Best of the blogs, September – on Science-Based Medicine, Jann Bellamy:
wrote “Integrative medicine proponents finally acknowledge their field is attracting bad apples but fail to identify the real source of their problem: It’s rejection of science-based medicine, not lack of training in integrative medicine.” “Orac” also commented on Respectful Insolence, noting that “practice drift” into unscientific methods is a “feature, not a bug, in ‘integrative medicine’.” In “integrative medicine,” there really is no science-based standard to tell a physician whether he or she is competent to practice in that area. That’s because, for so many of the modalities that ‘integrative medicine’ integrates into medicine, there is no science or even scientific plausibility to support them. So it shouldn’t be a surprise that the sort of physician attracted to such a specialty has little fealty to science and is therefore prone to ‘practice drift’.”
posted “AAFP [American Academy of Family Physicians] should publish research behind finding that functional medicine lacks evidence, contains harmful and dangerous practices.” He wrote, “we are not given a complete history of the AAFP’s review and left in the dark regarding what the research revealed or exactly which claims are ‘potentially dangerous.’ Given the lavish claims made for functional medicine by practitioners and the paucity of research, the AAFP, in my opinion, has a duty to protect the public’s health, safety, and welfare by publishing its findings in full.”
Scott Gavura:
discussed bacterial contamination in homeopathic remedies.
Sam Homola:
wrote “The Chiropractic Technique Parade.” “Failure of the chiropractic establishment to renounce the scientifically indefensible vertebral subluxation theory assures an unending parade of questionable chiropractic diagnostic and treatment methods for correction of putative vertebral subluxations.”
Steven Novella:
posted “Chelation Therapy for Autism is Quackery.”
wrote “A Culture of Standards Matters.” “Perhaps the most dangerous effect of the alternative medicine movement has been an erosion of the culture of dedication to science and standards within medicine.”
discussed Kelly Brogan, who “sells an impressive array of pseudoscience wrapped in the standard alternative tropes.”
On Respectful Insolence, “Orac”:
wrote “What the Department of Family Medicine at the University of Michigan teaches about acupuncture.” “Basically, there is no skepticism in the entire module. It’s taught the way that an acupuncturist would teach acupuncture. There isn’t even anything resembling a serious acknowledgement that science doesn’t support acupuncture. It’s just assumed that it works…”
criticized Parsley Health, a functional medicine concierge practice of Dr. Robin Berzin. “…one reason why woo is flourishing these days is because those selling unproven treatment methods are so much better at marketing than conventional doctors are. They have the patient portals that go beyond what most other practices and hospitals have. They make their clinics look like spas that cater to a patient’s every whim. Add to that something like functional medicine, a specialty that tells each patient that he or she is so biologically unique that the treatment must be equally unique (whether that’s true or not), and it’s a message most people won’t be able to resist because they won’t see the emptiness at its core.”
posted “European Atherosclerosis Society: Publishing quackademic pseudoscience about traditional Chinese medicine in its official journal.” “The European Atherosclerosis Society should be ashamed for publishing this combination of pseudoscience, revisionist history, and a defense of prescientific vitalism…”
concluded a four-part discussion of Clínica 0-19, a cancer clinic in Mexico Part 1 Part 2 Part 3 Part 4. The doctors running the clinic constitute the Instituto de Oncología Intervencionista (IDOI), and specialize in the treatment of diffuse intrinsic pontine glioma (DIPG), a type of brain tumor. Children from around the world have been brought to be treated with an unproven method at costs of hundreds of thousands of dollars, “inspired by stories of seemingly miraculous results spread on Facebook pages” and crowdfunding websites, with their stories told by “credulous journalists.” “Orac” summarizes: “The more I look at Clínica 0-19, IDOI, and what Drs. Siller and Garcia are doing, the more I hear echoes of Stanislaw Burzynski, but worse.” He calls on them to publish their protocols, conduct clinical trials, welcome international experts to review their statistical methodology, and demonstrate that their treatment is superior to the current standard of care.
responded to a defense of acupuncture by Carlo Giovanardi. A study of acupuncture for in vitro fertilization found no benefit; Giovanardi found the study to be flawed. “Orac” wrote, “as we see all too often whenever a rigorously designed acupuncture trial produces a negative result, true believers find a way to discount it.”
posted “Rappin’ Hillary Simpson, #crazymothers, and #DearDoctor: Antivaxers blaming doctors for vaccinating children. Again.” “…the #DearDoctor movement is not about doing what’s best for autistic children. It’s about the delusion that autism has somehow ‘stolen’ antivaxers’ real children and that doctors are complicit in that theft.”
wrote “Vaccine Injury Awareness Week 2018: Barbara Loe Fisher and Joe Mercola bring the antivaccine pseudoscience a month early.”
