pharmaceutical industry, clinical trials
June 20 2016 by Ray Sahelian, M.D.
Each year, an estimated 700,000 persons experience adverse drug events that lead to emergency department visits, according to a study in the October 18, 2006 issue of Journal of the American Medical Association (JAMA). Insulins or warfarin, drugs that typically require ongoing monitoring to prevent overdose or toxicity, were implicated in 1 in every 7 estimated adverse drug effect treated in emergency departments.
Generic drugs have long carried a stigma for at least some people. Patients sometimes feel scared and shortchanged when prescribed them, and some physicians have been wary of their safety and efficacy, compared with brand-name counterparts.
Drug company ties to medical schools and hospitals
Two-thirds of academic leaders surveyed at U.S. medical schools and teaching hospitals have financial ties to drug companies. Some of these individuals serve as paid consultants and most accept industry money for free meals and drinks. This may influence the promotion of prescription medications in the treatment of diseases versus natural treatments and cures.
sponsored seminars and meals
The American Psychiatric Association reported in March of 2009 that it will end medical education seminars and meals sponsored by drug companies at its annual meetings to minimize chances for financial conflicts of interest. The American Psychiatric Association represents 38,000 doctors and is among the first to say no to the drug-company sponsored seminars at its meetings.
Drug trials funded by the pharmaceutical industry usually have positive outcomes according to a 2010 study in the Annals of Internal Medicine. Researchers from the United States and Canada looked at 546 drug trials registered in ClinicalTrials dot gov, a registry of both federal and private trials in the United States and abroad. 346 of them, or 63 percent, were funded by the drug industry. The remaining 200 were paid for by government or non-profit organizations. Study authors found that more than 85 percent of industry-funded trials in their sample posted favorable outcomes and were 4 times more likely to report findings that favored their drug.
Pharmaceutical drug company clinical trial
Pharmaceutical drug companies initiating clinical trials often use ghost authors and medical writers whose contributions are not credited in the research papers. "Ghost authorship is common but it is often kept secret because it is in the interest of both the industry and the academic authors who lend their names to papers they have had very little or, in some cases, nothing to do with," says Peter Gotzsche, of the Nordic Cochrane Centre in Copenhagen, Denmark. The names of authors and researchers are omitted from the published research papers because this may serve the commercial interests of the company sponsoring the trial. "We have seen again and again that the conclusions in trial reports and other types of articles are given a spin by industry so that the conclusions are too positive compared to the data presented," Peter Gotzsche said.
Here is a list of Drug Company businesses:
Actavis - Iceland's Actavis Group acquired U.S.-based specialty generics drug company Abrika Pharmaceuticals for up to $235 million in Nov 2006. The deal is the second this month by the acquisitive Icelandic firm, which lost out in a $2.5 billion battle for Pliva of Croatia to U.S. rival Barr Pharmaceuticals Inc in September.
Altus Pharmaceuticals is a drug company that focuses on products to treat a number of serious medical conditions associated with gastrointestinal and metabolic disease areas.
Amgen is a biotech drug company
Cephalon makes modafinil, also known as Provigil.
Eli Lilly drug company
Genentech is a drug company that makes Herceptin for breast cancer
GlaxoSmithKline Plc is Europe's biggest drug company.
Ivax Corporation drug company
Johnson and Johnson drug company
Lilly drug company
3M Co. said in November it has agreed to sell its slow-growing global pharmaceuticals business for nearly $2.1 billion in a three-part transaction.
Graceway Pharmaceuticals Inc. will buy 3M's pharmaceutical operations in the United States, Canada and Latin America for $875 million. Graceway is a portfolio company of Chicago-based private equity firm GTCR Golder Rauner. Swedish drugs group Meda AB will buy 3M's pharmaceutical business in Europe for $857 million. Australian private equity firms Ironbridge Capital and Archer Capital will acquire 3M's pharmaceutical operations in the Asia-Pacific region, including Australia and South Africa, for $349 million.
Merck drug company
Mylan drug company has EpiPen medication and has been accused of inflating the prices.
Perrigo Company, based out of Allegan, Michigan, bills itself as the world’s largest manufacturer of store-brand nonprescription drugs. Wal-Mart Stores Inc., CVS Corp., Walgreen Co. and Costco Wholesale Corp. are among the companies Perrigo supplies with health care products.
Sanofi-Aventis is the world's third-largest drug company.
