Autores de articulos legalmente responsables en caso de lesiones del paciente

Proponen que los autores firmantes de un artículo sean legalmente responsables en caso de que el paciente sufra lesiones · 30 Enero 2012 1
Un triunvirato de expertos plantea que los médicos que avalen trabajos realizados según las directrices de laboratorios farmacéuticos sean legalmente responsables ante la posibilidad de que un paciente sufra lesiones.

Proponen que los firmantes sean legalmente responsables ante la posibilidad de que los pacientes sufran lesiones.
El investigador español Xavier Bosch, del Hospital Clínic, ha planteado en un artículo publicado en PLoS Medicineque se adopten medidas legales para luchar contra el llamado ‘medical ghostwriting’, práctica consistente en conferir autoridad a un texto pseudopublicitario por el procedimiento de contratar la firma de un ‘autor invitado’.
Bosch y los coautores del artículo, Bijan Esfandiari, abogado en un bufete de Los Ángeles especializado en malas prácticas médicas, y Leemon McHenry, investigador del Departamento de Filosofía de la Universidad Estatal de California, recogen tres modelos teóricos de responsabilidad penal que afectarían principalmente a estos ‘guest authors’.
Así, los expertos proponen que los firmantes sean legalmente responsables ante la posibilidad de que los pacientes sufran lesiones por causa de una práctica que aquéllos han avalado, y plantean que esas mismas responsabilidades se extiendan a las empresas patrocinadoras. Ambos planteamientos se basan en que los artículos pueden influir en el juicio clínico, aumentar las ventas de productos y los costes de atención sanitaria del gobierno, y poner a los pacientes en riesgo.
Los autores también consideran una forma de ghostwriting “las conferencias y los congresos médicos sobre enfermedades en los que se habla de los beneficios de un producto, si el discurso ha sido preparado a partir de las directrices de una compañía”.

Ver artículo en PLoS MEDICINE

  • Despite growing concern about medical ghostwriting, pharmaceutical companies, universities, medical journals, and communication companies employing ghostwriters have thus far failed to adequately stem the problem. As a result, some commentators have proposed that legal remedies could be sought by patients harmed by drugs publicized in ghostwritten papers.
  • In this Essay, we build on a recent analysis by Stern and Lemmens in PLoS Medicine to outline specific areas of legal liability.
  • For example, when an injured patient’s physician directly or indirectly relies upon a journal article containing false or manipulated safety and efficacy data, the authors, including guest authors, can be held legally liable for patient injuries.
  • In addition, guest authors of ghostwritten articles published by Medicare- and Medicaid-recognized peer-reviewed medical journals used as clinical evidence for indications for off-label uses may be liable under the federal False Claims Act for inducing the United States government to reimburse prescriptions under false pretenses.
  • Paying guest authors of ghostwritten papers may influence clinical judgment, increase product sales and government health care costs, and put patients at risk by misrepresenting risk-benefit. Therefore, both physicians and sponsor companies may be liable under the federal Anti-Kickback Statute.
  • Although guest authors and pharmaceutical defendants may argue a First Amendment right to participate in ghostwriting, the US Supreme Court has firmly held that the First Amendment does not shield fraud.


After months of hard, collaborative work, just published the first version of the open access guide for pharma about using social media. While drug companies, healthcare professionals and e-patients wait for FDA guidelines on social media, with an expert crowd we created our own guidelines to serve as a basis for more detailed, extended guides.

You can download the PDF (14 pages) here!

Please feel free to download it, share it with your colleagues and join us to create an even more sophisticated second version which we can submit to the FDA. Give us feedback on Twitter through#pharmaSMguide!

The original Google Docs document contains more details, negative and positive social media-related pharma case studies as well.

Best regards,

Dr. Bertalan Mesko

Managing director and founder
Webicina LLC
Twitter: Berci

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How Big Pharma Forced Poor Countries to Keep Drug Prices High

Source: The Fix
A new cache of Wikileaks docs claims that American pharmaceutical companies successfully strong-armed dozens of smaller, poorer nations to keep drug prices and profits high, often with the help of hapless U.S. diplomats.
Let the sunshine in. Photo via

