribune highlights an interesting challenge in ensuring patient safety — the evaluation of product quality and good manufacturing processes for healthcare products in the global marketplace.  According to a recent report from the FDA, it would take 13 years to evaluate every current international manufacturing facilty that supplies medications for the American market.  13 years…  And that’s just for a single evaluation of each facility.

If Canada, the U.S. or other developed countries were to stop importing foreign medical products, there wouldn’t be enough medicines available for many patients.  On the other hand, recent scandals such as the tainted heparin or melamine-laced milk from China clearly highlight the potential risk of untested products.  Clearly, a middle ground must be established soon to ensure that patients can get the medicines they need — without worrying they’ll do more harm than good.

US surveys of foreign drug makers would take time
International Herald Tribune

WASHINGTON: A lot can happen in 13 years. A new president. Medical discoveries. Economic boom and bust.

But 13 years also is how long it would take U.S. inspectors to visit each of 3,249 foreign manufacturing plants that supply medications for the American market, according to congressional investigators.

Their report being released Wednesday concluded that the Food and Drug Administration is nowhere near to closing an oversight gap so as to make foreign facilities get the same scrutiny as domestic U.S. plants. Pharmaceutical factories in the United States get a federal inspection every 2.7 years, on average.

Although the FDA will soon be placing inspectors in China and India, “given the growth in foreign drug manufacturing for the U.S. market, and the large gaps in FDA’s foreign drug inspection program, significant challenges remain,” the Government Accountability Office said in its report.

The report “confirms that the system deployed by FDA to police (foreign) facilities and keep Americans safe from poorly manufactured drugs is understaffed, overwhelmed and completely inadequate,” said Democratic Rep. Bart Stupak.

He was among lawmakers pushing legislation to impose fees on drug and food imports that would pay for more inspectors. The Bush administration agreed to a funding increase, but balked at new fees.

An adulterated blood thinner from China put a spotlight this year on the safety of drugs manufactured abroad. Hundreds of frail patients undergoing kidney dialysis and heart operations were sickened by tainted heparin, and some died.

Responding to the report, the FDA said it recognizes that more inspections are needed as part of a broader import safety plan. The agency questioned, however, the investigators’ conclusion that it should apply the same kind of scrutiny to foreign plants as it does to domestic ones.

“The conclusion that FDA should endeavor to conduct foreign inspections based on the same criteria as domestic inspections is … problematic because of the differences in regulatory methodology and resources,” the FDA said.

The report found that the FDA is not even sure how many foreign facilities are producing for the American market. One government database suggests it is 6,760. Another, which government officials believe to be more accurate, says about 3,000.

The 3,249 number comes from a list the FDA uses to set enforcement priorities. Of those on the list, it manages to inspect an average of 247 a year. By comparison, the agency inspected an average of 1,528 domestic plants a year from 2002-2007. About 3,000 facilities turn out medicines in the United States.

Congressional investigators found that the FDA’s rationale for picking which foreign plants to inspect often differs from how the agency selects domestic plants. Most domestic inspections involve continuing surveillance on whether a plant is following good manufacturing practices. Foreign inspections, however, are driven by requirements to inspect a facility before it is approved to ship medications. The GAO recommended more surveillance inspections of foreign plants.

“It is important that (the FDA) ensure that foreign and domestic establishments with similar characteristics be inspected at a similar frequency,” the GAO report said.

When FDA inspectors find problems at an overseas plant, the manufacturers usually act to fix them. The report found it can take as long as four or five years for the FDA to conduct a follow-up inspection.

Hockey fans speak out on the regulation of natural health products

Since the issue of natural health product regulation is one that affects all Canadians, it is encouraging to see those outside the health industry engaging in the discussion as well.  The following are excerpts from a discussion about natural health products on a Toronto Maple Leaf community based website:

Vitamin C will still be available on the shelf after this bill is put through.  This targets the sale of health products that promote certain benefits  that have yet to be medically proven.

