Stats from end of year (04) MSTL (Medical Technology Stock Letter):

Of the 400 drugs approved from 98 to 03, only 53 were of new compounds and only 15 were shown to be better than existing treatments. 

This means that 385 drugs confused doctors, increased risk of another VIOXX, were often more expensive than existing treatments, and made monitoring side effect much more difficult.  Free enterprise at work.

Supervision is need, but not from government who are bribed through campaign contributions, but through an independent body of medical scientists comprised of those whose role is that of teaching and treatment, and basic research--and certain not involved in the testing for the pharmecuetical industry.--jk

With each new drug there is a chance of duplicating the VIOXX experience.

WHAT FOR THE HIGH PROFITS:

1.          3/4^th of the profits go towards marketing—all those TV adds, magazine adds, perks to doctors, soft money to politicians, medical journal adds, and like.

2.          Of the research most of it is market driven; mainly in the form of trying to make a knockoff of a competitor’s drug.  This brings us back to the opening numbers where the knockoff is with a few exceptions not significantly better than the existing drug.

3.          The funding arrangement passed by Congress in 1992 entails that that most of the funds raised by the FDA from the drug companies and it is for the very drugs that they are reviewing (http://healthfully.org/medicalcrap/id16.html).  There is nothing left for comparative studies are long-term follow ups.

4.          With so many drugs on the market, doctors are less likely to knowingly select between the choices.

Pharmaceutical industry data

Scientific Evidence:  Oregon Drug Effectiveness Review Report, December 2004.  Prices:  Median of price range for 30-day supply of pills from AARP analysis of retail prices during November 2004.  [For scanned picture]

New medicines 1975 to 1997 licensed world wide was 1,223 of which only 4 were developed by the pharmaceutical industry R&D activities—source Journal of the American Medical Association

Indian, one of the few developing countries which has a pharmaceutical industry spends only 2% of its revenue on R&D ($152 million), while the major pharmaceutical companies spend 15.6 ($33.2 billion)—source Organization of Pharmaceutical Producers of India.   

Cost per year of saving a life by malaria vaccine $15; through chemotherapy for breast cancer $58,000.

The market for pharmaceuticals in low-income countries is small. 

Sources:  Pharmaceutical Manufactures Association 2004; World Health Organization 2004

Disease burden as cause of death:  33% in poor countries, 2.5% in rich countries.

Source:  WHO Global Burden of Disease, 2004 project

http://healthyskepticism.org/,  The Medical Lobby for Appropriate Marketing (MaLAM) was established in 1983 and in 2001 changed to a new name: Healthy Skepticism.  An excellent resource for articles both from journal and the popular press. 

Healthy Skepticism Library number: 1785
Publication type: journal article

Ismail A.
Prescription for Power: Drug makers' lobbying army ensures their legislative dominance
The Center for Public Integrity 2005 Apr 28

Full text:
The deep-pocketed pharmaceutical and health products industry has lobbied on more than 1,400 congressional bills since 1998 and spent a whopping $759 million during that period, a Center for Public Integrity review of lobbying records revealed. Drug companies and manufacturers of health products have used more professional lobbyists in the last six and a half years—almost 3,000—than any other organized interest, the analysis also found. In comparison, the insurance industry, second-largest in terms of spending, spent $644 million in the same period and employed just over 2,000 lobbyists.

In recent years, the pharmaceutical industry has scored a series of legislative victories on Capitol Hill, which could potentially translate into tens of billions of dollars of additional revenue to drug companies annually. The federal government will buy drugs worth at least $40 billion from the companies every year once the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 goes into effect next year. In addition, critics have accused the industry of having undue influence over the Food and Drug Administration, the agency that regulates pharmaceutical interests.

For every member of Congress in office since '98, there were four and a half pharmaceutical industry lobbyists.

Industry-watchers say the drug companies' recent successes in Congress and with the FDA show how effective their lobbying campaign is. "The [lobbying] money is very well-spent," said Dr. Jerry Avorn, author of Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs. "The fact that we are the only country in the industrialized world that does not have any provision for negotiating drug prices, the fact that we are spending far more per capita on drugs than any other country and the fact that when legislation is written it often seems to be exactly the kind of legislation that benefits the pharmaceutical industry [shows] they are getting their money's worth."


Find out more about the pharmaceutical and health products industry's lobbying

In 2003, the year that the legislation passed allowing prescription drug coverage through Medicare, 298 pharmaceutical and health industry groups spent $143 million lobbying the federal government. They employed 1,274 professional lobbyists.

