Demand for congressional hearings into FDA process on Dendreon’s Provenge

December 18, 2007
The below is from the blog of -
Howard (Jack) West, MD
Dr. West serves as the Founder and Managing Member of OncTalk, LLC. He is a medical oncologist and Director of Medical Therapeutics for Thoracic Oncology at the Swedish Cancer Institute in Seattle, Washington.

Request for Congressional Inquiry into Drug Approval Process

  Returning to a situation I’ve written about in a couple of prior posts about the contentious saga of the Dendreon (local Seattle company) investigational vaccine Provenge for prostate cancer (posts here and here), three senators have requested a congressional inquiry into the FDA decision to withhold approval of provenge after it had been recommended for approval by an advisory committee to the FDA, as described in a story here.  As described in the second of the posts listed above, this issue was pursued primarily by the group CaretoLive, comprised of prostate cancer advocates and some investors who feel that there was far too much onco-politics in the high level FDA recommendations for who would participate in the final committee, and that two key academic oncologists who served on the committee had potentially significant conflicts of interest that may have denied provenge a completely fair opportunity, and in the process denied prostate cancer patients a potentially helpful treatment.

continued at: 

http://onctalk.com/2007/12/14/request-for-congressional-inquiry-into-drug-approval-process/

I have been following this issue and I am so happy to see that a congressional hearing is likely to investigate the conflicts of interest (COIs) of a couple of the participants on the FDA advisory committee re:  Provenge.  This has only occurred because of the advocacy of the prostate cancer community who were appalled by the FDA decision-making process in this instance.  If I was a journalist, this would make a very interesting book IMO as this scenario outlines how FDA advisory committee members are not neutral/objective, have their own turfs to protect both in terms of ideology/approaches about treatment but also with regard to which companies they are on the boards of, what hedge funds their family members may be representatives of, etc.  It has been an eye-opener for me watching the Provenge saga unfold and I am very thankful that there are people fighting this FDA decision as it stinks of corruption and greed.  

Most of all, that the prostate cancer community has managed to raise such a stink about the delay of Provenge as a treatment for end-stage prostate cancer sufferers, have kept at this issue until it has reached the point of a congressional hearing in the U.S.,  is a tribute to the human spirit that says enough is enough - this is a travesty. 

“Dr Drug Rep” - url for NYT’s article

November 26, 2007

"Dr Drug Rep"

November 25, 2007

http://www.nytimes.com/2007/11/25/magazine/25memoir-t.html?em&ex=1196226000&en=14f86674a4b9bfd7&ei=5087%0A

This article is by a psychiatrist who became a spokesperson for Wyeth’s anti-depressant drug Effexor XR.  I found the comments about data-mining by pharmaceutical companies in tracking the medications that physicians prescribe so that reps. can hone their strategies to target specific physicians and psychiatrists with their sales-pitches enlightening.  People in poor health, especially those suffering from depression, are unlikely to challenge their doctors as they just want to feel better. 

“Corporate culture: rewarding the rich at the expense of the poor” (article url)

November 11, 2007

at http://www.thepost.ie/post/pages/p/story.aspx-qqqt=THE+INSIDER-qqqs=themarket-qqqs=computersinbusiness-qqqid=28095-qqqx=1.asp

Investors Against Genocide

October 27, 2007

I just came across these websites which list corporate investments in Darfur in an article entitled Buffett, Darfur, Mutual Funds and Myanmar by Mark Gunther (see http://www.huffingtonpost.com/marc-gunther/buffett-darfur-mutual-f_b_68461.html).

Here is the opening sentence: 

By now, you’ve probably read that Berkshire Hathaway, the investment firm led by Warren Buffett, has sold most if not all of its holdings in PetroChina. PetroChina is the publicly listed unit of the China National Petroleum Co., which has come under harsh criticism for doing business with the repressive government of Sudan.