Edzard Ernst:
posted “TCM by injection? The idea frightens me.” “I have to admit that TCM [traditional Chinese medicine] injections frighten the hell out of me. I feel that before we inject any type of substance into patients, we ought to know as a bare minimum: for what conditions, if any, they have been proven to be efficacious, what adverse effects each active ingredient can cause, with what other drugs they might interact, how reliable the quality control for these injections is. Somehow doubt that these issues have been fully addressed in China. Therefore, I can only hope the Chinese manufacturers are not planning to export their dubious TCM injections.”
disputed the conclusions of a review suggesting that homeopathy is useful for treating depression.
discussed the Ayurvedic technique of oil pulling. “To me, the evidence looks promising as far as oral health is concerned. For all other indication, oil pulling is neither plausible nor evidence-based.”
asked, “Is 2018 the year when research into homeopathy died a natural death?”
criticized a review of alternative therapies for psoriasis.
listed 10 unscientific practices offered by physiotherapists, countering the claim that they have a “highly science based approach.”
posted “Homeopathy: yet another systematic review fails to prove its effectiveness.”
wrote “Homeopathy for preventing complications of immunisation: another study and another negative result.”
discussed the retraction of a meta-analysis of acupuncture for chronic constipation. Turning to the larger issue of Cochrane reviews coming from China, he wrote: “The stream of such reviews has only increased and is now a true worry (at least for me). My suspicion – and I stress that it is merely that – is that, if one would rigorously re-evaluate these reviews, their majority would need to be retracted just as the above paper.”
reported on a 2017 reference guide on homeopathy from the Royal Pharmaceutical Society. The first of its key points is: “The Royal Pharmaceutical Society (RPS) does not endorse homeopathy as a form of treatment because there is no scientific basis for homeopathy nor any evidence to support the clinical efficacy of homeopathic products beyond a placebo effect.”
characterized a study of osteopathy for oncology geriatric patients: “I think, it might the worst bit of research in 2018 so far.”
discussed a meta-analysis of fish oil for anxiety. “I think this is a fine meta-analysis reporting clear results…the average effect size is modest, but the findings are nevertheless intriguing.”
reported on a trial of homeopathy for hot flashes in breast cancer patients. Even though the authors “try to squeeze out some positive messages,” the study is “squarely negative.”
September – Turner published “Direct-to-consumer marketing of stem cell interventions by Canadian businesses” (Regen Med. 2018 Sep;13(6):643-58 Paper News story). “Businesses’ representations could result in patients making health-related decisions informed by marketing claims rather than best available scientific evidence.”
September – Sobel published “Facilitated Communication Redux: Persistence of a Discredited Technique” (Skeptic Magazine 2018. 23(3):6-9). “A discredited technique that persists based on encouraging false hope, can lead to traumatization of the individual, shattering of their families, and misguided clinical decision-making. It must be opposed by health care professionals.”
September – A column by Wallis in Scientific American (September, p. 24) was entitled “The So-Called Right to Try: A new law to let dying patients access unapproved drugs raises false hope.”
September – A study compared chiropractic care to usual care for back and neck pain (Elder et al. J Gen Intern Med. 2018 Sep;33(9):1469-77 Abstract). No difference was found for patient-reported or economic outcomes.
September – Cramer and others reviewed yoga for anxiety (Depress Anxiety. 2018 Sep;35(9):830-43 Abstract). “In conclusion, yoga might be an effective and safe intervention for individuals with elevated levels of anxiety. There was inconclusive evidence for effects of yoga in anxiety disorders. More high‐quality studies are needed and are warranted given these preliminary findings and plausible mechanisms of action.”
September – Harriet Hall’s first “Reality is the Best Medicine” column for Skeptical Inquirer (42(5):28-29 (2018)) dealt with pseudoscientific ideas and products concerning the vagina. “Vaginas needn’t be fed with garlic or yogurt or jade eggs or anything else. They don’t need cleansing with douches or anything else. Any advice to the contrary is quackery until proven otherwise.”