Among the hundreds of thousands of secret US State Department cables recently released by WikiLeaks, the controversial whistleblower website, a cache reveals US diplomats defending the interests of big pharmaceutical companies, even at the risk of the hosting nation’s own public health priorities. The memos dutifully detail the many embassy meetings with local Big Pharma reps, during which US officials are presented with laundry lists of issues to raise with one or another local government ministry. Invariably the goal of the exercise is for pharma to pressure the US to pressure the host country to give favorable treatment to expensive brand name drugs, typically by preventing in-country manufacturing or marketing of far cheaper generic versions.
Separate cables show such industry profiteering tactics threatening to taint US diplomatic relations in emerging nations such as Hong Kong, the Dominican Republic, the PhilippinesTurkeyVenezuelaSaudi Arabia, and India. Overall, a familiar picture emerges of a diplomatic corps if not held hostage by, at least a captive audience to, the financial interests of the biggest American pharma companies as they come into covert conflict with developing nations that quite naturally prioritize the health care of their people over the high margins that Big Pharma has come to expect. With several hundred drugs and vaccines in development to treat addiction, the scourge of hundreds of millions worldwide, the affordability and accessibility of these innovative (and, no doubt, expensive) medicines will become a pitched battle in global public health over the next decade. The outcome of the skirmishes sketched in the WikiLeaks cables will help decide whether profits or people prove victorious.
The cables by no means paint a uniform portrait of government lackeys doing industry’s bidding. Many memos betray a between-the-lines irritation at pharma’s monomaniacal self-interest. Still, there is a disturbing silence on the obvious moral or ethical objections to industry demands for high price, long patents, and other protections despite the cost in human lives. Only a single cable—from the outgoing US ambassador to Poland in 2009—lays bare the vast greed that drives these complex, highly technical negotiations.
The developing nations, contrary to what you might expect, in many ways hold the best cards in this political game. Emerging nations have the fastest-growing economies, the most upwardly mobile middle classes, and the biggest untapped markets in the world. And in their impressive pushback against Big Pharma, India has been the 800-pound gorilla over the past decade. A democracy with well-educated but relatively inexpensive brain power, the pharma industry views India not merely as a market but as a potential new hub of drug development and testing.
There is a disturbing silence on the obvious moral objections to industry demands for high prices, long patents, and other protections despite the cost in human lives. Only a single cable lays bare the vast greed that drives these complex, technical negotiations.
Aware of its advantage, India has played hardball, starting with its approval of local generic HIV drugs for its hundreds of thousands of citizens with the virus—a defiant challenge to Big Pharma, which had refused to discount its own brand-name AIDS drugs to affordable levels. (In the US, HIV treatment costs as much as $15,000 a year; the Indian generic knocked out knockoffs with a $350 price tag.) In addition, India’s supreme court has been fearless in shooting down foreign pharmas when they sue for patent infringement by Indian generic companies. When an emerging nation’s entire legal and legislative apparatus unite to oppose industry interests, the company can either fold its hand or fold up its tent. When drug companies retaliated by boycotting India and refusing to sell new drugs there, they attracted universal opprobrium for denying sick people medicines.
Typically, the WikiLeaks memo from the US embassy in New Delhi detail a laundry list of complaints by the Organization of Pharmaceutical Producers of India, including a new price-control regime to keep drug costs more affordable and a wholesale rejection, over US objections, of so-called data exclusivity, allowing a generic firm to bring knockoffs to market as soon as a branded patent ends.
Drug prices are only one of the issues raised in the cables. Equally important to Big Pharma is obtaining patent protection in new markets. Patents, which confer market exclusivity on a product, are especially dear to drugmakers because truly innovative medicines are among the riskiest and most expensive investments around; a company spends, on average, $1 billion and 10 years to bring a new drug to market, and the rate of failure in late-stage development is more than 50%. Without a patent to allow the manufacturer a monopoly to sell the drug for a limited period of time, a competitor could copycat the molecule virtually overnight. 
But what is a fair compromise between an innovator’s need to recoup profits from an invention and the public’s need to access medicine at an affordable price? In the US, with its political system owned and operated by corporations, the answer is, as much as the market will bear—one reason that our health-care is the most expensive and the least efficient in the developed world. But it turns out that most nations in the rest of the world are far less servile to Big Pharma than Uncle Sam.
In the Dominican Republic a group of Big Pharma reps met with a US counsel to request a speedup in the very slow rate at which the small nation’s patent approval office was stamping drugmakers’ filings: out of 700 filed over the past decade, fewer than 10 had been processed! The diplomat penning the memo, which was all analysis and no action, commented wryly that the Dominican Republican was evidently waiting to see if the anti-corporate winds blowing across Latin America marked a lasting change in the political weather. 
The politics of patent protection of pharmaceuticals tend to make for tedious reading, as do the details of the World Trade Organization’s treaty called the Trade-Related aspects of Intellectual Property Rights (TRIPS) agreement, which gives private companies broad protections for their medicine monopolies, including a guarantee of 20-year patent protection before competitors can flood the market with generics. (A monopoly is, by definition, not a free market.)  But, as longtime consumer activist James Love, who heads the Knowledge Ecology International organization, explained to The Fix,“All the things the US is doing is whatever benefits a handful of companies like Pfizer, Abbott, Merck, and so on. The US basically pushes for anything they want.” Whenever they score a major victory for these companies, they try to push it further. Love explained, “What does the US want? The US wants more.” 
Although under the TRIPS agreement, pharmaceutical companies could register their drugs for 20-year patents in any nation via that country’s regulatory apparatus. But they don’t want to risk the sly Dominican Republic–style delay. So they want more. They want automatic monopolies in every country. In practice, the easiest way to get these monopolies is by having the State Department pressure governments in the developing world to grant them long periods of data exclusivity. The data at issue consists of the mountain of information from the numerous clinical trials showing safety and efficacy to win approval from the FDA. By demanding data exclusivity, Big Pharma is essentially trying, Love explained, “to create an intellectual property right over the very knowledge that a drug is safe and effective—something that is completely independent of a patent.”
A generic-drugmaker would be forced to repeat the entire clinical-trials process, an immense waste of time and money since the work has already been done, in order to get stamped OK to market. This is why American diplomats sought to write in data exclusivity clauses into trade agreements with countries like India, which India has simply scoffed at, enabling the country to begin manufacturing generic AIDS drugs.
The Wikileaks documents reveal that the data-exclusivity controversy—given the intense pushback by emerging nations against granting pharma de facto monopolies even where they do not have patents over their drugs—is a concern verging on an obsession of the industry, which in turn does its best to rally in-country US officials to the issue.
But to little effect. In the Philippines, for example, was having none of Big Pharma’s knowledge monopoly. The author of the cable noted drily that it was passing laws that “respect the letter but not the spirit” of TRIPS on data exclusivity and “new use patents” (patent protection for already-approved drugs that get additional OK’s for new conditions, such as the antidepressant Cymbalta a.k.a. the anti-pain treatment Lyrica for fibromyalgia). In the US, when Cymbalta’s antidepressant patent runs out, generic companies will cannibalize its sales with cheap versions, but the Lyrica/fibromyalgia patent will still have several years of life, so while doctors may prescribe generic Cymbalta for either medical condition, many insurance companies will not cover the generic as an anti-fibromyalgia, even though it amounts to chump change, because of Lyrica’s patent.
As the WikiLeaks memo from the Manila embassy indicates, even after a meeting with a high-level US trade official, the Philippine legislators refused to budge on the “new use patent” issue, citing India’s new legislation, which bars such foreign patents. One reportedly told the trade rep, “Is the US going to go to the mat with India over this issue?”
The case of Poland provides unique insight into the role of US diplomatic efforts in advocating for Big Pharma. Because many medicines are too expensive for Poles to purchase without government subsidies, the Polish government—like most EU nations—maintains a list of drugs that it will subsidize. Getting a drug on this list is a pharma’s top objective as it is a prerequisite for penetration of the Polish market. 
“While pharmaceutical companies often assert that they would be happy with a transparent process, even if it led to decisions not to fund their drugs, in practice they seem to resent all government measures aimed at cost containment, as these limit sales,” Ambassador Ashe wrote.
When George W. Bush appointed his former Yale roommate, Victor Ashe, as ambassador to Poland, this issue became a constant demand on his time. Almost as soon as he arrived in Warsaw, the former Knoxville, Tennessee, mayor became the obedient mouthpiece of American drug companies’ interests, writing a letter urging the Ministry of Health not to lower the prices of the drugs on that list. Each year of his tenure, his office would obsess over the announcement of that list, sending detailed cables to Washington about which companies and products had gained access to the Polish market. (“None of Eli Lilly’s products were added, a blow to the company. Eli Lilly’s officials observed that the Ministry has offered no explanation.”) 
Ashe’s office also had to negotiate meetings between the Ministry of Health and Big Pharma representatives about the list of subsidized drugs. The industry via Ashe complained about a lack of transparency—a legitimate concern given that not only Poland’s health ministry but that of many other countries made its decisions behind closed doors. Big Pharma is, like most industries, addicted to clear-cut quid pro quo with US elected officials, and when it encounters resistance from other governments, the industry tends to be dumbfounded.
Finally, in 2009, after Obama had been elected and Ashe was packing up his office, he sent a remarkably blunt cable to Washington lamenting the unreasonable avarice of US pharma companies in the face of grave budget constraints for health care: “The situation in Poland should be assessed in light of the general European background. While Polish spending on health care has been increasing (Poland now spends…about $3 billion on pharmaceuticals), the cost of pharmaceuticals also continues to increase. The Polish government has to make tough policy choices regarding which drugs to fund, and at what level. While pharmaceutical companies often assert that they would be happy with a transparent process, even if it led to decisions not to fund their drugs, in practice they seem to resent all government measures aimed at cost containment, as these also inevitably limit drug companies’ sales.”
Although this cable is striking for its candor, it cannot be dismissed as the ranting of a disgruntled outgoing official; rather, this is the conclusion reached by a thick-skinned US politician whose tolerance for industry profiteering was simply exhausted by Big Pharma.
When price or patent negotiations between a pharma and a nation fail, and the nation lacks the purchasing power to access essential medicines, TRIPS allows it to institute a “compulsory license”—to shred the patent if the disease, left untreated, constitutes a public-health emergency. Such an action routinely sparks dire ire from American diplomats, as it did in Thailand, when the Thai government broke the monopoly on a prohibitively expensive HIV drug and instead imported a cheap Indian version. Offended that Thailand resorted to this option without first entering into price negotiations with the drugmaker, the US embassy began to pressure the Thai government to do so. The cable is frank about how this action would be perceived by the Thai people: “Their [for-profit medicines providers] role in saving lives through innovation has been almost totally obscured, replaced with the image of rich foreigners taking advantage of sick, defenseless Thais. Taking control of technology through a CL is, in this climate, perceived as a brave (and virtuous) act.”
In nasty retaliation, the US government placed Thailand on a “watch list” for countries that violate international trade rules, a punishment that could have serious negative effects on its economy. In2008, a new “pro-business” Thai government assumed power, and on its first day in office, agreed to review the compulsory licenses. 
The most arresting of the WikiLeaks cable may be the one from the US embassy in Venezuela, alerting the State Department to a threatened move by the loose-cannon socialist President Hugo Chavez to trash the intellectual property rights of all pharmaceutical products by publicizing on the Internet the technical information contained in each patent. Such a move would have made the molecular engineering involved in many brand name drugs available worldwide—an open source of pharma secrets. But as is so often the case with Chavez, his fighting words carry little force. Yet many Venezualans were outraged at the what the WikiLeaks cable revealed about US efforts at intervention.
Dr. Drummond Rennie, the deputy editor of the Journal of the American Medical Association and a professor of medicine at the University of California, San Francisco, said, “What worries me is the monolithic overuse of power to push pills. That’s not a future we should encourage. It’s the worst possible future.”
James Love is worried about this projection of American power abroad. As he said, “I think it’s just horrible. Everybody has their own take, and some people [in the US] don’t care about the lives of people in developing countries. I think it says something about us as a people.”
Jed Bickman is a frequent contributor to The Fix. He also writes for The Nation, CounterPunch and other websites and magazines. Walter Armstrong is deputy editor at The Fix.