Gunther goes on to say:

There’s no way to know what led Buffett to sell PetroChina. Berkshire bought the stock in 2003, investing about $488 million; at the end of last year, the stock was worth $3.3 billion. So he may simply have decided to take profits.

The websites noted in this article are:

http://investorsagainstgenocide.googlepages.com/

http://www.savedarfur.org/page/content/index/

New book I want to read

October 6, 2007

The Secret History of the War on Cancer by Devra Davis (Basic Books, $27.95).

“Fat Cats Protection League” - article by George Monbiot

September 5, 2007

 

Wherever you hear the words “free market”, you’ll find massive state handouts to corporations

By George Monbiot. Published in the Guardian 4th September 2007

After my column last week, several people wrote to point out that the neoliberal project - which demands a minimal state and maximum corporate freedom - actually relies on constant government support. They are of course quite right. The current financial crisis, caused by a failure to regulate financial services properly, is being postponed by government bail-outs. The US Federal Reserve has reduced its lending rate to the commercial banks, while the Bundesbank organised a E3.5bn rescue of the lending company IKB. This happens whenever the banks suffer the consequences of the freedom they demand. But over the past week an even starker example has emerged.

In Britain the split loyalties of the major political parties has created a hybrid system of public provision. If it left public services intact, the party in power would be roasted by the corporate media, but if it attempted full-scale privatisation, it would be booted out of office. So the last Conservative government devised a plan which would keep both sides if not exactly happy then at least totally bewildered. They called it the private finance initiative, or PFI. Corporations would build and run our schools, hospitals, roads and prisons and rent them to the state. This, the Tories maintained, would enable costs to be cut, while ensuring that public services remained free of charge.

continued at http://www.monbiot.com/archives/2007/09/04/the-fat-cats-protection-league/

“The Energy Emergency” (url)

September 3, 2007

The Energy Emergency By Mortimer B. Zuckerman Posted 9/2/07

http://www.usnews.com/usnews/opinion/articles/070902/10edit.htm

Oil is America’s Achilles heel. WE are addicted to it. Every American consumer burns about double what a European consumes–26 barrels a year for us, 12 for Europeans. We have 5 percent of the world’s population and consume 25 percent of the world’s oil, and we have only 3 percent of the world’s reserves. If you think there is a gas crunch now, marked by the largest oil price spike in a generation, it will be a bagatelle when China and India bring a couple of billion more people on to their highways: They are replicating our love affair with the automobile. Expect them within a generation to buy 80 million cars. We are in a new world order.

The balance of power has shifted between the fuel-guzzling West and the oil-rich producing countries. They have increasing leverage over us, with political, economic, and military consequences. We are literally over a barrel. Here’s how the chips fall. After World War II, the oil world was dominated by the "Seven Sisters," the name given to the oil companies controlling Middle East oil. These have shrunk to four: Chevron, British Petroleum, Exxon Mobil, and Royal Dutch Shell. They have been pushed aside by seven state-owned national companies, Seven Brothers, if you like: Saudi Arabia’s Aramco, Russia’s Gazprom, CNPC of China, NIOC of Iran, Venezuela’s PDVSA, Brazil’s Petrobras, and Petronas of Malaysia. The Seven Brothers control almost a third of the world’s oil and gas production and more than a third of its total oil and gas reserves. By contrast, the survivors of the Seven Sisters control only about 10 percent of output and hold just 3 percent of the reserves. The Brothers are the rule makers, the international oil companies the rule takers. It is not going to change.

In the next 40 years, 90 percent of new supplies, according to the International Energy Agency, will come from developing countries. Thirty years ago, 40 percent came from the industrialized nations. Massive consequences. Nor is oil discovery keeping pace with demand. In 1930, we found 10 billion new barrels of oil and used 1.5 billion; in 1964, we discovered 48 billion barrels and consumed approximately 12 billion; in 1988, we found 23 billion barrels and used 23 billion barrels; in 2005, we found 5 billion to 6 billion barrels and consumed 30 billion barrels.

