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Monday, January 31, 2011

Open Wide and Swallow


Welcome To the Cure

"Step right up, America! Welcome to the world of miracle health cures! Products are available for anything that ails you: Drugs to make your penis bigger, drugs to enhance your sexual fulfillment, drugs to induce your dramatic weight loss, drugs to cure your arthritis, drugs to shrink your tumors, drugs to restore your youth. Take advantage of evolutionary innovations, scientific breakthroughs, exclusive products, and secret ingredients. And, every product comes with a  money-back guarantee. If after 30 days you are not satisfied with the product, your uncashed check will be returned to you."

Have you tried the "miracle cold buster" Airborne? Airborne is line of popular herbal supplements marketed as On-the-Go and Airborne Nighttime to Airborne Gummi and Airborne Power Pixies, which is sweetened for children. Oprah Winfrey, Howard Stern, and Kevin Costner endorsed the products. Airborne's teacher-inventor appeared on the “Dr. Phil” and “Live With Regis and Kelly” television shows bragging about the product's effectiveness -- “if a schoolteacher who’s around germy little kids all the time can find something that keeps her from getting sick,” then her solution should work for anyone, right?

Wrong.  The makers of Airborne have decided to settle the false-advertising complaints in a class-action lawsuit for $23.3 million. While agreeing to reimburse customers for up to six purchases of Airborne products, the company made no stunning admissions. “Defendants deny any wrongdoing or illegal conduct, but have agreed to settle the litigation,” the company said in a statement.

The fact remains that that Airborne Inc. reportedly took in more than $100 million from sniffly consumers through 2006. (Mike Nizza, "Makers of Airborne Settle False-Ad Suit With Refunds," The New York Times, March 4 2008)

  
Pharmaceutical Companies and Big Pharma

Pharmaceutical companies are commercial businesses whose focus is to research, develop, market and/or distribute drugs. They can deal in generic and/or brand medications. And, these companies are subject to a variety of laws and regulations regarding the patenting, testing, and marketing of drugs, particularly prescription drugs. The pharmaceutical industry is constantly looking for better, quicker methods to get their best, safe innovations to market.

From its very beginnings at the start of the 19th Century, the pharmaceutical industry began a steady development as one of the most successful and influential industries. It has been for many years either the #1 or #1 most profitable industry in the United States. The industry is “one of the largest employers of scientists in the United States – and its success or failure relies heavily on their ability to make breakthroughs,” according to the Pharmaceutical Research and Manufacturers of America.  The U.S. Department of Labor and Statistics reports that this industry -- as well the overlapping, interdisciplinary field of biotechnology -- rank among the fastest growing industries in the United States.

Fast growing industry indeed -- in the United States, prescriptions have increased over the past decade to 3.4 billion annually, a 61 percent increase. The retail sales of prescription drugs jumped 250 percent from $72 billion to $250 billion, while the average price of prescriptions has more than doubled from $30 to $68.
(pharmaceuticalsalescompanies.com)

No doubt, the United States is a "pill popping nation." A Kaiser Family Foundation study found the average number of retail prescriptions per capita increased from 8.9 in 1997 to 12.6 in 2007. In this relentless stream of pills, aren't you glad you can still rely on prescription drugs and their trustworthy manufacturers as safe allies against terrible illnesses? Well, you may want to rethink both your reliance on numbers of Rx medications and on the drug industry.

A dangerous misconception in the United States, among both patients and physicians, is that when you're sick you need a drug to feel better. Of course, in many cases ill people require a drug, but drugs are overused and overprescribed, even in cases where the risks far exceed any potential benefits. A study from the New England Journal of Medicine (November 2010) found absolutely no correlation between spending more on drugs and improved patient outcomes. (Maggie Fox, "More Drugs Do Not Always Mean Better Care: Studies," Reuters, November 3 2010)

In this study, Yuting Zhang of the University of Pittsburgh Graduate School of Public Health found big variations in how much doctors and hospitals spend on drugs to treat Medicare patients across the United States, but there was no correlation between that spending and how well patients did. "That contradicts the idea that high spending leads to better prescription practices," Zhang said in a statement.

Her team used data from the records of 500,000 patients using Medicare, the federal health insurance plan for the elderly. In regions with higher overall per capita medical spending, they found that patients were also more likely to be given prescriptions for riskier drugs.