September 1 – The American Society of Clinical Oncology (ASCO) has endorsed clinical practice guidelines from the society for Integrative Oncology (ISO) for therapies during and after breast cancer treatment (Lyman et al., J Clin Oncol. 2018 Sep 1;36(25):2647-55 Paper). “Key recommendations include the following: Music therapy, meditation, stress management, and yoga are recommended for anxiety/stress reduction. Meditation, relaxation, yoga, massage, and music therapy are recommended for depression/mood disorders. Meditation and yoga are recommended to improve quality of life. Acupressure and acupuncture are recommended for reducing chemotherapy-induced nausea and vomiting. Acetyl-l-carnitine is not recommended to prevent chemotherapy-induced peripheral neuropathy because of a possibility of harm. No strong evidence supports the use of ingested dietary supplements to manage breast cancer treatment–related adverse effects.”
September 6 – The Berkeley Wellness Letter published “3 Strikes Against Omega-3 Capsules.” “Recent studies may have put the kibosh on three common health claims made for fish oil (omega-3) supplements.”
September 9 – A Cochrane review found no evidence of benefit of homeopathic medicines for preventing and treating acute respiratory tract infections in children (Hawke et al. Cochrane Database Syst Rev. 2018 Sep 9;9:CD005974 Abstract).
September 13 – Newman wrote “Is cancer fundraising fuelling quackery?” (BMJ. 2018 Sep 12;362:k3829 Preview). The article discussed treatments at the Integrative Whole Health Clinic in Tijuana, Mexico, and the Hallwang clinic in Germany. David Gorski discussed the investigation on Science-Based Medicine.
September 20 – “The Federal Trade Commission today, for the first time, charged a marketer and seller of intravenously injected therapy products (iV Cocktails) with making a range of deceptive and unsupported health claims about their ability to treat serious diseases such as cancer, multiple sclerosis, and congestive heart failure” (Press release). “The iV Cocktails, which were advertised as an alternative to traditional medical therapy, are actually a simple mix of water, vitamins, minerals, and herbs injected directly into the bloodstream for between $100 and $250 per ‘treatment’.” David Gorski discussed the events on Science-Based Medicine. “I would say that this is a good start, but that it doesn’t go nearly far enough because it appears to be allowing the company to continue to market its product. Unfortunately, that’s probably because the complaint was about deceptive advertising. What really needs to happen is that the FDA needs to get involved, because this company clearly appeared to be making distinct medical claims and selling a concoction that appears all the FDA legal definitions of what constitutes a drug.”
September 20 – Xi and others reviewed “Effects of Acupuncture on the Outcomes of Assisted Reproductive Technology” (Evid Based Complement Alternat Med. 2018 Sep 20;2018:7352735 Paper). Because of the low quality of the studies, “The evidence for acupuncture to treat couples with subfertility undergoing ART remains unclear.”
September 25 – A review of the cardiovascular effects of Emblica officinalis (EO) fruit was published by Hashem-Dabaghian and others (J Cardiovasc Thorac Res. 2018;10(3):118-28 Paper). “EO influences various cardiovascular risk-factors. However, there is not sufficient evidence to confirm the plant efficacy in preventing and treating CVD [cardiovascular disease].”
September 25 – Stephen Barrett published “A Skeptical Look at Thyroflex Testing” on Quackwatch. “Thyroflex testing uses a spring-loaded reflex hammer connected to a computer to assess the functioning of the patient's thyroid gland. Proponents claim that it is more accurate than standard blood tests that measure hormone levels. This article explains why I question its value.”
September 27- An Article by Cyranoski was entitled “The Big Push for Chinese Medicine” (Nature. 2018 Sep;561(7724):448-50). “For the first time, the World Health Organization will recognize traditional medicine in its influential global medical compendium.” The article describes how the updated international disease classification (ICD-11) will include terminology from traditional Chinese medicine, as well as other efforts by China to expand the business of TCM. “Critics argue that there is no physiological evidence that qi or meridians exist, and scant evidence that TCM works.” Arthur Grollman is quoted as saying “The thing they want is to make it sound official and be recognized by the insurance companies…” Steven Novella, "Orac," and Edzard Ernst all commented in blog posts. Novella and “Orac” criticized the “false balance” in the Nature story. Novella also wrote, “The WHO is now endorsing and encouraging the spread of nonsensical magical treatments for real and serious medical conditions for which we have effective science-based treatments.” “Orac” described some of the “fantasy codes” that will be part of ICD-11, and noted that “By facilitating the spread of TCM, whether intentionally or not the WHO is promoting animal cruelty and, likely, the extinctions of endangered species.” Ernst stated that “The message therefore can only be that the WHO endorses TCM as safe and effective…the WHO’s endorsement of TCM and its obsolete concepts is not just not understandable, it is a dangerous step backwards and, in my view, even intolerable.”