With countries like China and India now in the mix, worldwide demand is growing by an average of 2 million to 3 million barrels a day every year. The world has to discover a new Saudi Arabia-size oil supplier every five years to meet this demand. But it’s just not going to happen. These overwhelming numbers could produce oil prices above $100 a barrel in short order, which will ultimately have massive consequences for the world’s economy and the way we live our lives. They might well cause a global recession.

How will we in the West cope when by 2030 the IEA nations will have to import 85 percent of their oil (it’s 63 percent today)? None of the oil companies are investing enough. Big Oil in the West is allocating as much as 60 percent of profits to dividends and stock buybacks and reinvesting only about a third in the oil business. And the Seven Brothers are keeping an ever tighter leash on both production and investment. They have the money, all right. Revenues have roughly doubled in the past four years. But their governments see high prices for us as meaning more income for them, while they see investment in new capacity as risking the kind of sharp price decline that occurred in the 1990s. So the national energy firms are obliged to dedicate a big chunk of their profits to support national treasuries and various political constituencies.

Mexico has treated its oil company as a national bank vault; Hugo Chávez of Venezuela spends two thirds (that’s now about $7 billion) of PDVSA’s budget on populist social programs; Gazprom spends the majority of its money on nonenergy activities such as banks and media companies. Even worse, because these national companies have become a source of political patronage, they are short of skilled workers and experienced managers. National pride inhibits them from relying on the technological skills of the western companies, so they don’t have the professionals needed to grow their production (with the exception of Saudi Aramco and, to some extent, Petrobras). We can no longer count on the Middle East to act as the world’s energy shock absorber, raising output to meet a shortage. So much for supply. Simultaneously, the oil-producing countries are consuming more of their own production.

While China’s energy appetite has grabbed the headlines, by the end of this decade alone, domestic consumption will reduce the oil exports of the producers by as much as 2.5 million barrels a day. And they are guzzlers. How could they not be when gasoline prices in places like Venezuela, Iran, and the rest of the Middle East are as little as a tenth of U.S. domestic prices, averaging between 20 and 80 cents a gallon? The net effect of all this is that the world is going to be even more energy dependent on the Organization of Petroleum Exporting Countries and Russia. Keeping oil safe for the West once meant safeguarding supply lines from the Middle East. Now we have to build alliances and deploy ships and troops to protect other supply routes outside the Middle East, going as far as the Caspian Sea, the Andean region of South America, and West Africa.

There are other political complications inhibiting new supplies. In many countries, environmental issues have become absolutist. They conflict with the capacity to tap additional energy resources in Alaska, not to speak of the continental shelf in the waters off the lower 48 states, which, according to a recent study by the National Petroleum Council, contains enough oil to provide gasoline for 116 million cars for 47 years. Some trade-off is going to have to be considered, and this will roil the political scene forever.

As for conservation, it is not enough for the West to improve its own energy policies. Countries such as India and China must also do so. We don’t know how fast these countries can and will reduce the energy intensity of their own rapid economic growth. How are we going to maintain our efforts to fight global warming by curtailing carbon dioxide when consumers in developing countries thirsting for oil will want to resort to abundant national sources of coal? They will argue that they are entitled to a phase of cheap (that is, coal) energy-intensive economic development.

Is it fair, they argue, to penalize them for coming late to the development party when rich countries, during their period of rapid growth, were allowed to use as much energy as they wished with no restrictions? Political purposes. Then there are the implications of state-owned companies in countries like Russia and Venezuela that are not just responding to market forces but are using their pricing and power for political purposes.

The income generated by oil exports has supported their authoritarian regimes, which means that political reform and liberalization may suffer as the oil wealth is used by leaders in producer states to buy off their opposition. The oil revenues have clearly helped Vladimir Putin in Russia, Chávez in Venezuela, and Mahmoud Ahmadinejad in Iran. Indeed, they deliberately seek control of the energy sectors to make sure that they themselves are the source of opportunity and wealth for their people.