People do beg their physicians for some new, more effective drug. Still, one of the major facilitators of a "pill popping nation" are the physicians who are too willing to take their information (as well as gifts, sometimes small, sometimes large) from pharmaceutical company representatives), rather than from more reputable sources. No one involved in perpetuating the existence of the "pill popping nation" should be greedy, take valuable gifts or money from associates, nor be affected by advertising. Instead, these doctors should apply their attention to the principles of conservative prescribing:

Rule #1: Use the drugs that they know are safe and work, 

Rule #2: Be cautious of new “miracle drugs."

In addition to doctors, more of the big facilitators of pharmaceuticals are modern medical organizations, paid Key opinion leaders (KOL), even medical journals that uncritically publish some of the drug companies' written studies. And, of course, most importantly, the pharmaceutical companies, themselves.

You might think, at least, that the rise of prescription drug distribution and consumption of pills makes America a healthier nation. But, with all these drugs, many people are not in stellar health. Instead, chronic disease rates are rising as evidenced in a study conducted by Columbia University health policy professors Peter A. Muennig and Sherry A. Glied and published in the academic journal Health Affairs.

The study revealed that the United States now ranks 49th for male and female life expectancy worldwide, a ranking that has fallen sharply from fifth place in 1950.(Sahil Kapur, "US Slips to 49th in Life Expectancy," Healthcare-Now, October 25 2010)

The report by Muenning and Glied found the prime culprit of the plunge to be America’s deteriorating health care system, marred by ever-rising costs and growing numbers of uninsured and under-insured individuals.

Noting that the United States spends over twice as much per capita on health care than other industrialized nations, the report adds: “The observation that Americans are spending relatively more on health but living relatively shorter, less healthy lives has led some critics to allege that the US health care system is ‘uniquely inefficient.’”

Certainly, a large part of this rabid spending is going toward the excessive and unnecessary use of prescription drugs. Certain medical procedures require their extensive use. Dr. Paul Griner of the University of Rochester estimated that unnecessary or inappropriate tests and procedures add up to about 20 percent of health care spending.(Maggie Fox, "More Drugs Do Not Always Mean Better Care: Studies," Reuters, November 3
 2010)


A Closer Look At Marketing Prescription Medications

In 2005 money spent on pharmaceutical marketing in the US was estimated at $29.9 billion with one estimate as high as $57 billion. (CB Sufrin & JS Ross JS, "Pharmaceutical Industry Marketing: Understanding Its Impact on Women's Health," Obstet Gynecol Surv 63, September 2008) When the US numbers were broken down, 56% was free samples, 25% was detailing of physicians, 12.5% was direct to consumer advertising, 4% on hospital detailing, and 2% on journal ads. (www.medicine.mcgill.ca)

Currently, there are approximately 90,000 pharmaceutical sales reps in the United States pursuing some 830,000 pharmaceutical prescribers. A pharmaceutical representative will often try to see a given physician every few weeks. Representatives often have a call list of about 200 physicians with 120 targets that should be visited in 1-2 week cycles.

The top twenty pharmaceutical companies and their two trade groups, Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Industry Organization, lobbied on at least 1,600 pieces of legislation between 1998 and 2004. According to the non-partisan Center for Responsive Politics, pharmaceutical companies spent $900 million on lobbying between 1998 and 2005, more than any other industry.

During the same period, the two trade groups donated $89.9 million to federal candidates and political parties, giving approximately three times as much to Republicans as to Democrats. (R. Jeffrey Smith & Jeffrey H. Bimbaud, "Drug Bill Illustrates Lobby's Pull," The Washington Post, January 12 2007) 

The potential for financial conflicts of interest, bias, and ethical dilemmas impacts both the pharmaceutical  industry and physicians. Activities once considered independent of promotional intent, including continuing medical education and medical research, are used, including paying to publish articles about promoted drugs for the medical literature and alleged suppression of unfavorable study results. (Jane E. Henny, "Safeguarding Patient Welfare: Who's In Charge?" Annals of Internal Medicine)

Steinman and colleagues provide numerous examples of conflicts that arise when physicians receive compensation or other benefits from manufacturers in exchange for assistance with the marketing of drugs for off-label uses.Whether the audience is a single patient or a group of fellow physicians, when the physician has accepted financial or other support (for example, slide preparation) from a manufacturer and has not told the audience about the arrangement, then that physician has gone over the line. (MA Steinman, LA Bero, M Chren, CS Landefeld, "Narrative Review: The Promotion of Gabapentin: An Analysis of Internal Industry Documents," Annals of  Internal Medicine 145, 2006)

In October 2002, the Office of the Inspector General of the U.S. Department of Health and Human Services published a draft Guidance Document for manufacturers. It pointed out that the Medicare and Medicaid anti-kickback statute is an avenue for prosecution when industry uses gifts or other inducements to increase prescribing by physicians, whether on- or off-label.