It’s obvious to me that many of you do not rely or depend on natural herbal medicinal supplements, in lieu of   prescription drugs, to keep oneself alive.  The only 2 parties that understand people’s trepidation over this proposed legislation in the name of “consumer protection” which it isn’t, are the NDP and the Greens.  They seem to understand it better than all-of-you-can!!

I understand your point – My entire family goes to Naturopath instead of doctors.  However – Natural remedies can have VERY adverse side effects too.  They can also be created by unscrupulous people and not do anything close to what they claim.

When people’s health and well-being is at risk you can not possibly just trust that the manufacturer is looking out for your best interests.  ALL healthcare products need to be tested and approved for the use they claim to be for.

Dietary supplements cause 600 ‘adverse events’

USA Today reports that serious side effects from the use of food supplements resulted in 604 “adverse-event” reports — a list that includes at least five deaths — through the first six months that such accounts have been required by law.

This information is based on data from the U.S. (as reported by the Office of Nutritional Products, Labeling and Dietary Supplements in the Food and Drug Administration’s Center for Food Safety and Applied Nutrition), but one would certainly expect similar results (proportional to the population) in Canada. 

Sen. Richard Durbin, who sponsored the legislation requiring supplement manufacturers to inform the FDA when there are adverse events, said “Five years ago, the dietary supplement industry claimed that they had no reports of health problems — zero — related to their products.  Thanks in part to our legislation, we today know there are hundreds of serious problems each year, many involving hospitalization and death.”

Better regulation of natural health products — in the U.S. and Canada – would help ensure consumers have access to safe and effective products.

The complete article from USA Today is included below:

Dietary supplements cause 600 ‘adverse events’
First data since reporting law
By A.J. Perez
USA TODAY

Serious side effects from the use of food supplements resulted in 604 “adverse-event” reports — a list that includes at least five deaths — through the first six months that such accounts have been required by law.

The Office of Nutritional Products, Labeling and Dietary Supplements in the Food and Drug Administration’s Center for Food Safety and Applied Nutrition acknowledged receiving 368 mandatory reports from supplement manufacturers and 236 reports from consumers or health care professionals.

An adverse event can be anything from a concern that a supplement isn’t working to a serious illness that follows consumption. FDA spokesman Michael Herndon said five deaths and 85 hospitalizations were reported through April 15, the most current numbers available. “Some of these deaths were likely due to underlying medical conditions,” he says.

The FDA did not identify the supplements linked to the adverse events. The agency defines dietary supplements as including vitamins, minerals, amino acids, herbs or botanicals, and enzyme supplements.

Dietary supplements have long been a controversial topic, with consumer advocates critical of the fact that, unlike with drugs, supplement makers don’t have to prove their products are safe or effective before they reach the market.

Sen. Richard Durbin, D-Ill., sponsored legislation in 2006 to require supplement manufacturers to inform the FDA when there are adverse events. The bill took effect Jan. 1.

“Five years ago, the dietary supplement industry claimed that they had no reports of health problems — zero — related to their products,” Durbin said in an e-mail.

“Thanks in part to our legislation, we today know there are hundreds of serious problems each year, many involving hospitalization and death,” he says.

If the trend continues, there will be fewer than the 960 adverse-event reports the FDA had estimated it would receive each year.

“These numbers don’t alarm us,” says Steve Mister, president and chief executive of the supplement trade group Council for Responsible Nutrition. “We thought they would be much less than the FDA estimate.”

The legislation pushed by Durbin came in the wake of several deaths related to the now-banned supplement ephedra. The weight-loss and energy enhancer was implicated in the deaths of Minnesota Vikings offensive lineman Korey Stringer in 2001 and Baltimore Orioles pitcher Steve Bechler in 2003.

“There’s still no assurance that supplements are safe,” says Peter Lurie, deputy director of Public Citizen’s Health Research Group. “Many people are under the impression that the FDA has approved supplements, but that’s not the case. There’s really no assurance that what manufacturers say is in the product is really in there.”

