The April 22 New York Times reported that the FDA has made progress in tracing Heparing contamination--which has resulted in more than 80 deaths in the United States--to Chinese suppliers. Following this drama points out serious problems in our future relationship with Chinese authorities, as we continue to send manufacturing jobs overseas.
Continue reading "The latest word on Heparin contamination" »
One of the medical profession's most respected journals, the Journal of the American Medical Association, published an article this week examining the extent of "ghost-writing" that occurred in published Vioxx research. The authors unearthed evidence that documented the extent to which drug maker Merck wrote its own laudatory studies before lining up prestigious physicians to sign on to the final product as lead authors. The study authors and the editors of JAMA concluded that such ghost-writing is extremely common in the pharmaceutical field, in particular, and that medical journals should more carefully examine pharmaceutical research to detect undisclosed bias.
Continue reading "Big Pharma ghost-writes the scholarly articles published by MD "researchers"" »
The January issue of The New England Journal of Medicine took a close look at research on antidepressants to examine whether doctors, patients and regulators get an accurate picture of the effectiveness of medications. They found that drug manufacturers bury negative or inconclusive results, but publish and hype positive results. The result is a misleading view of the effectiveness of medications, a view that over-states their likely effectiveness.
The Bush appointees to the US Supreme Court are on a mission to preempt state rules and laws protecting citizens from unsafe products and drugs. Johnson & Johnson's inadequate disclosure to the FDA with regard to Its Ortho Evra birth control patch demonstrates the inadequacy of the extreme conservative approach to regulation.
Continue reading "The birth control patch as evidence of the danger of federal premption" »
Dr. Stafford recently authored an article objecting to the FDA's proposed new rules which would allow broader off-label drug use by easing restrictions on marketing drugs for off-label use. "Off-label" drug use is the term used when physicians (legally) prescribe a drug for a use that has never been scientifically supported and for which the drug was not expressly approved. Currently, physicians are allowed to exercise this discretion, however, drug reps are not allowed to promote off-label uses.
This proposed easing of regulations is yet another example of the Bush Administration's round-heeled approach to industry regulation and its coziness with the pharmaceutical industry, in particular. In short, the Bush Administration has yet to meet a henhouse that it wouldn't regulate by inserting a fox, and Dr. Stafford judiciously identifies the problems with this approach.
The FDA's role should be to assure that medications are used only where scientific data supports their use, and it should be the clearinghouse that controls the dissemination of accurate, balanced information on data. If it eschews this role and allows drug marketers who have a profit incentive to control the flow of information to harried doctors, no good can come to consumers.
Today, NPR reported that the number of deaths attributable to contaminated Heparin had risen above 100 for the 13 months from January of '07 to February of '08. The Traverse City Record Eagle for April 9 cited a lower death total, in the 60s, for an undefined period.
The contaminated Heparin is produced by a Wisconsin manufacturer and produced at a plant in China. The contamination is thought to originate with an unlicensed supplier of raw material not regulated by the FDA or the Chinese government. Further explanation of this issue is available in earlier blog entries discussing contaminated Heparin, under the title "product injuries".
As it turns out, all of the doctors involved in the lung cancer screening controversy had money coming in from somewhere. The two Weill Cornell doctors who recommended spiral CT scanning for lung cancer and suggested it would save lives had based their research on a 3.6 million dollar grant they received from the tobacco companies. Critics questioned whether their research conclusions might blunt the drive to reduce smoking by suggesting that it was "curable". On top of that influence, it turns out the two doctors would have received royalties from the licensing of General Electric diagnostic technology if screening were to be widely adopted.
The two outspoken critics of the Weill Cornell doctors also had a financial stake: one was a radiologist who received $30,000.00 from tobacco interests for testifying that screening had not been proven effective and should not be charged to tobacco companies. She put this money into a Medical School account at UCLA, according to the New York Times. The other physician was paid $700.00 to sign an affidavit summarizing the current research and concluding that unproven CT scan screening would not be advisable: the TImes reported that this doctor returned his affidavit money, but did not indicate whether it was before or after the controversy arose. Our conclusion: doctors can make a lot of money outside their medical practice when drugs and medical equipment are thrown in the mix.
As the actual data from studies on Vytorin and Zetia is finally released, it appears to show that thousands of consumers have been paying for expensive drugs that do them no good in trying to avoid heart attack or stroke.
The cigarette industry--makers of the world's most unsafe product--won another round in the U.S. Courts when a federal appeals court threw out the class action lawsuit on behalf of smokers of "light" cigarettes.