Still, in response to concerns about continuing medical education and research programs, a compromise permitted the industry to finance continuing education and other activities through grant-making instead of marketing. (S Chimonas, DJ Rothman, "New Federal Guidelines for Physician-pharmaceutical Industry Relations: The Politics of Policy Formation, Health Aff 24, 2005)

So, you see, in the 21st century, more people than ever are taking prescription medications that have been aggressively and successfully marketed. Despite the productive marketing, the fact is that some of the medications have questionable safety records. The entire process of marketing Rx drugs calls for some tough questions:

1. What clinical trial data do pharmaceutical companies' selectively suppress?


2. How does the pharmaceutical industry influence what gets published in medical journals and taught in continuing medical education courses?


3. Are the federal institutions that oversee pharmaceutical research too closely linked to the industry?


4. How do bioethicists who provide consultations to pharmaceutical companies manage their delicate roles? 



Evidence shows that marketing practices can negatively affect both patients and the health care profession. (CS Landefeld, MA Steinman, “The Neurontin Legacy – Marketing Through Misinformation and Manipulation," New England Journal of  Medicine 360, January 8 2009) 

The following is a sterling example. In May, 2004, the so-called Neurontin Affair was exposed  as the result of the heroic efforts by a young biologist David Franklin who worked for Parke-Davis. Warner-Lambert agreed to plead guilty to pay more than $430 to resolve criminal charges and civil liabilities. The next day, a class-action suit was filed in federal court on behalf of private parties who had paid for illegally marketed Neurontin. This extraordinary settlement was appropriate given the series of marketing "tactics" that included education, publications, and research whose promotional intent was disguised, plus more transparent activities such as advertising and sales visits.

It is illegal to market for non-FDA-approved indications, but Parke-Davis did it aggressively and effectively, with Neurontin's sales rising from $98 in 1995 to nearly $3 billion in 2004.

The company commissioned “research” to show the drug’s effectiveness, suppressed publication of studies that showed it had no effect on neuropathic pain, and in the words of epidemiologist Kay Dickersin, who performed a “recently unsealed 318-page analysis of research sponsored by Parke-Davis…concluded that available documents demonstrate 'a remarkable assemblage of evidence of reporting biases that amount to outright deception of the biomedical community, and suppression of the scientific truth…’” (Josh Freeman, "The 'Neurontin Legacy,'" Medicine and Social Justice, January 22 2009)

The evidence uncovered in the Neurontin Affair supports something many already suspect about the nature of pharmaceutical company promotion.“Promotion,” write Landefeld and Steinman, “was neither discrete, compartmentalized, nor readily apparent; instead, it was intercalculated in nearly every aspect of physicians’ professional lives, from the accoutrements of practice to lectures, professional meetings, and publications. Although some pharmaceutical marketing may be less opaque, deceptive and manipulative, evidence indicates that drug promotion can corrupt the science, teaching and practice of medicine.” (CS Landefeld CS and MA Steinman, “The Neurontin Legacy – Marketing Through Misinformation and Manipulation, NEJM 360,  January 8 2009)

The $430 million fine was a small part of the profits that Parke-Davis/Warner-Lambert/Pfizer made through the off-label use of the drug.


Dr. Marcia Angell argues that problems with the industry run even deeper. In her new book, The Truth About Drug Companies: How They Deceive Us and What to Do About It, the former editor of the New England Journal of Medicine contends that the industry has become a marketing machine that produces few innovative drugs and is dependent on monopoly rights and public-sponsored research. (Peter Meredith, "The Truth About Drug Companies," Mother Jones, September 6 2004)

Dr. Angell claims that the pharmaceutical industry is not “engine of innovation” perceived by many Americans. According to her, the top U.S. drug makers spend 2.5 times as much on marketing and administration as they do on research. At least a third of the drugs marketed by industry leaders were discovered by universities or small biotech companies, writes Angell, but they’re sold to the public at inflated prices.