Disease Mongering

Disease mongering

Disease mongering is a pejorative term for the practice of widening the diagnostic boundaries of illnesses, and promoting public awareness of such, in order to expand the markets for those who sell and deliver treatments, which may include pharmaceutical companies, physicians, and other professional or consumer organizations.[1] Examples include male pattern baldness and certainsocial phobias.[1]
In discussions specifically about psychiatric diagnosis, the term is frequently used by proponents of the antipsychiatry movement[2] and Scientology-based critics[3] as just one part of their criticism of psychiatry or specifically biopsychiatry. Examples include ADHD and bipolar disorder.[4]
Proponents of this practice argue that the pharmaceutical industry is only providing the public with information about its options and that actual prescription is a matter to be discussed between patient and doctor. Opponents, however, claim that this approach leads to the unnecessary prescription of drugs, that its motivation is primarily or only to profit the drug companies, and that it may actually harm instead of help patients.[1]
A 2006 Newcastle, New South Wales international conference, reported in PLoS Medicine, explored the phenomenon of disease mongering.[5] Journalist Ray Moynihan satirised disease mongering in a BMJ “news” item that appeared in its April Fool’s Day edition 2006, titled “Scientists find new disease: motivational deficiency disorder”.[6]



[edit]See also


  1. a b c Moynihan R, Heath I, Henry D (2002). “Selling sickness: the pharmaceutical industry and disease mongering”BMJ 324 (7342): 886–91. doi:10.1136/bmj.324.7342.886PMC 1122833PMID 11950740.
  2. ^ Fred Baughman (2000-09-25). “The Rise and Fall of ADD/ADHD”. ICSPP. Retrieved 2007-06-03.
  3. ^ Stephen Barlas and Psychiatric Times staff (2006-04-16). “Psychiatric Profession Current Target of Citizens Commission on Human Rights”.CCHR. Retrieved 2007-06-03.
  4. ^ Healy D (2006). “The latest mania: selling bipolar disorder”PLoS Med. 3 (4): e185. doi:10.1371/journal.pmed.0030185PMC 1434505.PMID 16597178.
  5. ^ Moynihan R, Henry D (eds).. “A Collection of Articles on Disease Mongering.”PLoS medicine, 2006.. Retrieved 2007-06-12.
  6. ^ Moynihan R (2006). “Scientists find new disease: motivational deficiency disorder.”BMJ 332 (7544): p. 745. doi:10.1136/bmj.332.7544.745-a.