Best of the blogs, October – on Science-Based Medicine, Jann Bellamy:
posted “FTC settles deceptive advertising claims against amniotic stem cell clinics.” “According to critics, amniotic stem cell treatments are promoted by physicians, chiropractors and naturopathic doctors, including at seminars where participants are encouraged to sign up on the spot. But, as they point out, there are no actual live stem cells in ‘amniotic stem cell treatments.’…The FTC apparently chose [to] ignore this particular issue,” ruling instead on the basis that there is no evidence that the treatments are effective.
James Coyne:
wrote “Debunking the magical power of the placebo effect for chronic pain (yet again).” Coyne criticized a paper in Nature Communications, as well as its exaggerated press coverage.
David Gorski:
noted that “Last week, The Journal of Alternative and Complementary Medicine published a Special Focus Issue on 'integrative oncology'. In reality, it’s propaganda that promotes pseudoscience and the ‘integration’ of quackery into oncology.”
discussed “My Cancer Free Life: A reality series designed to promote Stanislaw Burzynski's quackery.”
wrote “The Integrative Oncology Scholars Program: Indoctrinating the next generation of ‘integrative oncology’ believers.”
Harriet Hall:
wrote “The AAFP [American Academy of Family Physicians] is not following its own standards for CME [continuing medical education]. Its monograph on Musculoskeletal Therapies devotes 1/4 of its content to acupuncture, dry needling, and cupping; and one of its four ‘key practice recommendations’ is to consider electroacupuncture for fibromyalgia…There is an obvious disconnect between what the AAFP says are its standards for CME and the CME it actually offers. I feel angry and betrayed by my own professional organization, an organization that I was once proud to belong to.”
posted: “Ayurveda recommends gold water, silver water, and copper water to treat various conditions. There is no evidence that they work or even that they contain gold, silver, or copper…The recommendations are from Ayurveda and are based on ancient superstitions, not modern scientific evidence.”
Scott Gavura:
posted “Drugs in your supplements.” “Supplements are a billion-dollar business, but quality control is questionable. A new study shows that supplements may be adulterated with unlabelled prescription drugs.”
Braden MacBeth:
wrote “A Review of Flipping the Script: Parents Fight Back.” “Flipping the Script argues that parents should have the right to refuse maintenance chemotherapy on behalf of their children while also expressing anti-vaccination views, promoting alternative medicine, and trying to sell you on ridiculous scientific and conspiracy theories. This film displays a critical lack of self-awareness and knowledge of science, medical ethics, literacy, and basic human decency… I don’t think this film should be on Amazon Prime. It gives dangerous, unqualified medical advice to viewers who may be parents with children who have cancer."
Blythe Nilson:
posted “Thermography is Not Approved for Breast Cancer Screening in Canada.” “Thermography clinics capitalize on the unjustified fears some women have that radiation doses from mammograms are dangerous and can be avoided by using thermography. The truth is that thermography is unproven and can burden women with false negative or false positives that can cause psychological stress, delayed treatment, unnecessary treatment, or worse, and charge a lot of money for the experience.”
Steven Novella:
discussed alkaline water: “there is no plausibility to the claims of any health benefits, and what evidence we have is negative. Its popularity grows despite this.”
Justin Quiles:
posted “A Call for Caution on Antioxidant Supplementation.” “…this post digs a little deeper into the basic science of antioxidants, and the importance of understanding more than just one part of a complex biological system before you interfere with it.”