Ralph W. Moss, PhD, cites that Taxol, the cancer drug discovered by the National Institutes of Health. Bristol-Myers Squibb charges hapless consumers $1,000 per treatment, or eight times what it cost the NCI to synthesize. The National Cancer Institute spent $32 million of taxpayer's money researching taxol, a toxic drug made from the bark of Pacific yew trees. It then gave exclusive rights to harvest the yew, as well as "monopoly control over the data from federally funded research," to Bristol-Myers Squibb, the world's largest producer of chemotherapy.  In this sweet deal, BMS pays no royalties on taxol sales and only a pittance for the rights to the yew tree bark. The company agreed to pay the NIH only 0.5 percent in royalties for the drug. (Ralph W. Moss, PhD, "From the Cancer Chronicles #20," The Moss Reports, March 1994)

Linda Marsa uncovers an "entangled financial web between government, industry, and academia" in her article for Omni. Marsa states that drug makers have "their own network of principal investigators (PIs), scientists, and doctors at leading medical schools around the country...."(Linda Marsa, "Unhealthy Alliances," Omni, February 1994)

Dr. Angell reports that the majority of the new products the pharmaceutical industry puts out are “me-too” drugs, which are almost identical to current treatments but “no better than drugs already on the market to treat the same condition.” She says around 75 percent of new drugs approved by the FDA are me-too drugs. They can be less effective than current drugs, but as long as they’re more effective than a placebo, they can get the regulatory green light. (Peter Meredith, "The Truth About Drug Companies," Mother Jones, September 6 2004)

The drug industry, no matter its enterprising marketing, lives on taxpayer-funded research to a large extent. And, it thrives on government-granted monopoly rights in the form of patents and FDA-conferred exclusivity.
Shouldn't the industry have more obligation to the public that helps fund it? Dr. Angell believes they should open their books so that the public knows more about their business and more about the "justified" claims they make.

Findings in a recent study (2008) published by the Public Library of Science support the position that "the U.S. pharmaceutical industry is marketing-driven and challenges the perception of a research-driven, life-saving, pharmaceutical industry, while arguing in flavor of a change in the industry’s priorities in the direction of less promotion." The numbers clearly show how promotion predominates over research and development in the pharmaceutical industry, contrary to the industry's claim.The research supports petition in favor of transforming the workings of the industry in the direction of more research and less promotion.(MA Gagnon & J Lexchin, “The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States,” PLoS Medicine, January 3 2008)

  
Saving the Worst for Last 

Shane Ellison, M.Sc., summarizes the rise of OxyContin so well that this long quote is essential for relating the story of the popularity of this potential lethal drug. Shane holds a Master's degree in organic chemistry and has first-hand industry experience with drug research, design, and synthesis.(Shane Ellison, "False Advertising of OxyContin (trademark)" ConsumerHealthDigest.com, 2010)

"According to the Food and Drug Administration (FDA), Purdue Pharma L.P. circulated false Direct-to-Consumer (DTC) advertising through their endorsements of OxyContin in the world's most prestigious medical journal, the Journal of the American Medical Association (JAMA).


"The division of Drug Marketing, Advertising and Communications of the FDA sent a letter to Purdue Pharma stating that they were in clear violation of FDA regulations. Their violation: making unsubstantiated claims of effectiveness and grossly overstating the safety profile of OxyContin while promoting it for obtaining a "Life with Relief." Despite Purdue Pharma's non- compliance with the law, the FDA did not press charges.


"Putting wealth before health, Purdue Pharma L.P. distributed 15,000 copies of an OxyContin video to physicians without submitting it to the FDA for review. Entitled I Got My Life Back: Patients in Pain Tell Their Story, the video presented pain relief experiences of various patients and the pain medications, including OxyContin, they had been prescribed. 


"FDA regulations require pharmaceutical manufacturers to submit all promotional materials for approved prescription drug products to the FDA at the time of their initial use. Purdue Pharma L.P. did not comply with this regulation. Thus, the FDA did not have an opportunity to review the video to ensure that the information it contained was truthful, balanced, and accurately communicated. Purdue and the FDA acknowledged the oversight of not submitting the video to FDA for approval. No action was taken.


"Releasing a second version of the video, Purdue Pharma L.P. followed legal procedure by submitting it to the FDA for review. Though, in its report to Congress, the U.S. General Accounting Office (GAO) stated that the FDA failed to review the video. Later, it was discovered that it, like the first video, made unsubstantiated claims and minimized the risks associated with taking OxyContin. Most astounding, Purdue Pharma L.P. claimed that OxyContin had been shown to cause addiction in less than 1 percent of patients - a damned lie.


"Pushing for approval by the FDA in 1995, Purdue Pharma L.P. insisted that OxyContin be used only for cancer pain. Purdue Pharma sold $1 billion worth of OxyContin in less than five years from the time of its approval thanks to false DTC advertising. In addition to profits, false marketing has led to devastating effects on those people who were prescribed Oxycontin under the wrong conditions. Consider that the number of people who used OxyContin for illicit purposes at least once increased from 399,000 to 957,000 in a single year.