[edit]Further reading

  • Saddichha S (2010).”Disease Mongering in Psychiatry: Is It Fact or Fiction?” World Medical & Health Policy: Vol. 2: Iss. 1, Article 15. DOI: 10.2202/1948-4682.1042
  • Peter Conrad (2007), The Medicalization of Society: On the Transformation of Human Conditions into Treatable DisordersBaltimore:Johns Hopkins University Press.
  • Payer, Lynn (1992). Disease-Mongers. New York: John Wiley. ISBN 0-47100-737-4.
  • Moynihan, Ray; Alan Cassels (2005). Selling sickness: How the world’s biggest pharmaceutical companies are turning us all into patients. New York: Nation Books. ISBN 1-56025-697-4.
  • Cassels, Alan (2007). The ABCs of Disease Mongering: An Epidemic in 26 Letters. Victoria, British Columbia, Canada: EmDash Publishing. ISBN 978-0-9780182-3-8.
  • Melody Petersen (2008), Our Daily Meds: How the Pharmaceutical Companies Transformed Themselves into Slick Marketing Machines and Hooked the Nation on Prescription Drugs.
  • Christopher Lane (2008), Shyness: How Normal Behavior Became a Sickness.

[edit]External links

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Drugs News and Health Blog

Source: Before you take the pill (Doug Bremmer)

Spurious Advances in Antipsychotics, Indeed

An article from the Jan. 3 2009 issue of The Lancet used a meta analysis to show that so-called first generation antipsychotics (FGAs) and second generation antipsychotics (SGAs) are not that much different in terms of efficacy, safety, and side effect profiles. The purported superiority of SGAs for negative symptoms and fewer side effects for SGAs were primarily the results of comparator studies that put them up against high dose haloperidol.
I have been reading a book called Hooked: the Medical Profession and the Pharmaceutical Industry by Howard Brody, MD PhD, of the University of Texas, Galveston, which I highly recommend as an interesting book that adds a lot even for those of you who feel you are “read out” on this topic, and this episode of comparing new drugs to old drugs given at doses that cause more side effects without providing more efficacy (which is stacking the deck in favor of the new drugs) is a pharmaceutical industry tactic that he identifies, although this is the first time we have heard of it as applied to antipsychotic “life saving drugs”.
Psychiatrists moved en masse from the FGAs to the SGAs largely because of concerns about tardive dyskinesia, extra pyramidal side effects, and what may have been a misguided belief that these drugs worked better, fueled by pharmaceutical marketing. As the paper shows, most studies in the literature were found to be using high dose haloperidol (>7.5 mg/day) (Haldol) as the comparison drug, which biased the trials in favor of showing a better side effect profile for the newer drugs. When studies using lower potency first generation drugs were focused on, the differences in safety and efficacy were considerably diminished. Specifically, the SGA drugs as a whole were not seen to be specifically better for negative symptoms of schizophrenia, which does not support marketing claims to the contrary. The drugs that were better for negative symptoms were also equally better for positive symptoms and depression. Although clozapine, olanzapine, and risperidone were marginally better for extra pyramidal side effects, which is largely why psychiatrists moved so heavily into SGAs in the first place, the effects were not large, and there were no significant differences for the other SGAs. The only SGAs that were shown to be better for psychotic symptoms than low dose FGAs were amisulpride (Solian, Sultopride), clozapine (Clozaril), olanzapine (Zyprexa) and risperidone (Risperdal). These drugs, however, caused more weight gain than haloperidol (but not low potency FGAs). Only Amisulpride and sertindole (Serlect) were better for quality of life. Aripiprazole (Abilify) was only better for depression and quetiapine (Seroquel) was better for positive symptoms and depression. Sertindole (Serlect), ziprasidone (Geodon), and zotepine (Zoleptil) were not better for any symptom area.
The recent CATIE study compared SGAs to the FGA perphenazine (Trilafon), and found that most of them were not better for efficacy or side effects, only olanzapine had a longer time to discontinuation (the primary outcome) and clozapine was better for symptoms. However, clozapine has bothersome blood monitoring requirements because of the risk of aplastic anemia, and olanzapine has some worrisome diabetes risks. What was most amazing about the CATIE study, however, was the fact that half of people stopped taking their meds after a couple of months, which indicates that people feel really lousy on these drugs.
The article was accompanied by and editorial by Turner and Horton entitled “The Spurious Advance of Antipsychotic Therapy” in which the authors said that psychiatrists had been “beguiled” (presumably by the pharmaceutical industry) into believing that the SGAs were superior (a point highlighted by others like Vera Sharav of the Alliance for Human Research Protection (AHRP). Although I wouldn’t agree with the emphasis that there isno difference between these drugs, it is true that the safety and efficacy of these drugs have been greatly distorted, that we should stop using the distinction of SGA-FGA or talking about unique profiles of “atypicals”. In addition, It is unclear if the extra cost of these drugs justifies their use when there is an increased risk of obesity and diabetes with not that great of an advantage for extra pyramidal side effects. Certainly for the drugs not better than low potency FGAs there is not.
Guess we got duped by pharma. Yet again.
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Why Do Americans Take So Many Prescription Drugs?