The passage of the new Medicare law had been an industry priority for many years. No wonder: The 415-page legislation contains several windfalls for drug companies, including a controversial provision that prohibits the federal government from negotiating with companies on drug prices.

The industry has also mounted campaigns to weaken federal regulation, strengthen patent protections, extend patents, win tax credits and get the federal machinery to protect its interests abroad, among other issues.

Other big wins on Capitol Hill include the extension of the Prescription Drug User Fee Act through September 2007, authorizing the FDA to continue collecting industry money to process drug approval applications. The FDA expects to take in more than $284 million in user fees this year alone. The user fee has helped FDA to hire more than 1,200 new employees—and thereby to reduce drug approval time. But many observers, such as Avorn and Thomas Moore, a fellow at George Washington University's Center for Health Services Research and Policy and author of Prescription for Disaster, a book on drug safety, oppose the arrangement because that money gives the industry greater leverage. The user fee act implies that the main mission of the FDA is to facilitate speedy approval of drug, Avorn said. He added that the legislation and the agency's "shrinking capacity to follow post-marketing safety problems, all together suggest that the needs of the industry have loomed larger at FDA than public health mission."

"The User Fee Act has left the pharmaceutical industry paying a very significant share of FDA's total budget," Moore said. "Each reauthorization is sort of another step to come to the bargaining table, if you will, to see if they can obtain some additional benefits."

Many critics also argue that by making the FDA dependent on the industry, it also opens the doors for a culture of conflict-of-interest to thrive.

In 2002, the industry also succeeded in getting the Best Pharmaceuticals for Children Act passed. The law encourages companies to test drugs in kids by extending patents for six months.

Drug interests have also successfully blocked a number of bills that would have affected its bottom line, among them, legislative efforts to control drug prices, legalizing drug importation, closing loopholes in patent laws etc.

Former government insiders
Leading the industry's lobbying efforts was the trade group Pharmaceutical Research and Manufacturers of America, the seventh largest lobbying organization in the country. PhRMA alone spent almost $93 million on lobbying in the last six and a half years.



Besides its 38 in-house lobbyists, PhRMA employed 160 lobbyists in 2003-2004. Since 1998, the organization used 64 different firms to lobby 35 federal agencies on 38 issues separately identified under the Lobbying Disclosure Act of 1995.

The Biotechnology Industry Organization, a trade organization that represents biotech and biomedicine companies, spent more than $27 million since '98.

The Center analysis revealed the extent to which the industry used former government insiders to influence the federal government. Of the nearly 3,000 professionals who lobbied for the industry, 805 were former federal officials, including more than 50 former members from the House and a dozen from the Senate.

Both PhRMA and BIO are headed by former members of Congress. PhRMA's president is former Rep. Billy Tauzin (R-La.), who chaired the House energy and commerce committee until last year and was one of the co-sponsors of the Medicare legislation. The House Energy and Commerce Committee's jurisdiction includes the drug industry. Tauzin's former colleague on the committee, James Greenwood (R-Pa.) heads BIO. The former Pennsylvania congressman, who sponsored or backed numerous bills favorable to the industry, including the Best Pharmaceuticals for Children Act of 2002, joined BIO last July under controversial circumstances. As chairman of the Energy and Commerce Committee's Subcommittee on Oversight and Investigation, just before he accepted the position he was scheduled to hear testimony on possible links between antidepressant use and suicide among children. Because of the conflict of interest, he cancelled the hearing.

Both Tauzin and Greenwood have not yet registered to lobby—both recently retired congressmen have to wait for at least a year before they can legally lobby their colleagues. But the industry has employed at least 48 former members of the U.S. House of Representatives and 15 ex-senators to lobby.

That includes Sens. Bob Dole (R-Kan.), Birch Bayh (D-Ind.), Lloyd Bentsen (D-Texas), Dennis Deconcini (D-Ariz.), Steve Symms (R-Idaho), Tim Hutchinson (R-Ark.) and Howard Baker (R-Tenn.) and Reps. Bob Livingston (R-La.), Bill Paxon (R-N.Y.) and James Blanchard (D-Mich.). Dole and Bayh are the authors of the Bayh-Dole Act of 1980, which gave the drug industry greater access to government-funded research.

The Center's findings didn't surprise the industry's longtime critics. Rep. Bernie Sanders (I-Vt.), who has introduced several measures in Congress to regulate drug companies, says that the pharmaceutical industry has the most powerful lobby in Washington, D.C.. "Uniquely in the industrialized world, our government does not regulate the pharmaceutical industry—rather the pharmaceutical industry regulates the government, which is why Americans pay by far the highest prices in the world for medicines they need," he told the Center.