On Respectful Insolence, “Orac”:
wrote: “ Suzanne Somers ‘grew a new breast’ with stem cells plus fat transfer? Not so fast…”
posted a two-part report from a “mole” attending an anti-vaccine “One Conversation” event. Part 1 Part 2. His October 18 post dealt with another anti-vaccine symposium.
stated that “The Republican Party has become the antivaccine party.” “Antivaccine views used to be seen only on the fringes of the Republican Party, but they’re rapidly becoming mainstream Republican.”
published another article dealing with vaccines, “The problem with SB 277, the law that eliminated personal belief exemptions (PBEs) in California.” “SB 277 is good, but it has two glaring holes in it.”
Edzard Ernst:
found somewhat encouraging a study of osteopathy for chronic low back pain. However, the study had some flaws, was in need of replication, “and the techniques employed are, if I am not mistaken, as much physiotherapeutic as osteopathic.”
reviewing a new study, wrote: “Is evening primrose oil effective after all? I still have my doubts!”
discussed a new review of aromatherapy for psychological symptoms. “What makes this review truly dismal is the fact that the authors fail to discuss the poor quality of the primary studies. They are of such deplorable rigor that one can really not draw any conclusion at all from them. I therefore find the conclusions of this new paper unacceptable and think that our statement (even though a few years old) is much more accurate: the evidence is not sufficiently convincing that aromatherapy is an effective therapy for any condition.”
in discussing another paper on aromatherapy, in this case for anxiety, wrote: “this means that the paper is not helpful in any way. All it can possibly do is to mislead the public.”
wrote “Bee venom acupuncture? No thanks!” A new trial for arthritis claimed to show safety and effectiveness, but the trial was too small to show either. “Bee venom can cause anaphylaxis, and several deaths have been reported in patients who successfully received the therapy prior to the adverse event.”
asked “Is the latest ‘proof’ of homeopathy fraudulent?” “It has been pointed out that there are several oddities in this paper which are highly suspicious of scientific misconduct or fraud.” The paper was discussed in Ars Technica and Nature.
posted “Emotional Freedom Technique, a combination of two types of BS.” Reviews of the method “conveniently forget to mention that the primary studies tend to be of poor or even very poor quality.” They “thus turn out to be a confirmation of the ‘rubbish in, rubbish out’ principle…”
discussed homotoxicology: “It is little more than homeopathic nonsense + detox nonsense + some more nonsense.”
found a paper on chiropractic effects on functioning and well-being of neck- and back-pain patients to be worthless because it had no control group. “I am concerned that a leading journal (Spine) publishes such rubbish.”
discussed another paper without an adequate control group, this time comparing healing touch to oncology massage for cancer pain. The results are equally consistent with a negative effect of both treatments.
reported on a review showing no benefit of acupuncture for alcohol withdrawal syndrome.
noted that a study of chiropractic for athletic performance found slightly worse ability after spinal manipulation, leaving Ernst to wonder what indication chiropractic should look for next.
discussed a trial of mini-scalpel acupuncture: “It is a veritable treasure trove of mistakes, flaws, errors, fallacies etc.”
criticized a review of homeopathy for depression. “It is, in my view, an exercise in promotion rather than a piece of research. The conclusion that homeopathy has a ‘promising risk/benefit profile’ is frightfully dangerous and irresponsible.”
found many flaws in a study of homeopathy for cocaine craving.
discussed China’s decision to allow trade in horns of tigers and rhinos as long as they are bred in captivity. The horns are used in some traditional Chinese medicines, but there is no evidence of effectiveness. The World Wildlife Fund found the decision “deeply concerning” because it will make it more difficult to control illegal trade in the horns.
October – Li and others published “Integrative medicine or infiltrative pseudoscience?” (Surgeon. 2018 Oct;16(5):271-7 Abstract). “Recently, the non-evidence-based practice of complementary and alternative medicine (CAM) has been increasing in the United States and around the world, particularly at medical institutions known for providing rigorous evidence-based care. The use of CAM may cause harm to patients through interactions with evidence-based medications or if patients choose to forego evidence-based care.”
October – A review of “Omega-3 fatty acids' supplementation in Alzheimer's disease” (Canhada et al. Nutr Neurosci. 2018 Oct;21(8):529-538 Abstract) concluded “The effects of omega-3 fatty acids supplementation in mild AD corroborate epidemiological observational studies showing that omega-3 fatty acids may be beneficial in disease onset, when there is slight impairment of brain function. Although some studies have shown changes in scales of cognitive function in more severe cases, they are not enough to support omega-3 fatty acids supplementation in the treatment of AD.”