Continue reading "Cigarette class action goes up in smoke" »
Back in October of 2006, Dr. Claudia Henschke of Weill Cornell Medical College stunned the medical community with research and speculation suggesting that early CT scan screening could prevent eighty percent of lung cancer deaths. Turns out, a tobacco company paid for the research.
Continue reading "Cigarette companies underwrite research to put a better face on lung cancer" »
The manufacturers of Cerezyme, a drug essential to the treatment of Gaucher disease, a rare, sometimes fatal disorder, charge more than $300,000.00 per year for the drug, according to the New York Times. By charging such high prices for a few patients (1,500 in the U.S., 5,000 total) the company generated revenues of 1.1 billion dollars in sales. This price is driven by market forces-not the cost of development. The company is exploiting a monopoly on the drug, despite the fact that most of the scientific research and development work on the drug was paid for by the federal government--which now pays again to purchase its own work product.
Recent approval of the drug Avastin by the FDA raises ethical and financial questions that we all need to consider. Avastin was recently given "accelerated approval" for treatment of advanced breast cancer on the basis of a single clinical trial that showed that when used with a second drug, it:
1. does not extend overall survival rates;
2. causes serious side effects, including a reported half-dozen deaths; and
3. holds tumor progression at bay for about 5 and 1/2 months.
The British National Health Service refuses to pay for Avastin for advanced breast cancer, citing the above limitations, and the cost: $92,000.00 per year, per patient. This is the kind of health care issue that should be discussed by our politicians and by all of us. What will we pay and what risks will we take, not to live longer, but to control our cancer better for six months? Are we willing to pay higher taxes or insurance premiums in order to afford this kind of expense? Are we willing to ration health care so it is available only to the wealthy? By refusing to consider and discuss these issues, that is precisely what we are doing.
We should note, too, that while Avastin is expensive, it is not unusually expensive: many drugs are priced comparably.
The U.S. Senate recently adopted legislation, though watered down, that would improve product safety for American families.
The government's recent decision to pay compensation to a young girl who apparently suffered brain damage after being inoculated against childhood disease, has added to the controversy over whether a previously-used preservative causes autism.
Continue reading "Controversy over vaccination safety and autism" »
Mark Pryor, an Arkansas Democrat, has sponsored a bill to create an easily accessible database for dangerous products. Given the ineptitude and inadequate resources of the Bush-led Consumer Product Safety Commission, the difficulty of supporting any government entity through tax revenue, and the practical ineffectiveness of product recalls, this is an excellent idea that would help consumers to protect themselves and their children.
Continue reading "A clearing house for dangerous products is proposed" »
The US Supreme Court voted 4-4 to give the drug industry complete immunity for drugs approved by the FDA, despite fraudulent actions by the manufacturer that hid or distorted data to secure approval.
About half of the nation's heparin supply--a blood thinner essential to kidney dialysis, many surgeries, and other medical procedures, has apparently been contaminated at its source in China. Efforts to trace the source of the problem have been stymied by China's mass of small producers and by lack of regulation and record-keeping.
The AP reported that safety officials recalled 24,000 cribs last Thursday. They were manufactured in Indonesia, and are supplied with inappropriate brackets that don't allow their mattresses to be lowered to the proper level. As a result, children would be able to crawl over the railing and fall out. The cribs recalled were imported by Munire Furniture, Inc., and sold under the names Majestic Curved Top, Majestic Flat Top, Essex, Brighton-Sussex and Captiva.
Consumers claimed one small victory this week when Pfizer yanked its adds for Lipitor that featured Dr. Robert Jarvik. On every other front, it was a miserable week for ordinary people in the battle against Big Pharma.
Continue reading "A big week for big pharma; small victories and big losses for consumers" »
President Bush spent much of his two terms in office repaying favors to various industries that supported his election. One of the most substantial contributors to his elections was the medical/pharmaceutical industry, and that industry has also been a major beneficiary of his largesse. This week the Supreme Court upheld the legislation Bush's Administration sought and obtained, intended to immunize medical device manufacturers ifor injuries resulting from product defects, so long as the device had been approved by the FDA. A similar new law, addressing drugs approved by the FDA, will be before the Court soon.
Fentanyl patches manufactured by PriCara, a division of Johnson & Johnson under the trade name ALZA Corp, and by Actavis South Atlantic, LLC, have been recalled in the past two weeks. The Actavis patches were also packaged and marketed under its previous name, Abrika Pharmaceuticals, Inc. The recalled patches may overdose patients and caregivers on handling, due to a design flaw that may allow the powerful opioid drug to leak.
After a year of overwhelming toy recalls in 2007, the toy industry is working with the American National Standards Institute to adopt a series of standards governing toy safety and quality. Unfortunately, the standards will only be voluntary, since the Bush Administration and Senate Republicans refuse to regulate anyone.