"Recognizing the dangers of OxyContin, the Drug Enforcement Agency (DEA) has listed OxyContin as a Schedule II controlled substance in the USA. According to the DEA, since its release on the market, the annual number of prescriptions for the "synthetic morphine" has risen from around 300,000 to nearly 6 million. During that same period, the number of oxycodone-related deaths has skyrocketed by 400%. Currently, OxyContin is the number one prescribed Schedule II narcotic in the United States.


"False advertising is the number one tool used by drug companies to turn perfectly healthy people into patients. While the FDA has acknowledged Purdue Pharma's indiscretions by acting as a paper tiger, it has done nothing to ameliorate it. They have failed as the self-proclaimed custodians of national health." (http://www.consumerhealthdigest.com/oxycontin.htm)
  
The group RAPP, Relatives Against Purdue Pharma, is comprised of family members, friends and concerned citizens, committed to changing current Government and FDA guidelines concerning the powerful prescription narcotic, Oxycontin. RAAP conducts peaceful protests, nationwide, in an effort to have this dangerous drug more closely regulated and returned to the medical purpose of it’s development and manufacture – administration to cancer patients and patients with severe chronic pain. (http://oxyabusekills.com/katey.html)

The group boldly cites many alleged examples of Purdue Pharma's corporate greed, which they have documented in newspapers, magazines, television, and the book, Painkiller, by Barry Meier, a New York Times journalist:
   
*Sales representatives for Purdue Pharma have come forward to reveal the aggressive marketing practices that Purdue trained them to use. They reported the tactic of "targeting general practitioners,” advising them that less than 1% of patients get addicted and that OxyContin is less likely to be abused. One representative for Purdue Pharma claims to have been fired for refusing to deal with “PILL MILL” doctors.

 *Purdue Pharma was aware of the doctors who were writing HUGE numbers of prescriptions for OxyContin, but never once offered this data to law enforcement, even after they received a large number of death reports resulting from over prescribed OxyContin.

*In the year, 2001, Purdue Pharma spent two hundred million dollars in advertising to promote OxyContin, even after they had knowledge of the hundreds of addiction and death reports.

*"The former Acting Director of FDA Review Division", was the lead actor and prime mover to get OxyContin pushed through FDA approval. After retiring from the FDA he was given a job by Purdue Pharma.

*Many of the death reports are from relatives and the addiction reports from patients, many of whom should never have been prescribed OxyContin.

*Purdue Pharma reported they were shocked that people were crushing OxyContin in spite of the proof that Purdue Pharma was warned that this had also happened to another one of their time-released drugs, MS Contin.

*A Clinical Researcher employed by Purdue Pharma alleges in a lawsuit filed against the pharmaceutical company that he had informed Purdue management of a flaw in the design of the drug’s time-released coating. In addition, this employee claims that he was advised to not alert Purdue Pharma’s in-house drug regulators of this flaw, including the government. Shortly thereafter, this employee’s job was terminated.

*Purdue Pharma approached the FDA for OxyContin’s approval, claiming that their “research” revealed that less than 1% of those who used the drug would become addicted; however, recent media reports refute that claim, contending that Purdue Pharma had evidence that the addiction rate would be much higher.

*Many elected officials, along with law enforcement who once fought the OxyContin epidemic, have been hired by Purdue Pharma and, now, as paid employees of the company, tout OxyContin’s “safety and effectiveness.”

*“Cutting a deal” with Florida’s former State Attorney General, Bob Butterworth, on his last day in office, included Mr. Butterworth accepting a two million dollar donation for a prescription monitoring program to be engineered by one of his closest friends who Purdue Pharma had hired as a lobbyist, under the terms that the state would drop its investigation into Purdue Pharma’s marketing practices.

*The FDA produced warning letters to Purdue Pharma, addressing their “false and misleading” advertising in magazines and promotional materials.

*A New York Federal Judge recently ruled that Purdue Pharma misled government officials to prevent other companies from marketing a generic form of OxyContin.

*Purdue Pharma is now attempting to get approved a time-released Dilauded pain killer to treat moderate pain called Palladone, and it is reportedly ten times stronger than OxyContin.

"They have bought politicians and doctors. They've looked at everyone and anyone who could stand in their way and they're thrown money at them. The only hope we have is a grassroots revolution that will make the politicians decide they love votes more than drug company money."  -Dr. Marcia Angell
 





 
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