Logo of the United States National Cancer Inst...Image via Wikipedia
Why Do Americans Take So Many Prescription Drugs?
J. Douglas Bremner, MD
Scope of the Problem
“Today we are faced with what may be the single greatest drug safety catastrophe in the history of this country or the history of the world… In my opinion, the FDA has let the American people down, and sadly, betrayed a public trust.”Those ominous words, spoken by David J. Graham, M.D., M.P.H., Associate Director of Drug Safety for the Food and Drug Administration (FDA), on November 18, 2004, were part of Congressional testimony concerning the dangers of Vioxx. The drug had just been taken off the market because of evidence that the arthritis medication increased the risk of heart attacks. Yet he could have been talking about the prescription drug industry in general, especially since he noted that Vioxx was not the only medication that posed serious health threats. It was only the tip of the iceberg. Graham identified five widely-prescribed drugs still on the market that are particularly dangerous, including Accutane, Bextra, Crestor, Meridia, and Serevent (in 2005 Bextra was taken off the market).
While it’s true that many drugs help people live longer and better lives, myriad others may hurt you in other ways that you don’t know about. Dr. Graham’s testimony provided the public a fleeting glimpse at that knowledge, normally hidden from view or frustratingly difficult for the average person to access. Pharmaceutical and supplement manufacturers have to increase sales and profits, as all businesses must, and they do so in part by developing drugs to treat disease and also by convincing people they need meds to prevent disease or lessen the perceived risk of future illness. The result is that nondisclosure of potentially harmful side effects of the drugs they make has become routine.
How We Got HereThe latest drive to get new pills on the shelves and into people’s mouths began when government deregulation and an earnest attempt to help AIDS-HIV patients access important life-extending drugs collided. In the 1980s there was a strong movement to decrease the role of government regulation in all businesses, and budgets of regulatory agencies like the FDA were slashed as part of that effort. The Reagan Administration painted the FDA as a bloated bureaucracy that was slowing down the approval of drugs and getting in the way of business.
There was some truth to that claim. At that time it could take up to two years to gain drug approval, two years too long if you were suffering from HIV-AIDS. Throughout the 1980s, AIDS activists and patients echoed the drug companies’ sentiments, complaining that it took too long to bring disease-fighting drugs to market. The pharmaceutical industry lent a sympathetic ear and a loud voice to calls for speed in approvals of AIDS drugs such as Agenerase (amprenavir). Since drugs are on patent for a limited number of years, every year spent waiting for approval from the FDA meant losing a year of profits.
Couple that with the fact that the FDA could now honestly say that, because of cuts, it was understaffed. The answer was essentially legislation allowing pharmaceutical companies to pay the salaries of the staff at the FDA. In 1992, the Prescription Drug User Fee Act (PDUFA) stipulated that a fee (now $576,000) be paid to the FDA by the pharmaceutical companies for each new drug application. The number of staff at the Center for Drug Evaluation and Research (CDER) doubled overnight. Today, the FDA receives about $260 million a year from these fees. Part of the bill stipulated that funding by Congress for new drug evaluations had to increase by 3% per year. Since the overall funding for the FDA did not increase at 3% per year, the FDA had to actually cut funding for surveillance and research of approved drugs.
Another interesting phenomenon resulted from the change in law: the boundaries between the drug companies, FDA, and doctors became increasingly blurred. FDA officials sometimes move to jobs in the pharmaceutical industry, which means they may not want to burn their bridges with industry. The same FDA officials who approve the drugs are responsible for monitoring them after they are on the market, which gives them an obvious disincentive to say that the drugs they earlier certified as safe were now unsafe. Finally, the FDA gets input from outside advisory panels made up of doctors who are experts in their fields. Most of these doctors receive payments as consultants, research grants and support for travel to conferences from drug companies. In some cases, the doctors are working as paid consultants to the same companies whose drugs are coming up for approval by their advisory committees.
For instance, as reported by USA Today on October 16, 2004 (“Cholesterol Guidelines Become a Morality Play”) eight of the nine doctors who formed a committee in 2001 to advise the government on cholesterol guidelines for the public were making money from the very same companies that made the cholesterol lowering drugs that they were urging millions of Americans to take. For example, one of the committee members, Dr. H. Bryan Brewer, was the Chief of the Molecular Disease Branch at the National Institute of Health. He worked as a consultant or speaker for 10 different pharmaceutical companies, making over $100,000 over three years while he was on the committee, and sat on one of their boards (Los Angeles Times, December 22, 2004, “The National Institutes of Health: Public Servant or Private Marketer?”). Dr. Brewer left the NIH in 2005 in the midst of adverse publicity about potential conflicts of interest. Nassir Ghaemi, MD, a psychiatrist at Emory University, was quoted in the Emory Academic Exchange (February, 2007) as saying, “Critics say we are being influenced and don’t realize it—that drug companies are smarter than we are and know a lot more about human psychology than we think, and they’re probably right about that to some extent.”
Expert consensus guidelines have a potent effect on doctors; they can be held liable if they do not adhere to accepted standards of care. Dr. Curt D. Furberg, a former head of clinical trials at the National Heart, Lung, and Blood Institute and now a professor at Wake Forest University in North Carolina, explained how such information reached physicians: “The [company] reps tell the doctors, ‘You should follow these guidelines,’ implying that you’re not a good doctor if you don’t follow these guidelines.” (Los Angeles Times, December 22, 2004, “The National Institutes of Health: Public Servant or Private Marketer?”)”
The result of this co-mingling was a boon for drug makers, approval time of their products decreased from 20 months to six months right after the law changed. However, the number of drugs that had to be later withdrawn also increased from 2% of drugs to 5% of drugs.
There is another troubling dichotomy that could have terrible repercussions for our health: while the number of people with disease is not growing, the number of adult Americans taking medication is increasing – half of us take prescription drugs and 81% of us take at least one kind of pill everyday – and that percentage is expected to rise in the coming years. To gain the most market share, companies have to invent drugs for diseases that previously had no treatment (or treat problems that may not necessarily require drug treatment, such as “restless leg syndrome”), or create prevention medications for alleged risks (like the risk of fracture in the elderly) by expanding the potential pool of medication takers. That meant moving from the realm of giving medications to sick people, to giving medications to people who looked well, but might be at an increased risk based on the result of a blood test or some other hidden marker of disease. Thus the era of disease prevention and risk factor modification was born.