Continue reading "The toy industry wants to set "voluntary" standards" »
When drugs are approved for sale in the U.S., the high-intensity marketing campaigns are limited to selling the drug for the approved purposes only: manufacturers' sales representatives are not allowed to push the drug for non-approved uses. In another example of what large contributions can achieve with the Bush Administration, the FDA is now seeking to change this decades-old rule.
Continue reading "The FDA cowtows further to "big pharma"" »
According to the February 16 New York Times, the Chinese company that supplies much of the active ingredient for a brand of blood thinner that has been linked to four deaths in the U.S., was never certified by China's drug regulators to make pharmaceutical products.
Continue reading "More on the heparin problem--guess what, it leads to China...." »
Our nation's beef marketers are bound and determined to make vegans of us all. A California meat packer, Westland/Hallmark Meat Company, just recalled 143 million pounds of beef. Of course, most of it has already been eaten and the company won't have to take it back.
The Associated Press reported today that injuries and deaths associated with All-terrain vehicles have reached an all-time high and continue to trend upward.
Amgen Inc. markets the drug Enbrel for treatment of severe psoriasis. Now it is accused of attempting to market the drug more widely, despite the fact that the drug carries significant and dangerous side-effects and dangers.
Continue reading "Drugmaker's marketing of Enbrel is investigated" »
After the tragic Virginia Tech shootings, public officials were falling all over themselves with promises of legislation to make guns less available to felons and persons with severe psychiatric issues. This month, the NRA managed to defeat those efforts by blocking reform that would have regulated the sale of guns at weekend gun shows.
Heparin manufactured by Baxter Healthcare, almost half the nation's supply of this essential blood thinner, has been contaminated and is a serious health threat.
The New York Times reported today the the U.S. government and Eli Lilly, the manufacturer of Zyprexa, are close to reaching a deal to settle civil and criminal charges against the company for illegal "off-label marketing". The drug has only been approved for the treatment of schizophrenia or severe bipolar disorder, and apparently it is very effective in that role. Not satisfied with the performance of its best-selling drug in that role, however, Lilly reportedly attempted to market the drug to doctors as a treatment for mild bipolar disorder and for dementia. Although a drug, once approved, may be utilized by a physician for any purpose, it is illegal for the manufacturer to purposely market the drug for unapproved purposes.
The New York Times reported on January 31 that Shanghai Hualian, a subsidiary of the state-owned conglomerate Shanghai Pharmaceutical Group, had been identified as the operator of a factory that produced contaminated leukemia drugs. The drugs were contaminated with a third cancer treatment chemical, vincristine sulfate, and caused paralysis in nearly 200 Chinese patients who received it. Apparently approximately one-half of the leukemia patients have suffered permanent paralysis.
The same company has declared its intention to sell half a dozen other chemicals in the United States, although the FDA would not confirm that fact. It also is the sole manufacturer of the drug RU 486, mifepristone, the so-called "abortion drug"for the American market. The latter drug is manufactured at a different facility which was reportedly inspected by the FDA in May.
Continue reading "More evidence of contamination in Chinese drug ingredients" »
The January 30 issue of the New York Times included a lengthy critique of the conflict of interest that has been uncovered with the artificial spinal disc "Prodisc". The artificial disc sells for about $10,000.00 and has generated significant profits for its manufacturers and investors, even though Medicare and many private insurers will not pay for its use or the expensive surgery to install it.
The Times reported that it has recently come to light that the medical researcher/doctors who endorsed the Prodisc and who were involved in the study that purportedly demonstrated its effectiveness were also investors in the product. Thus, there is substantial question whether they were neutral, objective researchers with regard to the effectiveness of the surgical installation or the analysis of the resulting data.
Continue reading "Low back pain: Controversy over back surgery and Prodisc" »
The World Customs Organization recently claimed that seven percent of all items traded in the world economy are counterfeit. According to the organization, almost 200 billion dollars per year of counterfeit products will enter the United States each year. Obviously, this creates a tremendous opportunity for consumers to be injured by unsafe and under-regulated consumer items such as tooth paste, children's jewelry, toys, pet food and drugs. Further, the U.S. Food and Drug Administration and the Consumer Product Safety Commission are both under-funded and under-manned, as the federal budget has been stripped to provide tax savings or to fund the war in the middle East.
Experts advise consumers to attempt to protect themselves by use of the "three P trilogy: price, place and packaging". If the price is too good to be true, you aren't getting what you think you are. If you are buying "out of the mainstream", you are at risk. If the packaging looks inferior or unusual in any manner, don't trust the contents.
