Just how tainted has medicine become?

[phooph]

Just how tainted has medicine become?

THE LANCET
Volume 359, Number 9313

Chief executives of multinational pharmaceutical companies have much to celebrate this week. They saw spending on prescription drugs in the USA soar by a remarkable 17% in 2001, according to figures recently released by the National Institute for Health Care Management Foundation. As bonuses for corporate leaders ratchet upwards, so does the unalleviated financial pressure on the elderly, the largest users of these drugs. Direct-to-consumer advertising campaigns for cholesterol-lowering agents, anti-ulcer medications, anti-arthritics, and antidepressants have beenstrikingly successful. Total retail spending on prescription drugs was US$155 billion in 2001, almost double what it was in 1997.

The escalating influence of big pharma in medicine persuaded editors of medical journals to come together last year and agree strict rules on reporting sponsorship and conflicts of interest (see Lancet2001; 358: 854–56). While this consensus sets the highest standards yet for disclosing commercial influences in medical research, there are signs that it does not go far enough—or, at the very least, that this guidance is not being fully heeded.

A study of the interactions between authors of clinical practice guidelines and the pharmaceutical industry, published in JAMA in February, found
serious omissions in declarations of conflicts of interest. Almost 90% of authors received research funding from or acted as consultants for a drug
company. Over half had connections with companies whose drugs were being reviewed in the guideline, and the same proportion indicated that there was no formal procedure for reporting these interactions.

The guidelines studied covered all fields where prescription drug use has seen the greatest increases. An especially corrosive example of such a
commercial influence, involving one of the most respected US specialist societies—the American Heart Association—was described in the BMJ last
month. Was the AHA sensible to accept US$11 million in donations from Genentech while at the same time producing guidelines about thrombolytics in stroke? Genentech is the US producer of one such
thrombolytic, which was recommended for use in the AHA 2000 guidance on stroke management.

Prestigious institutions are also not averse from mixing research with commercial gain from industry partnerships. The Seattle Timeshas conducted one of the most thorough investigations of how such relations threaten to poison patient care. In a series of articles published last year, staff reporters Duff Wilson and David Heath claimed to reveal how investigators at the Fred Hutchinson Cancer Research Center completed experiments with biotechnology products in which they had a direct financial interest. The journalists allege that doctors did not tell patients that others had died using these products and that there were safer alternatives available. The Center denies these allegations but
admits that it “could have handled better” perceptions of conflict of interest.

These concerns extend to journal editors, especially those who edit part-time while continuing to work in clinical practice and research. The rules issued by the International Committee of Medical Journal Editors state that, “Editors who make final decisions about manuscripts must have no personal, professional, or financial involvement in any of the issues they
might judge”. However, the editor of the British Journal of Psychiatrywas recently questioned about his membership of a drug-company sponsored
“educational organisation”, for which he received £2000 annually, together with his decision to publish a paper favouring a drug manufactured by the same company. Only after receiving the letter questioning his behaviour did the editor change his journal’s procedure, excluding himself from decisions about work sponsored by that same company. He avoided the issue about whether he should have any commercial liaisons while acting as editor of a
supposedly independent medical journal. The Lancet’s policy is that editors should divest themselves of all such links upon assuming their new
duties.

To return to our first question: how tainted by commercial conflicts has medicine become? Heavily, and damagingly so, is the answer. A more important question arises: do those doctors who support this culture for the best of intentions—eg, to undertake important research that would otherwise remain unfunded—have the courage to oppose practices that
bring the whole of medicine into disrepute?

THELANCET • Vol 359 • April 6, 2002 • www.thelancet.com

[Sylph]

At least the problem was reported a mainstream journal, and hopefully more attention is focused on potential conflicts of interest in the drug biz.

There is plenty of sleaze and greed among drug manufacturers and the scientists charged to study them. I agree that prescription drugs are over prescribed and often dangerous.

Supplements have problems too. One fourth don’t have the amount of ingredient they are supposed to have. Many have heavy metals. Unlike with prescription drugs, there is no procedure in place to report any adverse reactions or even take problem herbs/supplements off the shelves if one is identified. People don't tell their doctors, often, that they take an herb, and if that herb caused blood thinning that lead to a hemorrhage after a little bump on the head, who is going to figure that out? Or a person stops taking their diabetes or heart medicine in favor of some supplement from overseas...

Consumer Labs is a good organization to address thie problem of quality of supplements, but you have to sign up and pay to see all the reports. Maybe worth it, if you spend a lot of money on certain supplements.

Some excerpts from a good, balanced article that had positive things to say about supplements, too.