To promote this shift, for the past two decades the pharmaceutical industry has pushed educational programs, which they claim are designed to identify people in need of treatment or prevention with medication. This is usually done by donating money to organizations who advocate on behalf of a specific disease who will in turn “get the word out,” increasing public awareness and screening, and expanding the number of individuals who will potentially take the medication. This is fine for identifying individuals with undiagnosed high blood pressure or to detect the early stages of colon cancer. But awareness campaigns are not always meant to be purely, altruistically educational. Most are linked to a drug company’s marketing campaign.
There are a number of conditions for which we are now urged to obtain screening and potential treatment, including high cholesterol, osteoporosis, hypertension, diabetes, and undetected heart disease. However, the potential benefit of medications to treat these conditions is often exaggerated, side effects are minimized, and in some cases recommendations are applied to people based on evidence from different groups of people (e.g. women with risk factors for heart disease are urged to take cholesterol lowering medications based on studies in men). In addition, doctors who work as paid consultants to the pharmaceutical industry often write the guidelines about who should take the drugs, so it is unclear how unbiased their recommendations really are.
Another factor that has expanded use of prescription medications happened in 1997, when the FDA lifted the ban on direct to consumer advertising along with the law that required ads to list every possible side effect. Soon after, Americans were bombarded daily with commercials for prescription drugs. The US is the only country in the world where you can turn on the TV and have an announcer tell you to go ‘ask your doctor’ for a drug. Doctors often will give medications to patients even if they don’t think they need it. For example, one study showed that 54% of the time doctors will prescribe a specific brand and type of medication if patients ask for it.
A Bleak DiagnosisWith so many of us popping pills or gulping down spoonfuls of medicine, it’s not surprising that more of us report related adverse effects. One hundred thousand Americans die every year from the effects of prescription medications. Over a million Americans a year are admitted to the hospital because they have had a bad reaction to a medication. About a quarter of the prescriptions that doctors write for the elderly have a potentially life threatening error. Many of these people are getting medications that they don’t need, or for problems that can be appropriately and safely addressed without drugs. For example, most cases of adult onset diabetes can be prevented and possibly cured with a change in diet alone – and with considerably fewer negative side effects and numerous healthy ones, like weight loss, and lower blood pressure and cholesterol.
In 2005 in the aftermath of the Vioxx debacle and withdrawal from the market, the Institute of Medicine was asked to provide recommendations for ways to improve drug safety. As part of this process they interviewed Janet Woodcock, Deputy Commissioner of Operations at the FDA. As reported by The New York Times on June 9, 2005 (“Drug Safety System is Broken, Top FDA Official Says”), she told them that the nation’s drug safety system had, “pretty much broken down.” She went on to say that “the keystone of the current system is the prescriber, and that person is the one who decides if the benefits of a drug outweigh the risks for that patient. This system has obviously broken down to some extent as far as the fully informed provider and the fully informed patients.” She charged that neither doctors nor patients had enough information about the side effects of drugs to make informed decisions about taking them. Dr. Woodcock went on to say that, “the bottom line is that a lot of drug safety problems are actually preventable, [because] most adverse events are from known side effects.”
Unfortunately, your doctor may not be able to provide you with all the details on side effects. They aren’t hiding anything; they just can’t keep up with new information. There are over 5,000 medical journals; each publishes 20 articles a month, meaning there a million articles published each year. It’s impossible for anyone to read all of this, let alone a busy general practitioner or internist, or even a specialist, who are often buried by insurance forms and HMO paperwork. Most of the information doctors receive is distilled versions of research results that are assembled by the pharmaceutical industry and distributed through promotional materials and the product representatives that visit doctors’ offices. Legitimate publications are distributed, but papers that are not favorable are ignored, and favorable data within papers are highlighted to the exclusion of less favorable data.
In addition drug companies hire academic physicians to give lectures, but require them to show only the slides that have been approved by the company. The companies support “grand rounds” lectures (the traditional lectures given by outside speakers to the entire department) at universities, but retain the option of approving or disapproving the speakers. I know about this first hand because I have personally been affected by these policies. I fought to not use company-approved slides and was dropped as a speaker, and I was not approved as a grand rounds speaker, and the university where I was lecturing had to find funds from other sources to pay for me to give grand rounds.
Marcia Angell wrote about other ways drug companies distort the flow of information to doctors about the risks and benefits of medications in her excellent book, The Truth About the Drug Companies. She contends that doctors get most of their information about drugs during the weekly visits from drug company product representatives who are typically young, attractive women with no background in health or science; in fact, as reported by The New York Times on November 28, 2005, drug companies often recruit former college cheerleaders for this job (“Gimme an Rx! Cheerleaders Pump Up Drug Sales”).
Reps are sent into the field with a list of talking points to help them answer questions, as well as packets of product-favorable articles and other material such as copies of expert consensus guidelines (created by their paid consultants) to leave with doctors. These articles often have critical information buried in tables without comment, or assert conclusions that are not supported by the data in the paper.
Drug companies also buy information about the medications that doctors prescribe from major chain drug stores like CVS, and then use this information to reward doctors who prescribe their drugs frequently, with trips to resorts and other perks. Drug companies also lavish dinners, gifts, and paid trips to conferences on doctors. Research studies show that, although doctors deny that the perks have any effect on their prescribing practices, there are changes in objective measures, like how often a doctor will try to have a drug from that particular company put on his hospital’s formulary.
Do We Get Our Money’s Worth?I’m not saying that some drugs don’t ever successfully prevent disease, or that newly described diseases and syndromes are necessarily invalid. But the fact is that no matter how you look at it, the US (and to a lesser extent other countries) has a prescription drug problem. The US spends two times more on drugs, and takes twice as many drugs, as other countries, and has worse health. That means we are paying money for drugs that are not working for us.
Despite the fact that Americans spend twice as much on health care as any other country in the world, we have some of the worst healthcare outcomes in the industrialized world, including total life expectancy, and survival of children to their 5th birthday. In a survey of 13 industrialized nations, the US was found to be last in many health-related measures, and overall was 2nd to the last. Countries with the best health care included Japan, Sweden, and Canada, in that order. Factors that were thought to explain worse healthcare outcomes in the US included the lack of a developed and effective primary care system and higher rates of poverty. Even England, which has higher rates of smoking and drinking and a fattier diet, has better health than the US.