For two years, Merck and Schering-Plough have been delaying the release of their test results from a study of the effectiveness of their cholesterol-lowering drug, Zetia and the Vitorin pill that relies on Zetia to reduce cholesterol. By law, manufacturers of drugs are required to disclose study results "immediately". These manufacturers have been stonewalling the media and medical professions, claiming that that the results were not available, even though the study ended two years earlier.
Finally, in January 2008, the results were released and they demonstrated no cholesterol-reducing effect for Zetia and Vitorin, and IN FACT DEMONSTRATED THAT ARTERIAL INFLAMMATION or "plaque formation"--the fatal element in coronary artery disease--INCREASED BY FIFTY PERCENT OVER THE COURSE OF THE STUDY in the test subjects. Thus, the ultimate purpose for administering the drugs--to reduce the risk of heart attack and stroke caused by plaque--was NOT served by prescribing these drugs and in fact the drug worked at cross-purposes to the needs of the patients.
Sales and advertising of the two drugs have continued aggressively during the interim and totaled 5 billion dollars in 2007. Meanwhile, a spokesperson for Schering, Lee Davies, claimed that the two year delay was "unrelated to the negative findings" which were "unavailable" to the companies until two weeks ago. Does anyone accept those claims? This is unmitigated greed--hiding these disastrous study results in order to continue to maximize sales and profit. How many patients enrolled in the study suffered stroke or myocardial infarct that would not have occurred if they were switched to an effective drug regimen? Is this significantly different than voluntary manslaughter? Right now 5 million people are relying on these drugs to reduce their risk of heart attack and stroke: according to the study, it is causing their plaque to increase twice as fast as the control group!
The patients who participated in this study were suffering from intractably high LDL or "bad" cholesterol". Perhaps something will come from the on-going studies of the drugs to justify prescribing them. Our unscientific analysis, however, suggests that it would be unethical to continue a patient on this drug regimen, given these test results. At a minimum, this study should be the catalyst to a more effective rule actually requiring the prompt disclosure of drug study data.
Past research has shown great variability in the success of product recalls, but the average recall results in the actual return of about 18 percent of the defective or dangerous products sold. Most of the remaining eighty percent remain in commerce, although some find their way to landfills. The latter is an imperfect solution where the defect is toxicity, as with, for example, lead jewelry. It is a better solution than another regular alternative: many toxic products are simply re-packaged and shipped to an unregulated third-world market. Other products end up on e-bay.
In one month, 1100 of the 100,000 children's gardening tools recalled by Jo-Ann Stores had been returned. After two months, NO defective Cub Scout badges had been returned to the manufacturer. Low-priced products, often toys and trinkets, are returned at rates much lower than the "average" of eighteen percent. The New York Times quoted a figure of only five percent. Ultimately, the CPSC "recall" system is as defective as the products recalled and a tepid solution for genuine hazards. A much better system would regulate the products before they are widely disseminated, and provide a more systematic approach to accounting for recalled materials.
Many people do not realize that most protective headgear must be replaced or refurbished after one or more serious impacts. Many bicycle helmets, for example, are safe for only one significant impact and must be replaced immediately after any incident. Even without a serious impact, to be effective, many helmets must be replaced or refurbished after several years of wear.
A Pennsylvania company called Circle Systems, Inc. refurbishes used football helmets. It is one of 30 American companies that inspect and replace worn parts in more than 1.6 million helmets used at virtually every level of amateur football. By a voluntary protocol, these companies have agreed that all helmets must be tested prior to their return to the field. Circle Systems is the second-largest company reconditioning about 300,000 helmets a year, and it has been accused of omitting the testing step of most reconditioning helmets. The company is owned by Schutt Sports, which claims the testing problem is attributable to "inherited" employees who have since left the company. It agrees that Circle Systems was engaged in a "questionable practice". The FBI is currently investigating. If bigwigs with the company did not contribute to the Bush election campaigns, they may be prosecuted to the full extent of the law.
On December 13, the New York Times published an update on its continuing account of defective Medtronic defibrillator leads. The paper pointed out yet again that replacing these brittle leads, which are prone to failure, costs about $12,000.00, but that Medtronic will contribute only $800.00 to the expense of replacing a lead that has not yet fractured. Replacement is a painstaking 90 minute procedure fraught with serious potential risks. The defibrillator market is worth 5.6 million dollars annually, internationally, with much of the profit originating in the U.S.
In response to brittleness identified in the Fidelis leads, Medtronic has returned to selling the older, but more reliable Quattro defibrillator lead. By its response to the failure of Fidilis leads, Medtronic has been allowed to capture enormous profit from selling the defibrillators and leads, while leaving the detritus of its product failures to be covered by individual patients, their insurers, or the federal government through Medicare and Medicaid. Of course, for Michigan patients, if the device was approved by the FDA, the consumer has no recourse, regardless of failure, and regardless of negligence in design or fraud in covering up the problem.