Duke university has an integrative medical center for holistic cancer care…the best of both worlds. "Integrating complementary and alternative therapies seems to be the wave of the future. Perhaps dietitians can help their patients wade through the sea of supplements to find the true treasures."
https://www.todaysdietitian.com/newarchives/jan2007pg34.shtml
With public safety at stake, some organizations are developing initiatives to better protect consumers from false claims and potentially dangerous products.
The dietary supplement industry seems to be a magnet for controversy. Its not uncommon to find your e-mail inbox flooded with spam on supplements claiming to enlarge choice body parts or spy best-selling diet books peddling an array of dietary supplements aimed at weight loss, antiaging, and beauty. Whats a soul to do but cave in and pop a few pills? And this is just what people are doing. The Office of Dietary Supplements reports that in 2004, consumers spent $20.3 billion on dietary supplements.
Daniel Fabricant, PhD, vice president of scientific affairs at the Natural Products Association, says in defense of dietary supplements, smart buyer doesn’t confuse the e-mail spammers making egregious claims with the legitimate dietary supplement industry [any] more than they would confuse the spammers claiming to give away cars with the legitimate automotive industry.

When it comes to life-threatening diseases such as cancer, even one consumer who falls prey to a supplement suggesting that it cures cancer in lieu of traditional treatments such as chemotherapy and radiation is too many.

In a study published in Family Medicine in 2002, researchers from the Scripps Center for Integrative Medicine in La Jolla, Calif., conducted Internet searches using the linked terms herb and cancer, resulting in matches for each of the six primary search engines of between 11,730 and 58,605. Further cross matching with the three master search engines revealed that prevention, treatment, and cure were discussed at rates of 92%, 89%, and 58%, respectively.

The National Center for Complementary and Alternative Medicine (NCCAM) is busy funding studies on a number of supplements such as echinacea and glucosamine/chondroitin. The NCCAMs position is that there is scientific evidence for the effectiveness of some complementary and alternative medicine treatments, but for most, there are key questions yet to be answered through well-designed scientific studies, such as whether they are safe and work for the diseases or conditions for which they are used.

A Whole Batch of Problems
There are lots of problems with dietary supplements. There are no regulations that dictate appropriate serving recommendations. There is no organized collection of adverse events so that safety problems can be spotted early, says Cooperman (of Consumer Labs).
"The area that we focus most on is product quality. We are seeing one fourth of the products that we select for testing to have a quality problem. We find products with none or little of their claimed ingredients, products contaminated with lead or pesticides, [and] tablets that won’t break apart to release their ingredients. Many products don’t even specify a dose that is known to work." Cooperman gives an example of zinc lozenges for colds. Three fourths of the products that ConsumerLab.com tested did not have or suggest the amount of zinc that has been shown to be effective.
So what happens to all the products that don’t contain what they are supposed to contain? Cooperman reports, It is very rare that a manufacturer recalls a supplement, even after a report comes out on a product. The retailer is not required to recall the supplement. Only when people are really being hurt does [the] FDA take serious action against a manufacturer.
Heller agrees: [The] FDA does not have recall authority over supplements. If there are fly-by-night supplements being made, they are not going to get off the market or off of shelves. Heller also believes the structure/function claims allowed on dietary supplements are close to disease claims and that many dietary ingredients in supplements on the market are grandfathered in, so there’s a presumption of safety rather than the actual determination of safety.