Vanda Pharmaceuticals Inc. is a young biotechnology drug company based in Rockville, Maryland. Vanda has an experimental insomnia drug VEC-162, a melatonin receptor agonist that helps regulate disruptions in the body's circadian rhythm. VEC-162 works by resetting a patient's natural body clock and therefore does not appear to have the side effects often associated with central nervous system depressants such as hypnotics and sedatives, says Mihael Polymeropoulos, Vanda's chief executive. Vanda expects to file for approval of VEC-162 at the end of 2008 or the beginning of 2009. The company is also exploring the potential of the drug as a treatment for depression. Vanda was founded just over three years ago by Polymeropoulos, who was formerly the vice president of pharmacogenetics at Novartis AG.
Watson drug company
Wyeth drug company makes the popular Prempro
Can you trust the information published in medical journals?
Just a few days after announcing a crackdown on researchers who do not disclose their ties to a drug company, the editor of JAMA said she was misled again. A month ago the journal published a study linking severe migraines to heart attacks. All six authors of the study have done consulting work or received research funding from makers of treatments for migraines or heart-related problems, but apparently they did not disclose this to the editor of JAMA.
My thoughts: Studies are very expensive to do. When you think about it, why would anyone want to sponsor such as study if they did not get some financial benefit from the outcome. What's the big deal about finding out whether those with severe migraine headaches have a higher rate of heart attacks? Always keep a skeptical mind. Did you know that the majority of the health news on local stations and some national news shows are fed by press releases from big companies and public relations firms? Local stations just don't have the funds to go out and tape a new health segment for each night's news. They often will show a video feed sent to them by a big PR firm and rarely do they question the findings that are spoonfed to them.
Caution regarding research funded by a drug company
2007 - Breast cancer studies funded by drug companies are more likely to yield positive findings than those without drug company backing. A team led by Dr. Jeffrey Peppercorn of the University of North Carolina School of Medicine found industry-backed studies tended to be designed differently than the others. The study was the latest to find drug company funded research producing more positive results. There are similar findings on heart, stroke and bone marrow cancer research.
Drug company lobbyists
With Democrats taking control of Congress and vowing measures to cut drug prices, the U.S. pharmaceutical industry has revamped its huge lobbying operation. After years of lavishing attention mostly on Republicans, who suffered heavy losses in the Nov. 7, 2006 elections, the drug industry is hiring more Democrats to defend itself at hearings before congressional committees.
Alzheimer's scientist accused of moonlighting for drug maker
December 2006 - Federal prosecutors charged a leading government Alzheimer’s researcher with engaging in a criminal conflict of interest by earning $285,000 in private consulting fees from a drug company. In a rare criminal case against a government scientist, the National Institutes of Health’s Dr. Trey Sunderland was accused of performing consulting work for drug company Pfizer Inc. that improperly overlapped with his government duties. Sunderland’s case was highlighted during a congressional investigation that examined the large number of NIH scientists who earned money moonlighting as outside consultants for private biotechnology and drug companies. That investigation prompted the NIH, the government’s premier health research organization, to institute tough new ethics rules that bar such deals. Scientists recently told NIH the new rules are so strict that many are considering leaving the agency.
We emailed firstname.lastname@example.org to find out how to get reprint rights for the website on August 15, 2006
Risky Rx: Drug
maker's secret strategies -
‘Disturbing’ glimpse into how marketing dupes doctors — and patients
Robert Bazell - Chief science and health correspondent
We know that physicians meet a parade of drug company sales representatives from their first days of medical school to retirement and that they see drug ads every time they pick up a medical journal. But a study in this week's issue of the Annals of Internal Medicine provides extensive detail about how drug companies push their products in far more subtle ways. Some drug makers pay key leaders in a field of medicine, such as chairs of departments in medical schools, tens of thousands of dollars if they are saying the right things about their product. They manipulate medical education sessions, lectures, articles in medical journals, research studies, even personal conversations between physicians to get their product message across. "It is very disturbing," says lead author Dr. Michael Steinman of the University of California, San Francisco and the San Francisco VA Hospital. "It really does a disservice to patient care." Reliable estimates put the drug industry’s expenditure on promotion to doctors at $18.5 billion — that's about $30,000 a year for every physician in the U.S. Companies conceal the specifics of those efforts with a jealousy worthy of a state secret. Now a huge collection of drug company internal documents — revealed as part of a lawsuit —offers a wealth of detail.