A recent study by the New York Times and others identified a serious problem with regulating counterfeit drugs from overseas. For example in May of 2006, British authorities identified and intercepted a shipment of more than 800 pounds of illicit drugs which were counterfeits of well-known drugs sold by Merck, Novartis, AstraZeneca, Pfizer and Procter & Gamble. The drugs involved were life-supporting medications for treating high blood pressure, cholestrol, acid reflux, cancer, and other serious medical problems. Many of the drugs were contaminated. In July of '07 a half million fake Plavix pills that originated in Mauritius were seized in Dubai's free trade zone. In June, Panamanian authorities seized a warehouse full of contraband internet pharmaceuticals.
Government and pharmaceutical representatives maintain that the trade in unregulated, counterfeit pharmaceuticals has blossomed with the creation of free trade zones around the world. The enormous mark-up of prices for medicines in the United States, coupled with the capacity to "launder" and mis-label pharmaceuticals in various free-trade zones, has created an international criminal enterprise worth billions of dollars, supplying American consumers with medications that are dirt cheap and often dirty. Frequently, they are provided with false packaging suggesting a provenance in Canada.
Currently, Canada provides almost 800 million dollars per year worth of low-cost meds to two million uninsured or underinsured Americans who cannot afford artificially inflated American prices. When large pharmaceutical companies such as Pfizer and Merck attempted to eliminate the Canadians' supply of medications, Canadian firms were forced to buy indirectly through other overseas suppliers and have now found their supply chain to be contaminated. Many of the unregulated and contaminated pharmaceuticals have been traced to the illicit drug trade in China which was described at length in a 2007 New York Times investigation.
Fish farming has become an enormous international business, and nowhere is it bigger than in China, where 115 billion pounds of farmed fish were produced in 2006. As food imports from China increase, it is becoming more apparent that the safety of this important supply of imported food cannot be assumed. The New York Times reported on December 15, 2007, that much of the fish farming that produces Chinese exports is carried on in bodies of water that are polluted by all forms of toxins: human waste, industrial byproducts, illegal veterinary drugs and pesticides are all introduced into the water supply--either inadvertently or purposely--resulting in exposure to various forms of cancer-causing substances and bacteria. Currently the regulatory scheme to detect and control these problems does not exist in China and is not being implemented by food exporters or importers.
While Thailand--another major supplier of fish to the U.S. market--has experienced only two fish rejections at the U.S. border this year, a single Chines supplier, Fuqing, has experienced 43 rejections in 2007 alone. In response, the U.S. and Chinese governments recently signed a half-measure that would begin to regulate the conditions under which food farming is conducted. Unfortunately, given the magnitude of the problem, and the manner in which Chinese government authorities elevate production over environment in all respects, it is unlikely that recent agreements will have a significant impact.
After months of concern over the potential hormonal-disrupting effect of the chemical base in Nalgene bottles, Canadian authorities have removed them from retail shelves. The active ingredient that allows the bottles to be constructed with clear, unbreakable plastic has been documented over several decades to influence hormonal balance. The bottles' manufacturer argues that the release of this chemical to consumers is inconsequential, however, Canadian authorities decided not to allow the risk.
Bans have been considered by local American authorities, but threatened legal action by the manufacturing industry has thus far precluded formal action. There is no substitute for the use of the chemical whose safety is disputed, and critics recognize that using "one-time-only" soft plastic bottles is a substantial environmental nightmare in its own right.
2007 has seen a near-record number of beef recalls of a record quantity of meat. Sadly, it has involved not only the marginal or small producers or the corner-cutting operations such as Topps Meat of New Jersey. Topps was a family-owned company that was purchased by investors who attempted to increase profits by minimizing safety issues, promptly shipped almost 22 million pounds of tainted hamburger that had to be recalled, and then declared bankruptcy in November of 2007. Recalls have also been made by producers such as Tyson Fresh Meats, who have been recognized as leaders in the industry, in terms of installing devices and procedures to attempt to eliminate E-coli toxins, in particular.
E-coli is present in the lower digestive system of cows (and people) and is not usually dangerous. One strain of E-coli is dangerous, however, and if an animal carcass is contaminated with fecal matter from the animal's hyde or intestines, the toxic strain of E-coli can cause illness or death. Hamburger is the most common cause of illness because the toxin from a single source can be disseminated throughout enormous batches of meat and then not destroyed by thorough heating. Meat products that are sold and prepared without being ground are more effectively de-contaminated by surface heat, even if not fully cooked.