Tired of suffering a tarnished reputation at the hands of shady supplement makers, those in the dietary supplement industry are also banding together to clean up the industry. The supplement industry has had bad press in recent years. Some of the industry supports adverse event reporting as a way of repairing that image, says Heller. The Natural Products Association, along with several other dietary supplement organizations and consumer groups, is supporting legislation in both the House and Senate that would require the reporting of serious adverse experiences for dietary supplements and over-the-counter drugs. (The Senate recently passed this legislation.) Kalman, who performs clinical trails for the food and supplement industry, also finds more and more companies working on independent research for supplements.
The American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition, and the Natural Products Association recently announced a voluntary industrywide protocol, Standardized Information of Dietary Ingredients, to facilitate the exchange of information between ingredient suppliers and finished product manufacturers to help identify and qualify supplement ingredients from trustworthy sources.
Good Manufacturing Practices
One action eagerly awaited is Good Manufacturing Practices (GMP) for supplements. The FDA is authorized to create GMP regulations describing conditions under which dietary supplements must be prepared, packed, and stored. The FDA published a proposed rule in March 2003, but until this proposed rule is finalized, dietary supplements must comply with food GMPs that are primarily concerned with safety and sanitation rather than quality.
It’s been 12 years since they have been promised, and there are still no established GMPs for supplements. There is a lot of talk about them coming out this year, but they say that every year. If GMPs are approved, manufacturers will be required to make the products the same way from lot to lot. This would be a step in the right direction, says Cooperman. To be even more meaningful, GMPs would include standards around what is supposed to be in the product. For example, what levels of specific plant chemicals should be in a product claiming to be gingko, garlic, or ginseng.
Fabricant reports that rather than waiting for the federal GMPs to be issued, his association developed its own GMP certification program in 1999. The Natural Products Association has certified nearly 60 companies and provided education for representatives from more than 350 dietary supplement companies. Their standard is used by other organizations as the basis of their dietary supplement GMP program. GMPs mean understanding, analyzing, controlling, and documenting the manufacturing process. It is a third party audit system, says Fabricant.
Dietary Supplement Certification
Voluntary certification can offer supplement consumers some quality assurance. ConsumerLab.com, which offers a voluntary certification program, is finding more and more manufacturers interested in certification. They allow manufacturers and distributors to use specific CL Seals to identify products that have met ConsumerLab.com standards based on its product reviews.
NSF International, a public health and safety company, also developed an independent product evaluation program to address dietary supplements. Their voluntary testing and certification program verifies the identity and quantity of dietary ingredients listed on the product label; ensures the product does not contain undeclared ingredients or unacceptable levels of contaminants; and demonstrates conformance to currently recommended industry GMPs for dietary supplements.

Enforcement Action
There is a little bit of action, a joint program between [the] FTC and FDA, to go after products on the Web, says Heller. [The] FDA is increasing enforcement on dietary supplements, but its not at the level it should be.
The FTC and FDA work together against fighting dietary supplement fraud. The FDA has primary responsibility for claims on product labeling and the FTC has primary authority over advertising claims. The FDA can identify fraudulent products through market surveys, inspections, Internet searches, adverse event reports, consumer complaints, informants, and referrals from other government agencies. The highest priority for the FDA are products that pose direct health hazards to consumers. When a problem arises with a supplement, the FDA can act by working with the products marketer to correct the problem voluntarily. If that doesnt work, the FDA may bring a lawsuit to seize the product and enjoin the firm marketing it. The FDA can also seek criminal penalties against parties breaking the law.
Although it may seem like a drop in the bucket, many examples do exist in which the FDA and FTC went after supplement makers that broke the law. Recently, it made news when the FDA and FTC sent warning letters to dozens of U.S.- and foreign-owned Web sites selling or advertising dietary supplements that claimed to cure, treat, or prevent diabetes. These were discovered through an Internet sweep for fraudulent sites and products.
In todays world of healthcare, there is room for both traditional and alternative therapies. For cancer patients visiting the Duke Center for Integrative Medicine in North Carolina, the health team may recommend specific vitamins, Chinese herbs, and acupuncture in addition to chemotherapy. The healthcare team takes into consideration the whole person, including support systems, spiritual practices, and stress reduction in an effort to help patients better tolerate chemotherapy.
Integrating complementary and alternative therapies seems to be the wave of the future. Perhaps dietitians can help their patients wade through the sea of supplements to find the true treasures.
" Sharon Palmer, RD, is a contributing editor at Today’s Dietitian and a freelance food and nutrition writer in southern California.

References

[phooph]

Unfortunately money rules and despite much discussion in medical circles there is yet to be a change of practice because economics drives the problem. There was an announcement yesterday that drug companies are now required to put permanent inspectors in China to oversee the manufacture of their drugs there. This came about due to the same issues you mention below regarding supplements. Drugs have been manufactured there that contained contaminants or were devoid of active ingredients. This has received scant coverage in the media, but people have been harmed and killed by these bogus drugs sold through pharmacies in the US.

I would like to see strict standardization in supplements, but that means an oversight agency and the FDA is already unable to keep up with what it is mandated to do. I think the industry needs to create a seal of approval and a strict standardization protocol with testing and some way needs to be found to insulate it from undue influence from the manufacturers much as the organic industry has done.

There is much ignorance among consumers regarding herbs and vitamins. I think that herbs that are blood thinners, for instance, should carry a specific warning, but then the drug manufacturers would claim that makes it a drug and it must go through the drug approval process to carry that warning. That process costs several million to a billion dollars. No one is going to do that for ginko as it is prohibitively expensive. Supplement manufactures are prohibited by the FDA from making any medical claims on their products. The drug industry is behind that. Only pharmaceuticals can make such claims. They are protecting their turf.