Adverse-event reporting has been required for prescription and some non-prescription drugs for years. The FDA took in 482,154 adverse-event reports for prescription drugs last year.

Top-selling supplements

1. Multivitamins
2. Sports nutrition powders/formulas
3. Calcium
4. B vitamins
5. Vitamin C
6. Glucosamine/chondroitin
7. Homeopathics
8. Other vitamins
9. Fish/animal oils
10. Coenzyme Q10

Source: Nutrition Business Journal 2007 survey

Should natural health products face stricter regulation?

This question has been a hot topic of discussion since the introduction of Bill C-51.  I came across this opinion on the Lintbox blog:

Should NHPs, including vitamins, herbs, and other products regulated by the Natural Health Products Regulation face stricter regulation, or should their availability be secured as a basic human right?  Similarly, should the government assure that medicines marketed toward the consumer are clinically proven to be effective, or should it allow natural products to be left unregulated as cultural merchandise?

Mitchell:

Let me preface this post by stating that I am a firm believer in both the free market and consumer choice. Though I do not necessarily believe in the restriction of harmful substances, I do believe that consumers must be properly informed as to the efficacy and potential harm of any product that they are buying, in order to make a proper, and informed, choice.  The demand for this information gives rise to the necessity of having an impartial third party regulate any products that consumers are not fully capable of evaluating for themselves.

Why do we regulate products?  We regulate when there is a risk of sever harm from sub-standard or inconsistent products.  This is true of food, water, pharmaceuticals, technology, and a whole host of other things that consumers lack the ability to assess.  We don’t expect every person to conduct a randomized, double-blinded, placebo-controlled trial every time they buy a bottle of aspirin – aside from the fact that most people probably wouldn’t know how, this would be wildly impractical and inefficient – so we have government bodies to regulate the efficacy of these drugs[1].

Natural Health Products (NHPs), like any other type of health product, are meant to treat diseases and conditions.  Of all things, medications are the most important to regulate, due to the large potential for harm of ineffective or inconsistent products.

By definition, medications are meant to induce an atypical reaction in the human body; these reactions are what aid the human body in fighting off diseases. As long as these reactions are controlled, they can often have the desired effect of triggering the body to take action against a disease or condition.  However, the body operates within a very specific set of parameters, and if any one thing is allowed to get too far out of balance, the resulting damage can often prove harmful – or even fatal – to the person taking the medication.  It is for this reason that we must know precisely what the effects (and side effects) of any given medication are, and what constitutes a safe dosage.  Through regulation, we can ensure that people know that the medicine will have the desired effect, and that they will be receiving a safe dose.
 
“The distinction between an “artificial” and “natural” drug is meaningless in every way that matters to a regulating body; because of this, we should not regulate “natural” products any differently.”

It is also important that medications are consistent in their dosage and quality.  When you take a medication, you want to know that the pills you pick up at the pharmacy are the same ones that your doctor prescribed.  Through regulation, we can ensure the consistency of products – both in terms of efficacy and safety.

Clearly, the regulation of natural health products is important.  People need to know that when they buy medicine – natural or not – that they are getting what they think they are getting.  So perhaps the bigger question is not whether natural health products deserve to be regulated, but whether they should be subjected to any different regulation than any other type of health products.

The distinction between “natural” and “artificial” does not really exist in the realm of physical objects.  When talking about food and drugs, the term “natural” becomes especially meaningless.  All of our food and medications are grown/manufactured/synthesized from things that we have found in nature.  There is no meaningful distinction (chemical, health, etc.) between Vitamin C synthesized in a lab, or extracted from a citrus fruit; likewise, the chemicals found in modern pharmaceuticals are no different from those found in nature.  Often, isolating drugs found in nature and then refining/purifying them in the lab is how we make our drugs.  This process helps ensure that the drugs are safe, and efficacious.  The distinction between an “artificial” and “natural” drug is meaningless in every way that matters to a regulating body; because of this, we should not regulate “natural” products any differently.  It is not the government’s job to certify the subjective benefits people derive from medications produced by different means.