Producers like Tyson have adopted procedures that involve cleaning the hydes of animals prior to slaughter, and then thorough steam-cleaning and acid washing of carcasses during processing. Unfortunately, the producers themselves and other food safety experts acknowledge that these procedures are not fail-safe (and this year's recalls confirm that conclusion). Irradiation of meat would kill the E-coli toxins, however, producers are wary of the impact of irradiation on taste and marketing. If meat-processing cannot be failsafe at the best of American producers, you can imagine the risk involved in purchasing meat from third-world producers with less sophisticated regulation and production.
Volunteers and non-profit agencies scrambling to do the work of the Bush Administration have documented overwhelming evidence of lead poisoning in toys on retailer's shelves during the '07 Christmas shopping season. While the Republican head of the Consumer Product Safety Commission denied that her agency needed the additional funding that had been removed from its budget over the past several years and was restored by Congress last month, her Agency continued to drop the ball in protecting our kids.
The American Academy of Pediatrics recommends that toys available to children not contain more than 40 ppm of available lead, due to the known, serious injuries and lifetime damages lead exposure causes. Recent tests on 1200 children's products, most still on shelves found that 35 percent contain lead levels far above the federal recall standard for lead paint, according to the Associated Press. Only twenty percent of the products had no evidence of lead or other dangerous chemicals. One third of the products contained lead levels above 600 ppm: 15 times the recommended level. The Hannah Montana Pop Star Card Game case tested at 3,056 ppm. The testing was done by the Michigan-based Ecology Center and the nantional Center for Health, Environment and Justice and related groups in eight other states.
Thus far in 2007, Mattell has recalled more than 21 million Chinese-made toys. The tainted products identified yesterday included Hannah Montana card game cases, Go Diego Go! backpacks and Circo brand shoes. The toys were on shelves at locations suchs as Toys 'R' Us, Wal-Mart and other major retailers. Interested parents can consult the Consumer Action Guide to Toxic Chemicals in Toys, at http.//www.healthytoys.org.
Dr. Daniel Carlat has written about his year as a drug rep on behalf of Wyeth. He is a psychiatrist who was courted to persuade other physicians to prescribe Effexor XR as a treatment for depression. Carlat explained that between fancy conferences in New York City (with theater tickets, haute cuisine, etc., and a $750 honorarium) and weekly medical lunches with potential prescribers ($500.00 or $750.00, depending on whether he had to drive an hour), he had supplemented his $140,000.00 private practice income with an additional $30,000.00 from Wyeth. Not an insubstantial annual salary enhancement.
Carlat explained that at first, he relied on metastudies which suggested that Effexor was ten percent more effective than serotonin reuptake inhibitors--the more common antidepressant--in achieving remission, and was completely comfortable serving as a salesman for Wyeth. Over the course of the year, however, he studied the issue more carefully and learned that Effexor had originally been compared only with Prozac, and was only five percent more effective than other SSRIs when compared with SSRIs other than Prozac. He was equally troubled by data showing that it was often very difficult to withdraw from Effexor--a serious issue when caregivers take into account the high likelihood that a particular drug regimen will need to be tweaked to achieve a response. In addition, Effexor caused problems with high blood pressure fifty percent more often than SSRIs did. Carlat began to wonder whether it made sense to prescribe a marginally more effective anti-depressant that would be more likely to cause problems with high blood pressure and be difficult to switch or withdraw.
Ultimately Carlat gave up his $500 dollar lunches when he began to feel intellectually dishonest and recognized that the Wyeth salespeople who accompanied him to the doctors' offices would not retain him if he gave up his role as a cheerleader for Effexor. When he honestly displayed equivocation on legitimate issues, his Wyeth companions made their displeasure clear immediately. And Carlat used his free time to began producing a pharmacological newsletter that reflected his own opinions without editing--or support--from drug manufacturers. He is on the faculty at Tufts and his newsletter is called the Carlat Psychiatry Report. We hope the satisfaction he feels as a result of practicing intellectual honesty makes up for the income he sacrificed.
After recalls of millions of pounds of hamburger, tainted seafood and all sorts of problems with e-coli in spinach and other fresh greens, American consumers are recognizing that their food supply is no longer the envy of the world. That recognition is evidenced by the Food Marketing Institute survey showing a decline in confidence over food safety among American consumers from 82 percent to 66 percent. One reason for this decline is corporate-friendly rules which, for example, do not require testing labs or importers to report a failed safety test. The results are reported only to the importer who paid for it--which is then free to send the tainted foodstuff to a different, less reliable lab, for approval. The FDA never learns of the failed test or concern over the imported product .