So how is our policy of promoting democracy going to work when this oil wealth tends to empower authoritarian elites? The big winners will be countries like Russia and the Middle East oil producers, including Iran. The big losers will be the poorer countries. The wealthier countries can absorb higher prices because of the continuing declines in the energy intensity of their growth. But poorer countries will be disadvantaged even more.

Look at a poor country like Pakistan, which doesn’t have oil and may lose as much as 10 percent of its gross domestic product over the next 25 years to higher oil prices. Pakistan’s economy doesn’t work well even today, and its demographic curve shows a continuing rise in population.

In America, the energy crunch will intensify a lot of old political issues and bring in some new ones. We have witnessed the bipartisan failure to institute a vigorous program of conservation. We have not even been able to enact an adequate, graduated program of targets for automobile and truck gas mileage. Despite their public advocacy and political promises, the Democrats in Congress have failed to take steps to deal with these issues. In fact, we live in a political culture where neither the Republicans nor the Democrats wish to ask Americans to make sacrifices, including taxes to reduce our consumption of gasoline.

Just think: If our cars had the same energy efficiencies as Europe’s today, we could save 4 million barrels a day-the equivalent of Iran’s total production. This whole question of energy should be a central issue in the presidential campaign. But which of the candidates has the nerve and ingenuity to devise a way of meeting environmental concerns while seeking reliable domestic production of energy at home?

We certainly cannot assume that alternative energy sources will have a major impact on an acceptable cost basis. We can build as many wind farms as we like, or as many ethanol plants, but it is not going to be possible to make much of a dent at an acceptable cost, because of the enormous volume of our daily imports of oil. We are facing a world of higher prices and increasingly tighter supplies, creating a growing gap between worldwide demand and worldwide production, at a time when non-OPEC energy production is peaking within a few years.

Eventually, this will make us even more dependent on OPECwith all of what that means. We also can’t seem to develop an appropriate energy policy that by definition will take years to implement, so that delays are only postponing the higher costs to the next generation.

It is we who are placing our own country over a barrel now.

This story appears in the September 10, 2007 print edition of U.S. News & World Report.

ED - Aside from the US POV of the author, I find it fascinating that Canada, with all of its oil resources and oil sands development, is not mentioned.  Is Canada subsumed by the US in terms of its resources?  Fascinating.

I do like reading these types of articles (and sharing them) as the fear of the ‘oil emergency’ from a US perspective likely influences or will influence US foreign policy.

“Oaxaca on Edge” by By SCOTT LIEBERTZ (counterpunch.org url)

July 21, 2007

July 20, 2007

"We’re Not Going to Allow Ourselves to be Stepped Upon"

The Mexican state of Oaxaca is once again in the grips of heightening tension as the famous Guelaguetzla festival approaches and a large segment of the population is planning a boycott and some fear that disgruntled activists hope to sabotage it. Oaxaca was once again in the news on Monday after an attempt to celebrate a "Guelaguetza Popular" was violently put down by police. But the unrest here is about much more than just rescuing an indigenous festival from corporate cooptation. Thousands of Oaxacans are still fuming about their corrupt governor and the impunity of those who killed more than a dozen protestors last year.

continued at http://www.counterpunch.org/liebertz07202007.html

“Market Forces Cited in Lymphoma Drugs’ Disuse” - NYT July 14/07

July 15, 2007

at http://www.nytimes.com/2007/07/14/health/14lymphoma.html?_r=1&oref=slogin

By Alex Berenson
NEW YORK TIMES NEWS SERVICE

July 14, 2007

The patients’ stories sound nearly impossible.

After an hourlong infusion, Linda Stephens, 58, has been cancer-free for seven years. Dan Wheeler, three years. Betsy de Parry, five years. Before treatment, the trio had late-stage non-Hodgkin’s lymphoma, a cancer of the immune system, and a grim prognosis.