As for this quote, "When it comes to life-threatening diseases such as cancer, even one consumer who falls prey to a supplement suggesting that it cures cancer in lieu of traditional treatments such as chemotherapy and radiation is too many." I would like to see the same standards applied to the medical industry as the deadliness of "traditional medicine" is well established and even recognized by those within the industry. Since most chemotherapy fails, I believe that all drugs claiming to cure cancer should be accompanied by a fact sheet detailing the success rate and the likely side effects including the death rate.

At least the problem was reported a mainstream journal, and hopefully more attention is focused on potential conflicts of interest in the drug biz.

There is plenty of sleaze and greed among drug manufacturers and the scientists charged to study them. I agree that prescription drugs are over prescribed and often dangerous.

Supplements have problems too. One fourth don’t have the amount of ingredient they are supposed to have. Many have heavy metals. Unlike with prescription drugs, there is no procedure in place to report any adverse reactions or even take problem herbs/supplements off the shelves if one is identified. People don't tell their doctors, often, that they take an herb, and if that herb caused blood thinning that lead to a hemorrhage after a little bump on the head, who is going to figure that out? Or a person stops taking their diabetes or heart medicine in favor of some supplement from overseas...

Consumer Labs is a good organization to address thie problem of quality of supplements, but you have to sign up and pay to see all the reports. Maybe worth it, if you spend a lot of money on certain supplements.

Some excerpts from a good, balanced article that had positive things to say about supplements, too.

Duke university has an integrative medical center for holistic cancer care…the best of both worlds. "Integrating complementary and alternative therapies seems to be the wave of the future. Perhaps dietitians can help their patients wade through the sea of supplements to find the true treasures."
https://www.todaysdietitian.com/newarchives/jan2007pg34.shtml
With public safety at stake, some organizations are developing initiatives to better protect consumers from false claims and potentially dangerous products.
The dietary supplement industry seems to be a magnet for controversy. Its not uncommon to find your e-mail inbox flooded with spam on supplements claiming to enlarge choice body parts or spy best-selling diet books peddling an array of dietary supplements aimed at weight loss, antiaging, and beauty. Whats a soul to do but cave in and pop a few pills? And this is just what people are doing. The Office of Dietary Supplements reports that in 2004, consumers spent $20.3 billion on dietary supplements.
Daniel Fabricant, PhD, vice president of scientific affairs at the Natural Products Association, says in defense of dietary supplements, smart buyer doesn’t confuse the e-mail spammers making egregious claims with the legitimate dietary supplement industry [any] more than they would confuse the spammers claiming to give away cars with the legitimate automotive industry.

When it comes to life-threatening diseases such as cancer, even one consumer who falls prey to a supplement suggesting that it cures cancer in lieu of traditional treatments such as chemotherapy and radiation is too many.

In a study published in Family Medicine in 2002, researchers from the Scripps Center for Integrative Medicine in La Jolla, Calif., conducted Internet searches using the linked terms herb and cancer, resulting in matches for each of the six primary search engines of between 11,730 and 58,605. Further cross matching with the three master search engines revealed that prevention, treatment, and cure were discussed at rates of 92%, 89%, and 58%, respectively.

The National Center for Complementary and Alternative Medicine (NCCAM) is busy funding studies on a number of supplements such as echinacea and glucosamine/chondroitin. The NCCAMs position is that there is scientific evidence for the effectiveness of some complementary and alternative medicine treatments, but for most, there are key questions yet to be answered through well-designed scientific studies, such as whether they are safe and work for the diseases or conditions for which they are used.

A Whole Batch of Problems
There are lots of problems with dietary supplements. There are no regulations that dictate appropriate serving recommendations. There is no organized collection of adverse events so that safety problems can be spotted early, says Cooperman (of Consumer Labs).
"The area that we focus most on is product quality. We are seeing one fourth of the products that we select for testing to have a quality problem. We find products with none or little of their claimed ingredients, products contaminated with lead or pesticides, [and] tablets that won’t break apart to release their ingredients. Many products don’t even specify a dose that is known to work." Cooperman gives an example of zinc lozenges for colds. Three fourths of the products that ConsumerLab.com tested did not have or suggest the amount of zinc that has been shown to be effective.
So what happens to all the products that don’t contain what they are supposed to contain? Cooperman reports, It is very rare that a manufacturer recalls a supplement, even after a report comes out on a product. The retailer is not required to recall the supplement. Only when people are really being hurt does [the] FDA take serious action against a manufacturer.
Heller agrees: [The] FDA does not have recall authority over supplements. If there are fly-by-night supplements being made, they are not going to get off the market or off of shelves. Heller also believes the structure/function claims allowed on dietary supplements are close to disease claims and that many dietary ingredients in supplements on the market are grandfathered in, so there’s a presumption of safety rather than the actual determination of safety.