Concern over issues such as this have lead the Food Marketing Institute's 1500 members to petition the Bush Administration to adopt new, more reliable rules and to stop coddling importers who put profit ahead of health and safety. Perhaps with the FMI's influence, the Republicans will re-join the effort to maintain the safety of the American food supply.
U.S. Cardiologists were complaining this week about the refusal of drug manufacturers to disclose the results of clinical trials on cholesterol-lowering drugs Zetia and Vytorin. Despite the fact that they are prescribed to almost 800,000 Americans every week, at a total cost of $4 billion dollars, the manufacturers have consistently refused to provide prescribing physicians, consumers, or insurance payors with the results of clinical trials investigating [or documenting] their effectiveness. We wonder why the physicians continue to prescribe these drugs if the manufacturers are unwilling to document that they are actually effective and continue to refuse and delay release of their test data? The reason for this delay and obfuscation seems patently obvious.
Despite heavy pressure from cardiologists, manufacturers Merck and Schering-Plough have refused to provide any results thus far, and have only promised to provide partial results in March of 2008. Further, they announced that they were changing the "endpoint" of the study, thus re-designing the goal of the study mid-stream: that is considered to be inappropriate in clinical research.
These medications reduce cholesterol in a manner that is different than "statin" drugs such as Lipitor. Unlike statins, these particular medications have never been shown to be effective in protecting patients from coronary artery disease. The manufacturer originally claimed that this study would document that effectiveness, however, it is now suggesting that such documentation will have to be delayed until 2010 or later (while billions of dollars of revenue are generated annually). The manufacturers' decision not to release their data must also be considered in the context of their 2005 agreement to "promptly" furnish drug effectiveness data. The results of this particular study have been promised to cardiologists several times in the past and were originally to be produced by March of 2007.
All-in-all, it is patently clear that the public has a significant interest in the data collected on patients included in these studies and that the FDA should be empowered to exercise greater control over this industry. With medical expenses, and pharmacological expenses in particular, draining an ever-greater share of the gross domestic product and influencing the lives of more and more Americans, it is inappropriate and absurd to leave the regulation of safety in this area to manufacturers who have billions of dollars in annual sales at risk. If, for example, these medications are not protecting patients against a future heart attack as well as a statin would, they and there doctors should be provided with the raw data that would allow them to make an informed decision about which medication to prescribe and purchase.
Democrats in Congress continue to push reforms in the Consumer Product Safety Commission, over objections from Republicans and particularly the Bush Administration. Belatedly concerned over the tsunami of unsafe products washing ashore and recalls, in particular, of dangerous toys, Congress is attempting to restore the CPSC's budget to its pre-war level and enhance its enforcement powers. Despite its incompetence, indeed irrelevance (the CPSC has ONE toy inspector, currently), over the past few years, the Administration is fighting the reform of the CPSC and its acting director has maintained that no the reforms are unnecessary.
The pending legislation in the House would enhance the CPSC budget, adopt standards on lead, renovate test labs, require third-party testing and generally focus on children's safety. The Senate's proposed reforms would add safety inspectors and assign additional safety agents at ports of entry to the U.S. Both versions would increase penalities for violators and give the agency more authority to recall products. In response, Republicans have suggested an "action plan" that relies upon volunatary reforms within the industry: even industry executives deride that suggestion. We think it was proposed by people who have been eating too many lead-based paint chips on one side of the Capital aisle.
Today, NIke recalled almost a quarter million football helmet chin straps because they broke under stress. The Company had received reports of 18 injuries caused after chin strips failed during play allowing the player's helmet to come off. The injuries varied from severe concussions to facial lacerations and apparently occurred over a period of years prior to the recall. Prior studies have shown that recalls of this sort actually recapture less than ten percent of the recalled products from the market, as consumers are either unaware of the recall or fail to respond.
Not surprisingly, the chin straps were manufactured in China.
The November 12 issue of the New York Times reported that the medical and pharmaceutical industries are re-examining the issue of drug-coated stents. These stents had been in widespread use over the past decade as a means of reducing the likelihood of re-clotting at the location of a stent used to preserve the integrity of coronary arteries. Over the past 18 months, research had suggested, however, that drug-coated stents presented a new hazard of later-developing clots. As a result, there was a dramatic reduction in the use of drug-coated stents, with the NYT suggesting that the sale of these stents dropped from 6 billion to 5 billion dollars over the last year. Very sick patients opted for open-heart surgery as an alternative, while other coronary artery disease patients chose bare metal stents or chemotherapy alone. Patients treated with drug-coated stents were placed on a longer regimen of anti-clotting medications as a precaution.