All three recovered after one dose of Bexxar or Zevalin, both federally approved drugs for lymphoma. And all three can count themselves as lucky.

Not just because their cancers responded so well. But because they got the treatment at all.

Non-Hodgkin’s lymphoma is the fifth-most common cancer in the United States, with 60,000 new cases and almost 20,000 deaths a year. But fewer than 2,000 patients received Bexxar or Zevalin last year – about 10 percent of candidates suitable for the drugs.

“Both Zevalin and Bexxar are very good products,” said Dr. Oliver W. Press, a professor at the University of Washington and chairman of the scientific advisory board of the Lymphoma Research Foundation. “It is astounding and disappointing” that they are used so little.

The reasons that more patients don’t get these drugs reflect the market-driven forces that can distort medical decisions, Press and other experts on lymphoma treatment say. The result can be high costs but not necessarily the best care.

Although the two drugs have not been clinically proven to prolong survival compared with other therapies, patients are more likely to respond to them than to standard treatments. Trials to test whether Bexxar and Zevalin do have a survival benefit are nearly complete.
Other, more thoroughly tested lymphoma drugs are preferred as first-line treatments. But doctors often repeatedly prescribe such drugs after they have lost their effectiveness – and when Bexxar and Zevalin might work better.

“Oncologists use everything in their cupboard before they refer,” Press said. “At least half the patients who get referred to me have had at least 10 courses of treatment.”

When Bexxar and Zevalin were approved, analysts expected they would be used widely. But the drugs have run into an obstacle that so far has been impassable. Because they are radioactive, they are almost always administered in hospitals, not doctors’ offices. As a result, cancer doctors are not paid by Medicare and private insurers for prescribing the drugs, as they are when they give patients a much more common treatment, chemotherapy.

In addition, most oncologists outside academic hospitals treat many different cancers and may be only vaguely familiar with the drugs, said Dr. Andrew D. Zelenetz, chief of the lymphoma service at the Memorial Sloan-Kettering Cancer Center. “There are a number of barriers,” Zelenetz said.

Press and Zelenetz acknowledge they have financial incentives to support the drugs. Press has been paid to speak at medical education seminars sponsored by the makers of the drugs, and Zelenetz is paid when the companies sponsor clinical trials at Memorial Sloan-Kettering.
Both said the money was a fraction of their overall income and had not colored their views.

Some patients say they would not have received Bexxar and Zevalin if they had not demanded them. Wheeler, of Kalamazoo, Mich., said he received Bexxar in April 2004 only after insisting on it when his lymphoma recurred.

“I told my local oncologist, ‘I want Bexxar; you give me a referral,’ ” Wheeler said. “I’ve been a real pain.”

Zevalin and Bexxar are the first in a new class of drugs called radioimmunotherapies. They deliver radioactive particles directly to cancerous cells to kill them. Idec, a San Diego company that is now part of Biogen Idec, invented Zevalin. Corixa, a Seattle company bought by GlaxoSmithKline, developed Bexxar. Both drugs are expensive, costing about $25,000 per treatment. But one dose is usually sufficient. The cost of the drugs is similar to a full four-month regimen of chemotherapy and Rituxan, another lymphoma treatment.

For decades, lymphoma has been treated with chemotherapy, drugs that attack cancer cells but that can have severe side effects. Alongside chemotherapy, most patients receive Rituxan. It was discovered by Idec, the same company that found Zevalin, and is marketed in the United States by Genentech, the world’s largest biotechnology company.

Since it was approved in 1997, Rituxan has become standard treatment for newly diagnosed lymphoma patients, based on clinical trials showing that it makes chemotherapy more effective.

Rituxan is the top-selling cancer drug worldwide, with sales in 2006 of $4 billion. A typical course of treatment costs $20,000.