In 1996, Dr. David Franklin, an employee of the drug company Parke-Davis, filed the lawsuit under federal whistleblower statutes alleging that the company was illegally promoting an epilepsy drug called Neurontin for so called “off-label” uses. Under federal law, once the FDA approves a drug, a doctor can prescribe it for anything. But the law specifically prohibits the drug company from promoting the drug for any unapproved uses. In 2004, the company, by then a division of Pfizer admitted guilt and agreed to pay $430 million in criminal and civil liability related to promoting the drug for off-label use. Spokespeople for Pfizer say that any wrong doing occurred before Pfizer acquired the company. But Pfizer fought hard to keep all the papers related to the suit under seal. A judge denied the request and they are now part of the Drug Industry Document Archive at the University of California, San Francisco. Steinman and his team summarized some of the key findings from the extensive collection in their paper. It is obvious why the company wanted to keep the documents from public view.
What is most interesting is not the illegal actions they reveal, but the details of activities that are perfectly legal. And according to people familiar with the industry, the methods detailed in these company memos are routine.
One tactic identifies certain doctors as “thought leaders,” “key influencers” and “movers and shakers” — those whose opinions influence the prescribing pattern of other doctors. Those whose views converge with the company goals are then showered with honoraria, research and educational grants. In the Parke-Davis case 14 such big shots got between $10,250 and $158,250 between 1993 and 1997.
“Medical education drives this market,” wrote the author of one Parke-Davis business plan in the files. Many state licensing boards require physicians to attend sessions in what is called continuing medical education (CME) to keep current in their field.
At one time, medical schools ran most CME courses. Now, an industry of medical education and communications committees (MECCs) run most of the courses. These companies with innocuous sounding names like Medical Education Systems set up courses, sometimes in conjunction with medical meetings, at other times often in fancy restaurants and resorts. The drug companies foot the bill, with the program usually noting it was financed by an “unrestricted educational grant” from the company.
The records in this case reveal in precise detail how the company attended planning sessions for the meeting and were allowed to tailor the content to meet their commercial goals.
Using MECCs, Parke-Davis set up conference calls so that doctors could talk to one another about the drugs. The moderators of the calls, often thought leaders or their younger assistants, received $250 to $500 a call. Drug company reps were on the line, instructed to stay in a “listen only” mode, but monitoring to be sure the pitch met their expectations.
The papers also reveal a “publication strategy” where the drug company would sponsor small trials of the drug and get the results published only if they met the company’s expectations. If the “core marketing team” found that results did not conform to the company’s goals, "the results will not be published," the documents reveal.
Besides arranging for its own favorable studies, Parke-Davis also contracted with MECCS to develop articles, review papers and letters to the editors of medical journals putting its product in a favorable light. The company paid the MECC $13,375 to $18,000 for each article, but the reader would not know the drug company or the MECC authored the article. The MECC paid $1,000 each to friendly doctors and pharmacists to sign their names to the articles — creating ghostwriters to make the material appear independent. Clearly, many of the physicians in these schemes are not innocent bystanders.
Whether it is ghost writing, making telephone calls to colleagues or leading a CME session, many of the doctors got paid well. Others received a free meal or transportation to a resort to listen to an “educational session.” Physicians often claim they are not influenced by payments and perks from the pharmaceutical industry. But with the methods so thoroughly detailed in these papers, drug companies clearly believe they are getting their money's worth.
NIH Cracks down on scientists with ties to a drug company
Nearly 40 percent of the scientists conducting hands-on research at the National Institutes of Health say they are looking for other jobs or are considering doing so to escape new ethics rules that have curtailed their opportunity to earn outside income, for instance with a drug company. The tightened rules were put in place last year after NIH found dozens of scientists had run afoul of existing restrictions on private consulting deals that had enriched them with money from drug company and biotechnology companies. Outside income from a drug company is now banned. NIH also is placing greater restrictions and disclosure requirements on employees' financial holdings.
Q. I have read everything on your site and would like you to address the fact that most "studies" by leading scientist are funded by a drug company wanting to promote their product. even in the New England Journal of Medicine. You can almost predict what an outcome will be on "who funded the study" The drug company who funded the study will get the outcome they want . The NIH, NCI and FDA have funded their share of bogus scientific studies. Nearly all contacts between a scientist and a drug company will state if the drug company does not like the results it will not be published and the scientist is not allowed to either. Many of the orthodox med we take today "kill" and I believe the drug companies know before they hit the market.
If there is a natural cure somewhere in the world.....say for Cancer. I think most of us know it will never be available for the general public...Cancer is a multi trillion dollar business. Our economy could not stand the effects of putting millions of people and medical centers out of business. Am I not right?
A. Many or most studies are funded by the drug company, and in the past, perhaps even now, if the result is not to their liking, it may sometimes not be published. Eventually the truth gradually does come out since drug companies do not have full control over the media and the internet.