The Orange County Register, Health & Science Section, Weds., Oct. 20, 1999, p. 20.

In Drug Studies, Money Counts

FUNDING: Drug-company sponsor­ship makes for less-critical views, researchers say.

By DON BABWIN

The Associated Press

CHICAGO — Studies on the cost-effectiveness of drugs are far more likely to report favor­able findings if they are spon­sored by the drug companies themselves rather than inde­pendent groups, researchers found.

Their study — funded by a pharmaceutical company — appears to confirm long-held suspicions that doctors are less critical about a drug's safety and effectiveness when they have financial ties to the manufacturer.

"It is possible that these fac­tors may result in some uncon­scious bias" in interpreting a study's findings, the research­ers said.

Last year, the conflict-of-in­terest issue made headlines when a report found that the vast majority of doctors who defended the safety of calcium channel-blockers had a finan­cial relationship with manu­facturers of the blood-pressure pills.  In the current study, pub­lished in today's Journal of the American Medical Associa­tion, the researchers looked at 44 studies on the cost-effective­ness of cancer drugs. Twenty of the studies were funded by pharmaceutical companies and 24 by nonprofit organiza­tions.  Those sponsored by nonprof­it groups reached unfavorable conclusions 38 percent of the time, compared with just 5 percent for studies spon­sored by pharmaceutical com­panies. Also, researchers in company-backed studies were slightly more likely to over­state the cost-effectiveness.  Some researchers receive funding directly from pharma­ceutical companies. Some get funding in the form of honorar­ia or travel expenses. Some hold stock in drug companies and profit directly from in­creased drug sales. 

Dr. Charles Bennett, the lead author and a professor at Northwestern Medical School, said that in addition to the pos­sibility of unconscious bias, there could be other explana­tions for the findings.  For example, pharmaceuti­cal companies are given early looks at studies. That enables them to abandon studies that appear to be unfavorable and focus on those they think are going to be positive, Bennett said.  Bennett said the findings should not be seen as a major criticism of pharmaceutical companies.  "Our study was sponsored by a pharmaceutical compa­ny," he said, adding that the company, Amgen Inc., did not comment on it before publica­tion. He also said his paper an­alyzed studies sponsored by Amgen, which fared no better than other company-spon­sored studies.  Bennett said the best thing would not be to stop pharma­ceutical companies fr6m spon­soring research, but to get oth­er types of sponsors to under­write studies, too, such as managed-care organizations. 

Amgen spokesman David Kaye said: "If you want the best physicians in the world, you have to let them run the trials. If you kill a study or over-control it, word gets out and the best investigators won't do your studies."  Others not involved with the study said the findings raise serious concerns.

"The best hypothesis I can tell for that is the person doing the research has internalized the values of their funder," said Sheldon Krimsky, a Tufts University professor who stud­ies scientific integrity and con­flict of interest and who wrote an editorial about the study in JAMA.  Dr. Sidney Wolfe, director of Public Citizen's Health Re­search Group in Washington, agreed: "As in other studies of the drug industry, this shows the financial interests of the drug industry rides over the actual data."

Comments on the 1992 legislation affecting the FDA, which required the drug companies to contribute to most of the cost for the approval of new drugs and which was followed by budget reductions of the FDA so that it couldn’t fund follow-up studies on safety and efficacy of approved drugs. These legislative changes were lobbied for by the drug industry.  The second is to further weaken the position of the smaller companies by adding an additional expense which thereby forced them to be even more dependent upon the drug giants in raising the funds for the trials and now also for FDA approval. 

How do you get honest reliable data:

1).  Have the drug companies contribute to a research pool, much like the way the State & Federal government contribute to the universities in a state to do other types of research.  Then let the university departments and the Graduate Study Department work out how those funds are to be allocated. 

2).  Drug companies could still do basic research, but the clinical trials would be run by the universities. 

3).  Those drugs developed by the universities could then manufactured at a cost plus formulation, with the profits therefrom flowing back into the general pool.   

1a).  Permit the university departments to funnel research into drugs into those area where the needs are greatest, such as where there is a lack of effective treatment, the lost to society is greater, and where it seems that an effective medication would be sufficiently likely to be produced in relatively short period of time.  They would be less likely to fund research on a me-to type of knockoff drugs which now make up 90% of the drugs approved by the FDA. 

2 & 3).  This would result in a much smaller role of the Pharmaceutical industry.  The benefits of this would be lower prices for drugs, a competitive advantage over foreign companies by lower pricing, and increased effort to develop drugs based on needs rather than profits.