It is no accident that we are paying the most money and getting the worst healthcare. In Overdosed America: The Broken Promise of American Medicine, author John Abramson, M.D. says we are pouring money into expensive drugs and medical devices that have marginal value over more economical alternatives. Meanwhile we neglect the development of things like primary care that can have a real impact on health. Forty-three million Americans go without insurance, and that number is growing. We are paying a lot of money for health care we may never even receive, through the rising costs of individual health insurance, health care benefits that drive companies into the ground, expensive Medicare Drug Benefits, and Medicaid costs that cannot be controlled.
Many of the aforementioned expenses are related to expensive drugs that we often don’t need, that are no more effective than older alternatives, or that are simply not as valuable as drug companies make them out to be. For example, studies have shown that peasants in Indian villages with the diagnosis of schizophrenia who get intermittent doses of chlorpromazine, the original antipsychotic that is dirt cheap, together with support from their family, actually dobetter in terms of having fewer psychotic symptoms than Americans who get expensive new generation anti-psychotics and traditional Western psychiatric care. Another example is Nexium, “the purple pill,” which works no better for gastric reflux than the older medications like Prilosec, even though it costs much more.
Drugs cost twice as much in the US as in Canada or Europe. A year of treatment with many medications can cost up to $3000. Billy Tauzin, President of the Pharmaceutical Research and Manufacturer’s Association (PhaRMA), the lobbying organization for the drug companies, in response to efforts to regulate the content of TV ads for drugs, was quoted by The New York Times (May 17, 2005) as saying, “We don’t make ice cream or handbags or automobiles, we make products that save lives.”(Drug Industry is Said to Work on Ad Code”).
The argument drug manufacturers make for the high cost of their products, which has become an old saw by now, is that the money supports research and development of new life-saving meds. And they also say that expensive advertising is needed not to sell drugs, but to educate doctors and patients. Indeed, a whopping 80% of their budgets is used for marketing.
The major drug companies don’t develop a lot of new drugs. The truth is, most new drugs are developed through basic science research performed in universities, and not in drug company laboratories. University scientists receive research grants from the National Institute of Health (NIH). The NIH is supported by money from taxes. Take the case of the Cox-2 inhibitors, like Vioxx. The mechanisms of Cox-2 inhibition that led to the development of the Cox-2 inhibitors were discovered at a university by researchers supported by taxpayer’s dollars.
In order to keep making money, companies are under enormous pressure to create new drugs they can patent and sell without competition for 20 years, after which patents run out and generic (cheaper) versions go to market. In fact, there really aren’t a lot of truly new drugs being developed these days. Most pharmaceuticals touted as new are essentially the same as other drugs in their class, with a slight chemical modification that allows the company to have a unique patent; these are called “me too” drugs.
Once the drug companies have developed a new drug, they patent it and begin clinical trials in the hopes of gaining FDA approval for its use. In order to get approval, they must perform two multi-center randomized placebo or sugar pill controlled studies demonstrating that their drug is better than nothing. This means that patients get randomly assigned to either the drug or placebo for, say, three months, and neither the doctors nor the patients know what they are on. This is the gold standard for evaluating risks and benefits of drugs, and is required to definitively evaluate drugs, as well as alternative treatments.
The placebo response is essentially how much better you do if you take a pill that you believe helps you, even if it really does nothing in terms of its actual effect on your body. At the end of the study the “blind” is removed and the doctors look to see if the drug was better than the placebo in improving the symptoms of the disease, or preventing some pre-defined event, like a heart attack. The company must do at least two studies showing the drug is better than placebo. If they did eight studies and only two showed that the drug was better than placebo that is good enough.
Because the drug companies are only required to show that the drugs are better than nothing we usually never know whether they are better than older drugs the new versions seek to replace. It is usually left to the marketing people to generate enthusiasm, through TV ads, product representative visits to doctor’s offices, and sponsored lectures, that the new drugs are safer or better than the old drug. They do this by picking some aspect of the drug’s properties that theoretically makes it better.
For example, when tricyclic antidepressants went off patent, the new generation of drugs was selective serotonin reuptake inhibitors, or SSRIs. Even though SSRIs were never shown to be better at treating depression than the old drugs, it was argued that because the SSRIs were more specific in blocking serotonin uptake, instead of a non-specific blockage of serotonin, norepinephrine, and other chemicals, that they would be more effective with fewer side effects. The same argument was made for the COX-2 inhibitors, like Vioxx, which were said to more specifically inhibit the COX receptor involved in pain, unlike the non-specific Non-steroidal Anti Inflammatory Drugs (NSAIDs).
The head of the American Psychiatric Association recently bemoaned the fact that psychiatrists had gone from the “bio-psycho-social” model to the “bio-bio-bio” model. Us doctors have become mesmerized with the idea that all depressions are caused by imbalances of serotonin that can be fixed only with a drug that acts on serotonin. However most cases of depression are caused by life traumas, spiritual upheavals, and other jolts along the road of life. That isn’t to say that these changes aren’t accompanied by changes in brain chemistry: it is both. But I think it is time that we acknowledge the role of emotion and spirituality in mental disorders. It only makes sense.
Merrill Goozner, M.D.’s book The $800 Million Pill: The Truth Behind the Cost of New Drugs, says that charging a lot for patented medications is unnecessary to pay for developing future drugs. The second generation of drugs for a particular disorder often will cost as much as ten times as much as the old drugs that have gone off patent. The few studies that did do direct comparisons usually did not show any improvement in efficacy over the old drugs. For example, the newer antidepressant drugs like Prozac have never been shown to work better than the older tricyclic antidepressant drugs.
Sometimes new drugs are found to have consequences much worse than older alternatives; when negative consequences come up, the companies typically resist admitting it for as long as possible. For instance, the painkiller Vioxx was a second-generation drug that was never shown to be better for pain relief than the old painkiller, Advil, which could be bought for a fraction of the cost, and over the counter. However Vioxx was marketed as having a lower risk of gastrointestinal bleeding. After the drug had been on the market for many years it was discovered that it increased the risk of heart attack by several fold (see Chapter Two). Tens of thousands of people died unnecessarily taking Vioxx, and to make matters worse, they had to pay a lot more money for the privilege. What this shows is that the FDA should require companies to test new drugs against old ones, and compare both efficacy and side effects.