October 1 – A study of cancer patients receiving conventional therapy found that those who also received complementary medicine had a higher risk of death, likely because they more often refused additional conventional treatment (Johnson et al., JAMA Oncol. 2018 Oct 1;4(10):1375-1381 Abstract). David Gorski discussed the study on Science-Based Medicine: “It’s clear from numerous studies that alternative medicine does not have even a neutral effect on cancer survival; its effect is uniformly negative. This study strongly suggests that even just ‘integrating’ such therapies into science-based oncology could have a pernicious effect on patient survival.” Edzard Ernst wrote: “the most serious risk of SCAM [so-called alternative medicine] is not a direct but an indirect one: the risk of neglecting effective therapies.”
October 2 – Carroll wrote “Given Their Potential for Harm, It’s Time to Focus on the Safety of Supplements” (JAMA. 2018 Oct 2;320(13):1306-7 Article). “…in the case of supplements, for many if not most people, the benefits appear to be minimal to nonexistent. The potential harms on the other hand are real and documented.”
October 9 – A meta-analysis by Jorat and others concerning coenzyme Q10 supplementation for patients with coronary artery disease “demonstrated the promising effects of CoQ10 supplementation on lowering lipid levels among patients with CAD, though it did not affect triglycerides, LDL-cholesterol and Lp(a) levels” (Lipids Health Dis. 2018 Oct 9;17(1):230 Paper).
October 12 – Tucker and others found that “Active pharmaceuticals continue to be identified in dietary supplements, especially those marketed for sexual enhancement or weight loss, even after FDA warnings. The drug ingredients in these dietary supplements have the potential to cause serious adverse health effects owing to accidental misuse, overuse, or interaction with other medications, underlying health conditions, or other pharmaceuticals within the supplement” (JAMA Netw Open. 2018 Oct 5;1(6):e183337 Paper).
October 13 – Gunter reported that “90% of products sold on goop.com under the guise of wellness cannot be backed by science and many flout common sense, never mind biological principles. Some therapies, such as the supplements, could be harmful as they are high in vitamin A and three of them contain green tea leaf extract which is associated with liver injury…There is also the concern that many supplements don’t even contain what they say.”
October 15 – The College of Chiropractors of British Columbia (the provincial regulatory agency) gave a deadline to chiropractors to remove scientifically unsupported claims from their web sites News story. “There is no acceptable scientific evidence that chiropractors can treat Alzheimer's disease, cancer, diabetes, infertility, infections, autism, ADHD or Down syndrome…”
October 17 – A review of herbal medicines for induction of labor was published by Zamawe et al. (BMJ Open. 2018 Oct 17;8(10):e022499 Paper). “The findings suggest that herbal medicines for IOL are effective, but there is inconclusive evidence of safety due to lack of good quality data. Thus, the use of herbal medicines for IOL should be avoided until safety issues are clarified.”
October 18 – According to an FTC Press release, “A California-based physician and the two companies he controls have settled charges of deceptively advertising that ‘amniotic stem cell therapy’ can treat serious diseases, including Parkinson’s disease, autism, macular degeneration, cerebral palsy, multiple sclerosis, and heart attacks.”
October 23 – Vox and others searched popular crowdfunding sites for campaigns to support five scientifically unsupported or potentially dangerous treatments (JAMA. 2018 Oct 23;320(16):1705-6 First paragraph). They found more than 1000 campaigns for these treatments, raising nearly $7 billion. Stories on the study were published by Stat and HealthDay.
October 24 – A review found that “There is currently no conclusive evidence on the safety and efficacy of acupuncture for infantile colic” (Lee et al. Evid Based Complement Alternat Med. 2018 Oct 24;2018:7526234 Paper).
October 25 – A CBC Story was entitled “Pharmacies selling DNA tests to help patients pick best medications.” However, the Canadian Medical Association “is skeptical about direct-to-consumer genetic tests overall…few physicians feel they have the necessary training and knowledge in genomics to provide adequate care in this area. Furthermore, these tests may have no clinical indication, produce uncertain results with ambiguous clinical applicability and have tenuous legal status…”
October 31 – Spain took actions to limit the use of homeopathic treatments News story. 2,000 products will need to show evidence of effectiveness by April, 2009, while another 10,000 will not be permitted.