Doctors agree that Rituxan is an excellent drug, with only minor side effects for most patients. Still, the few head-to-head clinical trials that have been conducted show Bexxar and Zevalin are as effective as Rituxan, if not better.

The Food and Drug Administration approved Zevalin in 2002 and Bexxar in 2003 for the treatment of slow-growing lymphoma that had failed previous treatments.

Wall Street analysts projected that Zevalin would reach $100 million in sales in 2003. But the drug hit roadblocks immediately. Its five-figure price caused insurers to balk, and its radioactivity made some oncologists worry it might prevent them from giving other treatments later.

Prescribing Zevalin also requires oncologists to coordinate care with the hospitals that administer it. To get either Zevalin or Bexxar, patients first receive a low-radiation diagnostic dose, then imaging scans, then a high-radiation therapeutic dose, which comes a week after the first dose. Over the next weeks, the patient’s red and white blood cell counts must be monitored.

The back-and-forth makes the treatment complicated to oversee, said Dr. Joseph M. Connors, a lymphoma specialist in Vancouver, British Columbia. “The doctors looking after people tend to turn to tools that they themselves know how to use and are familiar with,” Connors said.

For most oncologists, infusions of chemotherapy, Rituxan and other drugs remain their primary source of income. Even so, Connors said, doctors might turn to Bexxar and Zevalin if the drugs are proven to extend survival over older treatments. While preapproval trials showed the drugs shrank tumors more frequently than Rituxan and suggested patients would survive longer, the test groups were too small to confirm it.

Connors said Idec and Corixa should have designed their clinical trials to prove – not suggest – the drugs increased survival.

Two clinical trials meant to answer that question are under way, but their results have not been reported. Until they are, doctors will be reluctant to use Bexxar and Zevalin, Connors said.

Meanwhile, patients who have benefited from Bexxar and Zevalin say they cannot understand why they are not more widely used.

Betsy de Parry received Zevalin in 2002, when she was 52. She had already failed chemotherapy and Rituxan.

But she responded quickly to the injection and has remained cancer-free.

“It’s not that I believe that radioimmunotherapy is right for everybody,” she said. “I just think that patients, all patients, should know their options.”

“Two Models of Health Care Rationing” by By Dr. SUSAN ROSENTHAL, M.D. (counterpunch.org url)

July 3, 2007

 

June 27, 2007

Two Models of Health Care Rationing

Sick and Sicker

Everyone knows that Canadians live longer and have lower infant mortality rates than Americans. In Sicko, Michael Moore suggests that a Canadian-style medical system would solve this problem. Surprisingly, the evidence indicates that it would not.

A cross-border team of 17 researchers (including high-profile supporters of the Canadian system) examined a variety of medical problems, including cancer, coronary artery disease, chronic illness and surgical procedures. With the single exception of end-stage kidney disease, where Canadian patients fared better, they found no consistent difference in patient outcomes between the two nations.1 As I have argued elsewhere, the United States has the worst health statistics in the industrialized world because it is the most unequal society in the industrialized world.2

Although Canada’s medical system does not produce generally better patient outcomes, it is more equitable and far more economical. In 2003, the average American spent almost twice as much for medical care as the average Canadian. Exorbitant medical bills are a constant worry and a major cause of personal bankruptcy. Profit-taking is responsible for the high cost of American medicine. However, the Canadian system is also subject to market forces.

continued at http://www.counterpunch.org/rosenthal06272007.html

Dr. Susan Rosenthal has been practicing medicine for more than 30 years and has written many articles on the relationship between health and human relationships. She is also the author of Striking Flint: Genora (Johnson) Dollinger Remembers the 1936-1937 General Motors Sit-Down Strike (1996) and Market Madness and Mental Illness: The Crisis in Mental Health Care (1999) and Power and Powerlessness. She is a member of the National Writers Union, UAW Local 1981. She can be reached through her website: www.powerandpowerlessness.typepad.com