Given medical scares like Vioxx it’s not surprising that Americans have become wary of the FDA and drug companies, and both of their public images are beginning to suffer. The Economist reported November 24, 2004 (“Lessons For Pharma From Tobacco”) that less than 50% of us perceive drug companies as “favorable.” That’s only slightly above the low favorable ratings we give oil and tobacco companies.
Another reason why our confidence has been shaken is because of the common defense against charges of drug toxicity that drug companies use: “it was approved by the FDA.” There has even been proposed legislation to make a law that drug companies cannot be liable for drug safety problems if the FDA has approved the drug. The FDA is so paralyzed by politics, and the balance they want to achieve between scientific advancement, commerce, and safety, that it could be letting down its guard. For instance, Daniel Troy, the Chief Counsel for the FDA under George W. Bush in 2004 was a political appointee who formerly worked in a Washington law firm defending the interests of pharmaceutical companies. As reported by Drug Store News (December 22, 2004 “FDA Chief Counsel Resigns”) he worked as a “friend of the court” on cases where pharmaceutical companies had been sued for drug safety problems. The logic was that the FDA approved the drug and therefore had an interest in the outcome.
Finding AnswersIf you are like many Americans who is prescribed a drug or who loves someone who has been, you hop online to research and read about it (and the circumstances that warranted the prescription in the first place), and spend many frustrating hours coming up with little useful information. Worse, you may unwittingly be accessing information on the Internet that is not medically sound or is just anecdotal reports from individual consumers. In fact, research studies show that one out of four medical information web sites offer information that is inaccurate or misleading, and only one out of five are authored by identifiable medical experts.
The book on every doctor’s shelf, the Physicians Desk Reference (PDR), provides detailed information about drug side effects and drug interactions, but is based on product inserts that go into packages of drugs the FDA has approved. New information obtained on the millions of patients treated with drugs after they come onto the market is not incorporated into annual versions of the PDR. Since most of the consumer reference books on drugs are simply over the counter versions of the PDR, these books also do not include data on the millions of people who receive the drug after it comes on the market.
Many Americans have become disgusted with prescription drugs and the American medical establishment, who seem to be conspiring with what I call the Gang of Four (hospitals, insurance companies, the AMA and drug companies) to keep Americans sick and poor. And so they turn to alternative medicine, who frequently promote vitamins, herbs and supplements. And yet these promoters of alternative remedies are not always the peaceful, benign, and well intended people they make themselves out to be. In fact research has shown that some of the vitamins and supplements pose serious safety hazards, hazards that you may be unaware of. We have over indulgently endorsed the makers of vitamins and supplements. Those companies promote themselves as healthy alternatives to prescription medications. Many doctors take a hands-off approach to vitamins, or have the attitude that if they don’t do any harm it’s okay to take them.
However vitamins and supplements can and do indeed cause harm. And unfortunately the government has contributed to misinformation about vitamins and supplements. The US Department of Agriculture (USDA), whose job it is to promote the interests of agriculture (i.e., makers of meat and milk) and not health, regulate foods and beverages. Vitamins and supplements are classified as foods, not drugs. Lobbyists for the vitamin and supplements industry have blocked efforts by the Department of Health and Human Services (DHHS), the federal agency responsible for health, to get involved.
The USDA’s Recommended Daily Allowance (RDA) of vitamins and minerals has been great for the vitamin and supplement industry, as well as cereal makers who supercharge sales by adding vitamins, and minerals to breakfast foods, and then convince customers they need to eat these fortified products to get their minimal daily requirements of vitamins and minerals. This is despite the fact that there is no way to get enough of the recommended vitamins and minerals in normal food without overeating. Government recommendations are actually four times higher than what you really need. The fact is that youdon’t need extra vitamins, and that if you stick with fresh vegetables and fruit and other whole foods, you will stay healthy. Those making big money on vitamins and supplements are often doing so at the expense of your pocket book, and sometimes your life.
All this is not to say that many medications have not changed life for the better, particularly those that treat infections. However, ironically most recent health gains have come through increased knowledge of health risks and better health practices (or prevention). We smoke less, have better access to nutritious fruits and vegetables year round, pay more attention to cleanliness and hygiene, and have improved safety in general. For instance, in the 19th century it was not known that dirty water and shared cups could spread disease. Hand washing is still the single most powerful way to prevent the spread of communicable disease, but this was not discovered until 1847, when Ignaz Semmelweis, a young Viennese doctor in an obstetrics ward, observed that midwives who washed their hands had lower mortality rates among their patients than doctors, who often went from autopsy room to delivery ward without so much as a hand wipe.
Future advances in health will likely come more from changes in lifestyle, diet and exercise, than from medications. Almost all of the chronic conditions for which pills are prescribed are preventable through such changes. Other conditions like cancer are partially preventable.
It is time for Americans to rethink the role of medications and other pills in their lives in relation to other actions that can be taken to maximize health, such as making changes in diet; incorporating exercise into one’s daily routine; learning and using stress reduction techniques; and changing other behaviors like quitting smoking. The most common disorders, like diabetes and heart disease, are always better treated and prevented through changes in diet, exercise, and lifestyle that they are with medication. Pharmaceuticals can be life saving for some conditions, such as insulin for Type I diabetes, thyroid hormone for hypothyroidism, or antibiotics for life threatening infections. All of this has been shown through several scientific studies. Before you take that pill, consider taking charge of your health by making informed decisions and smart changes in your lifestyle. In some cases, however, you may need medications for prevention or treatment of disease, or to help you with troubling symptoms or disabilities. In those cases you should know as much as you can about the risks and benefits, so that when it is time to talk to your doctor you can make an informed decision that both of you are happy with.
J. Douglas Bremner MD is a physician and researcher and author of ‘Before You Take That Pill: Why the Drug Industry May be Bad for Your Health: Risks and Side Effects You Won’t Find on the Label of Commonly Prescribed Drugs, Vitamins and Supplements,’

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