Tired of suffering a tarnished reputation at the hands of shady supplement makers, those in the dietary supplement industry are also banding together to clean up the industry. The supplement industry has had bad press in recent years. Some of the industry supports adverse event reporting as a way of repairing that image, says Heller. The Natural Products Association, along with several other dietary supplement organizations and consumer groups, is supporting legislation in both the House and Senate that would require the reporting of serious adverse experiences for dietary supplements and over-the-counter drugs. (The Senate recently passed this legislation.) Kalman, who performs clinical trails for the food and supplement industry, also finds more and more companies working on independent research for supplements.
The American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition, and the Natural Products Association recently announced a voluntary industrywide protocol, Standardized Information of Dietary Ingredients, to facilitate the exchange of information between ingredient suppliers and finished product manufacturers to help identify and qualify supplement ingredients from trustworthy sources.
Good Manufacturing Practices
One action eagerly awaited is Good Manufacturing Practices (GMP) for supplements. The FDA is authorized to create GMP regulations describing conditions under which dietary supplements must be prepared, packed, and stored. The FDA published a proposed rule in March 2003, but until this proposed rule is finalized, dietary supplements must comply with food GMPs that are primarily concerned with safety and sanitation rather than quality.
It’s been 12 years since they have been promised, and there are still no established GMPs for supplements. There is a lot of talk about them coming out this year, but they say that every year. If GMPs are approved, manufacturers will be required to make the products the same way from lot to lot. This would be a step in the right direction, says Cooperman. To be even more meaningful, GMPs would include standards around what is supposed to be in the product. For example, what levels of specific plant chemicals should be in a product claiming to be gingko, garlic, or ginseng.
Fabricant reports that rather than waiting for the federal GMPs to be issued, his association developed its own GMP certification program in 1999. The Natural Products Association has certified nearly 60 companies and provided education for representatives from more than 350 dietary supplement companies. Their standard is used by other organizations as the basis of their dietary supplement GMP program. GMPs mean understanding, analyzing, controlling, and documenting the manufacturing process. It is a third party audit system, says Fabricant.
Dietary Supplement Certification
Voluntary certification can offer supplement consumers some quality assurance. ConsumerLab.com, which offers a voluntary certification program, is finding more and more manufacturers interested in certification. They allow manufacturers and distributors to use specific CL Seals to identify products that have met ConsumerLab.com standards based on its product reviews.
NSF International, a public health and safety company, also developed an independent product evaluation program to address dietary supplements. Their voluntary testing and certification program verifies the identity and quantity of dietary ingredients listed on the product label; ensures the product does not contain undeclared ingredients or unacceptable levels of contaminants; and demonstrates conformance to currently recommended industry GMPs for dietary supplements.

Enforcement Action
There is a little bit of action, a joint program between [the] FTC and FDA, to go after products on the Web, says Heller. [The] FDA is increasing enforcement on dietary supplements, but its not at the level it should be.
The FTC and FDA work together against fighting dietary supplement fraud. The FDA has primary responsibility for claims on product labeling and the FTC has primary authority over advertising claims. The FDA can identify fraudulent products through market surveys, inspections, Internet searches, adverse event reports, consumer complaints, informants, and referrals from other government agencies. The highest priority for the FDA are products that pose direct health hazards to consumers. When a problem arises with a supplement, the FDA can act by working with the products marketer to correct the problem voluntarily. If that doesnt work, the FDA may bring a lawsuit to seize the product and enjoin the firm marketing it. The FDA can also seek criminal penalties against parties breaking the law.
Although it may seem like a drop in the bucket, many examples do exist in which the FDA and FTC went after supplement makers that broke the law. Recently, it made news when the FDA and FTC sent warning letters to dozens of U.S.- and foreign-owned Web sites selling or advertising dietary supplements that claimed to cure, treat, or prevent diabetes. These were discovered through an Internet sweep for fraudulent sites and products.
In todays world of healthcare, there is room for both traditional and alternative therapies. For cancer patients visiting the Duke Center for Integrative Medicine in North Carolina, the health team may recommend specific vitamins, Chinese herbs, and acupuncture in addition to chemotherapy. The healthcare team takes into consideration the whole person, including support systems, spiritual practices, and stress reduction in an effort to help patients better tolerate chemotherapy.
Integrating complementary and alternative therapies seems to be the wave of the future. Perhaps dietitians can help their patients wade through the sea of supplements to find the true treasures.
" Sharon Palmer, RD, is a contributing editor at Today’s Dietitian and a freelance food and nutrition writer in southern California.

References

[Sylph]

You make excellent points...we agree on many things!