Newer studies have demonstrated that the issue is not as simple as originally thought, however. Some studies have suggested that perhaps the original studies identifying the risk of clotting may be skewed because drug-coated stents were used in sicker patients. Another study of 17,000 patients suggests that the survival of drug-coated stent patients is better, long-term, than the survival of bare-metal stent patients. Other physicians point to the risks and complications of open-heart surgery that must be weighed against the risk of late-developing clots. It will probably require several years of experience and more subtle investigation to tease out the "truth" about drug-coated stents. In the meantime, this is an issue that should be examined carefully by every patient and his or her physicians.
On November 10, 2007, the New York Times reported that the investment community considered the $5 billion settlement of Vioxx lawsuits to be a victory for the company. The painkiller Vioxx was pulled from the market after it was shown to contribute to the likelihood of myocardial infarcts and strokes. The settlement will occur only if 85 percent of the 27,000 pending lawsuit victims accept it, which the Federal Court apparently considers likely. News of the settlement pushed Merck's stock value up.
Merck had won about 2/3 of the cases that had been tried, including 8 of the last 10. Where it had lost, however, it had also been compelled to pay significant punitive damages. To receive a settlement, victims will have to prove that they actually suffered a stroke or heart attack within 14 days of taking Vioxx for at least 30 days. It will be difficult for Michigan resident victims to share in the recovery because the Michigan courts have granted immunity to any drug manufacturer whose product is approved by the FDA.
It will come as a surprise to almost no one that National Public Radio reported on November 8 that yet another Chinese-made toy had been yanked from the market. In this case, the toy was "AquaDots", one of Wal Mart's designated "toys of the year". The toy was designed in Australia and manufactured in China. A child uses the beads supplied to create a mosaic; the beads are then melded in place by applying water. The Australian doctors at Westmead Children's Hospital responded to a child's severe illness by ordering a urine sample and found GHB, the dangerous and banned chemical described colloquially as the "date rape drug" in the child's urine. The drug is known to cause seizures and respiratory failure and has caused fatalities.
Follow-up investigation confirmed that the two-year old had eaten some of the beads and vomited up some just before becoming comatose. Within 48 hours, the GHB disappeared from his system, confirming the recent ingestion of the chemical. The child's beads were then tested with a mass spectrometer, and the presence of GHB was confirmed on these beads, apparently used to prevent the water-soluble glues coating the beads from adhering prematurely. Although it wasn't listed on the manufacturer's list of ingredients, GHB apparently turned up on additional beads, and another Australian child was hospitalized with seizure and coma.
The North American distibutor of the beads immediately notified retailers to withdraw them from their shelves, and shortly thereafter the CPSC ordered the product recalled in the U.S. The manufacturer is now proposing to add a foul-tasting coating to the beads to discourage chidren from swallowing them. That doesn't seem to us to be an adequate solution--particularly at a time when candy makers mimic a popular movie by selling jelly beans that taste like vomit. It will probably be enough to satisfy the current administration's head of the Consumer Product Safety Commission, however: she has been willing to consume foul-tasting material on behalf of unregulated industry for some time now.
Right now, our citizens are saving significant sums by out-sourcing to cheap, unregulated labor and manufacturing in the third-world, production of everything we buy. We must have a principled discussion about whether we are willing to spend a few of those "saved" dollars to protect the safety of our children and ourselves. It is clear that China and other third-world governments will not, or cannot, protect our consumers. This is a new problem created by the "flat world", and our government has not only refused to address it: under President Bush we have even stripped the CPSC budget by half. We should be giving the matter some principled analysis and we are not.
Legislators in Michigan should reconsider, for example, their tort-reform grant of immunity to retailers who sell defective products. This immunity significantly reduces their financial incentive to market only safe products and eliminates their incentive to require that producers insure the products sold. As a result, suppliers from China, for example, where the government won't allow service of process, are out of the reach of injured consumers. And for a few cents saved on each product, our health care and welfare systems must provide for injured kids rather than the at-fault industry.
The Bush Administration has finally proposed an "Action Plan" to address consumer safety, however, it is too little, too late, given the prior dismantling of the Consumer Product Safety Commission. The FDA would get the right to recall foods (how absurd that it doesn't have that right, today, but keep in mind that recalls have been shown to be only marginally effective in removing many products from retail shelves or reclaiming them from purchasers). The FDA could require foreign manufacturers to certify that products comply with its standards, however, the current debacle in product safety suggests that would be a hollow gesture. It could levy larger fines (up to $10 million dollars), but marginal products produced by one of the thousands of marginal producers in China would be equally undeterred by potential fines of any size. Finally, the "action plan" continues to rely on self-policing by the various industries and does not provide for the funding necessary to take an active role in actually protecting consumers. That won't happen for as long as the "starve the beast of government" mentality remains prevalent.