However, there is another reason why governments should not regulate natural health products separately from other health products.  This has to do with a popular notion that products labeled as “natural” are intrinsically healthy – not because of their composition, but because they are “natural”.  Unfortunately, a product being marketed as “natural” is not necessarily safe or beneficial (just think that every toxin, poison, and radiation known to man is also “natural”).  Natural health products can be safe and beneficial, but we can only assess safety through testing and clinical trials; not by figuring out whether the product is “natural” or “organic”.  If the government chooses to regulate the two items separately, it only helps to reinforce the notion that there is some fundamental difference.  Regulators can send the right message by holding “natural” and “non-natural” health products to the same high standards.

However, this still leaves us with non-harmful, yet non-beneficial “natural” health products – things like glucosamine, which pose no health risk, yet also have no proven medical effect.  Whereas I do not believe we should be restricting the sale of these items, I do think that we have to take a stricter stance on allowing marketing tactics that make implicit health claims, even as they avoid making explicit claims. Saying that your product “helps support joints” isn’t a whole lot different from claiming it can help treat arthritis – except that the government is helpless to stop products being marketed using the former wording.  People should still be free to purchase all of the “natural” products they desire; however, it needs to be made clear that the products have no proven medical effect.

The bottom line is that I trust consumers (most of the time) to make the correct decisions regarding their health, but in order to do so, they need to be armed with the correct knowledge about the drugs and other health products they are buying.  For this, we need regulation.

[1]  Though it isn’t 100% necessary that the regulating body be a government organization, it’s certainly one of the most practical solutions to make sure the organization has proper funding, and is suitably non-biased.

Global economy; national safety standards

Proper regulation of Canadian-made products (food and health products in particular) is an important part of ensuring product quality and consumer safety.  What might be even more important, however, is the process of monitoring and evaluating products imported from overseas.

Recent incidents that highlight the need for regulatory authorities to be particularly diligent in the assessment of imported products include the contamination of Chinese made baby formula with melamine and the identification of poor manufacturing practices used by an Indian drug company.

Completely preventing the sale of foreign goods is an impractical solution — our economy relies on global trade.  Instead, it’s essential that products be properly regulated to make sure they meet the standards expected by Canadian consumers.

Articles highlighting these recent incidents are included below:

China’s toxic milk scare widens
(Toronto Star)  BEIJING–China was bracing for more bad news today amid mounting fears that the death toll from the country’s contaminated baby formula scandal is about to climb.

China’s deputy health minister said yesterday a second death had been confirmed and more than 1,250 babies now suffer from kidney stones after drinking the formula laced with melamine sold by Chinese dairy company Sanlu.

Melamine is a chemical used in making plastics. It is banned in food production.

Deputy minister Ma Xiaowei told reporters that of the 1,250 babies affected, more than 350 are hospitalized – and 53 of them are in “serious” condition.

…

State news agency Xinhua said it is believed the pair added melamine to the milk to boost nitrogen levels, which would falsely increase protein readings to pass tests.

The agency also reported there is now evidence that the melamine might have been present in Sanlu’s formula since late 2007.

More than 30 Ranbaxy drugs banned entry to US
The US Food and Drug Administration has blocked the import of more than 30 Ranbaxy drugs that have been manufactured in two plants in India after concerns were raised about the manufacturing practice.

The agency issued two Warning Letters to the generics drug maker yesterday and issued an Import Alert to detain at the US border any drugs manufactured at Ranbaxy’s Dewas and Paonta Sahib facilities. This is the second time in less than three years that the FDA has issued a Warning Letter to Ranbaxy.

The Warning Letters identify the agency’s concern about deficiencies and deviations from US current Good Manufacturing Practice requirements at the two Indian plants. The extent and nature of the violations led to the issuing of the Import Alert, the FDA said in a statement.